II 116th CONGRESS 2d Session S. 4503 IN THE SENATE OF THE UNITED STATES August 6, 2020 Mr. Warner (for himself, Mr. Daines , Ms. Duckworth , Mr. Cassidy , and Mr. Cornyn ) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend title XVIII of the Social Security Act to protect beneficiaries with limb loss and other orthopedic conditions by providing access to appropriate, safe, effective, patient-centered orthotic and prosthetic care, to reduce fraud, waste, and abuse with respect to orthotics and prosthetics, and for other purposes.

1. Short title This Act may be cited as the Medicare Orthotics and Prosthetics Patient-Centered Care Act . 2. Increasing protections for beneficiaries receiving orthotic and prosthetic care under the Medicare program (a) Distinguishing orthotists and prosthetists from suppliers of durable medical equipment and supplies Section 1834 of the Social Security Act ( 42 U.S.C. 1395m ) is amended— (1) in subsection (j)(5), by striking subparagraph (C) and redesignating the subsequent subparagraphs accordingly; and (2) by adding at the end the following new subsection: (x) Requirements for orthotists and prosthetists (1) Issuance and renewal of supplier number (A) Payment (i) In general No payment may be made under this part to an orthotic or prosthetic supplier unless such orthotic or prosthetic supplier obtains (and renews at such intervals as the Secretary may require) a supplier number. (ii) Clarification regarding providers under part A Nothing in clause (i) shall prohibit a provider otherwise permitted to receive payment for orthotics and prosthetics under part A from continuing to receive payment under such part without interruption. (B) Standards for possessing a supplier number An orthotic or prosthetic supplier may only obtain a supplier number if the supplier meets standards prescribed by the Secretary that include requirements that the orthotic or prosthetic supplier (and, where applicable, the orthotist or prosthetist)— (i) licensure and accreditation— (I) complies with all applicable State and Federal licensure and regulatory requirements; and (II) acquires accreditation from the American Board for Certification in Orthotics, Prosthetics and Pedorthics, Inc. or the Board of Certification/Accreditation, International, or other accreditation entity that the Secretary determines has standards that are equivalent to the standards of such Boards; (ii) maintains a physical facility on an appropriate site; (iii) has proof of appropriate liability insurance; and (iv) meets such other requirements as the Secretary shall specify. (C) Prohibition against multiple supplier numbers The Secretary may not issue more than one supplier number to any orthotic or prosthetic supplier unless the Secretary finds that the issuance of more than one number is appropriate to identify other entities under the ownership or control of the orthotic or prosthetic supplier. (2) Order for orthotics or prosthetics (A) Information provided by orthotists and prosthetists on detailed written orders for orthotics and prosthetics An orthotist or prosthetist may distribute to physicians, physician assistants, nurse practitioners, clinical nurse specialists, or individuals entitled to benefits under this part, a detailed written order for orthotics or prosthetics (as defined in paragraph (5)) for commercial purposes that contains the following information: (i) The identification of— (I) the orthotic or prosthetic supplier; and (II) the individual to whom the orthotics or prosthetics are furnished. (ii) The identification of the treating physician, physician assistant, nurse practitioner, or clinical nurse specialist. (iii) A description of the orthotics or prosthetics ordered. (iv) The date of the order described in this subparagraph. (B) Information on coding and descriptors of components provided If an orthotist or prosthetist distributes a detailed written order for orthotics or prosthetics described in subparagraph (A), the orthotist or prosthetist shall also list on the order the summary descriptors of the items and services being recommended prior to submission of the order to the treating physician for approval. (C) Signature by treating physician A detailed written order for orthotics or prosthetics described in subparagraph (A) shall be signed by the treating physician. (3) Limitation on patient liability Except as provided in paragraph (4), if an orthotist or prosthetist— (A) furnishes an orthosis or prosthesis to a beneficiary for which no payment may be made under this part; or (B) subject to section 1879, furnishes an orthosis or prosthesis to a beneficiary for which payment is denied under section 1862(a)(1), any expenses incurred for the orthosis or prosthesis furnished to an individual by the orthotist or prosthetist not on an assigned basis shall be the responsibility of such orthotist or prosthetist. The individual shall have no financial responsibility for such expenses and the orthotist or prosthetist shall refund on a timely basis to the individual (and shall be liable to the individual for) any amounts collected from the individual for such items and services. The provisions of subsection (a)(18) shall apply to refunds required under the previous sentence in the same manner as such provisions apply to refunds under such subsection. (4) Patient liability If an orthotist or prosthetist furnishes an orthosis or prosthesis to a patient for which payment is denied in advance under subsection (a)(15), expenses incurred for such orthosis or prosthesis furnished to the individual by the orthotist or prosthetist shall be the responsibility of the individual. (5) Definitions In this subsection: (A) Detailed written order for orthotics or prosthetics (i) In general The term detailed written order for orthotics or prosthetics means a form or other document prepared by an orthotist or prosthetist and signed by the physician (as defined by section 1861(r)) that contains information required by the Secretary to show that an orthosis or prosthesis is reasonable and necessary for the treatment of an illness or injury or to improve the functioning of a malformed body member. (ii) Clarification The detailed written order for orthotics or prosthetics shall not be considered alone for purposes of determining the reasonableness, medical necessity, and functional level (applicable to prosthetics) of orthotics and prosthetics. (B) Orthotics and prosthetics The term orthotics and prosthetics has the meaning given that term in section 1834(h)(4)(C). (C) Orthotist or prosthetist The term orthotist or prosthetist means an individual who is specifically trained and educated in the provision of, and patient care management related to, prosthetics and custom-fabricated or custom-fit orthotics, and— (i) in the case of a State that provides for the licensing of orthotists and prosthetists, is licensed by the State in which the orthotics or prosthetics were supplied; or (ii) in the case of a State that does not provide for the licensing of orthotists and prosthetists, is certified by the American Board for Certification in Orthotics, Prosthetics and Pedorthics, Inc. or by the Board of Certification/Accreditation, International, or is certified and approved by an entity that the Secretary determines has certification and approval standards that are essentially equivalent to the certification and approval standards of such Boards. . (b) Prohibiting payment for certain orthotics and prosthetics Section 1834(h)(1) of the Social Security Act ( 42 U.S.C. 1395m(h)(1) ) is amended by adding at the end the following new subparagraph: (I) Special payment rules for orthotics or prosthetics (i) In general No payment shall be made under this subsection for— (I) a prosthesis (excluding prosthetic supplies) that is delivered by drop shipment; (II) a custom-fabricated or custom-fitted orthosis (excluding orthotic supplies) described in subparagraph (F)(ii) that is delivered by drop shipment; and (III) an orthotic item that is not otherwise competitively bid that is delivered by drop shipment. (ii) Drop shipment defined In this subparagraph, the term drop shipment means the shipping of an orthosis or prosthesis to a beneficiary without receiving from a trained, educated, and certified or licensed health care practitioner, orthotist, or prosthetist direct patient care with respect to assessing, adjusting, and training in the care and use of the orthosis or prosthesis. . (c) Standardizing the definitions of orthotics and prosthetics Section 1834(h)(4) of the Social Security Act ( 42 U.S.C. 1395m(h)(4) ) is amended— (1) in subparagraph (B), by striking at the end and ; (2) in subparagraph (C)— (A) by striking the term orthotics and prosthetics has the meaning given such term and inserting the terms orthotics and prosthetics and orthoses and prostheses have the meaning given such terms ; and (B) by striking the period at the end and inserting ; and ; and (3) by inserting after subparagraph (C), as amended by paragraph (2), the following new subparagraph: (D) the terms prosthetics and prostheses refer to a device (including the clinical services associated with such device) that replaces all or part of a limb. . (d) Limitation of competitive acquisition for off-the-Shelf orthotics Section 1847(a) of the Social Security Act ( 42 U.S.C. 1395w–3(a) ) is amended— (1) in paragraph (2)(C), by inserting by the patient (and not by another person) after minimal self-adjustment ; and (2) in paragraph (7)(A)(i)— (A) by inserting , orthotist or prosthetist (as defined in section 1834(x)(5)(C)), after by a physician ; (B) by inserting , orthotist’s or prosthetist’s, after to the physician’s ; and (C) by inserting , orthotist’s or prosthetist’s, after of the physician’s . (e) Regulations Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall promulgate final regulations to implement the provisions of, and amendments made by, this Act.