[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 4503 Introduced in Senate (IS)]

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116th CONGRESS
  2d Session
                                S. 4503

      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.


_______________________________________________________________________


                   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.

    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 ``Medicare Orthotics and Prosthetics 
Patient-Centered Care Act''.

SEC. 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.
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