FDA, CMS to Pilot Parallel Device Reviews
The Food and Drug Administration and Centers for Medicare and Medicaid Services will launch a pilot program to conduct parallel reviews of medical devices deemed innovative.
The Food and Drug Administration and Centers for Medicare and Medicaid Services will launch a pilot program to conduct parallel reviews of medical devices deemed innovative.
The goal is to reduce the time between FDA approval and a Medicare national coverage determination of whether it will reimburse for use of an approved device.
"The efficiencies gained by parallel review are expected to benefit all interested parties," the agencies say in a notice issued Oct. 7 and being published in the Federal Register on Oct. 11. "Patients are expected to gain quicker access to innovative medical technologies if they are covered. The sponsor/requester gains timely insight to the information needs of CMS with respect to pursuing a positive NCD, as well as a potentially shortened time to payment due to a streamlined multi-review process. The agencies gain enhanced channels of communication. Specifically with regard to CMS, its early involvement will streamline the decision making process."
The notice, available here, explains provisions of the pilot program and how to submit an application to participate, and how the agencies will determine candidates with "truly innovative technologies".
The goal is to reduce the time between FDA approval and a Medicare national coverage determination of whether it will reimburse for use of an approved device.
"The efficiencies gained by parallel review are expected to benefit all interested parties," the agencies say in a notice issued Oct. 7 and being published in the Federal Register on Oct. 11. "Patients are expected to gain quicker access to innovative medical technologies if they are covered. The sponsor/requester gains timely insight to the information needs of CMS with respect to pursuing a positive NCD, as well as a potentially shortened time to payment due to a streamlined multi-review process. The agencies gain enhanced channels of communication. Specifically with regard to CMS, its early involvement will streamline the decision making process."
The notice, available here, explains provisions of the pilot program and how to submit an application to participate, and how the agencies will determine candidates with "truly innovative technologies".
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