No official summary available for this bill.
[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9184 Introduced in House (IH)]
<DOC>
118th CONGRESS
2d Session
H. R. 9184
To amend title XI of the Social Security Act to exclude from
antikickback and other sanctions certain travel and lodging
arrangements between manufacturers of drugs and individuals being
administered such drugs, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 30, 2024
Mr. Guthrie (for himself and Ms. Barragan) 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
_______________________________________________________________________
A BILL
To amend title XI of the Social Security Act to exclude from
antikickback and other sanctions certain travel and lodging
arrangements between manufacturers of drugs and individuals being
administered such drugs, and for other purposes.
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 ``Patient Access Act of 2024''.
SEC. 2. EXCLUDING FROM ANTIKICKBACK AND OTHER SANCTIONS CERTAIN TRAVEL
AND LODGING ARRANGEMENTS BETWEEN MANUFACTURERS OF DRUGS
AND INDIVIDUALS BEING ADMINISTERED SUCH DRUGS.
(a) In General.--Section 1128B of the Social Security Act (42
U.S.C. 1320a-7b) is amended--
(1) in subsection (b)(3)--
(A) in subparagraph (K), by striking at the end
``and'';
(B) in subparagraph (L)(iii), by striking at the
end the period and inserting ``; and''; and
(C) by adding at the end the following new
subparagraph:
``(M) an arrangement described in subsection (i) between a
manufacturer of a drug and an individual who is prescribed such
drug.''; and
(2) by adding at the end the following new subsection:
``(i) For purposes of subsection (b)(3)(M), an arrangement
described in this subsection between a manufacturer of a drug and an
individual who is prescribed such drug is an arrangement entered into
on or after January 1, 2025, that satisfies each of the following:
``(1) The arrangement provides for payment or reimbursement
by the manufacturer for transportation, lodging, meals, or
other incidental expenses specified by the Secretary connected
with the administration of such drug and relating to travel to
and from the facility at which such drug is to be administered,
for the individual and up to two caregivers of the individual
(as determined appropriate by the manufacturer, taking into
account the individual's age and medical needs) during any
portion of the period during which such individual is being
administered such drug (including initial visits to such
facility before such administration, and followup visits to
such facility after such administration, relating to the
administration of such drug).
``(2) The arrangement does not provide for payment or
reimbursement by the manufacturer for transportation, lodging,
meals, or other incidental expenses described in paragraph (1)
if the manufacturer knows that the individual is eligible to
receive at no cost, such transportation, lodging, meals, or
other out-of-pocket expenses, as applicable, from the facility
at which the drug is administered to the individual.
``(3) The manufacturer does not advertise the arrangement
and makes good-faith efforts to ensure that the availability of
such arrangement is not disclosed to such individual until
after such drug is prescribed to such individual, provided that
such manufacturer does not interfere with a health care
provider's ability to furnish such individual with any
information determined appropriate by the provider.
``(4) If the arrangement provides for payment or
reimbursement by the manufacturer for transportation described
in paragraph (1), such payment or reimbursement is only for--
``(A) travel that is practical and convenient,
taking into account the individual's mobility or
medical needs, which may include ground transportation,
air transportation, or transportation by train;
``(B) the costs directly associated with the travel
for the individual and caregivers as described in
paragraph (1), such as airfare, taxes, tolls, gas, or
other fees; and
``(C) travel between the individual's residence and
the closest facility that is available to administer
such drug in a manner that is medically appropriate (as
determined by the individual's health care provider)
for the individual (or between any lodging where such
individual is staying in relation to such
administration and such facility).
``(5) If the arrangement provides for payment or
reimbursement by the manufacturer for lodging described in
paragraph (1), such lodging is--
``(A) reasonable based on the individual's age and
medical needs;
``(B) near the facility at which such individual is
to be administered such drug; and
``(C) only provided during the period described in
paragraph (1).
``(6) If the arrangement provides for payment or
reimbursement by the manufacturer for meals or other incidental
expenses described in paragraph (1), the amount of such payment
or reimbursement does not exceed the per diem rate in effect
for meals and incidental expenses in the geographic area in
which such facility is located (as established by the General
Services Administration) for the individual and for each
caregiver allowed under the arrangement pursuant to paragraph
(1).
``(7) The individual--
``(A) is determined to have income that does not
exceed the median income applicable to a family of the
size involved in the geographic region (as specified by
the Secretary) in which such individual resides; and
``(B) lives more than 1 hour of driving distance
(or 50 miles) from the nearest facility that
administers such drug and is accepting patients.
``(8) Such an arrangement is offered by the manufacturer to
individuals regardless of the facility involved in the
administration of the drug and regardless of the insurance
status of the individual.
``(9) The arrangement requires the individual to agree to
not request reimbursement from any Federal health care program
for any costs for which payment or reimbursement is made by the
manufacturer under the arrangement.
``(10) The manufacturer certifies that the manufacturer
does not bill or shift the costs of the arrangement to any of
the Federal health care programs.''.
(b) GAO Study and Report.--Not later than 3 years after the date of
the enactment of this section, the Comptroller General of the United
States shall submit to Congress a report on arrangements between a
manufacturer of a drug and an individual who is prescribed such drug
described in subsection (i) of section 1128B of the Social Security Act
(42 U.S.C. 1320a-7b), as added by subsection (a). Such report shall
include--
(1) an analysis of the impact of such arrangements on--
(A) access to transformative therapies, including
rare disease gene therapies;
(B) access to drugs that are the subject of such
arrangements, including socioeconomic disparities with
respect to such access; and
(C) the utilization by such individuals of--
(i) biosimilar biological products that are
the subject to such arrangements, as compared
to the utilization of the biological products
that are the reference products for such
biosimilar biological products; and
(ii) generic drugs that are the subject to
such arrangements, as compared to the
utilization of the drugs that are the reference
drugs for such generic drugs;
(2) a description of any tax benefits obtained in
connection with such arrangements by manufacturers offering
such arrangements;
(3) a list of the drugs for which a manufacturer of such
drug offers such an arrangement;
(4) with respect to each drug that is the subject of such
an agreement--
(A) the average cost directly associated with the
travel to and from the facility at which such drug is
to be administered, for the individual administered
such drug under such an arrangement and caregivers of
the individual, as described in subsection (i)(1) of
section 1128B of the Social Security Act (42 U.S.C.
1320a-7b), as added by subsection (a);
(B) the average distance so traveled by such
individuals and caregivers;
(C) the average family annual income of such
individuals;
(D) the average length of stay at the facility at
which the drug is administered for such individuals;
(E) the total number of such individuals with whom
such an arrangement has been made; and
(F) the percentage of prescriptions for such drug
that are filled when such an arrangement is available
to the individual being administered such drug compared
to the percentage of prescriptions for such drug that
are filled when such an arrangement is not so
available; and
(5) an analysis of the efficacy of any oversight conducted
to ensure that such arrangements adhere to any applicable
guidance from the Office of the Inspector General of the
Department of Health and Human Services on avoiding waste,
fraud, and abuse.
<all>
Introduced in House
Introduced in House
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.
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.
Referred to the Subcommittee on Health.
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