II 115th CONGRESS 1st Session S. 1191 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.

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. 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. 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. 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. . 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. . 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. 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. 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 .