Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2016, 79489-79501 [2016-27315]

Download as PDF 79489 Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. Proposed Project Measuring Worker Well-being for Total Worker Health—New—National intended to generate data that can be used to validate a worker well-being survey instrument through testing of its psychometric properties. The survey includes questions on five domains of worker well-being including: worker evaluation and experiences with work; workplace physical environment and safety climate; organizational policies and culture; worker health status; and experiences outside of work (external context). For this study, the survey instrument will be programmed into a web-based survey that will be administered online to an existing nationwide survey panel of employed adults (KnowledgePanel®) hosted by our vendor, GfK. Deidentified data will be transmitted securely to RAND, and RAND researchers will analyze the data as a CDC contractor. The survey will be fielded to approximately 1,025 respondents in the GFK panel, and the expected burden per respondent for reading the email and completing the survey is 15 minutes or 0.25 hours of their time. This will be a one-time survey and panelists will not be asked to respond to this survey again in the future. The total estimated burden hours are 385 for reading the recruitment email and responding to the survey. There are no costs to the respondent other than their time. Institute for Occupational Safety and Health (NIOSH)—Centers for Disease Control and Prevention (CDC). Background and Brief Description As described in the Occupational Safety and Health Act of 1970 (PL 91– 596), the mission of NIOSH is to conduct research and investigations on work-related disease and injury and to disseminate information for preventing identified workplace hazards (Sections 20 (a) (1) and (d), Attachment 1). NIOSH is requesting a one-year approval for this data collection. Measuring worker well-being is the first step towards improving workplace policies, programs, and practices to promote prevention of disease and injury. The Total Worker Health® Program within NIOSH has made worker wellbeing a key aspect of its mission. The Total Worker Health (TWH) Program encompasses policies, programs, and practices that integrate protection from work-related safety and health hazards with promotion of injury and illness prevention efforts to advance worker well-being. The goal of TWH is not only to prevent disease or injury, but also to promote a culture of safety and health and an enhancement of overall wellbeing. In order to promote and enhance worker well-being it is first necessary to develop and validate instruments aimed at measuring the concept. This study is ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Average burden per response (in hrs.) Number of responses per respondent Total burden (in hrs.) Respondents Form name GFK Panelists ................................... GFK Panelists ................................... Recruitment email ............................ Worker Well-being survey ................ 1,540 1,025 1 1 5/60 15/60 128 257 Total ........................................... ........................................................... ........................ ........................ ........................ 385 Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2016–27261 Filed 11–10–16; 8:45 am] Centers for Medicare & Medicaid Services [CMS–9099–N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—July Through September 2016 BILLING CODE 4163–18–P mstockstill on DSK3G9T082PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: This quarterly notice lists CMS manual instructions, substantive SUMMARY: VerDate Sep<11>2014 17:26 Nov 10, 2016 Jkt 241001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 and interpretive regulations, and other Federal Register notices that were published from July through September 2016, relating to the Medicare and Medicaid programs and other programs administered by CMS. 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: E:\FR\FM\14NON1.SGM 14NON1 79490 Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices 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, MPA ................................. John Manlove ......................................... William Parham ...................................... Sarah Fulton, MHS ................................. Sarah Fulton, MHS ................................. JoAnna Baldwin, MS .............................. JoAnna Baldwin, MS .............................. Stuart Caplan, RN, MAS ........................ Linda Gousis, JD .................................... Sarah Fulton, MHS ................................. Sarah Fulton, MHS ................................. Stuart Caplan, RN, MAS ........................ Annette Brewer ....................................... I. Background mstockstill on DSK3G9T082PROD with NOTICES 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 VerDate Sep<11>2014 17:26 Nov 10, 2016 Jkt 241001 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. Format for the Quarterly Issuance Notices 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 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’’ PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 Phone number (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 786–4669 786–2749 786–2749 786–7205 786–7205 786–8564 786–8616 786–2749 786–2749 786–8564 786–6580 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 https:// www.cms.gov/manuals. Dated: November 7, 2016. Kathleen Cantwell, Director, Office of Strategic Operations and Regulatory Affairs. BILLING CODE 4120–01–P E:\FR\FM\14NON1.SGM 14NON1 mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 Jkt 241001 PO 00000 Frm 00081 Fmt 4703 Addendum 1: Medicare and Medicaid Manual Instructions (July through September 2016) 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\14NON1.SGM 14NON1 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 (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 of CMS manuals should contact the National Technical Information Service, Department of Commerce, 5301 Shawnee Road, Alexandria, VA 22312 Telephone (703-605-6050). You can download copies of the listed material free of charge at: https://cms.gov/manuals. How to Review Transmittals or Program Memoranda Those wishing to review transmittals and program memoranda can access this information at a local Federal Depository Library (FDL). Under the FDL program, government publications are sent to approximately 1,400 designated libraries throughout the United States. Some FDLs may have arrangements to transfer material to a local library not designated as an FDL. Contact any library to locate the nearest FDL. This information is available at 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 arc 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 manual for Medicare Internet Only Manual Publication Quarterly Update to the Correct Coding Initiative (CCI) Edits, Version22.3, Effective October 1, 2016 use (CMS-Pub. 100-04) Transmittal No. 3561. 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.gov/Manuals. Transmittal Manual/Subject/Publication Number 101 Medicare Fee-for-Service Change Request Correction and Rescind Process Change Management Process (Electronic Change Information Management Portal I Internet Only Manual Updates to Pub. 100-01, 100-02 and 100-04 to Correct Enurs and Omissions (SNF) Certification and Recertification by Physicians for Extended Care Services Admission of Medicare Patients for Care and Treatment 226 Ambulance Staffmg Requirements Vehicle Requirements for Basic Lite Support and Advanced Lite Support Definition of Ambulance Services Ground Ambulance Services I Ambulance Staffmg Requirements Vehicle Requirements for Basic Life Support and Advanced Life Support Definition of Ambulance Services I Internet Only Manual Updates to Pub. 100-0 L 100-02 and 100-04 to Correct Errors and Omissions (SNF Requirements - General 227 Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices 17:26 Nov 10, 2016 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: November 13, 2015 (80 FR 70218), February 4, 2016 (81 FR 6009), May 9, 2016 (81 FR 28072) and August 5, 2016 (81 FR 51901). We are providing only the specific updates that have occurred in the 3 -month period along with a hypcrlink to the website to access this information and a contact person for questions or additional information. 79491 EN14NO16.008</GPH> mstockstill on DSK3G9T082PROD with NOTICES 79492 VerDate Sep<11>2014 Jkt 241001 None PO 00000 i'''i\\y.~'~;:'i(,•\)'''\'\:~::: 3556 Frm 00082 Fmt 4703 3557 3558 Sfmt 4725 3559 E:\FR\FM\14NON1.SGM 3560 3561 3562 14NON1 3563 3564 3565 ;.\¥¥/(:;!:::. }\ \\i!, •;,:•:j:'~':~'?' Stern Cell Transplantation tor 'v!ultiple Myeloma, Myelofibrosis, Sickle Cell Disease, and Myelodysplastic Syndromes Stern Cell Transplantation Billing for Stern Cell Transplantation Billing for Autologous Stem Cell Transplants Billing for Allogeneic Stem Cell Transplants Stern Cell Transplantation July 2016 Update of the Hospital Outpatient Prospective Payment System COPPS) Implement Operating Rules- Phase III ERA EFT: CORE 360 Uniform Use of Claim Adjustment Reason Codes (CARC), Remittance Advice Remark Codes (RARC) and Claim Adjustment Group Code (CAGC) Rule -Update from CAQHCORE Update to Hospice Payment Rates, Hospice Cap, Hospice Wage Index and Hospice Pricer for FY 2017 Correction of Remark Code Information Preparation of Denial Notices Processing Initial Denial Qnarterly Update to the Correct Coding Initiative (CCI) Edits, Version 22.3, Effective October I, 20 16 Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print (MREP) and PC Print Update New Waived Tests Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP): Additional Instructions for the Implementation of Round 2 Recompete of the DMEPOS CRP and National Mail Order (NMO) Recompete Payment of a Part of a DMEPOS Item Payment for Capped Rental Items Items Payment for Repair and Replacement of Beneficiary-Owned Equipment Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmction '\i'(: 3569 3570 3571 3572 3573 3574 3575 3576 3577 3578 3579 15RO 3581 3582 3583 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Reopenings Update - Changes to Chapter 34 Reopenings and Revisions of Claim Determinations and Decisions- General Authority to Conduct a Reopening Reopenings Based on Clerical or Minor Errors and Omissions Telephone Reopenings - Required for AlB MACs (B) Only Informing the Provider Communities About the Telephone Reopenings Process Conducting the Telephone Reopening Monitoring the Telephone Reopening Timeframes to Reopen Claim Determinations Timeframes for Contractor Initiated Reopenings Timeframes for Party Requested Reopenings Timeframes for Adjudicator to Reopen Timeframes When a Party Requests an Adjudicator Reopen Their Decision Good Cause for Reopening Change in Substantive Law or Interpretative Policy Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmction October 2016 Qnarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Qnarterly Pricing Files Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Update-Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) Fiscal Year (FY) 2016 Annual Cpdatc Elt:clroconvulsivt: Tht:rapy (ECT) Paymt:nl Inpatient Rehabilitation Facility (IRF) Annual Update: Prospective Payment System (PPS) Pricer Changes for FY 2017 Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmction Multiple Procedure Payment Reduction (MPPR) on the Professional Compont:nl (PC) ofCt:rlain Diagnostic Imaging Proc"durt:s Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmction Issued to a specific audience, not posted to h1ternetih1tranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity Instruction Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity Instmction Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices 17:26 Nov 10, 2016 3568 ,,,,;M),:f;,,,~\:~::, f"''\'':;'.':\ 3566 EN14NO16.009</GPH> 3567 Medicare SNF PPS Overview Medicare SNF Coverage Guidelines Under PPS Hospital Providers of Exiended Care Services Prior Hospitalization and Transfer Requirements Three-Day Prior Hospitalization Three-Day Prior Hospitalization -Foreign Hospital Effect on Spell of Illness Mt:dical St:rvict: of an Inlt:rn or Rt:sidt:nl-in-Training Medical and Other Health Services Furnished to SNF Patients With Providers Services Furnished Under Definition of Durable Medical Equipment mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 3584 3586 3587 Jkt 241001 3588 3589 3590 PO 00000 3591 Frm 00083 3592 3593 Fmt 4703 3594 Sfmt 4725 3595 1596 E:\FR\FM\14NON1.SGM 3597 3598 3599 3600 14NON1 3601 3602 3603 3604 3605 3606 1607 3608 3609 1610 3611 3612 3613 3614 3615 3616 3617 Instructions for Downloading the Medicare ZIP Code File for January 2017 2017 Healthcare Common Procedure Coding System ( HCPCS) Annual Update Reminder Annual Clotting Factor Fumi shing Fee 1 Tpdate 2017 Clotting Factor Fumishing Fee Issued to a specific audience, not posted to IntemeV!ntranet due to Confidentiality of Instruction Annual Medicare Physician Fee Schedule (MPFS) Files Delivery and Implementation 2017 Annual Update for the Health Professional Shortage Area (HPSA) Bonus Payments Influenza Vaccine Payment Allowances - Annual Update for 2016-2017 St:ason Intemet Ouly Manual Updates to Pub. 100-01, 100-02 and 100-04 to Correct Errors and Omissions (SNF) Fumishing Services that are Subject to SNF Consolidated Billing Under an "'Arrangement" With an Outside Entity Under Arrangements" Relationships 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 Outpatient Surgery and Related Procedures - INCLUSION Decision Logic Used by the Pricer on Claims Issued to a specific audience, not posted to IntemeV!ntranet due to Sensitivity Instruction Changes to the Laboratmy National Coverage Detennination (NCO) Edit Software for January 2017 Update to Hepatitis B Deductible and Coinsurance and Screening Pap Smears Claims Processing Information Pneumococcal Pneumonia, Influenza Virus, and Hepatitis R Vaccines MS"' Messages Remittance Advice Codes Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity Instruction Implementation of New Influenza Virus Vaccine Code Table of Preventive and Screening Services Healthcare Common Procedure Coding System (HCPCS) and Diagnosis Codes CWP Edits on AID MAC (A) Claims CWF Edits on AlB MAC (B) Claims CWF Crossover Edits on AlB MAC (B) Claims '<}t:::'~\;,:::,::'}:'2' ;:.,::·c~Mtd~t\~~J.Nr'taW"liX~~lt.~ i,~\'i} i:~,::.:;,:;. J :::,:::;::\ ·. None ~;;.l:~:~::·,.:;~:i.··:. 270 271 272 ;::·;•.: .1\\m :~0:•·;~~;~;' :,;:h Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices 17:26 Nov 10, 2016 3585 Issued to a specific audience, not posted to IntemeV!ntranet due to Confidentiality of Instruction Issued to a specific audience, not posted to IntemeV!ntranet due to Sensitivity Instruction Issued to a specific audience, not posted to IntemeV!ntranet due to Sensitivity Instruction Issued to a specific audience, not posted to IntemeV!ntranet due to Confidentiality of Instruction Issued to a specific audience, not posted to IntemeV!ntranet due to Confidentiality of Instruction Issued to a specific audience, not posted to IntemeV!ntranet due to Confidentiality of Instruction Changt:s to lht: Fiscal lnlt:rmt:diary Shart:d Syst= (FISS) Inpalit:nl Providt:r Specific File (PSF) for Low-Volume Hospital Payment Adjustment Factor and New Inpatient Prospective Payment System (IPPS) Pricer Output Field for Islet Isolation Add-on Payment October 2016 Integrated Outpatient Code Editor (I!OCE) Specifications Version 17.3 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP): Additional Instructions for the Implementation of Round 2 Recompete of the DMEPOS CRP and National Mail Order (NMO) Recompete Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB)- October CY 2016 Update Quarterly Update to the Medicare Physician Fee Schedule Database CMPFSDB)- October CY 2016 Update Issued to a specific audience, not posted to IntemeVIntranet due to Sensitivity Instruction !Iealthcare Provider Taxonomy Codes (IIPTCs) October 2016 Code Set Updalt: October Quarterly Update tor 2016 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (Dl'v!EPOS) Fee Schedule Claim Status Category and Claim Status Codes Update Implement Operating Rules - Phase III Electronic Remittance Advice ERA) Electronic funds Transfer (EfT): CORE 360 Uniform Use of Claim Adjuslmt:nl Rt:ason Codt:s (CARC), R=illanct: Ad viet: R=ark Codt:s (RARC) and Claim Adjustment Group Code (CAGC) Rule -Update from Council for Affordable Quality Healthcare (CAQH) Committee on Operating Rules for Information Exchange (CORE) October 2016 Update of the Ambulatory Surgical Center (ASC) Payment System October 2016 Update of the Hospital Outpatient Prospective Payment System (OPPS) 2017 Annual Update of Health care Common Procedure Coding System (HCPCS) Codes for Skilled Nursing Facility (SNF) Consolidated Billing (CR) 1 Jpdate Payer Only Codes 1Jtilized hy Medicare Common Edits and Enhancements Modules (CEM) Code Set Update Notice of "'ew Interest Rate for Medicare Overpayments and Underpayments -4th Qtr Notification for FY 2016 Issued to a specific audience, not posted to IntemeV!ntranet due to Confidentiality of Instruction Issued to a specific audience, not posted to IntemeV!ntranet due to 79493 EN14NO16.010</GPH> mstockstill on DSK3G9T082PROD with NOTICES 79494 VerDate Sep<11>2014 I of Instruction 158 Jkt 241001 159 PO 00000 160 161 Frm 00084 Fmt 4703 :·•::• ~;>:Jt:S+~';:~;§ t~1 Revisions to the State Operations Manual (SOM) -Appendix PP- Guidance to Surveyors for Long Term Care Facilities Revisions to the State Operations Manual (SOM) -Chapter 5 Survey Exit Conference and Report to the Provider/Supplier Task 7: Exit Conference Revisions to State Operations Manual (SOM) Appendix J, Part II - Interpretive Guidelines - Responsibilities of Intermediate Care Facilities for Individuals with Intellectual Disabilities and Exhibit 355, Probes and Procedures for Appendix J Revisions to the State Operations Manual (SOM), Appendix I- Survey Procedures for Life Safety Code Surveys Revisions to the State Operations Manual (SOM) Chapter 7 Revisions to the State Operations Manual (SOM) Chapter 7 Mandatory Immediate Imposition of Federal Remedies Criteria for Mandatory Immediate Imposition of Federal Remedies Effective Dates for Immediate Imposition of Federal Remedies Prior to the Facility's Correction of Deficiencies Responsibilities of the State Survey Agency and the CMS Regional Office when there is an Immediate Imposition of Federal Remedies Imposition of a Civil Money Penalty when a Facility is not allowed an Opportunity to Correct Enforcement Action That Must Be Taken 2 Facilities Given an Opportunity to Correct Deficiencies prior to the Immediate Imposition of Federal Remedies Factors That Must Be Considered When Selecting Remedies Category 2 Sfmt 4725 l':c··:•;•':l\~~·.••.ct••y:~\ ~·;· 663 E:\FR\FM\14NON1.SGM 664 14NON1 665 667 668 669 ''"'"'J'\~. ·:~'>''\1\~i~'f:;cz>•\:: Denial Codes tor Missing or Insutlicient Documentation No Response or Insufficient Response to Additional Documentation Reopening Claims with Additional Information or Denied Due to Late or No Submission of Requested Information NotifYing the Provider Prepay Complex Provider Specific Review Prepay Complex Service Specific Review Postpay Complex Provider Specitlc Review Postpay Complex Service Specific Review The Process of Prior Authorization Prior Authorization Prior Authorization of Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplit:rs (DMEPOS) Issued to a specitlc audience, not posted to IntemeVIntranet due to Confidentiality of Instruction Issued to a specific audience, not posted to lntemeVlntranet due to Confidentiality of Instruction Revisions to h1structions Regarding the Fraud hwestigation Database (FID) and Other Program Integrity Procedures Issued to a specific audience, not posted to IntemeVIntranet due to Confidentiality of Instruction Issued to a specific audience, not posted to IntemeVIntranet due to Confidentiality of Instruction 670 671 Update of Payment Suspension h1structions Issued to a specific audience, not posted to IntemeVIntranet due to Confidentiality of Instruction Documentation for Durable Medical Equipment Prosthetics, Orthotics and Supplies (DMEPOS) Claims for Replacement of Essential Accessories for Beneficiary-Owned Continuous Positive Airway Pressure (CP AP) Devices and Rt:spiratory Assist Dt:vict:s (RADs) Issued to a specitlc audience, not posted to IntemeVIntranet due to Confidentiality of Instruction Duplicate Postpa;ment Claim Reviews Case Selection Update to Chapter 4, Pub. 100-08 Clarification of Ce1tain Policies in Pub. 100-08, Chapter 15 Regarding the Processing of Form CMS-855R Applications Issued to a specific audience, not posted to IntemeVIntranet due to Confidentiafity of Instruction 672 673 674 675 676 677 \'• QIO Manual Chapter 2 - Eligibility 26 ';lc;\;\;\•'{•;•<••···· ·t•~~~iUMm•iti~.~ :.. ~,~~·;;c None ••~1''?•' ; ..:: None ~(·~· None ..•;• ! ~ ;\;;,\1;;, ~'\ .; ~~; ·:~·; •,~•::•'~>r·"~··:;;t,%:·~~ .•• QIO Manual Chapter 2 - Eligibility 123 ~;!;\.•\}•i\:u •. '\.\•if.~;.::;: None ·<< 151 ;;< ••• 152 153 154 155 156 \~;'~i}l'!~~,·.··~·.;;,;,;<\' 1679 1680 1681 ;''.).:\ ~~~··:::··~.~ {\;\~··· •••••• ;•;:,•::f;{;:\;::, Shared System Enhancement 20 15 Archive/Remove Inactive Medicare Demonstration Projects Shared System Enhancement 20 15 Archive/Remove Inactive Medicare Demonstration Projects Issut:d to a spt:cific audit:nct:, not postt:d to Intt:md/ Intranet dut: to St:nsitivity Instruction Issued to a specific audience, not posted to IntemeV Intranet due to Sensitivity Instruction Issued to a specific audience, not posted to IntemeV Intranet due to Sensitivity Instruction Affordable Care Act Bundled Payments for Care Improvement Initiative Recnrrin<> File Updates Models 2 and 4 January 2017 Updates \;,;;'\i;c!:::;t0•.: i>;C,,. 'I\'\ ' 0)·,!\\ :,·.•:;.:; ..:'•' Shared Savings Program (SSP) Accountable Care Organization (ACO) QualifYing Stay Edits Issued to a specific audience, not posted to h1ternet/ h1tranet to Sensitivity of Instruction The Supplemental Security Income (SSI)/Medicare Beneficiary Data for Fiscal Year 2014 for Inpatient Prospective Payment System (IPPS) Hospitals, Inpatient Rehabilitation Facilities (IRFs), and Long Term Care Hospitals (LTC H) :.f ~;.);i!; .. Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices 17:26 Nov 10, 2016 157 666 EN14NO16.011</GPH> Crmfirl~nti'llity '.'.. i? );Y~\Jt•Y::;;•;'(~:~~.;;~:; mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 1682 1684 1685 Jkt 241001 1686 1687 PO 00000 1688 1689 1690 Frm 00085 1691 Fmt 4703 1693 1692 Sfmt 4725 1694 1695 E:\FR\FM\14NON1.SGM 1696 1697 14NON1 169R 1699 1700 1701 1702 1703 1704 1705 1706 1707 1708 1709 1710 1711 1712 1713 1714 1715 1716 1717 1718 1719 1720 1721 1722 .~:):,,~\;.i•i.·., 5R 59 Interchange (ED!) Front End Updates for January 2017 eMSN and Altemate Format MSN Service Improvements Coding Revisions to National Coverage Determination (NCDs) Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instruction Adding a Foreign Language Tagline Sheet to Medicare Summary Notices (MSNs) Medicare Appeals System (MAS) Level I Part A and Home, Heath, Hospice (HHH) Onboarding Effort Shared System Enhancement 2014- Identification of Fiscal Standard System (FISS) Obsolete Reports - Analysis Only Editing Update for Screening for Sexually Transmitted Infections Shared System Enhancement 20 14 - Identification of Fiscal Intermediary Standard System (FISS) Obsolete Reports- Analysis Only Updates to the 72X Type of Bill for Home and Self-Dialysis Training, Retraining, and Noctumal Hemodialysis Affordable Care Act- Operating Rules -Requirements for Phase II and Phase III Compliance for Batch Processing Section 504: Adding a Qualified Reader Preference in Alternate Formats Common Working File (CWF) to Remove Remaining Federal Tax Information (FTI) Received through the Internal Revenue Service (IRS), Social Security Administration (SSA), Centers for Medicare and Medicaid Services (CMS) Medicare Secondary Payer (MSP) Data Match Program from CWF. Issued to a specific audience, not posted to IntemeVIntranet due to Sensitivity of Instruction Reporting of All Recovery Auditor-Initiated Claim Adjustments and their Subsequent Adjustments for Periodic Interim Payment (PIP) Facilities Adding a Foreign I .anguage Tagline Sheet to Medicare Summary Notices (MSNs) Updating the Fiscal Intennediary Shared System (FISS) to Make Payment for Drugs and Biologicals Services for Outpatient Prospective Payment System (OPPS) Providers . tit,"!Ri "' m.1(gM '" ·~: .;•y ~ ;{ ::c·.,~ Issued to a specific audience, not posted to IntemeVIntranet due to Confidentiality of Instruction Issued to a specific audience, not posted to IntemeV!ntranet due to Confidmtiality of Instruction ;Y,:•,;;•g:;: lE"\•(i"'!~'~2'~·· None Addendum II: Regulation Documents Published in the Federal Register (July through September 2016) 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 Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices 17:26 Nov 10, 2016 1683 Issued to a specific audience, not posted to IntemeV Intranet to Sensitivity of Instruction Shared Savings Program (SSP) Accountable Care Organization (ACO) QualifYing Stay Edits Issued to a specific audience, not posted to IntemeV!ntranet due to Sensitivity of Instruction Updatt: tht: Primary Insurt:r's Policy Numbt:r of tht: Insurt:d Fidd to 17 Bytt:s on the Health Insurance Master Record (HIMR) Screen Found in the Medicare Secondary Payer (MSP) Auxiliary File. Part B Detail Line Expansion- MCS Phase 7 Common Working File (CWF) to Locate Medicare Beneficiary Record and Provide Responses to Provider Queries Part B Detail Line Expansion- MCS Phase 2 Update Common Working File (CWF) Editing to Not Allow Late Charge Billing by Prospective Payment System (PPS) Providers Issued to a specific audience, not posted to IntemeV!ntranet due to Sensitivity oflnstmction Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity oflnstruction Remove Part B Batch Eligibility Process (HELG) from the Common Working File (CWF)l693 Common Working File (CWF) to Remove Remaining Federal Tax Information (FIT) Received through the Internal Revenue Service (IRS), Social Security Administration (SSA), Centers for Medicare and Medicaid Services (CMS) Medicare Secondary Payer (MSP) Data Match Program from CWF. Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instruction Fiscal Intermediary Shared System (FISS) Heath Infonnation Technology for Economic and Clinical Health (HITECH) Quarterly Report Shared System Enhancement 2014- Additional Removal of Obsolete Reports and On-Request Jobs from the ViPS Medicare System (VMS)Implementation Reporting of All Recovery Auditor-Initiated Claim Adjustments and their Subsequent Adjustments for Periodic Interim Payment (PIP) Facilities Editing 1 Jpdate for Screening for Sexually Transmitted Infections Appropriate Use Criteria for Advanced Imaging- Analysis and Design Issued to a specific audience, not posted to IntemeVIntranet due to Sensitivity of Instruction Combined Common Edits/Enhancements (CCEM) Third Party Software Upgrades Section 504: Adding a Qualified Reader Preference in Alternate Formats Recovery Auditor Mass Adjustment and Reporting Process EnhancementsAnalysis Only Issued to a specific audience, not posted to IntemeV!ntranet due to Sensitivity of Instruction Issued to a specific audience, not posted to IntemeV!ntranet due to Sensitivity of Instruction Health Insurance Portability and Accountability Act (HIP AA) Electronic Data 79495 EN14NO16.012</GPH> mstockstill on DSK3G9T082PROD with NOTICES 79496 VerDate Sep<11>2014 Jkt 241001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4725 E:\FR\FM\14NON1.SGM Addendum III: CMS Rulings (July through September 2016) 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''"~<·",," .~m~. 0~ •• n~ou"'"~"~ For questions or additional information, contact Tiffany Lafferty (410-786-7548). 14NON1 Addendum IV: Medicare National Coverage Determinations (July through September 2016) Addendum IV includes completed national coverage detenninations (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 detennination by the Secretary for whether or not a particular item or service is covered nationally under the Medicare Program (title XVIII of the Act), but does not include a detennination of the code, if any, that is assigned to a particular covered item or service, or payment detennination 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 armounce 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. There were no updates that occurred in the 3-month period. This information is available at: www.cms.gov/medicare-coverage-database/. For questions or additional information, contact Wanda Belle, MPA (410-786-7491). Addendum V: FDA-Approved Category B Investigational Device Exemptions (IDEs) (July through September 2016) 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 BIDEs 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 April21, 1997 Federal Register (62 FR 19328). IDE Gl60070 Gl60123 Gl50157 Gl60128 Gl60129 Gl50266 Gl60133 Gl60135 Gl60130 Gl60139 Gl60017 Device Plasma Delipidation System Teosyal RHA Redensity (TPRL) LifeSeal Kit- LifeSeal Surgical Sealant and Delivery System (LifeSeal Applicator/LifeSeal Laparoscopic Applicator) SIR-Spheres microspheres brachytherapy device plus associated delivery accessories Embozene Microspheres Evoke Closed Loop Stimulator (CLS), Evoke eCLS, Evoke Percutaneous 12C Leads, Evoke Pocket Console (EPC), Evoke 12C Paddle Leads Trailblaze Pharos NUT lliC Companion Diagnostic Assay Biodegradable Temporizing Matrix Infi1se Bone Graft/Mastergraft Strip X-Seal6F Vascular Closure Device Start Date 07/06/2016 07/06/2016 07/07/2016 07/08/2016 07/12/2016 07113/2016 07113/2016 07113/2016 07/14/2016 07/22/2016 07/26/2016 Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices 17:26 Nov 10, 2016 EN14NO16.013</GPH> 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 infonnation on how to access electronic editions, printed editions, and reference copies. This infonuation is available on our website at: https://www. ems. govI quarterlyproviderupdates/downloads/Regs3Ql6QPU.pdf For questions or additional information, contact Terri Plumb (410-786-4481 ). mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 Jkt 241001 Gl60145 Gl60150 Gl60026 Gl60153 Gl50186 Gl60159 Gl60155 PO 00000 G160157 Gl60161 Gl60162 Frm 00087 Gl60170 Ul60158 Fmt 4703 Gl60165 G160171 Sfmt 4725 Gl30156 Gl60146 E:\FR\FM\14NON1.SGM Gl60173 Gl60178 Gl50244 Gl60177 14NON1 Gl60101 Gl60085 Gl60132 Gl60184 Gl60182 Gl60183 Gl60096 Ul60lgg Gl60185 Gl60190 Device Mirabilis System MAGE-AID hnmunohistochemistry (IHC) Clinical Trial Assay JIB System CERAMENTG Medtronic Valiant TAAA Stent Graft System Zepto Sir-Sphere Microspheres Echopulse High Intensity Focused Ultrasound Device Deep Brain Stimulation Surgery for Treatment of Focal Hand Dystonia tteris Antimicrobial Skin & Wound Cleanser Cortical Stimulation MagVenture MagPro XlOO with MagOption Magnetic Stimulator, 230V C-B60 Butterfly Coil Coil COOL-B64 AlP (dynmaic cooled butterfly active & sham coil) LlNX Reflux Management System 6 Month Double-Blind Randomized Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Small Particle Hyaluronic Acid to Treat Acne Scars Located on the Cheeks and Forehead BreathiD MCS System "C-Methacetin Breath Test (MBT) WATCHMAN T.eft Atrial Appendage Closure (T A AC) Device NEURAL ENABLED PROSTHESIS (NEP) 45mm Tongue hnplant, 55mm Tongue hnplant, 65mm Tongue hnplant, 75mm Tongue hnplant, Tongue hnplanter Kit M6-C Artificial Cervical Disc Ventana DLL3 (SC16.65) IHC Assay Wireless Cardiac Stimulation System, WiCS-LV System, WiCS,WiSE™ Arctic Front Advance Cardiac CryoAblation Catheter; Freezor MAX Cardiac CryoAblation Catheter Cerene Cryotherapy Device Chocolate Touch Paclitaxel Coated PTA Balloon Catheter GE Datex-Ohmeda Aisys CS2 Anesthesia System with Optional Et Control Feature GelrinC Cartilage Repair Device Medtronic TAAA Debranching Stent Graft System INTRAVASCULAR TEMPERATURE MANAGEMENT (IVTM) SYSTEM QUATTRO CATHETER Therasphere microspheres SUBCUTANEOUS MEDlAN NERVE NEUROMODULATION FOR DRUG-TREATMENT RESISTANT HYPERTESION Jarvik 2015 Ventricular Assist System AMPLATZER Duct Occluder II Additional Sizes Start Date 07/26/2016 07/26/2016 07/29/2016 08/03/2016 08/04/2016 08/05/2016 08/09/2016 08/12/2016 08/17/2016 08/18/2016 08/19/2016 08/19/2016 08/19/2016 08/25/2016 08/26/2016 08/26/2016 08/31/2016 09/01/2016 09/02/2016 09/07/2016 09/09/2016 Addendum VI: Approval Numbers for Collections of Information (July through September 2016) 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/public/do/PRAMain. For questions or additional information, contact William Parham (410-786-4669). Addendum VII: Medicare-Approved Carotid Stent Facilities, (July through September 2016) Addendum VII includes listings of Medicare-approved carotid stent facilities. All facilities listed meet CMS standards for performing carotid artery stenting for high risk patients. On March 17, 2005, we issued our decision memorandum on carotid artery stenting. We determined that carotid artery stenting with embolic protection is reasonable and necessary only if performed in facilities that have been determined to be competent in performing the evaluation, procedure, and follow-up necessary to ensure optimal patient outcomes. We have created a list of minimum standards for facilities modeled in part on professional society 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 at: https://www. ems. gov/MedicareApprovedFacilitie/CASF/list.asp#TopOfPage For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). 09/09/2016 Facility 09/12/2016 09/16/2016 09/16/2016 09/22/2016 09/23/2016 09/23/2016 09/26/2016 09/29/2016 09/30/2016 09/30/2016 Provider Number r-~~:· •·'' ,,;,;;::•;',;<;~-~ Effective Date State j.\fi?; ~;~~il''if;; Newton-Wellesley Hospital 220101 20 14 Washington Street Newton, MA 02462-1607 Temecula Valley Hospital 1679816201 31700 Temecula Parkway Temecula, CA 92592 Great Plains Health Heart & Vascular Center 1700855533 60 1 West Leota Street PO Box 1167 North Platte, NE 69101 •.;;'.!..•. ··~·;':\;;k::;::;;;,;J ~~til-~\~:. FROM: Presbyterian Hospital of Dallas 450462 TO: Texas Health Presbyterian Hospital of Dallas . 07/22/2016 MA 07/22/2016 CA 09/07/2016 NE ;::~; 05/10/2005 Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices 17:26 Nov 10, 2016 IDE Gl60034 Gl60141 ;,,;\?;\:::! TX 79497 EN14NO16.014</GPH> mstockstill on DSK3G9T082PROD with NOTICES 79498 VerDate Sep<11>2014 Jkt 241001 PO 00000 Frm 00088 Fmt 4703 Sfmt 4725 E:\FR\FM\14NON1.SGM 18200 Walnut Hill Lane Dallas, TX 75231-4496 FROM: Presbyterian Hospital of Denton TO: Texas Health Presbyterian Hospital Denton 3000 I-35N Denton, TX 76201 FROM: Harris Methodist Fort Worth Hospital TO: Texas Health Harris Methodist Hospital Fort Worth 1301 Pennsylvania Avenue Fort Worth, TX 76104 FROM: Arlington Memmial Hospital TO: Texas Health Arlington Memorial Hospital 800 West Randol Mill Road Arlington, TX 76012 FROM: Harris Methodist HEB TO: Texas Health Harris Methodist Hospital Hurst-Euless-Bedford 251 Westpark Way Euless, TX 76040 Mercy Health Partners 1700 Ointon Street Muskegon, MI 49442 Manchester Memorial Hospital 71 Haynes Street Manchester, CT 06040 FROM: Mercy Hospital TO: Regional Hospital of Scranton 746 Jefferson Avenue Scranton, PA 18501 FROM: Wyoming Valley Health Care System TO: Wilkes-Barre General Hospital 575 North River Street Wilkes Barre, PA 18764 Mercy Hospital 3663 South Miami Avenue Miami, FL 33133 Provider Number Effective Date State 450743 01/10/2007 TX 450115 04/20/2005 TX 450064 11104/2005 TX 450639 05/16/2005 TX 23-0066 12/2112005 MI 070027 03/09/2016 CT 390237 04/18/2006 PA 390137 04/26/2005 PA 10016700 08/26/2005 FL 14NON1 Addendum VIII: American College of Cardiology's National Cardiovascular Data Registry Sites (July through September 2016) Addendum VIII includes a list of the American College of Cardiology's National Cardiovascular Data Registry Sites. We cover implantable cardioverter defibrillators (ICDs) for certain clinical indications, as long as information about the procedures is reported to a central registry. Detailed descriptions of the covered indications are available in the 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) lCD Registry satisfies the data reporting requirements in the NCD. Hospitals needed to transition to the ACC-NCDR lCD Registry by April2006. 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 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 lCD 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.com/webncdr/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.com/webncdr/common. For questions or additional information, contact Sarah Fulton, MHS (410 786 2749). Facility ri"< ~~:. City New York Community Hospital Capital Medical Center Bartow Regional Medical Center Central Carolina (I ,ifePoint) CHI St. Luke's Health Memorial Livingston Skypark Surgery Center Victor Valley Global Medical Center Chambersburg Hospital Northeastern Nevada Regional Hospital Doctors Hospital of Manteca North Hawaii Community Hospital State •.••:+'{,~~t·;'f;;. ;>~~\·T~;~ ;•t\J,\1,>'.• Brooklyn Olympia Bartow Sanford Livingston Torrance Victorville Chambersburg Elko Manteca Kameula NY WA FL NC TX CA CA PA NV CA HI Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices 17:26 Nov 10, 2016 EN14NO16.015</GPH> Facility mstockstill on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 City Stroudsburg Elfers Olean Monongahela Vallejo Sonora Louisville State PA FL NY PA CA CA KY Jkt 241001 PO 00000 Frm 00089 Fmt 4703 Sfmt 4725 E:\FR\FM\14NON1.SGM Addendum IX: Active CMS Coverage-Related Guidance Documents (July through September 2016) CMS issued a guidance document on November 20, 2014 titled "Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development Document". Although CMS has several policy vehicles relating to evidence development activities including the investigational device exemption (IDE), the clinical trial policy, national coverage determinations and local coverage determinations, this guidance document is principally intended to help the public understand CMS's implementation of coverage with evidence development (CED) tlrrough the national coverage determination process. The document is available at https://www.cms.gov/medicare-coverage-database/details/medicarecoverage-document-details.aspx?MCDid=27. There are no additional Active CMS Coverage-Related Guidance Documents for the 3-month period. For questions or additional information, contact JoAnna Baldwin, MS (410-786-7205). Addendum X: List of Special One-Time Notices Regarding National Coverage Provisions (July through September 2016) There were no special one-time notices regarding national coverage provisions published in tl1e 3-month period. Tllis information is available at www.cms.hhs.gov/coverage. For questions or additional information, contact JoAnna Baldwin, MS (410-786 7205). 14NON1 Addendum XI: National Oncologic PET Registry (NOPR) (July through September 2016) 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 additions, deletions, or editorial changes to the listing of National Oncologic Positron Emission Tomography Registry (NOPR) in the 3-month period. This information is available at https://www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage. For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564). Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (July through September 2016) 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 VADs 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 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. We are providing only the specific updates to the list of Medicareapproved facilities that meet our standards that have occurred in the 3-month period. This information is available at https://www. ems. gov/MedicareApprovedF acilitie/VAD/list.asp#TopOfPage. For questions or additional information, contact Linda Gousis, JD, (410-786-8616). Facility Provider Number Date Approved 25-0001 08/17/2016 MS 10-0289 05/27/2015 FL :c ,., ,;,,:,;,.',t'}.cfii.•;;".d· University Hospitals and Health System 2500 North State Street Jackson, MS 39216 Cleveland Clinic Florida 3100 Weston Road Weston, FL 33331 State Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices 17:26 Nov 10, 2016 Facility St. Luke's Monroe Hospital Heart and Rhythm Institute of Trinity Olean General Hospital Monongahela Valley Hospital Kaiser Permanente Vallejo Cath Lab Sonora Regional Medical Center Norton Women's and Kosair Children's Hospital ·'''';t~~\\"1\~.-: 79499 EN14NO16.016</GPH> mstockstill on DSK3G9T082PROD with NOTICES 79500 VerDate Sep<11>2014 Jkt 241001 38-0091 09/14/2016 OR 17-0040 04/06/2016 KS 33-0106 09/28/2016 NY PO 00000 Frm 00090 Fmt 4703 Sfmt 4725 E:\FR\FM\14NON1.SGM 14NON1 Addendum XIII: Lung Volume Reduction Surgery (LVRS) (July through September 2016) 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 qualify and can qualify only with the other programs); • Credentialed by the Joint Commission (formerly, the Joint Commision on Accreditation ofHealthcare Organizations (JCAHO)) under their Disease Specific Certification Program for L VRS; and • Medicare approved for lung transplants. Only the first two types are in the list. There were no updates to the listing of facilities for lung volume reduction surgery published in the 3-month period. This information is available at www. ems. gov/MedicareApprovedF acilitie!L VRS/list.asp#TopOfPage. For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Addendum XIV: Medicare-Approved Bariatric Surgery Facilities (July through September 2016) EN14NO16.017</GPH> 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 (ESCOE) (program standards and requirements in effect on February 15, 2006). There were no additions, deletions, or editorial changes to Medicare-approved facilities that meet CMS' s minimum facility standards for bariatric surgery that have been certified by ACS and/or ASMBS in the 3-month period. This information is available at www.cms.gov/MedicareApprovedFacilitie/BSF/list.asp#TopOfPage. For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (July through September 2016) There were no FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials published in the 3-month period. This information is available on our website at www.cms.gov/MedicareApprovedFacilitie/PETDT!list.asp#TopOfPage. For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564 ). Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices 17:26 Nov 10, 2016 Kaiser Sunnyside Medical Center 10180 SE Sunnyside Road Clackamas, OR 97015-9303 T11e University of Kansas Hospital Authority 390 I Rainbow Boulevard Kansas City, KS 66160 "'orth Shore University Hospital 300 Community Drive 'v!anhasset, NY 11030 Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices [FR Doc. 2016–27315 Filed 11–10–16; 8:45 am] BILLING CODE 4120–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Agency Information Collection: Comprehensive Child Welfare Information System Notice The Office of Management and Budget (OMB) has assigned approval number 0970–0463 to the Comprehensive Child Welfare Information System (CCWIS) Final Rule (81 FR 35450, published June 2, 2016) information collection. The CCWIS Final Rule describes an optional child welfare information system. States and tribes electing to build a CCWIS must collect and report certain information to the Administration for Children and Families regarding their CCWIS plans. The information collection described in the Final Rule includes: • The automated function list (45 CFR 1355.52(i)(1)(ii)–(iii) and (i)(2)) • The data quality plan (45 CFR 1355.52(d)(5)) • The Notice of Intent (45 CFR 1355.52(i)(1)) The authority for the information collection expires on 10/31/2019 12:00:00 a.m. Authority: 42 U.S.C. 620 et seq., 42 U.S.C. 670 et seq.; 42 U.S.C. 1301 and 1302. Robert Sargis, Reports Clearance Officer. [FR Doc. 2016–27280 Filed 11–10–16; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–4169] Edward Manookian (Also Known as Ed Manning): Debarment Order AGENCY: Food and Drug Administration, HHS. mstockstill on DSK3G9T082PROD with NOTICES ACTION: Notice. The U.S. Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Edward Manookian from providing services in any capacity to a person that has an approved or pending drug SUMMARY: VerDate Sep<11>2014 17:26 Nov 10, 2016 Jkt 241001 product application. FDA bases this order on a finding that Mr. Manookian was convicted of felonies under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Mr. Manookian was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Manookian failed to request a hearing. Mr. Manookian’s failure to request a hearing constitutes a waiver of his right to a hearing concerning this action. DATES: This order is effective November 14, 2016. ADDRESSES: Submit applications for special termination of debarment to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Kenny Shade, Division of Enforcement, Food and Drug Administration, 12420 Parklawn Dr. (ELEM–4144), Rockville, MD 20857, 301–796–4640. SUPPLEMENTARY INFORMATION: I. Background Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B)) requires debarment of an individual if FDA finds that the individual has been convicted of a felony under Federal law for conduct relating to the regulation of any drug product under the FD&C Act. On August 28, 2015, the U.S. District Court for the Middle District of Tennessee entered judgment against Mr. Manookian for two counts of conspiracy to commit an offense against the United States, in violation of 18 U.S.C. 371. FDA’s finding that the debarment is appropriate is based on the felony convictions referenced herein. The factual basis for these convictions is as follows: Mr. Manookian was the President and owner of Melanocorp, Inc. (Melanocorp), a for-profit corporation that conducted operations in the Middle District of Tennessee, and his duties included overseeing the employees and operations of Melanocorp. Melanotan II (MII) was a peptide, or series of amino acids, that was marketed, sold, and shipped by Melanocorp to customers in the United States and abroad. Mr. Manookian’s company advertised MII, an unapproved new drug, as an injectable tanning product through an internet Web site. The Melanocorp Web site also advertised MII as being 100 percent U.S. made, whereas in fact some of the MII sold by Melanocorp was manufactured in and imported from China. PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 79501 On or about August 30, 2007, Melanocorp received a warning letter from FDA expressing concern about Melanocorp’s marketing of MII. The warning letter noted that, based on information and statements on the Melanocorp Web site, MII constituted a new drug under the FD&C Act that could not be introduced or delivered for introduction into interstate commerce without an FDA approved application. The warning letter concluded that the sale of MII without an FDA approved application violated the FD&C Act and instructed Mr. Manookian’s company to take prompt action to correct the violations cited in the warning letter. On or about September 17, 2007, after consulting with counsel, Mr. Manookian sent a letter to FDA stating that Melanocorp had stopped all promotion and sale of MII in the United States and had stopped taking orders for MII from U.S. residents. On or about November 29, 2007, FDA sent a letter to an attorney representing Melanocorp, which reiterated that MII was considered by FDA to be an unapproved drug and warned that its introduction or delivery for introduction into interstate commerce would be a violation of the FD&C Act. The letter specifically stated that the sale of MII outside of the United States violated the FD&C Act. On or about December 14, 2007, Mr. Manookian had a letter sent to FDA from his attorney confirming that Melanocorp had stopped taking orders for MII from U.S. residents. This letter also stated that Melanocorp did not disagree that FDA considered MII to be an unapproved new drug, but Mr. Manookian’s position was that Melanocorp could lawfully export MII, regardless of its status as an unapproved new drug. On or about December 28, 2007, FDA sent a letter to Mr. Manookian’s attorney which reiterated that unapproved new drugs do not qualify for export. Following receipt of the December 28, 2007, correspondence from FDA, Melanocorp continued to ship MII in interstate commerce. Melanocorp primarily sold MII to customers located abroad, but also shipped MII domestically on a more limited basis. From on or about September 17, 2007, and continuing through in or about April 2009, Mr. Manookian conspired with others to defraud the United States by causing Melanocorp to ship MII to customers in the United States despite telling FDA that Melanocorp would not distribute or market MII in the United States. As a result of these convictions, FDA sent Mr. Manookian by certified mail on E:\FR\FM\14NON1.SGM 14NON1

Agencies

[Federal Register Volume 81, Number 219 (Monday, November 14, 2016)]
[Notices]
[Pages 79489-79501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27315]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9099-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--July Through September 2016

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 July through September 2016, 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.

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------------------------------------------------------------------------
             Addenda                    Contact           Phone number
------------------------------------------------------------------------
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, MPA...     (410) 786-7491
 Determinations.
V FDA-Approved Category B IDEs..  John Manlove.......     (410) 786-6877
VI Collections of Information...  William Parham.....     (410) 786-4669
VII Medicare-Approved Carotid     Sarah Fulton, MHS..     (410) 786-2749
 Stent Facilities.
VIII American College of          Sarah Fulton, MHS..     (410) 786-2749
 Cardiology-National
 Cardiovascular Data Registry
 Sites.
IX Medicare's Active Coverage-    JoAnna Baldwin, MS.     (410) 786-7205
 Related Guidance Documents.
X One-time Notices Regarding      JoAnna Baldwin, MS.     (410) 786-7205
 National Coverage Provisions.
XI National Oncologic Positron    Stuart Caplan, RN,      (410) 786-8564
 Emission Tomography Registry      MAS.
 Sites.
XII Medicare-Approved             Linda Gousis, JD...     (410) 786-8616
 Ventricular Assist Device
 (Destination Therapy)
 Facilities.
XIII Medicare-Approved Lung       Sarah Fulton, MHS..     (410) 786-2749
 Volume Reduction Surgery
 Facilities.
XIV Medicare-Approved Bariatric   Sarah Fulton, MHS..     (410) 786-2749
 Surgery Facilities.
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

    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. Format for the Quarterly Issuance Notices

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

    Dated: November 7, 2016.
Kathleen Cantwell,
Director, Office of Strategic Operations and Regulatory Affairs.
BILLING CODE 4120-01-P

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[FR Doc. 2016-27315 Filed 11-10-16; 8:45 am]
BILLING CODE 4120-01-C

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