Coverage with Evidence Development Private Sector Pilot
With funding from the California HealthCare Foundation, CMTP is leading an innovative effort to launch a pilot Coverage with Evidence Development (CED) initiative for stakeholders in the private sector. Under CED, health plans agree to offer provisional coverage for a promising but unproven intervention while data are being collected to generate the evidence needed to inform coverage policy.
Previous work by CMTP has demonstrated broad support for the concept of CED among stakeholders in the private sector, but unclear leadership for conducting a CED project. Furthermore, health plans and purchasers would be unlikely to undertake such a project on their own without funding for a “live project” to trigger the required work. Therefore, CMTP has assembled a multi-stakeholder workgroup of representatives from private health plans, self-insured employers, patients, clinicians, researchers, and others to participate in this pilot effort. The overarching charge of the workgroup is to design a feasible research and implementation plan for a multi-payer collaborative CED project. If this project succeeds, we will have established a precedent and a model for other stakeholder groups to conduct similar projects.
During the first research phase, CMTP successfully selected 3 appropriate potential technologies for a pilot CED study. Staff members chose to focus this project on the broad disease category of cardiology, and initiated topic selection using a refined version of the in-house priority-setting process. Cardiology was chosen because it has a large burden of disease and many high cost technologies, there is high-demand by users for emerging technologies, a large amount of pressure on payers for these technologies, and because cardiac technologies are often discrete and thus better suited for a pilot effort to design a CED program.
The inaugural meeting of the stakeholder workgroup was held on September 23, 2009 in Baltimore, MD. At this meeting, participants were asked to:
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Select an appropriate technology for a CED initiative, and
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Identify operational and study design issues that will need to be addressed to complete the project.
Ultimately,
the multi-stakeholder workgroup agreed with a high degree of consensus to move
forward with this project in the area of pharmacogenetic testing for warfarin
dosing. Common reasons cited included high operational feasibility as it would
likely be a short trial to look at adverse effects, have unambiguous outcomes,
and would be a good precedent topic for looking at other types of genetic
tests. The workgroup also discussed a number of operational issues that need to
be further addressed, including anti-trust concerns, coverage model options,
interface with regulatory requirements, identification and communication issues
with both patients and providers, funding issues, informed consent and other
ethical issues, and study design options.
At a second meeting of the stakeholder workgroup on March 18, 2010, participants agreed on elements of a CED study design that resembled the Genetics Informatics Trial of Warfarin to Prevent Deep Venous Thrombosis (GIFT trial), which is currently led at the University of Washington in St. Louis and funded by the CMS CED program. CMTP is currently developing a new protocol for a “Young-GIFT” study for the private payer population, and is working with Aetna and United Healthcare to develop specific CED language for this project.
CMTP has recently received additional funding from the California Health Care Foundation for the next phase of this work that includes the development of a new study protocol, submission of an NIH proposal, and implementation of the study.
For more information on the operational and implementation issues in private sector CED that were addressed by CMTP staff and the workgroup, please consult CMTP’s Issue Brief.
