[Congressional Record Volume 170, Number 148 (Monday, September 23, 2024)]
[House]
[Pages H5587-H5588]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




          SENIORS' ACCESS TO CRITICAL MEDICATIONS ACT OF 2024

  Mr. BUCSHON. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 5526) 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, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 5526

       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 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.

     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''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Indiana (Mr. Bucshon) and the gentleman from New Jersey (Mr. Pallone) 
each will control 20 minutes.
  The Chair recognizes the gentleman from Indiana.


                             General Leave

  Mr. BUCSHON. Mr. Speaker, I ask unanimous consent that all Members 
may have 5 legislative days in which to revise and extend their remarks 
and include extraneous material in the Record on the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Indiana?
  There was no objection.
  Mr. BUCSHON. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, a silver lining of the COVID-19 pandemic, if there is 
one, was the proliferation of new, effective ways to deliver 
healthcare.
  Of course, we saw the rise of telehealth, but we also saw an 
increased use of mail to deliver prescription drugs to patients. 
Mailing prescription drugs to patients, especially those who live in 
rural communities, helped increase access to care and medication 
adherence by reducing the need to travel long distances to your nearest 
pharmacy.
  For seniors who may struggle with mobility, this change was 
especially important.

                              {time}  1600

  Unfortunately, Federal laws limit the ability for seniors to take 
advantage of these benefits.
  CMS states that if a Medicare beneficiary wants to see an independent 
physician that also owns a pharmacy, the Medicare beneficiary must pick 
up their drugs from that physician-owned pharmacy in person.
  That pharmacy cannot mail the drug directly to the patient or let a 
family member pick up the drug on the Medicare patient's behalf.
  During the COVID-19 pandemic, CMS relaxed this restriction. I have 
heard from countless oncologists across my home State about how during 
the COVID-19 pandemic era, those flexibilities improved access to care.
  H.R. 5526 would clarify that seniors can get drugs from physician-
owned pharmacies through the mail or have someone pick up those 
medications on their behalf, making it easier for seniors to get the 
care that they need.
  I encourage my colleagues to support this bill, and I reserve the 
balance of my time.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.

[[Page H5588]]

  Mr. Speaker, I rise today in support of H.R. 5526, the Seniors' 
Access to Critical Medications Act.
  This bill amends the Physician Self-Referral Law, also known as the 
Stark Law, to permit Medicare patients to have their physicians 
dispense prescription drugs to them in narrow circumstances, either 
through a caregiver or through a mail courier. Congress enacted the 
Stark Law to ensure that physician financial considerations do not 
influence patient care. Under the Stark Law, physicians are prohibited 
from making referrals to entities in which the physician has a 
financial stake.
  Medicare beneficiaries deserve the independent judgment of their 
physicians and access to treatment that is medically appropriate and 
necessary for them. The Stark Law is critical in ensuring that 
financial arrangements do not distort physician decisionmaking or raise 
healthcare costs.
  Now, current law includes specific and narrowly tailored exceptions 
such as the in-office ancillary services exception. This exception 
permits a physician with an ownership stake to provide an outpatient 
prescription drug or certain services to a patient at his or her office 
as part of an in-person visit. This is for the convenience of the 
patient but also because there are more limited program integrity 
concerns when the item or service is being delivered as part of an in-
person office visit.
  While I continue to have strong concerns with significantly weakening 
the Stark Law, I believe there are also limited instances in which it 
may be necessary for a caregiver or a family member to pick up the 
prescription drugs for patients or for them to be mailed. I believe 
there are limited program integrity concerns in these instances.
  This narrow Stark exception will help patients receive necessary 
medications more easily and protects Medicare beneficiaries by ensuring 
that financial considerations do not influence patient care.
  I urge my colleagues to join me in voting ``yes'' on H.R. 5526, and I 
reserve the balance of my time, Mr. Speaker.
  Mr. BUCSHON. Mr. Speaker, I yield 5 minutes to the gentlewoman from 
Tennessee (Mrs. Harshbarger).
  Mrs. HARSHBARGER. Mr. Speaker, I rise today in strong support of H.R. 
5526, the Seniors' Access to Critical Medications Act.
  I thank my co-lead, Democrat Representative Wasserman Schultz, and 
House Energy and Commerce Chair Rodgers and Ranking Member Pallone for 
allowing me to advance this important legislation.
  I spent 37 years working as a pharmacist in almost every area of 
pharmacy, and I know firsthand the importance of providing patients 
with serious illnesses timely and reliable access to their lifesaving 
medications.
  Under the Centers for Medicare and Medicaid Services' interpretation 
of the physician self-referral law, which is known as the Stark Law, it 
states that it is unlawful for a medical practice, such as a community 
oncology practice, to deliver a prescribed and filled drug to a patient 
by mail or courier, UPS or Fed Ex. CMS' interpretation doesn't even 
allow for a family member or a caregiver to pick up the patient's drug 
on their behalf.
  For Medicare seniors living in rural areas who don't have 
transportation or who are too sick to pick up their lifesaving drug, 
they are just simply out of luck in a lot of cases, or they are forced 
to rely on a nameless or faceless mail order pharmacy benefit manager, 
where these ``distant middlemen'' cannot quickly fine-tune necessary 
short-term changes or adjustments in their therapies.
  Some patients will go without their oral chemotherapy medication 
because they can't get transportation to pick their prescription up. It 
can change the entire outcome for those patients. We shouldn't have 
obstacles in the way of patients receiving the medications they need.
  The bipartisan Seniors' Access to Critical Medications Act simply 
ensures that cancer patients, as well as other patients, have timely 
access to the appropriate oral medications they need by allowing 
delivery of these medications or allowing family members or caregivers 
to pick up their medicines.
  I have heard from dozens upon dozens of Tennessee oncologists and 
other specialty physicians and patients, as well as others around the 
country, who have been deeply impacted by the unnecessary hurdles 
created by CMS' misguided interpretation of the Stark Law.
  During the pandemic, CMS recognized these barriers and issued a Stark 
waiver, lifting the restrictions that hindered patient access to these 
crucial medications.
  This bill restores those flexibilities, and I urge all my colleagues 
to support H.R. 5526 to protect Medicare beneficiaries' ability to 
receive the medications they need when they need them.
  Mr. PALLONE. Mr. Speaker, I support this legislation and urge its 
passage, and I yield back the balance of my time.
  Mr. BUCSHON. Mr. Speaker, in closing, I encourage a ``yes'' vote on 
this bill, and I yield back the balance of my time.
  The SPEAKER pro tempore (Mr. Edwards). The question is on the motion 
offered by the gentleman from Indiana (Mr. Bucshon) that the House 
suspend the rules and pass the bill, H.R. 5526, as amended.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill, as amended, was passed.
  The title of the bill was amended 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.''.
  A motion to reconsider was laid on the table.

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