Protect Patient Access to Pharmacies Act

II 118TH CONGRESS 1ST SESSION S. 2052 To amend title XVIII of the Social Security Act to enforce any willing pharmacy requirements and establish safeguards to ensure patient access to pharmacies in Medicare part D, and for other purposes. IN THE SENATE OF THE UNITED STATES JUNE 20, 2023 Mr. TESTER (for himself, Mrs. CAPITO, Mr. BROWN, and Mr. LANKFORD) in- troduced the following bill; which was read twice and referred to the Com- mittee on Finance A BILL To amend title XVIII of the Social Security Act to enforce any willing pharmacy requirements and establish safe- guards to ensure patient access to pharmacies in Medi- care part D, and for other purposes. 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 ‘‘Protect Patient Access 4 to Pharmacies Act’’. 5 VerDate Sep 11 2014 04:50 Jul 13, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2052.IS S2052 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •S 2052 IS SEC. 2. ESTABLISHING SAFEGUARDS TO ENSURE FAIR 1 MARKET COMPETITION FOR PHARMACIES IN 2 MEDICARE PART D. 3 Section 1860D–4(b)(1)(C) of the Social Security Act 4 (42 U.S.C. 1395w–104(b)(1)(C)) is amended by adding 5 at the end the following new clauses: 6 ‘‘(v) ENFORCING ANY WILLING PRO- 7 VIDER REQUIREMENTS TO SUPPORT PA- 8 TIENT CHOICE OF PHARMACY.—Not later 9 than September 30, 2024, the Secretary 10 shall require that total payment (including 11 dispensing fees) by a PDP sponsor offering 12 a prescription drug plan or MA organiza- 13 tion offering an MA–PD plan for each cov- 14 ered part D drug dispensed to an enrollee 15 by a network pharmacy (including spe- 16 cialty pharmacies (as defined under section 17 1860D–2(d)(4)(E))), net of any and all 18 price concessions, discounts, fees of any 19 type, incentive payments, or any other 20 form of remuneration, ensures that at a 21 minimum, such payment covers such phar- 22 macy’s costs to acquire and to dispense 23 each covered part D drug so that such 24 pharmacy may have the option to partici- 25 pate as a network provider, which shall in- 26 VerDate Sep 11 2014 04:50 Jul 13, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2052.IS S2052 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •S 2052 IS clude the ability to acquire and dispense 1 covered part D drugs and provide phar- 2 macy services necessary for dispensing 3 such drugs. In carrying out this clause, the 4 Secretary shall— 5 ‘‘(I) utilize pharmacy acquisition 6 cost data on each type of pharmacy 7 for each covered part D drug (exclud- 8 ing drugs purchased under section 9 340B of the Public Health Service 10 Act) and cost to dispense data from 11 each type of pharmacy (including 12 pharmacies not otherwise owned, con- 13 trolled, or affiliated with any other 14 pharmacy, plan, or pharmacy benefit 15 manager); 16 ‘‘(II) establish payment param- 17 eters for each covered part D drug 18 that considers how the drug is dis- 19 pensed and what pharmacy services 20 are provided by each type of phar- 21 macy to support drug management 22 with the individual for whom the drug 23 is dispensed; and 24 VerDate Sep 11 2014 04:50 Jul 13, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2052.IS S2052 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •S 2052 IS ‘‘(III) establish an appeal process 1 in which the pharmacy may appeal 2 payment, in writing and with sup- 3 porting documentation, to the Medi- 4 care Pharmaceutical and Technology 5 Ombudsman within 60 days following 6 notification of the payment or any ad- 7 justment of such payment of such a 8 drug, if a network pharmacy believes 9 that the amount a PDP offering a 10 prescription drug plan or an MA orga- 11 nization offering an MA–PD plan has 12 paid for such drug is below the phar- 13 macy’s lowest actual acquisition and 14 dispensing costs of such drug. 15 ‘‘(vi) UTILIZATION OF PHARMACY AC- 16 QUISITION COST DATA.—With respect to 17 the requirement under clause (v)(I) for the 18 Secretary to utilize pharmacy acquisition 19 cost data— 20 ‘‘(I) the Secretary shall utilize 21 pharmacy acquisition cost data de- 22 scribed in section 1927(f), relating to 23 a survey of retail prices; and 24 VerDate Sep 11 2014 04:50 Jul 13, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2052.IS S2052 pbinns on DSKJLVW7X2PROD with $$_JOB 5 •S 2052 IS ‘‘(II) for each covered part D 1 drug not included in the survey de- 2 scribed in section 1927(f), the Sec- 3 retary shall amend the survey or es- 4 tablish a survey.’’. 5 SEC. 3. ENSURING FAIR ASSESSMENT OF PHARMACY PER- 6 FORMANCE AND QUALITY. 7 Section 1860D–2(d) of the Social Security Act (42 8 U.S.C. 1395w–102(d)) is amended— 9 (1) in paragraph (1)(B), by striking ‘‘For pur- 10 poses’’ and inserting ‘‘Subject to paragraph (4), for 11 purposes’’; and 12 (2) by adding at the end the following new 13 paragraph: 14 ‘‘(4) APPLICATION OF PHARMACY PERFORM- 15 ANCE MEASURES.— 16 ‘‘(A) EVALUATION OF PHARMACY PER- 17 FORMANCE MEASURES.—Not later than 6 18 months after the date of enactment of this Act, 19 and annually thereafter, the Secretary shall 20 complete an evaluation of the performance 21 measures used by PDP sponsors offering pre- 22 scription drug plans and MA organizations of- 23 fering MA–PD plans to assess pharmacy price 24 concessions or any other fees based on perform- 25 VerDate Sep 11 2014 04:50 Jul 13, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2052.IS S2052 pbinns on DSKJLVW7X2PROD with $$_JOB 6 •S 2052 IS ance, as established in network pharmacy 1 agreements. Each such evaluation shall (to the 2 extent practicable) include at least 5 years of 3 retrospective information to examine the fol- 4 lowing: 5 ‘‘(i) How measures are being applied 6 to pharmacies, including whether such 7 measures are applied based on the type of 8 pharmacy (including specialty pharmacy), 9 drugs dispensed, and pharmacy services 10 used to dispense and manage drugs. 11 ‘‘(ii) Whether, with respect to each 12 such measure, such measure results in 13 anything of value including any fees, phar- 14 macy price concessions, discounts, or in- 15 centives, transferred to or received from a 16 pharmacy by a PDP sponsor offering a 17 prescription drug plan or MA organization 18 offering an MA–PD plan after the point- 19 of-sale of a drug, broken down by type of 20 pharmacy and the drug dispensed. 21 ‘‘(iii) The extent to which each meas- 22 ure is applied across prescription drug 23 plans offered by a PDP sponsor and MA– 24 VerDate Sep 11 2014 04:50 Jul 13, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2052.IS S2052 pbinns on DSKJLVW7X2PROD with $$_JOB 7 •S 2052 IS PD plans offered by an MA organization 1 and if such application is uniform. 2 ‘‘(iv) How measures are applied and if 3 they are uniformly applied to all in-net- 4 work types of pharmacies or only certain 5 pharmacies within a network. 6 ‘‘(v) How and when pharmacies are 7 provided notice of measures, as well as 8 methods and actual data calculations used 9 to evaluate performance, and evaluation 10 outcomes by type of pharmacy. 11 ‘‘(vi) How pharmacy performance is 12 evaluated using such measures and the ex- 13 tent to which the goals or targets are— 14 ‘‘(I) achievable at scale; 15 ‘‘(II) structured to improve pa- 16 tient outcomes; and 17 ‘‘(III) reasonable in the context 18 of industry data regarding baseline 19 patient behavior, such as improved 20 patient outcomes and measure per- 21 formance. 22 ‘‘(B) APPLICATION OF STANDARDIZED 23 PHARMACY PERFORMANCE MEASURES.—For 24 plan years beginning on or after January 1, 25 VerDate Sep 11 2014 04:50 Jul 13, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S2052.IS S2052 pbinns on DSKJLVW7X2PROD with $$_JOB 8 •S 2052 IS 2025, a PDP sponsor offering a prescription 1 drug plan or an MA organization offering an 2 MA–PD plan that makes incentive payments to 3 a pharmacy, or receives price concessions or 4 any other remuneration paid by a pharmacy, 5 based on measures of the performance or qual- 6 ity of work of the pharmacy, shall, for the pur- 7 poses of such incentive payments and price con- 8 cessions or fees with respect to covered part D 9 drugs dispensed by such pharmacy, only use 10 measures— 11 ‘‘(i) on the most recently updated list 12 maintained by the Secretary under sub- 13 paragraph (C), as listed under clause (ii) 14 of such subparagraph; and 15 ‘‘(ii) that are relevant to the perform- 16 ance of such pharmacy based on the type 17 of pharmacy, drugs dispensed, and phar- 18 macy services used to dispense and manage 19 drugs. 20 ‘‘(C) STANDARDIZED PHARMACY PER- 21 FORMANCE MEASURES.— 22 ‘‘(i) IN GENERAL.—Notwithstanding 23 any other provision of law, the Secretary 24 shall, taking into account evaluations 25 VerDate Sep 11 2014 04:50 Jul 13, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S2052.IS S2052 pbinns on DSKJLVW7X2PROD with $$_JOB 9 •S 2052 IS under subparagraph (A), establish or adopt 1 from one or more multi-stakeholder, neu- 2 tral, consensus-based measure development 3 organizations representing all types of 4 pharmacies (including pharmacies not oth- 5 erwise owned, controlled, or affiliated with 6 any other pharmacy, plan, or pharmacy 7 benefit manager) standardized pharmacy 8 quality measures and performance criteria, 9 such as cut points, or any type of payment 10 to be used by a PDP sponsor offering a 11 prescription drug plan and an MA organi- 12 zation offering an MA–PD plan for the 13 purposes of determining incentive pay- 14 ments and price concessions or fees de- 15 scribed in subparagraph (B). Such meas- 16 ures shall be evidence-based, feasible, ap- 17 propriate, and achievable based on indus- 18 try data, and focus on pharmacy perform- 19 ance and quality of care, as determined by 20 the Secretary, that the pharmacy can im- 21 pact based on covered part D drugs the 22 pharmacy dispenses and manages. 23 ‘‘(ii) MAINTENANCE OF LIST.—The 24 Secretary shall maintain a single list of 25 VerDate Sep 11 2014 04:50 Jul 13, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S2052.IS S2052 pbinns on DSKJLVW7X2PROD with $$_JOB 10 •S 2052 IS measures established or adopted under this 1 subparagraph. Such measures shall be 2 evaluated and such list updated on an on- 3 going basis through stakeholder consensus 4 organizations representing all types of 5 pharmacies as referenced in clause (i) to 6 ensure the measures on such list are evi- 7 dence-based, feasible, appropriate, and 8 achievable. Such list shall be published on 9 a public website not later than January 1, 10 2024, and updated thereafter as appro- 11 priate as determined by the Secretary. 12 ‘‘(D) TRANSPARENCY TO PHARMACY.—For 13 plan years beginning on or after January 1, 14 2025, the Secretary shall establish a uniform 15 process under which a PDP sponsor offering a 16 prescription drug plan and an MA organization 17 offering an MA–PD plan shall promptly dis- 18 close, upon receiving a claim for a covered part 19 D drug from a pharmacy, to such pharmacy all 20 pricing components related to such claim, in- 21 cluding the Network Reimbursement ID used to 22 price the claim, any service fees and other fees, 23 pharmacy price concessions, discounts, incen- 24 VerDate Sep 11 2014 04:50 Jul 13, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S2052.IS S2052 pbinns on DSKJLVW7X2PROD with $$_JOB 11 •S 2052 IS tives or anything else of value to or from the 1 pharmacy. 2 ‘‘(E) SPECIALTY PHARMACY.—For pur- 3 poses of this subparagraph and section 1860D– 4 4(b)(1)(C), not later than December 31, 2024, 5 the Secretary shall define the term ‘specialty 6 pharmacy’ in consultation with all relevant 7 stakeholders. 8 ‘‘(F) DEFINITIONS.—For purposes of this 9 subparagraph: 10 ‘‘(i) AFFILIATED.—The term ‘affili- 11 ated’ means, with respect to a pharmacy, 12 a PDP sponsor offering a prescription 13 drug plan, or an MA organization offering 14 an MA–PD plan, that the pharmacy, PDP 15 sponsor, or MA organization— 16 ‘‘(I) is directly or indirectly 17 through one or more intermediaries 18 wholly or partially owned by, con- 19 trolled by, or is under common owner- 20 ship of such pharmacy, PDP sponsor, 21 or MA organization; or 22 ‘‘(II) has a financial interest in 23 such pharmacy, PDP sponsor, or MA 24 organization. 25 VerDate Sep 11 2014 04:50 Jul 13, 2023 Jkt 039200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S2052.IS S2052 pbinns on DSKJLVW7X2PROD with $$_JOB 12 •S 2052 IS ‘‘(ii) TYPE OF PHARMACY.—The term 1 ‘type of pharmacy’ means any type of 2 pharmacy licensed by a State, including a 3 retail pharmacy, specialty pharmacy, and 4 any other type of pharmacy specified by 5 the Secretary.’’. 6 SEC. 4. ENCOURAGING USE OF PHARMACY PERFORMANCE 7 MEASURES THROUGH QUALITY RATINGS. 8 Section 1853(o)(4)(A) of the Social Security Act (42 9 U.S.C. 1395w–23(o)(4)(A)) is amended— 10 (1) by striking ‘‘DETERMINATION.—The qual- 11 ity’’ and inserting DETERMINATION.— 12 ‘‘(i) IN GENERAL.—Subject to clause 13 (ii), the quality’’; and 14 (2) by adding at the end the following new 15 clause: 16 ‘‘(ii) ENCOURAGING USE OF PHAR- 17 MACY PERFORMANCE MEASURES.— 18 ‘‘(I) IN GENERAL.—In the case 19 of a plan described in subclause (II), 20 with respect to the determination of 21 quality ratings on or after January 1, 22 2024, the Secretary shall provide for 23 an increase in the quality rating oth- 24 erwise determined under clause (i) in 25 VerDate Sep 11 2014 04:50 Jul 13, 2023 Jkt 039200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S2052.IS S2052 pbinns on DSKJLVW7X2PROD with $$_JOB 13 •S 2052 IS a manner determined appropriate by 1 the Secretary. 2 ‘‘(II) PLAN DESCRIBED.—For 3 purposes of subclause (I), a plan de- 4 scribed in this subclause is a prescrip- 5 tion drug plan offered by a PDP 6 sponsor or an MA–PD plan offered by 7 an MA organization that makes incen- 8 tive payments to a pharmacy, or re- 9 ceives price concessions or any other 10 remuneration paid by a pharmacy, 11 based on measures of the performance 12 or quality of work of the pharmacy.’’. 13 Æ VerDate Sep 11 2014 04:50 Jul 13, 2023 Jkt 039200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6301 E:\BILLS\S2052.IS S2052 pbinns on DSKJLVW7X2PROD with $$_JOB