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[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 1191 Introduced in Senate (IS)]

<DOC>

115th CONGRESS
  1st Session
                                S. 1191

To amend title XVIII of the Social Security Act to refine how Medicare 
     pays for orthotics and prosthetics and to improve beneficiary 
  experience and outcomes with orthotic and prosthetic care, and for 
                            other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                              May 22, 2017

 Mr. Grassley 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 refine how Medicare 
     pays for orthotics and prosthetics and to improve beneficiary 
  experience and outcomes with orthotic and prosthetic care, 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; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Medicare Orthotics 
and Prosthetics Improvement Act of 2017''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Modification of requirements applicable under Medicare to the 
                            designation of accreditation organizations 
                            for suppliers of orthotics and prosthetics.
Sec. 3. Application of existing accreditation and licensure 
                            requirements to certain prosthetics and 
                            custom-fabricated or custom-fitted 
                            orthotics.
Sec. 4. Eligibility for Medicare payment for orthotics and prosthetics 
                            based on supplier qualifications and 
                            complexity of care.
Sec. 5. Orthotist's and prosthetist's clinical notes as part of the 
                            patient's medical record.
Sec. 6. Distinguishing orthotists and prosthetists from suppliers of 
                            durable medical equipment and supplies.
Sec. 7. Clarification about minimal self-adjustment for off-the-shelf 
                            orthotics.
Sec. 8. Regulations.

SEC. 2. MODIFICATION OF REQUIREMENTS APPLICABLE UNDER MEDICARE TO THE 
              DESIGNATION OF ACCREDITATION ORGANIZATIONS FOR SUPPLIERS 
              OF ORTHOTICS AND PROSTHETICS.

    (a) In General.--Section 1834(a)(20)(B) of the Social Security Act 
(42 U.S.C. 1395m(a)(20)(B)) is amended--
            (1) by striking ``organizations.--Not later than'' and 
        inserting: ``organizations.--
                            ``(i) In general.--Subject to clause (ii), 
                        not later than''; and
            (2) by adding after clause (i), as added by paragraph (1), 
        the following new clauses:
                            ``(ii) Special requirements for 
                        accreditation of suppliers of orthotics and 
                        prosthetics.--For purposes of applying quality 
                        standards under subparagraph (A) for suppliers 
                        (other than suppliers described in clause 
                        (iii)) of items and services described in 
                        subparagraph (D)(ii), the Secretary shall 
                        designate and approve independent accreditation 
                        organizations under clause (i) only if such 
                        organizations are Boards or programs described 
                        in subsection (h)(1)(F)(iv). Not later than 
                        January 1, 2018, the Secretary shall ensure 
                        that at least one, and ideally multiple, 
                        independent accreditation organizations are 
                        designated and approved in accordance with this 
                        clause.
                            ``(iii) Exception.--Suppliers described in 
                        this clause are physicians, occupational 
                        therapists, or physical therapists who are 
                        licensed or otherwise regulated by the State in 
                        which they are practicing and who receive 
                        payment under this title, including regulations 
                        promulgated pursuant to this subsection.''.
    (b) Effective Date.--Each organization must satisfy the requirement 
of section 1834(a)(20)(B)(ii), as added by subsection (a)(2), not later 
than January 1, 2018, regardless of whether the organization is 
designated or approved as an independent accreditation organization 
before, on, or after the date of the enactment of this Act.

SEC. 3. APPLICATION OF EXISTING ACCREDITATION AND LICENSURE 
              REQUIREMENTS TO CERTAIN PROSTHETICS AND CUSTOM-FABRICATED 
              OR CUSTOM-FITTED ORTHOTICS.

    (a) In General.--Section 1834(h)(1)(F) of the Social Security Act 
(42 U.S.C. 1395m(h)(1)(F)) is amended--
            (1) in the heading, by inserting ``or custom-fitted'' after 
        ``custom-fabricated'';
            (2) in clause (i), in the matter preceding subclause (I), 
        by striking ``an item of custom-fabricated orthotics described 
        in clause (ii) or for an item of prosthetics unless such item 
        is'' and inserting ``an item of orthotics or prosthetics, 
        including an item of custom-fabricated orthotics described in 
        clause (ii), unless such item is'';
            (3) in clause (ii)(II), in the first sentence, by striking 
        ``a list of items to which this subparagraph applies'' and 
        inserting ``a list of items for purposes of clause (i)'';
            (4) in clause (iii)(III), by striking ``to provide or 
        manage the provision of prosthetics and custom-designed or -
        fabricated orthotics'' and inserting ``to provide or manage the 
        provision of orthotics and prosthetics (and custom-designed or 
        -fabricated orthotics, in the case of an item described in 
        clause (ii))''; and
            (5) by adding at the end the following new clause:
                            ``(v) Exemption of off-the-shelf orthotics 
                        included in a competitive acquisition 
                        program.--This subparagraph shall not apply to 
                        an item of orthotics described in paragraph 
                        (2)(C) of section 1847(a) furnished on or after 
                        January 1, 2018, that is included in a 
                        competitive acquisition area under such 
                        section.''.
    (b) Effective Date.--The amendments made by subsection (a) shall 
apply to orthotics and prosthetics furnished on or after January 1, 
2018.

SEC. 4. ELIGIBILITY FOR MEDICARE PAYMENT FOR ORTHOTICS AND PROSTHETICS 
              BASED ON SUPPLIER QUALIFICATIONS AND COMPLEXITY OF CARE.

    Section 1834(h) of the Social Security Act (42 U.S.C. 1395m(h)) is 
amended--
            (1) in paragraph (1)(F)(iii), in the matter preceding 
        subclause (I), by striking ``other individual who'' and 
        inserting ``other individual who, with respect to the provision 
        of orthotics and prosthetics furnished on or after January 1, 
        2018, and subject to paragraph (5)(A), satisfies all applicable 
        criteria of the provider qualification designation for such 
        orthotic or prosthetic, and who'';
            (2) in paragraph (1)(F)(iv), by inserting before the period 
        the following: ``and, with respect to the provision of 
        orthotics and prosthetics furnished on or after January 1, 
        2018, and subject to paragraph (5)(A), satisfies all applicable 
        criteria of the provider qualification designation for such 
        orthotic or prosthetic''; and
            (3) by adding at the end the following new paragraph:
            ``(5) Eligibility for payment based on supplier 
        qualifications and complexity of care.--
                    ``(A) Considerations for eligibility for 
                payments.--
                            ``(i) In general.--In applying clauses 
                        (iii) and (iv) of paragraph (1)(F) for purposes 
                        of determining whether payment may be made 
                        under this subsection for orthotics and 
                        prosthetics furnished on or after January 1, 
                        2018, the Secretary shall take into account the 
                        complexity of the respective item and, subject 
                        to clauses (ii), (iii), and (iv), the 
                        qualifications of the individual or entity 
                        furnishing and fabricating such respective item 
                        in accordance with this paragraph.
                            ``(ii) Individuals and entities exempted 
                        from supplier qualification criteria.--With 
                        respect to the provision of orthotics or 
                        prosthetics, any criteria for supplier 
                        qualifications shall not apply to physicians, 
                        occupational therapists, or physical therapists 
                        who are licensed or otherwise regulated by the 
                        State in which they are practicing and who 
                        receive payment under this title, including 
                        regulations promulgated pursuant to this 
                        subsection, for the provision of orthotics and 
                        prosthetics.
                            ``(iii) Suppliers medicare-eligible prior 
                        to january 1, 2018, exempted.--In the case of a 
                        qualified supplier who is eligible to receive 
                        payment under this title before January 1, 
                        2018, with respect to the provision of 
                        orthotics and prosthetics, any new criteria for 
                        provider qualifications established after such 
                        date shall not apply to such supplier, for the 
                        furnishing or fabrication of such an item.
                            ``(iv) Modifications.--The Secretary shall, 
                        in consultation with the Boards and programs 
                        described in paragraph (1)(F)(iv), periodically 
                        review the criteria for supplier qualifications 
                        and may implement by regulation any 
                        modifications to such criteria, as determined 
                        appropriate in accordance with such 
                        consultation. Any such modifications shall take 
                        effect no earlier than January 1, 2018.
                    ``(B) Assignment of billing codes.--For purposes of 
                subparagraph (A), the Secretary, in consultation with 
                representatives of the fields of occupational therapy, 
                physical therapy, orthotics, and prosthetics, shall 
                utilize and incorporate the set of L-codes listed, as 
                of the date of enactment of this paragraph, in the 
                Centers for Medicare & Medicaid Services document 
                entitled `Transmittal 656' (CMS Pub. 100-04, Change 
                Request 3959, August 19, 2005). Transmittal 656 shall 
                be the controlling source of category, product, and 
                code assignments for the orthotics and prosthetics 
                care, using the supplier qualification designation for 
                each HCPCS code as stated in such document. In the case 
                that Transmittal 656 is updated, reissued, or replaced 
                by a subsequent document, the preceding sentence shall 
                be applied with respect to the most recent update, 
                reissuance, or replacement of such document.''.

SEC. 5. ORTHOTIST'S AND PROSTHETIST'S CLINICAL NOTES AS PART OF THE 
              PATIENT'S MEDICAL RECORD.

    Section 1834(h) of the Social Security Act (42 U.S.C. 1395m(h)), as 
amended by section 4, is amended by adding at the end the following new 
paragraph:
            ``(6) Documentation created by orthotists and 
        prosthetists.--With respect to claims filed after the date of 
        the enactment of the Medicare Orthotics and Prosthetics 
        Improvement Act of 2017, for purposes of determining the 
        reasonableness, medical necessity, and functional level 
        (applicable to prosthetics) of orthotics and prosthetics, 
        documentation created by an orthotist or prosthetist shall be 
        considered part of the patient's medical record and, consistent 
        with the treatment of orthotic and prosthetic patient care 
        delivery stated in the health care professional exception 
        provided in clause (ii) of subsection (a)(20)(F), shall be 
        considered along with documentation created by other health 
        professionals, including physicians, nurse practitioners, 
        occupational therapists, and physical therapists.''.

SEC. 6. DISTINGUISHING ORTHOTISTS AND PROSTHETISTS FROM SUPPLIERS OF 
              DURABLE MEDICAL EQUIPMENT AND SUPPLIES.

    (a) Requirements for Suppliers of Medical Equipment and Supplies.--
Section 1834(j)(5) of the Social Security Act (42 U.S.C. 1395m(j)(5)) 
is amended by striking subparagraph (C).
    (b) Requirements for Orthotists and Prosthetists.--
            (1) In general.--Section 1834 of the Social Security Act 
        (42 U.S.C. 1395m) is amended by adding at the end the following 
        new subsection:
    ``(v) 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 or accreditation--
                                    ``(I) complies with all applicable 
                                State and Federal licensure and 
                                regulatory requirements; or
                                    ``(II) acquires accreditation from 
                                the American Board for Certification in 
                                Orthotics, Prosthetics and Pedorthics, 
                                Inc. (ABC) or the Board of 
                                Certification/Accreditation, 
                                International (BOC), or other 
                                accreditation entity that the Secretary 
                                determines has standards that are 
                                essentially 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, or to an individual enrolled 
                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, including the name, address, and 
                        telephone number of the physician.
                            ``(iii) A description of the orthotics or 
                        prosthetics ordered.
                            ``(iv) Any billing code identifying the 
                        orthotics or prosthetics.
                            ``(v) Diagnosis codes, a description of the 
                        individual's medical and functional condition, 
                        and information about the need for the 
                        orthotics or prosthetics.
                    ``(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 HCPCS codes and 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 individual liability.--Except as 
        provided in paragraph (4), if an orthotist or prosthetist--
                    ``(A) furnishes an orthosis or prosthesis to an 
                individual for which no payment may be made under this 
                part; or
                    ``(B) subject to section 1879, furnishes an 
                orthosis or prosthesis to an individual 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) Individual liability.--If an orthotist or prosthetist 
        furnishes an orthosis or prosthesis to an individual 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 be submitted 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 
                        work order for orthotics or prosthetic shall 
                        not be considered alone for purposes of 
                        determining the reasonableness, medical 
                        necessity, and functional level (applicable to 
                        prosthetics) of prosthetic devices and 
                        orthotics.
                    ``(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 of 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.''.
            (2) Impact on dmepos benefit.--The amendment made by 
        paragraph (1)--
                    (A) shall not be construed to create a separate 
                benefit category under title XVIII of the Social 
                Security Act for orthotic and prosthetic devices; but
                    (B) shall be construed as differentiating the 
                manner in which orthotic and prosthetic devices and 
                services are provided in contrast to other durable 
                medical equipment and supplies services covered under 
                such title.
    (c) Definition of Orthotics and Prosthetics Synonymous With 
Orthoses and Prostheses.--Section 1834(h)(4)(C) of the Social Security 
Act (42 U.S.C. 1395m(h)(4)(C)) is amended by inserting ``(which may 
also be referred to without distinction as `orthoses and prostheses')'' 
after ``the term `orthotics and prosthetics'''.
    (d) Limitation of Competitive Acquisition for Off-the-Shelf 
Orthotics.--Section 1847(a)(7)(A)(i) of the Social Security Act (42 
U.S.C. 1395w-3(a)(7)(A)(i)) is amended--
            (1) by inserting ``, orthotist or prosthetist (as defined 
        in section 1834(v)(5)(C)),'' after ``by a physician'';
            (2) by inserting ``, orthotist's or prosthetist's,'' after 
        ``to the physician's''; and
            (3) by inserting ``, orthotist's or prosthetist's,'' after 
        ``of the physician's''.
    (e) Effective Date.--The amendments made by this section shall take 
effect on the date of enactment of this Act, and apply to items and 
services furnished on or after such date.

SEC. 7. CLARIFICATION ABOUT MINIMAL SELF-ADJUSTMENT FOR OFF-THE-SHELF 
              ORTHOTICS.

    (a) In General.--Section 1847(a)(2)(C) of the Social Security Act 
(42 U.S.C. 1395w-3(a)(2)(C)) is amended--
            (1) by inserting ``furnished to a patient'' after ``section 
        1861(s)(9)'';
            (2) by inserting ``by that patient (and not by any other 
        person)'' after ``minimal self-adjustment''; and
            (3) by striking ``to fit to the individual'' and inserting 
        ``to fit to that patient''.
    (b) Inclusion in Medical and Other Health Services.--Section 
1861(s)(9) of the Social Security Act (42 U.S.C. 1395x(s)(9)) is 
amended--
            (1) by striking ``leg, arm'' and inserting ``(A) leg, 
        arm'';
            (2) in subparagraph (A), as added by paragraph (1), by 
        striking the semicolon at the end and inserting ``; and''; and
            (3) by adding the following new subparagraph:
            ``(B) off-the-shelf orthotics (as defined in section 
        1847(a)(2)(C)).''.
    (c) Effective Date.--The amendments made by this section shall take 
effect on April 1, 2007, and apply to items and services furnished on 
or after such date.

SEC. 8. REGULATIONS.

    The Secretary shall promulgate--
            (1) not later than 1 year after the enactment of this Act, 
        final regulations to implement the provisions of, and 
        amendments made by, this Act; and
            (2) not later than 120 days after the enactment of this 
        Act, final regulations to implement the provisions of, and 
        amendments made by, section 427 of the Medicare, Medicaid, and 
        SCHIP Benefits Improvement and Protections Act of 2000, as 
        enacted into law by section 1(a)(6) of Public Law 106-554.
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