Federal Register / Vol. 72, No. 101 / Friday, May 25, 2007 / Notices 29325 

hospitals. We will then make a final 

determination on the waiver request and 

notify the hospitals and the designated 

and requested OPOs. 

III. Hospital Waiver Request 

[If you choose to comment on issues in this 

section, please include the caption ‘‘Hospital 

Waiver Request’’ at the beginning of your 

comments.] 

As permitted by 42 CFR 486.308(e), 

the following two hospitals are 

requesting waivers in order to enter into 

an agreement with a designated OPO 

other than the OPO designated for the 

service area in which the hospital is 

located. 

Institute for Orthopeadic Surgery is 

requesting a waiver to work with: 

LifeLine of Ohio, 770 Kinnear Road, 

Columbus, OH 43212. 

Institute for Orthopeadic Surgery’s 

Designated OPO is: LifeConnection of 

Ohio, 40 Wyoming Street, Dayton, OH 

45409. 

Trinity at Terrace Park Medical Center 

is requesting a waiver to work with: 

Iowa Donor Network, 550 Madison 

Avenue, North Liberty, IA 52317. 

Trinity at Terrace Park Medical 

Center’s designated OPO is: Gift of Hope 

Organ and Tissue Donor Network, 660 

N. Industrial Drive, Elmhurst, IL 60126. 

Authority: Section 1138 of the Social 

Security Act (42 U.S.C. 1320b–8). 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; Program No. 93.774, Medicare—

Supplementary Medical Insurance, and 

Program No. 93.778, Medical Assistance 

Program) 

Dated: May 11, 2007 

Leslie V. Norwalk, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 07–2441 Filed 5–18–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3181–PN] 

Medicare Program; Application by the 

American Diabetes Association (ADA) 

for Continued Recognition as a 

National Accreditation Program for 

Accrediting Entities To Furnish 

Outpatient Diabetes Self-Management 

Training 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed notice. 

SUMMARY: This proposed notice 

announces the receipt of an application 

from the American Diabetes Association 

(ADA) for continued recognition as a 

national accreditation program for 

accrediting entities that wish to furnish 

outpatient diabetes self-management 

training to Medicare beneficiaries. 

Section 1865(b)(3) of the Social Security 

Act (the Act) requires that we publish a 

notice identifying the national 

accreditation body making the request, 

describing the nature of the request, and 

providing at least a 30-day public 

comment period. 

DATES: Comment Date: To be assured 

consideration, comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

June 25, 2007. 

ADDRESSES: In commenting, please refer 

to file code CMS–3181–PN. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (Fax) 

transmission. 

You may submit comments in one of 

four ways (no duplicates, please): 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http:// 

www.cms.hhs.gov/eRulemaking. Click 

on the link ‘‘Submit electronic 

comments on CMS regulations with an 

open comment period.’’ (Attachments 

should be in Microsoft Word, 

WordPerfect, or Excel; however, we 

prefer Microsoft Word.) 

2. By regular mail. You may mail 

written comments (one original and two 

copies) to the following address Only: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–3181–

PN, P.O. Box 8017, Baltimore, MD 

21244–8017. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments (one 

original and two copies) to the following 

address Only: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3181–PN, Mail Stop C4–26–05, 

7500 Security Boulevard, Baltimore, MD 

21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments (one original 

and two copies) before the close of the 

comment period to one of the following 

addresses. If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786–

9994 in advance to schedule your 

arrival with one of our staff members: 

Room 445–G, Hubert H. Humphrey 

Building, 200 Independence Avenue, 

SW., Washington, DC 20201; or 7500 

Security Boulevard, Baltimore, MD 

21244–1850. 

(Because access to the interior of the 

HHH Building is not readily available to 

persons without Federal government 

identification, commenters are 

encouraged to leave their comments in 

the CMS drop slots located in the main 

lobby of the building. A stamp-in clock 

is available for persons wishing to retain 

a proof of filing by stamping in and 

retaining an extra copy of the comments 

being filed.) 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

FOR FURTHER INFORMATION CONTACT: Joan 

A. Brooks, (410) 786–5526. 

SUPPLEMENTARY INFORMATION: 

Submitting Comments: We welcome 

comments from the public on all issues 

set forth in this proposed notice to assist 

us in fully considering the issues. You 

can assist us by referencing the file code 

CMS–3181–PN and the specific ‘‘issue 

identifier’’ that precedes the section on 

which you choose to comment. 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all electronic 

comments received before the close of 

the comment period on its public Web 

site as soon as possible after they have 

been received: http://www.cms.hhs.gov/ 

eRulemaking. Click on the link 

‘‘Electronic Comments on CMS 

Regulations’’ on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

[If you choose to comment on issues in this 

section, please include the caption 

‘‘Background’’ at the beginning of your 

comments.] 

Under the Medicare program, eligible 

beneficiaries may receive outpatient 

diabetes self-management training when 

ordered by the physician or qualified 

non-physician practitioner treating the 


jlentini on PROD1PC65 with NOTICES
29326 Federal Register / Vol. 72, No. 101 / Friday, May 25, 2007 / Notices 

beneficiary’s diabetes, provided certain 

requirements are met. We sometimes 

use national accreditation organizations 

to assess whether provider entities meet 

Medicare requirements when providing 

services for which Medicare payment is 

made. 

Under section 1865(b)(1) of the Act, a 

national accreditation organization must 

have an agreement in effect with the 

Secretary and meet the standards and 

requirements specified by the Secretary 

in 42 CFR part 410, subpart H to qualify 

for deeming authority. The regulations 

pertaining to application procedures for 

national accreditation organizations for 

diabetes self-management training 

services are specified at § 410.142 (CMS 

process for approving national 

accreditation organizations). 

A national accreditation organization 

applying for deeming authority must 

provide us with reasonable assurance 

that the accrediting organization 

requires accredited entities to meet 

requirements that are at least as 

stringent as CMS’s requirements. We 

may approve and recognize a nonprofit 

or not-for-profit organization with 

demonstrated experience in 

representing the interests of individuals 

with diabetes to accredit entities to 

furnish training. The accreditation 

organization, after being approved and 

recognized by CMS, may accredit an 

entity to meet one of the sets of quality 

standards in § 410.144 (Quality 

standards for deemed entities). 

Section 1865 (b)(2) of the Act further 

requires that we review the applying 

accreditation organization’s 

requirements for accreditation, as 

follows: 

• Survey procedures, 

• Ability to provide adequate 

resources for conducting required 

surveys, 

• Ability to supply information for 

use in enforcement activities, 

• Monitoring procedures for 

providers found out of compliance with 

the conditions or requirements, and 

• Ability to provide us with necessary 

data for validation. 

We then examine the national 

accreditation organization’s 

accreditation requirements to determine 

if they meet or exceed the Medicare 

conditions as we would have applied 

them. Section 1865(b)(3)(A) of the Act 

requires that we publish a notice 

identifying the national accreditation 

body making the request within 30 days 

of receipt of a completed application. 

The notice must describe the nature of 

the request and provide at least a 30-day 

public comment period. We have 210 

days from receipt of the request to 

publish a finding of approval or denial 

of the application. If we recognize an 

accreditation organization in this 

manner, any entity accredited by the 

national accreditation body’s CMSapproved program for that service will 

be ‘‘deemed’’ to meet the Medicare 

conditions for coverage. 

II. Purpose 

The purpose of this notice is to notify 

the public of the American Diabetes 

Association’s (ADA’s) request for the 

Secretary’s approval of its accreditation 

program for outpatient diabetes selfmanagement training services. This 

notice also solicits public comments on 

the ability of the ADA to develop and 

apply its standards to entities furnishing 

outpatient diabetes self-management 

training services that meet or exceed the 

Medicare conditions for coverage. 

III. Outpatient Diabetes SelfManagement Training Services 

Conditions for Coverage and 

Requirements 

The regulations specifying the 

Medicare conditions for coverage for 

outpatient diabetes self-management 

training services are located in 42 CFR 

part 410, subpart H. These conditions 

implement section 1861(qq) of the Act, 

which provides for Medicare Part B 

coverage of outpatient diabetes selfmanagement training services specified 

by the Secretary. 

Under section 1865(b)(2) of the Act 

and our regulations § 410.142 (CMS 

process for approving national 

accreditation organizations) and 

§ 410.143 (Requirements for approved 

accreditation organizations), we review 

and evaluate a national accreditation 

organization based on (but not 

necessarily limited to) the criteria set for 

in § 410.142(b). 

We may conduct on-site inspections 

of a national accreditation 

organization’s operations and office to 

verify information in the organization’s 

application and assess the 

organization’s compliance with its own 

policies and procedures. The onsite 

inspection may include, but is not 

limited to, reviewing documents, 

auditing documentation of meetings 

concerning the accreditation process, 

evaluating accreditation results or the 

accreditation status decision making 

process, and interviewing the 

organization’s staff. 

IV. Notice Upon Completion of Our 

Evaluation 

Upon completion of our evaluation, 

including evaluation of comments 

received as a result of this notice, we 

will publish a notice in the Federal 

Register announcing the result of our 

evaluation. 

V. Responses to Public Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

In accordance with the provisions of 

Executive Order 12866, the Office of 

Management and Budget did not review 

this notice. 

Authority: Section 1865 of the Social 

Security Act (42 U.S.C. 1395bb). 

(Catalog of Federal Domestic Assistance 

Program No. 93.773 Medicare-Hospital 

Insurance Program; and No. 93.774, 

Medicare-Supplementary Medical Insurance 

Program) 

Dated: May 11, 2007. 

Leslie V. Norwalk, 

Acting Administrator, Centers for Medicare 

& Medicare Services. 

[FR Doc. 07–2454 Filed 5–24–07; 8:45 am] 

BILLING CODE 4120–01–P 

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. 

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 


jlentini on PROD1PC65 with NOTICES