2010-15257. Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2010

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.

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 [phone].

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 [phone].

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 [phone].

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 [phone].

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 [phone].

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 [phone].

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 [phone].

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 [phone].

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 [phone].

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 [phone].

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 [phone].

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 [phone].

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 [phone].

Questions concerning fluorodeoxyglucose positron emission 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 [phone].

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 [phone].

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 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 [phone], Fax number [phone] (for credit card orders); or

National Technical Information Service, Department of Commerce, 5825 Port Royal Road, Springfield, VA 22161, Telephone [phone].

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 [phone]; 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)

Dated: June 15, 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.

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 (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

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

Publication date	FR Vol. 75 Page No.	42 CFR Parts affected	File code	Title of regulation
January 13, 2010	1844	412, 413, 422, and 495	CMS-0033-P	Medicare and Medicaid Programs; Electronic Health Record Incentive Program.
January 22, 2010	3742		CMS-7017-N2	Medicare Program; Meeting of the Advisory Panel on Medicare Education; Cancellation of the February 3, 2010 Meeting and Announcement of the March 31, 2010 Meeting.
	3743		CMS-1566-N	Medicare Program; Meeting of the Practicing Physicians Advisory Council, March 8, 2010.
January 26, 2010	4088		CMS-6023-N2	Medicare Program; Approval of Independent Accrediting Organizations To Participate in the Advanced Diagnostic Imaging Supplier Accreditation Program.
	4095		CMS-3222-N	Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee, March 24, 2010.
February 2, 2010	5410	45 CFR 146	CMS-4140-IFC	Interim Final Rules Under the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008.
February 3, 2010	5599		CMS-1341-NC	Medicare and Medicaid Programs; Announcement of Applications From Hospitals Requesting Waiver for Organ Procurement Service Area.
February 24, 2010	8374		CMS-1566-CN	Medicare Program; Meeting of the Practicing Physicians Advisory Council, March 8, 2010, Correction.
February 26, 2010	8971		CMS-1514-N	Medicare 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, 2010	8980		CMS-3223-N	Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee—April 22, 2010.
February 26, 2010	8982		CMS-3224-N	Medicare Program; Request for Nominations for Members of the Medicare Evidence Development & Coverage Advisory Committee.
March 26, 2010	14606		CMS-1570-N	Medicare Program; Request for Nominations to the Advisory Panel on Ambulatory Payment Classification Groups.
March 26, 2010	14906		CMS-9057-N	Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—October Through December 2009.
March 31, 2010	16149		CMS-2312-N	Medicaid 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.

Title	NCDM Section	TN No.	Issue date	Effective date
Repeal of Section 20.10, Cardiac Rehabilitation (CR) Programs	20.10	R116NCD	03/05/2010	02/22/2010
Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting	20.70	R115NCD	03/05/2010	12/09/2009
Outpatient Intravenous Insulin Treatment (Therapy)	40.70	R117NCD	03/09/2010	12/23/2009
Screening for the Human Immunodeficiency Virus (HIV) Infection	210.70	R118NCD	03/23/2010	12/08/2009
Positron Emission Tomography (NaF-18) to Identify Bone Metastasis of Cancer	220.60	R119NCD	03/26/2010	02/26/2010
Changes to the Laboratory National Coverage Determination (NCD) Edit Software for July 2010	190.00	R1963CP	04/30/2010	07/01/2010

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.

IDE	Category
BB14319	B
BB14334	B
BB14335	B
G080150	B
G090029	B
G090050	B
G090105	B
G090188	B
G090221	B
G090230	B
G090251	B
G090255	B
G090258	B
G090259	B
G090267	B
G090270	B
G090272	B
G090273	B
G090277	B
G100008	B
G100009	B
G100020	B
G100024	B
G100031	B
G100032	B
G100035	B
G100041	B

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:

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.

Facility	Provider No.	Effective date	State	Additional information
Palm Springs General Hospital, 1475 West 49th Street, Hialeah, FL 33012	100050	01/12/2010	FL
Parrish Medical Center, 951 N. Washington Avenue, Titusville, FL 32796	100028	01/12/2010	FL
New York Presbyterian Hospital, 177 Ft. Washington Avenue, New York, NY 10032	330101	05/05/2005	NY
Northside Hospital & Tampa Bay Heart Institute, 6000 49th Street North, St. Petersburg, FL 33709	1205880945	02/26/2010	FL
Orange Park Medical Center, 2001 Kingsley Avenue, Orange Park, FL 32073	100226	02/26/2010	FL
Saint Thomas Hospital, 4220 Harding Road, Nashville, TN 37205	440082	02/26/2010	TN
Marshall Medical Center North, 8000 Alabama HWT 69, Guntersville, AL 35976	15082417	04/02/2010	AL
Oklahoma Heart Hospital South LLC, 5200 E. I-240 Service Road, Oklahoma City, OK 73135-2610	1841442274	04/02/2010	OK
Great River Medical Center, 1221 S. Gear Avenue, West Burlington, IA 52655-1681	420680407	04/16/2010	IA
Liberty Hospital, P.O. Box 1002, Liberty, MO 64069-1002	260177	04/16/2010	MO
Scripps Memorial Hospital, Encinitas, 354 Santa Fe Drive ENC01, Encinitas, CA 92024	050503	04/16/2010	CA
University of Maryland Medical Center, 22 South Greene Street, Baltimore, MD 21201-1595	210002	04/16/2010	MD

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.

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.

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.

Facility	Provider No.	Date approved	State	Other information
Advocate Christ Medical Center, 4440 W 95th Street, Oak Lawn, Illinois	140208	12/17/2003	IL	Joint Commission Certified on 05/26/2007.
California Pacific Medical Center, 2333 Buchanan Street, San Francisco, California	050047	03/19/2004	CA
Baptist Memorial Hospital, 6019 Walnut Grove Road, Memphis, Tennessee	440048	04/07/2004	TN
Duke University Medical Center, DUMC Box 3943, Durham, North Carolina	340030	10/31/2003	NC
Fairview-University Medical Center, 2450 Riverside Avenue, Minneapolis, Minnesota	240080	10/28/2003	MN
Allegheny General Hospital, 320 E North Avenue, Pittsburgh, Pennsylvania	390050	12/10/2003	PA	Joint Commission Certified on 03/28/2008.
Barnes-Jewish Hospital, One Barnes-Jewish Hospital Plaza, Saint Louis, Missouri	260032	10/27/2003	MO	Joint Commission Certified on 08/22/2008.
Brigham and Women's Hospital, 15 Francis Street, Boston, Massachusetts	220110	01/09/2004	MA
Bryan LGH Medical Center East, 1600 S 48 Street, Lincoln, Nebraska	280003	10/23/2003	NE
Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Los Angeles, California	050625	12/29/2003	CA
Clarian Health Partners, Inc., 1701 N. Senate Avenue, Indianapolis, Indiana	150056	11/25/2003	IN
Cleveland Clinic, 9500 Euclid Avenue, Cleveland, Ohio	360180	12/03/2003	OH
Hahnemann University Hospital, Broad and Vine Streets, Philadelphia, Pennsylvania	390290	12/22/2003	PA	Joint Commission Certified on 09/19/2008.
Hospital of the University of Pennsylvania, 3400 Spruce Street, Philadelphia, Pennsylvania	390111	10/28/2003	PA	Joint Commission Certified on 05/23/2008.
Henry Ford Hospital, 2799 W. Grand Boulevard, Detroit, Michigan	230053	01/06/2004	MI
Inova Fairfax Hospital, 3300 Gallows Road, Falls Church, Virginia	490063	03/31/2004	VA
Jewish Hospital, 200 Abraham Flexner Way, Louisville, Kentucky	180040	11/10/2003	KY
Jackson Memorial Hospital, 1611 NW 12th Avenue, Miami, Florida	100022	01/12/2004	FL	University of Miami.
LDS Hospital, 8th Avenue and C Street, Salt Lake City, Utah	460010	10/23/2003	UT
Johns Hopkins Hospital, 600 N. Wolfe Street, Baltimore, Maryland	210009/1790700904	10/28/2003	MD	Joint Commission Certified on 07/09/2008.
Loyola University Medical Center, 2160 S. 1st Avenue, Maywood, Illinois	140276	01/30/2004	IL
Lutheran Hospital of Indiana, 7950 W. Jefferson Boulevard, Fort Wayne, Indiana	150017	10/29/2003	IN
Massachusetts General Hospital, 55 Fruit Street, Boston, Massachusetts	220071	12/15/2003	MA
Mayo Clinic, 4500 San Pablo Road, Jacksonville, Florida	100151	11/06/2003	FL
Medical City Dallas Hospital, 7777 Forest Lane, Dallas, Texas	450647	12/03/2003	TX
The Methodist Hospital, 6565 Fannin Street, Houston, Texas	450358	11/03/2003	TX
Montefiore Medical Center, 111 E. 210th Street, Bronx, New York	330059	11/14/2003	NY
Methodist Specialty and Transplant Hospital, 8026 Floyd Curl Drive, San Antonio, Texas	450388	11/19/2003	TX
Newark Beth Israel Medical Center, 201 Lyons Avenue, Newark, New Jersey	310002	11/14/2003	NJ
Mount Sinai Medical Center, 1190 5th Avenue, New York, New York	330024	11/25/2003	NY
New York-Presbyterian Hospital, 177 Fort Washington Avenue, New York, New York	330101	10/28/2003	NY	Columbia University Medical Center.
Ohio State University Medical Center, 410 W. 10th Avenue, Columbus, Ohio	360085	11/12/2003	OH
Oregon Health and Sciences University, 3181 SW Sam Jackson Park Road, Portland, Oregon	380009	11/21/2003	OR
OSF St Francis Medical Center, 530 NE Glen Oak Avenue, Peoria, Illinois	140067	11/12/2003	IL
Penn State Milton S Hershey Medical Center, 500 University Drive, Hershey, Pennsylvania	390256	10/29/2003	PA	Joint Commission Certified on 05/19/2008.
Rush-Presbyterian-St Luke Medical Center, 1653 W Congress Parkway, Chicago, Illinois	140119	11/14/2003	IL
Sentara Norfolk General Hospital, 600 Gresham Drive, Norfolk, Virginia	490007	11/10/2003	VA
Sacred Heart Medical Center, 101 W 8th Avenue, Spokane, Washington	500054	01/12/2004	WA
Seton Medical Center, 1201 W. 38th Street, Austin, Texas	450056	01/13/2004	TX
Shands at the University of Florida, 1600 SW Archer Road, Gainesville, Florida	100113	11/26/2003	FL
Sharp Memorial Hospital, 7901 Frost Street, San Diego, California	050100	12/01/2003	CA	Joint Commission Certified on 07/18/2008.
Stanford University Hospital and Clinics, 300 Pasteur Drive, Stanford, California	050441	12/22/2003	CA	Stanford University Medical Center.
St Francis Hospital, 6161 S. Yale Avenue, Tulsa, Oklahoma	370091	01/09/2004	OK
St Luke's Medical Center, 2900 W Oklahoma Avenue, Milwaukee, Wisconsin	520138	11/03/2003	WI
St Luke's Episcopal Hospital, 6720 Bertner Avenue, Houston, Texas	450193	10/28/2003	TX
St Vincent Hospital and Health Services, 2001 W. 86th Street, Indianapolis, Indiana	150084	01/05/2004	IN
St Paul Medical Center, 5909 Harry Hines Boulevard, Dallas, Texas	450044	12/10/2003	TX
Strong Memorial Hospital, 601 Elmwood Avenue, Rochester, New York	330285	10/29/2003	NY	Joint Commission Certified on 06/18/2008.
Tampa General Hospital, 2 Columbia Drive, Tampa, Florida	100128	11/26/2003	FL
Temple University Hospital, 3401 N. Broad Street, Philadelphia, Pennsylvania	390027	11/03/2003	PA
Tufts-New England Medical Center, 750 Washington Street, Boston, Massachusetts	220116	11/06/2003	MA
UCLA Medical Center, 10833 Le Conte Avenue, Los Angeles, California	050262	12/10/2003	CA
University Medical Center, 1501 N. Campbell Avenue, Tucson, Arizonia	030064	10/29/2003	AZ
University of Alabama at Birmingham Health System, 500 22nd Street S, Birmingham, Alabama	010033	10/29/2003	AL
University of Colorado Hospital, 4200 E. Ninth Avenue, Denver, Colorado	060024	11/06/2003	CO	9th & Colorado Campus, Joint Commission Certified on 07/23/2008.
The University of Chicago Hospitals and Health System, 5841 South Maryland Avenue, Chicago, Illinois	140088	02/25/2004	IL
University of Iowa Hospitals and Clinics, 200 Hawkins Drive, Iowa City, Iowa	160058	11/12/2003	IA
University of Maryland Medical Center, 22 S. Greene Street, Baltimore, Maryland	210002	11/12/2003	MD
University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan	230046	10/27/2003	MI	Joint Commission Certified on 03/28/2008.
University of North Carolina Hospitals, 101 Manning Drive, Chapel Hill, North Carolina	340061	05/05/2004	NC
University of Utah Hospital, 50 N Medical Drive, Salt Lake City, Utah	460009	12/22/2003	UT
University of Virginia Health System, 1215 Lee Street, Charlottesville, Virginia	490009	01/12/2004	VA
University of Washington Medical Center, 1959 NE Pacific Street, Seattle, Washington	500008	01/15/2004	WA
University of Wisconsin Hospitals and Clinics, 600 Highland Avenue, Madison, Wisconsin	520098	12/03/2003	WI
USC University Hospital, 1500 San Pablo, Los Angeles, California	050696	01/09/2004	CA
UPMC Presbyterian, 200 Lothrop Street, Pittsburgh, Pennsylvania	390164	10/23/2003	PA	Joint Commission Certified on 06/11/2008.
Virginia Commonwealth University Medical Center, 401 North 12th Street, Richmond, Virginia	490032	04/08/2004	VA	Medical College of Virginia Hospitals.
Vanderbilt University Medical Center, 1161 21st Avenue S, Nashville, Tennessee	440039	10/28/2003	TN
Ochsner Clinic Foundation, 1514 Jefferson Highway, New Orleans, Louisiana	190036	06/29/2004	LA
Baylor University Medical Center, 3500 Gaston Avenue, Dallas, TX	N/A	10/04/2007	TX	Joint Commission Certified on 10/04/2007.
The University of Michigan Hospitals and Health Centers, 1500 East Medical Center Drive, Ann Arbor, MI	230046	03/28/2008	MI	Joint Commission Certified on 03/28/2008.
Saint Mary's Hospital, 1216 Southwest Second Street, Rochester, MN	N/A	02/27/2008	MN	Joint Commission Certified on 02/27/2008.
Allegheny General Hospital, 320 East North Avenue, Pittsburgh, PA	N/A	03/08/2008	PA
Washington Hospital Center, 110 Irving Street, NW, Washington, DC	09-0011	04/23/2008	DC	Joint Commission Certified on 04/23/2008.
Integris Baptist Medical Center, 3300 Northwest Expressway, Oklahoma City, OK	1831103654	08/13/2008	OK	Joint Commission Certified on 08/13/08.
Mayo Clinic Hospital, 5777 East Mayo Boulevard, Phoenix, AZ	030103	02/27/2009	AZ	Joint Commission Certified on 02/27/09.
Northwestern Memorial Hospital, 251 E. Huron Street, Chicago, IL	140281	03/17/2009	IL	Joint Commission Certified on 03/17/09.
Lancaster General Hospital, 555 North Duke Street, Lancaster, PA	390100	05/20/2009	PA	Joint Commission certified on 05/20/09.
Hartford Hospital, 80 Seymour Street, Hartford, CT	070025	05/29/2009	CT	Joint Commission certified on 05/29/09.
Morristown Memorial Hospital, 100 Madison Avenue, Morristown, NJ	310015	06/17/09	NJ	Joint Commission certified on 6/17/09.
Thomas Jefferson University Hospital, 111 South 11th Street, Philadelphia, PA	390174	08/05/09	PA	Joint Commission certified on 8/5/09.
Emory University Hospital, 1364 Clifton Road, Atlanta, GA	110010	08/19/09	GA	Joint Commission certified on 8/19/09.
Maine Medical Center, 22 Bramhall Street, Portland, ME	200009	02/03/09	ME	Joint Commission certified on 02/03/09.
University of Kentucky Health Care—Chandler Hospital, 800 Rose Street, Lexington, KY		02/11/09	KY
Sutter Memorial Hospital, 5151 F Street, Sacramento, California	050108	10/21/09	CA	Joint Commission Certified on 10/21/09.
Baptist Health Medical Center—Little Rock, 9601 Interstate 630, Exit 7, Little Rock, Arizona	040114	12/02/09	AR	Joint Commission Certified on 12/02/09.
Westchester Medical Center, 100 Woods Road, Valhalla, New York	330234	01/05/10	NY	Joint 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 name	Date approved	State	Type of certification
Baylor College of Medicine, Houston, Texas	N/A	TEXAS	NETT
Brigham and Women's Hospital, Boston, MA	N/A	MASSACHUSETTS	NETT
Cedars-Sinai Medical Center, Los Angeles, CA	N/A	CALIFORNIA	NETT
Chapman Medical Center, Orange, CA	N/A	CALIFORNIA	NETT
Cleveland Clinic Foundation, Cleveland, OH	N/A	OHIO	NETT
Columbia University, New York, NY	N/A	NEW YORK	NETT
Duke University Medical Center, Durham, NC	N/A	NORTH CAROLINA	NETT
Johns Hopkins Hospital, Baltimore, MD	N/A	MARYLAND	NETT
Kaiser Foundation Hospital—Riverside, Riverside, CA	09/20/2006	CALIFORNIA	Joint Commission
Long Island Jewish Medical Center, New Hyde Park, NY	N/A	NEW YORK	NETT
Mayo Clinic, Rochester, MN	N/A	MINNESOTA	NETT
Memorial Medical Center, Springfield, IL	12/13/2006	ILLINOIS	Joint Commission
National Jewish Medical Center, Denver, CO	N/A	COLORADO	NETT
The Ohio State University Hospital, Columbus, OH	N/A	OHIO	Joint Commission
Ohio State University Medical Center, Columbus, OH	N/A	OHIO	NETT
Saint Louis University, Saint Louis, MO	N/A	MISSOURI	NETT
Temple University Hospital, Philadelphia, PA	08/23/2008	PENNSYLVANIA	Joint Commission
UCLA Medical Center, Los Angeles, CA	N/A	CALIFORNIA	NETT
University of California, San Diego, San Diego, CA	N/A	CALIFORNIA	NETT
University of Maryland Medical Center, Baltimore, MD	N/A	MARYLAND	NETT
University of Michigan Medical Center, Ann Arbor, MI	N/A	MICHIGAN	Joint Commission
University of Pennsylvania, Philadelphia, PA	N/A	PENNSYLVANIA	NETT
University of Pittsburgh, Pittsburgh, PA	N/A	PENNSYLVANIA	NETT
University of Washington, Seattle, WA	N/A	WASHINGTON	NETT
Washington University/Barnes Hospital, Saint Louis, MO	N/A	MISSOURI	Joint Commission
Allegheny General Hospital, Pittsburgh, PA	04/23/2008	PENNSYLVANIA	Joint 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 unsuccessful with medical treatment for obesity.

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

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

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 name	Provider No.	Date approved	State	Name of trial	Principal investigator
UCLA Medical Center 10833 Le Conte Avenue Los Angeles, CA 90095	HW13029	06/07/2006	CA	Early and Long-Term Value of Imaging Brain Metabolism	Dr. Daniel Silverman.
Santa Monica-UCLA Medical Center 1245 16th Street Suite 105 Santa Monica, CA 90404	W11817A	01/12/2007	CA	N/A	N/A.
University of Buffalo 3435 Main Street Buffalo, NY 14214	14414A	03/12/2007	NY	Metabolic 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 84108	460009	02/17/2009	UT	Metabolic Cerebral Imaging in Incipient Dementia (MCI-ID)	Norman Foster, M.D.
Medical University of South Carolina 169 Ashley Avenue PO Box 250322 Charleston, SC 29425	1073605879	02/17/2009	SC	N/A	Kenneth Spicer.
Cedars-Sinai Medical Center 8700 Beverly Boulevard Nuc Suite 1239 Los Angeles, CA 90048	951644600	10/09/2009	CA	“Early and Long-term Value of Imaging Brain Metabolism”	Dr. Alan Waxman.