Knowledge Base - Recent Articles

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.

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.

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.

In mid-November, the Comprehensive Error Rate Testing (CERT) published the 2024 Medicare Fee-for-Service Supplemental Improper Payment Data (https://www.cms.gov/files/document/2024-medicare-fee-service-supplemental-improper-payment-data.pdf). This report supplements the FY 2024 HHS Agency Final Report for Fiscal Year 2024, highlights common causes of improper payments, and includes tables allowing you to drill down into the review findings.

Estimated Improper Payment Rates

Calculation for the FY 2024 Medicare FFS improper payment rate included claims submitted during the 12-month period from July 1, 2022 through June 30, 2023. As compared to FY 2020 and 2021, the improper payment rate is trending up.

Table 1

“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. Improper payments are attributed to one of five major error categories (no documentation, insufficient documentation, medical necessity, incorrect coding, or other).

Unfortunately, like last year, “insufficient documentation” continues to be the main cause of improper payments. The CERT defines “insufficient documentation” as when the medical record documentation submitted is inadequate to support payment for the services billed. In other words, the CERT contractor reviewers could not conclude that the billed services were provided, were provided at the level billed, and/or were medically necessary. Claims are also placed into this category when a specific documentation element that is required as a condition of payment is missing, such as a physician signature on an order, or a form that is required to be completed in its entirety.

While the CERT data reports on improper payments in various settings (i.e., skilled nursing facilities, hospital outpatient, hospice), this article focuses on Part A (Hospital IPPS) findings.

“0 or 1 day” Length of Stay Claims

A compare of improper payments rates for Part A hospital claims by length of stay (LOS) has been a part of this annual report since the October 1, 2013 implementation of the Two-Midnight Rule. Table 1 trends short stays findings from the initial year this information was included in the CERT report.

Table 2

In addition, to the CERT’s focus on claims by length of stay, short stays (“0 of 1 Day” Stays) short stays are also actively being reviewed by the OIG as part of their Work Plan (https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000538.asp) and Livanta, the National Medicare Claim Review Contractor (https://livantaqio.com/en/ClaimReview/index.html), who reviews short stay claims across the nation on a monthly bases.  

Top 20 Service Types with Highest Improper Payments: Part A Hospital IPPS

Table D4 of the CERT report includes the top 20 DRG types with the highest improper payment rate. The table also details the percentage of error by each of the CERT’s major error categories.

For fourteen of the top 20 DRG types, the type of error with the highest percentage was error type medical necessity. A claim is placed in this category when the CERT contractor reviewer receives adequate documentation from the medical records submitted to make an informed decision that the services billed were not medically necessary based upon Medicare coverage and payment policies. The following three DRG types had the highest percent of errors attributed to medical necessity:

• DRG Pair 551 and 552 (Medical Back Problems): 99.6% error attributed to medical necessity.
• DRG 884 (Organic Disturbances & Intellectual Disability): 93.1% error attributed to medical necessity.
• DRG Pair 469 and 470 (Major Hip and Knee Joint Replacement or Reattachment of Lower Extremity): 92.8% error attributed to medical necessity.

   

  Top Root Causes of Improper Payments

  The 2024 CERT report includes the same top three service types with the highest improper payments in the Part A (Hospital IPPS) setting as in the 2023 report. Each of the three service types also have the same top root cause for improper payments in FY 2023 and FY 2024.

   

  In the 2024 report, the CERT identified the following new root causes of improper payments not noted listed in the 2023 report.

   

  New Root Causes for DRG 469 and 470

• Documentation to support conservative treatment for the billed surgical procedure(s) – missing,
• Preoperative surgeon’s office notes – missing,
• Documentation to support conservative treatment for the billed surgical procedure(s) – inadequate, and
• Radiographs to support medical necessity for the billed surgical procedure(s) – inadequate.

   

  New Root Cause for DRGs 273 and 274

• Documentation to support medical necessity for the procedure – Missing.

   

  New Root Causes for DRGs 266 and 267

• NCD requirements, other documentation required for payment – Missing, and
• Incorrect secondary diagnosis code – DRG change.

   

  Moving Forward

  Moving forward, here are ideas and resources to help in your efforts to prevent claims errors:

• Visit the CERT Provider Website (https://c3hub.certrc.cms.gov/) to find information about the CERT, how to submit records, view sample request letters and much more,
• Become familiar with National and Local Coverage Determinations and Local Coverage Articles that detail indications and limitations of coverage for applicable services. For example, CMS has published two resources related to Major Hip and Knee replacement:
  • MLN Product: Medicare Compliance Tips: Major Hip & Knee Replacement or Reattachment of Lower Extremity (https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/medicare-provider-compliance-tips/medicare-provider-compliance-tips.html#Hip), and
  • MLN Matters article SE19002: Total Knee Arthroplasty (TKA) Removal from the Medicare Inpatient-Only (IPO) List and Application of the 2-Midnight Rule (https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE19002.pdf), and
• Annually, take the time to review the new Supplemental Improper Payment Data report. Historically, a new FY report is released in late November.

Resource

Medicare Transmittals & MLN Articles

November 5, 2024: MLN MM13818: ICD-10 & Other Coding Revisions to National Coverage Determinations: April 2025 Update (CR 1 of 2)

CMS advises making sure your billing staff knows about newly available codes, recent coding changes, and National Coverage Determination (NCD) coding information. https://www.cms.gov/files/document/mm13818-icd-10-other-coding-revisions-national-coverage-determinations-april-2025-update-cr-1-2.pdf

November 5, 2024: MLN MM13828: ICD-10 & Other Coding Revisions to National Coverage Determinations: April 2025 Update (CR 2 of 2)

CMS advises making sure your billing staff know about the same updates as in MLN article (MM13818). https://www.cms.gov/files/document/mm13828-icd-10-other-coding-revisions-national-coverage-determinations-april-2025-update-cr-2-2.pdf

November 6, 2024: MLN MM13858: New Waived Tests

This article provides information about the new waived test approved by the FDA that will be effective January 1, 2025. https://www.cms.gov/files/document/mm13858-new-waived-tests.pdf

November 8, 2024: MLN MM13796: Medicare Deductible, Coinsurance, & Premium Rates: CY 2025 Update

This article includes Medicare Part A and Part B deductible, Part A and Part B coinsurance rates, and Part A and Part B premiums effective January 1, 2025. https://www.cms.gov/files/document/mm13796-medicare-deductible-coinsurance-premium-rates-cy-2025-update.pdf

November 22, 2024: MLN MM13846: Medicare Change of Status Notice Instructions (Expedited Determinations When a Patient is Reclassified from an Inpatient to an Outpatient Receiving Observation Services)

Hospitals (including Critical Access Hospitals) need to make sure your staff knows about:

• Appeal rights for eligible Medicare patients reclassified from an inpatient to outpatient receiving observation services,
• Medicare Change of Status Notice (MCSN) delivery requirements, and
• New Section 450 to the Medicare Claims Processing Manual, Chapter 30.

https://www.cms.gov/files/document/mm13846-medicare-change-status-notice-instructions.pdf

November 25, 2024: MLN MM13887: Medicare Physician Fee Schedule Final Rule Summary: CY 2025

Make sure your billing staff knows about change to the following services:

• Telehealth,
• Caregiver training,
• Therapy,
• Cardiovascular risk assessment and management,
• Evaluation and management (E/M),
• Behavioral Health,
• Advanced Primary Care Management (APCM),
• Global Surgery Payment, and
• Dental and Oral Health.

  https://www.cms.gov/files/document/mm13887-medicare-physician-fee-schedule-final-rule-summary-cy-2025.pdf

   

  Coverage Updates

  November 15, 2024: CMS National Coverage Determination (NCD) Dashboard Updated

  As of November 14, 2024, there are eight topics on the NCD wait list, four open NCDs, and two NCDs finalized in the past twelve months. https://www.cms.gov/files/document/ncddashboard2024.pdf

   

  Compliance Education Updates

  November 2024: MLN Booklet (MLN907166) Global Surgery Revised

  This booklet has been reviewed to add information about modifiers and about new G-code, HCPCS code G0559, for post-operative care services provided by a practitioner other than the one who performed the surgical procedure (or another practitioner in the same group practice). https://www.cms.gov/files/document/mln907166-global-surgery-booklet.pdf

   

  Other Updates

  November 1, 2024: Calendar Year (CY 2025 Medicare Physician Fee Schedule (PFS) Final Rule

  CMS finalized their proposal to establish coding and payment under the PFS for a new set of Advanced Primary Care Management Services (APCM) described by three new HCPCS G-codes (G0556, G0557, G0558). The finalized APCM incorporates elements of several existing care management and communication technology-based services. However, unlike existing care management codes, there are no time-based thresholds included in the service elements, which is intended to reduce the administrative burden associated with coding and billing. Instead, the new APCM codes are stratified into three levels based on an individual’s number of chronic conditions and status as a Qualified Medicare Beneficiary, reflecting the patient’s medical and social complexity. You can read additional high level summary of this final rule in a related CMS Fact Sheet at https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2025-medicare-physician-fee-schedule-final-rule and CMS Press Release at https://www.cms.gov/newsroom/press-releases/hhs-finalizes-physician-payment-rule-strengthening-person-centered-care-and-health-quality-measures

  November 1, 2024: CY 2025 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule (1809-FC)

  CMS is finalizing an update to OPPS payment rates of 2.9% for hospitals that meet applicable quality reporting requirements. Policies in this final rule will affect approximately 3,500 hospitals and approximately 6,100 ASCs.

   

  Following are the changes being made to the Medicare Inpatient Only (IPO) Procedure list effective January 1, 2025 as listed in Table 138 in the final rule:

   

  CPT Codes to be Added to IPO List

• 0894T (Cannulation of the liver allograft in preparation for connection to the normothermic perfusion device decannulation of the liver allograft following normothermic perfusion)
• 0895T (Connection of liver allograft to normothermic machine perfusion device, hemostasis control; initial 4 hours of monitoring time, including hourly physiological and laboratory assessments (e.g., perfusate temperature, perfusate pH, hemodynamic parameters, bile production, bile pH, bile glucose, biliary)
• 0896T (Connection of liver allograft to normothermic machine perfusion device, hemostasis control; each additional hour, including physiological and laboratory assessments (e.g., perfusate temperature, perfusate pH, hemodynamic parameters, bile production, bile PH, bile glucose, biliary bicarbonate, lactate levels, macroscopic

   

  CPT Removed from the IPO List

• 22848 (Pelvic fixation (attachment of caudal end of instrumentation to pelvic bony structures) other than sacrum (List separately in addition to code for primary procedure)

You can read a high level summary of this final rule in a related CMS Press Release at https://www.cms.gov/newsroom/press-releases/cms-announces-new-policies-reduce-maternal-mortality-increase-access-care-and-advance-health-equity.

November 1, 2024: Calendar Year 2025 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Final Rule (CMS-1805-F)

For CY 2025, CMS is increasing the ESRD PPS base rate to $273.82, which CMS expects will increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 2.7%. This final rule also includes changes to the methodology for calculating the ESRD facility wage index, changes to the Low-Volume Payment Adjustment (LVPA) methodology, and several changes to the ESRD outlier policy. You can read more in a related CMS Fact Sheet at https://www.cms.gov/newsroom/fact-sheets/calendar-year-2025-end-stage-renal-disease-esrd-prospective-payment-system-pps-final-rule-cms-1805-f.

November 4, 2024: CMS Update to Prior Authorization for Certain Hospital Outpatient Department (OPD) Services Initiative

CMS is changing the review timeframe for standard prior authorization decision from 10 business days to 7 calendar days for requests submitted on or after January 1, 2025. The timeframe for expedited requests remains 2 business days. https://www.cms.gov/data-research/monitoring-programs/medicare-fee-service-compliance-programs/prior-authorization-and-pre-claim-review-initiatives/prior-authorization-certain-hospital-outpatient-department-opd-services

Note, this change in the review timeframe will also go into effect for the Prior Authorization Process for Certain DMEPOS Items and Prior Authorization for Repetitive, Scheduled Non-Emergent Ambulance Transport Initiative.

November 8, 2024: CMS Fact Sheet: 2025 Medicare Parts A & B Premiums and Deductibles

CMS published a Fact Sheet that includes the 2025 premiums, deductibles, and coinsurance amounts for the Medicare Part A and Part B programs, and the 2025 Medicare Part D income-related monthly adjustments. The standard Part B premium will be $185.00 for 2025, an increase of $10.30 from $174.70 in 2024. The following table provides a comparison of Part A deductible, and coinsurance amounts for CY 2024 and CY 2025 by type of cost sharing.

https://www.cms.gov/newsroom/fact-sheets/2025-medicare-parts-b-premiums-and-deductibles

November 2024: Acentra Health Case Review Connections: Appeals Update – Safe Discharges

Acentra Health notes the following in their November edition of Case Review Connections for Acute Care:

“What are the key factors you are looking at for a safe discharge plan? What if a member needs a higher level of care, but there is no movement on finding a discharge plan?

Key considerations for a safe discharge plan:

• Secure a skilled nursing facility (SNF) bed, if applicable.
• If the beneficiary is going home, ensure they can safely return alone.
• Confirm that home health care is arranged.
• Ensure durable medical equipment (DME) is ordered and will arrive before discharge.

All arrangements needed for the discharge must be confirmed and not pending when the appeal is filed.”  https://acentraqio.com/bene/newsletter/november2024acute

MLN Fact Sheet: Rural Emergency Hospitals (MLN2259384)

This MLN Fact Sheet was updated in November to add new information on Indian Health Services Hospitals and CY 2025 payment amount. https://www.cms.gov/files/document/mln2259384-rural-emergency-hospitals.pdf

Medicare Transmittals & MLN Articles

October 3, 2024: Transmittal 12864 – Change Request (CR) 13800: October 2024 Update of the Ambulatory Surgical Center (ASC) Payment System

This CR replaced the September 5, 2024, Transmittal 12824. Updates included adding and removing HCPCS codes, adding new table 7 to add descriptor changes for HCPCS code A2024 and therefore, sub-section b. to policy section 5 has been added.  https://www.cms.gov/files/document/r12864cp.pdf

October 8, 2024: MLN MM13734: Inpatient & Long-Term Care Hospital Prospective Payment Systems: FY 2025 Changes – Revised

CMS made changes to the FY 2025 policies that apply to the wage index section of this MLN article.

https://www.cms.gov/files/document/mm13734-inpatient-long-term-care-hospital-prospective-payment-system-fy-2025-changes.pdf

October 11, 2024: MLN MM13734: Inpatient & Long-Term Care Hospital Prospective Payment Systems: FY 2025 Changes – Revised

In this third iteration of this MLN article, CMS has added language to information on page 4 regarding the FY 2025 wage index computation. https://www.cms.gov/files/document/mm13734-inpatient-long-term-care-hospital-prospective-payment-system-fy-2025-changes.pdf

October 15, 2024: MLN MM13590: Separate Payment for Essential Medicines – New Biweekly Interim Payments for the Inpatient Prospective Payment System

CMS advises making sure your billing staff knows about the payment adjustments for establishing and maintaining access to essential medicines, how providers can be paid (biweekly or annually), and how future payment will be determined. https://www.cms.gov/files/document/mm13590-separate-payment-essential-medicines-new-biweekly-interim-payments-inpatient-prospective.pdf

Coverage Updates

October 3, 2024: National Coverage Analysis (CAG-00468N): Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER)

In March 2023, Abbot submitted a letter to CMS requesting a National Coverage Analysis (NCA) for T-TEER indicating “that a national coverage policy for T-TEER will ensure long-term, predictable, and consistent coverage for all Medicare beneficiaries.” The NCA focuses on the clinical indications for use of T-TEER among Medicare beneficiaries.

Abbott’s TriClip™ therapy received FDA approval on April 2, 2024. Effective October 1, 2024, this technology is eligible for a New Technology Add-On Payment in the hospital inpatient setting. CMS estimates there will be 150 cases using this device nationwide in FY 2025.

The public comment period ends November 2, 2024. https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=316

October 30, 2024: Proposed Decision Memo (CAG-00466N): Implanted Pulmonary Artery Pressure Sensor (IPAPS) for Heart Failure Management

This proposed decision memo includes patient criteria, physician criteria, and that it be used under coverage with evidence development (CED). The public comment period ends November 29, 2024. https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=313&=

Compliance Education Updates

September 2024: MLN006559: MLN Education Tool: Medicare Preventive Services

This tool was updated in September for the following Medicare Preventive Services:

• Alcohol misuse screening and counseling: clarified frequency policy,
• Flu Shot & Administration: Updates with the 2024-2025 flu season vaccine codes,
• Pneumococcal Shot & Administration: Added CPT code 90684, effective June 27, 2024, with an implementation date of November 25, 2024,
• Prolonged Preventive Services: Added information on the “substantive portion” and how it relates to prolonged preventive services, and
• Sexually Transmitted Infection (STI) Screening & High Intensity Behavioral Counseling (HIBC) to Prevent STIs: Removed CPT code 0353U, effective June 30, 2024, added CPT code 0455U, effective July 1, 2024, and clarified frequency policy

https://www.cms.gov/medicare/prevention/prevntiongeninfo/medicare-preventive-services/mps-quickreferencechart-1.html

October 24, 2024: OIG Report (OEI-03-23-00380): Medicare Advantage: Questionable Use of Health Risk Assessments Continues to Drive Up Payments to Plans by Billions

Per the OIG, in-home health risk assessments (HRAs) and HRA-linked chart reviews generated 63% of the estimated $7.5 billion in risk-adjusted payments. They also indicate that “diagnoses reported only on these types of records heighten concerns about the validity of the diagnoses or the coordination of care for MA enrollees.” https://oig.hhs.gov/documents/evaluation/10028/OEI-03-23-00380.pdf

Other Updates

September 30, 2024: Acute Hospital care at Home Initiative Fact Sheet

CMS released a report on the agency’s study of the Acute Hospital Care at Home (AHCAH) initiative, which allows certain Medicare-certified hospitals to treat patients with inpatient-level care at home.

October 2, 2024: BFCC-QIO Livanta has New Address

Effective October 7, 2024, Livanta’s mailing address for correspondence to its Beneficiary and Family Centered Care – Quality Improvement Organization (BFCC-QIO) Program changed. Their new address for U.S. postal mail is:

BFCC-QIO Program

Livanta LLC

PO Box 2687

Virginia Beach, VA 23450

You can learn more about Livanta LLC on their website at https://www.livantaqio.cms.gov/en.

CMS Case Study: Urinary Catheter Case: CMS’ Swift Action Saves Billions

CMS published this case study in response to identifying a concerning risk in urinary catheter billings attributed to a small group of 15 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) supply companies that had recently changed ownership.

https://www.cms.gov/files/document/cpi-urinary-catheter-case-study.pdf

October 31, 2024: Sickle Cell Disease Provider Toolkit

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.

https://www.cms.gov/files/document/mm13800-ambulatory-surgical-center-payment-update-october-2024.pdf

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 4^th 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 4^th 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 30^th through the US Postal Service. To order your tests go to https://covidtests.gov/.

New Technologies Eligible for Add-On Payment (NTAPs) Background

Effective for discharges beginning on or after October 1, 2002, Section 1886(d)(5)(K)(i) of the Act requires the Secretary to establish a mechanism to recognize the costs of new medical services and technologies under the payment system under the subsection which establishes the system for paying for the operating costs of inpatient hospital services.

The system of payment for capital costs is established in section 1886(g) of the Act. For this reason, capital costs are not included in the add-on payments for a new medical service or technology.

NTAPs are not budget neutral and the “newness” for payment is limited to the 2-to-3-year period after the point at which data begin to become available reflecting the inpatient hospital code assigned to the new service or technology.

There are three pathways for a new service or technology to be approved for the add-on payment (Traditional pathway, Certain Antimicrobial Products Alternative Pathway, and Certain Transformative New Devices Alternative Pathway).

For the alternative pathways, a technology is not required to have a specified FDA designation at the time the application for NTAP is made. Instead, “CMS reviews the application based on the information provided by the applicant only under the alternative pathway specified by the applicant at the time of new technology add-on payment application submission. However, to receive approval for the new technology add-on payment under that alternative pathway, the technology must have the applicable FDA designation and meet all other requirements in the regulations in § 412.87(c) and (d), as applicable.”

Coding NTAPs

Section X New Technology was added to ICD-10-PCS effective October 1, 2015. CMS has indicated (https://www.cms.gov/Medicare/Coding/ICD10/Downloads/2016-Section-X-New-Technology-.pdf) that “Section X was created in response to public comments received regarding New Technology proposals presented at ICD-10 Coordination and Maintenance Committee Meetings, and general issues facing classification of new technology procedures.”  To receive payment for an eligible NTAP, the applicable section X New Technology ICD-10-PCS code must be on the claim submitted for adjudication.

FY 2024 NTAPS

In the FY 2024 IPPS Final Rule, CMS anticipated there would be 58,525 new technology cases eligible for an add-on payment.

A review of FY 2024 data available in the RealTime Medicare Data (RTMD) database (claims from October 1, 2023 through April 30, 2024) showed there were only 5,206 claims nationwide that included one of the new technology ICD-10-PCS procedure codes.

FY 2025 NTAPs by the Numbers

• A total of 40 technologies are eligible to receive an add-on payment,
• CMS estimates that 400,588 Medicare beneficiaries will receive one of these technologies in the hospital inpatient setting, and
• CMS estimates the Medicare spending on NTAPs will be approximately $769,530,626.97.

For Facilities with an Active Structural Heart Program

On February 1, 2024, the EVOQUE™ system received premarket approval for the improvement of health status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, for whom tricuspid valve replacement is deemed appropriate by the heart team.

In a February 20, 2024 letter to CMS, Edwards Lifesciences requested a Transcatheter Tricuspid Valve Replacement (TTVR) National Coverage Determination (NCD) to provide coverage for the EVOQUE™ tricuspid valve replacement system (EVOQUE™ system).

On June 20, 2024, CMS issued a National Coverage Analysis

(CAG-00467N) for TTVR. The public comment period ended on July 20, 2024 and the proposed Decision Memo due date is December 20, 2024.

Effective October 1, 2024, the EVOQUE™ system has been approved for the new technology add-on payment. Edwards Lifesciences estimates there will be 800 cases when this new technology will be used in FY 2025. The maximum add-on payment is $31,850.00. The CMS estimated total impact for this new technology in FY 2025 is $25,480,000.00.

The unique ICD-10-PCS code effective October 1, 2024 for this procedure is X2RJ3RA (replacement of tricuspid valve with multi-plan flex technology bioprosthetic valve, percutaneous approach, new technology group 10).

Sickle Cell Disease (SCD) New Technologies

Two technologies were approved for add-on payment in FY 2025 for the treatment of SCD.

• Vertex Pharmaceuticals, Inc.’s CASGEVY™ (exagamglogene autotemcel) is approved for the treatment of SCD in patients 12YO and older with recurrent vaso-occlusive crises (VOC). Vertex Pharmaceutical’s Inc. estimates there will be 117 cases when this new technology is used in FY 2025. The maximum add-on payment is $1,650,000.00. The CMS estimated total impact for this new technology in FY 2025 is $193,050,000.00.

   

• Bluebird bio, Inc’s LYFGENIA™ (lovotibeglogene autotemcel) is an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of patients 12YO and older with SCD and a history of vaso-occlusive events (VOE). Bluebird bio Inc. estimates there will be 40 cases when this new technology is used in FY 2025. The maximum add-on payment is $2,325,000.00. The CMS estimated total impact for this new technology in FY 2025 is $93,000,000.00.

Moving Forward

MMP believes not capturing ICD-10-PCS codes for technologies eligible for an add-on payment is a missed opportunity. Identifying and coding new technologies is an opportunity for your hospital to be compensated for the services you are providing to your hospital inpatient Medicare beneficiary population.

You will find a complete list of the new technologies eligible for add-on payment in the MAC Implementation File 8 (FY 2025 New Technology Add-on Payment) on the CMS FY 2025 IPPS Final Rule home page at https://www.cms.gov/medicare/payment/prospective-payment-systems/acute-inpatient-pps/fy-2025-ipps-final-rule-home-page.

MAC file 8 includes a list of technologies beginning to receive NTAP in FY 2025, a list of technologies continuing to receive NTAP in FY 2025, and a list of technologies that are no longer eligible for NTAP as of October 1, 2024. Each list includes the name of the technology, the maximum add-on payment, the ICD-10-CM PCS codes and in some cases ICD-10-CM diagnosis codes used to identify cases eligible for NTAP.

Action Items to Consider

• Determine if your hospital is using any of the technologies eligible for add-on payment.
• With 15 of the new technologies being drugs, share this information with your pharmacy to help identify if any of the medications eligible for an add-on payment are being used at your hospital.
• The only way Medicare knows when a new technology has been used is by including the ICD-10-PCS new technology code on the claim. In general, medications are not assigned an ICD-10-PCS code. Share this information with your Coding professionals.

• Does your EHR have the capability to flag new technologies as an alert for your Coding professionals?
• Is there an opportunity for your Clinical Documentation Integrity staff to assist in the identification of new technologies?