[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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