May 09, 2019

CMS Spells Out Plan to Remove Medicare’s Barriers to Innovation

Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma shed considerable light on the agency’s ambitious plans to remove government barriers to medical innovation and to improve its coverage, coding and payment processes in a May 2 presentation at the Medical Device Manufacturers Association Annual Meeting.

“Our often arcane and outmoded regulations around coverage, coding and payment can lead to unpredictability for innovators,” she said.

Key proposals in the massive undertaking described by Verma included the following:

  • Proposals to bring telehealth services, remote communication services and monitoring and care management in the Medicare Physician Fee Schedule for all Medicare beneficiaries, not just patients in rural areas
  • Redesigned the local coverage determination (LCD) processes as part of CMS’ “Patients over Paperwork” initiative to ensure a clear roadmap to local coverage
  • Efforts to reduce drug costs while increasing competition and encouraging the development of less costly biosimilars (almost identical copies of FDA-approved drugs not produced by the original manufacturer)
  • Payment policy changes to support broad access to transformative technologies, including certain antimicrobial drugs and Chimeric Antigen Receptor (CAR) T-cell therapies. These include an increase to the New Technology Add-On Payment (NTAP), which provides hospitals with additional payments for cases with high costs involving new technologies
  • Modernized payment policies for medical devices that are granted FDA Breakthrough Devices Program designation to expedite their entry into the market

Actions to enforce new CMS policies governing Medicare contractor prerogatives over local coverage determinations (LCD) are of particular interest to radiologists. Contractors continue to automatically “non-cover” technologies with Category III CPT codes for emerging technologies despite revisions to the authorized LCD process that restricted such practices in January. “Medicare contractors must now follow the new LCD process for every local coverage decision they make,” Verma said.

“In response to stakeholders, the agency is planning to issue more permanent HCPCS codes to enhance the ease of billing for new technologies,” Verma said. There will now be quarterly opportunities for submissions and decisions for drugs and also semi-annual opportunities for submissions and decisions for devices. The current process is annual and requires public meetings to collect stakeholder feedback.

“Given these proposals, CMS is sharing its strategy to address barriers to medical innovation in the Medicare program,” Verma said. She called on external stakeholders to ensure that potential barriers to innovation are identified and addressed as soon as possible, so patient access to transformative technologies is not diminished.