Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2024, 9902-9910 [2025-02787]
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[Federal Register Volume 90, Number 32 (Wednesday, February 19, 2025)] [Notices] [Pages 9902-9910] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2025-02787] [[Page 9902]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-9151-N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances--October Through December 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 number ---------------------------------------------------------------------------------------------------------------- I CMS Manual Instructions................................. Ronda Allen-Bonner............... (410) 786-4657 II Regulation Documents Published in the Federal Register. Terri Plumb...................... (410) 786-4481 III CMS Rulings........................................... Tiffany Lafferty................. (410) 786-7548 IV Medicare National Coverage Determinations.............. Wanda Belle, MPA................. (410) 786-7491 V FDA-Approved Category B IDEs............................ John Manlove..................... (410) 786-6877 VI Collections of Information............................. William Parham................... (410) 786-4669 VII Medicare-Approved Carotid Stent Facilities............ Sarah Fulton, MHS................ (410) 786-2749 VIII American College of Cardiology-National Sarah Fulton, MHS................ (410) 786-2749 Cardiovascular Data Registry Sites. IX Medicare's Active Coverage-Related Guidance Documents.. Lori Ashby, MA................... (410) 786-6322 X One-time Notices Regarding National Coverage Provisions. JoAnna Baldwin, MS............... (410) 786-7205 XI National Oncologic Positron Emission Tomography David Dolan, MBA................. (410) 786-3365 Registry Sites. XII Medicare-Approved Ventricular Assist Device David Dolan, MBA................. (410) 786-3365 (Destination Therapy) Facilities. XIII Medicare-Approved Lung Volume Reduction Surgery Sarah Fulton, MHS................ (410) 786-2749 Facilities. XIV Medicare-Approved Bariatric Surgery Facilities........ Sarah Fulton, MHS................ (410) 786-2749 XV Fluorodeoxyglucose Positron Emission Tomography for David Dolan, MBA................. (410) 786-3365 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. 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 [[Page 9903]] quarter. The publication dates of the previous four Quarterly Listing of Program Issuances notices are: January 30, 2024 (89 FR 5897), April 29, 2024 (89 FR 33356), July 22, 2024 (89 FR 59104) and November 7, 2024 (89 FR 88282). 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 (October Through December 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: https://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 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 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 A Social Determinants of Health Risk Assessment in the Annual Wellness Visit Policy Update in the Calendar Year 2024 Physician Fee Schedule Final Rule (CMS-Pub. 100-02) Transmittal No. 12865. 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 No. Manual/subject/publication No. ------------------------------------------------------------------------ Medicare General Information (CMS-Pub. 100-01) ------------------------------------------------------------------------ 12980................... Update to Medicare Deductible, Coinsurance and Premium Rates for Calendar Year (CY) 2025. 13880................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 13881................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 13883................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 13884................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 13885................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. ------------------------------------------------------------------------ Medicare Benefit Policy (CMS-Pub. 100-02) ------------------------------------------------------------------------ 12860................... Technical Revision Only to the Medicare Benefit Policy (MBP) Manual, Publication (Pub) 100-02, Chapter 15, section 50.4.2 Unlabeled Use of Drug. 12865................... A Social Determinants of Health Risk Assessment in the Annual Wellness Visit Policy Update in the Calendar Year 2024 Physician Fee Schedule Final Rule. 12999................... Implementation of Changes in the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Payment for Dialysis Furnished for Acute Kidney Injury (AKI) in ESRD Facilities for Calendar Year (CY) 2025. 13003................... Revisions to Medicare Part B Coverage of Pneumococcal Vaccinations for the Medicare Benefit Policy Manual Chapter 15, Section 50.4.4.2. 13011................... Updates to No Legal Obligation to Pay for or Provide Services and Examples of Application of Government Entity Exclusion (Pub. 100-02, chapter 16, sections 40 and 50.3.3 and newly created section 40.7) and Claims Submitted for Items or Services Furnished to Medicare Beneficiaries in State or Local Custody Under a Penal Authority (Pub. 100-04, chapter 1, section 10.4). ------------------------------------------------------------------------ [[Page 9904]] Medicare National Coverage Determination (CMS-Pub. 100-03) ------------------------------------------------------------------------ 12868................... Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Myelodysplastic Syndromes (MDS) National Coverage Determination (NCD) 110.23 12987................... National Coverage Determination (NCD) 210.15-- Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Prevention. ------------------------------------------------------------------------ Medicare Claims Processing (CMS-Pub. 100-04) ------------------------------------------------------------------------ 12864................... October 2024 Update of the Ambulatory Surgical Center [ASC] Payment System. 12865................... A Social Determinants of Health Risk Assessment in the Annual Wellness Visit Policy Update in the Calendar Year 2024 Physician Fee Schedule Final Rule. 12868................... Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Myelodysplastic Syndromes (MDS) National Coverage Determination (NCD) 110.23. 12869................... Fiscal Year (FY) 2025 Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) PPS Changes. 12870................... Medicare Part A Skilled Nursing Facility (SNF) Prospective Payment System (PPS) Pricer Update Fiscal Year (FY) 2025. 12883................... Update to the Internet Only Manual (IOM) Publication (Pub.) 100-04, Chapter 18 Section 170.1 and Chapter 32 Section 340.2 for Coding Revisions to the National Coverage Determinations (NCDs)--January 2025 Change Request (CR) 13706. 12886................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 12887................... Correction to Editing for Inpatient Part B Ancillary 12X Claims When Part A Benefits Exhaust and Manual Updates for Billing of Inpatient Pre-Entitlement Days. 12889................... Allowing Home Health (HH) Telehealth Services During an Inpatient Stay. 12890................... Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction. 12895................... 2025 Annual Update of Per-Beneficiary Threshold Amounts. 12896................... Ambulance Inflation Factor (AIF) for Calendar Year (CY) 2025 and Productivity Adjustment. 12909................... Corrections to Change Request (CR) 7270-- Changes to the Time Limits for Filing Medicare Fee For Service Claims. 12910................... Calendar Year (CY) 2025 Participation Enrollment and Medicare Participating Physicians and Suppliers Directory (MEDPARD) Procedures. 12911................... Home Health Prospective Payment System (HH PPS) Rate Update for Calendar Year (CY) 2025. 12914................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 12915................... Expanding the Number of Home Health (HH) Period of Care Records--Analysis Only. 12923................... Calendar Year (CY) 2025 Home Infusion Therapy (HIT) Payment Rates and Instructions for Retrieving the January 2025 Home Infusion Therapy (HIT) Services Payment Rates Through the CMS Mainframe Telecommunications System. 12926................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 12931................... File Conversions Related to the Spanish Translation of the Healthcare Common Procedure Coding System (HCPCS) Descriptions. 12934................... Medicare Change of Status Notice (MCSN) Manual Instructions. 12935................... New Waived Tests. 12936................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 12945................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 12948................... Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Myelodysplastic Syndromes (MDS) National Coverage Determination (NCD) 110.23. 12949................... National Fee Schedule for Medicare Part B Vaccine Administration CMS--January 2025''. 12950................... Update to Rural Health Clinic (RHC) All Inclusive Rate (AIR) Payment Limit for Calendar Year (CY) 2025. 12951................... Update to the Federally Qualified Health Center (FQHC) Prospective Payment System (PPS) for Calendar Year (CY) 2025. 12957................... Implementation of System Changes for the End Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury (AKI) for Calendar Year (CY) 2025. 12961................... Updates to the Publication 100-04 Claims Processing Manual in the Internet Only Manual (IOM) to Remove Obsolete Language Related to Medicare Fee-for-Service (FFS) Systems Claims Edits. 12964................... January 2025 Annual Rural Emergency Hospital (REH) Monthly Facility Payment Amount. 12967................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 12970................... Claim Status Category Codes (CSCC) and Claim Status Codes (CSC) Update. 12974................... Manual Update for Pneumococcal Vaccine for 21- Valent Conjugate Vaccine. 12975................... Summary of Policies in the Calendar Year (CY) 2025 Medicare Physician Fee Schedule (MPFS) Final Rule, Telehealth Originating Site Facility Fee Payment Amount and Telehealth Services List, CT Modifier Reduction List, and Preventive Services. 12976................... April 2025 Update to the Inpatient Prospective Payment System (IPPS) For Correction to Total Pass-Through Amounts Reported on the Provider Specific File (PSF) to Include Allogeneic Stem Cell Costs. 12977................... April 2025 Healthcare Common Procedure Coding System (HCPCS) Quarterly Update Reminder. 12978................... April 2025 Bi-Annual Update of the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10- CM). 12979................... Implementation of System Changes for the End Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury (AKI) for Calendar Year (CY) 2025. 12980................... 2025 Annual Update to the Therapy Code List. 12981................... 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. 12982................... Quarterly Update to Home Health (HH) Grouper. 12987................... Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Prevention. 12988................... Combined Common Edits/Enhancements Modules (CCEM) Code Set Update. 12990................... Update to the Internet Only Manual (IOM) Publication (Pub.) 100-04, Chapter 32 Sections 90, 190.2 and 300.2 for Coding Revisions to the National Coverage Determinations (NCDs)--April 2025 (1 of 2) Change Request (CR) 13818. 12991................... Calendar Year 2025 Update for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule. 12992................... Calendar Year (CY) 2025 Annual Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment. [[Page 9905]] 12993................... Quarterly Update for the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP)--April 2025. 12994................... April 2025 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files. 12995................... April 2025 Update to the Medicare Severity-- Diagnosis Related Group (MS-DRG) Grouper and Medicare Code Editor (MCE) Version 42.1. 12998................... Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to- Procedure (PTP) Edits, Version 31.1, Effective April 1, 2025. 13002................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 13010................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 13011................... Updates to No Legal Obligation to Pay for or Provide Services and Examples of Application of Government Entity Exclusion (Pub. 100-02, chapter 16, sections 40 and 50.3.3 and newly created section 40.7) and Claims Submitted for Items or Services Furnished to Medicare Beneficiaries in State or Local Custody Under a Penal Authority (Pub. 100-04, chapter 1, section 10.4). 13012................... Internet Only Manual (IOM) Update to 100-04 Chapter 12, Section 30.5--Payment for Codes for Chemotherapy Administration and Nonchemotherapy Injections and Infusions. 13019................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 13025................... Update to the Internet Only Manual (IOM) Publication (Pub.) 100-04, Chapter 18 Section 60.3 and Chapter 32 Sections 11.3.5, 60.4.1, 60.5.2, 320.2 and 412.1 for Coding Revisions to the National Coverage Determinations (NCDs)--April 2025 (2 of 2) Change Request (CR) 13828. 13026................... Billing Instructions Related to Expedited Determinations Based on Medicare Change of Status Notifications (MCSNs). ------------------------------------------------------------------------ Medicare Secondary Payer (CMS-Pub. 100-05) ------------------------------------------------------------------------ 12880................... Changes to The Electronic Correspondence Referral System (ECRS) to Remove the Drug Supplemental Type `O' (Other) as a Valid Option from Batch Submissions. 12891................... The Recovery and Adjustment of Medicare Claims where the Department of Veteran Affairs (VA) also Made Payment Using the Medicare Duplicate Payment (DP) Process. 13016................... Updates to the Medicare Carrier System (MCS), the Viable Information Processing Systems Medicare Systems (VMS) and the Common Working File (CWF) Processes to Capture and Further Automate the Medicare Secondary Payer (MSP) Processes. ------------------------------------------------------------------------ Medicare Financial Management (CMS-Pub. 100-06) ------------------------------------------------------------------------ 12968................... Requirements for Adjusting/Demanding and Reporting Office of the Inspector General (OIG) Identified Overpayments. 12969................... The Fiscal Intermediary Shared System (FISS) Submission of Copybook Files to the Provider and Statistical Reimbursement (PS&R) System. 13001................... The Fiscal Year 2025 Updates for the CMS Internet Only Manual (IOM) Publication (Pub.) 100-06, Medicare Financial Management Manual, Chapter 7--Internal Control Requirements. ------------------------------------------------------------------------ Medicare State Operations Manual (CMS-Pub. 100-07) ------------------------------------------------------------------------ None. ------------------------------------------------------------------------ Medicare Program Integrity (CMS-Pub. 100-08) ------------------------------------------------------------------------ 12872................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 12873................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 12985................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 12996................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 12997................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 13000................... Updates of Chapter 4 and Exhibits in Publication (Pub.) 100-08, Including the Unified Program Integrity Contractor (UPIC) and Medical Review Accuracy Contractor (MRAC) Coordination Process. 13004................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 13005................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 13006................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 13007................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 13008................... Chapter 3 Revisions (Segment 1) in Publication (Pub.) 100-08 Program Integrity Manual (PIM). 13018................... 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. ------------------------------------------------------------------------ [[Page 9906]] 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) ------------------------------------------------------------------------ 12983................... Making Care Primary (MCP) Informational Unsolicited Responses (IURs). ------------------------------------------------------------------------ One Time Notification (CMS-Pub. 100-20) ------------------------------------------------------------------------ 12862................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 12867................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 12878................... Reporting Identifiers for the Healthcare Integrated General Ledger Accounting System (HIGLAS) Payments Reported for Periodic Interim Payment (PIP) Claims. 12879................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 12881................... Tax Equity and Fiscal Responsibility Act (TEFRA) Reimbursement to Inpatient Prospective Payment System (IPPS) -Excluded Hospitals for Excess Costs Related to Providing CAR T-cell Therapy. 12882................... Implementation of a New National Uniform Billing Committee (NUBC) Condition Code ``KX'', ``Documentation on file. Requirements specified in the medical policy have been met.'' and Implementation of a New NUBC Value Code ``92'', ``Invoice Cost of Drug/Biologic. For use with Revenue Category 0636 when required by federal regulation.''. 12884................... Phase 4: Implementation to Expand Monetary Amount Fields Related to Billing and Payment to Accommodate 10-Digits in Length ($99,999,999.99). 12885................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 12889................... Correction to Pulmonary Rehabilitation Services for Indian Health Services (IHS). 12899................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 12903................... International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs)-- April 2025 (CR 1 of 2). 12904................... International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs)-- April 2025 (CR 2 of 2). 12908................... Implementation of the Award for the Jurisdiction D Durable Medical Equipment Medicare Administrative Contractor (JD DME MAC). 12916................... User Enhancement Change Request (UECR): Update the Multi-Carrier System (MCS) System Control Facility (SCF) System Element (SE) for Diagnosis Validation. 12917................... User Enhancement Change Request (UECR): Update the Summary Report--Healthcare Integrated General Ledger Accounting System (HIGLAS) 824 Status Notification Error Report (H99RJSUM). 12918................... User Enhancement Change Request (UECR): Update Multi-Carrier System (MCS) Import File Copy Request Screen. 12919................... Fiscal Intermediary Shared System (FISS)--User Enhancement Change Request (UECR)--Expand Reason Code Narrative Length. 12920................... Fiscal Intermediary Shared System (FISS)--User Enhancement Change Request (UECR)--Expand Provider Name Field on Provider Address Screen. 12921................... User Enhancement Change Request (UECR): Update Multi-Carrier System (MCS) Portal Re-Openings Negative/Zero Adjustments Report (H99RBPRZ). 12922................... Fiscal Intermediary Shared System (FISS)-- Delete Obsolete Reason Codes--Part 6. 12924................... Implementation of the Award for the Jurisdiction J (J-J) Part A and Part B Medicare Administrative Contractor (JJ A/B MAC). 12932................... Implementation of the Award for the Jurisdiction J (J-J) Part A and Part B Medicare Administrative Contractor (JJ A/B MAC). 12937................... User Enhancement Change Request (UECR): ViPS Medicare System (VMS)--Add Testing/Production Region Identifier Field on Screens. 12938................... User Enhancement Change Request (UECR): ViPS Medicare System (VMS)--Add Testing/Production Region Identifier Field on Screens. 12939................... User Enhancement Change Request (UECR): ViPS Medicare System (VMS)--Improve Processing of Capped Rental Items Billed with RT (right)/LT (left) Modifiers. 12940................... Fiscal Intermediary Shared System (FISS)-- Delete Obsolete Reason Codes--Part 5. 12941................... Updates to Allow Category II Codes to be Submitted on Rural Health Clinic (RHC) Claims. 12942................... User Enhancement Change Request (UECR): ViPS Medicare System (VMS)--Update the Quality Assurance (QA) subsystem to Automate Setting Date Ranges on the QA Selection--Date Card Screen (VMAP/2/2). 12944................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 12947................... Implementation of a New National Uniform Billing Committee (NUBC) Condition Code ``KX'', ``Documentation on file. Requirements specified in the medical policy have been met.'' and Implementation of a New NUBC Value Code ``92'', ``Invoice Cost of Drug/Biologic. For use with Revenue Category 0636 when required by federal regulation.''. [[Page 9907]] 12955................... Implementation CR--To Send Provider-Based Practice Location Types to the Fiscal Intermediary Shared System (FISS) on Provider Enrollment Chain & Ownership System (PECOS) Extract Files and for FISS to Process so Medicare Administrative Contractors (MACs) Do Not Have to Check Manually for These Locations. 12958................... Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction. 12960................... All-Inclusive Rate (AIR) Add-On Payment for High-Cost Drugs Provided by Indian Health Service (IHS) and Tribal Hospitals. 12965................... User Management in the Medicare Adjudication Portal (MAP) for 837D Dental Claims. 12973................... User Management in the Medicare Adjudication Portal (MAP) for 837D Dental Claims. 12984................... Issued to a specific audience, not posted to Internet/Intranet due to Sensitivity of Instruction. 12986................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 12989................... Phase 4: Implementation to Expand Monetary Amount Fields Related to Billing and Payment to Accommodate 10-Digits in Length ($99,999,999.99). 13009................... User Enhancement Change Request (UECR): ViPS Medicare System (VMS)--Improve Processing of Capped Rental Items Billed with RT (right)/LT (left) Modifiers. 13014................... Update to Billing Requirements for Intensive Outpatient Program (IOP) Services for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs). 13015................... Allow Payment for Healthcare Common Procedure Coding System (HCPCS) Code G2211 when Certain Part B Preventive Services are Provided on the Same Day. 13017................... Issued to a specific audience, not posted to Internet/Intranet due to Confidentiality of Instruction. 13027................... Adjustments in the Medicare Adjudication Portal (MAP) for 837D Dental Claims (Phase 2). ------------------------------------------------------------------------ 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 (July Through September 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). Addendum III: CMS Rulings (October Through December 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 https://www.cms.gov/Regulations-and-Guidance/Guidance/Rulings. For questions or additional information, contact Tiffany Lafferty (410-786-7548). Addendum IV: Medicare National Coverage Determinations (October Through December 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. Additional information on NCDs, including open NCDs and pending NCDs, can be found on the NCD Dashboard, which is posted on the CMS website at https://www.cms.gov/files/document/ncd-dashboard.pdf. For the purposes of this quarterly notice, we are providing only the specific updates to national coverage determinations (NCDs), or reconsiderations of completed NCDs published in the 3-month period. This information is available at: www.cms.gov/medicare-coverage-database/. For questions or additional information, contact Wanda Belle, MPA (410-786-7491). [[Page 9908]] ---------------------------------------------------------------------------------------------------------------- Title NCDM section Transmittal No. Issue date Effective date ---------------------------------------------------------------------------------------------------------------- National Coverage Determination (NCD) 210.15 12987 12/05/2024 04/07/2025 210.15--Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Prevention................................. ---------------------------------------------------------------------------------------------------------------- Addendum V: FDA-Approved Category B Investigational Device Exemptions (IDEs) (October Through December 2024) (Inclusion of this addenda is under discussion internally.) Addendum VI: Approval Numbers for Collections of Information (October Through December 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 (October Through December 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: https://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 (October Through December 2024) The initial data collection requirement through the American College of Cardiology's National Cardiovascular Data Registry (ACC- NCDR) 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 (October Through December 2024) CMS published three final guidance documents on August 7, 2024, 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: Coverage with Evidence Development: https://www.cms.gov/medicare-coverage-database/view/medicare-coverage-document.aspx?mcdid=38. CMS National Coverage Analysis Evidence Review: https://www.cms.gov/medicare-coverage-database/view/medicare-coverage-document.aspx?mcdid=37. Clinical Endpoints Guidance: Knee Osteoarthritis: https://www.cms.gov/medicare-coverage-database/view/medicare-coverage-document.aspx?mcdid=36. For questions or additional information, contact Lori Ashby, MA (410 786 6322). Addendum X: List of Special One-Time Notices Regarding National Coverage Provisions (October Through December 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). Addendum XI: National Oncologic PET Registry (NOPR) (October Through December 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 https://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 (October Through December 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 [[Page 9909]] for VADs implanted as destination therapy. For the purposes of this quarterly notice, we are providing only the specific updates to the list of Medicare-approved facilities that meet our standards that have occurred in the 3-month period. This information is available at https://www.cms.gov/MedicareApprovedFacilitie/VAD/list.asp#TopOfPage. For questions or additional information, contact David Dolan, MBA, (410-786-3365). ---------------------------------------------------------------------------------------------------------------- Provider Date of initial Date of re- Facility No. certification certification State ---------------------------------------------------------------------------------------------------------------- The following are new facilities ---------------------------------------------------------------------------------------------------------------- The Valley Hospital, 4 Valley Health Plaza, 310012 09/04/2024 n/a NJ Paramus, NJ 07652; Other information: DNV ID #: C701535; Previous Re-certification Dates: n/a. Saint Francis Hospital, 6161 South Yale 370091 09/10/2024 n/a OK Avenue, Tulsa, OK 74136; Other information: DNV ID #: C675228; Previous Re-certification Dates: n/a. East Jefferson General Hospital, 4200 Houma 190176 11/12/2024 n/a LA Blvd., Metairie, LA 70006; Other information: DNV ID #: C694266; Previous Re-certification Dates: n/a. Cooper University Hospital, 1 Cooper Plaza, 31-0014 11/14/2024 n/a NJ Camden, NJ 08103; Other information: DNV ID #: C653305; Previous Re-certification Dates: n/a. ---------------------------------------------------------------------------------------------------------------- The following facilities have editorial changes (in bold) ---------------------------------------------------------------------------------------------------------------- Ascension Seton, 1201 West 38th Street, 450056 03/06/2009 07/17/2024 TX Austin, TX 78705-1056; Other information: Joint Commission ID #8939; Previous Re- certification Dates: 03/06/2009; 07/15/ 2011; 09/04/2013; 10/20/2015; 10/03/2017; 10/23/2019; 04/13/2022. Lehigh Valley Hospital, 1200 S Cedar Crest 390133 10/29/2013 07/31/2024 PA Boulevard, Allentown, PA 18105; Other information: Joint Commission ID #4880; Previous Re-certification Dates: 10/29/ 2013; 11/10/2015; 12/12/2017; 03/04/2020; 05/28/2022. Mount Sinai Hospital, One Gustave L. Levy 330024 11/25/2008 08/14/2024 NY Place, New York, NY 10029-6574; Other information: Joint Commission ID #5829; Previous Re-certification Dates: 11/25/ 2008; 02/08/2011; 03/20/2013; 03/31/2015; 06/08/2017; 08/07/2019; 03/23/2022. UPMC Presbyterian Shadyside, 200 Lothrop 390164 06/10/2008 08/14/2024 PA Street, Pittsburgh, PA 15213; Other information: Joint Commission ID #6169; Previous Re-certification Dates: 06/10/ 2008; 05/21/2010; 04/12/2012; 03/25/2014; 04/13/2016; 03/20/2018; 12/09/2020; 06/03/ 2022. Advocate Christ Medical Center, 4440 W 95th 140208 09/28/2015 10/01/2024 IL Street, Oak Lawn, IL 60453; Other information: DNV ID #: 10000504196-MSC-DNV- USA; Previous Re-certification Dates: 9/28/ 2015; 10/01/2018; 10/21/2021. University of Texas Medical Branch, 301 450018 01/31/2012 08/28/2024 TX University Blvd., Galveston, TX 77555; Other information: Joint Commission ID #9058; Previous Re-certification Dates: 01/ 31/2012; 01/28/2014; 02/23/2016; 01/30/ 2018; 10/08/2020; 06/08/2022. University of California, Davis Medical 050599 10/06/2015 09/18/2024 CA Center, 2315 Stockton Boulevard, Sacramento, CA 95817; Other information: Joint Commission ID #10055; Previous Re- certification Dates: 10/06/2015; 02/06/ 2018; 12/10/2020; 09/14/2022. Carolinas Medical Center, 1000 Blythe 340113 05/11/2010 09/11/2024 NC Boulevard, Charlotte, NC 28232; Other information: Joint Commission ID #6480; Previous Re-certification Dates: 05/11/ 2010; 05/11/2012; 04/22/2014; 04/12/2016; 04/24/2018; 12/17/2020; 08/03/2022. MedStar Washington Hospital Center, 110 090011 04/22/2008 11/06/2024 DC Irving St. NW, Washington, DC 20010; Other information: Joint Commission ID #6308; Previous Re-certification Dates: 04/22/ 2008; 04/06/2010; 03/23/2012; 03/04/2014; 05/03/2016; 05/22/2018; 12/17/2020; 07/08/ 2022. WellSpan York Hospital, 1001 South George 390046 11/19/2013 09/11/2024 PA Street, York, PA 17405; Other information: Joint Commission ID #6228; Previous Re- certification Dates: 11/19/2013; 12/15/ 2015; 01/23/2018; 03/14/2020; 06/18/2022. NYU Langone Hospitals, 550 First Avenue, 330214 02/14/2012 11/06/2024 NY New York, NY 10016; Other information: Joint Commission ID #5820; Previous Re- certification Dates: 02/14/2012; 01/14/ 2014; 03/08/2016; 03/27/2018; 8/26/2020; 07/27/2022. Jersey Shore University Medical Center, 310073 10/16/2018 09/17/2024 NJ 1945 Corlies Avenue, Neptune, NJ 07753; Other information: DNV ID #: C727737; Previous Re-certification Dates: 10/16/ 2018; 10/14/2021. Rochester General Hospital, 1425 Portland 33-0125 10/29/2018 09/19/2024 NY Ave., Rochester, NY 14621; Other information: DNV ID #: C729533; Previous Re-certification Dates: 10/29/2018; 10/28/ 2021. Public Health Trust of Dade County Florida 100022 10/22/2009 09/11/2024 FL dba Jackson Memorial Hospital, 1611 Northwest 12th Avenue, Miami, FL 33136- 1094; Other information: Joint Commission ID #6850; Previous Re-certification Dates: 10/22/2009; 10/21/2011; 11/06/2013; 12/08/ 2015; 12/08/2017; 3/3/2020; 05/22/2022. The Johns Hopkins Hospital, 600 N Wolfe 210009 12/11/2007 08/21/2024 MD Street, Baltimore, MD 21287; Other information: Joint Commission ID #6252; Previous Re-certification Dates: 12/11/ 2007; 12/15/2009; 11/29/2011; 12/03/2013; 01/12/2016; 02/13/2018; 10/24/2020; 06/15/ 2022. Baptist Health Medical Center--Little Rock, 040114 11/10/2009 09/11/2024 AR 9601 Baptist Health Drive, Little Rock, AR 72205-7299; Other information: Joint Commission ID #8656; Previous Re- certification Dates: 11/10/2009; 11/08/ 2011; 12/11/2013; 01/12/2016; 12/15/2017; 02/12/2020; 05/07/2022. [[Page 9910]] Summa Health, 95 Arch Street, Suite 205, 360020 11/16/2021 11/07/2024 OH Akron, OH 44304; Other information: DNV ID #: C738012; Previous Re-certification Dates: 11/16/2021. Westchester Health Care Corporation, 100 330234 11/19/2009 09/25/2024 NY Woods Road, Valhalla, NY 10595; Other information: Joint Commission ID #2518; Previous Re-certification Dates: 11/19/ 2009; 11/15/2011; 12/03/2013; 12/08/2015; 12/19/2017; 03/07/2020; 06/30/2022. Scott & White Memorial Hospital, 2401 S 450054 12/07/2011 09/06/2024 TX 31st St., Temple, TX 76508-0001; Other information: Joint Commission ID #9241; Previous Re-certification Dates: 12/07/ 2011; 12/03/2013; 01/12/2016; 12/19/2017; 03/05/2020; 07/02/2022. ---------------------------------------------------------------------------------------------------------------- Addendum XIII: Lung Volume Reduction Surgery (LVRS) (October Through December 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):National Emphysema Treatment Trial (NETT) approved (Beginning 05/07/2007, these will no longer automatically qualify and can qualify only with the other programs); Credentialed by the Joint Commission (formerly, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)) under their Disease Specific Certification Program for LVRS; and Medicare approved for lung transplants. Only the first two types are in the list. 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 (October Through December 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/MedicareApproved Facilitie/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 (October Through December 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/Medicare ApprovedFacilitie/PETDT/list.asp#TopOfPage. For questions or additional information, contact David Dolan, MBA (410-786-3365). [FR Doc. 2025-02787 Filed 2-18-25; 8:45 am] BILLING CODE 4120-01-P
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