Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2021, 64492-64506 [2021-25103]

Download as PDF 64492 Federal Register / Vol. 86, No. 220 / Thursday, November 18, 2021 / Notices using a pay-per-call service, that they will not be liable for unauthorized nontoll charges on their telephone bills, and how to deal with disputes about telephone-billed purchases. Likely Respondents: telecommunications common carriers (subject to the reporting requirement only, unless acting as a billing entity), information providers (vendors) offering one or more pay-per-call services or programs, and billing entities. Estimated Annual Hours Burden: 1,029,570 hours (18 + 1,029,552). Reporting: 18 hours for reporting by common carriers. Disclosure: 1,029,552 [(21,240 hours for advertising by vendors + 21,732 hours for preamble disclosure which applies to every pay-per-call service + 7,080 burden hours for telephone-billed charges in billing statements (applies to vendors; applies to common carriers if acting as billing entity) + 11,500 burden hours for dispute resolution procedures in billing statements (applies to billing entities) + 968,000 hours for disclosures related to consumers reporting a billing error (applies to billing entities)]. Estimated annual cost burden: $50,456,136 (solely relating to labor costs).1 khammond on DSKJM1Z7X2PROD with NOTICES Request for Comment On August 18, 2021, the FTC sought public comment on the information collection requirements associated with the Rule. 86 FR 46254. The Commission received no germane comments. Pursuant to the OMB regulations, 5 CFR part 1320, that implement the PRA, 44 U.S.C. 3501 et seq., the FTC is providing this second opportunity for public comment while seeking OMB approval to renew the pre-existing clearance for the Rules. Your comment—including your name and your state—will be placed on the public record of this proceeding. Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, such as anyone’s Social Security number; date of birth; driver’s license number or other state identification number, or foreign country equivalent; passport number; financial account number; or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, your comment should not include any ‘‘trade secret or any commercial or financial information which . . . is privileged or confidential’’—as provided by Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)— including in particular competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names. Josephine Liu, Assistant General Counsel for Legal Counsel. DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–9132–N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—July Through September 2021 Centers for Medicare & Medicaid Services (CMS), HHS. AGENCY: ACTION: Notice This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 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: [FR Doc. 2021–25104 Filed 11–17–21; 8:45 am] BILLING CODE 6750–01–P 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 ............................... (410) (410) (410) (410) (410) (410) (410) (410) 786–1864 786–4481 786–7548 786–7491 786–6877 786–4669 786–2749 786–2749 JoAnna Baldwin, MS ............................ JoAnna Baldwin, MS ............................ David Dolan, MBA ................................ David Dolan, MBA ................................ (410) (410) (410) (410) 786–7205 786–7205 786–3365 786–3365 Sarah Fulton, MHS ............................... Sarah Fulton, MHS ............................... David Dolan, MBA ................................ Annette Brewer ..................................... (410) (410) (410) (410) 786–2749 786–2749 786–3365 786–6580 1 Non-labor (e.g., capital/other start-up) costs are generally subsumed in activities otherwise undertaken in the ordinary course of business (e.g., business records from which only existing information must be reported to the Commission, pay-per-call advertisements or audiotext to which VerDate Sep<11>2014 17:11 Nov 17, 2021 Jkt 256001 cost or other disclosures are added, etc.). To the extent that entities incur operating or maintenance expenses, or purchase outside services to satisfy the Rule’s requirements, staff believe those expenses are also included in (or, if contracted out, would be comparable to) the annual burden hour and cost PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 Phone number estimates provided below (where such costs are labor-related), or are otherwise included in the ordinary cost of doing business (regarding non-labor costs). E:\FR\FM\18NON1.SGM 18NON1 Federal Register / Vol. 86, No. 220 / Thursday, November 18, 2021 / Notices SUPPLEMENTARY INFORMATION I. Background khammond on DSKJM1Z7X2PROD with NOTICES The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs and coordination and oversight of private health insurance. Administration and oversight of these programs involves the following: (1) Furnishing information to Medicare and Medicaid beneficiaries, health care providers, and the public; and (2) maintaining effective communications with CMS regional offices, state governments, state Medicaid agencies, state survey agencies, various providers of health care, all Medicare contractors that process claims and pay bills, National Association of Insurance Commissioners (NAIC), health insurers, and other stakeholders. To implement the various statutes on which the programs are based, we issue regulations under the authority granted to the Secretary of the Department of Health and Human Services under sections 1102, 1871, 1902, and related provisions of the Social Security Act (the Act) and Public Health Service Act. We also issue various manuals, memoranda, and statements necessary to administer and oversee the programs efficiently. VerDate Sep<11>2014 17:11 Nov 17, 2021 Jkt 256001 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 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 64493 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. 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 Trenesha FultzMimms, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. Dated: November 12, 2021. Trenesha Fultz-Mimms, Federal Register Liaison, Department of Health and Human Services. BILLING CODE 4120–01–P E:\FR\FM\18NON1.SGM 18NON1 khammond on DSKJM1Z7X2PROD with NOTICES Jkt 256001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4725 E:\FR\FM\18NON1.SGM 18NON1 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 (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: https://cms.gov/manuals. How to Review Transmittals or Program Memoranda Those wishing to review tmnsmittals and progmm memomnda can access this information at a local Federal Depository Library (FOL). Under the FDL program, government publications are sent to approximately 1,400 designated libraries throughout the United States. Some FDLs may have arrangements to transfer material to a local library not designated as an FDL. Contact any library to locate the nearest FDL. This information is available at https://www.gpo.gov/libraries/ In addition, individuals may contact regional depository libraries that receive and retain at least one copy of most federal government 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.crns.gov/Manuals. Transmittal Number Manual/Subject/Publication Number 10880 Internet Only Manual Updates to Pub. 100-01, 100-02, and 100-04 to Implement Consolidated Appropriations Act Changes and Correct Errors and Omissions (SNF) 10880 Internet Only Manual Updates to Pub. 100-01, 100-02, and 100-04 to Implement Consolidated Appropriations Act Changes and Correct Errors and Omissions (SNF) 10888 National Coverage Determination (NCD) Removal Extra.corporeal Immunoadsorption (ECI) Using Protein A Columns Electrosleep Therapy Implantation of Gastrointestinal Reflux Devices Abarelixfor the Treatment of Prostate Cancer Magnetic Resonance Spectroscopy Positron Emission Tomography (PET) Scans FDG PET for Inflanunation and Infection National Coverage Determination (NCD 110.24): Chimeric Antigen Receptor (CAR) T-cell Therapy- This CR Rescinds and Fullv Replaces CR 11783. 10891 Federal Register / Vol. 86, No. 220 / Thursday, November 18, 2021 / Notices 17:11 Nov 17, 2021 Addendum I: Medicare and Medicaid Manual Instrm.1ions (July through September 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 Quarterly Update for Clinical Laboratory Fee Schedule (CLFS) and Laboratory Services Subject to Reasonable Charge Payment, use (CMS-Pub. 100-04) Transmittal No. 10988. Addendum I lists a unique CMS tnmsmittal 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. 64494 VerDate Sep<11>2014 EN18NO21.067</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: November 4, 2020 (85 FR 70168), March 17, 2021 (86 FR 14629), May 3, 2021 (86 FR 23373) and August 17, 2021 (86 FR 45986. 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 10927 Jkt 256001 10985 10862 PO 00000 Frm 00051 Fmt 4703 Sfmt 4725 E:\FR\FM\18NON1.SGM 18NON1 10865 10872 EN18NO21.068</GPH> 10878 10891 10898 10918 10919 10920 10929 10931 10932 10934 10935 10937 10940 10941 10942 10943 Changes to the Laboratory National Coverage Determination [NCD] Edit Software for October 2021 Update to the Internet-only Manual (IOM) Publication (Pub.) 100-04, Medicare Claims Processing Manual, Chapter 23 - Fee Schedule Administration and Coding Requirements, Section 20.9 - Fee Schedule Administration and Coding Requirements Kational Correct Coding Initiative (NCC!) Correct Coding Modifier Indicators (CCMI) and HCPCS Codes Modifiers Instructions for Codes With Modifiers (A/B MACs (B) Only Appeals Procedure-to-Procedure (PTP) Edits Medically Unlikely Edits (MUEs) Kational Correct Coding Initiative (NCC!) Edits Ouarterlv Updates 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 Rilling Requirementq A/B Medicare Administrative Contractor (MAC) (A) Bill Types A/B MAC (A) Revenue Codes A/B MAC Billing Healthcare Common Procedural Coding System (HCPCS) Codes A/B MAC 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 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 Sensilivilv of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity of Instruction Update to Hospice Payment Rates, Hospice Cap, Hospice Wage Index and Hosoice Pricer for FY 2022 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 Sensitivity 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 Inpatient Rehabilitation Facility (IRF) Annual Update: Prospective Payment System (PPS) Pricer Changes for FY 2022 64495 10875 10876 Section 50 in Chapter 30 of Publication (Pub.) 100-04 Manual Updates Section 50 in Chapter 30 of Publication (Pub.) 100-04 Manual Updates Advance Beneficiary Notice of Kon-coverage (ABN AI3N Scope ABN Uses Optional AHN Uses Issuance of the ABN Triggering Events ABN Standards Completing the ABN Retention Requirements ABN Delivery Requirements Options for Delivery Other than In-Person Effects of Lack of Notification, Medicare Review and Claim Adjudication Using ABNs for Medical Equipment and Supplies Claims When Denials Under §1814(a)(17)(R) of the Act (Prohibition Against Unsolicited Telephone Contacts) Are Expected ABNs for Medical Equipment and Supplies Claims Denied Under §1834(j)(l) oflhe Ad (Because lhe Supplier Did Nol Meet Supplier Number Requirements) ABNs for Claims Denied in Advance Under §1834(a)(15) of the Act ABN Standards for Upgraded Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) ABNs for items listed in a DMEPOS Competitive Bidding Program (CBP) /Collection ofF1111ds and Refunds Physicians' Services DMEPOS RR Provision for Claims for Medical Equipment and Supplies Time Limits and Penalties for Healthcare Providers and Suppliers in Making Refunds Supplier's Right to Recover Resalable Items for Which Refund Has Been Made CMS Regional Office (RO) Referral Procedures ABN Special Considerations Glossary July Quarterly Update for 2021 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule Annual Updates to the Prior Authorization/Pre-Claim Review Federal Holidav Schedule Tables for Generating Reports Instructions for Downloading lhe Medicare ZIP Code Files for October 2021 Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivitv oflnstruction 10877 Federal Register / Vol. 86, No. 220 / Thursday, November 18, 2021 / Notices 17:11 Nov 17, 2021 10981 Chimeric Antigen Receptor (CAR) T-cell therapy_ National Coverage Determination (NCD) Removal Extracorporeal Imm1111oadsorption (ECI) Using Protein A Colunms 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) 270.3 Blood-Derived Products for Chronic, Non-Healing Wounds Blood-Derived Products for Chronic. Non-Healing Wo1111ds Claims Processing Instructions for National Coverage Determination 20.33 "tation Transcatheter Edge-to-Edge Reoair fTEERl for Mitra! Valve Re khammond on DSKJM1Z7X2PROD with NOTICES 10947 10959 10961 Jkt 256001 10962 10964 10965 PO 00000 10966 10967 Frm 00052 Fmt 4703 10968 10969 Sfmt 4725 10970 10971 E:\FR\FM\18NON1.SGM 10972 10979 10981 18NON1 10983 EN18NO21.069</GPH> 10985 10987 10988 10991 10992 10996 10997 11000 10873 10921 10939 10887 10982 Claims Processing Instructions for National Coverage Determination 20.33 Transcatheter Edge-to-Edge Repair [TEER] for Mitral Valve Regurgitation Transcatheter Edge-to-Edge Repair (TEER) for Mitral Valve Regurgitation Coding Requirements for Mitral Valve TEER Claims Furnished on or After August 7, 2014 Claims Processing Requirements for Mitra! Valve TEER Services on Professional Claims Home Health Notices of Admission -- Additional Manual Instructions Submission of the Notice of Admission (NOA) HH PPS Claims Quarterly Update for Clinical Laboratory Fee Schedule (CLFS) and Laboratorv Services Subiect to Reasonable Charge Payment Instructions for Retrieving the January 2022 Medicare Physician Fee Schedule Database (MPFSDB) Files Through the CMS Mainframe Telecommunications Svstem Onarterlv Update to Home Health (HH) Grouper October 2021 Integrated Outpatient Code Editor (L'OCE) Specifications Version 22.3 October 2021 Update of the Hospital Outpatient Prospective Payment System COPPS) Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to hrternet/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 hrternet/Intranet due to a Confidentiality of Instruction Notice of New Interest Rate for Medicare Overpayments and Underpayments - 4th Otr Notification for FY 2021 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction None 10849 10867 10868 Revising Subsection 3.5.4, Tracking Medicare Contractors' Prepayment and Postpayment Reviews, in Chapter 3 of Publication (Pub.) 100-08 Tracking Medicare Contractors' Prepayment and Postpayment Reviews Issued to a specific audience, not posted to hrternet/Intranet due to a Confidentialitv of Instruction Third General Update to Chapter 10 of Publication (Pub.) 100-08 Third General Update lo Chapter 10 of Publication (Pub.) 100-08 Certified Providers and Certified Suppliers That Enroll Via the Form CMS- 855A Community Mental Health Centers (CMHCs Comprehensive Outpatient Rehabilitation Facilities (CORFs) End-Stage Renal Disease Facilities (ESRDs) Federally Qualified Health Centers (FQHCs) Histocompatibility Laboratories Home Health Agencies (HHAs Hospices Hospitals and Hospital Units Indian Health Services (!HS) Facilities Organ Procurement Organizations (OPOs) Outpatient Physical Therapy/Outpatient Speech Pathology Services (OPT/OSP) Federal Register / Vol. 86, No. 220 / Thursday, November 18, 2021 / Notices 17:11 Nov 17, 2021 10950 Inpatient Psychiatric Facilities Prospective Payment System (!PF PPS) Updates for Fiscal Year (FY) 2022 Annual Update Cost-of-Living Adiustment (COLA) for Alaska and Hawaii Issued to a specific audience, not posted to hrternet/Intranet due to a Confidentialitv of Instruction File Conversions Related lo the Spanish Translation of the Healthcare Common Procedure Coding Svstem (HCPCS) Descriptions Issued to a specific audience, not posted to hrternet/Intranet due to a Confidentialitv of Instruction Issued to a specific audience, not posted to hrternet/Intranet due to a Confidentialitv of Instruction Issued lo a specific audience, not posted lo lnlernel/Intranel due lo a Confidentialitv of Instruction Combined Common Edits/Enhancements Modules (CCEM) Code Set Update Issued to a specific audience, not posted to hrternet/Intranet due to a Sensitivitv of Instruction Issued to a specific audience, not posted to hrternet/Intranet due to a Sensilivilv oflnslruclion Implement Operating Rules - Phase Ill Electronic Remittance Advice (ERA) Electronic Funds Transfer (EFT): Committee on Operating Rules for Information Exchange (CORE) 360 Uniform Use of Claim Adjustment Reason Codes (CARC), Remittance Advice Remark Codes (RARC) and Claim Adjustment Group Code (CAGC) Rule - Update from Council for Affordable Quality Healthcare (CAQII) CORE Issued to a specific audience, not posted to hrternet/Intranet due to a Sensitivity of Instruction Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) - October 2021 Update Shared System Support Hours for Application Prograrmning Interfaces (APis) 2022 Annual Update for the Health Professional Shortage Area (HPSA) Bonus Payments January 2022 Healthcare Common Procedure Coding System (HCPCS) Quarterly Update Reminder Clotting Factor Furnishing Fee Instructions for Retrie"ing the January 2022 Opioid Treatment Program (OTP) Payment Rates Through the CMS Mainframe Telecommunications Svstem National Coverage Determination (NCD) 270.3 Blood-Derived Products for Chronic, Non-Healing Wounds Autologous Platelet-Rich Plasma (PRP) for Chronic Non-Healing Wounds Policy Healthcare Common Procedure Coding System (HCPCS) Codes, Diagnosis Coding and Frequency Requirements Types of Dill (TOD) Payment Method Place of Service (POS) for Professional Claims Medicare Summary Notices (MSNs), Remittance Advice Remark Codes (RCs), Claim Adiustment Reason Codes (CARCs) and Group Codes Influenza Vaccine Payment Allowances - Annual Update for 2021-2022 Season 64496 VerDate Sep<11>2014 10944 khammond on DSKJM1Z7X2PROD with NOTICES VerDate Sep<11>2014 Jkt 256001 PO 00000 10882 10893 Frm 00053 10909 Fmt 4703 10910 Sfmt 4725 E:\FR\FM\18NON1.SGM 10911 10913 10926 10945 18NON1 10958 10975 10976 10984 1900 Updates to Pub. 100-09, Chapter 6 Beneficiary and Provider Communications Manual, Chapter 6, Provider Customer Service Program Note Introduction to Provider Customer Service Program PCSP Electronic Mailing Lists PCUGCall Integration of POE, PCC, and PSS Activities in the PCSP Partners in Progress Meeting Provider Outreach and Education Partnering with External Entities and with Other MACs Analysis of Claims Submission Errors Provider Bulletins/Newsletters Direct Mailings for the PCSP Training Tailored for Small Medicare Providers Remittance Advice (RA) POE Advisory Groups (POE AGs Ask-the-Contractor Teleconferences POE Reporting Provider Service Plan (PSP) Provider Customer Service Program Activity Report (PAR) Discretionary Reporting Charging Fees to Providers for Medicare Education and Training Reimbursement from Providers for POE Staff Attendance at Provider Meetings Refunds/Credits for Cancellation of Education and Training Activities Provider Contact Center (PCC) Pre-Approved PCC Closures Emergency and Similar PCC Closures Inquiry Triage Process Responding to Coding Questions Provider Telephone Inquiries Provider Inquiries Line Troubleshooting PCC Service Interruptions Requesting Changes to Telephone Configurations Hours of Operation Providing Busy Signals 64497 EN18NO21.070</GPH> 10994 Organizational Requirements liability of Program Integrity Contractor Employees Anti-Fraud Training Procedural Requirements MAC Complaint Screening Referrals to the UPIC Home Health Agency Misuse of Requests for Anticipated Payments RAP Monitoring Education and Additional Monitoring Corrective Action Plans Kotification to the HHA CAP Submission CAP Acceptance and Monitoring CAP Closeout Suppression Kotice of RAP Suppression Monitoring During RAP Suppression Result of Initial RAP Suooression Monitoring Period Issued to a specific audience, not posted to InterneVIntranet due to Confidentiality of Instructions Federal Register / Vol. 86, No. 220 / Thursday, November 18, 2021 / Notices 17:11 Nov 17, 2021 10879 Religious Kon-Medical Health Care Institutions (RNHCis) Rural Health Clinics (RHCs) Skilled Nursing Facilities (SNFs) Miscellaneous Policies Other Enrollment Forms: Information and Processing Form CMS-588 - Electronic Funds Transfer (EFT) Authorization Agreement Form CMS-460 - Medicare Participating Physician or Supplier Agreement Provider and Supplier Business Structures Owning and Managing Information Organizational Owning and Managing Information Individual Owning and Managing Information Owning and Managing Information - Tax Identification Numbers (TINs) Billing Agencies Issued to a specific audience, not posted to InterneVIntranet due to Confidentiality of Instructions Issued to a specific audience, not posted to InterneVIntranet due to Confidentialitv of Instructions Revision to Medicare Administrative Contractor (MAC) Complaint Screening Process - Checking the Recovery Audit Contractor (RAC) Data Warehouse (RACDW) Prior to Claim Adiustment Complaint Screening Process Fourth General Update to Chapter 10 of Publication (Pub.) 100-08 Opioid Treatment Programs Opting-Out of Medicare Application Fees Screening: On-Site Inspections and Site Verifications Miscellaneous Enrollment Topics Updates lo Exhibit 16 in Exhibits Chapter of Publication (Pub.) 100-08 Model Payment Suspension Letters Opioid Treatment Programs Opting-Out of Medicare Application Fees Screening: On-Site Inspections and Site Verifications Miscellaneous Enrollment Topic Issued lo a specific audience, not posted lo Internet/Intranet due lo Confidentiality of Instructions Issued to a specific audience, not posted to InterneVIntranet due to Confidentialitv of Instructions Issued to a specific audience, not posted to InterneVIntranet due to Confidentiality of Instructions Removal of Provider Enrollment Policy from Chapter 15 in Publication (Pub.) 100-08 Issued to a specific audience, not posted to InterneVIntranet due to Confidentialitv of Instructions Changes of Information Involving Certified Providers and Certified Suppliers Issued to a specific audience, not posted to IntcrncVIntranct due to Confidentialitv of Instructions Updates to Chapters 1, 3, 4, 5, 8 and 9 of Publication (Pub.) 100-08 Quality of Care Issues and Potential Fraud Issues Provider Self Audits Signature Requirement~ Introduction Pro gram Intc grity Program Integrity Contractors Cnified Program Integrity Contractor Investigations Medicare Drug Inte!!ritv Contractor khammond on DSKJM1Z7X2PROD with NOTICES Jkt 256001 None None PO 00000 None None Frm 00054 None None Fmt 4703 10889 10894 Sfmt 4725 10924 10936 E:\FR\FM\18NON1.SGM 10938 10949 10956 10960 10974 18NON1 10978 10993 10848 10852 10856 10861 10863 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instructions Modifications/Improvements to Value-Based Insurance Design (VBID) Model Implementation Issued lo a specific audience, nol posted lo lnlerne1/Inlranel due lo Sensitivity of Instructions Federally Qualified Health Center (FQHC) Participation in and Payment Under the Marvland Primarv Care Program (MDPCP) - Implementation Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instructions Issued lo a specific audience, nol posted lo lnlerne1/Inlranel due lo Sensitivity of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Managing Clinician PPA and KCF PBA Implementation Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity oflnslructions Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instructions Kidney Care Choices (KCC) Kidney Care First (KCF) - Payment Mechanism (PM) and Benefit Enhancements (BEs) - Imolementation 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 Sensitivity oflnstructions Implementation of the Award for the Jurisdiction E (J-E) Part A and Part B Medicare Administrative Contractor (JE A/B MAC) Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Prior Authorization Coversheet Requirements User CR: MCS - Beneficiarv Do Not Forward DLV Flag Changes Needed Federal Register / Vol. 86, No. 220 / Thursday, November 18, 2021 / Notices 17:11 Nov 17, 2021 10930 Inquiry Tracking Data to be Reported in PCID PCC Training Closure Information to be Reported in PCIU Provider Electronic Mailing List Subscriber Data to be Reported in PCID Special Initiatives to be Reported in PCID Emergency and Similar PCC Closure Data to be Reported in PCID Telecommunications Service Interruptions to be Reported in PCID QCM QWCM Disclosure of Information Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions 64498 VerDate Sep<11>2014 EN18NO21.071</GPH> Provider Telephone Line Staffmg Quality Call Monitoring Quality Assurance Monitoring (QAM Remote Monitoring Telephone Responses to Provider Inquiries - QWCM Program Minimum Requirements Recording Calls QCM Calibration Provider Written Inquiries Telephone Responses to Provider Written Inquiries Electronic Responses to Provider Written Inquiries Guidelines for High Quality Responses to Provider Written Inquiries Stock Language/Form Letters QWCM Calibration 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 PCSP Staff Development and Education PCC Staff Development and Training Required Training for PCC Staff PCC Training Program PCC Training Documentation Provider Self-Service (PSS) Technology Interactive Voice Response(IVR) System Provider Education Website General Requirements W ebmaster and Attestation Requirements Website Governance CMS Feedback Contents Dissemination of Information from CMS to Providers Web-based Provider Educational Offerings Provider Claims Payment Alerts Electronic Mailing List Targeted Electronic Mailing Lists Electronic Mailing List Promotion Social Media Internet-based Provider Portal Service Interruptions Surveys Provider Satisfaction Survey MAC Survey Participation Requirements Closed-Loop Ticketing MAC Satisfaction Score Performance Management Electronic Mailing List Subscribership Call Completion Average Speed of Answer (ASA) Callbacks PCSP Data Reporting PIES Due Date for Data Submission to PIES MAC Contract and PCSP Data to be Reported in PCID Additional Data to be Reported Monthly in PCID and Reporting Due Dates khammond on DSKJM1Z7X2PROD with NOTICES VerDate Sep<11>2014 10890 10895 10896 10928 Jkt 256001 10933 PO 00000 10948 10951 Frm 00055 10953 10954 10955 Fmt 4703 10957 Sfmt 4725 10963 E:\FR\FM\18NON1.SGM 10977 10986 10989 10990 18NON1 10340 10980 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 Confidentialitv of Instructions None None EN18NO21.072</GPH> For questions or additional information, contact Terri Plumb (410-786-4481). Addendum ID: CMS Rulings (July through September 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 https://www.cms.gov/Regulationsand-Guidance/Guidance/Rulings. For questions or additional information, contact Tiffany Lafferty (410-786-7548). Addendum IV: Medicare National Coverage Determinations (July through September 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 64499 Addendum II: Regulation Documents Published in the Federal Register (July through September 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 https://www.gpoaccess.gov/fr/. The following website https://www.archives.gov/federal-register/ provides information on how to access electronic editions, printed editions, and reference copies. This information is available on our website at: https://www.cms.gov/fi1es/document/regs3q21qpu.pdf Federal Register / Vol. 86, No. 220 / Thursday, November 18, 2021 / Notices 17:11 Nov 17, 2021 10899 Replacing Home Health Requests for Anticipated Payment (RAPs) with a Notice of Admission <NOA) - Imolemenlalion Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity oflnstructions Additional Payment Edits for DMEPOS Suppliers of Custom Fabricated and Prefabricated (Custom Fitted) Orthotics. Update to Change Request (CR) 3959, CR 8390, and CR 8730 Viable Information Processing Systems (ViPS) Medicare Systems (VMS) Changes to Accommodate National Provider Identifier Associations Medicare Fee-for-Service (FFS) Coverage of Costs for Kidney Acquisitions in Maryland Waiver (MW) Hospitals for Medicare Advantage (MA) Beneficiaries Implementation of the Capital Related Assets Adjustment (CRA) for the Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES) Under the End Stage Renal Disease Prospective Pavment Svstem (ESRD PPS) Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity oflnstructions Phase One Changes Needed to Implement the Revised Process for Handling Undeliverable Beneficiarv Addresses in VMS Update to Nursing and Allied Health (N&AH) Education Medicare Advantaee !MA) Pavment Rates - Calendar Year !CY) 2019 User CR: MCS - Mass Load "PJ" Seements User CR: Multi-Carrier-System (MCS) - Expand Number of Details on Provider Profiles Inauirv (Pl) Screen Send Electronic Funds Transfer [EFT] Information from Provider Enrollment Chain and Ownership System [PECOS] to Fiscal Intermediary Shared System [FISS] - Implementation CR, Consolidation of January 2022 and April 2022 Releases International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs)--January 2022 Replacing Home Health Requests for Anticipated Payment (RAPs) with a Notice of Admission (NOA) - Imolementation Send Electronic Funds Transfer [EFT] Information from Provider Enrollment Chain and Ownership System [PECOS] to ViPS Medicare System [VMS]: Implementation CR User CR: MCS - Enhancement to Automate the XHIC Error Process User CR: MCS - Enhance Health Professional Shortaee Area (HPSA) Reoorts khammond on DSKJM1Z7X2PROD with NOTICES Jkt 256001 PO 00000 Frm 00056 National Coverage Determination (NCD) 270.3 Blood-Derived Products for Chronic, Non-Healing Wounds National Coverage Determination 20.33 Transcatheter Edge-To-Edge Repair [Teer] For Mitra! Valve National Coverage Determination (NCD) Removal NCDM Section NCD270.3 NCD20.33 Fmt 4703 Sfmt 4725 "NCD20.5 NCD30.4 NCU 100.9 NCD II0.19 NCD 220.2.1 NCD 220.6.16".3 Tnmsmitta I Number Issue Date Effective Date 10981 09/15/2021 04/13/2021 10985 10927 09/08/2021 08/02/2021 01/19/2021 01/01/2021 E:\FR\FM\18NON1.SGM Addendum V: FDA-Approved Category B Investigational Device Exemptions (IDEs) (July through September 2021) (Inclusion of this addenda is under discussion internally.) 18NON1 Addendum VI: Approval Numbers for Collections of Information (July through September 2021) 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). Addendum VII: Medicare-Approved Carotid Stent Facilities (July through September 2021) 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 EN18NO21.073</GPH> J<'acility Provider Number J<:tlecti.ve Date State Banner Del Webb Medical Center 14502 W. Meeker Boulevard Sun Citv West AZ 85375 Orlando Health - Health Central Hospital 1222 S. Orange Avenue MP 856. Orlando, FL 32806 WakeMed Cary Hospital 1900 Kildaire Farm Road Carv, NC 27518 Community Hospital South 1402 East County Line Indianaoolis, IN 46227 Huntsville Health System - Marshall, 431 Highway North Boaz, AL 35957 Sutter Roseville Medical Center One Medical Plaza Roseville, CA 95661 030093 06/29/2021 AZ 1184709057 06/29/2021 FL 340173 04/05/2021 NC 150128 09/07/2021 IN 0l0005 09/21/2021 AL 050309 09/28/2021 CA 300029 06/01/2005 NH 150173 07/02/2009 TN 050007 l0/11/2005 CA FROM: Portsmouth Regional Hospital TO: HCA Healthcare Services of New Hampshire, Inc. 333 Borthwick Avenue Portsmouth, NH 03801 FROM: Clarian Arnett Health TO: Indiana University Health Arnett 5165 McCarty Lane Lafavette IN 47905 FROM: Mills Peninsula Health Services TO: Mills Peninsula Medical Center FROM: 1783 El Camino Real TO: 1501 Trousdale Drive Burlingame, CA 94010 Federal Register / Vol. 86, No. 220 / Thursday, November 18, 2021 / Notices 17:11 Nov 17, 2021 Title 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 Ure 3-monU1 period. This infonnation is available at: https://wvvw.cms.gov/MedicareApprovedFacilitie/CASF/list.asp#TopOfPage For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). 64500 VerDate Sep<11>2014 been posted on the CMS website. For the purposes of this quarterly notice, we are providing only the specific updates to national coverage detenninations (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, MPA (410-786-7491). khammond on DSKJM1Z7X2PROD with NOTICES VerDate Sep<11>2014 Facility Jkt 256001 PO 00000 St. Lucie Medical Center 1800 SE Tiffany Avenue Port St. Lucie, FL 34952 Effective Date State 05/26/2005 UT 450530 10/20/2006 TX 10-0260 08/19/2021 FL Frm 00057 Fmt 4703 Sfmt 4725 Addendum VIII: American College of Cardiology's National Cardiovascular Data Registry Sites (July through September 2021) The initial data collection requirement through the American College of Cardiology's National Cardiovascular Data Registiy (ACCNCDR) has setVed to develop and improve the evidence base for the use of I CDs in certain Medicare beneficiaries. The data collection requirement ended with the posting of the final decision memo for Implantable Cardioverter Defibrillators on February 15, 2018. For questions or additional infonnation, contact Sarah Fulton, MHS (410-786-2749). E:\FR\FM\18NON1.SGM Addendum IX: Active CMS Coverage-Related Guidance Documents 18NON1 AddendumX: EN18NO21.074</GPH> Addendum XI: National Oncologic PET Registry (NOPR) (July through September 2021) 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 Registiy 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 registiy. 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 infonnation is available at https://www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage. For questions or additional infonnation, contact David Dolan, MBA (410786-3365). Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (July through September 2021) 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 memorandum on V ADs 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 V ADs 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 infonnation is available at 64501 (July through September 2021) CMS issued a guidance document on November 20, 2014 titled "Guidance for the Public, Indusuy, and CMS Staff: Coverage with Evidence Development Document". Although CMS has several policy vehicles relating to evidence development activities including the investigational device exemption (IDE), the clinical trial policy, national coverage determinations and local coverage determinations, this guidance document is principally intended to help the public understand CMS' s implementation of coverage with evidence development (CED) through the national coverage determination process. The document is available at https://www.ems.gov/medicare-coverage-database/details/medicarecoverage-document-details.aspx?MCDid=27. There are no additional Active CMS Coverage-Related Guidance Documents for the 3-month period. For questions or additional infonnation, contact JoAnna Baldwin, MS (410-786-7205). List of Special One-Time Notices Regarding National Coverage Provisions (July through September 2021) There were no special one-time notices regarding national coverage provisions published in the 3-month period. This infonnation is available at https://www.cms.gov . For questions or additional infonnation, contact JoAnna Baldwin, MS (410-786 7205). Federal Register / Vol. 86, No. 220 / Thursday, November 18, 2021 / Notices 17:11 Nov 17, 2021 FROM: Utah Valley Regional Medical Center TO: IHC Health Services, Inc. dba Utah Valley Hospital 1034 N 500 West Provo UT 84604 FROM: Mainland Medical Center TO: HCA Houston Healthcare Mainland Campus 6801 Emmett F. Lowry Expressway Texas City, TX 77591 Provider Number 460001 khammond on DSKJM1Z7X2PROD with NOTICES (410-786-3365). Jkt 256001 Provider Number Date of Initial Certification Daylor Scott & White All Saints Medical Center Fort Worth 1400 8th Avenue Port Worth, TX 76104 450137 05/26/2021 State TX PO 00000 Frm 00058 Previous Re-certification Dates: n/a AU Medical Center 1120 15th Street Augusta, GA 30912 Fmt 4703 Sfmt 4725 Previous Re-certification Dates: n/a 110034 "' E:\FR\FM\18NON1.SGM TO: Adventist Health System/Sunbelt Inc. dba Florida Hospital FROM Adventist Health System/Sunbelt Inc. dba Advent Health 601 East Rollins Street Orlando, FL 32803 08/06/2021 GA ; 100007 10/24/2012 06/12/2021 FL 18NON1 Joint Commission ID # 6584 Previous Re-certification Dates: Date of Recertification State 460009 01/13/2009 05/21/2021 UT Certificate#: 10000435189MSC-DNV GL-USA Previous Re-certification Dates: 01/13/2009; 07/13/2011; 06/18/2013; 06/23/2015; 08/08/2017; 05/25/2018 Medical City Dallas 7777 Forest Lane Dallas, TX 75230 450647 09/09/2008 04/03/2021 TX Other information: Joint Commission ID # 9008 Previous Re-certification Dates: 09/09/2008; 08/10/2010; 07/17/2012; 06/27/2014; 07/12/2016 Vauderbilt University Medical Center 1211 Medical Center Drive Na~hville, TN 37232-2101 440039 04/2012012 04/28/2021 TN 100038 08/20/2014 03/27/2021 FL 340091 01/07/2014 04/17/2021 NC Joint Commission ID # 7892 Previous Re-certification Dates: 04/20/2012; 03/11/2014; 04/05/2016- 05/08/2018 Memorial Regional Hospital 350 I Johnson Street Hollywood, FL 33021 Other infonnation: Joint Commission ID # 6873 Previous Re-~erlificalion Dates: 10/24/2012: 10/07/2014; 11/15/2016; 01/30/2019 Medical University of South Carolina Medical Center 169 Ashley Avenue Charleston, SC 29425 Date of Initial Certification Other information: Other information: DNV GL# 10000469761Assessment Services-DNV GL-USA Other information DNV ID # 10000483076MSC-DNV-USA EN18NO21.075</GPH> DateofRecertification 09/23/2010; 09/07/2012; 08/05/2014; 09/13/2016; 09/26/2018 University of Utah, Hospitals and Clinics 50 N. Medical Drive Salt Lake City, UT 84132 Provider Number Joint Commission ID# 6811 420004 09/23/2010 03/24/2021 WI Previous Re-certification Dates: 2016-08-11; 2014-08-20 Moses H. Cone Memorial Hospital 1200 North Elm Street Greensboro, NC 27401-1020 Other information: Joint Commission ID # 6504 Federal Register / Vol. 86, No. 220 / Thursday, November 18, 2021 / Notices 17:11 Nov 17, 2021 Facility Facility 64502 VerDate Sep<11>2014 https://www.cms.gov/MedicareApprovedFacilitieNAD/list.asp#TopOfPage. For questions or additional information, contact David Dolan, MBA, khammond on DSKJM1Z7X2PROD with NOTICES VerDate Sep<11>2014 Facility DateofRccertification State Jkt 256001 PO 00000 Frm 00059 Previous Re-certification Dates: 2010-06-08; 2012-0525; 2014-04-15; 2016-06-15; 2018-07-18 University of Iowa Hospitals and Clinics 200 Hawkins Drive Iowa City, IA 52242 390111 06/08/2010 05/06/2021 PA 160058 06/22/2010 04/08/2021 IA Fmt 4703 Sfmt 4725 09/14/2010 05/05/2021 IN E:\FR\FM\18NON1.SGM 18NON1 Previous Re-certification Dates: 09/14/2010; 10/24/2012; 10/21/2014; 11/01/2016 Emory Saint Joseph's Hospital of Atlanta, Inc. 5665 Peachtree Dunwoody Road Atlanta, GA 30342 07/13/2010 05/08/2021 CA 380004 12/06/2011 07/24/2021 OR 250001 08/16/2016 05/20/2021 MS 450193 10/2812003 06/05/2021 TX 360003 12/13/2011 05/19/2021 OH State GA Other information: Joint Commission ID # 9098 Previous Re-certification Dates: 10/07/2008; 11/17/2010; 11/06/2012; University of Cincinnati Medical Center, LLC 234 Goodman Street Cincinnati, OH 45219 Other information: Joint Commission ID # 6988 64503 Previous Re-certification Dates: 07/13/2010; 07/11/2012; 06/03/2014; 07/12/2016; 06/05/2018 110082 Date of Recertification 04/14//2021 Other information: Joint Commission ID # 8064 Previous Re-certification Dates: 08/16/2016; 08/08/2018 CHI SL Luke's Health Baylor College of Medicine Medical Ctr 6720 Bertner Avenue Houston, TX 77030 Other information: Joint Commission ID# 7157 Date of Initial Certification 02/11/2014 Other information: Joint Commission ID# 9705 Previous Re-certification Dates: 12/06/2011; 12/10/2013; 01/26/2016; 02/13/2018 University of Mississippi Medical Center 2500 North State Street Jackson, MS 39216 150017 Provider Number 050017 Other information: Joint Commission ID# 10053 Previous Re-certification Dates: 02/11/2014; 03/08/2016; 03/13/2018 Providence St. Vincent Medical Center 9205 SW Barnes Road Portland, OR 97225 Joint Commission ID # 8266 Previous Re-certification Dates: 06/22/201 O; 07/26/2012; 07/29/2014; 08/02/2016; 7/11/2018 Lutheran Hospital of Indiana 7950 West Jefferson Boulevard For! Wayne, IN 46804 Facility Mercy General Hospital 4001 J Street Sacramento, CA 95819 Other infonnation: Joint Commission ID# 6129 Other information: Joint Commission ID # 6652 EN18NO21.076</GPH> Date of Initial Certification Federal Register / Vol. 86, No. 220 / Thursday, November 18, 2021 / Notices 17:11 Nov 17, 2021 Previous Re-certification Dates: 01/07/2014; 02/09/2016; 02/13/2018 Hospital of the University of Pennsylvania 3400 Spruce Street Philadelphia, PA 19104 Provider Number khammond on DSKJM1Z7X2PROD with NOTICES 08/12/2008 DateofRccertification 05/29/2021 State Facility IN Previous Re-certification Dates: 08/12/2008; 07/20/2010; 07/24/2012; 07/08/2014; 08/23/2016 Catholic Health Initiatives Iowa, Corp. 11 ll 6th A venue Des Moines, IA 50314 Jkt 256001 PO 00000 Frm 00060 Fmt 4703 Previous Re-certification Dates: 08/12/2008; 08/17/2010; 08/17/2012; 08/19/2014; 10/04/2016 University of Wisconsin Hospitals and Clinics Authority 600 Highland Avenue Madison, WI 53792 520098 08/05/2008 06/04/2021 WI Sfmt 4725 E:\FR\FM\18NON1.SGM 050327 02/07/2012 05/15/2021 CA 18NON1 Other infonnation: Joint Commission ID # 9898 Previous Re-~erlificalion Dates: 02/07/2012; 01/23/2014; 02/23/2016; 04/10/2018 INTEGRIS Baptist Medical Center 3300 Northwest Expressway Oklahoma City, OK 73112 Previous Re-certification Dates: 10/23/2008; 10/01/2010; 10/03/2012; 09/23/2014; 11/08/2016- 12/5/2018 Tufts Medical Center 800 Wa.~hington Street Boston, MA 02111 Other information: Joint Commission TD# 5518 Previous Re-certification Dates: 10/23/2008; 10/01/2010; 10/03/2012; 09/23/2014; 11/08/2016; 12/5/2018 Brigham and Women's Hospital 75 Francis Street Boston, MA 02115 Other infonnation: Joint Commission ID# 7656 Previous Re-certification Dates: 08/05/2008: 08/24/2010; 08/07/2012; 07/17/2014; 08/09/2016 Loma Linda University Medical Center 11234 Anderson Street Loma Linda, CA 92354 Provider Number Date of Initial Certification Date of Recertification State 160083 01/06/2015 07/01/2021 IA 220116 10/23/2008 06/23/2021 MA 220ll0 11/0412008 07/10/2021 MA 200009 11/05/2008 07/08/2021 ME Other information: Joint Commission ID# 5518 Other information: Joint Commission ID# 188549 Other information: Joint Commission ID # 8872 EN18NO21.077</GPH> 150056 Date of Initial Certification 370028 08/12/2008 06/19/2021 OK Other information: Joint Commission ID# 5503 Previous Re-certification Dates: 11/04/2008; 12/09/2010; 12/07/2012; 11/07/2014; 12/13/2016- 2/27/2019 FROM: Mame Medical Center TO: MameHealth 22 Bramhall Street Portland, ME 04102 Other information: Joint Commission ID# 5445 Previous Re-certification Dates: 11/05/2008; 09/27/2016; 10/3/2018 Federal Register / Vol. 86, No. 220 / Thursday, November 18, 2021 / Notices 17:11 Nov 17, 2021 Previous Re-certification Dates: 12/13/2011; 01/07/2014; 02/23/2016: 03/13/2018 FROM: Old: Indiana University Health Methodist Hospital TO: Indiana University Health, Inc. 1701 North Senate Boulevard Indianapolis, IN 46202 Provider Number 64504 VerDate Sep<11>2014 Facility khammond on DSKJM1Z7X2PROD with NOTICES VerDate Sep<11>2014 Facility Sharp Memorial Hospital 7901 Frost Street San Diego, CA 92123 Date of Initial Certification 07/17/2008 Date of Recertification 06/05/2021 State CA 360085 08/28/2021 OH Previous Re-certification Dates: 12/15/2018 Tannnie Hayes, Director, LVRS, 614-293-3629 Jkt 256001 330106 09/27/2016 06/26/2021 NY PO 00000 Frm 00061 Other information: Joint conunission ID# 2091 Previous Re-certification Dates: 09/27/2016; 9119/2018 Fmt 4703 Sfmt 4725 E:\FR\FM\18NON1.SGM 18NON1 Addendum XIII: Lung Volume Reduction Surgery (LVRS) (July through September 2021) Addendum XIII includes a listing of Medicare-approved facilities that are eligible to receive coverage for lung volume reduction surgery. Until May 17, 2007, facilities that participated in the National Emphysema Treatment Trial were also eligible to receive coverage. The following three types of facilities are eligible for reimbursement for Lung Volume Reduction Surgery (LVRS): • National Emphysema Treatment Trial (NETT) approved (Beginning 05/07/2007, these will no longer automatically qualify and can qualify only with the other programs); • Credentialed by the Joint Commission (formerly, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)) under their Disease Specific Certification Program for LVRS; and • Medicare approved for lung transplants. Only the first two types are in the list. There was an update to the listing of facilities for lung volume reduction surgery published in the 3-month period. This information is available at www .cms.gov/MedicareApproved.Facilitie/LVRS/list.asp#TopOfPage. For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Certification Date State Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (July through September 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.cms.gov/MedicareApprovedFacilitie/PETDT/list.asp#TopOfPage. For questions or additional information, contact David Dolan, MBA (410786-3365). 64505 Provider# Addendum XIV: Medicare-Approved Bariatric Surgery Facilities (July through September 2021) 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 (ESCOE) (program standards and requirements in effect on February 15, 2006). There were no additions, deletions, or editorial changes to Medicare-approved facilities that meet CMS' minimum facility standards forbariatric 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). Federal Register / Vol. 86, No. 220 / Thursday, November 18, 2021 / Notices 17:11 Nov 17, 2021 Previous Re-certification Dates: 07/17/2008; 06/29/2010; 08/14/2012; 09/09/2014; 08/09/2016; 8/15/2018 Korth Shore University Hospital 300 Community Drive Manhasset, NY 11030 Ohio State University Hospitals 410 West Tenth Avenue, DN 168 Columbus, OH 43210 Other information: Joint Commission ID # 7029 Other information: Joint Commission IV# 3910 Facility Name EN18NO21.078</GPH> Provider Number 050100 64506 Federal Register / Vol. 86, No. 220 / Thursday, November 18, 2021 / Notices The Food and Drug Administration (FDA or Agency) is withdrawing approval of 18 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. SUMMARY: [FR Doc. 2021–25103 Filed 11–17–21; 8:45 am] BILLING CODE 4120–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–1195] Approval is withdrawn as of December 20, 2021. DATES: Discovery Therapeutics, LLC, et al.; Withdrawal of Approval of 18 Abbreviated New Drug Applications AGENCY: FOR FURTHER INFORMATION CONTACT: Food and Drug Administration, HHS. ACTION: Notice. The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling. SUPPLEMENTARY INFORMATION: Application No. Drug Applicant ANDA 040619 ......... Methimazole Tablets, 15 milligrams (mg) ............................. ANDA 070254 ......... Naloxone Hydrochloride (HCl) Injection, 0.4 mg/milliliters (mL). Bupivacaine HCl Injection, 0.25% ......................................... Morphine Sulfate Injection, 1 mg/mL .................................... Desmopressin Acetate Injection, 0.004 mg/mL .................... Tretinoin Cream, 0.05% ........................................................ Ciprofloxacin Injection, 200 mg/20 mL (10 mg/mL) and 400 mg/40 mL (10 mg/mL). Lidocaine HCl Solution, 4% ................................................... Chloroprocaine HCl Injection, 3% ......................................... Chloroprocaine HCl Injection, 2% ......................................... Levocetirizine Dihydrochloride Tablets, 5 mg ....................... Discovery Therapeutics, LLC, 2831 Deer Hound Way, Palm Harbor, FL 34683. Hospira, Inc., 275 North Field Dr., Building H1, Lake Forest, IL 60045. Do. Do. Do. ZO Skin Health, Inc., 9685 Research Dr., Irvine, CA 92618. Hospira, Inc. ANDA ANDA ANDA ANDA ANDA 070586 071850 075220 076498 077245 ......... ......... ......... ......... ......... ANDA ANDA ANDA ANDA 080409 087446 087447 201653 ......... ......... ......... ......... ANDA 202524 ......... ANDA 202857 ......... ANDA 203885 ......... ANDA 207864 ......... ANDA 209489 ......... ANDA 210283 ......... ANDA 210855 ......... khammond on DSKJM1Z7X2PROD with NOTICES Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993–0002, 240– 402–6980, Martha.Nguyen@fda.hhs.gov. Levetiracetam Extended Release Tablets, 500 mg and 750 mg. Daptomycin Powder for Injection, 500 mg/vial ...................... Amiodarone HCl Injection, 50 mg/mL ................................... Eptifibatide Injection, 2 mg/mL and 75 mg/100 mL .............. Caspofungin Acetate Powder for Injection, 50 mg/vial and 70 mg/vial. Clofarabine Injection, 20 mg/20 mL (1 mg/mL) .................... Sodium Nitroprusside Injection, 25 mg/mL ........................... Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of December 20, 2021. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on December 20, 2021 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first. VerDate Sep<11>2014 Do. Do. Do. Sun Pharmaceutical Industries, Inc., U.S. Agent for Sun Pharmaceutical Industries Ltd., 270 Prospect Plains Rd., Cranbury, NJ 08512. Rouses Point Pharmaceuticals, LLC, 11 Commerce Dr., Cranford, NJ 07016. Hospira, Inc. Do. The WhiteOak Group, LLC, U.S. Agent for Hybio Pharmaceutical Co., Ltd., 1629 K St. NW, Suite 300, Washington, DC 20006. Cipla USA, Inc., U.S. Agent for Cipla Limited, 10 Independence Blvd., Suite 300, Warren, NJ 07059. Hospira, Inc. Cipla USA, Inc. 17:11 Nov 17, 2021 Jkt 256001 Dated: November 12, 2021. Lauren K. Roth, Associate Commissioner for Policy. Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting The meeting will be closed to the public as indicated below in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Board of Scientific Counselors, NICHD. Name of Committee: Board of Scientific Counselors, NICHD. Date: December 3, 2021. Time: 10:00 a.m. to 5:00 p.m. Agenda: A report by the Acting Scientific Director, NICHD, on the status of the NICHD [FR Doc. 2021–25111 Filed 11–17–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\18NON1.SGM 18NON1

Agencies

[Federal Register Volume 86, Number 220 (Thursday, November 18, 2021)]
[Notices]
[Pages 64492-64506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25103]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9132-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--July Through September 2021

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 July through September 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.

------------------------------------------------------------------------
            Addenda                   Contact           Phone number
------------------------------------------------------------------------
I CMS Manual Instructions......  Ismael Torres....        (410) 786-1864
II Regulation Documents          Terri Plumb......        (410) 786-4481
 Published in the Federal
 Register.
III CMS Rulings................  Tiffany Lafferty.        (410) 786-7548
IV Medicare National Coverage    Wanda Belle, MPA.        (410) 786-7491
 Determinations.
V FDA-Approved Category B IDEs.  John Manlove.....        (410) 786-6877
VI Collections of Information..  William Parham...        (410) 786-4669
VII Medicare-Approved Carotid    Sarah Fulton, MHS        (410) 786-2749
 Stent Facilities.
VIII American College of         Sarah Fulton, MHS        (410) 786-2749
 Cardiology-National
 Cardiovascular Data Registry
 Sites.
IX Medicare's Active Coverage-   JoAnna Baldwin,          (410) 786-7205
 Related Guidance Documents.      MS.
X One-time Notices Regarding     JoAnna Baldwin,          (410) 786-7205
 National Coverage Provisions.    MS.
XI National Oncologic Positron   David Dolan, MBA.        (410) 786-3365
 Emission Tomography Registry
 Sites.
XII Medicare-Approved            David Dolan, MBA.        (410) 786-3365
 Ventricular Assist Device
 (Destination Therapy)
 Facilities.
XIII Medicare-Approved Lung      Sarah Fulton, MHS        (410) 786-2749
 Volume Reduction Surgery
 Facilities.
XIV Medicare-Approved Bariatric  Sarah Fulton, MHS        (410) 786-2749
 Surgery Facilities.
XV Fluorodeoxyglucose Positron   David Dolan, MBA.        (410) 786-3365
 Emission Tomography for
 Dementia Trials.
All Other Information..........  Annette Brewer...        (410) 786-6580
------------------------------------------------------------------------


[[Page 64493]]


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.
    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 
Trenesha Fultz-Mimms, who is the Federal Register Liaison, to 
electronically sign this document for purposes of publication in the 
Federal Register.

    Dated: November 12, 2021.
Trenesha Fultz-Mimms,
Federal Register Liaison, Department of Health and Human Services.
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[FR Doc. 2021-25103 Filed 11-17-21; 8:45 am]
BILLING CODE 4120-01-C
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