[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