PUBLIC LAW 106-554^APPENDIX F 114 STAT. 2763A-521 licensed in orthotics or prosthetics by the State in which the item is supplied; or "(III) in the case of a State that does not provide for the Ucensing of orthotics and prosthetics, is specifically trsiined and educated to provide or manage the provision of prosthetics and customdesigned or -fabricated orthotics, and is certified by the American Board for Certification in Orthotics and Prosthetics, Inc. or by the Board for Orthotist/Prosthetist Certification, or is credentialed and approved by a program that the Secretary determines, in consultation with appropriate experts in orthotics and prosthetics, has training and education standards that are necessary to provide such prosthetics and orthotics. "(iv) QUALIFIED SUPPLIER DEFINED. —In this subparagraph, the term 'qualified supplier* means any entity that is accredited by the American Board for Certification in Orthotics and Prosthetics, Inc. or by the Board for Orthotist/Prosthetist Certification, or accredited and approved by a program that the Secretary determines has accreditation and approval standards that are essentially equivalent to those of such Board.". (b) EFFECTIVE DATE. —Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall promulgate revised regulations to carry out the amendment made by subsection (a) using a negotiated rulemaking process under subchapter III of chapter 5 of title 5, United States Code. (c) GAO STUDY AND REPORT.— Jl) STUDY.— The Comptroller General of the United States shall conduct a study on HCFA Ruling 96-1, issued on September 1, 1996, with respect to distinguishing orthotics from durable medical equipment under the medicare program under title XVIII of the Social Security Act. The study shall assess the following matters: (A) The compliance of the Secretary of Health and Human Services with the Administrative Procedures Act (under chapter 5 of title 5, United States Code) in making such ruling. (B) The potential impact of such ruling on the health care furnished to medicare beneficiaries under the medicare program, especially those beneficiaries with degenerative musculoskeletal conditions. (C) The potential for fraud and abuse under the medicare program if payment were provided for orthotics used as a component of durable medical equipment only when made under the special payment provision for certain prosthetics and custom-fabricated orthotics under section 1834(h)(1)(F) of the Social Security Act, as added by subsection (a) and furnished by qualified practitioners under that section. (D) The impact on payments under titles XVIII and XIX of the Social Security Act if such ruling were overturned.
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