[Federal Register Volume 71, Number 158 (Wednesday, August 16, 2006)]
[Notices]
[Pages 47230-47232]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-6933]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-6040-N]


Medicare Program; Durable Medical Equipment, Prosthetics, 
Orthotics, and Supplies (DMEPOS) Supplier Accreditation Applications 
From Independent Accrediting Bodies

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

ACTION: Notice.

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SUMMARY: This notice informs independent accreditation organizations of 
an opportunity to submit an application to participate in the durable 
medical equipment, prosthetics, orthotics and supplies (DMEPOS) 
accreditation program. DMEPOS accreditation is required for DMEPOS 
suppliers. This notice contains information on how to apply for CMS 
approval.

DATES: Applications will be considered if received at the appropriate 
address, provided in the ADDRESSES section, no later than 5 p.m. d.s.t, 
on October 2, 2006.

ADDRESSES: Applications should be sent to: Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244. 
Mail stop C3-02-16, Attention: Sandra Bastinelli.

FOR FURTHER INFORMATION CONTACT: Sandra Bastinelli, (410) 786-3630.

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 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 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:
    <bullet> 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.
    <bullet> Prosthetic devices, orthotics, and prosthetics described 
in section 1834(h)(4) of the Act.
    <bullet> Items described in section 1842(s)(2) of the Act, which 
include medical supplies; home dialysis supplies and equipment; 
therapeutic shoes; parenteral and enteral nutrients, equipment, and 
supplies; electromyogram devices; salivation devices; blood products; 
and transfusion medicine.
    Section 1834(a)(20)(E) of the Act explicitly authorizes the 
Secretary to establish the quality standards by program instruction to 
ensure that suppliers that wish to participate in

[[Page 47231]]

competitive bidding will know what standards they must meet to be 
awarded a contract. The standards will be applied prospectively and 
will be published on our Web site. Section 1847(b)(2)(A)(i) of the Act 
requires a DMEPOS supplier to meet the quality standards specified by 
the Secretary under section 1834(a)(20) of the Act before being awarded 
a contract under the Medicare DMEPOS Competitive Bidding Program.
    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 CMS to approve non-DMEPOS 
national accreditation organizations. CMS deems providers or suppliers 
to have met Medicare conditions of participation or coverage if they 
are accredited by a national accreditation organization approved by 
CMS.
    We are responsible for the oversight and monitoring of the State 
Agencies and the approved accreditation organizations. The procedures 
implemented by the Secretary for designating private and national 
accreditation organizations for non-DMEPOS national accreditation 
organizations and the Federal review process for such accreditation 
organizations are located at 42 CFR part 422 (for Medicare Advantage 
organizations) and part 488 (for most providers and suppliers).

II. Provisions of the Notice

    This notice solicits applications from any independent 
accreditation organization that has the ability to accredit at least 
one of the supplier categories identified by the National Supplier 
Clearinghouse.

A. Eligible Organizations

    Any independent accreditation organization that can show evidence 
of the ability to accredit at least one supplier category, as 
identified by the National Supplier Clearinghouse, and within the time 
frames set forth by CMS, is eligible to apply. Information on the 
National Supplier Clearinghouse can be found at http://www.palmettogba.com.

B. Application Requirements

    To be considered for approval of deeming authority for Medicare 
requirements under Sec.  424.58, an independent accreditation 
organization must furnish to CMS all of the following information:
    (1) A list of the types of DMEPOS suppliers, and a list of products 
and services for which the organization is requesting approval.
    (2) A description of the duration of accreditation.
    (3) A detailed comparison of the organization's accreditation 
requirements and standards with the applicable Medicare DMEPOS quality 
standard requirements such as a crosswalk.
    (4) A detailed description of the organization's survey process, 
including--
    <bullet> Frequency of the surveys performed.
    <bullet> Procedures for performing unannounced surveys.
    <bullet> Copies of the organization's survey forms, guidelines and 
instructions to surveyors.
    <bullet> 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, and the procedures used to monitor the correction of 
deficiencies found during an accreditation survey.
    <bullet> Policies and procedures used when an organization has a 
dispute regarding survey findings or an adverse decision.
    <bullet> Procedures for coordinating surveys with another 
accrediting organization if the organization does not accredit all 
products the supplier provides.
    (5) Detailed information about the individuals who perform surveys 
for the accreditation organization including--
    <bullet> The size and composition of accreditation teams for each 
type of provider and supplier accredited.
    <bullet> The education and experience requirements surveyors must 
meet.
    <bullet> The content and frequency of the in-service training 
provided to survey personnel.
    <bullet> The evaluation systems used to monitor the performance of 
individual surveyors and survey teams.
    <bullet> 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.
    (6) 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.
    (7) 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).
    (8) 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. These policies and procedures must include 
notifying CMS of facilities that fail to meet the requirements of the 
accrediting organization.
    (9) A description of all types and categories of accreditation 
offered by the organization, the duration of each type and category of 
accreditation, and a statement specifying the types and categories of 
accreditation for which approval of deeming authority is sought.
    (10) A list of all currently accredited suppliers, the type and 
category of accreditation currently held by each supplier, and the 
expiration date of each supplier's current accreditation.
    (11) A list of all accreditation surveys scheduled to be performed 
by the organization.
    (12) A plan for reducing the burden and cost of accreditation to 
small suppliers.
    The accreditation organization must also submit the following 
supporting documentation:
    (1) A written presentation that demonstrates the organization's 
ability to furnish CMS with electronic data in ASCII comparable code.
    (2) A resource analysis that demonstrates that the organization's 
staffing, funding, and other resources are adequate to perform the 
required surveys and related activities.
    (3) A statement acknowledging that, as a condition for approval of 
deeming authority, the organization will agree to--
    <bullet> Prioritize surveys for those suppliers in the 10 
Metropolitan Statistical Areas (MSAs) that need to bid in late 2007.
    <bullet> Prioritize surveys for those suppliers in the 80 MSAs that 
need to bid in early 2008.
    <bullet> Consider any previous accreditation, certification, and/or 
licensure findings that indicate that

[[Page 47232]]

DMPOS quality standards are being met at the time the accreditation 
organization surveys the supplier.
    <bullet> Use a streamlined process that considers only compliance 
with CMS' DME quality standards.
    <bullet> Notify CMS, in writing, of any supplier that had its 
accreditation revoked, withdrawn, revised, or any other remedial or 
adverse action taken against it by the accreditation organization 
within 30 calendar days of any such action taken.
    <bullet> Notify all accredited suppliers within 10 calendar days of 
CMS' withdrawal of the organization's approval of deeming authority.
    <bullet> Notify CMS, in writing, at least 30 calendar days in 
advance of the effective date of any proposed changes in accreditation 
requirements.
    <bullet> Submit to CMS, within 30 calendar days of a change in CMS 
requirements, an acknowledgement of CMS' notification of the change, as 
well as a revised crosswalk reflecting the new requirements, and inform 
CMS about how the organization plans to alter its requirements to 
conform to CMS' new requirements.
    <bullet> Permit its surveyors to serve as witnesses if CMS takes an 
adverse action based on accreditation findings.
    <bullet> Notify CMS, in writing, within 2 calendar days of a 
deficiency identified in any accreditation entity where the deficiency 
poses an immediate jeopardy to the entity's beneficiaries or a hazard 
to the general public.
    <bullet> Provide, on an annual basis, summary data specified by CMS 
that relates to the past years' accreditations and trends.
    <bullet> Attest that the organization will not perform any DMEPOS 
accreditation surveys of Medicare participating suppliers with which it 
has a financial relationship with or interest.
    <bullet> Conform accreditation requirements to changes in Medicare 
requirements.
    If CMS determines that additional information is necessary to make 
a determination for approval or denial of the accreditation 
organization's application for deeming authority, the organization will 
be notified and afforded an opportunity to provide the additional 
information. CMS may visit the organization's offices to verify 
representations made by the organization in its application, including, 
but not limited to, review of documents and interviews with the 
organization's staff. The accreditation organization will receive a 
formal notice from CMS stating whether the request for deeming 
authority has been approved or denied, the rationale for any denial and 
reconsideration, and reapplication procedures. CMS will make every 
effort to issue a final decision no more than 30 days from the time the 
completed application is received by CMS.
    An accreditation organization may withdraw its application for 
approval of deeming authority at any time before the formal notice of 
approval is received. An accreditation organization that has been 
notified that its request for deeming authority has been denied may 
request reconsideration in accordance with Sec.  488.201 through Sec.  
488.211 in Subpart D. Any accreditation organization whose request for 
approval of deeming authority has been denied may resubmit its 
application if the organization: (1) Revises its accreditation program 
to address the rationale for denial of its previous request; (2) 
provides reasonable assurance that its accredited companies meet 
applicable Medicare requirements; and (3) resubmits the application in 
its entirety. If an accreditation organization has requested a 
reconsideration of CMS's determination that its request for deeming 
approval is denied, it may not submit a new application for deeming 
authority for the type of provider or supplier that is at issue in the 
reconsideration until the reconsideration is final.

C. Evaluation of Proposals

    A panel consisting of subject matter experts will evaluate the 
proposals using criteria already established by CMS in the survey and 
certification process. The deadline for the submission of proposals is 
October 2, 2006.

III. Collection of Information Requirements

    The preamble of this notice discusses the information collection 
requirements associated with DMEPOS supplier accreditation from 
independent accrediting bodies. An independent accreditation 
organization must furnish to CMS all of information in the 12 items 
listed in section II.B. of this notice. In addition, each organization 
must also submit all of the necessary supporting documentation. This 
information is necessary to give the independent accreditation 
organizations the opportunity to submit proposals to implement and 
operate the DMEPOS accreditation programs. DMEPOS accreditation is 
required for DMEPOS suppliers that wish to bill Part B. The information 
supplied by the independent accreditation organizations will be used to 
evaluate the accreditation organizations ability to meet CMS' 
regulations.
    The burden associated with this information collection requirement 
is the time and effort required to document, compile, and submit the 
necessary application information to CMS. We estimate that 10 entities 
will submit the application information to CMS in order to be deemed 
independent accrediting bodies. We also estimate that it will take each 
of the entities approximately 20 hours to comply with this requirement 
for an annual total of 200 burden hours.
    The aforementioned information collection requirements have been 
submitted to the Office of Management and Budget (OMB) for emergency 
approval with a 10-day public comment period. In the August 4, 2006 
Federal Register (71 FR 44300), we published a notice announcing the 
request for emergency approval of the information collection 
requirements. These requirements are not effective until they have been 
approved by OMB.

    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 Program No. 93.774, 
Medicare--Supplementary Medical Insurance Program)

    Dated: July 25, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 06-6933 Filed 8-10-06; 4:01 pm]
BILLING CODE 4120-01-P