Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-April through June 2017, 36404-36416 [2017-16252]

Download as PDF 36404 Federal Register / Vol. 82, No. 149 / Friday, August 4, 2017 / Notices performance of the agency’s functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments must be received by October 3, 2017. ADDRESSES: When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways: 1. Electronically. You may send your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) that are accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number ___, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS’ Web site address at https://www.cms.hhs.gov/ PaperworkReductionActof1995. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov. 3. Call the Reports Clearance Office at (410) 786–1326. FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786–4669. SUPPLEMENTARY INFORMATION: Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection’s supporting statement and associated materials (see ADDRESSES). CMS–381 Identification of Extension Units of Medicare Approved Outpatient Physical Therapy/Outpatient Speech Pathology (OPT/OSP) Providers and Supporting Regulations Under the PRA (44 U.S.C. 3501– 3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. Information Collection 1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Identification of Extension Units of Medicare Approved Outpatient Physical Therapy/Outpatient Speech Pathology (OPT/OSP) Providers and Supporting Regulations; Use: The provider uses the form to report to the state survey agency extension locations that it has added since the date of last report. The form is used by the state survey agencies and by our regional offices to identify and monitor extension locations to ensure their compliance with the federal requirements for the providers of outpatient physical therapy and speechlanguage pathology services. Form Number: CMS–381 (OMB control number: 0938–0273); Frequency: Annually; Affected Public: Private Sector; Business or other for-profit and not-for-profit institutions; Number of Respondents: 2,161; Total Annual Responses: 2,161; Total Annual Hours: 540. (For policy questions regarding this collection contact Sarah Fahrendorf at 410–786–3112.) Dated: August 1, 2017. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2017–16483 Filed 8–3–17; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–9104–N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—April through June 2017 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 April through June 2017, 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. SUMMARY: Addenda Contact I CMS Manual Instructions ........................................................................................ II Regulation Documents Published in the Federal Register .................................. III CMS Rulings .......................................................................................................... IV Medicare National Coverage Determinations ....................................................... V FDA-Approved Category B IDEs ........................................................................... VI Collections of Information ..................................................................................... VII Medicare—Approved Carotid Stent Facilities ...................................................... VIII American College of Cardiology-National Cardiovascular Data Registry Sites IX Medicare’s Active Coverage-Related Guidance Documents ................................ X One-time Notices Regarding National Coverage Provisions ................................. XI National Oncologic Positron Emission Tomography Registry Sites ..................... XII Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities XIII Medicare-Approved Lung Volume Reduction Surgery Facilities ........................ 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 .................................. VerDate Sep<11>2014 15:13 Aug 03, 2017 Jkt 241001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\04AUN1.SGM 04AUN1 Phone number (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 36405 Federal Register / Vol. 82, No. 149 / Friday, August 4, 2017 / Notices Addenda Contact XIV Medicare-Approved Bariatric Surgery Facilities ................................................. XV Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials ......... All Other Information .................................................................................................. Sarah Fulton, MHS .................................. Stuart Caplan, RN, MAS ......................... Annette Brewer ........................................ SUPPLEMENTARY INFORMATION 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 VerDate Sep<11>2014 15:13 Aug 03, 2017 Jkt 241001 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’’ PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 Phone number (410) 786–2749 (410) 786–8564 (410) 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: July 20, 2017. Kathleen Cantwell, Director, Office of Strategic Operations and Regulatory Affairs. BILLING CODE 4120–01–C E:\FR\FM\04AUN1.SGM 04AUN1 36406 VerDate Sep<11>2014 Jkt 241001 PO 00000 Frm 00051 Fmt 4703 Addendum 1: Medicare and Medicaid Manual Instructions (April through June 2017) 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\04AUN1.SGM 04AUN1 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 pmposes 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 EN04AU17.000</GPH> arrangements to transfer material to a local library not designated as an FDL. Contact any library to locate the nearest FDL. This information is available at https://www.gpo.gov/libraries/ In addition, individuals may contact regional depository libraries that receive and retain at least one copy of most federal government publications, either in printed or microfilm form, for use by the general public. These libraries provide reference services and interlibrary loans; however, they are not sales outlets. Individuals may obtain information about the location of the nearest regional depository library from any library. CMS publication and transmittal numbers arc 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 Percutaneous Image-guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS) use (CMS-Pub. 100-03) Transmittal No. 196. 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 cmyunction 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 Affordable Care Act Bundled Payments for Care Improvement Initiative Recurring File Updates Models 2 and 4 October 2017 Updates Update to General Information, Eligibility, and Entitlement, Chapter 7Contract Administrative Requirements, Section 40 - Shared System Maintainer for Releases 196 197 3744 B Virus (HBV) Infection Issued to a specit!c audience, not posted to Internet! Intranet due to Confidentiality of Instruction Federal Register / Vol. 82, No. 149 / Friday, August 4, 2017 / Notices 15:13 Aug 03, 2017 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: August 5, 2016 (81 FR 51901), November 2016 (81 FR 79489, February 23, 2017 (82 FR 11456), and May 5, 2017 (82 FR 21241). We are providing only the specific updates that have occurred in the 3 -month period along with a hyperlinl<: to the website to access this information and a contact person for questions or additional information. VerDate Sep<11>2014 3745 3747 3748 3749 Jkt 241001 3750 3751 3752 PO 00000 3753 3754 Frm 00052 Fmt 4703 Sfmt 4725 3755 3756 E:\FR\FM\04AUN1.SGM 3757 3758 3759 3760 04AUN1 3761 3762 3763 3764 3765 3766 3767 3768 3769 3770 3771 3772 3773 3774 3775 3776 1777 3778 Qualified Medicare Beneficiary Indicator in the Medicare Fee-For-Service Claims Processing System Modifications to the Common Working File (CWF) In Support ofthe Coordination of Benefits Agreement (COBA) Crossover Process Claims Crossover Disposition a!ld Coordination of Benefits Agreement By-Pass Indicators Scr~~ning for th~ Human lnlmunoddiciency Virus (HIV) Infection Healthcare Common Procedure Coding System (HCPCS) for HIV Screening Tests Billing Requirements Payment Method Diagnosis Code Reporting Medicare Summary Notice (MSN) a!ld Claim Adjustment Reason Codes (CARCs) Issued to a specific audience, not posted to IntemeV!ntranet due to Confidentiality of Instruction April Quarterly Update for 2017 Durable Medical Equipment, Prosthetics, Orthotics, a!ld Supplies (DMEPOS) Fee Schedule Issued to a specific audience, not posted to IntemeV!ntranet due to Confidentiality of Instmction Issued to a specific audience, not posted to IntemeV!ntranet due to Confidentiality of Instruction New Waived Tests Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB)- July CY 2017 Update Issued to a specific audience, not posted to h1temeVh1tranet due to Confidentiality of Instruction Changes to the Payment Policies for Reciprocal Billing Arrangements and Fee-For-Time Compensation Arrangements (formerly referred to as Locum Exceptions to Assignment of Provider's Right to Payment)-Claims Submitted to AlB MACs Part B Payment Under Reciprocal Billing Arrangements- Claims Submitted to AlB MACs PartB Payment Under Fee-For-Time Compensation Arrangements (formerly referred to as Locum Tenens Arrangements)- Claims Submitted to AlB MACs PartE Billing Procedures for Entities Qualified to Receive Payment on Basis of Reassignment- for AlB MAC Part B Processed Claims Correcting Unacceptable Payment Arrangements Tenens Arrangements) Two N~w "K" Cod~s for Therap~utic Continuous Glucos~ Monitors Issued to a specific audience, not posted to lntemeV Intranet due to Confidentiality of Instruction July 2017 Integrated Outpatient Code Editor (TIOCE) Specifications Version 18.2 Screening for the !Iuman lnlmunodeficiency Vims (IIIV) Infection Healthcare Common Procedure Coding System (HCPCS) for HIV Screening Tests Billing Requirements Payment Method Diagnosis Code Reporting Medicare Summary Notice (MSN) and Claim Adjustment Reason Codes Federal Register / Vol. 82, No. 149 / Friday, August 4, 2017 / Notices 15:13 Aug 03, 2017 3746 Issued to a specific audience, not posted to IntemeV!ntranet due to Confidentiality of Instruction July 20 17 Quarterly Average Sales Price (ASP) 'v!edicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files Payment for Moderate Sedation Services Quarterly Update to the National Correct Coding h1itiative (NCCI) Procedure to Procedure (PTP) Edits, Version 23.2, Effective July 1, 2017 Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction New Fields in the Fiscal Intermediary Shared System (FISS) Inpatient and Outpatient Provider Specific Files (PSF) Two New "K" Codes for T11erapeutic Continuous Glucose Monitors 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 Instmction lnlplementation of New Influenza Vims Vaccine Code Table of Preventive and Screening Services Healthcare Common Procedure Coding System (HCPCS) and Diagnosis Codes Payment for Pneumococcal Pneumonia Vims, Influenza Virus, and Hepatitis B Virus and Their Administration on Institutional Claims Payment Procedures for Renal Dialysis Facilities (RDF CWF Edits on AB MAC (A) Claims CWF Edits on AB MAC (B) Claims CWF Crossover Edits for AB MAC (B) Claims 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 Instmction Issued to a specific audience, not posted to hltemeVh!tmnet 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 Instmction July Qumierly Update for 2017 Durable Medical Equipment, Prosthetics, Orthotics, a!ld Supplies (DMEPOS) Fee Schedule Screening for Hepatitis B Virus (HBV) Infection Screening for Hepatitis B Virus (HBV) Institutional Billing Requirements Professional Billing Requirements Diagnosis Code Reporting Requirements Claim Adjustment Reason Cod~s (CARCs), Ren~ittanc~ Ad vic~ Ren~ark Messages New Physician Specialty Code for Advanced Heart Failure and Transpla!lt Cardiology, Medical Toxicology, and Hematopoietic Cell Transplantation and Cellular Therapy Physicia!l Specialty Codes Table of Preventive and Screening Services Deductible and Coinsura!lce 36407 EN04AU17.001</GPH> 36408 VerDate Sep<11>2014 3779 3781 Jkt 241001 PO 00000 3782 3783 Frm 00053 3784 3785 Fmt 4703 3786 3787 3788 3789 Sfmt 4725 3790 3791 E:\FR\FM\04AUN1.SGM 3792 3793 04AUN1 119 282 283 EN04AU17.002</GPH> 169 710 711 712 713 714 715 716 Cellular Therapy Medicare State Operations Manual (CMS-Pub. 100-07) New to State Operations Manual (SOM) Appendix Z, Emergency Preparedness for All Provider and Certified Supplier Types Medicare Proe:ram Inte!V'ity (CMS-Pub. 100-08) Update to Pub. 100-08, Chapter 15 Federally Qualified Health Centers (FQHCs) Section 4 of the Form CMS-8551 Submission of Paper and Internet-based PECOS Certification Statements Processing Form CMS-855R Applications Electronic Funds Transfer (EFT) Payments and CHOWs Tie-In/Tie-Out Notices and Referrals to the State/RO Ambulatory Surgical Centers (ASCs)/Portable X-ray Suppliers (PXRS) Tie-In/Tie-Out Notices and Referrals to the State/RO Release of Information File Maintenance Approval Letter Guidance Model Approval Letter Denial Example #5 - Existing or Delinquent Overpayments Update to Pub. 100-08, Chapter 15 Diabetes Self-Management Training (DSMT) Section 4 of the Form CMS-8551 Submission of Paper and Internet-based PECOS Certification Statements Processing Form CMS-855R Applications Electronic Funds Transfer (EFT) Payments and CHOWs Tie-In/Tie-Out Notices and Referrals to the State/RO Ambulatory Surgical Centers (ASCs)/Portable X-ray Suppliers (PXRS) TieIn/Tie-Out Notices and Referrals to the State/RO Release of Information File Maintenance Approval Letter Guidance Model Approval Letter Denial Example #5 - Existing or Delinquent Overpayments Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Scribe Services Signature Requirements Comprehensive Error Rate Testing (CERT) File Layout for Social Security Number Removal Initiative (SSNRI) Update to Pub. 100-08, Chapter 15 Federally Qualified Health Centers (FQHCs) Section 4 of the Form CMS-8551 Submission of Paper and Internet-based PECOS Certification Statements Processing Form CMS-855R Applications Electronic Funds Transfer (EFT) Payments and CHOWs Tie-In/Tie-Out Notices and Referrals to the State/RO Ambulatory Surgical Centers (ASCs)/Portable X-ray Suppliers (PXRS) Tie-In/Tie-Out Notices and Referrals to the State/RO Release of Information ClarifYing Medical Review of Hospital Claims for Part A Payment Medical Review of Hospital Claims for Part A Payment Federal Register / Vol. 82, No. 149 / Friday, August 4, 2017 / Notices 15:13 Aug 03, 2017 3780 (CARCs) Instructions to Process Services Not Authorized by the Veterans Administration (VA) in a Non-VA Facility Reported With Value Code (VC) 42 Requirements for Processing Non Veterans Administration (VA) Authorized Inpatient Claims Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print (MREP) and PC Print Update Implement Operating Rules - Phase III Electronic Remittance Advice (ERA) Electronic Funds Transfer (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 Council for Affordable Quality Healthcare (CAQH) Committee on Operating Rules for Information Exchange (CORE) Claim Status Category and Claim Status Codes Update July 2017 Update ofthe Hospital Outpatient Prospective Payment System (OPPS) Instructions for Downloading the Medicare ZIP Code File for October Files Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction Common Edits and Enhancements Modules (CEM) Code Set Update Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction July 2017 Update of the Ambulatory Surgical Center (ASC) Payment System Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction July 2017 Update ofthe Ambulatory Surgical Center (ASC) Payment System Screening for Hepatitis B Virus (HBV) Infection Screening for Hepatitis B Virus (HBV) Institutional Billing Requirements Professional Billing Requirements Diagnosis Code Reporting Requirements Claim Adjustment Reason Codes (CARCs), Remittance Advice Remark Codes (RARCs), Group Codes, and Medicare Summary Notice (MSN) Messages Medicare Secondary Payer (CMS-Pub. 100-05) Implement the International Classification of Diseases, Tenth Revision (lCD10) 2018 General Equivalence Mappings (GEMs) Tables in the Common Working File (CWF) for Purposes of Processing Non-Group Health Plan (NGHP) Medicare Secondary Payer (MSP) Records and Claims Medicare Financial Management (CMS-Pub. 100-06) Notice of New Interest Rate for Medicare Overpayments and Underpayments -3rd Qtr Notification for FY 2017 New Physician Specialty Code for Advanced Heart Failure and Transplant Cardiology, Medical Toxicology, and Hematopoietic Cell Transplantation and VerDate Sep<11>2014 Jkt 241001 PO 00000 718 719 Frm 00054 720 721 Fmt 4703 Sfmt 4725 E:\FR\FM\04AUN1.SGM 04AUN1 Evaluation of Prepayment Edits Suppression and/or Exclusion- Examples Workload Medical Review of Home Health Demand Bills Referrals to the Quality Improvement Organization (QIO Medical Review Definitions Definition Automated Medical Review Non-Medical Record Review Automated Medical Review Non-Medical Record Review Prepay Provider Specific Medical Record Review Prepay Service Specific Medical Record Review Prepay Provider Specific Probe Medical Record Review Prepay Service Specific Probe Medical Record Review Postpay Provider Specific Probe Medical Record Review Postpay Service Specific Probe Medical Record Review Postpay Provider Specific Medical Record Review Postpay Service Specific Medical Record Review Monthly Reporting of Medical Review Savings 722 ClarifYing Date and Timing Requirements for Certain Durable Medical Equipment Prosthetics Orthotics and Supplies (DMEPOS) Medicare Contractor Beneficiary_ and Provider Communications_(CMS-Pub. 100-09) None Medicare Quality Improvement Ol'l!;anization (CMS- Pub. 100-10) QIO Manual Chapter 16 - "Healthcare Quality Improvement Program" 30 Quality Improvement Interventions Developing and Spreading Successful Interventions Documenting and Disseminating Results Medicare End Stage Renal Disease Network Organizations (CMS Pub 100-14) None Medicaid Pr02ram Integrity Disease Network Ol'l!;anizations (CMS Pub 100-15) None Medicare Managed Care (CMS-Pub. 100-16) None Medicare Business Partners Systems Security (CMS-Pub. 100-17) None Demonstrations (CMS-Pub. 100-19) 172 Suppression ofG9678 (Oncology Care Model Monthly Enhanced Oncology Services) Claims OCM Beneficiary Medicare Summary Notice 173 Medicare Care Choices Model - Per Beneficiary per Month Payment (PBPM) Implementation (eligibility updates and clarification) Payment of G9678 (Oncology Care Model Monthly Enhanced Oncology 174 Services) Claims for Beneficiaries Receiving Care in an Inpatient Setting One Time Notification (CMS-Pub. 100-20) Common Working File (CWF) to Archive Inactive Part B Consistency Edits 1815 1816 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instruction Enrollment Data Base (EDB) and Common Working File (CWF) Data 1817 Federal Register / Vol. 82, No. 149 / Friday, August 4, 2017 / Notices 15:13 Aug 03, 2017 717 Conducting Patient Status Reviews of Claims for Medicare Part A Payment for Inpatient Hospital Admissions Federally Qualified Health Centers (FQHCs) Section 4 of the Form CMS-855I Submission of Paper and Internet-based PECOS Certification Statements Processing Form CMS-855R Applications Electronic Funds Transfer (EFT) Payments and CHOWs Tie-In/Tie-Out Notices and Referrals to the State/RO Ambulatory Surgical Centers (ASCs)/Portable X-ray Suppliers (PXRS) Tie-In/Tie-Out Notices and Referrals to the State!RO Release of Information File Maintenance Model Approval Letter Denial Example #5 - Existing or Delinquent Overpayments Reviewing for Adverse Legal Actions (ALA) Update to Reporting Requirements Reconsideration Requests- Non-certified Providers/Suppliers External Reporting Requirements Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction Elimination of Routine Reviews Including Documentation Compliance Reviews and Instituting Three Medical Reviews Overview of Prepayment and Postpayment Reviews Provider Notice Requesting Additional Documentation During Prepayment and Postpayment Revi ew Third-party Additional Documentation Request Special Provisions for Lab Additional Documentation Requests No Response or Insufficient Response to Additional Documentation Requests Reopening Claims with Additional Information or Denied due to Late or No Submission of Requested Information Use of Claims History Information in Claim Payment Determinations Types of Review: Medical Record Review, Non-Medical Record Review, and Automated Review Complex Medical Review Non-Complex Review Automated Review Electronic and Paper Claims Prepayment Review of Claims Involving Utilization Parameters Prepayment Medical Record Review Edits Postpayment Medical Record Review of Claims Re-opening Claims Case Selection CMS Mandated Edits Tracking Medicare Contractors' Postpayment Reviews Denial Types Beneficiary Notification NotifYing the Provider Corrective Actions 36409 EN04AU17.003</GPH> 36410 VerDate Sep<11>2014 1818 1820 1821 Jkt 241001 1822 1823 PO 00000 1824 1825 Frm 00055 1826 1827 Fmt 4703 1828 1829 Sfmt 4725 1830 1831 E:\FR\FM\04AUN1.SGM 1835 04AUN1 1836 EN04AU17.004</GPH> 1832 1833 1834 Addendum II: Regulation Documents Published in the Federal Register (April through June 2017) Regulations and Notices Regulations and notices are published in the daily Federal Register. To purchase individual copies or subscribe to the Federal Register, contact GPO at www.gpo.gov/fdsys. When ordering individual copies, it is necessary to cite either the date of publication or the volume number and page number. The Federal Register is available as an online database through GPO Access. The online database is updated by 6 a.m. each day the Federal Register is published. The database includes both text and graphics from Volume 59, Number 1 (January 2, 1994) through the present date and can be accessed at https://www.gpoaccess.gov/fr/. The following website https://www.archives.gov/federal-register/ provides information on how to access electronic editions, printed editions, and reference copies. This information is available on our website at: http :1/www. ems. govI quarterlyprovidempdates/downloads/Regs2Ql7QPU.pdf For questions or additional information, contact Terri Plumb (410-786-4481 ). Addendum III: CMS Rulings (April through June 2017) CMS Rulings are decisions of the Administrator that serve as precedent final opinions and orders and statements of policy and interpretation. They provide clarification and interpretation of complex or ambiguous provisions of the law or regulations relating to Medicare, Medicaid, Utilization and Quality Control Peer Review, private health insurance, and related matters. The rulings can be accessed at https://www.cms.gov/Regulationsand-Guidance/Guidance/Rulings. For questions or additional information, contact Tiffany Lafferty (410-786-7548). Addendum IV: Medicare National Coverage Determinations (April through June 2017) 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 Federal Register / Vol. 82, No. 149 / Friday, August 4, 2017 / Notices 15:13 Aug 03, 2017 1819 Resync- Analysis and Design Annual Updates to the Prior Authorization/Pre-Claim Review Federal Holiday Schedule Tables for Generating Reports Update to Common Working File (CWF) Blood Editing on Medicare Advantage (MA) Enrollees' Inpatient Claims for Indirect Medical Education (!ME) Payment Issued to a specific audience, not posted to InterneV Intranet due to Sensitivity of 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 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Instruction Issued to a specific audience, not posted to IntemeV Intranet due to Sensitivity Instruction Issued to a specific audience, not posted to InterneV Intranet due to Sensitivity 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 Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Instruction Issued to a specific audience, not posted to IntemeV Intranet due to Sensitivity Instruction Issued to a specific audience, not posted to InterneV Intranet due to Sensitivity Instruction Introductory Letters for Suppliers and Providers Related to the Prior Authorization for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items Update FISS Editing to Include the Admitting Diagnosis Code Field implementing the remittance advice messaging for the 20-hour weekly minimum for Partial Hospitalization Program services Analysis and Design Working Sessions for the Development of a PrePayment Common Additional Documentation Request (ADR) Letter Reason Codes 36233 and 36330 Bypass for Claims Submitted on the 72x Type of Bill for Services Provided to Beneficiaries with Acute Kidney Injury (AKI) and edits related to not separately payable drugs Analysis Only-Provider Number Validation Update for the Shared Systems Maintainer (SSM) Medicare Quality Report~ Incentive Programs (CMS- Pub. 100-22) I None Information Security Acceptable Risk Safeguards (CMS-Pub. 100-25) I None VerDate Sep<11>2014 Jkt 241001 PO 00000 Frm 00056 Title Fmt 4703 Sfmt 4725 Screening for Hepatitis B Virus (HBV) Infection Percut'lneous hnageguided Lumbar Decompression for Lumbar Spinal Stenosis NCDM Section Transmittal Number Issue Date Effective Date 210.6 197 04/28/2017 09/28/2016 150.13 196 05/22/21017 12/08/20 16 E:\FR\FM\04AUN1.SGM 04AUN1 Addendum V: FDA-Approved Category B Investigational Device Exemptions (IDEs) (April through June 2017) Addendum Vincludes 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 G170059 0160267 G170058 G170060 G170027 0170064 0170065 0170066 0170067 0170068 0170071 0160156 0170073 G160257 0170078 0170079 0160224 BB17426 0160227 0170085 G170087 0150110 G170090 0170049 0170095 G170093 G170084 BB17455 0170098 0160235 0170102 0170105 0170109 Device BREATHIDMCS Revolution Peripheral Atherectomy System Panoramic in ECGi in Patients with Recurrent AF after PV Isolation Fectoscopic Repair of Myelomeningocele (MMC) in Fetuses with Isolated Spina Bifida AquaBeam System Water II Study INDIGO Aspiration System Panoramic ECGi to guide Ablation ofNon-Paroxysmal AF: Effect oflbutilide on AF Source Location and Organization JET-PCB Trial Intramural Needle Ablation for the Treatment of Refractory Ventricular Arrhythmias CardioMEMS HF System Embosphere Microspheres LimFlow System OsiaSystem Princess FILLER Lidocaine Avinger's Pantheris Atherectomy Catheter NovoTTF-200A (TTFields) Countour PVA, Embosphere and Embozene Particles CliniMACS TCRalpha-beta!CD19 Combined Depletion System Svelte Sirolimus-Eluting Coronary Stent Guardant360 CDx Test OsiaSystem Emervel Lips Artimes pro Balloon Dilatation Catheter RADAR: Real-time electrogram Analysis for Drivers of AtRial fibrillation RADIESSE (+)Lidocaine 1.5cc A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients gammaCore-R Cytori Celution System nJVEDERM VOLBELLA XC for Correction of Infraorbital Hollowing BuMA Supreme Biodegradable Drug Coated Coronary Stent System Foundation Medicine Blood First Assay Screening Trial (BFAST) Clinical Trial Assay (CTA) Insulin Pump System with Predictive Low Glucose Suspend SPY Portable Handheld hnaging (SPY-PHI) System (HH9000); IC2000 (lndocyanine Green for Injection, USP) Start Date 04/05/2017 04/05/2017 04/06/2017 04/07/2017 04/ 10/2017 04113/2017 04113/2017 04113/2017 04113/2017 04/ 14/2017 04/20/2017 04/20/2017 04/21 /2017 04/26/201 7 04/27/2017 04/30/2017 05/02/2017 05/02/2017 05/03/2017 05/03/2017 05/05/2017 05/05/2017 05/08/2017 05/09/2017 05/11 /2017 05/ 12/2017 05/ 16/2017 05/17/2017 05/ 18/2017 Federal Register / Vol. 82, No. 149 / Friday, August 4, 2017 / Notices 15:13 Aug 03, 2017 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 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 are providing only the specific updates that have occurred in the 3month period. This information is available at: www.crns.gov/medicarecoverage-database/. For questions or additional information, contact Wanda Belle, MPA (410-786-7491). 05/18/2017 05/19/2017 05/26/2017 05/26/2017 36411 EN04AU17.005</GPH> 36412 VerDate Sep<11>2014 IDE Gl 70112 Gl 70111 Gl 70116 Gl 70118 Gl 70110 Jkt 241001 Gl 70120 Gl 70119 PO 00000 Gl 70125 Gl 70128 Gl 70081 Frm 00057 Fmt 4703 Sfmt 4725 E:\FR\FM\04AUN1.SGM 04AUN1 EN04AU17.006</GPH> Gl 70127 Gl 70129 Gl 70130 Gl 70132 Gl70140 Gl 70077 Gl 70138 Gl 70144 Gl70016 Gl 70139 Gl 70147 BB17524 Gl 70133 Gl 70146 Start Date 05/30/2017 06/011201 7 06/02/2017 06/02/2017 06/02/201 7 06/05/2017 06/06/2017 06/07/2017 06/1 2/2017 06/1 4/2017 0611 5/201 7 06/1 6/2017 06/ 16/201 7 06/1 6/2017 06/1 6/2017 06/2112017 Addendum VII: Medicare-Approved Carotid Stent Facilities, (April through June 2017) 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). Facility 06/22/2017 06/23/2017 06/23/2017 06123/2017 06/28/2017 06/28/2017 06/29/2017 06/30/2017 06/30/201 7 Addendum VI: Approval Numbers for Collections of Information (April through June 2017) 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). P1·ovider Effective Number Date The following facilities are new listings for this quarter. Parkview Medical Center 060020 04/05/2017 400 W. 16th Street Pueblo, CO 81003 St Francis Xavier Hospital 420065 04/27/2017 2095 Henry Tecklenburg Drive Charleston, SC 29414 Garfield Medical Center 050737 0511 2/2017 525 N. Garfield Avenue Monterey Park, CA 91754 Kaiser Foundation Hospital Sacramento 1952476665 06/30/2017 2025 Morse Avenue Sacramento, CA 95825 The following facilities have editorial changes (in bold). 230020 07/07/2005 FROM: Oakwood Hospital and Medical Center TO: Beaumont Hospital- Dearborn 18101 Oakwood Boulevard Dearborn, MI 48123-2500 P.OBox 2500 150007 09/08/2005 FROM: Howard Regional Health System TO: Community Howard Regional Health 3500 South Lafountain Street Kokomo, IN 46904-9011 P.O. Box9011 06/07/2005 4501 24 FROM: Brackemide:e Hospital State co sc CA CA MI IN TX Federal Register / Vol. 82, No. 149 / Friday, August 4, 2017 / Notices 15:13 Aug 03, 2017 Gl 70114 Device SPY Portable Handheld hnaging (SPY-PHI) System (HH9000); IC2000 (Indocyanine Green for Inj ection, USP) Micra Atrial TRacking Using A Ventricular AccELerometer (MARVEL) clini cal feasibility study MED-EL SYNCRONY Cochlear hnplant System RETINA IMPLANT Alpha AMS TVRS Clip Delivery System, TVRS Steerable Guide Catheter Left Atrial Anatomy Reconstructi on Using Model Based Fast Anatomical Mapping B-FAST bTMB CTA MAGE-A4 hnmunohistochemistry (IHC) Clinical Trial Assay (CTA) my( hoice HRD CDx Transderrnal Compress XIENCE Apine Everolimus Eluting Coronary Stent System; XIENCE X pedition Everolimus Eluting Coronary Stent System MagPro MST manufactured by MagVenture, Inc. Apollo System SurgiMed Collagen Matrix Belotero Balance with Integral Lidocaine (Project description) NY-ES0-1 hnmunohistochemi stry (IHC) Clinical Trial Assay (CTA) Exablate Model4000 Type-1 system Telsa Magt1etic Resonance Research Device Cardiva Mid-Bore Venous Vascular Closure System (VVCS) RxLAL, Light Delivery Device and Rx Sight Insertion Device Cochlear hnplantation during Vestibular Schwannoma Removal or during Labyrinthectomy surgery for treatment of Meniere's disease RCStim Model1114R or 1114L Soft Ti ssue Stimulator Treatment of erectile dysfunction (ED) Med-El cochlear implant insertion electrode RestoreSensor SureScan MRI Implantable Neurostimulation System VerDate Sep<11>2014 Facility P1·ovider Number Effective Date CA Jkt 241001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4725 E:\FR\FM\04AUN1.SGM 04AUN1 Addendum VIII: American College of Cardiology's National Cardiovascular Data Registry Sites (April through June 2017) 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 lCD 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 lCD 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 https://www.cms.hhs.gov/Manuals/IOM/itemdetail.asp?filterType=none&filt erByDID=99&sortByDID= 1&sortOrder=ascending&itemiD=CMSO 14961 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 lCD implantation for primary prevention, the beneficiary must receive the scan in a facility that participates in the ACC-NCDR lCD registry. The entire list of facilities that participate in the ACC-NCDR lCD 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). I City The followinl!: facilities are new listinl!:s for this quarter. Brooklyn Interfaith Medical Center Mid-Columbia Medical Center The Dalles Midstate Medical Center Meriden Olmsted Medical Center Rochester UNMH - Sandoval Regional Medical Center Rio Rancho Houston Methodist The Woodlands The Woodlands Glacial Ridge Hospital District Glenwood Promedica Defiance Regional Hospital Defiance Alaska Cardiovascular Surgery Center, LLC Anchorage Lakeview Hospital Bountiful Fort Sutter Surgery Center, L.P. Sacramento Holy Cross Germantown Hospital Germantown Ellwood City Hospital Ellwood City Marshfield Clinic -Wausau Center Marshfield Facility State NY OR CT MN NM TX MN OH AK UT CA MD PA Wl Addendum IX: Active CMS Coverage-Related Guidance Documents (April through June 2017) 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) through the national coverage determination process. The document is available at https://www. ems. 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). Federal Register / Vol. 82, No. 149 / Friday, August 4, 2017 / Notices 15:13 Aug 03, 2017 TO: Dell Seton Medical Center at The University of Texas 1500 Red River Street Austin, TX 78701 The following facilities are terminations for this 1 uarter. San Ramon Regional Medical Center 050689 06/07/2005 6001 Norris Canyon Road San Ramon, CA 94583 State 36413 EN04AU17.007</GPH> 36414 VerDate Sep<11>2014 Jkt 241001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4725 E:\FR\FM\04AUN1.SGM Addendum XI: National Oncologic PET Registry (NOPR) (April through June 2017) 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 http: //www. ems. gov/MedicareApprovedF acilitie/NOPR/list.asp#TopOfPage. For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564 ). 04AUN1 Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (April through June 2017) 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 I, 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. There were no additions, deletions, or editorial changes to the list of Medicare-approved facilities that meet our standards that have occurred in the 3 -month period. This information is available at https://www. ems. gov /MedicareApprovedF acilitieNAD/list.asp#TopOfPage. For questions or additional information, contact Linda Gousis, JD, (410-786-8616). Addendum XIII: Lung Volume Reduction Surgery (LVRS) (April through June 2017) Addendum XIII includes a listing of Medicare-approved facilities that are eligible to receive coverage for lung volume reduction surgery. Until May 17, 2007, facilities that participated in the National Emphysema Treatment Trial were also eligible to receive coverage. The following three types of facilities are eligible for reimbursement for Lung Volume Reduction Surgery (LVRS): • National Emphysema Treatment Trial (NETT) approved (Beginning 05/07/2007, these will no longer automatically qualify and can qualify only with the other programs); • Credentialed by the Joint Commission (formerly, the Joint Commision on Accreditation 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.cms.gov/MedicareApprovedFacilitie!LVRS/list.asp#TopOfPage. For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Addendum XIV: Medicare-Approved Bariatric Surgery Facilities (April through June 2017) 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) Federal Register / Vol. 82, No. 149 / Friday, August 4, 2017 / Notices 15:13 Aug 03, 2017 EN04AU17.008</GPH> Addendum X: List of Special One-Time Notices Regarding National Coverage Provisions (April through June 2017) There were no special one-time notices regarding national coverage provisions published in the 3-month period. This information is available at www.cms.hhs.gov/coverage. For questions or additional information, contact JoAnna Baldwin, MS (410-786 7205). VerDate Sep<11>2014 Jkt 241001 PO 00000 Frm 00060 www. ems. gov /MedicareApprovedF acilitie/B SF/list.asp#TopOfPage. For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Fmt 4703 Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (April through June 2017) Sfmt 9990 E:\FR\FM\04AUN1.SGM 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). 04AUN1 Federal Register / Vol. 82, No. 149 / Friday, August 4, 2017 / Notices 15:13 Aug 03, 2017 greater than or equal to 35, have at least one co-morbidity related to obesity and have been previously unsuccessful with medical treatment for obesity. This decision also stipulated that covered bariatric surgery procedures are reasonable and necessary only when performed at facilities that are: ( 1) certified by the American College of Surgeons (ACS) as a Levell Bariatric Surgery Center (program standards and requirements in effect on February 15, 2006); or (2) certified by the American Society for Bariatric Surgery (ASBS) as a Bariatric Surgery Center of Excellence (BSCOE) (program standards and requirements in effect on February 15, 2006). 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 36415 EN04AU17.009</GPH> 36416 Federal Register / Vol. 82, No. 149 / Friday, August 4, 2017 / Notices [FR Doc. 2017–16252 Filed 8–3–17; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Form OCSE–396, ‘‘Child Support Enforcement Program Quarterly Financial Report’’, Form OCSE–34, ‘‘Child Support Enforcement Program Quarterly Collection Report’’. OMB No.: 0970–0181. Description: Form OCSE–396 and Form OCSE–34 are financial reports submitted following the end of each fiscal quarter by grantees administering the Child Support Enforcement Program in accordance with plans approved under title IV–D of the Social Security Act. Submission of these forms enables grantees to meet their statutory and regulatory requirement to report program expenditures and child support collections, respectively, from the previous fiscal quarter. States use Form OCSE–396 to report quarterly expenditures made in the previous quarter and to estimate program expenditures to be made and the incentive payments to be earned in the upcoming quarter. The Administration for Children and Families provides Federal funding to States for the Child Support Enforcement Program at the rate of 66 percent for all allowable and legitimate administrative costs of this program. Tribes use OMB Form SF–425 to report quarterly expenditures made in the previous quarter. Form SF–425 is not included as part of this comment request. As part of this request, minor changes are being proposed only in response to amendments to Federal regulations: • 45 CFR 304.25(b) was amended to extend the quarterly reporting deadline for both reports from ‘‘30’’ to ‘‘45’’ days after the end of each fiscal quarter. • 45 CFR part 95 was amended to require that all expenditures for a Statewide Child Support Enforcement System will now require an approved Advanced Planning Document (APD). Therefore, Line 6 on Form OCSE–396, ‘‘ADP Costs Without APD Required’’ is being eliminated as no longer necessary. The necessary instructions are being amended in response to both changes. Respondents: 54 States (including Puerto Rico, Guam, the Virgin Islands and the District of Columbia) for Forms OCSE–396 and OCSE–34 plus approximately 60 Tribes for Form OCSE–34. ANNUAL BURDEN ESTIMATES Number of respondents Instrument Form OCSE–396 ............................................................................................. Form OCSE–34 ............................................................................................... Estimated Total Annual Burden Hours: 7,680. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington, DC 20201. Attention Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: OIRA_ SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2017–16390 Filed 8–3–17; 8:45 am] BILLING CODE 4184–01–P VerDate Sep<11>2014 15:13 Aug 03, 2017 Jkt 241001 54 114 DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Presidential Advisory Council on HIV/AIDS Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/ AIDS (PACHA or the Council) will be holding a meeting and will discuss recommendations regarding programs, policies, and research to promote effective, prevention, treatment and cure of HIV disease and AIDS. The meeting will be open to the public. DATES: The Council meeting is scheduled to convene on Wednesday, August 30, 2017 from 9:00 a.m. to approximately 5:00 p.m. (ET). The meeting will be open to the public. ADDRESSES: 200 Independence Avenue SW., Washington, DC 20201 in the Penthouse (eighth floor), Room 800. FOR FURTHER INFORMATION CONTACT: Ms. Caroline Talev, Public Health Analyst, SUMMARY: PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 Number of responses per respondent 4 4 Average burden hours per response Total burden hours 6 14 1,296 6,384 Presidential Advisory Council on HIV/ AIDS, 330 C Street SW., Room L106B, Washington, DC 20024; (202) 795–7622 or Caroline.Talev@hhs.gov. More detailed information about PACHA can be obtained by accessing the Council’s page on the AIDS.gov site at www.aids.gov/pacha. PACHA was established by Executive Order 12963, dated June 14, 1995, as amended by Executive Order 13009, dated June 14, 1996. In a memorandum, dated July 13, 2010, and under Executive Order 13703, dated July 30, 2015, the President gave certain authorities to the PACHA for implementation of the National HIV/AIDS Strategy for the United States (Strategy). PACHA is currently operating under the authority given in Executive Order 13708, dated September 30, 2015. PACHA provides advice, information, and recommendations to the Secretary regarding programs, policies, and research to promote effective treatment, prevention, and cure of HIV disease and AIDS, including considering common co-morbidities of those infected with HIV as needed, to promote effective HIV prevention and treatment and quality services to persons living with HIV disease and AIDS. SUPPLEMENTARY INFORMATION: E:\FR\FM\04AUN1.SGM 04AUN1

Agencies

[Federal Register Volume 82, Number 149 (Friday, August 4, 2017)]
[Notices]
[Pages 36404-36416]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16252]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9104-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--April through June 2017

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 April through June 2017, relating to 
the Medicare and Medicaid programs and other programs administered by 
CMS.

FOR FURTHER INFORMATION CONTACT: It is possible that an interested 
party may need specific information and not be able to determine from 
the listed information whether the issuance or regulation would fulfill 
that need. Consequently, we are providing contact persons to answer 
general questions concerning each of the addenda published in this 
notice.

------------------------------------------------------------------------
            Addenda                  Contact            Phone 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,    (410) 786-7205
 Related Guidance Documents.     MS.
X One-time Notices Regarding    JoAnna Baldwin,    (410) 786-7205
 National Coverage Provisions.   MS.
XI National Oncologic Positron  Stuart Caplan,     (410) 786-8564
 Emission Tomography Registry    RN, 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.

[[Page 36405]]

 
XIV Medicare-Approved           Sarah Fulton, MHS  (410) 786-2749
 Bariatric Surgery Facilities.
XV Fluorodeoxyglucose Positron  Stuart Caplan,     (410) 786-8564
 Emission Tomography for         RN, MAS.
 Dementia Trials.
All Other Information.........  Annette Brewer...  (410) 786-6580
------------------------------------------------------------------------


SUPPLEMENTARY INFORMATION

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: July 20, 2017.
Kathleen Cantwell,
Director, Office of Strategic Operations and Regulatory Affairs.
BILLING CODE 4120-01-C

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[FR Doc. 2017-16252 Filed 8-3-17; 8:45 am]
 BILLING CODE 4120-01-P

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