Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2021, 23373-23384 [2021-09081]

Download as PDF Federal Register / Vol. 86, No. 83 / Monday, May 3, 2021 / Notices Secretary of Health and Human Services, the Assistant Secretary for Health, and the Director, CDC, regarding the elimination of tuberculosis. Specifically, the Council makes recommendations regarding policies, strategies, objectives, and priorities; addresses the development and application of new technologies; and reviews the extent to which progress has been made toward eliminating tuberculosis. Matters to be Considered: The agenda will include discussions on (1) 2020 TB provisional surveillance data; (2) Tuberculosis Trials Consortium Update; (3) COVID impact on TB programs; (4) Perceptions of non-U.S.-born persons on the link between country of birth and TB risk; (5) Using Big Data to Understand Latent Tuberculosis Care in the United States; and (6) Bacillus Calmette-Guerin Vaccine Guidance Development. Agenda items are subject to change as priorities dictate. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2021–09006 Filed 4–30–21; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–9130–N] ACTION: Notice. This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 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: Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—January Through March 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 jbell on DSKJLSW7X2PROD with NOTICES delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. 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 VerDate Sep<11>2014 20:34 Apr 30, 2021 Jkt 253001 23373 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 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 Phone No. (410) 786–1864 (410) 786–4481 (410)786–7548 (410) 786–7491 (410) 786–6877 (410) 786–4669 (410) 786–2749 (410) 786–2749 (410) 786–7205 (410) 786–7205 (410) 786–3365 (410) 786–3365 (410) 786–2749 (410) 786–2749 (410) 786–3365 (410) 786–6580 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 E:\FR\FM\03MYN1.SGM 03MYN1 23374 Federal Register / Vol. 86, No. 83 / Monday, May 3, 2021 / Notices jbell on DSKJLSW7X2PROD with NOTICES 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 20:34 Apr 30, 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 https:// www.cms.gov/manuals. The Director of the Office of Strategic Operations and Regulatory Affairs of the PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 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: April 16, 2021. Trenesha Fultz-Mimms, Federal Register Liaison, Department of Health and Human Services. BILLING CODE 4120–01–P E:\FR\FM\03MYN1.SGM 03MYN1 VerDate Sep<11>2014 20:34 Apr 30, 2021 Jkt 253001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4725 E:\FR\FM\03MYN1.SGM 03MYN1 EN03MY21.022</GPH> How to Review Transmittals or Program Memoranda Those wishing to review transmittals and progrnm memoranda can access this infonnation at a local Federal Depository Librnry (FDL). Under the FDL program, government publications are sent to approximately 1,400 designated libraries throughout the United States. Some FDLs may have arrangements to transfer material to a local library not designated as an FDL. Contact any library to locate the nearest FDL. This information is available at https://www.gpo.gov/librnries/ Tn addition, individuals may contact regional depository libraries that receive and retain at least one copy of most federal government 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. Addendum I: Medicare and Medicaid Manual Instructions (January through March 2021) The CMS Manual System is used by CMS progrnm components, partners, providers, contractors, Medicare Advantage organizations, and State Survey Agencies to administer CMS progrnms. 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. 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 Progrnm Issuances notices are: April 24, 2020 (85 FR 23030), August 12, 2020 (85 FR 48691), November 4, 2020 (85 FR 70168) and March 17, 2021 (86 FR 14629). 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 jbell on DSKJLSW7X2PROD with NOTICES 10559 10557 10550 10551 10568 Transmittal Number Instructions for Retrieving: the 2021 Pricing: and Healthcare Common Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivitv of Instruction January 2021 Update of the Ambulatory Surgical Center (ASC) Payment System Modernization of the Electronic Files Transfer (EFn Associated with the National Coordination of Benefits Agreement (COBA) Consolidated Claims Crossover Process Coordination of Benefits A<>reement (COBA) Detailed Error Reoort None Implementation of Changes in the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Payment for Dialysis Furnished for Acute Kidnev lniurv (AKI) in ESRD Facilities for Calendar Year (CY) 2021 None Manual/Subject/Publication Number 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 Trnnsmittal Numbers will no longer be detennined 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. publications, either in printed or microfilm form, for use by the general public. These librnries provide reference services and interlibrary loans; however, they are not sales outlets. Individuals may obtain information about the location of the nearest regional depository librd.l)' from any librnry. 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 Healthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits, use (CMS-Pub. 100-04) Transmittal No. 10564. Addendum I lists a unique CMS transmittal number for each instruction in our manuals or progrnm 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. Federal Register / Vol. 86, No. 83 / Monday, May 3, 2021 / Notices 23375 VerDate Sep<11>2014 20:34 Apr 30, 2021 Jkt 253001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4725 E:\FR\FM\03MYN1.SGM EN03MY21.023</GPH> 03MYN1 10621 10618 10616 10615 10614 10613 10611 10601 10599 10596 10597 10593 10592 10579 10582 10574 10575 10572 10571 10569 10565 10564 10563 10562 jbell on DSKJLSW7X2PROD with NOTICES Notification Process Coordination of Benefits Agreement (COHA) Eligibility File Claims Recovery Process Crossover Process April 2021 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Ouarterlv Pricing Files Issued to a specific audience, not posted to hrternet/hrtranet due to a Confidentialitv of Instruction Healthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Comoetitive Bidding Program (CBP) - April 2021 Updates to Skilled Nursing Facility (SNF) Patient Driven Payment Model (PDPM) Claims Patient Readmitted Within 30 Days After Discharge Total and Noncovered Charges Fiscal Year (FY) 2021 Inpatient Prospective Payment System (IPPS) and Long Term Care Hosoital (LTCH) PPS Changes April 2021 Update to the Fiscal Ycar (FY) 2021 Inpatient Prospective Pavmenl Svslem OPPS) Shared Svstem Support Hours for Application Programming hrterfaces ( APis) Calendar Year (CY) 2021 Annual Update for Clinical Laboratory Fee Schedule and Laboratorv Services Subiect to Reasonable Charge Pavment Special Provisions for Radiology Additional Documentation Requests Pile Conversions Related to the Spanish Translation of the Ilealthcare Common Procedure Coding Svstem (HCPCS) Descriptions Fiscal Intermediary Shared System (FISS)- Eliminate Multiple Common Working File (CWF) Reolies Received in the Same Cvcle Modernization of the Electronic Files Transfer (EFT) Processes Associated with Medicare Integrated Systems Testing (MIST) Contractor Testing and Fiscal Intermediary Shared System (FISS) Alpha Testing with the Coordination of Benefits and Recovery (COB and R) System on Behalf of the Benefits Coordination and Recoverv Center <BCRC) Correction to Period Sequence Edits on Home Health Claims Submission of Condition Codes to the Inpatient Prospective Payment System (!PPS) Pricer to Report Services Provided as Part of an Expanded Access Aooroval or Emen!encv Use Authorization Health Insurance Portability and Accountability Act (IIIPAA) Electronic Data Interchange (EDI) Front End Updates for July 2021 Modifications to the National Coordination of Benefits Agreement (COBA) Claims Crossover Process Completion of Removal/Moving of Instructions from Chapter 15 of Publication (Pub.) 100-08 to Chaoter 10 of Pub. 100-08 Healthcare Common Procedure Coding System (IICPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits Healthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits Clinical Laboratory Fee Schedule -Medicare Travel Allowance Fees for Collection of Specimens User Change Request (CR): Multi-Carrier System (MCS) - Correct Coding Initiative (CCI) Related Procedure Codes Common Working File (CWF) Edits for Medicare Telehealth Services and Manual Update Updated Billing Requirements for Home Infusion Therapy (HIT) Services on 10567 10560 10553 10561 10548 10667 10666 10665 10663 10660 10657 10658 10655 10656 10651 10650 10641 10646 10639 10638 10635 10634 10631 10624 Issued to a specific audience, not posted to hrternet/hrtranet due to Confidentialitv of Instructions Second Update to Policies on the Enrollment of Opioid Treatment Programs (OTPs) Ooioid Treatment Programs Update to Chapter 12 (The Comprehensive Error Rate Testing (CERT) Program) of Publication (Pub.) 100-08 The Comprehensive Error Rate Testing (CERT) Program MAC Communication with the CERT Pro!!ram None The Fiscal hrtermediary Shared System (FISS) Submission of Copybook Files to the Provider and Statistical Reimbursement (PS&R) System Notice of New Interest Rate for Medicare Overpayments and Underpayments -2nd Qtr Notification for FY 2021 None or After Januarv 1, 2021 International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination <NCDs)--Julv 2021 Quarterly Update to the Medicare Physician Fee Schedule Dataha~e (MPFSDB)-Aoril2021Uodate User CR: ViPS Medicare System (VMS) - Update Interactive Corresoondence Online Reoorting (ICOR) Mail Date Calculation Claims Processing Instructions for National Coverage Determination (NCD) 20.4 Tmnlantable Cardiac Defibrillators OCDs) Modernization of the Electronic Files Transfer (EFT) Associated with the National Coordination of Benefits Airreement (COBA) Crossover Process Update to the Manual for Telephone Services, Physician Assistant (PA) Supervision, and Medical Record Documentation for Part B Services Updates to Chapter 4 of Publication (Pub.) 100-08 Primary Care First (PCF) and Serious Illness Patient (SIP) Models: Part 3: IURs and Edits for Non-Seauential Claims Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easv Print <MREP) and PC Print Update July 2021 Healthcare Common Procedure Coding System (HCPCS) Quarterly Update Reminder Mobile Personal Identitv Verification (PIV) Station Installation Quarterly Update for Clinical J .ahoratory Fee Schedule and J .ahoratory Services Subject to Reasonable Charge Pavment Combined Common Edits/Enhancements Modules (CCEM) Code Set Uodate Changes to the Laboratory National Coverage Determination (NCD) Edit Software for July 2021 The Intravenous Immune Globulin (!VIG) Demonstration: Demonstration is ending on December 31, 2023 Revisions to Medicare Administrative Contractor (MAC) Standardized Monthly Status Report (MSR) Narrative Template Updates to Medicare Benefit Policy Manual and Medicare Claims Processing Manual for Onioid Treatment Programs (Manual Lodates Onlv) April 2021 Update of the Hospital Outpatient Prospective Payment System COPPS) April 2021 Integrated Outpatient Code Editor (1/OCE) Specifications Version 22.1 23376 Federal Register / Vol. 86, No. 83 / Monday, May 3, 2021 / Notices VerDate Sep<11>2014 20:34 Apr 30, 2021 Jkt 253001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4725 E:\FR\FM\03MYN1.SGM 03MYN1 EN03MY21.024</GPH> 10701 10700 10699 10680 10676 10675 10664 10653 10649 10642 10619 10612 10609 10608 10591 10585 10581 10570 jbell on DSKJLSW7X2PROD with NOTICES None None None None None Overview of the CERT Process Providing Sample Information to the CERT Review Contractor Providing Feedback Information to the CERT Review Contractor Disputing a CERT Decision Handling Overpayments and Underpayments Resulting from the CERT Findings Ilandling Appeals Resulting from CERT-Initiated Denials CERT Appeal Results 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 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 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 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 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 Confidentialitv of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instructions Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity oflnstructions 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 Confidentialitv 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 Confidentialitv of Instructions Addendum II: Regulation Documents Published in the Federal Register (January through March 2021) None None None Shared System Enhancement 2018: Rewrite Fiscal Intermediary Shared System (FISS) module FSSD6001, Common Working File (CWF) Unsolicited Response Function Send Electronic Funds Transfer (EFT) Information from Provider Enrollment Chain and Ownership System (PECOS) to Multi-Carrier System (MCS) Phase 2 Modification to Existing Common Working File (CWF) Edits for Osteoporosis Drug Codes Billable on Home Health Claims International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs)-Aoril 2021 Changes to the End Stage Renal Disease (ESRD) PRICER to Accept the New Outpatient Provider Specific File Supplemental Wage Index Fields, the Network Reduction Calculation and New Value Code for Time on Machine 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 Internet/Intranet due to Sensitivity of Instructions User CR: ViPS Medicare System (VMS) - Update Interactive Correspondence Online Reporting (ICOR) Mail Date Calculation Mobile Personal Identity Verification (PIV) Station Installation Revisions to Medicare Administrative Contractor (MAC) Standardized Monthly Status Reoort (MSR) Narrative Template Modification to Existing Common Working File (CWF) Edits for Osteoporosis Drug Codes Dillable on Ilome Ilealth Claims Send Electronic Funds Transfer (EFT) Information from Provider Enrollment Chain and Ownership System (PECOS) to Multi-Carrier System (MCS) Phase 2 Create a Kew Media Preference Indicator Custom Format and New eMedicare Correspondence Preference Indicator 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 Internet/Intranet due to Sensitivity of Instructions Regulations and Notices Regulations and notices are published in the daily Federal Register. To purchase individual copies or subscribe to the Federal 10712 10694 10673 10670 10655 10663 10634 10603 10595 10587 10576 10566 10552 10551 10549 10556 10555 None None Federal Register / Vol. 86, No. 83 / Monday, May 3, 2021 / Notices 23377 VerDate Sep<11>2014 20:34 Apr 30, 2021 Jkt 253001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4725 E:\FR\FM\03MYN1.SGM 03MYN1 EN03MY21.025</GPH> Addendum IV: Medicare National Coverage Determinations (January through March 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 setVice 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 setVice. 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, Addendum ID: CMS Rulings (January through March 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 mlings can be accessed at https://www.cms.gov/Regulationsand-Guidance/Guidance/Rulings. For questions or additional information, contact Tiffany Lafferty (410-786-7548). For questions or additional information, contact Terri Plumb (410-786-4481). 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/regslq2lqpu.pdf jbell on DSKJLSW7X2PROD with NOTICES NCD20.4 NCDM Section 10635 Transmittal Number 03/23/2021 Issue Date 02/15/2018 Effective Date Addendum VII: Medicare-Approved Carotid Stent Facilities (January through March 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 only if performed in facilities that have been determined to be competent in performing the evaluation, procedure, and follow-up necessary to ensure optimal patient outcomes. We have created a list of minimum standards for facilities modeled in part on professional society statements on competency. All facilities must at least meet our standards in order to receive coverage for carotid artery stenting for high risk patients. For the purposes of this quarterly notice, we are providing only the specific updates that have occurred in the 3-month period. This information is available at: https://www.cms.gov/MedicareApprovedFacilitie/CASF/list.asp#TopOfPage For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Addendum VI: Approval Numbers for Collections of Information (January through March 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 V: FDA-Approved Category B Investigational Device Exemptions (IDEs) (January through March 2021) (Inclusion of this addenda is under discussion internally.) Claims Processing Instructions for National Coverage Determination (NCD) 20.4 hnplantable Cardiac Defibrillators (ICDs) Title 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). 23378 Federal Register / Vol. 86, No. 83 / Monday, May 3, 2021 / Notices VerDate Sep<11>2014 20:34 Apr 30, 2021 Jkt 253001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4725 E:\FR\FM\03MYN1.SGM EN03MY21.026</GPH> 03MYN1 FROM: J D Archbold Memorial Hospital TO: John D. Archbold Memorial 915 Gordon A venue Thomasville GA 31792-6614 CA OR 03/16/2021 03/16/2021 050382 380017 GA WA 03/16/2021 500150 06/22/2006 TX 03/16/2021 1932152337 110038 AL FL 03/02/2021 03/02/2021 FL 010104 1184709057 03/02/2021 IN 03/02/2021 150183 1336221019 NY CA 02/09/2021 01/26/2021 1487812624 050503 ID 01/19/2021 1992798409 OH VA 02/12/2021 State 01/11/2021 360234 Mercy Health West 3300 Mercy West Boulevard Cincinnati, OH 45211 Sentara Williamsburg Regional Medical Center I 00 Sentara Circle Williamsburg, VA 23188 Kootenai Hospital District dba Kootenai Health 2300 Kootenai Health Way Coeur d'Alene ID 83814 Scripps Memorial Hospital Encinitas 354 Santa Fe Drive PO Box 230817 Encinitas CA 92024 Bellevue Hospital 462 First Avenue New York NY 10016 Prime Healthcare Services-Monroe LLC 4011 S Monroe Medical Park Boulevard Bloomington, IN 47403 Other information: dba Monroe Hospital Orlando Health South Lake Hospital 1900 Don Wickham Drive Clermont FL 34711 Orlando Health Dr. P. Phillips Hospital 9400 Turkey Lane Orlando, FL 32819 Affinity Hospital LLC d/b/a Grandview Medical Center %90 Grandview Parkway Birmingham AL 35243 Memorial Hermann Katy 23900 Katy Freeway Katv. TX 77494 Legacy Salmon Creek Medical Center 2211 NE 139th Street Vancouver, WA 98686 Emanate Health Medical Center 210 W. San Bernardino Road Covina, CA 91723 Legacy Good Samaritan Medical Center 1015 NW 22nd Avenue Portland, OR 97211 Effective Date 1780694372 Provider Number Facility jbell on DSKJLSW7X2PROD with NOTICES 330126 Provider Number 39-0101 05/02/2011 01/11/2012 Effective Date NY PA State AddendumX: List of Special One-Time Notices Regarding National Coverage Provisions (January through March 2021) There were no special one-time notices regarding nationa1 coverage provisions published in the 3-month period. This information is Addendum IX: Active CMS Coverage-Related Guidance Documents (January through March 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 investigationa1 device exemption (IDE), the clinical trial policy, nationa1 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 nationa1 coverage determination process. The document is available at https://www.ems.gov/medicare-coverage-database/details/medicarecoverage-document-details.aspx?MCD Id=27. There are no additiona1 Active CMS Coverage-Related Guidance Documents for the 3-month period. For questions or additiona1 information, contact JoAnna Baldwin, MS (410-786-7205). Addendum VIII: American College of Cardiology's National Cardiovascular Data Registry Sites (January through March 2021) The initial data collection requirement through the American College of Cardiology's National Cardiovascular Data Registty (ACCNCDR) has served 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 CardioverterDefibrillators onFebruaiy 15, 2018. For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). FROM: Memorial Hospital TO: UPMC Memorial 1701 hmovation Drive York PA 17408 FROM: Orange Regional Medical Center TO: Gamet Health Medical Center 707 East Main Street Middletown. NY 10940 Facility Federal Register / Vol. 86, No. 83 / Monday, May 3, 2021 / Notices 23379 VerDate Sep<11>2014 20:34 Apr 30, 2021 Jkt 253001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4725 E:\FR\FM\03MYN1.SGM 03MYN1 EN03MY21.027</GPH> Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (January through March 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 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 infrastmcture to ensure optimal patient outcomes. We established facility standards and an application process. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy. For the purposes of this quarterly notice, we are providing only the specific updates to the list of Medicare-approved facilities that meet our standards that have occurred in the 3-month period. This information is available at https://www.cms.gov/MedicareApprovedFacilitieNAD/list.asp#TopOfPage. For questions or additional information, contact David Dolan, MBA, (410-786-3365). Addendum XI: National Oncologic PET Registry (NOPR) (January through March 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 Registry as one of these clinical studies. Therefore, in order for a beneficiary to receive a Medicare-covered PET scan, the beneficiary must receive the scan in a facility that participates in the registry. There were no additions, deletions, or editorial changes to the listing of National Oncologic Positron Emission Tomography Registry (NOPR) in the 3-month period. This information is available at https://www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage. For questions or additional information, contact David Dolan, MBA (410786-3365). available at https://www.cms.gov. For questions or additional information, contact JoAnna Baldwin, MS (410-786 7205). jbell on DSKJLSW7X2PROD with NOTICES Previous Re-certification Dates: 01/31/2012; 01/28/2014; 02/23/2016; 01/30/2018 Other information: Joint Commission ID# 9058 Previous Re-certification Dates: 04/01/2008; 03/24/2010; 03/16/2012; 04/08/2014; 06/07/2016; 05/22/2018 University of Texas Medical Branch 301 University Boulevard Galveston, TX 77555-0518 Other information: Joint Commission ID# 6075 Previous Re-certification Dates: 2018-11-14; 2014-1021 · 2016-11-22 Penn State Milton S. Hershey Medical Center 500 University Drive Hershey, PA 17033 Other information: DNV-GL # 492949-2020-VAD Previous Re-certification Dates: 03/06/2007; 02/13/2009; 08/19/2011; 08/30/2013; 10/02/2015; 11/10/2017 The Johns Hopkins Hospital 600 N. Wolfe Street Baltimore, MD 21287 450018 390256 210009 260032 Barnes-Jewish Hospital 1 Dames Jewish Plaza Saint Louis, MO 63110Albuquerque, NM 87102 Other information: Joint Commission ID # 8387 Provider Number Facility 01/31/2012 04/01/2008 10/08/2020 09/11/2020 10/24/2020 10/22/2020 03/26/2007 12/11/2007 DateofRccertification Date of Initial Certification TX PA MD NM State 23380 Federal Register / Vol. 86, No. 83 / Monday, May 3, 2021 / Notices VerDate Sep<11>2014 20:34 Apr 30, 2021 Jkt 253001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4725 E:\FR\FM\03MYN1.SGM EN03MY21.028</GPH> 03MYN1 Other infonnation: Joint Commission ID# 7457 Previous Re-certification Dates: 12/19/2017 University of Michigan Health System 1500 E Medical Center Drive, SPC 5474 Ann Arbor, MI 48109 Other information: Joint Commission ID II 519792-2020-V AD Previous Re-certification Dates: 03/26/2009; 08/26/2011; 10/10/2013: 11/03/2015; 12/05/2017 Chippenham Hospital, a campus of CJW Medical Center 7101 Jahnke Road Richmond, VA 23225 Other information: Joint Commission ID # 2908 Previous Re-certification Dates: 12/4/2017 University of Minnesota Medical Center, Fairview 2450 Riverside Avenue Minneapolis, MN 55454 Other information: DNV GL Certificate # 4573672020-VAD Previous Re-certification Dates: 06/10/2008: 05/21/2010; 04/12/2012; 03/25/2014; 04/13/2016; 03/20/2018 Hillcrest Medical Center 1120 S Utica Tulsa, OK 74104 Other infonnation: Joint Commission ID# 390164 UPMC Presbyterian Shadyside 200 Lothrop Street Pittsburgh, PA 15213 Facility jbell on DSKJLSW7X2PROD with NOTICES 230046 490112 240080 370001 Provider Number 6169 03/27/2008 12/19/2017 03/26/2009 12/04/2017 Date of Initial Certification 06/10/2008 12/03/2020 12/21/2020 09/11/20201 11/25/2020 DateofRccertification 12/09/2020 MI VA MN OK PA State Previous Re-certification Dates: Other information: Joint Commission ID # 6308 Previous Re-certification Dates: 05/11/2010; 05/11/2012; 04/22/2014; 04/12/2016; 04/24/2018 MedStar Washington Hospital Center 110 Irving St, NW \Vashington, DC 20010 Other information: Joint Commission ID # 6480 Previous Re-certification Dates: 10/06/2015; 02/06/2018 Carolinas Medical Center 1000 Blythe Boulevard Charlotte, NC 28232 Other information: Joint Commission TD# 10055 Previous Re-certification Dates: 03/0712008; 04/02/2010; 03/13/2012; 02/11/2014; 03/15/2016- 03/30/2018 University of California, Davis Medical Center 2315 Stockton Boulevard Sacramento, CA 95817 Other information: Joint Commission ID# 6158 Previous Re-certification Dates: 03/27/2008; 03/18/2010; 03/07/2012; 02/04/2014; 03/15/2016- 04/24/2018 FROM: Allegheny General Hospital; TO: West Penn Allegheny Health System, Inc. 320 East North Avenue Pittsburgh, PA 15212 Facility 090011 340113 050599 390050 Provider Number 04/2212008 05/11/2010 10/06/2016 03/0712008 Date of Initial Certification 12/17/2020 12/17/2020 12/10/2020 01/09/2021 Date of Recertification DC NC CA PA State Federal Register / Vol. 86, No. 83 / Monday, May 3, 2021 / Notices 23381 VerDate Sep<11>2014 20:34 Apr 30, 2021 Jkt 253001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4725 E:\FR\FM\03MYN1.SGM EN03MY21.029</GPH> 03MYN1 Previous Re-certification Dates: 2010-06-16; 2012-0606; 2014-05-06; 2016-06-21; 2018-05-09 Other information: Joint Commission ID# 8351 Previous Re-certification Dales: 11/03/2010; 11/14/2012; 11/18/2014· 12/06/2016 Saint Luke's Hospital of Kansas City 4401 Womall Road Kansas City, MO 64111 Other information: Joint Commission ID # 568395-2021-V AD Previous Re-certification Dates: 02/06/2009; 09/20/2011; 10/01/2013; 12/15/2015; 02/06/2018 MultiCare Tacoma General Hospital 315 Martin Luther King Jr. Way Tacoma, WA98338 Other information: Joint Commission ID # #: 5965 Previous Re-certification Dates: 11/14/2012; 09/09/2014; 10/18/2016 Kewark Beth Israel Medical Center 201 Lyons Avenue Kewark, NJ 07112 Other information: Joint Commission ID # 9880 04/22/2008; 04/06/201 O; 03/23/2012; 03/04/2014; 05/03/2016; 05/22/2018 Scripps Memorial Hospital La Jolla 9888 Genesee Avenue La Jolla, CA 92037 Facility jbell on DSKJLSW7X2PROD with NOTICES 260138 500129 310002 050324 Provider Number 06/16/2010 11/03/2010 02/06/2009 11/14/2012 Date of Initial Certification 02/06/2021 02/09/2021 11/26/2020 12/16/2020 Date of Recertification MO WA NJ CA State Addendum XN: Medicare-Approved Bariatric Surgery Facilities (January through March 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 determined that bariatric surgical procedures are reasonable and necessary for Medicare beneficiaries who have a body-mass index (BMI) greater than or equal to 35, have at least one co-morbidity related to obesity and have been previously unsuccessful with medical treatment for obesity. This decision also stipulated that covered bariatric surgery procedures are reasonable and necessary only when performed at facilities that are: (1) certified by the American College of Surgeons (ACS) as a 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) (progrnm standards and requirements in effect on February 15, 2006). Addendum XIII: Lung Volume Reduction Surgery (LVRS) (January through March 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 (LYRS): • 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 L VRS; and • Medicare approved for lung transplants. Only the first two types are in the list. There were no updates to the listing of facilities for lung volume reduction surgery published in the 3-month period. This information is available at www.cms.gov/MedicareApprovedFacilitie/LVRS/list.asp#TopOfPage. For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). 23382 Federal Register / Vol. 86, No. 83 / Monday, May 3, 2021 / Notices VerDate Sep<11>2014 20:34 Apr 30, 2021 Jkt 253001 PO 00000 Frm 00042 Fmt 4703 Sfmt 9990 E:\FR\FM\03MYN1.SGM 03MYN1 EN03MY21.030</GPH> Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (January through March 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#TopO:tPage. For questions or additional information, contact David Dolan, MBA (410786-3365). 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.ems.gov/MedicareApprovedFacilitie/BSF/list.asp#TopOfPage. For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 86, No. 83 / Monday, May 3, 2021 / Notices 23383 23384 Federal Register / Vol. 86, No. 83 / Monday, May 3, 2021 / Notices [FR Doc. 2021–09081 Filed 4–30–21; 8:45 am] BILLING CODE 4120–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS–10450 and CMS–10249] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services, Health and Human Services (HHS). ACTION: Notice. AGENCY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. DATES: Comments must be received by July 2, 2021. ADDRESSES: When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways: 1. Electronically. You may send your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) that are accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 20:34 Apr 30, 2021 Jkt 253001 Attention: Document Identifier/OMB Control Number: CMS–P–0015A, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS’ website address at website address at https://www.cms.gov/ Regulations-and-Guidance/Legislation/ PaperworkReductionActof1995/PRAListing.html. FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786–4669. SUPPLEMENTARY INFORMATION: Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection’s supporting statement and associated materials (see ADDRESSES). CMS–10450 Consumer Assessment of Healthcare Providers and Systems (CAHPS) Survey for Merit-based Incentive Payment Systems (MIPS) CMS–10249 Administrative Requirements for Section 6071 of the Deficit Reduction Act Under the PRA (44 U.S.C. 3501– 3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. Information Collection 1. Type of Information Collection Request: Extension of a currently approved Information Collection; Title of Information Collection: Consumer Assessment of Healthcare Providers and Systems (CAHPS) Survey for Meritbased Incentive Payment Systems (MIPS); Use: CMS is submitting updates to one information collection request associated with the CAHPS for MIPS survey. The CAHPS for MIPS survey is PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 used in the Quality Payment Program (QPP) to collect data on fee-for-service Medicare beneficiaries’ experiences of care with eligible clinicians participating in MIPS and is designed to gather only the necessary data that CMS needs for assessing physician quality performance, and related public reporting on physician performance, and should complement other data collection efforts. The survey consists of the core Agency for Healthcare Research and Quality (AHRQ) CAHPS Clinician & Group Survey, version 3.0, plus additional survey questions to meet CMS’s information and program needs. The survey information is used for quality reporting, the Care Compare website, and annual statistical experience reports describing MIPS data for all MIPS eligible clinicians. This 2021 information collection request addresses changes to the CAHPS for MIPS Survey associated with the CY 2021 Physician Fee Schedule (PFS) final rule. In order to address the increased use of telehealth care due to the Public Health Emergency (PHE) for COVID–19, an additional question is added to the CAHPS for MIPS survey to integrate one telehealth item to assess the patientreported usage of telehealth services. In addition, the cover page of the CAHPS for MIPS Survey is revised to include a reference to care in telehealth settings. The CAHPS for MIPS survey results in burden to three different types of entities: Groups and virtual groups, vendors, and beneficiaries associated with administering the survey. Virtual groups are subject to the same requirements as groups; therefore, we will refer only to groups as an inclusive term for both unless otherwise noted. The estimated time to administer the 2021 CAHPS for MIPS survey has increased from 12.9 minutes to 13.1 minutes; however, there was an overall decrease in burden as the number of respondents decreased. Form Number: CMS–10450 (OMB control number: 0938–1222); Frequency: Yearly; Affected Public: Business or other forprofits and Not-for-profit institutions and Individuals and Households; Number of Respondents: 30,249; Total Annual Responses: 30,249; Total Annual Hours: 6,902 (For policy questions regarding this collection contact Alesia Hovatter at 410–786– 6861.) 2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Administrative Requirements for Section 6071 of the Deficit Reduction Act; Use: State Operational Protocols should provide enough information such that: The CMS E:\FR\FM\03MYN1.SGM 03MYN1

Agencies

[Federal Register Volume 86, Number 83 (Monday, May 3, 2021)]
[Notices]
[Pages 23373-23384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09081]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9130-N]


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


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

[[Page 23374]]

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: April 16, 2021.
Trenesha Fultz-Mimms,
Federal Register Liaison, Department of Health and Human Services.
BILLING CODE 4120-01-P

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[FR Doc. 2021-09081 Filed 4-30-21; 8:45 am]
BILLING CODE 4120-01-C

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