Sec. 7602. Amputation Reduction and Compassion Act

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Part P of title III of the Public Health Service Act ( 42 U.S.C. 280g et seq. ), as amended by section 7254, is further amended by adding at the end the following new section: 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.

There is authorized to be appropriated to carry out this section such sums as may be necessary for each of fiscal years 2023 through 2027. . Section 1861 of the Social Security Act ( 42 U.S.C. 1395x ), as amended by sections 2007, 4221, 4251, 6011, 7220, and 7601, is amended— in subsection (s)(2)— in subparagraph (KK), by striking and at the end; in subparagraph (LL), by striking the period at the end and inserting ; and ; and by adding at the end the following new subparagraph: peripheral artery disease screening tests furnished to at-risk beneficiaries (as such terms are defined in subsection (rrr)). ; and by adding at the end the following new subsection:

The term peripheral artery disease screening test means— noninvasive physiologic studies of extremity arteries (commonly referred to as ankle-brachial index testing); arterial duplex scans of lower extremity arteries vascular; and 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. The term at-risk beneficiary means an individual entitled to, or enrolled for, benefits under part A and enrolled for benefits under part B— who is 65 years of age or older; 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; who is younger than 50 years of age with diabetes mellitus and one additional risk factor for atherosclerosis; or with a known atherosclerotic disease in another vascular bed such as coronary, carotid, subclavian, renal, or mesenteric artery stenosis, or abdominal aortic aneurysm.

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. . Section 1861(ww)(2) of the Social Security Act ( 42 U.S.C. 1395x(ww)(2) ) is amended— in subparagraph (N), by moving the margins of such subparagraph 2 ems to the left; by redesignating subparagraph

(O)as subparagraph (P); and by inserting after subparagraph

(N)the following new subparagraph: Peripheral artery disease screening tests furnished to at-risk beneficiaries (as such terms are defined in subsection (rrr)). . Section 1833(a) of the Social Security Act ( 42 U.S.C. 1395l(a) ), as amended by sections 4251(c)(3), 6011(a)(4), and 7220, is amended— in paragraph (1)— 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)) ; by striking and before

(GG); and by inserting before the semicolon at the end the following: , and

(HH)with respect to peripheral artery disease screening tests furnished to at-risk beneficiaries (as such terms are defined in section 1861(rrr)), 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 in paragraph (2)— in subparagraph (G), by striking and at the end; in subparagraph (H), by striking the comma at the end and inserting ; and ; and by inserting after subparagraph

(H)the following new subparagraph: with respect to peripheral artery disease screening tests (as defined in paragraph

(1)of section 1861(rrr)) 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), . Section 1833(b) of the Social Security Act ( 42 U.S.C. 1395l(b) ), as amended by section 6075, is amended, in the first sentence— by striking and before

(13); and by inserting , 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(rrr)) before the period at the end. Section 1833(t)(1)(B)(iv) of the Social Security Act ( 42 U.S.C. 1395l(t)(1)(B)(iv) ) is amended— by striking , or personalized and inserting , personalized ; and by inserting , or peripheral artery disease screening tests furnished to at-risk beneficiaries (as such terms are defined in section 1861(rrr)) after personalized prevention plan services (as defined in section 1861(hhh)(1)) . Section 1848(j)(3) of the Social Security Act ( 42 U.S.C. 1395w–4(j)(3) ), as amended by section 4251(c)(4), is amended by inserting , (2)(MM), after (2)(II) . Section 1862(a)(1) of the Social Security Act ( 42 U.S.C. 1395y(a)(1) ), as amended by section 7601, is amended— in subparagraph (P), by striking and at the end; in subparagraph (Q), by striking the semicolon at the end and inserting , and ; and by adding at the end the following new subparagraph: in the case of peripheral artery disease screening tests furnished to at-risk beneficiaries (as such terms are defined in section 1861(rrr)), which are performed more frequently than is covered under such section; . Section 1834(n) of the Social Security Act ( 42 U.S.C. 1395m(n) ) is amended— 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; 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; by striking and all that follows through Certain Preventive Services any other provision of this title and inserting: Certain Preventive Services.— Notwithstanding any other provision of this title ; and by adding at the end the following new paragraph: The Secretarial authority described in paragraph

(1)shall not apply with respect to preventive services described in section 1861(ww)(2)(O). . The amendments made by this subsection shall apply with respect to items and services furnished on or after January 1, 2023. Section 1905 of the Social Security Act ( 42 U.S.C. 1396d ) as amended by sections 2007(d)(3) and 5201(a)(5)(G)(i), is amended— in subsection (a)— by redesignating paragraph

(33)as paragraph (34); in paragraph (32), by striking and after the semicolon; and by inserting after paragraph

(32)the following new paragraph: peripheral artery disease screening tests furnished to at-risk beneficiaries (as such terms are defined in subsection (qq)); and ; and by adding at the end the following new subsection: The term peripheral artery disease screening test means— noninvasive physiologic studies of extremity arteries (commonly referred to as ankle-brachial index testing); arterial duplex scans of lower extremity arteries vascular; and 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. The term at-risk beneficiary means an individual enrolled under a State plan (or a waiver of such plan)— who is 65 years of age or older; 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; who is younger than 50 years of age with diabetes mellitus and one additional risk factor for atherosclerosis; or with a known atherosclerotic disease in another vascular bed such as coronary, carotid, subclavian, renal, or mesenteric artery stenosis, or abdominal aortic aneurysm. The Secretary shall, in consultation with appropriate organizations, establish standards regarding the frequency for peripheral artery disease screening tests described in subsection (a)(33) for purposes of coverage under a State plan under this title. . Subsections (a)(2) and (b)(2) of section 1916 of the Social Security Act ( 42 U.S.C. 1396o ), as amended by section 7154(b)(1), are each amended— in subparagraph (J), by striking or after the comma at the end; in subparagraph (K), by striking ; and and inserting , or ; and by adding at the end the following new subparagraph: peripheral artery disease screening tests furnished to at-risk beneficiaries (as such terms are defined in section 1905(hh)); and . Section 1916A(b)(3)(B) of the Social Security Act ( 42 U.S.C. 1396o–1(b)(3)(B) ), as amended by section 7154(b)(2), is amended by adding at the end the following new clause: Peripheral artery disease screening tests furnished to at-risk beneficiaries (as such terms are defined in section 1905(qq)). . Section 1902(a)(10)(A) of the Social Security Act ( 42 U.S.C. 1396a(a)(10)(A) ), as amended by section 2007(d)(2), is amended by striking and

(31)and inserting (31), and

(33). Section 2713 of the Public Health Service Act ( 42 U.S.C. 300gg–13 ) is amended— by amending subsection (a), as amended by section 7220(a)(1)(A), to read as follows: 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— 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; 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; 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; 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; any prescription drug approved by the Food and Drug Administration for the prevention of HIV (other than a drug subject to preauthorization requirements consistent with section 2729A), administrative fees for such drugs, laboratory and other diagnostic procedures associated with the use of such drugs, and clinical follow-up and monitoring, including any related services recommended in current United States Public Health Service clinical practice guidelines, without limitation; and with respect to at-risk enrollees, peripheral artery disease screening tests. For purposes of paragraph (1)(E): The term peripheral artery disease screening test means— noninvasive physiologic studies of extremity arteries (commonly referred to as ankle-brachial index testing); arterial duplex scans of lower extremity arteries vascular; and 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. The term at-risk enrollee means an individual enrolled in a group health plan or group or individual health insurance coverage— who is 65 years of age or older; 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; who is younger than 50 years of age with diabetes mellitus and one additional risk factor for atherosclerosis; or with a known atherosclerotic disease in another vascular bed such as coronary, carotid, subclavian, renal, or mesenteric artery stenosis, or abdominal aortic aneurysm. 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. 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. 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. ; and in subsection (b)(1)— by striking subsection (a)(1) or (a)(2) or a guideline under subsection (a)(3) and inserting subparagraph

(A)or

(B)of subsection (a)(1) or a guideline under subparagraph

(C)of such subsection ; and by striking described in subsection

(a)and inserting described in subsection (a)(1) . The amendments made by paragraph

(1)shall apply with respect to plan years beginning on or after January 1, 2023. Section 1834 of the Social Security Act ( 42 U.S.C. 1395m ), as amended by section 4221(b)(2), is amended by adding at the end the following new subsection: In the case of nontraumatic amputation services furnished by a supplier on or after January 1, 2023, 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— 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 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. In this subsection: The term anatomical testing services means arterial duplex scanning, computed tomography angiography, and magnetic resonance angiography. The term nontraumatic amputation services means amputations as a result of atherosclerotic vascular disease or a related comorbidity of such disease (including diabetes). . The Secretary of Health and Human Services (referred to in this subsection 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. After appropriate testing and validation of the measures developed under paragraph (1), 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— the merit-based incentive payment system under section 1848(q) of such Act ( 42 U.S.C. 1395w–4(q) ); incentive payments for participation in eligible alternative payment models under section 1833(z) of such Act ( 42 U.S.C. 1395l(z) ); the shared savings program under section 1899 of such Act ( 42 U.S.C. 1395jjj ); models under section 1115A of such Act ( 42 U.S.C. 1315a ); and such other payment systems or models as the Secretary may specify.

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