Pathways’ Picks March 16: Capitol Hill Activity, IMDRF Meeting Delayed, Rare Recall Order

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ARTICLE SUMMARY:

In this week’s roundup: Medtech got attention in Congress this week in new bills, mark-ups, and hearings tied to digital health, pandemic response, diagnostics, and Cures 2.0; the International Medical Device Regulatory Forum postponed its leadership meeting this week; FDA handed Philips Respironics a rarely-leveraged recall notification order; the agency’s revised premarket cyber guidance will be out soon, and more.

Capitol Hill Picks

An active medtech week in Congress:

Recognizing prescription digital therapeutics. A bipartisan bill that would establish a path to coverage and payment for prescription digital therapeutics (PDTs) was introduced in both the House and Senate March 10. The current Medicare statute lacks a clear-cut benefit category for these tools, blocking Medicare coverage for the expanding number of FDA-authorized evidence-based software platforms. The Access to Prescription Digital Therapeutics Act, co-sponsored by Sens. Shelly Moore Capito (R-WV) and Jeanne Shaheen (D-NH) and Reps. David McKinley (R-WV) and Mike Thompson (D-CA), would establish the benefit category and set a framework for a market-based payment system for the tools. The lawmakers’ attention follows several recent coding victories for PDT firms, which have so far been trying build reimbursement support from pharmacy benefit managers and Medicaid plans, among other sources. (For more on the bill and PDT reimbursement context see, “Prescription Digital Therapeutics: Reimbursement Picture Comes into Focus,” Market Pathways, March 16, 2022.)

Pandemic bill advances. Broad-based legislation intended to strengthen pandemic preparedness in the US passed through a Senate committee this week in a lopsided 20-2 vote, suggesting the PREVENT Pandemics Act is headed for relatively straightforward passage in that chamber. The bill, approved by the Health, Education, Labor, and Pensions (HELP) committee, includes an array of provisions to ensure sufficient supplies of devices and drugs in an emergency, including increased mandates on device makers to maintain a redundancy risk management plan and to report potential shortages. It also contains a measure allowing FDA to consult third parties to support emergency use authorization reviews of IVDs and language directing FDA to improve identify and adapt best practices for communicating with medical product sponsors. Further, it calls for reforms at the Centers for Disease Control and Prevention and other agencies, and it would enact President Biden’s Advanced Research Projects Authority for Health (ARPA-H) initiative. The House Energy and Commerce Committee will hold a hearing March 17 (see below, “Cures 2.0, and more”) to discuss an array of healthcare bills including the ARPA-H package, but not the broader pandemic bill.

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