On October 24, 2016, the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) announced the full implementation and indefinite extension of the Program for Parallel Review of Medical Devices (the Parallel Review Program). The Program, which is intended to reduce the time between FDA marketing approval or FDA’s granting of a de novo request and Medicare coverage decisions through CMS’s National Coverage Determination (NCD) process, facilitates earlier access to innovative medical technologies by allowing the agencies to review information about a medical device concurrently while continuing to make their premarket review and coverage decisions consistent with their respective statutory authority. 

In 2010, FDA and CMS announced their intention to initiate a pilot version of the Program to establish a process for concurrent evaluation of certain medical devices.  See 75 Fed. Reg. 57,045 (Sept. 17, 2010). The following year, the agencies published guiding principles for the Program and procedures for participation, see 76 Fed. Reg. 62,808 (Oct. 11, 2011) and, in 2013, extended the Program for two years after the initial pilot phase concluded, see 78 Fed. Reg. 76,628 (Dec. 18, 2013). With last week’s announcement, the Program has been fully implemented and extended indefinitely. See 81 Fed. Reg. 73,113 (Oct. 24, 2016).

In support of this decision, the agencies note that the Program benefits manufacturers by giving them the opportunity to receive and address input from both agencies during pivotal clinical trial design and that concurrent review can reduce the time from the end of the FDA review process to an NCD. 

To be considered for the program, manufacturers must submit the following information to Parallel-Review@fda.hhs.gov before beginning the pivotal clinical trial design development phase:

• Basic information about the manufacturer, product, disease, or condition the device treats, and its state (stage) of development 

• Manufacturer’s statements

  • regarding its intent to meet jointly with both FDA and CMS to gather and incorporate feedback in clinical trial design

  • that the device will require an original or supplemental PMA or for FDA to grant a de novo request

  • that the device addresses the public health needs of the Medicare population

Devices excluded by statute from Medicare Part A or Part B coverage are not eligible for the program.

As was the case during the pilot Program phase, the agencies will accept a maximum of five devices into the program per year. When deciding whether to accept a device, the agencies intend to prioritize innovative medical devices and devices expected to have the most impact on the Medicare population. 

The agencies have approved one medical device during the pilot Program phase, but full implementation of the program signals the agencies’ interest in encouraging the development of innovative devices. In considering whether to apply for the Program, companies should consider the following:

• Whether the device can be covered by a Medicare regional contractor without a NCD, i.e., whether the device can otherwise be reimbursed under existing codes or through local coverage determinations (LCDs);

• Whether an adverse NCD would create obstacles to obtaining a LCD or third-party payer coverage and reimbursement;

• Separate coding and reimbursement considerations not addressed by the Parallel Review Program

• If the device will be primarily used in patient populations not covered by Medicare

• Whether and to what extent FDA’s decision to decline clearance or approval of an indication could affect Medicare coverage of off-label indications; and

Whether FDA knowledge of the company’s intent to obtain Medicare coverage for an unapproved indication could delay FDA approval as it applies scrutiny to those prospective indications.