IIB 118th CONGRESS 2d Session H. R. 5526 IN THE SENATE OF THE UNITED STATES September 24, 2024 Received; read twice and referred to the Committee on Finance AN ACT To amend title XVIII of the Social Security Act to clarify the application of the in-office ancillary services exception to the physician self-referral prohibition for covered outpatient drugs furnished under the Medicare program, and to provide coverage of external infusion pumps and non-self-administrable home infusion drugs under such program.

1. Short title This Act may be cited as the Seniors’ Access to Critical Medications Act of 2024 . 2. Clarifying the application of the in-office ancillary services exception to the physician self-referral prohibition for covered outpatient drugs furnished under the Medicare program (a) In general Section 1877(b)(2) of the Social Security Act ( 42 U.S.C. 1395nn(b)(2) ) is amended by adding at the end the following new sentence: With respect to services described in subsection (h)(6)(J) consisting of covered part D drugs (as defined in section 1860D–2(e)) furnished to an individual during the period beginning on January 1, 2025, and ending on December 31, 2029, such drugs shall be treated as having been furnished in accordance with subparagraph (A)(ii) if such drugs are picked up in a building described in subclause (I) or (II) of such subparagraph by such individual, or a family member or caregiver on behalf of such individual, or delivered to such individual by a mail, delivery, or courier service, but only if, during the 1-year period ending on the date such drugs were so furnished, such individual had a face-to-face encounter with the prescriber of such drugs (not including any such encounter conducted via telehealth), and only if such prescriber (or another physician or practitioner (as described in section 1842(b)(18)(C)) in the same practice as such prescriber (as determined by tax identification number)) furnished to such individual, during such 1-year period, another item or service for which payment was made under this title, and only if such individual has an ongoing relationship with such prescriber. . (b) Report Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a report that contains— (1) the number of individuals who were furnished drugs in a manner that would constitute a violation of section 1877 of the Social Security Act ( 42 U.S.C. 1395nn ) but for the amendment made by subsection (a); (2) an analysis of the change in expenditures under title XVIII of such Act ( 42 U.S.C. 1395 et seq. ) attributable to such amendment; (3) a description of which drugs were furnished in a manner described in paragraph (1); and (4) such amendment’s impact on prices for such drugs. 3. Medicare coverage of external infusion pumps and non-self-administrable home infusion drugs Section 1861(n) of the Social Security Act ( 42 U.S.C. 1395x(n) ) is amended by adding at the end the following new sentence: Beginning with the first calendar quarter beginning on or after the date that is one year after the date of the enactment of the Seniors’ Access to Critical Medications Act of 2024 , an external infusion pump and associated home infusion drug (as defined in subsection (iii)(3)(C)) or other associated supplies that do not meet the appropriate for use in the home requirement applied to the definition of durable medical equipment under section 414.202 of title 42, Code of Federal Regulations (or any successor to such regulation) shall be treated as meeting such requirement if each of the following criteria is satisfied: (1) The prescribing information approved by the Food and Drug Administration for the home infusion drug associated with the pump instructs that the drug should be administered by or under the supervision of a health care professional. (2) A qualified home infusion therapy supplier (as defined in subsection (iii)(3)(D)) administers or supervises the administration of the drug or biological in a safe and effective manner in the patient’s home (as defined in subsection (iii)(3)(B)). (3) The prescribing information described in paragraph (1) instructs that the drug should be infused at least 12 times per year— (A) intravenously or subcutaneously; or (B) at infusion rates that the Secretary determines would require the use of an external infusion pump. . 4. Medicare Improvement Fund Section 1898(b)(1) of the Social Security Act ( 42 U.S.C. 1395iii(b)(1) ) is amended by striking $0 and inserting $114,000,000 .

Passed the House of Representatives September 23, 2024. Kevin F. McCumber, Clerk.