Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2011


This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2011, relating to the Medicare and Medicaid programs and other programs administered by CMS.


Federal Register, Volume 76 Issue 242 (Friday, December 16, 2011)

Federal Register Volume 76, Number 242 (Friday, December 16, 2011)


Pages 78267-78281

From the Federal Register Online via the Government Printing Office

FR Doc No: 2011-32107



Centers for Medicare & Medicaid Services


Medicare and Medicaid Programs; Quarterly Listing of Program Issuances--July Through September 2011

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

ACTION: Notice.


SUMMARY: This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2011, relating to the Medicare and

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Medicaid programs and other programs administered by CMS.

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 each of the addenda published in this notice.


Addenda Contact Phone number


I CMS Manual Instructions................ Ismael Torres.................. (410) 786-1864

II Regulation Documents Published in the Terri Plumb.................... (410) 786-4481

Federal Register.

III CMS Rulings.......................... Tiffany Lafferty............... (410) 786-7548

IV Medicare National Coverage Wanda Belle.................... (410) 786-7491


V FDA-Approved Category B IDEs........... John Manlove................... (410) 786-6877

VI Collections of Information............ Mitch Bryman................... (410) 786-5258

VII Medicare -Approved Carotid Stent Sarah J. McClain............... (410) 786-2294


VIII American College of Cardiology- JoAnna Baldwin, MS............. (410) 786-7205

National Cardiovascular Data Registry


IX Medicare's Active Coverage-Related Lori Ashby..................... (410) 786-6322

Guidance Documents.

X One-time Notices Regarding National Lori Ashby..................... (410) 786-6322

Coverage Provisions.

XI National Oncologic Positron Emission Stuart Caplan, RN, MAS......... (410) 786-8564

Tomography Registry Sites.

XII Medicare-Approved Ventricular Assist JoAnna Baldwin, MS............. (410) 786-7205

Device (Destination Therapy) Facilities.

XIII Medicare-Approved Lung Volume JoAnna Baldwin, MS............. (410) 786-7205

Reduction Surgery Facilities.

XIV Medicare-Approved Bariatric Surgery Kate Tillman, RN, MAS.......... (410) 786-9252


XV Fluorodeoxyglucose Positron Emission Stuart Caplan, RN, MAS......... (410) 786-8564

Tomography for Dementia Trials.

All Other Information.................... Annette Brewer................. (410) 786-6580


I. Background

Among other things, the Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs and coordination and oversight of private health insurance. Administration and oversight of these programs involves the following: (1) Furnishing information to Medicare and Medicaid beneficiaries, health care providers, and the public; and (2) maintaining effective communications with CMS regional offices, State governments, State Medicaid agencies, State survey agencies, various providers of health care, all Medicare contractors that process claims and pay bills, National Association of Insurance Commissioners (NAIC), health insurers, and other stakeholders. 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) and Public Health Service Act. We also issue various manuals, memoranda, and statements necessary to administer and oversee the programs efficiently.

Section 1871(c) 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.

II. Summary of the Solicitation for Comments and Response to Comments

As explained in the notice with comment period that published in the August 8, 2011 Federal Register (76 FR 48564), technology has advanced since we published our first notice on June 9, 1988, and the information provided in this notice is now available in more efficient, economical, and accessible ways to meet the requirement for publication set forth in the statute. Each quarter, we publish the most current and relevant information; however, many of the quarterly notices simply duplicate the information that was previously published, since there often are no new relevant updates in some categories for the quarter. In addition, there is a 3-month lapse between the information available on the Web site and information covered by this quarterly notice.

In the August 8, 2011 notice (76 FR 48564), we solicited comments on alternative formats to provide this information to the public. For example, we explained that we could publish a notice that provided only Web links to the addenda, or provide this information on a newly-

created CMS Quarterly Issuance Web page. We solicited comments and any additional information as to whether these alternative processes would improve accessibility to information. We also inquired whether a new format would pose a problem to those who access the information contained in this notice or pose an unintended burden to beneficiaries, providers, and suppliers. We did not receive any comments in response to our solicitation.

III. Revised Format for the Quarterly Issuance Notices

While we are publishing the quarterly notice required by section 1871(c) of the Act, we will no longer republish duplicative information that is available to the public elsewhere. We believe this approach is in alignment with CMS' commitment to the general principles of the President's Executive Order 13563 released January 2011entitled ``Improving Regulation and Regulatory Review,'' which promotes modifying and streamlining an agency's regulatory program to be more effective in achieving regulatory objectives. Section 6 of Executive Order 13563 requires agencies to identify regulations that may be ``outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand or repeal them in accordance with what has been learned.'' This approach is also in alignment with the President's Open Government and Transparency Initiative that establishes a system of transparency, public participation, and collaboration.

Therefore, beginning with this quarterly notice, we will provide only the specific updates that have occurred in the 3-month period along with a hyperlink to the full listing that is available on the CMS Web site or the appropriate data registries that are used as our resources. This information is the most current up-to-date information, and will be available earlier than we publish our quarterly notice. We believe

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the Web site list provides more timely access for beneficiaries, providers, and suppliers. We also believe the Web site offers a more convenient tool for the public to find the full list of qualified providers for these specific services and offers more flexibility and ``real time''accessibility. In addition, many of the Web sites have listservs; that is, the public can subscribe and receive immediate notification of any updates to the Web site. These listservs avoid the need to check the Web site, as notification of updates is automatic and sent to the subscriber as they occur. If assessing a Web site proves to be difficult, the contact person listed can provide information.

IV. How To Use the Notice

This notice is organized into 15 addenda so that a reader may access the subjects published during the quarter covered by the notice 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 should view the manuals at

Authority: (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare--Hospital Insurance, Program No. 93.774, Medicare--

Supplementary Medical Insurance Program, and Program No. 93.714, Medical Assistance Program) .

Dated: December 8, 2011 .

Jacquelyn Y. White,

Director, Office of Strategic Operations and Regulatory Affairs.


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FR Doc. 2011-32107 Filed 12-15-11; 8:45 am