Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2011 and Proposal for Future Notices, 48564-48692 [2011-19954]

Agencies

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

[Federal Register Volume 76, Number 152 (Monday, August 8, 2011)]
[Notices]
[Pages 48564-48692]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19954]



[[Page 48563]]

Vol. 76

Monday,

No. 152

August 8, 2011

Part IV





Department of Health and Human Services





-----------------------------------------------------------------------





 Centers for Medicare and Medicaid Services





-----------------------------------------------------------------------





 Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances-January Through March 2011 and Proposal for Future Notices; 
Notice

Federal Register / Vol. 76 , No. 152 / Monday, August 8, 2011 / 
Notices

[[Page 48564]]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9066-NC]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--January Through March 2011 and Proposal for Future Notices

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice with comment period.

-----------------------------------------------------------------------

SUMMARY: This quarterly notice lists CMS manual instructions, 
substantive and interpretive regulations, and other Federal Register 
notices that were published from January through March 2011, relating 
to the Medicare and Medicaid programs and other programs administered 
by CMS. It also solicits comments on a process that CMS is considering 
to provide current up-to-date information in a Web friendly format. We 
are soliciting feedback on options that would improve accessibility and 
be less burdensome to beneficiaries, providers, and suppliers.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on September 7, 
2011.

ADDRESSES: In commenting, please refer to file code CMS-9066-NC. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    1. Electronically. You may submit electronic comments on this 
regulation to https://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address only: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-9066-NC, P.O. Box 8012, 
Baltimore, MD 21244-1850.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address only: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-9066-NC, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. Alternatively, you may deliver (by hand or 
courier) your written comments only to the following address prior to 
the close of the comment period: Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
please call telephone number (410) 786-7195 in advance to schedule your 
arrival with one of our staff members.
    Comments erroneously mailed to the address indicated as appropriate 
for hand or courier delivery may be delayed and received after the 
comment period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following Web 
site as soon as possible after they have been received: https://www.regulations .gov. Follow the search instructions on that Web site 
to view public comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, at the headquarters of the 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 
a.m. to 4 p.m. To schedule an appointment to view public comments, 
phone 1-800-743-3951.

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 each of the addenda.

------------------------------------------------------------------------
             Addenda                    Contact          Phone number
------------------------------------------------------------------------
I CMS Manual Instructions.......  Ismael Torres.....  (410) 786-1864
II Regulation Documents           Terri Plumb.......  (410) 786-4481
 Published in the Federal
 Register.
III CMS Rulings.................  Tiffany Lafferty..  (410)786-7548
IV Medicare National Coverage     Wanda Belle.......  (410) 786-7491
 Determinations.
V FDA-Approved Category B IDEs..  John Manlove......  (410) 786-6877
VI Collections of Information...  Mitch Bryman......  (410) 786-5258
VII Medicare-Approved Carotid     Sarah J. McClain..  (410) 786-2294
 Stent Facilities.
VIII American College of          JoAnna Baldwin, MS  (410) 786-7205
 Cardiology-National
 Cardiovascular Data Registry
 Sites.
IX Medicare's Active Coverage-    Lori Ashby........  (410) 786-6322
 Related Guidance Documents.
X One-time Notices Regarding      Lori Ashby........  (410) 786-6322
 National Coverage Provisions.
XI National Oncologic Positron    Stuart Caplan, RN,  (410) 786-8564
 Emission Tomography Registry      MAS.
 Sites.
XII Medicare-Approved             JoAnna Baldwin, MS  (410) 786-7205
 Ventricular Assist Device
 (Destination Therapy)
 Facilities.
XIII Medicare-Approved Lung       JoAnna Baldwin, MS  (410) 786-7205
 Volume Reduction Surgery
 Facilities.
XIV Medicare-Approved Bariatric   Kate Tillman, RN,   (410) 786-9252
 Surgery Facilities.               MAS.
XV Fluorodeoxyglucose Positron    Stuart Caplan, RN,  (410) 786-8564
 Emission Tomography for           MAS.
 Dementia Trials.
All Other Information...........  Annette Brewer....  (410) 786-6580
------------------------------------------------------------------------

Background

    Among other things, the Centers for Medicare & Medicaid Services 
(CMS) is responsible for administering the Medicare and Medicaid 
programs and coordination and oversight of private health insurance. 
Administration and oversight of these programs involves the following: 
(1) Furnishing information to Medicare and Medicaid beneficiaries, 
health care providers, and the public; and (2) maintaining effective 
communications with CMS regional offices, State governments, State 
Medicaid agencies, State survey

[[Page 48565]]

agencies, various providers of health care, all Medicare contractors 
that process claims and pay bills, National Association of Insurance 
Commissioners (NAIC), health insurers, and other stakeholders. 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) and 
Public Health Service Act. We also issue various manuals, memoranda, 
and statements necessary to administer and oversee the programs 
efficiently.
    Section 1871(c) 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 have been announcing 
each quarter the most current and relevant information; however, many 
of the quarterly notices simply duplicate the information that was 
previously published, since there often are no new relevant updates in 
some categories for the quarter. While we plan to publish the quarterly 
notice required by section 1871(c) of the Act, we are proposing steps 
to avoid republishing duplicative information that is available to the 
public elsewhere. Moreover, we plan to use our Web site to provide 
complete and timely information with respect to certain types of 
Medicare providers for specific services. We believe that the Web site 
offers a more convenient tool for the public to find the full list of 
qualified providers for these specific services and offers more 
flexibility and ``real time''accessibility to the public.
    Since the publication of our first notice on June 9, 1988, 
technology has advanced, and the information provided in this notice is 
now available in more efficient, economical, and accessible ways to 
meet the requirement for publication set forth in the statute. Starting 
with the next quarterly notice, which will publish in September 2011, 
we propose to provide only the specific updates that have occurred in 
the 3-month period along with a hyperlink to the full listing that is 
available on the CMS Web site or the appropriate data registries that 
are used as our resources. This information is the most current up-to-
date information, and will be available earlier than we publish our 
quarterly notice. Currently, there is a 3-month lapse between the 
information available on the Web site and information covered by this 
quarterly notice. The Web site list provides more timely access for 
beneficiaries, providers, and suppliers. Also, many of the Web sites 
have listservs; that is, the public can subscribe and receive immediate 
notification of any updates to the Web site. These listservs avoid the 
need to check the Web site, as notification of updates is automatic and 
sent to the subscriber as they occur.
    If assessing a Web site proves to be difficult, the contact person 
listed can provide information. We are soliciting comments as to 
whether this approach poses a problem to those who access the 
information set out in this notice. In addition, we are soliciting 
comments on alternative formats to provide this information to the 
public. For example, we could publish a notice that only provides Web 
links to these addenda, or we could create a CMS Quarterly Issuance Web 
page that provides all of the addenda. We welcome comments and any 
additional information as to whether these alternative processes would 
improve accessibility to information or pose an unintended burden to 
beneficiaries, providers, and suppliers.
    We believe this approach is in alignment with CMS' commitment to 
the general principles of the President's Executive Order 13563 
released January 2011entitled ``Improving Regulation and Regulatory 
Review,'' which promotes modifying and streamlining an agency's 
regulatory program to be more effective in achieving regulatory 
objectives. Section 6 of Executive Order 13563 requires agencies to 
identify regulations that may be ``outmoded, ineffective, insufficient, 
or excessively burdensome, and to modify, streamline, expand or repeal 
them in accordance with what has been learned.'' This approach is also 
in alignment with the President's Open Government and Transparency 
Initiative that establishes a system of transparency, public 
participation, and collaboration.

How to Use the Notice

    This notice is organized so that a reader may access the subjects 
published during the quarter covered by the notice 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 should view the manuals at https://www.cms.gov/manuals.
    To aid the reader, we have organized and divided this current 
listing into 15 addenda.

Addendum I: Medicare and Medicaid Manual Instructions,
Addendum II: Regulation Documents Published in the Federal Register,
Addendum III: CMS Rulings,
Addendum IV: National Coverage Determinations,
Addendum V: FDA-Approved Category B IDEs,
Addendum VI: Approval Numbers for the Collections of Information,
Addendum VII: Medicare-Approved Carotid Stent Facilities,
Addendum VIII: American College of Cardiology's National 
Cardiovascular Data Registry Sites,
Addendum IX: Active CMS Coverage-Related Guidance Documents,
Addendum X: Special One-Time Notices Regarding National Coverage 
Provisions,
Addendum XI: National Oncologic Positron Emission Tomography 
Registry (NOPR) Sites,
Addendum XII: Medicare-Approved Ventricular Assist Device 
(Destination Therapy) Facilities,
Addendum XIII: Lung Volume Reduction Surgery,
Addendum XIV: Medicare-Approved Bariatric Surgery Facilities,
Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases 
Clinical Trials.

    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: August 2, 2011.
Jacquelyn Y. White,
Director, Office of Strategic Operations and Regulatory Affairs.

Publication Dates for the Previous Four Quarterly Notices

    We publish this notice at the end of each quarter reflecting 
information released by CMS during the previous quarter. The 
publication dates of the previous four Quarterly Listing of Program 
Issuances notices are: June 28, 2010 (75 FR 36786), September 24, 2010 
(75 FR 58790), December 17, 2010 (75 FR 79174), and March 31, 2011 (76 
FR 17873).
    For the purposes of this quarterly notice, we are providing a 
complete listing in each addendum for the ending date of the period 
covered by this notice. Based on our proposal for future quarterly 
notices, we would provide only the specific updates that have occurred 
in the three-month period along with a hyperlink to the Web site to 
access this information and a contact person for questions or 
additional information.

Addendum I: Medicare and Medicaid Manual Instructions (January Through 
March 2011)

    The CMS Manual System is used by CMS program components, partners, 
providers, contractors, Medicare

[[Page 48566]]

Advantage organizations, and State Survey Agencies to administer CMS 
programs. It offers day-to-day operating instructions, policies, and 
procedures based on statutes and regulations, guidelines, models, and 
directives. In 2003, we transformed the CMS Program Manuals into a Web 
user-friendly presentation and renamed it the CMS Online Manual System.

How To Obtain Manuals

    The Internet-only Manuals (IOMs) are a replica of the Agency's 
official record copy. Paper-based manuals are CMS manuals that were 
officially released in hardcopy. The majority of these manuals were 
transferred into the Internet-only manual (IOM) or retired. Pub 15-1, 
Pub 15-2 and Pub 45 are exceptions to this rule and are still active 
paper-based manuals. The remaining paper-based manuals are for 
reference purposes only. If you notice policy contained in the paper-
based manuals that was not transferred to the IOM, send a message via 
the CMS Feedback tool.
    Those wishing to subscribe to old versions of CMS manuals should 
contact the National Technical Information Service, Department of 
Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone (703-605-
6050). You can download copies of the listed material free of charge 
at: https://cms.gov/manuals.

How To Review Transmittals or Program Memoranda

    Those wishing to review transmittals and program memoranda can 
access this information 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. This information is available at https://www.gpo.gov/libraries/.
    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.
    CMS publication and transmittal numbers are shown in the listing 
entitled Medicare and Medicaid Manual Instructions. To help FDLs locate 
the materials, use the CMS publication and transmittal numbers. For 
example, to find the Medicare National Coverage Determination 
publication titled Screening for the Human Immunodeficiency Virus (HIV) 
Infection Screening for the Human Immunodeficiency Virus (HIV) 
Infection--use CMS-Pub. 100-03, Transmittal No. 131.
    Addendum I lists a unique CMS transmittal number for each 
instruction in our manuals or program memoranda and its subject number. 
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 manual.
    For the purposes of this quarterly notice, we list below all the 
manuals, subjects, publication numbers, and the corresponding 
transmittal numbers for the ending date of the period covered by this 
notice. Based on our proposal for future quarterly notices, we would 
continue to provide only the specific updates to the list of manual 
instructions that have occurred in the three-month period along with a 
hyperlink to the Web site to access this information and a contact 
person for questions or additional information.
    This information is available on our Web site at https://
www.cms.gov/Manuals. For questions or additional information, contact 
Ismael Torres (410-786-1864).
BILLING CODE 4120-01-P

[[Page 48567]]

[GRAPHIC] [TIFF OMITTED] TN08AU11.037


[[Page 48568]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.038


[[Page 48569]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.039


[[Page 48570]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.040


[[Page 48571]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.041

BILLING CODE 4120-01-C

Addendum II: Regulation Documents Published in the Federal Register 
(January through March 2011)

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 GPO at https://www.gpo.gov/fdsys. 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 available 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) through the present date and 
can be accessed at https://www.gpoaccess.gov/fr/. The 
following Web site https://www.archives.gov/federal-register/ provides 
information on how to access electronic editions, printed editions, and 
reference copies.
    Addendum II lists all substantive and interpretive Medicare and 
Medicaid regulations and general notices published in the Federal 
Register during the quarter covered by this notice.
BILLING CODE 4120-01-P

[[Page 48572]]

[GRAPHIC] [TIFF OMITTED] TN08AU11.042

BILLING CODE 4120-01-C
    For the purposes of this quarterly notice, we list dates published, 
the Federal Register citations, parts of the Code of Federal 
Regulations (CFR) that have changed (if applicable), agency file codes, 
and titles of the regulations for the ending date of the period covered 
by this notice. Based on our proposal for future quarterly notices, we 
would discontinue publishing the list of all substantive and 
interpretive Medicare and Medicaid regulations and general notices 
published in the Federal Register. We would continue to provide the 
hyperlink to the Web site to access this information and a contact 
person for questions or additional information.

[[Page 48573]]

    This information is available on our Web site at: https://www.cms.gov/quarterlyproviderupdates/downloads/Regs-1Q11QPU.pdf.
    For questions or additional information, contact Terri Plumb (410-
786-4481).

Addendum III: CMS Rulings

    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.
    The rulings can be accessed at  https://www.cms.gov/Rulings/CMSR/list.asp#TopOfPage.
    For questions or additional information, contact Tiffany Lafferty 
(410-786-7548).

Addendum IV: Medicare National Coverage Determinations (January through 
March 2011)

    Addendum IV includes completed national coverage determinations 
(NCDs), or reconsiderations of completed NCDs, from the quarter covered 
by this notice. Completed decisions are identified by the section of 
the National Coverage Determination Manual (NCDM) in which the decision 
appears, the title, the date the publication was issued, and the 
effective date of the decision.
    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 the Medicare Program (title XVIII of the 
Act), but does not include a determination of the code, if any, that is 
assigned to a particular covered item or service, or payment 
determination for a particular covered item or service. The entries 
below include information concerning completed decisions as well as 
sections on program and decision memoranda, which also announce 
decisions or, in some cases, explain why it was not appropriate to 
issue an NCD. Information on completed decisions as well as pending 
decisions has also been posted on the CMS Web site.
[GRAPHIC] [TIFF OMITTED] TN08AU11.043

    Based on our proposal for future quarterly notices, we would 
continue to provide only the specific updates that have occurred in the 
three-month period along with a hyperlink to the Web site to access 
this information and a contact person for questions or additional 
information.
    This information is available on our Web site at: https://www.cms.gov/medicare-coverage-database/.
    For questions or additional information, contact Wanda Belle (410-
786-7491).

Addendum V: FDA-Approved Category B Investigational Device Exemptions 
(IDEs) (January through March 2011)

    Addendum V includes listings of the FDA-approved investigational 
device exemption (IDE) numbers that the FDA assigns. The listings are 
organized according to the categories to which the devices are assigned 
(that is, Category A or Category B), and identified by the IDE number.
    For the purposes of this quarterly notice, we list the Category B 
IDEs as of the ending date of the period covered by this notice. Based 
on our proposal for future quarterly notices, we would continue to 
provide only the specific updates that have occurred in the three-month 
period along with a hyperlink to the Web site to access this 
information and a contact person for questions or additional 
information.
    For questions or additional information, contact John Manlove (410-
786-6877).

[[Page 48574]]

[GRAPHIC] [TIFF OMITTED] TN08AU11.044

Addendum VI: Approval Numbers for Collections of Information (January 
through March 2011)

    Addendum VI 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.
    All approval numbers are available to the public at Reginfo.gov, 
through a computer system that supports the information collection 
review process. Under the review process, approved information 
collection requests are assigned OMB control numbers. A single control 
number may apply to several related information collections.
BILLING CODE 4120-01-P

[[Page 48575]]

[GRAPHIC] [TIFF OMITTED] TN08AU11.045


[[Page 48576]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.046


[[Page 48577]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.047

BILLING CODE 4120-01-C
    For the purposes of this quarterly notice, we list all active 
approval numbers as of the ending date of the period covered by this 
notice. Based on our proposal for future quarterly notices, we would 
discontinue publishing the listing 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. We would continue to provide the hyperlink to the Web site to 
access this information and a contact person for questions or 
additional information.
    This information is available at  https://www.reginfo.gov/public/do/PRAMain.
    For questions or additional information, contact Mitch Bryman (410-
786-5258).

Addendum VII: Medicare-Approved Carotid Stent Facilities, (January 
Through March 2011)

    Addendum VII includes listings of Medicare-approved carotid stent 
facilities. All facilities listed meet CMS standards for performing 
carotid artery stenting for high risk patients.
    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 satements on 
competency. All facilities must at least meet our standards in order to 
receive coverage for carotid artery stenting for high risk patients.
    For the purposes of this quarterly notice, we list all Medicare-
approved carotid stent facilities that meet the CMS standards as of the 
ending date of the period covered by this notice. Based on our proposal 
for future quarterly notices, we would provide only the specific 
updates that have occurred in the three-month period along with a 
hyperlink to the Web site to access this information and a contact 
person for questions or additional information.
    This information is available on our Web site at: https://www.cms.gov/MedicareApprovedFacilitie/CASF/list.asp#TopOfPage. For 
questions or additional information, contact Sarah J. McClain (410-786-
2294).
BILLING CODE 4120-01-P

[[Page 48578]]

[GRAPHIC] [TIFF OMITTED] TN08AU11.048


[[Page 48579]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.049


[[Page 48580]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.050


[[Page 48581]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.051


[[Page 48582]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.052


[[Page 48583]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.053


[[Page 48584]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.054


[[Page 48585]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.055


[[Page 48586]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.056


[[Page 48587]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.057


[[Page 48588]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.058


[[Page 48589]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.059


[[Page 48590]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.060


[[Page 48591]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.061


[[Page 48592]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.062


[[Page 48593]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.063


[[Page 48594]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.064


[[Page 48595]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.065


[[Page 48596]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.066


[[Page 48597]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.067


[[Page 48598]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.068


[[Page 48599]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.069


[[Page 48600]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.070


[[Page 48601]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.071


[[Page 48602]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.072


[[Page 48603]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.073


[[Page 48604]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.074


[[Page 48605]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.075


[[Page 48606]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.076


[[Page 48607]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.077


[[Page 48608]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.078


[[Page 48609]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.079

BILLING CODE 4120-01-C

Addendum VIII: American College of Cardiology's National Cardiovascular 
Data Registry Sites (January Through March 2011)

    Addendum VIII includes a list of the American College of 
Cardiology's National Cardiovascular Data Registry Sites. We cover 
implantable cardioverter defibrillators (ICDs) for certain clinical 
indications, as long as information about the procedures is reported to 
a central registry. Detailed descriptions of the covered indications 
are available in the National Coverage Determination (NCD).
    In January 2005, CMS established the ICD Abstraction Tool through 
the Quality Network Exchange (QNet) as a temporary data collecton 
mechanism. On October 27, 2005, CMS announced that the American College 
of Cardiology's National Cardiovascular Data Registry (ACC-NCDR) ICD 
Registry satisfies the data reporting requirements in the NCD. 
Hospitals needed to transition to the ACC-NCDR ICD Registry by April 
2006.
    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. The 
facilities that have been designated in the quarter covered by this 
notice are listed. The entire list of facilities that participate in 
the ACC-NCDR ICD registry can be found at https://www.ncdr.com/webncdr/common.
    For the purposes of this quarterly notice, we list the Medicare-
approved ICD facilities as of the ending date of the period covered by 
this notice. Based on our proposal for future quarterly notices, we 
would provide only the specific updates that have occurred in the 
three-month period along with a hyperlink to the Web site to access 
this information and a contact person for questions or additional 
information.
    This information is available by accessing our Web site and 
clicking on the link for the American College of Cardiology's National 
Cardiovascular Data Registry at: https://www.ncdr.com/webncdr/common.
    For questions or additional information, contact Joanna Baldwin, MS 
(410-786-7205).
BILLING CODE 4120-01-P

[[Page 48610]]

[GRAPHIC] [TIFF OMITTED] TN08AU11.080


[[Page 48611]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.081


[[Page 48612]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.082


[[Page 48613]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.083


[[Page 48614]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.084


[[Page 48615]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.085


[[Page 48616]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.086


[[Page 48617]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.087


[[Page 48618]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.088


[[Page 48619]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.089


[[Page 48620]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.090


[[Page 48621]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.091


[[Page 48622]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.092


[[Page 48623]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.093


[[Page 48624]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.094


[[Page 48625]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.095


[[Page 48626]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.096


[[Page 48627]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.097


[[Page 48628]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.098


[[Page 48629]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.099


[[Page 48630]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.100


[[Page 48631]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.101


[[Page 48632]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.102


[[Page 48633]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.103


[[Page 48634]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.104


[[Page 48635]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.105


[[Page 48636]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.106

BILLING CODE 4120-01-C

Addendum IX: Active CMS Coverage-Related Guidance Documents (January 
Through March 2011)

    Addendum IX 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 began listing the current versions of our 
guidance documents in each quarterly listings notice.

[[Page 48637]]

    In the September 24, 2004 Federal Register (69 FR 57325), we 
published a notice in which we explained how we would develop coverage-
related guidance documents. These guidance documents are issued 
pursuant to section 1862(l)(1) of the Social Security. 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 IX includes a list of active CMS guidance documents as of 
the ending date of the period covered by this notice.
    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: Factors CMS Considers in Referring Topics to the 
Medicare Coverage Advisory Committee.
    Date of Issuance: December 12, 2006.
    Document Name: National Coverage Determinations with Data 
Collection as a Condition of Coverage: Coverage With Evidence 
Development.
    Date of Issuance: July 12, 2006.
    For the purposes of this quarterly notice, we list the active 
coverage-related guidance documents as of the ending date of the period 
covered by this notice. Based on our proposal for future quarterly 
notices, we would discontinue publishing this addendum unless there was 
an update to the list of guidance documents. We would continue to 
provide the hyperlink to the Web site to access this information and a 
contact person for questions or additional information.
    To obtain full-text copies of these documents, visit the CMS 
Coverage Web site at https://www.cms.gov/mcd/index_list.asp?list_type=mcd_1 and click on the archives link.
    For questions or additional information, contact Lori Ashby (410-
786-6322).

Addendum X: List of Special One-Time Notices Regarding National 
Coverage Provisions (January Through March 2011)

    Addendum X includes a list of special one-time notices regarding 
national coverage provisions. We publish a list of issues that require 
public notification, such as a particular clinical trial or research 
study that qualifies for Medicare coverage.
    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. 
Details surrounding these conditions, however, 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 X 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.
    There were no special one-time notices regarding national coverage 
provisions published in the January through March 2011 quarter.
    For the purposes of this quarterly notice, we provide the 
information that there are no special one-time notices as of the ending 
date of the period covered by this notice. Based on our proposal for 
future quarterly notices, we would discontinue publishing this addendum 
unless there was a circumstance requiring publication of a special one-
time notice. We would continue to provide the hyperlink to the Web site 
to access this information and a contact person for questions or 
additional information.
    This information is available at https://www.cms.hhs.gov/coverage.
    For questions or additional information, contact Lori Ashby (410-
786-6322).

Addendum XI: National Oncologic PET Registry (NOPR) (January Through 
March 2011)

    Addendum XI 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.
    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.
    For the purposes of this quarterly notice, we provide the list of 
facilities that meet CMS's requirements for performing PET scans under 
National Coverage Determination CAG-00181N as of the ending date of the 
period covered by this notice. Based on our proposal for future 
quarterly notices, we would provide only the specific updates that have 
occurred in the three-month period along with a hyperlink to the Web 
site to access this information and a contact person for questions or 
additional information.
    This information is available at https://www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage.
    For questions or additional information, contact Stuart Caplan, RN, 
MAS (410-786-8564).
BILLING CODE 4120-01-P

[[Page 48638]]

[GRAPHIC] [TIFF OMITTED] TN08AU11.107


[[Page 48639]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.108


[[Page 48640]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.109


[[Page 48641]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.110


[[Page 48642]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.111


[[Page 48643]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.112


[[Page 48644]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.113


[[Page 48645]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.114


[[Page 48646]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.115


[[Page 48647]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.116


[[Page 48648]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.117


[[Page 48649]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.118


[[Page 48650]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.119


[[Page 48651]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.120


[[Page 48652]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.121


[[Page 48653]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.122


[[Page 48654]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.123


[[Page 48655]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.124


[[Page 48656]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.125


[[Page 48657]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.126


[[Page 48658]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.127


[[Page 48659]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.128


[[Page 48660]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.129


[[Page 48661]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.130


[[Page 48662]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.131


[[Page 48663]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.132


[[Page 48664]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.133


[[Page 48665]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.134


[[Page 48666]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.135


[[Page 48667]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.136


[[Page 48668]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.137


[[Page 48669]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.138


[[Page 48670]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.139


[[Page 48671]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.140


[[Page 48672]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.141


[[Page 48673]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.142


[[Page 48674]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.143


[[Page 48675]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.144


[[Page 48676]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.145


[[Page 48677]]



Addendum XII: Medicare-Approved Ventricular Assist Device (Destination 
Therapy) Facilities (January Through March 2011)

    Addendum XII 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.
    On October 1, 2003, we issued our decision memorandum on 
ventricular assist devices (VADs) for the clinical indication of 
destination therapy. We determined that VADs 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 VADs implanted as 
destination therapy.
    For the purposes of this quarterly notice, we list all Medicare-
approved facilities that meet our standards as of the ending date of 
the period covered by this notice. Based on our proposal for future 
quarterly notices, we would provide only the specific updates that have 
occurred in the three-month period along with a hyperlink to the Web 
site to access this information and a contact person for questions or 
additional information.
    This information is available on our Web site at https://www.cms.gov/MedicareApprovedFacilitie/VAD/list.asp#TopOfPage.
    For questions or additional information, contact JoAnna Baldwin, MS 
(410-786-7205).
BILLING CODE 4120-01-P

[[Page 48678]]

[GRAPHIC] [TIFF OMITTED] TN08AU11.146


[[Page 48679]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.147


[[Page 48680]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.148

BILLING CODE 4120-01-C

Addendum XIII: Lung Volume Reduction Surgery (LVRS) (January Through 
March 2011)

    Addendum XIII 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 were also eligible to receive 
coverage.
    The following 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 
Commission 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.

[[Page 48681]]

[GRAPHIC] [TIFF OMITTED] TN08AU11.149

    For the purposes of this quarterly notice, we list all Medicare-
approved facilities that meet the CMS standards as of the ending date 
of the period covered by this notice. Based on our proposal for future 
quarterly notices, we would provide only the specific updates that have 
occurred in the three-month period along with a hyperlink to the Web 
site to access this information and a contact person for questions or 
additional information.
    This information is available on our Web site at https://www.cms.gov/MedicareApprovedFacilitie/LVRS/list.asp#TopOfPage.
    For questions or additional information, contact JoAnna Baldwin, MS 
(410-786-7205).

Addendum XIV Medicare-Approved Bariatric Surgery Facilities (January 
Through March 2011)

    Addendum XIV 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.
    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 
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).
    For the purposes of this quarterly notice, we list all Medicare-
approved facilities that meet CMS's minimum facility standards for 
bariatric surgery and have been certified by ACS and/or ASMBS as of the 
ending date of the period covered by this notice. Based on our proposal 
for future quarterly notices, we would provide only the specific 
updates that have occurred in the three-month period along with a 
hyperlink to the Web site to access this information and a contact 
person for questions or additional information.
    This information is available on our Web site at https://www.cms.gov/MedicareApprovedFacilitie/BSF/list.asp#TopOfPage.
    For questions or additional information, contact Kate Tillman, RN, 
MAS (410-786-9252).
BILLING CODE 4120-01-P

[[Page 48682]]

[GRAPHIC] [TIFF OMITTED] TN08AU11.150


[[Page 48683]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.151


[[Page 48684]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.152


[[Page 48685]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.153


[[Page 48686]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.154


[[Page 48687]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.155


[[Page 48688]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.156


[[Page 48689]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.157


[[Page 48690]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.158


[[Page 48691]]


[GRAPHIC] [TIFF OMITTED] TN08AU11.159


[[Page 48692]]


BILLING CODE 4120-01-C

Addendum XV FDG-PET for Dementia and Neurodegenerative Diseases 
Clinical Trials (January Through March 2011)

    Addendum XV includes a listing of Medicare-approved clinical trials 
for fluorodeoxyglucose positron emission tomography (FDG-PET) for 
dementia and neurodegenerative diseases.
    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.
[GRAPHIC] [TIFF OMITTED] TN08AU11.160

    For the purposes of this quarterly notice, we list all Medicare-
approved clinical trials as of the ending date of the period covered by 
this notice. Based on our proposal for future quarterly notices, we 
would discontinue publishing this addendum unless there were additional 
Medicare-approved clinical trials for fluorodeoxyglucose positron 
emission tomography (FDG-PET) for dementia and neurodegenerative 
diseases. We would continue to provide the hyperlink to the Web site to 
access this information and a contact person for questions or 
additional information.
    This information is available on our Web site at https://www.cms.gov/MedicareApprovedFacilitie/PETDT/list.asp#TopOfPage.
    For questions or additional information, contact Stuart Caplan, RN, 
MAS (410-786-8564).

[FR Doc. 2011-19954 Filed 8-5-11; 8:45 am]
BILLING CODE 4120-01-P