,,ii ,calendar ,no4 #acc #aafth ,,congress #ast ,session ,s4 #ahie ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #ai1 #bjai,mr4 ,alexander 7for himself and ,mrs4 ,murray7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,july #h1 #bjai,reported by ,mr4 ,alexander1 with an amendment,strike out all after the enacting clause and insert the part printed in italic ,a ,,bill ,to lower health care costs4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,lower ,health ,care ,costs ,act4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,title ,i--,ending ,surprise ,medical ,bills,sec4 #aja4 ,protecting patients against out-of-network deductibles in emergencies4,sec4 #ajb4 ,protection against surprise bills4,sec4 #ajc4 ,benchmark for payment4,sec4 #ajd4 ,effective date4,sec4 #aje4 ,ending surprise air ambulance bills4,sec4 #ajf4 ,report4,title ,,ii--,reducing the ,prices of ,prescription ,drugs,sec4 #bja4 ,biological product patent transparency4,sec4 #bjb4 ,orange book modernization4,sec4 #bjc4 ,ensuring timely access to generics4,sec4 #bjd4 ,protecting access to biological products4,sec4 #bje4 ,preventing blocking of generic drugs4,sec4 #bjf4 ,education on biological products4,sec4 #bjg4 ,biological product innovation4,sec4 #bjh4 ,clarifying the meaning of new chemical entity4,sec4 #bji4 ,streamlining the transition of biological products4,sec4 #baj4 ,orphan drug clarification4,sec4 #baa4 ,prompt approval of drugs related to safety information4,sec4 #bab4 ,conditions of use for biosimilar biological products4,sec4 #bac4 ,modernizing the labeling of certain generic drugs4,title ,,iii--,improving ,transparency in ,health ,care,sec4 #cja4 ,increasing transparency by removing gag clauses on price and quality information4,sec4 #cjb4 ,banning anticompetitive terms in facility and insurance contracts that limit access to higher quality1 lower cost care4,sec4 #cjc4 ,designation of a nongovernmental1 nonprofit transparency organization to lower ,americans' health care costs4,sec4 #cjd4 ,protecting patients and improving the accuracy of provider directory information4,sec4 #cje4 ,timely bills for patients4,sec4 #cjf4 ,health plan oversight of pharmacy benefit manager services4,sec4 #cjg4 ,government ,accountability ,office study on profit- and revenue-sharing in health care4,sec4 #cjh4 ,disclosure of direct and indirect compensation for brokers and consultants to employer-sponsored health plans and enrollees in plans on the individual market4,sec4 #cji4 ,ensuring enrollee access to cost-sharing information4,sec4 #caj4 ,strengthening parity in mental health and substance use disorder benefits4,sec4 #caa4 ,technical amendments4,sec4 #cab4 ,third-party administrators4,title ,,iv--,improving ,public ,health,sec4 #dja4 ,improving awareness of disease prevention4,sec4 #djb4 ,grants to address vaccine-preventable diseases4,sec4 #djc4 ,guide on evidence-based strategies for public health department obesity prevention programs4,sec4 #djd4 ,expanding capacity for health outcomes4,sec4 #dje4 ,public health data system modernization4,sec4 #djf4 ,innovation for maternal health4,sec4 #djg4 ,training for health care providers4,sec4 #djh4 ,study on training to reduce and prevent discrimination4,sec4 #dji4 ,perinatal quality collaboratives4,sec4 #daj4 ,integrated services for pregnant and postpartum women4,sec4 #daa4 ,extension for community health centers1 the ,national ,health ,service ,corps1 and teaching health centers that operate ,,gme programs4,sec4 #dab4 ,other programs4,,title ,v--,improving the ,exchange of ,health ,information,sec4 #eja4 ,requirement to provide health claims1 network1 and cost information4,sec4 #ejb4 ,recognition of security practices4,sec4 #ejc4 ,,gao study on the privacy and security risks of electronic transmission of individually identifiable health information to and from entities not covered by the ,health ,insurance ,portability and ,accountability ,act4,sec4 #ejd4 ,technical corrections4 ,i ,ending ,surprise ,medical ,bills #aja4 ,protecting patients against out-of-network deductibles in emergencies ,section #bgai;,a7b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ai;a7 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in the matter preceding subparagraph 7,a71 by inserting or a freestanding emergency room after hospital2 and 7,b7 in subparagraph 7,c7-- 7i7 in clause 7ii77,i71 by inserting or emergency room after emergency department2 and 7ii7 in subparagraph 7,c77ii77,,ii71 by adding1 a deductible1 after 7expressed as2 and 7#b7 in paragraph 7#b77;,b7-- 7,a7 in clause 7i7-- 7i7 by inserting or freestanding emergency room after hospital2 and 7ii7 by inserting or emergency room after emergency department2 and 7,b7 in clause 7ii71 by inserting or emergency room after hospital4 #ajb4 ,protection against surprise bills 7a7 ,,phsa ,section #bgai;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ai;a7 is amended by adding at the end the following3 7e7 ,coverage of certain out-of-,network services 7#a7 ,in general ,subject to subsection 7h71 in the case of an enrollee in a group health plan or group or individual health insurance coverage who receives out-of-network1 ancillary1 non-emergency services at an in-network facility1 including any referrals for diagnostic services-- 7,a7 the cost-sharing requirement 7expressed as a copayment amount1 coinsurance rate1 or deductible7 with respect to such services shall be the same requirement that would apply if such services were provided by an in-network practitioner1 and any coinsurance or deductible shall be based on in-network rates2 and 7,b7 such cost-sharing amounts shall be counted towards the in-network deductible and in-network out-of-pocket maximum amount under the plan or coverage for the plan year4 7#b7 ,definition ,for purposes of this subsection1 the term facility has the meaning given the term health care facility in section #bgbi;,a7c74 7f7 ,coverage of out-of-,network services for enrollees admitted after emergency services 7#a7 ,notice and consent ,subject to subsection 7h71 in the case of an enrollee in a group health plan or group or individual health insurance coverage who receives emergency services1 or maternal care for a woman in labor1 in the emergency department of an out-of-network facility and has been stabilized 7within the meaning of subsection 7b77#b77;,c771 if the patient is subsequently admitted to the out-of-network facility for care1 the cost-sharing requirement 7expressed as a copayment amount1 coinsurance rate1 or deductible7 with respect to any out-of-network services is the same requirement that would apply if such services were provided by a participating provider1 unless the enrollee1 once stable and in a condition to receive such information1 including having sufficient mental capacity-- 7,a7 has been provided by the facility1 prior to the provision of any post-stabilization1 out-of-network service at such facility1 with-- 7i7 paper and electronic notification that the practitioner or facility is an out-of-network health care provider and the out-of-network rate of the provider1 as applicable1 and the option to affirmatively consent to receiving services from such practitioner or facility2 and 7ii7 the estimated amount that such provider may charge the participant1 beneficiary1 or enrollee for such items and services involved2 7,b7 has been provided by the plan or coverage1 prior to the provision of any post-stabilization1 out-of-network service at such facility1 with-- 7i7 paper and electronic notification that the practitioner or facility is an out-of-network health care provider and the out-of-network rate of the provider1 as applicable1 and the option to affirmatively consent to receiving services from such practitioner or facility2 7ii7 a list of in-network practitioners or facilities that could provide the same services1 and an option for a referral to such providers2 and 7iii7 information about whether prior authorization or other care management limitations may be required in advance of receiving in-network care at the facility2 and 7,c7 has acknowledged that the out-of-network treatment may not be covered or may be covered at an out-of-network cost-sharing amount1 requiring higher cost-sharing obligations of the enrollee than if the service were provided at an in-network facility1 and has assumed1 in writing1 full responsibility of out-of-pocket costs associated with services furnished after the enrollee has been stabilized1 from the out-of-network practitioner or facility1 as applicable4 7#b7 ,requirements of notice ,the notice under paragraph 7#a7 shall be in a format determined by the ,secretary to give a reasonable layperson clear comprehension of the terms of the agreement1 including all possible financial responsibilities1 including the requirements that the notice-- 7,a7 does not exceed one page in length2 7,b7 is readily identifiable for its purpose and as a contract of consent2 7,c7 clearly states that consent is optional2 7,d7 includes an estimate of the amount that such provider will charge the participant1 beneficiary1 or enrollee for such items and services involved2 and 7,e7 be available in the #ae most common languages in the facility's geographic area1 with the facility making a good faith effort to provide oral notice in the enrollee's primary language if it is not one of such #ae languages4 7g7 ,prohibition on billing more than an in-,network rate under certain circumstances 7#a7 ,in general ,a facility or practitioner furnishing-- 7,a7 emergency services1 as defined in subsection 7b77#b71 regardless of the ,state in which the patient resides2 7,b7 services at an in-network facility described in subsection 7e72 or 7,c7 out-of-network services furnished after the enrollee has been stabilized 7within the meaning of subsection 7b77#b77;,c771 where the notice and option for referral required under subsection 7f77#a7 have not been provided to the enrollee and the assumption of responsibility for out-of-pocket costs under subsection 7f77#b7 has not been obtained1 may not bill an enrollee in a group health plan or group or individual health insurance coverage for amounts beyond the cost-sharing amount that would apply under subsection 7b77#a77;,c77ii77,,ii71 7e71 or 7f71 as applicable4 7#b7 ,notice ,a facility furnishing services described in paragraph 7#a7 shall provide enrollees in a group health plan or group or individual health insurance coverage with a one-page notice1 in #af-point font1 upon intake at the emergency room or being admitted at the facility of the prohibition on balance billing under paragraph 7#a7 and who to contact for recourse if they are sent a balance bill in violation of such paragraph4 ,the facility shall be responsible for obtaining the signature from the enrollee on such notice4 ,the ,secretary shall issue regulations within #f months of the date of enactment of the ,lower ,health ,care ,costs ,act on the requirements for the notice under this paragraph4 7#c7 ,enforcement 7,a7 ,in general ,subject to subparagraph 7,b71 a facility or practitioner that violates a requirement under paragraph 7#a7 shall be subject to a civil monetary penalty of not more than #aj1jjj for each act constituting such violation4 7,b7 ,procedure ,the provisions of section #aabh;,a of the ,social ,security ,act1 other than subsections 7a7 and 7b7 and the first sentence of subsection 7c77#a7 of such section1 shall apply to civil money penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a of the ,social ,security ,act4 7,c7 ,safe harbor ,the ,secretary shall waive the penalties described under subparagraph 7,a7 with respect to a facility or1 practitioner who unknowingly violates paragraph 7#a7 with respect to an enrollee1 if such facility or practitioner1 within #cj days of the violation1 withdraws the bill that was in violation of paragraph 7#a71 and1 as applicable1 reimburses the group health plan1 health insurance issuer1 or enrollee1 as applicable1 in an amount equal to the amount billed in violation of paragraph 7#a71 plus interest1 at an interest rate determined by the ,secretary4 7h7 ,maintaining ,state surprise billing protections 7#a7 ,in general ,notwithstanding section #ead of the ,employee ,retirement ,income ,security ,act of #aigd1 except with respect to self-insured group health plans1 nothing in this section shall prevent a ,state from establishing or continuing in effect an alternate method under ,state law for determining the appropriate compensation for services described in subsection 7b71 7e71 or 7f74 7#b7 ,additional application ,in the case of group health plans or health insurance coverage in the individual or group market offered in a ,state that has not enacted an alternate method described in paragraph 7#a71 such as arbitration or a benchmark1 or for services described in subsection 7b71 7e71 or 7f7 that are not covered by such ,state's alternate method described in paragraph 7#a71 the provisions of this section shall apply4 7#c7 ,self-insured plans ,subsections 7b71 7e71 and 7f7 shall apply to a self-insured group health plan that is not subject to ,state insurance regulation4 4 7b7 ,coverage under ,federal ,employees ,health ,benefits ,program ,section #hijd of title #e1 ,united ,states ,code1 is amended by adding at the end the following3 7c7 ,any health benefits plan offered under this chapter shall be treated as a group health plan or group or individual health insurance coverage for purposes of subsections 7e7 through 7g7 of section #bgai;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ai;a7 7except for paragraph 7#c7 of such subsection 7g774 4 #ajc4 ,benchmark for payment 7a7 ,in general ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq47 is amended by adding at the end the following3 #bgbi;,a4 ,benchmark for payment 7a7 ,establishment of benchmark ,a group health plan or health insurance issuer offering group or individual health insurance coverage shall pay facilities or practitioners furnishing services for which such facilities and practitioners are prohibited from billing enrollees under section #bgai;,a7g71 the median in-network rate1 using a methodology determined under subsection 7b7 for the same or similar services offered by the group health plan or health insurance issuer in that geographic region4 7b7 ,median in-,network rate 7#a7 ,in general ,for purposes of this section1 the term median in-network rate means1 with respect to health care services covered by a group health plan or group or individual health insurance coverage1 the median negotiated rate under the applicable plan or coverage recognized under the plan or coverage as the total maximum payment for the service minus the in-network cost-sharing for such service under the plan or coverage1 for the same or a similar service that is provided by a provider in the same or similar specialty and in the geographic region in which the service is furnished4 7#b7 ,rulemaking ,not later than #a year after the date of enactment of the ,lower ,health ,care ,costs ,act1 the ,secretary shall1 through rulemaking1 determine the methodology a group health plan or health insurance issuer is required to use to determine the median in-network rate described in paragraph 7#a71 differentiating by business line1 the information the plan or issuer shall share with the nonparticipating provider involved when making such a determination1 and the geographic regions applied for purposes of this subparagraph4 ,such rulemaking shall take into account payments that are made by health insurance issuers that are not on a fee-for-service basis4 7#c7 ,certain insurers ,if a group health plan or health insurance issuer offering group or individual health insurance coverage does not have sufficient information to calculate a median in-network rate for this service or provider type1 or amount of1 claims for services 7as determined by the applicable ,state authority1 in the case of health insurance coverage1 or by the ,secretary of ,labor1 in the case of a self-insured group health plan7 covered under the list of out-of-network services set by the ,state authority or ,secretary of ,labor1 as applicable1 in a particular geographic area1 such plan or issuer shall demonstrate that it will use a database free of conflicts of interest that has sufficient information reflecting allowed amounts paid to individual health care providers for relevant services provided in the applicable geographic region1 and that such plan or issuer will use that database to determine a median in-network rate4 ,the group health plan or health insurance issuer shall cover the cost of accessing the database4 7#d7 ,rule of construction ,nothing in this subsection shall prevent a group health plan or health insurance issuer from establishing separate calculations of a median in-network rate under paragraph 7#a7 for services delivered in nonhospital facilities1 including freestanding emergency rooms4 7c7 ,facility ,for purposes of this section1 the term health care facility includes hospitals1 hospital outpatient departments1 critical access hospitals1 ambulatory surgery centers1 laboratories1 radiology clinics1 and any other facility that provides services that are covered under a group health plan or health insurance coverage1 including settings of care subject to section #bgai;,a7b74 4 7b7 ,non-,federal governmental plans ,section #bgbb7;a77#b77;,e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ba7;a77#b77;,e77 is amended by inserting 1 except that such election shall be available with respect to section #bgbi;,a before the period4 #ajd4 ,effective date ,the amendments made by sections #aja1 #ajb1 and #ajc shall take effect beginning in the second plan year that begins after the date of enactment of this ,act4 #aje4 ,ending surprise air ambulance bills 7a7 ,in general ,part ,a of title ,,xxvii of the ,public ,health ,service ,act is amended by inserting after section #bgai;,a 7#db ,u4,s4,c4 #cjj;gg-#ai;a7 the following3 #bgai;,b4 ,ending surprise air ambulance bills 7a7 ,in general ,in the case of an enrollee in a group health plan or group or individual health insurance coverage who receives air ambulance services from an out-of-network provider-- 7#a7 the cost-sharing requirement 7expressed as a copayment amount1 coinsurance rate1 or deductible7 with respect to such services shall be the same requirement that would apply if such services were provided by an in-network practitioner1 and any coinsurance or deductible shall be based on in-network rates2 and 7#b7 such cost-sharing amounts shall be counted towards the in-network deductible and in-network out-of-pocket maximum amount under the plan or coverage for the plan year4 7b7 ,payment rate ,a group health plan or health insurance issuer shall pay for air ambulance services for purposes of subsection 7a7 at the median in-network as defined in subsection 7c74 7c7 ,median in-,network rate 7#a7 ,in general ,for purposes of this section1 the term median in-network rate means1 with respect to air ambulance services covered by a group health plan or group or individual health insurance coverage1 the median negotiated rate under the applicable plan or coverage recognized under the plan or coverage as the total maximum payment for the service1 minus the in-network cost-sharing for such service under the plan or coverage1 for the same or a similar service that is provided by a provider in the same or similar specialty1 and in the geographic region in which the service is furnished4 7#b7 ,rulemaking ,not later than #f months after the date of enactment of the ,lower ,health ,care ,costs ,act1 the ,secretary shall1 through rulemaking1 determine the methodology a group health plan or health insurance issuer is required to use to determine the median in-network rate described in paragraph 7#a71 the information the plan or issuer shall share with the non-participating provider involved when making such a determination1 and the geographic regions applied for purposes of this subsection4 ,such rulemaking shall take into account payments that are made by issuers that are not on a fee-for-service basis4 7#c7 ,certain insurers ,if a group health plan or health insurance issuer offering group or individual health insurance coverage does not have sufficient information to calculate a median in-network rate for this service or provider type1 or amount of1 claims for services 7as determined by the applicable ,state authority1 in the case of health insurance coverage1 or by the ,secretary of ,labor1 in the case of a self-insured group health plan7 covered under the list of out-of-network services set by the ,state authority or ,secretary of ,labor1 as applicable1 in a particular geographic area1 such plan or issuer shall demonstrate that it will use a database free of conflicts of interest that has sufficient information reflecting allowed amounts paid to individual health care providers for relevant services provided in the applicable geographic region1 and that such plan or issuer will use that database to determine a median in-network rate4 ,the group health plan or health insurance issuer shall cover the cost of accessing the database4 7#d7 ,clarification ,for purposes of this subsection1 the ,secretary may define geographic regions that are different from the geographic regions identified for purposes of section #bgbi;,a7b7 to ensure that an adequate number of air ambulance services are in-network in each geographic region so that a median in-network rate for air ambulance services may be calculated for each such region4 7d7 ,cost-,sharing limitation ,an air ambulance service provider may not bill an enrollee in a group health plan or group or individual health insurance coverage for amounts beyond the cost-sharing amount that applies under subsection 7a74 7e7 ,enforcement 7#a7 ,in general ,subject to paragraph 7#b71 an air ambulance service provider that violates subsection 7d7 shall be subject to a civil monetary penalty of not more than #aj1jjj for each act constituting such violation4 7#b7 ,procedure ,the provisions of section #aabh;,a of the ,social ,security ,act1 other than subsections 7a7 and 7b7 and the first sentence of subsection 7c77#a7 of such section1 shall apply to civil money penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a of the ,social ,security ,act4 7#c7 ,safe harbor ,the ,secretary shall waive the penalties described under paragraph 7#a7 with respect to an air ambulance service provider who unknowingly violates subsection 7d7 with respect to an enrollee1 if such air ambulance service provider within #cj days of the violation1 withdraws the bill that was in violation of subsection 7d71 and1 as applicable1 reimburses the group health plan1 health insurance issuer1 or enrollee1 as applicable1 in an amount equal to the amount billed in violation of subsection 7d71 plus interest1 at an interest rate determined by the ,secretary4 4 7b7 ,effective date ,section #bgai;,b of the ,public ,health ,service ,act1 as added by subsection 7a71 shall take effect on the date that is #a year after the date of enactment of this ,act4 #ajf4 ,report ,not later than #a year after the effective date described in section #ajd1 and annually for the following #d years1 the ,secretary of ,health and ,human ,services1 in consultation with the ,federal ,trade ,commission and the ,attorney ,general1 shall-- 7#a7 conduct a study on-- 7,a7 the effects of the amendments made by sections #aja1 #ajb1 and #ajc1 including any patterns of vertical or horizontal integration of health care facilities1 providers1 group health plans1 or health insurance issuers2 7,b7 the effects of the amendments made by sections #aja1 #ajb1 and #ajc on overall health care costs2 and 7,c7 recommendations for effective enforcement of #bgbi;,a as added by section #ajc1 including potential challenges to addressing anti-competitive consolidation by health care facilities1 providers1 group health plans1 or health insurance issuers2 and 7#b7 submit a report on such study to the ,committee on ,health1 ,education1 ,labor1 and ,pensions1 the ,committee on ,commerce1 ,science1 and ,transportation1 the ,committee on ,finance1 and the ,committee on the ,judiciary of the ,senate and the ,committee on ,education and ,labor1 the ,committee on ,energy and ,commerce1 the ,committee on ,ways and ,means1 and the ,committee on the ,judiciary of the ,house of ,representatives4 ,,ii ,reducing the ,prices of ,prescription ,drugs #bja4 ,biological product patent transparency 7a7 ,in general ,section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 is amended by adding at the end the following3 7o7 ,additional requirements with respect to patents 7#a7 ,approved application holder listing requirements 7,a7 ,in general ,beginning on the date of enactment of the ,lower ,health ,care ,costs ,act1 within #fj days of approval of an application under subsection 7a7 or 7k71 the holder of such approved application shall submit to the ,secretary a list of each patent required to be disclosed 7as described in paragraph 7#c774 7,b7 ,previously approved or licensed biological products 7i7 ,products licensed under section #cea of the ,,phsa ,not later than #cj days after the date of enactment of the ,lower ,health ,care ,costs ,act1 the holder of a biological product license that was approved under subsection 7a7 or 7k7 before the date of enactment of such ,act shall submit to the ,secretary a list of each patent required to be disclosed 7as described in paragraph 7#c774 7ii7 ,products approved under section #eje of the ,,ffdca ,not later than #cj days after ,march #bc1 #bjbj1 the holder of an approved application for a biological product under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act that is deemed to be a license for the biological product under this section on ,march #bc1 #bjbj1 shall submit to the ,secretary a list of each patent required to be disclosed 7as described in paragraph 7#c774 7,c7 ,updates ,the holder of a biological product license that is the subject of an application under subsection 7a7 or 7k7 shall submit to the ,secretary a list that includes-- 7i7 any patent not previously required to be disclosed 7as described in paragraph 7#c77 under subparagraph 7,a7 or 7,b71 as applicable1 within #cj days of the earlier of-- 7,i7 the date of issuance of such patent by the ,united ,states ,patent and ,trademark ,office2 or 7,,ii7 the date of approval of a supplemental application for the biological product2 and 7ii7 any patent1 or any claim with respect to a patent1 included on the list pursuant to this paragraph1 that the ,patent ,trial and ,appeal ,board of the ,united ,states ,patent and ,trademark ,office determines in a decision to be invalid or unenforceable1 within #cj days of such decision4 7#b7 ,publication of information 7,a7 ,in general ,within #a year of the date of enactment of the ,lower ,health ,care ,costs ,act1 the ,secretary shall publish and make available to the public a single1 easily searchable1 list that includes-- 7i7 the official and proprietary name of each biological product licensed under subsection 7a7 or 7k71 and of each biological product application approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act and deemed to be a license for the biological product under this section on ,march #bc1 #bjbj2 7ii7 with respect to each biological product described in clause 7i71 each patent submitted in accordance with paragraph 7#a72 7iii7 the date of approval and application number for each such biological product2 7iv7 the marketing status1 dosage form1 route of administration1 strength1 and1 if applicable1 reference product1 for each such biological product2 7v7 the licensure status for each such biological product1 including whether the license at the time of listing is approved1 withdrawn1 or revoked2 7vi7 with respect to each such biological product1 any period of any exclusivity under paragraph 7#f71 7#g77;,a71 or 7#g77;,b7 of subsection 7k7 of this section or section #ebg of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 and any extension of such period in accordance with subsection 7m7 of this section1 for which the ,secretary has determined such biological product to be eligible1 and the date on which such exclusivity expires2 7vii7 information regarding any determination of biosimilarity or interchangeability for each such biological product2 and 7viii7 information regarding approved indications for each such biological product1 in such manner as the ,secretary determines appropriate4 7,b7 ,updates ,every #cj days after the publication of the first list under subparagraph 7,a71 the ,secretary shall revise the list to include-- 7i7 7,i7 each biological product licensed under subsection 7a7 or 7k7 during the #cj-;day period2 and 7,,ii7 with respect to each biological product described in subclause 7,i71 the information described in clauses 7i7 through 7viii7 of subparagraph 7,a72 and 7ii7 any updates to information previously published in accordance with subparagraph 7,a74 7,c7 ,noncompliance ,beginning #ah months after the date of enactment of the ,lower ,health ,care ,costs ,act1 the ,secretary1 in consultation with the ,director of the ,united ,states ,patent and ,trademark ,office1 shall publish and make available to the public a list of any holders of biological product licenses1 and the corresponding biological product or products1 that failed to submit information as required under paragraph 7#a71 including any updates required under paragraph 7#a77;,c71 in such manner and format as the ,secretary determines appropriate4 ,if information required under paragraph 7#a7 is submitted following publication of such list1 the ,secretary shall remove such holders of such biological product licenses from the public list in a reasonable period of time4 7#c7 ,patents required to be disclosed ,in this section1 a patent required to be disclosed is any patent for which the holder of a biological product license approved under subsection 7a7 or 7k71 or a biological product application approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act and deemed to be a license for a biological product under this section on ,march #bc1 #bjbj1 believes a claim of patent infringement could reasonably be asserted by the holder1 or by a patent owner that has granted an exclusive license to the holder with respect to the biological product that is the subject of such license1 if a person not licensed by the holder engaged in the making1 using1 offering to sell1 selling1 or importing into the ,united ,states of the biological product that is the subject of such license4 4 7b7 ,disclosure of patents ,section #cea7l77#c77;,a77i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7l77#c77;,a77i77 is amended by inserting included in the list provided by the reference product sponsor under subsection 7o77#a7 after a list of patents4 7c7 ,review and ,report on ,noncompliance ,not later than #cj months after the date of enactment of this ,act1 the ,secretary shall-- 7#a7 solicit public comments regarding appropriate remedies1 in addition to the publication of the list under subsection 7o77#b77;,c7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 as added by subsection 7a71 with respect to holders of biological product licenses who fail to timely submit information as required under subsection 7o77#a7 of such section #cea1 including any updates required under subparagraph 7,c7 of such subsection 7o77#a72 and 7#b7 submit to ,congress an evaluation of comments received under paragraph 7#a7 and the recommendations of the ,secretary concerning appropriate remedies4 7d7 ,regulations ,the ,secretary of ,health and ,human ,services may promulgate regulations to carry out subsection 7o7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 as added by subsection 7a74 7e7 ,rule of construction ,nothing in this ,act1 including an amendment made by this ,act1 shall be construed to require or allow the ,secretary of ,health and ,human ,services to delay the licensing of a biological product under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 #bjb4 ,orange book modernization 7a7 ,submission of patent information for brand name drugs 7#a7 ,in general ,paragraph 7#a7 of section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 is amended to read as follows3 7b7 7#a7 7,a7 ,any person may file with the ,secretary an application with respect to any drug subject to the provisions of subsection 7a74 ,such persons shall submit to the ,secretary as part of the application-- 7i7 full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use2 7ii7 a full list of the articles used as components of such drug2 7iii7 a full statement of the composition of such drug2 7iv7 a full description of the methods used in1 and the facilities and controls used for1 the manufacture1 processing1 and packing of such drug2 7v7 such samples of such drug and of the articles used as components thereof as the ,secretary may require2 7vi7 specimens of the labeling proposed to be used for such drug2 7vii7 any assessments required under section #eje;,b2 and 7viii7 the patent number and expiration date1 of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture1 use1 or sale of the drug1 and that-- 7,i7 claims the drug for which the applicant submitted the application and is a drug substance patent or a drug product patent2 or 7,,ii7 claims the method of using the drug for which approval is sought or has been granted in the application4 7,b7 ,if an application is filed under this subsection for a drug1 and a patent of the type described in subparagraph 7,a77viii7 that claims such drug or a method of using such drug is issued after the filing date but before approval of the application1 the applicant shall amend the application to include such patent information4 7,c7 ,upon approval of the application1 the ,secretary shall publish the information submitted under subparagraph 7,a77viii74 4 7#b7 ,guidance ,the ,secretary of ,health and ,human ,services shall1 in consultation with the ,director of the ,national ,institutes of ,health and with representatives of the drug manufacturing industry1 review and develop guidance1 as appropriate1 on the inclusion of women and minorities in clinical trials required under subsection 7b77#a77;,a77i7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 as amended by paragraph 7#a74 7b7 ,conforming changes to requirements for subsequent submission of patent information ,section #eje7;c77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 is amended-- 7#a7 by inserting before the first sentence the following3 ,not later than #cj days after the date of approval of an application under subsection 7b71 the holder of the approved application shall file with the ,secretary the patent number and the expiration date of any patent described in subclause 7,i7 or 7,,ii7 of subsection 7b77#a77;,a77viii71 except that a patent that claims a method of using such drug shall be filed only if approval for such use has been granted in the application4 ,the holder of the approved application shall file with the ,secretary the patent number and the expiration date of any patent described in subclause 7,i7 or 7,,ii7 of subsection 7b77#a77;,a77viii7 that is issued after the date of approval of the application1 not later than #cj days of the date of issuance of the patent1 except that a patent that claims a method of using such drug shall be filed only if approval for such use has been granted in the application42 7#b7 by inserting after the patent number and the expiration date of any patent which the following3 fulfills the criteria in subsection 7b7 and2 7#c7 by inserting after the third sentence 7as amended by paragraph 7#a77 the following3 ,patent information that is not the type of patent information required by subsection 7b77#a77;,a77viii7 shall not be submitted under this paragraph42 and 7#d7 by inserting after could not file patent information under subsection 7b7 because no patent the following3 of the type required to be submitted in subsection 7b74 7c7 ,listing of exclusivities ,subparagraph 7,a7 of section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 is amended by adding at the end the following3 7iv7 ,for each drug included on the list1 the ,secretary shall specify any exclusivity period that is applicable1 for which the ,secretary has determined the expiration date1 and for which such period has not yet expired under-- 7,i7 clause 7ii71 7iii71 or 7iv7 of subsection 7c77#c77;,e7 of this section2 7,,ii7 clause 7iv7 or 7v7 of paragraph 7#e77;,b7 of this subsection2 7,,iii7 clause 7ii71 7iii71 or 7iv7 of paragraph 7#e77;,f7 of this subsection2 7,,iv7 section #eje;,a2 7,v7 section #eje;,e2 7,,vi7 section #ebg7;a72 or 7,,vii7 section #eje7u7 4 7d7 ,orange book updates with respect to invalidated patents 7#a7 ,in general 7,a7 ,amendments ,section #eje7;j77#g77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77;,a771 as amended by subsection 7c71 is further amended by adding at the end the following3 7v7 ,in the case of a listed drug for which the list under clause 7i7 includes a patent or patent claim for the drug1 or a patent or a patent claim for the use of such drug1 and where the ,under ,secretary of ,commerce for ,intellectual ,property and ,director of the ,united ,states ,patent and ,trademark ,office has canceled any claim of the patent relating to such drug or such use pursuant to a decision by the ,patent ,trial and ,appeal ,board in an inter partes review conducted under chapter #ca of title #ce1 ,united ,states ,code1 or a post-grant review conducted under chapter #cb of that title1 and from which no appeal has been taken1 or can be taken1 the holder of the applicable approved application shall notify the ,secretary1 in writing1 within #ad days of such cancellation1 and1 if the patent has been deemed wholly inoperative or invalid1 or if a patent claim has been canceled1 the revisions required under clause 7iii7 shall include striking the patent or information regarding such patent claim from the list with respect to such drug4 4 7,b7 ,application ,the amendment made by subparagraph 7,a7 shall not apply with respect to any determination with respect to a patent or patent claim that is made prior to the date of enactment of this ,act4 7#b7 ,no effect on first applicant exclusivity period ,section #eje7;j77#e77;,b77iv77,i7 is amended by adding at the end the following3 ,this subclause shall apply even if a patent is stricken from the list under paragraph 7#g77;,a71 pursuant to paragraph 7#g77;,a77v71 provided that1 at the time that the first applicant submitted an application under this subsection containing a certification described in paragraph 7#b77;,a77vii77,,iv71 the patent that was the subject of such certification was included in such list with respect to the listed drug44 #bjc4 ,ensuring timely access to generics ,section #eje7q7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7q77#a77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a77i71 by inserting 1 #aj4ca1 after #aj4cj2 7,b7 in subparagraph 7,e7-- 7i7 by striking application and and inserting application or2 7ii7 by striking ,if the ,secretary and inserting the following3 7i7 ,in general ,if the ,secretary 2 and 7iii7 by striking the second sentence and inserting the following3 7ii7 ,primary purpose of delaying 7,i7 ,in general ,for purposes of this subparagraph1 a petition or supplement to a petition may be considered to be submitted with the primary purpose of delaying an application under subsection 7b77#b7 or 7j7 of this section or section #cea7k7 of the ,public ,health ,service ,act1 if the petitioner has the purpose of setting aside1 delaying1 rescinding1 withdrawing1 or preventing submission1 review1 or the approval of such an application4 7,,ii7 ,factors ,in determining whether a petition was submitted with the primary purpose of delaying an application1 the ,secretary may consider the following factors3 7aa7 ,whether the petition was submitted in accordance with paragraph 7#b77;,b71 based on when the petitioner knew or reasonably should have known the relevant information relied upon to form the basis of such petition4 7bb7 ,whether the petitioner has submitted multiple or serial petitions raising issues that reasonably could have been known to the petitioner at the time of submission of the earlier petition or petitions4 7cc7 ,whether the petition was submitted close in time to a known1 first date upon which an application under subsection 7b77#b7 or 7j7 of this section or section #cea7k7 of the ,public ,health ,service ,act could be approved4 7dd7 ,whether the petition was submitted without any relevant data or information in support of the scientific positions forming the basis of such petition4 7ee7 ,whether the petition raises the same or substantially similar issues as a prior petition to which the ,secretary has responded substantively already1 including if the subsequent submission follows such response from the ,secretary closely in time4 7ff7 ,whether the petition requests changing the applicable standards that other applicants are required to meet1 including requesting testing1 data1 or labeling standards that are more onerous or rigorous than the standards applicable to the listed drug1 reference product1 or petitioner's version of the same drug4 7gg7 ,the petitioner's record of submitting petitions to the ,food and ,drug ,administration that have been determined by the ,secretary to have been submitted with the primary purpose of delay4 7hh7 ,other relevant and appropriate factors1 which the ,secretary shall describe in guidance4 7,,iii7 ,guidance ,the ,secretary may issue or update guidance1 as appropriate1 to describe factors the ,secretary considers in accordance with subclause 7,,ii74 2 7,c7 by adding at the end the following3 7iii7 ,referral to the ,federal ,trade ,commission ,the ,secretary shall establish procedures for referring to the ,federal ,trade ,commission any petition or supplement to a petition that the ,secretary determines was submitted with the primary purpose of delaying approval of an application4 ,such procedures shall include notification to the petitioner and an opportunity for judicial review after the issuance of an order by the ,federal ,trade ,commission4 2 7,d7 by striking subparagraph 7,f72 7,e7 by redesignating subparagraphs 7,g7 through 7,i7 as subparagraphs 7,f7 through 7,h71 respectively2 and 7,f7 in subparagraph 7,h71 as so redesignated1 by striking submission of this petition and inserting submission of this document2 7#b7 in paragraph 7#b7-- 7,a7 by redesignating subparagraphs 7,a7 through 7,c7 as subparagraphs 7,c7 through 7,e71 respectively2 7,b7 by inserting before subparagraph 7,c71 as so redesignated1 the following3 7,a7 ,in general ,a person shall submit a petition to the ,secretary under paragraph 7#a7 before filing a civil action in which the person seeks to set aside1 delay1 rescind1 withdraw1 or prevent submission1 review1 or approval of an application submitted under subsection 7b77#b7 or 7j7 of this section or section #cea7k7 of the ,public ,health ,service ,act4 ,such petition and any supplement to such a petition shall describe all information and arguments that form the basis of the relief requested in any civil action described in the previous sentence4 7,b7 ,timely submission of citizen petition ,a petition and any supplement to a petition shall be submitted within #fj days after the person knew1 or reasonably should have known1 the information that forms the basis of the request made in the petition or supplement4 2 7,c7 in subparagraph 7,c71 as so redesignated1 by-- 7i7 in the heading1 striking within #aej days2 7ii7 in clause 7i71 striking during the #aej-;day period referred to in paragraph 7#a77;,f712 and 7iii7 amending clause 7ii7 to read as follows3 7ii7 on or after the date that is #aea days after the date of submission of the petition1 the ,secretary approves or has approved the application that is the subject of the petition without having made such a final decision4 2 7,d7 by amending subparagraph 7,d71 as so redesignated1 to read as follows3 7,d7 ,dismissal of certain civil actions 7i7 ,petition ,if a person files a civil action against the ,secretary in which a person seeks to set aside1 delay1 rescind1 withdraw1 or prevent submission1 review1 or approval of an application submitted under subsection 7b77#b7 or 7j7 of this section or section #cea7k7 of the ,public ,health ,service ,act without complying with the requirements of subparagraph 7,a71 the court shall dismiss without prejudice the action for failure to exhaust administrative remedies4 7ii7 ,timeliness ,if a person files a civil action against the ,secretary in which a person seeks to set aside1 delay1 rescind1 withdraw1 or prevent submission1 review1 or approval of an application submitted under subsection 7b77#b7 or 7j7 of this section or section #cea7k7 of the ,public ,health ,service ,act without complying with the requirements of subparagraph 7,b71 the court shall dismiss with prejudice the action for failure to timely file a petition4 7iii7 ,final response ,if a civil action is filed against the ,secretary with respect to any issue raised in a petition timely filed under paragraph 7#a7 in which the petitioner requests that the ,secretary take any form of action that could1 if taken1 set aside1 delay1 rescind1 withdraw1 or prevent submission1 review1 or approval of an application submitted under subsection 7b77#b7 or 7j7 of this section or section #cea7k7 of the ,public ,health ,service ,act before the ,secretary has issued a final response to any such petition submitted1 the court shall dismiss without prejudice the action for failure to exhaust administrative remedies4 2 and 7,e7 in subparagraph 7,e71 as so redesignated-- 7i7 in clause 7ii71 by striking 1 if issued2 and 7ii7 in clause 7iii71 by striking final agency action as defined under subparagraph 7#b77;,a7 and inserting the final response to the petitioner2 and 7#c7 in paragraph 7#d7-- 7,a7 by striking ,exceptions and all that follows through ,this subsection does and inserting ,exceptions--,this subsection does2 7,b7 by striking subparagraph 7,b72 and 7,c7 by redesignating clauses 7i7 and 7ii7 as subparagraphs 7,a7 and 7,b71 respectively1 and adjusting the margins accordingly4 #bjd4 ,protecting access to biological products ,section #cea7k77#g7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77#g77 is amended by adding at the end the following3 7,d7 ,deemed licenses 7i7 ,no additional exclusivity through deeming ,an approved application that is deemed to be a license for a biological product under this section pursuant to section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji shall not be treated as having been first licensed under subsection 7a7 for purposes of subparagraphs 7,a7 and 7,b74 7ii7 ,limitation on exclusivity ,subparagraph 7,c7 shall apply to any reference product1 without regard to whether-- 7,i7 such product was first licensed under subsection 7a72 or 7,,ii7 the approved application for such product was deemed to be a license for a biological product as described in clause 7i74 7iii7 ,applicability ,any unexpired period of exclusivity under section #ebg or section #eje;,a7c77#a77;,a77ii7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act with respect to a biological product shall continue to apply to such biological product after an approved application for the biological product is deemed to be a license for the biological product as described in clause 7i74 4 #bje4 ,preventing blocking of generic drugs ,section #eje7;j77#e77;,b77iv77,i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,b77iv77,i77 is amended-- 7#a7 by striking #ahj days after the date and inserting 8#ahj days after the earlier of the following3 7aa7 ,the date 2 and 7#b7 by adding at the end the following3 7bb7 ,the date on which all of the following conditions are first met3 7,,aa7 ,an application for the drug submitted by an applicant other than a first applicant could receive approval1 if no first applicant were eligible for #ahj-;day exclusivity under this clause4 7,,bb7 ,thirty-three months have passed since the date of submission of an application for the drug by one first applicant1 if there is only one first applicant1 or1 in the case of more than one first applicant1 #cc months have passed since the date of submission of all such applications4 7,,cc7 ,approval of an application for the drug submitted by at least one first applicant would not be precluded under clause 7iii74 7,,dd7 ,no application for the drug submitted by any first applicant is approved at the time the conditions under subitems 7,,aa71 7,,bb71 and 7,,cc7 are all met1 regardless of whether such an application is subsequently approved4 4 #bjf4 ,education on biological products ,subpart #a of part ,f of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb et seq47 is amended by adding at the end the following3 #ceb;,a4 ,education on biological products 7a7 ,internet website 7#a7 ,in general ,the ,secretary may establish1 maintain1 and operate an internet website to provide educational materials for health care providers1 patients1 and caregivers1 regarding the meaning of the terms1 and the standards for review and licensing of1 biological products1 including biosimilar biological products and interchangeable biosimilar biological products4 7#b7 ,content ,educational materials provided under paragraph 7#a7 may include explanations of-- 7,a7 key statutory and regulatory terms1 including biosimilar and interchangeable1 and clarification regarding the appropriate use of interchangeable biosimilar biological products2 7,b7 information related to development programs for biological products1 including biosimilar biological products and interchangeable biosimilar biological products and relevant clinical considerations for prescribers1 which may include1 as appropriate and applicable1 information related to the comparability of such biological products2 7,c7 the process for reporting adverse events for biological products1 including biosimilar biological products and interchangeable biosimilar biological products2 and 7,d7 the relationship between biosimilar biological products and interchangeable biosimilar biological products licensed under section #cea7k7 and reference products 7as defined in section #cea7;i771 including the standards for review and licensing of each such type of biological product4 7#c7 ,format ,the educational materials provided under paragraph 7#a7 may be-- 7,a7 in formats such as webinars1 continuing medical education modules1 videos1 fact sheets1 infographics1 stakeholder toolkits1 or other formats as appropriate and applicable2 and 7,b7 tailored for the unique needs of health care providers1 patients1 caregivers1 and other audiences1 as the ,secretary determines appropriate4 7#d7 ,other information ,in addition to the information described in paragraph 7#b71 the internet website established under paragraph 7#a7 shall include the following information1 as a single1 searchable database3 7,a7 ,the action package of each biological product licensed under subsection 7a7 or 7k71 within #cj days of licensure1 or1 in the case of a biological product licensed before the date of enactment of the ,lower ,health ,care ,costs ,act1 not later than #a year after such date of enactment4 7,b7 ,the summary review of each biological product licensed under subsection 7a7 or 7k71 within #g days of licensure1 except where such materials require redaction by the ,secretary1 or1 in the case of a biological product licensed before the date of enactment of the ,lower ,health ,care ,costs ,act1 not later than #a year after such date of enactment4 7#e7 ,confidential and trade secret information ,this subsection does not authorize the disclosure of any trade secret1 confidential commercial or financial information1 or other matter described in section #eeb7;b7 of title #e4 7b7 ,continuing medical education ,the ,secretary shall advance education and awareness among health care providers regarding biological products1 including biosimilar biological products and interchangeable biosimilar biological products1 as appropriate1 including by developing or improving continuing medical education programs that advance the education of such providers on the prescribing of1 and relevant clinical considerations with respect to biological products1 including biosimilar biological products and interchangeable biosimilar biological products4 4 #bjg4 ,biological product innovation ,section #cea7;j7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;j77 is amended-- 7#a7 by striking except that a product and inserting 8except that-- 7#a7 a product 2 7#b7 by striking ,act4 and inserting ,act2 and2 and 7#c7 by adding at the end the following3 7#b7 no requirement under such ,act regarding an official compendium 7as defined in section #bja7;j7 of such ,act71 or other reference in such ,act to an official compendium 7as so defined71 shall apply with respect to a biological product subject to regulation under this section4 4 #bjh4 ,clarifying the meaning of new chemical entity ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended-- 7#a7 in section #eje 7#ba ,u4,s4,c4 #cee7-- 7,a7 in subsection 7c77#c77;,e7-- 7i7 in clause 7ii71 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 and 7ii7 in clause 7iii71 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 7,b7 in subsection 7j77#e77;,f7-- 7i7 in clause 7ii71 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 and 7ii7 in clause 7iii71 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 7,c7 in subsection 7l77#b77;,a77i71 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 7,d7 in subsection 7s71 in the matter preceding paragraph 7#a71 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 and 7,e7 in subsection 7u77#a71 in the matter preceding subparagraph 7,a7-- 7i7 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 and 7ii7 by striking same active ingredient and inserting same active moiety2 7#b7 in section #eab7;c77#b77;,f7 7#ba ,u4,s4,c4 #cfj;b7c77#b77;,f77-- 7,a7 in clause 7i71 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 7,b7 in clause 7ii71 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 and 7,c7 in clause 7v71 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 7#c7 in section #ebd7;a77#d77;,c7 7#ba ,u4,s4,c4 #cfjn7a77#d77;,c771 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 7#d7 in section #ebi7;a77#d77;,a77ii7 7#ba ,u4,s4,c4 #cfj;ff7a77#d77;,a77ii771 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 and 7#e7 in section #efe;,a7a77#d77;,d7 7#ba ,u4,s4,c4 #cfj;bbb-#d;a7a77#d77;,d771 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations774 #bji4 ,streamlining the transition of biological products ,section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji 7,public ,law #aaa-adh7 is amended by adding at the end the following3 ,with respect to an application for a biological product under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 with a filing date that is not later than ,september #bc1 #bjai1 the ,secretary shall continue to review and approve such application under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 even if such review and approval process continues after ,march #bc1 #bjbj4 ,effective on the later of ,march #bc1 #bjbj1 or the date of approval of such application under such section #eje1 such approved application shall be deemed to be a license for the biological product under section #cea of the ,public ,health ,service ,act44 #baj4 ,orphan drug clarification ,section #ebg7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7c77 is amended by adding at the end the following3 7#c7 ,applicability ,this subsection applies to any drug designated under section #ebf that was approved under section #eje of this ,act or licensed under section #cea of the ,public ,health ,service ,act after the date of enactment of the ,,fda ,reauthorization ,act of #bjag1 regardless of the date of on which such drug was designated under section #ebf4 4 #baa4 ,prompt approval of drugs related to safety information ,section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is amended by adding at the end the following3 7z7 ,prompt ,approval of ,drugs ,when safety information ,is ,added to ,labeling 7#a7 ,general rule ,a drug for which an application has been submitted or approved under subsection 7b77#b7 or 7j7 shall not be considered ineligible for approval under this section or misbranded under section #ejb on the basis that the labeling of the drug omits safety information1 including contraindications1 warnings1 precautions1 dosing1 administration1 or other information pertaining to safety1 when the omitted safety information is protected by exclusivity under clause 7iii7 or 7iv7 of subsection 7j77#e77;,f71 clause 7iii7 or 7iv7 of subsection 7c77#c77;,e71 or section #ebg7;a71 or by an extension of such exclusivity under section #eje;,a or #eje;,e4 7#b7 ,labeling ,notwithstanding clauses 7iii7 and 7iv7 of subsection 7j77#e77;,f71 clauses 7iii7 and 7iv7 of subsection 7c77#c77;,e71 or section #ebg1 the ,secretary shall require that the labeling of a drug approved pursuant to an application submitted under subsection 7b77#b7 or 7j7 that omits safety information described in paragraph 7#a7 include a statement of any appropriate safety information that the ,secretary considers necessary to assure safe use4 7#c7 ,availability and scope of exclusivity ,this subsection does not affect-- 7,a7 the availability or scope of exclusivity or an extension of exclusivity described in subparagraph 7,a7 or 7,b7 of section #eje;,a7o77#c72 7,b7 the question of the eligibility for approval under this section of any application described in subsection 7b77#b7 or 7j7 that omits any other aspect of labeling protected by exclusivity under-- 7i7 clause 7iii7 or 7iv7 of subsection 7j77#e77;,f72 7ii7 clause 7iii7 or 7iv7 of subsection 7c77#c77;,e72 or 7iii7 section #ebg7;a72 or 7,c7 except as expressly provided in paragraphs 7#a7 and 7#b71 the operation of this section or section #ebg4 4 #bab4 ,conditions of use for biosimilar biological products ,section #cea7k77#b77;,a77iii7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77#b77;,a77iii77 is amended-- 7#a7 in subclause 7,i71 by striking 2 and and inserting a semicolon2 7#b7 in subclause 7,,ii71 by striking the period and inserting 2 and2 and 7#c7 by adding at the end the following3 7,,iii7 may include information to show that the conditions of use prescribed1 recommended1 or suggested in the labeling proposed for the biological product have been previously approved for the reference product4 4 #bac4 ,modernizing the labeling of certain generic drugs ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by inserting after section #ejc;,c the following3 #ejc;,d4 ,process to update labeling for certain drugs 7a7 ,definitions ,for purposes of this section3 7#a7 ,the term covered drug means a drug approved under section #eje7;c7-- 7,a7 for which there are no unexpired patents included in the list under section #eje7;j77#g7 and no unexpired period of market exclusivity2 7,b7 for which the approval of the application has been withdrawn for reasons other than safety or effectiveness2 and 7,c7 for which1 with respect to the labeling-- 7i7 new scientific evidence is available regarding the conditions of use of the drug2 7ii7 there is a relevant accepted use in clinical practice that is not reflected in the approved labeling2 or 7iii7 the labeling of such drug does not reflect current legal and regulatory requirements4 7#b7 ,the term period of market exclusivity1 with respect to a drug approved under section #eje7;c71 means any period of market exclusivity under clause 7ii71 7iii71 or 7iv7 of section #eje7;c77#c77;,e71 clause 7ii71 7iii71 or 7iv7 of section #eje7;j77#e77;,f71 or section #eje;,a1 #eje;,e1 or #ebg4 7#c7 ,the term generic version means a drug approved under section #eje7;j7 whose reference drug is a covered drug4 7#d7 ,the term relevant accepted use means a use for a drug in clinical practice that is supported by scientific evidence that appears to the ,secretary to meet the standards for approval under section #eje4 7#e7 ,the term selected drug means a covered drug for which the ,secretary has determined through the process under subsection 7c7 that the labeling should be changed4 7b7 ,identification of covered drugs ,the ,secretary may identify covered drugs for which labeling updates would provide a public health benefit4 ,to assist in identifying covered drugs1 the ,secretary may do one or both of the following3 7#a7 ,enter into cooperative agreements or contracts with public or private entities to review the available scientific evidence concerning such drugs4 7#b7 ,seek public input concerning such drugs1 including input on whether there is a relevant accepted use in clinical practice that is not reflected in the approved labeling of such drugs or whether new scientific evidence is available regarding the conditions of use for such drug1 by-- 7,a7 holding one or more public meetings2 7,b7 opening a public docket for the submission of public comments2 or 7,c7 other means1 as the ,secretary determines appropriate4 7c7 ,selection of drugs for updating ,if the ,secretary determines1 with respect to a covered drug1 that the available scientific evidence meets the standards under section #eje for adding or modifying information to the labeling or providing supplemental information to the labeling regarding the use of the covered drug1 the ,secretary may initiate the process under subsection 7d74 7d7 ,initiation of the process of updating ,if the ,secretary determines that labeling changes are appropriate for a selected drug pursuant to subsection 7c71 the ,secretary shall provide notice to the holders of approved applications for a generic version of such drug that-- 7#a7 summarizes the findings supporting the determination of the ,secretary that the available scientific evidence meets the standards under section #eje for adding or modifying information or providing supplemental information to the labeling of the covered drug pursuant to subsection 7c72 7#b7 provides a clear statement regarding the additional1 modified1 or supplemental information for such labeling1 according to the determination by the ,secretary 7including1 as applicable1 modifications to add the relevant accepted use to the labeling of the drug as an additional indication for the drug72 and 7#c7 states whether the statement under paragraph 7#b7 applies to the selected drug as a class of covered drugs or only as to a specific drug product4 7e7 ,response to notification ,within #cj days of receipt of notification provided by the ,secretary pursuant to subsection 7d71 the holder of an approved application for a generic version of the selected drug shall-- 7#a7 agree to change the approved labeling to reflect the additional1 modified1 or supplemental information the ,secretary has determined to be appropriate2 or 7#b7 notify the ,secretary that the holder of the approved application does not believe that the requested labeling changes are warranted and submit a statement detailing the reasons why such changes are not warranted4 7f7 ,review of application holder's response 7#a7 ,in general ,upon receipt of the application holder's response1 the ,secretary shall promptly review each statement received under subsection 7e77#b7 and determine which labeling changes pursuant to the ,secretary's notice under subsection 7d7 are appropriate1 if any4 ,if the ,secretary disagrees with the reasons why such labeling changes are not warranted1 the ,secretary shall provide opportunity for discussions with the application holders to reach agreement on whether the labeling for the covered drug should be updated to reflect current scientific evidence1 and if so1 the content of such labeling changes4 7#b7 ,changes to labeling ,after considering all responses from the holder of an approved application under paragraph 7#a7 or 7#b7 of subsection 7e71 and any discussion under paragraph 7#a71 the ,secretary may order such holder to make the labeling changes the ,secretary determines are appropriate4 ,such holder of an approved application shall-- 7,a7 update its paper labeling for the drug at the next printing of that labeling2 7,b7 update any electronic labeling for the drug within #cj days2 and 7,c7 submit the revised labeling through the form1 ,supplement--,changes ,being ,effected4 7g7 ,violation ,if the holder of an approved application for the generic version of the selected drug does not comply with the requirements of subsection 7f77#b71 such generic version of the selected drug shall be deemed to be misbranded under section #ejb4 7h7 ,limitations2 generic drugs 7#a7 ,in general ,with respect to any labeling change required under this section1 the generic version shall be deemed to have the same conditions of use and the same labeling as a reference drug for purposes of clauses 7i7 and 7v7 of section #eje7;j77#b77;,a74 ,any labeling change so required shall not have any legal effect for the applicant that is different than the legal effect that would have resulted if a supplemental application had been submitted and approved to conform the labeling of the generic version to a change in the labeling of the reference drug4 7#b7 ,supplemental applications ,changes to labeling made in accordance with this paragraph shall not be eligible for an exclusivity period under this ,act4 7i7 ,drug product classes ,in the case of a selected drug for which the labeling changes ordered by the ,secretary under subsection 7d77#b7 are required for a class of covered drugs1 such labeling changes shall be made for generic versions of such drug in that class4 7j7 ,rules of construction 7#a7 ,approval standards ,this section shall not be construed as altering the applicability of the standards for approval of an application under section #eje4 ,no order shall be issued under this subsection unless the evidence supporting the changed labeling meets the standards for approval applicable to any change to labeling under section #eje4 7#b7 ,removal of information ,nothing in this section shall be construed to give the ,secretary additional authority to remove approved indications for drugs1 other than the authority to remove certain indications from the labels of certain covered drugs1 as described in this section4 7k7 ,reports ,not later than #d years after the date of the enactment of the ,lower ,health ,care ,costs ,act and every #d years thereafter1 the ,secretary shall prepare and submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 a report that-- 7#a7 describes the actions of the ,secretary under this section1 including-- 7,a7 the number of covered drugs and description of the types of drugs the ,secretary has selected for labeling changes and the rationale for such recommended changes2 and 7,b7 the number of times the ,secretary entered into discussions concerning a disagreement with an application holder or holders and a summary of the decision regarding a labeling change1 if any2 and 7#b7 includes any recommendations of the ,secretary for modifying the program under this section4 4 ,,iii ,improving ,transparency in ,health ,care #cja4 ,increasing transparency by removing gag clauses on price and quality information ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq471 as amended by section #ajc1 is amended by adding at the end the following3 #bgbi;,b4 ,increasing transparency by removing gag clauses on price and quality information 7a7 ,increasing price and quality transparency for plan sponsors and consumers 7#a7 ,group health plans ,a group health plan or a health insurance issuer offering group health insurance coverage may not enter into an agreement with a health care provider1 network or association of providers1 third-party administrator1 or other service provider offering access to a network of providers that would directly or indirectly restrict a group health plan or health insurance issuer from-- 7,a7 providing provider-specific cost or quality of care information1 through a consumer engagement tool or any other means1 to referring providers1 the plan sponsor1 enrollees1 or eligible enrollees of the plan or coverage2 7,b7 electronically accessing de-identified claims and encounter data for each enrollee in the plan or coverage1 upon request and consistent with the privacy regulations promulgated pursuant to section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act1 the amendments to this ,act made by the ,genetic ,information ,nondiscrimination ,act of #bjjh1 and the ,americans with ,disabilities ,act of #aiij1 with respect to the applicable health plan or health insurance coverage1 including1 on a per claim basis-- 7i7 financial information1 such as the allowed amount1 or any other claim-related financial obligations included in the provider contract2 7ii7 provider information1 including name and clinical designation2 7iii7 service codes2 or 7iv7 any other data element normally included in claim or encounter transactions when received by a plan or issuer2 or 7,c7 sharing data described in subparagraph 7,a7 or 7,b7 with a business associate as defined in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or successor regulations71 consistent with the privacy regulations promulgated pursuant to section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act1 the amendments to this ,act made by the ,genetic ,information ,nondiscrimination ,act of #bjjh1 and the ,americans with ,disabilities ,act of #aiij4 7#b7 ,individual health insurance coverage ,a health insurance issuer offering individual health insurance coverage may not enter into an agreement with a health care provider1 network or association of providers1 or other service provider offering access to a network of providers that would1 directly or indirectly restrict the health insurance issuer from-- 7,a7 providing provider-specific price or quality of care information1 through a consumer engagement tool or any other means1 to referring providers or the plan sponsor1 enrollees1 or eligible enrollees of the plan or coverage2 or 7,b7 sharing data described in subparagraph 7,a7 with a business associate as defined in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or successor regulations71 consistent with the privacy regulations promulgated pursuant to section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act1 the amendments to this ,act made by the ,genetic ,information ,nondiscrimination ,act of #bjjh1 and the ,americans with ,disabilities ,act of #aiij1 for plan design1 plan administration1 and plan1 financial1 legal1 and quality improvement activities4 7#c7 ,clarification regarding public disclosure of information ,nothing in paragraph 7#a77;,a7 or 7#b77;,a7 prevents a health care provider1 network or association of providers1 or other service provider from placing reasonable restrictions on the public disclosure of the information described in such paragraphs 7#a7 and 7#b74 7#d7 ,attestation ,a group health plan or a health insurance issuer offering group or individual health insurance coverage shall annually submit to1 as applicable1 the applicable authority described in section #bgbc or the ,secretary of ,labor1 an attestation that such plan or issuer is in compliance with the requirements of this subsection4 7#e7 ,rule of construction ,nothing in this section shall be construed to otherwise limit group health plan or plan sponsor access to data currently permitted under the privacy regulations promulgated pursuant to section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act1 the amendments to this ,act made by the ,genetic ,information ,nondiscrimination ,act of #bjjh1 and the ,americans with ,disabilities ,act of #aiij4 4 #cjb4 ,banning anticompetitive terms in facility and insurance contracts that limit access to higher quality1 lower cost care 7a7 ,in general ,section #bgbi;,b of the ,public ,health ,service ,act1 as added by section #cja1 is amended by adding at the end the following3 7b7 ,protecting ,health ,plans ,network ,design ,flexibility 7#a7 ,in general ,a group health plan or a health insurance issuer offering group or individual health insurance coverage shall not enter into an agreement with a provider1 network or association of providers1 or other service provider offering access to a network of service providers if such agreement1 directly or indirectly-- 7,a7 restricts the group health plan or health insurance issuer from-- 7i7 directing or steering enrollees to other health care providers2 or 7ii7 offering incentives to encourage enrollees to utilize specific health care providers2 7,b7 requires the group health plan or health insurance issuer to enter into any additional contract with an affiliate of the provider as a condition of entering into a contract with such provider2 7,c7 requires the group health plan or health insurance issuer to agree to payment rates or other terms for any affiliate not party to the contract of the provider involved2 or 7,d7 restricts other group health plans or health insurance issuers not party to the contract1 from paying a lower rate for items or services than the contracting plan or issuer pays for such items or services4 7#b7 ,additional requirement for self-insured plans ,a self-insured group health plan shall not enter into an agreement with a provider1 network or association of providers1 third-party administrator1 or other service provider offering access to a network of providers if such agreement1 directly or indirectly requires the group health plan to certify1 attest1 or otherwise confirm in writing that the group health plan is bound by the terms of the contract between the service provider and a third-party administrator that the group health plan is not party to and is not allowed to review4 7#c7 ,exception for certain group model issuers ,paragraph 7#a77;,a7 shall not apply to a group health plan or a health insurance issuer offering group or individual health insurance coverage with respect to a health maintenance organization 7as defined in section #bgia7;b77#c77 if such health maintenance organization operates primarily through exclusive contracts with multi-specialty physician groups1 nor to any arrangement between such a health maintenance organization and its affiliates4 7#d7 ,attestation ,a group health plan or a health insurance issuer offering group or individual health insurance coverage shall annually submit to1 as applicable1 the applicable authority described in section #bgbc or the ,secretary of ,labor1 an attestation that such plan or issuer is in compliance with the requirements of this subsection4 7c7 ,maintenance of existing ,,hipaa1 ,,gina1 and ,,ada protections ,nothing in this section shall modify1 reduce1 or eliminate the existing privacy protections and standards provided by reason of ,state and ,federal law1 including the requirements of parts #afj and #afd of title #de1 ,code of ,federal ,regulations 7or any successor regulations74 7d7 ,regulations ,the ,secretary1 in coordination with the ,secretary of ,labor and the ,secretary of the ,treasury1 not later than #a year after the date of enactment of the ,lower ,health ,care ,costs ,act1 shall promulgate regulations to carry out this section4 7e7 ,rule of construction ,nothing in this section shall be construed to limit network design or cost or quality initiatives by a group health plan or health insurance issuer1 including accountable care organizations1 exclusive provider organizations1 networks that tier providers by cost or quality or steer enrollees to centers of excellence1 or other pay-for-performance programs4 4 7b7 ,effective date ,section #bgbi;,b of the ,public ,health ,service ,act 7as added by section #cja and amended by subsection 7a77 shall apply with respect to any contract entered into after the date of enactment of this ,act4 ,with respect to an applicable contract that is in effect on the date of enactment of this ,act1 such section #bgbi;,b shall apply on the earlier of the date of renewal of such contract or #c years after such date of enactment4 #cjc4 ,designation of a nongovernmental1 nonprofit transparency organization to lower ,americans' health care costs 7a7 ,in general ,subpart ,c of part #g of subtitle ,b of title ,i of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aaia et seq47 is amended by adding at the end the following3 #gce4 ,designation of a nongovernmental1 nonprofit transparency organization to lower ,americans' health care costs 7a7 ,in general ,the ,secretary1 in consultation with the ,secretary of ,health and ,human ,services1 not later than #f months after the date of enactment of the ,lower ,health ,care ,costs ,act1 shall have in effect a contract with a nonprofit entity to support the establishment and maintenance of a database that receives and utilizes health care claims information and related information and issues reports that are available to the public and authorized users1 and are submitted to the ,department of ,labor4 7b7 ,requirements 7#a7 ,in general ,the database established under subsection 7a7 shall-- 7,a7 improve transparency by using de-identified health care data to-- 7i7 inform patients about the cost1 quality1 and value of their care2 7ii7 assist providers and hospitals1 as they work with patients1 to make informed choices about care2 7iii7 enable providers1 hospitals1 and communities to improve services and outcomes for patients by benchmarking their performance against that of other providers1 hospitals1 and communities2 7iv7 enable purchasers1 including employers1 employee organizations1 and health plans1 to develop value-based purchasing models1 improve quality1 and reduce the cost of health care and insurance coverage for enrollees2 7v7 enable employers and employee organizations to evaluate network design and construction1 and the cost of care for enrollees2 7vi7 facilitate ,state-led initiatives to lower health care costs and improve quality2 and 7vii7 promote competition based on quality and cost2 7,b7 collect medical claims1 prescription drug claims1 and remittance data consistent with the protections and requirements of subsection 7d72 7,c7 be established in such a manner that allows the data collected pursuant to subparagraph 7,b7 to be shared with any ,state all-payer claims database or regional database operated with authorization from ,states1 at cost1 using a standardized format1 if such ,state or regional database also submits claims data to the database established under this section2 and 7,d7 be available to-- 7i7 the ,director of the ,congressional ,budget ,office1 the ,comptroller ,general of the ,united ,states1 the ,executive ,director of the ,medicare ,payment ,advisory ,commission1 and the ,executive ,director of the ,medicaid and ,,chip ,payment ,advisory ,commission1 upon request1 subject to the privacy and security requirements of authorized users under subsection 7e77#b72 and 7ii7 authorized users1 including employers1 employee organizations1 providers1 researchers1 and policymakers1 subject to subsection 7e74 7#b7 ,privacy and security ,the entity receiving a contract under subsection 7a7 shall-- 7,a7 be subject to the breach notification rule under subpart ,d of part #afd of title #de1 ,code of ,federal ,regulations 7or any successor regulations71 the security rule under part #afj and subparts ,a and ,c of part #afd of title #de1 ,code of ,federal ,regulations 7or any successor regulations71 and the privacy rule under part #afj and subparts ,a and ,e of part #afd of title #de1 ,code of ,federal ,regulations 7or any successor regulations72 and 7,b7 consistent with the requirements and prohibitions in the regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif-- 7i7 ensure that the database under subsection 7a7 is capable of-- 7,i7 receiving data under subsection 7d72 7,,ii7 providing data access to authorized users2 and 7,,iii7 storing data on secure servers in a manner that is consistent with the privacy1 security1 and breach notification requirements under section #acdjb of the ,,hitech ,act and under the regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif2 7ii7 not disclose to the public any individually identifiable health information or proprietary financial information2 7iii7 strictly limit staff access to the data to staff with appropriate training1 clearance1 and background checks and require regular privacy and security training2 7iv7 maintain effective security standards for transferring data or making data available to authorized users2 7v7 develop a process for providing access to data to authorized users1 in a secure manner that maintains privacy and confidentiality of data2 7vi7 adhere to current best security practices with respect to the management and use of such data for health services research1 in accordance with applicable ,federal privacy law2 and 7vii7 report on the security methods of the entity to the ,secretary1 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 and the ,committee on ,education and ,labor of the ,house of ,representatives4 7#c7 ,consultation 7,a7 ,advisory committee ,not later than #ahj days after the date of enactment of the ,lower ,health ,care ,costs ,act1 the ,secretary shall convene an ,advisory ,committee 7referred to in this section as the ,committee71 consisting of #aa members1 to advise the ,secretary1 the contracting entity1 and ,congress on the establishment1 operations1 and use of the database established under this section4 7,b7 ,membership 7i7 ,appointment ,in accordance with clause 7ii71 the ,secretary1 in consultation with the ,secretary of ,health and ,human ,services1 and the ,comptroller ,general of the ,united ,states shall1 not later than #a year after the date of enactment of the ,lower ,health ,care ,costs ,act1 appoint members to the ,committee who have distinguished themselves in the fields of health services research1 health economics1 health informatics1 or the governance of ,state all-payer claims databases1 or who represent organizations likely to submit data to or use the database1 including patients1 employers1 or employee organizations that sponsor group health plans1 health care providers1 health insurance issuers1 and third-party administrators of group health plans4 ,such members shall serve #c-year terms on a staggered basis4 ,vacancies on the ,committee shall be filled by appointment consistent with this subsection not later than #c months after the vacancy arises4 7ii7 ,composition ,in accordance with clause 7i7-- 7,i7 the ,secretary1 in consultation with the ,secretary of ,health and ,human ,services1 shall appoint to the ,committee-- 7aa7 #a member selected by the ,secretary1 in coordination with the ,secretary of ,health and ,human ,services1 to serve as the chair of the ,committee2 7bb7 the ,assistant ,secretary for ,planning and ,evaluation of the ,department of ,health and ,human ,services2 7cc7 #a representative of the ,centers for ,medicare ,medicaid ,services2 7dd7 #a representative of the ,agency for ,health ,research and ,quality2 7ee7 #a representative of the ,office for ,civil ,rights of the ,department of ,health and ,human ,services with expertise in data privacy and security2 and 7ff7 #a representative of the ,national ,center for ,health ,statistics2 and 7,,ii7 the ,comptroller ,general of the ,united ,states shall appoint to the ,committee-- 7aa7 #a representative of an employer that sponsors a group health plan2 7bb7 #a representative of an employee organization that sponsors a group health plan2 7cc7 #a academic researcher with expertise in health economics or health services research2 7dd7 #a patient advocate2 and 7ee7 #b additional members4 7,c7 ,duties ,the ,committee shall-- 7i7 assist and advise the ,secretary on the management of the contract under subsection 7a72 7ii7 assist and advise the entity receiving the contract under subsection 7a7 in establishing-- 7,i7 the scope and format of the data to be submitted under subsection 7d72 7,,ii7 the appropriate uses of data by authorized users1 including developing standards for the approval of requests by organizations to access and use the data2 and 7,,iii7 the appropriate formats and methods for making reports and analyses based on the database to the public2 7iii7 conduct an annual review of whether data was used according to the appropriate uses as described in clause 7ii77,,ii71 and advise the designated entity on using the data for authorized purposes2 7iv7 report1 as appropriate1 to the ,secretary and ,congress on the operation of the database and opportunities to better achieve the objectives of this section2 7v7 establish additional restrictions on researchers who receive compensation from entities described in subsection 7e77#b77;,b77ii71 in order to protect proprietary financial information2 and 7vi7 establish objectives for research and public reporting4 7#d7 ,state requirements ,a ,state may require health insurance issuers and other payers to submit claims data to the database established under this section1 provided that such data is submitted in a form and manner established by the ,secretary1 and pursuant to subsection 7d77#d77;,b74 7#e7 ,sanctions ,the ,secretary shall take appropriate action to sanction users who attempt to re-identify data accessed pursuant to paragraph 7#a77;,d74 7c7 ,contract requirements 7#a7 ,competitive procedures ,the ,secretary shall enter into the contract under subsection 7a7 using full and open competition procedures pursuant to chapter #cc of title #da1 ,united ,states ,code4 7#b7 ,eligible entities ,to be eligible to enter into a contract described in subsection 7a71 an entity shall-- 7,a7 be a private nonprofit entity governed by a board that includes representatives of the academic research community and individuals with expertise in employer-sponsored insurance1 research using health care claims data and actuarial analysis2 7,b7 conduct its business in an open and transparent manner that provides the opportunity for public comment on its activities2 and 7,c7 agree to maintain an active certification as a qualified entity under section #ahgd7;e7 of the ,social ,security ,act 7or any successor program7 throughout the contract period4 7#c7 ,considerations ,in awarding the contract under subsection 7a71 the ,secretary shall consider an entity's experience in-- 7,a7 health care claims data collection1 aggregation1 quality assurance1 analysis1 and security2 7,b7 supporting academic research on health costs1 spending1 and utilization for and by privately insured patients2 7,c7 working with large health insurance issuers and third-party administrators to assemble a national claims database2 7,d7 effectively collaborating with and engaging stakeholders to develop reports2 7,e7 meeting budgets and timelines1 including in connection with report generation2 and 7,f7 facilitating the creation of1 or supporting1 ,state all-payer claims databases4 7#d7 ,contract term ,a contract awarded under this section shall be for a period of #e years1 and may be renewed after a subsequent competitive bidding process under this section4 7#e7 ,transition of contract ,if the ,secretary1 following a competitive process at the end of the contract period1 selects a new entity to maintain the database1 all data shall be transferred to the new entity according to a schedule and process to be determined by the ,secretary4 ,upon termination of a contract1 no entity may keep data held by the database or disclose such data to any entity other than the entity so designated by the ,secretary4 ,the ,secretary shall include enforcement terms in any contract with an organization chosen under this section1 to ensure the timely transfer of all data to a new entity in the event of contract termination4 7d7 ,receiving health information 7#a7 ,requirements 7,a7 ,in general ,an applicable self-insured group health plan shall1 through its health insurance issuer1 third-party administrator1 pharmacy benefit manager1 or other entity designated by the group health plan1 electronically submit all claims data with respect to the plan1 pursuant to subparagraph 7,b74 7,b7 ,scope of information and format of submission ,the entity awarded the contract under subsection 7a71 in consultation with the ,committee described in subsection 7b77#c71 and pursuant to the privacy and security requirements of subsection 7b77#b71 shall-- 7i7 specify the data elements required to be submitted under subparagraph 7,a71 which shall include all data related to transactions described in subparagraphs 7,a7 and 7,e7 of section #aagc7;a77#b7 of the ,social ,security ,act1 including all data elements normally present in such transactions when adjudicated1 and enrollment information2 7ii7 specify the form and manner for such submissions1 and the historical period to be included in the initial submission2 and 7iii7 offer an automated submission option to minimize administrative burdens for entities required to submit data4 7,c7 ,de-identification of data ,the entity awarded the contract under subsection 7a7 shall-- 7i7 establish a process under which data is de-identified in accordance with section #afd4ead7;a7 of title #de1 ,code of ,federal ,regulations 7or any successor regulations71 while retaining the ability to link data longitudinally for the purposes of research on cost and quality1 and the ability to complete risk adjustment and geographic analysis2 7ii7 ensure that any third-party subcontractors who perform the de-identification process described in clause 7i7 retain the minimum necessary information to perform such a process1 and adhere to effective security and encryption practices in data storage and transmission2 7iii7 store claims and other data collected under this subsection only in de-identified form1 in accordance with section #afd4ead7;a7 of title #de1 ,code of ,federal ,regulations 7or any successor regulations72 and 7iv7 ensure that data is encrypted1 in accordance with the regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif4 7#b7 ,applicable self-insured group health plan ,for purposes of paragraph 7#a71 a self-insured group health plan is an applicable self-insured group health plan if such plan is self-administered1 or is administered by a health insurance issuer or third-party administrator that meets one or both of the following criteria3 7,a7 ,administers health benefits for more than #ej1jjj enrollees4 7,b7 ,is one of the #e largest administrators or issuers of self-insured group health plans in a ,state in which such administrator operates1 as measured by the number of enrollees4 7#c7 ,issuers and third-party administrators ,in the case of a health insurance issuer or third-party administrator that is required under this subsection to submit claims data with respect to an applicable self-insured group health plan1 such issuer or administrator shall submit claims data with respect to all self-insured group health plans that the issuer or administrator administers1 including such plans that are not applicable self-insured group health plans1 as described in paragraph 7#b74 7#d7 ,receiving other information 7,a7 ,medicare data ,the entity awarded the contract under subsection 7a7 shall maintain active certification as a qualified entity pursuant to section #ahgd7;e7 of the ,social ,security ,act for the term of the contract awarded under subsection 7a74 7,b7 ,state data ,the entity awarded the contract under subsection 7a7 shall collect data from ,state all-payer claims databases that seek access to the database established under this section4 7#e7 ,availability of data ,an entity required to submit data under this subsection may not place any restrictions on the use of such data by authorized users4 7e7 ,uses of information 7#a7 ,in general ,the entity awarded the contract under subsection 7a7 shall make the database available to users who are authorized under this subsection1 at cost1 and reports and analyses based on the data available to the public with no charge4 7#b7 ,authorization of users 7,a7 ,in general ,an entity may request authorization by the entity awarded the contract under subsection 7a7 for access to the database in accordance with this paragraph4 7,b7 ,application ,an entity desiring authorization under this paragraph shall submit to the entity awarded the contract an application for such access1 which shall include-- 7i7 in the case of an entity requesting access for research purposes-- 7,i7 a description of the uses and methodologies for evaluating health system performance using such data2 and 7,,ii7 documentation of approval of the research by an institutional review board1 if applicable for a particular plan of research2 or 7ii7 in the case of an entity such as an employer1 health insurance issuer1 third-party administrator1 or health care provider1 requesting access for the purpose of quality improvement or cost-containment1 a description of the intended uses for such data4 7,c7 ,requirements 7i7 ,research ,upon approval of an application for research purposes under subparagraph 7,b77i71 the authorized user shall enter into a data use and confidentiality agreement with the entity awarded the contract under subsection 7a71 which shall include a prohibition on attempts to reidentify and disclose protected health information and proprietary financial information4 7ii7 ,quality improvement and cost-containment ,in consultation with the ,committee described in subsection 7b77#c71 the ,secretary shall1 through rulemaking1 establish the form and manner in which authorized users described in subparagraph 7,b77ii7 may access data4 ,data provided to such authorized users shall be provided in a form and manner such that users may not obtain individually identifiable price information with respect to direct competitors4 ,upon approval1 such authorized user shall enter into a data use and confidentiality agreement with the entity4 7iii7 ,customized reports ,employers and employer organizations may request customized reports from the entity awarded the contract under subsection 7a71 at cost1 subject to the requirements of this section with respect to privacy1 security1 and proprietary financial information4 7iv7 ,non-customized reports ,the entity awarded the contract under subsection 7a71 in consultation with the ,committee1 shall make available to all authorized users aggregate data sets1 free of charge4 7f7 ,funding 7#a7 ,initial funding ,there are authorized to be appropriated1 and there are appropriated1 out of monies in the ,treasury not otherwise appropriated1 #bj1jjj1jjj for fiscal year #bjbj1 for the implementation of the initial contract and establishment of the database under this section4 7#b7 ,ongoing funding ,there are authorized to be appropriated #ae1jjj1jjj for each of fiscal years #bjba through #bjbe1 for purposes of carrying out this section 7other than the grant program under subsection 7h774 7g7 ,annual report 7#a7 ,submission ,not later than ,march #a1 #bjba1 and ,march #a of each year thereafter1 the entity receiving the contract under subsection 7a7 shall submit to ,congress1 the ,secretary of ,labor1 and the ,secretary of ,health and ,human ,services1 and publish online for access by the general public1 a report containing a description of-- 7,a7 trends in the price1 utilization1 and total spending on health care services1 including a geographic analysis of differences in such trends2 7,b7 limitations in the data set2 7,c7 progress towards the objectives of this section2 and 7,d7 the performance by the entity of the duties required under such contract4 7#b7 ,public reports and research ,the entity receiving a contract under subsection 7a7 shall1 in coordination with authorized users1 make analyses and research available to the public on an ongoing basis to promote the objectives of this section4 7h7 ,grants to ,states 7#a7 ,in general ,the ,secretary1 in consultation with the ,secretary of ,health and ,human ,services1 may award grants to ,states for the purpose of establishing and maintaining ,state all-payer claims databases that improve transparency of data in order to meet the goals of subsection 7a77#a74 7#b7 ,requirement ,to be eligible to receive the funding under paragraph 7#a71 a ,state shall submit data to the database as described in subsection 7b77#a77;,c71 using the format described in subsection 7d77#a74 7#c7 ,funding ,there is authorized to be appropriated #ajj1jjj1jjj for the period of fiscal years #bjbj through #bjbi for the purpose of awarding grants to ,states under this subsection4 7i7 ,exemption from public disclosure 7#a7 ,in general ,claims data provided to the database1 and the database itself shall not be considered public records and shall be exempt from public disclosure requirements4 7#b7 ,restrictions on uses for certain proceedings ,data disclosed to authorized users shall not be subject to discovery or admission as public information1 or evidence in judicial or administrative proceedings without consent of the affected parties4 7j7 ,definitions 7#a7 ,protected health information ,the term protected health information has the meaning given such term in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or any successor regulations74 7#b7 ,proprietary financial information ,the term proprietary financial information means data that would disclose the terms of a specific contract between an individual health care provider or facility and a specific group health plan1 ,medicaid managed care organization or other managed care entity1 or health insurance issuer offering group or individual coverage4 7k7 ,rule of construction ,nothing in this section shall be construed to affect or modify enforcement of the privacy1 security1 or breach notification rules promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7or successor regulations74 4 7b7 ,,gao report 7#a7 ,in general ,the ,comptroller ,general of the ,united ,states shall conduct a study on-- 7,a7 the performance of the entity awarded a contract under section #gce7;a7 of the ,employee ,retirement ,income ,security ,act of #aigd1 as added by subsection 7a71 under such contract2 7,b7 the privacy and security of the information reported to the entity2 and 7,c7 the costs incurred by such entity in performing such duties4 7#b7 ,reports ,not later than #b years after the effective date of the first contract entered into under section #gce7;a7 of the ,employee ,retirement ,income ,security ,act of #aigd1 as added by subsection 7a71 and again not later than #d years after such effective date1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report containing the results of the study conducted under paragraph 7#a71 together with recommendations for such legislation and administrative action as the ,comptroller ,general determines appropriate4 7c7 ,clerical amendment ,the table of contents in section #a of the ,employee ,retirement ,income ,security ,act of #aigd is amended by inserting after the item relating to section #gcd the following new item3 ,sec4 #gce4 ,designation of a nongovernmental1 nonprofit transparency organization to lower ,americans' health care costs4 4 #cjd4 ,protecting patients and improving the accuracy of provider directory information ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq471 as amended by sections #cja and #cjb1 is further amended by adding at the end the following3 #bgbi;,c4 ,protecting patients and improving the accuracy of provider directory information 7a7 ,network status of providers 7#a7 ,in general ,beginning on the date that is one year after the date of enactment of this section1 a group health plan or a health insurance issuer offering group or individual health insurance coverage shall-- 7,a7 establish business processes to ensure that all enrollees in such plan or coverage receive proof of a health care provider's network status-- 7i7 through a written electronic communication from the plan or issuer to the enrollee1 as soon as practicable and not later than #a business day after a telephone inquiry is made by such enrollee for such information2 and 7ii7 in real-time through an online health care provider directory search tool maintained by the plan or issuer2 and 7,b7 include in any print directory a disclosure that the information included in the directory is accurate as of the date of the last data update and that enrollees or prospective enrollees should consult the group health plan or issuer's electronic provider directory on its website or call a specified customer service telephone number to obtain the most current provider directory information4 7#b7 ,group health plan and health insurance issuer business processes ,beginning on the date that is one year after the date of enactment of the ,lower ,health ,care ,costs ,act1 a group health plan or a health insurance issuer offering group or individual health insurance coverage shall establish business processes to-- 7,a7 verify and update1 at least once every #ij days1 the provider directory information for all providers included in the online health care provider directory search tool described in paragraph 7#a77;,a77ii72 and 7,b7 remove any provider from such online directory search tool if such provider has not verified the directory information within the previous #f months or the plan or issuer has been unable to verify the provider's network participation4 7b7 ,cost-,sharing limitations 7#a7 ,in general ,a group health plan or a health insurance issuer offering group or individual health insurance coverage shall not apply1 and shall ensure that no provider applies cost-sharing to an enrollee for treatment or services provided by a health care provider in excess of the normal cost-sharing applied for in-network care 7including any balance bill issued by the health care provider involved71 if such enrollee1 or health care provider referring such enrollee1 demonstrates 7based on the electronic information described in subsection 7a77#a77;,a77i7 or a copy of the online provider directory described in subsection 7a77#a77;,a77ii7 on the date the enrollee attempted to obtain the provider's network status7 that the enrollee relied on the information described in subsection 7a77#a71 if the provider's network status or directory information on such directory was incorrect at the time the treatment or services involved was provided4 7#b7 ,refunds to enrollees ,if a health care provider submits a bill to an enrollee in violation of paragraph 7#a71 and the enrollee pays such bill1 the provider shall reimburse the enrollee for the full amount paid by the enrollee in excess of the in-network cost-sharing amount for the treatment or services involved1 plus interest1 at an interest rate determined by the ,secretary4 7c7 ,provider business processes ,a health care provider shall have in place business processes to ensure the timely provision of provider directory information to a group health plan or a health insurance issuer offering group or individual health insurance coverage to support compliance by such plans or issuers with subsection 7a77#a74 ,such providers shall submit provider directory information to a plan or issuers1 at a minimum-- 7#a7 when the provider begins a network agreement with a plan or with an issuer with respect to certain coverage2 7#b7 when the provider terminates a network agreement with a plan or with an issuer with respect to certain coverage2 7#c7 when there are material changes to the content of provider directory information described in subsection 7a77#a72 and 7#d7 every #ij days throughout the duration of the network agreement with a plan or issuer4 7d7 ,enforcement 7#a7 ,in general ,subject to paragraph 7#b71 a health care provider that violates a requirement under subsection 7c7 or takes actions that prevent a group health plan or health insurance issuer from complying with subsection 7a77#a7 or 7b7 shall be subject to a civil monetary penalty of not more than #aj1jjj for each act constituting such violation4 7#b7 ,safe harbor ,the ,secretary may waive the penalty described under paragraph 7#a7 with respect to a health care provider that unknowingly violates subsection 7b77#a7 with respect to an enrollee if such provider rescinds the bill involved and1 if applicable1 reimburses the enrollee within #cj days of the date on which the provider billed the enrollee in violation of such subsection4 7#c7 ,procedure ,the provisions of section #aabh;,a of the ,social ,security ,act1 other than subsections 7a7 and 7b7 and the first sentence of subsection 7c77#a7 of such section1 shall apply to civil money penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a of the ,social ,security ,act4 7e7 ,savings clause ,nothing in this section shall prohibit a provider from requiring in the terms of a contract1 or contract termination1 with a group health plan or health insurance issuer-- 7#a7 that the plan or issuer remove1 at the time of termination of such contract1 the provider from a directory of the plan or issuer described in subsection 7a77#a72 or 7#b7 that the plan or issuer bear financial responsibility1 including under subsection 7b71 for providing inaccurate network status information to an enrollee4 7f7 ,definition ,for purposes of this section1 the term provider directory information includes the names1 addresses1 specialty1 and telephone numbers of individual health care providers1 and the names1 addresses1 and telephone numbers of each medical group1 clinic1 or facility contracted to participate in any of the networks of the group health plan or health insurance coverage involved4 7g7 ,rule of construction ,nothing in this section shall be construed to preempt any provision of ,state law relating to health care provider directories or network adequacy4 4 #cje4 ,timely bills for patients 7a7 ,in general 7#a7 ,amendment ,part ,p of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is amended by adding at the end the following3 #cii,v-#g4 ,timely bills for patients 7a7 ,in general ,the ,secretary shall require-- 7#a7 health care facilities1 or in the case of practitioners providing services outside of such a facility1 practitioners1 to provide to patients a list of services rendered during the visit to such facility or practitioner1 and1 in the case of a facility1 the name of the provider for each such service1 upon discharge or by postal or electronic communication as soon as practicable and not later than #e calendar days after discharge2 and 7#b7 health care facilities and practitioners to send all adjudicated bills to the patient as soon as practicable1 but not later than #de calendar days after discharge4 7b7 ,payment after billing ,no patient may be required to pay a bill for health care services any earlier than #cj calendar days after receipt of a bill for such services4 7c7 ,effect of violation 7#a7 ,notification and refund requirements 7,a7 ,provider lists ,if a facility or practitioner fails to provide a patient a list as required under subsection 7a77#a71 such facility or practitioner shall report such failure to the ,secretary4 7,b7 ,billing ,if a facility or practitioner bills a patient after the #de-;calendar-day period described in subsection 7a77#b71 such facility or practitioner shall-- 7i7 report such bill to the ,secretary2 and 7ii7 refund the patient for the full amount paid in response to such bill with interest1 at a rate determined by the ,secretary4 7#b7 ,civil monetary penalties 7,a7 ,in general ,the ,secretary may impose civil monetary penalties of up to #aj1jjj a day on any facility or practitioner that-- 7i7 fails to provide a list required under subsection 7a77#a7 more than #aj times1 beginning on the date of such tenth failure2 7ii7 submits more than #aj bills outside of the period described in subsection 7a77#b71 beginning on the date on which such facility or practitioner sends the tenth such bill2 7iii7 fails to report to the ,secretary any failure to provide lists as required under paragraph 7#a77;,a71 beginning on the date that is #de calendar days after discharge2 or 7iv7 fails to send any bill as required under subsection 7a77#b71 beginning on the date that is #de calendar days after the date of discharge or visit1 as applicable4 7,b7 ,procedure ,the provisions of section #aabh;,a of the ,social ,security ,act1 other than subsections 7a7 and 7b7 and the first sentence of subsection 7c77#a7 of such section1 shall apply to civil money penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a of the ,social ,security ,act4 7#c7 ,safe harbor ,the ,secretary may exempt a practitioner or facility from the penalties under paragraph 7#b77;,a7 or extend the period of time specified under subsection 7a77#b7 for compliance with such subsection if a practitioner or facility-- 7,a7 makes a good faith attempt to send a bill within #cj days but is unable to do so because of an incorrect address2 or 7,b7 experiences extenuating circumstances 7as defined by the ,secretary71 such as a hurricane or cyberattack1 that may reasonably delay delivery of a timely bill4 4 7#b7 ,rulemaking ,not later than #a year after the date of enactment of this ,act1 the ,secretary shall promulgate final regulations to define the term extenuating circumstance for purposes of section #cii,v-#g7;c77#c77;,b7 of the ,public ,health ,service ,act1 as added by paragraph 7#a74 7b7 ,group health plan and health insurance issuer requirements ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa71 as amended by section #cjd1 is further amended by adding to the end the following3 #bgbi;,d4 ,timely bills for patients 7a7 ,in general ,a group health plan or health insurance issuer offering group or individual health insurance coverage shall have in place business practices with respect to in-network facilities and practitioners to ensure that claims are adjudicated in order to facilitate facility and practitioner compliance with the requirements under section #cii,v-#g7;a74 7b7 ,clarification ,nothing in subsection 7a7 prohibits a provider and a group health plan or health insurance issuer from establishing in a contract the timeline for submission by either party to the other party of billing information1 adjudication1 sending of remittance information1 or any other coordination required between the provider and the plan or issuer necessary for meeting the deadline described in section #cii,v-#g7;a77#b74 4 7c7 ,effective date ,the amendments made by subsections 7a7 and 7b7 shall take effect #f months after the date of enactment of this ,act4 #cjf4 ,health plan oversight of pharmacy benefit manager services ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq471 as amended by section #cje1 is further amended by adding at the end the following3 #bgbi;,e4 ,health plan oversight of pharmacy benefit manager services 7a7 ,in general ,a group health plan or health insurance issuer offering group or individual health insurance coverage or an entity or subsidiary providing pharmacy benefits management services shall not enter into a contract with a drug manufacturer1 distributor1 wholesaler1 subcontractor1 rebate aggregator1 or any associated third party that limits the disclosure of information to plan sponsors in such a manner that prevents the plan or coverage1 or an entity or subsidiary providing pharmacy benefits management services on behalf of a plan or coverage from making the reports described in subsection 7b74 7b7 ,reports to group plan sponsors 7#a7 ,in general ,beginning with the first plan year that begins after the date of enactment of the ,lower ,health ,care ,costs ,act1 not less frequently than once per plan quarter1 a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefits management services on behalf of a group health plan shall submit to the plan sponsor 7as defined in section #c7af77;,b7 of the ,employee ,retirement ,income ,security ,act of #aigd7 of such group health plan or health insurance coverage a report in accordance with this subsection and make such report available to the plan sponsor in a machine-readable format4 ,each such report shall include1 with respect to the applicable group health plan or health insurance coverage-- 7,a7 information collected from drug manufacturers by such issuer or entity on the total amount of copayment assistance dollars paid1 or copayment cards applied1 that were funded by the drug manufacturer with respect to the enrollees in such plan or coverage2 7,b7 a list of each covered drug dispensed during the reporting period1 including1 with respect to each such drug during the reporting period-- 7i7 the brand name1 chemical entity1 and ,national ,drug ,code2 7ii7 the number of enrollees for whom the drug was filled during the plan year1 the total number of prescription fills for the drug 7including original prescriptions and refills71 and the total number of dosage units of the drug dispensed across the plan year1 including whether the dispensing channel was by retail1 mail order1 or specialty pharmacy2 7iii7 the wholesale acquisition cost1 listed as cost per days supply and cost per pill1 or in the case of a drug in another form1 per dose2 7iv7 the total out-of-pocket spending by enrollees on such drug1 including enrollee spending through copayments1 coinsurance1 and deductibles2 and 7v7 for any drug for which gross spending of the group health plan or health insurance coverage exceeded #aj1jjj during the reporting period-- 7,i7 a list of all other available drugs in the same therapeutic category or class1 including brand name drugs and biological products and generic drugs or biosimilar biological products that are in the same therapeutic category or class2 and 7,,ii7 the rationale for preferred formulary placement of a particular drug or drugs in that therapeutic category or class2 7,c7 a list of each therapeutic category or class of drugs that were dispensed under the health plan or health insurance coverage during the reporting period1 and1 with respect to each such therapeutic category or class of drugs1 during the reporting period-- 7i7 total gross spending by the plan1 before manufacturer rebates1 fees1 or other manufacturer remuneration2 7ii7 the number of enrollees who filled a prescription for a drug in that category or class2 7iii7 if applicable to that category or class1 a description of the formulary tiers and utilization mechanisms 7such as prior authorization or step therapy7 employed for drugs in that category or class2 7iv7 the total out-of-pocket spending by enrollees1 including enrollee spending through copayments1 coinsurance1 and deductibles2 and 7v7 for each therapeutic category or class under which three or more drugs are marketed and available-- 7,i7 the amount received1 or expected to be received1 from drug manufacturers in rebates1 fees1 alternative discounts1 or other remuneration-- 7aa7 to be paid by drug manufacturers for claims incurred during the reporting period2 or 7bb7 that is related to utilization of drugs1 in such therapeutic category or class2 7,,ii7 the total net spending by the health plan or health insurance coverage on that category or class of drugs2 and 7,,iii7 the net price per dosage unit or course of treatment incurred by the health plan or health insurance coverage and its enrollees1 after manufacturer rebates1 fees1 and other remuneration for drugs dispensed within such therapeutic category or class during the reporting period2 7,d7 total gross spending on prescription drugs by the plan or coverage during the reporting period1 before rebates and other manufacturer fees or remuneration2 7,e7 total amount received1 or expected to be received1 by the health plan or health insurance coverage in drug manufacturer rebates1 fees1 alternative discounts1 and all other remuneration received from the manufacturer or any third party related to utilization of drug or drug spending under that health plan or health insurance coverage during the reporting period2 7,f7 the total net spending on prescription drugs by the health plan or health insurance coverage during the reporting period2 and 7,g7 amounts paid directly or indirectly in rebates1 fees1 or any other type of remuneration to brokers1 consultants1 advisors1 or any other individual or firm who referred the group health plan's or health insurance issuer's business to the pharmacy benefit manager4 7#b7 ,privacy requirements ,health insurance issuers offering group health insurance coverage and entities providing pharmacy benefits management services on behalf of a group health plan shall provide information under paragraph 7#a7 in a manner consistent with the privacy1 security1 and breach notification regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7or successor regulations71 and shall restrict the use and disclosure of such information according to such privacy regulations4 7#c7 ,disclosure and redisclosure 7,a7 ,limitation to business associates ,a group health plan receiving a report under paragraph 7#a7 may disclose such information only to business associates of such plan as defined in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or successor regulations74 7,b7 ,clarification regarding public disclosure of information ,nothing in this section prevents a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefits management services on behalf of a group health plan from placing reasonable restrictions on the public disclosure of the information contained in a report described in paragraph 7#a74 7c7 ,limitations on spread pricing 7#a7 ,prescription drug transactions with pharmacies independent of the issuer or pharmacy benefits manager ,if the pharmacy that dispenses a prescription drug to an enrollee in a group health plan or group or individual health insurance coverage is not wholly or partially owned by such plan1 such issuer1 or an entity providing pharmacy benefit management services under such plan or coverage1 such plan1 issuer1 or entity shall not charge the plan1 issuer1 or enrollee a price for such prescription drug that exceeds the price paid to the pharmacy1 excluding penalties paid by pharmacies to such plan1 issuer1 or entity4 7#b7 ,intra-company prescription drug transactions ,if the mail order1 specialty1 or retail pharmacy that dispenses a prescription drug to an enrollee in a group health plan or health insurance coverage is wholly or partially owned by such health insurance issuer or an entity providing pharmacy benefit management services under a group health plan or group or individual health insurance coverage1 the price charged for such drug by such pharmacy to such group health plan or health insurance issuer offering group or individual health insurance coverage may not exceed the lesser of-- 7,a7 the wholesale acquisition cost of the drug paid by the pharmacy1 plus clearly documented dispensing costs1 including pharmacy profit2 or 7,b7 the median price charged to the group health plan or health insurance issuer when the same drug is dispensed to enrollees in the plan or coverage by other similarly situated pharmacies not wholly or partially owned by the health insurance issuer or entity providing pharmacy benefits management services1 as described in paragraph 7#a74 7#c7 ,supplementary reporting for intra-company prescription drug transactions ,a health insurance issuer of group health insurance coverage or an entity providing pharmacy benefits management services under a group health plan or group health insurance coverage that conducts transactions with a wholly or partially owned pharmacy1 as described in paragraph 7#b71 shall submit1 together with the report under subsection 7b71 a supplementary quarterly report to the plan sponsor that includes-- 7,a7 an explanation of any benefit design parameters that encourage enrollees in the plan or coverage to fill prescriptions at mail order1 specialty1 or retail pharmacies that are wholly or partially owned by that issuer or entity2 7,b7 the percentage of total prescriptions charged to the plan1 coverage1 or enrollees in the plan or coverage1 that were dispensed by mail order1 specialty1 or retail pharmacies that are wholly or partially owned by the issuer or entity providing pharmacy benefits management services2 and 7,c7 a list of all drugs dispensed by such wholly or partially owned pharmacy and charged to the plan or coverage1 or enrollees of the plan or coverage1 during the applicable quarter1 and1 with respect to each drug-- 7i7 the amount charged per dosage unit or course of treatment with respect to enrollees in the plan or coverage1 including amounts charged to the plan or coverage and amounts charged to the enrollee2 7ii7 the median amount charged to the plan or coverage1 per dosage unit or course of treatment1 and including amounts paid by the enrollee1 when the same drug is dispensed by other pharmacies that are not wholly or partially owned by the issuer or entity and that are included in the pharmacy network of that plan or coverage2 7iii7 the interquartile range of the costs1 per dosage unit or course of treatment1 and including amounts paid by the enrollee1 when the same drug is dispensed by other pharmacies that are not wholly or partially owned by the issuer or entity and that are included in the pharmacy network of that plan or coverage2 and 7iv7 the lowest cost per dosage unit or course of treatment1 for such drug1 including amounts charged to the plan or issuer and enrollee1 that is available from any pharmacy included in the network of the plan or coverage4 7d7 ,full rebate pass-,through to plan 7#a7 ,in general ,a pharmacy benefits manager1 a third-party administrator of a group health plan1 a health insurance issuer offering group health insurance coverage1 or an entity providing pharmacy benefits management services under such health plan or health insurance coverage shall remit #ajj percent of rebates1 fees1 alternative discounts1 and all other remuneration received from a pharmaceutical manufacturer1 distributor or any other third party1 that are related to utilization of drugs under such health plan or health insurance coverage1 to the group health plan4 7#b7 ,form and manner of remittance ,such rebates1 fees1 alternative discounts1 and other remuneration shall be-- 7,a7 remitted to the group health plan in a timely fashion after the period for which such rebates1 fees1 or other remuneration is calculated1 and in no case later than #ij days after the end of such period2 7,b7 fully disclosed and enumerated to the group health plan sponsor1 as described in 7b77#a72 and 7,c7 available for audit by the plan sponsor1 or a third-party designated by a plan sponsor no less than once per plan year4 7e7 ,enforcement 7#a7 ,failure to provide timely information ,a health insurance issuer or an entity providing pharmacy benefit management services that violates subsection 7a71 fails to provide information required under subsection 7b71 engages in spread pricing as defined in subsection 7c71 or fails to comply with the requirements of subsection 7d71 or a drug manufacturer that fails to provide information under subsection 7b77#a77;,a71 in a timely manner shall be subject to a civil monetary penalty in the amount of #aj1jjj for each day during which such violation continues or such information is not disclosed or reported4 7#b7 ,false information ,a health insurance issuer1 entity providing pharmacy benefit management services1 or drug manufacturer that knowingly provides false information under this section shall be subject to a civil money penalty in an amount not to exceed #ajj1jjj for each item of false information4 ,such civil money penalty shall be in addition to other penalties as may be prescribed by law4 7#c7 ,procedure ,the provisions of section #aabh;,a of the ,social ,security ,act1 other than subsections 7a7 and 7b7 and the first sentence of subsection 7c77#a7 of such section shall apply to civil monetary penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a of the ,social ,security ,act4 7f7 ,definitions ,in this section-- 7#a7 the term similarly situated pharmacy means1 with respect to a particular pharmacy1 another pharmacy that is approximately the same size 7as measured by the number of prescription drugs dispensed71 and that serves patients in the same geographical area1 whether through physical locations or mail order2 and 7#b7 the term wholesale acquisition cost has the meaning given such term in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act4 4 #cjg4 ,government ,accountability ,office study on profit- and revenue-sharing in health care 7a7 ,study ,not later than #a year after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct a study to-- 7#a7 describe what is known about profit- and revenue-sharing relationships in the commercial health care markets1 including those relationships that-- 7,a7 involve one or more-- 7i7 physician groups that practice within a hospital included in the profit- or revenue-sharing relationship1 or refer patients to such hospital2 7ii7 laboratory1 radiology1 or pharmacy services that are delivered to privately insured patients of such hospital2 7iii7 surgical services2 7iv7 hospitals or group purchasing organizations2 or 7v7 rehabilitation or physical therapy facilities or services2 and 7,b7 include revenue- or profit-sharing whether through a joint venture1 management or professional services agreement1 or other form of gain-sharing contract2 7#b7 describe ,federal oversight of such relationships1 including authorities of the ,department of ,health and ,human ,services and the ,federal ,trade ,commission to review such relationships and their potential to increase costs for patients1 and identify limitations in such oversight2 and 7#c7 as appropriate1 make recommendations to improve ,federal oversight of such relationships4 7b7 ,report ,not later than #a year after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall prepare and submit a report on the study conducted under subsection 7a7 to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,education and ,labor and the ,committee on ,energy and ,commerce of the ,house of ,representatives4 #cjh4 ,disclosure of direct and indirect compensation for brokers and consultants to employer-sponsored health plans and enrollees in plans on the individual market 7a7 ,group health plans ,section #djh7;b77#b7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77 is amended-- 7#a7 by striking 7#b7 ,contracting or making and inserting 7#b77;,a7 ,contracting or making2 and 7#b7 by adding at the end the following3 7,b7 7i7 ,no contract or arrangement for services between a covered plan and a covered service provider1 and no extension or renewal of such a contract or arrangement1 is reasonable within the meaning of this paragraph unless the requirements of this clause are met4 7ii7 7,i7 ,for purposes of this subparagraph3 7aa7 ,the term covered plan means a group health plan as defined section #gcc7;a74 7bb7 ,the term covered service provider means a service provider that enters into a contract or arrangement with the covered plan and reasonably expects #a1jjj 7or such amount as the ,secretary may establish in regulations to account for inflation since the date of enactment of the ,lower ,health ,care ,costs ,act1 as appropriate7 or more in compensation1 direct or indirect1 to be received in connection with providing one or more of the following services1 pursuant to the contract or arrangement1 regardless of whether such services will be performed1 or such compensation received1 by the covered service provider1 an affiliate1 or a subcontractor3 7,,aa7 ,brokerage services1 for which the covered service provider1 an affiliate1 or a subcontractor reasonably expects to receive indirect compensation or direct compensation described in item 7dd71 provided to a covered plan with respect to selection of insurance products 7including vision and dental71 recordkeeping services1 medical management vendor1 benefits administration 7including vision and dental71 stop-loss insurance1 pharmacy benefit management services1 wellness services1 transparency tools and vendors1 group purchasing organization preferred vendor panels1 disease management vendors and products1 compliance services1 employee assistance programs1 or third-party administration services4 7,,bb7 ,consulting1 for which the covered service provider1 an affiliate1 or a subcontractor reasonably expects to receive indirect compensation or direct compensation described in item 7dd71 related to the development or implementation of plan design1 insurance or insurance product selection 7including vision and dental71 recordkeeping1 medical management1 benefits administration selection 7including vision and dental71 stop-loss insurance1 pharmacy benefit management services1 wellness design and management services1 transparency tools1 group purchasing organization agreements and services1 participation in and services from preferred vendor panels1 disease management1 compliance services1 employee assistance programs1 or third-party administration services4 7cc7 ,the term affiliate1 with respect to a covered service provider1 means an entity that directly or indirectly 7through one or more intermediaries7 controls1 is controlled by1 or is under common control with1 such provider1 or is an officer1 director1 or employee of1 or partner in1 such provider4 7dd7 7,,aa7 ,the term compensation means anything of monetary value1 but does not include non-monetary compensation valued at #bej 7or such amount as the ,secretary may establish in regulations to account for inflation since the date of enactment of the ,lower ,health ,care ,costs ,act1 as appropriate7 or less1 in the aggregate1 during the term of the contract or arrangement4 7,,bb7 ,the term direct compensation means compensation received directly from a covered plan4 7,,cc7 ,the term indirect compensation means compensation received from any source other than the covered plan1 the plan sponsor1 the covered service provider1 or an affiliate4 ,compensation received from a subcontractor is indirect compensation1 unless it is received in connection with services performed under a contract or arrangement with a subcontractor4 7ee7 ,the term responsible plan fiduciary means a fiduciary with authority to cause the covered plan to enter into1 or extend or renew1 the contract or arrangement4 7ff7 ,the term subcontractor means any person or entity 7or an affiliate of such person or entity7 that is not an affiliate of the covered service provider and that1 pursuant to a contract or arrangement with the covered service provider or an affiliate1 reasonably expects to receive #a1jjj 7or such amount as the ,secretary may establish in regulations to account for inflation since the date of enactment of the ,lower ,health ,care ,costs ,act1 as appropriate7 or more in compensation for performing one or more services described in item 7bb7 under a contract or arrangement with the covered plan4 7,,ii7 ,for purposes of this subparagraph1 a description of compensation or cost may be expressed as a monetary amount1 formula1 or a per capita charge for each enrollee or1 if the compensation or cost cannot reasonably be expressed in such terms1 by any other reasonable method1 including a disclosure that additional compensation may be earned but may not be calculated at the time of contract if such a disclosure includes a description of the circumstances under which the additional compensation may be earned and a reasonable and good faith estimate if the covered service provider cannot otherwise readily describe compensation or cost and explains the methodology and assumptions used to prepare such estimate4 ,any such description shall contain sufficient information to permit evaluation of the reasonableness of the compensation or cost4 7,,iii7 ,no person or entity is a covered service provider within the meaning of subclause 7,i77bb7 solely on the basis of providing services as an affiliate or a subcontractor that is performing one or more of the services described in subitem 7,,aa7 or 7,,bb7 of such subclause under the contract or arrangement with the covered plan4 7iii7 ,a covered service provider shall disclose to a responsible plan fiduciary1 in writing1 the following3 7,i7 ,a description of the services to be provided to the covered plan pursuant to the contract or arrangement4 7,,ii7 ,if applicable1 a statement that the covered service provider1 an affiliate1 or a subcontractor will provide1 or reasonably expects to provide1 services pursuant to the contract or arrangement directly to the covered plan as a fiduciary 7within the meaning of section #c7ba774 7,,iii7 ,a description of all direct compensation1 either in the aggregate or by service1 that the covered service provider1 an affiliate1 or a subcontractor reasonably expects to receive in connection with the services described in subclause 7,i74 7,,iv7 7aa7 ,a description of all indirect compensation that the covered service provider1 an affiliate1 or a subcontractor reasonably expects to receive in connection with the services described in subclause 7,i7-- 7,,aa7 including compensation from a vendor to a brokerage firm based on a structure of incentives not solely related to the contract with the covered plan2 and 7,,bb7 not including compensation received by an employee from an employer on account of work performed by the employee4 7bb7 ,a description of the arrangement between the payer and the covered service provider1 an affiliate1 or a subcontractor1 as applicable1 pursuant to which such indirect compensation is paid4 7cc7 ,identification of the services for which the indirect compensation will be received1 if applicable4 7dd7 ,identification of the payer of the indirect compensation4 7,v7 ,a description of any compensation that will be paid among the covered service provider1 an affiliate1 or a subcontractor1 in connection with the services described in subclause 7,i7 if such compensation is set on a transaction basis 7such as commissions1 finder's fees1 or other similar incentive compensation based on business placed or retained71 including identification of the services for which such compensation will be paid and identification of the payers and recipients of such compensation 7including the status of a payer or recipient as an affiliate or a subcontractor71 regardless of whether such compensation also is disclosed pursuant to subclause 7,,iii7 or 7,,iv74 7,,vi7 ,a description of any compensation that the covered service provider1 an affiliate1 or a subcontractor reasonably expects to receive in connection with termination of the contract or arrangement1 and how any prepaid amounts will be calculated and refunded upon such termination4 7iv7 ,a covered service provider shall disclose to a responsible plan fiduciary1 in writing a description of the manner in which the compensation described in clause 7iii71 as applicable1 will be received4 7v7 7,i7 ,a covered service provider shall disclose the information required under clauses 7iii7 and 7iv7 to the responsible plan fiduciary not later than the date that is reasonably in advance of the date on which the contract or arrangement is entered into1 and extended or renewed4 7,,ii7 ,a covered service provider shall disclose any change to the information required under clauses 7iii7 and 7iv7 as soon as practicable1 but not later than #fj days from the date on which the covered service provider is informed of such change1 unless such disclosure is precluded due to extraordinary circumstances beyond the covered service provider's control1 in which case the information shall be disclosed as soon as practicable4 7vi7 7,i7 ,upon the written request of the responsible plan fiduciary or covered plan administrator1 a covered service provider shall furnish any other information relating to the compensation received in connection with the contract or arrangement that is required for the covered plan to comply with the reporting and disclosure requirements under this ,act4 7,,ii7 ,the covered service provider shall disclose the information required under clause 7iii77,i7 reasonably in advance of the date upon which such responsible plan fiduciary or covered plan administrator states that it is required to comply with the applicable reporting or disclosure requirement1 unless such disclosure is precluded due to extraordinary circumstances beyond the covered service provider's control1 in which case the information shall be disclosed as soon as practicable4 7vii7 ,no contract or arrangement will fail to be reasonable under this subparagraph solely because the covered service provider1 acting in good faith and with reasonable diligence1 makes an error or omission in disclosing the information required pursuant to clause 7iii7 7or a change to such information disclosed pursuant to clause 7v77,,ii77 or clause 7vi71 provided that the covered service provider discloses the correct information to the responsible plan fiduciary as soon as practicable1 but not later than #cj days from the date on which the covered service provider knows of such error or omission4 7viii7 7,i7 ,pursuant to subsection 7a71 subparagraphs 7,c7 and 7,d7 of section #djf7;a77#a7 shall not apply to a responsible plan fiduciary1 notwithstanding any failure by a covered service provider to disclose information required under clause 7iii71 if the following conditions are met3 7aa7 ,the responsible plan fiduciary did not know that the covered service provider failed or would fail to make required disclosures and reasonably believed that the covered service provider disclosed the information required to be disclosed4 7bb7 ,the responsible plan fiduciary1 upon discovering that the covered service provider failed to disclose the required information1 requests in writing that the covered service provider furnish such information4 7cc7 ,if the covered service provider fails to comply with a written request described in subclause 7,,ii7 within #ij days of the request1 the responsible plan fiduciary notifies the ,secretary of the covered service provider's failure1 in accordance with subclauses 7,,ii7 and 7,,iii74 7,,ii7 ,a notice described in subclause 7,i77cc7 shall contain-- 7aa7 the name of the covered plan2 7bb7 the plan number used for the annual report on the covered plan2 7cc7 the plan sponsor's name1 address1 and employer identification number2 7dd7 the name1 address1 and telephone number of the responsible plan fiduciary2 7ee7 the name1 address1 phone number1 and1 if known1 employer identification number of the covered service provider2 7ff7 a description of the services provided to the covered plan2 7gg7 a description of the information that the covered service provider failed to disclose2 7hh7 the date on which such information was requested in writing from the covered service provider2 and 7ii7 a statement as to whether the covered service provider continues to provide services to the plan4 7,,iii7 ,a notice described in subclause 7,i77cc7 shall be filed with the ,department not later than #cj days following the earlier of-- 7aa7 the covered service provider's refusal to furnish the information requested by the written request described in subclause 7,i77bb72 or 7bb7 #ij days after the written request referred to in subclause 7,i77cc7 is made4 7,,iv7 ,if the covered service provider fails to comply with the written request under subclause 7,i77bb7 within #ij days of such request1 the responsible plan fiduciary shall determine whether to terminate or continue the contract or arrangement under section #djd4 ,if the requested information relates to future services and is not disclosed promptly after the end of the #ij-;day period1 the responsible plan fiduciary shall terminate the contract or arrangement as expeditiously as possible1 consistent with such duty of prudence4 7ix7 ,nothing in this subparagraph shall be construed to supersede any provision of ,state law that governs disclosures by parties that provide the services described in this section1 except to the extent that such law prevents the application of a requirement of this section4 4 7b7 ,applicability of existing regulations ,nothing in the amendments made by subsection 7a7 shall be construed to affect the applicability of section #beej4djh;b-#b of title #bi1 ,code of ,federal ,regulations 7or any successor regulations71 with respect to any applicable entity other than a covered plan or a covered service provider 7as defined in section #djh7;b77#b77;,b77ii7 of the ,employee ,retirement ,income ,security ,act of #aigd1 as amended by subsection 7a774 7c7 ,individual market coverage ,subpart #a of part ,b of title ,,xvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#da et seq47 is amended by adding at the end the following3 #bgdf4 ,disclosure to enrollees of individual market coverage 7a7 ,in general ,a health insurance issuer offering individual health insurance coverage shall make disclosures to enrollees in such coverage1 as described in subsection 7b71 and reports to the ,secretary1 as described in subsection 7c71 regarding direct or indirect compensation provided to an agent or broker associated with enrolling individuals in such coverage4 7b7 ,disclosure ,a health insurance issuer described in subsection 7a7 shall disclose to an enrollee the amount of direct or indirect compensation provided to an agent or broker for services provided by such agent or broker associated with plan selection and enrollment4 ,such disclosure shall be-- 7#a7 made prior to the individual finalizing plan selection2 and 7#b7 included on any documentation confirming the individual's enrollment4 7c7 ,reporting ,a health insurance issuer described in subsection 7a7 shall report to the ,secretary any direct or indirect compensation provided to an agent or broker associated with enrolling individuals in such coverage4 7d7 ,rulemaking ,not later than #a year after the date of enactment of the ,lower ,health ,care ,costs ,act1 the ,secretary shall finalize1 through notice-and-comment rulemaking1 the form and manner in which issuers described in subsection 7a7 are required to make the disclosures described in subsection 7b7 and the reports described in subsection 7c74 4 7d7 ,transition rule ,no contract executed prior to the effective date described in subsection 7e7 by a group health plan subject to the requirements of section #djh7;b77#b77;,b7 of the ,employee ,retirement ,income ,security ,act of #aigd 7as amended by subsection 7a77 or by a health insurance issuer subject to the requirements of section #bgdf of the ,public ,health ,service ,act 7as added by subsection 7c77 shall be subject to the requirements of such section #djh7;b77#b77;,b7 or such section #bgdf1 as applicable4 7e7 ,effective date ,the amendments made by subsections 7a7 and 7c7 shall take effect #b years after the date of enactment of this ,act4 #cji4 ,ensuring enrollee access to cost-sharing information 7a7 ,in general ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq471 as amended by section #cjf1 is further amended by adding at the end the following3 #bgbi;,f4 ,provision of cost-sharing information 7a7 ,provider disclosures ,a provider that is in-network with respect to a group health plan or a health insurance issuer offering group or individual health insurance coverage shall provide to an enrollee in the plan or coverage who submits a request for the information described in paragraph 7#a7 or 7#b71 together with accurate and complete information about the enrollee's coverage under the applicable plan or coverage-- 7#a7 as soon as practicable and not later than #b business days after the enrollee requests such information1 a good faith estimate of the expected enrollee cost-sharing for the provision of a particular health care service 7including any service that is reasonably expected to be provided in conjunction with such specific service72 and 7#b7 as soon as practicable and not later than #b business days after an enrollee requests such information1 the contact information for any ancillary providers for a scheduled health care service4 7b7 ,insurer disclosures ,a group health plan or a health insurance issuer offering group or individual health insurance coverage shall provide an enrollee in the plan or coverage with a good faith estimate of the enrollee's cost-sharing 7including deductibles1 copayments1 and coinsurance7 for which the enrollee would be responsible for paying with respect to a specific health care service 7including any service that is reasonably expected to be provided in conjunction with such specific service71 as soon as practicable and not later than #b business days after receiving a request for such information by an enrollee4 7c7 ,enforcement 7#a7 ,in general ,subject to paragraph 7#b71 a health care provider that violates a requirement under subsection 7a7 shall be subject to a civil monetary penalty of not more than #aj1jjj for each act constituting such violation4 7#b7 ,procedure ,the provisions of section #aabh;,a of the ,social ,security ,act1 other than subsections 7a7 and 7b7 and the first sentence of subsection 7c77#a7 of such section1 shall apply to civil money penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a of the ,social ,security ,act4 4 7b7 ,effective date ,section #bgbi;,g of the ,public ,health ,service ,act1 as added by subsection 7a71 shall apply with respect to plan years beginning on or after ,january #a1 #bjba4 #caj4 ,strengthening parity in mental health and substance use disorder benefits ,section #bgbf of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#bf7 is amended-- 7#a7 in subsection 7a71 by adding at the end the following3 7#h7 ,compliance requirements 7,a7 ,nonquantitative treatment limitation 7nqtl7 requirements ,in the case of a group health plan or a health insurance issuer offering group or individual health insurance coverage that provides both medical and surgical benefits and mental health or substance use disorder benefits1 the plan or coverage shall perform comparative analyses about the design and application of nonquantitative treatment limitations 7referred to in this paragraph as the ,,nqtl7 in accordance with the following process1 and make available to the ,secretary upon request within #fj days beginning ,january #a1 #bjbj1 and within #cj days beginning ,january #a1 #bjba1 the following information3 7i7 ,the specific plan or coverage language regarding the ,,nqtl1 that applies to such plan or coverage1 and a description of all mental health or substance use disorder and medical_/surgical services to which it applies in each respective benefits classification4 7ii7 ,the factors used to determine that an ,,nqtl will apply to mental health or substance use disorder benefits and medical_/surgical benefits4 7iii7 ,the evidentiary standard 7both identified and deidentified7 for the factors identified in clause 7ii7 and any other evidence relied upon to design and apply the ,,nqtl to mental health or substance use disorder benefits and medical_/surgical benefits4 7iv7 ,the comparative analyses demonstrating that the processes and strategies used to design the ,,nqtl1 as written and in operation1 and the as written processes and strategies used to apply the ,,nqtl for mental health or substance use disorder benefits are comparable to1 and are applied no more stringently than1 the processes and strategies used to design the ,,nqtl1 as written and in operation1 and the as written processes and strategies used to apply the ,,nqtl to medical_/surgical benefits4 7v7 ,a disclosure of the specific findings and conclusions reached by the plan or coverage that the results of the analyses described in this subparagraph indicate that the plan or coverage is in compliance with this section4 7,b7 ,secretary request process 7i7 ,submission upon complaint ,the ,secretary shall request that a group health plan or a health insurance issuer offering group or individual health insurance coverage submit the comparative analyses described in subparagraph 7,a7 if the ,secretary has received any complaints from plan participants or participating providers about such a plan or coverage that involve mental health or substance use disorder benefits4 7ii7 ,random submissions ,the ,secretary shall request the comparative analyses described in subparagraph 7,a7 from no fewer than #ej plans or coverages selected at random1 annually1 and such plans or coverages shall not-- 7,i7 be the same plans or coverages for which the comparative analyses are requested under clause 7i72 7,,ii7 be the same plan or coverage being investigated by the ,department regarding ,n,q,t,ls or that has been investigated by the ,department regarding ,n,q,t,ls within the last #e years2 and 7,,iii7 be the same plan or coverage that has been selected under clause 7i7 or 7ii7 within the last #e years4 7iii7 ,additional information ,in instances in which the ,secretary has concluded that the plan or coverage has not submitted sufficient information for the ,secretary to review the comparative analyses described in subparagraph 7,a71 as requested under clauses 7i7 and 7ii71 the ,secretary shall specify to the plan or coverage the information the plan or coverage must submit to be responsive to the request under clauses 7i7 and 7ii7 for the ,secretary to review the comparative analyses described in subparagraph 7,a7 for compliance with this section4 7iv7 ,required action ,in instances in which the ,secretary has reviewed the comparative analyses described in subparagraph 7,a71 as requested under clauses 7i7 and 7ii71 and determined that the plan or coverage is not in compliance with this section1 the ,secretary shall specify to the plan or coverage the actions the plan or coverage must take to be in compliance with this section4 ,documents or communications produced in connection with the ,secretary's recommendations to the plan or coverage shall not be subject to disclosure pursuant to section #eeb of title #e1 ,united ,states ,code4 7v7 ,report ,not later than #a year after the date of enactment of this paragraph1 and annually thereafter1 the ,secretary shall submit to the ,committee on ,education and ,labor of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report that contains-- 7,i7 each of the comparative analyses requested under clauses 7i7 and 7ii71 except that the identity of each plan or coverage and any contracted entity of a plan or coverage shall be redacted2 7,,ii7 the ,secretary's conclusions as to whether each plan or coverage submitted sufficient information for the ,secretary to review the comparative analyses requested under clauses 7i7 and 7ii7 for compliance with this section2 7,,iii7 for each plan or coverage that did submit sufficient information for the ,secretary to review the comparative analyses requested under clause 7i71 the ,secretary's conclusions as to whether and why the plan or coverage is in compliance with this section2 7,,iv7 the ,secretary's specifications described in clause 7iii7 for each plan or coverage that the ,secretary determined did not submit sufficient information for the ,secretary to review the comparative analyses requested under clauses 7i7 and 7ii7 for compliance with this section2 and 7,v7 the ,secretary's specifications described in clause 7iv7 of the actions each plan or coverage that the ,secretary determined is not in compliance with this section must take to be in compliance with this section1 including the reason why the ,secretary determined the plan or coverage is not in compliance4 7,c7 ,compliance program guidance document update process 7i7 ,in general ,the ,secretary shall include select instances of noncompliance that the ,secretary discovers upon reviewing the comparative analyses requested under clauses 7i7 and 7ii7 of subparagraph 7,b7 in the compliance program guidance document described in section #bgbf7;a77#f71 as it is updated every #b years1 except that all instances shall be deidentified and such instances shall not disclose any protected health information or individually identifiable information4 7ii7 ,guidance and regulations ,not later than #ah months after the date of enactment of this paragraph1 the ,secretary shall finalize any draft or interim guidance and regulations relating to mental health parity under this section4 7iii7 ,state ,any instances of noncompliance the ,secretary discovers upon reviewing the comparative analyses requested under clauses 7i7 and 7ii7 of subparagraph 7,b7 shall be shared with a ,state for coverage offered by a health insurance issuer in the group market1 in accordance with section #bgbf7;a77#f77;,b77iii77,,ii74 4 #caa4 ,technical amendments 7a7 ,,erisa ,section #gae of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aahe;d7 is amended-- 7#a7 in subsection 7a77#a71 by striking 7as amended by the ,patient ,protection and ,affordable ,care ,act7 and inserting 7including any subsequent amendments to such part72 and 7#b7 in subsection 7b7-- 7,a7 by striking 7as amended by the ,patient ,protection and ,affordable ,care ,act7 and inserting 7including any subsequent amendments to such part72 and 7,b7 by striking 7as so amended74 7b7 ,,irc ,section #ihae of the ,internal ,revenue ,code of #aihf is amended-- 7#a7 in subsection 7a77#a71 by striking 7as amended by the ,patient ,protection and ,affordable ,care ,act7 and inserting 7including any subsequent amendments to such part72 and 7#b7 in subsection 7b7-- 7,a7 by striking 7as amended by the ,patient ,protection and ,affordable ,care ,act7 and inserting 7including any subsequent amendments to such part72 and 7,b7 by striking 7as so amended74 7c7 ,applicability ,the amendments made by subsections 7a7 and 7b7 shall take effect as though included in the enactment of the ,patient ,protection and ,affordable ,care ,act 7,public ,law #aaa-adh74 #cab4 ,third-party administrators ,any obligation on a third-party administrator under this ,act 7including the amendments made by this ,act7 shall not affect any other direct or indirect requirement under any other provision of ,federal law that applies to third-party administrators offering services to group health plans4 ,,iv ,improving ,public ,health #dja4 ,improving awareness of disease prevention ,the ,public ,health ,service ,act is amended by striking section #cac of such ,act 7#db ,u4,s4,c4 #bde7 and inserting the following3 #cac4 ,public awareness campaign on the importance of vaccinations 7a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention and in coordination with other offices and agencies1 as appropriate1 shall award competitive grants to one or more public or private entities to carry out a national1 evidence-based campaign to increase awareness and knowledge of the safety and effectiveness of vaccines for the prevention and control of diseases1 combat misinformation about vaccines1 and disseminate scientific and evidence-based vaccine-related information1 with the goal of increasing rates of vaccination across all ages1 as applicable1 particularly in communities with low rates of vaccination1 to reduce and eliminate vaccine-preventable diseases4 7b7 ,consultation ,in carrying out the campaign under this section1 the ,secretary shall consult with appropriate public health and medical experts1 including the ,national ,academy of ,medicine and medical and public health associations and nonprofit organizations1 in the development1 implementation1 and evaluation of the evidence-based public awareness campaign4 7c7 ,requirements ,the campaign under this section shall-- 7#a7 be a national1 evidence-based initiative2 7#b7 include the development of resources for communities with low rates of vaccination1 including culturally and linguistically appropriate resources1 as applicable2 7#c7 include the dissemination of vaccine information and communication resources to public health departments1 health care providers1 and health care facilities1 including such providers and facilities that provide prenatal and pediatric care2 7#d7 be complementary to1 and coordinated with1 any other ,federal1 ,state1 or local efforts1 as appropriate2 and 7#e7 assess the effectiveness of communication strategies to increase rates of vaccination4 7d7 ,additional activities ,the campaign under this section may-- 7#a7 include the use of television1 radio1 the internet1 and other media and telecommunications technologies2 7#b7 be focused to address specific needs of communities and populations with low rates of vaccination2 and 7#c7 include the dissemination of scientific and evidence-based vaccine-related information1 such as-- 7,a7 advancements in evidence-based research related to diseases that may be prevented by vaccines and vaccine development2 7,b7 information on vaccinations for individuals and communities1 including individuals for whom vaccines are not recommended by the ,advisory ,committee for ,immunization ,practices1 and the effects of low vaccination rates within a community on such individuals2 7,c7 information on diseases that may be prevented by vaccines2 and 7,d7 information on vaccine safety and the systems in place to monitor vaccine safety4 7e7 ,evaluation ,the ,secretary shall-- 7#a7 establish benchmarks and metrics to quantitatively measure and evaluate the awareness campaign under this section2 7#b7 conduct qualitative assessments regarding the awareness campaign under this section2 and 7#c7 prepare and submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives an evaluation of the awareness campaign under this section4 7f7 ,authorization of appropriations ,there are authorized to be appropriated to carry out this section and section #cag7k7 such sums as may be necessary for fiscal years #bjbj through #bjbd4 4 #djb4 ,grants to address vaccine-preventable diseases ,section #cag7k77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;b7k77#a77 is amended-- 7#a7 in subparagraph 7,c71 by striking 2 and and inserting a semicolon2 7#b7 in subparagraph 7,d71 by striking the period and inserting a semicolon2 and 7#c7 by adding at the end the following3 7,e7 planning1 implementation1 and evaluation of activities to address vaccine-preventable diseases1 including activities to-- 7i7 identify communities at high risk of outbreaks related to vaccine-preventable diseases1 including through improved data collection and analysis2 7ii7 pilot innovative approaches to improve vaccination rates in communities and among populations with low rates of vaccination2 7iii7 reduce barriers to accessing vaccines and evidence-based information about the health effects of vaccines2 7iv7 partner with community organizations and health care providers to develop and deliver evidence-based interventions1 including culturally and linguistically appropriate interventions1 to increase vaccination rates2 7v7 improve delivery of evidence-based vaccine-related information to parents and others2 and 7vi7 improve the ability of ,state1 local1 tribal1 and territorial public health departments to engage communities at high risk for outbreaks related to vaccine-preventable diseases2 and 7,f7 research related to strategies for improving awareness of scientific and evidence-based vaccine-related information1 including for communities with low rates of vaccination1 in order to understand barriers to vaccination1 improve vaccination rates1 and assess the public health outcomes of such strategies4 4 #djc4 ,guide on evidence-based strategies for public health department obesity prevention programs 7a7 ,development and dissemination of an evidence-,based strategies guide ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 not later than #b years after the date of enactment of this ,act1 shall-- 7#a7 develop a guide on evidence-based strategies for ,state1 territorial1 and local health departments to use to build and maintain effective obesity prevention and reduction programs1 and1 in consultation with stakeholders that have expertise in ,tribal health1 a guide on such evidence-based strategies with respect to ,indian ,tribes and ,tribal organizations for such ,indian ,tribes and ,tribal organizations to use for such purpose1 both of which guides shall-- 7,a7 describe an integrated program structure for implementing interventions proven to be effective in preventing and reducing the incidence of obesity2 and 7,b7 recommend-- 7i7 optimal resources1 including staffing and infrastructure1 for promoting nutrition and obesity prevention and reduction2 and 7ii7 strategies for effective obesity prevention programs for ,state and local health departments1 ,indian ,tribes1 and ,tribal organizations1 including strategies related to-- 7,i7 the application of evidence-based and evidence-informed practices to prevent and reduce obesity rates2 7,,ii7 the development1 implementation1 and evaluation of obesity prevention and reduction strategies for specific communities and populations2 7,,iii7 demonstrated knowledge of obesity prevention practices that reduce associated preventable diseases1 health conditions1 death1 and health care costs2 7,,iv7 best practices for the coordination of efforts to prevent and reduce obesity and related chronic diseases2 7,v7 addressing the underlying risk factors and social determinants of health that impact obesity rates2 and 7,,vi7 interdisciplinary coordination between relevant public health officials specializing in fields such as nutrition1 physical activity1 epidemiology1 communications1 and policy implementation1 and collaboration between public health officials and community-based organizations2 and 7#b7 disseminate the guides and current research1 evidence-based practices1 tools1 and educational materials related to obesity prevention1 consistent with the guide1 to ,state and local health departments1 ,indian ,tribes1 and ,tribal organizations4 7b7 ,technical assistance ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall provide technical assistance to ,state and local health departments1 ,indian ,tribes1 and ,tribal organizations to support such health departments in implementing the guide developed under subsection 7a77#a74 7c7 ,indian ,tribes2 ,tribal organizations ,the terms ,indian ,tribe and ,tribal organization have the meanings given the terms ,indian tribe and tribal organization1 respectively1 in section #d of the ,indian ,self-,determination and ,education ,assistance ,act 7#be ,u4,s4,c4 #ecjd74 #djd4 ,expanding capacity for health outcomes ,title ,,iii of the ,public ,health ,service ,act is amended by inserting after section #ccj,m 7#db ,u4,s4,c4 #bed;c-#ai7 the following3 #ccj,n4 ,expanding capacity for health outcomes 7a7 ,definitions ,in this section3 7#a7 ,eligible entity ,the term eligible entity means an entity providing health care services in rural areas1 frontier areas1 health professional shortage areas1 or medically underserved areas1 or to medically underserved populations or ,native ,americans1 including ,indian tribes or tribal organizations4 7#b7 ,health professional shortage area ,the term health professional shortage area means a health professional shortage area designated under section #ccb4 7#c7 ,indian tribe ,the terms ,indian tribe and tribal organization have the meanings given such terms in section #d of the ,indian ,self-,determination and ,education ,assistance ,act4 7#d7 ,medically underserved population ,the term medically underserved population has the meaning given the term in section #ccj7;b77#c74 7#e7 ,native ,americans ,the term ,native ,americans has the meaning given such term in section #gcf and includes ,indian tribes and tribal organizations4 7#f7 ,technology-enabled collaborative learning and capacity building model ,the term technology-enabled collaborative learning and capacity building model means a distance health education model that connects specialists with multiple other health care professionals through simultaneous interactive videoconferencing for the purpose of facilitating case-based learning1 disseminating best practices1 and evaluating outcomes4 7b7 ,program established ,the ,secretary shall1 as appropriate1 award grants to evaluate1 develop1 and1 as appropriate1 expand the use of technology-enabled collaborative learning and capacity building models1 to increase access to health care services1 such as those to address chronic diseases and conditions1 mental health1 substance use disorders1 prenatal and maternal health1 pediatric care1 pain management1 palliative care1 and other specialty care in medically underserved areas and for medically underserved populations4 7c7 ,use of funds 7#a7 ,in general ,grants awarded under subsection 7b7 shall be used for-- 7,a7 the development and acquisition of instructional programming1 and the training of health care providers and other professionals that provide or assist in the provision of services through such models2 7,b7 information collection and evaluation activities to study the impact of such models on patient outcomes and health care providers1 and to identify best practices for the expansion and use of such models2 or 7,c7 other activities consistent with achieving the objectives of the grants awarded under this section1 as determined by the ,secretary4 7#b7 ,other uses ,in addition to any of the uses under paragraph 7#a71 grants awarded under subsection 7b7 may be used for-- 7,a7 equipment to support the use and expansion of technology-enabled collaborative learning and capacity building models1 including for hardware and software that enables distance learning1 health care provider support1 and the secure exchange of electronic health information2 or 7,b7 support for health care providers and other professionals that provide or assist in the provision of services through such models4 7d7 ,length of grants ,grants awarded under subsection 7b7 shall be for a period of up to #e years4 7e7 ,application ,an eligible entity that seeks to receive a grant under subsection 7b7 shall submit to the ,secretary an application1 at such time1 in such manner1 and containing such information as the ,secretary may require4 ,such application criteria shall include an assessment of the effect of technology-enabled collaborative learning and capacity building models on patient outcomes and health care providers4 7f7 ,technical assistance ,the ,secretary shall provide 7either directly through the ,department of ,health and ,human ,services or by contract7 technical assistance to eligible entities1 including recipients of grants under subsection 7b71 on the development1 use1 and evaluation of technology-enabled collaborative learning and capacity building models in order to expand access to health care services provided by such entities1 including for medically underserved areas and to medically underserved populations4 7g7 ,report by ,secretary ,not later than #d years after the date of enactment of this section1 the ,secretary shall prepare and submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 and post on the internet website of the ,department of ,health and ,human ,services1 a report including1 at minimum-- 7#a7 a description of any new and continuing grants awarded to entities under subsection 7b7 and the specific purpose and amounts of such grants2 7#b7 an overview of-- 7,a7 the evaluations conducted under subsections 7b7 or 7f72 and 7,b7 technical assistance provided under subsection 7f72 and 7#c7 a description of any significant findings or developments in patient outcomes and health care providers and best practices for eligible entities expanding1 using1 or evaluating technology-enabled collaborative learning and capacity building models4 7h7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section1 such sums as may be necessary for each of fiscal years #bjbj through #bjbd4 4 #dje4 ,public health data system modernization ,subtitle ,c of title ,,xxviii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#ca et seq47 is amended by adding at the end the following3 #bhbb4 ,public health data system modernization grants 7a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall-- 7#a7 award grants to ,state1 local1 ,tribal1 and territorial public health departments for the expansion and modernization of public health data systems1 to assist public health departments in-- 7,a7 assessing current data infrastructure capabilities and gaps to improve and increase consistency in data collection1 storage1 analysis1 and1 as appropriate1 to improve dissemination of public health-related information2 7,b7 improving secure public health data collection1 transmission1 exchange1 maintenance1 and analysis2 7,c7 simplifying and supporting reporting by health care providers1 as applicable1 pursuant to ,state law1 including through the use of health information technology1 to ,state1 local1 ,tribal1 and territorial public health departments1 including public health officials in multiple jurisdictions within such ,state1 as appropriate2 7,d7 enhancing interoperability of public health data systems 7including systems created or accessed by public health departments7 with health information technology1 including certified health information technology2 7,e7 supporting earlier disease and health condition detection1 such as through near real-time data monitoring1 to support rapid public health responses2 and 7,f7 supporting activities within the applicable jurisdiction related to the expansion and modernization of electronic case reporting2 7#b7 as appropriate1 conduct activities related to the interoperability and improvement of applicable public health data systems used by the ,centers for ,disease ,control and ,prevention1 and1 in coordination with the ,office of the ,national ,coordinator for ,health ,information ,technology1 the designation of data and technology standards for health information systems of the public health infrastructure with deference given to standards published by standards development organizations and voluntary consensus-based standards bodies2 and 7#c7 develop and utilize public-private partnerships for technical assistance and related implementation support for ,state1 local1 ,tribal1 and territorial public health departments1 and the ,centers for ,disease ,control and ,prevention1 on the expansion and modernization of electronic case reporting and public health data systems1 as applicable4 7b7 ,requirements 7#a7 ,in general ,the ,secretary may not award a grant under subsection 7a77#a7 unless the applicant supports standards endorsed by the ,national ,coordinator for ,health ,information ,technology pursuant to section #cjja7;c77#a7 or adopted by the ,secretary under section #cjjd4 7#b7 ,waiver ,the ,secretary may waive the requirement under paragraph 7#a7 with respect to an applicant if the ,secretary determines that the activities under subsection 7a7 cannot otherwise be carried out within the applicable jurisdiction4 7#c7 ,application ,a ,state1 local1 ,tribal1 or territorial health department applying for a grant under this section shall submit an application to the ,secretary at such time and in such manner as the ,secretary may require4 ,such application shall include information describing-- 7,a7 the activities that will be supported by the grant2 and 7,b7 how the modernization of such public health data systems will support or impact the public health infrastructure of the health department1 including a description of remaining gaps1 if any1 and the actions needed to address such gaps4 7c7 ,use of funds ,an entity receiving a grant under this section may use amounts received under such grant for one or both of the following3 7#a7 ,carrying out activities described in subsection 7a77#a7 to support public health data systems 7including electronic case reporting71 which may include support for1 and training of1 professionals with expertise in contributing to and using such systems 7including public health data scientists74 7#b7 ,developing and disseminating information related to the use and importance of public health data4 7d7 ,strategy and implementation plan ,not later than #ahj days after the date of enactment of the ,lower ,health ,care ,costs ,act1 the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 a coordinated strategy and an accompanying implementation plan that identifies and demonstrates the steps the ,secretary will carry out to-- 7#a7 update and improve applicable public health data systems used by the ,centers for ,disease ,control and ,prevention2 and 7#b7 carry out the activities described in this section to support the improvement of ,state1 local1 ,tribal1 and territorial public health data systems4 7e7 ,consultation ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall consult with ,state1 local1 ,tribal1 and territorial health departments1 professional medical and public health associations1 associations representing hospitals or other health care entities1 health information technology experts1 and other appropriate entities regarding the plan and grant program to modernize public health data systems pursuant to this section4 ,such activities may include the provision of technical assistance related to the exchange of information by such public health data systems used by relevant health care and public health entities at the local1 ,state1 ,federal1 ,tribal1 and territorial levels4 7f7 ,report to ,congress ,not later than #a year after the date of enactment of this section1 the ,secretary shall submit a report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives that includes-- 7#a7 a description of any barriers to-- 7,a7 public health authorities implementing electronic case reporting and interoperable public health data systems2 or 7,b7 the exchange of information pursuant to electronic case reporting2 7#b7 an assessment of the potential public health impact of implementing electronic case reporting and interoperable public health data systems2 and 7#c7 a description of the activities carried out pursuant to this section4 7g7 ,electronic case reporting ,in this section1 the term electronic case reporting means the automated identification1 generation1 and bilateral exchange of reports of health events among electronic health record or health information technology systems and public health authorities4 7h7 ,authorization of appropriations ,for the purpose of carrying out this section1 there are authorized to be appropriated such sums as may be necessary for fiscal years #bjbj through #bjbd4 4 #djf4 ,innovation for maternal health 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 in consultation with experts representing a variety of clinical specialties1 ,state1 tribal1 or local public health officials1 researchers1 epidemiologists1 statisticians1 and community organizations1 shall establish a program to award competitive grants to eligible entities for the purpose of-- 7#a7 identifying1 developing1 or disseminating best practices to improve maternal health care quality and outcomes1 eliminate preventable maternal mortality and severe maternal morbidity1 and improve infant health outcomes1 which may include-- 7,a7 information on evidence-based practices to improve the quality and safety of maternal health care in hospitals and other health care settings of a ,state or health care system1 including by addressing topics commonly associated with health complications or risks related to prenatal care1 labor care1 birthing1 and postpartum care2 7,b7 best practices for improving maternal health care based on data findings and reviews conducted by a ,state maternal mortality review committee that address topics of relevance to common complications or health risks related to prenatal care1 labor care1 birthing1 and postpartum care2 and 7,c7 information on addressing determinants of health that impact maternal health outcomes for women before1 during1 and after pregnancy2 7#b7 collaborating with ,state maternal mortality review committees to identify issues for the development and implementation of evidence-based practices to improve maternal health outcomes and reduce preventable maternal mortality and severe maternal morbidity2 7#c7 providing technical assistance and supporting the implementation of best practices identified in paragraph 7#a7 to entities providing health care services to pregnant and postpartum women2 and 7#d7 identifying1 developing1 and evaluating new models of care that improve maternal and infant health outcomes1 which may include the integration of community-based services and clinical care4 7b7 ,eligible entities ,to be eligible for a grant under subsection 7a71 an entity shall-- 7#a7 submit to the ,secretary an application at such time1 in such manner1 and containing such information as the ,secretary may require2 and 7#b7 demonstrate in such application that the entity has a demonstrated expertise in data-driven maternal safety and quality improvement initiatives in the areas of obstetrics and gynecology or maternal health4 7c7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated such sums as may be necessary for each of fiscal years #bjbj through #bjbd4 #djg4 ,training for health care providers ,title ,,vii of the ,public ,health ,service ,act is amended by striking section #gfc 7#db ,u4,s4,c4 #bidp7 and inserting the following3 #gfc4 ,training for health care providers 7a7 ,grant program ,the ,secretary shall establish a program to award grants to accredited schools of allopathic medicine1 osteopathic medicine1 and nursing1 and other health professional training programs for the training of health care professionals to reduce and prevent discrimination 7including training related to implicit biases7 in the provision of health care services related to prenatal care1 labor care1 birthing1 and postpartum care4 7b7 ,eligibility ,to be eligible for a grant under subsection 7a71 an entity described in such subsection shall submit to the ,secretary an application at such time1 in such manner1 and containing such information as the ,secretary may require4 7c7 ,reporting requirement ,each entity awarded a grant under this section shall periodically submit to the ,secretary a report on the status of activities conducted using the grant1 including a description of the impact of such training on patient outcomes1 as applicable4 7d7 ,best practices ,the ,secretary may identify and disseminate best practices for the training of health care professionals to reduce and prevent discrimination 7including training related to implicit biases7 in the provision of health care services related to prenatal care1 labor care1 birthing1 and postpartum care4 7e7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated such sums as may be necessary for each of fiscal years #bjbj through #bjbd4 4 #djh4 ,study on training to reduce and prevent discrimination ,not later than #b years after date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall1 through a contract with an independent research organization1 study and make recommendations for accredited schools of allopathic medicine1 osteopathic medicine1 and nursing1 and other health professional training programs on best practices related to training to reduce and prevent discrimination1 including training related to implicit biases1 in the provision of health care services related to prenatal care1 labor care1 birthing1 and postpartum care4 #dji4 ,perinatal quality collaboratives ,section #cag,k7a77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;b-#ab7;a77#b77 is amended by adding at the end the following3 7,e7 7i7 ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention and in coordination with other offices and agencies1 as appropriate1 shall establish or continue a competitive grant program for the establishment or support of perinatal quality collaboratives to improve perinatal care and perinatal health outcomes for pregnant and postpartum women and their infants4 ,a ,state or ,indian ,tribe may use funds received through such grant to-- 7,i7 support the use of evidence-based or evidence-informed practices to improve outcomes for maternal and infant health2 7,,ii7 work with clinical teams2 experts2 ,state1 local1 and1 as appropriate1 tribal public health officials2 and stakeholders1 including patients and families1 to identify1 develop1 or disseminate best practices to improve perinatal care and outcomes2 and 7,,iii7 employ strategies that provide opportunities for health care professionals and clinical teams to collaborate across health care settings and disciplines1 including primary care and mental health1 as appropriate1 to improve maternal and infant health outcomes1 which may include the use of data to provide timely feedback across hospital and clinical teams to inform responses1 and to provide support and training to hospital and clinical teams for quality improvement1 as appropriate4 7ii7 ,to be eligible for a grant under clause 7i71 an entity shall submit to the ,secretary an application in such form and manner and containing such information as the ,secretary may require4 4 #daj4 ,integrated services for pregnant and postpartum women 7a7 ,grants ,title ,,iii of the ,public ,health ,service ,act is amended by inserting after section #ccj,n of such ,act1 as added by section #djd1 the following3 #ccj,o4 ,integrated services for pregnant and postpartum women 7a7 ,in general ,the ,secretary may award grants for the purpose of establishing or operating evidence-based or innovative1 evidence-informed programs to deliver integrated health care services to pregnant and postpartum women to optimize the health of women and their infants1 including to reduce adverse maternal health outcomes1 pregnancy-related deaths1 and related health disparities 7including such disparities associated with racial and ethnic minority populations71 and as appropriate1 by addressing issues researched under subsection 7b77#b7 of section #cag,k4 7b7 ,integrated services for pregnant and postpartum women 7#a7 ,eligibility ,to be eligible to receive a grant under subsection 7a71 a ,state or ,indian ,tribe 7as defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act7 shall work with relevant stakeholders that coordinate care 7including coordinating resources and referrals for health care and social services7 to develop and carry out the program1 including-- 7,a7 ,state1 tribal1 and local agencies responsible for ,medicaid1 public health1 social services1 mental health1 and substance use disorder treatment and services2 7,b7 health care providers who serve pregnant women2 and 7,c7 community-based health organizations and health workers1 including providers of home visiting services and individuals representing communities with disproportionately high rates of maternal mortality and severe maternal morbidity1 and including those representing racial and ethnicity minority populations4 7#b7 ,terms 7,a7 ,limitation ,the ,secretary may award a grant under subsection 7a7 to up to #aj ,states4 7,b7 ,period ,a grant awarded under subsection 7a7 shall be made for a period of #e years4 7,c7 ,prioritization ,in awarding grants under subsection 7a71 the ,secretary shall prioritize applications from ,states or ,indian ,tribes with the highest rates of maternal mortality and severe maternal morbidity1 and shall consider health disparities related to maternal mortality and severe maternal morbidity1 including such disparities associated with racial and ethnic minority populations4 7,d7 ,evaluation ,the ,secretary shall require grantees to evaluate the outcomes of the programs supported under the grant4 7c7 ,authorization of appropriations ,there are authorized to be appropriated to carry out this section such sums as may be necessary for each of fiscal years #bjbj through #bjbd4 4 7b7 ,report on grant outcomes and dissemination of best practices 7#a7 ,report ,not later than ,april #a1 #bjbe1 the ,secretary of ,health and ,human ,services shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report that describes-- 7,a7 the outcomes of the activities supported by the grants awarded under the amendments made by this section on maternal and child health2 7,b7 best practices and models of care used by recipients of grants under such amendments2 and 7,c7 obstacles identified by recipients of grants under such amendments1 and strategies used by such recipients to deliver care1 improve maternal and child health1 and reduce health disparities4 7#b7 ,dissemination of best practices ,not later than ,october #a1 #bjbe1 the ,secretary of ,health and ,human ,services shall disseminate information on best practices and models of care used by recipients of grants under the amendments made by this section 7including best practices and models of care relating to the reduction of health disparities1 including such disparities associated with racial and ethnic minority populations1 in rates of maternal mortality and severe maternal morbidity7 to relevant stakeholders1 which may include health providers1 medical schools1 nursing schools1 relevant ,state1 tribal1 and local agencies1 and the general public4 #daa4 ,extension for community health centers1 the ,national ,health ,service ,corps1 and teaching health centers that operate ,,gme programs 7a7 ,community health centers funding ,section #ajejc7;b77#a77;,f7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #bed;b-#b7;b77#a77;,f77 is amended by striking fiscal year #bjai and inserting each of fiscal years #bjai through #bjbd4 7b7 ,national ,health ,service ,corps ,section #ajejc7;b77#b77;,f7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #bed;b-#b7;b77#b77;,f77 is amended by striking and #bjai and inserting through #bjbd4 7c7 ,teaching ,health ,centers that operate ,graduate ,medical ,education ,programs ,section #cdj;,h7g77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;h7g77#a77 is amended by striking and #bjai and inserting through #bjbd4 7d7 ,application of provisions ,amounts appropriated pursuant to this section for each of fiscal years #bjai through #bjbd shall be subject to the requirements contained in ,public ,law #aae-bde for funds for programs authorized under sections #ccj through #cdj of the ,public ,health ,service ,act4 7e7 ,conforming amendments ,paragraph 7#d7 of section #cjad7;h7 of title #ah1 ,united ,states ,code1 as amended by section #ejija of ,public ,law #aae-abc1 is amended by striking and section #ejija7;e7 of the ,advancing ,chronic ,care1 ,extenders1 and ,social ,services ,act and inserting 1 section #ejija7;e7 of the ,advancing ,chronic ,care1 ,extenders1 and ,social ,services ,act1 and section #daa7;d7 of the ,lower ,health ,care ,costs ,act4 #dab4 ,other programs 7a7 ,type ,i ,section #ccj;,b7b77#b77;,d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bed;c-#b7;b77#b77;,d77 is amended by striking and #bjai and inserting through #bjbd4 7b7 ,indians ,subparagraph 7,d7 of section #ccj;,c7c77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bed;c-#c7;c77#b77;,d77 is amended by striking and #bjai and inserting through #bjbd4 ,v ,improving the ,exchange of ,health ,information #eja4 ,requirement to provide health claims1 network1 and cost information 7a7 ,in general ,part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg et seq47 is amended by inserting after section #bgae;,a the following3 #bgae;,b4 ,requirement to provide health claims1 network1 and cost information 7a7 ,in general ,a group health plan or a health insurance issuer offering group or individual health insurance coverage shall make available for access1 exchange1 or use without special effort1 through application programming interfaces 7or successor technology or standards71 the information described in subsection 7b71 in the manner described in subsection 7b7 and otherwise consistent with this section4 7b7 ,information ,the following information is required to be made available1 in such form and manner as the ,secretary may specify1 as described in subsection 7a73 7#a7 ,historical claims1 provider encounter1 and payment data for each enrollee1 which shall-- 7,a7 include adjudicated medical and prescription drug claims and equivalent encounters1 including all data elements contained in such transactions-- 7i7 that were adjudicated by the group health plan or health insurance issuer during the previous #e years or the enrollee's entire period of enrollment in the applicable plan or coverage if such period is less than #e years2 7ii7 that involve benefits managed by any third party1 such as a pharmacy benefits manager or radiology benefits manager that manages benefits or adjudicates claims on behalf of the plan or coverage2 and 7iii7 from any other health plan or health insurance coverage issued or administered by the same insurance issuer1 in which the same enrollee was enrolled during the previous #e years2 and 7,b7 be available-- 7i7 in a single1 longitudinal format that is easy to understand and secure1 and that may update automatically1 including by using the standards adopted for implementation of section #cjja7;c77#e77;,d77iv72 7ii7 as soon as practicable1 and in no case later than the period of time determined by the ,secretary1 after the claim is adjudicated or the data is received by the health plan or health insurance issuer2 and 7iii7 to the enrollee1 and any providers or third-party applications or services authorized by the enrollee1 for #e years after the end date of the enrollee's enrollment in the plan or in any coverage offered by the health insurance issuer4 7#b7 ,identifying directory information for all in-network providers1 including facilities and practitioners1 that participate in the plan or coverage1 which shall-- 7,a7 include-- 7i7 the national provider identifier for in-network facilities and practitioners2 and 7ii7 the name1 address1 phone number1 and specialty for each such facility and practitioner1 based on the most recent interaction between the plan or coverage and that facility or practitioner2 7,b7 be capable of returning a list of participating in-network facilities and practitioners1 in a given specialty or at a particular facility type1 within a specified geographic radius2 and 7,c7 be capable of returning the network status1 when presented with identifiers for a given enrollee and facility or practitioner4 7#c7 ,estimated patient out-of-pocket costs1 including costs expected to be incurred through a deductible1 copayment1 coinsurance1 or other form of cost-sharing1 for-- 7,a7 a designated set of common services or episodes of care1 to be established by the ,secretary through rulemaking1 including1 at a minimum-- 7i7 in the case of services provided by a hospital1 the #ajj most common diagnosis-related groups1 as used in the ,medicare ,inpatient ,prospective ,patient ,system 7or successor episode-based reimbursement methodology7 at that hospital1 based on claims data adjudicated by the group health plan or health insurance issuer2 7ii7 in the case of services provided in an outpatient setting1 including radiology1 lab tests1 and outpatient surgical procedures1 any service rendered by the facility or practitioner1 and reimbursed by the health plan or health insurance issuer2 and 7iii7 in the case of post-acute care1 including home health providers1 skilled nursing facilities1 inpatient rehabilitation facilities1 and long-term care hospitals1 the patient out-of-pocket costs for an episode of care1 as the ,secretary may determine1 which permits users to reasonably compare costs across different facility and service types2 and 7,b7 all prescription drugs currently included on any tier of the formulary of the plan or coverage4 7c7 ,availability and access ,the application programming interfaces1 including all data required to be made available through such interfaces1 shall-- 7#a7 be made available by the applicable group health plan or health insurance issuer1 at no charge1 to-- 7,a7 enrollees in the group health plan or health insurance coverage2 7,b7 third parties authorized by the enrollee2 7,c7 facilities and practitioners who are under contract with the plan or coverage2 and 7,d7 business associates of such facilities and practitioners1 as defined in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or any successor regulations72 7#b7 be available to enrollees in the group health plan or health insurance coverage1 and to third-party applications or services facilitating such access by enrollees1 during the enrollment process and for a minimum of #e years after the end date of the enrollee's enrollment in the plan or in any coverage offered by the health insurance issuer2 7#c7 permit persistent access by third-party applications or services authorized by the enrollee1 for a reasonable period of time1 consistent with current security practices2 7#d7 employ the applicable content1 vocabulary1 and technical standards1 including1 as appropriate1 such standards adopted by the ,secretary pursuant to title ,,xxx2 and 7#e7 employ security and authentication standards1 as the ,secretary determines appropriate4 7d7 ,rule of construction regarding privacy ,nothing in this section shall be construed to alter existing obligations under the privacy1 security1 and breach notification rules promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act 7or successor regulations71 under part #b of title #db1 ,code of ,federal ,regulations 7or successor regulations71 under section #ddd of the ,general ,education ,provisions ,act 7#bj ,u4,s4,c4 #abcb;g7 7commonly referred to as the ,family ,educational ,rights and ,privacy ,act of #aigd71 under the amendments made by the ,genetic ,information ,nondiscrimination ,act1 or under ,state privacy law4 4 7b7 ,effective date ,section #bgae;,b of the ,public ,health ,service ,act1 as added by subsection 7a71 shall take effect #a year after the date of enactment of this ,act4 #ejb4 ,recognition of security practices ,part #a of subtitle ,d of the ,health ,information ,technology for ,economic and ,clinical ,health ,act 7#db ,u4,s4,c4 #agica et seq47 is amended by adding at the end the following3 #acdab4 ,recognition of security practices 7a7 ,in general ,consistent with the authority of the ,secretary under sections #aagf and #aagg of the ,social ,security ,act1 when making determinations relating to fines under section #acdaj1 decreasing the length and extent of an audit under section #acdaa1 or remedies otherwise agreed to by the ,secretary1 the ,secretary shall consider whether the entity or business associate had1 for not less than the previous #ab months1 recognized security practices in place that may-- 7#a7 mitigate fines under section #acdaj2 7#b7 result in the early1 favorable termination of an audit under section #acdaa2 and 7#c7 limit the remedies that would otherwise be agreed to in any agreement between the entity or business associate and the ,department of ,health and ,human ,services4 7b7 ,additional consideration ,at the election of the entity or business associate1 the ,secretary may provide further consideration to an entity or business associate that can adequately demonstrate that such recognized security practices were in place1 as determined by the ,secretary4 7c7 ,definition and miscellaneous provisions 7#a7 ,recognized security practices ,the term recognized security practices means the standards1 guidelines1 best practices1 methodologies1 procedures1 and processes developed under section #b7;c77#ae7 of the ,national ,institute of ,standards and ,technology ,act1 the approaches promulgated under section #dje7;d7 of the ,cybersecurity ,information ,sharing ,act of #bjae1 and any other program or processes that are equivalent to such requirements as may be developed through regulations4 ,such practices shall be determined by the entity or business associate1 except where additional consideration is requested under subsection 7b74 7#b7 ,limitation ,nothing in this section shall be construed as providing the ,secretary authority to-- 7,a7 increase fines under section #acdaj1 or the length1 extent or quantity of audits under section #acdaa1 due to a lack of compliance with the recognized security practices2 or 7,b7 mandate1 direct1 or condition the award of any ,federal grant1 contract1 or purchase1 on compliance with such recognized security practices4 7#c7 ,no liability for nonparticipation ,nothing in this section shall be construed to subject an entity or business associate to liability for electing not to engage in the recognized security practices defined by this section4 7#d7 ,rule of construction ,nothing in this section shall be construed to limit the ,secretary's authority to enforce the ,,hipaa ,security rule 7part #afj of title #de1 ,code of ,federal ,regulations1 and subparts ,a and ,c of part #afd of such title71 or to supersede or conflict with an entity or business associate's obligations under the ,,hipaa ,security rule4 4 #ejc4 ,,gao study on the privacy and security risks of electronic transmission of individually identifiable health information to and from entities not covered by the ,health ,insurance ,portability and ,accountability ,act 7a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct a study to-- 7#a7 describe the roles of ,federal agencies and the private sector with respect to protecting the privacy and security of individually identifiable health information transmitted electronically to and from entities not covered by the regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note72 7#b7 identify recent developments regarding the use of application programming interfaces to access individually identifiable health information1 and implications for the privacy and security of such information2 7#c7 identify practices in the private sector1 such as terms and conditions for use1 relating to the privacy1 disclosure1 and secondary uses of individually identifiable health information transmitted electronically to or from entities1 selected by an individual1 that are not subject to the regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif2 and 7#d7 identify steps the public and private sectors can take to improve the private and secure access to and availability of individually identifiable health information4 7b7 ,report ,not later than #a year after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report concerning the findings of the study conducted under subsection 7a74 #ejd4 ,technical corrections 7a7 ,in general ,section #cjbb7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#eb7;b77 is amended by adding at the end the following new paragraph3 7#d7 ,application of authorities under ,inspector ,general ,act of #aigh ,in carrying out this subsection1 the ,inspector ,general shall have the same authorities as provided under section #f of the ,inspector ,general ,act of #aigh 7#e ,u4,s4,c4 ,app474 4 7b7 ,effective date ,the amendment made by subsection 7a7 shall take effect as if included in the enactment of the #bast ,century ,cures ,act 7,public ,law #aad-bee74 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,lower ,health ,care ,costs ,act4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,,title ,i--,ending surprise medical bills,sec4 #aja4 ,protecting patients against out-of-network deductibles in emergencies4,sec4 #ajb4 ,protection against surprise bills4,sec4 #ajc4 ,benchmark for payment4,sec4 #ajd4 ,effective date4,sec4 #aje4 ,ending surprise air ambulance bills4,sec4 #ajf4 ,report4,,title ,,ii--,reducing the prices of prescription drugs,sec4 #bja4 ,biological product patent transparency4,sec4 #bjb4 ,orange ,book modernization4,sec4 #bjc4 ,ensuring timely access to generics4,sec4 #bjd4 ,protecting access to biological products4,sec4 #bje4 ,preventing blocking of generic drugs4,sec4 #bjf4 ,education on biological products4,sec4 #bjg4 ,biological product innovation4,sec4 #bjh4 ,clarifying the meaning of new chemical entity4,sec4 #bji4 ,streamlining the transition of biological products4,sec4 #baj4 ,orphan drug clarification4,sec4 #baa4 ,prompt approval of drugs related to safety information4,sec4 #bab4 ,conditions of use for biosimilar biological products4,sec4 #bac4 ,modernizing the labeling of certain generic drugs4,sec4 #bad4 ,actions for delays of generic drugs and biosimilar biological products4,sec4 #bae4 ,reducing the price of prescription drugs4,,title ,,iii--,improving transparency in health care,sec4 #cja4 ,increasing transparency by removing gag clauses on price and quality information4,sec4 #cjb4 ,banning anticompetitive terms in facility and insurance contracts that limit access to higher quality1 lower cost care4,sec4 #cjc4 ,designation of a nongovernmental1 nonprofit transparency organization to lower ,americans' health care costs4,sec4 #cjd4 ,protecting patients and improving the accuracy of provider directory information4,sec4 #cje4 ,timely bills for patients4,sec4 #cjf4 ,health plan oversight of pharmacy benefit manager services4,sec4 #cjg4 ,government ,accountability ,office study on profit- and revenue-sharing in health care4,sec4 #cjh4 ,disclosure of direct and indirect compensation for brokers and consultants to employer-sponsored health plans and enrollees in plans on the individual market4,sec4 #cji4 ,ensuring enrollee access to cost-sharing information4,sec4 #caj4 ,strengthening parity in mental health and substance use disorder benefits4,sec4 #caa4 ,technical amendments4,sec4 #cab4 ,third-party administrators4,sec4 #cac4 ,group health plan reporting requirements4,sec4 #cad4 ,study by ,comptroller ,general of ,united ,states4,,title ,,iv--,improving public health,sec4 #dja4 ,improving awareness of disease prevention4,sec4 #djb4 ,grants to address vaccine-preventable diseases4,sec4 #djc4 ,guide on evidence-based strategies for public health department obesity prevention programs4,sec4 #djd4 ,expanding capacity for health outcomes4,sec4 #dje4 ,public health data system modernization4,sec4 #djf4 ,innovation for maternal health4,sec4 #djg4 ,training for health care providers4,sec4 #djh4 ,study on training to reduce and prevent discrimination4,sec4 #dji4 ,perinatal quality collaboratives4,sec4 #daj4 ,integrated services for pregnant and postpartum women4,sec4 #daa4 ,extension for community health centers1 the national health service corps1 and teaching health centers that operate ,,gme programs4,sec4 #dab4 ,other programs4,sec4 #dac4 ,native ,american suicide prevention4,sec4 #dad4 ,minimum age of sale of tobacco products4,sec4 #dae4 ,sale of tobacco products to individuals under the age of #ba4,,title ,v--,improving the exchange of health information,sec4 #eja4 ,requirement to provide health claims1 network1 and cost information4,sec4 #ejb4 ,recognition of security practices4,sec4 #ejc4 ,,gao study on the privacy and security risks of electronic transmission of individually identifiable health information to and from entities not covered by the ,health ,insurance ,portability and ,accountability ,act4,sec4 #ejd4 ,technical corrections4,sec4 #eje4 ,public meeting4 ,i ,ending surprise medical bills #aja4 ,protecting patients against out-of-network deductibles in emergencies ,section #bgai;,a7b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ai;a7 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in the matter preceding subparagraph 7,a71 by inserting or a freestanding emergency room after hospital2 and 7,b7 in subparagraph 7,c7-- 7i7 in clause 7ii77,i71 by inserting or freestanding emergency room after emergency department2 and 7ii7 in subparagraph 7,c77ii77,,ii71 by adding1 a deductible1 after 7expressed as2 and 7#b7 in paragraph 7#b77;,b7-- 7,a7 in clause 7i7-- 7i7 by inserting or freestanding emergency room after hospital2 and 7ii7 by inserting or freestanding emergency room after emergency department2 and 7,b7 in clause 7ii71 by inserting or freestanding emergency room after hospital4 #ajb4 ,protection against surprise bills 7a7 ,,phsa ,section #bgai;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ai;a7 is amended by adding at the end the following3 7e7 ,out-of-network ancillary services 7#a7 ,coverage of services ,subject to subsection 7h71 in the case of an enrollee in a group health plan or group or individual health insurance coverage who receives out-of-network ancillary services at an in-network facility1 including any referrals for diagnostic services1 and such services would be covered under such plan or coverage if provided in-network-- 7,a7 the cost-sharing requirement 7expressed as a copayment amount1 coinsurance rate1 or deductible7 with respect to such services shall be the same requirement that would apply if such services were provided by an in-network practitioner1 and any coinsurance or deductible shall be based on in-network rates2 and 7,b7 amounts paid toward such cost-sharing shall be counted towards the in-network deductible and in-network out-of-pocket maximum amount1 as applicable1 under the plan or coverage for the plan year4 7#b7 ,notice before providing non-emergency services ,subject to subsection 7h71 in the case of an enrollee in a group health plan or group or individual health insurance coverage who receives out-of-network1 non-emergency services that are not ancillary services1 from an out-of-network provider at an in-network facility1 and such services would be covered under such plan or coverage if provided in-network1 the cost-sharing requirement 7expressed as a copayment amount1 coinsurance rate1 or deductible7 with respect to such services shall be the same requirement that would apply if such services were provided by an in-network practitioner1 and any coinsurance or deductible shall be based on in-network rates1 unless1 as soon as practicable1 and in no case later than #dh hours prior to providing non-emergency services that are not ancillary services-- 7,a7 the in-network facility provides to the enrollee who is scheduled to receive such services notice that-- 7i7 is provided in paper or electronic form 7and including electronic notification whenever practicable72 7ii7 states that such service will be provided out-of-network2 7iii7 includes the estimated amount that such practitioner or facility may charge the enrollee for such services2 and 7iv7 provides the option to affirmatively consent to receiving such services from such practitioner or facility2 7,b7 such enrollee signs such notice consenting to receive such services from an out-of-network provider at an in-network facility1 and acknowledging that the out-of-network services may be covered at an out-of-network cost-sharing amount1 requiring higher cost-sharing obligations of the enrollee than if the service were provided by an in-network practitioner or facility2 and 7,c7 such facility maintains documentation of the enrollee's signature or confirmation of receipt of such information under subparagraph 7,b7 in the enrollee's patient record for #b years after the date of services4 7#c7 ,definition ,for purposes of this subsection1 the term facility has the meaning given the term health care facility in section #bgbi;,a7c74 7f7 ,coverage of out-of-network services for enrollees admitted after emergency services 7#a7 ,protection for enrollees admitted to the hospital for emergency services prior to stabilization ,in the case of an enrollee in a group health plan or group or individual health insurance coverage who receives emergency services1 or maternal care for a woman in labor1 in the emergency department of an out-of-network facility and has not been stabilized 7within the meaning of subsection 7b77#b77;,c771 if the patient is subsequently admitted to the out-of-network facility for care1 the cost-sharing requirement 7expressed as a copayment amount1 coinsurance rate1 or deductible7 with respect to any out-of-network services provided to the enrollee prior to being stable and in a condition to receive information under 7#b71 is the same requirement that would apply as under subsection 7b77#b77;,c77ii77,,ii74 7#b7 ,notice and consent 7,a7 ,in general ,subject to subsection 7h71 in the case of an enrollee in a group health plan or group or individual health insurance coverage who receives emergency services1 or maternal care for a woman in labor1 in the emergency department of an out-of-network facility and has been stabilized 7within the meaning of subsection 7b77#b77;,c771 if the patient is subsequently admitted to the out-of-network facility for care1 the cost-sharing requirement 7expressed as a copayment amount1 coinsurance rate1 or deductible7 with respect to any out-of-network services is the same requirement that would apply if such services were provided by an in-network provider1 unless the enrollee1 once stable and in a condition to receive such information1 including having sufficient mental capacity-- 7i7 has been provided by the facility1 prior to the provision of any post-stabilization1 out-of-network service at such facility1 with-- 7,i7 paper or electronic notification that the practitioner or facility is an out-of-network health care provider and the out-of-network rate of the provider1 as applicable1 and the option to affirmatively consent to receiving services from such practitioner or facility2 and 7,,ii7 the estimated amount that such provider may charge the participant1 beneficiary1 or enrollee for such services involved2 7ii7 has been provided by the plan or coverage1 prior to the provision of any post-stabilization1 out-of-network service at such facility1 with-- 7,i7 paper or electronic notification 7and including electronic notification whenever practicable7 that the practitioner or facility is an out-of-network health care provider1 and the option to affirmatively consent to receiving services from such practitioner or facility2 7,,ii7 a list of in-network practitioners or facilities in the relevant geographic area that could provide the same services1 and an option for a referral to such providers2 and 7,,iii7 information about whether prior authorization or other care management limitations may be required in advance of receiving in-network services at the facility2 7iii7 has acknowledged1 in writing1 that the out-of-network services provided after the individual has been stabilized may not be covered or may be covered at an out-of-network cost-sharing amount1 requiring higher cost-sharing obligations of the enrollee than if the service were provided at an in-network facility4 7,b7 ,requirements of notice ,the notice under subparagraph 7,a7 shall be in a format determined by the ,secretary to give a reasonable layperson clear comprehension of the terms of the agreement1 including all possible financial responsibilities1 including the requirements that the notice-- 7i7 does not exceed one page in length2 7ii7 is readily identifiable for its purpose and as a contract of consent2 7iii7 clearly states that consent to potential out-of-network charges is optional and that the enrollee has the choice to transfer to an in-network facility2 7iv7 includes an estimate of the amount that such provider will charge the participant1 beneficiary1 or enrollee for such services involved2 and 7v7 be available in the #ae most common languages in the facility's geographic area1 with the facility making a good faith effort to provide oral notice in the enrollee's primary language if it is not one of such #ae languages4 7,c7 ,maintenance of records ,a facility shall maintain documentation of notice given to an enrollee pursuant to this subsection and the enrollee's confirmation of receipt of such information in the enrollee's patient record for #b years after the date of services4 7#c7 ,rulemaking ,not later than #f months after the date of enactment of the ,lower ,health ,care ,costs ,act1 the ,secretary shall issue regulations to carry out this subsection1 which shall include clarification on how to determine whether an individual is stabilized and the timing of the notice required under this paragraph4 7g7 ,prohibition on billing more than an in-network rate under certain circumstances 7#a7 ,in general ,a facility or practitioner furnishing-- 7,a7 emergency services1 as defined in subsection 7b77#b71 regardless of the ,state in which the patient resides2 7,b7 out-of-network services at an in-network facility described in subsection 7e77#a72 7,c7 out-of-network services at an in-network facility described in subsection 7e77#b71 where the notice and consent for receiving such services out-of-network did not meet the requirement of such subsection2 7,d7 services furnished by an out-of-network provider after an enrollee has been admitted to the hospital for emergency services but prior to stabilization1 as described in subsection 7f77#a72 or 7,e7 out-of-network services furnished after the enrollee has been stabilized 7within the meaning of subsection 7b77#b77;,c771 where the notice and option for receiving care at an alternate facility required under subsection 7f77#b7 have not been provided to the enrollee and the enrollee did not give consent under subsection 7f77#c71 may not bill an enrollee in a group health plan or group or individual health insurance coverage for amounts beyond the cost-sharing amount that would apply under subsection 7b77#a77;,c77ii77,,ii71 7e77#a71 7e77#b71 or 7f71 as applicable4 7#b7 ,notice ,a facility furnishing services described in paragraph 7#a7 shall provide enrollees in a group health plan or group or individual health insurance coverage with a one-page notice1 in #af-point font1 upon intake at the emergency room or being admitted at the facility of the prohibition on balance billing under paragraph 7#a7 and who to contact for recourse if they are sent a balance bill in violation of such paragraph4 ,the facility shall be responsible for obtaining the signature from the enrollee on such notice4 ,the ,secretary shall issue regulations within #f months of the date of enactment of the ,lower ,health ,care ,costs ,act on the requirements for the notice under this paragraph4 7h7 ,maintaining ,state surprise billing protections 7#a7 ,in general ,nothing in this section shall prevent a ,state from establishing or continuing in effect1 with respect to health insurance issuers1 facilities1 or practitioners1 an alternate method under ,state law for determining the appropriate compensation for services described in subsection 7b71 7e71 or 7f74 7#b7 ,additional application ,in the case of group health plans or group or individual health insurance coverage offered in a ,state that has not established an alternate method described in paragraph 7#a71 such as arbitration or a benchmark1 or for services described in subsection 7b71 7e71 or 7f7 that are not covered by such ,state's alternate method described in paragraph 7#a71 the provisions of this section shall apply4 7#c7 ,self-insured plans ,subsections 7b71 7e71 and 7f7 shall apply to a self-insured group health plan that is not subject to ,state insurance regulation4 7i7 ,definitions ,in this section3 7#a7 ,in-network ,the term in-network1 with respect to a group health plan or health insurance coverage means a provider that has a contractual relationship with the plan4 7#b7 ,enrollee ,the term enrollee1 with respect to health insurance coverage or a group health plan1 includes a participant1 dependent1 or beneficiary4 7#c7 ,ancillary services ,the term ancillary services means non-emergency care that is-- 7,a7 provided by anesthesiologists1 pathologists1 emergency medicine providers1 intensivists1 radiologists1 neonatologists1 hospitalists1 and assistant surgeons1 whether the care is provided by a physician or non-physician practitioner2 7,b7 a diagnostic service 7including radiology and lab services72 or 7,c7 provided by such other specialty practitioner not typically selected by the patients receiving the care1 which the ,secretary may add periodically to such definition through rulemaking4 4 7b7 ,enforcement of balance billing prohibitions ,part ,c of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ia et seq47 is amended by adding at the end the following3 #bgie4 ,enforcement of balance billing prohibitions 7a7 ,in general ,subject to subsection 7b71 a facility or practitioner that violates a requirement under section #bgai;,a7g77#a7 or fails to provide notice or obtain consent as required under subsection 7e77#b7 or 7f77#b7 shall be subject to a civil monetary penalty of not more than #aj1jjj for each act constituting such violation4 7b7 ,procedure ,the provisions of section #aabh;,a of the ,social ,security ,act1 other than subsections 7a7 and 7b7 and the first sentence of subsection 7c77#a7 of such section1 shall apply to civil money penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a of the ,social ,security ,act4 7c7 ,safe harbor 7#a7 ,in general ,the ,secretary shall waive the penalties described under subsection 7a7 with respect to a facility or1 practitioner who does not knowingly violate1 and should not have reasonably known it violated1 section #bgai;,a7g77#a7 with respect to an enrollee1 if such facility or practitioner1 within #cj days of the violation1 withdraws the bill that was in violation of section #bgai;,a7g77#a71 and1 as applicable1 reimburses the group health plan1 health insurance issuer1 or enrollee1 in an amount equal to the difference between the amount billed and the amount allowed to be billed under section #bgai;,a7g77#a71 plus interest1 at an interest rate determined by the ,secretary4 7#b7 ,hardship exemption ,the ,secretary may establish a hardship exemption to the penalties under this section4 7#c7 ,state enforcement ,the ,secretary shall waive penalties under this section with respect to a facility or practitioner that has already been subject to enforcement action under ,state law for a violation described in subsection 7a74 4 7c7 ,application to grandfathered plans ,section #abea7;a7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjaa7;a77 is amended by adding at the end the following3 7#e7 ,application of additional provisions ,subsections 7b7 through 7h7 of section #bgai;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ai;a7 shall apply to grandfathered health plans for plan years beginning with the second plan year that begins after the date of enactment of the ,lower ,health ,care ,costs ,act4 4 7d7 ,coverage under ,federal ,employees ,health ,benefits ,program ,section #hijd of title #e1 ,united ,states ,code1 is amended by adding at the end the following3 7c7 ,any health benefits plan offered under this chapter shall be treated as a group health plan or group or individual health insurance coverage for purposes of subsections 7e7 through 7g7 of section #bgai;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ai;a7 7except for paragraph 7#c7 of such subsection 7g774 4 #ajc4 ,benchmark for payment 7a7 ,in general ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq47 is amended by adding at the end the following3 #bgbi;,a4 ,benchmark for payment 7a7 ,establishment of benchmark ,a group health plan or health insurance issuer offering group or individual health insurance coverage shall pay providers1 including facilities and practitioners1 furnishing services for which such facilities and practitioners are prohibited under section #bgai;,a7g7 from billing enrollees for amounts beyond the cost-sharing amount that would apply under subsection 7b77#a77;,c77ii77,,ii71 7e71 or 7f7 of section #bgai;,a1the median in-network rate for such services provided to enrollees1 using a methodology determined under subsection 7b7 for the same or similar services offered by the group health plan or health insurance issuer in that geographic region4 ,such payment shall be made in a timely fashion in order to ensure compliance with sections #cii,v-#g and #bgbi;,d4 7b7 ,median in-network rate 7#a7 ,in general ,for purposes of this section1 the term median in-network rate means1 with respect to health care services covered by a group health plan or group or individual health insurance coverage1 the median contracted rate under the applicable plan or coverage recognized under the plan or coverage as the total maximum payment for the service minus the in-network cost-sharing for such service under the plan or coverage1 for the same or a similar service that is provided by a provider in the same or similar specialty and in the geographic region in which the service is furnished4 7#b7 ,rulemaking 7,a7 ,in general ,not later than #a year after the date of enactment of the ,lower ,health ,care ,costs ,act1 the ,secretary shall1 through rulemaking1 determine the methodology a group health plan or health insurance issuer is required to use to determine the median in-network rate described in paragraph 7#a71 differentiating by business line1 the information the plan or issuer shall share with the out-of-network provider involved when making such a determination1 and the geographic regions applied for purposes of this subsection4 ,such rulemaking shall take into account payments that are made by health insurance issuers that are not on a fee-for-service basis4 7,b7 ,geographic regions ,in establishing geographic regions under subparagraph 7,a71 the ,secretary shall consider adequate access to services in rural areas and health professional shortage areas1 as defined in section #ccb4 ,the ,secretary shall consult with the ,national ,association of ,insurance ,commissioners in establishing the geographic regions4 ,the ,secretary shall update the geographic regions periodically1 as appropriate1 taking into account the findings of the report under section #ajf of the ,lower ,health ,care ,costs ,act4 7#c7 ,certain insurers ,if a group health plan or health insurance issuer offering group or individual health insurance coverage does not have sufficient information to calculate a median in-network rate for this service or provider type1 or amount of1 claims for services 7as determined by the applicable ,state authority1 in the case of health insurance coverage1 or by the ,secretary of ,labor1 in the case of a self-insured group health plan7 covered under the list of out-of-network services set by the ,state authority or ,secretary of ,labor1 as applicable1 in a particular geographic area1 such plan or issuer shall demonstrate that it will use a database free of conflicts of interest that has sufficient information reflecting allowed amounts paid to individual health care providers for relevant services provided in the applicable geographic region1 and that such plan or issuer will use that database to determine a median in-network rate4 ,the group health plan or health insurance issuer shall cover the cost of accessing the database4 7#d7 ,rule of construction ,nothing in this subsection shall prevent a group health plan or health insurance issuer from establishing separate calculations of a median in-network rate under paragraph 7#a7 for services delivered in nonhospital facilities1 including freestanding emergency rooms4 7c7 ,facility ,for purposes of this section1 the term health care facility or facility includes hospitals1 hospital outpatient departments1 critical access hospitals1 ambulatory surgery centers1 laboratories1 radiology clinics1 freestanding emergency rooms1 and any other facility that provides services that are covered under a group health plan or health insurance coverage1 including settings of care subject to section #bgai;,a7b74 4 7b7 ,non-,federal governmental plans ,section #bgbb7;a77#b77;,e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ba7;a77#b77;,e77 is amended by inserting 1 except that such election shall be available with respect to section #bgbi;,a before the period4 #ajd4 ,effective date ,the amendments made by sections #aja1 #ajb1 and #ajc shall take effect beginning in the second plan year that begins after the date of enactment of this ,act4 #aje4 ,ending surprise air ambulance bills 7a7 ,in general ,part ,a of title ,,xxvii of the ,public ,health ,service ,act is amended by inserting after section #bgai;,a 7#db ,u4,s4,c4 #cjj;gg-#ai;a7 the following3 #bgai;,b4 ,ending surprise air ambulance bills 7a7 ,in general ,in the case of an enrollee in a group health plan or group or individual health insurance coverage who receives air ambulance services from an out-of-network provider1 if such services would be covered if provided by an in-network provider-- 7#a7 the cost-sharing requirement 7expressed as a copayment amount1 coinsurance rate1 or deductible7 with respect to such services shall be the same requirement that would apply if such services were provided by an in-network practitioner1 and any coinsurance or deductible shall be based on in-network rates2 and 7#b7 such cost-sharing amounts shall be counted towards the in-network deductible and in-network out-of-pocket maximum amount under the plan or coverage for the plan year4 7b7 ,payment rate ,a group health plan or health insurance issuer shall pay for air ambulance services for purposes of subsection 7a7 at the median in-network as defined in subsection 7c74 7c7 ,median in-network rate 7#a7 ,in general ,for purposes of this section1 the term median in-network rate means1 with respect to air ambulance services covered by a group health plan or group or individual health insurance coverage1 the median contracted rate under the applicable plan or coverage recognized under the plan or coverage as the total maximum payment for the service1 minus the in-network cost-sharing for such service under the plan or coverage1 for the same or a similar service that is provided by a provider in the same or similar specialty1 and in the geographic region in which the service is furnished4 7#b7 ,rulemaking 7,a7 ,in general ,not later than #f months after the date of enactment of the ,lower ,health ,care ,costs ,act1 the ,secretary shall1 through rulemaking1 determine the methodology a group health plan or health insurance issuer is required to use to determine the median in-network rate described in paragraph 7#a71 the information the plan or issuer shall share with the out-of-network provider involved when making such a determination1 and the geographic regions applied for purposes of this subsection4 ,such rulemaking shall take into account payments that are made by issuers that are not on a fee-for-service basis4 7,b7 ,geographic regions ,in establishing geographic regions as described in subparagraph 7,a71 the ,secretary shall consider adequate access to services in rural areas4 ,the ,secretary shall consult with the ,national ,association of ,insurance ,commissioners in establishing the geographic regions4 ,the ,secretary shall update the geographic regions periodically1 as appropriate1 taking into account the findings of the report under section #ajf of the ,lower ,health ,care ,costs ,act4 7#c7 ,certain insurers ,if a group health plan or health insurance issuer offering group or individual health insurance coverage does not have sufficient information to calculate a median in-network rate for this service or provider type1 or amount of1 claims for services 7as determined by the applicable ,state authority1 in the case of health insurance coverage1 or by the ,secretary of ,labor1 in the case of a self-insured group health plan7 covered under the list of out-of-network services set by the ,state authority or ,secretary of ,labor1 as applicable1 in a particular geographic area1 such plan or issuer shall demonstrate that it will use a database free of conflicts of interest that has sufficient information reflecting allowed amounts paid to individual health care providers for relevant services provided in the applicable geographic region1 and that such plan or issuer will use that database to determine a median in-network rate4 ,the group health plan or health insurance issuer shall cover the cost of accessing the database4 7#d7 ,clarification ,for purposes of this subsection1 the ,secretary may define geographic regions that are different from the geographic regions identified for purposes of section #bgbi;,a7b7 to ensure that an adequate number of air ambulance services are in-network in each geographic region so that a median in-network rate for air ambulance services may be calculated for each such region4 7d7 ,cost-sharing limitation ,an air ambulance service provider may not bill an enrollee in a group health plan or group or individual health insurance coverage for amounts beyond the cost-sharing amount that applies under subsection 7a74 7e7 ,enforcement 7#a7 ,in general ,subject to paragraph 7#b71 an air ambulance service provider that violates subsection 7d7 shall be subject to a civil monetary penalty of not more than #aj1jjj for each act constituting such violation4 7#b7 ,procedure ,the provisions of section #aabh;,a of the ,social ,security ,act1 other than subsections 7a7 and 7b7 and the first sentence of subsection 7c77#a7 of such section1 shall apply to civil money penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a of the ,social ,security ,act4 7#c7 ,safe harbor ,the ,secretary shall waive the penalties described under paragraph 7#a7 with respect to a air ambulance service provider who unknowingly violates subsection 7d7 with respect to an enrollee1 if such air ambulance service provider within #cj days of the violation1 withdraws the bill that was in violation of subsection 7d71 and1 as applicable1 reimburses the group health plan1 health insurance issuer1 or enrollee1 as applicable1 in an amount equal to the amount billed in violation of subsection 7d71 plus interest1 at an interest rate determined by the ,secretary4 4 7b7 ,effective date ,section #bgai;,b of the ,public ,health ,service ,act1 as added by subsection 7a71 shall take effect on the date that is #a year after the date of enactment of this ,act4 #ajf4 ,report ,not later than #a year after the effective date described in section #ajd1 and annually for the following #d years1 the ,secretary of ,health and ,human ,services1 in consultation with the ,federal ,trade ,commission and the ,attorney ,general1 shall-- 7#a7 conduct a study on-- 7,a7 the effects of the amendments made by sections #aja1 #ajb1 #ajc1 and #aje1 including any patterns of vertical or horizontal integration of health care facilities1 providers1 group health plans1 or health insurance issuers2 7,b7 the effects of the amendments made by sections #aja1 #ajb1 #ajc1 and #aje on overall health care costs2 7,c7 the effects of the amendments made by sections #aja1 #ajb1 #ajc1 and #aje on access to services1 including specialty services1 in rural areas and health professional shortage areas as defined in section #ccb2 and 7,d7 recommendations1 made in consultation with the ,secretary of ,labor and the ,secretary of the ,treasury1 for effective enforcement of #bgbi;,a of the ,public ,health ,service ,act1 as added by section #ajc1 including potential challenges to addressing anti-competitive consolidation by health care facilities1 providers1 group health plans1 or health insurance issuers2 and 7#b7 submit a report on such study to the ,committee on ,health1 ,education1 ,labor1 and ,pensions1 the ,committee on ,commerce1 ,science1 and ,transportation1 the ,committee on ,finance1 and the ,committee on the ,judiciary of the ,senate and the ,committee on ,education and ,labor1 the ,committee on ,energy and ,commerce1 the ,committee on ,ways and ,means1 and the ,committee on the ,judiciary of the ,house of ,representatives4 ,,ii ,reducing the prices of prescription drugs #bja4 ,biological product patent transparency 7a7 ,in general ,section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 is amended by adding at the end the following3 7o7 ,additional requirements with respect to patents 7#a7 ,approved application holder listing requirements 7,a7 ,in general ,beginning on the date of enactment of the ,lower ,health ,care ,costs ,act1 within #fj days of approval of an application under subsection 7a7 or 7k71 the holder of such approved application shall submit to the ,secretary a list of each patent required to be disclosed 7as described in paragraph 7#c774 7,b7 ,previously approved or licensed biological products 7i7 ,products licensed under section #cea of the ,,phsa ,not later than #cj days after the date of enactment of the ,lower ,health ,care ,costs ,act1 the holder of a biological product license that was approved under subsection 7a7 or 7k7 before the date of enactment of such ,act shall submit to the ,secretary a list of each patent required to be disclosed 7as described in paragraph 7#c774 7ii7 ,products approved under section #eje of the ,,ffdca ,not later than #cj days after ,march #bc1 #bjbj1 the holder of an approved application for a biological product under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act that is deemed to be a license for the biological product under this section on ,march #bc1 #bjbj1 shall submit to the ,secretary a list of each patent required to be disclosed 7as described in paragraph 7#c774 7,c7 ,updates ,the holder of a biological product license that is the subject of an application under subsection 7a7 or 7k7 shall submit to the ,secretary a list that includes-- 7i7 any patent not previously required to be disclosed 7as described in paragraph 7#c77 under subparagraph 7,a7 or 7,b71 as applicable1 within #cj days of the earlier of-- 7,i7 the date of issuance of such patent by the ,united ,states ,patent and ,trademark ,office2 or 7,,ii7 the date of approval of a supplemental application for the biological product2 and 7ii7 any patent1 or any claim with respect to a patent1 included on the list pursuant to this paragraph1 that the ,patent ,trial and ,appeal ,board of the ,united ,states ,patent and ,trademark ,office determines in a written decision to cancel as unpatentable1 within #cj days of such decision4 7#b7 ,publication of information 7,a7 ,in general ,within #a year of the date of enactment of the ,lower ,health ,care ,costs ,act1 the ,secretary shall publish and make available to the public a single1 easily searchable list that includes-- 7i7 the official and proprietary name of each biological product licensed1 or deemed to be licensed1 under subsection 7a7 or 7k72 7ii7 with respect to each biological product described in clause 7i71 each patent submitted in accordance with paragraph 7#a72 7iii7 the date of licensure and application number for each such biological product2 7iv7 the marketing status1 dosage form1 route of administration1 strength1 and1 if applicable1 reference product1 for each such biological product2 7v7 the licensure status for each such biological product1 including whether the license at the time of listing is approved1 withdrawn1 or revoked2 7vi7 with respect to each such biological product1 any period of exclusivity under paragraph 7#f71 7#g77;,a71 or 7#g77;,b7 of subsection 7k7 of this section or section #ebg of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 and any extension of such period in accordance with subsection 7m7 of this section1 for which the ,secretary has determined such biological product to be eligible1 and the date on which such exclusivity expires2 7vii7 any determination of biosimilarity or interchangeability for each such biological product2 and 7viii7 information regarding approved indications for each such biological product1 in such manner as the ,secretary determines appropriate4 7,b7 ,updates ,every #cj days after the publication of the first list under subparagraph 7,a71 the ,secretary shall revise the list to include-- 7i7 7,i7 each biological product licensed under subsection 7a7 or 7k7 during the #cj-;day period2 and 7,,ii7 with respect to each biological product described in subclause 7,i71 the information described in clauses 7i7 through 7viii7 of subparagraph 7,a72 and 7ii7 any updates to information previously published in accordance with subparagraph 7,a74 7,c7 ,noncompliance ,beginning #ah months after the date of enactment of the ,lower ,health ,care ,costs ,act1 the ,secretary1 in consultation with the ,director of the ,united ,states ,patent and ,trademark ,office1 shall publish and make available to the public a list of any holders of biological product licenses1 and the corresponding biological product or products1 that failed to submit information as required under paragraph 7#a71 including any updates required under paragraph 7#a77;,c71 in such manner and format as the ,secretary determines appropriate4 ,if information required under paragraph 7#a7 is submitted following publication of such list1 the ,secretary shall remove such holders of such biological product licenses from the public list in a reasonable period of time4 7#c7 ,patents required to be disclosed ,in this section1 a patent required to be disclosed is any patent for which the holder of a biological product license approved under subsection 7a7 or 7k71 or a biological product application approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act and deemed to be a license for a biological product under this section on ,march #bc1 #bjbj1 believes a claim of patent infringement could reasonably be asserted by the holder1 or by a patent owner that has granted an exclusive license to the holder with respect to the biological product that is the subject of such license1 if a person not licensed by the owner engaged in the making1 using1 offering to sell1 selling1 or importing into the ,united ,states of the biological product that is the subject of such license4 4 7b7 ,disclosure of patents ,section #cea7l77#c77;,a77i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7l77#c77;,a77i77 is amended by inserting included in the list provided by the reference product sponsor under subsection 7o77#a7 after a list of patents4 7c7 ,review and ,report on ,noncompliance ,not later than #cj months after the date of enactment of this ,act1 the ,secretary shall-- 7#a7 solicit public comments regarding appropriate remedies1 in addition to the publication of the list under subsection 7o77#b77;,c7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 as added by subsection 7a71 with respect to holders of biological product licenses who fail to timely submit information as required under subsection 7o77#a7 of such section #cea1 including any updates required under subparagraph 7,c7 of such subsection 7o77#a72 and 7#b7 submit to ,congress an evaluation of comments received under paragraph 7#a7 and the recommendations of the ,secretary concerning appropriate remedies4 7d7 ,regulations ,the ,secretary of ,health and ,human ,services may promulgate regulations to carry out subsection 7o7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 as added by subsection 7a74 7e7 ,rule of construction ,nothing in this ,act1 including an amendment made by this ,act1 shall be construed to require or allow the ,secretary of ,health and ,human ,services to delay the licensing of a biological product under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 #bjb4 ,orange ,book modernization 7a7 ,submission of patent information for brand name drugs 7#a7 ,in general ,paragraph 7#a7 of section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 is amended to read as follows3 7b7 7#a7 7,a7 ,any person may file with the ,secretary an application with respect to any drug subject to the provisions of subsection 7a74 ,such persons shall submit to the ,secretary as part of the application-- 7i7 full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use2 7ii7 a full list of the articles used as components of such drug2 7iii7 a full statement of the composition of such drug2 7iv7 a full description of the methods used in1 and the facilities and controls used for1 the manufacture1 processing1 and packing of such drug2 7v7 such samples of such drug and of the articles used as components thereof as the ,secretary may require2 7vi7 specimens of the labeling proposed to be used for such drug2 7vii7 any assessments required under section #eje;,b2 and 7viii7 the patent number and expiration date1 of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture1 use1 or sale of the drug1 and that-- 7,i7 claims the drug for which the applicant submitted the application and is a drug substance patent or a drug product patent2 or 7,,ii7 claims the method of using the drug for which approval is sought or has been granted in the application4 7,b7 ,if an application is filed under this subsection for a drug1 and a patent of the type described in subparagraph 7,a77viii7 that claims such drug or a method of using such drug is issued after the filing date1 the applicant shall amend the application to include such patent information4 4 7#b7 ,guidance ,the ,secretary of ,health and ,human ,services shall1 in consultation with the ,director of the ,national ,institutes of ,health and with representatives of the drug manufacturing industry1 review and develop guidance1 as appropriate1 on the inclusion of women and minorities in clinical trials required under subsection 7b77#a77;,a77i7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 as amended by paragraph 7#a74 7b7 ,conforming changes to requirements for subsequent submission of patent information ,section #eje7;c77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77#b77 is amended-- 7#a7 by inserting before the first sentence the following3 ,not later than #cj days after the date of approval of an application under subsection 7b71 the holder of the approved application shall file with the ,secretary the patent number and the expiration date of any patent described in subclause 7,i7 or 7,,ii7 of subsection 7b77#a77;,a77viii71 except that a patent that is identified as claiming a method of using such drug shall be filed only if the patent claims a method of use approved in the application4 ,the holder of the approved application shall file with the ,secretary the patent number and the expiration date of any patent described in subclause 7,i7 or 7,,ii7 of subsection 7b77#a77;,a77viii7 that is issued after the date of approval of the application1 not later than #cj days after the date of issuance of the patent1 except that a patent that claims a method of using such drug shall be filed only if approval for such use has been granted in the application42 7#b7 by inserting after the patent number and the expiration date of any patent which the following3 fulfills the criteria in subsection 7b7 and2 7#c7 by inserting after the third sentence 7as amended by paragraph 7#a77 the following3 ,patent information that is not the type of patent information required by subsection 7b77#a77;,a77viii7 shall not be submitted under this paragraph42 and 7#d7 by inserting after could not file patent information under subsection 7b7 because no patent the following3 of the type required to be submitted in subsection 7b77#a77;,a77viii74 7c7 ,listing of exclusivities ,subparagraph 7,a7 of section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 is amended by adding at the end the following3 7iv7 ,for each drug included on the list1 the ,secretary shall specify any exclusivity period that is applicable1 for which the ,secretary has determined the expiration date1 and for which such period has not yet expired under-- 7,i7 clause 7ii71 7iii71 or 7iv7 of subsection 7c77#c77;,e7 of this section2 7,,ii7 clause 7iv7 or 7v7 of paragraph 7#e77;,b7 of this subsection2 7,,iii7 clause 7ii71 7iii71 or 7iv7 of paragraph 7#e77;,f7 of this subsection2 7,,iv7 section #eje;,a2 7,v7 section #eje;,e2 7,,vi7 section #ebg7;a72 or 7,,vii7 subsection 7u7 4 7d7 ,orange book updates with respect to invalidated patents 7#a7 ,in general 7,a7 ,amendments ,section #eje7;j77#g77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77;,a771 as amended by subsection 7c71 is further amended by adding at the end the following3 7v7 ,in the case of a listed drug for which the list under clause 7i7 includes a patent for such drug1 and where the ,under ,secretary of ,commerce for ,intellectual ,property and ,director of the ,united ,states ,patent and ,trademark ,office have cancelled any claim of the patent pursuant to a decision by the ,patent ,trial and ,appeal ,board in an inter partes review conducted under chapter #ca of title #ce1 ,united ,states ,code1 or a post-grant review conducted under chapter #cb of that title1 and from which no appeal has been taken1 or can be taken1 the holder of the applicable approved application shall notify the ,secretary1 in writing1 within #ad days of such cancellation1 and1 if the patent has been deemed wholly inoperative or invalid1 or if a patent claim has been cancelled1 the revisions required under clause 7iii7 shall include striking the patent or information regarding such patent claim from the list with respect to such drug1 as applicable1 except that the ,secretary shall not remove a patent from the list before the expiration of any #ahj-;day exclusivity period under paragraph 7#e77;,b77iv7 that relies on a certification described in paragraph 7#b77;,a77vii77,,iv7 with respect to such patent4 4 7,b7 ,application ,the amendment made by subparagraph 7,a7 shall not apply with respect to any determination with respect to a patent or patent claim that is made prior to the date of enactment of this ,act4 7#b7 ,no effect on first applicant exclusivity period ,section #eje7;j77#e77;,b77iv77,i71 as amended by section #bje1 is amended by adding at the end the following3 ,this subclause shall apply even if a patent is stricken from the list under paragraph 7#g77;,a71 pursuant to paragraph 7#g77;,a77v71 provided that1 at the time that the first applicant submitted an application under this subsection containing a certification described in paragraph 7#b77;,a77vii77,,iv71 the patent that was the subject of such certification was included in such list with respect to the listed drug44 #bjc4 ,ensuring timely access to generics ,section #eje7q7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7q77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a77i71 by inserting 1 #aj4ca1 after #aj4cj2 7,b7 in subparagraph 7,e7-- 7i7 by striking application and and inserting application or2 7ii7 by striking ,if the ,secretary and inserting the following3 7i7 ,in general ,if the ,secretary 2 and 7iii7 by striking the second sentence and inserting the following3 7ii7 ,primary purpose of delaying 7,i7 ,in general ,in determining whether a petition was submitted with the primary purpose of delaying an application1 the ,secretary may consider the following factors3 7aa7 ,whether the petition was submitted in accordance with paragraph 7#b77;,b71 based on when the petitioner knew or reasonably should have known the relevant information relied upon to form the basis of such petition4 7bb7 ,whether the petitioner has submitted multiple or serial petitions or supplements to petitions raising issues that reasonably could have been known to the petitioner at the time of submission of the earlier petition or petitions4 7cc7 ,whether the petition was submitted close in time to a known1 first date upon which an application under subsection 7b77#b7 or 7j7 of this section or section #cea7k7 of the ,public ,health ,service ,act could be approved4 7dd7 ,whether the petition was submitted without relevant data or information in support of the scientific positions forming the basis of such petition4 7ee7 ,whether the petition raises the same or substantially similar issues as a prior petition to which the ,secretary has responded substantively already1 including if the subsequent submission follows such response from the ,secretary closely in time4 7ff7 ,whether the petition requests changing the applicable standards that other applicants are required to meet1 including requesting testing1 data1 or labeling standards that are more onerous or rigorous than the standards the ,secretary has determined to be applicable to the listed drug1 reference product1 or petitioner's version of the same drug4 7gg7 ,the petitioner's record of submitting petitions to the ,food and ,drug ,administration that have been determined by the ,secretary to have been submitted with the primary purpose of delay4 7hh7 ,other relevant and appropriate factors1 which the ,secretary shall describe in guidance4 7,,ii7 ,guidance ,the ,secretary may issue or update guidance1 as appropriate1 to describe factors the ,secretary considers in accordance with subclause 7,,ii74 2 7,c7 by adding at the end the following3 7iii7 ,referral to the ,federal ,trade ,commission ,the ,secretary shall establish procedures for referring to the ,federal ,trade ,commission any petition or supplement to a petition that the ,secretary determines was submitted with the primary purpose of delaying approval of an application4 ,such procedures shall include notification to the petitioner by the ,secretary4 2 7,d7 by striking subparagraph 7,f72 7,e7 by redesignating subparagraphs 7,g7 through 7,i7 as subparagraphs 7,f7 through 7,h71 respectively2 and 7,f7 in subparagraph 7,h71 as so redesignated1 by striking submission of this petition and inserting submission of this document2 7#b7 in paragraph 7#b7-- 7,a7 by redesignating subparagraphs 7,a7 through 7,c7 as subparagraphs 7,c7 through 7,e71 respectively2 7,b7 by inserting before subparagraph 7,c71 as so redesignated1 the following3 7,a7 ,in general ,a person shall submit a petition to the ,secretary under paragraph 7#a7 before filing a civil action in which the person seeks to set aside1 delay1 rescind1 withdraw1 or prevent submission1 review1 or approval of an application submitted under subsection 7b77#b7 or 7j7 of this section or section #cea7k7 of the ,public ,health ,service ,act4 ,such petition and any supplement to such a petition shall describe all information and arguments that form the basis of the relief requested in any civil action described in the previous sentence4 7,b7 ,timely submission of citizen petition ,a petition and any supplement to a petition shall be submitted within #fj days after the person knew1 or reasonably should have known1 the information that forms the basis of the request made in the petition or supplement4 2 7,c7 in subparagraph 7,c71 as so redesignated-- 7i7 in the heading1 by striking within #aej days2 7ii7 in clause 7i71 by striking during the #aej-;day period referred to in paragraph 7#a77;,f712 and 7iii7 by amending clause 7ii7 to read as follows3 7ii7 on or after the date that is #aea days after the date of submission of the petition1 the ,secretary approves or has approved the application that is the subject of the petition without having made such a final decision4 2 7,d7 by amending subparagraph 7,d71 as so redesignated1 to read as follows3 7,d7 ,dismissal of certain civil actions 7i7 ,petition ,if a person files a civil action against the ,secretary in which a person seeks to set aside1 delay1 rescind1 withdraw1 or prevent submission1 review1 or approval of an application submitted under subsection 7b77#b7 or 7j7 of this section or section #cea7k7 of the ,public ,health ,service ,act without complying with the requirements of subparagraph 7,a71 the court shall dismiss without prejudice the action for failure to exhaust administrative remedies4 7ii7 ,timeliness ,if a person files a civil action against the ,secretary in which a person seeks to set aside1 delay1 rescind1 withdraw1 or prevent submission1 review1 or approval of an application submitted under subsection 7b77#b7 or 7j7 of this section or section #cea7k7 of the ,public ,health ,service ,act without complying with the requirements of subparagraph 7,b71 the court shall dismiss with prejudice the action for failure to timely file a petition4 7iii7 ,final response ,if a civil action is filed against the ,secretary with respect to any issue raised in a petition timely filed under paragraph 7#a7 in which the petitioner requests that the ,secretary take any form of action that could1 if taken1 set aside1 delay1 rescind1 withdraw1 or prevent submission1 review1 or approval of an application submitted under subsection 7b77#b7 or 7j7 of this section or section #cea7k7 of the ,public ,health ,service ,act before the ,secretary has taken final agency action on the petition within the meaning of subparagraph 7,c71 the court shall dismiss without prejudice the action for failure to exhaust administrative remedies4 2 and 7,e7 in clause 7iii7 of subparagraph 7,e71 as so redesignated1 by striking as defined under subparagraph 7#b77;,a7 and inserting within the meaning of subparagraph 7,c72 and 7#c7 in paragraph 7#d7-- 7,a7 by striking ,exceptions and all that follows through ,this subsection does and inserting ,exceptions4--,this subsection does2 7,b7 by striking subparagraph 7,b72 and 7,c7 by redesignating clauses 7i7 and 7ii7 as subparagraphs 7,a7 and 7,b71 respectively1 and adjusting the margins accordingly4 #bjd4 ,protecting access to biological products ,section #cea7k77#g7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77#g77 is amended by adding at the end the following3 7,d7 ,deemed licenses 7i7 ,no additional exclusivity through deeming ,an approved application that is deemed to be a license for a biological product under this section pursuant to section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji shall not be treated as having been first licensed under subsection 7a7 for purposes of subparagraphs 7,a7 and 7,b74 7ii7 ,application of limitations on exclusivity ,subparagraph 7,c7 shall apply with respect to a reference product referred to in such subparagraph that was the subject of an approved application that was deemed to be a license pursuant to section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji4 7iii7 ,applicability ,the exclusivity periods described in section #ebg1 section #eje;,a7b77#a77;,a77ii71 and section #eje;,a7c77#a77;,a77ii7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act shall continue to apply to a biological product after an approved application for the biological product is deemed to be a license for the biological product under subsection 7a7 pursuant to section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji4 4 #bje4 ,preventing blocking of generic drugs 7a7 ,in general ,section #eje7;j77#e77;,b77iv77,i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,b77iv77,i77 is amended-- 7#a7 by striking #ahj days after the date and inserting 8#ahj days after the earlier of the following3 7aa7 ,the date 2 and 7#b7 by adding at the end the following3 7bb7 ,the date on which all of the following conditions are first met1 provided no application submitted by any first applicant is approved on or before such date3 7,,aa7 ,an application for the drug submitted by an applicant other than a first applicant has received tentative approval and could receive approval1 if no first applicant were eligible for #ahj-;day exclusivity under this clause1 and such applicant has not entered into an agreement that would prevent commercial marketing upon approval and has submitted a notification to the ,secretary documenting that it has not entered into an agreement that would prevent commercial marketing4 7,,bb7 ,thirty-three months have passed since the date of submission of an application for the drug by one first applicant1 if there is only one first applicant1 or1 in the case of more than one first applicant1 #cc months have passed since the date of submission of all such applications4 7,,cc7 ,approval of an application for the drug submitted by at least one first applicant would not be precluded under clause 7iii74 4 7b7 ,information ,not later than #fj days of the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this subsection as the ,secretary7 shall publish1 as appropriate and available1 information sufficient to allow applicants to assess whether the conditions described in subitems 7,,aa7 through 7,,cc7 of section #eje7;j77#e77;,b77iv77,i77bb7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as amended by subsection 7a77 have been or will be satisfied for all applications where the exclusivity period under 7iv77,i7 of section #eje7;j77#e77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as so amended7 has not expired1 and shall provide updates to reflect the most recent information available to the ,secretary4 #bjf4 ,education on biological products ,subpart #a of part ,f of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb et seq47 is amended by adding at the end the following3 #ceb;,a4 ,education on biological products 7a7 ,internet website 7#a7 ,in general ,the ,secretary may maintain and operate an internet website to provide educational materials for health care providers1 patients1 and caregivers1 regarding the meaning of the terms1 and the standards for review and licensing of1 biological products1 including biosimilar biological products and interchangeable biosimilar biological products4 7#b7 ,content ,educational materials provided under paragraph 7#a7 may include-- 7,a7 explanations of key statutory and regulatory terms1 including biosimilar and interchangeable1 and clarification regarding the use of interchangeable biosimilar biological products2 7,b7 information related to development programs for biological products1 including biosimilar biological products and interchangeable biosimilar biological products and relevant clinical considerations for prescribers1 which may include1 as appropriate and applicable1 information related to the comparability of such biological products2 7,c7 an explanation of the process for reporting adverse events for biological products1 including biosimilar biological products and interchangeable biosimilar biological products2 and 7,d7 an explanation of the relationship between biosimilar biological products and interchangeable biosimilar biological products licensed under section #cea7k7 and reference products 7as defined in section #cea7;i771 including the standards for review and licensing of each such type of biological product4 7#c7 ,format ,the educational materials provided under paragraph 7#a7 may be-- 7,a7 in formats such as webinars1 continuing medical education modules1 videos1 fact sheets1 infographics1 stakeholder toolkits1 or other formats as appropriate and applicable2 and 7,b7 tailored for the unique needs of health care providers1 patients1 caregivers1 and other audiences1 as the ,secretary determines appropriate4 7#d7 ,other information ,in addition to the information described in paragraph 7#b71 the ,secretary shall continue to publish the following information3 7,a7 ,the action package of each biological product licensed under subsection 7a7 or 7k74 7,b7 ,the summary review of each biological product licensed under subsection 7a7 or 7k74 7#e7 ,confidential and trade secret information ,this subsection does not authorize the disclosure of any trade secret1 confidential commercial or financial information1 or other matter described in section #eeb7;b7 of title #e4 7b7 ,continuing education ,the ,secretary shall advance education and awareness among health care providers regarding biological products1 including biosimilar biological products and interchangeable biosimilar biological products1 as appropriate1 including by developing or improving continuing medical education programs that advance the education of such providers on the prescribing of1 and relevant clinical considerations with respect to1 biological products1 including biosimilar biological products and interchangeable biosimilar biological products4 4 #bjg4 ,biological product innovation ,section #cea7;j7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;j77 is amended-- 7#a7 by striking except that a product and inserting 8except that-- 7#a7 a product 2 7#b7 by striking ,act4 and inserting ,act2 and2 and 7#c7 by adding at the end the following3 7#b7 no requirement under such ,act regarding an official compendium 7as defined in section #bja7;j7 of such ,act71 or other reference in such ,act to an official compendium 7as so defined71 shall apply with respect to a biological product subject to regulation under this section4 4 #bjh4 ,clarifying the meaning of new chemical entity 7a7 ,in general ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended-- 7#a7 in section #eje 7#ba ,u4,s4,c4 #cee7-- 7,a7 in subsection 7c77#c77;,e71 by striking active ingredient 7including any ester or salt of the active ingredient7 each place it appears and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 7,b7 in subsection 7j77#e77;,f71 by striking active ingredient 7including any ester or salt of the active ingredient7 each place it appears and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 7,c7 in subsection 7l77#b77;,a7-- 7i7 by amending clause 7i7 to read as follows3 7i7 not later than #cj days after the date of approval of such applications-- 7,i7 for a drug1 no active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 of which has been approved in any other application under this section2 or 7,,ii7 for a biological product1 no active ingredient of which has been approved in any other application under section #cea of the ,public ,health ,service ,act2 and 2 and 7ii7 in clause 7ii71 by inserting or biological product before the period2 7,d7 by amending subsection 7s7 to read as follows3 7s7 ,referral to advisory committee ,the ,secretary shall-- 7#a7 refer a drug or biological product to a ,food and ,drug ,administration advisory committee for review at a meeting of such advisory committee prior to the approval of such drug or biological if it is-- 7,a7 a drug1 no active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 of which has been approved in any other application under this section2 or 7,b7 a biological product1 no active ingredient of which has been approved in any other application under section #cea of the ,public ,health ,service ,act2 or 7#b7 if the ,secretary does not refer a drug or biological product described in paragraph 7#a7 to a ,food and ,drug ,administration advisory committee prior to such approval1 provide in the action letter on the application for the drug or biological product a summary of the reasons why the ,secretary did not refer the drug or biological product to an advisory committee prior to approval4 2 and 7,e7 in subsection 7u77#a71 in the matter preceding subparagraph 7,a7-- 7i7 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 and 7ii7 by striking same active ingredient and inserting same active moiety2 7#b7 in section #eab7;c77#b77;,f7 7#ba ,u4,s4,c4 #cfj;b7c77#b77;,f771 by striking active ingredient 7including any ester or salt of the active ingredient7 each place it appears and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 7#c7 in section #ebd7;a77#d7 7#ba ,u4,s4,c4 #cfjn7a77#d771 by amending subparagraph 7,c7 to read as follows3 7,c7 is for-- 7i7 a human drug1 no active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 of which has been approved in any other application under section #eje7;b77#a72 or 7ii7 a biological product1 no active ingredient of which has been approved in any other application under section #cea of the ,public ,health ,service ,act4 2 7#d7 in section #ebi7;a77#d7 7#ba ,u4,s4,c4 #ba ,u4,s4,c4 #cfj;ff7a77#d771 by striking subparagraphs 7,a7 and 7,b7 and inserting the following3 7,a7 is for a drug or biological product that is for the prevention or treatment of a rare pediatric disease2 7,b7 7i7 is for such a drug-- 7,i7 that contains no active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 that has been previously approved in any other application under subsection 7b77#a71 7b77#b71 or 7j7 of section #eje2 and 7,,ii7 that is the subject of an application submitted under section #eje7;b77#a72 or 7ii7 or is for such a biological product-- 7,i7 that contains no active ingredient that has been previously approved in any other application under section #cea7;a7 or #cea7k7 of the ,public ,health ,service ,act2 and 7,,ii7 that is the subject of an application submitted under section #cea7;a7 of the ,public ,health ,service ,act2 2 and 7#e7 in section #efe;,a7a77#d7 7#ba ,u4,s4,c4 #cfj;bbb-#d;a7a77#d771 by amending subparagraph 7,d7 to read as follows3 7,d7 is for-- 7i7 a human drug1 no active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 of which has been approved in any other application under section #eje7;b77#a72 or 7ii7 a biological product1 no active ingredient of which has been approved in any other application under section #cea of the ,public ,health ,service ,act4 4 7b7 ,technical corrections ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq7 is amended-- 7#a7 in section #eje 7#ba ,u4,s4,c4 #cee7-- 7,a7 in subsection 7c77#c77;,e71 by repealing clause 7i72 and 7,b7 in subsection 7j77#e77;,f71 by repealing clause 7i72 and 7#b7 in section #eje;,a7c77#a77;,a77i77,,ii7 7#ba ,u4,s4,c4 #cee;a7c77#a77;,a77i771 by striking 7c77#c77;,d7 and inserting 7c77#c77;,e74 #bji4 ,streamlining the transition of biological products ,section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji 7,public ,law #aaa-adh7 is amended by adding at the end the following3 ,with respect to an application for a biological product submitted under section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 with a filing date that is not later than ,september #bc1 #bjai1 and that does not receive final approval on or before ,march #bc1 #bjbj1 such application shall be deemed to be withdrawn and the ,secretary shall refund the fee paid under section #gcf7;a77#a77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7a77#a77;,b774 ,notwithstanding any such withdrawal of the drug application1 the ,secretary shall consider any previously conducted scientific review and accelerate review of any such subsequent application with respect to such biological product under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 ,the ,secretary shall provide additional assistance to the sponsor or manufacturer of such application44 #baj4 ,orphan drug clarification ,section #ebg7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7c77 is amended by adding at the end the following3 7#c7 ,applicability ,this subsection applies to any drug designated under section #ebf for which an application was approved under section #eje of this ,act or licensed under section #cea of the ,public ,health ,service ,act after the date of enactment of the ,,fda ,reauthorization ,act of #bjag1 regardless of the date of on which such drug was designated under section #ebf4 4 #baa4 ,prompt approval of drugs related to safety information ,section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is amended by adding at the end the following3 7z7 ,prompt ,approval of ,drugs ,when safety information ,is ,added to ,labeling 7#a7 ,general rule ,a drug for which an application has been submitted or approved under subsection 7b77#b7 or 7j7 shall not be considered ineligible for approval under this section or misbranded under section #ejb on the basis that the labeling of the drug omits safety information1 including contraindications1 warnings1 precautions1 dosing1 administration1 or other information pertaining to safety1 when the omitted safety information is protected by exclusivity under clause 7iii7 or 7iv7 of subsection 7j77#e77;,f71 clause 7iii7 or 7iv7 of subsection 7c77#c77;,e71 or section #ebg7;a71 or by an extension of such exclusivity under section #eje;,a or #eje;,e4 7#b7 ,labeling ,notwithstanding clauses 7iii7 and 7iv7 of subsection 7j77#e77;,f71 clauses 7iii7 and 7iv7 of subsection 7c77#c77;,e71 or section #ebg1 the ,secretary shall require that the labeling of a drug approved pursuant to an application submitted under subsection 7b77#b7 or 7j7 that omits safety information described in paragraph 7#a7 include a statement of any appropriate safety information that the ,secretary considers necessary to assure safe use4 7#c7 ,availability and scope of exclusivity ,this subsection does not affect-- 7,a7 the availability or scope of exclusivity or an extension of exclusivity described in subparagraph 7,a7 or 7,b7 of section #eje;,a7o77#c72 7,b7 the question of the eligibility for approval under this section of any application described in subsection 7b77#b7 or 7j7 that omits any other aspect of labeling protected by exclusivity under-- 7i7 clause 7iii7 or 7iv7 of subsection 7j77#e77;,f72 7ii7 clause 7iii7 or 7iv7 of subsection 7c77#c77;,e72 or 7iii7 section #ebg7;a72 or 7,c7 except as expressly provided in paragraphs 7#a7 and 7#b71 the operation of this section or section #ebg4 4 #bab4 ,conditions of use for biosimilar biological products ,section #cea7k77#b77;,a77iii7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77#b77;,a77iii7 is amended-- 7#a7 in subclause 7,i71 by striking 2 and and inserting a semicolon2 7#b7 in subclause 7,,ii71 by striking the period and inserting 2 and2 and 7#c7 by adding at the end the following3 7,,iii7 may include information to show that the conditions of use prescribed1 recommended1 or suggested in the labeling proposed for the biological product have been previously approved for the reference product4 4 #bac4 ,modernizing the labeling of certain generic drugs ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by inserting after section #ejc;,c the following3 #ejc;,d4 ,process to update labeling for certain drugs 7a7 ,definitions ,for purposes of this section3 7#a7 ,the term covered drug means a drug approved under section #eje7;c7-- 7,a7 for which there are no unexpired patents included in the list under section #eje7;j77#g7 and no unexpired period of exclusivity2 7,b7 for which the approval of the application has been withdrawn for reasons other than safety or effectiveness2 and 7,c7 for which1 with respect to the labeling-- 7i7 new scientific evidence is available regarding the conditions of use of the drug2 7ii7 there is a relevant accepted use in clinical practice that is not reflected in the approved labeling2 or 7iii7 the labeling of such drug does not reflect current legal and regulatory requirements4 7#b7 ,the term period of exclusivity1 with respect to a drug approved under section #eje7;c71 means any period of exclusivity under clause 7ii71 7iii71 or 7iv7 of section #eje7;c77#c77;,e71 clause 7ii71 7iii71 or 7iv7 of section #eje7;j77#e77;,f71 or section #eje;,a1 #eje;,e1 or #ebg4 7#c7 ,the term generic version means a drug approved under section #eje7;j7 whose reference drug is a covered drug4 7#d7 ,the term relevant accepted use means a use for a drug in clinical practice that is supported by scientific evidence that appears to the ,secretary to meet the standards for approval under section #eje4 7#e7 ,the term selected drug means a covered drug for which the ,secretary has determined through the process under subsection 7c7 that the labeling should be changed4 7b7 ,identification of covered drugs ,the ,secretary may identify covered drugs for which labeling updates would provide a public health benefit4 ,to assist in identifying covered drugs1 the ,secretary may do one or both of the following3 7#a7 ,enter into cooperative agreements or contracts with public or private entities to review the available scientific evidence concerning such drugs4 7#b7 ,seek public input concerning such drugs1 including input on whether there is a relevant accepted use in clinical practice that is not reflected in the approved labeling of such drugs or whether new scientific evidence is available regarding the conditions of use for such drug1 by-- 7,a7 holding one or more public meetings2 7,b7 opening a public docket for the submission of public comments2 or 7,c7 other means1 as the ,secretary determines appropriate4 7c7 ,selection of drugs for updating ,if the ,secretary determines1 with respect to a covered drug1 that the available scientific evidence meets the standards under section #eje for adding or modifying information to the labeling or providing supplemental information to the labeling regarding the use of the covered drug1 the ,secretary may initiate the process under subsection 7d74 7d7 ,initiation of the process of updating ,if the ,secretary determines that labeling changes are appropriate for a selected drug pursuant to subsection 7c71 the ,secretary shall provide notice to the holders of approved applications for a generic version of such drug that-- 7#a7 summarizes the findings supporting the determination of the ,secretary that the available scientific evidence meets the standards under section #eje for adding or modifying information or providing supplemental information to the labeling of the covered drug pursuant to subsection 7c72 7#b7 provides a clear statement regarding the additional1 modified1 or supplemental information for such labeling1 according to the determination by the ,secretary 7including1 as applicable1 modifications to add the relevant accepted use to the labeling of the drug as an additional indication for the drug72 and 7#c7 states whether the statement under paragraph 7#b7 applies to the selected drug as a class of covered drugs or only to a specific drug product4 7e7 ,response to notification ,within #cj days of receipt of notification provided by the ,secretary pursuant to subsection 7d71 the holder of an approved application for a generic version of the selected drug shall-- 7#a7 agree to change the approved labeling to reflect the additional1 modified1 or supplemental information the ,secretary has determined to be appropriate2 or 7#b7 notify the ,secretary that the holder of the approved application does not believe that the requested labeling changes are warranted and submit a statement detailing the reasons why such changes are not warranted4 7f7 ,review of application holder's response 7#a7 ,in general ,upon receipt of the application holder's response1 the ,secretary shall promptly review each statement received under subsection 7e77#b7 and determine which labeling changes pursuant to the ,secretary's notice under subsection 7d7 are appropriate1 if any4 ,if the ,secretary disagrees with the reasons why such labeling changes are not warranted1 the ,secretary shall provide opportunity for discussions with the application holders to reach agreement on whether the labeling for the covered drug should be updated to reflect current scientific evidence1 and if so1 the content of such labeling changes4 7#b7 ,changes to labeling ,after considering all responses from the holder of an approved application under paragraph 7#a7 or 7#b7 of subsection 7e71 and any discussion under paragraph 7#a71 the ,secretary may order such holder to make the labeling changes the ,secretary determines are appropriate4 ,such holder of an approved application shall-- 7,a7 update its paper labeling for the drug at the next printing of that labeling2 7,b7 update any electronic labeling for the drug within #cj days2 and 7,c7 submit the revised labeling through the form1 ,supplement--,changes ,being ,effected4 7g7 ,violation ,if the holder of an approved application for the generic version of the selected drug does not comply with the requirements of subsection 7f77#b71 such generic version of the selected drug shall be deemed to be misbranded under section #ejb4 7h7 ,limitations2 generic drugs 7#a7 ,in general ,with respect to any labeling change required under this section1 the generic version shall be deemed to have the same conditions of use and the same labeling as a reference drug for purposes of clauses 7i7 and 7v7 of section #eje7;j77#b77;,a74 ,any labeling change so required shall not have any legal effect for the applicant that is different than the legal effect that would have resulted if a supplemental application had been submitted and approved to conform the labeling of the generic version to a change in the labeling of the reference drug4 7#b7 ,supplemental applications ,changes to labeling made in accordance with this paragraph shall not be eligible for an exclusivity period under this ,act4 7i7 ,drug product classes ,in the case of a selected drug for which the labeling changes ordered by the ,secretary under subsection 7d77#b7 are required for a class of covered drugs1 such labeling changes shall be made for generic versions of such drug in that class4 7j7 ,rules of construction 7#a7 ,approval standards ,this section shall not be construed as altering the applicability of the standards for approval of an application under section #eje4 ,no order shall be issued under this subsection unless the evidence supporting the changed labeling meets the standards for approval applicable to any change to labeling under section #eje4 7#b7 ,removal of information ,nothing in this section shall be construed to give the ,secretary additional authority to remove approved indications for drugs1 other than the authority described in this section4 7k7 ,reports ,not later than #d years after the date of the enactment of the ,lower ,health ,care ,costs ,act and every #d years thereafter1 the ,secretary shall prepare and submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 a report that-- 7#a7 describes the actions of the ,secretary under this section1 including-- 7,a7 the number of covered drugs and description of the types of drugs the ,secretary has selected for labeling changes and the rationale for such recommended changes2 and 7,b7 the number of times the ,secretary entered into discussions concerning a disagreement with an application holder or holders and a summary of the decision regarding a labeling change1 if any2 and 7#b7 includes any recommendations of the ,secretary for modifying the program under this section4 4 #bad4 ,actions for delays of generic drugs and biosimilar biological products 7a7 ,definitions ,in this section-- 7#a7 the term commercially reasonable1 market-based terms means-- 7,a7 a nondiscriminatory price for the sale of the covered product at or below1 but not greater than1 the most recent wholesale acquisition cost for the drug1 as defined in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b772 7,b7 a schedule for delivery that results in the transfer of the covered product to the eligible product developer consistent with the timing under subsection 7b77#b77;,a77iv72 and 7,c7 no additional conditions are imposed on the sale of the covered product2 7#b7 the term covered product-- 7,a7 means-- 7i7 any drug approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or biological product licensed under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb72 7ii7 any combination of a drug or biological product described in clause 7i72 or 7iii7 when reasonably necessary to support approval of an application under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 as applicable1 or otherwise meet the requirements for approval under either such section1 any product1 including any device1 that is marketed or intended for use with such a drug or biological product2 and 7,b7 does not include any drug or biological product that appears on the drug shortage list in effect under section #ejf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e71 unless-- 7i7 the drug or biological product has been on the drug shortage list in effect under such section #ejf;,e continuously for more than #f months2 or 7ii7 the ,secretary determines that inclusion of the drug or biological product as a covered product is likely to contribute to alleviating or preventing a shortage4 7#c7 the term device has the meaning given the term in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba72 7#d7 the term eligible product developer means a person that seeks to develop a product for approval pursuant to an application for approval under subsection 7b77#b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or for licensing pursuant to an application under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k772 7#e7 the term license holder means the holder of an application approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or the holder of a license under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 for a covered product2 7#f7 the term ,,rems means a risk evaluation and mitigation strategy under section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a72 7#g7 the term ,,rems with ,,etasu means a ,,rems that contains elements to assure safe use under section #eje-a7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;f772 7#h7 the term ,secretary means the ,secretary of ,health and ,human ,services2 7#i7 the term single1 shared system of elements to assure safe use means a single1 shared system of elements to assure safe use under section #eje-a7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;f772 and 7#aj7 the term sufficient quantities means an amount of a covered product that the eligible product developer determines allows it to-- 7,a7 conduct testing to support an application under-- 7i7 subsection 7b77#b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 or 7ii7 section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k772 and 7,b7 fulfill any regulatory requirements relating to approval of such an application4 7b7 ,civil action for failure ,to provide sufficient quantities of a covered product 7#a7 ,in general ,an eligible product developer may bring a civil action against the license holder for a covered product seeking relief under this subsection in an appropriate district court of the ,united ,states alleging that the license holder has declined to provide sufficient quantities of the covered product to the eligible product developer on commercially reasonable1 market-based terms4 7#b7 ,elements 7,a7 ,in general ,to prevail in a civil action brought under paragraph 7#a71 an eligible product developer shall prove1 by a preponderance of the evidence-- 7i7 that-- 7,i7 the covered product is not subject to a ,,rems with ,,etasu2 or 7,,ii7 if the covered product is subject to a ,,rems with ,,etasu-- 7aa7 the eligible product developer has obtained a covered product authorization from the ,secretary in accordance with subparagraph 7,b72 and 7bb7 the eligible product developer has provided a copy of the covered product authorization to the license holder2 7ii7 that1 as of the date on which the civil action is filed1 the product developer has not obtained sufficient quantities of the covered product on commercially reasonable1 market-based terms2 7iii7 that the eligible product developer has submitted a written request to purchase sufficient quantities of the covered product to the license holder1 and such request-- 7,i7 was sent to a named corporate officer of the license holder2 7,,ii7 was made by certified or registered mail with return receipt requested2 7,,iii7 specified an individual as the point of contact for the license holder to direct communications related to the sale of the covered product to the eligible product developer and a means for electronic and written communications with that individual2 and 7,,iv7 specified an address to which the covered product was to be shipped upon reaching an agreement to transfer the covered product2 and 7iv7 that the license holder has not delivered to the eligible product developer sufficient quantities of the covered product on commercially reasonable1 market-based terms-- 7,i7 for a covered product that is not subject to a ,,rems with ,,etasu1 by the date that is #ca days after the date on which the license holder received the request for the covered product2 and 7,,ii7 for a covered product that is subject to a ,,rems with ,,etasu1 by #ca days after the later of-- 7aa7 the date on which the license holder received the request for the covered product2 or 7bb7 the date on which the license holder received a copy of the covered product authorization issued by the ,secretary in accordance with subparagraph 7,b74 7,b7 ,authorization for covered product subject to a ,,rems with ,,etasu 7i7 ,request ,an eligible product developer may submit to the ,secretary a written request for the eligible product developer to be authorized to obtain sufficient quantities of an individual covered product subject to a ,,rems with ,,etasu4 7ii7 ,authorization ,not later than #abj days after the date on which a request under clause 7i7 is received1 the ,secretary shall1 by written notice1 authorize the eligible product developer to obtain sufficient quantities of an individual covered product subject to a ,,rems with ,,etasu for purposes of-- 7,i7 development and testing that does not involve human clinical trials1 if the eligible product developer has agreed to comply with any conditions the ,secretary determines necessary2 or 7,,ii7 development and testing that involves human clinical trials1 if the eligible product developer has-- 7aa7 7,,aa7 submitted protocols1 informed consent documents1 and informational materials for testing that include protections that provide safety protections comparable to those provided by the ,,rems for the covered product2 or 7,,bb7 otherwise satisfied the ,secretary that such protections will be provided2 and 7bb7 met any other requirements the ,secretary may establish4 7iii7 ,notice ,a covered product authorization issued under this subparagraph shall state that the provision of the covered product by the license holder under the terms of the authorization will not be a violation of the ,,rems for the covered product4 7#c7 ,affirmative defense ,in a civil action brought under paragraph 7#a71 it shall be an affirmative defense1 on which the defendant has the burden of persuasion by a preponderance of the evidence-- 7,a7 that1 on the date on which the eligible product developer requested to purchase sufficient quantities of the covered product from the license holder-- 7i7 neither the license holder nor any of its agents1 wholesalers1 or distributors was engaged in the manufacturing or commercial marketing of the covered product2 and 7ii7 neither the license holder nor any of its agents1 wholesalers1 or distributors otherwise had access to inventory of the covered product to supply to the eligible product developer on commercially reasonable1 market-based terms2 7,b7 that-- 7i7 the license holder sells the covered product through agents1 distributors1 or wholesalers2 7ii7 the license holder has placed no restrictions1 explicit or implicit1 on its agents1 distributors1 or wholesalers to sell covered products to eligible product developers2 and 7iii7 the covered product can be purchased by the eligible product developer in sufficient quantities on commercially reasonable1 market-based terms from the agents1 distributors1 or wholesalers of the license holder2 or 7,c7 that the license holder made an offer to the individual specified pursuant to paragraph 7#b77;,a77iii77,,iii71 by a means of communication 7electronic1 written1 or both7 specified pursuant to such paragraph1 to sell sufficient quantities of the covered product to the eligible product developer at commercially reasonable market-based terms-- 7i7 for a covered product that is not subject to a ,,rems with ,,etasu1 by the date that is #ad days after the date on which the license holder received the request for the covered product1 and the eligible product developer did not accept such offer by the date that is #g days after the date on which the eligible product developer received such offer from the license holder2 or 7ii7 for a covered product that is subject to a ,,rems with ,,etasu1 by the date that is #bj days after the date on which the license holder received the request for the covered product1 and the eligible product developer did not accept such offer by the date that is #aj days after the date on which the eligible product developer received such offer from the license holder4 7#d7 ,remedies 7,a7 ,in general ,if an eligible product developer prevails in a civil action brought under paragraph 7#a71 the court shall-- 7i7 order the license holder to provide to the eligible product developer without delay sufficient quantities of the covered product on commercially reasonable1 market-based terms2 7ii7 award to the eligible product developer reasonable attorney's fees and costs of the civil action2 and 7iii7 award to the eligible product developer a monetary amount sufficient to deter the license holder from failing to provide eligible product developers with sufficient quantities of a covered product on commercially reasonable1 market-based terms1 if the court finds1 by a preponderance of the evidence-- 7,i7 that the license holder delayed providing sufficient quantities of the covered product to the eligible product developer without a legitimate business justification2 or 7,,ii7 that the license holder failed to comply with an order issued under clause 7i74 7,b7 ,maximum monetary amount ,a monetary amount awarded under subparagraph 7,a77iii7 shall not be greater than the revenue that the license holder earned on the covered product during the period-- 7i7 beginning on-- 7,i7 for a covered product that is not subject to a ,,rems with ,,etasu1 the date that is #ca days after the date on which the license holder received the request2 or 7,,ii7 for a covered product that is subject to a ,,rems with ,,etasu1 the date that is #ca days after the later of-- 7aa7 the date on which the license holder received the request2 or 7bb7 the date on which the license holder received a copy of the covered product authorization issued by the ,secretary in accordance with paragraph 7#b77;,b72 and 7ii7 ending on the date on which the eligible product developer received sufficient quantities of the covered product4 7,c7 ,avoidance of delay ,the court may issue an order under subparagraph 7,a77i7 before conducting further proceedings that may be necessary to determine whether the eligible product developer is entitled to an award under clause 7ii7 or 7iii7 of subparagraph 7,a71 or the amount of any such award4 7c7 ,limitation of liability ,a license holder for a covered product shall not be liable for any claim under ,federal1 ,state1 or local law arising out of the failure of an eligible product developer to follow adequate safeguards to assure safe use of the covered product during development or testing activities described in this section1 including transportation1 handling1 use1 or disposal of the covered product by the eligible product developer4 7d7 ,no violation of ,,rems ,section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7 is amended by adding at the end the following new subsection3 7l7 ,provision of samples not a violation of strategy ,the provision of samples of a covered product to an eligible product developer 7as those terms are defined in section #bad7;a7 of the ,lower ,health ,care ,costs ,act7 shall not be considered a violation of the requirements of any risk evaluation and mitigation strategy that may be in place under this section for such drug4 4 7e7 ,rule of construction 7#a7 ,definition ,in this subsection1 the term antitrust laws-- 7,a7 has the meaning given the term in subsection 7a7 of the first section of the ,clayton ,act 7#ae ,u4,s4,c4 #ab72 and 7,b7 includes section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to the extent that such section applies to unfair methods of competition4 7#b7 ,antitrust laws ,nothing in this section shall be construed to limit the operation of any provision of the antitrust laws4 7f7 ,,rems approval process for subsequent filers ,section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a71 as amended by subsection 7d71 is further amended-- 7#a7 in subsection 7g77#d77;,b7-- 7,a7 in clause 7i7 by striking or after the semicolon2 7,b7 in clause 7ii7 by striking the period at the end and inserting 2 or2 and 7,c7 by adding at the end the following3 7iii7 accommodate different1 comparable aspects of the elements to assure safe use for a drug that is the subject of an application under section #eje7;j71 and the applicable listed drug4 2 7#b7 in subsection 7i77#a71 by striking subparagraph 7,c7 and inserting the following3 7,c7 7i7 ,elements to assure safe use1 if required under subsection 7f7 for the listed drug1 which1 subject to clause 7ii71 for a drug that is the subject of an application under section #eje7;j7 may use-- 7,i7 a single1 shared system with the listed drug under subsection 7f72 or 7,,ii7 a different1 comparable aspect of the elements to assure safe use under subsection 7f74 7ii7 ,the ,secretary may require a drug that is the subject of an application under section #eje7;j7 and the listed drug to use a single1 shared system under subsection 7f71 if the ,secretary determines that no different1 comparable aspect of the elements to assure safe use could satisfy the requirements of subsection 7f74 2 7#c7 in subsection 7i71 by adding at the end the following3 7#c7 ,shared ,,rems ,if the ,secretary approves1 in accordance with paragraph 7#a77;,c77i77,,ii71 a different1 comparable aspect of the elements to assure safe use under subsection 7f7 for a drug that is the subject of an abbreviated new drug application under section #eje7;j71 the ,secretary may require that such different comparable aspect of the elements to assure safe use can be used with respect to any other drug that is the subject of an application under section #eje7;j7 or #eje7;b7 that references the same listed drug4 2 and 7#d7 by adding at the end the following3 7m7 ,separate ,,rems ,when used in this section1 the terms different1 comparable aspect of the elements to assure safe use or different1 comparable approved risk evaluation and mitigation strategies means a risk evaluation and mitigation strategy for a drug that is the subject of an application under section #eje7;j7 that uses different methods or operational means than the strategy required under subsection 7a7 for the applicable listed drug1 or other application under section #eje7;j7 with the same such listed drug1 but achieves the same level of safety as such strategy4 4 7g7 ,rule of construction ,nothing in this section1 the amendments made by this section1 or in section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a71 shall be construed as-- 7#a7 prohibiting a license holder from providing an eligible product developer access to a covered product in the absence of an authorization under this section2 or 7#b7 in any way negating the applicability of a ,,rems with ,,etasu1 as otherwise required under such section #eje-a1 with respect to such covered product4 #bae4 ,reducing the price of prescription drugs ,title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda et seq47 is amended by adding at the end the following3 ,w ,drug ,price ,reporting2 ,drug ,value ,fund #cii,,oo4 ,reporting on justification for drug price increases 7a7 ,definitions ,in this section3 7#a7 ,manufacturer ,the term manufacturer means the person-- 7,a7 that holds the application for a drug approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or the license issued under section #cea of this ,act2 or 7,b7 who is responsible for setting the price for the drug4 7#b7 ,qualifying drug ,the term qualifying drug means any drug that is approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensed under subsection 7a7 or 7k7 of section #cea of this ,act-- 7,a7 that has a wholesale acquisition cost of #ajj or more per month supply1 or per a course of treatment that lasts less than a month1 and is-- 7i7 7,i7 subject to section #ejc7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 or 7,,ii7 commonly administered by hospitals 7as determined by the ,secretary72 and 7ii7 not designated by the ,secretary as a vaccine2 and 7,b7 for which1 during the previous calendar year1 at least #a dollar of the total amount of sales were for individuals enrolled under the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 or under a ,state ,medicaid plan under title ,,xix of such ,act 7#db ,u4,s4,c4 #acif et seq47 or under a waiver of such plan4 7#c7 ,wholesale acquisition cost ,the term wholesale acquisition cost has the meaning given that term in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 7b7 ,report 7#a7 ,report required ,the manufacturer of a qualifying drug shall submit a report to the ,secretary for each price increase of a qualifying drug that will result in an increase in the wholesale acquisition cost of that drug that is equal to-- 7,a7 #aj percent or more over a #ab-month period2 or 7,b7 #be percent or more over a #cf-month period4 7#b7 ,report deadline ,each report described in paragraph 7#a7 shall be submitted to the ,secretary not later than #cj days prior to the planned effective date of such price increase4 7c7 ,contents ,a report under subsection 7b7 shall1 at a minimum1 include-- 7#a7 with respect to the qualifying drug-- 7,a7 the percentage by which the manufacturer will raise the wholesale acquisition cost of the drug on the planned effective date of such price increase2 7,b7 a justification for1 and description of1 each manufacturer's price increase that will occur during the #ab-month period described in subsection 7b77#a77;,a7 or the #cf-month period described in subsection 7b77#a77;,b71 as applicable2 7,c7 the identity of the initial developer of the drug2 7,d7 a description of the history of the manufacturer's price increases for the drug since the approval of the application for the drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or the issuance of the license for the drug under section #cea1 or since the manufacturer acquired such approved application or license2 7,e7 the current list price of the drug2 7,f7 the total expenditures of the manufacturer on-- 7i7 materials and manufacturing for such drug2 and 7ii7 acquiring patents and licensing for such drug2 7,g7 the percentage of total expenditures of the manufacturer on research and development for such drug that was derived from ,federal funds2 7,h7 the total expenditures of the manufacturer on research and development for such drug that is used for-- 7i7 basic and preclinical research2 7ii7 clinical research2 7iii7 new drug development2 7iv7 pursuing new or expanded indications for such drug through supplemental applications under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea of this ,act2 and 7v7 carrying out postmarket requirements related to such drug1 including those under section #eje7o77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7,i7 the total revenue and the net profit generated from the qualifying drug for each calendar year since the approval of the application for the drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or the issuance of the license for the drug under section #cea1 or since the manufacturer acquired such approved application or license2 and 7,j7 the total costs associated with marketing and advertising for the qualifying drug2 7#b7 with respect to the manufacturer-- 7,a7 the total revenue and the net profit of the manufacturer-- 7i7 for the #ab-month period preceding the date of the report1 in the case of a report based on an increase described in subsection 7b77#a77;,a72 or 7ii7 for the #cf-month period preceding the date of the report1 in the case of a report based on an increase described in subsection 7b77#a77;,b72 7,b7 all stock-based performance metrics used by the manufacturer to determine executive compensation-- 7i7 for the#ab-month period preceding the date of the report1 in the case of a report based on an increase described in subsection 7b77#a77;,a72 or 7ii7 for the #cf-month period preceding the date of the report1 in the case of a report based on an increase described in subsection 7b77#a77;,b72 and 7,c7 any additional information the manufacturer chooses to provide related to drug pricing decisions1 such as total expenditures on-- 7i7 drug research and development2 or 7ii7 clinical trials on drugs that failed to receive approval by the ,food and ,drug ,administration2 and 7#c7 such other related information as the ,secretary considers appropriate1 as specified through notice and comment rulemaking4 7d7 ,civil penalty ,any manufacturer of a qualifying drug that fails to submit a report for the drug as required by this section shall be subject to a civil penalty of #ajj1jjj for each day on which the violation continues4 7e7 ,public posting 7#a7 ,in general ,subject to paragraph 7#c71 not later than #cj days after the submission of a report under subsection 7b71 the ,secretary shall post the report on the public website of the ,department of ,health and ,human ,services4 7#b7 ,format ,in developing the format of such report for public posting1 the ,secretary shall consult stakeholders1 including beneficiary groups1 and shall seek feedback on the content and format from consumer advocates and readability experts to ensure such public reports are user-friendly to the public and are written in plain language that consumers can readily understand4 7#c7 ,trade secrets and confidential information ,in carrying out this section the ,secretary shall enforce current law concerning the protection of confidential commercial information and trade secrets4 4 #cii,,oo-#a4 ,use of civil penalty amounts ,the ,secretary shall1 without further appropriation1 collect civil penalties under section #cii,,oo and use the funds derived from such civil penalties1 in addition to any other amounts available to the ,secretary1 to carry out activities described in this part and to improve consumer and provider information about drug value and drug price transparency4 #cii,,oo-#b4 ,annual report to ,congress 7a7 ,in ,general ,subject to subsection 7b71 the ,secretary shall submit to ,congress1 and post on the public website of the ,department of ,health and ,human ,services in a way that is easy to find1 use1 and understand1 an annual report-- 7#a7 summarizing the information reported pursuant to section #cii,,oo2 and 7#b7 including copies of the reports and supporting detailed economic analyses submitted pursuant to such section4 7b7 ,trade secrets and confidential information ,in carrying out this section the ,secretary shall enforce current law concerning the protection of confidential commercial information and trade secrets4 4 ,,iii ,improving transparency in health care #cja4 ,increasing transparency by removing gag clauses on price and quality information ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq471 as amended by section #ajc1 is amended by adding at the end the following3 #bgbi;,b4 ,increasing transparency by removing gag clauses on price and quality information 7a7 ,increasing price and quality transparency for plan sponsors and group and individual market and consumers 7#a7 ,group health plans ,a group health plan or health insurance issuer offering group health insurance coverage may not enter into an agreement with a health care provider1 network or association of providers1 third-party administrator1 or other service provider offering access to a network of providers that would directly or indirectly restrict a group health plan or health insurance issuer from-- 7,a7 providing provider-specific cost or quality of care information1 through a consumer engagement tool or any other means1 to referring providers1 the plan sponsor1 enrollees1 or eligible enrollees of the plan or coverage2 7,b7 electronically accessing de-identified claims and encounter data for each enrollee in the plan or coverage1 upon request and consistent with the privacy regulations promulgated pursuant to section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act1 the amendments to this ,act made by the ,genetic ,information ,nondiscrimination ,act of #bjjh1 and the ,americans with ,disabilities ,act of #aiij1 with respect to the applicable health plan or health insurance coverage1 including1 on a per claim basis-- 7i7 financial information1 such as the allowed amount1 or any other claim-related financial obligations included in the provider contract2 7ii7 provider information1 including name and clinical designation2 7iii7 service codes2 or 7iv7 any other data element normally included in claim or encounter transactions when received by a plan or issuer2 or 7,c7 sharing data described in subparagraph 7,a7 or 7,b7 with a business associate as defined in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or successor regulations71 consistent with the privacy regulations promulgated pursuant to section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act1 the amendments to this ,act made by the ,genetic ,information ,nondiscrimination ,act of #bjjh1 and the ,americans with ,disabilities ,act of #aiij4 7#b7 ,individual health insurance coverage ,a health insurance issuer offering individual health insurance coverage may not enter into an agreement with a health care provider1 network or association of providers1 or other service provider offering access to a network of providers that would directly or indirectly restrict the health insurance issuer from-- 7,a7 providing provider-specific price or quality of care information1 through a consumer engagement tool or any other means1 to referring providers1 enrollees1 or eligible enrollees of the plan or coverage2 or 7,b7 sharing1 for plan design1 plan administration1 and plan1 financial1 legal1 and quality improvement activities1 data described in subparagraph 7,a7 with a business associate as defined in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or successor regulations71 consistent with the privacy regulations promulgated pursuant to section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act1 the amendments to this ,act made by the ,genetic ,information ,nondiscrimination ,act of #bjjh1 and the ,americans with ,disabilities ,act of #aiij4 7#c7 ,clarification regarding public disclosure of information ,nothing in paragraph 7#a77;,a7 or 7#b77;,a7 prevents a health care provider1 network or association of providers1 or other service provider from placing reasonable restrictions on the public disclosure of the information described in such paragraphs 7#a7 and 7#b74 7#d7 ,attestation ,a group health plan or a health insurance issuer offering group or individual health insurance coverage shall annually submit to1 as applicable1 the applicable authority described in section #bgbc or the ,secretary of ,labor1 an attestation that such plan or issuer is in compliance with the requirements of this subsection4 7#e7 ,rule of construction ,nothing in this section shall be construed to otherwise limit group health plan1 plan sponsor1 or health insurance issuer access to data currently permitted under the privacy regulations promulgated pursuant to section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act1 the amendments to this ,act made by the ,genetic ,information ,nondiscrimination ,act of #bjjh1 and the ,americans with ,disabilities ,act of #aiij4 4 #cjb4 ,banning anticompetitive terms in facility and insurance contracts that limit access to higher quality1 lower cost care 7a7 ,in general ,section #bgbi;,b of the ,public ,health ,service ,act1 as added by section #cja1 is amended by adding at the end the following3 7b7 ,protecting ,health ,plans ,network ,design ,flexibility 7#a7 ,in general ,a group health plan or a health insurance issuer offering group or individual health insurance coverage shall not enter into an agreement with a provider1 network or association of providers1 or other service provider offering access to a network of service providers if such agreement1 directly or indirectly-- 7,a7 restricts the group health plan or health insurance issuer from-- 7i7 directing or steering enrollees to other health care providers2 or 7ii7 offering incentives to encourage enrollees to utilize specific health care providers2 or 7,b7 requires the group health plan or health insurance issuer to enter into any additional contract with an affiliate of the provider1 such as an affiliate of the provider1 as a condition of entering into a contract with such provider2 7,c7 requires the group health plan or health insurance issuer to agree to payment rates or other terms for any affiliate not party to the contract of the provider involved2 or 7,d7 restricts other group health plans or health insurance issuers not party to the contract from paying a lower rate for items or services than the contracting plan or issuer pays for such items or services4 7#b7 ,additional requirement for self-insured plans ,a self-insured group health plan shall not enter into an agreement with a provider1 network or association of providers1 third-party administrator1 or other service provider offering access to a network of providers if such agreement directly or indirectly requires the group health plan to certify1 attest1 or otherwise confirm in writing that the group health plan is bound by restrictive contracting terms between the service provider and a third-party administrator that the group health plan is not party to1 without a disclosure that such terms exist4 7#c7 ,exception for certain group model issuers ,paragraph 7#a77;,a7 shall not apply to a group health plan or health insurance issuer offering group or individual health insurance coverage with respect to-- 7,a7 a health maintenance organization 7as defined in section #bgia7;b77#c771 if such health maintenance organization operates primarily through exclusive contracts with multi-specialty physician groups1 nor to any arrangement between such a health maintenance organization and its affiliates2 or 7,b7 a value-based network arrangement1 such as an exclusive provider network1 accountable care organization1 center of excellence1 a provider sponsored health insurance issuer that operates primarily through aligned multi-specialty physician group practices or integrated health systems1 or such other similar network arrangements as determined by the ,secretary through rulemaking4 7#d7 ,attestation ,a group health plan or health insurance issuer offering group or individual health insurance coverage shall annually submit to1 as applicable1 the applicable authority described in section #bgbc or the ,secretary of ,labor1 an attestation that such plan or issuer is in compliance with the requirements of this subsection4 7c7 ,maintenance of existing ,,hipaa1 ,,gina1 and ,,ada protections ,nothing in this section shall modify1 reduce1 or eliminate the existing privacy protections and standards provided by reason of ,state and ,federal law1 including the requirements of parts #afj and #afd of title #de1 ,code of ,federal ,regulations 7or any successor regulations74 7d7 ,regulations ,the ,secretary1 not later than #a year after the date of enactment of the ,lower ,health ,care ,costs ,act1 shall promulgate regulations to carry out this section4 7e7 ,rule of construction ,nothing in this section shall be construed to limit network design or cost or quality initiatives by a group health plan or health insurance issuer1 including accountable care organizations1 exclusive provider organizations1 networks that tier providers by cost or quality or steer enrollees to centers of excellence1 or other pay-for-performance programs4 7f7 ,clarification with respect to antitrust laws ,compliance with this section does not constitute compliance with the antitrust laws1 as defined in subsection 7a7 of the first section of the ,clayton ,act 7#ae ,u4,s4,c4 #ab7;a774 4 7b7 ,effective date ,section #bgbi;,b of the ,public ,health ,service ,act 7as added by section #cja and amended by subsection 7a77 shall apply with respect to any contract entered into on or after the date that is #ah months after the date of enactment of this ,act4 ,with respect to an applicable contract that is in effect on the date of enactment of this ,act1 such section #bgbi;,b shall apply on the earlier of the date of renewal of such contract or #c years after such date of enactment4 #cjc4 ,designation of a nongovernmental1 nonprofit transparency organization to lower ,americans' health care costs 7a7 ,in general ,subpart ,c of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ia et seq471 as amended by section #ajb1 is further amended by adding at the end the following3 #bgif4 ,designation of a nongovernmental1 nonprofit transparency organization to lower ,americans' health care costs 7a7 ,in general ,the ,secretary1 in consultation with the ,secretary of ,labor1 not later than #a year after the date of enactment of the ,lower ,health ,care ,costs ,act1 shall enter into a contract with a nonprofit entity to support the establishment and maintenance of a database that receives and utilizes health care claims information and related information and issues reports that are available to the public and authorized users1 and are submitted to the ,department of ,health and ,human ,services4 7b7 ,requirements 7#a7 ,in general ,the database established under subsection 7a7 shall-- 7,a7 improve transparency by using de-identified health care data to-- 7i7 inform patients about the cost1 quality1 and value of their care2 7ii7 assist providers and hospitals1 as they work with patients1 to make informed choices about care2 7iii7 enable providers1 hospitals1 and communities to improve services and outcomes for patients by benchmarking their performance against that of other providers1 hospitals1 and communities2 7iv7 enable purchasers1 including employers1 employee organizations1 and health plans1 to develop value-based purchasing models1 improve quality1 and reduce the cost of health care and insurance coverage for enrollees2 7v7 enable employers and employee organizations to evaluate network design and construction1 and the cost of care for enrollees2 7vi7 facilitate ,state-led initiatives to lower health care costs and improve quality2 and 7vii7 promote competition based on quality and cost2 7,b7 collect medical claims1 prescription drug claims1 and remittance data consistent with the protections and requirements of subsection 7d72 7,c7 be established in such a manner that allows the data collected pursuant to subparagraph 7,b7 to be shared with any ,state all-payer claims database or regional database operated with authorization from ,states1 at cost1 using a standardized format1 if such ,state or regional database also submits claims data to the database established under this section2 and 7,d7 be available to-- 7i7 the ,director of the ,congressional ,budget ,office1 the ,comptroller ,general of the ,united ,states1 the ,executive ,director of the ,medicare ,payment ,advisory ,commission1 and the ,executive ,director of the ,medicaid and ,,chip ,payment ,advisory ,commission1 upon request1 subject to the privacy and security requirements of authorized users under subsection 7e77#b72 and 7ii7 authorized users1 including employers1 employee organizations1 providers1 researchers1 and policymakers1 subject to subsection 7e74 7#b7 ,privacy and security2 breach notifications 7,a7 ,regulations 7i7 ,in general ,the ,secretary shall issue regulations prescribing the extent to which1 and the manner in which1 the following rules 7and any successors of such rules7 shall apply to the activities under this section of an entity receiving a contract under subsection 7a73 7,i7 ,the ,privacy ,rule under part #afj and subparts ,a and ,e of part #afd of title #de1 ,code of ,federal ,regulations 7or any successor regulations74 7,,ii7 ,the ,security ,rule under part #afj and subparts ,a and ,c of part #afd of such title #de 7or any successor regulations74 7,,iii7 ,the ,breach ,notification ,rule under part #afj and subparts ,a and ,d of part #afd of such title #de 7or any successor regulations74 7ii7 ,supplemental regulations ,in order to ensure data privacy and security and the notification of breaches1 the ,secretary may issue such supplemental regulations on the subjects of the rules listed under clause 7i7 as the ,secretary determines appropriate to address differences between the activities described by this section and the activities covered by such rules4 7,b7 ,enforcement ,section #aagf of ,social ,security ,act shall apply with respect to a violation of this paragraph in the same manner such section #aagf applies to a violation of part ,c of title ,,xi of the ,social ,security ,act1 and the ,secretary may include in the regulations promulgated under this section provisions to apply such section to this paragraph4 7,c7 ,procedure 7i7 ,timing ,the ,secretary shall issue the initial set of regulations under this paragraph not later than #a year after the date of enactment of the ,lower ,health ,care ,costs ,act4 7ii7 ,authority to use interim final procedures ,the ,secretary may make such initial set of regulations effective and final immediately upon issuance1 on an interim basis1 and provide for a period of public comment on such initial set of regulations after the date of publication4 7,d7 ,requirements of entity ,the entity receiving the contract under this section shall-- 7i7 not disclose to the public any individually identifiable health information or proprietary financial information2 7ii7 strictly limit staff access to the data to staff with appropriate training1 clearance1 and background checks and require regular privacy and security training2 7iii7 maintain effective security standards for transferring data or making data available to authorized users2 7iv7 develop a process for providing access to data to authorized users1 in a secure manner that maintains privacy and confidentiality of data2 and 7v7 adhere to current best security practices with respect to the management and use of such data for health services research1 in accordance with applicable ,federal privacy law 7#c7 ,consultation 7,a7 ,advisory committee ,not later than #ahj days after the date of enactment of the ,lower ,health ,care ,costs ,act1 the ,secretary shall convene an ,advisory ,committee 7referred to in this section as the ,committee71 consisting of #ac members1 to advise the ,secretary1 the contracting entity1 and ,congress on the establishment1 operations1 and use of the database established under this section4 7,b7 ,membership 7i7 ,appointment ,in accordance with clause 7ii71 the ,secretary1 in consultation with the ,secretary of ,labor and the ,comptroller ,general of the ,united ,states shall1 not later than #ahj days after the date of enactment of the ,lower ,health ,care ,costs ,act1 appoint members to the ,committee who have distinguished themselves in the fields of health services research1 health economics1 health informatics1 or the governance of ,state all-payer claims databases1 or who represent organizations likely to submit data to or use the database1 including patients1 employers1 or employee organizations that sponsor group health plans1 health care providers1 health insurance issuers1 or third-party administrators of group health plans4 ,such members shall serve #c-year terms on a staggered basis4 ,vacancies on the ,committee shall be filled by appointment consistent with this subsection not later than #c months after the vacancy arises4 7ii7 ,composition ,in accordance with clause 7i7-- 7,i7 the ,secretary1 in consultation with the ,secretary of ,labor1 shall appoint to the ,committee-- 7aa7 #a member selected by the ,secretary1 in coordination with the ,secretary of ,labor1 to serve as the chair of the ,committee2 7bb7 the ,assistant ,secretary for ,planning and ,evaluation of the ,department of ,health and ,human ,services1 or a designee of such ,assistant ,secretary2 7cc7 #a representative of the ,centers for ,medicare ,medicaid ,services2 7dd7 #a representative of the ,agency for ,health ,research and ,quality2 7ee7 #a representative of the ,office for ,civil ,rights of the ,department of ,health and ,human ,services with expertise in data privacy and security2 7ff7 #a representative of the ,national ,center for ,health ,statistics2 and 7gg7 #a representative of the ,employee ,benefits and ,security ,administration of the ,department of ,labor2 and 7,,ii7 the ,comptroller ,general of the ,united ,states shall appoint to the ,committee-- 7aa7 #a representative of an employer that sponsors a group health plan2 7bb7 #a representative of an employee organization that sponsors a group health plan2 7cc7 #a academic researcher with expertise in health economics or health services research2 7dd7 #a consumer advocate2 and 7ee7 #b additional members4 7,c7 ,duties ,the ,committee shall-- 7i7 advise the ,secretary on the management of the contract under subsection 7a72 7ii7 assist and advise the entity receiving the contract under subsection 7a7 in establishing-- 7,i7 the scope and format of the data to be submitted under subsection 7d72 7,,ii7 best practices with respect to de-identification of data1 as appropriate2 7,,iii7 the appropriate uses of data by authorized users1 including developing standards for the approval of requests by organizations to access and use the data2 and 7,,iv7 the appropriate formats and methods for making reports and analyses based on the database to the public2 7iii7 conduct an annual review of whether data was used according to the appropriate uses as described in clause 7ii77,,ii71 and advise the designated entity on using the data for authorized purposes2 7iv7 report1 as appropriate1 to the ,secretary and ,congress on the operation of the database and opportunities to better achieve the objectives of this section2 7v7 establish additional restrictions on researchers who receive compensation from entities described in subsection 7e77#b77;,b77ii71 in order to protect proprietary financial information2 and 7vi7 establish objectives for research and public reporting4 7#d7 ,state requirements ,a ,state may require health insurance issuers and other payers to submit claims data to the database established under this section1 provided that such data is submitted to the entity awarded the contract under this section in a form and manner established by the ,secretary1 and pursuant to subsection 7d77#d77;,b74 7#e7 ,sanctions ,the ,secretary shall take appropriate action to sanction users who attempt to re-identify data accessed pursuant to paragraph 7#a77;,d74 7c7 ,contract requirements 7#a7 ,competitive procedures ,the ,secretary shall enter into the contract under subsection 7a7 using full and open competition procedures pursuant to chapter #cc of title #da1 ,united ,states ,code4 7#b7 ,eligible entities ,to be eligible to enter into a contract described in subsection 7a71 an entity shall-- 7,a7 be a private nonprofit entity governed by a board that includes representatives of the academic research community and individuals with expertise in employer-sponsored insurance1 research using health care claims data and actuarial analysis2 7,b7 conduct its business in an open and transparent manner that provides the opportunity for public comment on its activities2 and 7,c7 agree to comply with any requirements imposed under the rulemaking described in subsection 7d77#d77;,a74 7#c7 ,considerations ,in awarding the contract under subsection 7a71 the ,secretary shall consider an entity's experience in-- 7,a7 health care claims data collection1 aggregation1 quality assurance1 analysis1 and security2 7,b7 supporting academic research on health costs1 spending1 and utilization for and by privately insured patients2 7,c7 working with large health insurance issuers and third-party administrators to assemble a national claims database2 7,d7 effectively collaborating with and engaging stakeholders to develop reports2 7,e7 meeting budgets and timelines1 including in connection with report generation2 and 7,f7 facilitating the creation of1 or supporting1 ,state all-payer claims databases4 7#d7 ,contract term ,a contract awarded under this section shall be for a period of #e years1 and may be renewed after a subsequent competitive bidding process under this section4 7#e7 ,transition of contract ,if the ,secretary1 following a competitive process at the end of the contract period1 selects a new entity to maintain the database1 all data shall be transferred to the new entity according to a schedule and process to be determined by the ,secretary4 ,upon termination of a contract1 no entity may keep data held by the database or disclose such data to any entity other than the entity so designated by the ,secretary4 ,the ,secretary shall include enforcement terms in any contract with an organization chosen under this section1 to ensure the timely transfer of all data1 and any associated code or algorithms1 to a new entity in the event of contract termination4 7d7 ,receiving health information 7#a7 ,requirements 7,a7 ,in general ,the ,secretary of ,labor shall ensure that the applicable self-insured group health plan1 through its third-party administrator1 pharmacy benefit manager1 or other entity designated by the group health plan1 as applicable1 electronically submits all claims data with respect to the plan1 pursuant to subparagraph 7,b74 7,b7 ,scope of information and format of submission ,the entity awarded the contract under subsection 7a71 in consultation with the ,committee described in subsection 7b77#c71 and pursuant to the privacy and security requirements of subsection 7b77#b71 shall-- 7i7 specify the data elements required to be submitted under subparagraph 7,a71 which shall include all data related to transactions described in subparagraphs 7,a7 and 7,e7 of section #aagc7;a77#b7 of the ,social ,security ,act1 including all data elements normally present in such transactions when adjudicated1 and enrollment information2 7ii7 specify the form and manner for such submissions1 and the historical period to be included in the initial submission2 and 7iii7 offer an automated submission option to minimize administrative burdens for entities required to submit data4 7,c7 ,de-identification of data ,the entity awarded the contract under subsection 7a7 shall-- 7i7 establish a process under which data is de-identified consistent with the de-identification requirements under section #afd4ead of title #de1 ,code of ,federal ,regulations 7or any successor regulations71 while retaining the ability to link data longitudinally for the purposes of research on cost and quality1 and the ability to complete risk adjustment and geographic analysis2 7ii7 ensure that any third-party subcontractors who perform the de-identification process described in clause 7i7 retain only the minimum necessary information to perform such a process1 and adhere to effective security and encryption practices in data storage and transmission2 7iii7 store claims and other data collected under this subsection only in de-identified form1 in accordance with section #afd4ead of title #de1 ,code of ,federal ,regulations 7or any successor regulations72 and 7iv7 ensure that individually identifiable data is encrypted1 in accordance with guidance issued by the ,secretary under section #acdjb7;h77#b7 of the ,,hitech ,act4 7#b7 ,applicable self-insured group health plan ,for purposes of paragraph 7#a71 a self-insured group health plan is an applicable self-insured group health plan if such plan is self-administered1 or is administered by a third-party plan administrator that meets #a or both of the following criteria3 7,a7 ,administers health1 medical1 or pharmacy benefits for more than #ej1jjj enrollees4 7,b7 ,is one of the #e largest administrators or issuers of self-insured group health plans in a ,state in which such administrator operates1 as measured by the aggregate number of enrollees in plans administered by such administrator in such ,state1 as determined by the ,secretary4 7#c7 ,third-party administrators ,in the case of a third-party administrator that is required under this subsection to submit claims data with respect to an applicable self-insured group health plan1 such administrator shall submit claims data with respect to all self-insured group health plans that the administrator administers1 including such plans that are not applicable self-insured group health plans1 as described in paragraph 7#b74 7#d7 ,receiving other information 7,a7 ,medicare data ,the ,secretary1 through rulemaking1 shall ensure that the data made available to such entity is available to qualified entities under section #ahgd7;e7 of the ,social ,security ,act is made available to the entity awarded a contract under subsection 7a74 7,b7 ,state data ,the entity awarded the contract under subsection 7a7 shall collect data from ,state all payer claims databases that seek access to the database established under this section4 7#e7 ,availability of data ,an entity required to submit data under this subsection may not place any restrictions on the use of such data by authorized users4 7e7 ,uses of information 7#a7 ,in general ,the entity awarded the contract under subsection 7a7 shall make the database available to users who are authorized under this subsection1 at cost1 and reports and analyses based on the data available to the public with no charge4 7#b7 ,authorization of users 7,a7 ,in general ,an entity may request authorization by the entity awarded the contract under subsection 7a7 for access to the database in accordance with this paragraph4 7,b7 ,application ,an entity desiring authorization under this paragraph shall submit to the entity awarded the contract an application for such access1 which shall include-- 7i7 in the case of an entity requesting access for research purposes-- 7,i7 a description of the uses and methodologies for evaluating health system performance using such data2 and 7,,ii7 documentation of approval of the research by an institutional review board1 if applicable for a particular plan of research2 or 7ii7 in the case of an entity such as an employer1 health insurance issuer1 third-party administrator1 or health care provider1 requesting access for the purpose of quality improvement or cost-containment1 a description of the intended uses for such data4 7,c7 ,requirements 7i7 ,research ,upon approval of an application for research purposes under subparagraph 7,b77i71 the authorized user shall enter into a data use and confidentiality agreement with the entity awarded the contract under subsection 7a71 which shall include a prohibition on attempts to reidentify and disclose individually identifiable health information and proprietary financial information4 7ii7 ,quality improvement and cost-containment ,in consultation with the ,committee described in subsection 7b77#c71 the ,secretary shall1 through rulemaking1 establish the form and manner in which authorized users described in subparagraph 7,b77ii7 may access data4 ,data provided to such authorized users shall be provided in a form and manner such that users may not obtain individually identifiable price information with respect to direct competitors4 ,upon approval1 such authorized user shall enter into a data use and confidentiality agreement with the entity4 7iii7 ,customized reports ,employers and employer organizations may request customized reports from the entity awarded the contract under subsection 7a71 at cost1 subject to the requirements of this section with respect to privacy1 security1 and proprietary financial information4 7iv7 ,non-customized reports ,the entity awarded the contract under subsection 7a71 in consultation with the ,committee1 shall make available to all authorized users aggregate data sets1 free of charge4 7f7 ,funding 7#a7 ,initial funding ,there are authorized to be appropriated1 and there are appropriated1 out of monies in the ,treasury not otherwise appropriated1 #bj1jjj1jjj for fiscal year #bjbj1 for the implementation of the initial contract and establishment of the database under this section4 7#b7 ,ongoing funding ,there are authorized to be appropriated #ae1jjj1jjj for each of fiscal years #bjba through #bjbe1 for purposes of carrying out this section 7other than the grant program under subsection 7h774 7g7 ,annual report 7#a7 ,submission ,on each of the dates described in paragraph 7#b71 the entity receiving the contract under subsection 7a7 shall submit to ,congress1 the ,secretary of ,health and ,human ,services1 and the ,secretary of ,labor and publish online for access by the general public1 a report containing a description of-- 7,a7 trends in the price1 utilization1 and total spending on health care services1 including a geographic analysis of differences in such trends2 7,b7 limitations in the data set2 7,c7 progress towards the objectives of this section2 and 7,d7 the performance by the entity of the duties required under such contract4 7#b7 ,dates described ,the reports described in paragraph 7#a7 shall be submitted-- 7,a7 not later than #c years after the date of enactment of the ,lower ,health ,care ,costs ,act2 7,b7 the later of #a year after the date that is #c years after such date of enactment or ,march #a of the year after the date that is #c years after such date of enactment2 and 7,c7 ,march #a of each year thereafter4 7#c7 ,public reports and research ,the entity receiving a contract under subsection 7a7 shall1 in coordination with authorized users1 make analyses and research available to the public on an ongoing basis to promote the objectives of this section4 7h7 ,grants to ,states 7#a7 ,in general ,the ,secretary1 in consultation with the ,secretary of ,labor1 may award grants to ,states for the purpose of establishing and maintaining ,state all-payer claims databases that improve transparency of data in order to meet the goals of subsection 7a77#a74 7#b7 ,requirement ,to be eligible to receive the funding under paragraph 7#a71 a ,state shall submit data to the database as described in subsection 7b77#a77;,c71 using the format described in subsection 7d77#a74 7#c7 ,funding ,there is authorized to be appropriated #ajj1jjj1jjj for the period of fiscal years #bjbj through #bjbi for the purpose of awarding grants to ,states under this subsection4 7i7 ,exemption from public disclosure 7#a7 ,in general ,claims data provided to the database1 and the database itself shall not be considered public records and shall be exempt from public disclosure requirements4 7#b7 ,restrictions on uses for certain proceedings ,data disclosed to authorized users shall not be subject to discovery or admission as public information1 or evidence in judicial or administrative proceedings without consent of the affected parties4 7j7 ,definitions 7#a7 ,individually identifiable health information ,the term individually identifiable health information has the meaning given such term in section #aaga7f7 of the ,social ,security ,act4 7#b7 ,proprietary financial information ,the term proprietary financial information means data that would disclose the terms of a specific contract between an individual health care provider or facility and a specific group health plan1 ,medicaid managed care organization or other managed care entity1 or health insurance issuer offering group or individual coverage4 7k7 ,rule of construction ,nothing in this section shall be construed to affect or modify enforcement of the privacy1 security1 or breach notification rules promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7or successor regulations74 4 7b7 ,,gao report 7#a7 ,in general ,the ,comptroller ,general of the ,united ,states shall conduct a study on-- 7,a7 the performance of the entity awarded a contract under section #bgie7;a7 of the ,public ,health ,service ,act1 as added by subsection 7a71 under such contract2 7,b7 the privacy and security of the information reported to the entity2 and 7,c7 the costs incurred by such entity in performing such duties4 7#b7 ,reports ,not later than #b years after the effective date of the first contract entered into under section #bgie7;a7 of the ,public ,health ,service ,act1 as added by subsection 7a71 and again not later than #d years after such effective date1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report containing the results of the study conducted under paragraph 7#a71 together with recommendations for such legislation and administrative action as the ,comptroller ,general determines appropriate4 #cjd4 ,protecting patients and improving the accuracy of provider directory information 7a7 ,in general ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq471 as amended by sections #cja and #cjb1 is further amended by adding at the end the following3 #bgbi;,c4 ,protecting patients and improving the accuracy of provider directory information 7a7 ,network status of providers 7#a7 ,in general ,beginning on the date that is one year after the date of enactment of this section1 a group health plan or a health insurance issuer offering group or individual health insurance coverage shall-- 7,a7 establish business processes to ensure that all enrollees in such plan or coverage receive proof of a health care provider's network status1 based on what a plan or issuer knows or could reasonably know-- 7i7 through a written electronic communication from the plan or issuer to the enrollee1 as soon as practicable and not later than #a business day after a telephone inquiry is made by such enrollee for such information2 7ii7 through an oral confirmation1 documented by such issuer or coverage1 and kept in the enrollee's file for a minimum of #b years2 and 7iii7 in real-time through an online health care provider directory search tool maintained by the plan or issuer2 and 7,b7 include in any print directory a disclosure that the information included in the directory is accurate as of the date of the last data update and that enrollees or prospective enrollees should consult the group health plan or issuer's electronic provider directory on its website or call a specified customer service telephone number to obtain the most current provider directory information4 7#b7 ,group health plan and health insurance issuer business processes ,beginning on the date that is one year after the date of enactment of the ,lower ,health ,care ,costs ,act1 a group health plan or a health insurance issuer offering group or individual health insurance coverage shall establish business processes to-- 7,a7 verify and update1 at least once every #ij days1 the provider directory information for all providers included in the online health care provider directory search tool described in paragraph 7#a77;,a77iii72 and 7,b7 remove any provider from such online directory search tool if such provider has not verified the directory information within the previous #f months or the plan or issuer has been unable to verify the provider's network participation4 7b7 ,cost-sharing limitations 7#a7 ,in general ,a group health plan or a health insurance issuer offering group or individual health insurance coverage shall not apply1 and shall ensure that no provider applies cost-sharing to an enrollee for treatment or services provided by a health care provider in excess of the normal cost-sharing applied for in-network care 7including any balance bill issued by the health care provider involved71 if such enrollee1 or health care provider referring such enrollee1 demonstrates 7based on the electronic1 written information described in subsection 7a77#a77;,a77i71 the oral confirmation described in subsection 7a77#a77;,a77ii71 or a copy of the online provider directory described in subsection 7a77#a77;,a77iii7 on the date the enrollee attempted to obtain the provider's network status7 that the enrollee relied on the information described in subsection 7a77#a71 if the provider's network status or directory information on such directory was incorrect at the time the treatment or services involved was provided4 7#b7 ,refunds to enrollees ,if a health care provider submits a bill to an enrollee in violation of paragraph 7#a71 and the enrollee pays such bill1 the provider shall reimburse the enrollee for the full amount paid by the enrollee in excess of the in-network cost-sharing amount for the treatment or services involved1 plus interest1 at an interest rate determined by the ,secretary4 7c7 ,provider business processes ,a health care provider shall have in place business processes to ensure the timely provision of provider directory information to a group health plan or a health insurance issuer offering group or individual health insurance coverage to support compliance by such plans or issuers with subsection 7a77#a74 ,such providers shall submit provider directory information to a plan or issuers1 at a minimum-- 7#a7 when the provider begins a network agreement with a plan or with an issuer with respect to certain coverage2 7#b7 when the provider terminates a network agreement with a plan or with an issuer with respect to certain coverage2 7#c7 when there are material changes to the content of provider directory information described in subsection 7a77#a72 and 7#d7 every #ij days throughout the duration of the network agreement with a plan or issuer4 7d7 ,enforcement 7#a7 ,in general ,subject to paragraph 7#b71 a health care provider that violates a requirement under subsection 7c7 or takes actions that prevent a group health plan or health insurance issuer from complying with subsection 7a77#a7 or 7b7 shall be subject to a civil monetary penalty of not more than #aj1jjj for each act constituting such violation4 7#b7 ,safe harbor ,the ,secretary may waive the penalty described under paragraph 7#a7 with respect to a health care provider that unknowingly violates subsection 7b77#a7 with respect to an enrollee if such provider rescinds the bill involved and1 if applicable1 reimburses the enrollee within #cj days of the date on which the provider billed the enrollee in violation of such subsection4 7#c7 ,procedure ,the provisions of section #aabh;,a of the ,social ,security ,act1 other than subsections 7a7 and 7b7 and the first sentence of subsection 7c77#a7 of such section1 shall apply to civil money penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a of the ,social ,security ,act4 7e7 ,savings clause ,nothing in this section shall prohibit a provider from requiring in the terms of a contract1 or contract termination1 with a group health plan or health insurance issuer-- 7#a7 that the plan or issuer remove1 at the time of termination of such contract1 the provider from a directory of the plan or issuer described in subsection 7a77#a72 or 7#b7 that the plan or issuer bear financial responsibility1 including under subsection 7b71 for providing inaccurate network status information to an enrollee4 7f7 ,definition ,for purposes of this section1 the term provider directory information includes the names1 addresses1 specialty1 and telephone numbers of individual health care providers1 and the names1 addresses1 and telephone numbers of each medical group1 clinic1 or facility contracted to participate in any of the networks of the group health plan or health insurance coverage involved4 7g7 ,rule of construction ,nothing in this section shall be construed to preempt any provision of ,state law relating to health care provider directories or network adequacy4 4 7b7 ,effective date ,section #bgbi;,c of the ,public ,health ,service ,act1 as added by subsection 7a71 shall take effect with respect to plan years beginning on or after the date that is #ah months after the date of enactment of this ,act4 #cje4 ,timely bills for patients 7a7 ,in general 7#a7 ,amendment ,part ,p of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g et seq47 is amended by adding at the end the following3 #cii,v-#g4 ,timely bills for patients 7a7 ,in general ,the ,secretary shall require-- 7#a7 health care facilities1 or in the case of practitioners providing services outside of such a facility1 practitioners1 to provide to patients a list of services rendered during the visit to such facility or practitioner1 and1 in the case of a facility1 the name of the provider for each such service1 upon discharge or end of the visit or by postal or electronic communication as soon as practicable and not later than #e calendar days after discharge or date of visit2 and 7#b7 health care facilities and practitioners to furnish all adjudicated bills to the patient as soon as practicable1 but not later than #de calendar days after discharge or date of visit4 7b7 ,payment after billing ,no patient may be required to pay a bill for health care services any earlier than #ce days after the postmark date of a bill for such services4 7c7 ,effect of violation 7#a7 ,notification and refund requirements 7,a7 ,provider lists ,if a facility or practitioner fails to provide a patient a list as required under subsection 7a77#a71 such facility or practitioner shall report such failure to the ,secretary4 7,b7 ,billing ,if a facility or practitioner bills a patient after the #de-;calendar-day period described in subsection 7a77#b71 such facility or practitioner shall-- 7i7 report such bill to the ,secretary2 and 7ii7 refund the patient for the full amount paid in response to such bill with interest1 at a rate determined by the ,secretary4 7#b7 ,civil monetary penalties 7,a7 ,in general ,the ,secretary may impose civil monetary penalties of up to #aj1jjj a day on any facility or practitioner that-- 7i7 fails to provide a list required under subsection 7a77#a7 more than #aj times1 beginning on the date of such tenth failure2 7ii7 submits more than #aj bills outside of the period described in subsection 7a77#b71 beginning on the date on which such facility or practitioner sends the tenth such bill2 7iii7 fails to report to the ,secretary any failure to provide lists as required under paragraph 7#a77;,a71 beginning on the date that is #de calendar days after discharge or visit2 or 7iv7 fails to send any bill as required under subsection 7a77#b71 beginning on the date that is #de calendar days after the date of discharge or visit1 as applicable4 7,b7 ,procedure ,the provisions of section #aabh;,a of the ,social ,security ,act1 other than subsections 7a7 and 7b7 and the first sentence of subsection 7c77#a7 of such section1 shall apply to civil money penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a of the ,social ,security ,act4 7#c7 ,safe harbor ,the ,secretary may exempt a practitioner or facility from the penalties under paragraph 7#b77;,a7 or extend the period of time specified under subsection 7a77#b7 for compliance with such subsection if a practitioner or facility-- 7,a7 makes a good-faith attempt to send a bill within #cj days but is unable to do so because of an incorrect address2 or 7,b7 experiences extenuating circumstances 7as defined by the ,secretary71 such as a hurricane or cyberattack1 that may reasonably delay delivery of a timely bill4 4 7#b7 ,rulemaking ,not later than #a year after the date of enactment of this ,act1 the ,secretary shall promulgate final regulations to define the term extenuating circumstance for purposes of section #cii,v-#g7;c77#c77;,b7 of the ,public ,health ,service ,act1 as added by paragraph 7#a74 7b7 ,group health plan and health insurance issuer requirements ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa71 as amended by section #cjd1 is further amended by adding at the end the following3 #bgbi;,d4 ,timely bills for patients 7a7 ,in general ,a group health plan or health insurance issuer offering group or individual health insurance coverage shall have in place business practices with respect to in-network facilities and practitioners to ensure that claims are adjudicated in order to facilitate facility and practitioner compliance with the requirements under section #cii,v-#g7;a74 7b7 ,clarification ,nothing in subsection 7a7 prohibits a provider and a group health plan or health insurance issuer from establishing in a contract the timeline for submission by either party to the other party of billing information1 adjudication1 sending of remittance information1 or any other coordination required between the provider and the plan or issuer necessary for meeting the deadline described in section #cii,v-#g7;a77#b74 4 7c7 ,effective date ,the amendments made by subsections 7a7 and 7b7 shall take effect #f months after the date of enactment of this ,act4 #cjf4 ,health plan oversight of pharmacy benefit manager services ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq471 as amended by section #cje7;b71 is further amended by adding at the end the following3 #bgbi;,e4 ,health plan oversight of pharmacy benefit manager services 7a7 ,in general ,a group health plan or health insurance issuer offering group health insurance coverage or an entity or subsidiary providing pharmacy benefits management services shall not enter into a contract with a drug manufacturer1 distributor1 wholesaler1 subcontractor1 rebate aggregator1 or any associated third party that limits the disclosure of information to plan sponsors in such a manner that prevents the plan or coverage1 or an entity or subsidiary providing pharmacy benefits management services on behalf of a plan or coverage from making the reports described in subsection 7b74 7b7 ,reports to group plan sponsors 7#a7 ,in general ,beginning with the first plan year that begins after the date of enactment of the ,lower ,health ,care ,costs ,act1 not less frequently than once every #f months1 a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefits management services on behalf of a group health plan shall submit to the plan sponsor 7as defined in section #c7af77;,b7 of the ,employee ,retirement ,income ,security ,act of #aigd7 of such group health plan or health insurance coverage a report in accordance with this subsection and make such report available to the plan sponsor in a machine-readable format4 ,each such report shall include1 with respect to the applicable group health plan or health insurance coverage-- 7,a7 information collected from drug manufacturers by such issuer or entity on the total amount of copayment assistance dollars paid1 or copayment cards applied1 that were funded by the drug manufacturer with respect to the enrollees in such plan or coverage2 7,b7 a list of each covered drug dispensed during the reporting period1 including1 with respect to each such drug during the reporting period-- 7i7 the brand name1 chemical entity1 and ,national ,drug ,code2 7ii7 the number of enrollees for whom the drug was filled during the plan year1 the total number of prescription fills for the drug 7including original prescriptions and refills71 and the total number of dosage units of the drug dispensed across the plan year1 including whether the dispensing channel was by retail1 mail order1 or specialty pharmacy2 7iii7 the wholesale acquisition cost1 listed as cost per days supply and cost per pill1 or in the case of a drug in another form1 per dose2 7iv7 the total out-of-pocket spending by enrollees on such drug1 including enrollee spending through copayments1 coinsurance1 and deductibles2 7v7 for any drug for which gross spending of the group health plan or health insurance coverage exceeded #aj1jjj during the reporting period-- 7,i7 a list of all other available drugs in the same therapeutic category or class1 including brand name drugs and biological products and generic drugs or biosimilar biological products that are in the same therapeutic category or class2 and 7,,ii7 the rationale for preferred formulary placement of a particular drug or drugs in that therapeutic category or class2 7,c7 a list of each therapeutic category or class of drugs that were dispensed under the health plan or health insurance coverage during the reporting period1 and1 with respect to each such therapeutic category or class of drugs1 during the reporting period-- 7i7 total gross spending by the plan1 before manufacturer rebates1 fees1 or other manufacturer remuneration2 7ii7 the number of enrollees who filled a prescription for a drug in that category or class2 7iii7 if applicable to that category or class1 a description of the formulary tiers and utilization mechanisms 7such as prior authorization or step therapy7 employed for drugs in that category or class2 7iv7 the total out-of-pocket spending by enrollees1 including enrollee spending through copayments1 coinsurance1 and deductibles2 and 7v7 for each therapeutic category or class under which #c or more drugs are included on the formulary of such plan or coverage-- 7,i7 the amount received1 or expected to be received1 from drug manufacturers in rebates1 fees1 alternative discounts1 or other remuneration-- 7aa7 to be paid by drug manufacturers for claims incurred during the reporting period2 or 7bb7 that is related to utilization of drugs1 in such therapeutic category or class2 7,,ii7 the total net spending1 after deducting rebates1 price concessions1 alternative discounts or other remuneration from drug manufacturers1 by the health plan or health insurance coverage on that category or class of drugs2 and 7,,iii7 the net price per course of treatment or #cj-;day supply incurred by the health plan or health insurance coverage and its enrollees1 after manufacturer rebates1 fees1 and other remuneration for drugs dispensed within such therapeutic category or class during the reporting period2 7,d7 total gross spending on prescription drugs by the plan or coverage during the reporting period1 before rebates and other manufacturer fees or remuneration2 7,e7 total amount received1 or expected to be received1 by the health plan or health insurance coverage in drug manufacturer rebates1 fees1 alternative discounts1 and all other remuneration received from the manufacturer or any third party1 other than the plan sponsor1 related to utilization of drug or drug spending under that health plan or health insurance coverage during the reporting period2 7,f7 the total net spending on prescription drugs by the health plan or health insurance coverage during the reporting period2 and 7,g7 amounts paid directly or indirectly in rebates1 fees1 or any other type of remuneration to brokers1 consultants1 advisors1 or any other individual or firm who referred the group health plan's or health insurance issuer's business to the pharmacy benefit manager4 7#b7 ,privacy requirements ,health insurance issuers offering group health insurance coverage and entities providing pharmacy benefits management services on behalf of a group health plan shall provide information under paragraph 7#a7 in a manner consistent with the privacy1 security1 and breach notification regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7or successor regulations71 and shall restrict the use and disclosure of such information according to such privacy regulations4 7#c7 ,disclosure and redisclosure 7,a7 ,limitation to business associates ,a group health plan receiving a report under paragraph 7#a7 may disclose such information only to business associates of such plan as defined in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or successor regulations74 7,b7 ,clarification regarding public disclosure of information ,nothing in this section prevents a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefits management services on behalf of a group health plan from placing reasonable restrictions on the public disclosure of the information contained in a report described in paragraph 7#a71 except that such issuer or entity may not restrict disclosure of such report to governmental agencies pursuant to an investigation or enforcement action4 7,c7 ,limited form of report ,the ,secretary shall define through rulemaking a limited form of the report under paragraph 7#a7 required of plan sponsors who are drug manufacturers1 drug wholesalers1 or other direct participants in the drug supply chain1 in order to prevent anti-competitive behavior4 7c7 ,limitations on spread pricing 7#a7 ,prescription drug transactions with pharmacies independent of the issuer or pharmacy benefits manager ,if the pharmacy that dispenses a prescription drug to an enrollee in a group health plan or group or individual health insurance coverage is not wholly or partially-owned by such plan1 such issuer1 or an entity providing pharmacy benefit management services under such plan or coverage1 such plan1 issuer1 or entity shall not charge the plan1 issuer1 or enrollee a price for such prescription drug that exceeds the price paid to the pharmacy1 excluding penalties paid by pharmacies to such plan1 issuer1 or entity4 7#b7 ,intra-company prescription drug transactions ,if the mail order1 specialty1 or retail pharmacy that dispenses a prescription drug to an enrollee in a group health plan or health insurance coverage is wholly or partially owned by1 and submits claims to1 such health insurance issuer or an entity providing pharmacy benefit management services under a group health plan or group or individual health insurance coverage1 the price charged for such drug by such pharmacy to such group health plan or health insurance issuer offering group or individual health insurance coverage may not exceed the lesser of-- 7,a7 the amount paid to the pharmacy for acquisition of the drug2 or 7,b7 the median price charged to the group health plan or health insurance issuer when the same drug is dispensed to enrollees in the plan or coverage by other similarly-situated pharmacies not wholly or partially owned by the health insurance issuer or entity providing pharmacy benefits management services1 as described in paragraph 7#a74 7#c7 ,supplementary reporting for intra-company prescription drug transactions ,a health insurance issuer of group health insurance coverage or an entity providing pharmacy benefits management services under a group health plan or group health insurance coverage that conducts transactions with a wholly or partially-owned pharmacy1 as described in paragraph 7#b71 shall submit1 together with the report under subsection 7b71 a supplementary report every #f months to the plan sponsor that includes-- 7,a7 an explanation of any benefit design parameters that encourage enrollees in the plan or coverage to fill prescriptions at mail order1 specialty1 or retail pharmacies that are wholly or partially-owned by that issuer or entity2 7,b7 the percentage of total prescriptions charged to the plan1 coverage1 or enrollees in the plan or coverage1 that were dispensed by mail order1 specialty1 or retail pharmacies that are wholly or partially-owned by the issuer or entity providing pharmacy benefits management services2 and 7,c7 a list of all drugs dispensed by such wholly or partially-owned pharmacy and charged to the plan or coverage1 or enrollees of the plan or coverage1 during the applicable quarter1 and1 with respect to each drug-- 7i7 the amount charged per course of treatment or #cj-;day supply with respect to enrollees in the plan or coverage1 including amounts charged to the plan or coverage and amounts charged to the enrollee2 7ii7 the median amount charged to the plan or coverage1 per course of treatment or #cj-;day supply1 including amounts paid by the enrollee1 when the same drug is dispensed by other pharmacies that are not wholly or partially-owned by the issuer or entity and that are included in the pharmacy network of that plan or coverage2 7iii7 the interquartile range of the costs1 per course of treatment or #cj-;day supply1 including amounts paid by the enrollee1 when the same drug is dispensed by other pharmacies that are not wholly or partially-owned by the issuer or entity and that are included in the pharmacy network of that plan or coverage2 7iv7 the lowest cost per course of treatment or #cj-;day supply1 for such drug1 including amounts charged to the plan or issuer and enrollee1 that is available from any pharmacy included in the network of the plan or coverage4 7d7 ,full rebate pass-through to plan 7#a7 ,in general ,a pharmacy benefits manager1 a third-party administrator of a group health plan1 a health insurance issuer offering group health insurance coverage1 or an entity providing pharmacy benefits management services under such health plan or health insurance coverage shall remit #ajj percent of rebates1 fees1 alternative discounts1 and all other remuneration received from a pharmaceutical manufacturer1 distributor or any other third party1 that are related to utilization of drugs under such health plan or health insurance coverage1 to the group health plan4 7#b7 ,form and manner of remittance ,such rebates1 fees1 alternative discounts1 and other remuneration shall be-- 7,a7 remitted to the group health plan in a timely fashion after the period for which such rebates1 fees1 or other remuneration is calculated1 and in no case later than #ij days after the end of such period2 7,b7 fully disclosed and enumerated to the group health plan sponsor1 as described in 7b77#a72 7,c7 available for audit by the plan sponsor1 or a third-party designated by a plan sponsor no less than once per plan year2 and 7,d7 returned to the issuer or entity providing pharmaceutical benefit management services by the group health plan if audits by such issuer or entity indicate that the amounts received are incorrect after such amounts have been paid to the group health plan4 7#c7 ,audit of rebate contracts ,a pharmacy benefits manager1 a third-party administrator of a group health plan1 a health insurance issuer offering group health insurance coverage1 or an entity providing pharmacy benefits management services under such health plan or health insurance coverage shall make rebate contracts with drug manufacturers available for audit by such plan sponsor or designated third-party1 subject to confidentiality agreements to prevent re-disclosure of such contracts4 7e7 ,enforcement 7#a7 ,in general ,the ,secretary1 in consultation with the ,secretary of ,labor and the ,secretary of the ,treasury1 shall enforce this section4 7#b7 ,failure to provide timely information ,a health insurance issuer or an entity providing pharmacy benefit management services that violates subsection 7a71 fails to provide information required under subsection 7b71 engages in spread pricing as defined in subsection 7c71 or fails to comply with the requirements of subsection 7d71 or a drug manufacturer that fails to provide information under subsection 7b77#a77;,a71 in a timely manner shall be subject to a civil monetary penalty in the amount of #aj1jjj for each day during which such violation continues or such information is not disclosed or reported4 7#c7 ,false information ,a health insurance issuer1 entity providing pharmacy benefit management services1 or drug manufacturer that knowingly provides false information under this section shall be subject to a civil money penalty in an amount not to exceed #ajj1jjj for each item of false information4 ,such civil money penalty shall be in addition to other penalties as may be prescribed by law4 7#d7 ,procedure ,the provisions of section #aabh;,a of the ,social ,security ,act1 other than subsection 7a7 and 7b7 and the first sentence of subsection 7c77#a7 of such section shall apply to civil monetary penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a of the ,social ,security ,act4 7#e7 ,safe harbor ,the ,secretary may waive penalties under paragraph 7#b71 or extend the period of time for compliance with a requirement of this section1 for an entity in violation of this section that has made a good-faith effort to comply with this section4 7f7 ,rule of construction ,nothing in this section shall be construed to prohibit payments to entities offering pharmacy benefits management services for bona fide services using a fee structure not contemplated by this section1 provided that such fees are transparent to group health plans and health insurance issuers4 7g7 ,definitions ,in this section-- 7#a7 the term similarly situated pharmacy means1 with respect to a particular pharmacy1 another pharmacy that is approximately the same size 7as measured by the number of prescription drugs dispensed71 and that serves patients in the same geographical area1 whether through physical locations or mail order2 and 7#b7 the term wholesale acquisition cost has the meaning given such term in sectionb#ahdg;,a7c77#f77;,b7 of the ,social ,security ,act4 4 #cjg4 ,government ,accountability ,office study on profit- and revenue-sharing in health care 7a7 ,study ,not later than #a year after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct a study to-- 7#a7 describe what is known about profit- and revenue-sharing relationships in the commercial health care markets1 including those relationships that-- 7,a7 involve one or more-- 7i7 physician groups that practice within a hospital included in the profit- or revenue-sharing relationship1 or refer patients to such hospital2 7ii7 laboratory1 radiology1 or pharmacy services that are delivered to privately insured patients of such hospital2 7iii7 surgical services2 7iv7 hospitals or group purchasing organizations2 or 7v7 rehabilitation or physical therapy facilities or services2 and 7,b7 include revenue- or profit-sharing whether through a joint venture1 management or professional services agreement1 or other form of gain-sharing contract2 7#b7 describe ,federal oversight of such relationships1 including authorities of the ,department of ,health and ,human ,services and the ,federal ,trade ,commission to review such relationships and their potential to increase costs for patients1 and identify limitations in such oversight2 and 7#c7 as appropriate1 make recommendations to improve ,federal oversight of such relationships4 7b7 ,report ,not later than #a year after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall prepare and submit a report on the study conducted under subsection 7a7 to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,education and ,labor and ,committee on ,energy and ,commerce of the ,house of ,representatives4 #cjh4 ,disclosure of direct and indirect compensation for brokers and consultants to employer-sponsored health plans and enrollees in plans on the individual market 7a7 ,group health plans ,section #djh7;b77#b7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77 is amended-- 7#a7 by striking 7#b7 ,contracting or making and inserting 7#b77;,a7 ,contracting or making2 and 7#b7 by adding at the end the following3 7,b7 7i7 ,no contract or arrangement for services between a covered plan and a covered service provider1 and no extension or renewal of such a contract or arrangement1 is reasonable within the meaning of this paragraph unless the requirements of this clause are met4 7ii7 7,i7 ,for purposes of this subparagraph3 7aa7 ,the term covered plan means a group health plan as defined section #gcc7;a74 7bb7 ,the term covered service provider means a service provider that enters into a contract or arrangement with the covered plan and reasonably expects #a1jjj 7or such amount as the ,secretary may establish in regulations to account for inflation since the date of enactment of the ,lower ,health ,care ,costs ,act1 as appropriate7 or more in compensation1 direct or indirect1 to be received in connection with providing one or more of the following services1 pursuant to the contract or arrangement1 regardless of whether such services will be performed1 or such compensation received1 by the covered service provider1 an affiliate1 or a subcontractor3 7,,aa7 ,brokerage services1 for which the covered service provider1 an affiliate1 or a subcontractor reasonably expects to receive indirect compensation or direct compensation described in item 7dd71 provided to a covered plan with respect to selection of insurance products 7including vision and dental71 recordkeeping services1 medical management vendor1 benefits administration 7including vision and dental71 stop-loss insurance1 pharmacy benefit management services1 wellness services1 transparency tools and vendors1 group purchasing organization preferred vendor panels1 disease management vendors and products1 compliance services1 employee assistance programs1 or third party administration services4 7,,bb7 ,consulting1 for which the covered service provider1 an affiliate1 or a subcontractor reasonably expects to receive indirect compensation or direct compensation described in item 7dd71 related to the development or implementation of plan design1 insurance or insurance product selection 7including vision and dental71 recordkeeping1 medical management1 benefits administration selection 7including vision and dental71 stop-loss insurance1 pharmacy benefit management services1 wellness design and management services1 transparency tools1 group purchasing organization agreements and services1 participation in and services from preferred vendor panels1 disease management1 compliance services1 employee assistance programs1 or third party administration services4 7cc7 ,the term affiliate1 with respect to a covered service provider1 means an entity that directly or indirectly 7through one or more intermediaries7 controls1 is controlled by1 or is under common control with1 such provider1 or is an officer1 director1 or employee of1 or partner in1 such provider4 7dd7 7,,aa7 ,the term compensation means anything of monetary value1 but does not include non-monetary compensation valued at #bej 7or such amount as the ,secretary may establish in regulations to account for inflation since the date of enactment of the ,lower ,health ,care ,costs ,act1 as appropriate7 or less1 in the aggregate1 during the term of the contract or arrangement4 7,,bb7 ,the term direct compensation means compensation received directly from a covered plan4 7,,cc7 ,the term indirect compensation means compensation received from any source other than the covered plan1 the plan sponsor1 the covered service provider1 or an affiliate4 ,compensation received from a subcontractor is indirect compensation1 unless it is received in connection with services performed under a contract or arrangement with a subcontractor4 7ee7 ,the term responsible plan fiduciary means a fiduciary with authority to cause the covered plan to enter into1 or extend or renew1 the contract or arrangement4 7ff7 ,the term subcontractor means any person or entity 7or an affiliate of such person or entity7 that is not an affiliate of the covered service provider and that1 pursuant to a contract or arrangement with the covered service provider or an affiliate1 reasonably expects to receive #a1jjj 7or such amount as the ,secretary may establish in regulations to account for inflation since the date of enactment of the ,lower ,health ,care ,costs ,act1 as appropriate7 or more in compensation for performing one or more services described in item 7bb7 under a contract or arrangement with the covered plan4 7,,ii7 ,for purposes of this subparagraph1 a description of compensation or cost may be expressed as a monetary amount1 formula1 or a per capita charge for each enrollee or1 if the compensation or cost cannot reasonably be expressed in such terms1 by any other reasonable method1 including a disclosure that additional compensation may be earned but may not be calculated at the time of contract if such a disclosure includes a description of the circumstances under which the additional compensation may be earned and a reasonable and good faith estimate if the covered service provider cannot otherwise readily describe compensation or cost and explains the methodology and assumptions used to prepare such estimate4 ,any such description shall contain sufficient information to permit evaluation of the reasonableness of the compensation or cost4 7,,iii7 ,no person or entity is a covered service provider within the meaning of subclause 7,i77bb7 solely on the basis of providing services as an affiliate or a subcontractor that is performing one or more of the services described in subitem 7,,aa7 or 7,,bb7 of such subclause under the contract or arrangement with the covered plan4 7iii7 ,a covered service provider shall disclose to a responsible plan fiduciary1 in writing1 the following3 7,i7 ,a description of the services to be provided to the covered plan pursuant to the contract or arrangement4 7,,ii7 ,if applicable1 a statement that the covered service provider1 an affiliate1 or a subcontractor will provide1 or reasonably expects to provide1 services pursuant to the contract or arrangement directly to the covered plan as a fiduciary 7within the meaning of section #c7ba774 7,,iii7 ,a description of all direct compensation1 either in the aggregate or by service1 that the covered service provider1 an affiliate1 or a subcontractor reasonably expects to receive in connection with the services described in subclause 7,i74 7,,iv7 7aa7 ,a description of all indirect compensation that the covered service provider1 an affiliate1 or a subcontractor reasonably expects to receive in connection with the services described in subclause 7,i7-- 7,,aa7 including compensation from a vendor to a brokerage firm based on a structure of incentives not solely related to the contract with the covered plan2 and 7,,bb7 not including compensation received by an employee from an employer on account of work performed by the employee4 7bb7 ,a description of the arrangement between the payer and the covered service provider1 an affiliate1 or a subcontractor1 as applicable1 pursuant to which such indirect compensation is paid4 7cc7 ,identification of the services for which the indirect compensation will be received1 if applicable4 7dd7 ,identification of the payer of the indirect compensation4 7,v7 ,a description of any compensation that will be paid among the covered service provider1 an affiliate1 or a subcontractor1 in connection with the services described in subclause 7,i7 if such compensation is set on a transaction basis 7such as commissions1 finder's fees1 or other similar incentive compensation based on business placed or retained71 including identification of the services for which such compensation will be paid and identification of the payers and recipients of such compensation 7including the status of a payer or recipient as an affiliate or a subcontractor71 regardless of whether such compensation also is disclosed pursuant to subclause 7,,iii7 or 7,,iv74 7,,vi7 ,a description of any compensation that the covered service provider1 an affiliate1 or a subcontractor reasonably expects to receive in connection with termination of the contract or arrangement1 and how any prepaid amounts will be calculated and refunded upon such termination4 7iv7 ,a covered service provider shall disclose to a responsible plan fiduciary1 in writing a description of the manner in which the compensation described in clause 7iii71 as applicable1 will be received4 7v7 7,i7 ,a covered service provider shall disclose the information required under clauses 7iii7 and 7iv7 to the responsible plan fiduciary not later than the date that is reasonably in advance of the date on which the contract or arrangement is entered into1 and extended or renewed4 7,,ii7 ,a covered service provider shall disclose any change to the information required under clause 7iii7 and 7iv7 as soon as practicable1 but not later than #fj days from the date on which the covered service provider is informed of such change1 unless such disclosure is precluded due to extraordinary circumstances beyond the covered service provider's control1 in which case the information shall be disclosed as soon as practicable4 7vi7 7,i7 ,upon the written request of the responsible plan fiduciary or covered plan administrator1 a covered service provider shall furnish any other information relating to the compensation received in connection with the contract or arrangement that is required for the covered plan to comply with the reporting and disclosure requirements under this ,act4 7,,ii7 ,the covered service provider shall disclose the information required under clause 7iii77,i7 reasonably in advance of the date upon which such responsible plan fiduciary or covered plan administrator states that it is required to comply with the applicable reporting or disclosure requirement1 unless such disclosure is precluded due to extraordinary circumstances beyond the covered service provider's control1 in which case the information shall be disclosed as soon as practicable4 7vii7 ,no contract or arrangement will fail to be reasonable under this subparagraph solely because the covered service provider1 acting in good faith and with reasonable diligence1 makes an error or omission in disclosing the information required pursuant to clause 7iii7 7or a change to such information disclosed pursuant to clause 7v77,,ii77 or clause 7vi71 provided that the covered service provider discloses the correct information to the responsible plan fiduciary as soon as practicable1 but not later than #cj days from the date on which the covered service provider knows of such error or omission4 7viii7 7,i7 ,pursuant to subsection 7a71 subparagraphs 7,c7 and 7,d7 of section #djf7;a77#a7 shall not apply to a responsible plan fiduciary1 notwithstanding any failure by a covered service provider to disclose information required under clause 7iii71 if the following conditions are met3 7aa7 ,the responsible plan fiduciary did not know that the covered service provider failed or would fail to make required disclosures and reasonably believed that the covered service provider disclosed the information required to be disclosed4 7bb7 ,the responsible plan fiduciary1 upon discovering that the covered service provider failed to disclose the required information1 requests in writing that the covered service provider furnish such information4 7cc7 ,if the covered service provider fails to comply with a written request described in subclause 7,,ii7 within #ij days of the request1 the responsible plan fiduciary notifies the ,secretary of the covered service provider's failure1 in accordance with subclauses 7,,ii7 and 7,,iii74 7,,ii7 ,a notice described in subclause 7,i77cc7 shall contain-- 7aa7 the name of the covered plan2 7bb7 the plan number used for the annual report on the covered plan2 7cc7 the plan sponsor's name1 address1 and employer identification number2 7dd7 the name1 address1 and telephone number of the responsible plan fiduciary2 7ee7 the name1 address1 phone number1 and1 if known1 employer identification number of the covered service provider2 7ff7 a description of the services provided to the covered plan2 7gg7 a description of the information that the covered service provider failed to disclose2 7hh7 the date on which such information was requested in writing from the covered service provider2 and 7ii7 a statement as to whether the covered service provider continues to provide services to the plan4 7,,iii7 ,a notice described in subclause 7,i77cc7 shall be filed with the ,department not later than #cj days following the earlier of-- 7aa7 ,the covered service provider's refusal to furnish the information requested by the written request described in subclause 7,i77bb72 or 7bb7 #ij days after the written request referred to in subclause 7,i77cc7 is made4 7,,iv7 ,if the covered service provider fails to comply with the written request under subclause 7,i77bb7 within #ij days of such request1 the responsible plan fiduciary shall determine whether to terminate or continue the contract or arrangement under section #djd4 ,if the requested information relates to future services and is not disclosed promptly after the end of the #ij-;day period1 the responsible plan fiduciary shall terminate the contract or arrangement as expeditiously as possible1 consistent with such duty of prudence4 7ix7 ,nothing in this subparagraph shall be construed to supersede any provision of ,state law that governs disclosures by parties that provide the services described in this section1 except to the extent that such law prevents the application of a requirement of this section4 4 7b7 ,applicability of existing regulations ,nothing in the amendments made by subsection 7a7 shall be construed to affect the applicability of section #beej4djh;b-#b of title #bi1 ,code of ,federal ,regulations 7or any successor regulations71 with respect to any applicable entity other than a covered plan or a covered service provider 7as defined in section #djh7;b77#b77;,b77ii7 of the ,employee ,retirement ,income ,security ,act of #aigd1 as amended by subsection 7a774 7c7 ,individual market coverage ,subpart #a of part ,b of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#da et seq47 is amended by adding at the end the following3 #bgdf4 ,disclosure to enrollees of individual market coverage 7a7 ,in general ,a health insurance issuer offering individual health insurance coverage shall make disclosures to enrollees in such coverage1 as described in subsection 7b71 and reports to the ,secretary1 as described in subsection 7c71 regarding direct or indirect compensation provided to an agent or broker associated with enrolling individuals in such coverage4 7b7 ,disclosure ,a health insurance issuer described in subsection 7a7 shall disclose to an enrollee the amount of direct or indirect compensation provided to an agent or broker for services provided by such agent or broker associated with plan selection and enrollment4 ,such disclosure shall be-- 7#a7 made prior to the individual finalizing plan selection2 and 7#b7 included on any documentation confirming the individual's enrollment4 7c7 ,reporting ,a health insurance issuer described in subsection 7a7 shall annually report to the ,secretary1 prior to the beginning of open enrollment1 any direct or indirect compensation provided to an agent or broker associated with enrolling individuals in such coverage4 7d7 ,rulemaking ,not later than #a year after the date of enactment of the ,lower ,health ,care ,costs ,act1 the ,secretary shall finalize1 through notice-and-comment rulemaking1 the form and manner in which issuers described in subsection 7a7 are required to make the disclosures described in subsection 7b7 and the reports described in subsection 7c74 4 7d7 ,transition rule ,no contract executed prior to the effective date described in subsection 7e7 by a group health plan subject to the requirements of section #djh7;b77#b77;,b7 of the ,employee ,retirement ,income ,security ,act of #aigd 7as amended by subsection 7a77 or by a health insurance issuer subject to the requirements of section #bgdf of the ,public ,health ,service ,act 7as added by subsection 7c77 shall be subject to the requirements of such section #djh7 b77#b77;,b7 or such section #bgdf1 as applicable4 7e7 ,effective date ,the amendments made by subsections 7a7 and 7c7 shall take effect #b years after the date of enactment of this ,act4 #cji4 ,ensuring enrollee access to cost-sharing information 7a7 ,in general ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq471 as amended by section #cjf1 is further amended by adding at the end the following3 #bgbi;,f4 ,provision of cost-sharing information 7a7 ,provider disclosures ,a provider that is in-network with respect to a group health plan or a health insurance issuer offering group or individual health insurance coverage shall provide to an enrollee in the plan or coverage who submits a request for the information described in paragraph 7#a7 or 7#b71 together with accurate and complete information about the enrollee's coverage under the applicable plan or coverage-- 7#a7 as soon as practicable and not later than #b business days after the enrollee requests such information1 a good faith estimate of the expected enrollee cost-sharing for the provision of a particular health care service 7including any service that is reasonably expected to be provided in conjunction with such specific service72 and 7#b7 as soon as practicable and not later than #b business days after an enrollee requests such information1 the contact information for any ancillary providers for a scheduled health care service4 7b7 ,insurer disclosures ,a group health plan or a health insurance issuer offering group or individual health insurance coverage shall provide an enrollee in the plan or coverage with a good faith estimate of the enrollee's cost-sharing 7including deductibles1 copayments1 and coinsurance7 for which the enrollee would be responsible for paying with respect to a specific health care service 7including any service that is reasonably expected to be provided in conjunction with such specific service71 as soon as practicable and not later than #b business days after a request for such information by an enrollee4 7c7 ,enforcement 7#a7 ,in general ,subject to paragraph 7#b71 a health care provider that violates a requirement under subsection 7a7 shall be subject to a civil monetary penalty of not more than #aj1jjj for each act constituting such violation4 7#b7 ,procedure ,the provisions of section #aabh;,a of the ,social ,security ,act1 other than subsections 7a7 and 7b7 and the first sentence of subsection 7c77#a7 of such section1 shall apply to civil money penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a of the ,social ,security ,act4 4 7b7 ,effective date ,section #bgbi;,g of the ,public ,health ,service ,act1 as added by subsection 7a71 shall apply with respect to plan years beginning on or after the date that is #ah months after the date of enactment of this ,act4 #caj4 ,strengthening parity in mental health and substance use disorder benefits ,section #bgbf of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#bf7 is amended-- 7#a7 in subsection 7a71 by adding at the end the following3 7#h7 ,compliance requirements 7,a7 ,nonquantitative treatment limitation 7nqtl7 requirements ,in the case of a group health plan or a health insurance issuer offering group or individual health insurance coverage that provides both medical and surgical benefits and mental health or substance use disorder benefits and that imposes nonquantitative treatment limitations 7referred to in this section as ,,nqtl7 on mental health or substance use disorder benefits1 the plan or issuer offering health insurance coverage in connection with such a plan1 shall perform comparative analyses of the design and application of ,n,q,t,ls in accordance with the following process1 and make available to the applicable ,state authority 7or1 as applicable1 to the ,secretary of ,labor with respect to group health plans or the ,secretary of ,health and ,human ,services with respect to health insurance coverage71 upon request within #fj days beginning #f months after the date of enactment of the ,lower ,health ,care ,costs ,act1 the following information3 7i7 ,the specific plan or coverage terms regarding the ,,nqtl1 that applies to such plan or coverage1 and a description of all mental health or substance use disorder and medical or surgical benefits to which it applies in each respective benefits classification4 7ii7 ,the factors used to determine that the ,,nqtl will apply to mental health or substance use disorder benefits and medical or surgical benefits4 7iii7 ,the evidentiary standards used for the factors identified in clause 7ii71 when applicable1 provided that every factor shall be defined and any other source or evidence relied upon to design and apply the ,,nqtl to mental health or substance use disorder benefits and medical or surgical benefits4 7iv7 ,the comparative analyses demonstrating that the processes1 strategies1 evidentiary standards1 and other factors used to design the ,,nqtl1 as written1 and the operation processes and strategies as written and in operation that are used to apply the ,,nqtl for mental health or substance use disorder benefits are comparable to1 and are applied no more stringently than1 the processes1 strategies1 evidentiary standards1 and other factors used to design the ,,nqtl1 as written1 and the operation processes and strategies as written and in operation that are used to apply the ,,nqtl to medical or surgical benefits4 7v7 ,a disclosure of the specific findings and conclusions reached by the plan or coverage that the results of the analyses described in this subparagraph indicate that the plan or coverage is in compliance with this section4 7,b7 ,secretary request process 7i7 ,submission upon request ,with respect to group health plans or health insurance coverage for which the ,secretary is enforcing this section in accordance with section #bgbc1 the ,secretary1 in consultation with the ,secretary of ,labor and the ,secretary of ,treasury1 shall request that a group health plan or a health insurance issuer offering group or individual health insurance coverage submit the comparative analyses described in subparagraph 7,a7 for plans that involve potential violations of this section concerning ,n,q,t,ls and any other instances in which the ,secretary determines appropriate4 ,the ,secretary shall request not fewer than #bj such analyses per year4 7ii7 ,additional information ,in instances in which the ,secretary has concluded that the plan or coverage has not submitted sufficient information for the ,secretary to review the comparative analyses described in subparagraph 7,a71 as requested under clause 7i71 the ,secretary shall specify to the plan or coverage the information the plan or coverage must submit to be responsive to the request under clause 7i7 for the ,secretary to review the comparative analyses described in subparagraph7,a7 for compliance with this section4 ,nothing in this paragraph shall require the ,secretary to conclude that a plan is in compliance with this section solely based upon the inspection of the comparative analyses described in subparagraph 7,a71 as requested under clause 7i74 7iii7 ,required action ,in instances in which the ,secretary has reviewed the comparative analyses described in subparagraph 7,a71 as requested under clause 7i71 and determined that the plan or coverage is not in compliance with this section1 the plan or coverage shall specify to the ,secretary the actions the plan or coverage will take to be in compliance with this section4 ,documents or communications produced in connection with the ,secretary's recommendations to the plan or coverage shall not be subject to disclosure pursuant to section #eeb of title #e1 ,united ,states ,code4 7iv7 ,report ,not later than #a year after the date of enactment of this paragraph1 and annually thereafter1 the ,secretary shall submit to the ,committee on ,education and ,labor of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report that contains-- 7,i7 a summary of the comparative analyses requested under clause 7i71 except that the identity of each plan or coverage and any contracted entity of a plan or coverage shall be redacted2 7,,ii7 the ,secretary's conclusions as to whether each plan or coverage submitted sufficient information for the ,secretary to review the comparative analyses requested under clause 7i7 for compliance with this section2 7,,iii7 for each plan or coverage that did submit sufficient information for the ,secretary to review the comparative analyses requested under clause 7i71 the ,secretary's conclusions as to whether and why the plan or coverage is in compliance with the disclosure requirements under this section2 7,,iv7 the ,secretary's specifications described in clause 7ii7 for each plan or coverage that the ,secretary determined did not submit sufficient information for the ,secretary to review the comparative analyses requested under clause 7i7 for compliance with this section2 and 7,v7 the ,secretary's specifications described in clause 7iii7 of the actions each plan or coverage that the ,secretary determined is not in compliance with this section must take to be in compliance with this section1 including the reason why the ,secretary determined the plan or coverage is not in compliance4 7,c7 ,compliance program guidance document update process 7i7 ,in general ,the ,secretary shall include select instances of noncompliance that the ,secretary discovers upon reviewing the comparative analyses requested under subparagraph 7,b77i7 in the compliance program guidance document described in section #bgbf7;a77#f71 as it is updated every #b years1 except that all instances shall be deidentified and such instances shall not disclose any protected health information or individually identifiable information4 7ii7 ,guidance and regulations ,not later than #ah months after the date of enactment of this paragraph1 the ,secretary shall finalize any draft or interim guidance and regulations relating to mental health parity under this section4 7iii7 ,state ,the ,secretary shall share information on findings of compliance and noncompliance discovered upon reviewing the comparative analyses requested under subparagraph 7,b77i7 shall be shared with the ,state where the group health plan is located or the ,state where the health insurance issuer is licensed to do business for coverage offered by a health insurance issuer in the group market1 in accordance with section #bgbf7;a77#f77;,b77iii77,,ii74 4 #caa4 ,technical amendments 7a7 ,,erisa ,section #gae of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aahe;d7 is amended-- 7#a7 in subsection 7a77#a71 by striking 7as amended by the ,patient ,protection and ,affordable ,care ,act7 and inserting 7including any subsequent amendments to such part72 and 7#b7 in subsection 7b7-- 7,a7 by striking 7as amended by the ,patient ,protection and ,affordable ,care ,act7 and inserting 7including any subsequent amendments to such part72 and 7,b7 by striking 7as so amended74 7b7 ,,irc ,section #ihae of the ,internal ,revenue ,code of #aihf is amended-- 7#a7 in subsection 7a77#a71 by striking 7as amended by the ,patient ,protection and ,affordable ,care ,act7 and inserting 7including any subsequent amendments to such part72 and 7#b7 in subsection 7b7-- 7,a7 by striking 7as amended by the ,patient ,protection and ,affordable ,care ,act7 and inserting 7including any subsequent amendments to such part72 and 7,b7 by striking 7as so amended74 7c7 ,applicability ,the amendments made by subsections 7a7 and 7b7 shall take effect as though included in the enactment of the ,patient ,protection and ,affordable ,care ,act 7,public ,law #aaa-adh74 #cab4 ,third-party administrators ,any obligation on a third-party administrator under this ,act 7including the amendments made by this ,act7 shall not affect any other direct or indirect requirement under any other provision ,federal law that applies to third-party administrators offering services to group health plans4 #cac4 ,group health plan reporting requirements ,part ,c of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ia et seq471 as amended by section #cjc1 is further amended by adding at the end the following3 #bgig4 ,group health plan reporting 7a7 ,in general ,a group health plan or health insurance issuer offering group or individual health insurance coverage shall submit to the ,secretary1 not later than ,march #a of each year1 the following information with respect to the health plan in the previous plan year3 7#a7 ,the beginning and end dates of the plan year4 7#b7 ,the number of enrollees4 7#c7 ,each ,state in which the plan is offered4 7#d7 ,the #ej brand prescription drugs most frequently dispensed by pharmacies for claims paid by the issuer1 and the total number of paid claims for each such drug4 7#e7 ,the #ej most costly prescription drugs with respect to the plan by total annual spending1 and the annual amount spent by the plan for each such drug4 7#f7 ,the #ej prescription drugs with the greatest increase in plan expenditures over the plan year preceding the plan year that is the subject of the report1 and1 for each such drug1 the change in amounts expended by the plan in each such plan year4 7#g7 ,total spending on health care services by such group health plan1 broken down by-- 7,a7 the type of costs1 including-- 7i7 hospital costs2 7ii7 health care provider and clinical service costs2 7iii7 costs for prescription drugs2 and 7iv7 other medical costs2 and 7,b7 spending on prescription drugs by-- 7i7 the health plan2 and 7ii7 the enrollees4 7#h7 ,the average monthly premium-- 7,a7 paid by employers on behalf of enrollees2 and 7,b7 paid by enrollees4 7#i7 ,any impact on premiums by rebates1 fees1 and any other remuneration paid by drug manufacturers to the plan or its administrators or service providers1 with respect to prescription drugs prescribed to enrollees in the plan1 including-- 7,a7 the amounts so paid for each therapeutic class of drugs2 and 7,b7 the amounts so paid for each of the #be drugs that yielded the highest amount of rebates and other remuneration under the plan from drug manufacturers during the plan year4 7#aj7 ,any reduction in premiums and out-of-pocket costs associated with rebates1 fees1 or other remuneration described in paragraph 7#i74 7b7 ,report ,not later than #ah months after the date on which the first report is required under subsection 7a7 and biannually thereafter1 the ,secretary1 acting through the ,assistant ,secretary of ,planning and ,evaluation and in coordination with the ,inspector ,general of the ,department of ,health and ,human ,services1 shall make available on the internet website of the ,department of ,health and ,human ,services a report on prescription drug reimbursements under group health plans1 prescription drug pricing trends1 and the role of prescription drug costs in contributing to premium increases or decreases under such plans1 aggregated in such a way as no drug or plan specific information will be made public4 7c7 ,privacy protections ,no confidential or trade secret information submitted to the ,secretary under subsection 7a7 shall be included in the report under subsection 7b74 4 #cad4 ,study by ,comptroller ,general of ,united ,states 7a7 ,in general ,the ,comptroller ,general of the ,united ,states 7referred to in this section as the ,comptroller ,general7 shall1 in consultation with appropriate stakeholders1 conduct a study on the role of pharmacy benefit managers4 7b7 ,permissible examination ,in conducting the study required under subsection 7a71 the ,comptroller ,general may examine various qualitative and quantitative aspects of the role of pharmacy benefit managers1 such as the following3 7#a7 ,the role that pharmacy benefit managers play in the pharmaceutical supply chain4 7#b7 ,the state of competition among pharmacy benefit managers1 including the market share for the ,nation's largest pharmacy benefit managers4 7#c7 ,the use of rebates and fees by pharmacy benefit managers1 including-- 7,a7 the extent to which rebates are passed on to health plans and whether such rebates are passed on to individuals enrolled in such plans2 7,b7 the extent to which rebates are kept by such pharmacy benefit managers2 and 7,c7 the role of any fees charged by such pharmacy benefit managers4 7#d7 ,whether pharmacy benefit managers structure their formularies in favor of high-rebate prescription drugs over lower-cost1 lower-rebate alternatives4 7#e7 ,the average prior authorization approval time for pharmacy benefit managers4 7#f7 ,factors affecting the use of step therapy by pharmacy benefit managers4 7c7 ,report ,not later than #c years after the date of enactment of this ,act1 the ,comptroller ,general shall submit to the ,secretary of ,health and ,human ,services1 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report containing the results of the study conducted under subsection 7a71 including policy recommendations4 ,,iv ,improving public health #dja4 ,improving awareness of disease prevention ,the ,public ,health ,service ,act is amended by striking section #cac of such ,act 7#db ,u4,s4,c4 #bde7 and inserting the following3 #cac4 ,public awareness campaign on the importance of vaccinations 7a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention and in coordination with other offices and agencies1 as appropriate1 shall award competitive grants to one or more public or private entities to carry out a national1 evidence-based campaign to increase awareness and knowledge of the safety and effectiveness of vaccines for the prevention and control of diseases1 combat misinformation about vaccines1 and disseminate scientific and evidence-based vaccine-related information1 with the goal of increasing rates of vaccination across all ages1 as applicable1 particularly in communities with low rates of vaccination1 to reduce and eliminate vaccine-preventable diseases4 7b7 ,consultation ,in carrying out the campaign under this section1 the ,secretary shall consult with appropriate public health and medical experts1 including the ,national ,academy of ,medicine and medical and public health associations and nonprofit organizations1 in the development1 implementation1 and evaluation of the evidence-based public awareness campaign4 7c7 ,requirements ,the campaign under this section shall-- 7#a7 be a national1 evidence-based initiative2 7#b7 include the development of resources for communities with low rates of vaccination1 including culturally- and linguistically-appropriate resources1 as applicable2 7#c7 include the dissemination of vaccine information and communication resources to public health departments1 health care providers1 and health care facilities1 including such providers and facilities that provide prenatal and pediatric care2 7#d7 be complementary to1 and coordinated with1 any other ,federal1 ,state1 local1 or ,tribal efforts1 as appropriate2 and 7#e7 assess the effectiveness of communication strategies to increase rates of vaccination4 7d7 ,additional activities ,the campaign under this section may-- 7#a7 include the use of television1 radio1 the internet1 and other media and telecommunications technologies2 7#b7 be focused to address specific needs of communities and populations with low rates of vaccination2 and 7#c7 include the dissemination of scientific and evidence-based vaccine-related information1 such as-- 7,a7 advancements in evidence-based research related to diseases that may be prevented by vaccines and vaccine development2 7,b7 information on vaccinations for individuals and communities1 including individuals for whom vaccines are not recommended by the ,advisory ,committee for ,immunization ,practices1 and the effects of low vaccination rates within a community on such individuals2 7,c7 information on diseases that may be prevented by vaccines2 and 7,d7 information on vaccine safety and the systems in place to monitor vaccine safety4 7e7 ,evaluation ,the ,secretary shall-- 7#a7 establish benchmarks and metrics to quantitatively measure and evaluate the awareness campaign under this section2 7#b7 conduct qualitative assessments regarding the awareness campaign under this section2 and 7#c7 prepare and submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and ,committee on ,energy and ,commerce of the ,house of ,representatives an evaluation of the awareness campaign under this section4 7f7 ,supplement not supplant ,funds appropriated under this section shall be used to supplement and not supplant other ,federal1 ,state1 and local public funds provided for activities described in this section4 7g7 ,authorization of appropriations ,there are authorized to be appropriated to carry out this section and section #cag7k7 such sums as may be necessary for fiscal years #bjbj through #bjbd4 4 #djb4 ,grants to address vaccine-preventable diseases 7a7 ,in general ,section #cag7k77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;b7k77#a77 is amended-- 7#a7 in subparagraph 7,c71 by striking 2 and and inserting a semicolon2 7#b7 in subparagraph 7,d71 by striking the period and inserting a semicolon2 and 7#c7 by adding at the end the following3 7,e7 planning1 implementation1 and evaluation of activities to address vaccine-preventable diseases1 including activities to-- 7i7 identify communities at high risk of outbreaks related to vaccine-preventable diseases1 including through improved data collection and analysis2 7ii7 pilot innovative approaches to improve vaccination rates in communities and among populations with low rates of vaccination2 7iii7 reduce barriers to accessing vaccines and evidence-based information about the health effects of vaccines2 7iv7 partner with community organizations and health care providers to develop and deliver evidence-based interventions1 including culturally- and linguistically-appropriate interventions1 to increase vaccination rates2 7v7 improve delivery of evidence-based vaccine-related information to parents and others2 and 7vi7 improve the ability of ,state1 local1 tribal1 and territorial public health departments to engage communities at high risk for outbreaks related to vaccine-preventable diseases2 and 7,f7 research related to strategies for improving awareness of scientific and evidence-based vaccine-related information1 including for communities with low rates of vaccination1 in order to understand barriers to vaccination1 improve vaccination rates1 and assess the public health outcomes of such strategies4 4 7b7 ,supplemental grant funds ,section #ccj7;d77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bed;b7 is amended-- 7#a7 in subparagraph 7,f71 by striking and at the end2 7#b7 in subparagraph 7,g71 by striking the period and and inserting 2 and2 and 7#c7 by adding at the end the following3 7,h7 improving access to recommended immunizations4 4 #djc4 ,guide on evidence-based strategies for public health department obesity prevention programs 7a7 ,development and dissemination of an evidence-based strategies guide ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 not later than #b years after the date of enactment of this ,act1 shall-- 7#a7 develop a guide on evidence-based strategies for ,state1 territorial1 and local health departments to use to build and maintain effective obesity prevention and reduction programs1 and1 in consultation with ,indian ,tribes and ,tribal organizations1 a guide on such evidence-based strategies with respect to ,indian ,tribes and ,tribal organizations for such ,indian ,tribes and ,tribal organizations to use for such purpose1 both of which guides shall-- 7,a7 describe an integrated program structure for implementing interventions proven to be effective in preventing and reducing the incidence of obesity2 and 7,b7 recommend-- 7i7 optimal resources1 including staffing and infrastructure1 for promoting nutrition and obesity prevention and reduction2 and 7ii7 strategies for effective obesity prevention programs for ,state1 territorial1 and local health departments1 ,indian ,tribes1 and ,tribal organizations1 including strategies related to-- 7,i7 the application of evidence-based and evidence-informed practices to prevent and reduce obesity rates2 7,,ii7 the development1 implementation1 and evaluation of obesity prevention and reduction strategies for specific communities and populations2 7,,iii7 demonstrated knowledge of obesity prevention practices that reduce associated preventable diseases1 health conditions1 death1 and health care costs2 7,,iv7 best practices for the coordination of efforts to prevent and reduce obesity and related chronic diseases2 7,v7 addressing the underlying risk factors and social determinants of health that impact obesity rates2 and 7,,vi7 interdisciplinary coordination between relevant public health officials specializing in fields such as nutrition1 physical activity1 epidemiology1 communications1 and policy implementation1 and collaboration between public health officials1 community-based organizations1 and others1 as appropriate2 and 7#b7 disseminate the guides and current research1 evidence-based practices1 tools1 and educational materials related to obesity prevention1 consistent with the guide1 to ,state1 territorial1 and local health departments1 ,indian ,tribes1 and ,tribal organizations4 7b7 ,technical assistance ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall provide technical assistance to ,state1 territorial1 and local health departments1 ,indian ,tribes1 and ,tribal organizations to support such health departments in implementing the guide developed under subsection 7a77#a74 7c7 ,indian ,tribes2 ,tribal organizations ,the terms ,indian ,tribe and ,tribal organization have the meanings given the terms ,indian tribe and tribal organization1 respectively1 in section #d of the ,indian ,self-,determination and ,education ,assistance ,act 7#be ,u4,s4,c4 #ecjd74 #djd4 ,expanding capacity for health outcomes ,title ,,iii of the ,public ,health ,service ,act is amended by inserting after section #ccj,m 7#db ,u4,s4,c4 #bed;c-#ai7 the following3 #ccj,n4 ,expanding capacity for health outcomes 7a7 ,definitions ,in this section3 7#a7 ,eligible entity ,the term eligible entity means an entity providing health care services in rural areas1 frontier areas1 health professional shortage areas1 or medically underserved areas1 or to medically underserved populations or ,native ,americans1 including ,indian tribes or tribal organizations4 7#b7 ,health professional shortage area ,the term health professional shortage area means a health professional shortage area designated under section #ccb4 7#c7 ,indian tribe ,the terms ,indian tribe and tribal organization have the meanings given such terms in section #d of the ,indian ,self-,determination and ,education ,assistance ,act4 7#d7 ,medically underserved population ,the term medically underserved population has the meaning given the term in section #ccj7;b77#c74 7#e7 ,native ,americans ,the term ,native ,americans has the meaning given such term in section #gcf and includes ,indian tribes and tribal organizations4 7#f7 ,technology-enabled collaborative learning and capacity building model ,the term technology-enabled collaborative learning and capacity building model means a distance health education model that connects health care professionals1 and particularly specialists1 with multiple other health care professionals through simultaneous interactive videoconferencing for the purpose of facilitating case-based learning1 disseminating best practices1 and evaluating outcomes4 7b7 ,program established ,the ,secretary shall1 as appropriate1 award grants to evaluate1 develop1 and1 as appropriate1 expand the use of technology-enabled collaborative learning and capacity building models1 to increase access to health care services1 such as those to address chronic diseases and conditions1 mental health1 substance use disorders1 prenatal and maternal health1 pediatric care1 pain management1 palliative care1 and other specialty care in rural areas1 frontier areas1 health professional shortage areas1 or medically underserved areas and for medically underserved populations or ,native ,americans1 including ,indian ,tribes and ,tribal organizations4 7c7 ,use of funds 7#a7 ,in general ,grants awarded under subsection 7b7 shall be used for-- 7,a7 the development and acquisition of instructional programming1 and the training of health care providers and other professionals that provide or assist in the provision of services through such models2 7,b7 information collection and evaluation activities to study the impact of such models on patient outcomes and health care providers1 and to identify best practices for the expansion and use of such models2 or 7,c7 other activities consistent with achieving the objectives of the grants awarded under this section1 as determined by the ,secretary4 7#b7 ,other uses ,in addition to any of the uses under paragraph 7#a71 grants awarded under subsection 7b7 may be used for-- 7,a7 equipment to support the use and expansion of technology-enabled collaborative learning and capacity building models1 including for hardware and software that enables distance learning1 health care provider support1 and the secure exchange of electronic health information2 or 7,b7 support for health care providers and other professionals that provide or assist in the provision of services through such models4 7d7 ,length of grants ,grants awarded under subsection 7b7 shall be for a period of up to #e years4 7e7 ,application ,an eligible entity that seeks to receive a grant under subsection 7b7 shall submit to the ,secretary an application1 at such time1 in such manner1 and containing such information as the ,secretary may require4 ,such application criteria shall include an assessment of the effect of technology-enabled collaborative learning and capacity building models on patient outcomes and health care providers4 7f7 ,access to broadband ,in administering grants under this section1 the ,secretary may coordinate with other agencies to ensure that funding opportunities are available to support access to reliable1 high-speed internet for grantees4 7g7 ,technical assistance ,the ,secretary shall provide 7either directly through the ,department of ,health and ,human ,services or by contract7 technical assistance to eligible entities1 including recipients of grants under subsection 7b71 on the development1 use1 and evaluation of technology-enabled collaborative learning and capacity building models in order to expand access to health care services provided by such entities1 including for medically underserved areas and to medically underserved populations or ,native ,americans1 including ,indian tribes and ,tribal organizations4 7h7 ,research and evaluation ,the ,secretary1 in consultation with stakeholders with appropriate expertise in such models1 shall develop a strategic plan to research and evaluate the evidence for such models4 ,the ,secretary shall use such plan to inform the activities carried out under this section4 7i7 ,report by ,secretary ,not later than #d years after the date of enactment of this section1 the ,secretary shall prepare and submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 and post on the ,internet website of the ,department of ,health and ,human ,services1 a report including1 at minimum-- 7#a7 a description of any new and continuing grants awarded to entities under subsection 7b7 and the specific purpose and amounts of such grants2 7#b7 an overview of-- 7,a7 the evaluations conducted under subsections 7b7 or 7f72 and 7,b7 technical assistance provided under subsection 7g72 and 7#c7 a description of any significant findings or developments in patient outcomes and health care providers and best practices for eligible entities expanding1 using1 or evaluating technology-enabled collaborative learning and capacity building models1 including through the activities described in subsection 7g74 7j7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section1 such sums as may be necessary for each of fiscal years #bjbj through #bjbd4 4 #dje4 ,public health data system modernization ,subtitle ,c of title ,,xxviii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#ca et seq47 is amended by adding at the end the following3 #bhbb4 ,public health data system modernization grants 7a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall-- 7#a7 award grants to ,state1 local1 ,tribal1 and territorial public health departments for the expansion and modernization of public health data systems1 to assist public health departments in-- 7,a7 assessing current data infrastructure capabilities and gaps to improve and increase consistency in data collection1 storage1 analysis1 and1 as appropriate1 to improve dissemination of public health-related information2 7,b7 improving secure public health data collection1 transmission1 exchange1 maintenance1 and analysis2 7,c7 simplifying and supporting reporting by health care providers1 as applicable1 pursuant to ,state law1 including through the use of health information technology1 to ,state1 local1 ,tribal1 and territorial public health departments1 including public health officials in multiple jurisdictions within such ,state1 as appropriate2 7,d7 enhancing interoperability of public health data systems 7including systems created or accessed by public health departments7 with health information technology1 including health information technology certified under section #cjja7;c77#e72 7,e7 supporting earlier disease and health condition detection1 such as through near real-time data monitoring1 to support rapid public health responses2 and 7,f7 supporting activities within the applicable jurisdiction related to the expansion and modernization of electronic case reporting2 7#b7 as appropriate1 conduct activities related to the interoperability and improvement of applicable public health data systems used by the ,centers for ,disease ,control and ,prevention1 and1 in coordination with the ,office of the ,national ,coordinator for ,health ,information ,technology1 the designation of data and technology standards for health information systems of the public health infrastructure with deference given to standards published by standards development organizations and voluntary consensus-based standards bodies2 and 7#c7 develop and utilize public-private partnerships for technical assistance and related implementation support for ,state1 local1 ,tribal1 and territorial public health departments1 and the ,centers for ,disease ,control and ,prevention1 on the expansion and modernization of electronic case reporting and public health data systems1 as applicable4 7b7 ,requirements 7#a7 ,in general ,the ,secretary may not award a grant under subsection 7a77#a7 unless the applicant uses or agrees to use standards recognized by the ,national ,coordinator for ,health ,information ,technology pursuant to section #cjja7;c77#a7 or adopted by the ,secretary under section #cjjd4 7#b7 ,waiver ,the ,secretary may waive the requirement under paragraph 7#a7 with respect to an applicant if the ,secretary determines that the activities under subsection 7a7 cannot otherwise be carried out within the applicable jurisdiction4 7#c7 ,application ,a ,state1 local1 ,tribal1 or territorial health department applying for a grant under this section shall submit an application to the ,secretary at such time and in such manner as the ,secretary may require4 ,such application shall include information describing-- 7,a7 the activities that will be supported by the grant2 and 7,b7 how the modernization of such public health data systems will support or impact the public health infrastructure of the health department1 including a description of remaining gaps1 if any1 and the actions needed to address such gaps4 7c7 ,use of funds ,an entity receiving a grant under this section may use amounts received under such grant for one or both of the following3 7#a7 ,carrying out activities described in subsection 7a77#a7 to support public health data systems 7including electronic case reporting71 which may include support for1 and training of1 professionals with expertise in contributing to and using such systems 7including public health data scientists74 7#b7 ,developing and disseminating information related to the use and importance of public health data4 7d7 ,strategy and implementation plan ,not later than #ahj days after the date of enactment of the ,lower ,health ,care ,costs ,act1 the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 a coordinated strategy and an accompanying implementation plan that identifies and demonstrates the steps the ,secretary will carry out to-- 7#a7 update and improve applicable public health data systems used by the ,centers for ,disease ,control and ,prevention2 and 7#b7 carry out the activities described in this section to support the improvement of ,state1 local1 ,tribal1 and territorial public health data systems4 7e7 ,consultation ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall consult with ,state1 local1 ,tribal1 and territorial health departments1 professional medical and public health associations1 associations representing hospitals or other health care entities1 health information technology experts1 and other appropriate entities regarding the plan and grant program to modernize public health data systems pursuant to this section4 ,such activities may include the provision of technical assistance related to the exchange of information by such public health data systems used by relevant health care and public health entities at the local1 ,state1 ,federal1 ,tribal1 and territorial levels4 7f7 ,report to ,congress ,not later than #a year after the date of enactment of this section1 the ,secretary shall submit a report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives that includes-- 7#a7 a description of any barriers to-- 7,a7 public health authorities implementing interoperable public health data systems and electronic case reporting2 7,b7 the exchange of information pursuant to electronic case reporting2 or 7,c7 reporting by health care providers using such public health data systems1 as appropriate1 and pursuant to ,state law2 7#b7 an assessment of the potential public health impact of implementing electronic case reporting and interoperable public health data systems2 and 7#c7 a description of the activities carried out pursuant to this section4 7g7 ,electronic case reporting ,in this section1 the term electronic case reporting means the automated identification1 generation1 and bilateral exchange of reports of health events among electronic health record or health information technology systems and public health authorities4 7h7 ,authorization of appropriations ,for the purpose of carrying out this section1 there are authorized to be appropriated such sums as may be necessary for fiscal years #bjbj through #bjbd4 4 #djf4 ,innovation for maternal health ,title ,,iii of the ,public ,health ,service ,act is amended by inserting after section #ccj,n of such ,act1 as added by section #djd1 the following3 #ccj,o4 ,innovation for maternal health 7a7 ,in general ,the ,secretary1 in consultation with experts representing a variety of clinical specialties1 ,state1 tribal1 or local public health officials1 researchers1 epidemiologists1 statisticians1 and community organizations1 shall establish or continue a program to award competitive grants to eligible entities for the purpose of-- 7#a7 identifying1 developing1 or disseminating best practices to improve maternal health care quality and outcomes1 eliminate preventable maternal mortality and severe maternal morbidity1 and improve infant health outcomes1 which may include-- 7,a7 information on evidence-based practices to improve the quality and safety of maternal health care in hospitals and other health care settings of a ,state or health care system1 including by addressing topics commonly associated with health complications or risks related to prenatal care1 labor care1 birthing1 and postpartum care2 7,b7 best practices for improving maternal health care based on data findings and reviews conducted by a ,state maternal mortality review committee that address topics of relevance to common complications or health risks related to prenatal care1 labor care1 birthing1 and postpartum care2 and 7,c7 information on addressing determinants of health that impact maternal health outcomes for women before1 during1 and after pregnancy2 7#b7 collaborating with ,state maternal mortality review committees to identify issues for the development and implementation of evidence-based practices to improve maternal health outcomes and reduce preventable maternal mortality and severe maternal morbidity2 7#c7 providing technical assistance and supporting the implementation of best practices identified in paragraph 7#a7 to entities providing health care services to pregnant and postpartum women2 and 7#d7 identifying1 developing1 and evaluating new models of care that improve maternal and infant health outcomes1 which may include the integration of community-based services and clinical care4 7b7 ,eligible entities ,to be eligible for a grant under subsection 7a71 an entity shall-- 7#a7 submit to the ,secretary an application at such time1 in such manner1 and containing such information as the ,secretary may require2 and 7#b7 demonstrate in such application that the entity is capable of carrying out data-driven maternal safety and quality improvement initiatives in the areas of obstetrics and gynecology or maternal health4 7c7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated such sums as may be necessary for each of fiscal years #bjbj through #bjbd4 4 #djg4 ,training for health care providers ,title ,,vii of the ,public ,health ,service ,act is amended by striking section #gfc 7#db ,u4,s4,c4 #bidp7 and inserting the following3 #gfc4 ,training for health care providers 7a7 ,grant program ,the ,secretary shall establish a program to award grants to accredited schools of allopathic medicine1 osteopathic medicine1 and nursing1 and other health professional training programs for the training of health care professionals to reduce and prevent discrimination 7including training related to implicit biases7 in the provision of health care services related to prenatal care1 labor care1 birthing1 and postpartum care4 7b7 ,eligibility ,to be eligible for a grant under subsection 7a71 an entity described in such subsection shall submit to the ,secretary an application at such time1 in such manner1 and containing such information as the ,secretary may require4 7c7 ,reporting requirement ,each entity awarded a grant under this section shall periodically submit to the ,secretary a report on the status of activities conducted using the grant1 including a description of the impact of such training on patient outcomes1 as applicable4 7d7 ,best practices ,the ,secretary may identify and disseminate best practices for the training of health care professionals to reduce and prevent discrimination 7including training related to implicit biases7 in the provision of health care services related to prenatal care1 labor care1 birthing1 and postpartum care4 7e7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated such sums as may be necessary for each of fiscal years #bjbj through #bjbd4 4 #djh4 ,study on training to reduce and prevent discrimination ,not later than #b years after date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall1 through a contract with an independent research organization1 conduct a study and make recommendations for accredited schools of allopathic medicine1 osteopathic medicine1 and nursing1 and other health professional training programs on best practices related to training to reduce and prevent discrimination1 including training related to implicit biases1 in the provision of health care services related to prenatal care1 labor care1 birthing1 and postpartum care4 #dji4 ,perinatal quality collaboratives ,section #cag,k7a77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;b-#ab7;a77#b77 is amended by adding at the end the following3 7,e7 7i7 ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention and in coordination with other offices and agencies1 as appropriate1 shall establish or continue a competitive grant program for the establishment or support of perinatal quality collaboratives to improve perinatal care and perinatal health outcomes for pregnant and postpartum women and their infants4 ,a ,state1 ,indian ,tribe1 or ,tribal organization may use funds received through such grant to-- 7,i7 support the use of evidence-based or evidence-informed practices to improve outcomes for maternal and infant health2 7,,ii7 work with clinical teams2 experts2 ,state1 local1 and1 as appropriate1 tribal public health officials2 and stakeholders1 including patients and families1 to identify1 develop1 or disseminate best practices to improve perinatal care and outcomes2 and 7,,iii7 employ strategies that provide opportunities for health care professionals and clinical teams to collaborate across health care settings and disciplines1 including primary care and mental health1 as appropriate1 to improve maternal and infant health outcomes1 which may include the use of data to provide timely feedback across hospital and clinical teams to inform responses1 and to provide support and training to hospital and clinical teams for quality improvement1 as appropriate4 7ii7 ,to be eligible for a grant under clause 7i71 an entity shall submit to the ,secretary an application in such form and manner and containing such information as the ,secretary may require4 4 #daj4 ,integrated services for pregnant and postpartum women 7a7 ,grants ,title ,,iii of the ,public ,health ,service ,act is amended by inserting after section #ccj,o of such ,act1 as added by section #djf1 the following3 #ccj,p4 ,integrated services for pregnant and postpartum women 7a7 ,in general ,the ,secretary may award grants for the purpose of establishing or operating evidence-based or innovative1 evidence-informed programs to deliver integrated health care services to pregnant and postpartum women to optimize the health of women and their infants1 including to reduce adverse maternal health outcomes1 pregnancy-related deaths1 and related health disparities 7including such disparities associated with racial and ethnic minority populations71 and1 as appropriate1 by addressing issues researched under subsection 7b77#b7 of section #cag,k4 7b7 ,integrated services for pregnant and postpartum women 7#a7 ,eligibility ,to be eligible to receive a grant under subsection 7a71 a ,state1 ,indian ,tribe1 or ,tribal organization 7as such terms are defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act7 shall work with relevant stakeholders that coordinate care 7including coordinating resources and referrals for health care and social services7 to develop and carry out the program1 including-- 7,a7 ,state1 ,tribal1 and local agencies responsible for ,medicaid1 public health1 social services1 mental health1 and substance use disorder treatment and services2 7,b7 health care providers who serve pregnant and postpartum women2 and 7,c7 community-based health organizations and health workers1 including providers of home visiting services and individuals representing communities with disproportionately high rates of maternal mortality and severe maternal morbidity1 and including those representing racial and ethnicity minority populations4 7#b7 ,terms 7,a7 ,period ,a grant awarded under subsection 7a7 shall be made for a period of #e years4 ,any supplemental award made to a grantee under subsection 7a7 may be made for a period of less than #e years4 7,b7 ,preference ,in awarding grants under subsection 7a71 the ,secretary shall-- 7i7 give preference to ,states1 ,indian ,tribes1 and ,tribal organizations that have the highest rates of maternal mortality and severe maternal morbidity relative to other such ,states1 ,indian ,tribes1 or ,tribal organizations1 respectively2 and 7ii7 shall consider health disparities related to maternal mortality and severe maternal morbidity1 including such disparities associated with racial and ethnic minority populations4 7,c7 ,priority ,in awarding grants under subsection 7a71 the ,secretary shall give priority to applications from up to #ae entities described in subparagraph 7,b77i74 7,d7 ,evaluation ,the ,secretary shall require grantees to evaluate the outcomes of the programs supported under the grant4 7c7 ,authorization of appropriations ,there are authorized to be appropriated to carry out this section such sums as may be necessary for each of fiscal years #bjbj through #bjbd4 4 7b7 ,report on grant outcomes and dissemination of best practices 7#a7 ,report ,not later than ,february #a1 #bjbf1 the ,secretary of ,health and ,human ,services shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report that describes-- 7,a7 the outcomes of the activities supported by the grants awarded under the amendments made by this section on maternal and child health2 7,b7 best practices and models of care used by recipients of grants under such amendments2 and 7,c7 obstacles identified by recipients of grants under such amendments1 and strategies used by such recipients to deliver care1 improve maternal and child health1 and reduce health disparities4 7#b7 ,dissemination of best practices ,not later than ,august #a1 #bjbf1 the ,secretary of ,health and ,human ,services shall disseminate information on best practices and models of care used by recipients of grants under the amendments made by this section 7including best practices and models of care relating to the reduction of health disparities1 including such disparities associated with racial and ethnic minority populations1 in rates of maternal mortality and severe maternal morbidity7 to relevant stakeholders1 which may include health providers1 medical schools1 nursing schools1 relevant ,state1 tribal1 and local agencies1 and the general public4 #daa4 ,extension for community health centers1 the national health service corps1 and teaching health centers that operate ,,gme programs 7a7 ,community health centers ,section #ajejc7;b77#a77;,f7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #bed;b-#b7;b77#a77;,f77 is amended by striking fiscal year #bjai and inserting each of fiscal years #bjai through #bjbd4 7b7 ,national ,health ,service ,corps ,section #ajejc7;b77#b77;,f7 of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #bed;b-#b7;b77#b77;,f77 is amended by striking and #bjai and inserting through #bjbd4 7c7 ,teaching ,health ,centers that operate ,graduate ,medical ,education ,programs ,section #cdj;,h7g77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;h7g77#a77 is amended by striking and #bjai and inserting through #bjbd4 7d7 ,application of provisions ,amounts appropriated pursuant to this section for each of fiscal years #bjai through #bjbd shall be subject to the requirements contained in ,public ,law #aae-bde for funds for programs authorized under sections #ccj through #cdj of the ,public ,health ,service ,act4 7e7 ,conforming amendments ,paragraph 7#d7 of section #cjad7;h7 of title #ah1 ,united ,states ,code1 as amended by section #ejija of ,public ,law #aae-abc1 is amended by striking and section #ejija7;e7 of the ,advancing ,chronic ,care1 ,extenders1 and ,social ,services ,act and inserting 1 section #ejija7;e7 of the ,advancing ,chronic ,care1 ,extenders1 and ,social ,services ,act1 and section #daa7;d7 of the ,lower ,health ,care ,costs ,act4 #dab4 ,other programs 7a7 ,type ,i ,section #ccj;,b7b77#b77;,d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bed;c-#b7;b77#b77;,d77 is amended by striking and #bjai and inserting through #bjbd4 7b7 ,indians ,subparagraph 7,d7 of section #ccj;,c7c77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bed;c-#c7;c77#b77;,d77 is amended by striking and #bjai and inserting through #bjbd4 #dac4 ,native ,american suicide prevention ,section #ebj;,e7b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;bb-#cf7;b7 is amended by inserting after paragraph 7#c7 the following3 7#d7 ,consultation ,a ,state applying for a grant or cooperative agreement under this section shall1 in the development and implementation of a statewide early intervention strategy1 consult or confer with entities described in paragraph 7#a77;,c7 in such ,state4 4 #dad4 ,minimum age of sale of tobacco products 7a7 ,in general ,section #ijf7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chg;f7d77 is amended-- 7#a7 in paragraph 7#c77;,a77ii71 by striking #ah years and inserting #ba years2 and 7#b7 by adding at the end the following3 7#e7 ,minimum age of sale ,it shall be unlawful for any retailer to sell a tobacco product to any person younger than #ba years of age4 4 7b7 ,regulations ,not later than #ahj days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall publish in the ,federal ,register a final rule to update the regulations issued under chapter ,,ix of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chg et seq47 as appropriate1 only to carry out the amendments made by subsection 7a71 including updating the relevant age verification requirements under part #aadj of title #ba1 ,code of ,federal ,regulations to require age verification for individuals under the age of #cj4 ,such final rule shall-- 7#a7 take full effect not later than #ij days after the date on which such final rule is published2 and 7#b7 be deemed to be in compliance with all applicable provisions of chapter #e of title #e1 ,united ,states ,code and all other provisions of law relating to rulemaking procedures4 7c7 ,notification ,not later than #ij days after the date of enactment of this ,act1 the ,secretary shall provide written notification to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives regarding the progress of the ,department of ,health and ,human ,services towards promulgating the final rule under subsection 7b74 ,if1 #ahj days after the date of enactment of this ,act1 such rule has not been promulgated in accordance with subsection 7b71 the ,secretary shall provide a written notification and a justification for the delay in rulemaking to such committees4 7d7 ,penalties for violations 7#a7 ,in general ,section #ajc7q77#b7 of the ,family ,smoking ,prevention and ,tobacco ,control ,act 7,public ,law #aaa-ca7 is amended-- 7,a7 in subparagraph 7,a71 in the matter preceding clause 7i71 by inserting section #ijf7;d77#e7 or of after violations of2 and 7,b7 in subparagraph 7,c71 by inserting section #ijf7;d77#e7 or of after a retailer of4 7#b7 ,repeated violations ,section #cjc7;f77#h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;f77#h77 is amended by inserting section #ijf7;d77#e7 or of after repeated violations of4 7#c7 ,misbranded products ,section #ijc7;a77#g77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chg;c7 is amended by inserting section #ijf7;d77#e7 or of after violation of4 #dae4 ,sale of tobacco products to individuals under the age of #ba 7a7 ,in general ,section #aibf of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx-#bf7 is amended-- 7#a7 in the heading-- 7,a7 by striking ,state law regarding2 and 7,b7 by striking #ah and inserting #ba2 7#b7 by striking subsections 7a7 and 7d72 7#c7 by redesignating subsections 7b7 and 7c7 as subsections 7a7 and 7b71 respectively2 7#d7 by amending subsection 7a71 as so redesignated1 to read as follows3 7a7 ,in general ,a funding agreement for a grant under section #aiba is that the ,state involved will-- 7#a7 annually conduct random1 unannounced inspections to ensure that retailers do not sell tobacco products to individuals under the age of #ba2 and 7#b7 annually submit to the ,secretary a report describing-- 7,a7 the activities carried out by the ,state to ensure that retailers do not sell tobacco products to individuals under the age of #ba2 7,b7 the extent of success the ,state has achieved in ensuring that retailers do not sell tobacco products to individuals under the age of #ba2 and 7,c7 the strategies to be utilized by the ,state to ensure that retailers do not sell tobacco products to individuals under the age of #ba during the fiscal year for which the grant is sought4 2 7#e7 in subsection 7b71 as so redesignated-- 7,a7 by striking paragraphs 7#a71 7#b71 7#c71 and 7#d72 7,b7 by striking ,before making and inserting the following3 7#a7 ,in general ,before making 2 7,c7 by striking for the first applicable fiscal year or any subsequent fiscal year2 7,d7 by striking subsections 7a7 and 7b7 and inserting subsection 7a72 7,e7 by striking equal to-- and inserting up to #aj percent of the amount determined under section #aicc for the ,state for the applicable fiscal year42 and 7,f7 by adding at the end the following3 7#b7 ,limitation 7,a7 ,in general ,a ,state shall not have funds withheld pursuant to paragraph 7#a7 if such ,state for which the ,secretary has made a determination of noncompliance under such paragraph-- 7i7 certifies to the ,secretary by ,may #a of the fiscal year for which the funds are appropriated1 consistent with subparagraph 7,b71 that the ,state will commit additional ,state funds1 in accordance with paragraph 7#a71 to ensure that retailers do not sell tobacco products to individuals under #ba years of age2 7ii7 agrees to comply with a negotiated agreement for a corrective action plan that is approved by the ,secretary and carried out in accordance with guidelines issued by the ,secretary2 or 7iii7 is a territory that receives less than #a1jjj1jjj for a fiscal year under section #aiba4 7,b7 ,certification 7i7 ,in general ,the amount of funds to be committed by a ,state pursuant to subparagraph 7,a77i7 shall be equal to #a percent of such ,state's substance abuse allocation determined under section #aicc for each percentage point by which the ,state misses the retailer compliance rate goal established by the ,secretary4 7ii7 ,state expenditures ,for a fiscal year in which a ,state commits funds as described in clause 7i71 such ,state shall maintain ,state expenditures for tobacco prevention programs and for compliance activities at a level that is not less than the level of such expenditures maintained by the ,state for the preceding fiscal year1 plus the additional funds for tobacco compliance activities required under clause 7i74 ,the ,state shall submit a report to the ,secretary on all ,state obligations of funds for such fiscal year and all ,state expenditures for the preceding fiscal year for tobacco prevention and compliance activities by program activity by ,july #ca of such fiscal year4 7iii7 ,discretion ,the ,secretary shall exercise discretion in enforcing the timing of the ,state obligation of the additional funds required by the certification described in subparagraph 7,a77i7 as late as ,july #ca of such fiscal year4 7,c7 ,failure to certify ,if a ,state described in subparagraph 7,a7 fails to certify to the ,secretary pursuant to subparagraph 7,a77i7 or enter into1 or comply with1 a negotiated agreement under subparagraph 7,a77ii71 the ,secretary may take action pursuant to paragraph 7#a74 2 and 7#f7 by adding at the end the following3 7c7 ,implementation of reporting requirements 7#a7 ,transition period ,the ,secretary shall-- 7,a7 not withhold amounts under subsection 7b7 for the #c-year period immediately following the date of enactment of the ,lower ,health ,care ,costs ,act2 and 7,b7 use discretion in exercising its authority under subsection 7b7 during the #b-year period immediately following the #c-year period described in subparagraph 7,a71 to allow for a transition period for implementation of the reporting requirements under subsection 7a77#b74 7#b7 ,regulations or guidance ,not later than #ahj days after the date of enactment of the ,lower ,health ,care ,costs ,act the ,secretary shall update regulations under part #if of title #de1 ,code of ,federal ,regulations or guidance on the retailer compliance rate goal under subsection 7b71 the use of funds provided under section #aiba for purposes of meeting the requirements of this section1 and reporting requirements under subsection 7a77#b74 7#c7 ,coordination ,the ,secretary shall ensure the ,assistant ,secretary for ,mental ,health and ,substance ,use coordinates1 as appropriate1 with the ,commissioner of ,food and ,drugs in providing technical assistance under this section to ,states1 related to ensuring retailers do not sell tobacco products to individuals under the age of #ba1 that is consistent with applicable regulations issued by the ,food and ,drug ,administration4 7d7 ,transitional grants 7#a7 ,in general ,the ,secretary shall award grants under this subsection to each ,state that receives funding under section #aiba to ensure compliance of each such ,state with this section4 7#b7 ,use of funds ,a ,state receiving a grant under this subsection-- 7,a7 shall use amounts received under such grant for activities to plan for or ensure compliance in the ,state with subsection 7a72 and 7,b7 in the case of a ,state for which the ,secretary has made a determination under subsection 7b7 that the ,state is prepared to meet1 or has met1 the requirements of subsection 7a71 may use such funds for tobacco cessation activities1 strategies to prevent the use of tobacco products by individuals under the age of #ba1 or allowable uses under section #aiba4 7#c7 ,supplement not supplant ,grants under this subsection shall be used to supplement and not supplant other ,federal1 ,state1 and local public funds provided for activities under paragraph 7#b74 7#d7 ,authorization of appropriations ,to carry out this subsection1 there are authorized to be appropriated #ah1ehj1gij for each of fiscal years #bjbj through #bjbd4 7#e7 ,sunset ,this subsection shall have no force or effect after ,september #cj1 #bjbd4 7e7 ,technical assistance ,the ,secretary shall provide technical assistance to ,states related to the activities required under this section4 4 7b7 ,report to ,congress ,not later than #c years after the date of enactment of this ,act1 the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report on the status of implementing the requirements of section #aibf of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx-#bf71 as amended by subsection 7a71 and a description of any technical assistance provided under subsection 7e7 of such section1 including the number of meetings requested and held related to technical assistance4 7c7 ,conforming amendment ,section #bab of division ,d of the ,consolidated ,appropriations ,act1 #bjaj 7,public ,law #aaa-aag7 is repealed4 ,v ,improving the exchange of health information #eja4 ,requirement to provide health claims1 network1 and cost information 7a7 ,in general ,part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg et seq47 is amended by inserting after section #bgae;,a the following3 #bgae;,b4 ,requirement to provide health claims1 network1 and cost information 7a7 ,in general ,a group health plan or a health insurance issuer offering group or individual health insurance coverage shall make available for access1 exchange1 and use without special effort1 through application programming interfaces 7or successor technology or standards71 the information described in subsection 7b71 in the manner described in subsection 7b7 and otherwise consistent with this section4 7b7 ,information ,the following information is required to be made available1 as the ,secretary may specify3 7#a7 ,historical claims1 provider encounter1 and payment data for each enrollee1 which shall-- 7,a7 include adjudicated medical and prescription drug claims and equivalent encounters1 including all data elements contained in such transactions-- 7i7 that were adjudicated by the group health plan or health insurance issuer during the previous #e years or the enrollee's entire period of enrollment in the applicable plan or coverage if such period is less than the previous #e years2 7ii7 that involve benefits managed by any third party1 such as a pharmacy benefits manager or radiology benefits manager that manages benefits or adjudicates claims on behalf of the plan or coverage2 and 7iii7 from any other health plan or health insurance coverage offered by the same insurance issuer1 in which the same enrollee was enrolled during the previous #e years2 and 7,b7 be available to an enrollee or former enrollee1 the enrollee's providers1 and any third-party applications or services authorized by the enrollee-- 7i7 through the application programming interfaces 7or successor technology or standards7 as required by this paragraph1 in a single1 longitudinal format that is easy to understand1 secure1 and that may update automatically2 7ii7 as soon as practicable1 and in no case later than the period of time determined by the ,secretary1 after the claim is adjudicated or the data is received by the health plan or health insurance issuer2 and 7iii7 to the enrollee1 former enrollee1 and any providers or third-party applications or services authorized by the enrollee1 for #e years after the end date of the enrollee's enrollment in the plan or in any coverage offered by the health insurance issuer4 7#b7 ,identifying directory information for all in-network providers1 including facilities and practitioners1 that participate in the plan or coverage1 which shall-- 7,a7 include-- 7i7 the national provider identifier for in-network facilities and practitioners2 and 7ii7 the name1 address1 phone number1 and specialty for each such facility and practitioner1 based on the most recent interaction between the plan or coverage and that facility or practitioner2 7,b7 be capable of returning the information necessary to establish a list of participating in-network facilities and practitioners1 in a given specialty or at a particular facility type1 within a specified geographic radius2 and 7,c7 be capable of returning the network status1 when presented with identifiers for a given enrollee and facility or practitioner4 7#c7 ,estimated enrollee out-of-pocket costs1 including costs expected to be incurred through a deductible1 co-payment1 coinsurance1 or other form of cost-sharing1 for-- 7,a7 a designated set of common services or episodes of care1 to be established by the ,secretary through rulemaking1 including1 at a minimum-- 7i7 in the case of services provided by a hospital1 the #ajj most common diagnosis-related groups1 as used in the ,medicare ,inpatient ,prospective ,patient ,system 7or successor episode-based reimbursement methodology7 at that hospital1 based on claims data adjudicated by the group health plan or health insurance issuer2 7ii7 in the case of services provided in an out-patient setting1 including radiology1 lab tests1 and out-patient surgical procedures1 any service rendered by the facility or practitioner1 and reimbursed by the health plan or health insurance issuer2 and 7iii7 in the case of post-acute care1 including home health providers1 skilled nursing facilities1 inpatient rehabilitation facilities1 and long-term care hospitals1 the patient out-of-pocket costs for an episode of care1 as the ,secretary may determine1 which permits users to reasonably compare costs across different facility and service types2 and 7,b7 all prescription drugs currently included on any tier of the formulary of the plan or coverage4 7#d7 ,a list of the categories of providers of ancillary services1 as defined in section #bgai7;,a77i77#c71 for which the plan or coverage has no in-network providers4 7c7 ,availability and access ,subject to all applicable ,federal and ,state privacy1 security1 and breach notification laws1 the application programming interfaces1 including all data required to be made available through such interfaces1 shall-- 7#a7 be made available by the applicable group health plan or health insurance issuer1 at no charge1 to-- 7,a7 enrollees and prospective enrollees in the group health plan or health insurance coverage2 7,b7 third parties authorized by the enrollee2 7,c7 facilities and practitioners who are under contract with the plan or coverage2 and 7,d7 business associates of such facilities and practitioners1 as defined in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or any successor regulations72 7#b7 be available to enrollees in the group health plan or health insurance coverage1 and to third-party applications or services facilitating such access by enrollees1 during the enrollment process and for a minimum of #e years after the end date of the enrollee's enrollment in the plan or in any coverage offered by the health insurance issuer2 7#c7 permit persistent access by third party applications or services authorized by the enrollee1 for a reasonable period of time1 consistent with the requirements of the ,,hipaa ,security rule 7part #afj of title #de ,code of ,federal ,regulations and subparts ,a and ,c of part #afd of such title72 7#d7 employ the applicable content1 vocabulary1 and technical standards1 as determined by the ,secretary pursuant to title ,,xxx2 and 7#e7 employ security and authentication standards1 as the ,secretary determines appropriate4 7d7 ,rule of construction regarding privacy ,nothing in this section shall be construed to alter existing obligations of a covered entity or business associate under the privacy1 security1 and breach notification rules promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act or section #acdjb of the ,,hitech ,act1 or to alter the ,secretary's existing authority to modify such rules1 under part #b of title #db1 ,code of ,federal ,regulations 7or successor regulations71 under section #ddd of the ,general ,education ,provisions ,act 7#bj ,u4,s4,c4 #abcb;g7 7commonly referred to as the ,family ,educational ,rights and ,privacy ,act of #aigd71 under the amendments made by the ,genetic ,information ,nondiscrimination ,act1 or under ,state privacy law4 4 7b7 ,effective date ,section #bgae;,b of the ,public ,health ,service ,act1 as added by subsection 7a71 shall take effect #ah months after the date of enactment of this ,act4 #ejb4 ,recognition of security practices ,part #a of subtitle ,d of the ,health ,information ,technology for ,economic and ,clinical ,health ,act 7#db ,u4,s4,c4 #agica et seq47 is amended by adding at the end the following3 #acdab4 ,recognition of security practices 7a7 ,in general ,consistent with the authority of the ,secretary under sections #aagf and #aagg of the ,social ,security ,act1 when making determinations relating to fines under section #acdaj1 decreasing the length and extent of an audit under section #acdaa1 or remedies otherwise agreed to by the ,secretary1 the ,secretary shall consider whether the covered entity or business associate has adequately demonstrated that it had1 for not less than the previous #ab months1 recognized security practices in place that may-- 7#a7 mitigate fines under section #acdaj2 7#b7 result in the early1 favorable termination of an audit under section #acdaa2 and 7#c7 mitigate the remedies that would otherwise be agreed to in any agreement with respect to resolving potential violations of the ,,hipaa ,security rule 7part #afj of title #de ,code of ,federal ,regulations and subparts ,a and ,c of part #afd of such title7 between the covered entity or business associate and the ,department of ,health and ,human ,services4 7b7 ,definition and miscellaneous provisions 7#a7 ,recognized security practices ,the term recognized security practices means the standards1 guidelines1 best practices1 methodologies1 procedures1 and processes developed under section #b7;c77#ae7 of the ,national ,institute of ,standards and ,technology ,act1 the approaches promulgated under section #dje7;d7 of the ,cybersecurity ,act of #bjae1 and other programs and processes that address cybersecurity and that are developed1 recognized1 or promulgated through regulations under other statutory authorities4 ,such practices shall be determined by the covered entity or business associate4 7#b7 ,limitation ,nothing in this section shall be construed as providing the ,secretary authority to increase fines under section #acdaj1 or the length1 extent or quantity of audits under section #acdaa1 due to a lack of compliance with the recognized security practices4 7#c7 ,no liability for nonparticipation ,subject to paragraph 7#d71 nothing in this section shall be construed to subject a covered entity or business associate to liability for electing not to engage in the recognized security practices defined by this section4 7#d7 ,rule of construction ,nothing in this section shall be construed to limit the ,secretary's authority to enforce the ,,hipaa ,security rule 7part #afj of title #de ,code of ,federal ,regulations and subparts ,a and ,c of part #afd of such title71 or to supersede or conflict with an entity or business associate's obligations under the ,,hipaa ,security rule4 4 #ejc4 ,,gao study on the privacy and security risks of electronic transmission of individually identifiable health information to and from entities not covered by the ,health ,insurance ,portability and ,accountability ,act 7a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct a study to-- 7#a7 describe the roles of ,federal agencies and the private sector with respect to protecting the privacy and security of individually identifiable health information transmitted electronically to and from entities not covered by the regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note72 7#b7 identify recent developments regarding the use of application programming interfaces to access individually identifiable health information1 and implications for the privacy and security of such information2 7#c7 identify practices in the private sector1 such as terms and conditions for use1 relating to the privacy1 disclosure1 and secondary uses of individually identifiable health information transmitted electronically to or from entities1 selected by an individual1 that are not subject to the regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif2 and 7#d7 identify steps the public and private sectors can take to improve the private and secure access to and availability of individually identifiable health information4 7b7 ,report ,not later than #a year after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report concerning the findings of the study conducted under subsection 7a74 #ejd4 ,technical corrections 7a7 ,in general ,section #cjbb7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#eb7;b77 is amended by adding at the end the following new paragraph3 7#d7 ,application of authorities under ,inspector ,general ,act of #aigh ,in carrying out this subsection1 the ,inspector ,general shall have the same authorities as provided under section #f of the ,inspector ,general ,act of #aigh 7#e ,u4,s4,c4 ,app474 4 7b7 ,effective date ,the amendment made by subsection 7a7 shall take effect as if included in the enactment of the #bast ,century ,cures ,act 7,public ,law #aad-bee74 #eje4 ,public meeting 7a7 ,in general ,not later than #ahj days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall convene a public meeting for purposes of discussing and providing input on patient-matching metrics for the purpose of enabling interoperability and the exchange of health information across health care organizations4 7b7 ,experts ,the public meeting under this section may include-- 7#a7 representatives of relevant ,federal agencies 7including representatives from the ,office of the ,national ,coordinator for ,health ,information ,technology72 7#b7 ,state1 local1 ,tribal1 and territorial public health officials2 7#c7 stakeholders with expertise in health information exchange2 7#d7 stakeholders with expertise in capabilities relevant to patient matching1 such as experts in informatics and data analytics2 7#e7 stakeholders affected by record-matching 7including patients1 hospitals1 health systems1 payers1 health information exchanges1 and prescription drug monitoring programs72 and 7#f7 other representatives1 as the ,secretary determines appropriate4 7c7 ,topics ,such public meeting shall include a discussion of-- 7#a7 standards and processes for assessing the accuracy of patient-matching algorithms2 7#b7 performance metrics for health care providers purchasing patient-matching technology and algorithm developers2 7#c7 the development of benchmarks for the accuracy of patient-matching algorithms2 7#d7 considerations for ,state1 local1 ,tribal1 and territorial capabilities and infrastructure related to data exchange1 interoperability1 and matching patient records2 7#e7 opportunities for the incorporation of innovative technologies to improve patient matching2 and 7#f7 privacy and security protections4 ,july #h1 #bjai,reported with an amendment