[Federal Register Volume 75, Number 123 (Monday, June 28, 2010)]
[Notices]
[Pages 36786-37185]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15257]
[[Page 36785]]
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Part II
Book 2 of 2 Books
Pages 36785-37286
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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Medicare and Medicaid Programs; Quarterly Listing of Program; Notice
Federal Register / Vol. 75, No. 123 / Monday, June 28, 2010 /
Notices
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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.
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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:
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--
[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.
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). 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.
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
[[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
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[GRAPHIC] [TIFF OMITTED] TN28JN10.001
[[Page 36791]]
[GRAPHIC] [TIFF OMITTED] TN28JN10.002
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[GRAPHIC] [TIFF OMITTED] TN28JN10.003
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[GRAPHIC] [TIFF OMITTED] TN28JN10.004
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[GRAPHIC] [TIFF OMITTED] TN28JN10.005
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[GRAPHIC] [TIFF OMITTED] TN28JN10.006
[[Page 36796]]
[GRAPHIC] [TIFF OMITTED] TN28JN10.007
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[GRAPHIC] [TIFF OMITTED] TN28JN10.008
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[GRAPHIC] [TIFF OMITTED] TN28JN10.009
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[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
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FR Vol. 75 42 CFR Parts
Publication date Page No. affected File code Title of regulation
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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.
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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.
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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.......................................
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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
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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=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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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.
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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 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).
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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.
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Facility name Provider No. Date approved State Name of trial Principal investigator
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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''.
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[FR Doc. 2010-15257 Filed 6-25-10; 8:45 am]
BILLING CODE 4120-01-P