Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2011, 78267-78281 [2011-32107]

Download as PDF jlentini on DSK4TPTVN1PROD with NOTICES Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Notices have to provide a short statement about why they are electing to implement an unreasonable rate increase. This statement would be entered into a data entry text box in the Rate Review Data Collection System and would not need to be more than a paragraph or two in length. There is no form or instructions associated with this statement apart from the requirements provided in the regulation. The Final Justification Statement will be posted on an HHS Web site in the same location as the Preliminary Justification and Rate Review Final Determination. Additionally, health insurance issuers implementing rate increases that were determined to be unreasonable, must post all of this information—the Preliminary Justification, the Rate Review Final Determination, and the Final Justification Statement on their Web sites for a period of 3 years. In addition to the aforementioned requirements, we revised the information collection request as a result of an amendment to the regulation discussed in the final rule that published September 6, 2011 (76 FR 54969). The amendment to the rate review final rule updated the applicability of the rate review requirements to include products that would be considered part of the individual or small group market had they not been sold through associations, including those that are consider to be large group products under State law or have been otherwise excluded from State’s existing definitions for individual and small group products. This change resulted in an increase in the total number of rate increases that are subject to the rate review reporting requirements. The amendment did not propose any changes to the information that issuers must submit for each rate increase. Thus, burden associated with each rate increase submission remains unchanged from the final rate review rule. The revised association product reporting requirements took effect on November 1, 2011. CMS received a 6 month Emergency PRA approval for the revised association reporting requirements on October 31, 2011 (OMB–0938–1141). CMS is now requesting a 3-year OMB approval of these collection requirements. Form Number: CMS–10379 (OCN: 0938– 1141); Frequency: Annually; Affected Public: Private Sector and States; Number of Respondents: 452; Number of Responses: 3,571; Total Annual Hours: 14,630. (For policy questions regarding this collection, contact Sally McCarty at (301) 492–4489. For all other issues call (410) 786–1326.) VerDate Mar<15>2010 16:42 Dec 15, 2011 Jkt 226001 4. Type of Information Collection Request: New information collection; Title of Information Collection: Medical Loss Ratio Annual Reporting and Rebate Calculation; Use: Under Section 2718 of the Affordable Care Act and implementing regulations at 45 CFR Part 158 (75 FR 74864, December 1, 2010 (Interim Final Rule); 75 FR 82277, December 30, 2010 (Technical Correction); and 76 FR 76574, December 7, 2011 (Final Rule with comment period)), a health insurance issuer (issuer) offering group or individual health insurance coverage must submit a report to the Secretary concerning the amount the issuer spends each year on claims, quality improvement expenses, non-claims costs, Federal and State taxes and licensing and regulatory fees, and the amount of earned premium. An issuer must provide an annual rebate to enrollees if the amount it spends on certain costs compared to its premium revenue (excluding Federal and States taxes and licensing and regulatory fees) does not meet a certain ratio, referred to as the medical loss ratio (MLR). An interim final rule (IFR) implementing the MLR was published on December 1, 2010 (75 FR 74865) and modified by technical corrections on December 30, 2010 (75 FR 82277), which added Part 158 to Title 45 of the Code of Federal Regulations. The IFR is effective January 1, 2011. A final rule regarding selected provisions of the interim final rule was published on December 7, 2011 (76 FR 76574) and an interim final rule regarding an issue not included in issuers’ reporting requirements (distribution of rebates by non-federal governmental plans) was also published on December 7, 2011 (76 FR 76596). Each issuer is required to submit MLR data annually, including information about any rebates it must provide, on a form prescribed by CMS for each large group market, small group market, and individual market within each State in which the issuer conducts business. Data is to be submitted electronically through CMS’ Health Insurance Oversight System (HIOS). Additionally, each issuer is required to maintain for a period of seven years all documents, records and other evidence that support the data included in each issuer’s annual report to the Secretary. Form Number: CMS–10418; Frequency: Annually; Affected Public: Private Sector: Business or other for-profits and not-for-profit institutions; Number of Respondents: 527; Number of Responses: 5,530; Total Annual Hours: 352,563. (For policy questions regarding this collection, contact Carol Jimenez at PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 78267 (301) 492–4457. For all other issues, call (410) 786–1326.) To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS’ Web Site address at https://www.cms.hhs.gov/ PaperworkReductionActof1995, or Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call the Reports Clearance Office on (410) 786– 1326. In commenting on the proposed information collections please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in one of the following ways by February 14, 2012: 1. Electronically. You may submit your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number llll, Room C4–26– 05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. Dated: December 13, 2011. Martique Jones, Director, Regulations Development Group, Division B Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2011–32290 Filed 12–15–11; 8:45 a.m.] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–9068–N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—July Through September 2011 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: 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 SUMMARY: E:\FR\FM\16DEN1.SGM 16DEN1 78268 Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Notices 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 I CMS Manual Instructions ....................................................................... II Regulation Documents Published in the Federal Register ................. III CMS Rulings ........................................................................................ IV Medicare National Coverage Determinations ..................................... V FDA–Approved Category B IDEs ......................................................... VI Collections of Information .................................................................... VII Medicare –Approved Carotid Stent Facilities ..................................... VIII American College of Cardiology-National Cardiovascular Data Registry Sites. IX Medicare’s Active Coverage-Related Guidance Documents .............. X One-time Notices Regarding National Coverage Provisions ............... XI National Oncologic Positron Emission Tomography Registry Sites ... XII Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities. XIII Medicare-Approved Lung Volume Reduction Surgery Facilities ...... XIV Medicare-Approved Bariatric Surgery Facilities ................................ XV Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials. All Other Information ................................................................................ Ismael Torres .................................................... Terri Plumb ....................................................... Tiffany Lafferty .................................................. Wanda Belle ..................................................... John Manlove ................................................... Mitch Bryman .................................................... Sarah J. McClain .............................................. JoAnna Baldwin, MS ........................................ (410) (410) (410) (410) (410) (410) (410) (410) 786–1864 786–4481 786–7548 786–7491 786–6877 786–5258 786–2294 786–7205 Lori Ashby ......................................................... Lori Ashby ......................................................... Stuart Caplan, RN, MAS .................................. JoAnna Baldwin, MS ........................................ (410) (410) (410) (410) 786–6322 786–6322 786–8564 786–7205 JoAnna Baldwin, MS ........................................ Kate Tillman, RN, MAS .................................... Stuart Caplan, RN, MAS .................................. (410) 786–7205 (410) 786–9252 (410) 786–8564 Annette Brewer ................................................. (410) 786–6580 jlentini on DSK4TPTVN1PROD with NOTICES 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. VerDate Mar<15>2010 16:42 Dec 15, 2011 Jkt 226001 Phone number II. Summary of the Solicitation for Comments and Response to Comments We did not receive any comments in response to our solicitation. 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. III. Revised Format for the Quarterly Issuance Notices PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 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 E:\FR\FM\16DEN1.SGM 16DEN1 Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Notices jlentini on DSK4TPTVN1PROD with NOTICES 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 VerDate Mar<15>2010 16:42 Dec 15, 2011 Jkt 226001 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 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 78269 description of our Medicare manuals should view the manuals at https://www. cms.gov/manuals. 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. BILLING CODE 4120–01–P E:\FR\FM\16DEN1.SGM 16DEN1 VerDate Mar<15>2010 Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Notices 16:42 Dec 15, 2011 Jkt 226001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4725 E:\FR\FM\16DEN1.SGM 16DEN1 EN16DE11.000</GPH> jlentini on DSK4TPTVN1PROD with NOTICES 78270 VerDate Mar<15>2010 16:42 Dec 15, 2011 Jkt 226001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4725 E:\FR\FM\16DEN1.SGM 16DEN1 78271 EN16DE11.001</GPH> jlentini on DSK4TPTVN1PROD with NOTICES Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Notices VerDate Mar<15>2010 Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Notices 16:42 Dec 15, 2011 Jkt 226001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4725 E:\FR\FM\16DEN1.SGM 16DEN1 EN16DE11.002</GPH> jlentini on DSK4TPTVN1PROD with NOTICES 78272 VerDate Mar<15>2010 16:42 Dec 15, 2011 Jkt 226001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4725 E:\FR\FM\16DEN1.SGM 16DEN1 78273 EN16DE11.003</GPH> jlentini on DSK4TPTVN1PROD with NOTICES Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Notices VerDate Mar<15>2010 Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Notices 16:42 Dec 15, 2011 Jkt 226001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4725 E:\FR\FM\16DEN1.SGM 16DEN1 EN16DE11.004</GPH> jlentini on DSK4TPTVN1PROD with NOTICES 78274 VerDate Mar<15>2010 16:42 Dec 15, 2011 Jkt 226001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4725 E:\FR\FM\16DEN1.SGM 16DEN1 78275 EN16DE11.005</GPH> jlentini on DSK4TPTVN1PROD with NOTICES Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Notices VerDate Mar<15>2010 Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Notices 16:42 Dec 15, 2011 Jkt 226001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4725 E:\FR\FM\16DEN1.SGM 16DEN1 EN16DE11.006</GPH> jlentini on DSK4TPTVN1PROD with NOTICES 78276 VerDate Mar<15>2010 16:42 Dec 15, 2011 Jkt 226001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4725 E:\FR\FM\16DEN1.SGM 16DEN1 78277 EN16DE11.007</GPH> jlentini on DSK4TPTVN1PROD with NOTICES Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Notices VerDate Mar<15>2010 Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Notices 16:42 Dec 15, 2011 Jkt 226001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4725 E:\FR\FM\16DEN1.SGM 16DEN1 EN16DE11.008</GPH> jlentini on DSK4TPTVN1PROD with NOTICES 78278 VerDate Mar<15>2010 16:42 Dec 15, 2011 Jkt 226001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4725 E:\FR\FM\16DEN1.SGM 16DEN1 78279 EN16DE11.009</GPH> jlentini on DSK4TPTVN1PROD with NOTICES Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Notices VerDate Mar<15>2010 Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Notices 16:42 Dec 15, 2011 Jkt 226001 PO 00000 Frm 00056 Fmt 4703 Sfmt 9990 E:\FR\FM\16DEN1.SGM 16DEN1 EN16DE11.010</GPH> jlentini on DSK4TPTVN1PROD with NOTICES 78280 Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Notices [FR Doc. 2011–32107 Filed 12–15–11; 8:45 am] BILLING CODE 4120–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–1586–N] Medicare Program; First Semi-Annual Meeting of the Advisory Panel on Hospital Outpatient Payment (HOP— Formerly Known as the Advisory Panel on Ambulatory Payment Classification Groups—APC Panel)—February 27, 28, and 29, 2012 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: This notice announces the first semi-annual meeting of the Advisory Panel on Hospital Outpatient Payment (HOP), formerly known as the Advisory Panel on Ambulatory Payment Classification Groups (the APC Panel) for 2012. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on the clinical integrity of the APC groups and their associated weights, and hospital outpatient supervision issues. DATES: Meeting Date: The first semiannual meeting in 2012 is scheduled for the following dates and times: • Monday, February 27, 2012, 1 p.m. to 5 p.m. eastern standard time (e.s.t.) 1 • Tuesday, February 28, 2012, 9 a.m. to 5 p.m. (e.s.t.) 1 • Wednesday, February 29, 2012, 9 a.m. to 5 p.m. (e.s.t.) 1 SUMMARY: 1 The Note: times listed in this notice are approximate times; consequently, the meetings may last longer than listed in this notice, but will not begin before the posted times. jlentini on DSK4TPTVN1PROD with NOTICES Deadlines Deadline for Presentations and Comments (which includes both hardcopy and email submissions)—5 p.m. (e.s.t.), Friday, December 30, 2011. (See below for submission instructions.) Deadline for Meeting Registration (Note: Those who do not pre register may not be able to attend the meeting since seating space is limited)—5 p.m. (e.s.t.), Friday, January 27, 2012. Deadline for Requests for Special Accommodations—5 p.m. (e.s.t.), Friday, January 27, 2012. VerDate Mar<15>2010 16:42 Dec 15, 2011 Jkt 226001 Submission Instructions for Presentations and Comments Because of staffing and resource limitations, we cannot accept written comments and or presentations by FAX, nor can we print written comments and presentations received by email for dissemination at the meeting. Presentations: Presentations must be based on the scope of the Panel designated in the Charter. Any presentations outside of the scope of this Panel will be returned and or amendments requested. Unrelated topics include, but are not limited to, the conversion factor, charge compression, revisions to the cost report, pass-through payments, correct coding, new technology applications (including supporting information/ documentation), provider payment adjustments, and which types of practitioners are permitted to supervise hospital outpatient services. All presentations will be considered public information and will be posted on the CMS Web site. Presenters should not send pictures of patients in any of the documents (unless their faces have been blocked out) or include any examples with patient identifiable information. In order to consider presentation and/ or comment requests, we will need to receive the following information: 1. A hardcopy of your presentation; only hardcopy comments and presentations can be reproduced for public dissemination. We note that all presentations are limited to 5 minutes per individual or organization. 2. An email copy of your presentations sent to the Panel mailbox, APCPanel.cms.hhs.gov or to the DFO, Paula.Smith@cms.hhs.gov. 3. Form CMS–20017 with complete contact information that includes name, address, phone, and email addresses for all presenters and a contact person that can answer any questions and or provide revisions that are requested for the presentation. Æ Presenters must clearly explain the actions that they are requesting CMS to take in the appropriate section of the form. A presenter’s relationship to the organization that they represent must also be clearly listed. Æ The form is now available through the CMS Forms Web site. The Uniform Resource Locator (URL) for linking to this form is as follows: https://www.cms. hhs.gov/cmsforms/downloads/ cms20017.pdf. ADDRESSES: Meeting Location: The meeting will be held in the Auditorium, CMS Central Office, 7500 Security Boulevard, Woodlawn, Maryland 21244–1850. PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 78281 For inquiries about the Panel, contact the Designated Federal Officier (DFO): Paula Smith, 7500 Security Boulevard, Mail Stop C4–05–17, Woodlawn, MD 21244–1850. Phone: (410) 786–4709. Mail hardcopies and email copies to the following addresses: Paula Smith, DFO, CMS, CM, HAPC, DOC—HOPS Panel, 7500 Security Blvd., Woodlawn, MD 21244–1850, Mail Stop C4–05–17, Paula.Smith@ cms.hhs.gov or APCPanel@cms.hhs. gov. FOR FURTHER INFORMATION CONTACT: Note: We recommend that you advise couriers of the following information: When delivering hardcopies of presentations to CMS, if no one answers at the above phone number, call (410) 786–4532 or (410) 786– 7267. News media representatives must contact our Public Affairs Office at (202) 690–6145. Advisory Committees’ Information Lines: The phone numbers for the CMS Federal Advisory Committee Hotline are 1–(877) 449–5659 (toll free) and (410) 786–9379 (local). Web Sites: For additional information on the Panel and updates to the Panel’s activities, we are referring readers to view our Web site at the following: https://www.cms.hhs.gov/FACA/05_ AdvisoryPanelonAmbulatoryPayment ClassificationGroups.asp#TopOfPage. (Use control + click the mouse in order to access the previous URL.) Note: There is an underscore after FACA/ 05 (like this_); there is no space. You may also search information about the Panel and its membership in the FACA database at the following URL: https://www.fido.gov/ facadatabase/public.asp. SUPPLEMENTARY INFORMATION: I. Background The Secretary of the Department of Health and Human Services (DHHS) (the Secretary) is required by section 1833(t)(9)(A) of the Social Security Act (the Act) and section 222 of the Public Health Service Act (PHS Act) to consult with an expert outside advisory panel regarding the clinical integrity of the Ambulatory Payment Classification (APC) groups and relative payment weights. The Hospital Outpatient Payment (HOP) Panel (which was formerly known as the Advisory Panel on Ambulatory Payment Classification Groups) is governed by the provisions of the Federal Advisory Committee Act (FACA) (Pub. L. 92–463), as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory panels. E:\FR\FM\16DEN1.SGM 16DEN1

Agencies

[Federal Register Volume 76, Number 242 (Friday, December 16, 2011)]
[Notices]
[Pages 78267-78281]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32107]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9068-N]


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

[[Page 78268]]

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
 Determinations.
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
 Facilities.
VIII American College of Cardiology-       JoAnna Baldwin, MS.............  (410) 786-7205
 National Cardiovascular Data Registry
 Sites.
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
 Facilities.
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

[[Page 78269]]

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 https://www.cms.gov/manuals.

    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.
BILLING CODE 4120-01-P

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[FR Doc. 2011-32107 Filed 12-15-11; 8:45 am]
BILLING CODE 4120-01-C

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