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Medicare Program; Approval of Deeming Authority for National Accreditation Organizations to Accredit Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Suppliers

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Information about this document as published in the Federal Register.

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Centers for Medicare & Medicaid Services (CMS), HHS.




This notice announces the 10 national accreditation organizations that have been approved by CMS to accredit durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers seeking to participate in the Medicare program.

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Alisa Overgaard, (410) 786-2167.

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I. Background

Section 302(a)(1) of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) (Pub. L. 108-173) added section 1834(a)(20) of Start Printed Page 29327the Social Security Act (the Act) and requires the Secretary to establish and implement quality standards for suppliers of certain items, including consumer service standards, to be applied by recognized independent accreditation organizations. Suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) must comply with the quality standards to furnish any item for which payment is made under Medicare Part B, and to receive and retain a provider or supplier billing number used to submit claims for reimbursement for any such item for which payment may be made under Medicare. Section 1834(a)(20)(D) of the Act requires us to apply these quality standards to suppliers of the following items for which we deem the standards to be appropriate:

  • Covered items, as defined in section 1834(a)(13) of the Act, for which payment may be made under section 1834(a) of the Act.
  • Prosthetic devices, orthotics, and prosthetics described in section 1834(h)(4) of the Act.
  • Items described in section 1842(s)(2) of the Act, which include—(1) medical supplies; (2) home dialysis supplies and equipment; (3) therapeutic shoes; (4) parenteral and enteral nutrients; (5) equipment, and supplies; (6) electromyogram devices; (7) salivation devices; (8) blood products; and (9) transfusion medicine.

Section 1834(a)(20)(B) of the Act requires the Secretary, notwithstanding section 1865(b) of the Act, to designate and approve one or more independent accreditation organizations to apply the quality standards to suppliers of DMEPOS and other items. For most providers and suppliers, the Medicare program currently contracts with State Agencies to perform survey and review functions for such providers and suppliers to approve their participation in or coverage under the Medicare program. Additionally, section 1865(b) of the Act sets forth the general procedures for us to approve non-DMEPOS national accreditation organizations. We deem providers or suppliers to have met Medicare conditions of participation or coverage if they are accredited by a national accreditation organization that we have approved.

II. Deeming Application Approval Process

We compared the standards contained in all the accrediting organization applications with that of the CMS quality standards as posted on the CMS Web site​competitiveAcqforDMEPOS and those requirements set forth in the August 16, 2006 Federal Register notice (71 FR 47230).

An internal professional panel reviewed 11 applications, which were assessed on the basis of the criteria set out in the August 16, 2006 Federal Register notice. Those criteria included (but were not limited to) requirements in § 424.58(b). According to that notice, applicants had to furnish the following documentation and information to CMS:

  • A description of all types and categories of accreditation offered by the organization for which approval of deeming authority is sought.
  • A description of the duration of accreditation.
  • A detailed comparison of the organization's accreditation requirements and standards with the applicable Medicare DMEPOS quality standard requirements such as a crosswalk.
  • A detailed description of the organization's survey process, including:

—Frequency of the surveys performed;

—Procedures for performing unannounced surveys;

—A description of the accreditation survey review process and the accreditation status decision-making process, including the process for addressing deficiencies identified with the accreditation requirements.

—The procedures used to monitor the correction of deficiencies found during an accreditation survey;

—Policies and procedures used when an organization has a dispute regarding survey findings or an adverse decision;

—Procedures for coordinating surveys with another accrediting organization if the organization does not accredit all products the supplier provides.

  • Detailed information about the individuals who perform survey for the accreditation organization including:

—The size and composition of accreditation teams for each type of provider and supplier accredited.

—The education and experience requirements surveyors must meet.

—The content and frequency of the in-service training provided to survey personnel.

—The evaluation systems used to monitor the performance of individual surveyors and survey teams.

—Policies and procedures regarding an individual's participation in the survey or accreditation decision process of any organization with which the individual is professionally or financially affiliated.

  • A description of the organization's data management and analysis system for its surveys and accreditation decisions, including the kinds of reports, tables, and other displays generated by that system.
  • The organization's procedures for responding to and for the investigation of complaints against accredited facilities, including policies and procedures regarding coordination of these activities with appropriate licensing bodies (that is, National Supplier Clearinghouse, CMS, and ombudsman programs.)
  • The organization's policies and procedures for the withholding or removal of accreditation status for facilities that fail to meet the accreditation organization's standards or requirements, and other actions taken by the organization in response to noncompliance with its standards and requirements, including the procedures for notifying CMS of facilities that fail to meet the requirements of the accrediting organization.

See the August 16, 2006 Federal Register (71 FR 47230) for a full description of the documentation and information requirements.

The national accreditation organizations that have applied for approval of deeming authority provided us with assurance that the accreditation organizations met requirements that were at least as stringent as the Medicare quality standards.

The following organizations have been recognized as national accreditation organizations and have been given deeming authority to accredit DMEPOS suppliers seeking to participate in the Medicare program:

  • Joint Commission on Accreditation of Healthcare Organizations
  • Community Health Accreditation Program
  • Healthcare Quality Association on Accreditation
  • National Board of Accreditation for Orthotic Suppliers
  • Board for Orthotist/Prosthetist Certification
  • Accreditation Commission for Healthcare, Inc.
  • National Association of Boards of Pharmacy
  • Commission on Accreditation of Rehabilitation Facilities
  • American Board for Certification in Orthotics and Prosthetics, Inc. and the Board of Certification in Pedorthics (We note that on January 1, 2007 these 2 organizations merged and we have updated our Web site to reflect this change. The organizations' new name is the American Board for Certification in Start Printed Page 29328Orthotics, Prosthetics, and Pedorthics, Inc.).
  • The Compliance Team, Inc.
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Authority: Section 1834(a)(20) of the Social Security Act (42 U.S.C. 1395m(a)(20)).

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(Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance Program; and No. 93.774, Medicare—Supplementary Medical Insurance Program)

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Dated: May 17, 2007.

Leslie V. Norwalk,

Acting Administrator, Centers for Medicare & Medicaid Services.

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[FR Doc. E7-10156 Filed 5-24-07; 8:45 am]