[Billing Code 4120-01-P] DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-9149-N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances— April through June 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 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 Contact 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 David Dolan, MBA Annette Brewer Phone Number (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 (410) 786-3365 (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 http://www.cms.gov/manuals. The Director of the Office of Strategic Operations and Regulatory Affairs of the Centers for Medicare & Medicaid Services (CMS), Kathleen Cantwell, having reviewed and approved this document, authorizes 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. Publication Dates for the Previous Four Quarterly Notices We publish this notice at the end of each quarter reflecting information released by CMS during the previous quarter. The publication dates of the previous four Quarterly Listing of Program Issuances notices are: August 4, 2023 (88 FR 51814), October 26, 2023 (88 FR 73591), January 30, 2024 (89 FR 5897) and April 29, 2024 (89 FR 33356). 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. Addendum I: Medicare and Medicaid Manual Instructions (April through June 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. 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: http://cms.gov/manuals. How to Review Transmittals or Program Memoranda Those wishing to review transmittals and program memoranda can access this information at a local Federal Depository Library (FDL). Under the FDL program, government publications are sent to approximately 1,400 designated libraries throughout the United States. Some FDLs may have arrangements to transfer material to a local library not designated as an FDL. Contact any library to locate the nearest FDL. This information is available at http://www.gpo.gov/libraries/ In addition, individuals may contact regional depository libraries that receive and retain at least one copy of most federal government 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 for Clarification on Services Under the Medicare Hospice Benefit for Dually Eligible Veterans (CMS-Pub. 100-02) Transmittal No. 12589. 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. Fee-For Service Transmittal Numbers Please Note: Beginning Friday, March 20, 2020, there will be the following change regarding the Advance Notice of Instructions due to a CMS internal process change. Fee-For Service Transmittal Numbers will no longer be determined by Publication. The Transmittal numbers will be issued by a single numerical sequence beginning with Transmittal Number 10000. For the purposes of this quarterly notice, we list only the specific updates to the list of manual instructions that have occurred in the 3-month period. This information is available on our website at www.cms.gov/Manuals. Transmittal Number 12566 12568 12637 12638 12589 12599 12600 Manual/Subject/Publication Number Medicare General Information (CMS-Pub. 100-01) 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 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 Confidentiality of Instruction Medicare Benefit Policy (CMS-Pub. 100-02) Manual Updates for Clarification on Services Under the Medicare Hospice Benefit for Dually Eligible Veterans A Social Determinants of Health Risk Assessment in the Annual Wellness Visit Policy Update in the Calendar Year 2024 Physician Fee Schedule Final Rule Expand Diabetes Screening and Diabetes Definitions Policy Update in the Calendar Year 2024 Physician Fee Schedule Final Rule Medicare National Coverage Determination (CMS-Pub. 100-03) National Coverage Determination (NCD) 20.7 Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting Percutaneous Transluminal Angioplasty (PTA) (Various Effective Dates Below) 12590 12565 12570 12571 12573 12575 12576 12577 12578 12584 12587 12594 12596 12599 12600 12601 12604 12606 12607 12608 12609 Technical Revision Only to the National Coverage Determination (NCD) Manual, Publication (Pub) 100-03, Chapter 1, Part 4, section 310.1 Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Myelodysplastic Syndromes (MDS) National Coverage Determination (NCD) 110.23 Medicare Claims Processing (CMS-Pub. 100-04) Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction CY 2024 Home Infusion Therapy (HIT) Payment Rates and Instructions for Retrieving the January 2024 Home Infusion Therapy (HIT) Services Payment Rates Through the CMS Mainframe Telecommunications System National Coverage Determination (NCD) 20.7 Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting Manual Update to Section 20.7 in Chapter 23 of Publication (Pub) 100-04 Internet Only Manual Updates to Publication 100-04 to Implement Updates to Policy (Inpatient Rehabilitation Facility (IRF)) Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Additional Enforcement of Required County Codes on Home Health Claims Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction April Quarterly Update for 2024 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule Additional Implementation Edits on Hospice Claims for Hospice Certifying Physician Medicare Enrollment Notice of Election (NOE) Remove Modify Notice of Termination/Revocation (NOTR) Change of Provider/Transfer Notice Cancellation of an Election Change of Ownership Notice Data Required on the Institutional Claim to A/B MAC (HHH) Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Outlier Reconciliation and Cost-to-Charge Ratio (CCR) Updates for the Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) PPS File Conversions Related to the Spanish Translation of the Healthcare Common Procedure Coding System (HCPCS) Descriptions A Social Determinants of Health Risk Assessment in the Annual Wellness Visit Policy Update in the Calendar Year 2024 Physician Fee Schedule Final Rule Expand Diabetes Screening and Diabetes Definitions Policy Update in the Calendar Year 2024 Physician Fee Schedule Final Rule Update to Several Sections of the Internet-only Manual (IOM) Publication (Pub.) 100-04, Medicare Claims Processing Manual, Chapter 23 - Fee Schedule Administration and Coding Requirements Internet-Only Manual (IOM) Updates for Split (or Shared) Evaluation and Management Visits Quarterly Update for Clinical Laboratory Fee Schedule (CLFS) and Laboratory Services Subject to Reasonable Charge Payment Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Enhancements to Home Health Consolidated Billing Edits 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 Confidentiality of Instruction 12611 12612 12614 12615 12621 12627 12628 12629 12635 12644 12646 12649 12650 12652 12653 12654 12655 12657 12659 12660 12661 12664 12665 12666 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 Sensitivity of Instruction Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Myelodysplastic Syndromes (MDS) National Coverage Determination (NCD) 110.23 Quarterly Update to the End-Stage Renal Disease Prospective Payment System (ESRD PPS) Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) - July 2024 Update Additional Implementation Edits on Hospice Claims for Hospice Certifying Physician Medicare Enrollment 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 Confidentiality of Instruction National Coverage Determination (NCD) 200.3 - Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (AD)1 Annual Updates to the Prior Authorization/Pre-Claim Review Federal Holiday Schedule Tables for Generating Reports October 2024 (2025 File) Update of the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) Healthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits Quarterly Update to Home Health (HH) Grouper October 2024 Healthcare Common Procedure Coding System (HCPCS) Quarterly Update Reminder Quarterly Update for Clinical Laboratory Fee Schedule (CLFS) and Laboratory Services Subject to Reasonable Charge Payment Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print (MREP) and PC Print Update Combined Common Edits/Enhancements Modules (CCEM) Code Set Update Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction Implement Operating Rules – Phase III Electronic Remittance Advice (ERA) Electronic Funds Transfer (EFT): Committee on Operating Rules for Information Exchange (CORE) 360 Uniform Use of Claim Adjustment Reason Codes (CARC), Remittance Advice Remark Codes (RARC) and Claim Adjustment Group Code (CAGC) Rule - Update from Council for Affordable Quality Healthcare (CAQH) CORE Changing the Frequency of No-Pay Medicare Summary Notice (MSN) Mailings from Every 90 Days to Every 120 Days July 2024 Update of the Hospital Outpatient Prospective Payment System (OPPS) July 2024 Integrated Outpatient Code Editor (I/OCE) Specifications Version 25.2 July 2024 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files 12671 12677 12682 12683 12685 12686 12687 12688 12690 12691 12692 12693 12564 12568 12648 12583 12597 219 220 221 222 223 224 Billing and Payment for Telehealth Services with Place of Service (POS) 10 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 30.3, Effective October 1, 2024 Update to the Internet Only Manual (IOM) Publication (Pub.) 100-04, Chapter 32, Section 150.3 for Coding Revisions to the National Coverage Determinations (NCDs)--October 2024 Change Request (CR)13596 July Quarterly Update for 2024 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule Instructions for Downloading the Medicare ZIP Code File for October 2024 Files Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction Fiscal Year (FY) 2025 Annual Update to the Medicare Code Editor (MCE) and International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) and Procedure Coding System (ICD-10-PCS) Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Changes to the Laboratory National Coverage Determination (NCD) Edit Software for October 2024 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction October 2024 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files Expand Diabetes Screening and Diabetes Definitions Policy Update in the Calendar Year 2024 Physician Fee Schedule Final Rule - This CR Rescinds and Fully Replaces CR 13487. Medicare Secondary Payer (CMS-Pub. 100-05) Changes to The Electronic Correspondence Referral System (ECRS) Web Includes Updates to Submitting Duplicate and Overlapping Drug Records; Addition of Action Code (DR) to Investigate Deleted Drug Records and Updates to the Electronic Data Interchange (EDI) and Coordination of Benefits Voluntary Agreement (COBVA) Email Addresses Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction Medicare Financial Management (CMS-Pub. 100-06) Notice of New Interest Rate for Medicare Overpayments and Underpayments -3rd Quarter Notification for FY 2024 The Fiscal Intermediary Shared System (FISS) Submission of Copybook Files to the Provider and Statistical Reimbursement (PS&R) System Medicare State Operations Manual (CMS-Pub. 100-07) Revisions to the State Operations Manual (SOM) Appendix B – Home Health Agencies Revisions to State Operations Manual (SOM) Appendix A-Hospitals Revisions to the State Operations Manual (SOM) Chapter 10 –Informal Dispute Resolution (IDR) and Enforcement Procedures for Home Health Agencies and Hospice Programs Revisions to the State Operations Manual (SOM) Appendix M-Hospice Revisions to the State Operations Manual (SOM) Appendix G – RHC Revisions to State Operations Manual (SOM), Chapter 2, section 2779A1 – CCN for Medicare Providers Medicare Program Integrity (CMS-Pub. 100-08) 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 Confidentiality of Instruction 12582 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction 12591 Stay of Enrollment 12592 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction 12593 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction 12602 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction 12603 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction 12633 Medical Review Policies for Signature Requirements 12656 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction 12663 Medical Review Policies for Signature Requirements 12679 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction 12680 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction 12681 Fraud Prevention System (FPS) Edit – FPS14 – Denial of Pacemaker, Cardioverter, and Cardiovascular Monitoring Services Frequency - This CR Rescinds and Fully Replaces CR 11594. 12700 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Medicare Contractor Beneficiary and Provider Communications (CMS-Pub. 100-09) None Medicare Quality Improvement Organization (CMS- Pub. 100-10) None Medicare Program of All-Inclusive Care for the Elderly (CMS- Pub. 100-11) None Medicare End Stage Renal Disease Network Organizations (CMS Pub 100-14) None Medicaid Program Integrity Disease Network Organizations (CMS Pub 100-15) None Medicare Managed Care (CMS-Pub. 100-16) None Medicare Business Partners Systems Security (CMS-Pub. 100-17) None Medicare Prescription Drug Benefit (CMS-Pub. 100-18) None Demonstrations (CMS-Pub. 100-19) 12563 Guiding an Improved Dementia Experience (GUIDE) Model Implementation 12567 Making Care Primary (MCP) Model Implementation 12596 Conversions Related to the Spanish Translation of the Healthcare Common Procedure Coding System (HCPCS) Descriptions 12598 Create APIs to Support ACO REACH Model - Full Agile Pilot 12620 Primary Care First (PCF) Model: Updated Appendix B - Prohibited Healthcare Common Procedure Coding System (HCPCS) Codes 12622 Extension of Payment Period for Pennsylvania Rural Health Model 12643 Making Care Primary (MCP) Model Implementation 12647 Guiding an Improved Dementia Experience (GUIDE) Model Implementation 12651 Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction 12605 12613 12616 12617 12619 12623 12625 12626 12630 12631 12632 12634 12636 12640 12641 12658 12667 12668 12669 12672 12675 12678 12689 12698 12701 One Time Notification (CMS-Pub. 100-20) 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 Sensitivity of Instruction Fiscal Intermediary Shared System (FISS) - User Enhancement Change Request (UECR) - Create a Beneficiary Liable Reason Code for National Coverage Determination (NCD) 210.14 User Enhancement Change Request (UECR) - Enhance the MCS Desktop Tool (MCSDT) Table Manager and Customer Service Representative (CSR) Security Table User Enhancement Change Request (UECR) - Enhance the Multi-Carrier System Desktop Tool (MCSDT) to Export Tables Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Fiscal Intermediary Shared System (FISS) User Enhancement Change Request (UECR) - Expiration of a Unique Tracking Number (UTN) on the Prior Authorization (PA) Tracking File International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs)— October 2024 Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction Fiscal Intermediary Shared System (FISS) - New Process to Create and Use Overridable Reason Codes Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Implement Edits on Hospice Claims Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction Updates to the Recovery Audit Contractor Data Warehouse (RACDW) Suppression Upload File Format Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction Clarification of Liability for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Claims Overlapping Inpatient Hospital Stays User Enhancement Change Request (UECR) - Enhance the Multi-Carrier System Desktop Tool (MCSDT) to Export Tables Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction Replacement Wheelchair Equipment When the Manufacturer Exits Wheelchair Business Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity 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 Sensitivity of Instruction Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction New State Codes for Arizona, California, Nevada, and Texas Fiscal Intermediary Shared System (FISS) - User Enhancement Change Request (UECR) - Create a Beneficiary Liable Reason Code for National Coverage Determination (NCD) 210.14 Medicare Quality Reporting Incentive Programs (CMS- Pub. 100-22) None State Payment of Medicare Premiums (CMS-Pub.100-24) None Information Security Acceptable Risk Safeguards (CMS-Pub. 100-25) None For questions or additional information, contact Ismael Torres (410-786-1864). Addendum II: Regulation Documents Published in the Federal Register (April through June 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 http://www.gpoaccess.gov/fr/index.html. The following website http://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). Addendum III: CMS Rulings (April through June 2024) CMS Rulings are decisions of the Administrator that serve as precedent final opinions and orders and statements of policy and interpretation. They provide clarification and interpretation of complex or ambiguous provisions of the law or regulations relating to Medicare, Medicaid, Utilization and Quality Control Peer Review, private health insurance, and related matters. The rulings can be accessed at http://www.cms.gov/Regulationsand-Guidance/Guidance/Rulings. For questions or additional information, contact Tiffany Lafferty (410-786-7548). Addendum IV: Medicare National Coverage Determinations (April through June 2024) Addendum IV includes completed national coverage determinations (NCDs), or reconsiderations of completed NCDs, from the quarter covered by this notice. Completed decisions are identified by the section of the NCD Manual (NCDM) in which the decision appears, the title, the date the publication was issued, and the effective date of the decision. An NCD is a determination by the Secretary for whether or not a particular item or service is covered nationally under the Medicare Program (title XVIII of the Act), but does not include a determination of the code, if any, that is assigned to a particular covered item or service, or payment determination for a particular covered item or service. The entries below include information concerning completed decisions, as well as sections on program and decision memoranda, which also announce decisions or, in some cases, explain why it was not appropriate to issue an NCD. Information on completed decisions as well as pending decisions has also been posted on the CMS website. For the purposes of this quarterly notice, 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). Title Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Myelodysplastic Syndromes (MDS) National Coverage Determination (NCD) 110.23 NCDM Section NCD 110.23 Transmittal Number Issue Date Effective Date 05/09/2024 03/06/2024 Addendum V: FDA-Approved Category B Investigational Device Exemptions (IDEs) (April through June 2024) (Inclusion of this addenda is under discussion internally.) Addendum VI: Approval Numbers for Collections of Information (April through June 2024) All approval numbers are available to the public at Reginfo.gov. Under the review process, approved information collection requests are assigned OMB control numbers. A single control number may apply to 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 (April through June 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. There were no additions, deletions, or editorial changes to the listing for Medicare-approved carotid stent facilities for this 3-month period. This information is available at: http://www.cms.gov/MedicareApprovedFacilitie/CASF/list.asp#TopOfPage For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Addendum VIII: American College of Cardiology’s National Cardiovascular Data Registry Sites (April through June 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 final 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 (April through June 2024) CMS issued a guidance document on November 20, 2014 titled “Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development Documentâ€. Although CMS has several policy vehicles relating to evidence development activities including the investigational device exemption (IDE), the clinical trial policy, national coverage determinations and local coverage determinations, this guidance document is principally intended to help the public understand CMS’s implementation of coverage with evidence development (CED) through the national coverage determination process. The document is available at http://www.cms.gov/medicare-coverage-database/details/medicarecoverage-document-details.aspx?MCDId=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=1&sortBy=title&bc=16 https://www.cms.gov/medicare-coverage-database/view/medicarecoverage-document.aspx?mcdid=34&docTypeId=1&sortBy=title&bc=16 https://www.cms.gov/medicare-coverage-database/view/medicarecoverage-document.aspx?mcdid=33&docTypeId=1&sortBy=title&bc=16 For questions or additional information, contact Lori Ashby, MA (410 786 6322). Addendum X: List of Special One-Time Notices Regarding National Coverage Provisions (April through June 2024) There were no special one-time notices regarding national coverage provisions published in the 3-month period. This information is available at http://www.cms.gov . For questions or additional information, contact JoAnna Baldwin, MS (410-786 7205). Addendum XI: National Oncologic PET Registry (NOPR) (April through June 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 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 http://www.cms.gov/MedicareApprovedFacilitie/NOPR/list.asp#TopOfPage. For questions or additional information, contact David Dolan, MBA (410-786-3365). Addendum XII: Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities (April through June 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 http://www.cms.gov/MedicareApprovedFacilitie/VAD/list.asp#TopOfPage. For questions or additional information, contact David Dolan, MBA, (410-786-3365). Facility Provider Date of Initial Date of ReNumber Certification certification The following facility is a new listing. Virginia Mason Medical 50-0005 03/07/2024 n/a Center 1100 Ninth Avenue Seattle, WA 98101 State WA Other information: DNV ID #: C667499 Previous Re-certification Dates: n/a The following facilities have editorial changes (in bold). Shands Teaching Hospitals & 100113 11/26/2003 01/31/2024 Clinics, Inc. 1600 SW Archer Road Gainesville, FL 32608 FL Other information: Joint Commission ID #6804 Previous Re-certification Dates: 11/18/2008; 02/08/2011; 02/12/2013; 01/27/2015; 02/14/2017; 04/24/2019; 12/16/2021 Stanford Health Care 300 Pasteur Drive Stanford, CA 94305 Other information: Joint Commission ID #10010 Previous Re-certification Dates: 11/24/2010; 12/12/2012; 12/09/2014; 03/14/2017; 08/28/2019; 12/15/2021 12/22/2003 01/31/2024 CA Cedars-Sinai Health System 8700 Beverly Boulevard Los Angeles, CA 90048 12/29/2003 04/12/2024 CA Other information: Joint Commission ID #9792 Previous Re-certification Dates: 12/11/2008; 06/21/2011; 06/11/2013; 05/29/2015; 07/11/2017; 09/11/2019; 02/26/2022 Wellstar Kennestone Hospital 677 Church Street Marietta, GA 30060 Northeast Georgia Medical Center 743 Spring Street Gainesville, GA 30501 11/07/2017 02/07/2024 GA Previous Re-certification Dates: 04/26/2018; 05/05/2021 Pitt County Memorial Hospital, Inc. DBA Vidant Medical Center 2100 Stantonsburg Road Greenville, NC 27835-6028 Other information: Joint Commission ID #6506 Previous Re-certification Dates: 11/07/2017; 11/22/2019; 01/15/2022 University of Chicago Medical Center 5841 South Maryland Avenue Chicago, IL 60637 Previous Re-certification Dates: 09/26/2017; 12/17/2019; 02/09/2022 Florida Health Sciences Center Inc. 1 Tampa General Circle Tampa, FL 33606 02/24/2009 02/07/2024 IL Other information: Joint Commission ID #7315 Other information: Joint Commission ID #6934 Previous Re-certification Dates: 02/24/2009; 08/17/2011; 09/04/2013; 09/15/2015; 10/24/2017; 12/17/2019; 01/22/2022 Emory University Hospital 1364 Clifton Road NE Atlanta, GA 30322 Previous Re-certification Dates: 12/19/2008; 04/05/2011; 04/09/2013; 04/21/2015; 06/06/2017; 7/24/2019; 01/20/2022 Baptist Memorial Hospital Memphis 6019 Walnut Grove Road Memphis, TN 38120 Previous Re-certification Dates: 08/18/2009; 09/09/2011; 08/29/2013; 08/11/2015; 09/26/2017; 11/20/2019; 02/12/2022 04/26/2018 05/05/2024 GA 09/26/2017 02/21/2024 NC 12/18/2008 02/28/2024 FL 04/07/2007 03/13/2024 TN Other information: DNV ID #: C690194 Other information: Joint Commission ID #6711 Other information: Joint Commission ID #6689 110010 08/18/2009 02/14/2024 GA Other information: Joint Commission ID #7869 Previous Re-certification Dates: 01/27/2009; 05/20/2011; 04/17/2013; 06/02/2015; 07/25/2017; 09/17/2019; 02/19/2022 UT Southwestern Medical Center/William P. Clements Jr. University Hospital 6201 Harry Hines Boulevard Dallas, TX 75390-9262 12/10/2003 03/13/2024 TX Other information: Joint Commission ID #9013 Previous Re-certification Dates: 12/17/2008; 06/07/2011; 06/04/2013; 06/23/2015; 08/08/2017; 10/11/2019; 02/12/2022 University Hospital Cleveland Medical Center 11100 Euclid Avenue Cleveland, OH 44106 36-0137 02/09/2010 04/17/2024 OH 11/14/2008 03/13/2024 KY Other information: Joint Commission ID #: 9219 03/23/2024 OH Previous Re-certification Dates: 07/14/2015; 08/29/2017; 10/23/2019; 02/26/2022 Texas Heart Hospital of the Southwest LLP 1100 Allied Drive Plano, TX 75093-5348 06/15/2011 03/16/2024 TX Previous Re-certification Dates: 06/15/2011; 07/09/2013; 07/14/2015; 08/22/2017; 9/7/2019; 01/28/2022 Christiana Care Health Services, Inc. 4755 Ogletown-Stanton Road Newark, DE 19718 07/25/2013 04/10/2024 DE 07/09/2009 03/27/2024 PA 02/04/2009 04/04/2024 AZ Other information: Joint Commission ID #6237 03/13/2009 03/14/2024 CA Other information: Joint Commission ID #5033 Previous Re-certification Dates: 03/13/2009; 08/16/2011; 09/10/2013; 10/06/2015; 10/20/2017; 12/4/2019; 02/02/2022 Methodist Hospital 7700 Floyd Curl Drive San Antonio, TX 78229 07/14/2015 Other information: Joint Commission ID #: Other information: Joint Commission ID #7765 Previous Re-certification Dates: 11/14/2008; 03/22/2011; 02/26/2013; 03/24/2015; 05/23/2017; 8/6/2019; 02/23/2022 Keck Hospital of USC 1500 San Pablo Street Los Angeles, CA 90033 Other information: Joint Commission ID #: 7030 Other information: DNV ID #: C669039 Previous Re-certification Dates: 02/09/2010; 01/24/2012; 01/30/2014; 02/23/2016; 02/09/2018; 0121-2021; 08/17/2022 UofL Health - Louisville, Inc. 200 Abraham Flexner Way Louisville, KY 40202 Previous Re-certification Dates: 01/27/2009; 07/12/2011; 07/09/2013; 07/07/2015; 08/08/2017; 10/23/2019; 01/22/2022 Riverside Methodist Hospital 3535 Olentangy River Road Columbus, OH 43214-3998 Previous Re-certification Dates: 07/25/2013; 07/21/2015; 10/24/2017; 12/21/2019; 03/03/2022 Thomas Jefferson University Hospitals, Inc. 111 South 11th Street Philadelphia, PA 19107 Other information: Joint Commission ID #6132 01/27/2009 03/08/2024 TX Previous Re-certification Dates: 07/09/2009; 09/13/2011; 10/17/2013; 09/22/2015; 09/20/2017; 11/6/2019; 02/24/2022 Banner-University Medical Center Tucson Campus 1625 North Campbell Avenue Tucson, AZ 85719 10/31/2017; 12/18/2019; 03/24/2022 Ochsner Medical Center 1516 Jefferson Highway New Orleans, LA 70121 Other information: Joint Commission ID #: 9514 Previous Re-certification Dates: 02/04/2009; 04/27/2011; 03/15/2013; 02/24/2015; 04/18/2017; 7/12/2019; 03/05/2022 Baylor Scott and White All Saints – Fort Worth 1400 8th Avenue Fort Worth, TX 76104 5/26/2021 5/26/2024 TX 05/19/2011 04/06/2024 Other information: Joint Commission ID #8993 Previous Re-certification Dates: 08/21/2007; 08/27/2009; 10/07/2011; 11/20/2013; 11/10/2015; LA Previous Re-certification Dates: 05/28/2009; 11/09/2011; 12/12/2013; 01/05/2016; 12/12/2017; 03/12/2020; 03/10/2022 Morristown Medical Center 100 Madison Avenue Morristown, NJ 07960 06/16/2009 04/17/2024 NJ AZ Previous Re-certification Dates: 06/16/2009; 09/28/2011; 10/31/2013; 11/17/2015; 12/12/2017; 1/25/2020; 03/23/2022 02/06/2009 05/08/2024 CA 08/21/2007 04/17/2024 TX Other information: Joint Commission ID #9944 Previous Re-certification Dates: 02/06/2009; 08/09/2011; 08/13/2013; 09/15/2015; 10/06/2017; 12/04/2019; 04/09/2022 Baylor University Medical Center 3500 Gaston Avenue Dallas, TX 75246-2017 04/03/2024 Other information: Joint Commission ID #5958 Other information: Joint Commission ID #9489 Previous Re-certification Dates: 05/19/2011; 05/07/2013; 06/09/2015; 07/25/2017; 07-10-2019; 03/03/2022 Ronald Reagan UCLA Medical Center 757 Westwood Plaza Los Angeles, CA 90095 05/28/2009 Other information: Joint Commission ID # Other information: DNV ID #: 10000469761 Previous Re-certification Dates: 5/26/2021 Banner - University Medical Center Phoenix 1111 East McDowell Road Phoenix, AZ 85006 Addendum XIII: Lung Volume Reduction Surgery (LVRS) (April through June 2024) Addendum XIII includes a listing of Medicare-approved facilities that are eligible to receive coverage for lung volume reduction surgery. Until May 17, 2007, facilities that participated in the National Emphysema Treatment Trial were also eligible to receive coverage. The following three types of facilities are eligible for reimbursement for Lung Volume Reduction Surgery (LVRS): â— National Emphysema Treatment Trial (NETT) approved (Beginning 05/07/2007, these will no longer automatically qualify and can qualify only with the other programs); â— Credentialed by the Joint Commission (formerly, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)) under their Disease Specific Certification Program for LVRS; and â— 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#TopOfPage. For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Addendum XIV: Medicare-Approved Bariatric Surgery Facilities (April through June 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. 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 (BSCOE) (program standards and requirements in effect on February 15, 2006). There were no additions, deletions, or editorial changes to Medicare-approved facilities that meet CMS’ minimum facility standards for bariatric surgery that have been certified by ACS and/or ASMBS in the 3-month period. This information is available at www.cms.gov/MedicareApprovedFacilitie/BSF/list.asp#TopOfPage. For questions or additional information, contact Sarah Fulton, MHS (410-786-2749). Addendum XV: FDG-PET for Dementia and Neurodegenerative Diseases Clinical Trials (April through June 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.asp#TopOfPage. For questions or additional information, contact David Dolan, MBA (410-786-3365). [FR Doc. 2024-16040 Filed: 7/19/2024 8:45 am; Publication Date: 7/22/2024]