Medicare Orthotics and Prosthetics Patient-Centered Care Act

I 117TH CONGRESS 1ST SESSION H. R. 1990 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 pros- thetics, and for other purposes. IN THE HOUSE OF REPRESENTATIVES MARCH 17, 2021 Mr. THOMPSON of California (for himself, Mr. GUTHRIE, Mr. THOMPSON of Pennsylvania, and Mr. BUTTERFIELD) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subse- quently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To amend title XVIII of the Social Security Act to protect beneficiaries with limb loss and other orthopedic condi- tions 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 Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 01:46 May 13, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1990.IH H1990 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 1990 IH SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Medicare Orthotics and 2 Prosthetics Patient-Centered Care Act’’. 3 SEC. 2. INCREASING PROTECTIONS FOR BENEFICIARIES 4 RECEIVING ORTHOTIC AND PROSTHETIC 5 CARE UNDER THE MEDICARE PROGRAM. 6 (a) DISTINGUISHING ORTHOTISTS AND 7 PROSTHETISTS FROM SUPPLIERS OF DURABLE MEDICAL 8 EQUIPMENT AND SUPPLIES.—Section 1834 of the Social 9 Security Act (42 U.S.C. 1395m) is amended— 10 (1) in subsection (j)(5), by striking subpara- 11 graph (C) and redesignating the subsequent sub- 12 paragraphs accordingly; and 13 (2) by adding at the end the following new sub- 14 section: 15 ‘‘(x) REQUIREMENTS FOR ORTHOTISTS AND 16 PROSTHETISTS.— 17 ‘‘(1) ISSUANCE AND RENEWAL OF SUPPLIER 18 NUMBER.— 19 ‘‘(A) PAYMENT.— 20 ‘‘(i) IN GENERAL.—No payment may 21 be made under this part to an orthotic or 22 prosthetic supplier unless such orthotic or 23 prosthetic supplier obtains (and renews at 24 such intervals as the Secretary may re- 25 quire) a supplier number. 26 VerDate Sep 11 2014 01:46 May 13, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1990.IH H1990 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 1990 IH ‘‘(ii) CLARIFICATION REGARDING PRO- 1 VIDERS UNDER PART A.—Nothing in 2 clause (i) shall prohibit a provider other- 3 wise permitted to receive payment for 4 orthotics and prosthetics under part A 5 from continuing to receive payment under 6 such part without interruption. 7 ‘‘(B) STANDARDS FOR POSSESSING A SUP- 8 PLIER NUMBER.—An orthotic or prosthetic sup- 9 plier may only obtain a supplier number if the 10 supplier meets standards prescribed by the Sec- 11 retary that include requirements that the 12 orthotic or prosthetic supplier (and, where ap- 13 plicable, the orthotist or prosthetist)— 14 ‘‘(i) licensure and accreditation— 15 ‘‘(I) complies with all applicable 16 State and Federal licensure and regu- 17 latory requirements; and 18 ‘‘(II) acquires accreditation from 19 the American Board for Certification 20 in Orthotics, Prosthetics and Pedorth- 21 ics, Inc. or the Board of Certification/ 22 Accreditation, International, or other 23 accreditation entity that the Secretary 24 determines has standards that are 25 VerDate Sep 11 2014 01:46 May 13, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1990.IH H1990 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 1990 IH equivalent to the standards of such 1 Boards; 2 ‘‘(ii) maintains a physical facility on 3 an appropriate site; 4 ‘‘(iii) has proof of appropriate liability 5 insurance; and 6 ‘‘(iv) meets such other requirements 7 as the Secretary shall specify. 8 ‘‘(C) PROHIBITION AGAINST MULTIPLE 9 SUPPLIER NUMBERS.—The Secretary may not 10 issue more than one supplier number to any 11 orthotic or prosthetic supplier unless the Sec- 12 retary finds that the issuance of more than one 13 number is appropriate to identify other entities 14 under the ownership or control of the orthotic 15 or prosthetic supplier. 16 ‘‘(2) ORDER FOR ORTHOTICS OR PROS- 17 THETICS.— 18 ‘‘(A) INFORMATION PROVIDED BY 19 ORTHOTISTS AND PROSTHETISTS ON DETAILED 20 WRITTEN ORDERS FOR ORTHOTICS AND PROS- 21 THETICS.—An orthotist or prosthetist may dis- 22 tribute to physicians, physician assistants, 23 nurse practitioners, clinical nurse specialists, or 24 individuals entitled to benefits under this part, 25 VerDate Sep 11 2014 01:46 May 13, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1990.IH H1990 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 1990 IH a detailed written order for orthotics or pros- 1 thetics (as defined in paragraph (5)) for com- 2 mercial purposes that contains the following in- 3 formation: 4 ‘‘(i) The identification of— 5 ‘‘(I) the orthotic or prosthetic 6 supplier; and 7 ‘‘(II) the individual to whom the 8 orthotics or prosthetics are furnished. 9 ‘‘(ii) The identification of the treating 10 physician, physician assistant, nurse prac- 11 titioner, or clinical nurse specialist. 12 ‘‘(iii) A description of the orthotics or 13 prosthetics ordered. 14 ‘‘(iv) The date of the order described 15 in this subparagraph. 16 ‘‘(B) INFORMATION ON CODING AND 17 DESCRIPTORS OF COMPONENTS PROVIDED.—If 18 an orthotist or prosthetist distributes a detailed 19 written order for orthotics or prosthetics de- 20 scribed in subparagraph (A), the orthotist or 21 prosthetist shall also list on the order the sum- 22 mary descriptors of the items and services being 23 recommended prior to submission of the order 24 to the treating physician for approval. 25 VerDate Sep 11 2014 01:46 May 13, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1990.IH H1990 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 1990 IH ‘‘(C) SIGNATURE BY TREATING PHYSI- 1 CIAN.—A detailed written order for orthotics or 2 prosthetics described in subparagraph (A) shall 3 be signed by the treating physician. 4 ‘‘(3) LIMITATION ON PATIENT LIABILITY.—Ex- 5 cept as provided in paragraph (4), if an orthotist or 6 prosthetist— 7 ‘‘(A) furnishes an orthosis or prosthesis to 8 a beneficiary for which no payment may be 9 made under this part; or 10 ‘‘(B) subject to section 1879, furnishes an 11 orthosis or prosthesis to a beneficiary for which 12 payment is denied under section 1862(a)(1), 13 any expenses incurred for the orthosis or prosthesis 14 furnished to an individual by the orthotist or pros- 15 thetist not on an assigned basis shall be the respon- 16 sibility of such orthotist or prosthetist. The indi- 17 vidual shall have no financial responsibility for such 18 expenses and the orthotist or prosthetist shall refund 19 on a timely basis to the individual (and shall be lia- 20 ble to the individual for) any amounts collected from 21 the individual for such items and services. The pro- 22 visions of subsection (a)(18) shall apply to refunds 23 required under the previous sentence in the same 24 VerDate Sep 11 2014 01:46 May 13, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H1990.IH H1990 kjohnson on DSK79L0C42PROD with BILLS 7 •HR 1990 IH manner as such provisions apply to refunds under 1 such subsection. 2 ‘‘(4) PATIENT LIABILITY.—If an orthotist or 3 prosthetist furnishes an orthosis or prosthesis to a 4 patient for which payment is denied in advance 5 under subsection (a)(15), expenses incurred for such 6 orthosis or prosthesis furnished to the individual by 7 the orthotist or prosthetist shall be the responsibility 8 of the individual. 9 ‘‘(5) DEFINITIONS.—In this subsection: 10 ‘‘(A) DETAILED WRITTEN ORDER FOR 11 ORTHOTICS OR PROSTHETICS.— 12 ‘‘(i) IN GENERAL.—The term ‘detailed 13 written order for orthotics or prosthetics’ 14 means a form or other document prepared 15 by an orthotist or prosthetist and signed 16 by the physician (as defined by section 17 1861(r)) that contains information re- 18 quired by the Secretary to show that an 19 orthosis or prosthesis is reasonable and 20 necessary for the treatment of an illness or 21 injury or to improve the functioning of a 22 malformed body member. 23 ‘‘(ii) CLARIFICATION.—The detailed 24 written order for orthotics or prosthetics 25 VerDate Sep 11 2014 01:46 May 13, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H1990.IH H1990 kjohnson on DSK79L0C42PROD with BILLS 8 •HR 1990 IH shall not be considered alone for purposes 1 of determining the reasonableness, medical 2 necessity, and functional level (applicable 3 to prosthetics) of orthotics and prosthetics. 4 ‘‘(B) ORTHOTICS AND PROSTHETICS.—The 5 term ‘orthotics and prosthetics’ has the mean- 6 ing given that term in section 1834(h)(4)(C). 7 ‘‘(C) ORTHOTIST OR PROSTHETIST.—The 8 term ‘orthotist or prosthetist’ means an indi- 9 vidual who is specifically trained and educated 10 in the provision of, and patient care manage- 11 ment related to, prosthetics and custom-fab- 12 ricated or custom-fit orthotics, and— 13 ‘‘(i) in the case of a State that pro- 14 vides for the licensing of orthotists and 15 prosthetists, is licensed by the State in 16 which the orthotics or prosthetics were 17 supplied; or 18 ‘‘(ii) in the case of a State that does 19 not provide for the licensing of orthotists 20 and prosthetists, is certified by the Amer- 21 ican Board for Certification in Orthotics, 22 Prosthetics and Pedorthics, Inc. or by the 23 Board of Certification/Accreditation, Inter- 24 national, or is certified and approved by an 25 VerDate Sep 11 2014 01:46 May 13, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H1990.IH H1990 kjohnson on DSK79L0C42PROD with BILLS 9 •HR 1990 IH entity that the Secretary determines has 1 certification and approval standards that 2 are essentially equivalent to the certifi- 3 cation and approval standards of such 4 Boards.’’. 5 (b) PROHIBITING PAYMENT FOR CERTAIN 6 ORTHOTICS AND PROSTHETICS.—Section 1834(h)(1) of 7 the Social Security Act (42 U.S.C. 1395m(h)(1)) is 8 amended by adding at the end the following new subpara- 9 graph: 10 ‘‘(I) SPECIAL PAYMENT RULES FOR 11 ORTHOTICS OR PROSTHETICS.— 12 ‘‘(i) IN GENERAL.—No payment shall 13 be made under this subsection for— 14 ‘‘(I) a prosthesis (excluding pros- 15 thetic supplies) that is delivered by 16 drop shipment; 17 ‘‘(II) a custom-fabricated or cus- 18 tom-fitted orthosis (excluding orthotic 19 supplies) described in subparagraph 20 (F)(ii) that is delivered by drop ship- 21 ment; and 22 ‘‘(III) an orthotic item that is 23 not otherwise competitively bid that is 24 delivered by drop shipment. 25 VerDate Sep 11 2014 01:46 May 13, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H1990.IH H1990 kjohnson on DSK79L0C42PROD with BILLS 10 •HR 1990 IH ‘‘(ii) DROP SHIPMENT DEFINED.—In 1 this subparagraph, the term ‘drop ship- 2 ment’ means the shipping of an orthosis or 3 prosthesis to a beneficiary without receiv- 4 ing from a trained, educated, and certified 5 or licensed health care practitioner, 6 orthotist, or prosthetist direct patient care 7 with respect to assessing, adjusting, and 8 training in the care and use of the orthosis 9 or prosthesis.’’. 10 (c) STANDARDIZING THE DEFINITIONS OF 11 ORTHOTICS AND PROSTHETICS.—Section 1834(h)(4) of 12 the Social Security Act (42 U.S.C. 1395m(h)(4)) is 13 amended— 14 (1) in subparagraph (B), by striking at the end 15 ‘‘and’’; 16 (2) in subparagraph (C)— 17 (A) by striking ‘‘the term ‘orthotics and 18 prosthetics’ has the meaning given such term’’ 19 and inserting ‘‘the terms ‘orthotics and pros- 20 thetics’ and ‘orthoses and prostheses’ have the 21 meaning given such terms’’; and 22 (B) by striking the period at the end and 23 inserting ‘‘; and’’; and 24 VerDate Sep 11 2014 01:46 May 13, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H1990.IH H1990 kjohnson on DSK79L0C42PROD with BILLS 11 •HR 1990 IH (3) by inserting after subparagraph (C), as 1 amended by paragraph (2), the following new sub- 2 paragraph: 3 ‘‘(D) the terms ‘prosthetics’ and ‘pros- 4 theses’ refer to a device (including the clinical 5 services associated with such device) that re- 6 places all or part of a limb.’’. 7 (d) LIMITATION OF COMPETITIVE ACQUISITION FOR 8 OFF-THE-SHELF ORTHOTICS.—Section 1847(a) of the 9 Social Security Act (42 U.S.C. 1395w–3(a)) is amended— 10 (1) in paragraph (2)(C), by inserting ‘‘by the 11 patient (and not by another person)’’ after ‘‘minimal 12 self-adjustment’’; and 13 (2) in paragraph (7)(A)(i)— 14 (A) by inserting ‘‘, orthotist or prosthetist 15 (as defined in section 1834(x)(5)(C)),’’ after 16 ‘‘by a physician’’; 17 (B) by inserting ‘‘, orthotist’s or prosthet- 18 ist’s,’’ after ‘‘to the physician’s’’; and 19 (C) by inserting ‘‘, orthotist’s or prosthet- 20 ist’s,’’ after ‘‘of the physician’s’’. 21 (e) REGULATIONS.—Not later than 1 year after the 22 date of the enactment of this Act, the Secretary of Health 23 and Human Services shall promulgate final regulations to 24 VerDate Sep 11 2014 01:46 May 13, 2021 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H1990.IH H1990 kjohnson on DSK79L0C42PROD with BILLS 12 •HR 1990 IH implement the provisions of, and amendments made by, 1 this Act. 2 Æ VerDate Sep 11 2014 01:46 May 13, 2021 Jkt 019200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6301 E:\BILLS\H1990.IH H1990 kjohnson on DSK79L0C42PROD with BILLS