Knowledge Base Category -
Medicare Transmittals & MLN Articles
May 9, 2025: MLN MM14025: New Waived Tests
FDA has approved six new waived tests under Clinical Laboratory Improvement Amendments (CLIA) that will be effective July 1, 2025.
https://www.cms.gov/files/document/mm14025-new-waived-tests.pdf
Coverage Updates
May 23, 2025: MLN MM14000: National Coverage Determination 20.36: Implantable Pulmonary Artery Pressure Sensors (IPAPS) for Heart Failure Management
For services performed on or after January 13, 2025, CMS determined the evidence is sufficient to cover IPAPS for heart failure (HF) management under Coverage with Evidence Development (CED) when provided according to an FDA market-authorized indication and indications in NCD 20.36 are met. CMS advises that your billing staff knows about the NCD, criteria for coverage, CED study criteria and claim processing requirements. https://www.cms.gov/files/document/mm14000-national-coverage-determination-2036-implantable-pulmonary-artery-pressure-sensors-heart.pdf
May 23, 2025: MLN MM13922: Qualifications for Speech-Language Pathologies Providing Outpatient Speech-Language Pathology Services
Make sure your billing staff knows about updates to the Medicare Benefit Policy Manual, Chapter 15, section 230.3 to match the regulatory provision for the qualifications of SLPs providing outpatient therapy services. The implementation and effective date for the updates was April 18, 2025. https://www.cms.gov/files/document/mm13922-qualifications-speech-language-pathologists-providing-outpatient-speech-language-pathology.pdf
Compliance Education Updates
May 2025: MLN Fact Sheet (MLN006951) Swing Bed Services Updates
This MLN Fact Sheet was updated to include the following:
- Billing Instructions for when a patient has a change of status review on their qualifying inpatient hospital stay,
- Swing bed services and the 96-hour certification requirement time exemption, and
- Home health and swing bed patients.
https://www.cms.gov/files/document/mln006951-swing-bed-services.pdf
Other Updates
May 6, 2025: OIG Brief: $17 Billion in potential cost savings could be generated if Congress takes action based on these HHS-OIG reports
This OIG notes in this brief that “some of the reports recommend legislative actions while others recommend program or process changes that Congress could address. The potential savings reflect the conditions and timeframes within the scope of each report. https://oig.hhs.gov/about-oig/hhs-oig-impact/potential-cost-savings-in-hhs-programs/potential-cost-savings-in-hhs-programs-legislative-actions/
May 19, 2025: Palmetto GBA JM Adds Low Biller Targets to Active Medical Review List
In the Medicare Fee-for-Service Payment Integrity Scorecard for the Q1 2025 reporting period, CMS noted that they are on track to begin the Low Biller program in May 2025. The Low Biller program is a modified version of Targeted Probe and Educate program which will allow the program to include more providers who may not bill enough claims of a particular service type to be included in the traditional program.
On May 19, 2025, Palmetto GBA Jurisdiction M published an updated Medical Review List. Included in the list was a new Low Biller Probe and Educate Part A review of HCPCS J9271 (Pembrolizumab (Keytruda®).
https://palmettogba.com/jma/did/btpod0a22i
May 21, 2025: CMS Strategy to Accelerate Medicare Advantage Audits
In a press release, CMS notes “the last significant recovery of MA overpayments occurred following the audit of payment year (PY) 2007, despite federal estimates suggesting MA plans may overbill the government by approximately $17 billion annually.” To address the backlog a plan has been introduced to complete all remaining Risk Adjustment Data Validation (RADV) audits for PY 2018 to PY 2024 by early 2026. Two key elements of this plan include:
- Workforce expansion: CMS increasing its team of medical coders from 40 to approximately 2,000 by September 1, 2025. These coders will manually verify flagged diagnoses to ensure accuracy, and
- Increased audit volume: By leveraging technology, CMS will be able to increase audits to all eligible MA plans (approximately 550 MA plans) and increase auditing from 35 records per health plan to between 35 and 200 records based on the size of the health plan.
May 22, 2025: MACs to Resume Short Stay Inpatient Reviews
CMS announced that “beginning September 1, 2025, the MACs will assume responsibility for conducting patient status reviews to determine the appropriateness of Part A payment for short stay inpatient hospital claims, which previously were conducted by Beneficiary and Family Centered Care (BFCC) Quality Improvement Organization (QIO) (BFCC-QIO). While this change impacts where medical records will be sent and the contractor making claim review decisions, the policy for assessing short stay inpatient admissions remains unchanged.”
Short stay inpatient admissions have been closely scrutinized by contractors since the implementation of the 2 Midnight Rule on October 1, 2013. MACs are not new to this type of review as they conducted probe and educate reviews through September 30, 2015.
The CERT also focuses on inpatient denials by length of stay. In the 2024 report, 0- or 1-day stays continued to have the highest improper payment rate of all inpatient stays at 24.3% with project improper payments of $1.7 billion.
You can find more information about this notice on the CMS.gov Inpatient Hospital Reviews webpage at https://www.cms.gov/data-research/monitoring-programs/medicare-fee-service-compliance-programs/medical-review-and-education/hospital-patient-status-reviews.
For a look back at the history of short stay review and useful downloads can be found on the CMS Inpatient Hospital Reviews webpage at https://www.cms.gov/research-statistics-data-and-systems/monitoring-programs/medicare-ffs-compliance-programs/medical-review/inpatienthospitalreviews.
May 22, 2025: CMS Fast Facts: Annual Update
CMS noted in the Thursday, May 21, 2025, edition of MLN Connects that the CMS Fast Facts have been updated to include data for 2022-2025. This data can be used as a “quick reference statistical summary for information on Medicare and Medicaid enrollment, utilization, expenditures, and Medicare provider counts. https://www.cms.gov/training-education/medicare-learning-network/newsletter/2025-05-22-mlnc#_Toc198712331
May 22, 2025: OIG Brief: Potential Cost Savings: HHS Actions
The OIG indicates in this brief that there is $50B in potential savings through recovery and payment program improvements based on their work. They cited 35 reports where they had identified this potential cost savings. The largest example of misspent funds was $783.6M that could be recovered from misspent COVID-19 Uninsured Program funds.
One example of “select reports with potential savings” is the report Medicare Could Save Millions if It Implements an Expanded Hospital Transfer Payment Policy for Discharges to Post-acute Care. Based on their sample results, the OIG “estimated that Medicare could have saved approximately $694 million, or an average of $6,470 per claim, from 2017 through 2019 if it had expanded its hospital transfer policy to include all MS-DRGs.”
May 30, 2025: HHS-OIG Fiscal Year 2026 Justification of Estimates for Congress
The OIG is requesting $454.4 million for FY 2026 with 81% of this money ($367.4 million) for oversight of Medicare and Medicaid. The OIG notes that for every $1 invested in OIG, there is an expected return of $11 in government recoveries and receivables. https://oig.hhs.gov/documents/budget/10322/FY%202026%20OIG%20CJ.pdfBeth Cobb
Medicare Transmittals & MLN Articles
March 28, 2025: Transmittal 13079: January 2025 Update of the Ambulatory Surgical Center (ASC) Payment System
Transmittal 13079 replaces Transmittal 13044 that was issued January 10, 2025. The original document has been updated to add an additional requirement and note for MACs for their work implementing the updates. All the other information remained the same. https://www.cms.gov/files/document/r13079cp.pdf
April 1, 2025: MLN MM13993: Hospital Outpatient Prospective Payment System: April 2025 Update
This article highlights coding and billing changes for certain lab tests, COVID-19 monoclonal antibody therapy products, and hospital OPPS device categories. It also highlights changes to APCs, surgical and imaging procedures, drugs, biologicals, and radiopharmaceuticals, and skin substitute products.
April 3, 2025: MLN MM13990: DMEPOS Fee Schedule: April 2025 Quarterly Update
CMS advises that your billing staff needs to know about new HCPCS codes, new fee schedule amounts, new HCPCS codes on the fee schedule file for DMEPOS repairs and servicing, complex rehabilitative power wheelchair accessories, and lymphedema compressions treatment items. https://www.cms.gov/files/document/mm13990-dmepos-fee-schedule-april-2025-quarterly-update.pdf
April 25, 2025: MLN MM14017: Ambulatory Surgical Center Payment System: April 2025 Update
CMS advised that your billing staff be aware of updates effective April 1, 2025 (i.e., a new HCPCS code for simulation angiogram for radioembolization of tumors). https://www.cms.gov/files/document/mm14017-ambulatory-surgical-center-payment-system-april-2025-update.pdf
Coverage Updates
March 19, 2025: Transcatheter Tricuspid Valve Replacement (TTVR) Final Decision Memo (CAG-00467N)
CMS now covers TTVR for the treatment of symptomatic tricuspid regurgitation (TR) under Coverage with Evidence Development (CED) when provisions in the Decision Memo are met for patient, physician, and CED study criteria. Specific to that patient, it is covered when “despite optimal medical therapy (OMT), patients must have symptomatic TR with tricuspid valve replacement being considered as appropriate by a heart team.” The heart team, at a minimum, must include a cardiac surgeon, interventional cardiologist, cardiologist with training and experience in heart failure management, electrophysiologist, multi-modality imaging specialists, and an interventional cardiographer. “All of the specialists listed above must have experience in the care and treatment of tricuspid regurgitation.” CMS also notes that “all CMS-approved CED studies must meet the patient and physician criteria. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=314&fromTracking=Y&
March 20, 2025: Change Request (CR) 13939: ICD-10 and Other Coding Revisions to National Coverage Determinations (NCDs) – July 2025
This change request provides a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to NCDs. No policy change is being made. NCDs with updates:
NCD 80.2, 80.2.1, 80.3.1: OPT Verteporfin,
NCD 90.2 Next Generation Sequencing,
NCD 100.1 Bariatric Surgery,
NCD 110.18 Aprepitant,
NCD 110.23 Stem Cell Transplants,
NCD 110.24 CAR T-cell Therapy,
NCD 160.18 Vagus Nerve Stimulation,
NCD 210.3 Colorectal Cancer Screening, and
NCD 250.3 IVIG for Treatment Autoimmune Mucocutaneous Blistering Disease.
https://www.cms.gov/files/document/r13097otn.pdf
April 3, 2025: Proposed Decision Memo (CAG-00468N) Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER)
Just under a month after the final decision memo for Transcatheter Tricuspid Valve Replacement (TTVR) was published, CMS released a proposed decision memo for T-TEER procedure. The Benefit Category for this procedure is inpatient hospital services and physicians’ services.
Abbott submitted the request for a National Coverage Analysis (NCA) to evaluate this procedure indicating that “The T-TEER procedure is intended to treat patients with symptomatic tricuspid regurgitation (TR). T-TEER procedures are performed percutaneously using a catheter-based technology to approximate the leaflets of the tricuspid valve with a clip device.
The T-TEER procedure using Abbott’s TriClip™ system was developed leveraging the experience of the MitraClip™ therapy, which is used to treat mitral valve regurgitation using transcatheter edge-to-edge repair of the mitral valve.”
The TripClip™ G4 System received FDA premarket approval on April 1, 2024 as a Breakthrough Device. This system was granted new technology eligible for add-on payment status effective October 1, 2024. The maximum add-on payment for FY 2025 is $26,000.
The ICD-10-PCS code used to describe this procedure is 02UJ3JZ (supplement tricuspid valve with synthetic substitute, percutaneous approach). This procedure groups to DRG pair 266/267 (endovascular cardiac valve replacement and supplement procedures with MCC and without MCC respectively).
The public comment period for this NCA ends May 3, 2025. https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=316
Compliance Education Updates
April 2025: MLN Booklet (MLN901705) Telehealth & Remote Patient Monitoring
CMS has updated this MLN booklet including information about some telehealth flexibilities that have been extended through September 30, 2025. https://www.cms.gov/files/document/mln901705-telehealth-remote-patient-monitoring.pdf
April 2025: MLN Educational Tool Medicare Preventive Services (MLN006559)
CMS has made changes to preventive screening for colorectal cancer and ultrasound abdominal aortic aneurysm. https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/medicare-preventive-services/MPS-QuickReferenceChart-1.html#COLO_CAN
Other Updates
March 6, 2025: Livanta Publishes Year 3 Review Findings for Higher-Weighted DRG Validation
In their February 2025 edition of “The Livanta Claims Review Advisor,” Livanta shares their higher-weighted diagnosis related groups (HWDRG) validation reviews for reviews completed from November 1, 2023 through October 31, 2024. Of the 6,447 claims found to be in error, 5,744 (10%) were a result of DRG changes and 703 (1%) were a result of failure to meet the guidelines of the Two-Midnight Rule. CMS Region 4 (AL, FL, GA, KY, MS, NC, SC, and TN) have the highest volume of claims reviewed and the highest regional error rate at 14%. For the third review cycle, sepsis DRGs (871 and 872) collectively continue to account for the highest percentage of DRGs found to be in error. Livanta posts their newsletters on their Provider Education and Toolkit webpage at https://www.livantaqio.cms.gov/en/ClaimReview/Provider/provider_education.html.Beth Cobb
Medicare Transmittals & MLN Articles
December 19, 2024: MLN MM13898: Revisions to Medicare Part B Coverage of Pneumococcal Vaccinations Policy
Make sure your billing staff knows about updated Medicare coverage requirements for pneumococcal vaccinations and changes to align with the Advisory Committee on Immunization Practices (ACIP) recommendations for pneumococcal vaccination coverage. https://www.cms.gov/files/document/mm13898-revisions-medicare-part-b-coverage-pneumococcal-vaccinations-policy.pdf
December 26, 2024: MLN MM13473: How to Use the Office & Outpatient Evaluation and Management Visit Complexity Add-on Code G2211
This MLN article was released on January 1, 2024 and updated on December 26, 2024. CMS has added information on how to use G2211 with modifier 25 for certain Medicare Part B services starting January 1, 2025. Substantive content changes are in dark red. https://www.cms.gov/files/document/mm13473-how-use-office-and-outpatient-evaluation-and-management-visit-complexity-add-code-g2211.pdf
Coverage Updates
December 12, 2024: MLN MM13843: National Coverage Determination 210.15: Pre-Exposure Prophylaxis (PrEP) for HIV Prevention
CMS advises that you make sure your billing staff knows about the national coverage of PrEP using FDA-approved antiretroviral drugs to prevent HIV, HCPCS and diagnosis codes, and billing and payment requirements. https://www.cms.gov/files/document/mm13843-national-coverage-determination-21015-pre-exposure-prophylaxis-prep-hiv-prevention.pdf
December 19, 2024: Proposed Decision Memo (CAG-00467N): Transcatheter Tricuspid Valve Replacement (TTVR)
CMS has proposed to cover TTVR under Coverage with Evidence Development (CED) for the treatment of symptomatic tricuspid regurgitation (TR) when furnished with an FDA-approved complete TTVR system, the TR is graded as at least severe and meets the coverage criteria listed in the proposed decision memo. The comment period for this proposed decision memo is from December 19, 2024 through January 18, 2025. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=314
Other Updates
December 2, 2024: Beneficiary Notices Initiative (BNI) Fee for Service Medicare Change of Status Notice (MCSN) Webpage Updated
CMS updated this webpage to provide information about this new notice and appeals process for Original Medicare beginning February 14, 2025. https://www.cms.gov/medicare/forms-notices/beneficiary-notices-initiative-bni/ffs-mcsn
December 2024: New ICD-10-PCS Codes Effective April 1, 2025
CMS announced 50 new ICD-10-PCS codes, effective April 1, 2025. Of note, 35 of the new ICD-10-PCS codes are new technology, group 10 X-codes. CMS also noted that the April 1, 2025 code update files are now available. Use these codes for discharges occurring from April 1, 2025 – September 30, 2025, and for patient encounters occurring from April 1, 2025 – September 30, 2025. https://www.cms.gov/medicare/coding-billing/icd-10-codes
December 20, 2024: Review and Decision Timeframe Update Reminder from Palmetto GBA
Palmetto GBA, the Medicare Administrative Contractor (MAC) for Jurisdictions J and M published an article reminding providers that effective January 1, 2025, CMS will reduce the timeframe requirements for MACs to provide a hospital outpatient department (OPD) prior authorization request (PAR) provisional affirmed or non-affirmed decision within seven calendar days of receipt of the request. https://www.palmettogba.com/palmetto/jja.nsf/DID/QIXFKBAMOI#ls
December 27, 2024: Proposed HIPAA Security Rule to Strengthen Cybersecurity for Electronic Protected Health Information
The Office for Civil Rights (OCR) at HHS issued a Notice of Proposed Rulemaking (NPRM) to modify the HIPAA Security Rule to strengthen cybersecurity protections for electronic protected health information (ePHI). Read about the NPRM in a related HHS Fact Sheet at https://www.hhs.gov/hipaa/for-professionals/security/hipaa-security-rule-nprm/factsheet/index.html.
Beth Cobb
Medicare Transmittals & MLN Articles
January 2, 2025: MLN Matters MM13918: Billing Instructions: Expedited Determinations Based on Medicare Change of Status Notifications
The implementation date for this new process is February 15, 2025. CMS advised that you make sure your billing staff knows about when patients are eligible to appeal a hospital status discharge, the Beneficiary and Family Centered Care (BFCC-QIO) role in the appeals process, and about claims processing based on the BFCC-QIO appeal decision. https://www.cms.gov/files/document/mm13918-billing-instructions-expedited-determinations-based-medicare-change-status-notifications.pdf
January 13, 2025: MLN MM13947: Travel Allowance Fees for Specimen Collection – 2025 Updates
Change Request (CR) 13947) revised travel allowance payment for CY 2025 when billed on a per mileage basis using HCPCS code P9603 or billed on a flat rate basis using HCPCS code P9604. Make sure your billing staff knows about the update to the CY 2025 specimen collection fees and travel allowance mileage rate, how to determine eligibility for the specimen collection fee, and know the travel allowance policies. https://www.cms.gov/files/document/mm13947-travel-allowance-fees-specimen-collection-2025-updates.pdf
January 14, 2025: MLN MM13934: Ambulatory Surgical Center Payment Update – January 2025
Make sure your billing staff knows about January payment system updates for new device categories, CPT, and HCPCS codes, drugs and biologicals, skin substitutes, and non-opioid treatments for pain relief.
January 15, 2025: MLN MM13933: Hospital Outpatient Prospective Payment System: January 2025 Update
CMS advises that you make sure your billing staff knows about January 1, 2025 coding updates, device pass-through status updates, changes to the comprehensive ambulatory payment classification, updates related to drugs, biologicals, and pharmaceuticals, and changes to the Outpatient Prospective Payment System (OPPS) Pricer logic. https://www.cms.gov/files/document/mm13933-hospital-outpatient-prospective-payment-system-january-2025-update.pdf
January 16, 2025: MLN MM13923: Payment for Medicare Part B Preventive Vaccines & Their Administration for Rural Health Clinics & Federally Qualified Health Centers
Make sure your billing staff knows that Hepatitis B vaccines are paid like other Part B preventive vaccines starting January 1, 2025, and new claim-based payments for Part B preventive vaccines and their administration are starting July 1, 2025. https://www.cms.gov/files/document/mm13923-payment-medicare-part-b-preventive-vaccines-their-administration-rural-health-clinics.pdf
Coverage Updates
January 10, 2025: National Coverage Analysis: Cardiac Contractility Modulation (CCM) for Heart Failure
The NCA issue is that despite advancements in treatment options, mortality in heart failure (HF) patients is high. “CCM is designed to treat select HF patients who continue to have persistent symptoms despite guideline-directed medical therapy (GDMT) and are ineligible for cardiac resynchronization therapy (CRT). CCM devices deliver electrical stimulation to the heart muscle to increase the strength of the heart’s contractions. CMS notes, this technology may improve symptoms, quality of life, functional capacity, and exercise tolerance.
CMS has received a formal request to provide coverage for CCM for heart failure. This is a Transitional Coverage for Emerging Technologies (TECT) pilot that tested the processes and concepts of TECT. The scope of this NCA is limited to CCM for heart failure.
The public comment period is from January 1, 2025 to February 9, 2025. https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=317
January 13, 2025: Final Decision Memo (CAG-00466N): Implantable Pulmonary Artery Pressure Sensors (IPAPS) for Heart Failure Management
In this final Decision Memo CMS indicates that they will cover IPAPA for heart failure management under coverage with evidence development when all listed patient criteria in this document are met. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=313
January 13, 2025: National Coverage Analysis (NCA CAG-0047ON) Renal Denervation for Uncontrolled Hypertension
In December 2024, Medtronic submitted a letter requesting a National Coverage Determination (NCD) for renal denervation (RDN). Medtronic’s Symplicity Spyral™ RDN System was granted premarket approval on November 17, 2023. This system is described as an option for hypertension treatment that is adjunctive to medications to help lower blood pressure.
The scope of this NCA is limited to radiofrequency and ultrasound-based denervation procedures. CMS is soliciting public comment. They are particularly interested in comments that include scientific evidence describing the role of RDN. They are also interested in health disparities and equity aspects that should be considered in this review. The public comment period ends February 12, 2025 with an expected proposed decision memo in mid- July 2025.
Of note, effective October 1, 2024, this system was approved for a new technology add-on payment in the hospital IPPS final rule. https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=318
Other Updates
January 14, 2025: CY 2025 Therapy Services Updates
CMS updated this webpage to reflect the 2025 threshold amounts for rehabilitative services. The following is a compare of 2024 and 2025 threshold amounts.
|
Calendar Year |
Physical Therapy (PT) and Speech-Language Pathology (SLP) services combined |
Occupational Therapy (OT) Services |
|
2024 |
$2,330 |
$2,330 |
|
2025 |
$2,410 |
$2,410 |
|
Source: CMS Therapy Caps webpage: https://www.cms.gov/medicare/coding-billing/therapy-services |
||
Links to more information is available in the Thursday January 16, 2025 edition of MLN Connects at https://www.cms.gov/training-education/medicare-learning-network/newsletter/2025-01-16-mlnc.
Beth Cobb
Medicare Transmittals & MLN Articles
September 5, 2024: MLN MM13784: Hospital Outpatient Prospective Payment System: October 2024 Update
This article contains updates for proprietary laboratory analyses (PLA) codes, device pass through, drugs, biologicals, and radiopharmaceuticals, skin substitutes, blood products, and other coding changes. https://www.cms.gov/files/document/mm13784-hospital-outpatient-prospective-payment-system-october-2024-update.pdf
September 5, 2024: MLN MM13880: Ambulatory Surgical Center Payment Update – October 2024
This MLN article provided payment system updates for October for new CPT and HCPCS codes, drugs and biologicals, and skin substitutes.
September 18, 2024: MLN MM13734: Inpatient & Long-Term Care Hospital Prospective Payment Systems: FY 2025 Changes – Revised
This article, originally published on August 29, 2024, was updated on September 18, 2024. CMS corrected the number of deleted and total MS-DRGs for FY 2025 and updated the Change Request (CR) link. https://www.cms.gov/files/document/mm13734-inpatient-long-term-care-hospital-prospective-payment-system-fy-2025-changes.pdf
Coverage Updates
September 10, 2024: Final Rule to Amend the Mammography Quality Standards Act (MQSA)
On March 10, 2023, the FDA issued the final rule to amend the MQSA regulations. Facilities subject to the MQSA must comply with all applicable requirements, including the breast density notification, no later than September 10, 2024. https://www.fda.gov/radiation-emitting-products/mammography-quality-standards-act-and-program/important-information-final-rule-amend-mammography-quality-standards-act-mqsa
September 11, 2024: Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure consequent to COPD
CMS received a request for reconsideration of National Coverage Determination (NCD) 280.1, to establish coverage policies for the use of noninvasive home mechanical ventilators and respiratory assist devices for Medicare beneficiaries with various respiratory conditions. CMS accepted the request for the indication of chronic obstructive pulmonary disease and will develop a new NCD section.
CMS is soliciting public comment relevant to the requester. They are particularly interested in comments that include scientific evidence, specifically any peer-reviewed literature, which describes the role of BPAP or HMVs in the home management of chronic respiratory failure in patients with COPD. They are also interested in aspects of health disparities and health equity that should be considered in the review. The comment period ends October 11, 2024. https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=315
September 30, 2024: Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent Human Immunodeficiency Virus (HIV) Infection: Final Decision Memo
After considering public comments, CMS is expanding coverage from their proposed decision and will cover PrEP using antiretroviral drugs approved by the FDA to prevent HIV in individuals at increased risk of HIV Acquistion. This determination is made by the physician or health care practitioner who assesses the individual’s history. CMS also covers furnishing HIV PrEP using antiretroviral drugs, including the supplying, or dispensing of these drugs and the administration of injectable PrEP. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=310&fromTracking=Y&
Compliance Education Updates
MLN Booklet MLN906765: Items and Services Not Covered Under Medicare – Revised
CMS updates this MLN booklet in July to add language about dental coverage exceptions. Substantive content changes are in dark red. https://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnproducts/downloads/items-and-services-not-covered-under-medicare-booklet-icn906765.pdf
Other Updates
September 4, 2024: CMS Issues Request for Information on Potential Consolidation of Some Medicare Administrative Contractor Jurisdictions
In the September 6, 2024 edition of the CMS Round Up, CMS indicated they had issued a request for information on September 4th to obtain feedback from the industry and the public about the potential consolidation of four Medicare Administrative Contractor (MAC) jurisdictions into two, as well as to obtain input on extending MAC contracts to 10 years. https://www.cms.gov/newsroom/cms-round-up/cms-roundup-september-6-2024
September 4, 2024: MLN Connects Hospital Price Transparency: Use a CMS Template Layout
CMS published the following information in the Thursday, September 4th edition of MLN Connects
“As of July 1, 2024, hospitals must conform to a CMS template layout and data specifications for making public their standard charge information in a comprehensive machine-readable file (MRF). Starting January 1, 2025, you’re also required to encode additional elements.
We have resources to help you meet these new requirements:
- Visit the Data Dictionary GitHub Repository to access the CMS templates and data dictionary with technical instructions for encoding your required standard charge information
- Use the Online Validator Tool to check that your MRF complies with the CMS template layout and data encoding requirements
Hospital Price Transparency regulations require each hospital operating in the U.S. to publish a comprehensive MRF with the standard charges for all items and services they provide.
More information:
- Register for the October 21 webinar on meeting the upcoming January 2025 requirements.
- Email questions to PriceTransparancyHospitalCharges@cms.hhs.gov”
September 12, 2024: Rural Emergency Hospitals Provisions, Conversion Process, & Conditions of Participation: Revised
CMS announced in the Thursday, September 12th edition of MLN Connects that they have released guidance on the enrollment and conversion process for eligible facilities interested in participating in the Medicare and Medicaid programs as a rural emergency hospital. https://www.cms.gov/training-education/medicare-learning-network/newsletter/2024-09-12-mlnc
You can learn more about REHs on the CMS REH webpage at https://www.cms.gov/medicare/health-safety-standards/quality-safety-oversight-guidance-laws-regulations/hospitals/rural-emergency-hospitals
September 26, 2024: CMS Memorandum: Compliance with Residents’ Rights Requirements related to Nursing Home Residents’ Right to Vote
CMS issued this memorandum to affirm the regulatory expectations that ensures nursing home residents have the unimpeded ability to exercise their right to vote as a citizen of the United States. https://www.cms.gov/files/document/qso-24-21-nh.pdf
September 30, 2024: Order Your 4 Free At-home COVID-19 Tests
The federal government is once again providing free at-home COVID-19 tests. Each household is eligible to receive four at-home test kits. They began shipping for free September 30th through the US Postal Service. To order your tests go to https://covidtests.gov/.
Beth Cobb
CMS published details about this five-year mandatory model as part of the FY 2025 IPPS and LTCH PPS Final Rule. CMS indicates that it will incentivize coordination between care providers during a surgery as well as the services provided during the 30 days after surgery with the aim of:
- Improving the quality of care of people with Medicare undergoing certain surgical procedures;
- reducing hospitalization and recovery time;
- lowering Medicare spending; and
- driving equitable outcomes.
The model is set to start in January 2026 and end in December 2030.
TEAM Participation
All acute care hospitals, with limited exceptions, located within the mandatory Core-Based Statistical Areas (CBSAs) that CMS selected will be required to participate in TEAM.
CMS will allow a one-time opportunity for hospitals that participate until the last performance period in the BPCI Advanced model or CJR model, that are not located in a mandatory CBSA to voluntarily opt into TEAM.
A final list of the selected mandatory CBSAs is available in the FY 2025 IPPS Final Rule Table X.Z.-05: Final List of CBSAs for Selection into TEAM
TEAM Episode
An Episode will include non-excluded Medicare Parts A and B items and services and would begin with an anchor hospitalization or anchor procedure and will end 30 days after hospital discharge.
The following table is available in the final rule and provides the specific TEAM episode categories and related billing codes.
|
Episode Category |
Billing Codes (MS-DRG/HCPCS) |
|
Lower Extremity Joint Replacement (LEJR) |
MS-DRG: 469, 470, 521, 522 HCPCS: 27447, 27130, 27702 |
|
Surgical Hip and Femur Fracture Treatment (SHFFT) |
MS-DRG: 480, 481, 482 |
|
Coronary Artery Bypass Graft Surgery (CABG) |
MS-DRG: 231, 232, 233, 234, 235, 236 |
|
Spinal Fusion |
MS-DRG: 402, 426, 427, 428, 429, 430, 447, 448, 450, 451, 471, 472, 473 HCPCS: 22551, 22554, 22612, 22630, 22633 |
|
Major Bowel Procedure |
MS-DRG: 329, 330, 331 |
|
Source: Table X.A.-08: Final Team Episode and Billing Categories in FY 2025 IPPS Final Rule |
|
Billing Medicare
TEAM participants will continue to bill Medicare FFS for services furnished to Medicare FFS beneficiaries. However, the TEAM participant may also receive a reconciliation payment amount from CMS depending on their Composite Quality Score (CQS) and if their performance year spending is less than their reconciliation target price.
Participants may also owe CMS a repayment amount, subject to their quality performance adjustment, if their spending is above the reconciliation target price.
Target Prices will be based on 3 years of baseline data, prospectively trended forward to the relevant performance year, and calculated at the level of MS-DRG/HCPCS episode type and region.
The Target Prices will include a discount factor, a normalization factor, a retrospective trend adjustment factor, and a beneficiary and provider level risk-adjustment.
Moving Forward
Determine if your hospital is in one of the selected mandatory CBSA. If your hospital will be part of this model, you can find additional information and resources available on the CMS Innovation Center’s TEAM webpage at:https://www.cms.gov/priorities/innovation/innovation-models/team-model
Resource
CMS FY 2025 IPPS Final Rule webpage: https://www.cms.gov/medicare/payment/prospective-payment-systems/acute-inpatient-pps/fy-2025-ipps-final-rule-home-page
Beth Cobb
May 28, 2024: CMS Updates to Include Marriage and Family Therapists and Mental Health Counselors for Hospice, Rural Health Clinics, and Federally Qualified Health Centers
In the memorandum summary sent to State Survey Agency Directors, CMS notes the CY 2024 PFS final rule updated the Hospice Conditions of Participation, the Rural Health Clinic (RHC) Conditions for Certification, and the Federally Qualified Health Center (FQHC) Conditions for Coverage to implement provisions of the Consolidated Appropriations Act, 2023.
For Hospices: The interdisciplinary team must now include at least one social worker, marriage and family therapist or mental health counselor as part of the team. The hospice personnel requirements were updated to add these disciplines.
For RHCs and FQHCs: Staffing and personnel requirements were updated to include marriage and family therapists and mental health counselors as part of the collaborative team approach to providing services. Also, definitions of several health care professionals who are already eligible to provide services at RHCs and FQHCs were updated, including the definition of “nurse practitioner,” to align with current standards of professional practice. https://www.cms.gov/files/document/qso-24-12-hospice-fqhc/rhc.pdf
Comprehensive Error Rate Testing Program: Reduced Sample Size Starting Reporting Year (RY) 2025
The CERT selects a stratified random sample of Part A/B claims submitted to the Medicare Administrative Contractors (MACs). The sample size allows CMS to calculate a national improper payment rate and contractor-and-service-specific improper payment rates. The sample size is considered to reflect all claims processed by the Medicare FFS program in the report period. CMS recently announced that beginning with the RY 2025, the sample size will be permanently reduced from 50,000 to 37,500 claims annually. CMS notes on their CERT webpage that “it is important to note that the improper payment rate is not a “fraud rate,” but is a measurement of payments that did not meet Medicare requirements.”
June 7, 2024: FDA Approves Expanded Age Indication for GSK’s Arexvy
GSK noted in their announcement that “over 13 million US adults aged 50-59 have a medical condition that increased their risk of RSV outcomes.” Further, the US FDA has approved Arexvy (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years who are at increased risk for example, adults with COPD, asthma, heart failure and/or diabetes.
- June 7, 2024 FDA Letter to GlaxoSmithKline (GSK) Biologicals: https://www.fda.gov/media/179248/download?attachment=&utm_medium=email&utm_source=govdelivery
June 10, 2024: OIG Semiannual Report to Congress
OIG released their semiannual report for the 6-month period ending March 31, 2024. Inspector General Christi A. Grim notes that OIG used experts and authorities, highly developed data analysis techniques, and strong partnerships with other law enforcement and oversight entities, OIG identified $2.76 billion in expected recoveries and issued 195 recommendations and completed 60 audits and 18 evaluations in this reporting period. Inspector General Grim went on to indicate that OIG’s health care work consistently yields a positive return on investment of around $10 returned to every $1 invested. https://oig.hhs.gov/documents/sar/9905/Spring_2024_SAR.pdf
June 11, 2024: Long COVID Defined
The National Academies of Sciences, Engineering, and Medicine (NASEM) released a new definition for “Long COVID” – “that it is an infection-associated chronic condition that occurs after COVID-19 infection and is present for at least three months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems.” https://www.nationalacademies.org/news/2024/06/federal-government-clinicians-employers-and-others-should-adopt-new-definition-for-long-covid-to-aid-in-consistent-diagnosis-documentation-and-treatment
June 20, 2024 MLN Connects: Watch out for Medicare Record Request Phishing Scam
CMS notes they have identified phishing scams for medical records. In the June 20th edition of MLN Connects they provide an example, signs of a scam to look for in a request. https://www.cms.gov/training-education/medicare-learning-network/newsletter/2024-06-20-mlncBeth Cobb
Medicare MLN Articles
May 23, 2024: MLN MM13620: HCPCS Codes & Clinical Laboratory Improvement Amendments Edits: October 2024
This article reviews discontinued HCPCS codes, new HCPCS codes, and HCPCS codes subject to and excluded from CLIA edits as of October 1, 2024. https://www.cms.gov/files/document/mm13620-hcpcs-codes-clinical-laboratory-improvement-amendments-edits-october-2024.pdf
June 3, 2024: MLN MM13632: Hospital Outpatient Prospective Payment System: July 2024 Update
Make sure your billing staff knows about payment system updates for July including new CPT and HCPCS codes, covered devices for OPPS pass-through payments, drugs, biologicals and radiopharmaceutical, and skin substitutes.
June 13, 2024: MLN MM13658: DMEPOS Fee Schedule: July 2024 Quarterly Update
In this article you will find updates to CY 2024 fee schedule amounts for certain DMEPOS codes and information in changes in payment policy and new fee schedule information for HCPCS codes K1007 and E2298.
https://www.cms.gov/files/document/mm13658-dmepos-fee-schedule-july-2024-quarterly-update.pdf
June 13, 2024: MLN MM13656: Ambulatory Surgical Center Payment Update – July 2024
This article includes July updates for new CPT and HCPCS codes, coverage of Elios System for patients with primary open-angle glaucoma, and information about skin substitutes.
https://www.cms.gov/files/document/mm13656-ambulatory-surgical-center-payment-update-july-2024.pdf
June 13, 2024: MLN MM13651: Medicare Benefit Policy Manual Update: DMEPOS Benefit Category Determinations
This article highlights updates to Section 110.8, Medicare Benefit Policy Manual, Chapter 15, and information about added DMEPOS items and their national benefit category determination (BCDs).
Coverage Updates
May 24, 2024: MLN MM13598: National Coverage Determination 200.3: Monoclonal Antibodies for the Treatment of Alzheimer's Disease
Make sure your billing staff knows about FDA-approved monoclonal antibodies, criteria for coverage, coding information, and claims processing instructions. https://www.cms.gov/files/document/mm13598-national-coverage-determination-2003-monoclonal-antibodies-treatment-alzheimers-disease.pdf
June 20, 2024: National Coverage Analysis (NCA): Transcatheter Tricuspid Valve Replacement (TTVR)
CMS notes that TTVR is a new technology for use in treating tricuspid regurgitation (TR) and they have received a formal request to provide coverage for the EVOQUE tricuspid valve replacement system (EVOQUE system). This NCA will focus on clinical indications for use of TTVR among Medicare beneficiaries. The public comment period for this NCA is from June 20, 2024, to July 20, 2024. https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=314
June 25, 2024: NCA: Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent Human Immunodeficiency Virus (HIV) Infection
CMS updated this NCA noting that they released a Technical Frequently Asked Questions for Pharmacies. In response feedback, this document provides technical detail following the previous posting of the fact sheet on April 15, 2024. CMS also noted the final NCD is expected to be similar to the proposed published July 12, 2023, and pharmacies should prepare not to ready for this transition. They are sharing as much information as possible before issuing the final NCD to avoid disruptions for beneficiaries. https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=310&ncacaldoctype=all&status=all&sortBy=status&bc=17
Compliance Education Updates
May 2024: MLN006559: Medicare Preventive Services
This MLN educational tool was revised in May to update the applicable codes for Hepatitis C screening. This tool includes helpful information related to HCPCS & CPT codes, ICD-10 codes, what Medicare covers, the frequency of screening, what the patient pays and additional miscellaneous notes. You will also find applicable coverage requirements when one has been published for the preventive service (i.e., for bone mass measurement you will find a link to national coverage determination 150.3: Bone (Mineral) Density Studies. https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/medicare-preventive-services/MPS-QuickReferenceChart-1.html#BONE_MASS
Beth Cobb
Coverage Updates
April 30, 2024: New National Coverage Analysis (NCA)Tracking Sheet for Implanted Pulmonary Artery Pressure Sensor for Heart Failure Management (CAG-00466N)
CMS posted a National Coverage Analysis (NCA) Tracking Sheet regarding a request from Abbott to provide coverage for the CardioMEMS™ HF System. This device measures Pulmonary artery (PA) pressures by using a combination of an implantable PA pressure sensor and a remote hemodynamic monitoring system that is accessible by the physician. CMS is soliciting public comment until May 30, 2024 and has indicated a proposed Decision Memo due date of October 30, 2024. https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=313
May 2, 2024: CMS Statement on Proposed LCD for Skin Substitute Grafts/Cellular and Tissue-Based Products for Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
CMS notes in the May 2, 2024 edition of MLN Connects that they are aware of the MACs having issued a collaborative proposed Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers Local Coverage Determination (LCD). CMS strongly encourages interested parties to provide comments during the public comment period that is open until June 8, 2024.
May 10, 2024: MLN MM13596: ICD-10 & Other Coding Revisions to National Coverage Determinations: October 2024 Update
This article highlights new codes and recent coding changes related to the Next Generation Sequencing (NGS) (NCD 90.2), Bariatric Surgery for Treatment of Co-Morbid Conditions Related to Morbid Obesity (NCD 100.1), and the Aprepitant for Chemotherapy-Induced Emesis (NCD 110.18). https://www.cms.gov/files/document/mm13596-icd-10-other-coding-revisions-national-coverage-determinations-october-2024-update.pdf
May 13, 2024: MLN MM13604: National Coverage Determination 110.23: Allogeneic Hematopoietic Stem Cell Transplantation
Make sure your billing staff knows about coverage for HSCT using bone marrow, peripheral blood or umbilical cord blood stem cell products for Medicare patients and all other indications for stem cell transplantation not otherwise specified. https://www.cms.gov/files/document/mm13604-national-coverage-determination-11023-allogeneic-hematopoietic-stem-cell-transplantation.pdf
Compliance Education Updates
May 2024: MLN Fact Sheet: Swing Bed Services
CMS has updated this fact sheet to include information about covered Critical Access Hospital (CAH) swing bed services. https://www.cms.gov/files/document/mln006951-swing-bed-services.pdf
Other Updates
May 9, 2024: CMS Publication – Part B Drug Payment Limits Overview
In the Thursday, May 9th edition of MLN Connects, CMS noted they have published a Part B Drug Payment Limits Overview document to explain the Average Sales Price (ASP) payment limit calculation and other Medicare Part B drug payment methodologies including Wholesale Acquisition Cost (WAC), Average Wholesale Price (AWP), Average Manufacturer Price (AMP), Widely Available Market Price (WAMP), and Contractor Pricing.
May 9, 2024: Mental Health: It’s Important at Every Stage of Life
Also in the Thursday, May 9th edition of MLN Connects, CMS noted that mental and physical health are equally important components of overall health, and they provide links to information about appropriate preventive services and preventive services (i.e. Medicare & Mental Health Coverage) covered by Medicare.
May 21, 2024: CMS Launches New Option for Individuals to Report Potential Violations of the Emergency Medical Treatment and Labor Act (EMTALA)
CMS announced the launch of a new web resource to educate the public and promote patients’ access to emergency medical care to which they are entitled under federal law. https://www.cms.gov/newsroom/press-releases/biden-harris-administration-launches-new-option-report-potential-violations-federal-law-and-continue
Beth Cobb
Medicare Transmittals & MLN Articles
April 25, 2024: MLN MM13449: Stay of Enrollment – Revised
This article provides information about a new provider enrollment status called a stay of enrollment and related updates to the Medicare Program Integrity Manual, Chapter 10. On April 25th, CMS reissued this article to revise the effective and implementation dates to May 30, 2024 and the web address of Change Request (CR) 13449. https://www.cms.gov/files/document/mm13449-stay-enrollment.pdf
May 3, 2024: MLN MM13487: Diabetes Screening & Definitions Update: CY 2024 Physician Fee Schedule Final Rule
CMS advises providers to make sure your billing staff knows about the revised regulatory definition of diabetes, the revised diabetes screening frequency limitations, and coverage of the Hemoglobin A1C (HbA1c) test for diabetes screening.
Prior to January 1, 2024 the HbA1C test (HCPCS code 83036) was covered for the purpose of diabetes management but not for diabetes screening. As of January 1, 2024, CMS now covers the HbA1c test for diabetes screening. https://www.cms.gov/files/document/mm13487-diabetes-screening-definitions-update-cy-2024-physician-fee-schedule-final-rule.pdf
May 3, 2024: MLN MM13486: Annual Wellness Visit: Social Determinants of Health Risk Assessment
Make sure your billing staff knows that the social determinants of health (SDOH) risk assessment is now an optional annual wellness visit (AWV) element and what the eligibility and billing requirements are for completing the SDOH risk assessment as part of the AWV. https://www.cms.gov/files/document/mm13486-annual-wellness-visit-social-determinants-health-risk-assessment.pdf
May 3, 2024: MLN MM13592: Updates for Split or Shared Evaluation & Management Visits
Information in this article for your billing staff include the definition of split or shared visit and substantive portion, and how to bill appropriately for split or shared evaluation and management (E/M) visits. https://www.cms.gov/files/document/mm13592-updates-split-or-shared-evaluation-management-visits.pdf
May 9, 2024: MLN MM13608: ESRD Prospective Payment System Quarterly Update
Make sure your billing staff knows about the Transitional Drug Add-On Payment Adjustment (TDAPA) for HCPCS code J0911 and the updated list of outlier services under the ESRD PPS. https://www.cms.gov/files/document/mm13608-esrd-prospective-payment-system-quarterly-update.pdf
May 16, 2024: MLN MM13617: Medicare Claims Processing Manual Update: Gap-Filling DMEPOS Fees
Make sure your billing staff knows about the revised Section 60.3 in the Medicare Claims Processing Manual, Chapter 23 and updated factors for gap-filling purposes.
May 23, 2024: MLN MM13598: NCD 200.3 – Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease (AD)
This article includes information about FDA-approved monoclonal antibodies, the criteria for coverage, coding information, and claims processing instructions. https://www.cms.gov/files/document/mm13598-national-coverage-determination-2003-monoclonal-antibodies-treatment-alzheimers-disease.pdf
May 24, 2024: MLN MM13613: Clinical Laboratory Fee Schedule & Laboratory Services Reasonable Charge Payment: Quarterly Update
This article was initially released on May 3rd, 2024 with guidance from CMS to make sure your billing staff know that the next private payor data reporting period of January 1, 2025 – March 31, 2025 and new and deleted HCPCS codes. No substantive changes were made in the May 24th revision other than to update the web address of the CR transmittal. https://www.cms.gov/files/document/mm13613-clinical-laboratory-fee-schedule-laboratory-services-reasonable-charge-payment-quarterly.pdf
Beth Cobb
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