,,ii #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 ,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