Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Notices 43177 

criteria outlined in section 3.2.2 would 

be a minimal requirement, but HHS 

would consider additional criteria that 

further distinguish models with greater 

and lesser support in evidence. HHS is 

committed to ensuring that these criteria 

are transparent, methodologically 

sound, and increase the likelihood that 

federal funds will contribute to 

improved outcomes for at-risk children 

and families. 

There are a number of different ways 

that such a system could be structured. 

We invite comments on the proposal to 

distinguish among evidence-based 

models based on a rubric that weighs 

factors relating to research quality and 

findings. For example, one relatively 

simple approach would rate models 

using an index constructed by weighting 

several factors equally. Models might be 

given points for meeting each of the 

following criteria: Favorable impacts 

sustained at least one year after program 

completion, favorable impacts 

replicated in distinct samples, favorable 

impacts in studies conducted by 

independent evaluators, quality and 

relevance of outcome measures; and 

balance between favorable and 

unfavorable and null findings. 

Additional factors which might be 

considered could include further indicia 

of the quality of the research design and 

implementation (as reflected in 

randomization, sample size, attrition, 

and baseline equivalence). We invite 

comments on HHS’ proposal to use 

evidence for program models as a factor 

in determining allocations of additional 

funds, how various factors should be 

weighed in assessing the evidence of 

effectiveness, how to define these 

categories, and any other role 

distinctions related to the strength of the 

evidence should play in funding 

allocation. As noted above, strength of 

evidence is proposed to be only one 

factor in the evaluation of the strength 

of States’ applications, and we invite 

comments on other appropriate factors 

as well. 

8.0 Future Considerations 

We invite comment on the following: 

• HHS anticipates the criteria for 

evidence-based models will likely need 

to be altered over time as the state of the 

field changes. If HHS believes the 

criteria need to be changed in future 

years, it is anticipated the public will 

have an opportunity to comment on the 

proposed revisions. 

• HHS intends to review the evidence 

base for home visiting models on an 

ongoing basis to ensure that new 

evidence is incorporated. 

9.0 Submission of Comments 

Comments may be submitted until 

August 17, 2010 by e-mail to: 

HVEE@mathematica-mpr.com. 

Dated: July 19, 2010. 

Mary K. Wakefield, 

Administrator, Health Resources and Services 

Administration. 

Carmen R. Nazario, 

Assistant Secretary, Administration for 

Children and Families. 

[FR Doc. 2010–18013 Filed 7–22–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1354–NC] 

Medicare and Medicaid Programs; 

Announcement of an Application From 

a Hospital Requesting Waiver for 

Organ Procurement Service Area 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice with comment period. 

SUMMARY: A hospital has requested a 

waiver of statutory requirements that 

would otherwise require the hospital to 

enter into an agreement with its 

designated Organ Procurement 

Organization (OPO). The request was 

made 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. 

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 

September 21, 2010. 

ADDRESSES: In commenting, please refer 

to file code CMS–1354–NC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the instructions under the ‘‘More Search 

Options’’ tab. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS– 

1354–NC, P.O. Box 8010, Baltimore, 

MD 21244–1850. 

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 to the 

following address ONLY: 

Department of Health and Human 

Services, Attention: CMS–1354–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 before the close 

of the comment period to either of the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201 

(Because access to the interior of the 

Hubert H. Humphrey 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.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244– 

1850. 

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. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Mark A. Horney, (410) 786–4554. 

SUPPLEMENTARY INFORMATION: 

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 comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

43178 Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Notices 

been received: http:// 

www.regulations.gov. Follow the search 

instructions 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 

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, pursuant to 

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

Service Act (42 U.S.C. 273(b)(1)) 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, pursuant 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 

a waiver of the above requirements from 

the Secretary 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 § 486.308(e) and (f). 

II. Waiver Request Procedures 

In October 1995, we issued a Program 

Memorandum (Transmittal No. A–95– 

11) detailing the waiver process and 

discussing the information 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 Health Resources and Services 

Administration’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 

hospital or others. We will then make a 

final determination on the waiver 

request and notify the hospital and the 

designated and requested OPOs. 

III. Hospital Waiver Requests 

As permitted by § 486.308(e), the 

following hospital has requested a 

waiver 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: 

Stafford Hospital (Medicare provider 

number 49–0140), of Stafford, Virginia, 

is requesting a waiver to work with: 

LifeNet Health, 1864 Concert Drive, 

Virginia Beach, VA 23453. 

The Hospital’s Designated OPO is: 

Washington Regional Transplant 

Consortium, 7619 Little River 

Turnpike, Suite 900, Annandale, VA 

22002. 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

(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: July 15, 2010. 

Marilyn Tavenner, 

Principal Deputy Administrator and Chief 

Operating Officer, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2010–18137 Filed 7–22–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–5047–N] 

Medicare Program; Solicitation for 

Proposals for the Medicare Imaging 

Demonstration 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice informs interested 

parties (here in there after referred to as 

conveners) of an opportunity to apply to 

participate in the Medicare Imaging 

Demonstration (MID) that was 

authorized by section 135(b) of the 

Medicare Improvements for Patients and 

Providers Act of 2008 (MIPPA). The goal 

of the MID is to collect data regarding 

physician compliance with 

appropriateness criteria selected by the 

Secretary under the terms of the statute 

in order to determine the 

appropriateness of advanced diagnostic 

imaging services furnished to Medicare 

beneficiaries. 

DATES: Proposals will be considered 

timely if they are received on or before 

5 p.m., Eastern Standard Time (E.S.T.) 

on September 21, 2010. 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES