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Statement of Need: CMS believes it is the intent of the Congress to strengthen DMEPOS supplier standards in order to protect beneficiaries and ensure the integrity of the Medicare program. Historically, there has been no Medicare requirement that a supplier of prosthetics and custom fabricated orthotics be certified or meet educational requirements other than what a state law may require. This proposed rule would provide a basis to improve the quality of orthotics and prosthetics furnished to Medicare beneficiaries by establishing minimum national supplier and practitioner qualifications and accreditation requirements for DMEPOS suppliers.

Summary of the Legal Basis: Section 1834(h) of the Social Security Act (the Act) establishes the payment rules for orthotics and prosthetics that are described in section 1861(s)(9) of the Act and in our regulations.

Alternatives: None. A rule is necessary to implement the proposed provisions.

Anticipated Costs and Benefits: This proposed rule is expected to provide savings for the Medicare program by establishing stringent safeguards that would protect the Medicare Trust Fund. It would also provide a basis to improve the provision and the quality of prosthetics and custom fabricated orthotics to Medicare beneficiaries by establishing that DMEPOS suppliers have the qualifications, specialized education, training, licensure, and certification.

Risks: Not publishing this proposed rule puts Medicare beneficiaries at risk. Beneficiaries would be best served by establishing safeguards that would provide a basis to improve the provision of quality prosthetics and custom fabricated orthotics to Medicare beneficiaries by establishing practitioner qualifications and accreditation requirements for DMEPOS suppliers.