[Federal Register Volume 75, Number 242 (Friday, December 17, 2010)]
[Notices]
[Pages 79174-79259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31543]



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Part III





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 
Issuances--July Through September 2010; Notice

Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / 
Notices

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9062-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--July Through September 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 July through September 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 tomography 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 
Medicaid substantive and interpretive regulations (proposed and final) 
published during this 3-month timeframe.

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 Terri Plumb, 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) 786-4481.
    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 Eulanda Grigg, Office 
of Strategic Operations and Regulatory Affairs, Regulations Development 
and Issuances Group, Centers for Medicare & Medicaid Services, C5-11-
16, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call 
(410) 786-7202.
    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 
Annette Brewer, Office of Strategic Operations and Regulatory Affairs, 
Regulations Development Group, Centers for Medicare & Medicaid 
Services, C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850, 
or you can call (410) 786-6580.

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 the following: (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, national coverage determinations (NCD), and FDA-approved 
investigational device exemptions (IDE) 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:
    <bullet> Addendum I lists the publication dates of the most recent 
quarterly listings of program issuances.
    <bullet> Addendum II identifies previous Federal Register documents 
that contain a description of all previously published CMS Medicare and 
Medicaid manuals and memoranda.
    <bullet> 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.
    <bullet> 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 following:
     ++ Date published;
     ++ Federal Register citation;
     ++ Parts of the Code of Federal Regulations (CFR) that have 
changed (if applicable);
     ++ Agency file code number; and
     ++ Title of the regulation.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> Addendum XIII includes a listing of Medicare-approved 
facilities 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.
    <bullet> 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.

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    <bullet> 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 must 
meet our standards in order to receive coverage for bariatric surgery 
procedures.
    <bullet> 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. CMS Rulings 
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. On occasion, we publish 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://www.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:
    <bullet> Titles XI, XVIII, and XIX of the Act.
    <bullet> CMS-related regulations.
    <bullet> CMS manuals and monthly revisions.
    <bullet> 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 National Coverage Determination publication titled 
``Positron Emission Tomography (FDG PET) for Initial Treatment Strategy 
(PI) in Solid Tumors and Myeloma,'' use CMS-Pub. 100-03, Transmittal 
No. 124.

    Authority: (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: December 10, 2010.
Jacquelyn Y. White,
Director, Office of Strategic Operations and Regulatory Affairs.
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[FR Doc. 2010-31543 Filed 12-16-10; 8:45 am]
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