[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]
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