Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

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###### Department of Health and Human Services

###### Centers for Medicare Medicaid Services

          - [CMS-9060-N]

# AGENCY:

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

# ACTION:

Notice.

# SUMMARY:

                            This notice lists CMS manual instructions, substantive and interpretive regulations, and other                             **Federal Register**                             notices that were published from April through June 2010, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations and a list of Medicare-approved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coverage-related guidance documents, and special one-time notices regarding national coverage provisions. Also included in this notice is a list of National Oncologic Positron Emissions Tomography Registry sites, a list of Medicare-approved ventricular assist device (destination therapy) facilities, a list of Medicare-approved lung volume reduction surgery facilities, a list of Medicare-approved clinical trials for fluorodeoxyglucose positron emissions tomogrogphy for dementia, and a list of Medicare-approved bariatric surgery facilities.                        

                            Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the                             **Federal Register**                             at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.                        

# 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.)

Questions concerning CMS manual instructions in Addendum III may be addressed to Ismael Torres, Office of Strategic Operations and Regulatory Affairs, Centers for Medicare & Medicaid Services, C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-1864.

                            Questions concerning regulation documents published in the                             **Federal Register**                             in Addendum IV may be addressed to Terri Plumb, Office of Strategic Operations and Regulatory Affairs, Centers for Medicare & Medicaid Services, C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-4481.                        

Questions concerning Medicare NCDs in Addendum V may be addressed to Patricia Brocato-Simons, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-0261.

Questions concerning FDA-approved Category B IDE numbers listed in Addendum VI may be addressed to John Manlove, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-13-04, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-6877.

Questions concerning approval numbers for collections of information in Addendum VII may be addressed to Melissa Musotto, Office of Strategic Operations and Regulatory Affairs, Regulations Development and Issuances Group, Centers for Medicare & Medicaid Services, C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-6962.

Questions concerning Medicare-approved carotid stent facilities in Addendum VIII may be addressed to Sarah J. McClain, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-2994.

Questions concerning Medicare's recognition of the American College of Cardiology-National Cardiovascular Data Registry sites in Addendum IX may be addressed to JoAnna Baldwin, MS, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-7205.

Questions concerning Medicare's active coverage-related guidance documents in Addendum X may be addressed to Beverly Lofton, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services,C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-7136.

Questions concerning one-time notices regarding national coverage provisions in Addendum XI may be addressed to Beverly Lofton, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services,C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-7136.

Questions concerning National Oncologic Positron Emission Tomography Registry sites in Addendum XII may be addressed to Stuart Caplan, RN, MAS, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services,C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-8564.

Questions concerning Medicare-approved ventricular assist device (destination therapy) facilities in Addendum XIII may be addressed to JoAnna Baldwin, MS, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-7205.

Questions concerning Medicare-approved lung volume reduction surgery facilities listed in Addendum XIV may be addressed to JoAnna Baldwin, MS, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-7205.

Questions concerning Medicare-approved bariatric surgery facilities listed in Addendum XV may be addressed to Kate Tillman, RN, MA, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-9252.

                            Questions concerning fluorodeoxyglucose positron emission                                   ( print page 58791)                                tomography for dementia trials listed in Addendum XVI may be addressed to Stuart Caplan, RN, MAS, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services, C1-09-06, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-8564.                        

Questions concerning all other information may be addressed to Annette Brewer, Office of Strategic Operations and Regulatory Affairs, Regulations Development Group, Centers for Medicare & Medicaid Services, C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-6580.

# SUPPLEMENTARY INFORMATION:

## I. Program Issuances

The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs. These programs pay for health care and related services for 39 million Medicare beneficiaries and 35 million 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.

                        Section 1871(c)(1) 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 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 timeframe.                    

## II. How To Use the Addenda

This notice is organized so that a reader may review the subjects of manual issuances, memoranda, substantive and interpretive regulations, national coverage determinations (NCD), and FDA-approved investigational device exemptions (IDE) published during the subject quarter 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 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 NCD 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 11 addenda:
    - Addendum I lists the publication dates of the most recent quarterly listings of program issuances.
    - Addendum II identifies previous Federal Register                          documents that contain a description of all previously published CMS Medicare and Medicaid manuals and memoranda.                    
    - Addendum III lists a unique CMS transmittal number for each instruction in our manuals or Program Memoranda and its subject matter. 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 manuals.
    - Addendum IV lists all substantive and interpretive Medicare and Medicaid regulations and general notices published in the Federal Register                          during the quarter covered by this notice. For each item, we list the following:                    

++ Date published;

                        ++                         **Federal Register**                         citation;                    

++ Parts of the Code of Federal Regulations (CFR) that have changed (if applicable);

++ Agency file code number; and

++ Title of the regulation.
    - Addendum V includes completed NCDs, or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified 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.
    - Addendum VI includes listings of the FDA-approved IDE categorizations, using the IDE numbers the FDA assigns. The listings are organized according to the categories to which the device numbers are assigned (that is, Category A or Category B), and identified by the IDE number.
    - Addendum VII 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 .
    - Addendum VIII includes listings of Medicare-approved carotid stent facilities. All facilities listed meet CMS standards for performing carotid artery stenting for high risk patients.
    - Addendum IX includes a list of the American College of Cardiology's National Cardiovascular Data registry sites. We cover implantable cardioverter defibrillators (ICDs) for certain indications, as long as information about the procedures is reported to a central registry.
    - Addendum X 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 will begin listing the current versions of our guidance documents in each quarterly listings notice.
    - Addendum XI includes a list of special one-time notices regarding national coverage provisions. We are publishing a list of issues that require public notification, such as a particular clinical trial or research study that qualifies for Medicare coverage.
    - Addendum XII 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.
    - Addendum XIII includes a listing of Medicare-approved facitilites 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.
    - Addendum XIV 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 are also eligible to receive coverage.       ( print page 58792)      
    - Addendum XV 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.
    - Addendum XVI includes a listing of Medicare-approved clinical trials for fluorodeoxyglucose positron emission tomography (FDG-PET) for dementia and neurodegenerative diseases.

## 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 the 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, 2005. (Updated titles of the Social Security Laws are available on the Internet at                         *http://www.ssa.gov/​OP_​Home/​ssact/​comp-toc.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.

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 “New Medicare Secondary Payer Insurer Type Codes Valid Insurance Type Codes,” use CMS-Pub. 100-03, Transmittal No. 74.

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: September 16, 2010.

Jacquelyn Y. White,

Director, Office of Strategic Operations and Regulatory Affairs.

## Addendum I

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

June 27, 2008 (73 FR 36596)

September 26, 2008 (73 FR 55902)

December 30, 2008 (73 FR 79982)

March 27, 2009 (74 FR 13516)

June 26, 2009 (74 FR 30689)

September 25, 2009 (74 FR 49076)

December 18, 2009 (74 FR 67310)

March 26, 2010 (75 FR 14906)

                        June 28, 2010 (75 FR 36786)                              ( print page 58793)    

## 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).                    
      ( print page 58794)          ( print page 58795)          ( print page 58796)          ( print page 58797)          ( print page 58798)          ( print page 58799)          ( print page 58800)          ( print page 58801)          ( print page 58802)          ( print page 58803)          ( print page 58804)          ( print page 58805)          ( print page 58806)          ( print page 58807)          ( print page 58808)          ( print page 58809)          ( print page 58810)          ( print page 58811)          ( print page 58812)          ( print page 58813)          ( print page 58814)          ( print page 58815)          ( print page 58816)          ( print page 58817)          ( print page 58818)          ( print page 58819)          ( print page 58820)          ( print page 58821)          ( print page 58822)          ( print page 58823)          ( print page 58824)          ( print page 58825)          ( print page 58826)          ( print page 58827)          ( print page 58828)          ( print page 58829)          ( print page 58830)          ( print page 58831)          ( print page 58832)          ( print page 58833)          ( print page 58834)          ( print page 58835)          ( print page 58836)          ( print page 58837)          ( print page 58838)          ( print page 58839)          ( print page 58840)          ( print page 58841)          ( print page 58842)          ( print page 58843)          ( print page 58844)          ( print page 58845)          ( print page 58846)          ( print page 58847)          ( print page 58848)          ( print page 58849)          ( print page 58850)          ( print page 58851)          ( print page 58852)          ( print page 58853)          ( print page 58854)          ( print page 58855)          ( print page 58856)          ( print page 58857)          ( print page 58858)          ( print page 58859)          ( print page 58860)          ( print page 58861)          ( print page 58862)          ( print page 58863)          ( print page 58864)          ( print page 58865)          ( print page 58866)          ( print page 58867)          ( print page 58868)          ( print page 58869)          ( print page 58870)          ( print page 58871)          ( print page 58872)          ( print page 58873)          ( print page 58874)          ( print page 58875)          ( print page 58876)          ( print page 58877)          ( print page 58878)          ( print page 58879)          ( print page 58880)          ( print page 58881)          ( print page 58882)          ( print page 58883)          ( print page 58884)          ( print page 58885)          ( print page 58886)          ( print page 58887)          ( print page 58888)          ( print page 58889)          ( print page 58890)          ( print page 58891)          ( print page 58892)          ( print page 58893)          ( print page 58894)          ( print page 58895)          ( print page 58896)          ( print page 58897)          ( print page 58898)          ( print page 58899)          ( print page 58900)          ( print page 58901)          ( print page 58902)          ( print page 58903)          ( print page 58904)          ( print page 58905)          ( print page 58906)          ( print page 58907)          ( print page 58908)          ( print page 58909)          ( print page 58910)          ( print page 58911)          ( print page 58912)          ( print page 58913)          ( print page 58914)          ( print page 58915)          ( print page 58916)          ( print page 58917)          ( print page 58918)          ( print page 58919)          ( print page 58920)          ( print page 58921)          ( print page 58922)          ( print page 58923)          ( print page 58924)          ( print page 58925)          ( print page 58926)          ( print page 58927)          ( print page 58928)          ( print page 58929)          ( print page 58930)          ( print page 58931)          ( print page 58932)          ( print page 58933)          ( print page 58934)          ( print page 58935)          ( print page 58936)          ( print page 58937)          ( print page 58938)          ( print page 58939)          ( print page 58940)          ( print page 58941)          ( print page 58942)          ( print page 58943)          ( print page 58944)          ( print page 58945)          ( print page 58946)          ( print page 58947)          ( print page 58948)          ( print page 58949)          ( print page 58950)          ( print page 58951)          ( print page 58952)          ( print page 58953)          ( print page 58954)          ( print page 58955)          ( print page 58956)          ( print page 58957)          ( print page 58958)          ( print page 58959)          ( print page 58960)    

BILLING CODE 4120-01-P

[FR Doc. 2010-23585 Filed 9-23-10; 8:45 am]

BILLING CODE 4120-01-C