II 119THCONGRESS 1 STSESSION S. 927 To amend title XIX of the Social Security Act to ensure accurate payments to pharmacies under Medicaid and to prevent the use of abusive spread pricing practices under Medicaid. IN THE SENATE OF THE UNITED STATES MARCH11 (legislative day, MARCH10), 2025 Mr. W ELCH(for himself, Mr. MARSHALL, Mr. WARNER, and Mr. CASSIDY) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend title XIX of the Social Security Act to ensure accurate payments to pharmacies under Medicaid and to prevent the use of abusive spread pricing practices under Medicaid. Be it enacted by the Senate and House of Representa-1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Protecting Pharmacies 4 in Medicaid Act’’. 5 VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS 2 •S 927 IS SEC. 2. ENSURING ACCURATE PAYMENTS TO PHARMACIES 1 UNDER MEDICAID. 2 (a) I NGENERAL.—Section 1927(f) of the Social Se-3 curity Act (42 U.S.C. 1396r–8(f)) is amended— 4 (1) in paragraph (1)(A)— 5 (A) by redesignating clause (ii) as clause 6 (iii); and 7 (B) by striking ‘‘and’’ after the semicolon 8 at the end of clause (i) and all that precedes it 9 through ‘‘(1)’’ and inserting the following: 10 ‘‘(1) D ETERMINING PHARMACY ACTUAL ACQUI -11 SITION COSTS.—The Secretary shall conduct a sur-12 vey of retail community pharmacy drug prices and 13 applicable non-retail pharmacy drug prices to deter-14 mine national average drug acquisition cost bench-15 marks (as such term is defined by the Secretary) as 16 follows: 17 ‘‘(A) U SE OF VENDOR .—The Secretary 18 may contract services for— 19 ‘‘(i) with respect to retail community 20 pharmacies, the determination of retail 21 survey prices of the national average drug 22 acquisition cost for covered outpatient 23 drugs that represent a nationwide average 24 of consumer purchase prices for such 25 drugs, net of all discounts, rebates, and 26 VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS 3 •S 927 IS other price concessions (to the extent any 1 information with respect to such discounts, 2 rebates, and other price concessions is 3 available) based on a monthly survey of 4 such pharmacies; and 5 ‘‘(ii) with respect to applicable non-re-6 tail pharmacies— 7 ‘‘(I) the determination of survey 8 prices, separate from the survey prices 9 described in clause (i), of the non-re-10 tail national average drug acquisition 11 cost for covered outpatient drugs that 12 represent a nationwide average of con-13 sumer purchase prices for such drugs, 14 net of all discounts, rebates, and other 15 price concessions (to the extent any 16 information with respect to such dis-17 counts, rebates, and other price con-18 cessions is available) based on a 19 monthly survey of such pharmacies; 20 and 21 ‘‘(II) at the discretion of the Sec-22 retary, for each type of applicable 23 non-retail pharmacy, the determina-24 tion of survey prices, separate from 25 VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS 4 •S 927 IS the survey prices described in clause 1 (i) or subclause (I) of this clause, of 2 the national average drug acquisition 3 cost for such type of pharmacy for 4 covered outpatient drugs that rep-5 resent a nationwide average of con-6 sumer purchase prices for such drugs, 7 net of all discounts, rebates, and other 8 price concessions (to the extent any 9 information with respect to such dis-10 counts, rebates, and other price con-11 cessions is available) based on a 12 monthly survey of such pharmacies; 13 and’’; 14 (2) in subparagraph (B) of paragraph (1), by 15 striking ‘‘subparagraph (A)(ii)’’ and inserting ‘‘sub-16 paragraph (A)(iii)’’; 17 (3) in subparagraph (D) of paragraph (1), by 18 striking clauses (ii) and (iii) and inserting the fol-19 lowing: 20 ‘‘(ii) The vendor must update the Sec-21 retary no less often than monthly on the 22 survey prices for covered outpatient drugs. 23 ‘‘(iii) The vendor must differentiate, 24 in collecting and reporting survey data, for 25 VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS 5 •S 927 IS all cost information collected, whether a 1 pharmacy is a retail community pharmacy 2 or an applicable non-retail pharmacy, in-3 cluding whether such pharmacy is an affil-4 iate (as defined in subsection (k)(14)), 5 and, in the case of an applicable non-retail 6 pharmacy, which type of applicable non-re-7 tail pharmacy it is using the relevant phar-8 macy type indicators included in the guid-9 ance required by subsection (d)(2) of sec-10 tion 2 of the Protecting Pharmacies in 11 Medicaid Act.’’; 12 (4) by adding at the end of paragraph (1) the 13 following: 14 ‘‘(F) S URVEY REPORTING .—In order to 15 meet the requirement of section 1902(a)(54), a 16 State shall require that any retail community 17 pharmacy or applicable non-retail pharmacy in 18 the State that receives any payment, reimburse-19 ment, administrative fee, discount, rebate, or 20 other price concession related to the dispensing 21 of covered outpatient drugs to individuals re-22 ceiving benefits under this title, regardless of 23 whether such payment, reimbursement, admin-24 istrative fee, discount, rebate, or other price 25 VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS 6 •S 927 IS concession is received from the State or a man-1 aged care entity or other specified entity (as 2 such terms are defined in section 3 1903(m)(9)(D)) directly or from a pharmacy 4 benefit manager or another entity that has a 5 contract with the State or a managed care enti-6 ty or other specified entity (as so defined), shall 7 respond to surveys conducted under this para-8 graph. 9 ‘‘(G) S URVEY INFORMATION .—Information 10 on national drug acquisition prices obtained 11 under this paragraph shall be made publicly 12 available in a form and manner to be deter-13 mined by the Secretary and shall include at 14 least the following: 15 ‘‘(i) The monthly response rate to the 16 survey including a list of pharmacies not in 17 compliance with subparagraph (F). 18 ‘‘(ii) The sampling methodology and 19 number of pharmacies sampled monthly. 20 ‘‘(iii) Information on price concessions 21 to pharmacies, including discounts, re-22 bates, and other price concessions, to the 23 extent that such information may be pub-24 VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS 7 •S 927 IS licly released and has been collected by the 1 Secretary as part of the survey. 2 ‘‘(H) P ENALTIES.— 3 ‘‘(i) I N GENERAL.—Subject to clauses 4 (ii), (iii), and (iv), the Secretary shall en-5 force the provisions of this paragraph with 6 respect to a pharmacy through the estab-7 lishment of civil money penalties applicable 8 to a retail community pharmacy or an ap-9 plicable non-retail pharmacy. 10 ‘‘(ii) B ASIS FOR PENALTIES .—The 11 Secretary shall impose a civil money pen-12 alty established under this subparagraph 13 on a retail community pharmacy or appli-14 cable non-retail pharmacy if— 15 ‘‘(I) the retail pharmacy or appli-16 cable non-retail pharmacy refuses or 17 otherwise fails to respond to a request 18 for information about prices in con-19 nection with a survey under this sub-20 section; 21 ‘‘(II) knowingly provides false in-22 formation in response to such a sur-23 vey; or 24 VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS 8 •S 927 IS ‘‘(III) otherwise fails to comply 1 with the requirements established 2 under this paragraph. 3 ‘‘(iii) P ARAMETERS FOR PEN -4 ALTIES.— 5 ‘‘(I) I N GENERAL.—A civil money 6 penalty established under this sub-7 paragraph may be assessed with re-8 spect to each violation, and with re-9 spect to each non-compliant retail 10 community pharmacy (including a 11 pharmacy that is part of a chain) or 12 non-compliant applicable non-retail 13 pharmacy (including a pharmacy that 14 is part of a chain), in an amount not 15 to exceed $100,000 for each such vio-16 lation. 17 ‘‘(II) C ONSIDERATIONS.—In de-18 termining the amount of a civil money 19 penalty imposed under this subpara-20 graph, the Secretary may consider the 21 size, business structure, and type of 22 pharmacy involved, as well as the type 23 of violation and other relevant factors, 24 VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS 9 •S 927 IS as determined appropriate by the Sec-1 retary. 2 ‘‘(iv) R ULE OF APPLICATION .—The 3 provisions of section 1128A (other than 4 subsections (a) and (b)) shall apply to a 5 civil money penalty under this subpara-6 graph in the same manner as such provi-7 sions apply to a civil money penalty or pro-8 ceeding under section 1128A(a). 9 ‘‘(I) L IMITATION ON USE OF APPLICABLE 10 NON-RETAIL PHARMACY PRICING INFORMA -11 TION.—No State shall use pricing information 12 reported by applicable non-retail pharmacies 13 under subparagraph (A)(ii) to develop or inform 14 payment methodologies for retail community 15 pharmacies.’’; 16 (5) in paragraph (2)— 17 (A) in subparagraph (A), by inserting ‘‘, 18 including payment rates and methodologies for 19 determining ingredient cost reimbursement 20 under managed care entities or other specified 21 entities (as such terms are defined in section 22 1903(m)(9)(D)),’’ after ‘‘under this title’’; and 23 VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS 10 •S 927 IS (B) in subparagraph (B), by inserting 1 ‘‘and the basis for such dispensing fees’’ before 2 the semicolon; 3 (6) by redesignating paragraph (4) as para-4 graph (5); 5 (7) by inserting after paragraph (3) the fol-6 lowing new paragraph: 7 ‘‘(4) O VERSIGHT.— 8 ‘‘(A) I N GENERAL.—The Inspector General 9 of the Department of Health and Human Serv-10 ices shall conduct periodic studies of the survey 11 data reported under this subsection, as appro-12 priate, including with respect to substantial 13 variations in acquisition costs or other applica-14 ble costs, as well as with respect to how internal 15 transfer prices and related party transactions 16 may influence the costs reported by pharmacies 17 that are affiliates (as defined in subsection 18 (k)(14)) or are owned by, controlled by, or re-19 lated under a common ownership structure with 20 a wholesaler, distributor, or other entity that 21 acquires covered outpatient drugs relative to 22 costs reported by pharmacies not affiliated with 23 such entities. The Inspector General shall pro-24 vide periodic updates to Congress on the results 25 VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS 11 •S 927 IS of such studies, as appropriate, in a manner 1 that does not disclose trade secrets or other 2 proprietary information. 3 ‘‘(B) A PPROPRIATION.—There is appro-4 priated to the Inspector General of the Depart-5 ment of Health and Human Services, out of 6 any money in the Treasury not otherwise ap-7 propriated, $5,000,000 for fiscal year 2026, to 8 remain available until expended, to carry out 9 this paragraph.’’; and 10 (8) in paragraph (5), as so redesignated— 11 (A) by inserting ‘‘, and $9,000,000 for fis-12 cal year 2026 and each fiscal year thereafter,’’ 13 after ‘‘2010’’; and 14 (B) by inserting ‘‘Funds appropriated 15 under this paragraph for fiscal year 2026 and 16 any subsequent fiscal year shall remain avail-17 able until expended.’’ after the period. 18 (b) D EFINITIONS.—Section 1927(k) of the Social Se-19 curity Act (42 U.S.C. 1396r–8(k)) is amended— 20 (1) in the matter preceding paragraph (1), by 21 striking ‘‘In the section’’ and inserting ‘‘In this sec-22 tion’’; and 23 (2) by adding at the end the following new 24 paragraphs: 25 VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS 12 •S 927 IS ‘‘(12) APPLICABLE NON-RETAIL PHARMACY .— 1 The term ‘applicable non-retail pharmacy’ means a 2 pharmacy that is licensed as a pharmacy by the 3 State and that is not a retail community pharmacy, 4 including a pharmacy that dispenses prescription 5 medications to patients primarily through mail and 6 specialty pharmacies. Such term does not include 7 nursing home pharmacies, long-term care facility 8 pharmacies, hospital pharmacies, clinics, charitable 9 or not-for-profit pharmacies, government phar-10 macies, or low dispensing pharmacies (as defined by 11 the Secretary). 12 ‘‘(13) A FFILIATE.—The term ‘affiliate’ means 13 any entity that is owned by, controlled by, or related 14 under a common ownership structure with a phar-15 macy benefit manager or a managed care entity or 16 other specified entity (as such terms are defined in 17 section 1903(m)(9)(D)).’’. 18 (c) E FFECTIVEDATE.— 19 (1) I N GENERAL.—Subject to paragraph (2), 20 the amendments made by this section shall take ef-21 fect on the first day of the first quarter that begins 22 on or after the date that is 6 months after the date 23 of enactment of this Act. 24 VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS 13 •S 927 IS (2) DELAYED APPLICATION TO APPLICABLE 1 NON-RETAIL PHARMACIES .—The pharmacy survey 2 requirements established by the amendments to sec-3 tion 1927(f) of the Social Security Act (42 U.S.C. 4 1396r–8(f)) made by this section shall apply to re-5 tail community pharmacies beginning on the effec-6 tive date described in paragraph (1), but shall not 7 apply to applicable non-retail pharmacies until the 8 first day of the first quarter that begins on or after 9 the date that is 18 months after the date of enact-10 ment of this Act. 11 (d) I DENTIFICATION OF APPLICABLENON-RETAIL 12 P HARMACIES.— 13 (1) I N GENERAL.—Not later than January 1, 14 2027, the Secretary of Health and Human Services 15 shall, in consultation with stakeholders as appro-16 priate, publish guidance specifying pharmacies that 17 meet the definition of applicable non-retail phar-18 macies (as such term is defined in subsection 19 (k)(12) of section 1927 of the Social Security Act 20 (42 U.S.C. 1396r–8), as added by subsection (b)), 21 and that will be subject to the survey requirements 22 under subsection (f)(1) of such section, as amended 23 by subsection (a). 24 VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS 14 •S 927 IS (2) INCLUSION OF PHARMACY TYPE INDICA -1 TORS.—The guidance published under paragraph (1) 2 shall include pharmacy type indicators to distinguish 3 between different types of applicable non-retail phar-4 macies, such as pharmacies that dispense prescrip-5 tions primarily through the mail and pharmacies 6 that dispense prescriptions that require special han-7 dling or distribution. An applicable non-retail phar-8 macy may be identified through multiple pharmacy 9 type indicators. 10 (e) I MPLEMENTATION.— 11 (1) I N GENERAL.—Notwithstanding any other 12 provision of law, the Secretary of Health and 13 Human Services may implement the amendments 14 made by this section by program instruction or oth-15 erwise. 16 (2) N ONAPPLICATION OF ADMINISTRATIVE PRO -17 CEDURE ACT.—Implementation of the amendments 18 made by this section shall be exempt from the re-19 quirements of section 553 of title 5, United States 20 Code. 21 (f) N ONAPPLICATION OF PAPERWORKREDUCTION 22 A CT.—Chapter 35 of title 44, United States Code, shall 23 not apply to any data collection undertaken by the Sec-24 retary of Health and Human Services under section 25 VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS 15 •S 927 IS 1927(f) of the Social Security Act (42 U.S.C. 1396r–8(f)), 1 as amended by this section. 2 SEC. 3. PREVENTING THE USE OF ABUSIVE SPREAD PRIC-3 ING IN MEDICAID. 4 (a) I NGENERAL.—Section 1927 of the Social Secu-5 rity Act (42 U.S.C. 1396r–8) is amended— 6 (1) in subsection (e), by adding at the end the 7 following new paragraph: 8 ‘‘(6) T RANSPARENT PRESCRIPTION DRUG PASS - 9 THROUGH PRICING REQUIRED .— 10 ‘‘(A) I N GENERAL.—A contract between 11 the State and a pharmacy benefit manager (re-12 ferred to in this paragraph as a ‘PBM’), or a 13 contract between the State and a managed care 14 entity or other specified entity (as such terms 15 are defined in section 1903(m)(9)(D) and col-16 lectively referred to in this paragraph as the 17 ‘entity’) that includes provisions making the en-18 tity responsible for coverage of covered out-19 patient drugs dispensed to individuals enrolled 20 with the entity, shall require that payment for 21 such drugs and related administrative services 22 (as applicable), including payments made by a 23 PBM on behalf of the State or entity, is based 24 VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS 16 •S 927 IS on a transparent prescription drug pass- 1 through pricing model under which— 2 ‘‘(i) any payment made by the entity 3 or the PBM (as applicable) for such a 4 drug— 5 ‘‘(I) is limited to— 6 ‘‘(aa) ingredient cost; and 7 ‘‘(bb) a professional dis-8 pensing fee that is not less than 9 the professional dispensing fee 10 that the State would pay if the 11 State were making the payment 12 directly in accordance with the 13 State plan; 14 ‘‘(II) is passed through in its en-15 tirety (except as reduced under Fed-16 eral or State laws and regulations in 17 response to instances of waste, fraud, 18 or abuse) by the entity or PBM to the 19 pharmacy or provider that dispenses 20 the drug; and 21 ‘‘(III) is made in a manner that 22 is consistent with sections 447.502, 23 447.512, 447.514, and 447.518 of 24 title 42, Code of Federal Regulations 25 VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS 17 •S 927 IS (or any successor regulation) as if 1 such requirements applied directly to 2 the entity or the PBM, except that 3 any payment by the entity or the 4 PBM for the ingredient cost of such 5 drug purchased by a covered entity 6 (as defined in subsection (a)(5)(B)) 7 may exceed the actual acquisition cost 8 (as defined in 447.502 of title 42, 9 Code of Federal Regulations, or any 10 successor regulation) for such drug 11 if— 12 ‘‘(aa) such drug was subject 13 to an agreement under section 14 340B of the Public Health Serv-15 ice Act; 16 ‘‘(bb) such payment for the 17 ingredient cost of such drug does 18 not exceed the maximum pay-19 ment that would have been made 20 by the entity or the PBM for the 21 ingredient cost of such drug if 22 such drug had not been pur-23 chased by such covered entity; 24 and 25 VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS 18 •S 927 IS ‘‘(cc) such covered entity re-1 ports to the Secretary (in a form 2 and manner specified by the Sec-3 retary), on an annual basis and 4 with respect to payments for the 5 ingredient costs of such drugs so 6 purchased by such covered entity 7 that are in excess of the actual 8 acquisition costs for such drugs, 9 the aggregate amount of such ex-10 cess; 11 ‘‘(ii) payment to the entity or the 12 PBM (as applicable) for administrative 13 services performed by the entity or PBM is 14 limited to an administrative fee that re-15 flects the fair market value (as defined by 16 the Secretary) of such services; 17 ‘‘(iii) the entity or the PBM (as appli-18 cable) makes available to the State, and 19 the Secretary upon request in a form and 20 manner specified by the Secretary, all costs 21 and payments related to covered outpatient 22 drugs and accompanying administrative 23 services (as described in clause (ii)) in-24 curred, received, or made by the entity or 25 VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS 19 •S 927 IS the PBM, broken down (as specified by the 1 Secretary), to the extent such costs and 2 payments are attributable to an individual 3 covered outpatient drug, by each such 4 drug, including any ingredient costs, pro-5 fessional dispensing fees, administrative 6 fees (as described in clause (ii)), post-sale 7 and post-invoice fees, discounts, or related 8 adjustments such as direct and indirect re-9 muneration fees, and any and all other re-10 muneration, as defined by the Secretary; 11 and 12 ‘‘(iv) any form of spread pricing 13 whereby any amount charged or claimed by 14 the entity or the PBM (as applicable) that 15 exceeds the amount paid to the pharmacies 16 or providers on behalf of the State or enti-17 ty, including any post-sale or post-invoice 18 fees, discounts, or related adjustments 19 such as direct and indirect remuneration 20 fees or assessments, as defined by the Sec-21 retary, (after allowing for an administra-22 tive fee as described in clause (ii)) is not 23 allowable for purposes of claiming Federal 24 matching payments under this title. 25 VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS 20 •S 927 IS ‘‘(B) PUBLICATION OF INFORMATION .— 1 The Secretary shall publish, not less frequently 2 than on an annual basis and in a manner that 3 does not disclose the identity of a particular 4 covered entity or organization, information re-5 ceived by the Secretary pursuant to subpara-6 graph (A)(iii)(III) that is broken out by State 7 and by each of the following categories of cov-8 ered entity within each such State: 9 ‘‘(i) Covered entities described in sub-10 paragraph (A) of section 340B(a)(4) of the 11 Public Health Service Act. 12 ‘‘(ii) Covered entities described in sub-13 paragraphs (B) through (K) of such sec-14 tion. 15 ‘‘(iii) Covered entities described in 16 subparagraph (L) of such section. 17 ‘‘(iv) Covered entities described in 18 subparagraph (M) of such section. 19 ‘‘(v) Covered entities described in sub-20 paragraph (N) of such section. 21 ‘‘(vi) Covered entities described in 22 subparagraph (O) of such section.’’; and 23 VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS 21 •S 927 IS (2) in subsection (k), as amended by section 1 2(b), by adding at the end the following new para-2 graph: 3 ‘‘(14) P HARMACY BENEFIT MANAGER .—The 4 term ‘pharmacy benefit manager’ means any person 5 or entity that, either directly or through an inter-6 mediary, acts as a price negotiator or group pur-7 chaser on behalf of a State, managed care entity (as 8 defined in section 1903(m)(9)(D)), or other specified 9 entity (as so defined), or manages the prescription 10 drug benefits provided by a State, managed care en-11 tity, or other specified entity, including the proc-12 essing and payment of claims for prescription drugs, 13 the performance of drug utilization review, the proc-14 essing of drug prior authorization requests, the man-15 aging of appeals or grievances related to the pre-16 scription drug benefits, contracting with pharmacies, 17 controlling the cost of covered outpatient drugs, or 18 the provision of services related thereto. Such term 19 includes any person or entity that acts as a price ne-20 gotiator (with regard to payment amounts to phar-21 macies and providers for a covered outpatient drug 22 or the net cost of the drug) or group purchaser on 23 behalf of a State, managed care entity, or other 24 specified entity or that carries out 1 or more of the 25 VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS 22 •S 927 IS other activities described in the preceding sentence, 1 irrespective of whether such person or entity calls 2 itself a pharmacy benefit manager.’’. 3 (b) C ONFORMINGAMENDMENTS.—Section 1903(m) 4 of such Act (42 U.S.C. 1396b(m)) is amended— 5 (1) in paragraph (2)(A)(xiii)— 6 (A) by striking ‘‘and (III)’’ and inserting 7 ‘‘(III)’’; 8 (B) by inserting before the period at the 9 end the following: ‘‘, and (IV) if the contract in-10 cludes provisions making the entity responsible 11 for coverage of covered outpatient drugs, the 12 entity shall comply with the requirements of 13 section 1927(e)(6)’’; and 14 (C) by moving the margin 2 ems to the 15 left; and 16 (2) by adding at the end the following new 17 paragraph: 18 ‘‘(10) No payment shall be made under this 19 title to a State with respect to expenditures incurred 20 by the State for payment for services provided by an 21 other specified entity (as defined in paragraph 22 (9)(D)(iii)) unless such services are provided in ac-23 cordance with a contract between the State and such 24 VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00022 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS 23 •S 927 IS entity which satisfies the requirements of paragraph 1 (2)(A)(xiii).’’. 2 (c) E FFECTIVEDATE.—The amendments made by 3 this section shall apply to contracts between States and 4 managed care entities, other specified entities, or phar-5 macy benefit managers that have an effective date begin-6 ning on or after the date that is 18 months after the date 7 of enactment of this Act. 8 (d) I MPLEMENTATION.— 9 (1) I N GENERAL.—Notwithstanding any other 10 provision of law, the Secretary of Health and 11 Human Services may implement the amendments 12 made by this section by program instruction or oth-13 erwise. 14 (2) N ONAPPLICATION OF ADMINISTRATIVE PRO -15 CEDURE ACT.—Implementation of the amendments 16 made by this section shall be exempt from the re-17 quirements of section 553 of title 5, United States 18 Code. 19 (e) N ONAPPLICATION OF PAPERWORKREDUCTION 20 A CT.—Chapter 35 of title 44, United States Code, shall 21 not apply to any data collection undertaken by the Sec-22 retary of Health and Human Services under section 23 VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00023 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS 24 •S 927 IS 1927(e) of the Social Security Act (42 U.S.C. 1396r– 1 8(e)), as amended by this section. 2 Æ VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6301 E:\BILLS\S927.IS S927 ssavage on LAPJG3WLY3PROD with BILLS