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Notice

Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2010

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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 January through March 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.

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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 Kathleen Smith, 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) 786-0626.

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 Start Printed Page 36787tomography 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 Kathleen Smith, 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) 786-0626.

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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 the Federal Register. We published our first notice June 9, 1988 (53 FR 21730). Although we are not mandated to do so by statute, for the sake of completeness of the listing of operational and policy statements, and to foster more open and transparent collaboration, we are continuing our practice of including Medicare substantive and interpretive regulations (proposed and final) published during the respective 3-month time frame.

II. How To Use the Addenda

This notice is organized so that a reader may review the subjects 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 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—

○ 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.
  • 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 Start Printed Page 36788must 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. 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 the Federal Register. Rulings, beginning with those released in 1995, are available online, through the CMS Home Page. The Internet address is http://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 Benefit Policy publication titled “Outpatient Intravenous Insulin Treatment (Therapy),” use CMS-Pub. 100-03, Transmittal No. 112.

(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)

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Dated: June 15, 2010.

Jacquelyn Y. White,

Director, Office of Strategic Operations and Regulatory Affairs.

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Addendum I

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

April 1, 2008 (73 FR 17422)

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)

Addendum II—Description of Manuals, Memoranda, and CMS Rulings

An extensive descriptive listing of Medicare manuals and memoranda was published on June 9, 1988, at 53 FR 21730 and supplemented on September 22, 1988, at 53 FR 36891 and December 16, 1988, at 53 FR 50577. Also, a complete description of the former CIM Start Printed Page 36789(now the NCDM) was published on August 21, 1989, at 54 FR 34555. A brief description of the various Medicaid manuals and memoranda that we maintain was published on October 16, 1992, at 57 FR 47468.

ADDENDUM III

Medicare and Medicaid Manual Instructions

January Through March 2010

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Addendum IV—Regulation Documents Published in the Federal Register January Through March 2010

Publication dateFR Vol. 75 Page No.42 CFR Parts affectedFile codeTitle of regulation
January 13, 20101844412, 413, 422, and 495CMS-0033-PMedicare and Medicaid Programs; Electronic Health Record Incentive Program.
January 22, 20103742CMS-7017-N2Medicare Program; Meeting of the Advisory Panel on Medicare Education; Cancellation of the February 3, 2010 Meeting and Announcement of the March 31, 2010 Meeting.
3743CMS-1566-NMedicare Program; Meeting of the Practicing Physicians Advisory Council, March 8, 2010.
January 26, 20104088CMS-6023-N2Medicare Program; Approval of Independent Accrediting Organizations To Participate in the Advanced Diagnostic Imaging Supplier Accreditation Program.
4095CMS-3222-NMedicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee, March 24, 2010.
February 2, 2010541045 CFR 146CMS-4140-IFCInterim Final Rules Under the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008.
February 3, 20105599CMS-1341-NCMedicare and Medicaid Programs; Announcement of Applications From Hospitals Requesting Waiver for Organ Procurement Service Area.
February 24, 20108374CMS-1566-CNMedicare Program; Meeting of the Practicing Physicians Advisory Council, March 8, 2010, Correction.
February 26, 20108971CMS-1514-NMedicare Program; Public Meetings in Calendar Year 2010 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations.
February 26, 20108980CMS-3223-NMedicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee—April 22, 2010.
February 26, 20108982CMS-3224-NMedicare Program; Request for Nominations for Members of the Medicare Evidence Development & Coverage Advisory Committee.
March 26, 201014606CMS-1570-NMedicare Program; Request for Nominations to the Advisory Panel on Ambulatory Payment Classification Groups.
March 26, 201014906CMS-9057-NMedicare and Medicaid Programs; Quarterly Listing of Program Issuances—October Through December 2009.
March 31, 201016149CMS-2312-NMedicaid and CHIP Programs; Meeting of the CHIP Working Group—April 26, 2010.

Addendum V—National Coverage Determinations [January Through March 2010]

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

TitleNCDM SectionTN No.Issue dateEffective date
Repeal of Section 20.10, Cardiac Rehabilitation (CR) Programs20.10R116NCD03/05/201002/22/2010
Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting20.70R115NCD03/05/201012/09/2009
Outpatient Intravenous Insulin Treatment (Therapy)40.70R117NCD03/09/201012/23/2009
Screening for the Human Immunodeficiency Virus (HIV) Infection210.70R118NCD03/23/201012/08/2009
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Positron Emission Tomography (NaF-18) to Identify Bone Metastasis of Cancer220.60R119NCD03/26/201002/26/2010
Changes to the Laboratory National Coverage Determination (NCD) Edit Software for July 2010190.00R1963CP04/30/201007/01/2010

Addendum VI—FDA-Approved Category B IDEs [January Through March 2010]

Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c) devices fall into one of three classes. To assist CMS under this categorization process, the FDA assigns one of two categories to each FDA-approved IDE. Category A refers to experimental IDEs, and Category B refers to non-experimental IDEs. To obtain more information about the classes or categories, please refer to the Federal Register notice published on April 21, 1997 (62 FR 19328).

The following list includes all Category B IDEs approved by FDA during the first quarter, January through March 2010.

IDECategory
BB14319B
BB14334B
BB14335B
G080150B
G090029B
G090050B
G090105B
G090188B
G090221B
G090230B
G090251B
G090255B
G090258B
G090259B
G090267B
G090270B
G090272B
G090273B
G090277B
G100008B
G100009B
G100020B
G100024B
G100031B
G100032B
G100035B
G100041B

Addendum VII—Approval Numbers for Collections of Information

Below we list all approval numbers for collections of information in the referenced sections of CMS regulations in Title 42; Title 45, Subchapter C; and Title 20 of the Code of Federal Regulations, which have been approved by the Office of Management and Budget:

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Addendum VIII—Medicare-Approved Carotid Stent Facilities [January Through March 2010]

On March 17, 2005, we issued our decision memorandum on carotid artery stenting. We determined that carotid artery stenting with embolic protection is reasonable and necessary only if performed in facilities that have been determined to be competent in performing the evaluation, procedure, and follow-up necessary to ensure optimal patient outcomes. We have created a list of minimum standards for facilities modeled in part on professional society statements on competency. All facilities must at least meet our standards in order to receive coverage for carotid artery stenting for high risk patients.

FacilityProvider No.Effective dateStateAdditional information
Palm Springs General Hospital, 1475 West 49th Street, Hialeah, FL 3301210005001/12/2010FL
Parrish Medical Center, 951 N. Washington Avenue, Titusville, FL 3279610002801/12/2010FL
New York Presbyterian Hospital, 177 Ft. Washington Avenue, New York, NY 1003233010105/05/2005NY
Northside Hospital & Tampa Bay Heart Institute, 6000 49th Street North, St. Petersburg, FL 33709120588094502/26/2010FL
Orange Park Medical Center, 2001 Kingsley Avenue, Orange Park, FL 3207310022602/26/2010FL
Saint Thomas Hospital, 4220 Harding Road, Nashville, TN 3720544008202/26/2010TN
Marshall Medical Center North, 8000 Alabama HWT 69, Guntersville, AL 359761508241704/02/2010AL
Oklahoma Heart Hospital South LLC, 5200 E. I-240 Service Road, Oklahoma City, OK 73135-2610184144227404/02/2010OK
Great River Medical Center, 1221 S. Gear Avenue, West Burlington, IA 52655-168142068040704/16/2010IA
Liberty Hospital, P.O. Box 1002, Liberty, MO 64069-100226017704/16/2010MO
Scripps Memorial Hospital, Encinitas, 354 Santa Fe Drive ENC01, Encinitas, CA 9202405050304/16/2010CA
University of Maryland Medical Center, 22 South Greene Street, Baltimore, MD 21201-159521000204/16/2010MD

Addendum IX

American College of Cardiology's National Cardiovascular Data Registry Sites [January Through March 2010]

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. Addendum IX includes the facilities that have been designated in the quarter covered by this notice.

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Addendum X

Active CMS Coverage-Related Guidance Documents [January Through March 2010]

On September 24, 2004, we published a notice in the Federal Register (69 FR 57325), in which we explained how we would develop coverage-related guidance documents. These guidance documents are required under section 731 of the MMA. In our notice, we committed to the public that, “At regular intervals, we will update a list of all guidance documents in the Federal Register.”

Addendum X includes a list of active CMS guidance documents as of the ending date of the period covered by this notice. To obtain full-text copies of these documents, visit the CMS Coverage Web site at http://www.cms.hhs.gov/​mcd/​index_​list.asp?​list_​type=​mcd_​1.

Document Name: Factors CMS Considers in Commissioning External Technology Assessments.

Date of Issuance: April 11, 2006.

Document Name: Factors CMS Considers in Opening a National Coverage Determination.

Date of Issuance: April 11, 2006.

Document Name: (Draft) Factors CMS Considers in Referring Topics to the Medicare Coverage Advisory Committee.

Date of Issuance: March 9, 2005.

Document Name: National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage With Evidence Development.

Date of Issuance: July 12, 2006.

Addendum XI

List of Special One-Time Notices Regarding National Coverage Provisions [January Through March 2010]

As medical technologies, the contexts under which they are delivered, and the health needs of Medicare beneficiaries grow increasingly complex, our national coverage determination (NCD) process must adapt to accommodate these complexities. As part of this adaptation, our national coverage decisions often include multi-faceted coverage determinations, which may place conditions on the patient populations eligible for coverage of a particular item or service, the providers who deliver a particular service, or the methods in which data are collected to supplement the delivery of the item or service (such as participation in a clinical trial).

We outline these conditions as we release new or revised NCDs. However, details surrounding these conditions may need to be shared with the public as “one-time notices” in the Federal Register. For example, we may require that a particular medical service may be delivered only in the context of a CMS-recognized clinical research study, which was not named in the NCD itself. We would then use Addendum XI of this notice, along with our coverage Web site at http://www.cms.hhs.gov/​coverage, to provide the public with information about the clinical research study that it ultimately recognizes.

Addendum XI includes any additional information we may need to share about the conditions under which an NCD was issued as of the ending date of the period covered by this notice.

There were no Special One-Time Notices Regarding National Coverage Provisions published this quarter.

Addendum XII—National Oncologic PET Registry (NOPR)

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. The following facilities have met the CMS's requirements for performing PET scans under National Coverage Determination CAG-00181N.

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Addendum XIII

Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities [January Through March 2010]

On October 1, 2003, we issued our decision memorandum on ventricular assist devices for the clinical indication of destination therapy. We determined that ventricular assist devices 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 ventricular assist devices implanted as destination therapy.

VAD Destination Therapy Facilities

The following facilities have met the CMS facility standards for destination therapy VADs.

FacilityProvider No.Date approvedStateOther information
Advocate Christ Medical Center, 4440 W 95th Street, Oak Lawn, Illinois14020812/17/2003ILJoint Commission Certified on 05/26/2007.
California Pacific Medical Center, 2333 Buchanan Street, San Francisco, California05004703/19/2004CA
Baptist Memorial Hospital, 6019 Walnut Grove Road, Memphis, Tennessee44004804/07/2004TN
Duke University Medical Center, DUMC Box 3943, Durham, North Carolina34003010/31/2003NC
Fairview-University Medical Center, 2450 Riverside Avenue, Minneapolis, Minnesota24008010/28/2003MN
Allegheny General Hospital, 320 E North Avenue, Pittsburgh, Pennsylvania39005012/10/2003PAJoint Commission Certified on 03/28/2008.
Barnes-Jewish Hospital, One Barnes-Jewish Hospital Plaza, Saint Louis, Missouri26003210/27/2003MOJoint Commission Certified on 08/22/2008.
Brigham and Women's Hospital, 15 Francis Street, Boston, Massachusetts22011001/09/2004MA
Bryan LGH Medical Center East, 1600 S 48 Street, Lincoln, Nebraska28000310/23/2003NE
Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Los Angeles, California05062512/29/2003CA
Clarian Health Partners, Inc., 1701 N. Senate Avenue, Indianapolis, Indiana15005611/25/2003IN
Cleveland Clinic, 9500 Euclid Avenue, Cleveland, Ohio36018012/03/2003OH
Hahnemann University Hospital, Broad and Vine Streets, Philadelphia, Pennsylvania39029012/22/2003PAJoint Commission Certified on 09/19/2008.
Hospital of the University of Pennsylvania, 3400 Spruce Street, Philadelphia, Pennsylvania39011110/28/2003PAJoint Commission Certified on 05/23/2008.
Henry Ford Hospital, 2799 W. Grand Boulevard, Detroit, Michigan23005301/06/2004MI
Inova Fairfax Hospital, 3300 Gallows Road, Falls Church, Virginia49006303/31/2004VA
Jewish Hospital, 200 Abraham Flexner Way, Louisville, Kentucky18004011/10/2003KY
Jackson Memorial Hospital, 1611 NW 12th Avenue, Miami, Florida10002201/12/2004FLUniversity of Miami.
LDS Hospital, 8th Avenue and C Street, Salt Lake City, Utah46001010/23/2003UT
Johns Hopkins Hospital, 600 N. Wolfe Street, Baltimore, Maryland210009/179070090410/28/2003MDJoint Commission Certified on 07/09/2008.
Loyola University Medical Center, 2160 S. 1st Avenue, Maywood, Illinois14027601/30/2004IL
Lutheran Hospital of Indiana, 7950 W. Jefferson Boulevard, Fort Wayne, Indiana15001710/29/2003IN
Massachusetts General Hospital, 55 Fruit Street, Boston, Massachusetts22007112/15/2003MA
Mayo Clinic, 4500 San Pablo Road, Jacksonville, Florida10015111/06/2003FL
Medical City Dallas Hospital, 7777 Forest Lane, Dallas, Texas45064712/03/2003TX
The Methodist Hospital, 6565 Fannin Street, Houston, Texas45035811/03/2003TX
Montefiore Medical Center, 111 E. 210th Street, Bronx, New York33005911/14/2003NY
Methodist Specialty and Transplant Hospital, 8026 Floyd Curl Drive, San Antonio, Texas45038811/19/2003TX
Newark Beth Israel Medical Center, 201 Lyons Avenue, Newark, New Jersey31000211/14/2003NJ
Mount Sinai Medical Center, 1190 5th Avenue, New York, New York33002411/25/2003NY
New York-Presbyterian Hospital, 177 Fort Washington Avenue, New York, New York33010110/28/2003NYColumbia University Medical Center.
Ohio State University Medical Center, 410 W. 10th Avenue, Columbus, Ohio36008511/12/2003OH
Oregon Health and Sciences University, 3181 SW Sam Jackson Park Road, Portland, Oregon38000911/21/2003OR
OSF St Francis Medical Center, 530 NE Glen Oak Avenue, Peoria, Illinois14006711/12/2003IL
Penn State Milton S Hershey Medical Center, 500 University Drive, Hershey, Pennsylvania39025610/29/2003PAJoint Commission Certified on 05/19/2008.
Rush-Presbyterian-St Luke Medical Center, 1653 W Congress Parkway, Chicago, Illinois14011911/14/2003IL
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Sentara Norfolk General Hospital, 600 Gresham Drive, Norfolk, Virginia49000711/10/2003VA
Sacred Heart Medical Center, 101 W 8th Avenue, Spokane, Washington50005401/12/2004WA
Seton Medical Center, 1201 W. 38th Street, Austin, Texas45005601/13/2004TX
Shands at the University of Florida, 1600 SW Archer Road, Gainesville, Florida10011311/26/2003FL
Sharp Memorial Hospital, 7901 Frost Street, San Diego, California05010012/01/2003CAJoint Commission Certified on 07/18/2008.
Stanford University Hospital and Clinics, 300 Pasteur Drive, Stanford, California05044112/22/2003CAStanford University Medical Center.
St Francis Hospital, 6161 S. Yale Avenue, Tulsa, Oklahoma37009101/09/2004OK
St Luke's Medical Center, 2900 W Oklahoma Avenue, Milwaukee, Wisconsin52013811/03/2003WI
St Luke's Episcopal Hospital, 6720 Bertner Avenue, Houston, Texas45019310/28/2003TX
St Vincent Hospital and Health Services, 2001 W. 86th Street, Indianapolis, Indiana15008401/05/2004IN
St Paul Medical Center, 5909 Harry Hines Boulevard, Dallas, Texas45004412/10/2003TX
Strong Memorial Hospital, 601 Elmwood Avenue, Rochester, New York33028510/29/2003NYJoint Commission Certified on 06/18/2008.
Tampa General Hospital, 2 Columbia Drive, Tampa, Florida10012811/26/2003FL
Temple University Hospital, 3401 N. Broad Street, Philadelphia, Pennsylvania39002711/03/2003PA
Tufts-New England Medical Center, 750 Washington Street, Boston, Massachusetts22011611/06/2003MA
UCLA Medical Center, 10833 Le Conte Avenue, Los Angeles, California05026212/10/2003CA
University Medical Center, 1501 N. Campbell Avenue, Tucson, Arizonia03006410/29/2003AZ
University of Alabama at Birmingham Health System, 500 22nd Street S, Birmingham, Alabama01003310/29/2003AL
University of Colorado Hospital, 4200 E. Ninth Avenue, Denver, Colorado06002411/06/2003CO9th & Colorado Campus, Joint Commission Certified on 07/23/2008.
The University of Chicago Hospitals and Health System, 5841 South Maryland Avenue, Chicago, Illinois14008802/25/2004IL
University of Iowa Hospitals and Clinics, 200 Hawkins Drive, Iowa City, Iowa16005811/12/2003IA
University of Maryland Medical Center, 22 S. Greene Street, Baltimore, Maryland21000211/12/2003MD
University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan23004610/27/2003MIJoint Commission Certified on 03/28/2008.
University of North Carolina Hospitals, 101 Manning Drive, Chapel Hill, North Carolina34006105/05/2004NC
University of Utah Hospital, 50 N Medical Drive, Salt Lake City, Utah46000912/22/2003UT
University of Virginia Health System, 1215 Lee Street, Charlottesville, Virginia49000901/12/2004VA
University of Washington Medical Center, 1959 NE Pacific Street, Seattle, Washington50000801/15/2004WA
University of Wisconsin Hospitals and Clinics, 600 Highland Avenue, Madison, Wisconsin52009812/03/2003WI
USC University Hospital, 1500 San Pablo, Los Angeles, California05069601/09/2004CA
UPMC Presbyterian, 200 Lothrop Street, Pittsburgh, Pennsylvania39016410/23/2003PAJoint Commission Certified on 06/11/2008.
Virginia Commonwealth University Medical Center, 401 North 12th Street, Richmond, Virginia49003204/08/2004VAMedical College of Virginia Hospitals.
Vanderbilt University Medical Center, 1161 21st Avenue S, Nashville, Tennessee44003910/28/2003TN
Ochsner Clinic Foundation, 1514 Jefferson Highway, New Orleans, Louisiana19003606/29/2004LA
Baylor University Medical Center, 3500 Gaston Avenue, Dallas, TXN/A10/04/2007TXJoint Commission Certified on 10/04/2007.
The University of Michigan Hospitals and Health Centers, 1500 East Medical Center Drive, Ann Arbor, MI23004603/28/2008MIJoint Commission Certified on 03/28/2008.
Saint Mary's Hospital, 1216 Southwest Second Street, Rochester, MNN/A02/27/2008MNJoint Commission Certified on 02/27/2008.
Allegheny General Hospital, 320 East North Avenue, Pittsburgh, PAN/A03/08/2008PA
Washington Hospital Center, 110 Irving Street, NW, Washington, DC09-001104/23/2008DCJoint Commission Certified on 04/23/2008.
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Integris Baptist Medical Center, 3300 Northwest Expressway, Oklahoma City, OK183110365408/13/2008OKJoint Commission Certified on 08/13/08.
Mayo Clinic Hospital, 5777 East Mayo Boulevard, Phoenix, AZ03010302/27/2009AZJoint Commission Certified on 02/27/09.
Northwestern Memorial Hospital, 251 E. Huron Street, Chicago, IL14028103/17/2009ILJoint Commission Certified on 03/17/09.
Lancaster General Hospital, 555 North Duke Street, Lancaster, PA39010005/20/2009PAJoint Commission certified on 05/20/09.
Hartford Hospital, 80 Seymour Street, Hartford, CT07002505/29/2009CTJoint Commission certified on 05/29/09.
Morristown Memorial Hospital, 100 Madison Avenue, Morristown, NJ31001506/17/09NJJoint Commission certified on 6/17/09.
Thomas Jefferson University Hospital, 111 South 11th Street, Philadelphia, PA39017408/05/09PAJoint Commission certified on 8/5/09.
Emory University Hospital, 1364 Clifton Road, Atlanta, GA11001008/19/09GAJoint Commission certified on 8/19/09.
Maine Medical Center, 22 Bramhall Street, Portland, ME20000902/03/09MEJoint Commission certified on 02/03/09.
University of Kentucky Health Care—Chandler Hospital, 800 Rose Street, Lexington, KY02/11/09KY
Sutter Memorial Hospital, 5151 F Street, Sacramento, California05010810/21/09CAJoint Commission Certified on 10/21/09.
Baptist Health Medical Center—Little Rock, 9601 Interstate 630, Exit 7, Little Rock, Arizona04011412/02/09ARJoint Commission Certified on 12/02/09.
Westchester Medical Center, 100 Woods Road, Valhalla, New York33023401/05/10NYJoint Commission Certified on 01/05/10.

Addendum XIV

Lung Volume Reduction Surgery (LVRS) [January Through March 2010]

Three types of facilities are eligible for reimbursement for Lung Volume Reduction Surgery (LVRS): National Emphysema Treatment Trial (NETT) approved (Beginning 05/07/2007, these will no longer automatically qualify and can qualify only with the other programs), Credentialed by the Joint Commission (formerly, the Joint Commision on Accreditation of Healthcare Organizations (JCAHO)) under their Disease Specific Certification Program for LVRS, and Medicare approved for lung transplants. Only the first two types are in the list.

Facility nameDate approvedStateType of certification
Baylor College of Medicine, Houston, TexasN/ATEXASNETT
Brigham and Women's Hospital, Boston, MAN/AMASSACHUSETTSNETT
Cedars-Sinai Medical Center, Los Angeles, CAN/ACALIFORNIANETT
Chapman Medical Center, Orange, CAN/ACALIFORNIANETT
Cleveland Clinic Foundation, Cleveland, OHN/AOHIONETT
Columbia University, New York, NYN/ANEW YORKNETT
Duke University Medical Center, Durham, NCN/ANORTH CAROLINANETT
Johns Hopkins Hospital, Baltimore, MDN/AMARYLANDNETT
Kaiser Foundation Hospital—Riverside, Riverside, CA09/20/2006CALIFORNIAJoint Commission
Long Island Jewish Medical Center, New Hyde Park, NYN/ANEW YORKNETT
Mayo Clinic, Rochester, MNN/AMINNESOTANETT
Memorial Medical Center, Springfield, IL12/13/2006ILLINOISJoint Commission
National Jewish Medical Center, Denver, CON/ACOLORADONETT
The Ohio State University Hospital, Columbus, OHN/AOHIOJoint Commission
Ohio State University Medical Center, Columbus, OHN/AOHIONETT
Saint Louis University, Saint Louis, MON/AMISSOURINETT
Temple University Hospital, Philadelphia, PA08/23/2008PENNSYLVANIAJoint Commission
UCLA Medical Center, Los Angeles, CAN/ACALIFORNIANETT
University of California, San Diego, San Diego, CAN/ACALIFORNIANETT
University of Maryland Medical Center, Baltimore, MDN/AMARYLANDNETT
University of Michigan Medical Center, Ann Arbor, MIN/AMICHIGANJoint Commission
University of Pennsylvania, Philadelphia, PAN/APENNSYLVANIANETT
University of Pittsburgh, Pittsburgh, PAN/APENNSYLVANIANETT
University of Washington, Seattle, WAN/AWASHINGTONNETT
Washington University/Barnes Hospital, Saint Louis, MON/AMISSOURIJoint Commission
Allegheny General Hospital, Pittsburgh, PA04/23/2008PENNSYLVANIAJoint Commission

Addendum XV—Medicare-Approved Bariatric Surgery Facilities

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 Start Printed Page 37130unsuccessful with medical treatment for obesity.

This decision also stipulated that covered bariatric surgery procedures are reasonable and necessary only when performed at facilities that are: (1) Certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Surgery Center (program standards and requirements in effect on February 15, 2006); or (2) certified by the American Society for Bariatric Surgery (ASBS) as a Bariatric Surgery Center of Excellence (BSCOE) (program standards and requirements in effect on February 15, 2006).

The following facilities have met our minimum facility standards for bariatric surgery and have been certified by American College of Surgeons (ACS) or American Society for Metabolic and Bariatric Surgery (ASMBS).

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Addendum XVI—FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials

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.

Facility nameProvider No.Date approvedStateName of trialPrincipal investigator
UCLA Medical Center 10833 Le Conte Avenue Los Angeles, CA 90095HW1302906/07/2006CAEarly and Long-Term Value of Imaging Brain MetabolismDr. Daniel Silverman.
Santa Monica-UCLA Medical Center 1245 16th Street Suite 105 Santa Monica, CA 90404W11817A01/12/2007CAN/AN/A.
University of Buffalo 3435 Main Street Buffalo, NY 1421414414A03/12/2007NYMetabolic Cerebral Imaging in Incipient Dementia (MCI-ID)Dr. Daniel Silverman.
Center for Alzheimer's Care, Imaging and Research (University of Utah) 650 Komas Drive Suite 106-A Salt Lake City, UT 8410846000902/17/2009UTMetabolic Cerebral Imaging in Incipient Dementia (MCI-ID)Norman Foster, M.D.
Medical University of South Carolina 169 Ashley Avenue PO Box 250322 Charleston, SC 29425107360587902/17/2009SCN/AKenneth Spicer.
Cedars-Sinai Medical Center 8700 Beverly Boulevard Nuc Suite 1239 Los Angeles, CA 9004895164460010/09/2009CA“Early and Long-term Value of Imaging Brain Metabolism”Dr. Alan Waxman.
End Supplemental Information

[FR Doc. 2010-15257 Filed 6-25-10; 8:45 am]

BILLING CODE 4120-01-P