I 113th CONGRESS 1st Session H. R. 3112 IN THE HOUSE OF REPRESENTATIVES September 17, 2013 Mr. Thompson of Pennsylvania (for himself and Mr. Thompson of California ) 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 subsequently 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 modify the designation of accreditation organizations for orthotics and prosthetics, to apply accreditation and licensure requirements to suppliers of such devices and items for purposes of payment under the Medicare program, and to modify the payment rules for such devices and items under such program to account for practitioner qualifications and complexity of care, and for other purposes.

1. Short title This Act may be cited as the Medicare Orthotics and Prosthetics Improvement Act of 2013 . 2. Modification of requirements applicable under medicare to 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 an independent accreditation organization under clause (i) only if such organization is a Board or program described in subsection (h)(1)(F)(iv). Not later than January 1, 2014, the Secretary shall ensure that at least one independent accreditation organization is 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 An organization must satisfy the requirement of section 1834(a)(20)(B)(ii), as added by subsection (a)(2), not later than January 1, 2014, regardless of whether such 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), 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), 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, 2014, that is included in a competitive acquisition program 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, 2014. 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 a category of orthotics and prosthetics care described in clause (i), (ii), (iii), (iv), or (v) of paragraph (5)(C) furnished on or after January 1, 2014, and subject to paragraph (5)(A), satisfies all applicable criteria of the supplier qualification designation for such category described in the respective clause, and who ; (2) in paragraph (1)(F)(iv), by inserting before the period the following: and, with respect to a category of orthotics and prosthetics care described in clause (i), (ii), (iii), (iv), or (v) of paragraph (5)(C) furnished on or after January 1, 2014, and subject to paragraph (5)(A), satisfies all applicable criteria of the provider qualification designation for such category described in the respective clause ; 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, 2014, 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) Individual and entities exempted from supplier qualification designation criteria With respect to an item of orthotics or prosthetics described in clause (ii), (iii), (iv) or (v) of subparagraph (C), any criteria for the supplier qualification designations under such respective clause, including application of subparagraph (D), 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, 2014, exempted In the case of a qualified supplier who is eligible to receive payment under this title before January 1, 2014— (I) with respect to an item of orthotics or prosthetics described in clause (i) of subparagraph (C), any criteria for the provider qualification designations under such clause, including application of subparagraph (D), shall not apply to such supplier, respectively, for the furnishing or fabrication of such an item so described; and (II) with respect to an item of orthotics or prosthetics described in clause (ii), (iii), or (iv) of subparagraph (C), any criteria for the supplier qualification designations under the respective clause (or a subsequent clause of such subparagraph), including application of subparagraph (D), shall not apply to such supplier, respectively, for the furnishing or fabrication of such an item described in such respective (or such subsequent) clause. (iv) Delayed application of certain supplier qualification designation criteria The supplier qualification designations under clauses (i), (ii), and (iii) of subparagraph (C), including the application of subparagraph (D) to such clauses, shall not be taken into account with respect to payment made under this subsection for orthotics and prosthetics furnished before January 1, 2015. (v) Modifications The Secretary shall, in consultation with the Boards and programs described in paragraph (1)(F)(iv), periodically review the criteria for the supplier qualification designation under subparagraph (C)(i)(III) and may implement by regulation any modifications to such criteria, as determined appropriate in accordance with such consultation. Any such modification shall take effect no earlier than January 1, 2016. (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 the 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 described in each of clauses (i) through (v) of subparagraph (C) 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 previous sentence shall be applied with respect to the most recent update, reissuance, or replacement of such document. (C) Categories of orthotic and prosthetic care described (i) Custom-fabricated limb prosthetics category The category of orthotic and prosthetic care described in this clause is a category for artificial legs and arms, including replacements (as described in section 1861(s)(9)) that are made from detailed measurements, images, or models in accordance with a prescription and that can only be utilized by a specific intended patient and for which payment is made under this part. The supplier qualification designation for the category shall reflect each of the following, in accordance with subparagraph (D): (I) The category of care involves the highest level of complexity with substantial clinical risk. (II) The category of care requires a supplier who satisfies any of the education requirements described in subclause (III), has completed a prosthetic residency accredited by the National Commission on Orthotic and Prosthetic Education ( NCOPE ), and is certified or licensed in prosthetics to ensure the comprehensive provision of prosthetic care. (III) The category of care requires a supplier who has completed any of the following education requirements: (aa) A bachelor’s degree or master’s degree in prosthetics as offered by educational institutions accredited by the Commission on Accreditation of Allied Health Education Programs. (bb) A bachelor’s degree, plus a certificate in prosthetics as offered by educational institutions accredited by the Commission on Accreditation of Allied Health Education Programs. (cc) A foreign degree determined by the World Education Service to be equivalent to an educational program in prosthetics accredited by the Commission on Accreditation of Allied Health Education Programs. (ii) Custom-fabricated orthotics ca­te­go­ry The category of orthotics and prosthetics care described in this clause is a category for custom-fabricated orthotics that are made from detailed measurements, images, or models in accordance with a prescription and that can only be utilized by a specific intended patient. The supplier qualification designation for the category shall reflect the following, in accordance with subparagraph (D): (I) The category of care involves the highest level of complexity with substantial clinical risk. (II) The category of care requires a supplier who satisfies any of the education requirements described in clause (i)(III) (except that for purposes of this subclause such clause shall be applied by substituting the term orthotics each place the term prosthetics is used), has completed an orthotic residency accredited by the National Commission on Orthotic and Prosthetic Education, and is certified or licensed in orthotics to ensure the appropriate provision of orthotic care. (iii) Custom-fitted high orthotics category The category of orthotic care described in this clause is a category for prefabricated orthotics that are manufactured with no specific patient in mind, but that are appropriately sized, adapted, modified, and configured (with the required tools and equipment) to a specific patient in accordance with a prescription. The supplier qualification designation for the category shall reflect the following, in accordance with subparagraph (D): (I) The category of care involves moderate to high complexity with substantial clinical risk. (II) The category of care requires a practitioner who either— (aa) satisfies any of the education requirements described in clause (i)(III), except that for purposes of this subclause such clause shall be applied by substituting the term orthotics each place the term prosthetics is used; or (bb) is certified or licensed in orthotics to ensure the appropriate provision of orthotic care within the practitioner’s normal scope of practice. (iv) Custom-fitted low orthotics category The category of orthotics and prosthetics care described in this clause is a category for prefabricated orthotics that are manufactured with no specific patient in mind, but that are appropriately sized and adjusted to a specific patient in accordance with a prescription. The supplier qualification designation for the category shall reflect the following: (I) The category of care involves a low level of complexity and low clinical risk. (II) The category of care requires a supplier that is certified or licensed within a limited scope of practice to ensure appropriate provision of orthotic care. The supplier’s education and training shall ensure that basic clinical knowledge and technical expertise is available to confirm successful fit and device compliance with the prescription. (v) Off-the-shelf The category of orthotic care described in this clause is described in section 1847(a)(2)(C). The supplier qualification designation for the category shall reflect that no formal credentialing, clinical education, or technical training is required to dispense such items. (D) Care based on sound clinical judgment and technical expertise Care described in clauses (i), (ii), and (iii) of subparagraph (C) shall be based on sound clinical judgment and technical expertise based on the supplier’s education and clinical training, in order to allow the practitioner to determine— (i) with respect to care described in clause (i) or (ii) of subparagraph (C), the device parameters and design, fabrication process, and functional purpose specific to the needs of the patient to maximize optimal clinical outcomes; and (ii) with respect to care described in clause (iii) of such subparagraph, the appropriate device relative to the diagnosis and specific to the needs of the patient to maximize optimal clinical outcomes. . 5. Consultation In implementing the provisions of, and amendments made by, this Act, the Secretary of Health and Human Services shall consult with appropriate experts in orthotics and prosthetics, including suppliers that furnish items within the categories of orthotic and prosthetic care described in paragraph (5)(C) of section 1834(h) of the Social Security Act ( 42 U.S.C. 1395m(h) ), as added by section 4. 6. Reports (a) Report on enforcing new licensing and accreditation requirements Not later than 18 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a report on the steps taken by the Department of Health and Human Services to ensure that the State licensure and accreditation requirements under section 1834(h)(1)(F) of the Social Security Act ( 42 U.S.C. 1395m(h)(1)(F) ), as amended by section 3, are enforced. Such report shall include a determination of the extent to which payments for orthotics and prosthetics under the Medicare program under title XVIII of such Act are made only to those suppliers that meet the relevant accreditation and licensure requirements under such section and a determination of whether additional steps are needed. (b) Report on fraud and abuse Not later than 30 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a report on the effect of the requirements under subsection (a)(20)(B)(ii) of section 1834 of the Social Security Act ( 42 U.S.C. 1395m ), as added by section 2, and subsection (h)(1)(F) of such section, as amended by section 3, on the occurrence of fraud and abuse under the Medicare program under title XVIII of such Act, with respect to orthotics and prosthetics for which payment is made under such program. 7. Reduction in medicare spending (a) Projection of cumulative effect on spending Not later than December 31, 2014, the Secretary of Health and Human Services (in this section referred to as the Secretary ), acting through the Chief Actuary of the Centers for Medicare & Medicaid Services (in this section referred to as the Chief Actuary ), shall submit to Congress, and have published in the Federal Register, a projection of the effect on cumulative Federal spending under part B of title XVIII of the Social Security Act for the period of years 2014 through 2018 as a result of the implementation of the provisions of, and amendments made by, this Act. (b) Strengthening standards applicable if savings not achieved (1) In general Subject to paragraph (2), if the Chief Actuary projects under subsection (a) that the implementation of the provisions of, and amendments made by, this Act will not result in a cumulative reduction in spending under such part of at least $250,000,000 for the period of years 2014 through 2018 (using a 2013 baseline), the Secretary shall, in accordance with the Chief Actuary’s projection, issue an interim final regulation (to take effect for 2015 and subsequent years) with a period for public comment on such regulation after the date of publication to strengthen the licensure, accreditation, and quality standards applicable to suppliers of orthotics and prosthetics under title XVIII of the Social Security Act, including such standards described in subsections (a)(20) and (h)(1)(F) of section 1834 of such Act ( 42 U.S.C. 1395m ), as amended by this Act, in order to produce such cumulative reduction by December 31, 2018. (2) Exception The interim final regulation issued under paragraph (1) shall not apply to a qualified physical therapist or qualified occupational therapist (as described in section 1834(h)(1)(F)(iii) of the Social Security Act ( 42 U.S.C. 1395m(h)(1)(F)(iii) )). 8. No effect on payment basis for orthotics and prosthetics or competitive bidding programs Nothing in the provisions of, or amendments made by, this Act shall have any effect on— (1) the determination of the payment basis for orthotics and prosthetics under section 1834(h) of the Social Security Act ( 42 U.S.C. 1395m(h) ); or (2) the implementation of competitive acquisition programs under section 1847 of such Act ( 42 U.S.C. 1395w–3 ), including such implementation with respect to off-the-shelf orthotics described in subsection (a)(2)(C) of that section, that are included in a competitive acquisition program in a competitive acquisition area under that section.