[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
[[Page 29327]]
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