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Daily Rules, Proposed Rules, and Notices of the Federal Government

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare Medicaid Services

[CMS-9056-N]

Medicare and Medicaid Programs; Quarterly Listing of Program Issuances--July Through September 2009

AGENCY: Centers for Medicare Medicaid Services (CMS), HHS.
ACTION: Notice.
SUMMARY: This notice lists CMS manual instructions, substantive and interpretive regulations, and otherFederal Registernotices that were published from July 2009 through September 2009, 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 theFederal Registerat 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: 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 theFederal Registerin Addendum IV may be addressed to Gwendolyn Johnson, Office of Strategic Operations and Regulatory Affairs, Centers for Medicare Medicaid Services, C4-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-6954.

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 emissiontomography 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 Gwendolyn Johnson, Office of Strategic Operations and Regulatory Affairs, Regulations Development Group, Centers for Medicare Medicaid Services, C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850, or you can call (410) 786-6954. 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 (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 theFederal 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 of manual issuances, memoranda, substantive and interpretive regulations, NCDs, and FDA-approved IDEs 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 previousFederal Registerdocuments 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 theFederal Registerduring the quarter covered by this notice. For each item, we list the—

○ Date published;

Federal Registercitation;

○ 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 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.

• 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.

• 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 facilitiesmust 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); orNational 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 dailyFederal Register. Interested individuals may purchase individual copies or subscribe to theFederal Registerby 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.

TheFederal Registeris also available on 24x microfiche and as an online database throughGPO Access.The online database is updated by 6 a.m. each day theFederal Registeris 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 ishttp://www.gpoaccess.gov/fr/index.html,by using local WAIS client software, or by telnet toswais.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. 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. Interested individuals can obtain copies from the nearest CMS Regional Office or review them at the nearest regional depository library. We have, on occasion, published rulings in theFederal Register. Rulings, beginning with those released in 1995, are available online, through the CMS Home Page. The Internet address ishttp://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 athttp://www.ssa.gov/OP_Home/ssact/comp-toc.htm.) The remaining portions ofCD-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 Benefit Policy publication titled “Sleep Testing for Obstructive Sleep Apnea (OSA),” use CMS-Pub. 100-03, Transmittal No. 103.

(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: December 2, 2009. Jacquelyn Y. White, Director, Office of Strategic Operations and Regulatory Affairs. BILLING CODE 4120-01-P EN18DE09.000 EN18DE09.001 EN18DE09.002 EN18DE09.003 EN18DE09.004 EN18DE09.005 EN18DE09.006 EN18DE09.007 EN18DE09.008 EN18DE09.009 EN18DE09.010 EN18DE09.011 EN18DE09.012 EN18DE09.013 EN18DE09.014 EN18DE09.015 EN18DE09.016 EN18DE09.017 EN18DE09.018 EN18DE09.019 EN18DE09.020 EN18DE09.021 EN18DE09.022 EN18DE09.023 EN18DE09.024 EN18DE09.025 EN18DE09.026 EN18DE09.027 EN18DE09.028 EN18DE09.029 EN18DE09.030 EN18DE09.031 EN18DE09.032 EN18DE09.033 EN18DE09.034 EN18DE09.035 EN18DE09.036 EN18DE09.037 EN18DE09.038 EN18DE09.039 EN18DE09.040 EN18DE09.041 EN18DE09.042 EN18DE09.043 EN18DE09.044 EN18DE09.045 EN18DE09.046 EN18DE09.047 EN18DE09.048 EN18DE09.049 EN18DE09.050 EN18DE09.051 EN18DE09.052 EN18DE09.053 EN18DE09.054 EN18DE09.055 EN18DE09.056 EN18DE09.057 EN18DE09.058 EN18DE09.059 EN18DE09.060 EN18DE09.061 EN18DE09.062 EN18DE09.063 EN18DE09.064 EN18DE09.065 EN18DE09.066 EN18DE09.067 EN18DE09.068 EN18DE09.069 EN18DE09.070 EN18DE09.071 EN18DE09.072 EN18DE09.073 EN18DE09.074 EN18DE09.075 EN18DE09.076 EN18DE09.077 EN18DE09.078 EN18DE09.079 EN18DE09.080 EN18DE09.081 EN18DE09.082 EN18DE09.083 EN18DE09.084 EN18DE09.085 EN18DE09.086 EN18DE09.087 EN18DE09.088 EN18DE09.089 EN18DE09.090 EN18DE09.091 EN18DE09.092 EN18DE09.093 EN18DE09.094 EN18DE09.095 EN18DE09.096 EN18DE09.097 EN18DE09.098 EN18DE09.099 EN18DE09.100 EN18DE09.101 EN18DE09.102 EN18DE09.103 EN18DE09.104 EN18DE09.105 EN18DE09.106 EN18DE09.107 EN18DE09.108 EN18DE09.109 EN18DE09.110 EN18DE09.111 EN18DE09.112 EN18DE09.113 EN18DE09.114 EN18DE09.115 EN18DE09.116 EN18DE09.117 EN18DE09.118 EN18DE09.119 EN18DE09.120 EN18DE09.121 EN18DE09.122 EN18DE09.123 EN18DE09.124 EN18DE09.125
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