Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January through March 2024, 33356-33366 [2024-09165]

Download as PDF 33356 Federal Register / Vol. 89, No. 83 / Monday, April 29, 2024 / Notices III. Evaluation of Deeming Authority Request khammond on DSKJM1Z7X2PROD with NOTICES In the September 23, 2019 Federal Register, we published TCT’s initial application for recognition as an accreditation organization for HIT (84 FR 49736). On September 28, 2020, we published notification of their approval as such an organization, effective October 1, 2020 through October 1, 2024 (85 FR 60799). TCT has since submitted all the necessary materials to enable us to make a determination concerning its request for continued recognition of its HIT accreditation program. This application was determined to be complete on March 2, 2024. Under section 1834(u)(5) of the Act and 42 CFR 488.1010 (Application and reapplication procedures for national home infusion therapy accrediting organizations), our review and evaluation of TCT will be conducted in accordance with, but not necessarily limited to, the following factors: • The equivalency of TCT’s standards for HIT as compared with CMS’ HIT requirements for participation in the Medicare program. • TCT’s survey process to determine the following: ++ The composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training. ++ The comparability of TCT’s to CMS’ standards and processes, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities. ++ TCT’s processes and procedures for monitoring a HIT supplier found out of compliance with TCT’s program requirements. ++ TCT’s capacity to report deficiencies to the surveyed facilities and respond to the facility’s plan of correction in a timely manner. ++ TCT’s capacity to provide CMS with electronic data and reports necessary for effective assessment and interpretation of the organization’s survey process. ++ The adequacy of TCT’s staff and other resources, and its financial viability. ++ TCT’s capacity to adequately fund required surveys. ++ TCT’s policies with respect to whether surveys are announced or unannounced, to ensure that surveys are unannounced. ++ TCT’s agreement to provide CMS with a copy of the most current accreditation survey together with any other information related to the survey as CMS may require (including corrective action plans). ++ TCT’s policies and procedures to avoid conflicts of interest, including the appearance of conflicts of interest, involving individuals who conduct surveys, audits or participate in accreditation decisions. ++ TCT’s agreement or policies for voluntary and involuntary termination of HIT suppliers. ++ TCT’s agreement or policies for voluntary and involuntary termination of the HIT AO program. IV. Collection of Information Requirements respond to the comments in the preamble to that document. The Administrator of the Centers for Medicare & Medicaid Services (CMS), Chiquita Brooks-LaSure, 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. Trenesha Fultz-Mimms, Federal Register Liaison, Centers for Medicare & Medicaid Services. [FR Doc. 2024–09172 Filed 4–26–24; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–9148–N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—January through March 2024 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). V. Response to Comments Because of the large number of public comments, we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published in the 3-month period, relating to the Medicare and Medicaid programs and other programs administered by CMS. FOR FURTHER INFORMATION CONTACT: It is possible that an interested party may need specific information and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing contact persons to answer general questions concerning each of the addenda published in this notice. SUMMARY: Addenda Contact I CMS Manual Instructions ...................................................................................................... II Regulation Documents Published in the Federal Register ................................................. III CMS Rulings ........................................................................................................................ IV Medicare National Coverage Determinations ..................................................................... V FDA-Approved Category B IDEs ......................................................................................... VI Collections of Information .................................................................................................... VII Medicare—Approved Carotid Stent Facilities .................................................................... VIII American College of Cardiology-National Cardiovascular Data Registry Sites ............... IX Medicare’s Active Coverage-Related Guidance Documents .............................................. X One-time Notices Regarding National Coverage Provisions ............................................... XI National Oncologic Positron Emission Tomography Registry Sites ................................... XII Medicare—Approved Ventricular Assist Device (Destination Therapy) Facilities ............. XIII Medicare—Approved Lung Volume Reduction Surgery Facilities .................................... XIV Medicare—Approved Bariatric Surgery Facilities ............................................................. Ismael Torres .......................... Terri Plumb ............................. Tiffany Lafferty ........................ Wanda Belle, MPA ................. John Manlove ......................... William Parham ....................... Sarah Fulton, MHS ................. Sarah Fulton, MHS ................. Lori Ashby, MA ....................... JoAnna Baldwin, MS .............. David Dolan, MBA .................. David Dolan, MBA .................. Sarah Fulton, MHS ................. Sarah Fulton, MHS ................. VerDate Sep<11>2014 20:54 Apr 26, 2024 Jkt 262001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\29APN1.SGM 29APN1 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) 786–6322 (410) 786–7205 (410) 786–3365 (410) 786–3365 (410) 786–2749 (410) 786–2749 Federal Register / Vol. 89, No. 83 / Monday, April 29, 2024 / Notices Addenda Contact XV Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials ....................... All Other Information .................................................................................................................. David Dolan, MBA .................. Annette Brewer ....................... SUPPLEMENTARY INFORMATION: khammond on DSKJM1Z7X2PROD with NOTICES 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. VerDate Sep<11>2014 20:54 Apr 26, 2024 Jkt 262001 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 00046 Fmt 4703 Sfmt 4703 33357 Phone No. (410) 786–3365 (410) 786–6580 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. Trenesha Fultz-Mimms, Federal Register Liaison, Department of Health and Human Services. BILLING CODE 4120–01–P E:\FR\FM\29APN1.SGM 29APN1 khammond on DSKJM1Z7X2PROD with NOTICES Jkt 262001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4725 E:\FR\FM\29APN1.SGM 29APN1 How to Obtain Manuals The Internet-only Manuals (IOMs) are a replica of the Agency's official record copy. Paper-based manuals are CMS manuals that were officially released in hardcopy. The majority of these manuals were transferred into the Internet-only manual (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. 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 .ems.gov/Manuals. 12531 I Issued to a specific audience, not posted to Internet/Intranet due to a C 12448 How to Review Transmittals or Program Memoranda Those wishing to review transmittals and program memoranda can access this information at a local Federal Depository Library (FDL). Under the FDL program, government publications are sent to approximately 1,400 designated libraries throughout the United States. Some FDLs may have arrangements to transfer material to a local library not designated as an FOL. Contact any library to locate the nearest FOL. 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 Manual/Subject/Publication Number Transmittal Number 12497 12532 Updates to Medicare Benefit Policy Manual and Medicare Claims Processing Manual for Marriage and Family Therapists (MFTs) and Mental Health Counselors (MHCs Pulmonary Rehabilitation, Cardiac Rehabilitation and Intensive Cardiac Rehabilitation (Pl{JCl{flCR) Expansion of Supervising Practitioners Update to Pub. 100-02 Medicare Benefit Policy Manual, Chapter 15, Section 110.8 Durable Medical Equipment Prosthetics Orthotics and Supplies (DMEPOS) Benefit Category Determinations and Add Section 145 Lvmphedema Compression Treatment Items None 12439 January 2024 Update of the Ambulatory Surgical Center (ASC) Payment Svstem Federal Register / Vol. 89, No. 83 / Monday, April 29, 2024 / Notices 20:54 Apr 26, 2024 Addendum I: Medicare and Medicaid Manual Instructions (January through March 2024) 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 Updates to Medicare Benefit Policy Manual and Medicare Claims Processing Manual for Marriage and Family Therapists (MFTs) and Mental Health Counselors (MHCs) (CMS-Pub. 100-02) Transmittal No. 12448. Addendum I lists a unique CMS transmittal number for each instruction in our manuals or program memoranda and its subject number. A transmittal may consist of a single or multiple instruction(s). Often, it is necessary to use information in a transmittal in conjunction with information currently in the manual. 33358 VerDate Sep<11>2014 EN29AP24.002</GPH> Publication Dates for the Previous Four Quarterly Notices We publish this notice atthe end of each quarter reflecting information released by CMS during the previous quarter. The publication dates of the previous four Quarterly Listing of Program Issuances notices are: May 12, 2023 (88 FR 30752), August 4, 2023 (88 FR 51814), October 26, 2023 (88 FR 73591) and January 30, 2024 (89 FR 5897). 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 12442 12443 12446 12449 Jkt 262001 12451 12452 PO 00000 12453 12455 Frm 00048 12456 12462 Fmt 4703 12472 12473 12474 Sfmt 4725 12475 12476 E:\FR\FM\29APN1.SGM 12491 12494 12497 12498 29APN1 12499 12500 12501 12503 12504 12511 12519 12521 12522 12527 12530 12535 12540 12547 12551 12552 12553 Update oflntemet Only Manual (TOM), Pub, 100-04, Chapter 8 - Outpatient ESRD Hospital, Independent Facilitv, and Phvsician/Supplier Claims Quarterly Update for Clinical Laboratory Fee Schedule (CLFS) and Laboratorv Services Subiect to Reasonable Charge Pavment Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv oflnstruction 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 Confidentiality oflnstruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv oflnstruction Changes to the Laboratory National Coverage Determination (NCD) Edit Software for J ulv 2024 July 2024 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Ouarterlv Pricing Files April 2024 Integrated Outpatient Code Editor (I/OCE) Specifications Version 25.1 April 2024 Update of the Hospital Outpatient Prospective Payment System (OPPS\ April Quarterly Update for 2024 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule 12438 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity oflnstruction 12456 New Physician Specialty Code for Epileptologists Claims Processing Timeliness - All Claims Part E - Interest Payment Data Classification of Claims for Counting Phvsician/Limited License Phvsician Soecialtv Codes Exhibit Notice of New Interest Rate for Medicare Overpayments and Underpayments -2nd Ouarter Notification for FY 2024 The Fiscal Intermediary Shared System (FISS) Submission of Copybook Files to the Provider and Statistical Reimbursement (PS&R) System Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv oflnstruction Updating Chapter 3, Sections 200,5 - 200,8, Limitation on Recoupment; Medicare Overpayments Manual Administrative Law Judge (AL.T) Third level and Suhsequent Levels of Administrative Appeals Actions on a Valid Notification for the ALJ or Subsequent Level Appeal Request Remanded back to the QJC from the AL.T Actions to Take After the ALJ or Subsequent Level Appeal Decision The Revised Overpayment Letter for ALJ and Subsequent Decisions Obligation to Pay Interest on Underpayments 935 Interest Calculation Assessment of 935 Interest Interest Rate and Calculation Periods on Recouped Funds for the Purposes of Paying 935 Interest Calculations for Each 30-Day Period at the ALJ or Subsequent Level Decision Timeftames when Calculation the 935 Interest Computing 935 Interest on Favorable Decisions from the ALJ and Subsequent Levels Tracking and Report the 935 Interest Pavments 12457 12492 12507 12509 33359 EN29AP24.003</GPH> 12517 Federal Register / Vol. 89, No. 83 / Monday, April 29, 2024 / Notices 20:54 Apr 26, 2024 12448 Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics, and Suoolies /DMEPOS) Comoetitive Bidding Program (CBP)-Aoril 2024 Clinical Laboratory Fee Schedule- Medicare Travel Allowance Fees for Collection of Snecimens and New Undates for 2024 Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv oflnstruction Updates to Medicare Benefit Policy Manual and Medicare Claims Processing Manual for Marriage and Family Therapists (MFTs) and Mental Health Counselors (MHCs April 2024 Quarterly Update to Healthcare Common Procedure Coding System (HCPCS) Codes Used for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Enforcement Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv oflnstruction Implementation of System Edits for Direct Graduate Medical Education (DOME) and Kidney Acquisition Pass-Thru Amount Fields of the Provider Specific File (PSF) 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 New Physician Specialtv Code for Epileptologists Update to the Payment for Grandfathered Tribal l'ederally Qualified Health Centers (FQHCs) for Calendar Year (CY) 2024 File Conversions Related to the Spanish Translation of the Healthcare Common Procedure Coding Svstem (HCPCS) Descriptions Indian Health Services ((HS) Hosoital Payment Rates for Calendar Year 2024 Quarterly Update to the End-Stage Renal Disease Prospective Payment Svstem (ESRD PPS) Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv oflnstruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv oflnstruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Pulmonaiy Rehabilitation, Cardiac Rehabilitation and Intensive Cardiac Rehabilitation /PR/CR/TCR\ Exnansion ofSunervisine Practitioners Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print CMREP) and PC Print Update Combined Common Edits/Enhancements Modules (CCEM) Code Set Uodate Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity oflnstruction Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) -April 2024 Update July 2024 Healthcare Common Procedure Coding System (HCPCS) Quarterly Update Reminder Home Infusion Therapy (HIT) Payment Rates and Instructions for Retrieving the January 2024 Home Infusion Therapy (HIT) Services Payment Rates Throueh the CMS Mainframe Telecommunications Svstem Manual Updates to Chapters 1 and 17 of the Medicare Claims Processing Manual to Reflect Policies Finalized in the Calendar Year (CY) 2024 Physician F cc Schedule Final Rule khammond on DSKJM1Z7X2PROD with NOTICES 218 12469 12478 12505 Jkt 262001 12512 12514 PO 00000 12515 Frm 00049 Fmt 4703 12520 12524 Sfmt 4725 12528 E:\FR\FM\29APN1.SGM 12541 12542 12543 12544 29APN1 12545 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 oflnstruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality oflnstruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Documentation Requirements for Refillable Durable Medical Equipment, Prosthetics, Orthotics, and Suoolies (DMEPOS Pourth Policy Change Request (CR) Regarding Implementation of the Provider Enrollment Chain and Ownershio Svstem (PECOS) 2.0 Updates of Chapter 4, Chapter 8, and Exhibits in Publication (Pub.) 100-08, Including Prioritization and Payment Suspension Language Guidance Investigations CMS Approval Terminating the Payment Suspension DME Payment Suspensions (MACs and UPICs Non-DME National Payment Susoensions (MACs and UPICs) Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality oflnstruction Stay of Enrollment Revalidation Solicitations Non-Responses to Revalidation and Extension Requests Receipt and Processing of Revalidation Applications 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 oflnstruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality uflnslructiun 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 Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality oflnstruction 130 None None 12412 12459 12465 12480 12496 12536 12538 12440 12441 None 12444 None None None None 12447 12450 12454 12463 12464 12470 EN29AP24.004</GPH> Update to Section 20.2.1 and 20.2.5-20.2.7 on the definitions of dual eligible special needs plans (D-SNPs) and additional requirements for certain D-SNPs General Definitions Eligibility Definitions D-SNP Defmitions Definition of a D-SNP Definition of a FIDE SNP Defmition of lllDE SNP Coordination-only D-SNPs Applicable Integrated Plan Additional Requirements for Certain D-SNPs Application ofFrailty Adjustment for FIDE SNPs Medicaid Carve-Outs and FIDE SNP and ffiDE SNP Starns Benefit Flexibility Eligibility Requirements Characteristics and Categories of flexible Supplemental benefits Benefit Flexibility Approval Process State D-SNP-only Contracts Limiting Certain MA Contracts to D-SNPs State Notification to CMS Integrated Materials Accountable Care Organization (ACO) REACH PY2023 Part Five Implementation Issued to a specific audience, not posted to Internet/Intranet due to a Sensitivity oflnstruction Enhancing Oncology Model (EOM) Monthly Enhanced Oncology Services (MEOS) Prohibited Codes Updates Payment ofMOOlO Enhancing Oncology Model (EOM) Monthly Enhanced Oncology Services (MEOS) Claims for Beneficiaries Receiving Care in an Inoatient Setting Making Care Primary CMCP) Model Implementation Guiding an Improved Dementia Experience (GUIDE) Model Implementation Making Care Primarv (MCP) Model Imolcmcntation International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs)--April 2024 Update--CR2 of2 International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs)--April 2024 Uodate--CR 1 of2 International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions tu National Coverage Determinations (NCDs)--January 2024 Update Modifications to the Automated Duolicate Primarv Paver (DPP) Process Updating Fiscal Intermediary Shared System (FISS) Editing for Practice Locations to Bvoass Non-OPPS Provider Svstem Uodates to Lumo Sum Utility for Addition ofWage Index Fields Fiscal Intermediary Shared System (FISS) - Delete Obsolete Reason Codes Part 3 Fiscal Intermediary Shared System (FISS) - Delete Obsolete Reason Codes Part Issued to a soecific audience, not oosted to Internet/Intranet due to a Federal Register / Vol. 89, No. 83 / Monday, April 29, 2024 / Notices 20:54 Apr 26, 2024 12458 Revisions to the State Operating Manual (SOM) Chapter 2; Community Mental Health Center (CMHC) Revisions to the State Operating Manual (SOM), Appendix F-Community Mental Health Centers 33360 VerDate Sep<11>2014 217 khammond on DSKJM1Z7X2PROD with NOTICES VerDate Sep<11>2014 12481 12482 12484 12485 Jkt 262001 12486 12487 PO 00000 12488 Frm 00050 12489 12490 Fmt 4703 12493 12506 Sfmt 4725 12508 E:\FR\FM\29APN1.SGM 12510 12513 12518 12537 29APN1 12539 12549 None None None EN29AP24.005</GPH> Addendum III: CMS Rulings (January through March 2024) CMS Rulings are decisions of the Administrator that serve as precedent fmal 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 (January through March 2024) Addendum IV includes completed national coverage determinations (NCOs), or reconsiderations of completed NCOs, from the quarter covered by this notice. Completed decisions are identified by the section of the NCO Manual (NCOM) in which the decision appears, the title, the date the publication was issued, and the effective date of the decision. An NCO 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 33361 For questions or additional information, contact Ismael Torres (410-786-1864). Addendum II: Regulation Documents Published in the Federal Register (January through March 2024) 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. For questions or additional information, contact Terri Plumb (410-786-4481). Federal Register / Vol. 89, No. 83 / Monday, April 29, 2024 / Notices 20:54 Apr 26, 2024 12483 Confidentiality of Instruction User Enhancement Change Request (UECR): ViPS Medicare System (VMS) - Add System Auditing Function Expert (SAFE) system to Online Documentation System (OLDS) for Error Messages User Enhancement Change Request (UECR): ViPS Medicare System (VMS) - Create Multi-line Add Functionality and View Only Mode to the Message File (MSSG) Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentiality of Instruction Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv ofinstruction User Enhancement Change Request (UECR): ViPS Medicare System (VMS) - FIND Command for SuperOp Value Set Defmition Screen User Enhancement Change Request (UECR): ViPS Medicare System (VMS) - FIND Command for Super Defmition Screen User Enhancement Change Request (UECR): ViPS Medicare System (VMS) - Update Electronic Funds Transfer (EFT) Process when a Change of Information ( COi) ls Received User Rnhancement Change Request (URCR): ViPS Medicare System (VMS) - lJndate Paging on Claim/Pricing Inquiry Snlit Screen User Enhancement Change Request (UECR): ViPS Medicare System (VMS)Uodate Suooression Adiustrnent Force Code Processing International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs)--July 2024 Uodate User Enhancement Change Request (UECR): New Multi- Carrier System (MCS) Inquiry Search Screen Using a Procedure Code to Display an Associated Rdit or Audit Appropriate Use Criteria for Advanced Diagnostic Imaging Policy Update in the Calendar Year 2024 Phvsician Fee Schedule Final Rule User Enhancement Change Request (UECR): ViPS Medicare System (VMS) - Cancellation Process Phase 2 Change Request (CR) to Implement the Medicare Program Final Action: Treatment of Medicare Part C Days in the Calculation of a Hospital's Medicare Disproportionate Patient Percentage Reoort ofHosoice Election for Part D (Resoonse File) Issued to a specific audience, not posted to Internet/Intranet due to a Confidentialitv ofinstruction Implementation to Expand Monetary Amount Fields Related to Billing and Payment to Accommodate IO-Digits in Len!!th ($99,999,999.99)- Phase 3 Fiscal Intermediary Shared System (FISS) User Enhancement Change Request (UECR) - Expiration ofa Unique Tracking Number (UTN) on the Prior Authorization (PA) Tracking File khammond on DSKJM1Z7X2PROD with NOTICES Jkt 262001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4725 E:\FR\FM\29APN1.SGM 29APN1 Addendum VI: Approval Numbers for Collections oflnformation (January through March 2024) 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 (.January through March 2024) 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). Provider Number EN29AP24.006</GPH> Date Approved State FROM: Saint John's Hospital and Health Center TO: Saint John's Health Center 2121 Santa Monica Boulevard Santa Monica, CA 90404 Provider Number 050290 Date Approved 02/09/2007 State Ca Addendum VIII: American College of Cardiology's National Cardiovascular Data Registry Sites (January through March 2024) The initial data collection requirement through the American College of Cardiology's National Cardiovascular Data Registry (ACCNCDR) has served to develop and improve the evidence base for the use of ICDs in certain Medicare beneficiaries. The data collection requirement ended with the posting of the fmal decision memo for Implantable Cardioverter Defibrillators on February 15, 2018. For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Addendum IX: Active CMS Coverage-Related Guidance Documents (January through March 2024) CMS issued a guidance document on November 20, 2014 titled "Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development Document". Although CMS has several policy 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.cms.gov/medicare-coverage-database/details/medicarecoverage-document-details.aspx?MCD1d=27. CMS published three proposed guidance documents on June 22, 2023 to provide a framework for more predictable and transparent evidence development and encourage innovation and accelerate beneficiary access to new items and services. The documents are available at: https://www.cms.gov/medicare-coverage-database/view/medicarecoverage-document.aspx?mcdid=35&docTypeid= l&sortBy=title&bc= 16 https://www.cms.gov/medicare-coverage-database/view/medicarecoverage-document.aspx?mcdid=34&doc·1ypeld= 1&sortBy=title&bc= 16 https://www.cms.gov/medicare-coverage-database/view/medicarecoverage-document.aspx?mcdid=33&docTypeid= 1&sortBy=title&bc= 16 Federal Register / Vol. 89, No. 83 / Monday, April 29, 2024 / Notices 20:54 Apr 26, 2024 Addendum V: FDA-Approved Category B Investigational Device Exemptions (IDEs) (January through March 2024) (Inclusion of this addenda is under discussion internally.) Facility 33362 VerDate Sep<11>2014 program and decision memoranda, which also announce decisions or, in some cases, explain why it was not appropriate to issue an NCO. Information on completed decisions as well as pending decisions has also been posted on the CMS website. For the purposes of this quarterly notice, there were no 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-coveragedatabase/. For questions or additional information, contact Wanda Belle, MPA (410-786-7491). khammond on DSKJM1Z7X2PROD with NOTICES VerDate Sep<11>2014 Jkt 262001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4725 E:\FR\FM\29APN1.SGM Addendum XI: National Oncologic PET Registry (NOPR) (January through March 2024) 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 perfonned 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/MedicareApprovedFacilitieiNOPR/list.asp#TopOfPage. For questions or additional information, contact David Dolan, MBA (410-786-3365). 29APN1 Facility Provider Number Date oflnitial Certification Date of Recertification Virtua Our Lady of Lourdes Medical Center 1600 Haddon Avenue Camden, NJ 08103 310029 01/03/2023 490063 12/09/2008 10/28/2023 150084 12/16/2008 11/08/2023 State NJ Other information: DNV ID#: C644464 Previous Re-certification Dates: n/a Inova Fairfax Hospital 3300 Gallows Road Falls Church, VA 22042 VA Other information: Joint Commission TD#: 6351 Previous Re-certification Dates: 12/09/2008; 03/22/2011; 05/01/2013; 06/09/2015; 07/25/2017; 9/25/2019; 1 1/17/2021 St. Vincent Hospital and Health Care Services, Inc. 2001 West 86th Street Indianapolis, IN 46260 Other information: Joint Commission IIJ #: 7178 IN Previous Re-certification Dates: 12/16/2008; 05/17/2011; 06/25/2013; 05/19/2015; 06/13/2017; 7/31/2019; 11/06/2021 33363 Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (January through March 2024) Addendum XII includes a listing of Medicare-approved facilities that receive coverage for ventricular assist devices (VADs) used as destination therapy. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy. On October 1, 2003, we issued our decision memorandum on VADs for the clinical indication of destination therapy. We determined that VADs used as destination therapy are reasonable and necessary only if performed in facilities that have been determined to have the experience and infrastructure to ensure optimal patient outcomes. We established facility standards and an application process. All facilities were required to meet our standards in order to receive coverage for VADs implanted as destination therapy. For the purposes of this quarterly notice, we are providing only the specific updates to the list of Medicare-approved facilities that meet our standards that have occurred in the 3-month period. This information is available at https://www.ems.gov/MedicareApprovedFacilitie/VAD/list.asp#TopO1Page. For questions or additional information, contact David Dolan, MBA, (410-786-3365). Federal Register / Vol. 89, No. 83 / Monday, April 29, 2024 / Notices 20:54 Apr 26, 2024 EN29AP24.007</GPH> For questions or additional information, contact Lori Ashby, MA (410 786 6322). Addendum X: List of Special One-Time Notices Regarding National Coverage Provisions (January through March 2024) There were no special one-time notices regarding national coverage provisions published in the 3-month period. This information is available at https://www.cms.gov. For questions or additional information, contact JoAnna Baldwin, MS (410-786 7205). khammond on DSKJM1Z7X2PROD with NOTICES 33364 VerDate Sep<11>2014 11/03/2010 02/09/2024 WA Jkt 262001 PO 00000 Previous Re-certification Dates: 11/03/201 O; 11/14/2012; 11/18/2014; 12/06/2016; 02/09/2021 T.oyola University Medical Center 2160 South First Avenue Maywood, TL 60153 140276 01/30/2004 12/01/2023 TT, Frm 00053 Fmt 4703 Sfmt 4725 E:\FR\FM\29APN1.SGM 29APN1 Previous Re-certification Dates: 12/18/2014; 01/24/2017; 03/06/2019; 10/30/2021 Previous Re-certification Dates: 07/18/2017; 9/11/2019; 12/04/2021 Tntermountain Healthcare Health Services Inc. 5121 South Cottonwood Street Murray, UT 84107 Previous Re-certification Dates: 10/31/2008; 12/07/2010; 12/11/2012; 12/16/2014; 01/24/2017; 3/13/2019; 11111/2021 UCSF Medical Center 505 Parnassus Avenue San Francisco, CA 94143 030103 01/27/2009 11/29/2023 07/18/2017 12/20/2023 MA 460010 10/31/2008 11/15/2023 UT 050454 09/19/2012 12/13/2023 CA 500008 02/10/2009 01/24/2024 WA AZ Other information: Joint Commission TD#: 10095 Other information: Joint Commission ID#: 261796 Previous Re-certification Dates: 0 l/27 /2009; 04/29/2011; 03/20/2013; 03/24/2015; 05/19/2017; 8/14/2019; 10/30/2021 St. Luke's University Hospital 801 Ostrum Street Bethlehem, PA 18015 220077 Other information: Joint Commission TD#: 9540 Other information: Joint Commission ID#: 7288 Previous Re-certification Dates: 05/10/2011; 04/16/2013; 03/17/2015; 05/09/2017; 6/26/2019; 11/17/2021 Mayo Clinic Arizona 5777 East Mayo Boulevard Phoenix, AZ 85054 Baystate Medical Center 759 Chestnut Street Springfield, MA O1199 Other information: Joint Commission ID#: 2768 Other information: DNV ID#: C565359 Other information: Joint Commission ID#: 6024 EN29AP24.008</GPH> 500129 Previous Re-certification Dates: 09/19/2012; 11/04/2014; 12/06/2016; 1/30/2019; 11/18/2021 University of Washington Medical Center 1959 Northeast Pacific Street, Dox 356151 Seattle, WA 98195-6151 390049 12/18/2014 12/06/2023 PA Other information: Joint Commission ID#: 9626 Previous Re-certification Dates: 02/10/2009; 10/18/2011; 11/22/2013; 12/08/2015; 12/05/2017; 11/20/2019; 01/26/2022 Federal Register / Vol. 89, No. 83 / Monday, April 29, 2024 / Notices 20:54 Apr 26, 2024 Multi Care Tacoma General Hospital 315 Martin Luther King Jr. Way Tacoma, WA 98338 khammond on DSKJM1Z7X2PROD with NOTICES VerDate Sep<11>2014 070025 03/31/2009 01/05/2024 CT Other information: Joint Commission ID II: 2649 Jkt 262001 Previous Re-certification Dates: 03/31/2009; 11/16/2011; 10/22/2013; 10/20/2015; 11/14/2017; 12/10/2019; 12/15/2021 Hackensack University Medical Center 30 Prospect Avenue Hackensack, NJ 07601 PO 00000 Frm 00054 310001 10/20/2015 01/18/2024 NJ 100151 03/17/2009 02/02/2024 FL Other information: Joint Commission ID#: 5934 Fmt 4703 Previous Re-certification Dates: 10/20/2015; 09/19/2017; 10/4/2019; 12/15/2021 Mayo Clinic Florida 4500 San Pablo Road Jacksonville, FL 32224 Sfmt 9990 Other information: Joint Commission ID#: 369946 E:\FR\FM\29APN1.SGM Previous Re-certification Dates: 03/l 7/2009; 10/19/2011; 09/24/2013; 09/15/2015; 10/03/2017; 11/6/2019; 01/15/2022 29APN1 Addendum XIV: Medicare-Approved Bariatric Surgery Facilities (January through March 2024) Addendum XIV includes a listing of Medicare-approved facilities that meet minimum standards for facilities modeled in part on professional society statements on competency. A11 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 Exce11ence (BSCOE) (program standards and requirements in effect on February 15, 2006). There were no additions, deletions, or editorial changes to Medicare-approved facilities that meet CMS' minimum facility standards for bariatric surgery that have been certified by ACS and/or ASMBS in the 3-month period. This information is available at www.ems.gov/MedicareApprovedFacilitie/BSF/list.asp#TopOfPage. For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Addendum XV: FOG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (January through March 2024) 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.aspftTopOfl>age. For questions or additional information, contact David Dolan, MBA (410-786-3365). 33365 Addendum XIII: Lung Volume Reduction Surgery (LVRS) (January through March 2024) Addendum XIII includes a listing of Medicare-approved facilities that arc eligible to receive coverage for lung volume reduction surgery. Until May 17, 2007, facilities that participated in the National Emphysema Treatment Trial were also eligible to receive coverage. The following three types of facilities are eligible for reimbursement for Lung Volume Reduction Surgery (L YRS): • National Emphysema Treatment Trial (NETT) approved (Beginning 05/07/2007, these will no longer automatica11y 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 YRS; and • Medicare approved for lung transplants. Only the first two types are in the list. For the purposes of this quarterly notice, there are no additions and deletions to a listing of Medicare-approved facilities that are eligible to receive coverage for lung volume reduction surgery. This information is available at www.cms.gov/MedicareApprovedFacilitie/LVRS/list.asp#TopOfl>age. For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Federal Register / Vol. 89, No. 83 / Monday, April 29, 2024 / Notices 20:54 Apr 26, 2024 EN29AP24.009</GPH> Hartford Hospital 80 Seymour Street Hartford, CT 06102-5037 33366 Federal Register / Vol. 89, No. 83 / Monday, April 29, 2024 / Notices [FR Doc. 2024–09165 Filed 4–26–24; 8:45 am] Written/Paper Submissions BILLING CODE 4120–01–C Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2010–N–0155 for ‘‘Veterinary Feed Directive Regulation Questions and Answers.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0155] Veterinary Feed Directive Regulation Questions and Answers; Small Entity Compliance Guide; Guidance for Industry (Revised); Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry (GFI) #120 entitled ‘‘Veterinary Feed Directive Regulation Questions and Answers.’’ This revised guidance document will aid industry in complying with the requirements of the veterinary feed directive (VFD) regulation. DATES: The announcement of the guidance is published in the Federal Register on April 29, 2024. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). VerDate Sep<11>2014 20:54 Apr 26, 2024 Jkt 262001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the guidance to the Policy and Regulations Staff (HFV–6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Dragan Momcilovic, Center for Veterinary Medicine (HFV–241), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402– 5944, Dragan.Momcilovic@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of September 30, 2015 (80 FR 58602), FDA announced the availability of GFI #120 entitled ‘‘Veterinary Feed Directive Regulation Questions and Answers’’ to assist industry in complying with the VFD regulation in 21 CFR part 558. This guidance also serves as a Small Entities Compliance Guide (SECG) to aid industry in complying with the requirements of the VFD final rule that published in the Federal Register on June 3, 2015 (80 FR 31708). FDA prepared this SECG in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104–121). In the Federal Register of March 28, 2019 (84 FR 11804), FDA announced the availability of a draft revised GFI #120 to provide additional information in response to questions that have been submitted by interested parties since 2015. FDA reviewed comments submitted in response to that notice by stakeholders, including animal producer organizations, the animal feed industry, veterinarians, and producers of electronic VFD software. The Agency is now announcing the availability of revised GFI #120 which refines and clarifies language in the draft guidance based on stakeholder feedback. Specifically, stakeholders asked FDA to clarify and change language related to the amount of VFD drug in feed, the issuance and effective dates of VFDs, definitions of and requirements for individuals who E:\FR\FM\29APN1.SGM 29APN1

Agencies

[Federal Register Volume 89, Number 83 (Monday, April 29, 2024)]
[Notices]
[Pages 33356-33366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09165]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-9148-N]


Medicare and Medicaid Programs; Quarterly Listing of Program 
Issuances--January through March 2024

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 in the 3-month period, 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   Terri Plumb.......    (410) 786-4481
 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-      Lori Ashby, MA....    (410) 786-6322
 Related Guidance Documents.
X One-time Notices Regarding        JoAnna Baldwin, MS    (410) 786-7205
 National Coverage Provisions.
XI National Oncologic Positron      David Dolan, MBA..    (410) 786-3365
 Emission Tomography Registry
 Sites.
XII Medicare--Approved Ventricular  David Dolan, MBA..    (410) 786-3365
 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.

[[Page 33357]]

 
XV Fluorodeoxyglucose Positron      David Dolan, MBA..    (410) 786-3365
 Emission Tomography for Dementia
 Trials.
All Other Information.............  Annette Brewer....    (410) 786-6580
------------------------------------------------------------------------


SUPPLEMENTARY INFORMATION:

I. Background

    The Centers for Medicare & Medicaid Services (CMS) is responsible 
for administering the Medicare and Medicaid programs and coordination 
and oversight of private health insurance. Administration and oversight 
of these programs involves the following: (1) furnishing information to 
Medicare and Medicaid beneficiaries, health care providers, and the 
public; and (2) maintaining effective communications with CMS regional 
offices, state governments, state Medicaid agencies, state survey 
agencies, various providers of health care, all Medicare contractors 
that process claims and pay bills, National Association of Insurance 
Commissioners (NAIC), health insurers, and other stakeholders. To 
implement the various statutes on which the programs are based, we 
issue regulations under the authority granted to the Secretary of the 
Department of Health and Human Services under sections 1102, 1871, 
1902, and related provisions of the Social Security Act (the Act) and 
Public Health Service Act. We also issue various manuals, memoranda, 
and statements necessary to administer and oversee the programs 
efficiently.
    Section 1871(c) of the Act requires that we publish a list of all 
Medicare manual instructions, interpretive rules, statements of policy, 
and guidelines of general applicability not issued as regulations at 
least every 3 months in the Federal Register.

II. Format for the Quarterly Issuance Notices

    This quarterly notice provides only the specific updates that have 
occurred in the 3-month period along with a hyperlink to the full 
listing that is available on the CMS website or the appropriate data 
registries that are used as our resources. This is the most current up-
to-date information and will be available earlier than we publish our 
quarterly notice. We believe the website list provides more timely 
access for beneficiaries, providers, and suppliers. We also believe the 
website offers a more convenient tool for the public to find the full 
list of qualified providers for these specific services and offers more 
flexibility and ``real time'' accessibility. In addition, many of the 
websites have listservs; that is, the public can subscribe and receive 
immediate notification of any updates to the website. These listservs 
avoid the need to check the website, as notification of updates is 
automatic and sent to the subscriber as they occur. If assessing a 
website proves to be difficult, the contact person listed can provide 
information.

III. How to Use the Notice

    This notice is organized into 15 addenda so that a reader may 
access the subjects published during the quarter covered by the notice 
to determine whether any are of particular interest. We expect this 
notice to be used in concert with previously published notices. Those 
unfamiliar with a description of our Medicare manuals should view the 
manuals at https://www.cms.gov/manuals.
    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.

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

[[Page 33358]]

[GRAPHIC] [TIFF OMITTED] TN29AP24.002


[[Page 33359]]


[GRAPHIC] [TIFF OMITTED] TN29AP24.003


[[Page 33360]]


[GRAPHIC] [TIFF OMITTED] TN29AP24.004


[[Page 33361]]


[GRAPHIC] [TIFF OMITTED] TN29AP24.005


[[Page 33362]]


[GRAPHIC] [TIFF OMITTED] TN29AP24.006


[[Page 33363]]


[GRAPHIC] [TIFF OMITTED] TN29AP24.007


[[Page 33364]]


[GRAPHIC] [TIFF OMITTED] TN29AP24.008


[[Page 33365]]


[GRAPHIC] [TIFF OMITTED] TN29AP24.009


[[Page 33366]]


[FR Doc. 2024-09165 Filed 4-26-24; 8:45 am]
BILLING CODE 4120-01-C

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.