Amputation Reduction and Compassion Act of 2023 or the ARC Act of 2023
This bill provides for coverage of peripheral artery disease screening tests without cost-sharing under Medicare and Medicaid for certain at-risk individuals. It also requires the development of certain educational programs, a payment model, and Medicare quality measures to reduce amputations relating to such disease.
[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4261 Introduced in House (IH)]
<DOC>
118th CONGRESS
1st Session
H. R. 4261
To amend titles XVIII and XIX of the Social Security Act to provide for
coverage of peripheral artery disease screening tests furnished to at-
risk beneficiaries under the Medicare and Medicaid programs without the
imposition of cost-sharing requirements, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 21, 2023
Mr. Payne (for himself, Mr. Grijalva, Ms. Sewell, Mr. Carter of
Louisiana, Mrs. Watson Coleman, Mr. Veasey, Mr. Stanton, Ms. Porter,
Mr. Smith of New Jersey, Mr. Van Drew, Ms. Norton, Mr. Gallego, Mrs.
Beatty, Mr. Sessions, Mr. Davis of North Carolina, Mr. Cardenas, Mr.
Doggett, Mr. Neguse, Mr. Johnson of Georgia, Mr. Vargas, Mrs. Sykes,
Mr. Takano, Ms. McCollum, Ms. Blunt Rochester, Ms. Kuster, Mr. Thompson
of Mississippi, Ms. Matsui, Mr. Allred, Mr. Bishop of Georgia, and Mr.
Carson) 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 titles XVIII and XIX of the Social Security Act to provide for
coverage of peripheral artery disease screening tests furnished to at-
risk beneficiaries under the Medicare and Medicaid programs without the
imposition of cost-sharing requirements, 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; FINDINGS.
(a) Short Title.--This Act may be cited as the ``Amputation
Reduction and Compassion Act of 2023'' or the ``ARC Act of 2023''.
(b) Findings.--Congress makes the following findings:
(1) Atherosclerosis occurs when blood flow is reduced
because arteries become narrowed or blocked with fatty
deposits.
(2) Atherosclerosis is responsible for more deaths in the
United States than any other condition, and heart attacks,
resulting from clogged coronary arteries, are the leading cause
of death in America.
(3) Atherosclerosis also occurs in the legs and is known as
peripheral artery disease (in this subsection referred to as
``PAD'') and having PAD significantly increases the risk for
heart attack, stroke, amputation, and death.
(4) While most Americans are aware of atherosclerosis in
the heart, many Americans have never heard of PAD and Americans
with PAD are often unaware of the serious risks of the disease.
(5) An estimated 21 million Americans have PAD, and about
200,000 of them--disproportionately minorities--suffer
avoidable amputations every year as a result of such disease.
(6) According to the Dartmouth Atlas, amputation risks for
African Americans living with diabetes are as much as four
times higher than the national average.
(7) Data analyses have similarly found that Native
Americans are more than twice as likely to be subjected to
amputation and Hispanics are up to 75 percent more likely to
have an amputation.
(8) Fifty-two percent of patients with an above-the-knee
amputation and 33 percent of patients with a below-the-knee
amputation will die within two years of their amputation.
(9) Screening and arterial testing for PAD is cost-
effective and should be part of routine medical care.
(10) Once PAD is detected, amputations and deaths can be
reduced through the use of national, evidence-based PAD care
guidelines.
(11) Americans with a PAD diagnosis are associated with a
67-percent increase in the risk of cardiac death compared to
people without a PAD diagnosis. Consequently, screening for PAD
enables health care professionals to identify cardiac risk
factors earlier and take proactive measures to reduce the risk
of cardiac death.
SEC. 2. PERIPHERAL ARTERY DISEASE EDUCATION PROGRAM.
Part P of title III of the Public Health Service Act (42 U.S.C.
280g et seq.) is amended by adding at the end the following new
section:
``SEC. 399V-7. PERIPHERAL ARTERY DISEASE EDUCATION PROGRAM.
``(a) Establishment.--The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, in collaboration with
the Administrator of the Centers for Medicare & Medicaid Services, the
Administrator of the Health Resources and Services Administration,
leading clinical and patient advocacy organizations, and other
interested stakeholders shall establish and coordinate a peripheral
artery disease education program to support, develop, and implement
educational initiatives and outreach strategies that inform health care
professionals and the public about the existence of peripheral artery
disease and methods to reduce amputations related to such disease,
particularly with respect to at-risk populations.
``(b) Best Practices.--The Secretary shall, as appropriate,
identify and disseminate to health care professionals best practices
with respect to peripheral artery disease.
``(c) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $6,000,000 for each of fiscal
years 2024 through 2028.''.
SEC. 3. MEDICARE COVERAGE OF PERIPHERAL ARTERY DISEASE SCREENING TESTS
FURNISHED TO AT-RISK BENEFICIARIES WITHOUT IMPOSITION OF
COST-SHARING REQUIREMENTS.
(a) In General.--Section 1861 of the Social Security Act (42 U.S.C.
1395x) is amended--
(1) in subsection (s)(2)--
(A) in subparagraph (JJ), by striking the semicolon
at the end and inserting ``; and''; and
(B) by adding at the end the following new
subparagraph:
``(KK) peripheral artery disease screening tests
furnished to at-risk beneficiaries (as such terms are
defined in subsection (nnn)).''; and
(2) by adding at the end the following new subsection:
``(nnn) Peripheral Artery Disease Screening Test; At-Risk
Beneficiary.--(1) The term `peripheral artery disease screening test'
means--
``(A) noninvasive physiologic studies of extremity arteries
(commonly referred to as ankle-brachial index testing);
``(B) arterial duplex scans of lower extremity arteries
vascular; and
``(C) such other items and services as the Secretary
determines, in consultation with relevant stakeholders, to be
appropriate for screening for peripheral artery disease for at-
risk beneficiaries.
``(2) The term `at-risk beneficiary' means an individual entitled
to, or enrolled for, benefits under part A and enrolled for benefits
under part B--
``(A) who is 65 years of age or older;
``(B) who is at least 50 years of age but not older than 64
years of age with risk factors for atherosclerosis (such as
diabetes mellitus, a history of smoking, hyperlipidemia, and
hypertension) or a family history of peripheral artery disease;
``(C) who is younger than 50 years of age with diabetes
mellitus and one additional risk factor for atherosclerosis; or
``(D) with a known atherosclerotic disease in another
vascular bed such as coronary, carotid, subclavian, renal, or
mesenteric artery stenosis, or abdominal aortic aneurysm.
``(3) The Secretary shall, in consultation with appropriate
organizations, establish standards regarding the frequency for
peripheral artery disease screening tests described in subsection
(s)(2)(KK) for purposes of coverage under this title.''.
(b) Inclusion of Peripheral Artery Disease Screening Tests in
Initial Preventive Physical Examination.--Section 1861(ww)(2) of the
Social Security Act (42 U.S.C. 1395x(ww)(2)) is amended--
(1) in subparagraph (N), by moving the margins of such
subparagraph 2 ems to the left;
(2) by redesignating subparagraph (O) as subparagraph (P);
and
(3) by inserting after subparagraph (N) the following new
subparagraph:
``(O) Peripheral artery disease screening tests
furnished to at risk-beneficiaries (as such terms are
defined in subsection (nnn)).''.
(c) Payment.--
(1) In general.--Section 1833(a) of the Social Security Act
(42 U.S.C. 1395l(a)) is amended--
(A) in paragraph (1)--
(i) in subparagraph (N), by inserting ``and
other than peripheral artery disease screening
tests furnished to at-risk beneficiaries (as
such terms are defined in section 1861(nnn))''
after ``other than personalized prevention plan
services (as defined in section
1861(hhh)(1))'';
(ii) by striking ``and'' before ``(HH)'';
and
(iii) by adding at the end the following:
``and (II) with respect to peripheral artery
disease screening tests furnished to at-risk
beneficiaries (as such terms are defined in
section 1861(nnn)), the amount paid shall be
100 percent of the lesser of the actual charge
for the services or the amount determined under
the payment basis determined under section
1848;''; and
(B) in paragraph (2)--
(i) in subparagraph (G), by striking
``and'' at the end;
(ii) in subparagraph (H), by striking the
semicolon at the end and inserting ``; and'';
and
(iii) by inserting after subparagraph (H)
the following new subparagraph:
``(I) with respect to peripheral artery disease screening
tests (as defined in paragraph (1) of section 1861(nnn))
furnished by an outpatient department of a hospital to at-risk
beneficiaries (as defined in paragraph (2) of such section),
the amount determined under paragraph (1)(II);''.
(2) No deductible.--Section 1833(b) of the Social Security
Act (42 U.S.C. 1395l(b)) is amended, in the first sentence--
(A) by striking ``, and'' before ``(13)''; and
(B) by inserting before the period at the end the
following: ``, and (14) such deductible shall not apply
with respect to peripheral artery disease screening
tests furnished to at-risk beneficiaries (as such terms
are defined in section 1861(nnn))''.
(3) Exclusion from prospective payment system for hospital
outpatient department services.--Section 1833(t)(1)(B)(iv) of
the Social Security Act (42 U.S.C. 1395l(t)(1)(B)(iv)) is
amended--
(A) by striking ``, or personalized'' and inserting
``, personalized''; and
(B) by inserting ``, or peripheral artery disease
screening tests furnished to at-risk beneficiaries (as
such terms are defined in section 1861(nnn))'' after
``personalized prevention plan services (as defined in
section 1861(hhh)(1))''.
(4) Conforming amendment.--Section 1848(j)(3) of the Social
Security Act (42 U.S.C. 1395w-4(j)(3)) is amended by striking
``(2)(FF) (including administration of the health risk
assessment) ,'' and inserting ``(2)(FF) (including
administration of the health risk assessment), (2)(KK),''.
(d) Exclusion From Coverage and Medicare as Secondary Payer for
Tests Performed More Frequently Than Allowed.--Section 1862(a)(1) of
the Social Security Act (42 U.S.C. 1395y(a)(1)) is amended--
(1) in subparagraph (O), by striking ``and'' at the end;
(2) in subparagraph (P), by striking the semicolon at the
end and inserting ``, and''; and
(3) by adding at the end the following new subparagraph:
``(Q) in the case of peripheral artery disease
screening tests furnished to at-risk beneficiaries (as
such terms are defined in section 1861(nnn)), which are
performed more frequently than is covered under such
section;''.
(e) Authority To Modify or Eliminate Coverage of Certain Preventive
Services.--Section 1834(n) of the Social Security Act (42 U.S.C.
1395m(n)) is amended--
(1) by redesignating subparagraphs (A) and (B) of paragraph
(1) as clauses (i) and (ii), respectively, and moving the
margins of such clauses, as so redesignated, 2 ems to the
right;
(2) by redesignating paragraphs (1) and (2) as
subparagraphs (A) and (B), respectively, and moving the margins
of such subparagraphs, as so redesignated, 2 ems to the right;
(3) by striking ``Certain Preventive Services'' and all
that follows through ``any other provision of this title'' and
inserting: ``Certain Preventive Services.--
``(1) In general.--Notwithstanding any other provision of
this title''; and
(4) by adding at the end the following new paragraph:
``(2) Inapplicability.--The Secretarial authority described
in paragraph (1) shall not apply with respect to preventive
services described in section 1861(ww)(2)(O).''.
(f) Effective Date.--The amendments made by this section shall
apply with respect to items and services furnished on or after January
1, 2024.
SEC. 4. MEDICAID COVERAGE OF PERIPHERAL ARTERY DISEASE SCREENING TESTS
FURNISHED TO AT-RISK BENEFICIARIES WITHOUT IMPOSITION OF
COST-SHARING REQUIREMENTS.
(a) In General.--Section 1905 of the Social Security Act (42 U.S.C.
1396d) is amended--
(1) in subsection (a)--
(A) in paragraph (30), by striking ``and'' at the
end;
(B) by redesignating paragraph (31) as paragraph
(32); and
(C) by inserting after paragraph (30) the following
new paragraph:
``(31) peripheral artery disease screening tests furnished
to at-risk beneficiaries (as such terms are defined in
subsection (jj)); and''; and
(2) by adding at the end the following new subsection:
``(jj) Peripheral Artery Disease Screening Test; At-Risk
Beneficiary.--
``(1) Peripheral artery disease screening test.--The term
`peripheral artery disease screening test' means--
``(A) noninvasive physiologic studies of extremity
arteries (commonly referred to as ankle-brachial index
testing);
``(B) arterial duplex scans of lower extremity
arteries vascular; and
``(C) such other items and services as the
Secretary determines, in consultation with relevant
stakeholders, to be appropriate for screening for
peripheral artery disease for at-risk beneficiaries.
``(2) At-risk beneficiary.--The term `at-risk beneficiary'
means an individual enrolled under a State plan (or a waiver of
such plan)--
``(A) who is 65 years of age or older;
``(B) who is at least 50 years of age but not older
than 64 years of age with risk factors for
atherosclerosis (such as diabetes mellitus, a history
of smoking, hyperlipidemia, and hypertension) or a
family history of peripheral artery disease;
``(C) who is younger than 50 years of age with
diabetes mellitus and one additional risk factor for
atherosclerosis; or
``(D) with a known atherosclerotic disease in
another vascular bed such as coronary, carotid,
subclavian, renal, or mesenteric artery stenosis, or
abdominal aortic aneurysm.
``(3) Frequency.--The Secretary shall, in consultation with
appropriate organizations, establish standards regarding the
frequency for peripheral artery disease screening tests
described in subsection (a)(31) for purposes of coverage under
a State plan under this title.''.
(b) No Cost Sharing.--
(1) In general.--Subsections (a)(2) and (b)(2) of section
1916 of the Social Security Act (42 U.S.C. 1396o) are each
amended--
(A) in subparagraph (I), by striking ``or'' at the
end;
(B) in subparagraph (J), by striking ``; and'' and
inserting ``, or''; and
(C) by adding at the end the following new
subparagraph:
``(K) peripheral artery disease screening tests
furnished to at-risk beneficiaries (as such terms are
defined in section 1905(jj)); and''.
(2) Application to alternative cost sharing.--Section
1916A(b)(3)(B) of the Social Security Act (42 U.S.C. 1396o-
1(b)(3)(B)) is amended by adding at the end the following new
clause:
``(xv) Peripheral artery disease screening
tests furnished to at-risk beneficiaries (as
such terms are defined in section 1905(jj)).''.
(c) Conforming Amendments.--
(1) Section 1902(nn)(3) of the Social Security Act (42
U.S.C. 1396a(nn)(3)) is amended by striking ``following
paragraph (31)'' and inserting ``following paragraph (32)''.
(2) Section 1905(a) of the Social Security Act (42 U.S.C.
1396d(a)) is amended by striking ``following paragraph (31)''
and inserting ``following paragraph (32)''.
SEC. 5. DEVELOPMENT AND IMPLEMENTATION OF QUALITY MEASURES.
(a) Development.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall, in
consultation with relevant stakeholders, develop quality measures for
nontraumatic, lower-limb, major amputation that utilize appropriate
diagnostic screening (including peripheral artery disease screening) in
order to encourage alternative treatments (including revascularization)
in lieu of such an amputation.
(b) Implementation.--Not later than 18 months after the date of
enactment of this Act, the Secretary shall complete appropriate testing
and validation of the measures developed under subsection (a) and shall
incorporate such measures in quality reporting programs for appropriate
providers of services and suppliers under the Medicare program under
title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.),
including for purposes of--
(1) the merit-based incentive payment system under section
1848(q) of such Act (42 U.S.C. 1395w-4(q));
(2) incentive payments for participation in eligible
alternative payment models under section 1833(z) of such Act
(42 U.S.C. 1395l(z));
(3) the shared savings program under section 1899 of such
Act (42 U.S.C. 1395jjj);
(4) models under section 1115A of such Act (42 U.S.C.
1315a); and
(5) such other payment systems or models as the Secretary
may specify.
SEC. 6. AMPUTATION PREVENTION PILOT PROGRAM.
(a) In General.--Section 1115A(b)(2)(B) of the Social Security Act
(42 U.S.C. 1315a(b)(2)(B)) is amended by adding at the end the
following new clause:
``(xxviii) Promoting voluntary,
nontraumatic lower-limb major amputation
prevention programs at hospitals, ambulatory
surgical centers, and office-based centers that
will increase access to amputation prevention
services, reduce amputation rates, and reduce
costs to such hospitals, surgical centers, and
office-based centers, through--
``(I) patient risk modification and
management;
``(II) early screening and
detection and surveillance;
``(III) testing and treatment for
peripheral artery disease; and
``(IV) improved care coordination
for individuals at high risk for
amputation.''.
(b) Testing of Model.--Not later than 18 months after the date of
the enactment of this Act, the Deputy Administrator and Director of the
Center for Medicare and Medicaid Innovation shall test the model
described under subsection (a).
<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.
Sponsor introductory remarks on measure. (CR H3129)
Referred to the Subcommittee on Health.
ASSUMING FIRST SPONSORSHIP - Mr. Jackson (IL) asked unanimous consent that he may hereafter be considered as the first sponsor of H.R. 4261, a bill originally introduced by Representative Payne, for the purpose of adding cosponsors and requesting reprintings pursuant to clause 7 of rule XII. Agreed to without objection.
Referred to the Subcommittee on Health.
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