Medicare and Medicaid Programs:
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
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 http://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: http://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 http://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: http://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 http://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 http:// 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 http://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 http://www.gpoaccess.gov/fr/index.html. The following Web site http://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: http://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 http://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: http://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 http://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: http://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 http://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 http://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: http://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 http://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 http://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 http://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 http://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 http://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 http://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 http://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 http://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
