Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July through September 2012, 67368-67379 [2012-27422]

Download as PDF 67368 Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Notices the individual named within the FOR FURTHER INFORMATION CONTACT section of this notice. Dated: September 24, 2012. Don Wright, Director, Office of Disease Prevention and Health Promotion. and interpretive regulations, and other Federal Register notices that were published from July through September 2012, relating to the Medicare and Medicaid programs and other programs administered by CMS. DEPARTMENT OF HEALTH AND HUMAN SERVICES [CMS–9075–N] Centers for Medicare & Medicaid Services 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. FOR FURTHER INFORMATION CONTACT: Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—July through September 2012 [FR Doc. 2012–27425 Filed 11–8–12; 8:45 am] BILLING CODE 4150–32–P Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: This quarterly notice lists CMS manual instructions, substantive SUMMARY: 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 .............. Lori Ashby ............................... Lori Ashby ............................... Stuart Caplan, RN, MAS ........ JoAnna Baldwin, MS .............. JoAnna Baldwin, MS .............. Kate Tillman, RN, MAS .......... Stuart Caplan, RN, MAS ........ Annette Brewer ....................... tkelley on DSK3SPTVN1PROD 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 VerDate Mar<15>2010 17:34 Nov 08, 2012 Jkt 229001 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. 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 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 Phone No. (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) 786–1864 786–4481 786–7548 786–7491 786–6877 786–5258 786–2294 786–7205 786–6322 786–6322 786–8564 786–7205 786–7205 786–9252 786–8564 786–6580 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, this quarterly notice provides 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 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 E:\FR\FM\09NON1.SGM 09NON1 Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Notices 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. III. How To Use the Notice tkelley on DSK3SPTVN1PROD with NOTICES This notice is organized into 15 addenda so that a reader may access the subjects published during the quarter VerDate Mar<15>2010 17:34 Nov 08, 2012 Jkt 229001 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— PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 67369 Hospital Insurance, Program No. 93.774, Medicare—Supplementary Medical Insurance Program, and Program No. 93.714, Medical Assistance Program) Dated: November 5, 2012. Kathleen Cantwell, Director, Office of Strategic Operations and Regulatory Affairs. BILLING CODE 4120–01–P E:\FR\FM\09NON1.SGM 09NON1 tkelley on DSK3SPTVN1PROD with NOTICES 67370 VerDate Mar<15>2010 Jkt 229001 PO 00000 Frm 00042 Fmt 4703 Addendum I: Medicare and Medicaid Manual Instructions (July through September 2012) The CMS Manual System is used by CMS program components, partners, providers, contractors, Medicare 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. Sfmt 4725 E:\FR\FM\09NON1.SGM 09NON1 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 (lOM) 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 10M, 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 (703605-6050). You can download copies ofthe listed material free of charge at: https://cms.gov/manuals. Transmittal Nnmber 79 I MannallSnbject/Pnblication Nnmber January 2013 Quarterly Updates to the CMS Standard File for Reason Codes for the Fiscal Intermediary Shared System (PISS) 00 144 145 146 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 EN09NO12.009</GPH> 2494 2495 I None Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain (CLBP) National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) Liver Transplantation for Patients with Malignancies Transcatheter Aortic Valve Replacement (TAVR) Adult Liver Transplantation Pharmacy Billing for Drugs Provided "Incident To" a Physician Service This CR rescinds and fully replaces CR 7109. Validation of Payment Group Codes for Prospective Payment Systems (PPS) I Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Notices 17:34 Nov 08, 2012 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 https://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 Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain (CLBP) use CMS-Pub. 100-03, Transmittal No. 144. 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 only the specific updates to the list of manual instructions that have occurred in the 3-month period. This information is available on our website at www.cms.govlManuals. 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: December 16,2011 (76 FR 78267), February 21,2012 (77 FR 9931), May 18,2012 (77 FR 29648) and August 17,2012 (77 FR 49799). For the purposes of this quarterly notice, we are providing only the specific updates that have occurred in the 3-month period along with a hyperlink to the website to access this information and a contact person for questions or additional information. tkelley on DSK3SPTVN1PROD with NOTICES VerDate Mar<15>2010 2498 2499 Jkt 229001 2500 PO 00000 2501 Frm 00043 2502 2503 Fmt 4703 2504 Sfmt 4725 2506 2507 2505 E:\FR\FM\09NON1.SGM 2508 2509 2510 2511 2512 09NON1 2513 2514 2515 2516 2517 2518 2519 2520 2521 2522 2523 2524 2525 2526 2527 2528 2529 2530 2531 2532 2533 2534 2535 Code or Where an ICD-lO VOO-Y99 Code is Reported as the First Diagnosis on the Claim Conditional Data Element Requirements for AlB MACs and DMEMACs Consolidated Claims Crossover Process Claims Crossover Disposition and Coordination of Benefits Agreement ByPass Indicators New Non- Physician Specialty Code for Centralized Flu Nonphysician Practitioner, Supplier, and Provider Specialty Codes Medicare Claims Processing Pub. 100-04 Chapter 24 Update for Security Requirements Inpatient Rehabilitation Facility (IRF) Annual Update: Prospective Payment System (PPS) Pricer Changes for FY 2013 Payment Provisions Under IRF PPS New Fiscal Intermediary Shared System (FISS) Consistency Edit to Validate Attending Physician NPI Update-Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) Fiscal Year (FY) 2013 Annual Update Claim Adjustment Reason Code (CARC), Remittance Advice Remark Code (RARC), and Medicare Remit Easy Print (MREP) and PC Print Update Issued to a specific audience, not posted to Internetiintranet due to Sensitivity of Instruction Revised Medicare Summary Notice (MSN) Message Regarding Outpatient Therapy Caps Issued to a specific audience, not posted to Internetiintranetl due to Confidentiality of Instruction October 2012 Update of the Ambulatory Surgical Center Payment System (ASC) Annual Update for the Health Professional Shortage Area (HPSA) Bonus Payments Issued to a specific audience, not posted to Internetiintranetl due to Sensitivity of Instruction Instructions for Downloading the Medicare ZIP Code File for January 2013 Healthcare Common Procedure Coding System (HCPCS) Annual Update Reminder October Update to the CY 2012 Medicare Physician Fee Schedule Database (MPFSDB) October 2012 Update of the Hospital Outpatient Prospective Payment System (OPPS) Transitional Outpatient Payments (TOPs) for CY 2010 through CY 2012 Fiscal Intermediary Billing Requirements Issued to a specific audience, not posted to Internetiintranet due to Sensitivity of Instruction Issued to a specific audience, not posted to Intemetiintranetl due to Confidentiality of Instruction Healthcare Provider Taxonomy Codes (HPTC) Update, October 2012 Chapter 24 Update to Remove Outdated Information FIs, Carriers, RHHIs, AlB MACs, and CEDI HIPAA Claim Level Edits Institutional Implementation Guide (IG) Edits Institutional Implementation Guide and Direct Data Entry Edits Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Notices 17:34 Nov 08, 2012 2496 2497 Based on Patient Assessments Systematic Validation of Claims Information Using Patient Assessments New Waived Tests Update to Hospice Payment Rates, Hospice Cap, Hospice Wage Index and the Hospice Prices for FY 2013 Issued to a specific audience, not posted to Internetiintranet due to Sensitivity ofInstruction Issued to a specific audience, not posted to InternetiIntraneti due to Confidentiality of Instruction Clarification of the Use of the Electronic Claim Format to Indicate Where a Service Was Performed Payment Jurisdiction Among Local BIMACs for Services Paid Under the Physician Fee Schedule and Anesthesia Claims Processing Instructions for Payment Jurisdiction Conditional Data Element Requirements for AlB MACs and DMEMACs Issued to a specific audience, not posted to Internetiintranetl due to Confidentiality of Instruction Issued to a specific audience, not posted to Internetiintranetl due to Confidentiality of Instruction Issued to a specific audience, not posted to InternetiIntraneti due to Confidentiality of Instruction Issued to a specific audience, not posted to Internetiintranet due to Sensitivity ofInstruction Issued to a specific audience, not posted to Internetiintranetl due to Confidentiality of Instruction Extracorporeal Photopheresis (ICD-l 0) Medicare Part A Skilled Nursing Facility (SNF) Prospective Payment System (PPS) Pricer Update FY 2013 Claim Status Category and Claim Status Codes Update Issued to a specific audience, not posted to Internetiintranetl due to Confidentiality of Instruction Payment of Global Surgical Split Care in a Method II Critical Access Hospital (CAH) Submitted with Modifier 54 and/or 55 Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain (CLBP) National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) Transcatheter Aortic Valve Replacement (TA VR) Furnished on or After May 1,2012 Coding Requirements for Requirements for Transcatheter Aortic Valve Replacement (TAVR) Services Furnished On or After May 1,2012 Claims Processing Requirements for TAVR Services on Professional Claims Claims Processing Requirements for TAVR Services on Inpatient Hospital Claim Liver Transplantation for Patients with Malignancies Liver Transplants October 2012 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files Notification for Beneficiaries Exceeding Financial Limitations Handling Form CMS-1500 Hard Copy Claims Where an ICD-9-CM "E" 67371 EN09NO12.010</GPH> tkelley on DSK3SPTVN1PROD with NOTICES 67372 VerDate Mar<15>2010 2538 2539 Jkt 229001 PO 00000 2540 Frm 00044 2541 2542 Fmt 4703 2543 Sfmt 4725 2544 E:\FR\FM\09NON1.SGM 2545 2546 2547 09NON1 87 88 89 211 212 EN09NO12.011</GPH> Indian Health Services (IHS) Hospital Payment Rates for Calendar Year 2012 Expiration of2012 Therapy Cap Revisions and User-Controlled Mechanism to Identify Legislative Effective Dates S Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction Fiscal Year (FY) 2013 Inpatient Prospective Payment System (IPPS), Long Term Care Hospital (LTCH) PPS Changes Medicare Code Editor (MCE) Disproportionate Share Hospital (DSH) Policy Changes Effective for Cost Reporting Periods beginning on or after October 1, 2009 Disproportionate Share Hospital (DSH) Policy Changes Effective for Cost Reporting Periods beginning on or after October 1, 2012 Repeat Admissions Outpatient Services Treated as Inpatient Services Replaced Devices Offered Without Cost or With a Credit Addenda A-Provider Specific File Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity ofInstruction Issued to a specific, audience not posted to InternetlIntranet due to Confidentiality of Instruction 2013 Annual Update of Healthcare Common Procedure Coding System (HCPCS) Codes for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Update Extracorporeal Photopheresis (ICD-l 0) Billing Requirements for Extracorporeal Photopheresis Healthcare Common Procedural Coding System (HCPCS), Applicable Diagnosis Codes and Procedure Code Medicare Summary Notices (MSNs), Remittance Advice Remark Codes (RAs) and Claim Adjustment Reason Code Contractor and Common Working File (CWF) Additional Instructions Related to Change Request (CR) 7633 - Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol Misuse Issued to a specific audience, not posted to Internet/ Intranet due to Confidentiality of Instruction Instructions for Retrieving the 2013 Pricing and HCPCS Data Files through CMS' Mainframe Telecommunications Systems Claim Status Category and Claim Status Codes Update Clarification of Medicare Conditional Payment Policy and Billing Procedures for Liability, No-Fault and Workers' Compensation Medicare Secondary Payer (MSP) Claims. Expanding the Coordination of Benefits (COB) Contractor Numbers to include 11139 and 11142 for the Common Working File (CWF) Definition of MSP/CWF Terms Expanding the Coordination of Benefits (COB) Contractor Numbers to include 11139 and 11142 for the Common Working File (CWF) Notice of New Interest Rate for Medicare Overpayments and Underpayments - 4th Notification for FY 2011 New Non- Physician Specialty Code for Centralized Flu Claims Processing 210 Timeliness - All Claims Part ElInterest Payment Data Non-Physician Practitioner/Supplier Specialty Codes Validation of Recovery Audit Program New Issues 82 CMS Certification Numbers for Medicaid-Only Hospitals and New State Code for Foreign Countries 00 None I 00 None I 00 None 00 None 108 109 This is the initial release of New Chapter 21, Compliance Program Guidelines This is the initial release of New Chapter 21, Compliance Program Guidelines 00 None 84 Revisions to the Method of Cost Settlement for Inpatient Services for Rural Hospitals Participating Under Demonstration Authorized by Section 41 OA of the Medicare Modernization Act. Sections 3123 and 10313 of the Affordable Care Act authorizes an expansion of the demonstration and an extension for an additional 5-year period. This CR makes revisions to CR 7505, which gives instructions for the additional 5-year period. 1101 Reporting of Recoupment for Overpayment on the Remittance Advice (RA) with Patient Control Number Direction to Modify Institutional Reason Code 39012 Health Insurance Portability and Accountability Act (HIPAA) 5010 and D.O Execution of the Annual Recertification Program Issued to a specific audience, not posted to InternetlIntranet due to Sensitivity of Instruction Issued to a specific, audience not posted to Internet/Intranet due to Confidentiality of Instruction Posting the Limiting Charge after Applying the e-Prescribing (eRx) Negative Adjustment The Medicare Secondary Payer Payment Module (MSPPA Y) to be Maintained by the Shared System Maintainers for all Future Enhancements Fee For Service Common Eligibility Services (FFS CES) - Common Working File (CWF) Detail Analysis, Design and Requirements Issued to a specific, audience not posted to IntemetlIntranet due to Confidentiality of Instruction Revision of Medicare Summary Notice (MSN) for Non-Competitive Bid Claims Expand Place of Service Address to Include Full Address I I 1102 ll03 1104 ll05 1106 1107 1108 1109 1110 1111 Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Notices 17:34 Nov 08, 2012 2536 2537 tkelley on DSK3SPTVN1PROD with NOTICES VerDate Mar<15>2010 1112 1114 1115 Jkt 229001 1116 1117 1118 PO 00000 1119 1120 Frm 00045 1121 1122 Fmt 4703 Sfmt 4725 E:\FR\FM\09NON1.SGM 09NON1 Addendum II: Regulation Documents Published in the Federal Register (July through September 2012) Regulations and Notices Regulations and notices are published in the daily Federal Register. To purchase individual copies or subscribe to the Federal Register, contact GPO at 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 https://www.gpoaccess.gov/fr/. The following Website https://www.archives.gov/federal-register/provides information on how to access electronic editions, printed editions, and reference copies. This information is available on our Website at: https://www .cms. gov!guarterlyproviderupdates!downloads/Regs3Q12QPU.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 https://www .cms. gov/Rulings!CMSRllist.asp#TopOfPage. For questions or additional information, contact Tiffany Lafferty (410-786-7548). Addendum IV: Medicare National Coverage Determinations (July through September 2012) 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 NCD Manual (NCDM) in which the decision appears, the title, the date the publication was issued, and the effective date of the decision. An NCD is a determination by the Secretary for whether or not a particular item or service is covered nationally under the Medicare Program (title XVIII ofthe 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 website. For the purposes of this quarterly notice, we list only the specific updates that have occurred in the 3-month period. This information is available on our website at: www.cms.gov!medicarecoverage-database!. For questions or additional information, contact Wanda BelleJ41O-786-7491). Title Liver Transplantation for Malignancies Transcutaneous Electrical Nerve Stimulation (TENS) Chronic Low Back Pain I NCDM I Transmittal Section NCD 260.1 NCD 160.27 Number I Issue Date I Effective Date R146NCD 08/03/2012 07/1312012 R144NCD 08/03/2012 Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Notices 17:34 Nov 08, 2012 1113 Health Insurance Portability and Accountability Act (HIPAA) 5010 837 Institutional (8371) Edits and 5010 837 Professional (837P) Edits January 2012 Issued to a specific audience, not posted to InternetlIntranet due to Sensitivity of Instruction New Field Established within FISS and MCS Implement Fraud Prevention Predictive Modeling Prepayment Edits for Shared Systems (xrefCR7787) Implement Fraud Prevention Predictive Modeling Prepayment Edits for Shared Systems (xrefCR7787) Manual Medical Review of Therapy Services Issued to a specific audience, not posted to InternetlIntranet due to Sensitivity of Instruction Implementation of the Award for the Jurisdiction 5 Part A and Part B Medicare Administrative Contractor (J5 AlB MAC) Reprocurment Including a New Workload Number for the Remaining WPS Legacy Workload Issued to a specific, audience not posted to InternetlIntranet due to Confidentiality of Instruction None International Classification of Diseases (ICD)-IO Conversion from ICD-9 and Related Code Infrastructure of the Medicare Shared Systems as They Relate to CMS National Coverage Determinations (NCDs) (CR 1 of3) (TCD-IO) 06/08/2012 67373 EN09NO12.012</GPH> tkelley on DSK3SPTVN1PROD with NOTICES 67374 VerDate Mar<15>2010 05/0112012 Jkt 229001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4725 IDE E:\FR\FM\09NON1.SGM 09NON1 BB15140 GI00021 Gl101l2 GII0162 Gl10186 Gll0217 Gll0221 Gll0223 Gll0227 GII0229 G120008 G120010 G120021 Gl20030 G120075 G120076 Gl20077 G120092 G120104 G120133 EN09NO12.013</GPH> Device Magellan System Stentys Coronary Stent System Formula Balloon-Expandable Stent Solace Intra Vesical Bladder Control System Spinal Modulation Neurostimulator System Unify Quadra MP CRT-DS Device Siello S Pacing Leads Consulta CRT-P Device Ingevity Active Fixation and Passive Fixation Pace Surpass Intracranial Embolization System Pulmonx Zephyr Endobronchial Valve NEO Baroreflex Activation Therapy Intuitive Surgical Davinci Nucleus Cochlear Implant System Vercise Deep Brain Stimulation Samurai Clinical Study Reliance 4-Front Clinical Study Non-Invasive Reduction of Fat in the Inner Thighs with the Zeltiq Cool Sculpting System Robot-Assisted MRI-Guided Prostate Biopsy Allegretto Wave Eye-Q Excimer Laser System Start Date 07/06/12 09/12/12 07/18112 08/09/12 09/19/12 08/08/12 09/12/12 09/12/12 07/13/12 07/11112 07/19/12 08/24/12 08/07/12 07/19/12 07/25/12 08/16/12 07/10/12 07/12/12 08/09/12 07/03/12 Gl20151 Gl20152 Gl20155 Gl20162 Gl20164 Gl20166 Gl20169 Gl20171 Gl20175 Gl20176 Gl20181 Gl20183 Gl20188 Gl20191 Gl20194 Gl20195 Deviate-AF Zenith P-Branch Embosphere Microspheres Solitaire FR Revascularization Device Michi Neuroprotection System Supera Veritas Peripheral Sten System Subqstim Study Rescue-VT Tria Beauty Fan Precision Device Implantable Myoelectric Sensors for Upper Extremity Prosthetic Control in Transradial Amputees Star S4 Excimer Laser System Lifevest Wearable Cardioverter Defibrillator (WDC) Prevent Star SR IR Excimer Laser System and IDesign Advanced Wavescan Studio for Wavefront-Guided Lasik Treatment of Mixed Astig Star SR IR Excimer Laser System and IDesign Advanced Wavescan Studio for Wavefront-Guided Lasik Treatment of Hyperopia U1thera System Model 8850-0001 Surtavi Medtronic Reveal XT Isertable Cardiac Monitor Model 9529 Native Outflow Tract TPV System B-Tevar Device Intra-Articular Hyaluronan C-Met Immunohistochemistry Pulmonary Artery Repair with Covered Cheatham Platinum Stent The Lone AFIB Trial Nucleus 24 Auditory Brainstem Implant The Moe Plasma Treatment System 07/06/12 07/11112 09/11112 07/18/12 07/18/12 07/18/12 07120/12 07/19112 07/18/12 07125/12 07/24/12 07/25/12 07126/12 08/08/12 08/08112 08/15/12 08/15112 08124/12 08/30/12 08124112 08129/12 09/05/12 09/12/12 09/19112 09121112 09/17/12 Addendum VI: Approval Numbers for Collections of Information (July through September 2012) All approval numbers are available to the public at Reginfo.gov. Under the review process, approved information collection requests are assigned OMB control numbers. A single control number may apply to several related information collections. This information is available at www.reginfo.gov/publicldo/PRAMain. For questions or additional information, contact Mitch Bryman (410-786-5258). Addendum VII: Medicare-Approved Carotid Stent Facilities, (July through September 2012) Addendum VII includes listings of Medicare-approved carotid stent facilities. All facilities listed meet CMS standards for performing Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Notices 17:34 Nov 08, 2012 Addendum V: FDA-Approved Category B Investigational Device Exemptions (IDEs) (July through September 2012) 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 only the specific updates to the Category B IDEs as of the ending date of the period covered by this notice and a contact person for questions or additional information. For questions or additional information, contact John Manlove (410-7866877). Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c) devices fall into one ofthree classes. To assist CMS under this categorization process, the FDA assigns one of two categories to each FDA-approved investigational device exemption (IDE). Category A refers to experimental IDEs, and Category B refers to non-experimental IDEs. To obtain more information about the classes or categories, please refer to the notice published in the April 21, 1997 Federal Register (62 FR 19328). Gl20135 Gl20136 Gl20141 Gl20142 Gl20143 Gl20144 Gl20146 Gl20147 Gl20149 Gl20150 tkelley on DSK3SPTVN1PROD with NOTICES VerDate Mar<15>2010 Jkt 229001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4725 E:\FR\FM\09NON1.SGM 09NON1 Facility Provider Number Effective Date State Carlsbad Medical Center 2430 W. Pierce Street Carlsbad, NM 88220 Denver Health Medical Center 777 Bannock Street, MC0960 Denver, CO 80204 Galion Community Hospital 269 Portland Way South Galion, OH 44833 Beaumont Health System - Troy 44201 Dequindre Road Troy, MI 48085 Texoma Medical Center 5016 South US Hwy 75 Denison, TX 75020 McLaren-Lapeer Region 1375 North Main Street Lapeer, MI 48446-1350 Lutheran Medical Center 150 55th Street Brooklyn, NY 11220-2574 Southside Regional Medical Center 200 Medical Park Boulevard Petersburg, VA 23805 Saint Agnes Hospital 900 Caton Avenue Baltimore, MD 21229 Mercy Hospital Washington 901 E 5th Street Washington, MO 63090 St. Joseph Regional Medical Center 415 6th Street Lewiston, ill 83501 320065 07/1112012 NM 060011 07/1112012 CO 1215907522 07/18/2012 OH 1306825997 07/25/2012 MI 1851390967 07/25/2012 TX 230193 08/06/2012 MI 330306 08/20/2012 NY 490067 08/29/2012 VA 210011 09/10/2012 MD 260052 09113/2012 MO 1225090954 09/24/2012 ill 350070 06105/2007 ND From: Dakota Specialty Institute To: Innovis Health dba Essentia Health 3000 32nd Avenue SW Fargo, ND 58104 Facility I Provider I Effective State Date 07/06/2006 IN 330005 05/03/2005 NY 170123 05/16/2005 KS 280030 06/27/2005 NE Addendum Vill: American College of Cardiology's National Cardiovascular Data Registry Sites (July through September 2012) 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 ofthe covered indications are available in the NCD. In January 2005, CMS established the ICD Abstraction Tool through the Quality Network Exchange (QNet) as a temporary data collection 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. Effective January 27,2005, to obtain reimbursement, Medicare NCD 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. Details of the clinical indications that are covered by Medicare and their respective data reporting requirements are available in the Medicare NCD Manual, which is on the CMS Website at htlp:llwww.cms.hhs.govlManuals/IOMIitemdetail.asp?filterType=none&filt erByDID=99&sortByDID= 1&sortOrder=ascending&itemID=CMSO 14961 Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Notices 17:34 Nov 08, 2012 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 statements 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 are providing only the specific updates that have occurred in the 3-month period. This information is available on our website at: https://www .cms. govlMedicareApprovedF acilitie/CASFIlist.asp#TopOfPage For questions or additional information, contact Sarah J. McClain (410-786-2294). 67375 EN09NO12.014</GPH> tkelley on DSK3SPTVN1PROD with NOTICES 67376 VerDate Mar<15>2010 Jkt 229001 Addendum IX: Active CMS Coverage-Related Guidance Documents (July through September 2012) There were no CMS coverage-related guidance documents published in the July through September 2012 quarter. To obtain full-text copies of these documents, visit the CMS Coverage website at https://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). PO 00000 Frm 00048 Fmt 4703 Sfmt 4725 E:\FR\FM\09NON1.SGM 09NON1 Facility Name City State Addendum X: List of Special One-Time Notices Regarding National Coverage Provisions (July through September 2012) There were no special one-time notices regarding national coverage provisions published in the July through September 2012 quarter. This information is available at www.cms.hhs.gov/coverage. For questions or additional information, contact Lori Ashby (410-786-6322). Children's Mercy Hospital Norwegian American Hospital Lake Wales Medical Center Thomas Hospital Ephraim McDowell Regional Medical Center Ponca City Medical Center Northwestern Lake Forest Hospital Wentworth-Douglass Hospital Oro Valley Hospital Seton Medical Center Harker Heights Jupiter Medical Center Hendricks Regional Health St. Anthony's Hospital Maine General Medical Center Southeast Georgia Health System Central Vermont Medical Center Inc Opelousas General Health System Lodi Memorial Hospital Memorial Hospital of Tampa San Francisco Heart and Vascular Institute Feather River Hospital Mercy Memorial Hospital Palestine Regional Medical Center University Medical Center Kansas City Chicago Lake Wales Fairhope Danville Ponca City Lake Forest Dover Ora Valley Harker Heights Jupiter Danville Houston Augusta Brunswick Berlin Opelousas Lodi Tampa Daly City Paradise Monroe Palestine Lubbock MO IL FL AL KY OK IL NH AZ TX FL IN TX ME GA VT LA CA FL CA CA MI TX TX Addendum XI: National Oncologic PET Registry (NOPR) (July through September 2012) 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. There were no updates to the listing of National Oncologic Positron Emission Tomography Registry (NOPR) in the July through September 2012 quarter. This information is available at https://www.cms.govlMedicareApprovedFacilitieINOPRIlist.asp#TopOtPag s;. For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564) Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Notices 17:34 Nov 08, 2012 EN09NO12.015</GPH> 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 ACC-NCDR ICD registry. Therefore, 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. The entire list of facilities that participate in the ACC-NCDR ICD registry can be found at www.ncdr.comlwebncdr/common For the purposes of this quarterly notice, we are providing only the specific updates that have occurred in the 3-month period. This information is available by accessing our website and clicking on the link for the American College of Cardiology's National Cardiovascular Data Registry at: www.ncdr.comlwebncdr/common. For questions or additional information, contact Joanna Baldwin, MS (410-786-7205). tkelley on DSK3SPTVN1PROD with NOTICES VerDate Mar<15>2010 Jkt 229001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4725 E:\FR\FM\09NON1.SGM 09NON1 Facility Provider Number Date Approved State Abington Memorial Hospital 1200 Old York Road Abington, PA 19001 Froedtert Memorial Lutheran Hospital 9200 West Wisconsin Avenue Milwaukee, WI 53226 Maimonides Medical Center 4802 Tenth Avenue Brooklyn, NY 11219 390231 07/10/2012 PA 520177 08/0112012 Wi 330194 08/24/2012 NY Addendum XIII: Lung Volume Reduction Surgery (L VRS) (July through September 2012) 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 Commision on Accreditation of Healthcare Organizations (JCAHO)) under their Disease Specific Certification Program for LVRS; and • Medicare approved for lung transplants. Only the first two types are in the list. There were no additions to the listing of facilities for lung volume reduction surgery published in the July through September 2012 quarter. This information is available on our website at www.cms.govlMedicareApprovedF acilitielLVRS/list.asp#TopOtPage. For questions or additional information, contact JoAnna Baldwin, MS (410-786-7205). Addendum XIV: Medicare-Approved Bariatric Surgery Facilities (July through September 2012) 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 Levell 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 only the specific updates to Medicare-approved facilities that meet CMS's minimum facility standards for bariatric surgery and have been certified by ACS and/or ASMBS in the 3-month period. This information is available on our website at www.cms.govlMedicareApprovedFacilitielB SFIlist.asp#TopOtPage. For Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Notices 17:34 Nov 08, 2012 Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (July through September 2012) Addendum XII includes a listing of Medicare-approved facilities that receive coverage for ventricular assist devices (VADs) used as destination therapy. All facilities were required to meet our standards in order to receive coverage for V ADs implanted as destination therapy. On October 1, 2003, we issued our decision memorandum on V ADs for the clinical indication of destination therapy. We determined that V ADs 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 are providing only the specific updates that have occurred to the list of Medicare-approved facilities that meet our standards in the 3-month period. This information is available on our website at htip:llwww.cms.gov/MedicareApprovedFacilitieNAD/list.asp#TopOtPage. For questions or additional information, contact JoAnna Baldwin, MS (410-786-7205). 67377 EN09NO12.016</GPH> tkelley on DSK3SPTVN1PROD with NOTICES 67378 VerDate Mar<15>2010 Jkt 229001 PO 00000 Frm 00050 Fmt 4703 Sfmt 9990 E:\FR\FM\09NON1.SGM 09NON1 Facility Provider Number Date Approved State Greater Baltimore Medical Center (GBMC) Comprehensive Obesity Management Program 6535 North Charles Street Physicians Pavilion North, Suite 125 Baltimore, MD 21204 The Bryn Mawr Hospital 130 South Bryan Mawr Avenue Bryn Mawr, PA 19010 Hurley Medical Center One Hurley Plaza Flint, MI 48503-5993 Surgical Weight Loss Program at Eastern Maine Medical Center 905 Union Street, Suite II Bangor, ME 4401 Saint Vincent Hospital 123 Summer Street Worcester, MA 01608 Mount Sinai Hospital 5 East 98th Street, 15th Floor New York, NY 10029 1396774238 06/07/12 MD 24371 03/16112 PA 230132 04/14/12 MI 1790789147 06/10/12 ME 220176 06/10/10 MA 1932103413 07/15/11 NY 1386749893 05/30/2007 IN 220175 07/14/2010 MA 260104 02/24/2006 MO 140213 03/1012006 IL MPI1790717650; PI-220 11 0 330013 08/14/2012 MA 06/02/2012 NY 010078 07/30/2007 AL 01-0054 12/18/2009 AL 390050 1112112006 PA St. Francis Hospital & Health Centers 1600 Albany Street Beech Grove, IN 46107 MetroWest Medical Center, Leonard Morse Hospital 67 Union Street, Fair 4 Natick, MAOl760 SSM DePaul Health Center 12266 DePaul Drive, Suite 310 Bridgeton, MO 63044 Silver Cross Hospital and Medical Centers 1900 Silver Cross Boulevard New Lenox, IL. 60451-9508 Brigham and Women's Hospital 75 Francis Street ASBII-3 Boston, MA 02115-619 Albany Medical Center 47 New Scotland Avenue Albany, NY 12208 Northeast Alabama Regional Medical Center 400 East 10th Street Anniston, AL 36207 Parkway Medical Center 1854 Beltline Road SW Decatur, AL 35601 Allegheny General Hospital 320 East North Avenue Pittsburgh, PA 15212 EN09NO12.017</GPH> Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (July through September 2012) There were no FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials published in the July through September 2012 quarter. This information is available on our website at www.cms.govlMedicareApprovedFacilitieIPETDT/list.asp#TopOfPage. For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564). Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Notices 17:34 Nov 08, 2012 questions or additional information, contact Kate Tillman, RN, MAS (410-786-9252). Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Notices [FR Doc. 2012–27422 Filed 11–08–12; 8:45 am] BILLING CODE 4120–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–1057] Draft Guidance for Industry and Food and Drug Administration Staff; Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices.’’ This draft guidance is to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance of highly multiplexed microbiological/medical countermeasures in vitro nucleic acid based diagnostic devices (HMMDs) intended to simultaneously detect and identify multiple pathogen nucleic acids extracted from a single appropriate human specimen or culture. This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 7, 2013. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled ‘‘Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices’’ to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301– 847–8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the draft guidance to https:// tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:34 Nov 08, 2012 Jkt 229001 www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: John Hobson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5555, Silver Spring, MD 20993–0002, 301–796–5892. SUPPLEMENTARY INFORMATION: I. Background This draft guidance is to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance of HMMDs intended to simultaneously detect and identify multiple pathogen nucleic acids extracted from a single appropriate human specimen or culture. For the purposes of this draft guidance document the multiplex level that is used to define HMMDs is the capability to detect ≥20 different organisms/ targets, in a single reaction, using a nucleic acid based technology and involves testing multiple targets through a common process of specimen preparation, amplification and/or detection, and result interpretation. HMMDs are used to aid in the diagnosis of infection. The scope of this draft guidance includes nucleic acid based devices that employ technologies such as polymerase chain reaction, reversetranscriptase polymerase chain reaction, bead-based liquid arrays, microarrays, re-sequencing approaches as well as the measurement of individual targets determined by ≥20 separate assays that are reported out simultaneously through the use of a diagnostic algorithm. This draft guidance is not intended to address devices that utilize detection mechanisms other than nucleic acid based approaches. The document does not apply to devices that are intended to screen donors of blood and blood components, and donors of human cells, tissues, and cellular and tissue-based products for communicable diseases. II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on highly multiplexed microbiological/ medical countermeasure in vitro nucleic acid based diagnostic devices. It does PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 67379 not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. To receive ‘‘Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices,’’ you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301–847–8149 to receive a hard copy. Please use the document number 1803 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to currently approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR parts 801 and 809 have been approved under OMB control number 0910–0485; the collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910–0120; and the collections of information in 21 CFR part 820 have been approved under OMB control number 0910–0073. V. Comments Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see ADDRESSES) or electronic comments to https:// www.regulations.gov. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. E:\FR\FM\09NON1.SGM 09NON1

Agencies

[Federal Register Volume 77, Number 218 (Friday, November 9, 2012)]
[Notices]
[Pages 67368-67379]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27422]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9075-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--July through September 2012

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 2012, relating 
to the Medicare and 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 No.
------------------------------------------------------------------------
I CMS Manual Instructions........  Ismael Torres......    (410) 786-1864
II Regulation Documents Published  Terri Plumb........    (410) 786-4481
 in the 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      Sarah J. McClain...    (410) 786-2294
 Stent Facilities.
VIII American College of           JoAnna Baldwin, MS.    (410) 786-7205
 Cardiology-National
 Cardiovascular Data Registry
 Sites.
IX Medicare's Active Coverage-     Lori Ashby.........    (410) 786-6322
 Related Guidance Documents.
X One-Time Notices Regarding       Lori Ashby.........    (410) 786-6322
 National Coverage Provisions.
XI National Oncologic Positron     Stuart Caplan, RN,     (410) 786-8564
 Emission Tomography Registry       MAS.
 Sites.
XII Medicare-Approved Ventricular  JoAnna Baldwin, MS.    (410) 786-7205
 Assist Device (Destination
 Therapy) Facilities.
XIII Medicare-Approved Lung        JoAnna Baldwin, MS.    (410) 786-7205
 Volume Reduction Surgery
 Facilities.
XIV Medicare-Approved Bariatric    Kate Tillman, RN,      (410) 786-9252
 Surgery Facilities.                MAS.
XV Fluorodeoxyglucose Positron     Stuart Caplan, RN,     (410) 786-8564
 Emission Tomography for Dementia   MAS.
 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. 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, this quarterly notice provides 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 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

[[Page 67369]]

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.

III. 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: November 5, 2012.
Kathleen Cantwell,
Director, Office of Strategic Operations and Regulatory Affairs.
BILLING CODE 4120-01-P

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[FR Doc. 2012-27422 Filed 11-08-12; 8:45 am]
BILLING CODE 4120-01-C

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