New Cures 2.0 bill extends key telehealth flexibilities, hastens CMS approval of medical devices

New legislation that makes major investments in medical research proposes creating permanent flexibilities on telehealth reimbursement and giving the Centers for Medicare & Medicaid Services the power to approve breakthrough medical devices faster. (Tupungato/GettyImages)

New major legislation would require Medicare to cover breakthrough medical devices faster and make permanent key flexibilities to telehealth reimbursement for providers.

Lawmakers introduced on Tuesday Cures 2.0 bipartisan legislation that builds on the 21st Century Cures Act of 2016. The legislation includes major investments in medical research including the creation of a new agency to research difficult diseases such as Alzheimer’s, but also contains several reforms to Medicare reimbursement and coverage.

The legislation would permanently remove Medicare’s geographic and originating site requirements that require a patient to live in a rural area and be in a doctor’s office to qualify for telehealth services.

The use of telehealth has exploded since the pandemic when patients were afraid of going to the doctor’s office. The Centers for Medicare & Medicaid Services also granted greater flexibility for providers to get reimbursement from Medicare for telehealth services.

But those flexibilities are expected to be removed at the end of the COVID-19 public health emergency, which will now sunset early next year.

The legislation would make some of those flexibilities permanent.

Another key provision is to codify a rule that would let Medicare automatically cover products approved or cleared by the Food and Drug Administration under the breakthrough therapy pathway, which grants advanced approval to devices that treat unmet medical needs.

The bill would allow CMS to temporarily cover breakthrough products approved by FDA for four years. The agency will have to make a permanent coverage determination in those four years. It also calls for the Government Accountability Office to offer recommendations on how to enhance Medicare coverage and reimbursement of innovative health technologies.

RELATED: CMS rescinds Trump-era rule expediting Medicare coverage of breakthrough devices

But the decision comes a few days after CMS issued a final rule that got rid of a Trump-era regulation that requires CMS to approve breakthrough medical devices under the same type of pathway as in the Cures 2.0 bill.

CMS said that it was concerned the clinical data necessary for the FDA breakthrough therapy approval may not meet Medicare’s guidelines for a coverage determination.

The insurance industry has fought the Trump-era rule, arguing that it could lead to premature coverage of medical devices.

The legislation now heads to the House Energy & Commerce Committee. The lawmakers behind the legislation—Democratic Rep. Dianne Degette of Colorado and Republican Rep. Fred Upton of Michigan—spearheaded the 2016 law.

“The federal government has shown, time and time again, that when it’s given the resources needed to accomplish the impossible, there’s not much it cannot do,” the lawmakers said in a statement.