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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8267 Introduced in House (IH)]

<DOC>

118th CONGRESS
  2d Session
                                H. R. 8267

  To amend titles XVIII and XIX of the Social Security Act to provide 
that priority research drugs shall not be treated as line extensions of 
 existing drugs for purposes of calculating manufacturer rebates under 
      the Medicare and Medicaid programs, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                              May 7, 2024

 Mr. Davis of North Carolina (for himself and Mr. Pfluger) 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 titles XVIII and XIX of the Social Security Act to provide 
that priority research drugs shall not be treated as line extensions of 
 existing drugs for purposes of calculating manufacturer rebates under 
      the Medicare and Medicaid programs, and for other purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Old Drugs, New Cures Act''.

SEC. 2. PRIORITY RESEARCH DRUGS.

    (a) In General.--Section 1927(c)(2)(C) of the Social Security Act 
(42 U.S.C. 1396r-8(c)(2)(C)) is amended by inserting the following new 
clause before the flush matter at the end:
                            ``(iv) Priority research drug.--
                                    ``(I) Request for designation.--Not 
                                later than 90 days following the date 
                                of enactment of this clause, the 
                                Secretary shall establish and make 
                                effective a process for the 
                                manufacturer of a covered outpatient 
                                drug to request that the Secretary 
                                designate the drug as a priority 
                                research drug.
                                    ``(II) Designation.--Not later than 
                                60 calendar days after the receipt of a 
                                request under subclause (I), the 
                                Secretary shall designate a covered 
                                outpatient drug as a priority research 
                                drug so long as it meets the following 
                                criteria:
                                            ``(aa) As of the date of 
                                        submission of such request, at 
                                        least 10 years have elapsed 
                                        since the date the drug was 
                                        approved under section 505(c) 
                                        of the Federal Food, Drug, and 
                                        Cosmetic Act or section 351(a) 
                                        of the Public Health Service 
                                        Act.
                                            ``(bb) The manufacturer of 
                                        the drug is investigating such 
                                        drug under section 505(i) of 
                                        the Federal Food, Drug, and 
                                        Cosmetic Act or section 
                                        351(a)(3) of the Public Health 
                                        Service Act for a new 
                                        indication that would address a 
                                        significant unmet medical need 
                                        because there is no alternative 
                                        drug approved under section 505 
                                        of the Federal Food, Drug, and 
                                        Cosmetic Act or licensed under 
                                        section 351 of the Public 
                                        Health Service Act for such 
                                        indication on the date that the 
                                        request under subclause (I) was 
                                        submitted to the Secretary.
                                            ``(cc) The new indication 
                                        described in item (bb) is for a 
                                        disease or condition that has a 
                                        high prevalence among 
                                        beneficiaries of Federal health 
                                        care programs. For purposes of 
                                        this clause, a disease or 
                                        condition has a high prevalence 
                                        among beneficiaries of Federal 
                                        health care programs if at 
                                        least 33 percent of claims in 
                                        the population targeted by the 
                                        new indication during the prior 
                                        calendar year were paid for 
                                        under--

                                                    ``(AA) a State plan 
                                                under this title or a 
                                                State child health plan 
                                                under title XXI;

                                                    ``(BB) part D of 
                                                title XVIII with 
                                                respect to an 
                                                individual who is 
                                                eligible for subsidies 
                                                under section 1860D-14;

                                                    ``(CC) the drug 
                                                discount program under 
                                                section 340B of the 
                                                Public Health Service 
                                                Act (42 U.S.C. 256b; or

                                                    ``(DD) a health 
                                                care program 
                                                administered by the 
                                                Department of Veterans 
                                                Affairs.''.

    (b) Exclusion of Priority Research Drugs From Medicaid Definition 
of Line Extension.--The flush matter at the end of section 
1927(c)(2)(C) of the Social Security Act (42 U.S.C. 1396r-8(c)(2)(C)) 
is amended by inserting ``a priority research drug (as designated under 
clause (iv)) or'' after ``does not include''.
    (c) Exclusion of Priority Research Drugs From Medicaid Best Price 
Special Rule for Selected Drugs.--Section 1927(c)(1)(C)(ii)(V) of the 
Social Security Act (42 U.S.C. 1396r-8(c)(1)(C)(ii)(V)) is amended by 
inserting ``unless such drug is also designated as a priority research 
drug under paragraph (2)(C)(iv) during such period'' before the period.
    (d) Exclusion of Priority Research Drugs From Medicare Definition 
of Line Extension.--Section 1860D-14B(b)(5)(B)(ii) of the Social 
Security Act (42 U.S.C. 1395w-114b(b)(5)(B)(ii)) is amended by 
inserting ``a priority research drug (as designated under section 
1927(c)(2)(C)(iv)) or'' after ``does not include''.
                                 <all>
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