,,ib ,union ,calendar ,no4 #ghf #aahth ,,congress #b;d ,session ,h4 ,r4 #hbfa ,report ,no4 #aah-hia1 ,part ,i ,,in ,,the ,,house ,,of ,,representatives ,may #g1 #bjbd ,mr4 ,schweikert 7for himself and ,mr4 ,thompson of ,california7 introduced the following bill2 which was referred to the ,committee on ,ways and ,means1 and in addition to the ,committee on ,energy and ,commerce1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,december #ag1 #bjbd ,reported from the ,committee on ,ways and ,means with an amendment ,strike out all after the enacting clause and insert the part printed in italic ,december #ag1 #bjbd ,referral to the ,committee on ,energy and ,commerce extended for a period ending not later than ,december #ai1 #bjbd ,december #ai1 #bjbd ,committee on ,energy and ,commerce discharged2 committed to the ,committee of the ,whole ,house on the ,state of the ,union and ordered to be printed ,for text of introduced bill1 see copy of bill as introduced on ,may #g1 #bjbd ,a ,,bill ,to amend title ,,xviii of the ,social ,security ,act to extend certain flexibilities and payment adjustments under the ,medicare program1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,preserving ,telehealth1 ,hospital1 and ,ambulance ,access ,act4 ,i ,preserving ,patients' ,access to ,care in the ,home #aja4 ,extension of certain telehealth flexibilities 7a7 ,removing geographic requirements and expanding originating sites for telehealth services ,section #ahcd7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77 is amended-- 7#a7 in paragraph 7#b77;,b77iii71 by striking ending ,december #ca1 #bjbd and inserting ending ,december #ca1 #bjbf2 and 7#b7 in paragraph 7#d77;,c77iii71 by striking ending on ,december #ca1 #bjbd and inserting ending on ,december #ca1 #bjbf4 7b7 ,expanding practitioners eligible to furnish telehealth services ,section #ahcd7m77#d77;,e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#d77;,e77 is amended by striking ending on ,december #ca1 #bjbd and inserting ending on ,december #ca1 #bjbf4 7c7 ,extending telehealth services for federally qualified health centers and rural health clinics ,section #ahcd7m77#h77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#h77;,a77 is amended by striking ending on ,december #ca1 #bjbd and inserting ending on ,december #ca1 #bjbf4 7d7 ,delaying the in-person requirements under medicare for mental health services furnished through telehealth and telecommunications technology 7#a7 ,delay in requirements for mental health services furnished through telehealth ,section #ahcd7m77#g77;,b77i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#g77;,b77i77 is amended1 in the matter preceding subclause 7,i71 by striking on or after and all that follows through described in section #aace7;g77#a77;,b77 and inserting on or after ,january #a1 #bjbg4 7#b7 ,mental health visits furnished by rural health clinics ,section #ahcd7y77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7y77#b77 is amended by striking ,january #a1 #bjbe and all that follows through the period at the end and inserting ,january #a1 #bjbg44 7#c7 ,mental health visits furnished by ,federally qualified health centers ,section #ahcd7o77#d77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7o77#d77;,b77 is amended by striking ,january #a1 #bjbe and all that follows through the period at the end and inserting ,january #a1 #bjbg44 7e7 ,allowing for the furnishing of audio-only telehealth services ,section #ahcd7m77#i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77#i77 is amended by striking ending on ,december #ca1 #bjbd and inserting ending on ,december #ca1 #bjbf4 7f7 ,extending use of telehealth to conduct face-to-face encounter prior to recertification of eligibility for hospice care ,section #ahad7;a77#g77;,d77i77,,ii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;f7a77#g77;,d77i77,,ii77 is amended-- 7#a7 by striking ending on ,december #ca1 #bjbd and inserting ending on ,december #ca1 #bjbf2 and 7#b7 by inserting 1 except that this subclause shall not apply in the case of such an encounter with an individual occurring on or after ,january #a1 #bjbe1 if such individual is located in an area that is subject to a moratorium on the enrollment of hospice programs under this title pursuant to section #ahff7;j77#g71 if such individual is receiving hospice care from a provider that is subject to enhanced oversight under this title pursuant to section #ahff7;j77#c71 or if such encounter is performed by a hospice physician or nurse practitioner who is not enrolled under section #ahff7;j7 and is not an opt-out physician or practitioner 7as defined in section #ahjb7;b77#f77;,d77 before the semicolon4 7g7 ,program instruction authority ,the ,secretary of ,health and ,human ,services may implement the amendments made by this section through program instruction or otherwise4 #ajb4 ,guidance on furnishing services via telehealth to individuals with limited ,english proficiency 7a7 ,in general ,not later than #a year after the date of the enactment of this section1 the ,secretary of ,health and ,human ,services1 in consultation with #a or more entities from each of the categories described in paragraphs 7#a7 through 7#g7 of subsection 7b71 shall issue and disseminate1 or update and revise as applicable1 guidance for the entities described in such subsection on the following3 7#a7 ,best practices on facilitating and integrating use of interpreters during a telemedicine appointment4 7#b7 ,best practices on providing accessible instructions on how to access telecommunications systems 7as such term is used for purposes of section #ahcd7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77 for individuals with limited ,english proficiency4 7#c7 ,best practices on improving access to digital patient portals for individuals with limited ,english proficiency4 7#d7 ,best practices on integrating the use of video platforms that enable multi-person video calls furnished via a telecommunications system for purposes of providing interpretation during a telemedicine appointment for an individual with limited ,english proficiency4 7#e7 ,best practices for providing patient materials1 communications1 and instructions in multiple languages1 including text message appointment reminders and prescription information4 7b7 ,entities described ,for purposes of subsection 7a71 an entity described in this subsection is an entity in #a or more of the following categories3 7#a7 ,health information technology service providers1 including-- 7,a7 electronic medical record companies2 7,b7 remote patient monitoring companies2 and 7,c7 telehealth or mobile health vendors and companies4 7#b7 ,health care providers1 including-- 7,a7 physicians2 and 7,b7 hospitals4 7#c7 ,health insurers4 7#d7 ,language service companies4 7#e7 ,interpreter or translator professional associations4 7#f7 ,health and language services quality certification organizations4 7#g7 ,patient and consumer advocates1 including such advocates that work with individuals with limited ,english proficiency4 #ajc4 ,establishment of modifier for recertifications of hospice care eligibility conducted through telehealth ,section #ahad7;a77#g77;,d77i77,,ii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;f7a77#g77;,d77i77,,ii771 as amended by section #aja7;f71 is further amended by inserting 1 provided that1 in the case of such an encounter occurring on or after the date that is #b years after the date of the enactment of the ,preserving ,telehealth1 ,hospital1 and ,ambulance ,access ,act1 such physician or nurse practitioner includes in any claim for such encounter one or more modifiers or codes specified by the ,secretary to indicate that such encounter was furnished through telehealth after as determined appropriate by the ,secretary4 #ajd4 ,extending acute hospital care at home waiver flexibilities ,section #ahff;,g of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;cc-#g7 is amended-- 7#a7 in subsection 7a77#a71 by striking #bjbd and inserting #bjbi2 and 7#b7 in subsection 7b7-- 7,a7 in the header1 by striking ,study and report and inserting ,studies and reports2 7,b7 in paragraph 7#a7-- 7i7 in the matter preceding subparagraph 7,a71 by striking ,the ,secretary and inserting ,not later than ,september #cj1 #bjbd1 and again not later than ,september #cj1 #bjbh1 the ,secretary2 7ii7 in clause 7iv71 by striking and at the end2 7iii7 in clause 7v71 by striking the period and inserting 2 and2 and 7iv7 by adding at the end the following new clause3 7vi7 in the case of the second study conducted under this paragraph1 the quality of care1 outcomes1 costs1 quantity and intensity of services1 and other relevant metrics between individuals who entered into the ,acute ,hospital ,care at ,home initiative directly from an emergency department compared with individuals who entered into the ,acute ,hospital ,care at ,home initiative directly from an existing inpatient stay in a hospital4 2 and 7,c7 in paragraph 7#b7-- 7i7 in the header1 by striking ,report and inserting ,reports2 and 7ii7 by inserting and again not later than ,september #cj1 #bjbh1 after #bjbd12 and 7iii7 by striking on the study conducted under paragraph 7#a74 and inserting the following3 on-- 7,a7 with respect to the first report submitted under this paragraph1 the first study conducted under paragraph 7#a72 and 7,b7 with respect to the second report submitted under this paragraph1 the second study conducted under paragraph 7#a74 4 #aje4 ,report on wearable medical devices ,not later than #ah months after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct a technology assessment of1 and submit to ,congress a report on1 the capabilities and limitations of wearable medical devices used to support clinical decision-making4 ,such report shall include a description of-- 7#a7 the potential for such devices to accurately prescribe treatments2 7#b7 an examination of the benefits and challenges of artificial intelligence to augment such capabilities2 and 7#c7 policy options to enhance the benefits and mitigate potential challenges of developing or using such devices4 #ajf4 ,enhancing certain program integrity requirements for ,,dme under ,medicare 7a7 ,durable medical equipment ,section #ahcd7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7a77 is amended by adding at the end the following new paragraph3 7#bc7 ,master ,list inclusion and claim review for certain items 7,a7 ,master ,list inclusion ,beginning ,january #a1 #bjbg1 for purposes of the ,master ,list described in section #dad4bcd7;b7 of title #db1 ,code of ,federal ,regulations 7or any successor regulation71 an item for which payment may be made under this subsection shall be treated as having aberrant billing patterns 7as such term is used for purposes of such section7 if the ,secretary determines that1 without explanatory contributing factors 7such as furnishing emergent care services71 a substantial number of claims for such items under this subsection are from an ordering physician or practitioner with whom the individual involved does not have a prior relationship1 as determined on the basis of claims4 7,b7 ,claim review ,with respect to items furnished on or after ,january #a1 #bjbg that are included on the ,master ,list pursuant to subparagraph 7,a71 if such an item is not subject to a determination of coverage in advance pursuant to paragraph 7#ae77;,c71 the ,secretary may conduct prepayment review of claims for payment for such item4 4 7b7 ,report on identifying clinical diagnostic laboratory tests at high risk for fraud and effective mitigation measures ,not later than ,january #a1 #bjbf1 the ,inspector ,general of the ,department of ,health and ,human ,services shall submit to ,congress a report assessing fraudulent claims for clinical diagnostic laboratory tests for which payment may be made under section #ahcd;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a7 and effective tools for reducing such fraudulent claims4 ,the report shall include-- 7#a7 which1 if any1 clinical diagnostic laboratory tests are identified as being at high risk of fraudulent claims1 and an analysis of the factors that contribute to such risk2 7#b7 with respect to a clinical diagnostic laboratory test identified under subparagraph 7,a7 as being at high risk of fraudulent claims-- 7,a7 the amount payable under such section #ahcd;,a with respect to such test2 7,b7 the number of such tests furnished to individuals enrolled under part ,b of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;j et seq472 7,c7 whether an order for such a test was more likely to come from a provider with whom the individual involved did not have a prior relationship1 as determined on the basis of prior payment experience2 and 7,d7 the frequency with which a claim for payment under such section #ahcd;,a included the payment modifier identified by code #ei or #ia2 and 7#c7 suggested strategies for reducing the number of fraudulent claims made with respect to tests so identified as being at high risk1 including-- 7,a7 an analysis of whether the ,centers for ,medicare ,medicaid ,services can detect aberrant billing patterns with respect to such tests in a timely manner2 7,b7 any strategies for identifying and monitoring the providers who are outliers with respect to the number of such tests that such providers order2 and 7,c7 targeted education efforts to mitigate improper billing for such tests4 ,,ii ,sustaining ,access to ,hospital and ,emergency ,services #bja4 ,extension of increased inpatient hospital payment adjustment for certain low-volume hospitals 7a7 ,in general ,section #ahhf7;d77#ab7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#ab77 is amended-- 7#a7 in subparagraph 7,b71 by striking during the portion of fiscal year #bjbe beginning on ,january #a1 #bjbe1 and ending on ,september #cj1 #bjbe1 and2 7#b7 in subparagraph 7,c77i7-- 7,a7 in the matter preceding subclause 7,i7-- 7i7 by striking or portion of a fiscal year2 and 7ii7 by striking #bjbd and the portion of fiscal year #bjbe beginning on ,october #a1 #bjbd1 and ending on ,december #ca1 #bjbd and inserting #bjbe2 7,b7 in subclause 7,,iii71 by striking #bjbd and the portion of fiscal year #bjbe beginning on ,october #a1 #bjbd1 and ending on ,december #ca1 #bjbd and inserting #bjbe2 and 7,c7 in subclause 7,,iv71 by striking the portion of fiscal year #bjbe beginning on ,january #a1 #bjbe1 and ending on ,september #cj1 #bjbe1 and2 and 7#c7 in subparagraph 7,d7-- 7,a7 in the matter preceding clause 7i71 by striking #bjbd or during the portion of fiscal year #bjbe beginning on ,october #a1 #bjbd1 and ending on ,december #ca1 #bjbd and inserting #bjbe2 and 7,b7 in clause 7ii71 by striking #bjbd and the portion of fiscal year #bjbe beginning on ,october #a1 #bjbd1 and ending on ,december #ca1 #bjbd and inserting #bjbe4 7b7 ,implementation ,notwithstanding any other provision of law1 the ,secretary of ,health and ,human ,services may implement the provisions of1 including the amendments made by1 this section by program instruction or otherwise4 #bjb4 ,extension of the ,medicare-dependent hospital program 7a7 ,in general ,section #ahhf7;d77#e77;,g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77;,g77 is amended-- 7#a7 in clause 7i71 by striking ,january #a1 #bjbe and inserting ,october #a1 #bjbe2 and 7#b7 in clause 7ii77,,ii71 by striking ,january #a1 #bjbe and inserting ,october #a1 #bjbe4 7b7 ,conforming amendments 7#a7 ,extension of target amount ,section #ahhf7;b77#c77;,d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7b77#c77;,d77 is amended-- 7,a7 in the matter preceding clause 7i71 by striking ,january #a1 #bjbe and inserting ,october #a1 #bjbe2 and 7,b7 in clause 7iv71 by striking #bjbd and the portion of fiscal year #bjbe beginning on ,october #a1 #bjbd1 and ending on ,december #ca1 #bjbd and inserting #bjbe4 7#b7 ,permitting hospitals to decline reclassification ,section #aceja7;e77#b7 of the ,omnibus ,budget ,reconciliation ,act of #aiic 7#db ,u4,s4,c4 #acieww note7 is amended by striking #bjbd1 or the portion of fiscal year #bjbe beginning on ,october #a1 #bjbd1 and ending on ,december #ca1 #bjbd and inserting #bjbe4 #bjc4 ,extension of add-on payments for ambulance services 7a7 ,in general ,section #ahcd7l7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7l77 is amended-- 7#a7 in paragraph 7#ab77;,a71 by striking ,january #a1 #bjbe and inserting ,october #a1 #bjbe2 and 7#b7 in paragraph 7#ac71 by striking ,january #a1 #bjbe in each place it appears and inserting ,october #a1 #bjbe in each such place4 7b7 ,program instruction authority ,notwithstanding any other provision of law1 the ,secretary of ,health and ,human ,services may implement the provisions of1 including amendments made by1 this section through program instruction or otherwise4 ,,iii ,offsets #cja4 ,revising phase-in of ,medicare clinical laboratory test payment changes 7a7 ,revised phase-in of reductions from private payor rate implementation ,section #ahcd;,a7b77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a7;b77#c77 is amended-- 7#a7 in subparagraph 7,a71 by striking #bjbg and inserting #bjbh2 and 7#b7 in subparagraph 7,b7-- 7,a7 in clause 7ii71 by striking #bjbd and inserting #bjbe2 and 7,b7 in clause 7iii71 by striking #bjbe through #bjbg and inserting #bjbf through #bjbh4 7b7 ,revised reporting period for reporting of private sector payment rates for establishment of ,medicare payment rates ,section #ahcd;,a7a77#a77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem-#a7;a77#a77;,b77 is amended-- 7#a7 in clause 7i71 by striking #bjbd and inserting #bjbe2 and 7#b7 in clause 7ii71 by striking #bjbe each place it appears and inserting #bjbf4 7c7 ,implementation ,the ,secretary of ,health and ,human ,services may implement the amendments made by this section by program instruction or otherwise4 #cjb4 ,arrangements with pharmacy benefit managers with respect to prescription drug plans and ,,ma-,,pd plans 7a7 ,in general 7#a7 ,prescription drug plans ,section #ahfj;,d-#ab of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7 is amended by adding at the end the following new subsection3 7h7 ,requirements relating to pharmacy benefit managers ,for plan years beginning on or after ,january #a1 #bjbg3 7#a7 ,agreements with pharmacy benefit managers ,each contract entered into with a ,,pdp sponsor under this part with respect to a prescription drug plan offered by such sponsor shall provide that any pharmacy benefit manager acting on behalf of such sponsor has a written agreement with the ,,pdp sponsor under which the pharmacy benefit manager1 and any affiliates of such pharmacy benefit manager1 as applicable1 agree to meet the following requirements3 7,a7 ,no income other than bona fide service fees 7i7 ,in general ,the pharmacy benefit manager and any affiliate of such pharmacy benefit manager shall not derive any remuneration with respect to any services provided on behalf of any entity or individual1 in connection with the utilization of covered part ,d drugs1 from any such entity or individual other than bona fide service fees1 subject to clauses 7ii7 and 7iii74 7ii7 ,incentive payments ,for the purposes of this subsection1 an incentive payment paid by a ,,pdp sponsor to a pharmacy benefit manager that is performing services on behalf of such sponsor shall be deemed a bona fide service fee7even if such payment does not otherwise meet the definition of such term under paragraph 7#g77;,b77 if such payment is a flat dollar amount1 is consistent with fair market value 7as specified by the ,secretary71 is related to services actually performed by the pharmacy benefit manager or affiliate of such pharmacy benefit manager1 on behalf of the entity making such payment1 in connection with the utilization of covered part ,d drugs1 and meets additional requirements1 if any1 as determined appropriate by the ,secretary4 7iii7 ,clarification on rebates and discounts used to lower costs for covered part d drugs ,rebates1 discounts1 and other price concessions received by a pharmacy benefit manager or an affiliate of a pharmacy benefit manager from manufacturers1 even if such price concessions are calculated as a percentage of a drug's price1 shall not be considered a violation of the requirements of clause 7i7 if they are fully passed through to a ,,pdp sponsor and are compliant with all regulatory and subregulatory requirements related to direct and indirect remuneration for manufacturer rebates under this part1 including in cases where a ,,pdp sponsor is acting as a pharmacy benefit manager on behalf of a prescription drug plan offered by such ,,pdp sponsor4 7iv7 ,evaluation of remuneration arrangements ,components of subsets of remuneration arrangements 7such as fees or other forms of compensation paid to or retained by the pharmacy benefit manager or affiliate of such pharmacy benefit manager71 as determined appropriate by the ,secretary1 between pharmacy benefit managers or affiliates of such pharmacy benefit managers1 as applicable1 and other entities involved in the dispensing or utilization of covered part ,d drugs 7including ,,pdp sponsors1 manufacturers1 pharmacies1 and other entities as determined appropriate by the ,secretary7 shall be subject to review by the ,secretary1 in consultation with the ,office of the ,inspector ,general of the ,department of ,health and ,human ,services1 as determined appropriate by the ,secretary4 ,the ,secretary1 in consultation with the ,office of the ,inspector ,general1 shall review whether remuneration under such arrangements is consistent with fair market value 7as specified by the ,secretary7 through reviews and assessments of such remuneration1 as determined appropriate4 7v7 ,disgorgement ,the pharmacy benefit manager shall disgorge any remuneration paid to such pharmacy benefit manager or an affiliate of such pharmacy benefit manager in violation of this subparagraph to the ,,pdp sponsor4 7vi7 ,additional requirements ,the pharmacy benefit manager shall-- 7,i7 enter into a written agreement with any affiliate of such pharmacy benefit manager1 under which the affiliate shall identify and disgorge any remuneration described in clause 7v7 to the pharmacy benefit manager2 and 7,,ii7 attest1 subject to any requirements determined appropriate by the ,secretary1 that the pharmacy benefit manager has entered into a written agreement described in subclause 7,i7 with any relevant affiliate of the pharmacy benefit manager4 7,b7 ,transparency regarding guarantees and cost performance evaluations ,the pharmacy benefit manager shall-- 7i7 define1 interpret1 and apply1 in a fully transparent and consistent manner for purposes of calculating or otherwise evaluating pharmacy benefit manager performance against pricing guarantees or similar cost performance measurements related to rebates1 discounts1 price concessions1 or net costs1 terms such as-- 7,i7 generic drug1 in a manner consistent with the definition of the term under section #dbc4d of title #db1 ,code of ,federal ,regulations1 or a successor regulation2 7,,ii7 brand name drug1 in a manner consistent with the definition of the term under section #dbc4d of title #db1 ,code of ,federal ,regulations1 or a successor regulation2 7,,iii7 specialty drug2 7,,iv7 rebate2 and 7,v7 discount2 7ii7 identify any drugs1 claims1 or price concessions excluded from any pricing guarantee or other cost performance calculation or evaluation in a clear and consistent manner2 and 7iii7 where a pricing guarantee or other cost performance measure is based on a pricing benchmark other than the wholesale acquisition cost 7as defined in section #ahdg;,a7c77#f77;,b77 of a drug1 calculate and provide a wholesale acquisition cost-based equivalent to the pricing guarantee or other cost performance measure in the written agreement4 7,c7 ,provision of information 7i7 ,in general ,not later than ,july #a of each year1 beginning in #bjbg1 the pharmacy benefit manager shall submit to the ,,pdp sponsor1 and to the ,secretary1 a report1 in accordance with this subparagraph1 and shall make such report available to such sponsor at no cost to such sponsor in a format specified by the ,secretary under paragraph 7#e74 ,each such report shall include1 with respect to such ,,pdp sponsor and each plan offered by such sponsor1 the following information with respect to the previous plan year3 7,i7 ,a list of all drugs covered by the plan that were dispensed including1 with respect to each such drug-- 7aa7 the brand name1 generic or non-proprietary name1 and ,national ,drug ,code2 7bb7 the number of plan enrollees for whom the drug was dispensed1 the total number of prescription claims for the drug 7including original prescriptions and refills1 counted as separate claims71 and the total number of dosage units of the drug dispensed2 7cc7 the number of prescription claims described in item 7bb7 by each type of dispensing channel through which the drug was dispensed1 including retail1 mail order1 specialty pharmacy1 long term care pharmacy1 home infusion pharmacy1 or other types of pharmacies or providers2 7dd7 the average wholesale acquisition cost1 listed as cost per day's supply1 cost per dosage unit1 and cost per typical course of treatment 7as applicable72 7ee7 the average wholesale price for the drug1 listed as cost per day's supply1 cost per dosage unit1 and cost per typical course of treatment 7as applicable72 7ff7 the total out-of-pocket spending by plan enrollees on such drug after application of any benefits under the plan1 including plan enrollee spending through copayments1 coinsurance1 and deductibles2 7gg7 total rebates paid by the manufacturer on the drug as reported under the ,detailed ,,dir ,report 7or any successor report7 submitted by such sponsor to the ,centers for ,medicare ,medicaid ,services2 7hh7 all other direct or indirect remuneration on the drug as reported under the ,detailed ,,dir ,report 7or any successor report7 submitted by such sponsor to the ,centers for ,medicare ,medicaid ,services2 7ii7 the average pharmacy reimbursement amount paid by the plan for the drug in the aggregate and disaggregated by dispensing channel identified in item 7cc72 7jj7 the average ,national ,average ,drug ,acquisition ,cost 7,,nadac72 and 7kk7 total manufacturer-derived revenue1 inclusive of bona fide service fees1 attributable to the drug and retained by the pharmacy benefit manager and any affiliate of such pharmacy benefit manager4 7,,ii7 ,in the case of a pharmacy benefit manager that has an affiliate that is a retail1 mail order1 or specialty pharmacy1 with respect to drugs covered by such plan that were dispensed1 the following information3 7aa7 ,the percentage of total prescriptions that were dispensed by pharmacies that are an affiliate of the pharmacy benefit manager for each drug4 7bb7 ,the interquartile range of the total combined costs paid by the plan and plan enrollees1 per dosage unit1 per course of treatment1 per #cj-;day supply1 and per #ij-;day supply for each drug dispensed by pharmacies that are not an affiliate of the pharmacy benefit manager and that are included in the pharmacy network of such plan4 7cc7 ,the interquartile range of the total combined costs paid by the plan and plan enrollees1 per dosage unit1 per course of treatment1 per #cj-;day supply1 and per #ij-;day supply for each drug dispensed by pharmacies that are an affiliate of the pharmacy benefit manager and that are included in the pharmacy network of such plan4 7dd7 ,the lowest total combined cost paid by the plan and plan enrollees1 per dosage unit1 per course of treatment1 per #cj-;day supply1 and per #ij-;day supply1 for each drug that is available from any pharmacy included in the pharmacy network of such plan4 7ee7 ,the difference between the average acquisition cost of the affiliate1 such as a pharmacy or other entity that acquires prescription drugs1 that initially acquires the drug and the amount reported under subclause 7,i77jj7 for each drug4 7ff7 ,a list inclusive of the brand name1 generic or non-proprietary name1 and ,national ,drug ,code of covered part ,d drugs subject to an agreement with a covered entity under section #cdj;,b of the ,public ,health ,service ,act for which the pharmacy benefit manager or an affiliate of the pharmacy benefit manager had a contract or other arrangement with such a covered entity in the service area of such plan4 7,,iii7 ,where a drug approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7referred to in this subclause as the listed drug7 is covered by the plan1 the following information3 7aa7 ,a list of currently marketed generic drugs approved under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act pursuant to an application that references such listed drug that are not covered by the plan1 are covered on the same formulary tier or a formulary tier typically associated with higher cost-sharing than the listed drug1 or are subject to utilization management that the listed drug is not subject to4 7bb7 ,the estimated average beneficiary cost-sharing under the plan for a #cj-;day supply of the listed drug4 7cc7 ,where a generic drug listed under item 7aa7 is on a formulary tier typically associated with higher cost-sharing than the listed drug1 the estimated average cost-sharing that a beneficiary would have paid for a #cj-;day supply of each of the generic drugs described in item 7aa71 had the plan provided coverage for such drugs on the same formulary tier as the listed drug4 7dd7 ,a written justification for providing more favorable coverage of the listed drug than the generic drugs described in item 7aa74 7ee7 ,the number of currently marketed generic drugs approved under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act pursuant to an application that references such listed drug4 7,,iv7 ,where a reference product 7as defined in section #cea7;i7 of the ,public ,health ,service ,act7 is covered by the plan1 the following information3 7aa7 ,a list of currently marketed biosimilar biological products licensed under section #cea7k7 of the ,public ,health ,service ,act pursuant to an application that refers to such reference product that are not covered by the plan1 are covered on the same formulary tier or a formulary tier typically associated with higher cost-sharing than the reference product1 or are subject to utilization management that the reference product is not subject to4 7bb7 ,the estimated average beneficiary cost-sharing under the plan for a #cj-;day supply of the reference product4 7cc7 ,where a biosimilar biological product listed under item 7aa7 is on a formulary tier typically associated with higher cost-sharing than the listed drug1 the estimated average cost-sharing that a beneficiary would have paid for a #cj-;day supply of each of the biosimilar biological products described in item 7aa71 had the plan provided coverage for such products on the same formulary tier as the reference product4 7dd7 ,a written justification for providing more favorable coverage of the reference product than the biosimilar biological product described in item 7aa74 7ee7 ,the number of currently marketed biosimilar biological products licensed under section #cea7k7 of the ,public ,health ,service ,act1 pursuant to an application that refers to such reference product4 7,v7 ,total gross spending on covered part ,d drugs by the plan1 not net of rebates1 fees1 discounts1 or other direct or indirect remuneration4 7,,vi7 ,the total amount retained by the pharmacy benefit manager or an affiliate of such pharmacy benefit manager in revenue related to utilization of covered part ,d drugs under that plan1 inclusive of bona fide service fees4 7,,vii7 ,the total spending on covered part ,d drugs net of rebates1 fees1 discounts1 or other direct and indirect remuneration by the plan4 7,,viii7 ,an explanation of any benefit design parameters under such plan that encourage plan enrollees to fill prescriptions at pharmacies that are an affiliate of such pharmacy benefit manager1 such as mail and specialty home delivery programs1 and retail and mail auto-refill programs4 7,,ix7 ,the following information3 7aa7 ,a list of all brokers1 consultants1 advisors1 and auditors that receive compensation from the pharmacy benefit manager or an affiliate of such pharmacy benefit manager for referrals1 consulting1 auditing1 or other services offered to ,,pdp sponsors related to pharmacy benefit management services4 7bb7 ,the amount of compensation provided by such pharmacy benefit manager or affiliate to each such broker1 consultant1 advisor1 and auditor4 7cc7 ,the methodology for calculating the amount of compensation provided by such pharmacy benefit manager or affiliate1 for each such broker1 consultant1 advisor1 and auditor4 7,x7 ,a list of all affiliates of the pharmacy benefit manager4 7,,xi7 ,a summary document submitted in a standardized template developed by the ,secretary that includes such information described in subclauses 7,i7 through 7,x74 7ii7 ,written explanation of contracts or agreements with drug manufacturers 7,i7 ,in general ,the pharmacy benefit manager shall1 not later than #cj days after the finalization of any contract or agreement between such pharmacy benefit manager or an affiliate of such pharmacy benefit manager and a drug manufacturer 7or subsidiary1 agent1 or entity affiliated with such drug manufacturer7 that makes rebates1 discounts1 payments1 or other financial incentives related to one or more covered part ,d drugs or other prescription drugs1 as applicable1 of the manufacturer directly or indirectly contingent upon coverage1 formulary placement1 or utilization management conditions on any other covered part ,d drugs or other prescription drugs1 as applicable1 submit to the ,,pdp sponsor a written explanation of such contract or agreement4 7,,ii7 ,requirements ,a written explanation under subclause 7,i7 shall-- 7aa7 include the manufacturer subject to the contract or agreement1 all covered part ,d drugs and other prescription drugs1 as applicable1 subject to the contract or agreement and the manufacturers of such drugs1 and a high-level description of the terms of such contract or agreement and how such terms apply to such drugs2 and 7bb7 be certified by the ,chief ,executive ,officer1 ,chief ,financial ,officer1 or ,general ,counsel of such pharmacy benefit manager1 or affiliate of such pharmacy benefit manager1 as applicable1 or an individual delegated with the authority to sign on behalf of one of these officers1 who reports directly to the officer4 7,,iii7 ,definition of other prescription drugs ,for purposes of this clause1 the term other prescription drugs means prescription drugs covered as supplemental benefits under this part or prescription drugs paid outside of this part4 7,d7 ,audit rights 7i7 ,in general ,not less than once a year1 at the request of the ,,pdp sponsor1 the pharmacy benefit manager shall allow for an audit of the pharmacy benefit manager to ensure compliance with all terms and conditions under the written agreement and the accuracy of information reported under subparagraph 7,c74 7ii7 ,auditor ,the ,,pdp sponsor shall have the right to select an auditor4 ,the pharmacy benefit manager shall not impose any limitations on the selection of such auditor4 7iii7 ,provision of information ,the pharmacy benefit manager shall make available to such auditor all records1 data1 contracts1 and other information necessary to confirm the accuracy of information provided under subparagraph 7,c71 subject to reasonable restrictions on how such information must be reported to prevent redisclosure of such information4 7iv7 ,timing ,the pharmacy benefit manager must provide information under clause 7iii7 and other information1 data1 and records relevant to the audit to such auditor within #f months of the initiation of the audit and respond to requests for additional information from such auditor within #cj days after the request for additional information4 7v7 ,information from affiliates ,the pharmacy benefit manager shall be responsible for providing to such auditor information required to be reported under subparagraph 7,c7 that is owned or held by an affiliate of such pharmacy benefit manager4 7#b7 ,enforcement 7,a7 ,in general ,each ,,pdp sponsor shall-- 7i7 disgorge to the ,secretary any amounts disgorged to the ,,pdp sponsor by a pharmacy benefit manager under paragraph 7#a77;,a77v72 7ii7 require1 in a written agreement with any pharmacy benefit manager acting on behalf of such sponsor or affiliate of such pharmacy benefit manager1 that such pharmacy benefit manager or affiliate reimburse the ,,pdp sponsor for any civil money penalty imposed on the ,,pdp sponsor as a result of the failure of the pharmacy benefit manager or affiliate to meet the requirements of paragraph 7#a7 that are applicable to the pharmacy benefit manager or affiliate under the agreement2 and 7iii7 require1 in a written agreement with any such pharmacy benefit manager acting on behalf of such sponsor or affiliate of such pharmacy benefit manager1 that such pharmacy benefit manager or affiliate be subject to punitive remedies for breach of contract for failure to comply with the requirements applicable under paragraph 7#a74 7,b7 ,reporting of alleged violations ,the ,secretary shall make available and maintain a mechanism for manufacturers1 ,,pdp sponsors1 pharmacies1 and other entities that have contractual relationships with pharmacy benefit managers or affiliates of such pharmacy benefit managers to report1 on a confidential basis1 alleged violations of paragraph 7#a77;,a7 or subparagraph 7,c74 7,c7 ,anti-retaliation and anti-coercion ,consistent with applicable ,federal or ,state law1 a ,,pdp sponsor shall not-- 7i7 retaliate against an individual or entity for reporting an alleged violation under subparagraph 7,b72 or 7ii7 coerce1 intimidate1 threaten1 or interfere with the ability of an individual or entity to report any such alleged violations4 7#c7 ,certification of compliance 7,a7 ,in general ,each ,,pdp sponsor shall furnish to the ,secretary 7in a time and manner specified by the ,secretary7 an annual certification of compliance with this subsection1 as well as such information as the ,secretary determines necessary to carry out this subsection4 7,b7 ,implementation ,notwithstanding any other provision of law1 the ,secretary may implement this paragraph by program instruction or otherwise4 7#d7 ,rule of construction ,nothing in this subsection shall be construed as prohibiting payments related to reimbursement for ingredient costs to any entity that acquires prescription drugs1 such as a pharmacy or wholesaler4 7#e7 ,standard formats 7,a7 ,in general ,not later than ,june #a1 #bjbf1 the ,secretary shall specify standard1 machine-readable formats for pharmacy benefit managers to submit annual reports required under paragraph 7#a77;,c77i74 7,b7 ,implementation ,notwithstanding any other provision of law1 the ,secretary may implement this paragraph by program instruction or otherwise4 7#f7 ,confidentiality 7,a7 ,in general ,information disclosed by a pharmacy benefit manager1 an affiliate of a pharmacy benefit manager1 a ,,pdp sponsor1 or a pharmacy under this subsection that is not otherwise publicly available or available for purchase shall not be disclosed by the ,secretary or a ,,pdp sponsor receiving the information1 except that the ,secretary may disclose the information for the following purposes3 7i7 ,as the ,secretary determines necessary to carry out this part4 7ii7 ,to permit the ,comptroller ,general to review the information provided4 7iii7 ,to permit the ,director of the ,congressional ,budget ,office to review the information provided4 7iv7 ,to permit the ,executive ,director of the ,medicare ,payment ,advisory ,commission to review the information provided4 7v7 ,to the ,attorney ,general for the purposes of conducting oversight and enforcement under this title4 7vi7 ,to the ,inspector ,general of the ,department of ,health and ,human ,services in accordance with its authorities under the ,inspector ,general ,act of #aigh 7section #djf of title #e1 ,united ,states ,code71 and other applicable statutes4 7,b7 ,restriction on use of information ,the ,secretary1 the ,comptroller ,general1 the ,director of the ,congressional ,budget ,office1 and the ,executive ,director of the ,medicare ,payment ,advisory ,commission shall not report on or disclose information disclosed pursuant to subparagraph 7,a7 to the public in a manner that would identify-- 7i7 a specific pharmacy benefit manager1 affiliate1 pharmacy1 manufacturer1 wholesaler1 ,,pdp sponsor1 or plan2 or 7ii7 contract prices1 rebates1 discounts1 or other remuneration for specific drugs in a manner that may allow the identification of specific contracting parties or of such specific drugs4 7#g7 ,definitions ,for purposes of this subsection3 7,a7 ,affiliate ,the term affiliate means any entity that is owned by1 controlled by1 or related under a common ownership structure with a pharmacy benefit manager or ,,pdp sponsor1 or that acts as a contractor or agent to such pharmacy benefit manager or ,,pdp sponsor1 insofar as such contractor or agent performs any of the functions described under subparagraph 7,c74 7,b7 ,bona fide service fee ,the term bona fide service fee means a fee that is reflective of the fair market value 7as specified by the ,secretary7 for a bona fide1 itemized service actually performed on behalf of an entity1 that the entity would otherwise perform 7or contract for7 in the absence of the service arrangement and that is not passed on in whole or in part to a client or customer1 whether or not the entity takes title to the drug4 ,such fee must be a flat dollar amount and shall not be directly or indirectly based on1 or contingent upon-- 7i7 drug price1 such as wholesale acquisition cost or drug benchmark price 7such as average wholesale price72 7ii7 the amount of discounts1 rebates1 fees1 or other direct or indirect remuneration with respect to covered part ,d drugs dispensed to enrollees in a prescription drug plan1 except as permitted pursuant to paragraph 7#a77;,a77ii72 7iii7 coverage or formulary placement decisions or the volume or value of any referrals or business generated between the parties to the arrangement2 or 7iv7 any other amounts or methodologies prohibited by the ,secretary4 7,c7 ,pharmacy benefit manager ,the term pharmacy benefit manager means any person or entity that1 either directly or through an intermediary1 acts as a price negotiator or group purchaser on behalf of a ,,pdp sponsor or prescription drug plan1 or manages the prescription drug benefits provided by such sponsor or plan1 including the processing and payment of claims for prescription drugs1 the performance of drug utilization review1 the processing of drug prior authorization requests1 the adjudication of appeals or grievances related to the prescription drug benefit1 contracting with network pharmacies1 controlling the cost of covered part ,d drugs1 or the provision of related services4 ,such term includes any person or entity that carries out one or more of the activities described in the preceding sentence1 irrespective of whether such person or entity calls itself a pharmacy benefit manager4 4 7#b7 ,,ma-,,pd plans ,section #aheg7;f77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;f77#c77 is amended by adding at the end the following new subparagraph3 7,f7 ,requirements relating to pharmacy benefit managers ,for plan years beginning on or after ,january #a1 #bjbg1 section #ahfj;,d-#ab7;h74 4 7#c7 ,nonapplication of paperwork reduction act ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to the implementation of this subsection4 7#d7 ,funding 7,a7 ,secretary ,in addition to amounts otherwise available1 there is appropriated to the ,centers for ,medicare ,medicaid ,services ,program ,management ,account1 out of any money in the ,treasury not otherwise appropriated1 #aac1jjj1jjj for fiscal year #bjbe1 to remain available until expended1 to carry out this subsection4 7,b7 ,,oig ,in addition to amounts otherwise available1 there is appropriated to the ,inspector ,general of the ,department of ,health and ,human ,services1 out of any money in the ,treasury not otherwise appropriated1 #bj1jjj1jjj for fiscal year #bjbe1 to remain available until expended1 to carry out this subsection4 7b7 ,,gao study and report on certain reporting requirements 7#a7 ,study ,the ,comptroller ,general of the ,united ,states 7in this subsection referred to as the ,comptroller ,general7 shall conduct a study on ,federal and ,state reporting requirements for health plans and pharmacy benefit managers related to the transparency of prescription drug costs and prices4 ,such study shall include an analysis of the following3 7,a7 ,federal statutory and regulatory reporting requirements for health plans and pharmacy benefit managers related to prescription drug costs and prices4 7,b7 ,selected ,states' statutory and regulatory reporting requirements for health plans and pharmacy benefit managers related to prescription drug costs and prices4 7,c7 ,the extent to which the statutory and regulatory reporting requirements identified in subparagraphs 7,a7 and 7,b7 overlap and conflict4 7,d7 ,the resources required by health plans and pharmacy benefit managers to comply with the reporting requirements described in subparagraphs 7,a7 and 7,b74 7,e7 ,other items determined appropriate by the ,comptroller ,general4 7#b7 ,report ,not later than #b years after the date on which information is first required to be reported under section #ahfj;,d-#ab7;h77#a77;,c7 of the ,social ,security ,act1 as added by subsection 7a77#a71 the ,comptroller ,general shall submit to ,congress a report containing the results of the study conducted under paragraph 7#a71 together with recommendations for legislation and administrative actions that would streamline and reduce the burden associated with the reporting requirements for health plans and pharmacy benefit managers described in paragraph 7#a74 7c7 ,med,p,a,c reports on agreements with pharmacy benefit managers with respect to prescription drug plans and ,,ma-,,pd plans ,the ,medicare ,payment ,advisory ,commission shall submit to ,congress the following reports3 7#a7 ,not later than ,march #ca1 #bjbh1 a report regarding agreements with pharmacy benefit managers with respect to prescription drug plans and ,,ma-,,pd plans4 ,such report shall include-- 7,a7 a description of trends and patterns1 including relevant averages1 totals1 and other figures for each of the types of information submitted2 7,b7 an analysis of any differences in agreements and their effects on plan enrollee out-of-pocket spending and average pharmacy reimbursement1 and any other impacts2 and 7,c7 any recommendations the ,commission determines appropriate4 7#b7 ,not later than ,march #ca1 #bjcj1 a report describing any changes with respect to the information described in paragraph 7#a7 over time1 together with any recommendations the ,commission determines appropriate4 #cjc4 ,extending the adjustment to the calculation of hospice cap amounts under the ,medicare program ,section #ahad7;i77#b77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;f7i77#b77;,b77 is amended-- 7#a7 in clause 7ii71 by striking #bjcc and inserting #bjcd2 and 7#b7 in clause 7iii71 by striking #bjcc and inserting #bjcd4 ,december #ai1 #bjbd ,committee on ,energy and ,commerce discharged2 committed to the ,committee of the ,whole ,house on the ,state of the ,union and ordered to be printed