Knowledge Base Category -

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?

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/.

Medicare Transmittals & MLN Articles

August 5, 2024: MLN MM13706: ICD-10 & Other Coding Revisions to National Coverage Determinations: January 2025 Update

Make sure key stakeholders are aware of new codes and recent coding changes that will be effective January 1, 2025. Change Request (CR) 13706 includes the following NCDs and NCD specific updates: 

• 20.33 TMVR/TEER: Effective January 1, 2025, any existing edits that require ICD-10 I34.0 and I34.1 be listed as primary will be deleted, along with clinical trial ICD-10 Z00.6 as secondary. These codes can appear in any position, and  
• 210.10 STIs: June 30, 2024 is the end date for CPT 0353U. Effective July 1, 2024 add CPT 0455U (used for combined chlamydia and gonorrhea testing).

   

  Also, CR 13706 removed the delayed termination of the Appropriate Use Criteria (AUC) Program modifiers with an effective date for the AUC modifier removal noted as being January 1, 2025. https://www.cms.gov/files/document/mm13706-icd-10-other-coding-revisions-national-coverage-determinations-january-2025-update.pdf

   

  August 6, 2024: MLN MM13707: Hospice Payments: FY 2025 Update

  This article provides information about payment rates, inpatient and aggregate caps, and wage index updates effective October 1, 2024. https://www.cms.gov/files/document/mm13707-hospice-payments-fy-2025-update.pdf

   

  August 6, 2024: MLN MM13632: Hospital Outpatient Prospective Payment System: July 2024 Update - Revised

  In this second iteration of this MLN article, CMS updated the number of certain drugs, biologicals, and radiopharmaceuticals and added new subsections g and j in Section 7. Substantive content changes are in dark red. https://www.cms.gov/files/document/mm13632-hospital-outpatient-prospective-payment-system-july-2024-update.pdf

   

  August 19, 2024: MLN MM13486: Annual Wellness Visit: Social Determinants of Health Risk Assessment - Revised

  This article was initially released May 3, 2024. In this update CMS has clarified that MACs will process G0136 using the Physician fee Schedule. https://www.cms.gov/files/document/mm13486-annual-wellness-visit-social-determinants-health-risk-assessment.pdf

   

   

  August 21, 2024: MLN MM13750: 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/mm13750-revisions-medicare-part-b-coverage-pneumococcal-vaccinations-policy.pdf

   

  August 22, 2024: MLN MM13766: Inpatient Psychiatric Facilities Prospective Payment System: FY 2025 Updates

  This article highlights key information for your billing staff for FY 2025, for example the refinements to adjustment factors and electroconvulsive therapy (ECT) payment per treatment. https://www.cms.gov/files/document/mm13766-inpatient-psychiatric-facilities-prospective-payment-system-fy-2025-updates.pdf

   

  August 26, 2024: MLN MM13757: New Waived Tests

  Make sure your billing staff knows about Clinical Laboratory Improvement Amendments (CLIA) requirements, the one new CLIA-waived test approved by the FDA, and use of modifier QW for CLIA-waived tests. https://www.cms.gov/files/document/mm13757-new-waived-tests.pdf

   

  August 29, 2024: MLN MM13734: Inpatient & Long-Term Care Hospital Prospective Payment System: FY 2025 Changes

  This thirteen-page article provides updates that will be effective October 1, 2024. For example, regarding the Hospital-Acquired Condition (HAC) Reduction Program, CMS expects to issue the final list of hospitals that are subject to the HAC Reduction Program for FY 2025 to MACs in mid-September 2024. https://www.cms.gov/files/document/mm13734-inpatient-long-term-care-hospital-prospective-payment-system-fy-2025-changes.pdf

   

  Coverage Updates

  August 5, 2024: CMS Prior Authorization and Pre-Claim Review Initiatives Update

  CMS is removing CPTs 64492 and 64494 from the list of codes that require prior authorization as a condition of payment. According to the revised Local Coverage Determinations for Facet Joint Interventions, three or four-level procedures are not medically necessary and non-covered. Therefore, the decision on the prior authorization request will always be non-affirmative, so submitting the request would be unnecessary. The full list of HCPCS codes has been updated to reflect this change. 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

   

  August 7, 2024: Final Notice – Transitional Coverage for Emerging Technologies (TCET) (CMS-3421-FN)

  CMS announced in the August 8, 2024, edition of MLN connects that CMS has issued a final procedural notice outlining a Medicare coverage pathway to achieve more timely and predictable access to certain new medical technologies for people with Medicare. The new TCET pathway for certain FDA-designated Breakthrough Devices increases the number of National Coverage Determinations (NCDs) that CMS will conduct per year and supports both improved patient care and innovation by providing a clear, transparent, and consistent coverage process while maintaining robust safeguards for the Medicare population.

   

  Link to August 8, 2024, MLN Connects: https://www.cms.gov/training-education/medicare-learning-network/newsletter/2024-08-08-mlnc

   

  August 21, 2024: MLN MM13604: National Coverage Determination 110.23: Allogeneic Hematopoietic Stem Cell Transplantation – Revised

  This MLN article was revised to add two procedure codes to the coding instructions (XW133C8 and XW143C8). https://www.cms.gov/files/document/mm13604-national-coverage-determination-11023-allogeneic-hematopoietic-stem-cell-transplantation.pdf

   

  Compliance Education Updates

  August 12, 2024: OIG Report: Medicare Improperly Paid Hospitals an Estimated $79M for Enrollees Who Had Received Mechanical Ventilation

  OIG performed this audit due to prior OIG audits finding hospitals did not fully comply with Medicare requirements for MS-DRGs that require enrollees to have received 96 or more consecutive hours (i.e., 4 days or more) of mechanical ventilation. This audit specifically evaluated if claims reporting a mechanical ventilation start date that was 5 to 10 days before the enrollee discharge date were at risk for billing errors. The audit included inpatient claims with dates of service from October 2015 through September 2021 that were grouped to MS-DRGs 207 and 870. They found that for 17 of 250 sampled claims hospitals did not comply with requirements. Based on this finding, the OIG estimated that Medicare improperly paid hospitals $79.4M for the audit period. CMS concurred with OIG recommendations to recover the identified overpayments and continue to educate providers to reinforce requirements for billing mechanical ventilation. https://oig.hhs.gov/documents/audit/9957/A-09-22-03002.pdf

   

  August 2024: MLN Fact Sheet MLN2886155: A Prescriber’s Guide to Medicare Prescription Drugs (Part D) Opioid Policies – Revised

  This MLN Fact Sheet was revised in August to add information on the expansion of the exempted patient definition. Effective January 1, 2025, CMS is expanding the definition of an exempted patient being treated for cancer-related pain to include:

• Patients undergoing active cancer treatment,
• Cancer survivors:
  • With chronic pain who’ve completed cancer treatment,
  • In clinical remission, and
  • Under surveillance only.

https://www.cms.gov/files/document/mln2886155-prescribers-guide-medicare-prescription-drug-part-d-opioid-policies.pdf

MLN Booklet MLN909188: Chronic Care Management Services – Revised

Earlier in May 2024, this MLN Booklet was revised to add new codes describing chronic pain management and treatment and added information about other care management services. https://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnproducts/downloads/chroniccaremanagement.pdf

Other Updates

August 1, 2024: FY 2025 Hospital IPPS and LTCH PPS Final Rule (CMS-1808-F)

For FY 2025, the increase in operating payment rates for acute care hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality Reporting (IQR) program and are meaningful electronic health record (EHR) users is 2.9%.

Link to Related CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/fy-2025-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-hospital-prospective-0

August 13, 2024: CMS Memorandum: Updated Model Signage for the Emergency Medical Treatment and Labor Act (EMTALA)

In the memorandum summary, CMS notes that they are “dedicated to safeguarding the health and safety of millions of individuals, a commitment that includes enforcing federal laws including EMTALA.” Further, CMS regulations require Medicare-participating hospitals to post signage outlining patients’ rights under EMTALA in the emergency department and areas where patients will be examined or treated, or wait to be examined or treated, for emergency medical conditions (EMCs). CMS is releasing updated model signage that hospitals may use to meet this obligation.” https://www.cms.gov/files/document/qso-24-17-emtala.docx

August 13, 2024: CMS Posts Content for Health Care Providers in Preparation of Coverage Transition from Part D to Part B of Antiretroviral Drugs to Prevent HIV

CMS is encouraging pharmacies and other affected parties to prepare now for this expected transition. They expect to release the final National Coverage Determination (NCD) in late September 2024. Coverage under Part B will begin once the final NCD is released. https://www.cms.gov/medicare/coverage/prep

August 15, 2024: HHS Press Release: Negotiating for Lower Drug Prices Works, Saves Billions

HHS announced agreements for new lower prices for 10 drugs that are “some of the most expensive and most frequently dispensed drugs in the Medicare program and are used to treat conditions such as heart disease, diabetes, and cancers.” New prices go into effect January 1, 2026 for people with Medicare Part D prescription drug coverage. CMS will continue to select up to 15 more drugs for 2027 and 2028, and up to 20 more drugs each year after that, as required by the Inflation Reduction Act (IRA).

HHS Press Release: https://www.hhs.gov/about/news/2024/08/15/historic-first-biden-harris-administration-successfully-negotiates-medicare-drug-prices-delivers-promise-lower-prescription-drug-costs-american-seniors.html

Additional resources were included in the Thursday, August 15, 2024 edition of MLN Connects at https://www.cms.gov/training-education/medicare-learning-network/newsletter/2024-08-15-mlnc

August 2024: CMS FAQs about Add-on HCPCS Code G2211

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.

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

Medicare Transmittals & MLN Articles

June 24, 2024: Changes to the Laboratory National Coverage Determination Edit Software: October 2024 Update

CMS advises providers to make sure your billing staff know about newly available codes, recent coding changes, and how to find NCD coding information.

https://www.cms.gov/files/document/mm13672-changes-laboratory-national-coverage-determination-edit-software-october-2024-update.pdf

June 25, 2024: MLN MM13656: Ambulatory Surgical Center Payment Update – July 2024

Initially released on June 13, 2024, this article was updated to remove HCPCS codes J3393, J3394, J9172, J9322, and J9324 from table of the change request, which now has 12 codes. https://www.cms.gov/files/document/mm13656-ambulatory-surgical-center-payment-update-july-2024.pdf

June 25, 2024: MLN MM13487: Diabetes Screening & Definitions Update: CY 2024 Physician Fee Schedule Final Rule

Initially released May 3, 2024, this article was updated to clarify claims processing requirements for ICD-10-CM diagnosis code Z13.1 and previously processed claims. https://www.cms.gov/files/document/mm13487-diabetes-screening-definitions-update-cy-2024-physician-fee-schedule-final-rule.pdf

June 27, 2024: Change Request (CR) 13649: Utilization of KX Modifier Medicare Physician Fee Schedule Payment for Dental Services Inextricably Linked to Covered Medical Services

This CR provides instructions to A/B MACs regarding usage of the KX modifier for dental services inextricably linked to covered medical services under the Medicare Physician Fee Schedule. CMS includes four examples of types of evidence that providers must submit to demonstrate the inextricable link between the dental service and covered medical service. https://www.cms.gov/files/document/r12702otn.pdf

July 18, 2024: MLN MM13717: Clinical Laboratory Fee Schedule & Laboratory Services Reasonable Charge Payment: October Update

Make sure your billing staff knows about the next private payor data reporting period of January 1, 2025 – March 31, 2025, and new and deleted HCPCS codes.

https://www.cms.gov/files/document/mm13717-clinical-laboratory-fee-schedule-laboratory-services-reasonable-charge-payment-october.pdf

July 18, 2024: MLN MM13286: Lymphedema Compression Treatment Items: Implementation

Now in it’s fourth iteration, this MLN article was updated on July 18^th to add information on how to prevent claims denial due to duplicate payments for compression bandaging systems. https://www.cms.gov/files/document/mm13286-lymphedema-compression-treatment-items-implementation.pdf

Compliance Education Updates

July: CMS’ Oral Health Cross-Cutting Initiative Fact Sheet

In the July 25, 2024, edition of MLN Connects, CMS released this Fact Sheet noting that overall health and well-being are impacted by oral health, affecting individuals, families, and communities. CMS is committed to eliminating barriers to oral health as part of our broader goal of improving quality, equity, and outcomes in the health care system. The CMS Oral Health Cross-Cutting Initiative aligns our programs and policies to better address oral health needs, and the fact sheet highlights this important work and accomplishments to date.

• Link to MLN Connects: https://www.cms.gov/training-education/medicare-learning-network/newsletter/2024-07-25-mlnc#_Toc172639983
• Link to Fact Sheet: https://www.cms.gov/files/document/oral-health-cci-fact-sheet.pdf

   

  July: CMS Request for Inpatient for Improving the PEPPER

  Also, in the July 25, 2024 edition of MLN Connects, CMS noted they are taking steps to improve the effectiveness, accessibility, and design of the Program for Evaluating Payment Patterns Electronic Reports (PEPPERs) and Comparative Billing Reports (CBRs). They note you can help by responding to their Request for Information (RFI) by August 19, 2024. https://www.cms.gov/training-education/medicare-learning-network/newsletter/2024-07-25-mlnc#_Toc172639983

   

  Other Updates

  CMS Publishes CY 2025 Final Rules for Home Health and End-Stage Renal Disease

  Links to related Final Rule Fact Sheets: 

• June 26, 2024: CY 2025 Home Health Prospective Payment System Proposed Rule Fact Sheet (CMS-1803-P)
• https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2025-home-health-prospective-payment-system-proposed-rule-fact-sheet-cms-1803-p

   

• June 27, 2024: CY 2025 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Proposed Rule Fact Sheet (CMS-1805-P)
• CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/calendar-year-2025-end-stage-renal-disease-esrd-prospective-payment-system-pps-proposed-rule-cms

June 27, 2024: CDC Recommendations Updated 2024-2025 COVID-19 and Flu Vaccines for Fall/Winter Virus Season

The CDC encourages providers to begin their influenza vaccination planning efforts now and to vaccinate patients as indicated once 2024-2025 influenza vaccines become available.

The FY 2025 IPPS Final Rule (CMS-1808-F) was issued by CMS August 1, 2024. This article focuses on finalized changes to Medicare Severity Diagnosis-Related Group (MS-DRG) classifications.

MDC 05: Diseases and Disorders of the Circulatory System:

Left Atrial Appendage Closure (LAAC) with Concomitant Ablation

Request: Create a new MS-DRG to better accommodate the cost of concomitant left atrial appendage closure and cardiac ablation for atrial fibrillation. “According to the requester, the manufacturer of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) device, patients who are indicated for a LAAC device can also have symptomatic AF. For these patients performing a cardiac ablation and LAAC procedure at the same time is ideal.”

CMS Proposal: After claims analysis CMS indicated that “taking into consideration that it clinically requires greater resources to perform concomitant left atrial appendage closure and cardiac ablation procedures, we are proposing to create a new base MS-DRG for cases reporting a LAAC procedure and a cardiac ablation procedure in MDC 05. The proposed new MS-DRG is MS-DRG 317 (Concomitant Left Atrial Appendage Closure and Cardiac Ablation).”

CMS has proposed to include the nine ICD-10-PCS procedure codes that describe LAAC procedures and 27 ICD-10-PCS procedure codes describing cardiac ablation for the proposed new MS-DRG.

Final Rule: CMS finalized their proposal to create new MS-DRG 317 (Concomitant Left Atrial Appendage Clouse and Cardiac Ablation) in MDC 05, with modification of the list of procedure codes describing cardiac ablation by removing four codes.

Neuromodulation Device Implant for Heart Failure (Barostim™ Baroreflex Activation Therapy)

The BAROSTIM™ system is the first neuromodulation device system designated to trigger the body’s main cardiovascular reflex to target symptoms of heart failure. The system is indicated for the improvement of symptoms of heart failure in a subset of patients with symptomatic New York Heart Association (NYHA) Class III or Class II heart failure, with a low left ventricular ejection fraction, who also do not benefit from guideline directed pharmacologic therapy or qualify for Cardiac Resynchronization Therapy (CRT).

This system was approved for new technology add-on payments for FY 2021 and FY 2022 and was discontinued in FY 2023.

Request: A request was submitted to reassign the ICD-10-PCS procedure codes describing the BAROSTIM™ system from MS-DRGs 252, 253, and 254 (Other Vascular Procedures with MCC, with CC, and without MCC respectively) to MS-DRGs 275 (Cardiac Defibrillator Implant with Cardiac Catheterization with MCC), MS-DRGs 276 and 277 (Cardiac Defibrillator Implant with MCC and without MCC respectively); or to other more clinically coherent MS-DRGs for implantable device procedures indicated for Class III heart failure patients. ICD-10-PCS codes uniquely identifying the implantation of the BAROSTIM™ system includes:

• 0JH60MZ (Insertion of stimulator generator into chest subcutaneous tissue and fascia, open approach)
• in combination with
• 03HK3MZ (Insertion of stimulator lead into right internal carotid artery, percutaneous approach) or
• 03HL3MZ (Insertion of stimulator lead into left internal carotid artery, percutaneous approach).

CMS Response: While there is no intravascular component when implanting a BAROSTIM™ system, they did agree that ICD, CRT-D, and CCM devices and the BAROSTIM™ system are clinically coherent in that they share an indication of heart failure, a major cause of morbidity and mortality in the United States, and that these cases demonstrate comparable resource utilization. As such, they are proposing to reassign the cases reporting procedure codes describing implantation of a BAROSTIM™ system to MS-DRG 276, even if there is no MCC reported, to better reflect the clinical severity and resource use involved.

They are also proposing to change the title of MS-DRG 276 from “Cardiac Defibrillator Implant with MCC” to “Cardiac Defibrillator Implant with MCC or Carotid Sinus Neurostimulator.”

Final Rule: CMS finalized their proposal to reassign the implantation of the BAROSTIM™ system to MS-DRG 276, even if there is no MCC reported. Also, the DRG name was changed to the above proposed name.

As part of the Annual Proposed and Final Rule process, CMS evaluates diagnosis codes and their impact on hospital resource utilization. The following timeline of events highlights CMS efforts from FY 2008 to what was finalized in the FY 2025 IPPS Final Rule.

FY 2008 IPPS Final Rule

CMS described their process for establishing three different levels of CC severity into which diagnosis codes would be subdivided. The categorization of diagnoses as a MCC, a CC, or a Non-CC was accomplished by evaluating each diagnosis code to determine the extent to which its presence as a secondary diagnosis would result in increased hospital resource use.

FY 2020 IPPS Proposed Rule

CMS noted with the transition to ICD-10-CM and the significant changes to diagnosis codes since FY 2008, a new comprehensive analysis was warranted. At that time, CMS proposed changes to the severity level designation for 1,492 ICD-10-CM diagnosis codes. After consideration of comments received, the proposal was not finalized.

October 8, 2019

CMS held a listening session that included a review of the methodology CMS utilized to mathematically measure the impact on resource use.

FY 2021 IPPS Final Rule

CMS discussed their plan to continue a comprehensive CC/MCC analysis, using a combination of mathematical analysis of claims data and the application of the following nine guiding principles:

1. Represents end of life/near death or has reached an advanced stage associated with systemic physiologic decompensation and disability,
2. Denotes organ system instability or failure.
3. Involves a chronic illness with susceptibility to exacerbations or abrupt decline.
4. Serves as a marker for advanced disease states across multiple different comorbid conditions.
5. Reflects systemic impact.
6. Post-operative/post-procedure condition/complication impacting recovery.
7. Typically requires higher level of care (that is, intensive monitoring, greater number of caregivers, additional testing, intensive care unit care, extended length of stay).
8. Impedes patient cooperation or management of care or both.
9. Recent (in the last 10 years) changes in best practice, or in practice guidelines and review of the extent to which these changes have led to concomitant changes in expected resource use.

FY 2025 IPPS Final Rule

CMS indicates they have continued to solicit feedback since the nine guiding principles were first introduced in the FY 2021 IPPS Final Rule but have received no additional feedback or comments since then.

Effective October 1, 2024, CMS finalized using the nine guiding principles in combination with mathematical analysis of claims to determine the extent to which the presence of a diagnosis code as a secondary diagnosis results in increased hospital resource use.

FY 2025 ICD-10-CM Diagnosis Severity Changes

For FY 2025 there are:

• 4 additions to the MCC list, and
• 104 additions to the CC list.

Social Determinants of Health Z-Codes

For FY 2025, CMS finalized their proposal to change the DRG designation for seven SDOH-Z codes from non-cc to CC and includes:

• Z59.10 (Inadequate housing, unspecified)
• Z59.11 (Inadequate housing environmental temperature)
• Z59.12 (Inadequate housing utilities)
• Z59.19 (Other inadequate housing)
• Z59.811 (Housing instability, housed, with risk of homelessness)
• Z59.812 (Housing instability, housed, homelessness in past 12 months)
• Z59.819 (Housing instability, housed unspecified).

CMS notes in the final rule that “we hope and expect that this finalization will foster the increased documentation and reporting of the diagnosis codes describing social and economic circumstances and continue to serve as an example for providers that when they document and report Z codes, CMS can further examine the claims data and consider future changes to the designation of these codes when reported as a secondary diagnosis.”

Resource

CMS has released the 2025 ICD-10-CM diagnosis code tables, the ICD-10-CM Coding Guidelines, and updated ICD-10-PCS procedure code tables and index and Addendum.

It is important to annually review the ICD-10-CM Official Guidelines for Coding and Reporting as “these guidelines have been developed to assist both the healthcare provider and the coder in identifying those diagnoses that are to be reported. The importance of consistent, complete documentation in the medical record cannot be overemphasized. Without such documentation accurate coding cannot be achieved. The entire record should be reviewed to determine the specific reason for the encounter and the conditions treated.”

When reading the guidelines, look for what is new and for when the guidelines indicate that you should query the provider if documentation is unclear. Finally, be sure to share this information with your Coding and Clinical Documentation Integrity staff as part of their preparedness plan for the October 1^st start of the 2025 CMS Fiscal Year.

Resources

• CMS.gov webpage: 2025 ICD-10-CM: https://www.cms.gov/medicare/coding-billing/icd-10-codes/2025-icd-10-cm
• CMS.gov webpage: 2025 ICD-10-PCS: https://www.cms.gov/medicare/coding-billing/icd-10-codes/2025-icd-10-pcs

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.

https://www.cms.gov/files/document/mm13632-hospital-outpatient-prospective-payment-system-july-2024-update.pdf

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).

https://www.cms.gov/files/document/mm13651-medicare-benefit-policy-manual-update-dmepos-benefit-category-determinations.pdf

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  

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