[Federal Register Volume 73, Number 188 (Friday, September 26, 2008)]
[Notices]
[Pages 55902-56323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-21594]
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Part II
Book 2 of 2 Books
55901-56446
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-
April Through June 2008; Notice
Federal Register / Vol. 73, No. 188 / Friday, September 26, 2008 /
Notice
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-9047-N]
Medicare and Medicaid Programs; Quarterly Listing of Program
Issuances--April Through June 2008
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 April 2008 through June 2008, 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 Gwendolyn Johnson, 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) 786-6954.
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
Gwendolyn Johnson, 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) 786-6954.
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
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must meet our standards in order to receive coverage for bariatric
surgery procedures.
Addendum XVI includes a listing of Medicare-approved
clinical trials for fluorodeoxyglucose positron emission tomography
(FDG-PET) for dementia and neurodegenerative diseases.
III. How To Obtain Listed Material
A. Manuals
Those wishing to subscribe to program manuals should contact either
the Government Printing Office (GPO) or the National Technical
Information Service (NTIS) at the following addresses:
Superintendent of Documents, Government Printing Office, ATTN: New
Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954, Telephone (202)
512-1800, Fax number (202) 512-2250 (for credit card orders); or
National Technical Information Service, Department of Commerce, 5825
Port Royal Road, Springfield, VA 22161, Telephone (703) 487-4630.
In addition, individual manual transmittals and Program Memoranda
listed in this notice can be purchased from NTIS. Interested parties
should identify the transmittal(s) they want. GPO or NTIS can give
complete details on how to obtain the publications they sell.
Additionally, most manuals are available at the following Internet
address: http://cms.hhs.gov/manuals/default.asp.
B. Regulations and Notices
Regulations and notices are published in the daily Federal
Register. Interested individuals may purchase individual copies or
subscribe to the Federal Register by contacting the GPO at the address
given above. When ordering individual copies, it is necessary to cite
either the date of publication or the volume number and page number.
The Federal Register is also available on 24x microfiche and as an
online database through GPO Access. The online database is updated by 6
a.m. each day the Federal Register is published. The database includes
both text and graphics from Volume 59, Number 1 (January 2, 1994)
forward. Free public access is available on a Wide Area Information
Server (WAIS) through the Internet and via asynchronous dial-in.
Internet users can access the database by using the World Wide Web; the
Superintendent of Documents home page address is http://www.gpoaccess.gov/fr/index.html, by using local WAIS client software,
or by telnet to swais.gpoaccess.gov, then log in as guest (no password
required). 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 ``Erythropoiesis
Stimulating Agents in Cancer and Related Neoplastic Conditions,'' use
CMS-Pub. 100-03, Transmittal No. 80.
(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: September 8, 2008.
Jacquelyn Y. White,
Director, Office of Strategic Operations and Regulatory Affairs.
BILLING CODE 4120-01-P
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[FR Doc. E8-21594 Filed 9-25-08; 8:45 am]
BILLING CODE 4120-01-C