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

Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Notices 43179 

ADDRESSES: Proposals should be mailed 

to the following address: Centers for 

Medicare & Medicaid Services, 

Attention: Linda R. Lebovic, 7500 

Security Boulevard, Mail Stop: C4–17– 

27, Baltimore, Maryland 21244–1850. 

FOR FURTHER INFORMATION CONTACT: 

Linda R. Lebovic at (410) 786–3402 or 

by e-mail at 

ImagingDemo135b@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

General Information: Please refer to 

file code [CMS–5047–N] on the 

application. Proposals (an unbound 

original and 3 copies plus an electronic 

copy on CD–ROM) must be typed for 

clarity and should not exceed 40 

double-spaced pages, exclusive of cover 

letter, the executive summary, resumes, 

forms, and supporting documentation. 

Because of staffing and resource 

limitations, we cannot accept proposals 

by facsimile (FAX) transmission. 

Applicants may, but are not required to, 

submit a total of 10 copies to assure that 

each reviewer receives a proposal in the 

manner intended by the applicant (for 

example, collated, tabulated color 

copies). Hard copies and electronic 

copies must be identical. 

Eligible Organizations: CMS 

anticipates that a wide variety of 

interested parties may be eligible to 

apply as conveners or in collaboration 

with other organizations to perform the 

responsibilities specified. Examples of 

conveners include, but are not limited 

to, medical specialty societies, 

physician groups, integrated health care 

delivery systems, independent practice 

associations, radiology benefit 

managers, health plans, information 

technology vendors, and collaborations 

among the above parties. 

I. Provisions of This Notice 

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. The authorizing 

legislation allows the Secretary to 

include in the demonstration advanced 

diagnostic imaging services such as 

those defined in § 1834(e)(1)(B) of the 

Social Security Act (the Act): Diagnostic 

magnetic resonance imaging (MRI), 

computed tomography (CT), nuclear 

medicine (including positron emission 

tomography) and such other diagnostic 

imaging services, including services 

described in § 1848(b)(4)(B) of the Act 

(excluding X-ray, ultrasound, and 

fluoroscopy), as specified by the 

Secretary in consultation with physician 

specialty organizations and other 

stakeholders. The law requires that the 

appropriateness criteria used in the 

demonstration be based on those 

developed or endorsed by medical 

specialty societies. The Centers for 

Medicare & Medicaid Services (CMS) 

worked with medical specialty societies 

and other stakeholders, including the 

AQA Alliance, to get their input and 

information on available 

appropriateness criteria. For purposes of 

this demonstration, the ‘‘appropriateness 

criteria’’ referenced in the statute will be 

published medical specialty society 

guidelines relevant to the 11 procedures 

studied in the demonstration that are 

developed or endorsed by relevant 

medical specialty societies, are 

consistent with the spirit of section 

135(b)(2)(B)(ii)(II), and which have been 

selected by the Secretary under the 

terms of the statute. (We believe the 

appropriateness criteria are the product 

of consensus and meet the spirit of 

section 135(b)(2)(B)(ii)(II) of MIPPA. 

Consequently, published medical 

specialty society guidelines relevant for 

the 11 procedures are included in the 

demonstration. 

The law prohibits the use of prior 

authorization in the demonstration. The 

design of the demonstration will permit 

evaluation of the appropriateness of 

imaging services across a range of 

advanced diagnostic imaging studies, 

geographic areas, demographic 

characteristics and practice settings 

(such as private and academic practices) 

in the Medicare fee-for-service program. 

CMS is seeking participation by 2,500 to 

3,500 physicians from 500 to 650 

physician practices that vary in size, 

specialty mix, type (academic and 

private practice), and location (urban, 

rural, and suburban) to obtain 

substantial sample size for the 

evaluation. 

The demonstration will test whether 

the use of decision support systems 

(DSSs) can improve quality of care and 

reduce unnecessary radiation exposure 

and utilization by promoting 

appropriate ordering of advanced 

diagnostic imaging services. Physician 

practices will receive feedback on the 

degree of appropriateness relative to the 

specified medical specialty society 

guidelines used under the 

demonstration. 

CMS is seeking conveners that can 

provide a panel of participating 

physician practices that agree to use an 

advanced diagnostic imaging DSS for 

purposes of this demonstration. The 

Secretary has chosen to use conveners 

as a vehicle to recruit physician 

practices for participation in the 

demonstration because it is expected 

that the likely applicants for the 

convener have well developed 

relationships (or the ability to establish) 

with a significant network of physicians 

that could be potential applicants for 

participation in the demonstration. 

Therefore, conveners would be highly 

effective at providing a robust panel of 

physicians that could satisfy the 

selection requirements outlined in the 

statute. The convener will secure a DSS 

for advanced diagnostic imaging 

services that will remain current with 

the medical specialty society guidelines 

used under the demonstration, recruit 

physician practices, and make the DSS 

available to physician practices 

participating in the demonstration. 

Through the DSS, a convener will 

collect data on physician ordering of the 

specified services and test results, and 

provide feedback to physicians on 

ordering appropriateness. The convener 

will also distribute payments (as 

determined by CMS) to the participating 

practices for reporting data. In this 

capacity, the convener will be 

responding to the solicitation on its 

behalf as applicant. For the 

demonstration, interested parties may 

need to collaborate as a convener in 

order to have a panel of participating 

physician practices, the availability of 

the DSS for use by the physician 

practices, and must comply with 

demonstration requirements. 

A competitive process will be used to 

select conveners. CMS anticipates 

selecting up to six conveners to 

participate in the 2-year demonstration. 

CMS is aware that certain arrangements 

under this demonstration could raise 

possible fraud, waste, and abuse 

concerns, including concerns under the 

anti-kickback statute and the physician 

self-referral law. While CMS has the 

authority to waive the application of 

certain fraud, waste, and abuse laws, it 

is anticipated that doing so, if at all, will 

only occur after evaluating the 

provisions of the proposals on a case-bycase basis and considering whether a 

waiver is necessary to carry out the 

demonstration project. 

Physician practices must apply 

through a convener and the convener’s 

application must include the criteria 

and rationale for recruiting physician 

practices and obtaining their buy-in for 

the use of the DSS. The Secretary has 

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43180 Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Notices 

chosen to use conveners as a vehicle to 

recruit physician practices for 

participation in the demonstration 

because it is expected that the likely 

applicants for the convener have well 

developed relationships (or the ability 

to establish) with a significant network 

of physicians that could be potential 

applicants for participation in the 

demonstration. Therefore, conveners 

would be highly effective at providing a 

robust panel of physicians that could 

satisfy the selection requirements 

outlined in the statute. Conveners must 

also disclose in the application whether 

the DSS may be retained by the 

participating practice after the 

demonstration is concluded and 

whether the DSS may be used to order 

items and services other than the subject 

imaging services. 

Applicants must submit their 

applications in the standard format 

outlined in CMS’ Medicare Waiver 

Demonstration Application and MID 

solicitation in order to be considered for 

review by the technical review panel. 

Applications not received in this format 

will not be considered for review. 

The Medicare Waiver Demonstration 

Application can be found electronically 

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

downloads/cms10069.pdf. 

For specific details regarding the MID, 

please refer to the solicitation on the 

CMS Web site at: http://www.cms.hhs.

gov/DemoProjectsEvalRpts/downloads/

Medicare_Imaging_Demonstration.pdf. 

II. Collection of Information 

Requirements 

Section 135(b)(4)(A) of the MIPPA 

(Pub. L. 110–275) exempts this 

demonstration from the Chapter 35 of 

Title 44 of the United States Code; 

however, the collection form entitled 

‘‘Medicare Demonstration Waiver 

Application’’ is currently approved 

under OMB control number 0938–0880. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: April 1, 2010. 

Charlene Frizzera, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2010–18139 Filed 7–22–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

General Medical Sciences Special Emphasis 

Panel, Research Centers in Trauma, Burn, 

and Peri-Operative Injury (P50). 

Date: August 17, 2010. 

Time: 1 p.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Natcher Building, 45 Center Drive, 

Room 3AN12B, Bethesda, MD 20892. 

Contact Person: Margaret J. Weidman, PhD, 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 45 

Center Drive, Room 3AN18B, Bethesda, MD 

20892, 301–594–3663, 

weidmanma@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.375, Minority Biomedical 

Research Support; 93.821, Cell Biology and 

Biophysics Research; 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.862, Genetics and 

Developmental Biology Research; 93.88, 

Minority Access to Research Careers; 93.96, 

Special Minority Initiatives, National 

Institutes of Health, HHS) 

Dated: July 19, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–18088 Filed 7–22–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Board on Radiation and 

Worker Health (ABRWH or Advisory 

Board), National Institute for 

Occupational Safety and Health 

(NIOSH) 

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

the Federal Advisory Committee Act 

(Pub. L. 92–463), and pursuant to the 

requirements of 42 CFR 83.15(a), the 

Centers for Disease Control and 

Prevention (CDC), announces the 

following meeting of the 

aforementioned committee: 

Board Public Meeting Times and Dates (All 

times are Eastern Time): 

8:15 a.m.–3 p.m., August 10, 2010. 

8:15 a.m.–4:15 p.m., August 11, 2010. 

8:15 a.m.–12 p.m., August 12, 2010. 

Public Comment Times and Dates (All times 

are Eastern Time): 

3:30 p.m.–5 p.m.,* August 10, 2010. 

4:30 p.m.–6 p.m.,* August 11, 2010. 

* Please note that the public comment 

periods may end before the times indicated, 

following the last call for comments. 

Members of the public who wish to provide 

public comment should plan to attend public 

comment sessions at the start times listed. 

Place: Shilo Inn Suites Hotel, 780 Lindsay 

Blvd., Idaho Falls, Idaho; Phone: 208–523– 

0088; Fax: 208–522–7420. Audio Conference 

Call via FTS Conferencing. The USA toll free 

dial in number is 1–866–659–0537 with a 

pass code of 9933701. 

Status: Open to the public, limited only by 

the space available. The meeting space 

accommodates approximately 150 people. 

Background: The Advisory Board was 

established under the Energy Employees 

Occupational Illness Compensation Program 

(EEOICP) Act of 2000 to advise the President 

on a variety of policy and technical functions 

required to implement and effectively 

manage the new compensation program. Key 

functions of the Advisory Board include 

providing advice on the development of 

probability of causation guidelines which 

have been promulgated by the Department of 

Health and Human Services (HHS) as a final 

rule, advice on methods of dose 

reconstruction which have also been 

promulgated by HHS as a final rule, advice 

on the scientific validity and quality of dose 

estimation and reconstruction efforts being 

performed for purposes of the compensation 

program, and advice on petitions to add 

classes of workers to the Special Exposure 

Cohort (SEC). 

In December 2000, the President delegated 

responsibility for funding, staffing, and 

operating the Advisory Board to HHS, which 

subsequently delegated this authority to the 

CDC. NIOSH implements this responsibility 

for CDC. The charter was issued on August 

3, 2001, renewed at appropriate intervals, 

and will expire on August 3, 2011. 

Purpose: This Advisory Board is charged 

with (a) Providing advice to the Secretary, 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES