IB 

Union Calendar No. 585 

118TH CONGRESS 

2D SESSION H. R. 5526 

[Report No. 118–691, Part I] 

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 drugs furnished under the Medicare program. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 18, 2023 

Mrs. HARSHBARGER (for herself, Ms. WASSERMAN SCHULTZ, Mr. 

FLEISCHMANN, Mr. DAVIS of North Carolina, Mrs. MILLER-MEEKS, and 

Mr. BALDERSON) 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 

SEPTEMBER 19, 2024 

Additional sponsors: Mr. JOHNSON of Ohio, Mr. HUDSON, Ms. BLUNT ROCHESTER, Mr. LALOTA, Mr. RUIZ, Mr. CARTER of Georgia, Mr. SOTO, Ms. 

SEWELL, Mr. COHEN, Ms. TOKUDA, Mr. CRENSHAW, Mr. BILIRAKIS, Mr. 

JOYCE of Pennsylvania, Ms. PINGREE, Ms. PEREZ, Mr. VAN DREW, Mr. 

PFLUGER, Mr. PAPPAS, Mr. FERGUSON, Mr. LAHOOD, Ms. KUSTER, Mr. 

DUNN of Florida, Mr. CROW, Mr. BUCSHON, Mr. BURGESS, Mr. LATTA, 

Mr. GOLDEN of Maine, Mrs. MILLER of West Virginia, Mr. 

KRISHNAMOORTHI, Mr. RUTHERFORD, Mr. OBERNOLTE, Mr. MANN, Mr. 

DESJARLAIS, Mr. BACON, Mr. NEHLS, Ms. BUDZINSKI, Mr. KUSTOFF, 

Ms. SPANBERGER, Mr. GOTTHEIMER, Ms. CARAVEO, Mr. GRIFFITH, Mr. 

SCHNEIDER, Mr. JACKSON of North Carolina, Mr. CARTWRIGHT, Mr. 

LANGWORTHY, Mr. MURPHY, Mr. TONKO, Mr. DUNCAN, Mr. 

D’ESPOSITO, Mr. WILLIAMS of New York, Mr. ROUZER, Mr. GREEN of 

Tennessee, Ms. MALLIOTAKIS, Mr. WEBER of Texas, Mr. TIFFANY, Ms. 

TITUS, Mrs. FLETCHER, Ms. ROSS, Mr. ALLRED, Mr. CARTER of Texas, 

Ms. STRICKLAND, Mr. MORAN, Mr. ESTES, and Mr. PHILLIPS


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•HR 5526 RH

SEPTEMBER 19, 2024 

Reported from the Committee on Energy and Commerce with amendments 

[Strike out all after the enacting clause and insert the part printed in italic] 

SEPTEMBER 19, 2024 

Committee on Ways and Means discharged; committed to the Committee of 

the Whole House on the State of the Union and ordered to be printed 

[For text of introduced bill, see copy of bill as introduced on September 18, 2023] 

A BILL 

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 drugs furnished under the Medicare program. 


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•HR 5526 RH

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Seniors’ Access to Crit5 ical Medications Act of 2024’’. 

6 SEC. 2. CLARIFYING THE APPLICATION OF THE IN-OFFICE 

7 ANCILLARY SERVICES EXCEPTION TO THE 

8 PHYSICIAN SELF-REFERRAL PROHIBITION 

9 FOR COVERED OUTPATIENT DRUGS FUR10 NISHED UNDER THE MEDICARE PROGRAM. 

11 (a) IN GENERAL.—Section 1877(b)(2) of the Social Se12 curity Act (42 U.S.C. 1395nn(b)(2)) is amended by adding 

13 at the end the following new sentence: ‘‘With respect to serv14 ices described in subsection (h)(6)(J) consisting of covered 

15 part D drugs (as defined in section 1860D–2(e)) furnished 

16 to an individual during the period beginning on January 

17 1, 2025, and ending on December 31, 2029, such drugs shall 

18 be treated as having been furnished in accordance with sub19 paragraph (A)(ii) if such drugs are picked up in a building 

20 described in subclause (I) or (II) of such subparagraph by 

21 such individual, or a family member or caregiver on behalf 

22 of such individual, or delivered to such individual by a 

23 mail, delivery, or courier service, but only if, during the 

24 1-year period ending on the date such drugs were so fur25 nished, such individual had a face-to-face encounter with 


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•HR 5526 RH

1 the prescriber of such drugs (not including any such en2 counter conducted via telehealth), and only if such indi3 vidual has an ongoing on preexisting relationship with such 

4 prescriber.’’. 

5 (b) REPORT.—Not later than 3 years after the date 

6 of the enactment of this Act, the Secretary of Health and 

7 Human Services shall submit to Congress a report that con8 tains— 

9 (1) the number of individuals who were fur10 nished drugs in a manner that would constitute a 

11 violation of section 1877 of the Social Security Act 

12 (42 U.S.C. 1395nn) but for the amendment made by 

13 subsection (a); 

14 (2) an analysis of the change in expenditures 

15 under title XVIII of such Act (42 U.S.C. 1395 et seq.) 

16 attributable to such amendment; 

17 (3) a description of which drugs were furnished 

18 in a manner described in paragraph (1); and 

19 (4) such amendment’s impact on prices for such 

20 drugs. 

21 SEC. 3. MEDICARE COVERAGE OF EXTERNAL INFUSION 

22 PUMPS AND NON-SELF-ADMINISTRABLE 

23 HOME INFUSION DRUGS. 

24 Section 1861(n) of the Social Security Act (42 U.S.C. 

25 1395x(n)) is amended by adding at the end the following 


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•HR 5526 RH

1 new sentence: ‘‘Beginning with the first calendar quarter 

2 beginning on or after the date that is one year after the 

3 date of the enactment of the ‘Seniors’ Access to Critical 

4 Medications Act of 2024’, an external infusion pump and 

5 associated home infusion drug (as defined in subsection 

6 (iii)(3)(C)) or other associated supplies that do not meet 

7 the appropriate for use in the home requirement applied 

8 to the definition of durable medical equipment under sec9 tion 414.202 of title 42, Code of Federal Regulations (or 

10 any successor to such regulation) shall be treated as meeting 

11 such requirement if each of the following criteria is satis12 fied: 

13 ‘‘(1) The prescribing information approved by 

14 the Food and Drug Administration for the home infu15 sion drug associated with the pump instructs that the 

16 drug should be administered by or under the super17 vision of a health care professional. 

18 ‘‘(2) A qualified home infusion therapy supplier 

19 (as defined in subsection (iii)(3)(D)) administers or 

20 supervises the administration of the drug or biological 

21 in a safe and effective manner in the patient’s home 

22 (as defined in subsection (iii)(3)(B)). 

23 ‘‘(3) The prescribing information described in 

24 paragraph (1) instructs that the drug should be in25 fused at least 12 times per year— 


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1 ‘‘(A) intravenously or subcutaneously; or 

2 ‘‘(B) at infusion rates that the Secretary de3 termines would require the use of an external in4 fusion pump.’’. 

5 SEC. 4. MEDICARE IMPROVEMENT FUND. 

6 Section 1898(b)(1) of the Social Security Act (42 

7 U.S.C. 1395iii(b)(1)) is amended by striking ‘‘$0’’ and in8 serting ‘‘$114,000,000’’. 

Amend the title so as to read: ‘‘A bill 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.’’. 


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Union Calendar No. 585 

118TH CONGRESS 

2D SESSION H. R. 5526 

[Report No. 118–691, Part I] 

A BILL 

To amend title XVIII of the Social Security Act to 

care program. prohibition for drugs furnished under the Mediservices exception to the physician self-referral clarify the application of the in-office ancillary 

SEPTEMBER 19, 2024 

Reported from the Committee on Energy and Commerce 

with amendments 

SEPTEMBER 19, 2024 

Committee on Ways and Means discharged; committed to 

Union and ordered to be printed the Committee of the Whole House on the State of the 


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