Thursday, April 7, 2022

Biggest-ever Academic Report about "Coverage with Evidence Development:" What Really Happens

There's a lot of discussion of "Coverage with Evidence Development" and "Parallel Review" at CMS, especially now in light of policy efforts variously called "MCIT"  (Medicare Coverage for Innovative Technology) and "TCEC" (Transitional Coverage for Emerging Technology.)  (Short video here, documents from Duke and Stanford here.)

I've always made two points. First, in ten years, "parallel review" with FDA and CMS has only been used twice (!) and both times, in highly unique, special policy circumstances.

Second, while CMS has a web page with a couple dozen "CED" projects dating back many years, I've pointed out there's never been a firm objective review of the successfulness or value-created by CED.  (Elsewhere, I've argued that CED is usually value-destroying when you apply the numbers - here).


Now, for the first time, at American Journal of Managed Care, we have an outstanding and thorough review by Zeitler et al., the first systematic and outcomes-oriented look at CED.   Highly recommended; and open access.

Find it here:

(Cloud copy here.)

Clipping the CONCLUSIONS:

The CED program is a powerful tool wielded by CMS when more data are required to make an assessment of whether a therapy or service is “reasonable and necessary” for Medicare beneficiaries. 

This systematic review of the CED program reveals variation in the program that leads to uncertainty among stakeholders whose partnership is fundamental to CED program success. Making the program more transparent and predictable may improve stakeholder engagement in a process that could ultimately bring promising therapies and services to Medicare beneficiaries in a timely way while offering a mechanism to restrict access to those therapies that are not beneficial. 

Changes to the CED program to improve transparency and predictability can be applied to future and existing CED NCDs. 

Furthermore, lessons learned may inform future policies to more expeditiously provide coverage for promising breakthrough devices or for therapies that fall outside the scope of the CED program, such as self-administered drugs.