```

[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7716 Introduced in House (IH)]

<DOC>

118th CONGRESS
  2d Session
                                H. R. 7716

    To amend title XVIII of the Social Security Act to provide for 
enforcement of standards for reasonable and relevant contract terms and 
conditions and essential retail pharmacy protections under the Medicare 
                                program.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             March 19, 2024

 Mr. Gallego introduced the following bill; which was referred to the 
 Committee on Energy and Commerce, and in addition to the Committee on 
   Ways and Means, for a period to be subsequently determined by the 
  Speaker, in each case for consideration of such provisions as fall 
           within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL

 
    To amend title XVIII of the Social Security Act to provide for 
enforcement of standards for reasonable and relevant contract terms and 
conditions and essential retail pharmacy protections under the Medicare 
                                program.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. PROVIDING FOR ENFORCEMENT OF STANDARDS FOR REASONABLE AND 
              RELEVANT CONTRACT TERMS AND CONDITIONS AND ESSENTIAL 
              RETAIL PHARMACY PROTECTIONS UNDER THE MEDICARE PROGRAM.

    (a) In General.--Section 1860D-4(b)(1) of the Social Security Act 
(42 U.S.C. 1395w-104(b)(1)) is amended by adding at the end the 
following new subparagraph:
                    ``(F) Enforcement of standards for reasonable and 
                relevant contract terms and conditions and essential 
                retail pharmacy protections.--
                            ``(i) Allegation submission process.--
                                    ``(I) In general.--Not later than 
                                January 1, 2028, the Secretary shall 
                                establish a process through which a 
                                pharmacy may submit an allegation of a 
                                violation by a PDP sponsor offering a 
                                prescription drug plan of--
                                            ``(aa) the standards for 
                                        reasonable and relevant 
                                        contract terms and conditions 
                                        under subparagraph (A)(ii); or
                                            ``(bb) the requirements for 
                                        total reimbursement for 
                                        essential retail pharmacies 
                                        that are independent community 
                                        pharmacies under subparagraph 
                                        (C)(v)(II).
                                    ``(II) Frequency of submission.--
                                            ``(aa) Violations of 
                                        reasonable and relevant 
                                        contract terms and 
                                        conditions.--

                                                    ``(AA) In 
                                                general.--Except as 
                                                provided in subitem 
                                                (BB), the allegation 
                                                submission process 
                                                under this clause shall 
                                                allow pharmacies to 
                                                submit any allegations 
                                                of violations described 
                                                in item (aa) of 
                                                subclause (I) not more 
                                                frequently than once 
                                                per plan year per 
                                                contract between a 
                                                pharmacy and a PDP 
                                                sponsor.

                                                    ``(BB) Allegations 
                                                relating to contract 
                                                changes.--In the case 
                                                where a contract is 
                                                amended or otherwise 
                                                updated following the 
                                                submission of 
                                                allegations by a 
                                                pharmacy with respect 
                                                to such contract and 
                                                plan year, the 
                                                allegation submission 
                                                process under this 
                                                clause shall allow such 
                                                pharmacy to submit an 
                                                additional allegation 
                                                related to those 
                                                changes with respect to 
                                                such contract and plan 
                                                year.

                                                    ``(CC) 
                                                Submissions.--Submission
                                                s of any allegations 
                                                under this item shall 
                                                be separate from any 
                                                submissions under item 
                                                (bb) and may include 
                                                multiple allegations of 
                                                such violations.

                                            ``(bb) Violations of 
                                        essential retail pharmacy 
                                        protections.--

                                                    ``(AA) In 
                                                general.--The 
                                                allegation submission 
                                                process under this 
                                                clause shall allow 
                                                essential retail 
                                                pharmacies that are 
                                                independent community 
                                                pharmacies to submit 
                                                any allegations of 
                                                violations described in 
                                                item (bb) of subclause 
                                                (I) once per calendar 
                                                quarter.

                                                    ``(BB) 
                                                Submissions.--Submission
                                                s of any allegations 
                                                under this item shall 
                                                be separate from any 
                                                submissions under item 
                                                (aa) and may include 
                                                multiple allegations of 
                                                such violations.

                                    ``(III) Access to relevant 
                                documents and materials.--A PDP sponsor 
                                subject to an allegation under this 
                                clause--
                                            ``(aa) shall provide 
                                        documents or materials, as 
                                        specified by the Secretary, 
                                        including contract offers made 
                                        by such sponsor to such 
                                        pharmacy or correspondence 
                                        related to such offers, to the 
                                        Secretary at a time and in a 
                                        form and manner specified by 
                                        the Secretary; and
                                            ``(bb) shall not prohibit 
                                        or otherwise limit the ability 
                                        of a pharmacy to submit such 
                                        documents or materials to the 
                                        Secretary for the purpose of 
                                        submitting an allegation or 
                                        providing evidence for such an 
                                        allegation under this clause.
                                    ``(IV) Standardized template.--The 
                                Secretary shall establish separate 
                                standardized templates for pharmacies 
                                to use for the submission of 
                                allegations described in items (aa) and 
                                (bb) of subclause (I). Each such 
                                template shall require that the 
                                submission include a certification by 
                                the pharmacy that the information 
                                included is accurate, complete, and 
                                true to the best of the knowledge, 
                                information, and belief of such 
                                pharmacy.
                                    ``(V) Preventing frivolous 
                                allegations.--In the case where the 
                                Secretary determines that a pharmacy 
                                has submitted frivolous allegations 
                                under this clause on a routine basis, 
                                the Secretary may temporarily prohibit 
                                such pharmacy from using the allegation 
                                submission process under this clause, 
                                as determined appropriate by the 
                                Secretary.
                                    ``(VI) Exemption from freedom of 
                                information act.--Allegations submitted 
                                under this clause shall be exempt from 
                                disclosure under section 552 of title 
                                5, United States Code.
                            ``(ii) Investigation.--The Secretary shall 
                        investigate, as determined appropriate by the 
                        Secretary, allegations submitted pursuant to 
                        clause (i).
                            ``(iii) Enforcement.--
                                    ``(I) Reasonable and relevant 
                                contract terms and conditions.--In the 
                                case where the Secretary determines 
                                that a PDP sponsor offering a 
                                prescription drug plan has violated the 
                                standards for reasonable and relevant 
                                contract terms and conditions under 
                                subparagraph (A)(ii), the Secretary 
                                shall use existing authorities under 
                                sections 1857(g) and 1860D-12(b)(3)(E) 
                                to impose civil monetary penalties or 
                                take other enforcement actions.
                                    ``(II) Essential retail pharmacy 
                                protections.--In the case where the 
                                Secretary determines that a PDP sponsor 
                                offering a prescription drug plan has 
                                violated the requirements for total 
                                reimbursement for essential retail 
                                pharmacies that are independent 
                                community pharmacies under subparagraph 
                                (C)(v)(II), the Secretary shall--
                                            ``(aa) if the amount of 
                                        total reimbursement paid by the 
                                        sponsor to an essential retail 
                                        pharmacy that is an independent 
                                        community pharmacy for a 
                                        covered part D drug was less 
                                        than the amount of total 
                                        reimbursement required to be 
                                        paid to the pharmacy under 
                                        subparagraph (C)(v)(II) for 
                                        such drug, require the PDP 
                                        sponsor to pay to the pharmacy 
                                        an amount equal to the 
                                        difference between such 
                                        amounts; and
                                            ``(bb) use existing 
                                        authorities under section 
                                        1857(g) and 1860D-12(b)(3)(E) 
                                        to impose civil monetary 
                                        penalties or take other 
                                        enforcement actions.
                                    ``(III) Application of civil 
                                monetary penalties.--The provisions of 
                                section 1128A (other than subsections 
                                (a) and (b)) shall apply to a civil 
                                monetary penalty under this clause in 
                                the same manner as such provisions 
                                apply to a penalty or proceeding under 
                                section 1128A(a).
                            ``(iv) Definitions.--In this subparagraph, 
                        the terms `essential retail pharmacy', 
                        `independent community pharmacy', and `total 
                        reimbursement' have the meaning given those 
                        terms in subparagraph (C)(v).''.
    (b) Conforming Amendment.--Section 1857(g)(1) of the Social 
Security Act (42 U.S.C. 1395w-27(g)(1)) is amended--
            (1) in subparagraph (J), by striking ``or'' after the 
        semicolon;
            (2) by redesignating subparagraph (K) as subparagraph (L);
            (3) by inserting after subparagraph (J), the following new 
        subparagraph:
                    ``(K) fails to comply with--
                            ``(i) the standards for reasonable and 
                        relevant contract terms and conditions under 
                        subparagraph (A)(ii) of section 1860D-4(b)(1); 
                        or
                            ``(ii) the requirements for total 
                        reimbursement for essential retail pharmacies 
                        that are independent community pharmacies under 
                        subparagraph (C)(v)(II) of such section; or'';
            (4) in subparagraph (L), as redesignated by subparagraph 
        (B), by striking ``through (J)'' and inserting ``through (K)''; 
        and
            (5) in the flush matter following subparagraph (L), as so 
        redesignated, by striking ``subparagraphs (A) through (K)'' and 
        inserting ``subparagraphs (A) through (L)''.
                                 <all>
```