Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2012, 11189-11201 [2013-03480]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices specifically questioning the government’s calculation of the public burden. Comment: The respondent commented that the extension of the information collection would violate the fundamental purposes of the Paperwork Reduction Act because of the burden it puts on the entity submitting the information and the agency collecting the information. The respondent opposes granting the extension of the information collection requirement. Response: In accordance with the Paperwork Act (PRA), agencies can request OMB approval of an existing information collection. The PRA requires that agencies use the Federal Register notice and comment process to extend the OMB’s approval every three years. This extension to a previously approved information collection pertains to the provision at GSAR 552.211–77, Packing List, which requires contractors to include a packing list that verifies the placement of the order and identifies the items shipped, a normal commercial practice. In addition to the information contractors would normally include on packing lists, the government requires identification of the name of the government credit cardholder, telephone number and the term ‘‘Credit Card’’ on the packing list in supply contracts. The purpose of the information collection is to facilitate administration of government credit card purchases. Often the government credit cardholder is different from the consignee receiving shipment of the supplies. Providing the additional information ensures the recipient of the packing list, the consignee, notifies the government credit cardholder that the shipment has been received. Once the notification of successful shipment has been received, the cardholder can then authorize payment. This feedback is essential for the cardholder to reconcile his/her monthly statements. This is especially important if the micropurchase threshold is raised to support a contingency operation declaration under FAR subpart 18.2. Not granting this extension would increase costs to the Government during the reconciliation process and may delay payments to contractors for shipments of supplies received. Comment: The respondent challenged the estimates used by the agency to calculate the public burden, stating that the burden was insufficient and inadequate to reflect the actual total burden. Specifically, the respondent noted that it was unclear as to how the estimated 4,000 information collection VerDate Mar<15>2010 19:09 Feb 14, 2013 Jkt 229001 respondents were derived and the estimated number of packing lists in a given year. Therefore, the respondent stated the agency should utilize actual data from the last fiscal year or an estimate of the last three to five fiscal years, reassess the estimated burden, and revise it upwards to be more accurate as was done in FAR Case 2007– 006. The respondent also found the ‘‘less than one minute per response estimate’’ to be unrealistically low stating the burden requires creating the packing list. Response: Serious consideration is given during the open comment period to all comments received and adjustments are made to the paperwork burden estimate when necessary. The burden is prepared taking into consideration the necessary criteria in OMB guidance for estimating the paperwork burden put on the entity submitting the information. Consideration is given to an entity in reviewing the instruction; using technology to collect, process and disclose information; adjusting existing practices to comply with requirements; searching data sources; completing and reviewing the response and transmitting or disclosing information. Estimated burden hours only include those actions that exceed those a company would take in the normal course of business. Careful consideration went into assessing the burden for this collection. Packing lists accompanying shipments of supplies are customary in the normal course of business, including the information listed in paragraph (a) of clause 552.211–77. The public burden is limited to the annotation on the packing list the name and telephone number of the government credit cardholder and the phrase ‘‘Credit Card.’’ While there is no centralized database for the collection of the packing lists in a fiscal year, the agency found the respondent’s suggestion to use actual data reasonable to calculate the public burden. The annual reporting burden was revised, using actual data from the government-wide Federal Procurement Data System (FPDS) for Fiscal Year (FY) 2012. Two types of actions were analyzed: GSA actions for supplies where the method of payment was made by government credit card; and, nonGSA actions for supplies where both payment was by a government credit card and a GSA indefinite delivery contract for supplies was referenced. Average costs were derived in order for the government to estimate the number of packing slips per order. Thus, an adjustment is made to the annual reporting burden after review of the methodology for computing the number PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 11189 of respondents and packing lists in a given year and the estimated hours per response. The government agreed with the respondent that the time per response did not allow for review and transmission of the government credit cardholder’s name and telephone number and the phrase ‘‘Credit Card’’ into its packing list system and adjusted the burden accordingly. Members of the public may submit comments for further consideration and are encouraged to provide data to support their request for an adjustment. C. Annual Reporting Burdens Respondents: 9,919. Responses per Respondent: 13. Hours per Response: .05. Total Burden Hours: 6447. Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (MVCB), 1275 First Street NE., Washington, DC 20417, telephone (202) 501–4755. Please cite OMB Control No. 3090–0246, Packing List Clause, in all correspondence. Dated: February 8, 2013. Joseph A Neurauter, Director, Office of Acquisition Policy, Senior Procurement Executive. [FR Doc. 2013–03558 Filed 2–14–13; 8:45 am] BILLING CODE 6820–61–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–9076–N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—October Through December 2012 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 October through December 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. SUMMARY: E:\FR\FM\15FEN1.SGM 15FEN1 11190 Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices 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 .............................. Lori Ashby ............................................... Lori Ashby ............................................... Stuart Caplan, RN, MAS ........................ JoAnna Baldwin, MS .............................. JoAnna Baldwin, MS .............................. Kate Tillman, RN, MAS .......................... Stuart Caplan, RN, MAS ........................ Annette Brewer ....................................... mstockstill on DSK4VPTVN1PROD 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 19:09 Feb 14, 2013 Jkt 229001 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 2011 entitled ‘‘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, PO 00000 Frm 00058 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 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. 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 http:// 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: February 8, 2013. Kathleen Cantwell, Director, Office of Strategic Operations and Regulatory Affairs. E:\FR\FM\15FEN1.SGM 15FEN1 mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Mar<15>2010 Jkt 229001 PO 00000 Frm 00059 Fmt 4703 Addendum I: Medicare and Medicaid Manual Instructions (October through December 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 ofTers day-to-day operating instructions, policies, and procedures based on statutes and regulations, guidelines, models, and directives. In 2003, we transfonned the CMS Program Manuals into a web user-friendly presentation and renamed it the CMS Online Manual System. Sfmt 4725 E:\FR\FM\15FEN1.SGM 15FEN1 How to Obtain Manuals The Internet-only Manuals (lOMs) 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 (10M) 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 ofCMS manuals should contact the National Technical Information Service, Department of Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone (703605-6050). You can download copies of the listed material free of charge at: lillr~mbgQYLm.ilJlllillB. How to Review Transmittals or Program Memoranda Those wishing to review transmittals and program memoranda can access this information at a local Federal Depository Library (FDL). Under the FDL program, government publications are sent to approximately 1,400 designated libraries throughout the United States. Some FDLs may have arrangements to transfer material to a local library not designated as an FDL. Contact any library to locate the nearest FDL. This information is available at ht1iM'!yy~gm2£rr:!l@!:.ill1s;."~ 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 sho\\11 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. 149. 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 ~1C!Y:Jm:lliJgQI@1ill:liJ1l1§. Transmittal Number 80 81 '«': ".': 160 Manual/Subject/Publication Number Manual Updates to Clarify SNF Claims Processing Hospital Insurance (Part A) for Inpatient Hospital, Hospice. Home Health and Skilled Nursing Facility (SNF) Services - A Brief Description Starting a Benefit Period Ending a Benefit Period Definition of Inpatient for Ending a Benefit Period Update to Medicare Deductible, Coinsurance and Premium Rates for 2013 Basis for Determining the Pmt A Coinsurance Amounts Pm B Annual Deductible Part B Premium Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices 19:09 Feb 14, 2013 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: February 21,2012 (77 FR 9931), May 18,2012 (77 FR 29648), August 17,2012 (77 FR 49799) and November 9,2012 (77 FR 67368). 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. Effect of Beneficiary Agreements Not to Use Medicare Coverage and When Payment May be Made to a Beneficiary for Service of an Opt-Out Physician/Practitioner Requirements of a Private Contract Requirements of the Opt-Out A fiidavit 11191 EN15FE13.000</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 11192 VerDate Mar<15>2010 Jkt 229001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4725 162 E:\FR\FM\15FEN1.SGM 163 164 148 15FEN1 149 2562 2563 EN15FE13.001</GPH> 2564 2565 2566 2567 2568 2569 2570 2571 2572 2573 Bariatric Surgery for the Treatment of Morbid Obesity National Coverage Determination, Addition of Laparoscopic Sleeve Gastrostomy (LSG) Bariatric Surgery for Treatment of Morbid Obesity Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain (CLBP) .;;z,y::; Influenza Vaccine Payment Allowances - Annual Update for 2012-2013 Season Revised and Clarified Place of Service (POS) Coding Instructions Site of Service Payment Differential Place of Service (POS) Instructions for the Professional Component (PC or Interpretation) and the Technical Component (TC) of Diagnostic Tests Items 14-33-Provider of Service or Supplier Information Place of Service Codes (POS) and Definitions Carrier Instructions for Place of Service (POS) Codes 2574 2575 2576 2577 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction Reasonable Charge Update for 2013 for Splints, Casts, and Certain Intraocular Lenses Medicare Physician Fee Schedule Database (MPFSDB) 2013 File Layout Manual Addendum Issued to a specific audience, not posted to Internet/Intranet/ due to Sensitivity of Instruction January 2013 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files Modifications to the National Coordination of Benefits Agreement (COBA) Crossover Process Coordination of Benefits Agreement (COBA) Detailed Error Report Notification Process Coordination of Benefits Agreement (COBA) 5010 Coordination of Benefits (COB) Requirements Annual Type of Service (TOS) Update Type of Service (TOS) Updated Billing Requirements for Outpatient Therapy Services -- Middle Class Tax Reliefand Jobs Creation Act (MCTRJCA) 01'2012 Carrier Specific Requirements for Certain Specialties/Services Provider of Service or Supplier Information Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Manual Updates to Clarity SNF Claims Processing Types of Services Subject to the Consolidated Billing Requirement for SNFs Services Included in Part A PPS Payment Not Billable Separately by the SNF Physician's Services and Other Professional Services Excluded From Part A PPS Payment and the Consolidated Billing Requirement Other Excluded Services Beyond the Scope of a SNf Part A Benefit Emergency Services Services Excluded from Part A PPS Payment and the Consolidated Billing Requirement on the Basis of Beneficiary Characteristics and Election Dialysis and Dialysis-Related Services to a Beneficiary With ES RD Hospice Care for a Beneficiary'S Tel1l1inallllness Other Services Excluded from SNF PPS and Consolidated Billing Ambulance Services Screening and Preventive Services Therapy Services Determine Utilization on Day of Discharge, Death, or Day Beginning a Leave of Absence Payment of Global Surgical Split Care in a Method II Critical Access Hospital (CAl-I) Submitted with Modifier 54 and/or 55 Payment of Global Surgical Split-Care in a Method II CAH Submitted with Modifier 54 and/or 55 Affordable Care Act (ACA) Section 3025 expansion of a tleid in the Inpatient Provider Specific File (PSF) Addendum A - Provider Specific File Update to the Fiscal Intermediary Shared Systems (FISS) for the End Stage Renal Disease (ESRD) Quality Incentive Program (QIP) Adjustments lor Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices 19:09 Feb 14, 2013 161 Failure to Maintain Opt-Out Actions to Take in Cases of Failure to Maintain Opt-Out Physician/Practitioner Who Has Never Enrolled in Medicare Excluded Physicians and Practitioners Relationship between Opt-Out and Medicare Participation Agreements Participating Physicians and Practitioners Maintaining Information on Opt-Out Physicians Informing Medicare Managed Care Plans of the Identity of the Opt-Out Physicians or Practitioners Informing the National Supplier Clearinghouse (NSC) of the Identity of the Opt-Out Physicians or Practitioners System Identification Emergency and Urgent Care Situations Denial of Payment to Employers of Opt-Out Physicians and Practitioners Denial of Payment to Beneficiaries and Others Paymenl [or Medically Necessary Services Ordered or Prescribed by an Oplout Physician or Practitioner Renewal of Opt-Out Early Tellnination of Opt-Out Application to the Medicare Advantage Program Claims Denial Notices to Opt-Out Physicians and Practitioners Claims Denial Notices to Beneficiaries Manual Updates to Clarify SNF Claims Processing Three-Day Prior Hospitalization General Daily Skilled Services Defined Definition of Durable Medical Equipment Issued to a specific audience, not posted to Internet/Intranet/ due to Sensitivity of Instruction Implementing the Claims-Based Data Collection Requirement for Outpatient Therapy Services -- Section 3005(g) of the Middle Class Tax Relief and Jobs Creation Act (MCTRJCA) of2012 Expansion of Medicare Telehealth Services for CY 2013 List of Medicare Telehealth Services mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Mar<15>2010 2578 2580 2581 Jkt 229001 2582 PO 00000 2583 2584 Frm 00061 2585 Fmt 4703 2587 2586 2588 Sfmt 4725 2589 2590 E:\FR\FM\15FEN1.SGM 15FEN1 2591 2592 2593 2594 2595 2596 2597 2598 2599 2600 2601 2602 2603 2604 2605 2606 2607 2608 2609 2610 2611 Type of Service (TOS) 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 Therapy Cap Values for Calendar Year (CY) 2013 Calendar Year (CY) 2013 Annual Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment New Place of Service (POS) Code for Place of Employment/Worksite Place of Service Codes (POS) and DeJinitions Implementing the Claims-Based Data Collection Requirement for Outpatient Therapy Services -- Section 3005(g) of the Middle Class Tax Relief and Jobs Creation Act (MCTRJCA) of 2012 Issued to a specific audience, not posted to Internet!lntranet/ due to Confidentiality ofTnstruction Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain (CLBP) Expansion of Medicare Telehealth Services for CY 2013 National Correct Coding Initiative (NCCI) Add-On Codes Replacement of Identical Letter, Dated December 19, 1996 with Subject Line, Correct Coding Initiative Add-On (ZZZ) Codes - ACTION CY 2013 Update for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule Gap-tilling DMEPOS Fees Quarterly Update to the Correct Coding Initiative (CCI) Edits, Version 19.1, Effective Update To Publication 100-04, Claims Processing Instructions For Chapter 12, Non-Physician Practitioners (NPPs) Assistant-at-Surgery Services Physician Assistant (PA) Services Payment Methodology Global Surgical Payments Limitations for Assistant-at-Surgery Services Furnished by Physician Assistants Outpatient Mental Health Treatment Limitation PA Billing to the Contractor Nurse Practitioner (NP) and Clinical Nurse Specialist (CNS) Services Payment Methodology Limitations for Assistant-at-Surgery Services Furnished by Nurse Practitioners and Clinical Nurse Specialists Outpatient Mental Health Treatment Limitation NP and CNS Billing to the Contractor Clinical Social Worker (CS W) Services Payment January 2013 Update of the Hospital Outpatient Prospective Payment System (OPPS) Composite APCs Payment Adjustment for Certain Cancer Hospitals for CY 2012 and CY 2013 Billing for "Sometimes Therapy" Services that May be Paid as Non-Therapy Services for Hospital Outpatients Special Partial Hospitalization Billing Requirements for Hospitals, Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices 19:09 Feb 14, 2013 2579 Children's Hospitals Enforcing Interim Billing for Partial Hospitalization Services Submitting Bills In Sequence for a Continuous Inpatient Stay or Course of Treatment Medicare System Update to Include Rendering Line Level National Provider Identifiers (NPls) for Primary Care Incentive Program (PClP) Payments to Critical Access Hospitals (CAHs) Issued to a specific audience, not posted to Internet/Intranet/ due to Confidentiality ofTnstruction Issued to a specific audience, not posted to Internet!Intranet/ due to Sensitivity oflnstruction New Erythropoietin Stimulating Agent (ESA) Pegincsatide Requirements for End Stage Renal Disease (ESRD) Coding for Adequacy of Dialysis, Vascular Access and Infection Erroneous Partial Episode Payment Adjustments on Certain Home Health Dual-Eligible Claims Issued to a specific audience, not posted to Internet!lntranet! due to Confidentiality of Instruction Issued to a specific audience, not posted to Internet!lntranet! due to Confidentiality of Instruction Issued to a specific audience, not posted to Internet!Intranet! due to Contidentiality oflnstruction Issued to a specific audience, not posted to Internet!lntranet/ due to Confidentiality of Instruction Implementation of Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Consolidated Billing Requirements and a Clarification of Outlier Services for Calendar Year 2013 Issued to a specific audience, not posted to Internet/lntranet/ due to Confidentiality of Instruction Bariatric Surgery for the Treatment of Morbid Obesity National Coverage Determination, Addition of Laparoscopic Sleeve Gastrectomy (LSG) Billing Requirements for Special Services General HCPCS Procedure Codes for Bariatric Surgery ICD-9 Procedure Codes for Bariatric Surgery (FIs only) ICD-9 Diagnosis Codes for BMI 2:35 Claims Guidance for Payment Instructions for Downloading the Medicare ZIP Code File tor April 2013 Home Health Prospective Payment System (HH PPS) Rate Update for Calendar Year (CY) 2013 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality oflnstruction Testing HIPAA Transactions Following a System Change General Remittance Completion Requirements Announcement of Medicare Rural Health Clinic (RHC) and Federally Qualified Health Centers (FQHC) Payment Rate Increases 2013 Annual Update to the Therapy Code List Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality oflnstruction Annual Type of Service erOS) Update 11193 EN15FE13.002</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 11194 VerDate Mar<15>2010 2612 2613 Jkt 229001 2614 PO 00000 2615 Frm 00062 Fmt 4703 00 Sfmt 4725 214 437 438 \·0i·'\.•·.\;{~ Notice of New Interest Rate for Medicare Overpayments and Underpayments -1st qtr. Notification for FY 2013 Medicare Financial Management Manual, Chapter 7, Internal Control Requirements CMS Contractor Internal Control Review Process and Timcline Risk Assessment Certification Package for Internal Controls (CpIC) Requirements OMB Circular A-123, Appendix A: Internal Controls Ovcr Financial Reporting (ICOFR) CPIC - Report of Internal Control Deficiencies Definitions of Control Deficiency, Significant Deficiency, and Material Weakness Material Weaknesses Identified During the Reporting Period Statement on Standards for Attestation Engagements (SSAE) Number 16, Reporting on Controls at Service Providers Corrective Action Plans Submission, Review, and Approval of Corrective Action Plans CMS Finding Numbers List ofCMS Contractor Control Objectives None Modification/Addition of Group Codes/Specialty Codes Non-Physician Practitioner/Supplier Specialty Codes 213 E:\FR\FM\15FEN1.SGM 15FEN1 215 216 '{'\>' {'Vi :.' {i••i ·.};.'.'i\;> 00 None 435 EN15FE13.003</GPH> 436 General Update to Chapter 15 ofthe Program Integrity Manual (pIM) - Part 439 440 441 IX Correspondence Address and E-mail Addresses Section 4 of the Form CMS-855A Section 4 of the Form CMS-855B Section 4 of the Form CMS-8551 Intervening Change of Ownership (CHOW) Reserved for Future Use Reserved for Future Use Denials Ordering/CertifYing Suppliers Who Do Not Have Medicare Billing Privileges Processing Initial Form CMS-8550 Submissions Form CMS-8550 Revocations CMS or Contractor Issued Deactivations Revocations Special Instructions Regarding Revocation Reason 8 Reserved for Future Use Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instmction Revision to Section 15.5.20 of Chapter 15 of the Program Integrity Manual (PIM) Processing Form CMS-855R Applications Progress Notes and Forms Progress Notes and Forms Issued to a specific audience, not posted to Internetiintranet/ due to Confidentiality of Instruction Revision to Appeals Section of Chapter 15 ofthc Program Integrity Manual (pIM) Appeals Process Appeals Involving Non-Certified Suppliers Corrective Action Plans (CAPs) Reconsideration Requests Additional Appeal Levels Appeals Involving Certified Providers and Certified Suppliers Corrective Action Plans (CAPs) Reconsideration Requests Additional Appeal Levels Retirement of the Program Integrity management Reporting (PIMR) System Medical Review Definitions Background Background Definitions Automated Medical Review Routine Medical Review Demand Bill Claims Review Medical Review Reopening Prepay Complex Provider Specific Review Prepay Complex Service Specific Review Prepay Complex Provider Specific Probe Review Prepay Complex Service Specific Probe Review Advanced Determination of Medicare Coverage (ADMC) Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices 19:09 Feb 14, 2013 Community Mental Health Centers, and Critical Access Hospitals [Jill Review for Partial Hospitalization Services Provided in Community Mental Health Centcrs (CMHC) Bill Review for Partial Hospitalization Services Provided in Community Mental Health Centers (CMHC) Revised and Clarified Place of Service (POS) Coding Instructions Site of Service Payment DilTerential Place of Service (POS) Instructions for the Professional Component (PC or Interpretation) and the Technical Component (TC) of Diagnostic Tests Items 14-33 - Provider of Service or Supplier Information Place of Service Codes (POS) and Definitions Updated Billing Requirements for Outpatient Therapy Services -Middle Class Tax Relief and Jobs Creation Act (MCTRJCA) of2012 Carrier Specific Requirements for Certain Specialties/Services Provider of Service or Supplier Information Revisions of the Financial Limitation for Outpatient Therapy ServicesSection 3005 of the Middle Class Tax Relief and Job Creation Act of2012 Application of Financial Limitations Claims Processing Requirements for Financial Limitations Notification for Beneficiaries Exceeding Financial Limitations ....Medicare$e~()lIdaryPaver fCMS~P:ub.;tOO~Q5) ....• None mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Mar<15>2010 None 00 None 00 None Jkt 229001 PO 00000 442 Frm 00063 443 Fmt 4703 Sfmt 4725 E:\FR\FM\15FEN1.SGM 15FEN1 ..,: "; :'.. 00 None 00 None 85 Revisions to the Method of Cost Settlement for Inpatient Services for Rural Hospitals Pmiicipating 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 Implementation of the Hospital Value-Based Purchasing Program and Hospital Readmission Reduction Program for the Rural Community Hospital Demonstration ;'; ,'''';<;, 86 c';;;:.;;; 1128 1129 1130 1l3l 1132 1133 1134 1135 1136 1137 1138 1139 1140 1141 1142 1143 1144 1145 Recompiling of Application Data Structure Descriptors Elimination of the Fiscal Intermediary Shared System (FISS) OtT Quarter User Releases Implementation of the Redesigned MSN Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction Issued to a specific, audience not posted to Internet/Intranet due to Con1identiality of Instruction New Informational Unsolicited Response (IUR) Process to Identify Previously Paid Claims for Services Furnished to Medicare Beneficiaries Classified as "Unlawfully Present" in the United States New Informational Unsolicited Response (IUR) Process to Identify Previously Paid Claims for Services Furnished to Incarcerated Medicare Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction National COITect Coding Initiative (NCC!) Associated Modifier Changes (Additions) PWK System Modifications for Processing Days Adding Bankruptcy Status Field to the Recovery Audit Contractor Daily and Weekly Reports Durable Medical Equipment (DME) National Competitive Bidding (NCB): National Mail Order (NMO) Program Implementation for Diabetic Supplies Termination of the Common Working File ELGB Provider Query The Supplemental Security Income (SSJ)/Medicare Beneficiary Data for Fiscal Year 20 I 0 for Inpatient Prospective Payment System (IPPS) Hospitals, Inpatient Rehabilitation Facilities (IRFs), and Long Term Care Hospitals (L TCHs) Editing for Duplicate Payment of Nonphysician Outpatient Services Provided During an Inpatient Hospital Admission Issued to a specific, audience not posted to Internet/Intranet due to Confidentiality of Instruction MCS/TACs System Edits Health Insurance Portability and Accountability Act (HIPAA) EDI Front End Updates for April 2013 Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices 00 19:09 Feb 14, 2013 444 Postpay Complex Provider Specific Probe Review Postpay Complex Service Specific Probe Review Postpay Complex Provider Specific Review Postpay Complex Service Specific Review Data Analysis Policy Development Medical Review Edit Development Externally Directed Reviews Provider Compliance Group Directed Reviews Coding Decisions Monthly Reporting of Medical Review Savings Reserved Reserved Reserved Update for Amendments, Corrections and Delayed Entries in Medical Documentation Amendments, Corrections and Delayed Entries in Medical Documentation National Coverage Determinations (NCDs) Coverage Provisions in Interpretive Manuals Local Coverage Determinations (LCDs) Durable Medical Equipment Medicare Administrative Contractors (DME MACs) Adoption or Rejection ofLCDs Recommended by Durable Medical Equipment Program Safeguard Contractors (DME PSCs) Individual Claim Determinations When To Develop New/Revised LCDs Content of an LCD Reasonable and Necessary Provisions in LCDs Coding Provisions in LCDs Use of Absolute Words in LCDs LCD Requirements That Alternative Item or Service Be Tried First LCD Development Process Evidence Supporting LCDs The Comment Period CAC Structure and Process LCD Reconsideration Process R Challenge of an LCD etired LCDs and The LCD Record The Challenge Subpoenas Dismissals for Cause Effectuating the Decision Evaluation of Local Coverage Determination (LCD) Topics for National Coverage Determination (NCD) Consideration Retirement of the Program Integrity Management Reporting (PIMR) System 11195 EN15FE13.004</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 11196 VerDate Mar<15>2010 1147 1148 1149 1150 Jkt 229001 1151 1152 PO 00000 1153 1154 Frm 00064 1155 1156 Fmt 4703 1157 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity oflnstruction Implementation of the Revised Health Insurance Claim Form CMS-1500 (02/12) (Analysis Only) Fee for Service Beneficiary Data Streamlining (FFS BDS) Multiple Procedure Payment Reduction (MPPR) on the Technical Component (TC) of Diagnostic Cardiovascular and Ophthalmology Procedures Issued to a specific, audience not posted to Internet/Intranet due to Confidentiality of Instruction Use ofQ6 Moditier for Locum Tenens by Providing Performing Provider NPI - Analysis only CR New Screens and Processes for ICD-9/ICD-1O, ICD-1O/ICD-9 Diagnosis and Procedure Codes Conversions for Medicare Secondary (MSP) Claims Using the General Equivalence Mappings (GEMS) 2013 Table in CWF Issued to a specific, audience not posted to Internet/Intranet due to Confidentiality ofInstruction Issued to a specific, audience not posted to Internet/Intranet due to Sensitivity ofInstruction Issued to a specific, audience not posted to Internet/lntranet due to Sensitivity of Instruction Addition of New Common Working File (CWF) Medicare Secondary Payer (MSP) Utilization Edit Codes for CWF to Send the Shared Systems When the Diagnosis Code on the Claim is Considered a Match with the Family ofDX Codes in CWF for Non-Group Health Plan (NGHP) MSP Claims Standardizing the Standard - Phase I Sfmt 4725 E:\FR\FM\15FEN1.SGM 15FEN1 Addendum II: Regulation Documents Published in the Federal Register (October through December 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 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 The following website provides information on how to access electronic editions, printed editions, and reference copies. This information is available on our website at: 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 ofthe 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 For questions or additional information, contact Tiffany Lafferty (410-786-7548). Addendum IV: Medicare National Coverage Determinations (October through December 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 XVlIl of the Act), but does not include a determination of the code, if any, that is assigned to a particular covered item or service, or payment determination for a particular covered item or service. The entries below include infonnation 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: 'w~Y}Y.&1][l'h~r@l£Qljg!IT: For questions or additional information, contact Wanda Belle (410-786-7491 ). Title Update to Pub. 100-08, Program Integrity Manual, Chapter 13 Transcutaneous Electrical Nerve NCDM Section Transmittal Number Issue Date Effective Date n/a R443 PI 12114/2012 01115/2013 NCD RI49'1CD 11/30/2012 06108/2012 Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices 19:09 Feb 14, 2013 EN15FE13.005</GPH> 1146 mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Mar<15>2010 160.27 G120110 G120111 GI20121 NCD 100.1 R148NCD 11109/2012 06/27/2012 Jkt 229001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4725 E:\FR\FM\15FEN1.SGM Addendum V: FDA-Approved Category B Investigational Device Exemptions (IDEs) (October through December 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 of three 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). 15FEN1 IDE BB15207 GI00294 GI10104 GllOl27 GIIOJ39 GII0190 GII0228 GII0238 GlI0246 GI20002 GI20090 G120091 Device Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi) Glucose Monitoring System Medtronic Activa SC Implantable Neurostimulation System Carotid Stent Revive SE Thrombectomy Device Tandem Heart System Zilver Vena Venous Stent Cobalt Stage One Acrylic Spacer Cement Surgimend PRS Fctal Bovine Absorb Bioresorbable Vascular Scaffold Libra Implantable Deep Brain Stimulation System for Adjunctive Treatment lor Treatment Resistance Major Depression Tecnis Multifocal Low-Add I-Piece Intraocular Lenses (I0LS), Start Date 10/09/12 11/08112 11120112 12/13112 11130112 11108/12 12/13112 10103/12 11128/12 12/14112 10/05/12 GI20156 G120159 GI20168 G120192 GI20204 G120207 GI20208 GI20211 GI20212 G120213 G120214 G[20221 GI20222 GI20223 GI20226 G[20233 G120234 Gl20237 GI20238 GI20245 GI20246 GI20247 GJ20249 GI20260 GI20261 0120262 GI20265 GI20267 GI20271 GI20273 G120277 G120282 Modelss ZKBOO and ZLBOO Prostate Artery Embolization Device Microvention Flow Re-Directional Endoluminal Device (FRED) Randomized, Double-Blinded, Sham Controlled Trial of Repetitive Transcranial Magnetic Stimulation in Depressed Activa Parkinsons Control Therapy Impella RP System ESVS Mesh !BV Valve System Venascal Saphcon Closure Systcm Cool Path Ablation Catheter AcrysoflQ Restor +8 Multitocal [ntraocular Lens Evolution Esophageal Stent System-Fully Covered Modell 06 With Automatic Stimulation Attain Performa Quadripolar Lead Nucleus 24 Auditory Brainstem Implant Belt Applicator tor Non-[nvasive Fat Reduction In The Outter Thigh Med IC Pharmdx Kit Solidalrity Oral Endotracheal Tube Stabilizer EENTOV[S MR Conditional System Small-Mo[ecule Functional Kinase Inhibitor Screen Nucleus CI422 SIR-Spheres Microspheres NRAS Mutation Clinical Trial Assay (CTA) Tissu.g1u Exab1ate Transcranial MRGFUS Thalmotomy Treatment Reset-VT Durolane 4.5 ML Activated HH Pathway Gene Expression Test iD NASHIDX Solesta Enlite Glucose Sensor Lenstec Tetraflex HD Posterior Chamber Intraocular Lens (lOL) Zenith T-Branch VYSIS CLL CDX FlSl I KIT (List Number: 07N67-020) Sebacia's Acne Treatment System (SA TS) Heartmatc II Left Ventricular Assist System Epicel 10/11/12 11115/12 10109/12 11107/12 11/08/12 11/06/12 11/02112 12113112 11120112 11113112 IO/l7/l2 10/18112 10/19112 10/19/12 12/28112 10/26/12 101261l2 12/21112 11/09/12 11114112 11/14/12 11114112 11120/12 11121112 11120112 11121112 12105112 12/04/12 12/05112 12/07/12 12/12/12 12119/12 12/20112 12/20112 12/19/12 Addendum VI: Approval Numbers for Collections of Information (October through December 2012) All approval numbers are available to the public at Reginfo.gov. Under the review process, approved infonnation collection requests are assigned OMB control numbers. A single control number may apply to several related infonnation collections. This infommtion is available at Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices 19:09 Feb 14, 2013 Stimulation (TENS) Chronic Low Back Pain Transcatheter Aortic Valve Replacement (TAVR) Bariatric Surgery for the Treatment for the Treatment of Morbid Obesity National Coverage Determination, Addition of Laparoscopic Sleeve Gastrostomy (LSG) 10/17/12 11197 EN15FE13.006</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 11198 VerDate Mar<15>2010 Facility Jkt 229001 PO 00000 Frm 00066 Fmt 4703 Addendum VII: Medicare-Approved Carotid Stent Facilities, (October through December 2012) Addendum VII includes listings of Medicare-approved carotid stent facilities. All facilities listed meet CMS standards for performing carotid artery stenting for high risk patients. On March 17,2005, we issued our decision memorandum on carotid artery stenting. We detennined that carotid artery stenting with embolic protection is reasonable and necessary only ifperfonned in facilities that have been detennined to be competent in perfonning 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 infonnation is available on our website at: Sfmt 4725 For questions or additional infonnation, contact Sarah J. McClain (410-786-2294). E:\FR\FM\15FEN1.SGM Facility 15FEN1 Provider Number Effective Date State Ephraim McDowell Regional Medical Center 217 South Third Street Danville, KY 40422 UC San Diego Sulpizio Cardiovascular Center 9434 Medical Center Drive La Jolla, CA 92037 Monroe Clinic 515 22nd Avenue Monroe, WI 53566 Northside Hospital Forsyth 1200 NOIihside Forsyth Drive Cumming, GA 30041 Spring Vaney Hospital Medical Center 5400 South Rainbow Boulevard Las Vegas, NV 89118 Marian Regional Medical Center 1400 East Church Street Santa Maria, CA 93454 180048 09/28/2012 KY 050025 10/24/2005 CA 520028 10/12/2012 WI 1376574277 10/3112012 GA 1346230323 11116/2012 12/28/2012 CA 050025 10/24/2005 CA FROM: UCSD La Jolla - John M. and Sally B. Thornton Hospital TO: UC San Diego Thornton Hospital 9300 Campus Point Drive La Jolla, CA 92037 EN15FE13.007</GPH> Effective Date 10/24/2005 State 230047 11/28/2005 MI CA Addendum VIII: American College of Cardiology's National Cardiovascular Data Registry Sites (October through December 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 infonnation about the procedures is reported to a central registry. Detailed descriptions of the covered indications are available in the NCO. 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 NCO. Hospitals needed to transition to the ACC-NCDR lCD Registry by April 2006. Effective January 27, 2005, to obtain reimbursement, Medicare NCO policy requires that providers implanting TCDs 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 NCO Manual, which is on the CMS Website at NV 050107 FROM: University of California San Diego Medical Center TO: UC San Diego Medical Center 200 W. Arbor Drive San Diego, CA 92103 FROM: St. Joseph's Healthcare TO: Henry Ford Macomb Hospitals 15855 Nineteen Mile Road Clinton Township, Ml 48038 Provider Number 050025 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 Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices 19:09 Feb 14, 2013 For questions or additional infonnation, contact Mitch Bryman (4lO-786-5258). mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Mar<15>2010 Jkt 229001 Facilit PO 00000 Sacred Heart on the Emerald Coast tomography (PET) scans for particular oncologic indications when they are perfonned 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 October through December 2012 quarter. This information is available at Frm 00067 For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564) Fmt 4703 Dyersburg Regional Medical Center Bedford Tucson Ruston Dyersburg AZ LA TN Sfmt 4725 E:\FR\FM\15FEN1.SGM Addendum IX: Active CMS Coverage-Related Guidance Documents (October through December 2012) There was one CMS coverage-related guidance documents published in the October through December 2012 quarter. To obtain the document, visit the CMS coverage website at For questions or additional infonnation, contact Lori Ashby (410-786-6322). 15FEN1 Addendum X: List of Special One-Time Notices Regarding National Coverage Provisions (October through December 2012) There were no special one-time notices regarding national coverage provisions published in the October through December 2012 For quarter. This information is available at questions or additional information, contact Lori Ashby (410-786-6322). Addendum XI: National Oncologic PET Registry (NOPR) (October through December 2012) Addendum XI includes a listing of National Oncologic Positron Emission Tomography Registry (NOPR) sites. We cover positron emission Facility Provider Number Effective Date State FROM: Hospital of Saint Raphael TO: YNHH- St. Raphael Campus 1450 Chapel Street New Haven, CT 05611 070022 03/06/2007 CT ,1, Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (October through December 2012) Addendum Xl[ includes a listing of Medicare-approved facilities that receive coverage for ventricular assist devices (V ADs) used as destination therapy. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy. On October 1, 2003, we issued our decision memorandum on VADs for the clinical indication of destination therapy. We determined that VADs used as destination therapy are reasonable and necessary only if performed in facilities that have been determined to have the experience and infrastructure to ensure optimal patient outcomes. We established facility standards and an application process. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy. For the purposes of this quarterly notice, we 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 Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices 19:09 Feb 14, 2013 registry. The entire list offacilities that participate in the ACC-NCDR lCD registry can be found at ~~:!:l£~~nLY~'!l£<grL!~lliTIQI1 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: For questions or additional information, contact Joanna Baldwin, MS (410-786-7205). 11199 EN15FE13.008</GPH> mstockstill on DSK4VPTVN1PROD with NOTICES 11200 VerDate Mar<15>2010 Jkt 229001 PO 00000 Facility Provider Number Date Approved State The Medical Center of Central Georgia 777 Hemlock Street Macon GA 31201 Florida Hospital 60 I East Rollins Street Orlando FL 32803 Scripps Memorial Hospital La Jolla 9888 Genesee Avenue La Jolla, CA 92037 110107 11/08/2012 GA 100007 10/29/2012 FL 050324 11126/2012 CA Frm 00068 Fmt 4703 Sfmt 4725 E:\FR\FM\15FEN1.SGM 15FEN1 Addendum XIII: Lung Volume Reduction Surgery (LVRS) (October through December 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 (L VRS): • National Emphysema Treatment Trial (NETT) approved (Beginning 05/07/2007, these will no longer automatically quality and can quality only with the other programs); • Credentialed by the Joint Commission (fonnerly, 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 offacilities for lung volume reduction surgery published in the October through December 2012 quarter. This infonnation is available on our website at For questions or additional infonnation, contact JoAnna Baldwin, MS (410-786-7205). Facility Temple University Hospital ~_ North Broad Street EN15FE13.009</GPH> Provider Number Date Approved State 3900027 11117/2012 PA Addendum XIV: Medicare-Approved Bariatric Surgery Facilities (October through December 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 detennined 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 perfonned 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 andlor ASMBS in the 3-month period. This infonnation is available on our website at For questions or additional infonnation, contact Kate Tillman, RN, MAS (410-786-9252). Facility Provider Number Date Approved State Duke Raleigh Hospital 3400 Wake Forest Road Raleigh, NC 27609 LiC San Diego Health System 200 West Arbor Drive #8401 San Diego, CA 92103 Central Mississippi Medical Center 1850 Chadwick Drive Jackson, MS 39204 Renown South Meadows Medical Center 10101 Double R BoulevardReno, NV 89521 1013916352 07116/2012 NC 1184722779 09/06/2012 CA 1033163092 08/26/2012 MS 1790789147 03/26/2012 NV Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices 19:09 Feb 14, 2013 For questions or additional infonnation, contact JoAnna Baldwin, MS (410-786-7205). mstockstill on DSK4VPTVN1PROD with NOTICES PO 00000 Frm 00069 Fmt 4703 Sfmt 9990 E:\FR\FM\15FEN1.SGM 15FEN1 Grinnell Regional Medical Center 210 Fourth Avenue Grinnell, IA 50112 FROM: SUNY Upstate Medical University TO: Upstate Medical University 750 E. Adams Street, University Hospital Syracuse, NY 13210 FROM: Marshall Medical Center North TO: Marshall Medical Centers 11491 US Hwy 431 Guntersville, AL 35950 FROM: Charleston Area Medical Center, Women and Children's Hospital TO: Charleston Area Medical Center, General Hospital 501 Morris Street Charleston, WV 25301 Oregon Health & Science University 3181 SW Sam Jackson Park Road, L223A Portland, OR 97239 Heartland Regional Medical Center 5325 Faraon Street Saint Joseph, MO 64506 FROM: St. John's Regional Health Center TO: Mercy Hospital, Springfield 1235 E. Cherokee Springfield, MO 65804 Beth Israel Deaconess Medical Center 330 Brookline Avenue Boston, MA 02215 University of North Carolina 101 Manning Drive Chapel Hill, NC 27599 Sentara Norfolk General Hospital 600 Gresham Drive Norfolk, VA 23507 Newton-Wellesley Hospital 2014 Washington Street Newton, MA 02462 Our Lady of Lourdes Regional Medical 4801 Ambassador Caffery Parkway Lafayette, Louisiana 70506 1174601397 07/3112012 FL 1629049846 09/06/2012 MS 1508845322 10/06/2012 NY 45-0044 05/28/2012 TX 590-62-4449 12114/2012 FL 1790715381 11115/2012 GA 1669420501 10/20/2012 lA 1578554630 03/27/2009 NY 01-0005 04/19/2010 AL 510022 04/04/2007 WV 107708, 380009; 1609824010 260006 011201/2012 MO 260065 03/05/2008 04-2103881 02/18/2012 MA 1932208576 08/23/2010 NC 4900073 09/30/2012 VA 1992737761 10/26/2012 05/24/2010 LA Saint Luke's Hospital of Kansas City 4401 Womall Road Kansas City, MO River Oaks Hospital Flowood, MS West Hills Hospital and Medical Center West Hills, CA Phoebe North Campus Albany, GA AnMed Health Medical Center Anderson, SC Fletcher Allen Health Care 111 Colchester Avenue Burlington, VT 05401 Kettering Medical Center Kettering, OH 07/27/2012 MA 1336294040; 05-0411 100289, 1083644033 1285672204 08106/2012 CA 10/1912012 FL 09125/2012 MD 330164 NPI# 1497941645 370091; 1144228487 1457456279 08/30/2012 NY 10/24/2012 OK 12/09/2012 NJ 340040 02112/2007 NC 1144312430 07/0112012 AL 050492; CMS# 1316027709 26-0138 06/27/2012 CA 01102/2010 MO 250138 050481 MS CA 110163 420027 470003 GA SC VT 360079 OH MA 190102 Saint Francis Hospital 6161 South Yale Avenue Tulsa, OK 74136 Hackensack University Medical Center 30 Prospect Avenue Hackensack, NJ 0760 I FROM: Pitt County Memorial Hospital TO: Vidant Medical Center 2100 Stantonsburg Road Greenville, NC 27835 Princeton Baptist Medical Center 917 Tuscaloosa Avenue, SW Birmingham, AL 35211 Community Medical Center-Clovis 2755 Herndon Avenue Clovis, CA 93611 1831151455 MO 06/27/2012 OR UMass Memorial Medical Center-Memorial Campus 55 Lake Avenue North; Room HI-760 Worcester, MA 01655 Kaiser Permanente South Bay 25825 S. Vermont Avenue Harbor City, CA 90710 Cleveland Clinic Florida 3100 Weston Road Weston, FL 33331 Sinai Hospital of Baltimore 2435 W. Belvedere Avenue Baltimore, MD 21215 Highland Hospital 1000 South Avenue Rochester, NY 14620 Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices Jkt 229001 [FR Doc. 2013–03480 Filed 2–14–13; 8:45 am] 19:09 Feb 14, 2013 BILLING CODE 4120–01–P VerDate Mar<15>2010 Jackson South Community Hospital 9333 S.W. 152nd Street Miami, FL 33157 North Mississippi Medical Center 830 South Gloster Street Tupelo, MS 38801 Huntington Hospital 270 Park Avenue Huntington, NY 11743 UT Southwestern Medical Center 5909 Harry Hines Boulevard Dallas, TX 75235 St. Vincent's Medical Center 1 ShircliffWay Jacksonville, FL 32204 Center for Surgical Weight Management at Gwinnett Medical Center - Duluth 3855 Pleasant Hill Road. Suite 210 Duluth, GA 30096 Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (October through December 2012) There were no FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials published in the October through December 2012 quarter. This infonnation is available on our website at For questions or additional infonnation, contact Stuart Caplan, RN, MAS (410-786-8564). 11201 EN15FE13.010</GPH>

Agencies

[Federal Register Volume 78, Number 32 (Friday, February 15, 2013)]
[Notices]
[Pages 11189-11201]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03480]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9076-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--October Through December 2012

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

ACTION: Notice.

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SUMMARY: This quarterly notice lists CMS manual instructions, 
substantive and interpretive regulations, and other Federal Register 
notices that were published from October through December 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.

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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           Terri Plumb........     (410) 786-4481
 Published 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             JoAnna Baldwin, MS.     (410) 786-7205
 Ventricular 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           MAS.
 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. 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 2011 entitled 
``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 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 http://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: February 8, 2013.
Kathleen Cantwell,
Director, Office of Strategic Operations and Regulatory Affairs.

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[FR Doc. 2013-03480 Filed 2-14-13; 8:45 am]
BILLING CODE 4120-01-P