Medicare and Medicaid Programs: Quarterly Listing of Program Issuances (January Through March 2010)
Federal Register: June 28, 2010 (Volume 75, Number 123)
Notices
Page 36785-37185
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr28jn10-157
Page 36785
Part II
Book 2 of 2 Books
Pages 36785-37286
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Medicare and Medicaid Programs; Quarterly Listing of Program; Notice
Page 36786
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 one-time 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 Medicare-approved 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 Medicare-approved 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 Medicare-approved 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 Medicare-approved 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 fluorodeoxyglucose positron emission
Page 36787
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:
-
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.
-
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--
cir
Date published;
cir
Federal Register citation;
cir
Parts of the Code of Federal Regulations (CFR) that have changed (if applicable);
cir
Agency file code number; and
cir
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
Page 36788
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.
-
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). Dial-in 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.
-
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
Page 36789
(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
Page 36790
GRAPHIC
TIFF OMITTED TN28JN10.001
Page 36791
GRAPHIC
TIFF OMITTED TN28JN10.002
Page 36792
GRAPHIC
TIFF OMITTED TN28JN10.003
Page 36793
GRAPHIC
TIFF OMITTED TN28JN10.004
Page 36794
GRAPHIC
TIFF OMITTED TN28JN10.005
Page 36795
GRAPHIC
TIFF OMITTED TN28JN10.006
Page 36796
GRAPHIC
TIFF OMITTED TN28JN10.007
Page 36797
GRAPHIC
TIFF OMITTED TN28JN10.008
Page 36798
GRAPHIC
TIFF OMITTED TN28JN10.009
Page 36799
GRAPHIC
TIFF OMITTED TN28JN10.010
Page 36800
GRAPHIC
TIFF OMITTED TN28JN10.011
Page 36801
GRAPHIC
TIFF OMITTED TN28JN10.012
Page 36802
GRAPHIC
TIFF OMITTED TN28JN10.013
Page 36803
Addendum IV--Regulation Documents Published in the Federal Register
January Through March 2010
FR Vol. 75
42 CFR Parts
Publication date
Page No.
affected
File code
Title of regulation
January 13, 2010................
1844 412, 413, 422, and CMS-0033-P......... Medicare and Medicaid 495.
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
20.10
R116NCD
03/05/2010
02/22/2010
Rehabilitation (CR) Programs...............
Percutaneous Transluminal Angioplasty (PTA)
20.70
R115NCD
03/05/2010
12/09/2009 of the Carotid Artery Concurrent with
Stenting...................................
Outpatient Intravenous Insulin Treatment
40.70
R117NCD
03/09/2010
12/23/2009
(Therapy)..................................
Screening for the Human Immunodeficiency
210.70
R118NCD
03/23/2010
12/08/2009
Virus (HIV) Infection......................
Page 36804
Positron Emission Tomography (NaF-18) to
220.60
R119NCD
03/26/2010
02/26/2010
Identify Bone Metastasis of Cancer.........
Changes to the Laboratory National Coverage
190.00
R1963CP
04/30/2010
07/01/2010
Determination (NCD) Edit Software for July 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
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:
Page 36805
GRAPHIC
TIFF OMITTED TN28JN10.014
Page 36806
GRAPHIC
TIFF OMITTED TN28JN10.015
Page 36807
GRAPHIC
TIFF OMITTED TN28JN10.016
Page 36808
GRAPHIC
TIFF OMITTED TN28JN10.017
Page 36809
GRAPHIC
TIFF OMITTED TN28JN10.018
Page 36810
GRAPHIC
TIFF OMITTED TN28JN10.019
Page 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,
100050
01/12/2010 FL
.......................... 1475 West 49th Street, Hialeah,
FL 33012.
Parrish Medical Center, 951 N.
100028
01/12/2010 FL
..........................
Washington Avenue, Titusville, FL 32796.
New York Presbyterian Hospital,
330101
05/05/2005 NY
.......................... 177 Ft. Washington Avenue, New
York, NY 10032.
Northside Hospital & Tampa Bay
1205880945
02/26/2010 FL
..........................
Heart Institute, 6000 49th Street
North, St..
Petersburg, FL 33709.............
Orange Park Medical Center, 2001
100226
02/26/2010 FL
..........................
Kingsley Avenue,.
Orange Park, FL 32073.............
Saint Thomas Hospital, 4220
440082
02/26/2010 TN
..........................
Harding Road, Nashville, TN 37205.
Marshall Medical Center North,
15082417
04/02/2010 AL
.......................... 8000 Alabama HWT 69,
Guntersville, AL 35976.
Oklahoma Heart Hospital South LLC,
1841442274
04/02/2010 OK
.......................... 5200 E. I-240 Service Road,
Oklahoma City, OK 73135-2610.
Great River Medical Center, 1221
420680407
04/16/2010 IA
..........................
S. Gear Avenue, West Burlington,
IA 52655-1681.
Liberty Hospital, P.O. Box 1002,
260177
04/16/2010 MO
..........................
Liberty, MO 64069-1002.
Scripps Memorial Hospital,
050503
04/16/2010 CA
..........................
Encinitas, 354 Santa Fe Drive
ENC01, Encinitas, CA 92024.
University of Maryland Medical
210002
04/16/2010 MD
..........................
Center, 22 South Greene Street,
Baltimore, MD 21201-1595.
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=asce nding&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.
Page 36812
GRAPHIC
TIFF OMITTED TN28JN10.020
Page 36813
GRAPHIC
TIFF OMITTED TN28JN10.021
Page 36814
GRAPHIC
TIFF OMITTED TN28JN10.022
Page 36815
GRAPHIC
TIFF OMITTED TN28JN10.023
Page 36816
GRAPHIC
TIFF OMITTED TN28JN10.024
Page 36817
GRAPHIC
TIFF OMITTED TN28JN10.025
Page 36818
GRAPHIC
TIFF OMITTED TN28JN10.026
Page 36819
GRAPHIC
TIFF OMITTED TN28JN10.027
Page 36820
GRAPHIC
TIFF OMITTED TN28JN10.028
Page 36821
GRAPHIC
TIFF OMITTED TN28JN10.029
Page 36822
GRAPHIC
TIFF OMITTED TN28JN10.030
Page 36823
GRAPHIC
TIFF OMITTED TN28JN10.031
Page 36824
GRAPHIC
TIFF OMITTED TN28JN10.032
Page 36825
GRAPHIC
TIFF OMITTED TN28JN10.033
Page 36826
GRAPHIC
TIFF OMITTED TN28JN10.034
Page 36827
GRAPHIC
TIFF OMITTED TN28JN10.035
Page 36828
GRAPHIC
TIFF OMITTED TN28JN10.036
Page 36829
GRAPHIC
TIFF OMITTED TN28JN10.037
Page 36830
GRAPHIC
TIFF OMITTED TN28JN10.038
Page 36831
GRAPHIC
TIFF OMITTED TN28JN10.039
Page 36832
GRAPHIC
TIFF OMITTED TN28JN10.040
Page 36833
GRAPHIC
TIFF OMITTED TN28JN10.041
Page 36834
GRAPHIC
TIFF OMITTED TN28JN10.042
Page 36835
GRAPHIC
TIFF OMITTED TN28JN10.043
Page 36836
GRAPHIC
TIFF OMITTED TN28JN10.044
Page 36837
GRAPHIC
TIFF OMITTED TN28JN10.045
Page 36838
GRAPHIC
TIFF OMITTED TN28JN10.046
Page 36839
GRAPHIC
TIFF OMITTED TN28JN10.047
Page 36840
GRAPHIC
TIFF OMITTED TN28JN10.048
Page 36841
GRAPHIC
TIFF OMITTED TN28JN10.049
Page 36842
GRAPHIC
TIFF OMITTED TN28JN10.050
Page 36843
GRAPHIC
TIFF OMITTED TN28JN10.051
Page 36844
GRAPHIC
TIFF OMITTED TN28JN10.052
Page 36845
GRAPHIC
TIFF OMITTED TN28JN10.053
Page 36846
GRAPHIC
TIFF OMITTED TN28JN10.054
Page 36847
GRAPHIC
TIFF OMITTED TN28JN10.055
Page 36848
GRAPHIC
TIFF OMITTED TN28JN10.056
Page 36849
GRAPHIC
TIFF OMITTED TN28JN10.057
Page 36850
GRAPHIC
TIFF OMITTED TN28JN10.058
Page 36851
GRAPHIC
TIFF OMITTED TN28JN10.059
Page 36852
GRAPHIC
TIFF OMITTED TN28JN10.060
Page 36853
GRAPHIC
TIFF OMITTED TN28JN10.061
Page 36854
GRAPHIC
TIFF OMITTED TN28JN10.062
Page 36855
GRAPHIC
TIFF OMITTED TN28JN10.063
Page 36856
GRAPHIC
TIFF OMITTED TN28JN10.064
Page 36857
GRAPHIC
TIFF OMITTED TN28JN10.065
Page 36858
GRAPHIC
TIFF OMITTED TN28JN10.066
Page 36859
GRAPHIC
TIFF OMITTED TN28JN10.067
Page 36860
GRAPHIC
TIFF OMITTED TN28JN10.068
Page 36861
GRAPHIC
TIFF OMITTED TN28JN10.069
Page 36862
GRAPHIC
TIFF OMITTED TN28JN10.070
Page 36863
GRAPHIC
TIFF OMITTED TN28JN10.071
Page 36864
GRAPHIC
TIFF OMITTED TN28JN10.072
Page 36865
GRAPHIC
TIFF OMITTED TN28JN10.073
Page 36866
GRAPHIC
TIFF OMITTED TN28JN10.074
Page 36867
GRAPHIC
TIFF OMITTED TN28JN10.075
Page 36868
GRAPHIC
TIFF OMITTED TN28JN10.076
Page 36869
GRAPHIC
TIFF OMITTED TN28JN10.077
Page 36870
GRAPHIC
TIFF OMITTED TN28JN10.078
Page 36871
GRAPHIC
TIFF OMITTED TN28JN10.079
Page 36872
GRAPHIC
TIFF OMITTED TN28JN10.080
Page 36873
GRAPHIC
TIFF OMITTED TN28JN10.081
Page 36874
GRAPHIC
TIFF OMITTED TN28JN10.082
Page 36875
GRAPHIC
TIFF OMITTED TN28JN10.083
Page 36876
GRAPHIC
TIFF OMITTED TN28JN10.084
Page 36877
GRAPHIC
TIFF OMITTED TN28JN10.085
Page 36878
GRAPHIC
TIFF OMITTED TN28JN10.086
Page 36879
GRAPHIC
TIFF OMITTED TN28JN10.087
Page 36880
GRAPHIC
TIFF OMITTED TN28JN10.088
Page 36881
GRAPHIC
TIFF OMITTED TN28JN10.089
Page 36882
GRAPHIC
TIFF OMITTED TN28JN10.090
Page 36883
GRAPHIC
TIFF OMITTED TN28JN10.091
Page 36884
GRAPHIC
TIFF OMITTED TN28JN10.092
Page 36885
GRAPHIC
TIFF OMITTED TN28JN10.093
Page 36886
GRAPHIC
TIFF OMITTED TN28JN10.094
Page 36887
GRAPHIC
TIFF OMITTED TN28JN10.095
Page 36888
GRAPHIC
TIFF OMITTED TN28JN10.096
Page 36889
GRAPHIC
TIFF OMITTED TN28JN10.097
Page 36890
GRAPHIC
TIFF OMITTED TN28JN10.098
Page 36891
GRAPHIC
TIFF OMITTED TN28JN10.099
Page 36892
GRAPHIC
TIFF OMITTED TN28JN10.100
Page 36893
GRAPHIC
TIFF OMITTED TN28JN10.101
Page 36894
GRAPHIC
TIFF OMITTED TN28JN10.102
Page 36895
GRAPHIC
TIFF OMITTED TN28JN10.103
Page 36896
GRAPHIC
TIFF OMITTED TN28JN10.104
Page 36897
GRAPHIC
TIFF OMITTED TN28JN10.105
Page 36898
GRAPHIC
TIFF OMITTED TN28JN10.106
Page 36899
GRAPHIC
TIFF OMITTED TN28JN10.107
Page 36900
GRAPHIC
TIFF OMITTED TN28JN10.108
Page 36901
GRAPHIC
TIFF OMITTED TN28JN10.109
Page 36902
GRAPHIC
TIFF OMITTED TN28JN10.110
Page 36903
GRAPHIC
TIFF OMITTED TN28JN10.111
Page 36904
GRAPHIC
TIFF OMITTED TN28JN10.112
Page 36905
GRAPHIC
TIFF OMITTED TN28JN10.113
Page 36906
GRAPHIC
TIFF OMITTED TN28JN10.114
Page 36907
GRAPHIC
TIFF OMITTED TN28JN10.115
Page 36908
GRAPHIC
TIFF OMITTED TN28JN10.116
Page 36909
GRAPHIC
TIFF OMITTED TN28JN10.117
Page 36910
GRAPHIC
TIFF OMITTED TN28JN10.118
Page 36911
GRAPHIC
TIFF OMITTED TN28JN10.119
Page 36912
GRAPHIC
TIFF OMITTED TN28JN10.120
Page 36913
GRAPHIC
TIFF OMITTED TN28JN10.121
Page 36914
GRAPHIC
TIFF OMITTED TN28JN10.122
Page 36915
GRAPHIC
TIFF OMITTED TN28JN10.123
Page 36916
GRAPHIC
TIFF OMITTED TN28JN10.124
Page 36917
GRAPHIC
TIFF OMITTED TN28JN10.125
Page 36918
GRAPHIC
TIFF OMITTED TN28JN10.126
Page 36919
GRAPHIC
TIFF OMITTED TN28JN10.127
Page 36920
GRAPHIC
TIFF OMITTED TN28JN10.128
Page 36921
GRAPHIC
TIFF OMITTED TN28JN10.129
Page 36922
GRAPHIC
TIFF OMITTED TN28JN10.130
Page 36923
GRAPHIC
TIFF OMITTED TN28JN10.131
Page 36924
GRAPHIC
TIFF OMITTED TN28JN10.132
Page 36925
GRAPHIC
TIFF OMITTED TN28JN10.133
Page 36926
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 CMS-recognized 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.
Page 36927
GRAPHIC
TIFF OMITTED TN28JN10.134
Page 36928
GRAPHIC
TIFF OMITTED TN28JN10.135
Page 36929
GRAPHIC
TIFF OMITTED TN28JN10.136
Page 36930
GRAPHIC
TIFF OMITTED TN28JN10.137
Page 36931
GRAPHIC
TIFF OMITTED TN28JN10.138
Page 36932
GRAPHIC
TIFF OMITTED TN28JN10.139
Page 36933
GRAPHIC
TIFF OMITTED TN28JN10.140
Page 36934
GRAPHIC
TIFF OMITTED TN28JN10.141
Page 36935
GRAPHIC
TIFF OMITTED TN28JN10.142
Page 36936
GRAPHIC
TIFF OMITTED TN28JN10.143
Page 36937
GRAPHIC
TIFF OMITTED TN28JN10.144
Page 36938
GRAPHIC
TIFF OMITTED TN28JN10.145
Page 36939
GRAPHIC
TIFF OMITTED TN28JN10.146
Page 36940
GRAPHIC
TIFF OMITTED TN28JN10.147
Page 36941
GRAPHIC
TIFF OMITTED TN28JN10.148
Page 36942
GRAPHIC
TIFF OMITTED TN28JN10.149
Page 36943
GRAPHIC
TIFF OMITTED TN28JN10.150
Page 36944
GRAPHIC
TIFF OMITTED TN28JN10.151
Page 36945
GRAPHIC
TIFF OMITTED TN28JN10.152
Page 36946
GRAPHIC
TIFF OMITTED TN28JN10.153
Page 36947
GRAPHIC
TIFF OMITTED TN28JN10.154
Page 36948
GRAPHIC
TIFF OMITTED TN28JN10.155
Page 36949
GRAPHIC
TIFF OMITTED TN28JN10.156
Page 36950
GRAPHIC
TIFF OMITTED TN28JN10.157
Page 36951
GRAPHIC
TIFF OMITTED TN28JN10.158
Page 36952
GRAPHIC
TIFF OMITTED TN28JN10.159
Page 36953
GRAPHIC
TIFF OMITTED TN28JN10.160
Page 36954
GRAPHIC
TIFF OMITTED TN28JN10.161
Page 36955
GRAPHIC
TIFF OMITTED TN28JN10.162
Page 36956
GRAPHIC
TIFF OMITTED TN28JN10.163
Page 36957
GRAPHIC
TIFF OMITTED TN28JN10.164
Page 36958
GRAPHIC
TIFF OMITTED TN28JN10.165
Page 36959
GRAPHIC
TIFF OMITTED TN28JN10.166
Page 36960
GRAPHIC
TIFF OMITTED TN28JN10.167
Page 36961
GRAPHIC
TIFF OMITTED TN28JN10.168
Page 36962
GRAPHIC
TIFF OMITTED TN28JN10.169
Page 36963
GRAPHIC
TIFF OMITTED TN28JN10.170
Page 36964
GRAPHIC
TIFF OMITTED TN28JN10.171
Page 36965
GRAPHIC
TIFF OMITTED TN28JN10.172
Page 36966
GRAPHIC
TIFF OMITTED TN28JN10.173
Page 36967
GRAPHIC
TIFF OMITTED TN28JN10.174
Page 36968
GRAPHIC
TIFF OMITTED TN28JN10.175
Page 36969
GRAPHIC
TIFF OMITTED TN28JN10.176
Page 36970
GRAPHIC
TIFF OMITTED TN28JN10.177
Page 36971
GRAPHIC
TIFF OMITTED TN28JN10.178
Page 36972
GRAPHIC
TIFF OMITTED TN28JN10.179
Page 36973
GRAPHIC
TIFF OMITTED TN28JN10.180
Page 36974
GRAPHIC
TIFF OMITTED TN28JN10.181
Page 36975
GRAPHIC
TIFF OMITTED TN28JN10.182
Page 36976
GRAPHIC
TIFF OMITTED TN28JN10.183
Page 36977
GRAPHIC
TIFF OMITTED TN28JN10.184
Page 36978
GRAPHIC
TIFF OMITTED TN28JN10.185
Page 36979
GRAPHIC
TIFF OMITTED TN28JN10.186
Page 36980
GRAPHIC
TIFF OMITTED TN28JN10.187
Page 36981
GRAPHIC
TIFF OMITTED TN28JN10.188
Page 36982
GRAPHIC
TIFF OMITTED TN28JN10.189
Page 36983
GRAPHIC
TIFF OMITTED TN28JN10.190
Page 36984
GRAPHIC
TIFF OMITTED TN28JN10.191
Page 36985
GRAPHIC
TIFF OMITTED TN28JN10.192
Page 36986
GRAPHIC
TIFF OMITTED TN28JN10.193
Page 36987
GRAPHIC
TIFF OMITTED TN28JN10.194
Page 36988
GRAPHIC
TIFF OMITTED TN28JN10.195
Page 36989
GRAPHIC
TIFF OMITTED TN28JN10.196
Page 36990
GRAPHIC
TIFF OMITTED TN28JN10.197
Page 36991
GRAPHIC
TIFF OMITTED TN28JN10.198
Page 36992
GRAPHIC
TIFF OMITTED TN28JN10.199
Page 36993
GRAPHIC
TIFF OMITTED TN28JN10.200
Page 36994
GRAPHIC
TIFF OMITTED TN28JN10.201
Page 36995
GRAPHIC
TIFF OMITTED TN28JN10.202
Page 36996
GRAPHIC
TIFF OMITTED TN28JN10.203
Page 36997
GRAPHIC
TIFF OMITTED TN28JN10.204
Page 36998
GRAPHIC
TIFF OMITTED TN28JN10.205
Page 36999
GRAPHIC
TIFF OMITTED TN28JN10.206
Page 37000
GRAPHIC
TIFF OMITTED TN28JN10.207
Page 37001
GRAPHIC
TIFF OMITTED TN28JN10.208
Page 37002
GRAPHIC
TIFF OMITTED TN28JN10.209
Page 37003
GRAPHIC
TIFF OMITTED TN28JN10.210
Page 37004
GRAPHIC
TIFF OMITTED TN28JN10.211
Page 37005
GRAPHIC
TIFF OMITTED TN28JN10.212
Page 37006
GRAPHIC
TIFF OMITTED TN28JN10.213
Page 37007
GRAPHIC
TIFF OMITTED TN28JN10.214
Page 37008
GRAPHIC
TIFF OMITTED TN28JN10.215
Page 37009
GRAPHIC
TIFF OMITTED TN28JN10.216
Page 37010
GRAPHIC
TIFF OMITTED TN28JN10.217
Page 37011
GRAPHIC
TIFF OMITTED TN28JN10.218
Page 37012
GRAPHIC
TIFF OMITTED TN28JN10.219
Page 37013
GRAPHIC
TIFF OMITTED TN28JN10.220
Page 37014
GRAPHIC
TIFF OMITTED TN28JN10.221
Page 37015
GRAPHIC
TIFF OMITTED TN28JN10.222
Page 37016
GRAPHIC
TIFF OMITTED TN28JN10.223
Page 37017
GRAPHIC
TIFF OMITTED TN28JN10.224
Page 37018
GRAPHIC
TIFF OMITTED TN28JN10.225
Page 37019
GRAPHIC
TIFF OMITTED TN28JN10.226
Page 37020
GRAPHIC
TIFF OMITTED TN28JN10.227
Page 37021
GRAPHIC
TIFF OMITTED TN28JN10.228
Page 37022
GRAPHIC
TIFF OMITTED TN28JN10.229
Page 37023
GRAPHIC
TIFF OMITTED TN28JN10.230
Page 37024
GRAPHIC
TIFF OMITTED TN28JN10.231
Page 37025
GRAPHIC
TIFF OMITTED TN28JN10.232
Page 37026
GRAPHIC
TIFF OMITTED TN28JN10.233
Page 37027
GRAPHIC
TIFF OMITTED TN28JN10.234
Page 37028
GRAPHIC
TIFF OMITTED TN28JN10.235
Page 37029
GRAPHIC
TIFF OMITTED TN28JN10.236
Page 37030
GRAPHIC
TIFF OMITTED TN28JN10.237
Page 37031
GRAPHIC
TIFF OMITTED TN28JN10.238
Page 37032
GRAPHIC
TIFF OMITTED TN28JN10.239
Page 37033
GRAPHIC
TIFF OMITTED TN28JN10.240
Page 37034
GRAPHIC
TIFF OMITTED TN28JN10.241
Page 37035
GRAPHIC
TIFF OMITTED TN28JN10.242
Page 37036
GRAPHIC
TIFF OMITTED TN28JN10.243
Page 37037
GRAPHIC
TIFF OMITTED TN28JN10.244
Page 37038
GRAPHIC
TIFF OMITTED TN28JN10.245
Page 37039
GRAPHIC
TIFF OMITTED TN28JN10.246
Page 37040
GRAPHIC
TIFF OMITTED TN28JN10.247
Page 37041
GRAPHIC
TIFF OMITTED TN28JN10.248
Page 37042
GRAPHIC
TIFF OMITTED TN28JN10.249
Page 37043
GRAPHIC
TIFF OMITTED TN28JN10.250
Page 37044
GRAPHIC
TIFF OMITTED TN28JN10.251
Page 37045
GRAPHIC
TIFF OMITTED TN28JN10.252
Page 37046
GRAPHIC
TIFF OMITTED TN28JN10.253
Page 37047
GRAPHIC
TIFF OMITTED TN28JN10.254
Page 37048
GRAPHIC
TIFF OMITTED TN28JN10.255
Page 37049
GRAPHIC
TIFF OMITTED TN28JN10.256
Page 37050
GRAPHIC
TIFF OMITTED TN28JN10.257
Page 37051
GRAPHIC
TIFF OMITTED TN28JN10.258
Page 37052
GRAPHIC
TIFF OMITTED TN28JN10.259
Page 37053
GRAPHIC
TIFF OMITTED TN28JN10.260
Page 37054
GRAPHIC
TIFF OMITTED TN28JN10.261
Page 37055
GRAPHIC
TIFF OMITTED TN28JN10.262
Page 37056
GRAPHIC
TIFF OMITTED TN28JN10.263
Page 37057
GRAPHIC
TIFF OMITTED TN28JN10.264
Page 37058
GRAPHIC
TIFF OMITTED TN28JN10.265
Page 37059
GRAPHIC
TIFF OMITTED TN28JN10.266
Page 37060
GRAPHIC
TIFF OMITTED TN28JN10.267
Page 37061
GRAPHIC
TIFF OMITTED TN28JN10.268
Page 37062
GRAPHIC
TIFF OMITTED TN28JN10.269
Page 37063
GRAPHIC
TIFF OMITTED TN28JN10.270
Page 37064
GRAPHIC
TIFF OMITTED TN28JN10.271
Page 37065
GRAPHIC
TIFF OMITTED TN28JN10.272
Page 37066
GRAPHIC
TIFF OMITTED TN28JN10.273
Page 37067
GRAPHIC
TIFF OMITTED TN28JN10.274
Page 37068
GRAPHIC
TIFF OMITTED TN28JN10.275
Page 37069
GRAPHIC
TIFF OMITTED TN28JN10.276
Page 37070
GRAPHIC
TIFF OMITTED TN28JN10.277
Page 37071
GRAPHIC
TIFF OMITTED TN28JN10.278
Page 37072
GRAPHIC
TIFF OMITTED TN28JN10.279
Page 37073
GRAPHIC
TIFF OMITTED TN28JN10.280
Page 37074
GRAPHIC
TIFF OMITTED TN28JN10.281
Page 37075
GRAPHIC
TIFF OMITTED TN28JN10.282
Page 37076
GRAPHIC
TIFF OMITTED TN28JN10.283
Page 37077
GRAPHIC
TIFF OMITTED TN28JN10.284
Page 37078
GRAPHIC
TIFF OMITTED TN28JN10.285
Page 37079
GRAPHIC
TIFF OMITTED TN28JN10.286
Page 37080
GRAPHIC
TIFF OMITTED TN28JN10.287
Page 37081
GRAPHIC
TIFF OMITTED TN28JN10.288
Page 37082
GRAPHIC
TIFF OMITTED TN28JN10.289
Page 37083
GRAPHIC
TIFF OMITTED TN28JN10.290
Page 37084
GRAPHIC
TIFF OMITTED TN28JN10.291
Page 37085
GRAPHIC
TIFF OMITTED TN28JN10.292
Page 37086
GRAPHIC
TIFF OMITTED TN28JN10.293
Page 37087
GRAPHIC
TIFF OMITTED TN28JN10.294
Page 37088
GRAPHIC
TIFF OMITTED TN28JN10.295
Page 37089
GRAPHIC
TIFF OMITTED TN28JN10.296
Page 37090
GRAPHIC
TIFF OMITTED TN28JN10.297
Page 37091
GRAPHIC
TIFF OMITTED TN28JN10.298
Page 37092
GRAPHIC
TIFF OMITTED TN28JN10.299
Page 37093
GRAPHIC
TIFF OMITTED TN28JN10.300
Page 37094
GRAPHIC
TIFF OMITTED TN28JN10.301
Page 37095
GRAPHIC
TIFF OMITTED TN28JN10.302
Page 37096
GRAPHIC
TIFF OMITTED TN28JN10.303
Page 37097
GRAPHIC
TIFF OMITTED TN28JN10.304
Page 37098
GRAPHIC
TIFF OMITTED TN28JN10.305
Page 37099
GRAPHIC
TIFF OMITTED TN28JN10.306
Page 37100
GRAPHIC
TIFF OMITTED TN28JN10.307
Page 37101
GRAPHIC
TIFF OMITTED TN28JN10.308
Page 37102
GRAPHIC
TIFF OMITTED TN28JN10.309
Page 37103
GRAPHIC
TIFF OMITTED TN28JN10.310
Page 37104
GRAPHIC
TIFF OMITTED TN28JN10.311
Page 37105
GRAPHIC
TIFF OMITTED TN28JN10.312
Page 37106
GRAPHIC
TIFF OMITTED TN28JN10.313
Page 37107
GRAPHIC
TIFF OMITTED TN28JN10.314
Page 37108
GRAPHIC
TIFF OMITTED TN28JN10.315
Page 37109
GRAPHIC
TIFF OMITTED TN28JN10.316
Page 37110
GRAPHIC
TIFF OMITTED TN28JN10.317
Page 37111
GRAPHIC
TIFF OMITTED TN28JN10.318
Page 37112
GRAPHIC
TIFF OMITTED TN28JN10.319
Page 37113
GRAPHIC
TIFF OMITTED TN28JN10.320
Page 37114
GRAPHIC
TIFF OMITTED TN28JN10.321
Page 37115
GRAPHIC
TIFF OMITTED TN28JN10.322
Page 37116
GRAPHIC
TIFF OMITTED TN28JN10.323
Page 37117
GRAPHIC
TIFF OMITTED TN28JN10.324
Page 37118
GRAPHIC
TIFF OMITTED TN28JN10.325
Page 37119
GRAPHIC
TIFF OMITTED TN28JN10.326
Page 37120
GRAPHIC
TIFF OMITTED TN28JN10.327
Page 37121
GRAPHIC
TIFF OMITTED TN28JN10.328
Page 37122
GRAPHIC
TIFF OMITTED TN28JN10.329
Page 37123
GRAPHIC
TIFF OMITTED TN28JN10.330
Page 37124
GRAPHIC
TIFF OMITTED TN28JN10.331
Page 37125
GRAPHIC
TIFF OMITTED TN28JN10.332
Page 37126
GRAPHIC
TIFF OMITTED TN28JN10.333
Page 37127
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
140208
12/17/2003 IL
Joint Commission
W 95th Street, Oak Lawn, Illinois.
Certified on 05/26/ 2007.
California Pacific Medical Center,
050047
03/19/2004 CA 2333 Buchanan Street, San Francisco,
California.
Baptist Memorial Hospital, 6019
440048
04/07/2004 TN
Walnut Grove Road, Memphis,
Tennessee.
Duke University Medical Center, DUMC
340030
10/31/2003 NC
Box 3943, Durham, North Carolina.
Fairview-University Medical Center,
240080
10/28/2003 MN 2450 Riverside Avenue, Minneapolis,
Minnesota.
Allegheny General Hospital, 320 E
390050
12/10/2003 PA
Joint Commission
North Avenue, Pittsburgh,
Certified on 03/28/
Pennsylvania.
2008.
Barnes-Jewish Hospital, One Barnes-
260032
10/27/2003 MO
Joint Commission
Jewish Hospital Plaza, Saint Louis,
Certified on 08/22/
Missouri.
2008.
Brigham and Women's Hospital, 15
220110
01/09/2004 MA
Francis Street, Boston,
Massachusetts.
Bryan LGH Medical Center East, 1600 S
280003
10/23/2003 NE 48 Street, Lincoln, Nebraska.
Cedars-Sinai Medical Center, 8700
050625
12/29/2003 CA
Beverly Boulevard, Los Angeles,
California.
Clarian Health Partners, Inc., 1701
150056
11/25/2003 IN
N. Senate Avenue, Indianapolis,
Indiana.
Cleveland Clinic, 9500 Euclid Avenue,
360180
12/03/2003 OH
Cleveland, Ohio.
Hahnemann University Hospital, Broad
390290
12/22/2003 PA
Joint Commission and Vine Streets, Philadelphia,
Certified on 09/19/
Pennsylvania.
2008.
Hospital of the University of
390111
10/28/2003 PA
Joint Commission
Pennsylvania, 3400 Spruce Street,
Certified on 05/23/
Philadelphia, Pennsylvania.
2008.
Henry Ford Hospital, 2799 W. Grand
230053
01/06/2004 MI
Boulevard, Detroit, Michigan.
Inova Fairfax Hospital, 3300 Gallows
490063
03/31/2004 VA
Road, Falls Church, Virginia.
Jewish Hospital, 200 Abraham Flexner
180040
11/10/2003 KY
Way, Louisville, Kentucky.
Jackson Memorial Hospital, 1611 NW
100022
01/12/2004 FL
University of Miami. 12th Avenue, Miami, Florida.
LDS Hospital, 8th Avenue and C
460010
10/23/2003 UT
Street, Salt Lake City, Utah.
Johns Hopkins Hospital, 600 N. Wolfe
210009/
10/28/2003 MD
Joint Commission
Street, Baltimore, Maryland.
1790700904
Certified on 07/09/ 2008.
Loyola University Medical Center,
140276
01/30/2004 IL 2160 S. 1st Avenue, Maywood,
Illinois.
Lutheran Hospital of Indiana, 7950 W.
150017
10/29/2003 IN
Jefferson Boulevard, Fort Wayne,
Indiana.
Massachusetts General Hospital, 55
220071
12/15/2003 MA
Fruit Street, Boston, Massachusetts.
Mayo Clinic, 4500 San Pablo Road,
100151
11/06/2003 FL
Jacksonville, Florida.
Medical City Dallas Hospital, 7777
450647
12/03/2003 TX
Forest Lane, Dallas, Texas.
The Methodist Hospital, 6565 Fannin
450358
11/03/2003 TX
Street, Houston, Texas.
Montefiore Medical Center, 111 E.
330059
11/14/2003 NY 210th Street, Bronx, New York.
Methodist Specialty and Transplant
450388
11/19/2003 TX
Hospital, 8026 Floyd Curl Drive, San
Antonio, Texas.
Newark Beth Israel Medical Center,
310002
11/14/2003 NJ 201 Lyons Avenue, Newark, New Jersey.
Mount Sinai Medical Center, 1190 5th
330024
11/25/2003 NY
Avenue, New York, New York.
New York-Presbyterian Hospital, 177
330101
10/28/2003 NY
Columbia University
Fort Washington Avenue, New York,
Medical Center.
New York.
Ohio State University Medical Center,
360085
11/12/2003 OH 410 W. 10th Avenue, Columbus, Ohio.
Oregon Health and Sciences
380009
11/21/2003 OR
University, 3181 SW Sam Jackson Park
Road, Portland, Oregon.
OSF St Francis Medical Center, 530 NE
140067
11/12/2003 IL
Glen Oak Avenue, Peoria, Illinois.
Penn State Milton S Hershey Medical
390256
10/29/2003 PA
Joint Commission
Center, 500 University Drive,
Certified on 05/19/
Hershey, Pennsylvania.
2008.
Rush-Presbyterian-St Luke Medical
140119
11/14/2003 IL
Center, 1653 W Congress Parkway,
Chicago, Illinois.
Page 37128
Sentara Norfolk General Hospital, 600
490007
11/10/2003 VA
Gresham Drive, Norfolk, Virginia.
Sacred Heart Medical Center, 101 W
500054
01/12/2004 WA 8th Avenue, Spokane, Washington.
Seton Medical Center, 1201 W. 38th
450056
01/13/2004 TX
Street, Austin, Texas.
Shands at the University of Florida,
100113
11/26/2003 FL 1600 SW Archer Road, Gainesville,
Florida.
Sharp Memorial Hospital, 7901 Frost
050100
12/01/2003 CA
Joint Commission
Street, San Diego, California.
Certified on 07/18/ 2008.
Stanford University Hospital and
050441
12/22/2003 CA
Stanford University
Clinics, 300 Pasteur Drive,
Medical Center.
Stanford, California.
St Francis Hospital, 6161 S. Yale
370091
01/09/2004 OK
Avenue, Tulsa, Oklahoma.
St Luke's Medical Center, 2900 W
520138
11/03/2003 WI
Oklahoma Avenue, Milwaukee,
Wisconsin.
St Luke's Episcopal Hospital, 6720
450193
10/28/2003 TX
Bertner Avenue, Houston, Texas.
St Vincent Hospital and Health
150084
01/05/2004 IN
Services, 2001 W. 86th Street,
Indianapolis, Indiana.
St Paul Medical Center, 5909 Harry
450044
12/10/2003 TX
Hines Boulevard, Dallas, Texas.
Strong Memorial Hospital, 601 Elmwood
330285
10/29/2003 NY
Joint Commission
Avenue, Rochester, New York.
Certified on 06/18/ 2008.
Tampa General Hospital, 2 Columbia
100128
11/26/2003 FL
Drive, Tampa, Florida.
Temple University Hospital, 3401 N.
390027
11/03/2003 PA
Broad Street, Philadelphia,
Pennsylvania.
Tufts-New England Medical Center, 750
220116
11/06/2003 MA
Washington Street, Boston,
Massachusetts.
UCLA Medical Center, 10833 Le Conte
050262
12/10/2003 CA
Avenue, Los Angeles, California.
University Medical Center, 1501 N.
030064
10/29/2003 AZ
Campbell Avenue, Tucson, Arizonia.
University of Alabama at Birmingham
010033
10/29/2003 AL
Health System, 500 22nd Street S,
Birmingham, Alabama.
University of Colorado Hospital, 4200
060024
11/06/2003 CO
9th & Colorado Campus,
E. Ninth Avenue, Denver, Colorado.
Joint Commission
Certified on 07/23/ 2008.
The University of Chicago Hospitals
140088
02/25/2004 IL and Health System, 5841 South
Maryland Avenue, Chicago, Illinois.
University of Iowa Hospitals and
160058
11/12/2003 IA
Clinics, 200 Hawkins Drive, Iowa
City, Iowa.
University of Maryland Medical
210002
11/12/2003 MD
Center, 22 S. Greene Street,
Baltimore, Maryland.
University of Michigan Health System,
230046
10/27/2003 MI
Joint Commission 1500 E. Medical Center Drive, Ann
Certified on 03/28/
Arbor, Michigan.
2008.
University of North Carolina
340061
05/05/2004 NC
Hospitals, 101 Manning Drive, Chapel
Hill, North Carolina.
University of Utah Hospital, 50 N
460009
12/22/2003 UT
Medical Drive, Salt Lake City, Utah.
University of Virginia Health System,
490009
01/12/2004 VA 1215 Lee Street, Charlottesville,
Virginia.
University of Washington Medical
500008
01/15/2004 WA
Center, 1959 NE Pacific Street,
Seattle, Washington.
University of Wisconsin Hospitals and
520098
12/03/2003 WI
Clinics, 600 Highland Avenue,
Madison, Wisconsin.
USC University Hospital, 1500 San
050696
01/09/2004 CA
Pablo, Los Angeles, California.
UPMC Presbyterian, 200 Lothrop
390164
10/23/2003 PA
Joint Commission
Street, Pittsburgh, Pennsylvania.
Certified on 06/11/ 2008.
Virginia Commonwealth University
490032
04/08/2004 VA
Medical College of
Medical Center, 401 North 12th
Virginia Hospitals.
Street, Richmond, Virginia.
Vanderbilt University Medical Center,
440039
10/28/2003 TN 1161 21st Avenue S, Nashville,
Tennessee.
Ochsner Clinic Foundation, 1514
190036
06/29/2004 LA
Jefferson Highway, New Orleans,
Louisiana.
Baylor University Medical Center,
N/A
10/04/2007 TX
Joint Commission 3500 Gaston Avenue, Dallas, TX.
Certified on 10/04/ 2007.
The University of Michigan Hospitals
230046
03/28/2008 MI
Joint Commission and Health Centers, 1500 East
Certified on 03/28/
Medical Center Drive, Ann Arbor, MI.
2008.
Saint Mary's Hospital, 1216 Southwest
N/A
02/27/2008 MN
Joint Commission
Second Street, Rochester, MN.
Certified on 02/27/ 2008.
Allegheny General Hospital, 320 East
N/A
03/08/2008 PA
North Avenue, Pittsburgh, PA.
Washington Hospital Center, 110
09-0011
04/23/2008 DC
Joint Commission
Irving Street, NW, Washington, DC.
Certified on 04/23/ 2008.
Page 37129
Integris Baptist Medical Center, 3300
1831103654
08/13/2008 OK
Joint Commission
Northwest Expressway, Oklahoma City,
Certified on 08/13/08.
OK.
Mayo Clinic Hospital, 5777 East Mayo
030103
02/27/2009 AZ
Joint Commission
Boulevard, Phoenix, AZ.
Certified on 02/27/09.
Northwestern Memorial Hospital, 251
140281
03/17/2009 IL
Joint Commission
E. Huron Street, Chicago, IL.
Certified on 03/17/09.
Lancaster General Hospital, 555 North
390100
05/20/2009 PA
Joint Commission
Duke Street, Lancaster, PA.
certified on 05/20/09.
Hartford Hospital, 80 Seymour Street,
070025
05/29/2009 CT
Joint Commission
Hartford, CT.
certified on 05/29/09.
Morristown Memorial Hospital, 100
310015
06/17/09 NJ
Joint Commission
Madison Avenue, Morristown, NJ.
certified on 6/17/09.
Thomas Jefferson University Hospital,
390174
08/05/09 PA
Joint Commission 111 South 11th Street, Philadelphia,
certified on 8/5/09.
PA.
Emory University Hospital, 1364
110010
08/19/09 GA
Joint Commission
Clifton Road, Atlanta, GA.
certified on 8/19/09.
Maine Medical Center, 22 Bramhall
200009
02/03/09 ME
Joint Commission
Street, Portland, ME.
certified on 02/03/09.
University of Kentucky Health Care-- ..............
02/11/09 KY
Chandler Hospital, 800 Rose Street,
Lexington, KY.
Sutter Memorial Hospital, 5151 F
050108
10/21/09 CA
Joint Commission
Street, Sacramento, California.
Certified on 10/21/09.
Baptist Health Medical Center--Little
040114
12/02/09 AR
Joint Commission
Rock, 9601 Interstate 630, Exit 7,
Certified on 12/02/09.
Little Rock, Arizona.
Westchester Medical Center, 100 Woods
330234
01/05/10 NY
Joint Commission
Road, Valhalla, New York.
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,
N/A TEXAS..................... NETT
Texas.
Brigham and Women's Hospital, Boston,
N/A MASSACHUSETTS............. NETT
MA.
Cedars-Sinai Medical Center, Los
N/A CALIFORNIA................ NETT
Angeles, CA.
Chapman Medical Center, Orange, CA.....
N/A CALIFORNIA................ NETT
Cleveland Clinic Foundation, Cleveland,
N/A OHIO...................... NETT
OH.
Columbia University, New York, NY......
N/A NEW YORK.................. NETT
Duke University Medical Center, Durham,
N/A NORTH CAROLINA............ NETT
NC.
Johns Hopkins Hospital, Baltimore, MD..
N/A MARYLAND.................. NETT
Kaiser Foundation Hospital--Riverside,
09/20/2006 CALIFORNIA................ Joint Commission
Riverside, CA.
Long Island Jewish Medical Center, New
N/A NEW YORK.................. NETT
Hyde Park, NY.
Mayo Clinic, Rochester, MN.............
N/A MINNESOTA................. NETT
Memorial Medical Center, Springfield,
12/13/2006 ILLINOIS.................. Joint Commission
IL.
National Jewish Medical Center, Denver,
N/A COLORADO.................. NETT
CO.
The Ohio State University Hospital,
N/A OHIO...................... Joint Commission
Columbus, OH.
Ohio State University Medical Center,
N/A OHIO...................... NETT
Columbus, OH.
Saint Louis University, Saint Louis, MO
N/A MISSOURI.................. NETT
Temple University Hospital,
08/23/2008 PENNSYLVANIA.............. Joint Commission
Philadelphia, PA.
UCLA Medical Center, Los Angeles, CA...
N/A CALIFORNIA................ NETT
University of California, San Diego,
N/A CALIFORNIA................ NETT
San Diego, CA.
University of Maryland Medical Center,
N/A MARYLAND.................. NETT
Baltimore, MD.
University of Michigan Medical Center,
N/A MICHIGAN.................. Joint Commission
Ann Arbor, MI.
University of Pennsylvania,
N/A PENNSYLVANIA.............. NETT
Philadelphia, PA.
University of Pittsburgh, Pittsburgh,
N/A PENNSYLVANIA.............. NETT
PA.
University of Washington, Seattle, WA..
N/A WASHINGTON................ NETT
Washington University/Barnes Hospital,
N/A MISSOURI.................. Joint Commission
Saint Louis, MO.
Allegheny General Hospital, Pittsburgh,
04/23/2008 PENNSYLVANIA.............. Joint Commission
PA.
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
Page 37130
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).
Page 37131
GRAPHIC
TIFF OMITTED TN28JN10.334
Page 37132
GRAPHIC
TIFF OMITTED TN28JN10.335
Page 37133
GRAPHIC
TIFF OMITTED TN28JN10.336
Page 37134
GRAPHIC
TIFF OMITTED TN28JN10.337
Page 37135
GRAPHIC
TIFF OMITTED TN28JN10.338
Page 37136
GRAPHIC
TIFF OMITTED TN28JN10.339
Page 37137
GRAPHIC
TIFF OMITTED TN28JN10.340
Page 37138
GRAPHIC
TIFF OMITTED TN28JN10.341
Page 37139
GRAPHIC
TIFF OMITTED TN28JN10.342
Page 37140
GRAPHIC
TIFF OMITTED TN28JN10.343
Page 37141
GRAPHIC
TIFF OMITTED TN28JN10.344
Page 37142
GRAPHIC
TIFF OMITTED TN28JN10.345
Page 37143
GRAPHIC
TIFF OMITTED TN28JN10.346
Page 37144
GRAPHIC
TIFF OMITTED TN28JN10.347
Page 37145
GRAPHIC
TIFF OMITTED TN28JN10.348
Page 37146
GRAPHIC
TIFF OMITTED TN28JN10.349
Page 37147
GRAPHIC
TIFF OMITTED TN28JN10.350
Page 37148
GRAPHIC
TIFF OMITTED TN28JN10.351
Page 37149
GRAPHIC
TIFF OMITTED TN28JN10.352
Page 37150
GRAPHIC
TIFF OMITTED TN28JN10.353
Page 37151
GRAPHIC
TIFF OMITTED TN28JN10.354
Page 37152
GRAPHIC
TIFF OMITTED TN28JN10.355
Page 37153
GRAPHIC
TIFF OMITTED TN28JN10.356
Page 37154
GRAPHIC
TIFF OMITTED TN28JN10.357
Page 37155
GRAPHIC
TIFF OMITTED TN28JN10.358
Page 37156
GRAPHIC
TIFF OMITTED TN28JN10.359
Page 37157
GRAPHIC
TIFF OMITTED TN28JN10.360
Page 37158
GRAPHIC
TIFF OMITTED TN28JN10.361
Page 37159
GRAPHIC
TIFF OMITTED TN28JN10.362
Page 37160
GRAPHIC
TIFF OMITTED TN28JN10.363
Page 37161
GRAPHIC
TIFF OMITTED TN28JN10.364
Page 37162
GRAPHIC
TIFF OMITTED TN28JN10.365
Page 37163
GRAPHIC
TIFF OMITTED TN28JN10.366
Page 37164
GRAPHIC
TIFF OMITTED TN28JN10.367
Page 37165
GRAPHIC
TIFF OMITTED TN28JN10.368
Page 37166
GRAPHIC
TIFF OMITTED TN28JN10.369
Page 37167
GRAPHIC
TIFF OMITTED TN28JN10.370
Page 37168
GRAPHIC
TIFF OMITTED TN28JN10.371
Page 37169
GRAPHIC
TIFF OMITTED TN28JN10.372
Page 37170
GRAPHIC
TIFF OMITTED TN28JN10.373
Page 37171
GRAPHIC
TIFF OMITTED TN28JN10.374
Page 37172
GRAPHIC
TIFF OMITTED TN28JN10.375
Page 37173
GRAPHIC
TIFF OMITTED TN28JN10.376
Page 37174
GRAPHIC
TIFF OMITTED TN28JN10.377
Page 37175
GRAPHIC
TIFF OMITTED TN28JN10.378
Page 37176
GRAPHIC
TIFF OMITTED TN28JN10.379
Page 37177
GRAPHIC
TIFF OMITTED TN28JN10.380
Page 37178
GRAPHIC
TIFF OMITTED TN28JN10.381
Page 37179
GRAPHIC
TIFF OMITTED TN28JN10.382
Page 37180
GRAPHIC
TIFF OMITTED TN28JN10.383
Page 37181
GRAPHIC
TIFF OMITTED TN28JN10.384
Page 37182
GRAPHIC
TIFF OMITTED TN28JN10.385
Page 37183
GRAPHIC
TIFF OMITTED TN28JN10.386
Page 37184
GRAPHIC
TIFF OMITTED TN28JN10.387
Page 37185
GRAPHIC
TIFF OMITTED TN28JN10.388
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............ HW13029................
06/07/2006 CA........... Early and Long-
Dr. Daniel Silverman. 10833 Le Conte Avenue..........
Term Value of
Los Angeles, CA 90095..........
Imaging Brain
Metabolism.
Santa Monica-UCLA Medical
W11817A................
01/12/2007 CA........... N/A............... N/A.
Center. 1245 16th Street...............
Suite 105......................
Santa Monica, CA 90404.........
University of Buffalo.......... 14414A.................
03/12/2007 NY........... Metabolic Cerebral Dr. Daniel Silverman. 3435 Main Street...............
Imaging in
Buffalo, NY 14214..............
Incipient
Dementia (MCI-ID).
Center for Alzheimer's Care,
460009.................
02/17/2009 UT........... Metabolic Cerebral Norman Foster, M.D.
Imaging and Research
Imaging in
(University of Utah).
Incipient 650 Komas Drive................
Dementia (MCI-ID).
Suite 106-A....................
Salt Lake City, UT 84108.......
Medical University of South
1073605879.............
02/17/2009 SC........... N/A............... Kenneth Spicer.
Carolina. 169 Ashley Avenue..............
PO Box 250322..................
Charleston, SC 29425...........
Cedars-Sinai Medical Center.... 951644600..............
10/09/2009 CA........... ``Early and Long- Dr. Alan Waxman. 8700 Beverly Boulevard.........
term Value of
Nuc Suite 1239.................
Imaging Brain
Los Angeles, CA 90048..........
Metabolism''.
FR Doc. 2010-15257 Filed 6-25-10; 8:45 am
BILLING CODE 4120-01-P
