Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2019, 18040-18053 [2019-08640]

Download as PDF 18040 Federal Register / Vol. 84, No. 82 / Monday, April 29, 2019 / Notices Solicitation of Public Comment Written comments and suggestions from the public should address one or more of the following four points: (1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. B. Purpose khammond on DSKBBV9HB2PROD with NOTICES The Federal Acquisition Regulation (FAR) clause at 52.236–13, Accident Prevention, requires Federal construction contractors to provide and maintain work environments and procedures which will safeguard the public and Government personnel, property, materials, supplies, and equipment exposed to contractor operations and activities; avoid interruptions of Government operations and delays in project completion dates; and control costs in the performance of the contract. For these purposes on contracts for construction or dismantling, demolition, or removal of improvements, the contractor is required to provide appropriate safety barricades, signs, and signal lights; comply with the standards issued by the Secretary of Labor at 29 CFR part 1926 and 29 CFR part 1910; and ensure that any additional measures the contracting officer determines to be reasonably necessary for the purposes are taken. Whenever the contracting officer becomes aware of any noncompliance with these requirements or any condition which poses a serious or imminent danger to health or safety, the contracting officer shall provide a notice to the contractor and request immediate corrective action. Per FAR 36.513, the contracting officer should inform the Occupational Safety and Health (OSH) Administration (OSHA), or other cognizant Federal, State, or local officials, of instances where the contractor has been notified to take immediate action to correct serious or imminent dangers. With regard to recordkeeping, the OSH Act specifies that ‘‘[e]ach employer shall make, keep and preserve, and make available to the Secretary . . . such records . . . as the Secretary . . . may prescribe by regulation as necessary or appropriate for the enforcement of this Act. . . .’’ (29 U.S.C. 657(c)(1)). Accordingly, OSHA has received the Office of Management and Budget (OMB) clearance for a number of related OMB Control Nos. When performance is on a Government facility or will involve work of a long duration or hazardous nature, before commencing the work, the contractor must submit a written proposed plan for implementing this clause, as required by alternate I of the clause. The plan shall include an analysis of the significant hazards to life, limb, and property inherent in contract work performance and a plan for controlling those hazards. C. Annual Reporting Burden Respondents: 362. Responses per Respondent: 1. Total Annual Responses: 362. Hours per Response: 22. Total Burden Hours: 7,964. Affected Public: Businesses or other for-profit and not-for-profit institutions. Frequency: On occasion. Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405, telephone 202–501–4755. Please cite OMB Control No. 9000–0060, Accident Prevention Plans, in all correspondence. Dated: April 23, 2019. Janet Fry, Director, Federal Acquisition Policy Division, Office of Governmentwide Acquisition Policy, Office of Acquisition Policy, Office of Governmentwide Policy. [FR Doc. 2019–08540 Filed 4–26–19; 8:45 am] BILLING CODE 6820–EP–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–9116–N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—January Through March 2019 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 January through March 2019, 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 .............................................. XIV. Medicare-Approved Bariatric 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 .... David Dolan ........................ Sarah Fulton, MHS ............ Sarah Fulton, MHS ............ VerDate Sep<11>2014 16:56 Apr 26, 2019 Jkt 247001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\29APN1.SGM 29APN1 Phone No. (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) 786–1864 786–4481 786–7548 786–7491 786–6877 786–4669 786–2749 786–2749 786–7205 786–7205 786–8564 786–3365 786–2749 786–2749 18041 Federal Register / Vol. 84, No. 82 / Monday, April 29, 2019 / Notices Addenda Contact Phone No. XV. Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials ............................... All Other Information ......................................................................................................................... Stuart Caplan, RN, MAS .... Annette Brewer .................. (410) 786–8564 (410) 786–6580 SUPPLEMENTARY INFORMATION: I. Background khammond on DSKBBV9HB2PROD with NOTICES The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs and coordination and oversight of private health insurance. Administration and oversight of these programs involves the following: (1) Furnishing information to Medicare and Medicaid beneficiaries, health care providers, and the public; and (2) maintaining effective communications with CMS regional offices, state governments, state Medicaid agencies, state survey agencies, various providers of health care, all Medicare contractors that process claims and pay bills, National Association of Insurance Commissioners (NAIC), health insurers, and other stakeholders. To implement the various statutes on which the programs are based, we issue regulations under the authority granted to the Secretary of the Department of Health and Human Services under sections 1102, 1871, 1902, and related provisions of the Social Security Act (the Act) and Public VerDate Sep<11>2014 16:56 Apr 26, 2019 Jkt 247001 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 website 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 website list provides more timely access for beneficiaries, providers, and suppliers. We also believe the website offers a more convenient tool for the public to find the full list of qualified providers for these specific services and offers PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 more flexibility and ‘‘real time’’ accessibility. In addition, many of the websites have listservs; that is, the public can subscribe and receive immediate notification of any updates to the website. These listservs avoid the need to check the website, as notification of updates is automatic and sent to the subscriber as they occur. If assessing a website 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: April 11, 2019. Kathleen Cantwell, Director, Office of Strategic Operations and Regulatory Affairs. BILLING CODE 4120–01–P E:\FR\FM\29APN1.SGM 29APN1 khammond on DSKBBV9HB2PROD with NOTICES 18042 VerDate Sep<11>2014 Publication Dates for the Previous Four Quarterly Notices Jkt 247001 PO 00000 Addendum I: Medicare and Medicaid Manual Instructions (January through March 2019) Frm 00049 Fmt 4703 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. In2003, we transforu1ed the CMS Program Manuals into a web user-friendly presentation and renamed it the CMS Online Manual System. Sfmt 4725 E:\FR\FM\29APN1.SGM 29APN1 How to Obtain Manuals The Internet-only Manuals (IOMs) are a replica of the Agency's official record copy. Paper-based manuals are CMS manuals that were officially released in hardcopy. The majority of these manuals were transferred into the Internet-only manual (10M) or retired. Pub 15-1, Pub 15-2 and Pub 45 are exceptions to this rule and are still active paper-based manuals. The remaining paper-based manuals are for reference purposes only. If you notice policy contained in the paper-based manuals that was not transferred to the 10M, send a message via the CMS Feedback tool. Those wishing to subscribe to old versions of CMS manuals should contact the National Technical Infornmtion Service, Department of C01mnerce, 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. 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 govenunent 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 rnay 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 Updates Related to Home Health Certification and Recertification Policy Changes, use (CMS-Pub. 100-02) Transmittal No. 258. Addendum I lists a unique CMS transmittal number for each instruction in our manuals or program memoranda and its subject number. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use information in a transmittal in conjunction with information currently in the manual. For the purposes of this quarterly notice, we list only the specific updates to the list of manual instructions that have occurred in the 3-month period. This information is available on our website at www .cms.gov/Manuals. Transmittal Number . .. 255 256 257 258 .~ How to Review Transmittals or Program Memoranda Those wishing to review transmittals and program memoranda can access this infonnation 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 EN29AP19.002</GPH> Manual/Subject/Publication Number 212 213 214 .Me(tlcilre:General Inflilmllti~n ((:1\fS~P!Jb.l{li,J-OlJ None ..· • ·::· •···.· Mildicariil'Bei1efit Plllii.:Y (CMS.:PU.b.l00-02') .. Updates to Reflect Removal of Functional Reporting Requirements aud Therapy Provisions of the Bipartisan Budget Act of2018 Update to Intensive Cardiac Rehabilitation (ICR) Programs Update to Publication 100-02 Provide Language-Only Changes for the New Medicare Card Project Manual Updates Related to Home Health Certification and Recertification Policy Changes · . ; . :Moohl.il.N1 Na:tiol\al Co'V!ll'age l)et~ru~ination (<;"MS-Pub. •lOfl:03) ' <: Update to Pub. 100-03 to Provide Language-Only Changes for the New Medicare Card Project National Coverage Detetmination (NCD) 20.4 Implantable Cardiac Defibrillators (ICD) National Coverage Determination (NCD90.2): Next Generation Sequencing (NGS) I . I •:.! Federal Register / Vol. 84, No. 82 / Monday, April 29, 2019 / Notices 16:56 Apr 26, 2019 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 4, 2018 (83 FR 19769), August 13, 2018 (83 FR 40043), November 2, 2018 (83 FR 55174) and February 19, 2019 (84 FR 4805). We are providing only the specific updates that have occurred in the 3month period along with a hyperlink to the website to access this information and a contact person for questions or additional information. khammond on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 ;: 4192 4194 Jkt 247001 4195 4196 4197 PO 00000 4198 4199 Frm 00050 4200 4201 Fmt 4703 4202 Sfmt 4725 4204 4203 4205 E:\FR\FM\29APN1.SGM 4207 29APN1 4210 4206 4208 4209 4211 4212 4213 4214 4215 ;. :· + ,· : • Medicllre Cfanns Pra£essme {L"'VIS-I'nb~ '100~04) ·· .. Quarterly Update for the Temporary Gap Period of the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP)- April 2019 Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 25.1 Effective April1, 2019 Update to Publication (Pub.) 100-04 Chapter 25to Provide Language-Only Changes for the New lV!edicare Card Project New Waived Tests Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instructions Chapter 30 Revisions in Publication (Pub.) 100-04, Medicare Claims Processing Manual Skilled Nursing Facility Advance Beneficiary Notice of Non-Coverage (SNF ABN) Clinical Laboratory Fee Schedule- Medicare Travel Allowance Fees for Collection of Specimens 2019 Durable Medical Equipment Prosthetics, Orthotics, and Supplies Healthcare Common Procedure Coding System (HCPCS) Code Jurisdiction List Update to Pub. 100-04 Chapter 1 to Provide Language-Only Changes for the New Medicare Card Project Update to Pub. 100-04 Chapters 8, 20, and 24 to Provide Language-Only Changes for the New Medicare Card Project Update to Pub. 100-04 Chapter 32 to Provide Language-Only Changes for the New Medicare Card Project January 2019 Update ofthe Hospital Outpatient Prospective Payment System (OPPS) Update to Pub. 100-04 Chapter 15 to Provide Language-Only Changes for the New Medicare Card Project Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Internet/lntranet due to Confidentiality of Instructions Calendar Year (CY) 2019 Annual Update for Clinical Laboratmy Fee Schedule and Laboratoty Services Subject to Reasonable Charge Payment Calendar Year (CY) 2019 Update for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule Update to Pub. 100-04 Chapter 10 to Provide Language-Only Changes for the New Medicare Card Project Update to Publication (Pub.) 100-04 Chapter 11 to Provide Language-Only Changes for the New Medicare Card Project Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions April2019 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files Updates to Reflect Removal of Functional Reporting Requirements and Therapy Provisions of the Bipartisan Budget Act of2018 Issued to a specific audience, not posted to Intemet/Intranet due to . 4216 4217 4218 4219 4220 4221 4222 4223 4224 4225 4226 4227 4228 4229 4230 4231 4232 4233 4234 4235 4236 4237 4238 4239 4240 Confidentiality of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Update to Pub. 100-04 Chapter 34 to Provide Language-Only Changes for the New Medicare Card Project Modifications to the National Coordination of Benefits Agreement (COBA) Crossover Process Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Update to Intensive Cardiac Rehabilitation (ICR) Programs File Conversions Related to the Spanish Translation of the Healthcare Common Procedure Coding System (HCPCS) Descriptions Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Update to Mammography Editing Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Independent Laboratory Billing of Laboratory Tests for End-Stage Renal Disease (ESRD) Beneficiaries and the Sunset of the CB Modifier Home Health (HH) Patient-Driven Groupings Model (PDGM) Split Implementation Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD)--Clarification of Payment Rules and Expansion of International Classification of Diseases Tenth Edition (ICD-10) Diagnosis Codes Implementation of the Medicare Performance Adjustment (MPA) for the Maryland Total Cost of Care (MD TCOC) Model Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Update to Publication (Pub.) 100-04 Chapter 26 to Provide Language-Only Changes for the New Medicare Card Project Update to Publication (Pub.) 100-04 Chapters 4 and 17 to Provide LanguageOnly Changes for the New Medicare Card Project Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB)--April2019 Update Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Update to Publication (Pub.) 100-04 Chapter 3 to Provide Language-Only Changes for the New Medicare Card Project Update to the Internet-Only-Manual (IOM) Publication (Pub.) 100-04, Chapter 32, Section 12.1 Combined Common Edits/Enhancements Modules (CCEM) Code Set Update Healthcare Provider Taxonomy Codes (HPTCs) April2019 Code Set Update Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instructions Federal Register / Vol. 84, No. 82 / Monday, April 29, 2019 / Notices 16:56 Apr 26, 2019 4193 '' .. 18043 EN29AP19.003</GPH> khammond on DSKBBV9HB2PROD with NOTICES 18044 VerDate Sep<11>2014 4241 4242 4244 4245 Jkt 247001 4246 PO 00000 4248 4247 4249 Frm 00051 4250 Fmt 4703 4252 4251 4253 Sfmt 4725 4254 4255 E:\FR\FM\29APN1.SGM 4256 4257 4258 4259 29APN1 4260 4261 4262 4263 4264 4265 EN29AP19.004</GPH> 4266 Quarterly Update to the National Con·ect Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 25.2 Effective July 1, 2019 4267 Evaluation and Management (E/M) when Performed with Superficial Radiation Treatment Issued to a specific audience, not posted to Intemet/Intranet due to 4268 Confidentiality of Instmctions 4269 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instmctions 4270 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instructions Update to the Internet-Only-Manual (IOM) Publication (Pub.) 100-04, 4271 Chapters 1 and 3 4272 Correction of the Fiscal Year (FY) 2019 Inpatient Prospective Payment System (IPPS) Pricer ,, .:·. I . / Medic~re Sec!lnd.aey;Payer €CMS-PnJJ.iOfl-05). i , ·. Update to Publication (Pub.) 100-05 to Provide Language-Only Changes for 125 the New Medicare Card Project c.. ' ·· ···· M(!cdit:ateFimirtCil!l!Ma!,laf!ejjtent(CMS:.:Prib.100"06) ··· · • ·· • I 310 Notice of New Interest Rate for Medicare Overpayments and Underpayments - 2nd Qtr Notification for FY 2019 311 Updating Chapter 3, Section 200, Limitation on Recoupment; Medicare Overpayments Manual, 2 of 4 CR . •. < ... ·I Metl.icari! State•Opem.tions lVIrurrud (CMS:.. P"ub~ Uld-00): · : 186 Revisions to State Operations Manual (SOM) Appendix Z, Emergency Preparedness for All Provider and Certified Supplier Types Revision to the State Operations Manual (SOM 100-07) Appendix Q 187 . "; •· • ;. •·.. ·• <em Medicare:Progl'IWl,Jntegrity.(CMS..Pub.l00-08) .··. • 1•··: 853 Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmctions Local Coverage Determinations (LCDs) 854 855 Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmctions Issued to a specific audience, not posted to Intemet/Intranet due to 856 Confidentiality of Instructions 857 Local Coverage Detem1inations (LCDs) 858 Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmctions Issued to a specific audience, not posted to Intemet/Intranet due to 859 Confidentiality of Instructions 860 Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions 861 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instmction Update to Chapter 15 of Publication (Pub.) 100-08 862 Local Coverage Determinations (LCDs) 863 864 Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Update to Chapter 15 of Publication (Pub.) 100-08 865 866 Update to Chapter 4, Section 4.11 in Publication (Pub.) 100-08 . . Federal Register / Vol. 84, No. 82 / Monday, April 29, 2019 / Notices 16:56 Apr 26, 2019 4243 Instructions for Downloading the Medicare ZIP Code Files for July 2019 April Quarterly Update for 2019 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule Modifications to tbe National Coordination of Benefits Agreement (COBA) Crossover Process Home Health (HH) Patient-Driven Groupings Model (PDGM)- Split Implementation Healthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits Evaluation and Management (E/M) when Performed with Superficial Radiation Treatment Update to Publication 100-04 Chapters 2, 6, and 18 to Provide LanguageOnly Changes for the New Medicare Card Project Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Update to Chapter 30 in Publication (Pub.) 100-04 to Provide Language-Only Changes for the New Medicare Card Project Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instructions Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easv Print (MREP) and PC Print Update Ensuring Only the Active Billing Hospice Can Submit a Revocation April2019 Update of the Hospital Outpatient Prospective Payment System (OPPS) April20 19 Integrated Outpatient Code Editor (I/OCE) Specifications Version 20.1 Implementation of the Medicare Petformance Adjustment (MPA) for the Maryland Total Cost of Care (MD TCOC) Model Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB)- April 2019 Update The purpose of this Change Request (CR) is to provide billing instructions for hospital Part B inpatient services Update to Chapter 31 in Publication (Pub.) 100-04to Provide Language-Only Changes for the New Medicare Card Project Update to the Payment for Grandfathered Tribal Federally Qualified Health Centers (FQHCs) for Calendar Year (CY) 2019 Issued to a specific audience, not posted to Intemet/Intranet due to Confidentiality of Instmctions April2019 Update of the Ambulatory Surgical Center (ASC) Payment System July 2019 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files Changes to the Laboratory National Coverage Determination (NCD) Edit Software for July 2019 khammond on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 867 2226 2227 2228 2229 2230 Jkt 247001 2231 2232 PO 00000 2233 2234 • ·.· ·· McdiQJ.iiiProemmlnteerity Dislla>!e Netw.or;J,;;. Orf!atmations(CMS Pub fOI)-:1;5): Frm 00052 I 1: • ; ! ·.•· I None ·.·· ·• Medicare Manal!ed care (CMS"PU.b; 100ZI6) •· • ·· Fmt 4703 I 217 Sfmt 4725 218 E:\FR\FM\29APN1.SGM 220 219 221 222 223 29APN1 2218 2219 2220 2221 2222 2223 2224 2225 • ; .. 2235 ; 2236 None Mc4ic.!l~ Qn!iln.es~ I•····· ,, ; Pitriners Systems$ecurity (CMS-J>uJ!, toQ-(7) None 2237 • · .; ··· ;; ··iDemonstriltinns (CMS~Pnb' fiJOc19) •' • • ·., ; • · · • ·· ·· ' Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instructions Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instructions Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instructions Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instructions Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instructions Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instructions Issued to a specific audience, not posted to Intemet/Intranet due to Sensitivity of Instructions O!tcT6n,e Notlflca(icil1. {CMS~fnll..lOOclO) ViPS Medicare System (VMS) Prepavment Review File Shared System Enhancement 2018: Enhance Common Working File (CWF) Intemal Testing Facility (ITF) Response Records Direct Mailing Notification to MACs Regru·ding Addressing the Opioid Crisis Fiscal Intermediary Standard System (FISS) Prepayment Review Report Update to the Medicare Fee-For-Service (FFS) Companion Guides Multi-Carrier System (MCS) Prepayment Review File ViPS Medicare System (VMS) Prepayment Review File Issued to a specific audience, not posted to Intemet/ Intranet due to Sensitivity of Instructions 2238 2239 2240 2241 2242 2243 2244 2245 2246 2247 2248 2249 Synchronize the Common Working File (CWF) and Enrollment Data Base (EDB) Entitlement Data New State Code for CA, FL, LA, lv!I, MS, OH, PA, 1N and TX Fiscal Intermediary Shared System (FISS) Enhancement of PC Print Billing Software Lock the Claim Term Date on File 41 ·Analysis Only Removal of Quality Programs from the Medicare Physician Fee Schedule (MPFS) Disclosure Report Processing Veterans Administration (VA) Inpatient Claims Exempt from Present on Admission (POA) Reporting Revising the Remittance Advice Messaging for the 20-Hour W eeldy Minimum for Partial Hospitalization Program (PHP) Services Shared System Enhancement 2018: Automate Health Insurance Master Record (HI!v!R) Lookup Within Common Working File (CWF) Utilizing Data from the USPS Secure Destruction Program to Suppress Mailing Medicare Summarv Notices (MSNs) to Undeliverable Addresses Ensuring Organ Acquisition Charges Are Not Included in the Inpatient Prospective Payment System (IPPS) Payment Calculation Issued to a specific audience, not posted to Intemet/ Intranet due to Sensitivity of lnstmctions Viable Information Processing Systems (ViPS) Medicare Systems (VMS) Changes to Accommodate National Provider Identifier Associations Analysis and Development Reduce/Eliminate Screen-Scraping for Shared Systems by Creating Transaction-based Access to Common Working File (CWF) Beneficiary Data - Analysis and Design Targeted Probe and Educate User CR: MCS- Print Report Edit/Audit and PJ/PLIPM Set-Up PJ/PL or PLIPM Segments Euhancingthe Verification Process of Common Working File (CWF) Part A Provider Inquiries Issued to a specific audience, not posted to Intemet/ Intranet due to Sensitivity of Instructions lntemational Classification of Diseases, 1Oth Revision (!CD-I 0) and Other Coding Revisions to National Coverage Determination (NCDs) Multi-Carrier System (MCS) Analysis Change Request (CR) to create Application Program Interfaces (APis) for Letter Writing Processing Instructions to L'pdate the Standard Paper Remit (SPR) Expand Narrative File Message Number Range Implementation Analysis Call to Discuss Multi-Carrier System (MCS) Limitation When Quantity Allowed is Greater Than Quantity Billed Implementation to Exchange the list of Electronic Medical Documentation Requests (eMDR) for Registered Providers via the Electronic Submission of Medical Documentation (esMD) System Analysis on Systems to use Documentation Code References in Additional Documentation Request (ADR) Letters and to Include Non-Medical ADRs for Electronic Medical Documentation Requests (eMDRs) via the Electronic Submission of Medical Documentation (esMD) System Federal Register / Vol. 84, No. 82 / Monday, April 29, 2019 / Notices 16:56 Apr 26, 2019 Update to Exhibit 16- Model Payment Suspension Letters in Publication (Pub.) 100-08 Update to Chapter 4, Section 4.7 in Publication (Pub.) 100-08 868 869 Fraud Prevention System (FPS) Edit- FPS36- Enhancement to Denial for Multiple Ankle-Foot/Knee-Ankle-Foot Orthoses Frequency Limit (This CR Rescinds and Fully Replaces CR 10465.) Manual Updates Related to Home Health Certification and Recertification 870 Policy Changes ·1\!l~dicllri Contractor ~ncficiil:rY alt4 Pt:oVi!lcf Comwrlclltiori!J {C.M:S-Pub. 190~11?). 41 Update to Publication (Pub.) 100-09 to Provide Language-Only Changes for the New Medicare Card Project I·' ·• ·· : MediCilrt Qmill.ty lmp~ovemeut GrJ!anlzatton(CMS. Puh.IOO-to:r ••· ·· ·· ·.·. None ; I• ·•· M~cai'c Elitt Sta~~:e Renal)>ise:as~ Netwi!rK Orl!arfizatious CCMS J.>"uli HI0-14) I None 18045 EN29AP19.005</GPH> khammond on DSKBBV9HB2PROD with NOTICES 18046 VerDate Sep<11>2014 2250 2252 2253 Jkt 247001 2254 2255 PO 00000 2256 2257 Frm 00053 2258 2259 Fmt 4703 2260 Sfmt 4725 2261 2262 2263 E:\FR\FM\29APN1.SGM 2264 2265 2266 29APN1 2267 2268 2269 2270 2271 2272 EN29AP19.006</GPH> 2273 2274 I Revision to the Cost Report Acceptability Checklists I Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instmctions ·• Melli~;am QWI)jty Rep!!rthll! lneeQ.Uve .PJ'O"l'aiJl$ (CMSc P!J.b•. lfl0,.2l} Update to Publication 100-22 to Provide Language-Only Changes for the 82 New Medicare Card Project ·· · ··· · Itlforijwl:ilin SeCU:rity A:a'.eptable Risl.i. Saf~~ards (CMS~Pnb. iiJ0-25) I None I ·' . Addendum II: Regulation Documents Published in the Federal Register (January through March 2019) 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 .ems. govI quarterlyprovidempdates/downloads/Re gs1Ql9QPU.pdf For questions or additional infommtion, contact Terri Plumb (410-786-4481 ). Addendum III: CMS Rulings (January through March 2019) CMS Rulings are decisions of the Administrator that seiVe 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~~-"'-'"-'.!.~~~-'-'-""""'~"""'""' For questions or additional information, contact Tiffany Lafferty (410-786-7548). i Federal Register / Vol. 84, No. 82 / Monday, April 29, 2019 / Notices 16:56 Apr 26, 2019 2251 User CR: ViPS Medicare System (VMS) changes to the IC4301- RAC Reopenings and Appeals Tracking Report to Display the Current Appeal Level Utilizing the Blank Page on Odd-Numbered Medicare Summary Notices to Promote CMS Priorities Implementation of the Skilled Nursing Facility (SNF) Patient Driven Payment Model (PDPM) Implementation of Additional Contact with Providers in the Event of a Rejected Cost Repmt Filing Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instmctions Shared System Enhancement 2018: Rewrite Fiscal Intermediary Shared System (FISS) module FSSB6001, Connnon Working File (CWF) Unsolicited Response Function Issued to a specific audience, not posted to Internet/ Intranet due to Sensitivity of Instmctions User CR: MCS- Health Professional Shortage Area (HPSA) No Pay Remittances Should Not Be Sent for Do Not Fotward (DNF) Provider User CR: MCS- Display Region on Select MCS Screens Modification of the MCS Claims Processing System Logic for Modifier 59, XE, XS, XP, and XU Involving the National Correct Coding Initiative (NCCI) Procedure to Procedure (PTP) Column One and Column Two Codes User CR: MCS- Add MSP Confirmed Flag and Cost Avoid to History Screen, IDR, and other Files Direct Mailing Notification to MACs Regarding Addressing the Opioid Crisis Ensuring Organ Acquisition Charges Are Not Included in the Inpatient Prospective Payment System (IPPS) Payment Calculation Implementation of the Award for the Jurisdiction 8 (J-8) Part A and Part B Medicare Administrative Contractor (J8 AlB MAC) Implementation to Exchange the list of Electronic Medical Documentation Requests (eMDR) for Registered Providers via the Electronic Submission of Medical Documentation (esMD) System Revising the Remittance Advice Messaging for the 20-Hour Weekly Minimum for Partial Hospitalization Program (PHP) Services Revising the Remittance Advice Messaging for the 20-Hour Weekly Minimum for Partial Hospitalization Program (PHP) Services New State Code for CA, FL, LA, MI, MS, OH, PA, TN and TX Instmctions Relating to the Self-Disallowance Requirement for Determining Jurisdiction over Appeals User CR: MCS- Health Professional Shortage Area (HPSA) No Pay Remittances Should Not Be Sent for Do Not Forward (DNF) Provider Implementation of the Skilled Nursing Facility (SNF) Patient Driven Payment Model (PDPM) The Supplemental Security Income (SSI)/Medicare Beneficiary Data for Fiscal Year 2017 for Inpatient Prospective Payment System (IPPS) Hospitals, Inpatient Rehabilitation Facilities (IRFs), and Long Term Care Hospitals (LTCHs) Issued to a specific audience, not posted to Intemet/ Intranet due to Sensitivity of Instmctions khammond on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 Jkt 247001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4725 E:\FR\FM\29APN1.SGM - - National Coverage Determination (NCD) 20.4 Implantable Cardiac Defibrillators (ICDs) Addendum VII: Medicare-Approved Carotid Stent Facilities, (January through March 2019) Addendum VII includes listings of Medicare-approved carotid stent facilities. All facilities listed meet CMS standards for perfornring 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 nrinimum 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 t11at have occurred in the 3-month period. This infonnation is available at: https://www .ems. gov/MedicareApprovedFacilitie/CASF/list. asp#TopOfPage For questions or additional infonnation, contact Sarah Fulton, MHS (410-786-2749). ·Facility - Title several related infonnation collections. This information is available at www.reginfo.gov/public/do/PRAMain. For questions or additional information, contact William Parham (410-786-4669). NCDM Section Transmittal Nwnber Issue Date 213 02/15/2019 Effective Date • NCD20.4 02115/2018 • 29APN1 Addendum V: FDA-Approved Category B Investigational Device Exemptions (IDEs) (January through March 2019) (Inclusion of this addenda is under discussion intemally.) Addendum VI: Approval Numbers for Collections of Information (January through March 2019) 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 Provider Effective Date State Number . ,, The followinl!fadliti~s are ni,>w .listm$: for tlris Cluar:ter• -< _::, ;!_ ·' West Houston Medical Center 450644 01110/2019 TX 12141 Richmond Avenue Houston, TX 77082 Pinnacle Hospital 1801969670 03/05/2019 IN 9301 Connecticut Drive Crown Point, IN 46307 .; The followml!;fadlities ltavet!ditbrial cJil,ln~i's (ill lmld):i - · •01120/2009 100055 FL FROM: Florida Hospital North Pinellas TO: AdventHealth North Pinellas 1395 South Pinellas Avenue Tarpon Springs, FL 34689 l''ROM: St. Anthony's Medical 260077 06/0112005 MO Center TO: Mercy Hospital South 100 10 Kennerly Road St. Louis, MO 63128 Providence-Providence Park 230019 06/27/2005 MI <; ·, Federal Register / Vol. 84, No. 82 / Monday, April 29, 2019 / Notices 16:56 Apr 26, 2019 Addendum IV: Medicare National Coverage Determinations (January through March 2019) Addendum IV includes completed national coverage determinations (NCDs), or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified by the section of the NCD Manual (NCDM) in which the decision appears, the title, the date the publication was issued, and the effective date of the decision. An NCD is a determination by the Secretary for whether or not a particular item or service is covered nationally under the Medicare Program (title XVIII 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 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. Infonnation 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. For the purposes of this quarterly notice, we are providing only the specific updates to national coverage detemrinations (NCDs), or reconsiderations of completed NCDs published in the 3-month period. This infonnation is available at: www.cms.gov/medicare-coverage-database/. For questions or additional information, contact Wanda Belle, MP A 18047 EN29AP19.007</GPH> khammond on DSKBBV9HB2PROD with NOTICES 18048 VerDate Sep<11>2014 Facility Provider Number Effective Date State Jkt 247001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4725 Other Information: Providence -Providence Park Hospital's second facility 47601 Grand River Novi MI 48374 390201 09/25/2006 FROM: Pocono Medical Center TO: LeHigh Valley HospitalPocono 206 East Brown Street East Stroudsburg, PA 18301 FROM: Munroe Regional Medical 05/23/2005 100062 Center TO: AdventHealth Ocala 1500 S.W. 1st Avenue Ocala, FL 34474 ·. < .• . c • "The foHowi.Ji2 facilitY has been removed~ VHS Brownsville Hospital DBA 450028 03/09/2016 Valley Baptist Medical Center Brownsville 1040 West Jefferson Street Brownsville, TX 78520 PA FL ·,· .. TX E:\FR\FM\29APN1.SGM 29APN1 Addendum VIII: American College of Cardiology's National Cardiovascular Data Registry Sites (January through March 2019) The initial data collection requirement through the American College of Cardiology's National Cardiovascular Data Registry (ACCNCDR) has seiVed to develop and improve the evidence base for the use of ICDs in certain Medicare beneficiaries. The data collection requirement ended with the posting of the final decision memo for Implantable CardioverterDefibrillators on February 15,2018. For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Addendum IX: Active CMS Coverage-Related Guidance Documents (January through March 2019) 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 EN29AP19.008</GPH> Addendum X: List of Special One-Time Notices Regarding National Coverage Provisions (January through March 2019) 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 2019) Addendum XI includes a listing of National Oncologic Positron Emission Tomography Registry (NOPR) sites. We cover positron emission tomography (PET) scans for particular oncologic indications when they are performed in a facility that participates in the NOPR. In January 2005, we issued our decision memorandum on positron emission tomography (PET) scans, which stated that CMS would cover PET scans for particular oncologic indications, as long as they were performed in the context of a clinical study. We have since recognized the National Oncologic PET Registry as one of these clinical studies. Therefore, in order for a beneficiary to receive a Medicare-covered PET scan, the beneficiary must receive the scan in a facility that participates in the registry. There were no additions, deletions, or editorial changes to the listing of National Oncologic Positron Emission Tomography Registry (NOPR) in the 3-month period. This information is available at https://www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage. For questions or additional information, contact Stuart Caplan, RN, MAS (410-786-8564). Federal Register / Vol. 84, No. 82 / Monday, April 29, 2019 / Notices 16:56 Apr 26, 2019 Hospital 16001 West Nine Mile Road Southfield, MI 4807 5 vehicles relating to evidence development activities including the investigational device exemption (IDE), the clinical trial policy, national coverage detenninations and local coverage detenninations, this guidance document is principally intended to help the public understand CMS's implementation of coverage with evidence development (CED) through the national coverage detennination 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). khammond on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 Jkt 247001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4725 Addendum XII includes a listing of Medicare-approved facilities that receive coverage for ventricular assist devices (VADs) used as destination therapy. All facilities were required to meet our standards in order to receive coverage for V ADs implanted as destination therapy. On October 1, 2003, we issued our decision memorandmn on VADs for the clinical indication of destination therapy. We determined that V ADs used as destination therapy are reasonable and necessary only if performed in facilities that have been determined to have the experience and infrastructure to ensure optimal patient outcomes. We established facility standards and an application process. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy. For the purposes of this quarterly notice, we are providing only the specific updates 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/MedicareApprovedFacilitie!VAD/list.asp#TopOfPage. For questions or additional information, contact David Dolan, JD, (410-786-3365). E:\FR\FM\29APN1.SGM Facility Date of Date of Initial Recertification Certification ·. ' ; The followhll! l:'acilitie!i a~·ne\v liStirii!s fflr this 4nirter. TriStar Centennial Medical 440161 12/12/2018 Center 2300 Patterson Street Nashville, TN 37203 29APN1 Other inf01mation: Joint Commission ID # 7888 Deborah Heart and Lung Center 200 Trenton Rd Browns Mills, NJ 08015 Provider Number 310031 02/05/2019 State :. .. TN Facility P1·ovider Number Geisinger Medical Center 100 North Academy A venue Danville, PA 17822 390006 Date of Recertification State PA DNV GL Certificate#: 283581-2019-VAD ·: : '! : Thefoll!)Winl! facilities h;lve~ditnrilil ehlllt~;~es ~in l,lold). : . .·.. . . :·• :: .··.··. 360085 11112/2003 OH FROM: Ohio State 10/24/2018 Unive1·sity TO: Ohio State University Hospitals 410 W lOth Avenue Columbus, OH 43210 Other information: Joint Commission ID #: 7029 V AD Previous Re-certification Dates: 2008-12-19; 2010-10-19; 2012-10-11; 2014-09-09; 201610-04 St. Francis Hospital 100 Port Washington Boulevard Roslyn, NY 11576 Other information: Joint Commission ID #: 5860 NorthShore University Health System 1301 Central Street, Suite 300 Evanston, IL 60201 Other Information: Joint Commission ID NJ Date of Initial Certification 02/06/2019 7343 330182 11/09/2016 11114/2018 NY 140010 10/26/2016 11115/2018 IL Federal Register / Vol. 84, No. 82 / Monday, April 29, 2019 / Notices 16:56 Apr 26, 2019 Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (January through March 2019) Other infonnation: DNV GL Certificate#: 283578-2019VAD 18049 EN29AP19.009</GPH> khammond on DSKBBV9HB2PROD with NOTICES 18050 VerDate Sep<11>2014 Facility Jkt 247001 PO 00000 Frm 00057 Other infotmation: Joint Commission ID #: 8387 VAD Previous Re-certification Dates: 2009-02-13; 2011-0819; 2013-08-30; 2015-10-02; 2017-11-10 The Medical Center of Central Georgia 777 Hemlock Street Macon, GA 312014440 W. 95th Street Oak Lawn, IL 60505 Fmt 4703 Sfmt 4725 Other infotmation: Joint Commission ID #: 6707 VAD Previous Re-certification Dates: 2014-10-21; 2016-11-22 FROM: Tufts-New England Medical Center TO: Tufts Medical Center 800 Washington Street Boston, MA 02111 260032 Date of Initial Certification 03/06/2007 Date of Recertification State Facility Prouder Number 11/07/2018 MO Lutheran Hospital of Indiana 7950 W Jefferson Boulevard Fort Wayne, IN 46804 E:\FR\FM\29APN1.SGM 29APN1 VAD Previous Re-certification Dates: 2008-10-28; 2010-10-19; 2012-10-26; 2014-10-16; 201611-08 State 12/05/2018 IN 330059 11114/2003 11/07/2018 NY 450193 10/28/2003 12/12/2018 TX Other information: Hospital was certified by CMS from 2003-10-29 until being decertified on 2007-07-30. Joint Commission lD #: 7157 110107 11108/2012 11/14/2018 IL V AD Previous Re-certification Dates: 2010-09-15; 2012-10-24: 2014-10-21; 2016-11-01 Montefiore Medical Center 111 E 210th Street Bronx, NY 10467 Other information: Joint Commission ID 220116 11106/2003 12/05/2018 MA Other information: Joint Commission ID #: 5518 V AD Previous Re-certification Dates: 2008-10-23; 2010-10-01; 2012-10-03; 2014-09-23; 201611-08 University of North Carolina Hospitals 101 Manning Drive Chapel Hill, NC 27514 Date of Recertification 150017 Date of Initial Certification 10/29/2003 340061 05/05/2004 11/28/2018 NC 2514 VAD Previous Re-certification Dates: 2008-11-12; 2010-10-08; 2012-10-23; 2014-09-23; 201610-18 FROM: St. Luke's Episcopal Hospital TO: CHI St. Luke's HealthBaylor College of Medicine Medical Center 6720 Bertner Avenue Houston, TX 77030 Other information: Joint Commission ID #: 9098 V AD Previous Re-certification Dates: 2008-10-08; 2010-11-17; 2012-11-06; 2014-10-16; 201611-22 ' Federal Register / Vol. 84, No. 82 / Monday, April 29, 2019 / Notices 16:56 Apr 26, 2019 Bames-Jewish Hospital 1 Eames Jewish Hospital Drive Saint Louis, MO 63110 Other information: Joint Commission ID #: 6478 EN29AP19.010</GPH> Pro~ider Number khammond on DSKBBV9HB2PROD with NOTICES VerDate Sep<11>2014 Facility 360180 Date of Initial Certification 12/03/2003 Date of Recertification State 12/12/2018 OH Addendum XIII: Lung Volume Reduction Surgery (LVRS) (January through March 2019) Jkt 247001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4725 Addendum XIII includes a listing of Medicare-approved facilities that are eligible to receive coverage for lung volume reduction surgery. Until May 17, 2007, facilities that participated in the National Emphysema Treatment Trial were also eligible to receive coverage. The following three types of facilities are eligible for reimbursement for Lung Volume Reduction Surgery (L VRS): • National Emphysema Treatment Trial (NETT) approved (Beginning 05/07/2007, these will no longer automatically qualify and can qualify only with the other programs); • Credentialed by the Joint Commission (formerly, the Joint Commision on Accreditation of Healthcare 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. For the purposes of this quarterly notice, we are providing only the specific 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/L VRS/list.asp#TopOfPage. For questions or additional information, contact Sarah Fulton, MHS (410-786-27 49). Other infmmation: Joint Commission Certified 2008-12-29. Joint Commission ID #: 7001 VAD Previous Re-certification Dates: 2008-12-29; 2010-11-23; 2012-12-11; 2014-12-02; 201611-08 . The ftfJI!lWinil: fai::ilitl:es have been removed. CHI Health Nebraska Heart 280128 11119/2014 12/13/2016 7500 South 91st Street Lincoln, NE 68526 . NE Other infotmation: E:\FR\FM\29APN1.SGM Joint Commission ID #: 524947 Joint Commission Withdrawal Date: 2019-01-03 Oregon Health and Sciences University 3181 SW Sam Jackson Park Road, Portland, OR 97239 380009 ll/2112003 04/18/2017 OR Facility Providet· Date of Date Approved Number De-certified. ... Tbe fOllow in!!: fatilitY blls editorial cbanl!es in bllld); Ohio State University Hospitals 360085 10/29/2016 410 West Tenth Avenue, DN 168 Columbus, OH 43210 Other information: Joint Commission ID #: 9707 29APN1 VAD Previous Re-certification Dates: 2008-11-12; 2011-0215; 2013-02-12; 2015-03-03 Joint Commission Withdrawal Date: 2019-01-03 Novant Health Forsyth Medical Center 3333 Silas Creek Parkway Winston Salem, NC 27103 Other infonnation: DNV GL Certified on 2018-0420 DNV GL De-Cettified on 201902-22 State ; OH Other information: Joint Commission ID #: 7029 340014 04/20/2018 NC LVRS Re-certification Dates: 2018-12-15 : •. .. J • ' i <Th~foiJow.ine•facilit:'>basbeenr'emovlld; Temple University Hospital, Inc. 3401 North Broad Street Philadelphia, PA 19140 390027 03/25/2017 ...•, 03/14/2019 ! ··. ;... Federal Register / Vol. 84, No. 82 / Monday, April 29, 2019 / Notices 16:56 Apr 26, 2019 Cleveland Clinic 9500 Euclid Avenue Cleveland, OH 44195 Provider Number .•• PA Addendum XIV: Medicare-Approved Bariatric Surgery Facilities 18051 EN29AP19.011</GPH> khammond on DSKBBV9HB2PROD with NOTICES 18052 VerDate Sep<11>2014 Jkt 247001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4725 E:\FR\FM\29APN1.SGM There were no additions, deletions, or editorial changes to Medicare-approved facilities that meet CMS' minimum facility standards for bariatric surgery that have been certified by ACS and/or ASMBS in the 3-month period. This infonnation is available at www. ems. gov/MedicareApprovedF acilitie/B SF/list.asp#TopOfPage. For questions or additional infommtion, contact Sarah Fulton, MHS (410-786-2749). Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (January through March 2019) 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. ems. gov/MedicareApprovedF acilitie/PETDT/list.asp#TopOfPage. For questions or additional information, contact Stnart Caplan, RN, MAS (410-786-8564). 29APN1 Federal Register / Vol. 84, No. 82 / Monday, April 29, 2019 / Notices 16:56 Apr 26, 2019 EN29AP19.012</GPH> (January through March 2019) Addendum XIV includes a listing of Medicare-approved facilities that meet minimum standards for facilities modeled in part on professional society statements on competency. All facilities must meet our standards in order to receive coverage for bariatric surgery procedures. On February 21, 2006, we issued our decision memorandum on bariatric surgery procedures. We detennined that bariatric surgical procedures are reasonable and necessary for Medicare beneficiaries who have a body-mass index (BMI) greater than or equal to 35, have at least one co-morbidity related to obesity and have been previously unsuccessful with medical treatment for obesity. This decision also stipulated that covered bariatric surgery procedures are reasonable and necessary only when performed at facilities that are: (1) certified by the American College of Surgeons (ACS) as a Level 1 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). Federal Register / Vol. 84, No. 82 / Monday, April 29, 2019 / Notices Comments received on or before May 28, 2019, will be provided to the committees. Comments received after that date will be taken into consideration by FDA. You may submit comments as follows: [FR Doc. 2019–08640 Filed 4–26–19; 8:45 am] BILLING CODE 4120–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–1646] Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice, establishment of a public docket; request for comments. ACTION: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. DATES: The meeting will be held on June 11, 2019, from 8 a.m. to 5 p.m. and June 12, 2019, from 8 a.m. to 5 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993–0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/ucm408555.htm. FDA is establishing a docket for public comment on this meeting. The docket number is FDA–2019–N–1646 . The docket will close on June 30, 2019. Submit either electronic or written comments on this public meeting by June 30, 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 30, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 30, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. khammond on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:56 Apr 26, 2019 Jkt 247001 Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2019–N–1646 for ‘‘Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.’’ Received comments, those filed in a timely manner (see the ADDRESSES section) will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 18053 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/ blacked out, will be available for public viewing and posted on https:// www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September18, 2015, or access the information at https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Moon Hee V. Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, Fax: 301–847–8533, email: DSaRM@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the E:\FR\FM\29APN1.SGM 29APN1

Agencies

[Federal Register Volume 84, Number 82 (Monday, April 29, 2019)]
[Notices]
[Pages 18040-18053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08640]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9116-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--January Through March 2019

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 2019, relating 
to the Medicare and Medicaid programs and other programs administered 
by CMS.

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

----------------------------------------------------------------------------------------------------------------
                   Addenda                                         Contact                          Phone No.
----------------------------------------------------------------------------------------------------------------
I. CMS Manual Instructions..................  Ismael Torres....................................   (410) 786-1864
II. Regulation Documents Published in the     Terri Plumb......................................   (410) 786-4481
 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 Stent         Sarah Fulton, MHS................................   (410) 786-2749
 Facilities.
VIII. American College of Cardiology-         Sarah Fulton, MHS................................   (410) 786-2749
 National Cardiovascular Data Registry Sites.
IX. Medicare's Active Coverage-Related        JoAnna Baldwin, MS...............................   (410) 786-7205
 Guidance Documents.
X. One-time Notices Regarding National        JoAnna Baldwin, MS...............................   (410) 786-7205
 Coverage Provisions.
XI. National Oncologic Positron Emission      Stuart Caplan, RN, MAS...........................   (410) 786-8564
 Tomography Registry Sites.
XII. Medicare-Approved Ventricular Assist     David Dolan......................................   (410) 786-3365
 Device (Destination Therapy) Facilities.
XIII. Medicare-Approved Lung Volume           Sarah Fulton, MHS................................   (410) 786-2749
 Reduction Surgery Facilities.
XIV. Medicare-Approved Bariatric Surgery      Sarah Fulton, MHS................................   (410) 786-2749
 Facilities.

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XV. Fluorodeoxyglucose Positron Emission      Stuart Caplan, RN, MAS...........................   (410) 786-8564
 Tomography for 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 website 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 website list provides more timely 
access for beneficiaries, providers, and suppliers. We also believe the 
website 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 
websites have listservs; that is, the public can subscribe and receive 
immediate notification of any updates to the website. These listservs 
avoid the need to check the website, as notification of updates is 
automatic and sent to the subscriber as they occur. If assessing a 
website 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: April 11, 2019.
Kathleen Cantwell,
Director, Office of Strategic Operations and Regulatory Affairs.
BILLING CODE 4120-01-P

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[FR Doc. 2019-08640 Filed 4-26-19; 8:45 am]
 BILLING CODE 4120-01-C

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