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New Legislation Would Cement Telehealth Flexibility, Speed Up Devices Approval

December 21, 2021

January 2022

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Cures 2.0, a bipartisan bill introduced by lawmakers in mid-November, would make key flexibilities for telehealth permanent and require Medicare to cover breakthrough medical devices more quickly.

The legislation builds on the 21st Century Cures Act of 2016 and would solidify some of the telehealth flexibility that has been necessary during the COVID-19 pandemic. Originally, flexibility related to telehealth and reimbursements was planned to expire post-pandemic, but the new legislation would allow patients to see their provider virtually even if they don’t live in a rural area and would continue to ensure providers are reimbursed for these services.

Another component of Cures 2.0 would allow Medicare to automatically cover products approved or cleared by the U.S. Food and Drug Administration (FDA) under the breakthrough therapy pathway, which grants advanced approval to devices that treat unmet medical needs. The bill would allow the Centers for Medicare & Medicaid Services to temporarily cover breakthrough products approved by the FDA for four years, during which time the agency would be required to make a permanent coverage determination. It also calls for the Government Accountability Office to offer recommendations on how to enhance Medicare coverage and reimbursement of innovative health technologies.

The legislation, which goes to the House Energy and Commerce Committee next, is being championed by the same lawmakers responsible for the 2016 law: Reps. Dianne Degette (D-CO) and Fred Upton (R-MI).

Source: Fierce Healthcare, November 16, 2021.

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