Monday, 

June 28, 2010 

Book 2 of 2 Books 

Pages 36785–37286 

Part II 

Department of 

Health and Human 

Services 

Centers for Medicare & Medicaid Services 

Medicare and Medicaid Programs; 

Quarterly Listing of Program; Notice 


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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–9059–N] 

Medicare and Medicaid Programs; 

Quarterly Listing of Program 

Issuances—January Through March 

2010 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice lists CMS manual 

instructions, substantive and 

interpretive regulations, and other 

Federal Register notices that were 

published from January through March 

2010, relating to the Medicare and 

Medicaid programs. This notice 

provides information on national 

coverage determinations (NCDs) 

affecting specific medical and health 

care services under Medicare. 

Additionally, this notice identifies 

certain devices with investigational 

device exemption (IDE) numbers 

approved by the Food and Drug 

Administration (FDA) that potentially 

may be covered under Medicare. This 

notice also includes listings of all 

approval numbers from the Office of 

Management and Budget for collections 

of information in CMS regulations and 

a list of Medicare-approved carotid stent 

facilities. Included in this notice is a list 

of the American College of Cardiology’s 

National Cardiovascular Data registry 

sites, active CMS coverage-related 

guidance documents, and special onetime notices regarding national coverage 

provisions. Also included in this notice 

is a list of National Oncologic Positron 

Emissions Tomography Registry sites, a 

list of Medicare-approved ventricular 

assist device (destination therapy) 

facilities, a list of Medicare-approved 

lung volume reduction surgery facilities, 

a list of Medicare-approved clinical 

trials for fluorodeoxyglucose positron 

emissions tomogrogphy for dementia, 

and a list of Medicare-approved 

bariatric surgery facilities. 

Section 1871(c) of the Social Security 

Act requires that we publish a list of 

Medicare issuances in the Federal 

Register at least every 3 months. 

Although we are not mandated to do so 

by statute, for the sake of completeness 

of the listing, and to foster more open 

and transparent collaboration efforts, we 

are also including all Medicaid 

issuances and Medicare and Medicaid 

substantive and interpretive regulations 

(proposed and final) published during 

this 3-month time frame. 

FOR FURTHER INFORMATION CONTACT: It is 

possible that an interested party may 

need specific information and not be 

able to determine from the listed 

information whether the issuance or 

regulation would fulfill that need. 

Consequently, we are providing contact 

persons to answer general questions 

concerning these items. Copies are not 

available through the contact persons. 

(See Section III of this notice for how to 

obtain listed material.) 

Questions concerning CMS manual 

instructions in Addendum III may be 

addressed to Ismael Torres, Office of 

Strategic Operations and Regulatory 

Affairs, Centers for Medicare & 

Medicaid Services, C4–26–05, 7500 

Security Boulevard, Baltimore, MD 

21244–1850, or you can call (410) 786– 

1864. 

Questions concerning regulation 

documents published in the Federal 

Register in Addendum IV may be 

addressed to Kathleen Smith, Office of 

Strategic Operations and Regulatory 

Affairs, Centers for Medicare & 

Medicaid Services, C4–14–03, 7500 

Security Boulevard, Baltimore, MD 

21244–1850, or you can call (410) 786– 

0626. 

Questions concerning Medicare NCDs 

in Addendum V may be addressed to 

Patricia Brocato-Simons, Office of 

Clinical Standards and Quality, Centers 

for Medicare & Medicaid Services, C1– 

09–06, 7500 Security Boulevard, 

Baltimore, MD 21244–1850, or you can 

call (410) 786–0261. 

Questions concerning FDA-approved 

Category B IDE numbers listed in 

Addendum VI may be addressed to John 

Manlove, Office of Clinical Standards 

and Quality, Centers for Medicare & 

Medicaid Services, C1–13–04, 7500 

Security Boulevard, Baltimore, MD 

21244–1850, or you can call (410) 786– 

6877. 

Questions concerning approval 

numbers for collections of information 

in Addendum VII may be addressed to 

Melissa Musotto, Office of Strategic 

Operations and Regulatory Affairs, 

Regulations Development and Issuances 

Group, Centers for Medicare & Medicaid 

Services, C5–14–03, 7500 Security 

Boulevard, Baltimore, MD 21244–1850, 

or you can call (410) 786–6962. 

Questions concerning Medicareapproved carotid stent facilities in 

Addendum VIII may be addressed to 

Sarah J. McClain, Office of Clinical 

Standards and Quality, Centers for 

Medicare & Medicaid Services, C1–09– 

06, 7500 Security Boulevard, Baltimore, 

MD 21244–1850, or you can call (410) 

786–2994. 

Questions concerning Medicare’s 

recognition of the American College of 

Cardiology-National Cardiovascular 

Data Registry sites in Addendum IX may 

be addressed to JoAnna Baldwin, MS, 

Office of Clinical Standards and 

Quality, Centers for Medicare & 

Medicaid Services, C1–09–06, 7500 

Security Boulevard, Baltimore, MD 

21244–1850, or you can call (410) 786– 

7205. 

Questions concerning Medicare’s 

active coverage-related guidance 

documents in Addendum X may be 

addressed to Beverly Lofton, Office of 

Clinical Standards and Quality, Centers 

for Medicare & Medicaid Services, C1– 

09–06, 7500 Security Boulevard, 

Baltimore, MD 21244–1850, or you can 

call (410) 786–7136. 

Questions concerning one-time 

notices regarding national coverage 

provisions in Addendum XI may be 

addressed to Beverly Lofton, Office of 

Clinical Standards and Quality, Centers 

for Medicare & Medicaid Services, C1– 

09–06, 7500 Security Boulevard, 

Baltimore, MD 21244–1850, or you can 

call (410) 786–7136. 

Questions concerning National 

Oncologic Positron Emission 

Tomography Registry sites in 

Addendum XII may be addressed to 

Stuart Caplan, RN, MAS, Office of 

Clinical Standards and Quality, Centers 

for Medicare & Medicaid Services, C1– 

09–06, 7500 Security Boulevard, 

Baltimore, MD 21244–1850, or you can 

call (410) 786–8564. 

Questions concerning Medicareapproved ventricular assist device 

(destination therapy) facilities in 

Addendum XIII may be addressed to 

JoAnna Baldwin, MS, Office of Clinical 

Standards and Quality, Centers for 

Medicare & Medicaid Services, C1–09– 

06, 7500 Security Boulevard, Baltimore, 

MD 21244–1850, or you can call (410) 

786–7205. 

Questions concerning Medicareapproved lung volume reduction 

surgery facilities listed in Addendum 

XIV may be addressed to JoAnna 

Baldwin, MS, Office of Clinical 

Standards and Quality, Centers for 

Medicare & Medicaid Services, C1–09– 

06, 7500 Security Boulevard, Baltimore, 

MD 21244–1850, or you can call (410) 

786–7205. 

Questions concerning Medicareapproved bariatric surgery facilities 

listed in Addendum XV may be 

addressed to Kate Tillman, RN, MA, 

Office of Clinical Standards and 

Quality, Centers for Medicare & 

Medicaid Services, C1–09–06, 7500 

Security Boulevard, Baltimore, MD 

21244–1850, or you can call (410) 786– 

9252. 

Questions concerning 

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tomography for dementia trials listed in 

Addendum XVI may be addressed to 

Stuart Caplan, RN, MAS, Office of 

Clinical Standards and Quality, Centers 

for Medicare & Medicaid Services, C1– 

09–06, 7500 Security Boulevard, 

Baltimore, MD 21244–1850, or you can 

call (410) 786–8564. 

Questions concerning all other 

information may be addressed to 

Kathleen Smith, Office of Strategic 

Operations and Regulatory Affairs, 

Regulations Development Group, 

Centers for Medicare & Medicaid 

Services, C5–14–03, 7500 Security 

Boulevard, Baltimore, MD 21244–1850, 

or you can call (410) 786–0626. 

SUPPLEMENTARY INFORMATION: 

I. Program Issuances 

The Centers for Medicare & Medicaid 

Services (CMS) is responsible for 

administering the Medicare and 

Medicaid programs. These programs pay 

for health care and related services for 

39 million Medicare beneficiaries and 

35 million Medicaid recipients. 

Administration of the two programs 

involves (1) furnishing information to 

Medicare beneficiaries and Medicaid 

recipients, health care providers, and 

the public and (2) maintaining effective 

communications with regional offices, 

State governments, State Medicaid 

agencies, State survey agencies, various 

providers of health care, all Medicare 

contractors that process claims and pay 

bills, and others. To implement the 

various statutes on which the programs 

are based, we issue regulations under 

the authority granted to the Secretary of 

the Department of Health and Human 

Services under sections 1102, 1871, 

1902, and related provisions of the 

Social Security Act (the Act). We also 

issue various manuals, memoranda, and 

statements necessary to administer the 

programs efficiently. 

Section 1871(c)(1) of the Act requires 

that we publish a list of all Medicare 

manual instructions, interpretive rules, 

statements of policy, and guidelines of 

general applicability not issued as 

regulations at least every 3 months in 

the Federal Register. We published our 

first notice June 9, 1988 (53 FR 21730). 

Although we are not mandated to do so 

by statute, for the sake of completeness 

of the listing of operational and policy 

statements, and to foster more open and 

transparent collaboration, we are 

continuing our practice of including 

Medicare substantive and interpretive 

regulations (proposed and final) 

published during the respective 3- 

month time frame. 

II. How To Use the Addenda 

This notice is organized so that a 

reader may review the subjects of 

manual issuances, memoranda, 

substantive and interpretive regulations, 

NCDs, and FDA-approved IDEs 

published during the subject quarter to 

determine whether any are of particular 

interest. We expect this notice to be 

used in concert with previously 

published notices. Those unfamiliar 

with a description of our Medicare 

manuals may wish to review Table I of 

our first three notices (53 FR 21730, 53 

FR 36891, and 53 FR 50577) published 

in 1988, and the notice published March 

31, 1993 (58 FR 16837). Those desiring 

information on the Medicare NCD 

Manual (NCDM, formerly the Medicare 

Coverage Issues Manual (CIM)) may 

wish to review the August 21, 1989, 

publication (54 FR 34555). Those 

interested in the revised process used in 

making NCDs under the Medicare 

program may review the September 26, 

2003, publication (68 FR 55634). 

To aid the reader, we have organized 

and divided this current listing into 11 

addenda: 

• Addendum I lists the publication 

dates of the most recent quarterly 

listings of program issuances. 

• Addendum II identifies previous 

Federal Register documents that 

contain a description of all previously 

published CMS Medicare and Medicaid 

manuals and memoranda. 

• Addendum III lists a unique CMS 

transmittal number for each instruction 

in our manuals or Program Memoranda 

and its subject matter. A transmittal may 

consist of a single or multiple 

instruction(s). Often, it is necessary to 

use information in a transmittal in 

conjunction with information currently 

in the manuals. 

• Addendum IV lists all substantive 

and interpretive Medicare and Medicaid 

regulations and general notices 

published in the Federal Register 

during the quarter covered by this 

notice. For each item, we list the— 

Æ Date published; 

Æ Federal Register citation; 

Æ Parts of the Code of Federal 

Regulations (CFR) that have changed (if 

applicable); 

Æ Agency file code number; and 

Æ Title of the regulation. 

• Addendum V includes completed 

NCDs, or reconsiderations of completed 

NCDs, from the quarter covered by this 

notice. Completed decisions are 

identified by the section of the NCDM 

in which the decision appears, the title, 

the date the publication was issued, and 

the effective date of the decision. 

• Addendum VI includes listings of 

the FDA-approved IDE categorizations, 

using the IDE numbers the FDA assigns. 

The listings are organized according to 

the categories to which the device 

numbers are assigned (that is, Category 

A or Category B), and identified by the 

IDE number. 

• Addendum VII includes listings of 

all approval numbers from the Office of 

Management and Budget (OMB) for 

collections of information in CMS 

regulations in title 42; title 45, 

subchapter C; and title 20 of the CFR. 

• Addendum VIII includes listings of 

Medicare-approved carotid stent 

facilities. All facilities listed meet CMS 

standards for performing carotid artery 

stenting for high risk patients. 

• Addendum IX includes a list of the 

American College of Cardiology’s 

National Cardiovascular Data registry 

sites. We cover implantable cardioverter 

defibrillators (ICDs) for certain 

indications, as long as information 

about the procedures is reported to a 

central registry. 

• Addendum X includes a list of 

active CMS guidance documents. As 

required by section 731 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) (Pub. 

L. 108–173, enacted on December 8, 

2003), we will begin listing the current 

versions of our guidance documents in 

each quarterly listings notice. 

• Addendum XI includes a list of 

special one-time notices regarding 

national coverage provisions. We are 

publishing a list of issues that require 

public notification, such as a particular 

clinical trial or research study that 

qualifies for Medicare coverage. 

• Addendum XII includes a listing of 

National Oncologic Positron Emission 

Tomography Registry (NOPR) sites. We 

cover positron emission tomography 

(PET) scans for particular oncologic 

indications when they are performed in 

a facility that participates in the NOPR. 

• Addendum XIII includes a listing of 

Medicare-approved facitilites that 

receive coverage for ventricular assist 

devices used as destination therapy. All 

facilities were required to meet our 

standards in order to receive coverage 

for ventricular assist devices implanted 

as destination therapy. 

• Addendum XIV includes a listing of 

Medicare-approved facilities that are 

eligible to receive coverage for lung 

volume reduction surgery. Until May 

17, 2007, facilities that participated in 

the National Emphysema Treatment 

Trial are also eligible to receive 

coverage. 

• Addendum XV includes a listing of 

Medicare-approved facilities that meet 

minimum standards for facilities 

modeled in part on professional society 

statements on competency. All facilities 


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must meet our standards in order to 

receive coverage for bariatric surgery 

procedures. 

• Addendum XVI includes a listing of 

Medicare-approved clinical trials for 

fluorodeoxyglucose positron emission 

tomography (FDG–PET) for dementia 

and neurodegenerative diseases. 

III. How To Obtain Listed Material 

A. Manuals 

Those wishing to subscribe to 

program manuals should contact either 

the Government Printing Office (GPO) 

or the National Technical Information 

Service (NTIS) at the following 

addresses: 

Superintendent of Documents, 

Government Printing Office, ATTN: 

New Orders, P.O. Box 371954, 

Pittsburgh, PA 15250–7954, 

Telephone (202) 512–1800, Fax 

number (202) 512–2250 (for credit 

card orders); or 

National Technical Information Service, 

Department of Commerce, 5825 Port 

Royal Road, Springfield, VA 22161, 

Telephone (703) 487–4630. 

In addition, individual manual 

transmittals and Program Memoranda 

listed in this notice can be purchased 

from NTIS. Interested parties should 

identify the transmittal(s) they want. 

GPO or NTIS can give complete details 

on how to obtain the publications they 

sell. Additionally, most manuals are 

available at the following Internet 

address: 

http://cms.hhs.gov/manuals/ 

default.asp. 

B. Regulations and Notices 

Regulations and notices are published 

in the daily Federal Register. Interested 

individuals may purchase individual 

copies or subscribe to the Federal 

Register by contacting the GPO at the 

address given above. When ordering 

individual copies, it is necessary to cite 

either the date of publication or the 

volume number and page number. 

The Federal Register is also available 

on 24x microfiche and as an online 

database through GPO Access. The 

online database is updated by 6 a.m. 

each day the Federal Register is 

published. The database includes both 

text and graphics from Volume 59, 

Number 1 (January 2, 1994) forward. 

Free public access is available on a 

Wide Area Information Server (WAIS) 

through the Internet and via 

asynchronous dial-in. Internet users can 

access the database by using the World 

Wide Web; the Superintendent of 

Documents home page address is http:// 

www.gpoaccess.gov/fr/index.html, by 

using local WAIS client software, or by 

telnet to swais.gpoaccess.gov, then log 

in as guest (no password required). Dialin users should use communications 

software and modem to call (202) 512– 

1661; type swais, then log in as guest 

(no password required). 

C. Rulings 

We publish rulings on an infrequent 

basis. CMS Rulings are decisions of the 

Administrator that serve as precedent 

final opinions and orders and 

statements of policy and interpretation. 

They provide clarification and 

interpretation of complex or ambiguous 

provisions of the law or regulations 

relating to Medicare, Medicaid, 

Utilization and Quality Control Peer 

Review, private health insurance, and 

related matters. Interested individuals 

can obtain copies from the nearest CMS 

Regional Office or review them at the 

nearest regional depository library. We 

have, on occasion, published rulings in 

the Federal Register. Rulings, beginning 

with those released in 1995, are 

available online, through the CMS 

Home Page. The Internet address is 

http://cms.hhs.gov/rulings. 

D. CMS’ Compact Disk-Read Only 

Memory (CD–ROM) 

Our laws, regulations, and manuals 

are also available on CD–ROM and may 

be purchased from GPO or NTIS on a 

subscription or single copy basis. The 

Superintendent of Documents list ID is 

HCLRM, and the stock number is 717– 

139–00000–3. The following material is 

on the CD–ROM disk: 

• Titles XI, XVIII, and XIX of the Act. 

• CMS-related regulations. 

• CMS manuals and monthly 

revisions. 

• CMS program memoranda. 

The titles of the Compilation of the 

Social Security Laws are current as of 

January 1, 2005. (Updated titles of the 

Social Security Laws are available on 

the Internet at http://www.ssa.gov/ 

OP_Home/ssact/comp-toc.htm.) The 

remaining portions of CD–ROM are 

updated on a monthly basis. 

Because of complaints about the 

unreadability of the Appendices 

(Interpretive Guidelines) in the State 

Operations Manual (SOM), as of March 

1995, we deleted these appendices from 

CD–ROM. We intend to re-visit this 

issue in the near future and, with the 

aid of newer technology, we may again 

be able to include the appendices on 

CD–ROM. 

Any cost report forms incorporated in 

the manuals are included on the CD– 

ROM disk as LOTUS files. LOTUS 

software is needed to view the reports 

once the files have been copied to a 

personal computer disk. 

IV. How To Review Listed Material 

Transmittals or Program Memoranda 

can be reviewed at a local Federal 

Depository Library (FDL). Under the 

FDL program, government publications 

are sent to approximately 1,400 

designated libraries throughout the 

United States. Some FDLs may have 

arrangements to transfer material to a 

local library not designated as an FDL. 

Contact any library to locate the nearest 

FDL. 

In addition, individuals may contact 

regional depository libraries that receive 

and retain at least one copy of most 

Federal Government publications, either 

in printed or microfilm form, for use by 

the general public. These libraries 

provide reference services and 

interlibrary loans; however, they are not 

sales outlets. Individuals may obtain 

information about the location of the 

nearest regional depository library from 

any library. 

For each CMS publication listed in 

Addendum III, CMS publication and 

transmittal numbers are shown. To help 

FDLs locate the materials, use the CMS 

publication and transmittal numbers. 

For example, to find the Medicare 

Benefit Policy publication titled 

‘‘Outpatient Intravenous Insulin 

Treatment (Therapy),’’ use CMS–Pub. 

100–03, Transmittal No. 112. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance, Program No. 93.774, Medicare— 

Supplementary Medical Insurance Program, 

and Program No. 93.714, Medical Assistance 

Program) 

Dated: June 15, 2010. 

Jacquelyn Y. White, 

Director, Office of Strategic Operations and 

Regulatory Affairs. 

Addendum I 

This addendum lists the publication 

dates of the most recent quarterly 

listings of program issuances. 

April 1, 2008 (73 FR 17422) 

June 27, 2008 (73 FR 36596) 

September 26, 2008 (73 FR 55902) 

December 30, 2008 (73 FR 79982) 

March 27, 2009 (74 FR 13516) 

June 26, 2009 (74 FR 30689) 

September 25, 2009 (74 FR 49076) 

December 18, 2009 (74 FR 67310) 

March 26, 2010 (75 FR 14906) 

Addendum II—Description of Manuals, 

Memoranda, and CMS Rulings 

An extensive descriptive listing of 

Medicare manuals and memoranda was 

published on June 9, 1988, at 53 FR 

21730 and supplemented on September 

22, 1988, at 53 FR 36891 and December 

16, 1988, at 53 FR 50577. Also, a 

complete description of the former CIM 


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(now the NCDM) was published on 

August 21, 1989, at 54 FR 34555. A brief 

description of the various Medicaid 

manuals and memoranda that we 

maintain was published on October 16, 

1992, at 57 FR 47468. 

ADDENDUM III 

Medicare and Medicaid Manual 

Instructions 

January Through March 2010 


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Addendum IV—Regulation Documents 

Published in the Federal Register 

January Through March 2010 

Publication date FR Vol. 75 

Page No. 42 CFR Parts affected File code Title of regulation 

January 13, 2010 ........... 1844 412, 413, 422, and 495 CMS–0033–P ................ Medicare and Medicaid Programs; Electronic 

Health Record Incentive Program. 

January 22, 2010 ........... 3742 ....................................... CMS–7017–N2 ............. Medicare Program; Meeting of the Advisory 

Panel on Medicare Education; Cancellation of 

the February 3, 2010 Meeting and Announcement of the March 31, 2010 Meeting. 

3743 ....................................... CMS–1566–N ............... Medicare Program; Meeting of the Practicing 

Physicians Advisory Council, March 8, 2010. 

January 26, 2010 ........... 4088 ....................................... CMS–6023–N2 ............. Medicare Program; Approval of Independent Accrediting Organizations To Participate in the 

Advanced Diagnostic Imaging Supplier Accreditation Program. 

4095 ....................................... CMS–3222–N ............... Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory 

Committee, March 24, 2010. 

February 2, 2010 ........... 5410 45 CFR 146 .................. CMS–4140–IFC ............ Interim Final Rules Under the Paul Wellstone 

and Pete Domenici Mental Health Parity and 

Addiction Equity Act of 2008. 

February 3, 2010 ........... 5599 ....................................... CMS–1341–NC ............. Medicare and Medicaid Programs; Announcement of Applications From Hospitals Requesting Waiver for Organ Procurement Service 

Area. 

February 24, 2010 ......... 8374 ....................................... CMS–1566–CN ............. Medicare Program; Meeting of the Practicing 

Physicians Advisory Council, March 8, 2010, 

Correction. 

February 26, 2010 ......... 8971 ....................................... CMS–1514–N ............... Medicare Program; Public Meetings in Calendar 

Year 2010 for All New Public Requests for Revisions to the Healthcare Common Procedure 

Coding System (HCPCS) Coding and Payment Determinations. 

February 26, 2010 ......... 8980 ....................................... CMS–3223–N ............... Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory 

Committee—April 22, 2010. 

February 26, 2010 ......... 8982 ....................................... CMS–3224–N ............... Medicare Program; Request for Nominations for 

Members of the Medicare Evidence Development & Coverage Advisory Committee. 

March 26, 2010 ............. 14606 ....................................... CMS–1570–N ............... Medicare Program; Request for Nominations to 

the Advisory Panel on Ambulatory Payment 

Classification Groups. 

March 26, 2010 ............. 14906 ....................................... CMS–9057–N ............... Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—October Through 

December 2009. 

March 31, 2010 ............. 16149 ....................................... CMS–2312–N ............... Medicaid and CHIP Programs; Meeting of the 

CHIP Working Group—April 26, 2010. 

Addendum V—National Coverage 

Determinations [January Through 

March 2010] 

A national coverage determination 

(NCD) is a determination by the 

Secretary with respect to whether or not 

a particular item or service is covered 

nationally under Title XVIII of the 

Social Security Act, but does not 

include a determination of what code, if 

any, is assigned to a particular item or 

service covered under this title, or 

determination with respect to the 

amount of payment made for a 

particular item or service so covered. 

We include below all of the NCDs that 

were issued during the quarter covered 

by this notice. The entries below 

include information concerning 

completed decisions as well as sections 

on program and decision memoranda, 

which also announce pending decisions 

or, in some cases, explain why it was 

not appropriate to issue an NCD. We 

identify completed decisions by the 

section of the NCDM in which the 

decision appears, the title, the date the 

publication was issued, and the 

effective date of the decision. 

Information on completed decisions as 

well as pending decisions has also been 

posted on the CMS Web site at http:// 

cms.hhs.gov/coverage. 

Title NCDM 

Section TN No. Issue date Effective date 

Repeal of Section 20.10, Cardiac Rehabilitation (CR) Programs ........... 20.10 R116NCD 03/05/2010 02/22/2010 

Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery 

Concurrent with Stenting ...................................................................... 20.70 R115NCD 03/05/2010 12/09/2009 

Outpatient Intravenous Insulin Treatment (Therapy) .............................. 40.70 R117NCD 03/09/2010 12/23/2009 

Screening for the Human Immunodeficiency Virus (HIV) Infection ......... 210.70 R118NCD 03/23/2010 12/08/2009 


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Title NCDM 

Section TN No. Issue date Effective date 

Positron Emission Tomography (NaF–18) to Identify Bone Metastasis 

of Cancer .............................................................................................. 220.60 R119NCD 03/26/2010 02/26/2010 

Changes to the Laboratory National Coverage Determination (NCD) 

Edit Software for July 2010 .................................................................. 190.00 R1963CP 04/30/2010 07/01/2010 

Addendum VI—FDA-Approved 

Category B IDEs [January Through 

March 2010] 

Under the Food, Drug, and Cosmetic 

Act (21 U.S.C. 360c) devices fall into 

one of three classes. To assist CMS 

under this categorization process, the 

FDA assigns one of two categories to 

each FDA-approved IDE. Category A 

refers to experimental IDEs, and 

Category B refers to non-experimental 

IDEs. To obtain more information about 

the classes or categories, please refer to 

the Federal Register notice published 

on April 21, 1997 (62 FR 19328). 

The following list includes all 

Category B IDEs approved by FDA 

during the first quarter, January through 

March 2010. 

IDE Category 

BB14319 ......................................... B 

BB14334 ......................................... B 

BB14335 ......................................... B 

G080150 ......................................... B 

G090029 ......................................... B 

G090050 ......................................... B 

G090105 ......................................... B 

G090188 ......................................... B 

G090221 ......................................... B 

G090230 ......................................... B 

G090251 ......................................... B 

G090255 ......................................... B 

G090258 ......................................... B 

G090259 ......................................... B 

G090267 ......................................... B 

G090270 ......................................... B 

G090272 ......................................... B 

G090273 ......................................... B 

G090277 ......................................... B 

G100008 ......................................... B 

IDE Category 

G100009 ......................................... B 

G100020 ......................................... B 

G100024 ......................................... B 

G100031 ......................................... B 

G100032 ......................................... B 

G100035 ......................................... B 

G100041 ......................................... B 

Addendum VII—Approval Numbers for 

Collections of Information 

Below we list all approval numbers 

for collections of information in the 

referenced sections of CMS regulations 

in Title 42; Title 45, Subchapter C; and 

Title 20 of the Code of Federal 

Regulations, which have been approved 

by the Office of Management and 

Budget: 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36805 


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36806 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36807 


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36808 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36809 


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36810 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36811 

Addendum VIII—Medicare-Approved 

Carotid Stent Facilities [January 

Through March 2010] 

On March 17, 2005, we issued our 

decision memorandum on carotid artery 

stenting. We determined that carotid 

artery stenting with embolic protection 

is reasonable and necessary only if 

performed in facilities that have been 

determined to be competent in 

performing the evaluation, procedure, 

and follow-up necessary to ensure 

optimal patient outcomes. We have 

created a list of minimum standards for 

facilities modeled in part on 

professional society statements on 

competency. All facilities must at least 

meet our standards in order to receive 

coverage for carotid artery stenting for 

high risk patients. 

Facility Provider No. Effective date State Additional 

information 

Palm Springs General Hospital, 1475 West 49th Street, Hialeah, FL 33012 ..... 100050 01/12/2010 FL 

Parrish Medical Center, 951 N. Washington Avenue, Titusville, FL 32796 ........ 100028 01/12/2010 FL 

New York Presbyterian Hospital, 177 Ft. Washington Avenue, New York, NY 

10032.

330101 05/05/2005 NY 

Northside Hospital & Tampa Bay Heart Institute, 6000 49th Street North, St. ...

Petersburg, FL 33709 ..........................................................................................

1205880945 02/26/2010 FL 

Orange Park Medical Center, 2001 Kingsley Avenue, ........................................

Orange Park, FL 32073 .......................................................................................

100226 02/26/2010 FL 

Saint Thomas Hospital, 4220 Harding Road, Nashville, TN 37205 .................... 440082 02/26/2010 TN 

Marshall Medical Center North, 8000 Alabama HWT 69, Guntersville, AL 

35976.

15082417 04/02/2010 AL 

Oklahoma Heart Hospital South LLC, 5200 E. I–240 Service Road, Oklahoma 

City, OK 73135–2610.

1841442274 04/02/2010 OK 

Great River Medical Center, 1221 S. Gear Avenue, West Burlington, IA 

52655–1681.

420680407 04/16/2010 IA 

Liberty Hospital, P.O. Box 1002, Liberty, MO 64069–1002 ................................ 260177 04/16/2010 MO 

Scripps Memorial Hospital, Encinitas, 354 Santa Fe Drive ENC01, Encinitas, 

CA 92024.

050503 04/16/2010 CA 

University of Maryland Medical Center, 22 South Greene Street, Baltimore, 

MD 21201–1595.

210002 04/16/2010 MD 

Addendum IX 

American College of Cardiology’s 

National Cardiovascular Data Registry 

Sites [January Through March 2010] 

In order to obtain reimbursement, 

Medicare national coverage policy 

requires that providers implanting ICDs 

for primary prevention clinical 

indications (that is, patients without a 

history of cardiac arrest or spontaneous 

arrhythmia) report data on each primary 

prevention ICD procedure. This policy 

became effective January 27, 2005. 

Details of the clinical indications that 

are covered by Medicare and their 

respective data reporting requirements 

are available in the Medicare National 

Coverage Determination (NCD) Manual, 

which is on the Centers for Medicare & 

Medicaid Services (CMS) Web site at 

http://www.cms.hhs.gov/Manuals/IOM/

itemdetail.asp?filterType=

none&filterByDID=99&sortByDID=1&

sortOrder=ascending&

itemID=CMS014961. 

A provider can use either of two 

mechanisms to satisfy the data reporting 

requirement. Patients may be enrolled 

either in an Investigational Device 

Exemption trial studying ICDs as 

identified by the FDA or in the 

American College of Cardiology’s 

National Cardiovascular Data Registry 

(ACC–NCDR) ICD registry. Therefore, in 

order for a beneficiary to receive a 

Medicare-covered ICD implantation for 

primary prevention, the beneficiary 

must receive the scan in a facility that 

participates in the ACC–NCDR ICD 

registry. 

We maintain a list of facilities that 

have been enrolled in this registry. 

Addendum IX includes the facilities 

that have been designated in the quarter 

covered by this notice. 


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36814 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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36820 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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36822 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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36824 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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36826 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36827 


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36828 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36829 


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36830 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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36832 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36833 


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36834 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36835 


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36836 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36837 


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36838 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36839 


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36840 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36841 


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36842 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36843 


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36844 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36845 


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36846 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36847 


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36848 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36849 


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36850 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36851 


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36852 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36853 


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36854 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36855 


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36856 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36857 


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36858 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36859 


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36860 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36861 


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36862 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36863 


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36864 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36865 


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36866 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36867 


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36868 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36869 


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36870 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36871 


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36872 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36873 


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36874 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36875 


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36876 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36877 


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36878 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36879 


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36880 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36881 


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36882 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36883 


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36884 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36885 


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36886 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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36888 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36889 


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36890 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36891 


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36892 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36893 


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36894 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36895 


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36896 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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36898 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36899 


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36900 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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36902 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36903 


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36904 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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36906 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36907 


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36908 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36909 


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36910 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36911 


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36912 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36913 


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36914 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36915 


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36916 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36917 


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36918 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36919 


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36920 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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36924 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36925 


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36926 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 

Addendum X 

Active CMS Coverage-Related Guidance 

Documents [January Through March 

2010] 

On September 24, 2004, we published 

a notice in the Federal Register (69 FR 

57325), in which we explained how we 

would develop coverage-related 

guidance documents. These guidance 

documents are required under section 

731 of the MMA. In our notice, we 

committed to the public that, ‘‘At regular 

intervals, we will update a list of all 

guidance documents in the Federal 

Register.’’ 

Addendum X includes a list of active 

CMS guidance documents as of the 

ending date of the period covered by 

this notice. To obtain full-text copies of 

these documents, visit the CMS 

Coverage Web site at http:// 

www.cms.hhs.gov/mcd/ 

index_list.asp?list_type=mcd_1. 

Document Name: Factors CMS 

Considers in Commissioning External 

Technology Assessments. 

Date of Issuance: April 11, 2006. 

Document Name: Factors CMS 

Considers in Opening a National 

Coverage Determination. 

Date of Issuance: April 11, 2006. 

Document Name: (Draft) Factors CMS 

Considers in Referring Topics to the 

Medicare Coverage Advisory 

Committee. 

Date of Issuance: March 9, 2005. 

Document Name: National Coverage 

Determinations with Data Collection as 

a Condition of Coverage: Coverage With 

Evidence Development. 

Date of Issuance: July 12, 2006. 

Addendum XI 

List of Special One-Time Notices 

Regarding National Coverage Provisions 

[January Through March 2010] 

As medical technologies, the contexts 

under which they are delivered, and the 

health needs of Medicare beneficiaries 

grow increasingly complex, our national 

coverage determination (NCD) process 

must adapt to accommodate these 

complexities. As part of this adaptation, 

our national coverage decisions often 

include multi-faceted coverage 

determinations, which may place 

conditions on the patient populations 

eligible for coverage of a particular item 

or service, the providers who deliver a 

particular service, or the methods in 

which data are collected to supplement 

the delivery of the item or service (such 

as participation in a clinical trial). 

We outline these conditions as we 

release new or revised NCDs. However, 

details surrounding these conditions 

may need to be shared with the public 

as ‘‘one-time notices’’ in the Federal 

Register. For example, we may require 

that a particular medical service may be 

delivered only in the context of a CMSrecognized clinical research study, 

which was not named in the NCD itself. 

We would then use Addendum XI of 

this notice, along with our coverage 

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

coverage, to provide the public with 

information about the clinical research 

study that it ultimately recognizes. 

Addendum XI includes any 

additional information we may need to 

share about the conditions under which 

an NCD was issued as of the ending date 

of the period covered by this notice. 

There were no Special One-Time 

Notices Regarding National Coverage 

Provisions published this quarter. 

Addendum XII—National Oncologic 

PET Registry (NOPR) 

In January 2005, we issued our 

decision memorandum on positron 

emission tomography (PET) scans, 

which stated that CMS would cover PET 

scans for particular oncologic 

indications, as long as they were 

performed in the context of a clinical 

study. We have since recognized the 

National Oncologic PET Registry as one 

of these clinical studies. Therefore, in 

order for a beneficiary to receive a 

Medicare-covered PET scan, the 

beneficiary must receive the scan in a 

facility that participates in the Registry. 

The following facilities have met the 

CMS’s requirements for performing PET 

scans under National Coverage 

Determination CAG–00181N. 


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36928 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36929 


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36930 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36931 


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36932 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36933 


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36934 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36935 


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36936 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36937 


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36938 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36939 


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36940 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36941 


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36942 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36943 


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36944 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36945 


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36946 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36947 


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36948 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36949 


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36950 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36951 


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36952 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36953 


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36954 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36955 


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36956 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36957 


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36958 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36959 


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36960 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36961 


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36962 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36963 


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36964 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36965 


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36966 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36967 


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36968 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36969 


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36970 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36971 


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36972 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36973 


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36974 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36975 


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36976 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36977 


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36978 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36979 


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36980 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36981 


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36982 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36983 


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36984 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36985 


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36986 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36987 


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36988 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36989 


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36990 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36991 


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36992 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36993 


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36994 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36995 


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36996 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36997 


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36998 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 36999 


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37000 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37001 


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37002 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37003 


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37004 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37005 


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37006 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37007 


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37008 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37009 


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37010 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37011 


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37012 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37013 


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37014 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37015 


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37016 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37017 


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37018 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37019 


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37020 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37021 


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37022 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37023 


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37024 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37025 


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37026 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37027 


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37028 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37029 


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37030 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37031 


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37032 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37033 


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37034 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37035 


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37036 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37037 


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37038 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37039 


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37040 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37041 


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37042 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37043 


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37044 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37045 


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37046 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37047 


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37048 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 37049 


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37050 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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37052 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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37054 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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37056 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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37058 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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37060 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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37062 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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37064 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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37066 Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 / Notices 


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Addendum XIII 

Medicare-Approved Ventricular Assist 

Device (Destination Therapy) Facilities 

[January Through March 2010] 

On October 1, 2003, we issued our 

decision memorandum on ventricular 

assist devices for the clinical indication 

of destination therapy. We determined 

that ventricular assist devices used as 

destination therapy are reasonable and 

necessary only if performed in facilities 

that have been determined to have the 

experience and infrastructure to ensure 

optimal patient outcomes. We 

established facility standards and an 

application process. All facilities were 

required to meet our standards in order 

to receive coverage for ventricular assist 

devices implanted as destination 

therapy. 

VAD Destination Therapy Facilities 

The following facilities have met the 

CMS facility standards for destination 

therapy VADs. 

Facility Provider No. Date approved State Other 

information 

Advocate Christ Medical Center, 4440 W 95th Street, Oak Lawn, 

Illinois.

140208 12/17/2003 IL Joint Commission Certified on 

05/26/2007. 

California Pacific Medical Center, 2333 Buchanan Street, San 

Francisco, California.

050047 03/19/2004 CA 

Baptist Memorial Hospital, 6019 Walnut Grove Road, Memphis, 

Tennessee.

440048 04/07/2004 TN 

Duke University Medical Center, DUMC Box 3943, Durham, North 

Carolina.

340030 10/31/2003 NC 

Fairview-University Medical Center, 2450 Riverside Avenue, Minneapolis, Minnesota.240080 10/28/2003 MN 

Allegheny General Hospital, 320 E North Avenue, Pittsburgh, 

Pennsylvania.

390050 12/10/2003 PA Joint Commission Certified on 

03/28/2008. 

Barnes-Jewish Hospital, One Barnes-Jewish Hospital Plaza, Saint 

Louis, Missouri.

260032 10/27/2003 MO Joint Commission Certified on 

08/22/2008. 

Brigham and Women’s Hospital, 15 Francis Street, Boston, Massachusetts.220110 01/09/2004 MA 

Bryan LGH Medical Center East, 1600 S 48 Street, Lincoln, Nebraska.280003 10/23/2003 NE 

Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Los Angeles, California.050625 12/29/2003 CA 

Clarian Health Partners, Inc., 1701 N. Senate Avenue, Indianapolis, Indiana.150056 11/25/2003 IN 

Cleveland Clinic, 9500 Euclid Avenue, Cleveland, Ohio .................. 360180 12/03/2003 OH 

Hahnemann University Hospital, Broad and Vine Streets, Philadelphia, Pennsylvania.390290 12/22/2003 PA Joint Commission Certified on 

09/19/2008. 

Hospital of the University of Pennsylvania, 3400 Spruce Street, 

Philadelphia, Pennsylvania.

390111 10/28/2003 PA Joint Commission Certified on 

05/23/2008. 

Henry Ford Hospital, 2799 W. Grand Boulevard, Detroit, Michigan 230053 01/06/2004 MI 

Inova Fairfax Hospital, 3300 Gallows Road, Falls Church, Virginia 490063 03/31/2004 VA 

Jewish Hospital, 200 Abraham Flexner Way, Louisville, Kentucky .. 180040 11/10/2003 KY 

Jackson Memorial Hospital, 1611 NW 12th Avenue, Miami, Florida 100022 01/12/2004 FL University of Miami. 

LDS Hospital, 8th Avenue and C Street, Salt Lake City, Utah ........ 460010 10/23/2003 UT 

Johns Hopkins Hospital, 600 N. Wolfe Street, Baltimore, Maryland 210009/ 

1790700904 

10/28/2003 MD Joint Commission Certified on 

07/09/2008. 

Loyola University Medical Center, 2160 S. 1st Avenue, Maywood, 

Illinois.

140276 01/30/2004 IL 

Lutheran Hospital of Indiana, 7950 W. Jefferson Boulevard, Fort 

Wayne, Indiana.

150017 10/29/2003 IN 

Massachusetts General Hospital, 55 Fruit Street, Boston, Massachusetts.220071 12/15/2003 MA 

Mayo Clinic, 4500 San Pablo Road, Jacksonville, Florida ............... 100151 11/06/2003 FL 

Medical City Dallas Hospital, 7777 Forest Lane, Dallas, Texas ...... 450647 12/03/2003 TX 

The Methodist Hospital, 6565 Fannin Street, Houston, Texas ........ 450358 11/03/2003 TX 

Montefiore Medical Center, 111 E. 210th Street, Bronx, New York 330059 11/14/2003 NY 

Methodist Specialty and Transplant Hospital, 8026 Floyd Curl 

Drive, San Antonio, Texas.

450388 11/19/2003 TX 

Newark Beth Israel Medical Center, 201 Lyons Avenue, Newark, 

New Jersey.

310002 11/14/2003 NJ 

Mount Sinai Medical Center, 1190 5th Avenue, New York, New 

York.

330024 11/25/2003 NY 

New York-Presbyterian Hospital, 177 Fort Washington Avenue, 

New York, New York.

330101 10/28/2003 NY Columbia University Medical 

Center. 

Ohio State University Medical Center, 410 W. 10th Avenue, Columbus, Ohio.360085 11/12/2003 OH 

Oregon Health and Sciences University, 3181 SW Sam Jackson 

Park Road, Portland, Oregon.

380009 11/21/2003 OR 

OSF St Francis Medical Center, 530 NE Glen Oak Avenue, Peoria, Illinois.140067 11/12/2003 IL 

Penn State Milton S Hershey Medical Center, 500 University 

Drive, Hershey, Pennsylvania.

390256 10/29/2003 PA Joint Commission Certified on 

05/19/2008. 

Rush-Presbyterian-St Luke Medical Center, 1653 W Congress 

Parkway, Chicago, Illinois.

140119 11/14/2003 IL 


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Facility Provider No. Date approved State Other 

information 

Sentara Norfolk General Hospital, 600 Gresham Drive, Norfolk, 

Virginia.

490007 11/10/2003 VA 

Sacred Heart Medical Center, 101 W 8th Avenue, Spokane, 

Washington.

500054 01/12/2004 WA 

Seton Medical Center, 1201 W. 38th Street, Austin, Texas ............ 450056 01/13/2004 TX 

Shands at the University of Florida, 1600 SW Archer Road, 

Gainesville, Florida.

100113 11/26/2003 FL 

Sharp Memorial Hospital, 7901 Frost Street, San Diego, California 050100 12/01/2003 CA Joint Commission Certified on 

07/18/2008. 

Stanford University Hospital and Clinics, 300 Pasteur Drive, Stanford, California.050441 12/22/2003 CA Stanford University Medical Center. 

St Francis Hospital, 6161 S. Yale Avenue, Tulsa, Oklahoma .......... 370091 01/09/2004 OK 

St Luke’s Medical Center, 2900 W Oklahoma Avenue, Milwaukee, 

Wisconsin.

520138 11/03/2003 WI 

St Luke’s Episcopal Hospital, 6720 Bertner Avenue, Houston, 

Texas.

450193 10/28/2003 TX 

St Vincent Hospital and Health Services, 2001 W. 86th Street, Indianapolis, Indiana.150084 01/05/2004 IN 

St Paul Medical Center, 5909 Harry Hines Boulevard, Dallas, 

Texas.

450044 12/10/2003 TX 

Strong Memorial Hospital, 601 Elmwood Avenue, Rochester, New 

York.

330285 10/29/2003 NY Joint Commission Certified on 

06/18/2008. 

Tampa General Hospital, 2 Columbia Drive, Tampa, Florida .......... 100128 11/26/2003 FL 

Temple University Hospital, 3401 N. Broad Street, Philadelphia, 

Pennsylvania.

390027 11/03/2003 PA 

Tufts-New England Medical Center, 750 Washington Street, Boston, Massachusetts.220116 11/06/2003 MA 

UCLA Medical Center, 10833 Le Conte Avenue, Los Angeles, 

California.

050262 12/10/2003 CA 

University Medical Center, 1501 N. Campbell Avenue, Tucson, 

Arizonia.

030064 10/29/2003 AZ 

University of Alabama at Birmingham Health System, 500 22nd 

Street S, Birmingham, Alabama.

010033 10/29/2003 AL 

University of Colorado Hospital, 4200 E. Ninth Avenue, Denver, 

Colorado.

060024 11/06/2003 CO 9th & Colorado Campus, Joint 

Commission Certified on 07/ 

23/2008. 

The University of Chicago Hospitals and Health System, 5841 

South Maryland Avenue, Chicago, Illinois.

140088 02/25/2004 IL 

University of Iowa Hospitals and Clinics, 200 Hawkins Drive, Iowa 

City, Iowa.

160058 11/12/2003 IA 

University of Maryland Medical Center, 22 S. Greene Street, Baltimore, Maryland.210002 11/12/2003 MD 

University of Michigan Health System, 1500 E. Medical Center 

Drive, Ann Arbor, Michigan.

230046 10/27/2003 MI Joint Commission Certified on 

03/28/2008. 

University of North Carolina Hospitals, 101 Manning Drive, Chapel 

Hill, North Carolina.

340061 05/05/2004 NC 

University of Utah Hospital, 50 N Medical Drive, Salt Lake City, 

Utah.

460009 12/22/2003 UT 

University of Virginia Health System, 1215 Lee Street, Charlottesville, Virginia.490009 01/12/2004 VA 

University of Washington Medical Center, 1959 NE Pacific Street, 

Seattle, Washington.

500008 01/15/2004 WA 

University of Wisconsin Hospitals and Clinics, 600 Highland Avenue, Madison, Wisconsin.520098 12/03/2003 WI 

USC University Hospital, 1500 San Pablo, Los Angeles, California 050696 01/09/2004 CA 

UPMC Presbyterian, 200 Lothrop Street, Pittsburgh, Pennsylvania 390164 10/23/2003 PA Joint Commission Certified on 

06/11/2008. 

Virginia Commonwealth University Medical Center, 401 North 12th 

Street, Richmond, Virginia.

490032 04/08/2004 VA Medical College of Virginia Hospitals. 

Vanderbilt University Medical Center, 1161 21st Avenue S, Nashville, Tennessee.440039 10/28/2003 TN 

Ochsner Clinic Foundation, 1514 Jefferson Highway, New Orleans, Louisiana.190036 06/29/2004 LA 

Baylor University Medical Center, 3500 Gaston Avenue, Dallas, 

TX.

N/A 10/04/2007 TX Joint Commission Certified on 

10/04/2007. 

The University of Michigan Hospitals and Health Centers, 1500 

East Medical Center Drive, Ann Arbor, MI.

230046 03/28/2008 MI Joint Commission Certified on 

03/28/2008. 

Saint Mary’s Hospital, 1216 Southwest Second Street, Rochester, 

MN.

N/A 02/27/2008 MN Joint Commission Certified on 

02/27/2008. 

Allegheny General Hospital, 320 East North Avenue, Pittsburgh, 

PA.

N/A 03/08/2008 PA 

Washington Hospital Center, 110 Irving Street, NW, Washington, 

DC.

09–0011 04/23/2008 DC Joint Commission Certified on 

04/23/2008. 


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Facility Provider No. Date approved State Other 

information 

Integris Baptist Medical Center, 3300 Northwest Expressway, 

Oklahoma City, OK.

1831103654 08/13/2008 OK Joint Commission Certified on 

08/13/08. 

Mayo Clinic Hospital, 5777 East Mayo Boulevard, Phoenix, AZ ..... 030103 02/27/2009 AZ Joint Commission Certified on 

02/27/09. 

Northwestern Memorial Hospital, 251 E. Huron Street, Chicago, IL 140281 03/17/2009 IL Joint Commission Certified on 

03/17/09. 

Lancaster General Hospital, 555 North Duke Street, Lancaster, PA 390100 05/20/2009 PA Joint Commission certified on 05/ 

20/09. 

Hartford Hospital, 80 Seymour Street, Hartford, CT ........................ 070025 05/29/2009 CT Joint Commission certified on 05/ 

29/09. 

Morristown Memorial Hospital, 100 Madison Avenue, Morristown, 

NJ.

310015 06/17/09 NJ Joint Commission certified on 6/ 

17/09. 

Thomas Jefferson University Hospital, 111 South 11th Street, 

Philadelphia, PA.

390174 08/05/09 PA Joint Commission certified on 8/ 

5/09. 

Emory University Hospital, 1364 Clifton Road, Atlanta, GA ............. 110010 08/19/09 GA Joint Commission certified on 8/ 

19/09. 

Maine Medical Center, 22 Bramhall Street, Portland, ME ............... 200009 02/03/09 ME Joint Commission certified on 02/ 

03/09. 

University of Kentucky Health Care—Chandler Hospital, 800 Rose 

Street, Lexington, KY.

........................ 02/11/09 KY 

Sutter Memorial Hospital, 5151 F Street, Sacramento, California ... 050108 10/21/09 CA Joint Commission Certified on 

10/21/09. 

Baptist Health Medical Center—Little Rock, 9601 Interstate 630, 

Exit 7, Little Rock, Arizona.

040114 12/02/09 AR Joint Commission Certified on 

12/02/09. 

Westchester Medical Center, 100 Woods Road, Valhalla, New 

York.

330234 01/05/10 NY Joint Commission Certified on 

01/05/10. 

Addendum XIV 

Lung Volume Reduction Surgery (LVRS) 

[January Through March 2010] 

Three types of facilities are eligible for 

reimbursement for Lung Volume 

Reduction Surgery (LVRS): National 

Emphysema Treatment Trial (NETT) 

approved (Beginning 05/07/2007, these 

will no longer automatically qualify and 

can qualify only with the other 

programs), Credentialed by the Joint 

Commission (formerly, the Joint 

Commision on Accreditation of 

Healthcare Organizations (JCAHO)) 

under their Disease Specific 

Certification Program for LVRS, and 

Medicare approved for lung transplants. 

Only the first two types are in the list. 

Facility name Date approved State Type of certification 

Baylor College of Medicine, Houston, Texas ......................... N/A TEXAS ................................... NETT 

Brigham and Women’s Hospital, Boston, MA ........................ N/A MASSACHUSETTS ............... NETT 

Cedars-Sinai Medical Center, Los Angeles, CA .................... N/A CALIFORNIA ......................... NETT 

Chapman Medical Center, Orange, CA ................................. N/A CALIFORNIA ......................... NETT 

Cleveland Clinic Foundation, Cleveland, OH ......................... N/A OHIO ...................................... NETT 

Columbia University, New York, NY ....................................... N/A NEW YORK ........................... NETT 

Duke University Medical Center, Durham, NC ....................... N/A NORTH CAROLINA ............... NETT 

Johns Hopkins Hospital, Baltimore, MD ................................. N/A MARYLAND ........................... NETT 

Kaiser Foundation Hospital—Riverside, Riverside, CA ......... 09/20/2006 CALIFORNIA ......................... Joint Commission 

Long Island Jewish Medical Center, New Hyde Park, NY ..... N/A NEW YORK ........................... NETT 

Mayo Clinic, Rochester, MN ................................................... N/A MINNESOTA .......................... NETT 

Memorial Medical Center, Springfield, IL ............................... 12/13/2006 ILLINOIS ................................ Joint Commission 

National Jewish Medical Center, Denver, CO ........................ N/A COLORADO .......................... NETT 

The Ohio State University Hospital, Columbus, OH .............. N/A OHIO ...................................... Joint Commission 

Ohio State University Medical Center, Columbus, OH .......... N/A OHIO ...................................... NETT 

Saint Louis University, Saint Louis, MO ................................. N/A MISSOURI ............................. NETT 

Temple University Hospital, Philadelphia, PA ........................ 08/23/2008 PENNSYLVANIA ................... Joint Commission 

UCLA Medical Center, Los Angeles, CA ............................... N/A CALIFORNIA ......................... NETT 

University of California, San Diego, San Diego, CA .............. N/A CALIFORNIA ......................... NETT 

University of Maryland Medical Center, Baltimore, MD ......... N/A MARYLAND ........................... NETT 

University of Michigan Medical Center, Ann Arbor, MI .......... N/A MICHIGAN ............................. Joint Commission 

University of Pennsylvania, Philadelphia, PA ......................... N/A PENNSYLVANIA ................... NETT 

University of Pittsburgh, Pittsburgh, PA ................................. N/A PENNSYLVANIA ................... NETT 

University of Washington, Seattle, WA .................................. N/A WASHINGTON ...................... NETT 

Washington University/Barnes Hospital, Saint Louis, MO ..... N/A MISSOURI ............................. Joint Commission 

Allegheny General Hospital, Pittsburgh, PA ........................... 04/23/2008 PENNSYLVANIA ................... Joint Commission

Addendum XV—Medicare-Approved 

Bariatric Surgery Facilities 

On February 21, 2006, we issued our 

decision memorandum on bariatric 

surgery procedures. We determined that 

bariatric surgical procedures are 

reasonable and necessary for Medicare 

beneficiaries who have a body-mass 

index (BMI) greater than or equal to 35, 

have at least one co-morbidity related to 

obesity, and have been previously 


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unsuccessful with medical treatment for 

obesity. 

This decision also stipulated that 

covered bariatric surgery procedures are 

reasonable and necessary only when 

performed at facilities that are: (1) 

Certified by the American College of 

Surgeons (ACS) as a Level 1 Bariatric 

Surgery Center (program standards and 

requirements in effect on February 15, 

2006); or (2) certified by the American 

Society for Bariatric Surgery (ASBS) as 

a Bariatric Surgery Center of Excellence 

(BSCOE) (program standards and 

requirements in effect on February 15, 

2006). 

The following facilities have met our 

minimum facility standards for bariatric 

surgery and have been certified by 

American College of Surgeons (ACS) or 

American Society for Metabolic and 

Bariatric Surgery (ASMBS). 


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Addendum XVI—FDG–PET for 

Dementia and Neurodegenerative 

Diseases Clinical Trials 

In a National Coverage Determination 

for fluorodeoxyglucose positron 

emission tomography (FDG–PET) for 

Dementia and Neurodegenerative 

Diseases (220.6.13) we indicated that an 

FDG–PET scan is considered reasonable 

and necessary in patients with mild 

cognitive impairment or early dementia 

only in the context of an approved 

clinical trial that contains patient 

safeguards and protections to ensure 

proper administration, use, and 

evaluation of the FDG–PET scan. 

Facility name Provider No. Date approved State Name of trial Principal investigator 

UCLA Medical Center ............

10833 Le Conte Avenue 

Los Angeles, CA 90095 

HW13029 .......... 06/07/2006 CA ....... Early and Long-Term Value 

of Imaging Brain Metabolism.

Dr. Daniel Silverman. 

Santa Monica-UCLA Medical 

Center.

1245 16th Street 

Suite 105 

Santa Monica, CA 90404 

W11817A .......... 01/12/2007 CA ....... N/A ........................................ N/A. 

University of Buffalo ...............

3435 Main Street 

Buffalo, NY 14214 

14414A ............. 03/12/2007 NY ....... Metabolic Cerebral Imaging 

in Incipient Dementia 

(MCI–ID).

Dr. Daniel Silverman. 

Center for Alzheimer’s Care, 

Imaging and Research 

(University of Utah).

650 Komas Drive 

Suite 106–A 

Salt Lake City, UT 84108 

460009 ............. 02/17/2009 UT ....... Metabolic Cerebral Imaging 

in Incipient Dementia 

(MCI–ID).

Norman Foster, M.D. 

Medical University of South 

Carolina.

169 Ashley Avenue 

PO Box 250322 

Charleston, SC 29425 

1073605879 ..... 02/17/2009 SC ....... N/A ........................................ Kenneth Spicer. 

Cedars-Sinai Medical Center

8700 Beverly Boulevard 

Nuc Suite 1239 

Los Angeles, CA 90048 

951644600 ....... 10/09/2009 CA ....... ‘‘Early and Long-term Value 

of Imaging Brain Metabolism’’.

Dr. Alan Waxman. 

[FR Doc. 2010–15257 Filed 6–25–10; 8:45 am] 

BILLING CODE 4120–01–P 


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