Knowledge Base Article

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?