Notice: Program Issuances and Coverage Decisions: Quarterly Listing

Friday,
September 28, 2007
Part II
Department of
Health and Human
Services
Centers for Medicare & Medicaid Services
Medicare and Medicaid Programs;

Quarterly Listing of Program Issuances—
April Through June 2007; Notice
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55282 Federal Register / Vol. 72, No. 188 / Friday, September 28, 2007 / Notices
DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: It is Cardiology-National Cardiovascular

HUMAN SERVICES possible that an interested party may Data Registry sites in Addendum IX may
need specific information and not be be addressed to JoAnna Baldwin, MS,
Centers for Medicare & Medicaid able to determine from the listed Office of Clinical Standards and
Services information whether the issuance or Quality, Centers for Medicare &
regulation would fulfill that need. Medicaid Services, C1–09–06, 7500
[CMS–9041–N] Consequently, we are providing contact Security Boulevard, Baltimore, MD
persons to answer general questions 21244–1850, or you can call (410) 786–
Medicare and Medicaid Programs; concerning these items. Copies are not 7205.
Quarterly Listing of Program available through the contact persons. Questions concerning Medicare’s
Issuances—April Through June 2007 (See Section III of this notice for how to active coverage-related guidance
obtain listed material.) documents in Addendum X may be
AGENCY: Centers for Medicare &
Questions concerning CMS manual addressed to Janet Brock, Office of
Medicaid Services (CMS), HHS.
instructions in Addendum III may be Clinical Standards and Quality, Centers
ACTION: Notice. addressed to Timothy Jennings, Office for Medicare & Medicaid Services, C1–
SUMMARY: This notice lists CMS manual
of Strategic Operations and Regulatory 09–06, 7500 Security Boulevard,
instructions, substantive and Affairs, Centers for Medicare & Baltimore, MD 21244–1850, or you can
interpretive regulations, and other Medicaid Services, C4–26–05, 7500 call (410) 786–2700.
Security Boulevard, Baltimore, MD Questions concerning one-time
Federal Register notices that were
21244–1850, or you can call (410) 786– notices regarding national coverage
published from April 2007 through June
2134. provisions in Addendum XI may be
2007, relating to the Medicare and
Questions concerning regulation addressed to Ellie Lund, Office of
Medicaid programs. This notice documents published in the Federal Clinical Standards and Quality, Centers
provides information on national Register in Addendum IV may be for Medicare & Medicaid Services, C1–
coverage determinations (NCDs) addressed to Gwendolyn Johnson, 09–06, 7500 Security Boulevard,
affecting specific medical and health Office of Strategic Operations and Baltimore, MD 21244–1850, or you can
care services under Medicare. Regulatory Affairs, Centers for Medicare call (410) 786–2281.
Additionally, this notice identifies & Medicaid Services, C4–14–03, 7500 Questions concerning National
certain devices with investigational Security Boulevard, Baltimore, MD Oncologic Positron Emission
device exemption (IDE) numbers 21244–1850, or you can call (410) 786– Tomography Registry sites in
approved by the Food and Drug 6954. Addendum XII may be addressed to
Administration (FDA) that potentially Questions concerning Medicare NCDs Stuart Caplan, RN, MAS, Office of
may be covered under Medicare. This in Addendum V may be addressed to Clinical Standards and Quality, Centers
notice also includes listings of all Patricia Brocato-Simons, Office of for Medicare & Medicaid Services, C1–
approval numbers from the Office of Clinical Standards and Quality, Centers 09–06, 7500 Security Boulevard,
Management and Budget for collections for Medicare & Medicaid Services, C1– Baltimore, MD 21244–1850, or you can
of information in CMS regulations and 09–06, 7500 Security Boulevard, call (410) 786–8564.
a list of Medicare-approved carotid stent Baltimore, MD 21244–1850, or you can Questions concerning Medicare-
facilities. Included in this notice is a list call (410) 786–0261. approved ventricular assist device
of the American College of Cardiology’s Questions concerning FDA-approved (destination therapy) facilities in
National Cardiovascular Data registry Category B IDE numbers listed in Addendum XIII may be addressed to
sites, active CMS coverage-related Addendum VI may be addressed to John JoAnna Baldwin, MS, Office of Clinical
guidance documents, and special one- Manlove, Office of Clinical Standards Standards and Quality, Centers for
time notices regarding national coverage and Quality, Centers for Medicare & Medicare & Medicaid Services, C1–09–
provisions. Also included in this notice Medicaid Services, C1–13–04, 7500 06, 7500 Security Boulevard, Baltimore,
is a list of National Oncologic Positron Security Boulevard, Baltimore, MD MD 21244–1850, or you can call (410)
Emissions Tomography Registry sites, a 21244–1850, or you can call (410) 786– 786–7205.
list of Medicare-approved ventricular 6877. Questions concerning Medicare-
assist device (destination therapy) Questions concerning approval approved lung volume reduction
facilities, a list of Medicare-approved numbers for collections of information surgery facilities listed in Addendum
lung volume reduction surgery facilities, in Addendum VII may be addressed to XIV may be addressed to JoAnna
a list of Medicare-approved clinical Melissa Musotto, Office of Strategic Baldwin, MS, Office of Clinical
trials for fluorodeoxyglucose positron Operations and Regulatory Affairs, Standards and Quality, Centers for
emissions tomogrogphy for dementia, Regulations Development and Issuances Medicare & Medicaid Services, C1–09–
and a list of Medicare-approved Group, Centers for Medicare & Medicaid 06, 7500 Security Boulevard, Baltimore,
bariatric surgery facilities. Services, C5–14–03, 7500 Security MD 21244–1850, or you can call (410)
Section 1871(c) of the Social Security Boulevard, Baltimore, MD 21244–1850, 786–7205.
Act requires that we publish a list of or you can call (410) 786–6962. Questions concerning Medicare-
Medicare issuances in the Federal Questions concerning Medicare- approved bariatric surgery facilities
Register at least every 3 months. approved carotid stent facilities in listed in Addendum XV may be
Although we are not mandated to do so Addendum VIII may be addressed to addressed to Kate Tillman, RN, MA,
by statute, for the sake of completeness Sarah J. McClain, Office of Clinical Office of Clinical Standards and
of the listing, and to foster more open Standards and Quality, Centers for Quality, Centers for Medicare &
and transparent collaboration efforts, we Medicare & Medicaid Services, C1–09– Medicaid Services, C1–09–06, 7500
are also including all Medicaid 06, 7500 Security Boulevard, Baltimore, Security Boulevard, Baltimore, MD
issuances and Medicare and Medicaid MD 21244–1850, or you can call (410) 21244–1850, or you can call (410) 786–
substantive and interpretive regulations 786–2994. 9252.
(proposed and final) published during Questions concerning Medicare’s Questions concerning
this 3-month time frame. recognition of the American College of fluorodeoxyglucose positron emission
Federal Register / Vol. 72, No. 188 / Friday, September 28, 2007 / Notices 55283
tomography for dementia trials listed in II. How To Use the Addenda using the IDE numbers the FDA assigns.
Addendum XVI may be addressed to This notice is organized so that a The listings are organized according to
Stuart Caplan, RN, MAS, Office of reader may review the subjects of the categories to which the device
Clinical Standards and Quality, Centers manual issuances, memoranda, numbers are assigned (that is, Category
for Medicare & Medicaid Services, C1– substantive and interpretive regulations, A or Category B), and identified by the
09–06, 7500 Security Boulevard, NCDs, and FDA-approved IDEs IDE number.
Baltimore, MD 21244–1850, or you can published during the subject quarter to • Addendum VII includes listings of
call (410) 786–8564. determine whether any are of particular all approval numbers from the Office of
interest. We expect this notice to be Management and Budget (OMB) for
Questions concerning all other collections of information in CMS
information may be addressed to used in concert with previously
published notices. Those unfamiliar regulations in title 42; title 45,
Gwendolyn Johnson, Office of Strategic subchapter C; and title 20 of the CFR.
Operations and Regulatory Affairs, with a description of our Medicare
• Addendum VIII includes listings of
Regulations Development Group, manuals may wish to review Table I of
our first three notices (53 FR 21730, 53 Medicare-approved carotid stent
Centers for Medicare & Medicaid facilities. All facilities listed meet CMS
Services, C5–14–03, 7500 Security FR 36891, and 53 FR 50577) published
in 1988, and the notice published March standards for performing carotid artery
Boulevard, Baltimore, MD 21244–1850, stenting for high risk patients.
31, 1993 (58 FR 16837). Those desiring
or you can call (410) 786–6954. • Addendum IX includes a list of the
information on the Medicare NCD
American College of Cardiology’s
SUPPLEMENTARY INFORMATION: Manual (NCDM, formerly the Medicare
National Cardiovascular Data registry
Coverage Issues Manual (CIM)) may
I. Program Issuances sites. We cover implantable cardioverter
wish to review the August 21, 1989,
defibrillators (ICDs) for certain
The Centers for Medicare & Medicaid publication (54 FR 34555). Those
indications, as long as information
Services (CMS) is responsible for interested in the revised process used in
about the procedures is reported to a
administering the Medicare and making NCDs under the Medicare
central registry.
Medicaid programs. These programs pay program may review the September 26, • Addendum X includes a list of
for health care and related services for 2003, publication (68 FR 55634). active CMS guidance documents. As
39 million Medicare beneficiaries and To aid the reader, we have organized
required by section 731 of the Medicare
35 million Medicaid recipients. and divided this current listing into 11
Prescription Drug, Improvement, and
Administration of the two programs addenda:
• Addendum I lists the publication Modernization Act of 2003 (MMA) (Pub.
involves (1) furnishing information to L. 108–173, enacted on December 8,
dates of the most recent quarterly
Medicare beneficiaries and Medicaid 2003), we will begin listing the current
listings of program issuances.
recipients, health care providers, and • Addendum II identifies previous versions of our guidance documents in
the public and (2) maintaining effective Federal Register documents that each quarterly listings notice.
communications with regional offices, contain a description of all previously • Addendum XI includes a list of
State governments, State Medicaid published CMS Medicare and Medicaid special one-time notices regarding
agencies, State survey agencies, various manuals and memoranda. national coverage provisions. We are
providers of health care, all Medicare • Addendum III lists a unique CMS publishing a list of issues that require
contractors that process claims and pay transmittal number for each instruction public notification, such as a particular
bills, and others. To implement the in our manuals or Program Memoranda clinical trial or research study that
various statutes on which the programs and its subject matter. A transmittal may qualifies for Medicare coverage.
are based, we issue regulations under consist of a single or multiple • Addendum XII includes a listing of
the authority granted to the Secretary of instruction(s). Often, it is necessary to National Oncologic Positron Emission
the Department of Health and Human use information in a transmittal in Tomography Registry (NOPR) sites. We
Services under sections 1102, 1871, conjunction with information currently cover positron emission tomography
1902, and related provisions of the in the manuals. (PET) scans for particular oncologic
Social Security Act (the Act). We also • Addendum IV lists all substantive indications when they are performed in
issue various manuals, memoranda, and and interpretive Medicare and Medicaid a facility that participates in the NOPR.
statements necessary to administer the regulations and general notices • Addendum XIII includes a listing of
programs efficiently. published in the Federal Register Medicare-approved facilities that
during the quarter covered by this receive coverage for ventricular assist
Section 1871(c)(1) of the Act requires devices used as destination therapy. All
that we publish a list of all Medicare notice. For each item, we list the—
Æ Date published; facilities were required to meet our
manual instructions, interpretive rules, standards in order to receive coverage
Æ Federal Register citation;
statements of policy, and guidelines of for ventricular assist devices implanted
Æ Parts of the Code of Federal
general applicability not issued as Regulations (CFR) that have changed (if as destination therapy.
regulations at least every 3 months in applicable); • Addendum XIV includes a listing of
the Federal Register. We published our Æ Agency file code number; and Medicare-approved facilities that are
first notice June 9, 1988 (53 FR 21730). Æ Title of the regulation. eligible to receive coverage for lung
Although we are not mandated to do so • Addendum V includes completed volume reduction surgery. Until May
by statute, for the sake of completeness NCDs, or reconsiderations of completed 17, 2007, facilities that participated in
of the listing of operational and policy NCDs, from the quarter covered by this the National Emphysema Treatment
statements, and to foster more open and notice. Completed decisions are Trial are also eligible to receive
transparent collaboration, we are identified by the section of the NCDM coverage.

continuing our practice of including in which the decision appears, the title, • Addendum XV includes a listing of
Medicare substantive and interpretive the date the publication was issued, and Medicare-approved facilities that meet
regulations (proposed and final) the effective date of the decision. minimum standards for facilities
published during the respective 3- • Addendum VI includes listings of modeled in part on professional society
month time frame. the FDA-approved IDE categorizations, statements on competency. All facilities
must meet our standards in order to asynchronous dial-in. Internet users can (Interpretive Guidelines) in the State
receive coverage for bariatric surgery access the database by using the World Operations Manual (SOM), as of March
procedures. Wide Web; the Superintendent of 1995, we deleted these appendices from
• Addendum XVI includes a listing of Documents home page address is CD–ROM. We intend to re-visit this
Medicare-approved clinical trials for http://www.gpoaccess.gov/fr/ issue in the near future and, with the
fluorodeoxyglucose positron emission index.html, by using local WAIS client aid of newer technology, we may again
tomography (FDG–PET) for dementia software, or by telnet to be able to include the appendices on
and neurodegenerative diseases. swais.gpoaccess.gov, then log in as guest CD–ROM.
III. How To Obtain Listed Material (no password required). Dial-in users Any cost report forms incorporated in
should use communications software the manuals are included on the CD–
A. Manuals and modem to call (202) 512–1661; type ROM disk as LOTUS files. LOTUS
Those wishing to subscribe to swais, then log in as guest (no password software is needed to view the reports
program manuals should contact either required). once the files have been copied to a
the Government Printing Office (GPO) C. Rulings personal computer disk.
or the National Technical Information
Service (NTIS) at the following We publish rulings on an infrequent IV. How To Review Listed Material
addresses: basis. CMS Rulings are decisions of the
Administrator that serve as precedent Transmittals or Program Memoranda
Superintendent of Documents, final opinions and orders and can be reviewed at a local Federal
Government Printing Office, ATTN: statements of policy and interpretation. Depository Library (FDL). Under the
New Orders, P.O. Box 371954, They provide clarification and FDL program, government publications
Pittsburgh, PA 15250–7954, interpretation of complex or ambiguous are sent to approximately 1,400
Telephone (202) 512–1800, Fax provisions of the law or regulations designated libraries throughout the
number (202) 512–2250 (for credit relating to Medicare, Medicaid, United States. Some FDLs may have
card orders); or Utilization and Quality Control Peer arrangements to transfer material to a
National Technical Information Service, local library not designated as an FDL.
Review, private health insurance, and
Department of Commerce, 5825 Port Contact any library to locate the nearest
related matters. Interested individuals
Royal Road, Springfield, VA 22161, FDL.
can obtain copies from the nearest CMS
Telephone (703) 487–4630.
Regional Office or review them at the In addition, individuals may contact
In addition, individual manual nearest regional depository library. We regional depository libraries that receive
transmittals and Program Memoranda have, on occasion, published rulings in and retain at least one copy of most
listed in this notice can be purchased the Federal Register. Rulings, beginning Federal Government publications, either
from NTIS. Interested parties should with those released in 1995, are in printed or microfilm form, for use by
identify the transmittal(s) they want. available online, through the CMS the general public. These libraries
GPO or NTIS can give complete details Home Page. The Internet address is provide reference services and
on how to obtain the publications they http:cms.hhs.gov/rulings. interlibrary loans; however, they are not
sell. Additionally, most manuals are sales outlets. Individuals may obtain
available at the following Internet D. CMS’s Compact Disk-Read Only
information about the location of the
address: http://cms.hhs.gov/manuals/ Memory (CD–ROM)
nearest regional depository library from
default.asp. Our laws, regulations, and manuals any library. For each CMS publication
B. Regulations and Notices are also available on CD–ROM and may listed in Addendum III, CMS
be purchased from GPO or NTIS on a publication and transmittal numbers are
Regulations and notices are published subscription or single copy basis. The
in the daily Federal Register. Interested shown. To help FDLs locate the
Superintendent of Documents list ID is materials, use the CMS publication and
individuals may purchase individual HCLRM, and the stock number is 717–
copies or subscribe to the Federal transmittal numbers. For example, to
139–00000–3. The following material is find the Medicare Benefit Policy
Register by contacting the GPO at the on the CD–ROM disk:
address given above. When ordering publication titled ‘‘Guidelines for
• Titles XI, XVIII, and XIX of the Act. Payment of Diabetes Self-Management
individual copies, it is necessary to cite • CMS-related regulations. Training,’’ use CMS–Pub. 100–02,
either the date of publication or the • CMS manuals and monthly
volume number and page number. Transmittal No. 72.
revisions.
The Federal Register is also available • CMS program memoranda. (Catalog of Federal Domestic Assistance
on 24x microfiche and as an online The titles of the Compilation of the Program No. 93.773, Medicare—Hospital
database through GPO Access. The Social Security Laws are current as of Insurance, Program No. 93.774, Medicare—
online database is updated by 6 a.m. January 1, 2005. (Updated titles of the Supplementary Medical Insurance Program,
each day the Federal Register is and Program No. 93.714, Medical Assistance
Social Security Laws are available on Program)
published. The database includes both the Internet at http://www.ssa.gov/
text and graphics from Volume 59, OP_Home/ssact/comp-toc.htm.) The Dated: September 14, 2007.
Number 1 (January 2, 1994) forward. remaining portions of CD–ROM are Jacquelyn Y. White,
Free public access is available on a updated on a monthly basis. Director, Office of Strategic Operations and
Wide Area Information Server (WAIS) Because of complaints about the Regulatory Affairs.
through the Internet and via unreadability of the Appendices BILLING CODE 4120–01–P
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EN28SE07.268</GPH>
EN28SE07.269</GPH>
EN28SE07.270</GPH>
EN28SE07.271</GPH>
EN28SE07.272</GPH>
EN28SE07.273</GPH>
EN28SE07.274</GPH>
EN28SE07.275</GPH>
EN28SE07.276</GPH>
EN28SE07.277</GPH>
EN28SE07.278</GPH>
EN28SE07.279</GPH>
EN28SE07.280</GPH>
EN28SE07.281</GPH>
EN28SE07.282</GPH>
EN28SE07.283</GPH>
EN28SE07.284</GPH>
EN28SE07.285</GPH>
EN28SE07.286</GPH>
EN28SE07.287</GPH>
EN28SE07.288</GPH>
EN28SE07.289</GPH>
EN28SE07.290</GPH>
EN28SE07.291</GPH>
EN28SE07.292</GPH>
EN28SE07.293</GPH>
EN28SE07.294</GPH>
EN28SE07.295</GPH>
EN28SE07.296</GPH>
EN28SE07.297</GPH>
EN28SE07.298</GPH>
EN28SE07.299</GPH>
EN28SE07.300</GPH>
EN28SE07.301</GPH>
EN28SE07.302</GPH>
EN28SE07.303</GPH>
EN28SE07.304</GPH>
EN28SE07.305</GPH>
EN28SE07.306</GPH>
EN28SE07.307</GPH>
EN28SE07.308</GPH>
EN28SE07.309</GPH>
EN28SE07.310</GPH>
EN28SE07.312</GPH>
EN28SE07.311</GPH>
EN28SE07.313</GPH>
EN28SE07.314</GPH>
EN28SE07.315</GPH>
EN28SE07.316</GPH>
EN28SE07.317</GPH>
EN28SE07.318</GPH>
EN28SE07.319</GPH>
EN28SE07.320</GPH>
EN28SE07.321</GPH>
EN28SE07.322</GPH>
EN28SE07.323</GPH>
EN28SE07.324</GPH>
EN28SE07.325</GPH>
EN28SE07.326</GPH>
EN28SE07.327</GPH>
EN28SE07.328</GPH>
EN28SE07.329</GPH>
EN28SE07.330</GPH>
EN28SE07.331</GPH>
EN28SE07.332</GPH>
EN28SE07.333</GPH>
EN28SE07.334</GPH>
EN28SE07.335</GPH>
EN28SE07.336</GPH>
EN28SE07.337</GPH>
EN28SE07.338</GPH>
EN28SE07.339</GPH>
EN28SE07.340</GPH>
[FR Doc. E7–18733 Filed 9–27–07; 8:45 am]

BILLING CODE 4120–01–P
EN28SE07.341</GPH>

Notice: Program Issuances and Coverage Decisions: Quarterly Listing

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Notice: Program Issuances and Coverage Decisions: Quarterly Listing

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Friday,

September 28, 2007

Medicare and Medicaid Programs;

DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: It is Cardiology-National Cardiovascular

transparent collaboration, we are identified by the section of the NCDM coverage.

[FR Doc. E7–18733 Filed 9–27–07; 8:45 am]

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