Federal Register / Vol. 72, No. 101 / Friday, May 25, 2007 / Notices 29323 

Dated: May 16, 2007. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 07–2578 Filed 5–24–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10207] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS) is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Physician SelfReferral Exceptions for Electronic 

Prescribing and Electronic Health 

Records (CMS–1303–F); Form Number: 

CMS–10207 (OMB#: 0938–1009); Use: 

Section 101 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) 

directs the Secretary to create an 

exception to the physician self-referral 

prohibition in section 1877 of the Act 

for certain arrangements in which a 

physician receives compensation in the 

form of items or services (not including 

cash or cash equivalents) 

(‘‘nonmonetary remuneration’’) that is 

necessary and used solely to receive and 

transmit electronic prescription 

information. In addition, using our 

separate legal authority under section 

1877(b)(4) of the Act, the regulation 

CMS–1303–F (71 FR 45140) created a 

separate regulatory exception for certain 

arrangements involving the provision of 

nonmonetary remuneration in the form 

of electronic health records software or 

information technology and training 

services necessary and used 

predominantly to create, maintain, 

transmit, or receive electronic health 

records. These exceptions are consistent 

with the President’s goal of achieving 

widespread adoption of interoperable 

electronic health records to improve the 

quality and efficiency of health care 

while maintaining the levels of security 

and privacy that consumers expect. 

The conditions for both exceptions 

require that arrangements for the items 

and services provided must be set forth 

in a written agreement, be signed by the 

parties involved, specify the items or 

services being provided and the cost of 

those items or services, and cover all of 

the electronic prescribing and/or 

electronic health records technology to 

be provided by the donating entity. We 

have suggested that, instead of one 

master agreement that is updated with 

each new donation, the parties may 

choose to create a specific new contract 

and then reference other agreements or 

cross-reference a master list of 

agreements. 

The requirements associated with the 

exception for electronic prescribing 

items and services are limited to 

donations made by hospitals to 

members of their medical staffs; by 

group practices to their physician 

members; and by PDP sponsors and MA 

organizations to prescribing physicians. 

The requirements associated with the 

exception for electronic health records 

software or information technology and 

training services include donations by 

entities furnishing DHS to physicians. 

The paperwork burden is the creation 

and execution of the written 

agreements. The burden associated with 

the written agreement requirement is 

the time and effort necessary for 

documentation of the agreement 

between the parties, including the 

signatures of the parties. Frequency: 

Recordkeeping and Reporting—On 

occasion; Affected Public: Business or 

other for-profit and Not-for-profit 

institutions; Number of Respondents: 

27,440; Total Annual Responses: 

54,730; Total Annual Hours: 17,545. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786–

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received at the address below, no 

later than 5 p.m. on July 24, 2007. 

CMS, Office of Strategic Operations 

and Regulatory Affairs, Division of 

Regulations Development—B, Attention: 

William N. Parham, III, Room C4–26–

05, 7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: May 21, 2007. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E7–10097 Filed 5–24–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1274–NC] 

Medicare and Medicaid Programs; 

Announcement of Applications From 

Two Hospitals Requesting Waivers for 

Organ Procurement Service Areas 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice with comment period. 

SUMMARY: This notice announces two 

hospitals’ requests for a waiver from 

entering into an agreement with its 

designated organ procurement 

organization (OPO), in accordance with 

section 1138(a)(2) of the Social Security 

Act (the Act). This notice requests 

comments from OPOs and the general 

public for our consideration in 

determining whether we should grant 

the requested waiver for each hospital. 

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 

July 24, 2007. 

ADDRESSES: In commenting, please refer 

to file code CMS–1274–NC. 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 


jlentini on PROD1PC65 with NOTICES
29324 Federal Register / Vol. 72, No. 101 / Friday, May 25, 2007 / Notices 

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–1274–

NC, 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–1274–NC, 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: 

Mark A. Horney, (410) 786–4554. 

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–1274–C 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 the 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.] 

Organ Procurement Organizations 

(OPOs) are not-for-profit organizations 

that are responsible for the 

procurement, preservation, and 

transport of transplantable organs to 

transplant centers throughout the 

country. Qualified OPOs are designated 

by the Centers for Medicare & Medicaid 

Services (CMS) to recover or procure 

organs in CMS-defined exclusive 

geographic service areas, according to 

section 371(b)(1)(F) of the Public Health 

Service Act (42 U.S.C. 273(b)(1)(F)) and 

our regulations at 42 CFR 486.306. Once 

an OPO has been designated for an area, 

hospitals in that area that participate in 

Medicare and Medicaid are required to 

work with that OPO in providing organs 

for transplant, according to section 

1138(a)(1)(C) of the Social Security Act 

(the Act), and our regulations at 42 CFR 

482.45. 

Section 1138(a)(1)(A)(iii) of the Act 

provides that a hospital must notify the 

designated OPO (for the service area in 

which it is located) of potential organ 

donors. Under section 1138(a)(1)(C) of 

the Act, every participating hospital 

must have an agreement to identify 

potential donors only with its 

designated OPO. 

However, section 1138(a)(2)(A) of the 

Act provides that a hospital may obtain 

from the Secretary, a waiver of the 

above requirements under certain 

specified conditions. A waiver allows 

the hospital to have an agreement with 

an OPO other than the one initially 

designated by CMS, if the hospital 

meets certain conditions specified in 

section 1138(a)(2)(A) of the Act. In 

addition, the Secretary may review 

additional criteria described in section 

1138(a)(2)(B) of the Act to evaluate the 

hospital’s request for a waiver. 

Section 1138(a)(2)(A) of the Act states 

that in granting a waiver, the Secretary 

must determine that the waiver—(1) is 

expected to increase organ donations; 

and (2) will ensure equitable treatment 

of patients referred for transplants 

within the service area served by the 

designated OPO and within the service 

area served by the OPO with which the 

hospital seeks to enter into an 

agreement under the waiver. In making 

a waiver determination, section 

1138(a)(2)(B) of the Act provides that 

the Secretary may consider, among 

other factors: (1) Cost-effectiveness; (2) 

improvements in quality; (3) whether 

there has been any change in a 

hospital’s designated OPO due to the 

changes made in definitions for 

metropolitan statistical areas; and (4) 

the length and continuity of a hospital’s 

relationship with an OPO other than the 

hospital’s designated OPO. Under 

section 1138(a)(2)(D) of the Act, the 

Secretary is required to publish a notice 

of any waiver application received from 

a hospital within 30 days of receiving 

the application, and to offer interested 

parties an opportunity to comment in 

writing during the 60-day period 

beginning on the publication date in the 

Federal Register. 

The criteria that the Secretary uses to 

evaluate the waiver in these cases are 

the same as those described above under 

sections 1138(a)(2)(A) and (B) of the Act 

and have been incorporated into the 

regulations at 42 CFR 486.308(e) and (f). 

II. Waiver Request Procedures 

[If you choose to comment on issues in this 

section, please include the caption ‘‘Waiver 

Request Procedures’’ at the beginning of your 

comments.] 

In October 1995, we issued a Program 

Memorandum (Transmittal No. A–95–

11) detailing the waiver process and 

discussing the information that 

hospitals must provide in requesting a 

waiver. We indicated that upon receipt 

of a waiver request, we would publish 

a Federal Register notice to solicit 

public comments, as required by section 

1138(a)(2)(D) of the Act. 

According to these requirements, we 

will review the request and comments 

received. During the review process, we 

may consult on an as-needed basis with 

the Public Health Service’s Division of 

Transplantation, the United Network for 

Organ Sharing, and our regional offices. 

If necessary, we may request additional 

clarifying information from the applying 


jlentini on PROD1PC65 with NOTICES
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