[Federal Register Volume 72, Number 101 (Friday, May 25, 2007)]
[Notices]
[Pages 29326-29328]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10156]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-6040-N2]


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

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

ACTION: Notice.

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SUMMARY: 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.

FOR FURTHER INFORMATION CONTACT: Alisa Overgaard, (410) 786-2167.

SUPPLEMENTARY INFORMATION: 

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

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the 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 www.cms.hhs.gov/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 Sec.  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

[[Page 29328]]

Orthotics, Prosthetics, and Pedorthics, Inc.).
     The Compliance Team, Inc.

    Authority: Section 1834(a)(20) of the Social Security Act (42 
U.S.C. 1395m(a)(20)).

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

    Dated: May 17, 2007.
Leslie V. Norwalk,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E7-10156 Filed 5-24-07; 8:45 am]
BILLING CODE 4120-01-P