Dive Brief:

The Food and Drug Administration has created a pathway for unauthorized digital health devices to access a new Medicare payment option.

In a policy published last week , the FDA said it will consider waiving typical market access rules for companies that want to join a new Centers for Medicare and Medicaid Services program.

The pathway could enable device developers to collect data through real-world use in the CMS’ Advancing Chronic Care with Effective, Scalable Solutions, or ACCESS, program.

Dive Insight:

The CMS created ACCESS to address barriers to care stemming from Medicare’s fee-for-service payment model. Rather than pay for specific services, Medicare will make recurring payme

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