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HHS/CMS RIN: 0938-AR84 Publication ID: Fall 2013 
Title: Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS): Special Payment Rules (CMS-6012-P) 
Abstract: This proposed rule would specify the qualification standards and the type of prosthetic and orthotic devices billable to the Medicare program. It also proposes the accreditation deadline for the entities billing orthotics and prosthetics and identifies the DMEPOS product categories exempt from accreditation requirements. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 42 CFR 424 
Legal Authority: 42 USC 1395m(h)(1); PL 106-554 (BIPA), sec 427 
Legal Deadline:  None

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.

Timetable:
Action Date FR Cite
NPRM  05/00/2014   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Sandra Bastinelli
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
7500 Security Boulevard,
Baltimore, MD 21244
Phone:410 786-3630
Email: sandra bastinelli@cms.hhs.gov

 
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