Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-April Through June 2021, 45986-45999 [2021-17602]

Download as PDF 45986 Federal Register / Vol. 86, No. 156 / Tuesday, August 17, 2021 / Notices and dollars, and improve Americans’ quality of life. CDC is mandated to provide ongoing administrative, research, and technical support for the operations of the CPSTF. During its meetings, the CPSTF considers the findings of systematic reviews of existing research and practice-based evidence and issues recommendations. CPSTF recommendations are not mandates for compliance or spending. Instead, they provide information about evidence-based options that decision makers and stakeholders can consider when they are determining what best meets the specific needs, preferences, available resources, and constraints of their jurisdictions and constituents. The CPSTF’s recommendations, along with the systematic reviews of the evidence on which they are based, are compiled in the The Community Guide. Matters proposed for discussion: The agenda will consist of deliberation on systematic reviews of literature and is open to the public. Topics will include Cancer Screening; HIV Prevention; Nutrition, Physical Activity, and Obesity; Social Determinants of Health, and Violence Prevention. Information Dated: August 11, 2021. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention. [FR Doc. 2021–17556 Filed 8–16–21; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services ACTION: Notice. This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April through June 2021, 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: [CMS–9131–N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—April Through June 2021 Centers for Medicare & Medicaid Services (CMS), HHS. AGENCY: Addenda Contact I CMS Manual Instructions ......................................................................................................... II Regulation Documents Published in the Federal Register ................................................... III CMS Rulings .......................................................................................................................... IV Medicare National Coverage Determinations ........................................................................ V FDA-Approved Category B IDEs ............................................................................................ VI Collections of Information ...................................................................................................... VII Medicare-Approved Carotid Stent Facilities ......................................................................... VIII American College of Cardiology-National Cardiovascular Data Registry Sites .................. IX Medicare’s Active Coverage-Related Guidance Documents ................................................ X One-time Notices Regarding National Coverage Provisions ................................................. XI National Oncologic Positron Emission Tomography Registry Sites ..................................... XII Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities .................. XIII Medicare-Approved Lung Volume Reduction Surgery Facilities ......................................... XIV Medicare-Approved Bariatric Surgery Facilities .................................................................. XV Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials .......................... All Other Information ..................................................................................................................... Ismael Torres ..................... Terri Plumb ......................... Tiffany Lafferty ................... Wanda Belle, MPA ............. John Manlove ..................... William Parham .................. Sarah Fulton, MHS ............ Sarah Fulton, MHS ............ JoAnna Baldwin, MS .......... JoAnna Baldwin, MS .......... David Dolan, MBA .............. David Dolan, MBA .............. Sarah Fulton, MHS ............ Sarah Fulton, MHS ............ David Dolan, MBA .............. Annette Brewer .................. SUPPLEMENTARY INFORMATION: I. Background khammond on DSKJM1Z7X2PROD with NOTICES regarding the start and end times for each day, and any updates to agenda topics, will be available on the Community Guide website (www.thecommunityguide.org) closer to the date of the meeting. The meeting agenda is subject to change without notice. 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 VerDate Sep<11>2014 17:08 Aug 16, 2021 Jkt 253001 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 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 Phone No. (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) 786–1864 786–4481 786–7548 786–7491 786–6877 786–4669 786–2749 786–2749 786–7205 786–7205 786–3365 786–3365 786–2749 786–2749 786–3365 786–6580 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 E:\FR\FM\17AUN1.SGM 17AUN1 Federal Register / Vol. 86, No. 156 / Tuesday, August 17, 2021 / Notices khammond on DSKJM1Z7X2PROD with NOTICES 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. VerDate Sep<11>2014 17:08 Aug 16, 2021 Jkt 253001 III. How To Use the Notice This notice is organized into 15 addenda so that a reader may access the subjects published during the quarter covered by the notice to determine whether any are of particular interest. We expect this notice to be used in concert with previously published notices. Those unfamiliar with a description of our Medicare manuals should view the manuals at http:// www.cms.gov/manuals. The Director of the Office of Strategic Operations and Regulatory Affairs of the PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 45987 Centers for Medicare & Medicaid Services (CMS), Kathleen Cantwell, having reviewed and approved this document, authorizes Lynette Willson, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. Dated: August 11, 2021. Lynette Wilson, Federal Register Liaison, Centers for Medicare and Medicaid Services. BILLING CODE 4120–01–P E:\FR\FM\17AUN1.SGM 17AUN1 khammond on DSKJM1Z7X2PROD with NOTICES Jkt 253001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4725 E:\FR\FM\17AUN1.SGM 17AUN1 How to Obtain Manuals The Internet-only Manuals (IOMs) arc 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 (IOM) 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 IOM, 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: http://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 http://www.gpo.gov/librarics/ In addition, individuals may contact regional depository libraries that receive and retain at least one copy of most federal government Fee-For Service Transmittal Numbers Please Note: Beginning Friday, March 20, 2020, there will be the following change regarding the Advance Notice of Instructions due to a CMS internal process change. Fee-For Service Transmittal Numbers will no longer be determined by Publication The Transmittal numbers will be issued by a single numerical sequence beginning with Transmittal Number 10000. 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 10757 10783 10784 10729 10738 Manual/Subject/Publication Number Physician Certification and Recertification of Services Manual Update to Incorporate Allowed Practitioners into Home Health Policy Certification and Recertification by Physicians and Allowed Practitioners for Home Health Services Content of the Phvsician's or Allowed Practitioner's Certification Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Updates to Medicare Benefit Policy Manual for Rural Health Clinic (RHC) and Federally Qualified Health Center (FQHC) Services (Manual Updates Only) of Acronyms Care Management Services General Care Management Services - Chronic Care Home Health Manual Update to huplement Calendar Year 2021 Request for Anticipated Pavment Policies and Corrections to Certification and Split Federal Register / Vol. 86, No. 156 / Tuesday, August 17, 2021 / Notices 17:08 Aug 16, 2021 Addendum I: Medicare and Medicaid Manual Instructions (April through June 2021) 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. 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 2021 Durable Medical Equipment Prosthetics, Orthotics, and Supplies Healthcare Common Procedure Coding System (HCPCS) Code Jurisdiction List, use (CMS-Pub. 100-04) Transmittal No. 10737. 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. 45988 VerDate Sep<11>2014 EN17AU21.000</GPH> Publication Dates for the Previous Four Quarterly Notices We publish this notice at the end of each quarter reflecting information released by CMS during the previous quarter. The publication dates of the previous four Quarterly Listing of Program Issuances notices are: August 12, 2020 (85 FR 48691), November 4, 2020 (85 FR 70168), March 17, 2021 (86 FR 14629) and May 3, 2021 (86 FR 23373). 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 khammond on DSKJM1Z7X2PROD with NOTICES VerDate Sep<11>2014 Percentage Payment Approach to the 30-Day Period Unit of Payment Requirements for Submission of"No-Pay" RAPs Who May Sign the Certification or Recertification? Recertification for Home Health Beneficiaries 10797 Jkt 253001 PO 00000 10818 10838 Frm 00038 Fmt 4703 Sfmt 4725 10702 10703 E:\FR\FM\17AUN1.SGM 10716 17AUN1 10704 10721 10722 10713 10724 10725 10728 10737 EN17AU21.001</GPH> April 2021 Update of the Ambulatory Surgical Center (ASC) Payment System Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity of Instruction Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Common Working File (CWF) Edits for Medicare Telehealth Services and Manual Update Telehealth Consultation Services, Emergency Department or Initial Inpatient versus Inpatient Evaluation and Management (E/M) Visits Payment for Subsequent Hospital Care Services and Subsequent Nursing Facilitv Care Services as Telehealth Services New Waived Tests Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction File Conversions Related to the Spanish Translation of the Healthcare Common Procedure Codine: Svstem (HCPCS) Descriotions Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction 2021 Durable Medical Equipment Prosthetics, Orthotics, and Supplies Healthcare Common Procedure Coding System (HCPCS) Code Jurisdiction List Revisions of Sections 30.6. l(B), 30.6.12, and 30.6.13(H) of Chapter 12 of Selection of Level of Evaluation and Manae:ement Service Critical Care Visits 10760 10762 10766 10768 10771 10773. 10775 10782 10788 10793 10794 10796 10803 10809 10810 10811 10812 10814 10815 10816 45989 10742 National Coverage Determination (NCD 110.24): Chimeric Antigen Receptor (CAR) T-cell Therapy - This CR Rescinds and Fully Replaces CR 11783. Chimeric Antigen Receptor (CAR) T-cell theraov National Coverage Determination (NCD) Removal Extracorporeal Immunoadsorption (ECI) Using Protein A Columns Electrosleep Therapy Implantation of Gastrointestinal Reflux Devices Abarclix for the Treatment of Prostate Cancer Magnetic Resonance Spectroscopy Positron Emission Tomography (PET) Scans FDG PET for Inflammation and Infection National Coverage Determination (NCD) 210.3 - Screening for Colorectal Cancer (CRC)-Rlood-Ra~ed Riomarker Test~ Colorectal Cancer Screening Tests National Coverage Determination (NCD) Removal Extracorporeal Immunoadsorption (ECI) Using Protein A Columns Electrosleep Therapy Implantation of Gastrointestinal Reflux Devices Abarelix for the Treatment of Prostate Cancer Magnetic Resonance Spectroscopy Positron Emission Tomography (PET) Scans FDG PET for Inflammation and Infection 10758 and Neonatal Intensive Care (Codes 99291 - 99292) Nursing Facility Services Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Replacing Home Health Request~ for Anticipated Payment (RAPs) with a Notice of Admission (NOA) -- Manual Instructions Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) - July 2021 Update Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction National Coverage Determination (NCD 110.24): Chimeric Antigen Receptor (CAR) T-cell Therapy- This CR Rescinds and Fully Replaces CR 11783. Chimeric Antigen Receptor (CAR) T-cell therapy Coverage Requirements Billing Requirements Medicare Administrative Contractor (MAC) (A) Bill Types Revenue Codes Billing Healthcare Common Procedural Coding System (HCPCS) Codes Diagnosis Requirements Payment Requirements Claim Adjustment Reason Codes (CARCs), Remittance Advice Remark Codes (RARCs), Group Codes, and Medicare Summary Notice (MS)<) Messages Claims Editing Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Annual Updates to the Prior Authorization/Pre-Claim Review Federal Holiday Schedule Tables for Generating Reports Quarterly Update for Clinical Laboratory Fee Schedule (CLFS) and Laboratorv Services Subiect to Reasonable Charge Payment October 2021 Healthcare Common Procedure Coding System (HCPCS) Ouarterly Update Reminder Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivitv of Instruction Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print fMREP) and PC Print Uodate Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Federal Register / Vol. 86, No. 156 / Tuesday, August 17, 2021 / Notices 17:08 Aug 16, 2021 10796 10756 khammond on DSKJM1Z7X2PROD with NOTICES Jkt 253001 10822 PO 00000 10823 10824 10825 Frm 00039 10826 10831 Fmt 4703 10833 Sfmt 4725 10834 108% 10837 E:\FR\FM\17AUN1.SGM 10839 17AUN1 10840 10844 10730 Claim Submission and Processing Payment, Claim Adjustments and Cancellations RESERVED Transfer Situation - Payment Effects Discharge and Readmission Situation Under HH PPS - Payment Effect~ Payment Adjustments - Partial Period Payment Adjustment Payment When Death Occurs During an HH PPS Period Payment Adjustments - Low Utilization Payment Adjustments (LUPAs RESERVED Payment Adjustments -Applying OASIS Assessment Items to Determine HIPPS Codes Payment Adjustments - Outlier Payments RESERVED Changes in a Beneficiary's Payment Source Glossary and Acronym List Home Health Prospective Payment System (HH PPS) Consolidated Billing Responsibilities of Home Health Agencies Responsibilities of Providers/Suppliers of Services Subject to Consolidated Billing Home health Consolidated Billing Edit~ in Medicare Systems Therapy Editing Other Editing Related to Home Health Consolidated Billing Only Notice of Admission (NOA) Received and Services Fall Within Admission Period No NOA Received and Therapy Services Rendered in the Home Eligibility Query to Determine Status CWF Response to Inquiry Timeliness and Limitations of CWF Responses National Home Health Prospective Payment Episode History File Opening and Length ofHH PPS Periods of Care RESERVED RESERVED Exhibit: Chart Summarizing the Effects of NOA/Claim Actions on the HH PPS Episode File Notice of Admission (NOA HH PPS Claims Beneficiary-Driven Demand Billing Under HH PPS No Payment Billing General Input/Output Record Layout RESERVED Decision Logic Used by the Pricer on Claims Annual Updates to the HH Pricer Medical and Other Health Services Submitted Using Type of Bill 034x Temporary Suspension of Home Health Services Pavment Procedures for Terminated HHAs Updates to the Internet Only Publication 100-04, Chapter I, Section 10.1 and Chapter 20, Section 10 A/B MACs [Part BJ and DME MACs Jurisdiction of Requests for Payment Where to Bill DMEPOS and PEN Items and Services Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Electronic Correspondence Referral System (ECRS) Updates to the Revised Remote Identity Proofmg, Implementation ofa New ECRS Web Error Code, and Multi-Factor Authentication (MFA) Process and Requirements for the Transition from Connect Direct to the Federal Register / Vol. 86, No. 156 / Tuesday, August 17, 2021 / Notices 17:08 Aug 16, 2021 EN17AU21.002</GPH> 10819 Confidentiality of Instruction National Coverage Determination (NCD) 210.3 - Screening for Colorectal Cancer (CRC)-Blood-Based Biomarker Tests Preventive and Screening Services Colorectal Cancer (CRC) Screening Payment Deductible and Coinsurance HCPCS Codes, Frequency Requirements, and Age Requirements CWF Edits Ambulatory Surgical Center (ASC) Facility Fee Determining High Risk for Developing CRC Non-Covered Services Billing Requirements for Claims Submitted to A/B MACs (A Medicare Summary Notice (MSN) Messages Remittance Advice Codes Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity of Instruction Combined Common Edits/Enhancements Modules (CCEM) Code Set Uodate July 2021 Integrated Outpatient Code Editor (1/OCE) Specifications Version 22.2 July 2021 Update of the Hospital Outpatient Prospective Payment System (OPPS) Clinic Visits Shared Svstem Suooort Hours for Aoolication Programming Interfaces ( APis) Healthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CUA) Edits Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP) - October 2021 Quarterlv Update to Home Health (HH) Grouper July 2021 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Ouarterlv Pricing Files National Coverage Determination (NCD) 20.9.1 Ventricular Assist Devices (VADs) Artificial Hearts and Related Devices Ventricular Assist Devices (VADs Post-Cardiotomy V ADs for Short-term or Long-term Mechanical Circulatory Support Other Replacement Accessories and Supplies for External V ADs or Any VAD Replacing Home Health Requests for Anticipated Payment (RAPs) with a Notice of Admission (NOA) -- Manual Instructions Creation of HH PPS and Subsequent Refinements RESERVED The HH PPS Unit of Payment Number, Duration, and Claims SubmissionofHH PPS Periods of Care More Than One Agency Furnished Home Health Services EITect of Eledion of Medicare Advantage (MA) Organization and Eligibility Changes on HH PPS RESERVED Basis of Medicare Prospective Payment Systems and Case-Mix Coding of HH PPS Case-Mix Groups on HH PPS Claims: HHRGs and HIPPS Cod Composition of HIPPS Codes for HH PPS Grouper Links Assessment and Payment RESERVED Submission of the Notice of Admission (NOA) 45990 VerDate Sep<11>2014 10818 khammond on DSKJM1Z7X2PROD with NOTICES VerDate Sep<11>2014 10786 10807 10723 10727 10733 10735 Jkt 253001 10736 10710 PO 00000 10731 10790 Frm 00040 10806 10821 Fmt 4703 10835 The Fiscal Intermediary Shared System (FISS) Submission of Copybook Files to the Provider and Statistical Reimbursement (PS&R) Svstem Notice of New Interest Rate for Medicare Overpayments and Underpayments -3rd Otr Notification for FY 2021 Issued to a specific audience, not posted to lntemeV!ntranet due to a Confidentialitv of Instruction The Fiscal Intermediary Shared System (FISS) Submission of Copybook Files to the Provider and Statistical Reimbursement (PS&R) Svstem Pub. 100-06, Chapter 4, Section 10 Revision (New Accounts Receivable (AR) Status Codes for Undeliverable Initial Demand Lottcrs and TcrminatcdiOut of Business Providers) Requirements for Collecting Part A and B Provider KonMSP Overpayments Issued to a specific audience, not posted to IntemeV!ntranet due to a Confidentialitv of Instruction 10740 10741 10743 10744 10745 Sfmt 4725 10749 E:\FR\FM\17AUN1.SGM 17AUN1 Revisions to the State Operations Manual (SOM) Appendix Z - Emergency Preparedness 10709 Update to Chapter 12 (The Comprehensive Error Rate Testing (CERT) Program) of Publication (Puh.) 100-08 Handling Overpaymentq and Underoavments Resulting from the CERT Findings Updates to Chapter 4 of Publication (Pub.) 100-08 Organizational Requirements Procedural Requirements Program Integrity Security Requirements Requests for Information From Outside Organizations Screening Leads Vetting Leads with CMS Conducting Investigations Reversed Denials by Administrative Law Judges on Open Cases Production of Medical Records and Documentation for an Appeals Case File Guidelines for Incentive Reward Program Complaint Tracking Fraud Alerts Administrative Relief from Program Integrity Review in the Presence ofa Disaster CPIC Hospice Cap Liability Process - Coordination with the MAC Referral of Cases to the OIG/OI Immediate Advisements to the OIG/01 Referral to Other Law Enforcement Agencies Reserved for Future Use Referral to State Agencies or Other Organizations UPICs and QIOs Discounts, Rebates, and Other Reductions in Price Identity Theft Investigations and Victimized Provider Waiver of Liability Procedure 10711 10750 10751 10752 10776 10777 10779 45991 204 Implementation of Provider Enrollment Provisions in CMS-6058-FC - Phase 1 - Continued Removal/Moving of Instructions from Chapter 15 of Publication (Pub.) 100-08 to Chapter IO of Pub. 100-08 Medicare Enrollment: Contractor Processing Duties Other Medicare Contractor Duties Develooment Letters Chapter 15 of Publication (Pub.) 100-08 Manual Redesign - Additional Release of Chapter 10 of Pub. 100-08, Modification of the Timeliness Standards Issued to a specific audience, not posted to IntemeV!ntranet due to Confidentiality oflnstructions Updates to Medicare Administrative Contractor (MAC) Appeals and Rebuttals Reporting Issued to a specific audience, not posted to lntemeV!ntranet due to Confidentiality of Instructions Voluntary Terminations of Enrollment Involving Certified Providers and Certified Suppliers Voluntary Terminations Model Letters for Voluntary Terminations Involving Certified Providers and Certified Suooliers Issued to a specific audience, not posted to IntemeV!ntranet due to Confidentiality of Instructions Issued to a specific audience, not posted to IntemeV!ntranet due to Confidentiality of Instructions Issued to a specific audience, not posted to IntemeV!ntranet due to Confidentiality of Instructions Issued to a specific audience, not posted to IntemeV!ntranet due to Confidentialitv of Instructions Updates to Chapter 4 and Chapter 5 of Publication (Pub.) 100-08 Identity Theft Investigations and Victimized Provider Waiver of Liability Certificates of Medical Necessity (CMNs) and DME Information Form (DIFs) Completing a CMN or UIF Cover Letters for CMNs DME MACs and UPICs Authority to Initiate an Overpayment and/or Civil Monetary Penalty (CMP) When Invalid CMNs or DIFs Are Identified Documentation in the Patient's Medical Record Supplier Documentation Evidence of Medical c'<ecessity for the Oxygen Claims Period of Medical Necessity- Home Dialysis Equipment Safeguards in Making Monthly Payments Pick-up Slips Advance Determination of Medicare Coverage (ADMC) of Customized DMEPOS Issued to a specific audience, not posted to IntemeV!ntranet due to Confidentiality of Instructions Issued to a specific audience, not posted to IntemeV!ntranet due to Confidentiality of Instructions Issued to a specific audience, not posted to IntemeV!ntranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentialitv of Instructions Issued to a specific audience, not posted to IntemeV!ntranet due to Confidentialitv of Instructions Issued to a specific audience, not posted to IntemeV!ntranet due to Confidentialitv of Instructions Federal Register / Vol. 86, No. 156 / Tuesday, August 17, 2021 / Notices 17:08 Aug 16, 2021 EN17AU21.003</GPH> 10753 Attachment 2 - ECRS Web Quick Reference Card, Version 2021/5 April Attachment 1 - ECRS Web User Guide, Version 6.6 CMS Electronic File Transfer (EFT) System Update the Common Working File (CWF) to Accept a Group Health Plan (GHP) and non-GHP (NGHP) Medicare Secondary Payer (MSP) Effective Date 3 Months from the Current Date for Medicare Enrolled and Medicare Entitled Beneficiaries Issued to a specific audience, not posted to lntemeV!ntranet due to a Confidentiality of Instruction Update the International Classification of Diseases, Tenth Revision (ICD-10) 2022 Tables in the Common Working File (CWF) for Purposes of Processing Non-Group Health Plan (NGHP) Medicare Secondary Payer (MSP) Records and Claims khammond on DSKJM1Z7X2PROD with NOTICES 10800 Jkt 253001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4725 E:\FR\FM\17AUN1.SGM 17AUN1 10808 10828 EN17AU21.004</GPH> 10829 10830 10841 10843 10705 11772 Issued to a specific audience, not posted to InterneV!ntranet due to Confidentialitv of Instructions Issued to a specific audience, not posted to InterneV!ntranet due to Confidentialitv of Instructions Issued to a specific audience, not posted to InterneV!ntranet due to Confidentiality of Instructions Issued to a specific audience, not posted to InterneV!ntranet due to Confidentiality of Instructions Issued to a specific audience, not posted to InterneV!ntranet due to Confidentialitv of Instructions Updates to Pub. 100-09, Chapter 6 Beneficiary and Provider Communications Manual, Chapwr 6, Provider Customer Service Program Quality Assurance Monitoring (QAM) Remote Monitoring Disaster Recovery Guidelines for High Quality Responses to Provider Telephone Inquiries Telephone Response Quality Monitoring Program Telephone Responses to Provider Inquiries -- QCM Program Minimum Requirements Recording Calls QCM Calibration Provider Written Inquiries Controlling Provider Written Inquiries Provider Written Inquiry Storage Duplicate Inquiries Telephone Responses to Provider Written Inquiries Electronic Responses lo Provider Written Check Off Letters Guidelines for High Quality Responses to Provider Written Stock Language/Form Letters Provider Written Response Quality Monitoring Program Written Responses to Provider Inquiries - QWCM Program Minimum Requirements QWCM Calibration Replying to Correspondence from Members of Congress Provider Walk-In Inquiries Guidelines for Provider Walk-In Service PRRS Operations Complex Provider Inquiries Complex Beneficiary Inquiries Provider Inquiry Tracking Updates to the CMS Standardized Provider Inquiry Chart MAC Inquiry Tracking Self-Data Review and Self-Validation Process Fraud and Abuse Provider Education Website Satisfaction Survey Staff Development and Education PCC Staffl)evelopment and Training Required Training for PCC Staff Provider Kotifications of PCC Training Closures PCC Training Documentation Provider Self-Service Technology Interactive Voice Response System Provider Education Website General Requirements Webrnaster and Attestation Website Governance Federal Register / Vol. 86, No. 156 / Tuesday, August 17, 2021 / Notices 17:08 Aug 16, 2021 10805 Issued to a specific audience, not posted to InterneV!ntranet due to Confidentialitv of Instructions Second General Cpdate to Chapter 10 of Publication (Pub.) 100-08, Program Integrity Manual Suppliers That Enroll Via the Form CMS-855B Ambulatory Surgical Centers (ASCs Ilome Infusion Therapy Suppliers Independent Clinical Laboratory Improvement Act Labs Independent Uiagnostic Testing Facilities (IDTFs) Intensive Cardiac Rehabilitation (!CR) Mammography Screening Centers (MSCs) Phamiacies Portable X-Ray Suppliers (PXRSs) Radiation Therapy Centers (RTCs Suppliers of Ambulance Services Individual Practitioners Who Enroll Via the Form CMS-8551 Anesthesiology Assistants Audiologists Certified Nurse-Midwives Certified Registered Nurse Anesthetists (CR.."As) Clinical Nurse Specialists Clinical Psychologists Clinical Social Workers l\urse Practitioners Occupational Therapists in Private Practice Physical Therapists in Private Practice Physician Physician Assistants Psychologists Practicing Independently Registered DietitianstNutrition Professionals Speech Language Pathologists in Private Practice Manufacturers of Replacement PartsiSupplies for Prosthetic Implants or Implantable Durable Medical Equipment (DME) Surgically Inserted at an Ambulatory Surgical Center (ASC) Enrollment Form: Infomiation and Processing CMS-20134 (Section 1 - Basic Information) CMS-20134 (Section 2 - Identifying Information) CMS-20134 (Section 3 - Final Adverse Legal Actions/Convictions) CMS-20134 (Section 4- MDPP Location Information) CMS-20134 (Sections 5 & 6 - Owning and Managing Organizations and Individuals) Reserved for Future Use CMS-20134 (Section 7 - Coach Roster) CMS-20134 (Section 8 - Billing Agency Information) CMS-20134 (Section 13 - Contact Person) CMS-20134 (Section 14-Penalties for Falsifying Information) CMS-20134 (Section 15 -Certification Statement and Authorized Officials) CMS-20134 (Section 16 - Delegated Officials) CMS-20134 (Section 17-Supporting Documents) Additional Form CMS-20134 Processin11: Information and Alternatives Issued to a specific audience, not posted to InterneV!ntranet due to Confidentiality oflnslruclions Issued to a specific audience, not posted to InterneV!ntranet due to Confidentiality of Instructions Provider Enrollment Rebuttal Process - Additional Instructions for Returning Applications and Deactivations 45992 VerDate Sep<11>2014 10799 khammond on DSKJM1Z7X2PROD with NOTICES VerDate Sep<11>2014 None None None Jkt 253001 None None PO 00000 None 10704 Frm 00042 10715 10726 Fmt 4703 10746 10747 Sfmt 4725 10774 10787 E:\FR\FM\17AUN1.SGM 10791 10802 PCID 17AUN1 10820 10712 10717 10718 10732 10734 10739 10748 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentialitv of Instructions Primary Care First (PCF) and Serious Illness Patient (SIP) Models: Part 3: IURs and Edits for Non-Seauential Claims Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentialitv of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instructions Issued to a specific audience, not posted to Interne1/Intranet due to Confidentiality of Instructions Direct Contracting (DC) Model - Professional and Global Options: Total Care Capitation (TCC), Primary Care Capitation (PCC), Advanced Payment Option (APO), Telehealth Expansion, 3-day SNF Rule Waiver, PostDisch~roe and Care-Manaeement Home Visits - Imolementation Primary Care First (PCF) and Serious Illness Patient (SIP) Models: Part 3: IURs and Edits for Non-Sequential Claims Issued to a specific audience, not posted to Internet/Intranet due to Confidentialitv oflnstructions MAC Participation in Change Requests Developed through Agile Methodology CoPnitive Assessment & Care Plan Services Addition of the QW Modifier to Healthcare Common Procedure Coding Svstem CHCPCS) Code 87636 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Interne1/Intranet due to Sensitivity of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions 45993 Access to PCID MAC Contract and PCSP Data to be Reported in PCID Additional Data to be Reported Monthly in PCID and Reporting Due Dates Inyuiry Tracking Data to be Reported in PCID PCC Training Closure Information to be Reported in PCID POE Data to be Reported in PCID Provider Electronic Mailing List (Listserv) Subscriber Data to be Reported in PCID Special Initiatives Activities to be Reported in PCID Special Initiatives Activities to be Reported in PCID Emergency and Similar PCC Closure Data to be Reported in PCID Telecommunications Service Interruptions to be Reported in PCID Provider Internet-based Portal Service Interruptions to be Reported in PCID Provider Internet-based Portal Functionality to be Reported in PCID Provider Education Website Analytic Data to be Reported in PCID Direct Mailing Information to be Reported in PCID QCM EN17AU21.005</GPH> 10813 Access to QCM QWCM Access to QWCM Disclosure of Information Issued to a specific audience, not posted to Internet/Intranet due to Confidcntialitv of Instructions Federal Register / Vol. 86, No. 156 / Tuesday, August 17, 2021 / Notices 17:08 Aug 16, 2021 CMS Feedback Contents Dissemination of Information from CMS to Providers Frequently Asked Questions Internet-based Provider Educational Offerings Provider Education Website Promotion Electronic Mailing Llst (Listserv) Targeted Electronic Mailing Lists (Listservs) Electronic Mailing Llst (Listserv) Promotion Social Media Internet-based Provider Portal Service Interruptions Survey Provider Satisfaction Survey MAC Survey Participation Requirements Continuous Improvement Closed-Loop Ticketing Survey Response Prohibition MCE User Guide Third-Party Contractor Platform System Users MAC Satisfaction Score PCSP Performance Management POE - Electronic Mailing List (Listscrv) Subscribcrship Telephone Standards Call Completion Call Acknowledgment Average Speed of Answer (ASA) Callback QCM Performance Standards QAM (Telephone) Performance Standard Standards for Written Responses to Provider Inquiries QWCM Performance Standards Timeliness of Responses to Written Provider Inquiries Timeliness of Responses to General Provider Inquiries Timeliness of Responses to Complex Provider Inquiries (PRRS) Timeliness of Responses to Complex Beneficiary Inquiries Timeliness of Responses to Congressional Inquiries PCSP Data Reporting PIE Access to PIES Due Date for Data Submission to PIES Data to be Reported Monthly in PIES khammond on DSKJM1Z7X2PROD with NOTICES 10785 10792 10795 Jkt 253001 10801 10804 PO 00000 10817 10827 Frm 00043 Fmt 4703 Sfmt 4725 E:\FR\FM\17AUN1.SGM 17AUN1 EN17AU21.006</GPH> 10832 10842 None None None Addendum II: Regulation Documents Published in the Federal Register (April through June 2021) 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 http://www.gpoaccess.gov/fr/. The following website http://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/files/document/regs2q2lqpu.pdf For questions or additional information, contact Terri Plumb (410-786-4481). Addendum ill: CMS Rulings (April through June 2021) 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 http://www.cms.gov/Regulationsand-Guidance/Guidance/Rulings. For questions or additional information, contact Tiffany Lafferty (410-786-7548). Addendum IV: Medicare National Coverage Determinations (April through June 2021) 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 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 to national coverage determinations (NCDs), or reconsiderations of completed NCDs published in the 3-month period. This information is available at: www.cms.gov/medicare-coverage-database/. For questions or additional information, contact Wanda Belle, MFA (410-786-7491). Title Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers NCDM Section NCD 110.24 Transmittal Number Issue Date Effective Date 12177 05/21/2021 08/07/2019 Federal Register / Vol. 86, No. 156 / Tuesday, August 17, 2021 / Notices 17:08 Aug 16, 2021 10789 Update to Rural Health Clinic (RHC) Pavment Limits Initiative to Reduce Avoidable Hospitalizations among Nursing Facility Residents (NFI) - Uodates and Clarifications Issued to a specific audience, not posted to Internetilntranet due to Sensitivity oflnstructions The Fiscal Intermediary Shared System (PISS) Business Requirement for Rejected Claims Throwing Off the Provider and Statistical Reimbursement (PS&R) Svstem Managed Care Davs Mobile Personal Identity Verification (PIV) Station Installation Replacing Home Health Requests for Anticipated Payment (RAPs) with a Notice of Admission (NOA) - Imolementation Additional Payment Edits for DMEPOS Suppliers of Custom Fabricated and Prefabricated (Custom Fitted) Orthotics. Update to Change Request (CR) 3959 CR 8390 and CR 873 International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs)--Julv 2021 International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs)--October 2021 Addition ofthe QW Modifier to Healthcare Common Procedure Coding System (HCPCS) Codes 0240U, 0241U, 87637 International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs)--Julv 2021 Implementation of the Hospital Outpatient Department (HOPD) Prior Authorization (PA) Paired Items of Service for the X12 278 PA Transactions 45994 VerDate Sep<11>2014 10780 10781 khammond on DSKJM1Z7X2PROD with NOTICES VerDate Sep<11>2014 Facility NCD20.920.9.1 10837 06/22/2021 12/01/2020 NCD210.3 10818 05/21/2021 01/19/2021 Addendum V: FDA-Approved Category B Investigational Device Exemptions (IDEs) (April through June 2021) (Inclusion of this addenda is under discussion internally.) Jkt 253001 Addendum VI: Approval Numbers for Collections of Information (April through June 2021) PO 00000 Frm 00044 All approval numbers are available to the public at Reginfo.gov. Under the review process, approved information collection requests are assigned 0MB 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). Fmt 4703 Addendum VII: Medicare-Approved Carotid Stent Facilities (April through June 2021) Sfmt 4725 E:\FR\FM\17AUN1.SGM 17AUN1 Addendum VII includes listings of Medicare-approved carotid stent facilities. All facilities listed meet CMS standards for performing carotid artery stenting for high risk patients. On March 17, 2005, we issued our decision memorandum on carotid artery stenting. We determined that carotid artery stenting with embolic protection is reasonable and necessary only if performed in facilities that have been determined to be competent in performing the evaluation, procedure, and follow-up necessary to ensure optimal patient outcomes. We have created a list of minimum standards for facilities modeled in part on professional society statements on competency. All facilities must at least meet our standards in order to receive coverage for carotid artery stenting for high risk patients. For the purposes of this quarterly notice, we are providing only the specific updates that have occurred in the 3-month period. This information is available at: http://www.cms.gov/MedicareApprovedFacilitie/CASF/list.asp#TopOfPage For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Provider Number Effective Date State New York Health+ Hospitals 462 I'' Street H-Building, Executive Administration New York, NY 10016 !nova Fair Oaks Hospital 330204 03/30/2021 NY 490101 04/26/2021 VA Orlando Health Old Address: 52 West Underwood Street Orlando, FL 32806 New Address: 1414 Kuhl Avenue Orlando, FL 32806 Previous Name: Gwinnett Medical Center New Name: Northside Hospital Gwinnett (For 1000 Medical Center Boulevard Lawrenceville, GA 30045 Previous Name: Bay Medical Center New Name: Ascension Sacred Heart Bay 615 North Bonita Avenue Panama City, FL 32402 Effective Date State 390233 04/13/2021 PA 1881632818 05/18/2021 FL 1417945627 05/18/2021 MT 050506 05/25/2021 CA 050382 06/08/2021 CA 1295868792 06/15/2021 VA 100006 05/23/2005 FL 110087 08/31/2005 GA 100026 05/23/2005 FL Addendum VIII: American College of Cardiology's National Cardiovascular Data Registry Sites (April through June 2021) The initial data collection requirement through the American College of Cardiology's National Cardiovascular Data Registry (ACCNCDR) has served 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 45995 Facility 3600 Joseph Siewick Drive Faitfax, VA 22033 UPMC Hanover 300 Highland Avenue Hanover PA 17331 St. Joseph's Hospital - North 4211 Van Dyke Road Lutz, FL 33558 Kalispell Regional Medical Center 310 Sunnyview Lane Kalispell, MT 59901 Sierra Vista Regional Medical Center 1010 Murray Avenue San Luis Obispo, CA 93405 Emanate Health-Queen of the Valley Hospital 1115 South Sunset Avenue WestCovina CA91790 Carilion New River Valley Medical Center 2900 Lamb Circle Christianburg, VA 24073 Provider Number Federal Register / Vol. 86, No. 156 / Tuesday, August 17, 2021 / Notices 17:08 Aug 16, 2021 EN17AU21.007</GPH> Artificial Hearts/ Related Devices & VADs for Bridge to Transplant/Destination Therapy Screening for Colorectal Cancer - Blood-Based Biomarker Tests khammond on DSKJM1Z7X2PROD with NOTICES Jkt 253001 PO 00000 Frm 00045 Fmt 4703 There were no special one-time notices regarding national coverage provisions published in the 3-month period. This information is available at http://www.cms.gov. For questions or additional information, contact JoAnna Baldwin, MS (410-786 7205). Sfmt 4725 Addendum XI: National Oncologic PET Registry (NOPR) (April through June 2021) E:\FR\FM\17AUN1.SGM 17AUN1 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 Registty (NOPR) in the 3-month period. This information is available at http://www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#TopotPage. For questions or additional information, contact David Dolan, MBA (410786-3365). 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. We determined that VADs used as destination therapy are reasonable and necessary only if performed in facilities that have been determined to have the experience and infrastructure to ensure optimal patient outcomes. We established facility standards and an application process. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy. For the pmposes 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 http://www.cms.gov/MedicareApprovedFacilitieNAD/list.asp#TopOfPage. For questions or additional information, contact David Dolan, MBA, (410-786-3365). Date of Recertification Facility Provider Number Date of Initial Certification HCA Houston Healthcare Medical Center 1313 Hermann Drive Houston, TX 77004 450659 04/13/2021 TX 050071 03/25/2021 CA 170040 03/08/2016 State Other information: DNV ID # 10000432549MSC-VAD-USA Previous Re-certification Dates: n/a Kaiser Foundation Hospital Santa Clara 700 Lawrence Expressway Santa Clara, CA 95051 Other information Joint Commission ID H 10123 Previous Re-certification Uates: n/a The University of Kansas Health System 4000 Cambridge Street Kansas Citv, KS 66160-7200 06/01/2021 KS Federal Register / Vol. 86, No. 156 / Tuesday, August 17, 2021 / Notices 17:08 Aug 16, 2021 AddendumX: List of Special One-Time Notices Regarding National Coverage Provisions (April through June 2021) Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (April through June 2021) 45996 VerDate Sep<11>2014 EN17AU21.008</GPH> (April through June 2021) CMS issued a guidance document on November 20, 2014 titled "Guidance for the Public, Industty, and CMS Staff: Coverage with Evidence Development Document". Although CMS has several policy vehicles relating to evidence development activities including the investigational device exemption (IDE), the clinical trial policy, national coverage determinations and local coverage determinations, this guidance document is principally intended to help the public understand CMS's implementation of coverage with evidence development (CED) through the national coverage determination process. The document is available at http://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 JoA1ma Baldwin, MS (410-786-7205). khammond on DSKJM1Z7X2PROD with NOTICES VerDate Sep<11>2014 Facility Provider Number Date of Initial Certification DateofRccertification State 520177 07/31/2012 01/07/2021 Jkt 253001 PO 00000 Previous Re-certification Dates: 10/16/2008; 10/19/2010; 10/26/2012; 10/16/2014; 11/08/20 l 6- 11/28/2018 Mayo Clinic Hospital Rochester 1216 Second Street SW Rochester, MN 55902-1906 Frm 00046 440082 06/22/2010 01/14/2021 TN Fmt 4703 Sfmt 4725 E:\FR\FM\17AUN1.SGM 17AUN1 Previous Re-certification Dates: 02/09/2010: 01/24/2012; 01/30/2014; 02/23/2016; 02/09/2018 240010 02/2612008 03/20/2021 M"l' 330182 11/08/2016 05/08/2021 NY 510001 07/26/2018 02/25/2021 WV 360163 02/17/2012 02/26/2021 OH Other information: Joint Commission ID# 5860 360137 02/09/2010 01/21/2021 OH Previous Re-certification Dates: 11/08/2016- 11/14/201 8 West Virginia University Hospitals, Inc. One Medical Center Drive Morgantown, WV 26506 Other information: Joint Commission ID II 6444 Previous Re-certification Dates: 2018-07-26 Christ Hospital 2139 Auburn Avenue Cincinnati, OH 45219 Previous Re-certification Dates: 45997 Other information: Joint Commission ID # 6987 EN17AU21.009</GPH> NC State Other information: Joint Commission ID# 8181 Previous Re-certification Dates: 02/26/2008; 02/09/2010; 02/21/2012; 02/21/2014; 04/05/2016; 03/23/2018 St. Francis Hospital 100 Port Washington Rlvd Roslyn, NY 11576 Joint Commission ID# 7891 Other infonnation: Joint Commission ID# 7017 Date of Recertification 02/17/2021 WI Other infonnation: Previous Re-certification Dates: 06/22/201 O; 06/22/2012; 05/20/2014: 07/13/2016 University Hospitals Cleveland Medical Center 11100 Euclid Avenue Cleveland, OH 44106 Date of Initial Certification 10/2612008 Other information: Joint Commission ID # 6478 Other information: Joint Commission ID# 7718 Previous Re-certification Dates: 07/31/2012; 07/08/2014; 08/09/2016 From: Saint Thomas West Hospital To: Ascension Saint Thomas Ho~pital 4220 Harding Road Nashville, TN 37205 Provider Number 340061 Federal Register / Vol. 86, No. 156 / Tuesday, August 17, 2021 / Notices 17:08 Aug 16, 2021 University of North Carolina Hospitals 101 Manning Drive Chapel Hill, NC 27514 Other information: Joint Commission ID # 8567 Previous Re-certification Dates: 03/08/2016 03/06/2018 Froedtert Memorial Lutheran Hospital, Inc 9200 West Wisconsin Avenue Milwaukee, WI 53226 Facility khammond on DSKJM1Z7X2PROD with NOTICES Date of Initial Certification DateofRccertification State 110029 04/26/2018 05/05/2021 Jkt 253001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4725 E:\FR\FM\17AUN1.SGM 17AUN1 EN17AU21.010</GPH> State Previous Re-certification Dates: 05/17/2016' 6/27/2018 060024 07/22/2008 03/10/2021 co 050047 12/08/2009 02/20/2021 CA 100080 01/24/2017 03/03/2021 FL 340002 05/17/2016 04/14/2021 NC Other infonnation: Joint Commission ID # 6836 Previom Re-certification Dates: 01/24/2017: 3/6/2019 Mission Hospital Date of Recertification Other information: Joint Commission ID # 6468 Other information: Joint Commission ID# 5152 Previous Re-certification Dates: 12/08/2009; 11/11/2011; 01/07/2014; 02/09/2016; 03/20/2018 JFK Medical Center 5301 South Congress Avenue Allanlis, FL 33462 Date of Initial Certification GA Other infonnation: Joint Commission ID # 9384 Previous Re-certification Dates: 07/22/2008: 08/17/2010; 08/10/2012; 07/22/2014; 07/26/2016 From: California Padfic Medical Center-Van Ness Campus 1101 Van Ness Avenue San Francisco, CA 94109 To: California Pacific Medical Center-Pacific Campus; Provider Number 509 Biltmore Avenue Asheville, NC 28801-4690 Other information: DNV GL-CSA ID# 10000464475-MSC-DNV GLUSA Previous Re-certification Dates: 04-26-2018 University of Colorado Hospital Authority 12605 E 16th Ave Aurora, CO 80045 Facility Addendum XIII: Lung Volume Reduction Surgery (LVRS) (April through June 2021) Addendum XIII includes a listing of Medicare-approved facilities tliat are eligible to receive coverage for lung volume reduction surgery, Until May 17, 2007, facilities tliat participated in the National Emphysenia Treatment Trial were also eligible to receive coverage, The following three types of facilities are eligible for reimbursement for Lung Volume Reduction Surgery (LVRS): • National Emphysenia Treatment Trial (NETT) approved (Beginning 05/07/2007, these will no longer autoniatically qualify and can qualify only with the other programs); • Credentialed by the Joint Commission (formerly, the Joint Commission 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 There were no updates to the listing of facilities for lung volume reduction surgery published in the 3-month period, This inforniation is available at www,cms,gov/MedicareApprovedFacilitie/LVRS/lisusp#TopOfPage, For questions or additional inforniation, contact Sarah Fulton, MHS (410-786-2749), Addendum XIV: Medicare-Approved Bariatric Surgery Facilities (April through June 2021) Addendum XIV includes a listing of Medicare-approved facilities tliat 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 tliat 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 tliat covered bariatric surgery procedures are reasonable and necessary only when perfonned at facilities tliat are: (1) certified by the American College of Surgeons (ACS) as a Level 1 Bariatric Federal Register / Vol. 86, No. 156 / Tuesday, August 17, 2021 / Notices 17:08 Aug 16, 2021 02/17/2012: 02/20/2014; 04/05/2016; 03/20/2018 Northeast Georgia Medical Center 743 Spring Street Gainesville, GA 30501 Provider Number 45998 VerDate Sep<11>2014 Facility Federal Register / Vol. 86, No. 156 / Tuesday, August 17, 2021 / Notices 45999 Surgery Center (program standards and requirements in effect on February 15, 2006)~ or (2) certified by the American Society for Bariatric Surgery (ASBS) as a Bariatric Surgery Center of Excellence (BSCOE) (program standards and requirements in effect on February 15, 2006). There were no additions, deletions, or editorial changes to Medicare-approved facilities that meet CMS' 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). Washington, DC 20005, (202) 357–6400. For information on HRSA’s role in the Program, contact the Director, National Vaccine Injury Compensation Program, 5600 Fishers Lane, Room 08N146B, Rockville, Maryland 20857; (301) 443– 6593, or visit our website at: http:// www.hrsa.gov/vaccinecompensation/ index.html. [FR Doc. 2021–17602 Filed 8–16–21; 8:45 am] BILLING CODE 4120–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Vaccine Injury Compensation Program; List of Petitions Received Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions. FOR FURTHER INFORMATION CONTACT: For information about requirements for filing petitions, and the Program in general, contact Lisa L. Reyes, Clerk of Court, United States Court of Federal Claims, 717 Madison Place NW, khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:08 Aug 16, 2021 Jkt 253001 The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa– 10 et seq., provides that those seeking compensation are to file a petition with the United States Court of Federal Claims and to serve a copy of the petition to the Secretary of HHS, who is named as the respondent in each proceeding. The Secretary has delegated this responsibility under the Program to HRSA. The Court is directed by statute to appoint special masters who take evidence, conduct hearings as appropriate, and make initial decisions as to eligibility for, and amount of, compensation. A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at 42 CFR 100.3. This Table lists for each covered childhood vaccine the conditions that SUPPLEMENTARY INFORMATION: PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines. Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa–12(b)(2), requires that ‘‘[w]ithin 30 days after the Secretary receives service of any petition filed under section 2111 the Secretary shall publish notice of such petition in the Federal Register.’’ Set forth below is a list of petitions received by HRSA on July 1, 2021, through July 31, 2021. This list provides the name of petitioner, city and state of vaccination (if unknown then city and state of person or attorney filing claim), and case number. In cases where the Court has redacted the name of a petitioner and/or the case number, the list reflects such redaction. Section 2112(b)(2) also provides that the special master ‘‘shall afford all interested persons an opportunity to submit relevant, written information’’ relating to the following: 1. The existence of evidence ‘‘that there is not a preponderance of the evidence that the illness, disability, E:\FR\FM\17AUN1.SGM 17AUN1 EN17AU21.011</GPH> Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (April through June 2021) 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/MedicareApprovedFacilitie/PETDT/list.asp#TopOfPage. For questions or additional information, contact David Dolan, MBA (410786-3365).

Agencies

[Federal Register Volume 86, Number 156 (Tuesday, August 17, 2021)]
[Notices]
[Pages 45986-45999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17602]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9131-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--April Through June 2021

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

ACTION: Notice.

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SUMMARY: This quarterly notice lists CMS manual instructions, 
substantive and interpretive regulations, and other Federal Register 
notices that were published from April through June 2021, relating to 
the Medicare and Medicaid programs and other programs administered by 
CMS.

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

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                  Addenda                                         Contact                          Phone 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      David Dolan, MBA................................     (410) 786-3365
 Tomography Registry Sites.
XII Medicare-Approved Ventricular Assist     David Dolan, MBA................................     (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.
XV Fluorodeoxyglucose Positron Emission      David Dolan, MBA................................     (410) 786-3365
 Tomography for Dementia Trials.
All Other Information......................  Annette Brewer..................................     (410) 786-6580
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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

[[Page 45987]]

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 http://www.cms.gov/manuals.
    The Director of the Office of Strategic Operations and Regulatory 
Affairs of the Centers for Medicare & Medicaid Services (CMS), Kathleen 
Cantwell, having reviewed and approved this document, authorizes 
Lynette Willson, who is the Federal Register Liaison, to electronically 
sign this document for purposes of publication in the Federal Register.

    Dated: August 11, 2021.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare and Medicaid Services.
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[FR Doc. 2021-17602 Filed 8-16-21; 8:45 am]
BILLING CODE 4120-01-C