CMS’ new tech innovation strategy targets ‘outdated’ regulation

CMS Administrator Seema Verma on Thursday unveiled new steps the agency is taking to bolster Medicare coverage of emerging medical technologies.

During remarks at the Medical Device Manufacturers Association’s annual meeting in Washington, Verma said the agency is removing what she called government barriers to innovation.

“When I came to CMS, I inherited outdated government rules and regulation that stifle innovation and access to innovative treatments,” she said. “Our often arcane and outmoded regulations around coverage, coding and payment can lead to unpredictability for innovators.”

The first CMS update would revamp the application process for codes under the Healthcare Common Procedure Coding System, or HCPCS.

Under the current system, the CMS only allows vendors to apply for new Level II codes once per year. The agency plans to redesign the process as a quarterly system for submissions and decisions related to drugs and a semi-annual system for submissions and decisions related to devices.

The second component clarifies coverage of Current Procedural Terminology, or CPT, temporary codes for emerging technologies, also known as category III codes.

For technologies that don’t fall under an existing Local Coverage Determination, Verma said Medicare contractors are not authorized to automatically forgo covering category III items and services. Instead, these contractors must follow the agency’s new Local Coverage Determination process for each decision they make. That process includes an evidence review of the technology in question.

These changes are part of the agency’s broader strategy to address barriers to innovation in the Medicare program, according to Verma.

“The advent of novel medical technologies requires CMS to remove barriers to ensure safe and effective treatments are readily accessible to beneficiaries without delaying patient care,” she said. “In essence, keeping new technologies and treatments moving from bench to bedside—and into the hands of those who need them most.”

As part of her remarks, Verma voiced opposition to Medicare for All-style proposals, saying “Medicare for All leads to innovation for none.”

The announcement builds on recent policies the CMS has proposed for emerging technologies.

Last week, the CMS proposed a new technology add-on payment for breakthrough medical devices that are significantly better than a device already on the market as part of its update to the hospital inpatient prospective payment system. Such devices already get expedited approval from the Food and Drug Administration.

https://www.modernhealthcare.com/government/cms-new-tech-innovation-strategy-targets-outdated-regulation