[Federal Register Volume 76, Number 62 (Thursday, March 31, 2011)]
[Notices]
[Pages 17870-17927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7373]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9063-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--October Through December 2010

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

ACTION: Notice.

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SUMMARY: This notice lists CMS manual instructions, substantive and 
interpretive regulations, and other Federal Register notices that were 
published from October through December 2010, relating to the Medicare 
and Medicaid programs.

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.)

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SUPPLEMENTARY INFORMATION:

I. Program Issuances

    Among other things, the Centers for Medicare & Medicaid Services 
(CMS) is responsible for administering the Medicare and Medicaid 
programs, which pay for health care and related services for Medicare 
beneficiaries and Medicaid recipients. Administration of the two 
programs involves the following: (1) Furnishing information to Medicare 
beneficiaries and Medicaid recipients, health care providers, and the 
public; and (2) maintaining effective communications with regional 
offices, State governments, State Medicaid agencies, State survey 
agencies, various providers of health care, all Medicare contractors 
that process claims and pay bills, and others. To implement the various 
statutes on which the programs are based, we issue regulations under 
the authority granted to the Secretary of the Department of Health and 
Human Services under sections 1102, 1871, 1902, and related provisions 
of the Social Security Act (the Act). We also issue various manuals, 
memoranda, and statements necessary to administer the programs 
efficiently.
    The statute 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 
published during the subject quarter to determine whether any are of

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particularinterest. 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 National Coverage Determinations 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 16 addenda:

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

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 GPO at the address 
given above. When ordering individual copies, it is necessary to cite 
either the date of publication or the volume number and page number.
    The Federal Register is also available on 24x microfiche and as an 
online database through GPO Access. The online database is updated by 6 
a.m. each day the Federal Register is published. The database includes 
both text and graphics from Volume 59, Number 1 (January 2, 1994) 
forward. Free public access is available on a Wide Area Information 
Server (WAIS) through the Internet and via asynchronous dial-in. 
Internet users can access the database by using the World Wide Web; the 
Superintendent of Documents home page address is http://www.gpoaccess.gov/fr/index.html, by using local WAIS client software, 
or by telnet to swais.gpoaccess.gov, then log in as guest (no password 
required). Dial-in users should use communications software and modem 
to call (202) 512-1661; type swais, then log in as guest (no password 
required).

C. Rulings

    We publish rulings on an infrequent basis. CMS Rulings are 
decisions of the Administrator that serve as precedent final opinions 
and orders and statements of policy and interpretation. CMS Rulings 
provide clarification and interpretation of complex or ambiguous 
provisions of the law or regulations relating to Medicare, Medicaid, 
Utilization and Quality Control Peer Review, private health insurance, 
and related matters. Interested individuals can obtain copies from the 
nearest CMS Regional Office or review them at the nearest regional 
depository library. On occasion, we publish rulings in the Federal 
Register. Rulings, beginning with those released in 1995, are available 
online, through the CMS Home Page. The Internet address is http://www.cms.hhs.gov/rulings.

D. CMS' Compact Disk-Read Only Memory (CD-ROM)

    Our laws, regulations, and manuals are also available on CD-ROM and 
may be purchased from GPO or NTIS on a subscription or single copy 
basis. The Superintendent of Documents list ID is HCLRM, and the stock 
number is 717-139-00000-3. The following material is on the CD-ROM 
disk:
     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, 2009. (Updated titles of the Social Security 
Laws are available on the Internet at http://ssa.gov/OP_Home/ssact/comp-ssa.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.

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    For each CMS publication listed in Addendum III, CMS publication 
and transmittal numbers are shown. To help FDLs locate the materials, 
use the CMS publication and transmittal numbers. For example, to find 
the Medicare National Coverage Determination publication titled 
Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for 
Myelodysplastic Syndrome (MDS) use CMS-Pub. 100-03, Transmittal No. 
127.
    The complete registry lists for Category B IDE numbers, National 
Cardiovascular Data Registry Sites, Carotid Stent Facilities, approved 
Bariatric Surgery Facilities, National Oncologic PET Registry Sites, 
approved Ventricular Assist Device Facilities, approved Lung Volume 
Reduction Surgery Facilities, and PET AD can be found on the CMS 
coverage Web site at http://www.cms.gov/MedicareApprovedFacilitie/01_Overview.asp#TopOfPage.

    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: March 23, 2011.
Jacquelyn Y. White,
Director, Office of Strategic Operations and Regulatory Affairs.

ADDENDUM I: Publication Dates of the Most Recent Quarterly Listings of 
Program Issuances

    This addendum lists the publication dates of the most recent 
quarterly listings of program issuances.

December 18, 2009 (74 FR 67310)
March 26, 2010 (75 FR 14906)
June 28, 2010 (75 FR 36786)
September 24, 2010 (75 FR 58790)
December 17, 2010 (75 FR 79174)

ADDENDUM II: Description of Manuals, Memoranda, and CMS Rulings

    An extensive descriptive listing of Medicare manuals and memoranda 
was published in the June 9, 1988 Federal Register (53 FR 21730) and 
supplemented in the September 22, 1988 Federal Register (53 FR 36891) 
and the December 16, 1988 Federal Register (53 FR 50577). Also, a 
complete description of the former CIM (now the NCDM) was published in 
the August 21, 1989 Federal Register (54 FR 34555). A brief description 
of the various Medicaid manuals and memoranda that we maintain was 
published in the October 16, 1992 Federal Register (57 FR 47468).

ADDENDUM III: Medicare and Medicaid Manual Instructions (October 
Through December 2010)

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ADDENDUM IV: Regulation Documents Published in the Federal Register 
October Through December 2010

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ADDENDUM V: National Coverage Determinations October Through December 
2010

    A national coverage determination (NCD) is a determination by the 
Secretary with respect to whether or not a particular item or service 
is covered nationally under Title XVIII of the Act, but does not 
include a determination of what code, if any, is assigned to a 
particular item or service covered under this title, or determination 
with respect to the amount of payment made for a particular item or 
service so covered. We include below all of the NCDs that were issued 
during the quarter covered by this notice. The entries below include 
information concerning completed decisions as well as sections on 
program and decision memoranda, which also announce decisions or, in 
some cases, explain why it was not appropriate to issue an NCD. We 
identify completed decisions by the section of the NCDM in which the 
decision appears, the title, the date the publication was issued, and 
the effective date of the decision. Information on completed decisions 
as well as pending decisions has also been posted on the CMS Web site 
at http://cms.gov/MCD.
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ADDENDUM VI: FDA-Approved Category B IDEs October Through December 2010
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ADDENDUM VII: Approval Numbers for Collections of Information

    Below we list all approval numbers for collections of information 
in the referenced sections of CMS regulations in Title 42; Title 45, 
Subchapter C; and Title 20 of the Code of Federal Regulations, which 
have been approved by the Office of Management and Budget. This 
information is available at http://www.reginfo.gov/public/do/PRAMain.

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ADDENDUM VIII: Medicare-Approved Carotid Stent Facilities October 
Through December 2010

    On March 17, 2005, we issued our decision memorandum on carotid 
artery stenting. We determined that carotid artery stenting with 
embolic protection is reasonable and necessary only if performed in 
facilities that have been determined to be competent in performing the 
evaluation, procedure, and follow-up necessary to ensure optimal 
patient outcomes. We have created a list of minimum standards for 
facilities modeled in part on professional society statements on 
competency. All facilities must at least meet our standards in order to 
receive coverage for carotid artery stenting for high risk patients. 
This notice reflects the changes, deletions and additions for this 
quarter. A full list of approved facilities is maintained on the CMS 
Web site at http://www.cms.gov/MedicareApprovedFacilitie/CASF/list.asp#TopOfPage

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ADDENDUM IX: American College of Cardiology's National Cardiovascular 
Data Registry Sites (October Through December 2010)

     In order to obtain reimbursement, Medicare national coverage 
policy requires that providers implanting OCDs 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 availabe in the 
Medicare National Coverage Determination (NCD) Manual, which is on the 
Centers for Medicare & Medicaid Serivce (CMS) Web site at http://
www.cms.hhs.gov/Manuals/IOM/itemdetail.asp?filterType=none&filter

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ByDID=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 benficiary must receive the scan in a 
facility that participates in the ACC-NCDR ICD registry. We maintain a 
list of facilities that have been enrolled in this registry. Addendum 
IX includes the facilities that have been designated in the quarter 
covered by this notice. The entire list of facilities that participate 
in the ACC-NCDR ICD registry can be found at www.ncdr.com/webncdr/common

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ADDENDUM X: Active CMS Coverage-Related Guidance Documents October 
Through December 2010

    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(1)(1) of the Act. In our notice, we committed 
to the public that, ``At regular intervals, we will update a list of 
all guidance documents in the Federal Register.''
    Addendum X includes a list of active CMS guidance documents as of 
the ending date of the period covered by this notice. To obtain full-
text copies of these documents, visit the CMS Coverage Web site at 
http://www.cms.gov/mcd/index_list.asp?list_type=mcd_1 .

Document Name: Factors CMS Considers in Commissioning External 
Technology Assessments
Date of Issuance: April 11, 2006
Document Name: Factors CMS Considers in Opening a National Coverage 
Determination
Date of Issuance: April 11, 2006
Document Name: 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

ADDENDUM XI: List of Special One-Time Notices Regarding National 
Coverage Provisions (October through December 2010)

    As medical technologies, the contexts under which they are 
delivered, and the health needs of Medicare beneficiaries grow 
increasingly complex, our national coverage determination (NCD) process 
must adapt to accommodate these complexities. As part of this 
adaptation, our national coverage decisions often include multi-faceted 
coverage determinations, which may place conditions on the patient 
populations eligible for coverage of a particular item or service, the 
providers who deliver a particular service, or the methods in which 
data are collected to supplement the delivery of the item or service 
(such as participation in a clinical trial).
    We outline these conditions as we release new or revised NCDs. 
However, details surrounding these conditions may need to be shared 
with the public as ``one-time notices'' in the Federal Register. For 
example, we may require that a particular medical service may be 
delivered only in the context of a CMS-recognized clinical research 
study, which was not named in the NCD itself. We would then use 
Addendum XI of this notice, along with our coverage Web site at http://www.cms.hhs.gov/coverage, to provide the public with information about 
the clinical research study that it ultimately recognizes. Addendum XI 
includes any additional information needed to share about the 
conditions under which an NCD was issued as of the ending date of the 
period covered by this notice.
    There were no Special One-Time Notices Regarding National Coverage 
Provisions published this quarter.

ADDENDUM XII: National Oncologic PET Registry (NOPR) (October Through 
December 2010)

    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. You can access the full list of 
facilities at http://www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage.

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ADDENDUM XIII: Medicare-Approved Ventricular Assist Device (Destination 
Therapy) Facilities (October Through December 2010)

    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.

VAD Destination Therapy Facilities

    The following facilities have met the CMS facility standards for 
destination therapy VADs during this quarter. You can access the full 
list at http://www.cms.gov/MedicareApprovedFacilitie/VAD/list.asp#TopOfPage.
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ADDENDUM XIV: Lung Volume Reduction Surgery (LVRS) (October Through 
December 2010)

    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 
Commision 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. You can access the full 
list of facilities at http://www.cms.gov/MedicareApprovedFacilitie/LVRS/list.asp#TopOfPage.

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ADDENDUM XV: Medicare-Approved Bariatric Surgery Facilities October 
Through December 2010

    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).
    The following facilities have met our minimum facility standards 
for bariatric surgery and have been certified by American College of 
Surgeons (ACS) or American Society for Metabolic and Bariatric Surgery 
(ASMBS) during this quarter. You can access the full listing at http://www.cms.gov/MedicareApprovedFacilitie/BSF/list.asp#TopOfPage.

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ADDENDUM XVI: FDG-PET for Dementia and Neurodegenerative Diseases 
Clinical Trials (October Through December 2010)

    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. You can access the full listing at http://www.cms.gov/MedicareApprovedFacilitie/PETDT/list.asp#TopOfPage.
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[FR Doc. 2011-7373 Filed 3-30-11; 8:45 am]
BILLING CODE 4120-01-C