Federal Register/Vol. 73, No. 125/Friday, June 27, 2008/Notices
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36596 Federal Register / Vol. 73, No. 125 / Friday, June 27, 2008 / Notices DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: It is Cardiology-National Cardiovascular HUMAN SERVICES possible that an interested party may Data Registry sites in Addendum IX may need specific information and not be be addressed to JoAnna Baldwin, MS, Centers for Medicare & Medicaid able to determine from the listed Office of Clinical Standards and Services information whether the issuance or Quality, Centers for Medicare & [CMS–9046–N] regulation would fulfill that need. Medicaid Services, C1–09–06, 7500 Consequently, we are providing contact Security Boulevard, Baltimore, MD Medicare and Medicaid Programs; persons to answer general questions 21244–1850, or you can call (410) 786– Quarterly Listing of Program concerning these items. Copies are not 7205. Issuances—January Through March available through the contact persons. Questions concerning Medicare’s 2008 (See Section III of this notice for how to active coverage-related guidance obtain listed material.) documents in Addendum X may be AGENCY: Centers for Medicare & Questions concerning CMS manual addressed to Beverly Lofton, Office of Medicaid Services (CMS), HHS. instructions in Addendum III may be Clinical Standards and Quality, Centers ACTION: Notice. addressed to Ismael Torres, Office of for Medicare & Medicaid Services, C1– Strategic Operations and Regulatory 09–06, 7500 Security Boulevard, SUMMARY: This notice lists CMS manual Affairs, Centers for Medicare & Baltimore, MD 21244–1850, or you can instructions, substantive and Medicaid Services, C4–26–05, 7500 call (410) 786–7136. interpretive regulations, and other Security Boulevard, Baltimore, MD Questions concerning one-time Federal Register notices that were 21244–1850, or you can call (410) 786– notices regarding national coverage published from January 2008 through 1864. provisions in Addendum XI may be March 2008, relating to the Medicare Questions concerning regulation addressed to Beverly Lofton, Office of and Medicaid programs. This notice documents published in the Federal Clinical Standards and Quality, Centers provides information on national Register in Addendum IV may be for Medicare & Medicaid Services, C1– coverage determinations (NCDs) addressed to Gwendolyn Johnson, 09–06, 7500 Security Boulevard, affecting specific medical and health Office of Strategic Operations and Baltimore, MD 21244–1850, or you can care services under Medicare. Regulatory Affairs, Centers for Medicare call (410) 786–7136. Additionally, this notice identifies & Medicaid Services, C4–14–03, 7500 Questions concerning National certain devices with investigational Security Boulevard, Baltimore, MD Oncologic Positron Emission device exemption (IDE) numbers 21244–1850, or you can call (410) 786– Tomography Registry sites in approved by the Food and Drug 6954. Addendum XII may be addressed to Administration (FDA) that potentially Questions concerning Medicare NCDs Stuart Caplan, RN, MAS, Office of may be covered under Medicare. This in Addendum V may be addressed to Clinical Standards and Quality, Centers notice also includes listings of all Patricia Brocato-Simons, Office of for Medicare & Medicaid Services, C1– approval numbers from the Office of Clinical Standards and Quality, Centers 09–06, 7500 Security Boulevard, Management and Budget for collections for Medicare & Medicaid Services, C1– Baltimore, MD 21244–1850, or you can of information in CMS regulations and 09–06, 7500 Security Boulevard, call (410) 786–8564. a list of Medicare-approved carotid stent Baltimore, MD 21244–1850, or you can Questions concerning Medicare- facilities. Included in this notice is a list call (410) 786–0261. approved ventricular assist device of the American College of Cardiology’s Questions concerning FDA-approved (destination therapy) facilities in National Cardiovascular Data registry Category B IDE numbers listed in Addendum XIII may be addressed to sites, active CMS coverage-related Addendum VI may be addressed to John JoAnna Baldwin, MS, Office of Clinical guidance documents, and special one- Manlove, Office of Clinical Standards Standards and Quality, Centers for time notices regarding national coverage and Quality, Centers for Medicare & Medicare & Medicaid Services, C1–09– provisions. Also included in this notice Medicaid Services, C1–13–04, 7500 06, 7500 Security Boulevard, Baltimore, is a list of National Oncologic Positron Security Boulevard, Baltimore, MD MD 21244–1850, or you can call (410) Emissions Tomography Registry sites, a 21244–1850, or you can call (410) 786– 786–7205. list of Medicare-approved ventricular 6877. Questions concerning Medicare- assist device (destination therapy) Questions concerning approval approved lung volume reduction facilities, a list of Medicare-approved numbers for collections of information surgery facilities listed in Addendum lung volume reduction surgery facilities, in Addendum VII may be addressed to XIV may be addressed to JoAnna a list of Medicare-approved clinical Melissa Musotto, Office of Strategic Baldwin, MS, Office of Clinical trials for fluorodeoxyglucose positron Operations and Regulatory Affairs, Standards and Quality, Centers for emissions tomography for dementia, Regulations Development and Issuances Medicare & Medicaid Services, C1–09– and a list of Medicare-approved Group, Centers for Medicare & Medicaid 06, 7500 Security Boulevard, Baltimore, bariatric surgery facilities. Services, C5–14–03, 7500 Security MD 21244–1850, or you can call (410) Section 1871(c) of the Social Security Boulevard, Baltimore, MD 21244–1850, 786–7205. Act requires that we publish a list of or you can call (410) 786–6962. Questions concerning Medicare- Medicare issuances in the Federal Questions concerning Medicare- approved bariatric surgery facilities Register at least every 3 months. approved carotid stent facilities in listed in Addendum XV may be Although we are not mandated to do so Addendum VIII may be addressed to addressed to Kate Tillman, RN, MA, by statute, for the sake of completeness Sarah J. McClain, Office of Clinical Office of Clinical Standards and of the listing, and to foster more open Standards and Quality, Centers for Quality, Centers for Medicare & and transparent collaboration efforts, we Medicare & Medicaid Services, C1–09– Medicaid Services, C1–09–06, 7500 are also including all Medicaid 06, 7500 Security Boulevard, Baltimore, Security Boulevard, Baltimore, MD issuances and Medicare and Medicaid MD 21244–1850, or you can call (410) 21244–1850, or you can call (410) 786– substantive and interpretive regulations 786–2994. 9252. (proposed and final) published during Questions concerning Medicare’s Questions concerning this 3-month time frame. recognition of the American College of fluorodeoxyglucose positron emission VerDate Aug<31>2005 18:50 Jun 26, 2008 Jkt 214001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4703 E:\FR\FM\27JNN2.SGM 27JNN2 jlentini on PROD1PC65 with NOTICES2 Federal Register / Vol. 73, No. 125 / Friday, June 27, 2008 / Notices 36597 tomography for dementia trials listed in II. How To Use the Addenda using the IDE numbers the FDA assigns. Addendum XVI may be addressed to This notice is organized so that a The listings are organized according to Stuart Caplan, RN, MAS, Office of reader may review the subjects of the categories to which the device Clinical Standards and Quality, Centers manual issuances, memoranda, numbers are assigned (that is, Category for Medicare & Medicaid Services, C1– substantive and interpretive regulations, A or Category B), and identified by the 09–06, 7500 Security Boulevard, IDE number. NCDs, and FDA-approved IDEs • Baltimore, MD 21244–1850, or you can published during the subject quarter to Addendum VII includes listings of call (410) 786–8564. determine whether any are of particular all approval numbers from the Office of Management and Budget (OMB) for Questions concerning all other interest. We expect this notice to be used in concert with previously collections of information in CMS information may be addressed to regulations in title 42; title 45, Gwendolyn Johnson, Office of Strategic published notices. Those unfamiliar with a description of our Medicare subchapter C; and title 20 of the CFR. Operations and Regulatory Affairs, • Addendum VIII includes listings of manuals may wish to review Table I of Regulations Development Group, Medicare-approved carotid stent Centers for Medicare & Medicaid our first three notices (53 FR 21730, 53 FR 36891, and 53 FR 50577) published facilities. All facilities listed meet CMS Services, C5–14–03, 7500 Security standards for performing carotid artery Boulevard, Baltimore, MD 21244–1850, in 1988, and the notice published March 31, 1993 (58 FR 16837). Those desiring stenting for high risk patients. or you can call (410) 786–6954. • Addendum IX includes a list of the information on the Medicare NCD American College of Cardiology’s SUPPLEMENTARY INFORMATION: Manual (NCDM, formerly the Medicare National Cardiovascular Data registry Coverage Issues Manual (CIM)) may sites. We cover implantable cardioverter I. Program Issuances wish to review the August 21, 1989, defibrillators (ICDs) for certain publication (54 FR 34555). Those The Centers for Medicare & Medicaid indications, as long as information interested in the revised process used in Services (CMS) is responsible for about the procedures is reported to a making NCDs under the Medicare administering the Medicare and central registry. Medicaid programs. These programs pay