Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 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 October through December 2010, relating to the Medicare and Medicaid programs.

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.)

SUPPLEMENTARY INFORMATION:

I. Program Issuances

Among other things, the Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs, which pay for health care and related services for Medicare beneficiaries and Medicaid recipients. Administration of the two programs involves the following: (1) Furnishing information to Medicare beneficiaries and Medicaid recipients, health care providers, and the public; and (2) maintaining effective communications with regional offices, State governments, State Medicaid agencies, State survey agencies, various providers of health care, all Medicare contractors that process claims and pay bills, and others. To implement the various statutes on which the programs are based, we issue regulations under the authority granted to the Secretary of the Department of Health and Human Services under sections 1102, 1871, 1902, and related provisions of the Social Security Act (the Act). We also issue various manuals, memoranda, and statements necessary to administer the programs efficiently.

The statute 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 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 National Coverage Determinations 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 16 addenda:

Addendum I: Publication Dates of the Most Recent Quarterly Listings of Program Issuances.

Addendum II: Description of Manuals, Memoranda, and CMS Rulings.

Addendum III: Medicare and Medicaid Manual Instructions.

Addendum IV: Regulation Documents Published in the Federal Register.

Addendum V: National Coverage Determinations.

Addendum VI: FDA-approved Category B IDEs.

Addendum VII: Approval Numbers for the Collections of Information.

Addendum VIII: Medicare-approved Carotid Stent Facilities.

Addendum IX: American College of Cardiology's National Cardiovascular Data Registry Sites.

Addendum X: Active CMS Coverage-Related Guidance Documents.

Addendum XI: Special One-Time Notices Regarding National Coverage Provisions.

Addendum XII: National Oncologic Positron Emission Tomography Registry (NOPR) Sites.

Addendum XIII: Medicare-approved Ventricular Assist Device (Destination Therapy) Facilities.

Addendum XIV: Lung Volume Reduction Surgery.

Addendum XV: Medicare-approved Bariatric Surgery Facilities.

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

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 GPO at the address given above. When ordering individual copies, it is necessary to cite either the date of publication or the volume number and page number.

The Federal Register is also available on 24x microfiche and as an online database through GPO Access. The online database is updated by 6 a.m. each day the Federal Register is published. The database includes both text and graphics from Volume 59, Number 1 (January 2, 1994) forward. Free public access is available on a Wide Area Information Server (WAIS) through the Internet and via asynchronous dial-in. Internet users can access the database by using the World Wide Web; the Superintendent of Documents home page address is http://www.gpoaccess.gov/fr/index.html,, by using local WAIS client software, or by telnet to swais.gpoaccess.gov, then log in as guest (no password required). Dial-in users should use communications software and modem to call (202) 512-1661; type swais, then log in as guest (no password required).

C. Rulings

We publish rulings on an infrequent basis. CMS Rulings are decisions of the Administrator that serve as precedent final opinions and orders and statements of policy and interpretation. CMS Rulings provide clarification and interpretation of complex or ambiguous provisions of the law or regulations relating to Medicare, Medicaid, Utilization and Quality Control Peer Review, private health insurance, and related matters. Interested individuals can obtain copies from the nearest CMS Regional Office or review them at the nearest regional depository library. On occasion, we publish rulings in the Federal Register. Rulings, beginning with those released in 1995, are available online, through the CMS Home Page. The Internet address is http://www.cms.hhs.gov/rulings.

D. CMS' Compact Disk-Read Only Memory (CD-ROM)

Our laws, regulations, and manuals are also available on CD-ROM and may be purchased from GPO or NTIS on a subscription or single copy basis. The Superintendent of Documents list ID is HCLRM, and the stock number is 717-139-00000-3. The following material is on the CD-ROM disk:

• Titles XI, XVIII, and XIX of the Act.
• CMS-related regulations.
• CMS manuals and monthly revisions.
• CMS program memoranda.

The titles of the Compilation of the Social Security Laws are current as of January 1, 2009. (Updated titles of the Social Security Laws are available on the Internet at http://ssa.gov/OP_Home/ssact/comp-ssa.htm.) The remaining portions of CD-ROM are updated on a monthly basis.

Because of complaints about the unreadability of the Appendices (Interpretive Guidelines) in the State Operations Manual (SOM), as of March 1995, we deleted these appendices from CD-ROM. We intend to re-visit this issue in the near future and, with the aid of newer technology, we may again be able to include the appendices on CD-ROM. Any cost report forms incorporated in the manuals are included on the CD-ROM disk as LOTUS files. LOTUS software is needed to view the reports once the files have been copied to a personal computer disk.

IV. How To Review Listed Material

Transmittals or Program Memoranda can be reviewed at a local Federal Depository Library (FDL). Under the FDL program, government publications are sent to approximately 1,400 designated libraries throughout the United States. Some FDLs may have arrangements to transfer material to a local library not designated as an FDL. Contact any library to locate the nearest FDL.

In addition, individuals may contact regional depository libraries that receive and retain at least one copy of most Federal Government publications, either in printed or microfilm form, for use by the general public. These libraries provide reference services and interlibrary loans; however, they are not sales outlets. Individuals may obtain information about the location of the nearest regional depository library from any library.

For each CMS publication listed in Addendum III, CMS publication and transmittal numbers are shown. To help FDLs locate the materials, use the CMS publication and transmittal numbers. For example, to find the Medicare National Coverage Determination publication titled Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Myelodysplastic Syndrome (MDS) use CMS-Pub. 100-03, Transmittal No. 127.

The complete registry lists for Category B IDE numbers, National Cardiovascular Data Registry Sites, Carotid Stent Facilities, approved Bariatric Surgery Facilities, National Oncologic PET Registry Sites, approved Ventricular Assist Device Facilities, approved Lung Volume Reduction Surgery Facilities, and PET AD can be found on the CMS coverage Web site at http://www.cms.gov/MedicareApprovedFacilitie/01_Overview.asp#TopOfPage.

Authority: (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; Program No. 93.774, Medicare—Supplementary Medical Insurance Program; and Program No. 93.714, Medical Assistance Program).

ADDENDUM I: Publication Dates of the Most Recent Quarterly Listings of Program Issuances

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

December 18, 2009 (74 FR 67310)

March 26, 2010 (75 FR 14906)

June 28, 2010 (75 FR 36786)

September 24, 2010 (75 FR 58790)

December 17, 2010 (75 FR 79174)

ADDENDUM II: Description of Manuals, Memoranda, and CMS Rulings

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

ADDENDUM III: Medicare and Medicaid Manual Instructions (October Through December 2010)

ADDENDUM IV: Regulation Documents Published in the Federal Register October Through December 2010

ADDENDUM V: National Coverage Determinations October Through December 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 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 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.gov/MCD.

ADDENDUM VI: FDA-Approved Category B IDEs October Through December 2010

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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. This information is available at http://www.reginfo.gov/public/do/PRAMain.

ADDENDUM VIII: Medicare-Approved Carotid Stent Facilities October Through December 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. This notice reflects the changes, deletions and additions for this quarter. A full list of approved facilities is maintained on the CMS Web site at http://www.cms.gov/MedicareApprovedFacilitie/CASF/list.asp#TopOfPage

ADDENDUM IX: American College of Cardiology's National Cardiovascular Data Registry Sites (October Through December 2010)

In order to obtain reimbursement, Medicare national coverage policy requires that providers implanting OCDs 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 availabe in the Medicare National Coverage Determination (NCD) Manual, which is on the Centers for Medicare & Medicaid Serivce (CMS) Web site at http://www.cms.hhs.gov/Manuals/IOM/itemdetail.asp?filterType=none&filter ByDID=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 benficiary 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. The entire list of facilities that participate in the ACC-NCDR ICD registry can be found at www.ncdr.com/webncdr/common

ADDENDUM X: Active CMS Coverage-Related Guidance Documents October Through December 2010

In the September 24, 2004 Federal Register (69 FR 57325), we published a notice in which we explained how we would develop coverage-related guidance documents. These guidance documents are issued pursuant to section 1862(1)(1) of the Act. 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.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: Factors CMS Considers in Referring Topics to the Medicare Coverage Advisory Committee

Date of Issuance: December 12, 2006

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

Date of Issuance: July 12, 2006

ADDENDUM XI: List of Special One-Time Notices Regarding National Coverage Provisions (October through December 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 needed 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) (October Through December 2010)

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. You can access the full list of facilities at http://www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage .

ADDENDUM XIII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (October Through December 2010)

On October 1, 2003, we issued our decision memorandum on ventricular assist devices (VADs) for the clinical indication of destination therapy. We determined that VADs used as destination therapy are reasonable and necessary only if performed in facilities that have been determined to have the experience and infrastructure to ensure optimal patient outcomes. We established facility standards and an application process. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy.

VAD Destination Therapy Facilities

The following facilities have met the CMS facility standards for destination therapy VADs during this quarter. You can access the full list at http://www.cms.gov/MedicareApprovedFacilitie/VAD/list.asp#TopOfPage .

ADDENDUM XIV: Lung Volume Reduction Surgery (LVRS) (October Through December 2010)

The following three types of facilities are eligible for reimbursement for Lung Volume Reduction Surgery (LVRS):

• National Emphysema Treatment Trial (NETT) approved (Beginning 05/07/2007, these will no longer automatically qualify and can qualify only with the other programs);
• Credentialed by the Joint Commission (formerly, the Joint 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. You can access the full list of facilities at http://www.cms.gov/MedicareApprovedFacilitie/LVRS/list.asp#TopOfPage.

ADDENDUM XV: Medicare-Approved Bariatric Surgery Facilities October Through December 2010

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) during this quarter. You can access the full listing at http://www.cms.gov/MedicareApprovedFacilitie/BSF/list.asp#TopOfPage.

ADDENDUM XVI: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (October Through December 2010)

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. You can access the full listing at http://www.cms.gov/MedicareApprovedFacilitie/PETDT/list.asp#TopOfPage.