Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 Department of Health and Human Services Centers for Medicare & Medicaid Services [CMS-9066-NC]
 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
 ACTION: Notice with comment period.
 SUMMARY: This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other 
                            **Federal Register**
                             notices that were published from January through March 2011, relating to the Medicare and Medicaid programs and other programs administered by CMS. It also solicits comments on a process that CMS is considering to provide current up-to-date information in a Web friendly format. We are soliciting feedback on options that would improve accessibility and be less burdensome to beneficiaries, providers, and suppliers.
 DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on September 7, 2011.
 ADDRESSES: In commenting, please refer to file code CMS-9066-NC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed): 1. 
                            *Electronically.*
                             You may submit electronic comments on this regulation to 
                            *http://www.regulations.gov.*
                             Follow the “Submit a comment” instructions. 2. 
                            *By regular mail.*
                             You may mail written comments to the following address only:  Centers for Medicare & Medicaid Services,  Department of Health and Human Services,  Attention: CMS-9066-NC,  P.O. Box 8012,  Baltimore, MD 21244-1850. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. 
                            *By express or overnight mail.*
                             You may send written comments to the following address only:  Centers for Medicare & Medicaid Services,  Department of Health and Human Services,  Attention: CMS-9066-NC, Mail Stop C4-26-05,  7500 Security Boulevard,  Baltimore, MD 21244-1850. 4. 
                            *By hand or courier.*
                             Alternatively, you may deliver (by hand or courier) your written comments only to the following address prior to the close of the comment period:  Centers for Medicare & Medicaid Services,  Department of Health and Human Services,  7500 Security Boulevard,  Baltimore, MD 21244-1850. If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members. Comments erroneously mailed to the address indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. For information on viewing public comments, see the beginning of the 
                            **SUPPLEMENTARY INFORMATION**
                             section.


SUPPLEMENTARY INFORMATION:  *Inspection of Public Comments:*
                         All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: 
                        *http://www.regulations.gov.*
                         Follow the search instructions on that Web site to view public comments. Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951. 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. Addenda
Contact
Phone numberI CMS Manual Instructions
Ismael Torres
(410) 786-1864II Regulation Documents Published in the 
                                    **Federal Register**
Terri Plumb
(410) 786-4481III CMS Rulings
Tiffany Lafferty
(410)786-7548IV Medicare National Coverage Determinations
Wanda Belle
(410) 786-7491V FDA-Approved Category B IDEs
John Manlove
(410) 786-6877VI Collections of Information
Mitch Bryman
(410) 786-5258VII Medicare-Approved Carotid Stent Facilities
Sarah J. McClain
(410) 786-2294VIII American College of Cardiology-National Cardiovascular Data Registry Sites
JoAnna Baldwin, MS
(410) 786-7205IX Medicare's Active Coverage-Related Guidance Documents
Lori Ashby
(410) 786-6322X One-time Notices Regarding National Coverage Provisions
Lori Ashby
(410) 786-6322XI National Oncologic Positron Emission Tomography Registry Sites
Stuart Caplan, RN, MAS
(410) 786-8564XII Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities
JoAnna Baldwin, MS
(410) 786-7205XIII Medicare-Approved Lung Volume Reduction Surgery Facilities
JoAnna Baldwin, MS
(410) 786-7205XIV Medicare-Approved Bariatric Surgery Facilities
Kate Tillman, RN, MAS
(410) 786-9252XV Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials
Stuart Caplan, RN, MAS
(410) 786-8564All Other Information
Annette Brewer
(410) 786-6580
 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 
                            ( print page 48565)
                            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**
                            . We have been announcing each quarter 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. While we plan to publish the quarterly notice required by section 1871(c) of the Act, we are proposing steps to avoid republishing duplicative information that is available to the public elsewhere. Moreover, we plan to use our Web site to provide complete and timely information with respect to certain types of Medicare providers for specific services. We believe that 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 to the public. Since the publication of our first notice on June 9, 1988, technology has advanced, 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. Starting with the next quarterly notice, which will publish in September 2011, we propose to 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. Currently, there is a 3-month lapse between the information available on the Web site and information covered by this quarterly notice. The Web site list provides more timely access for beneficiaries, providers, and suppliers. Also, 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. We are soliciting comments as to whether this approach poses a problem to those who access the information set out in this notice. In addition, we are soliciting comments on alternative formats to provide this information to the public. For example, we could publish a notice that only provides Web links to these addenda, or we could create a CMS Quarterly Issuance Web page that provides all of the addenda. We welcome comments and any additional information as to whether these alternative processes would improve accessibility to information or pose an unintended burden to beneficiaries, providers, and suppliers. 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. How to Use the Notice This notice is organized 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 
                            *http://www.cms.gov/​manuals.* To aid the reader, we have organized and divided this current listing into 15 addenda. Addendum I: Medicare and Medicaid Manual Instructions, Addendum II: Regulation Documents Published in the 
                                **Federal Register**
                                , Addendum III: CMS Rulings, Addendum IV: National Coverage Determinations, Addendum V: FDA-Approved Category B IDEs, Addendum VI: Approval Numbers for the Collections of Information, Addendum VII: Medicare-Approved Carotid Stent Facilities, Addendum VIII: American College of Cardiology's National Cardiovascular Data Registry Sites, Addendum IX: Active CMS Coverage-Related Guidance Documents, Addendum X: Special One-Time Notices Regarding National Coverage Provisions, Addendum XI: National Oncologic Positron Emission Tomography Registry (NOPR) Sites, Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities, Addendum XIII: Lung Volume Reduction Surgery, Addendum XIV: Medicare-Approved Bariatric Surgery Facilities, Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials. 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: August 2, 2011
                                *.* Jacquelyn Y. White, Director,  Office of Strategic Operations and Regulatory Affairs.
 Publication Dates for the Previous Four Quarterly Notices We publish this notice at the end of each quarter reflecting information released by CMS during the previous quarter. The publication dates of the previous four Quarterly Listing of Program Issuances notices are: June 28, 2010 (75 FR 36786), September 24, 2010 (75 FR 58790), December 17, 2010 (75 FR 79174), and March 31, 2011 (76 FR 17873). For the purposes of this quarterly notice, we are providing a complete listing in each addendum for the ending date of the period covered by this notice. Based on our proposal for future quarterly notices, we would provide only the specific updates that have occurred in the three-month period along with a hyperlink to the Web site to access this information and a contact person for questions or additional information. Addendum I: Medicare and Medicaid Manual Instructions (January Through March 2011) The CMS Manual System is used by CMS program components, partners, providers, contractors, Medicare 
                            ( print page 48566)
                            Advantage organizations, and State Survey Agencies to administer CMS programs. It offers day-to-day operating instructions, policies, and procedures based on statutes and regulations, guidelines, models, and directives. In 2003, we transformed the CMS Program Manuals into a Web user-friendly presentation and renamed it the CMS Online Manual System. How To Obtain Manuals The Internet-only Manuals (IOMs) are a replica of the Agency's official record copy. Paper-based manuals are CMS manuals that were officially released in hardcopy. The majority of these manuals were transferred into the Internet-only manual (IOM) or retired. Pub 15-1, Pub 15-2 and Pub 45 are exceptions to this rule and are still active paper-based manuals. The remaining paper-based manuals are for reference purposes only. If you notice policy contained in the paper-based manuals that was not transferred to the IOM, send a message via the CMS Feedback tool. Those wishing to subscribe to old versions of CMS manuals should contact the National Technical Information Service, Department of Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone (703-605-6050). You can download copies of the listed material free of charge at: 
                            *http://cms.gov/​manuals.* How To Review Transmittals or Program Memoranda Those wishing to review transmittals and program memoranda can access this information 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. This information is available at 
                            *http://www.gpo.gov/​libraries/​.* 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. CMS publication and transmittal numbers are shown in the listing entitled Medicare and Medicaid Manual Instructions. To help FDLs locate the materials, use the CMS publication and transmittal numbers. For example, to find the Medicare National Coverage Determination publication titled Screening for the Human Immunodeficiency Virus (HIV) Infection Screening for the Human Immunodeficiency Virus (HIV) Infection—use CMS-Pub. 100-03, Transmittal No. 131. Addendum I lists a unique CMS transmittal number for each instruction in our manuals or program memoranda and its subject number. 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 manual. For the purposes of this quarterly notice, we list below all the manuals, subjects, publication numbers, and the corresponding transmittal numbers for the ending date of the period covered by this notice. Based on our proposal for future quarterly notices, we would continue to provide only the specific updates to the list of manual instructions that have occurred in the three-month period along with a hyperlink to the Web site to access this information and a contact person for questions or additional information. This information is available on our Web site at 
                            *http://www.cms.gov/​Manuals.*
                             For questions or additional information, contact Ismael Torres (410-786-1864). 
 
  
 
  
 
  
 
  
 
  Addendum II: Regulation Documents Published in the Federal Register (January through March 2011) 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 
                            *http://www.gpo.gov/​fdsys.*
                             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 available 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) through the present date and can be accessed at 
                            *http://www.gpoaccess.gov/​fr/​index.html.*
                             The following Web site 
                            *http://www.archives.gov/​federal-register/​*
                             provides information on how to access electronic editions, printed editions, and reference copies. Addendum II 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 the purposes of this quarterly notice, we list dates published, the 
                            **Federal Register**
                             citations, parts of the Code of Federal Regulations (CFR) that have changed (if applicable), agency file codes, and titles of the regulations for the ending date of the period covered by this notice. Based on our proposal for future quarterly notices, we would discontinue publishing the list of all substantive and interpretive Medicare and Medicaid regulations and general notices published in the 
                            **Federal Register.**
                             We would continue to provide the hyperlink to the Web site to access this information and a contact person for questions or additional information.
                            ( print page 48573) This information is available on our Web site at: 
                            *http://www.cms.gov/​quarterlyproviderupdates/​downloads/​Regs-1Q11QPU.pdf.* For questions or additional information, contact Terri Plumb (410-786-4481). Addendum III: CMS Rulings 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. The rulings can be accessed at 
                            *http://www.cms.gov/​Rulings/​CMSR/​list.asp#TopOfPage.* For questions or additional information, contact Tiffany Lafferty (410-786-7548). Addendum IV: Medicare National Coverage Determinations (January through March 2011) Addendum IV includes completed national coverage determinations (NCDs), or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified by the section of the National Coverage Determination Manual (NCDM) in which the decision appears, the title, the date the publication was issued, and the effective date of the decision. 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 the Medicare Program (title XVIII of the Act), but does not include a determination of the code, if any, that is assigned to a particular covered item or service, or payment determination for a particular covered item or service. 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. Information on completed decisions as well as pending decisions has also been posted on the CMS Web site.  Based on our proposal for future quarterly notices, we would continue to provide only the specific updates that have occurred in the three-month period along with a hyperlink to the Web site to access this information and a contact person for questions or additional information. This information is available on our Web site at: 
                            *http://www.cms.gov/​medicare-coverage-database/​.* For questions or additional information, contact Wanda Belle (410-786-7491). Addendum V: FDA-Approved Category B Investigational Device Exemptions (IDEs) (January through March 2011) Addendum V includes listings of the FDA-approved investigational device exemption (IDE) numbers that the FDA assigns. The listings are organized according to the categories to which the devices are assigned (that is, Category A or Category B), and identified by the IDE number. For the purposes of this quarterly notice, we list the Category B IDEs as of the ending date of the period covered by this notice. Based on our proposal for future quarterly notices, we would continue to provide only the specific updates that have occurred in the three-month period along with a hyperlink to the Web site to access this information and a contact person for questions or additional information. For questions or additional information, contact John Manlove (410-786-6877). 
 
  Addendum VI: Approval Numbers for Collections of Information (January through March 2011) Addendum VI 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. All approval numbers are available to the public at Reginfo.gov, through a computer system that supports the information collection review process. Under the review process, approved information collection requests are assigned OMB control numbers. A single control number may apply to several related information collections. 
 
  
 
  
 
  For the purposes of this quarterly notice, we list all active approval numbers as of the ending date of the period covered by this notice. Based on our proposal for future quarterly notices, we would discontinue publishing the listing 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. We would continue to provide the hyperlink to the Web site to access this information and a contact person for questions or additional information. This information is available at 
                            *http://www.reginfo.gov/​public/​do/​PRAMain.* For questions or additional information, contact Mitch Bryman (410-786-5258). Addendum VII: Medicare-Approved Carotid Stent Facilities, (January Through March 2011) Addendum VII includes listings of Medicare-approved carotid stent facilities. All facilities listed meet CMS standards for performing carotid artery stenting for high risk patients. 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  satements on competency. All facilities must at least meet our standards in order to receive coverage for carotid artery stenting for high risk patients. For the purposes of this quarterly notice, we list all Medicare-approved carotid stent facilities that meet the CMS standards as of the ending date of the period covered by this notice. Based on our proposal for future quarterly notices, we would provide only the specific updates that have occurred in the three-month period along with a hyperlink to the Web site to access this information and a contact person for questions or additional information. This information is available on our Web site at: 
                            *http://www.cms.gov/​MedicareApprovedFacilitie/​CASF/​list.asp#TopOfPage.*
                             For questions or additional information, contact Sarah J. McClain (410-786-2294). 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  Addendum VIII: American College of Cardiology's National  Cardiovascular Data Registry Sites (January Through March 2011) Addendum VIII includes a list of the American College of Cardiology's National Cardiovascular Data Registry Sites. We cover implantable cardioverter defibrillators (ICDs) for certain clinical indications, as long as information about the procedures is reported to a central registry. Detailed descriptions of the covered indications are available in the National Coverage Determination (NCD). In January 2005, CMS established the ICD Abstraction Tool through the Quality Network Exchange (QNet) as a temporary data collecton mechanism. On October 27, 2005, CMS announced that the American College of Cardiology's National Cardiovascular Data Registry (ACC-NCDR) ICD Registry satisfies the data reporting requirements in the NCD. Hospitals needed to transition to the ACC-NCDR ICD Registry by April 2006. 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. The facilities that have been designated in the quarter covered by this notice are listed. The entire list of facilities that participate in the ACC-NCDR ICD registry can be found at 
                            *http://www.ncdr.com/​webncdr/​common.* For the purposes of this quarterly notice, we list the Medicare-approved ICD facilities as of the ending date of the period covered by this notice. Based on our proposal for future quarterly notices, we would provide only the specific updates that have occurred in the three-month period along with a hyperlink to the Web site to access this information and a contact person for questions or additional information. This information is available by accessing our Web site and clicking on the link for the American College of Cardiology's National Cardiovascular Data Registry at: 
                            *http://www.ncdr.com/​webncdr/​common.* For questions or additional information, contact Joanna Baldwin, MS (410-786-7205). 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  Addendum IX: Active CMS Coverage-Related Guidance Documents (January Through March 2011) Addendum IX 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 began listing the current versions of our guidance documents in each quarterly listings notice.
                            ( print page 48637) 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(l)(1) of the Social Security. 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 IX includes a list of active CMS guidance documents as of the ending date of the period covered by this notice. 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. For the purposes of this quarterly notice, we list the active coverage-related guidance documents as of the ending date of the period covered by this notice. Based on our proposal for future quarterly notices, we would discontinue publishing this addendum unless there was an update to the list of guidance documents. We would continue to provide the hyperlink to the Web site to access this information and a contact person for questions or additional information. 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*
                             and click on the archives link. For questions or additional information, contact Lori Ashby (410-786-6322). Addendum X: List of Special One-Time Notices Regarding National Coverage Provisions (January Through March 2011) Addendum X includes a list of special one-time notices regarding national coverage provisions. We publish a list of issues that require public notification, such as a particular clinical trial or research study that qualifies for Medicare coverage. 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. Details surrounding these conditions, however, 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 X 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. There were no special one-time notices regarding national coverage provisions published in the January through March 2011 quarter. For the purposes of this quarterly notice, we provide the information that there are no special one-time notices as of the ending date of the period covered by this notice. Based on our proposal for future quarterly notices, we would discontinue publishing this addendum unless there was a circumstance requiring publication of a special one-time notice. We would continue to provide the hyperlink to the Web site to access this information and a contact person for questions or additional information. This information is available at 
                            *http://www.cms.hhs.gov/​coverage.* For questions or additional information, contact Lori Ashby (410-786-6322). Addendum XI: National Oncologic PET Registry (NOPR) (January Through March 2011) Addendum XI 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. 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. For the purposes of this quarterly notice, we provide the list of facilities that meet CMS's requirements for performing PET scans under National Coverage Determination CAG-00181N as of the ending date of the period covered by this notice. Based on our proposal for future quarterly notices, we would provide only the specific updates that have occurred in the three-month period along with a hyperlink to the Web site to access this information and a contact person for questions or additional information. This information is available at 
                            *http://www.cms.gov/​MedicareApprovedFacilitie/​NOPR/​list.asp#TopOfPage.* For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564). 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (January Through March 2011) Addendum XII includes a listing of Medicare-approved facilities that receive coverage for ventricular assist devices used as destination therapy. All facilities were required to meet our standards in order to receive coverage for ventricular assist devices implanted as destination therapy. 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. For the purposes of this quarterly notice, we list all Medicare-approved facilities that meet our standards as of the ending date of the period covered by this notice. Based on our proposal for future quarterly notices, we would provide only the specific updates that have occurred in the three-month period along with a hyperlink to the Web site to access this information and a contact person for questions or additional information. This information is available on our Web site at 
                            *http://www.cms.gov/​MedicareApprovedFacilitie/​VAD/​list.asp#TopOfPage.* For questions or additional information, contact JoAnna Baldwin, MS (410-786-7205). 
 
  
 
  
 
  Addendum XIII: Lung Volume Reduction Surgery (LVRS) (January Through March 2011) Addendum XIII 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 were also eligible to receive coverage. 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 Commission 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. 
 
  For the purposes of this quarterly notice, we list all Medicare-approved facilities that meet the CMS standards as of the ending date of the period covered by this notice. Based on our proposal for future quarterly notices, we would provide only the specific updates that have occurred in the three-month period along with a hyperlink to the Web site to access this information and a contact person for questions or additional information. This information is available on our Web site at 
                            *http://www.cms.gov/​MedicareApprovedFacilitie/​LVRS/​list.asp#TopOfPage.* For questions or additional information, contact JoAnna Baldwin, MS (410-786-7205). Addendum XIV Medicare-Approved Bariatric Surgery Facilities (January Through March 2011) Addendum XIV 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. 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). For the purposes of this quarterly notice, we list all Medicare-approved facilities that meet CMS's minimum facility standards for bariatric surgery and have been certified by ACS and/or ASMBS as of the ending date of the period covered by this notice. Based on our proposal for future quarterly notices, we would provide only the specific updates that have occurred in the three-month period along with a hyperlink to the Web site to access this information and a contact person for questions or additional information. This information is available on our Web site at 
                            *http://www.cms.gov/​MedicareApprovedFacilitie/​BSF/​list.asp#TopOfPage*. For questions or additional information, contact Kate Tillman, RN, MAS (410-786-9252). 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 Addendum XV FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (January Through March 2011) Addendum XV includes a listing of Medicare-approved clinical trials for fluorodeoxyglucose positron emission tomography (FDG-PET) for dementia and neurodegenerative diseases. 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.  For the purposes of this quarterly notice, we list all Medicare-approved clinical trials as of the ending date of the period covered by this notice. Based on our proposal for future quarterly notices, we would discontinue publishing this addendum unless there were additional Medicare-approved clinical trials for fluorodeoxyglucose positron emission tomography (FDG-PET) for dementia and neurodegenerative diseases. We would continue to provide the hyperlink to the Web site to access this information and a contact person for questions or additional information. This information is available on our Web site at 
                            *http://www.cms.gov/​MedicareApprovedFacilitie/​PETDT/​list.asp#TopOfPage*. For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564).


BILLING CODE 4120-01-P BILLING CODE 4120-01-C [FR Doc. 2011-19954 Filed 8-5-11; 8:45 am]