The Alliance for Regenerative Medicine Submits Comments to CMS Regarding Medicare’s Hospital Inpatient Prospective Payment System’s New Technology Add-on Payment Program

WASHINGTON, D.C. – June 25, 2018

The Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the cell and gene therapy and broader regenerative medicine sector, today submitted its comments regarding the modification of Medicare’s New Technology Add-on Payment Program (NTAP) to reflect the potential added value of regenerative medicine products to the healthcare system. These comments were drafted in response to the proposed changes by the Centers for Medicare and Medicaid Services (CMS) to the Hospital Inpatient Prospective Payment System, issued August 2017.

ARM’s comments, available here, detail recommendations to improve the current NTAP and overall MS-DRG system with a focus on creating a methodology and system that balances appropriate access and cost-effective care to new and innovative therapies, including those comprising the regenerative medicine sector: gene therapies; cell therapies; and tissue engineered products.

In its comments, ARM makes four main recommendations regarding the NTAP program:

  • CMS should establish a cost-to-charge ratio (CCR) of 1.0 for CAR-T therapies: ARM urges CMS to finalize its payment proposal of implementing a CCR of 1.0 in order to approximate hospital costs for CAR-T therapies and help set an appropriate coverage and payment approach for CAR-T therapies post-NTAP within the overall MS-DRG system.
  • CMS should establish a new MS-DRG for CAR-T therapies: The clinical characteristics, treatment process, side effects, and resource utilization for patients with diffuse large B-cell lymphoma (DLBCL) who receive CAR-T differ significantly from those patients receiving a bone marrow transplant as characterized by MS-DRG 016. Therefore, ARM urges a new MS-DRG for CAR-T therapies which includes both the therapy costs and all of the associated care services for the delivery of the CAR-T to ensure appropriate access in the inpatient setting, near- and long-term.
  • Proposed add-on payments for new services and technologies for FY 2019: In order to satisfy Congress’s requirements that the new technology represent an advance in medical technology that substantially improves the patient’s diagnosis or existing treatment, ARM recommends that CMS recognize certain FDA approval designations (ie: RMAT or Breakthrough) as dispositive. ARM also encourages CMS to update and/or eliminate various outdated criteria related to clinical trial size, mechanism of action, etc. in order to reduces barriers to access to new therapies for Medicare beneficiaries in an inpatient setting.
  • CMS should establish a more frequent NTAP process: The current process provides for NTAPs to hospitals to occur only at the beginning of the fiscal year. ARM believes that this requirement unnecessarily delays access to innovative and often lifesaving therapies for Medicare beneficiaries. As such, ARM urges CMS to implement a quarterly NTAP approval process similar to the current outpatient pass through process.

CMS’s proposed changes to the Hospital Inpatient Prospective Payment System are available here.

About the Alliance for Regenerative Medicine:

The Alliance for Regenerative Medicine (ARM) is a global, multi-stakeholder organization that promotes innovation, growth, and delivery of transformative treatments or cures for patients suffering from chronic, debilitating, and often life-threatening diseases, many of which are rare diseases. ARM convenes all stakeholders with an interest in regenerative and advanced therapies to provide a unified voice for our 290+ member organizations, including companies – especially small- to medium-sized enterprises (SMEs); academic/research institutions; non-profit organizations; patient advocacy organizations, and other members of the global advanced therapies community. The organization’s aim is to connect all parts of the innovation lifecycle to address current unmet medical needs of patients, particularly through supporting commercialization objectives via legislative and policy frameworks that enable next generation therapies to reach those who need them. To learn more about ARM, visit