[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5526 Reported in House (RH)]

<DOC>





                                                 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

                           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.


 


    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 ``Seniors' Access to Critical 
Medications Act of 2024''.

SEC. 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 individual has an ongoing on preexisting 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.

SEC. 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.''.

SEC. 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''.
            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.''.
                                                 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 clarify the 
   application of the in-office ancillary services exception to the 
   physician self-referral prohibition for drugs furnished under the 
                           Medicare program.

_______________________________________________________________________

                           September 19, 2024

   Reported from the Committee on Energy and Commerce with amendments

                           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