Amputation Reduction and Compassion Act of 2021 or the ARC Act of 2021
This bill provides for coverage of peripheral artery disease screening tests without cost-sharing under Medicare, Medicaid, and private health insurance for certain at-risk individuals, and requires the development of certain educational programs and Medicare quality measures to reduce amputations relating to such disease.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2631 Introduced in House (IH)]
<DOC>
117th CONGRESS
1st Session
H. R. 2631
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, to amend title XXVII of the
Public Health Service Act to require group health plans and health
insurance issuers offering group or individual health insurance
coverage to provide coverage for such screening tests furnished to at-
risk enrollees of group health plans and group or individual health
insurance coverage without the imposition of cost sharing requirements,
and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 16, 2021
Mr. Payne (for himself, Mr. Gallego, Mr. Rush, Mr. Takano, Mr.
Grijalva, Ms. Porter, Mr. Soto, Mr. Butterfield, Mr. Van Drew, Ms.
Pressley, and Mr. Sires) 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, to amend title XXVII of the
Public Health Service Act to require group health plans and health
insurance issuers offering group or individual health insurance
coverage to provide coverage for such screening tests furnished to at-
risk enrollees of group health plans and group or individual health
insurance coverage 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 2021'' or the ``ARC Act of 2021''.
(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 and
the Administrator of the Health Resources and Services Administration,
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) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section such sums as may be necessary
for each of fiscal years 2022 through 2026.''.
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 (GG), by striking ``and'' at
the end;
(B) in subparagraph (HH), by striking the period at
the end and inserting ``; and''; and
(C) by adding at the end the following new
subparagraph:
``(II) peripheral artery disease screening tests
furnished to at-risk beneficiaries (as such terms are
defined in subsection (lll)).''; and
(2) by adding at the end the following new subsection:
``(lll) 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)(II) 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 (lll)).''.
(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(lll))''
after ``other than personalized prevention plan
services (as defined in section
1861(hhh)(1))'';
(ii) by striking ``and'' before ``(DD)'';
and
(iii) by striking ``such service,;'' at the
end and inserting the following: ``, and (EE)
with respect to peripheral artery disease
screening tests furnished to at-risk
beneficiaries (as such terms are defined in
section 1861(lll)), 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
comma 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(lll))
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)(EE),''.
(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 ``(12)''; and
(B) by inserting ``, and (13) 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(lll))'' before
the period at the end.
(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(lll))'' 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)(II)''.
(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(lll)), 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, 2022.
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 (hh)); and''; and
(2) by adding at the end the following new subsection:
``(hh) 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 (F), by striking ``or'' at the
end;
(B) in subparagraph (G), by striking ``; and'' and
inserting ``, or''; and
(C) by adding at the end the following new
subparagraph:
``(H) peripheral artery disease screening tests
furnished to at-risk beneficiaries (as such terms are
defined in section 1905(hh)); 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:
``(xii) Peripheral artery disease screening
tests furnished to at-risk beneficiaries (as
such terms are defined in section 1905(hh)).''.
(c) Mandatory Coverage.--Section 1902(a)(10)(A) of the Social
Security Act (42 U.S.C. 1396a(a)(10)(A)) is amended by striking ``and
(30)'' and inserting ``(30), and (31)''.
(d) 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 (30)'' 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 (30)''
and inserting ``following paragraph (32)''.
SEC. 5. REQUIREMENT FOR GROUP HEALTH PLANS AND HEALTH INSURANCE ISSUERS
OFFERING GROUP OR INDIVIDUAL HEALTH INSURANCE COVERAGE TO
PROVIDE COVERAGE FOR PERIPHERAL ARTERY DISEASE SCREENING
TESTS FURNISHED TO AT-RISK ENROLLEES WITHOUT IMPOSITION
OF COST SHARING REQUIREMENTS.
(a) In General.--Subsection (a) of section 2713 of the Public
Health Service Act (42 U.S.C. 300gg-13) is amended to read as follows:
``(a) Coverage of Preventive Health Services.--
``(1) In general.--A group health plan and a health
insurance issuer offering group or individual health insurance
coverage shall, at a minimum, provide coverage for and shall
not impose any cost sharing requirements for--
``(A) evidence-based items or services that have in
effect a rating of `A' or `B' in the current
recommendations of the United States Preventive
Services Task Force;
``(B) immunizations that have in effect a
recommendation from the Advisory Committee on
Immunization Practices of the Centers for Disease
Control and Prevention with respect to the individual
involved;
``(C) with respect to infants, children, and
adolescents, evidence-informed preventive care and
screenings provided for in the comprehensive guidelines
supported by the Health Resources and Services
Administration;
``(D) with respect to women, such additional
preventive care and screenings not described in
subparagraph (A) as provided for in comprehensive
guidelines supported by the Health Resources and
Services Administration for purposes of this
subparagraph; and
``(E) with respect to at-risk enrollees, peripheral
artery disease screening tests.
``(2) Peripheral artery disease screening test; at-risk
enrollee.--For purposes of paragraph (1)(E):
``(A) Peripheral artery disease screening test.--
The term `peripheral artery disease screening test'
means--
``(i) noninvasive physiologic studies of
extremity arteries (commonly referred to as
ankle-brachial index testing);
``(ii) arterial duplex scans of lower
extremity arteries vascular; and
``(iii) 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 enrollees.
``(B) At-risk enrollee.--The term `at-risk
enrollee' means an individual enrolled in a group
health plan or group or individual health insurance
coverage--
``(i) who is 65 years of age or older;
``(ii) 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;
``(iii) who is younger than 50 years of age
with diabetes mellitus and one additional risk
factor for atherosclerosis; or
``(iv) with a known atherosclerotic disease
in another vascular bed such as coronary,
carotid, subclavian, renal, or mesenteric
artery stenosis, or abdominal aortic aneurysm.
``(C) Frequency.--The Secretary shall, in
consultation with appropriate organizations, establish
standards regarding the frequency for peripheral artery
disease screening tests described in paragraph (1)(E)
for purposes of coverage under this section.
``(3) Clarification regarding breast cancer screening,
mammography, and prevention recommendations.--For the purposes
of this Act, and for the purposes of any other provision of
law, the current recommendations of the United States
Preventive Service Task Force regarding breast cancer
screening, mammography, and prevention shall be considered the
most current other than those issued in or around November
2009.
``(4) Rule of construction.--Nothing in this subsection
shall be construed to prohibit a plan or issuer from providing
coverage for services in addition to those recommended by the
United States Preventive Services Task Force or to deny
coverage for services that are not recommended by such Task
Force.''.
(b) Effective Date.--The amendment made by subsection (a) shall
apply with respect to plan years beginning on or after January 1, 2022.
SEC. 6. DISALLOWANCE OF PAYMENT FOR NONTRAUMATIC AMPUTATION SERVICES
FURNISHED WITHOUT ANATOMICAL TESTING SERVICES.
Section 1834 of the Social Security Act (42 U.S.C. 1395m) is
amended by adding at the end the following new subsection:
``(z) Disallowance of Payment for Nontraumatic Amputation Services
Furnished Without Anatomical Testing Services.--
``(1) In general.--In the case of nontraumatic amputation
services furnished by a supplier on or after January 1, 2022,
to an individual entitled to, or enrolled for, benefits under
part A and enrolled for benefits under this part, for which
payment is made under this part, payment may only be made under
this part if--
``(A) such supplier furnishes anatomical testing
services to such individual during the 3-month period
preceding the date on which such nontraumatic
amputation services is furnished; or
``(B) such individual has a pre-existing
dysfunctional or unsalvageable limb, life-threatening
sepsis, intractable infection, extensive gangrene or
necrotic tissue loss beyond salvage, a poor functional
status, severe dementia, or a short life expectancy
after shared decision-making with a health care team
and patient, family, or caregiver.
``(2) Definitions.--In this subsection:
``(A) Anatomical testing services.--The term
`anatomical testing services' means arterial duplex
scanning, computed tomography angiography, and magnetic
resonance angiography.
``(B) Nontraumatic amputation services.--The term
`nontraumatic amputation services' means amputations as
a result of atherosclerotic vascular disease or a
related comorbidity of such disease (including
diabetes).''.
SEC. 7. 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.--After appropriate testing and validation of
the measures developed under subsection (a), the Secretary 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.
<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 Social Security.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Health.
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