SummarySince Avalere last discussed Investigational Device Exemptions (IDEs), IDE regulatory and reimbursement policy landscape at FDA and CMS have issued some predicted changes; FDA has issued new draft guidance documents while CMS included many of these changes in their 2013 proposed physician payment rule.
CMS’ proposals include more centralized review of IDE trials, potentially led by the Coverage and Analysis Group (CAG), instead of leaving Category B device coverage up to MACs. This is an important development that may have significant impact on coverage for new device trials.
CMS proposed to cover the costs of routine items and services in a Category A study, and the costs of the investigational device and the routine items for Category B studies. In doing so, CMS laid down explicit criteria for automatic coverage: the study must be a pivotal study, and must also contain a superiority trial design. While this does not preclude CMS coverage for devices that have an IDE with inferiority trial design, it may offer a faster coverage process for pivotal studies that seek to demonstrate superiority to an existing/alternative device.
By centralizing the review process, CMS hopes to reduce variability, making reimbursement more consistent and easier for smaller companies; however, that will rely critically on how this rollout is implemented.
Several of these IDE trial designs – termed feasibility trials – are meant to be quite experimental and while evaluated by the FDA for safety parameters may lack adequate information on effectiveness. Therefore, it is still unclear if CMS will grant blanket approval for early feasibility IDE trials or if new criteria will be developed collaboratively by FDA and CMS at a later point. While much still remains to be determined, it is clear that FDA and CMS are no longer acting in isolation and that policy changes in one agency will largely affect the other.
Avalere’s new analysis not only goes through this entire process, but also highlights key recommendations for the life science industry:
- Evaluate the Final MPFS Rule: When CMS releases the final MPFS rule on or before November 27, trial sponsors will want to see if and how CMS addresses these concerns as their responses will dictate how useful this process is for study sponsors.
Efficiencies in Evidence Generation: As sponsors design clinical protocols for IDE studies to submit to FDA, they should take advantage of the fact that CMS will centrally review these studies and design them such that they also may address clinical utility and health outcome measures that may be the subject of coverage-related requirements later.
Ensure Pivotal Clinical Trials Take Payer Demands into Consideration: A less burdensome path to get FDA approval of an IDE study or technology does not mean that product sponsors should disregard the evidence requirements demanded by payers, like CMS. In fact, it is important for product sponsors to take into consideration the evidence demands of Medicare and other payers before, and not after they get FDA approval.