47230 Federal Register / Vol. 71, No. 158 / Wednesday, August 16, 2006 / Notices 

Security Number is voluntary, but it 

may make searching for a record easier 

and prevent delay), (c) parking space 

number (if appropriate); (d) vehicle 

license number (if appropriate) and (e) 

for the PSC Transhare Program, the 

requester must provide the commuter 

card number and the dates of 

participation in the Program. The 

requester must also understand that the 

knowing and willful request for 

acquisition of a record pertaining to an 

individual under false pretenses is a 

criminal offense subject to a fine. An 

individual who is the subject of records 

maintained in this records system may 

also request an accounting of 

disclosures that have been made of his 

or her records. 

REQUESTS BY TELEPHONE: 

Since positive identification of the 

caller cannot be established, telephone 

requests are not honored. 

CONTESTING RECORD PROCEDURES: 

Contact the System Manager specified 

above and reasonably identify the 

record, specify the information to be 

contested, the corrective action sought, 

and your reasons for requesting the 

correction, along with supporting 

information to show how the record is 

inaccurate, incomplete, untimely or 

irrelevant. 

RECORD SOURCE CATEGORIES: 

Records are developed from 

information supplied by applicants and, 

for handicapped parking assignments, 

by physicians and supervisors. 

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT: 

None. 

[FR Doc. E6–13389 Filed 8–15–06; 8:45 am] 

BILLING CODE 4168–17–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Ethics Subcommittee, Advisory 

Committee to the Director, Centers for 

Disease Control and Prevention (CDC); 

Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention announces the 

following Subcommittee meeting. 

Name: Ethics Subcommittee, 

Advisory Committee to the Director 

(ACD), CDC. 

Times and Dates: 8:30 a.m.–5 p.m., 

September 14, 2006; 8:30 a.m.–12 p.m., 

September 15, 2006. 

Place: Centers for Disease Control and 

Prevention, Tom Harkin Global 

Communications Center (Building 19), 

1600 Clifton Road, Atlanta, GA 30333. 

Status: Open to the public, limited 

only by the space available. The meeting 

room accommodates approximately 75 

people. 

Purpose: The Ethics Subcommittee 

will provide counsel to the ACD, CDC, 

regarding a broad range of public health 

ethics questions and issues arising from 

programs, scientists and practitioners. 

Matters to Be Discussed: Agenda 

items will include discussions in Public 

Health Ethics of Emergency Response; 

Ethical Considerations in Pandemic 

Influenza Preparedness; and Future 

Direction of the Ethics Subcommittee. 

Agenda items are subject to change as 

priorities dictate. 

FOR FURTHER INFORMATION CONTACT: For 

security reasons, please contact Drue 

Barrett, Ph.D., Designated Federal 

Official, Ethics Subcommittee, CDC, 

1600 Clifton Road, NE., M/S D–50, 

Atlanta, Georgia 30333. Telephone 404/ 

639–4690. E-mail: dbarrett@cdc.gov. 

The deadline for notification of 

attendance is September 7, 2006. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: August 9, 2006. 

Alvin Hall, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E6–13452 Filed 8–15–06; 8:45 am] 

BILLING CODE 4163–18–P 

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. 

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: 

• 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 

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 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 71, No. 158 / Wednesday, August 16, 2006 / Notices 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 nonDMEPOS 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 nonDMEPOS 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 § 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—

• Frequency of the surveys 

performed. 

• Procedures for performing 

unannounced surveys. 

• Copies of the organization’s survey 

forms, guidelines and instructions to 

surveyors. 

• 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. 

• 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. 

(5) Detailed information about the 

individuals who perform surveys 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. 

(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—

• Prioritize surveys for those 

suppliers in the 10 Metropolitan 

Statistical Areas (MSAs) that need to bid 

in late 2007. 

• Prioritize surveys for those 

suppliers in the 80 MSAs that need to 

bid in early 2008. 

• Consider any previous 

accreditation, certification, and/or 

licensure findings that indicate that 


jlentini on PROD1PC65 with NOTICES
47232 Federal Register / Vol. 71, No. 158 / Wednesday, August 16, 2006 / Notices 

DMPOS quality standards are being met 

at the time the accreditation 

organization surveys the supplier. 

• Use a streamlined process that 

considers only compliance with CMS’

DME quality standards. 

• 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. 

• Notify all accredited suppliers 

within 10 calendar days of CMS’

withdrawal of the organization’s 

approval of deeming authority. 

• Notify CMS, in writing, at least 30 

calendar days in advance of the effective 

date of any proposed changes in 

accreditation requirements. 

• 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. 

• Permit its surveyors to serve as 

witnesses if CMS takes an adverse 

action based on accreditation findings. 

• 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. 

• Provide, on an annual basis, 

summary data specified by CMS that 

relates to the past years’ accreditations 

and trends. 

• 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. 

• 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 § 488.201 through § 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, call the 

HRSA Reports Clearance Officer on 

(301) 443–1129. 


jlentini on PROD1PC65 with NOTICES