Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2010, 36786-37185 [2010-15257]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 75, Number 123 (Monday, June 28, 2010)]
[Notices]
[Pages 36786-37185]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15257]



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Part II

Book 2 of 2 Books

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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

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tomography for dementia trials listed in Addendum XVI may be addressed 
to Stuart Caplan, RN, MAS, Office of Clinical Standards and Quality, 
Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security 
Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-8564.
    Questions concerning all other information may be addressed to 
Kathleen Smith, Office of Strategic Operations and Regulatory Affairs, 
Regulations Development Group, Centers for Medicare & Medicaid 
Services, C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850, 
or you can call (410) 786-0626.

SUPPLEMENTARY INFORMATION:

I. Program Issuances

    The Centers for Medicare & Medicaid Services (CMS) is responsible 
for administering the Medicare and Medicaid programs. These programs 
pay for health care and related services for 39 million Medicare 
beneficiaries and 35 million Medicaid recipients. Administration of the 
two programs involves (1) furnishing information to Medicare 
beneficiaries and Medicaid recipients, health care providers, and the 
public and (2) maintaining effective communications with regional 
offices, State governments, State Medicaid agencies, State survey 
agencies, various providers of health care, all Medicare contractors 
that process claims and pay bills, and others. To implement the various 
statutes on which the programs are based, we issue regulations under 
the authority granted to the Secretary of the Department of Health and 
Human Services under sections 1102, 1871, 1902, and related provisions 
of the Social Security Act (the Act). We also issue various manuals, 
memoranda, and statements necessary to administer the programs 
efficiently.
    Section 1871(c)(1) of the Act requires that we publish a list of 
all Medicare manual instructions, interpretive rules, statements of 
policy, and guidelines of general applicability not issued as 
regulations at least every 3 months in the Federal Register. We 
published our first notice June 9, 1988 (53 FR 21730). Although we are 
not mandated to do so by statute, for the sake of completeness of the 
listing of operational and policy statements, and to foster more open 
and transparent collaboration, we are continuing our practice of 
including Medicare substantive and interpretive regulations (proposed 
and final) published during the respective 3-month time frame.

II. How To Use the Addenda

    This notice is organized so that a reader may review the subjects 
of manual issuances, memoranda, substantive and interpretive 
regulations, NCDs, and FDA-approved IDEs published during the subject 
quarter to determine whether any are of particular interest. We expect 
this notice to be used in concert with previously published notices. 
Those unfamiliar with a description of our Medicare manuals may wish to 
review Table I of our first three notices (53 FR 21730, 53 FR 36891, 
and 53 FR 50577) published in 1988, and the notice published March 31, 
1993 (58 FR 16837). Those desiring information on the Medicare NCD 
Manual (NCDM, formerly the Medicare Coverage Issues Manual (CIM)) may 
wish to review the August 21, 1989, publication (54 FR 34555). Those 
interested in the revised process used in making NCDs under the 
Medicare program may review the September 26, 2003, publication (68 FR 
55634).
    To aid the reader, we have organized and divided this current 
listing into 11 addenda:
     Addendum I lists the publication dates of the most recent 
quarterly listings of program issuances.
     Addendum II identifies previous Federal Register documents 
that contain a description of all previously published CMS Medicare and 
Medicaid manuals and memoranda.
     Addendum III lists a unique CMS transmittal number for 
each instruction in our manuals or Program Memoranda and its subject 
matter. A transmittal may consist of a single or multiple 
instruction(s). Often, it is necessary to use information in a 
transmittal in conjunction with information currently in the manuals.
     Addendum IV lists all substantive and interpretive 
Medicare and Medicaid regulations and general notices published in the 
Federal Register during the quarter covered by this notice. For each 
item, we list the--
    [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: https://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 https://www.gpoaccess.gov/fr/, 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 https://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 https://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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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.
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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 https://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......................

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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:

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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 https://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 
https://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 https://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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