Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2017, 21241-21251 [2017-09063]

Download as PDF 21241 Federal Register / Vol. 82, No. 86 / Friday, May 5, 2017 / Notices ID and password validation. The states are asked to provide information on issuers in their state and various Web sites maintained for consumers. The issuers are also tasked with providing information on their major medical insurance products and plans. They are ultimately given the choice to download a basic information template to enter data then upload into the web portal; to manually enter data within the web portal itself; or to submit .xml files containing their information. Once the states and issuers submit their data, they will receive an email notifying them of any errors, and that their submission was received. CMS is mandates that issuers verify and update their information on a quarterly basis and requests that States verify State-submitted information on an annual basis. In the event that an issuer enhances its existing plans, proposes new plans, or deactivates plans, the organization would be required to update the information in the web portal. Changes occurring during the three month quarterly periods will be allowed utilizing effective dates for both the plans and rates associated with the plans. Form Number: CMS–10320 (OMB control number: 0938–1086); Frequency: Annually, Quarterly; Affected Public: State, Local, and Tribal Governments; Number of Respondents: 305; Total Annual Responses: 5,500; Total Annual Hours: 89,725. (For policy questions regarding this collection contact Kim Heckstall at 410–786–1647.) 2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicare/ Medicaid Psychiatric Hospital Survey Data and Supporting Regulations; Use: The CMS–724 form is used to collect data that assists us in program planning and evaluation and in maintaining an accurate database on providers participating in the psychiatric hospital program. Specifically, we use the information collected on this form in evaluating the Medicare psychiatric hospital program. The form is also used for audit purposes; determining patient population and characteristics of the hospital; and survey term composition. Form Number: CMS–724 (OMB control number: 0938–0378); Frequency: Annually; Affected Public: Business or other for-profits and Not-for-profit institutions; Number of Respondents: 150; Total Annual Responses: 150; Total Annual Hours: 75. (For policy questions regarding this collection contact Stephanie Hursey at 410–786–4349.) Dated: May 2, 2017. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2017–09170 Filed 5–4–17; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–9103–N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—January Through March 2017 Centers for Medicare & Medicaid Services (CMS), HHS. AGENCY: ACTION: Notice. This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2017, relating to the Medicare and Medicaid programs and other programs administered by CMS. SUMMARY: 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: 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 ................................................................................................ SRADOVICH on DSK3GMQ082PROD with NOTICES Addenda Ismael Torres .......................................... Terri Plumb ............................................. Tiffany Lafferty ........................................ Wanda Belle, MPA ................................. John Manlove ......................................... William Parham ...................................... Sarah Fulton, MHS ................................. Sarah Fulton, MHS ................................. (410) 786–1864 (410) 786–4481 (410)786–7548 (410) 786–7491 (410) 786–6877 (410) 786–4669 (410) 786–2749 (410) 786–2749 JoAnna Baldwin, MS .............................. JoAnna Baldwin, MS .............................. Stuart Caplan, RN, MAS ........................ Linda Gousis, JD .................................... (410) (410) (410) (410) 786–7205 786–7205 786–8564 786–8616 Sarah Fulton, MHS ................................. Sarah Fulton, MHS ................................. Stuart Caplan, RN, MAS ........................ Annette Brewer ....................................... (410) (410) (410) (410) 786–2749 786–2749 786–8564 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 VerDate Sep<11>2014 17:43 May 04, 2017 Jkt 241001 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 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Phone number 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 E:\FR\FM\05MYN1.SGM 05MYN1 21242 Federal Register / Vol. 82, No. 86 / Friday, May 5, 2017 / Notices 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 SRADOVICH on DSK3GMQ082PROD with NOTICES This quarterly notice provides only the specific updates that have occurred in the 3-month period along with a VerDate Sep<11>2014 17:43 May 04, 2017 Jkt 241001 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 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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: May 1, 2017. Kathleen Cantwell Director, Office of Strategic Operations and Regulatory Affairs. BILLING CODE 4120–01–P E:\FR\FM\05MYN1.SGM 05MYN1 SRADOVICH on DSK3GMQ082PROD with NOTICES VerDate Sep<11>2014 Jkt 241001 PO 00000 Frm 00058 Fmt 4703 Addendum 1: Medicare and Medicaid Manual Instructions (January through March 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\05MYN1.SGM 05MYN1 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 tlris 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 are not sales outlets. Individuals may obtain information about the location of the nearest regional depository library from any library. CMS publication and transmittal numbers are shown in the listing entitled Medicare and Medicaid Manual Instructions. To help FDLs locate the materials, use the CMS publication and transmittal numbers. For example, to find the manual for Gender Dysphoria and Gender Reassignment Surgery use (CMS-Pub. 100-03) Transmittal No. 194. 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. Manual/Subject/Publication Number 233 Clarification of Payment Policy Changes for Negative Pressure Wound Therapy (NPWT) Using a Disposable Device and the Outlier Payment Methodology for Home Health Services National60-Day Episode Rate Outlier Payments Consolidated Billing Patient Confined to the Home Sequence of Qualifying Services and Other Medicare Covered Home Health Services Needs Skilled Nursing Care on an Intermittent Basis (Other than Solely Venipuncture for the Pmposes of Obtaining a Blood Sample), Physical Therapy, Speech-Language Pathology Services, or Has Continued Need for Occupational Therapy Physician Certification Supporting Documentation Requirements Wound Care Medical Supplies (Except for Drugs and Biologicals Other T11an Covered Osteoporosis Dmgs), the Use of Durable Medical Equipment Federal Register / Vol. 82, No. 86 / Friday, May 5, 2017 / Notices 17:43 May 04, 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: May 9, 2016 (81 FR 28072), August 5, 2016 (81 FR 51901), November 2016 (81 FR 79489 and February 23, 2017 (82 FR 11456). We are providing only the specific updates that have occurred in the 3-month period along with a hyperlink to the website to access this information and a contact person for questions or additional information. 21243 EN05MY17.000</GPH> SRADOVICH on DSK3GMQ082PROD with NOTICES 21244 VerDate Sep<11>2014 Jkt 241001 t'';'!i~i'?'•:;uiii 194 [;~,;~ ;',z1~:tf.{: 1;, z.:. 3688 3689 PO 00000 3690 Frm 00059 3692 Fmt 4703 3694 3691 3693 3695 Sfmt 4725 3696 3697 E:\FR\FM\05MYN1.SGM 3698 05MYN1 3699 3700 3701 EN05MY17.001</GPH> un 3702 3703 3704 t:\.l: 1 .':rs:;.;:···~'i Gender Dysphoria and Gender Reassignment Surgery :t: >'~i ~'iz:.:, 11 >.;,';; 3705 ;;;~:~c; ~i\'!;~· Update to the Federally Qualified Health Centers (FQHC) Prospective Payment System (PPS)- Recurring File Updates Durable Medical Equipment Prosthetics, Orthotics, and Supplies Healthcare Common Procedure Coding System (HCPCS) Code Jurisdiction List Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Changes to the Laboratory National Coverage Determination (NCD) Edit Software for April 2017 April2017 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files Medicare Physician Fee Schedule Database (MPFSDB) 2017 File Layout Manual Addendum Issued to a specific audience, not posted to Internet/ Intranet to Confidentiality of Instruction Medicare Outpatient Observation Notice (MOON) Instructions Part A Medicare Outpatient Observation Notice New Waived Tests Issued to a specific audience, not posted to Internet/ Intranet to Confidentiality of Instruction Medicare Outpatient Observation Notice (MOON) Instmctions Part A Medicare Outpatient Observation Notice Statutory Authority Scope Medicare Outpatient Observation Notice Alterations to the MOON Completing the MOON Hospital Delivery of the MOON Required Delivery Timeframes Refusal to Sign the MOON MOON Delivery to Representatives Ensuring Beneficiary Comprehension Completing the Additional Information Field of the MOON l\otice Retention for the MOON Intersection with State Observation Notices 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 Healthcare Common Procedure Coding System (HCPCS) Codes Subject to .:; 3706 3707 3708 3709 3710 3711 3712 3713 3714 3715 and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP)- April 2017 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 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 Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure to Procedure (PTP) Edits, Version 21.1, Effective Aprill, 2017 Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure to Procedure (PTP) Edits, Version 23.1, Effective April!, 2017 New "K" Code for Continuous Positive Airway Pressure Device Bundle Implementation of New Influenza Virus Vaccine Code Table of Preventive and Screening Services Healthcare Common Procedure Coding System (HCPCS) and Diagnosis Codes Payment for Pneumococcal Pneumonia Virus, Influenza Virus, and Hepatitis B Virus and Their Administration on Institutional Claims Procedures for Renal Dialysis Facilities (RDF) CWF Edits on AB MAC (A) Claims CWF Edits on AB 'v!AC (B) Claims CWF Crossover Edits for AB MAC (B) Claims New Fields in the Fiscal Intermediary Shared System (FISS) Inpatient and Outpatient Provider Specific Files (PSF) Addendum A, Provider Specific File Outpatient Provider Specific File Addendum A- Provider Specific File Outpatient Provider Specific File Changes to the National Coordination of Benefits Agreement (COBA) Crossover Process as a Result of the Social Security Number Removal Initiative (SSNRI) Beneficiary Insurance Assignment Selection Consolidation of the Claims Crossover Process Coordination of Benefits Agreement (COBA) Detailed Error Report Notification Process Coordination of Benefits Agreement (COBA) ASC X12 837 5010 Coordination of Benefits (COB) Flat File Errors Coordination of Benefits Agreement (COBA) ASC Xl2 837 Coordination of Benefits (COD) Mapping Requirements as of July 2012 l\ational Council for Prescription Drug Programs (NCPDP) New Version Coordination of l:lenetlts (COB) Requirements Qualified Medicare Beneficiary Indicator in the Medicare Fee-For-Service Claims Processing System Federal Register / Vol. 82, No. 86 / Friday, May 5, 2017 / Notices 17:43 May 04, 2017 234 and Furnishing Negative Pressure Wound Therapy Using a Disposable Device l\egative Pressure Wound Therapy Using a Disposable Device Coinsurance, Copayments, and Deductibles Clarification of Admission Order and Medical Review Requirements Covered Inpatient Hospital Services Covered Under Part A Hospital Inpatient Admission Order and Certification SRADOVICH on DSK3GMQ082PROD with NOTICES VerDate Sep<11>2014 3716 3718 Jkt 241001 3719 3720 PO 00000 3721 Frm 00060 3722 3723 3724 3725 Fmt 4703 3726 3727 Sfmt 4725 3728 E:\FR\FM\05MYN1.SGM 3730 05MYN1 3735 3729 3731 3732 3733 3734 3736 3737 3738 3739 3740 3741 3742 Issued to a specific audience, not posted to Intemet/Intranet due to Coni!dentiality of Instruction fl;;t~~~t~?.;i~:;:•~ #~~X'i!: '' ;:;.;{;i;Jt:~:£:rc~·:'~~:.s Remote Identity Proofing (RIDP) and Multi-Factor Authentication (MFA) for 117 Electronic Correspondence Referral System (ECRS) Web Users Electronic Correspondence Referral System for the Web (ECRS Web) Quick Reference Card 118 Individuals Not Subject to the Limitation on Medicare Secondary Payment (MSP) Individuals Not Subject to the Limitation on Payment •.. :;f,:i~?fi:?(f!:;z.:~:;-/~J'· i~: ·'i~:>' 11':.{1::;:;;;: 280 Notice of 'lew Interest Rate for Medicare Overpayments and Underpayments -2nd Qtr Notification for FY 2017 Imwvation Payment Contractor (!PC) for D1 D4 File Exchange 281 ~~~fi:'·fJ~ :,';!j:J!'"tz.l;; 167 168 ;;:;;~·?:'4!..<I+"i"?£Yi'?:r 702 703 704 705 706 707 708 709 ·. "tfmcfl'l);!;1~j.2"j;!*.':'?:?:!fii:;\';~ Revision to State Operations Manual (SOM) Appendix PP - Incorporate revised Requirements of Participation for Medicare and Medicaid certified nursing facilities Revision to State Operations Manual (SOM) Appendix PP - Incorporate revised Requirements of Participation for Medicare and Medicaid certified nursing facilities. -·'(fy~::;•,;;::;: 1~t:::::,:c 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 Instruction Home Health (HH) Language in Pub. 100-8 oflnstruclion Certification Requirements The Use of the Patient's Medical Record Documentation to Support Home Health Certification Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Order Requirements for Changing Suppliers Requirement of New Orders Issued to a specific audience, not posted to Intcmct/Intranct 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 Confidentiality of Instmction Issued to a specific audience, not posted to Intemet/Intranet due to Confirlentiality of Instruction <:. None !{~? ;;~j;~ Federal Register / Vol. 82, No. 86 / Friday, May 5, 2017 / Notices 17:43 May 04, 2017 3717 Extension of the Transition to the Fully Adjusted Durable :v!edical Equipment, Prosthetics, Orthotics and Supplies Payment Rates under Section 16007 of the 21st Century Cures Act Phase-In for Competitive Bidding Rates in Areas Not in a Competitive Bid Area Clinical Laboratory Fee Schedule- Medicare Travel Allowance Fees for Collection of Specimens Instructions to Process Services Not Authorized by the Veterans Administration (VA) in a Non-VA Facility Reported With Value Code (VC) 42 Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) - April CY 2017 Cpdate Issued to a specific audience, not posted to Internet/ Intranet due to Confidentiality of Instruction Updates to Pub. 100-04, Chapters 12, 17 and 23 to Correct Remittance Advice Messages Instructions for Downloading the Medicare ZIP Code File for July 2017 Health care Provider Taxonomy Codes (HPTCs) April 2017 Code Set Cpdate Common Edits and Enhancements Modules (CEM) Code Set Update Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easv Print (MREP) and PC Print Update April2017 Update of the Ambulatory Surgical Center (ASC) Payment System Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instruction April2017 Update of the Hospital Outpatient Prospective Payment System (OPPS) April Quarterly Update for 2017 Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Fee Schedule Payment for Oxygen Volume Adjustments and Portable Oxygen Equipment Billing for Oxygen and Oxygen Equipment Issued to a specific audience, not posted to Intcmct/Intranct due to Sensitivity of Instruction Indian Health Services (IHS) Hospital Payment Rates for Calendar Year 2017 Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP)- July 2017 Federally Qualified Health Centers (FQHC) Prospective Payment System (PPS) - Recurring File Updates April20 17 Integrated Outpatient Code Editor (I!OCE) Specifications Version 18.1 Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instruction Quarterly Updates to ESRD PRICER Changes to the Laboratory National Coverage Determination (NCD) Edit Software for July 2017 Billing for Advance Care Planning (ACP) Claims FISS Implementation of the Restructured Clinical Lab Fee Schedule New Waived Tests ;~'~?:":'2~:£ None :'fd'\ftrJ;:::;:o(Y rt.~JS"'!r~:, None ;~C"fi~i>.? None ;~~~z:: i~~''stF~.t •l:~i 1 ~,i;;~,;_,;f;':'tit~~')X/fJtzf'. None 21245 EN05MY17.002</GPH> SRADOVICH on DSK3GMQ082PROD with NOTICES 21246 VerDate Sep<11>2014 ! 1 </i!jl~~f; t?':'i?i~/1;1 ';;~./'· 0: 1787 None 170 171 ~t :~':1\c?i?fii~':;J;:; )i''J;~1::j! 1767 Jkt 241001 1768 PO 00000 1769 1770 1771 1772 Frm 00061 1773 1774 Fmt 4703 1775 1776 Sfmt 4725 1777 E:\FR\FM\05MYN1.SGM 1778 1779 1780 1781 05MYN1 17S2 1783 1784 1785 1786 EN05MY17.003</GPH> .::;+:r:;;;;;;,;.::;:;·:;".:;;z·;Xri'::•::~; Affordable Care Act Bundled Payments for Care Improvement Initiative Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Instruction 1788 1789 'ii1 !f~~/ ?.};,;;;!J~;~c!(:i!{zi~ig; Health Insurance Portability and Accountability Act (HIP AA) Electronic Data Interchange (EDI) Front End Updates for July 2017 Common Working File (CWF) Reorganization of Daily Beneficiary Extract Files Shared System Enhancement 2015: Resolve Operating Report (ORPT) Issues - Development and Implementation eMSN and Alternate Format MSN Service Improvements Modifications to the National Coordination of Benefits Agreement (COBA) Crossover Process Fraud Prevention System (FPS) 2 Edit Migration Testing Common Working File (CWF) Reorganization of Daily Beneficiary Extract Piles Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Instruction Shared System Enhancement 2014- Identification of Fiscal Intermediary Standard System (FISS) Obsolete Reports - Analysis Only Updated Editin<> of Professional Therapy Services Instructions to Hospitals on the Election of a Medicare-Supplemental Security Income (SSI) Component of the Disproportionate Share (DSH) Payment Adjustment for Cost Reports that Involve SSI Ratios for Fiscal Year (FY) 2004 and earlier, or SSI Ratios for Hospital Cost-reporting Periods for Patient Discharges Occurring before October 1, 2004 Issued to a specific audience, not posted to Internet/ 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 Internet/ 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 Internet/ Intranet due to Sensitivity Instruction Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Instruction Innovation Payment Contractor (IPC) for D1 D4 File Exchange Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Instruction Payment for Oxygen Volume Adjustments and Portable Oxygen EquipmentFISS Update for Additional International Classification of Diseases (ICD)-1 0 Codes for the System Changes to Implement Section 231 of the Consolidated Appropriations Act, 2016, Temporary Exception for Certain Severe Wound Discharges From Certain Long-Term Care Hospitals (LTCHs) 1790 1791 1792 1793 1794 1795 1796 1797 1798 1799 1800 1801 1802 1803 1804 1805 1806 1807 1808 1809 1810 1811 1812 1813 Federal Register / Vol. 82, No. 86 / Friday, May 5, 2017 / Notices 17:43 May 04, 2017 lrf:!i''~;;!:;t;;:;(;~i;;;(:;;::fr!!:~[/.,~3 New Common Working File (CWF) Medicare Secondary Payer (MSP) Type for Liability Medicare Set-Aside Arrangements (LMSAs) and No-Fault Medicare Set-Aside Arrangements (NFMSAs Combined Common Edits/Enhancements (CCEM) Proxool and Apache Software Upgrades Shared System Enhancement 2016: Common Working File (CWF) to Show Date for Informational Unsolicited Response (IUR) Indicator on Claim History Shared System Enhancement 2016: Complete Disablement of Health Maintenance Organization (HMO) Inquiry Transaction, HIHO, and Related Vestige within Common Working File (CWF) Change to Beneficiary Liability and Cost Report Days for Subclause (II) Long Term Care Hospitals (LTCHs) ICD-10 Coding Revisions to National Coverage Determination (NCDs) Analysis Only - Modification of Process for Handling the Provider Enrollment Chain Ownership System (PECOS) Extract File Provider Enrollment, Chain and Ownership System (PECOS) Extract FileAnalysis Advance Care Planning (ACP) Implementation for Outpatient Prospective Payment System (OPPS) Claims Processing Updates for VMS From Provider Enrollment, Chain and Ownership System (PECOS) Extract File Guidance on Implementing System Edits for Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) ICD-10 Coding Revisions to National Coverage Determinations (NCDs) Preventing Hospice Notices of Election with Future Dates Issued to a specific audience, not posted to Internet/ 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 Internet/ Intranet due to Sensitivity Instruction Innovation Payment Contractor (IPC) for D1 D4 File Exchange Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Instruction Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Instruction Health Insurance Portability and Accountability Act (HIP AA) Electronic Data Interchange (EDI) Front End Updates for July 2017 Intern and Resident Information System (IRIS) Data Upload into STAR Advanced Provider Screening (APS) Phase 1 Go-Live Client Letterv5.2 Upgrade- DME MAC Training and Testing Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity Instruction Shared System Enhancement 2014- Identification of Fiscal Intermediary Shared System (FISS) Obsolete On-Request Jobs- Analysis Only HIGLAS Connectivity Updates and Testing Shared System Enhancement 2015: Identify Inactive Medicare Demonstration Projects Within the Col1llllon Working File (CWF) SRADOVICH on DSK3GMQ082PROD with NOTICES VerDate Sep<11>2014 1814 Shared System Enhancement 2014- Identification ofFisca1 Intermediary Standard System (FISS) Obsolete Reports- Analysis Only 66 Issued to a specific audience, not posted to Internet/ Intranet due to Confidentiality of Instruction li:C;1;?;;X;1 ~l";j;!',(iij;';';;; None Jkt 241001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4725 E:\FR\FM\05MYN1.SGM Addendum IT: Regulation Documents Published in the Federal Register (January through March 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: https://www.cms.gov/quarterlyproviderupdates/downloads/Regs3Q16QPU.pdf For questions or additional information, contact Terri Plumb (410-786-4481). 05MYN1 Addendum III: CMS Rulings (January through March 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 llHIJ.IIvvwvv.~.:m:,q;u'i Kq;mauvu~ For questions or additional information, contact Tiffany Lafferty (410-786-7548). Title Gender Dysphoria and Gender Reassignment Surgery NCDM Section Transmittal Number Issue Date Effective Date NCO 140.9 194 03/03/2017 08/30/2016 Addendum V: FDA-Approved Category B Investigational Device Exemptions (IDEs) (January through March 2017) 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 tllis 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 Federal Register / Vol. 82, No. 86 / Friday, May 5, 2017 / Notices 17:43 May 04, 2017 ;,;iJfiJ'iii' ~,~;~r~~if Addendum IV: Medicare National Coverage Determinations (January through March 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 tl1e publication was issued, and the effective date of tl1e decision. An NCD is a determination by the Secretary for whether or not a particular item or service is covered nationally under the Medicare Program (title XVIII of the Act), but does not include a determination of the code, if any, that is assigned to a particular covered item or service, or payment determination for a particular covered item or service. The entries below include 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.cms.gov/medicarecoverage-database/. For questions or additional infonnation, contact Wanda Belle, MPA (410-786-7491). 21247 EN05MY17.004</GPH> SRADOVICH on DSK3GMQ082PROD with NOTICES 21248 VerDate Sep<11>2014 Jkt 241001 IDE BB17214 BB17240 BB17374 PO 00000 BB17376 Frm 00063 Fmt 4703 Gl60152 Gl60163 Gl60225 Gl60255 Gl60266 Gl60270 Sfmt 4725 E:\FR\FM\05MYN1.SGM Gl60273 Gl60276 G160277 Gl60278 Gl70001 Gl70002 Gl70003 Gl70004 Gl70006 Gl70007 Gl70010 Gl70011 05MYN1 Gl70014 Gl70017 Gl70018 Gl70019 Gl70020 Gl70024 Gl70026 Gl70028 Gl70031 G170035 EN05MY17.005</GPH> Device Transpose RT System CliniMACS CD34 Reagent System Magnetic- Activated Cell Sorter (CliniMACS, Miltenyi) for TCR??+/CD19+ Depeletion ofG-CSI' or GM-CSI' Mobilized Allogeneic Unrelated or Partially Matched Related Peripheral Stem Cells: Chemotherapy Amicus Separator System- Extracorporeal Photopheresis (ECP) ACCUSYTE 3-D FIDUCIAL MARKER Abre Venous Self-expanding Stent System ORBERA INTRAGASTRIC BALLOON Prostate Artery Embolization Insightec Exablate Prostate Artery Embolization for the Treatment of Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia Arrow StimuCath Continuous Nerve Block Set Olympus PK Morcellator and Pneumoliner CELCUITY CELX HER2 SIGNALING FUNCTION TEST PV-001 Pulmonary Valved Conduit VMllO and Olympus l\IR Laparoscopic System TULASystem NEUROPORT ARRAY, PN 6248, NEUROPORT BIOPOTENTIAL SIGNAL PROCESSOR SYSTEM, PN 5416 smART System FE NIX™ Continence Restoration System SAPPHIRE II PRO CORONARY DILATION CATHETER Bidirectional Cortical Neuroprosthetic System (BiCNS) Treatment of Severe Lower Urinary Tract Obstruction (LUTO) Aquadex FlexFlow Aquapheresis System Senza Spinal Cord Stimulation (SCS) System ExAblate MR guided focused ultrasound system MAGE-A3/A6 Screening Test Attain Stability Quad MRI Sure Scan 4798 Lead TAAA Debranching Stent Graft System Cochlear Reponse Telemetry Research Tool Subcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence Vivistim System for Stroke Activa RC Rechargeable Neurostimulator Model37612, Start Date 02/09/2017 02/03/2017 03/23/2017 IDE G170036 0170037 G170043 G170044 G170048 G170050 G170053 G170054 03/23/2017 01112/2017 01119/2017 03/29/2017 03/30/2017 01106/2017 01113/2017 01119/2017 01119/2017 01/20/2017 01126/2017 02/03/2017 02/03/2017 02/03/2017 02/02/2017 02/02/2017 02/08/2017 02/10/2017 02/10/2017 02/22/2017 02/22/2017 02/24/2017 02/2112017 02/24/2017 02/23/2017 02/28/2017 03/02/2017 03/10/2017 03/09/2017 G170055 G170056 Device Activa RC Recharger Model37651, DBS leads Models 3387S and 3389S, DBS extension Model37086, Patient Programmer Model #37642, External Neurostimulator Model37022, Clinician Programmer Model 8840, Medtronic Valiant Thoracoabdominal Stent Graft System Neocis Guidance System (NGS) Side Positioner VITARIA System Valiant Thoracoabdominal Stent Graft System Restylane; Restylane-L; Perlane; Restylane Lyft; Restylane Silk Edwards Alterra Adaptive Prestent Svstem HAC-Coil (H7) Deep Transcranial Magnetic Stimulation (DTMS) Device for the Treatment of Major Depression Disorder (MDD) TECNIS Next-Generation Intraocular Lens Unity Subcutaneous Infusion System Start Date 03/09/2017 03/15/2017 03/23/2017 03/17/2017 03/2112017 03/30/2017 03/29/2017 03/29/2017 03/30/2017 03/3112017 Addendum VI: Approval Numbers for Collections of Information (January through March 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). Addendum VII: Medicare-Approved Carotid Stent Facilities, (January through March 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 tllis quarterly notice, we are providing only the specific updates that have occurred in the 3-month period. This information is available at: Federal Register / Vol. 82, No. 86 / Friday, May 5, 2017 / Notices 17:43 May 04, 2017 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). SRADOVICH on DSK3GMQ082PROD with NOTICES VerDate Sep<11>2014 Facility li~~,,l;~i"t~0:z:,;; Jkt 241001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4725 E:\FR\FM\05MYN1.SGM 05MYN1 Provider Number Effective Date 050272 01110/2017 CA 050242 01126/2017 CA 140127 03/15/2017 IL 040119 03/30/2017 AR 470003 lit;';'';;;,;;; ;.;;;~;,,,Mtz 05/26/2005 VT 1881788933 10/26/2016 AR 140213 01123/2006 IL 370094 06/08/2005 OK 1073606901 06/05/2013 !viS 250072 05/06/2010 MS 440120 10/1112005 TN 230019 06/27/2005 •. j;:::;'(!;;;':' ;;,??~';;'";o~ [;:':;,F~0 :;;,'i:2f:z FROM: Fletcher Allen Health Care TO: University of Vermont Medical Center llll Colchester Avenue Burlington, VT 05401-1473 Baxter Regionallvledical Center 624 Hospital Drive Mountain Home, AR 72653 Silver Cross Hospital 1900 Silver Cross Boulevard New Lenox, IL 60453 FROM: Midwest Regional Medical Center TO: Alliance Health Midwest 2825 Parklawn Drive Midwest City, OK 73110 Memorial Hospital at Gulfport 4500 13th Street Gulfport, !viS 39501 !<'ROM: Central Mississippi Medical Center TO: Jackson HMA,LLC d/b/a Merit Health Central 1850 Chadwick Drive Jackson, !viS 39204 FROM: St. Mary's Health System TO: Tennova Healthcare- Physicians Regional Medical Center 900 E. Oak Hill Avenue Knoxville, TN 37917 FROM: Providence Hospital TO: Providence-Providence Park Hospital 16001 West Nine Mile Road Southfield, MI 4807 5 FROM: St. Elizabeth Health Center TO: St. Elizabeth Youngstown Hospital 1044 Belmont Avenue Youngstown, OH 44501-1790 Arizona Heart Hospital Provider Number Effective Date 100269 01126/2017 FL 050503 04/16/2010 CA State 1930 E. Thomas Road Phoenix, AZ 85016 ffi2'':.~:':J£;;';:;~;;· Palm West Hospital 13001 Southern Boulevard Loxahatchee, FL 33470-1150 P.O. Box 1150 Scripps Memorial Hospital Encinitas 354 Santa Fe Drive El\COl Encinitas, CA 92024 ;f;~;/;'' ri.'Y:f;1:iF !vii '' Redlands Community Hospital 350 Terracina Boulevard Redlands, CA 92373 Dignity Health Dominican Hospital 1555 Soquel Drive Santa Cruz, CA 95065 Advocate BroMenn Medical Center 1304 Franklin Avenue Normal, IL 61761 While River Medical Center 1710 Harrison Street Batesville, AR 72501 State Facility 360064 11116/2006 OH 030094 04/18/2005 AZ Addendum VIII: American College of Cardiology's National Cardiovascular Data Registry Sites (January through March 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 amiounced 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 ICD 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 Federal Register / Vol. 82, No. 86 / Friday, May 5, 2017 / Notices 17:43 May 04, 2017 https://www. ems. gov/MedicareApprovedF acilitie/CASF/list. asp#TopOfPage For questions or additional information, contact Sarah Fulton, MHS (410-786-27 49). A provider can use either of two mechanisms to satisfy the data reporting requirement. Patients may be enrolled either in an Investigational Device Exemption trial studying ICDs as identified by the FDA or in the ACC-NCDR ICD registry. Therefore, for a beneficiary to receive a Medicare-covered lCD implantation for primary prevention, the beneficiary must receive the scan in a facility that participates in the ACC-NCDR lCD 21249 EN05MY17.006</GPH> SRADOVICH on DSK3GMQ082PROD with NOTICES 21250 VerDate Sep<11>2014 Jkt 241001 Facility 1/:Si~/q City >·'' :;;i.i:j:; PO 00000 Frm 00065 Fmt 4703 Sfmt 4725 E:\FR\FM\05MYN1.SGM 05MYN1 Rancho Spring Medical Center Carolina Pines Regional Medical Center Protestant Memorial Medical Center Fairbanks Memorial Hospital Tennova- Dyersburg Regional Medical Center Baptist Health Richmond, Inc. The Hospitals of Providence Transmountain Campus CMSC LLC Dba Great Falls Clinic Hospital Centegra Hospital - Huntley Sacramento Heart Ambulatory Surgery Center, Inc. Piedmont Fayette Hospital Integris Miami Hospital Doctor's Same Day Sur<>ery Center Largo Ambulatory Surgery Center South Baltimore Ambulatory Surgery Center Tysons Corner Ambulatory Surgery Center Surgical Hospital of Oklahoma Beaumont ASC, LP Collin County ASP, LP Conroe ASC. LP Katy ASC, LP Lake Charles Ambulatory Surgery Center, LP Mid-Cities ASC, LP Phoenix ASC, LP Kaiser Permanente Orange County - Anaheim Medical Memorial Hermann Cypress Hospital State ~:c;;;)!( ~;jj~(;!;cf5~'j;;,ri Murrieta Hartsville Belleville Fairbanks Dyersburg Richmond El Paso CA IL AK TN KY TX Great Falls McHenry Sacramento MT IL CA Fayetteville Miami Sarasota Upper Marlboro Rockville Tysons Corner Oklahoma City Beaumont Plano The Woodlands Houston Lake Charles Bedford Phoenix Irvine GA OK FT. MD MD VA OK TX TX TX TX LA TX AZ CA Cypress TX sc Addendum IX: Active CMS Coverage-Related Guidance Documents (January through March 2017) CMS issued a guidance document on November 20, 2014 titled "Guidance for the Public, Industry, and CMS Staff: Coverage with EN05MY17.007</GPH> 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). Addendum X: List of Special One-Time Notices Regarding National Coverage Provisions (January through March 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). Addendum XI: National Oncologic PET Registry (NOPR) (January through March 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//WW\v. ems. gov/MedicareApprovedF acilitie/NOPR/list. asp#T opOfPage. For questions or additional infonnation, contact Stuart Caplan, RN, MAS (410-786-8564). Federal Register / Vol. 82, No. 86 / Friday, May 5, 2017 / Notices 17:43 May 04, 2017 registry. The entire list of facilities that participate in the ACC-NCDR lCD registry can be found at www.ncdr.com/webncdr/conunon 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/conunon. For questions or additional information, contact Sarah Fulton, MHS (410-786-27 49). SRADOVICH on DSK3GMQ082PROD with NOTICES PO 00000 Frm 00066 Fmt 4703 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 VADs for the clinical indication of destination therapy. W c 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 infonnation, contact Linda Gousis, JD, (410-786-8616). Sfmt 9990 E:\FR\FM\05MYN1.SGM Addendum XIII: Lung Volume Reduction Surgery (LVRS) (January through March 2017) 05MYN1 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): Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (January through March 2017) EN05MY17.008</GPH> Addendum XIV: Medicare-Approved Bariatric Surgery Facilities (January through March 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) 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). This information is available on our website at www. ems. gov/MedicareApprovedF acilitie/PETDT/list.asp#TopOfPage. For questions or additional infonnation, contact Stuart Caplan, RN, MAS (410-786-8564). 21251 There were no FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials published in the 3-month period. • National Emphysema Treatment Trial (NETT) approved (Beginning 05/07/2007, these will no longer automatically qualify and can qnali:fy only with the other programs); • Credentialed by the Joint Commission (fonnerly, the Joint Commision on Accreditation of Healthcare Organizations (JCAHO)) under their Disease Specific Certification Program for L VRS; and • Medicare approved for lung transplants. Only the first two types arc in the list. There were no updates to the listing of facilities for lung volume reduction surgery published in the 3-month period. This infonnation is available at www.cms.gov/MedicareApprovedFacilitie/L VRS/list.asp#TopOfPage. For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Federal Register / Vol. 82, No. 86 / Friday, May 5, 2017 / Notices Jkt 241001 [FR Doc. 2017–09063 Filed 5–4–17; 8:45 am] 17:43 May 04, 2017 BILLING CODE 4120–01–P VerDate Sep<11>2014 Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (January through March 2017)

Agencies

[Federal Register Volume 82, Number 86 (Friday, May 5, 2017)]
[Notices]
[Pages 21241-21251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09063]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9103-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--January Through March 2017

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

ACTION: Notice.

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

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

[[Page 21242]]

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: May 1, 2017.
Kathleen Cantwell
Director, Office of Strategic Operations and Regulatory Affairs.
BILLING CODE 4120-01-P

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[FR Doc. 2017-09063 Filed 5-4-17; 8:45 am]
BILLING CODE 4120-01-P

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