CMS is seeking public input on its policy of “coverage with evidence development” as it considers how to more effectively use this tool when making coverage decisions, particularly with new technologies that may not have sufficient data on effectiveness at time coverage begins.

In a Nov. 7 comment solicitation on the agency’s website, CMS noted that it is seeking feedback with the intention “to mature CED so that it fulfills its potential as a mechanism that simultaneously reduces barriers for innovation and enables CMS to make better informed decisions that improve health outcomes for Medicare beneficiaries.”

Under CED, CMS agrees to reimburse for technologies or procedures that the agency feels are not yet fully proven in exchange for having patients who receive such treatment participate in a registry or randomized clinical trial from which more data can be collected.

CMS is asking for comments on three subject areas: “implementation of CED through the national coverage determination process or other avenues under Part A and Part B; potential impact of CED on the Medicare program and its beneficiaries; and suggested approaches to CED to maximize benefit to Medicare beneficiaries.” Comments are due Jan. 6, 2012.

“We will weigh public input on CED with our internal lessons learned to develop a guidance document that better aligns CED with the rapidly evolving changes in our health care system,” the agency said in the posting, adding that CED “has the potential to accelerate Medicare beneficiaries’ access to innovative items and services and use evidence to identify the setting(s) in which a patient population is more likely to see the greatest benefit from an item or service.”

The agency said CED has produced some “gains in innovation” but experience “indicates we still have room to improve the CED process.”

CMS recently entertained the idea of using CED in an effort to gain more information about the prostate cancer vaccine Provenge, but ultimately backed off that approach, deciding there was enough data to support coverage within its labeled indication and leaving off-label coverage decisions to local contractors Also see "Medicare Will Cover Provenge Labeled Uses, CMS Proposes; Off-Label Is Up To Contractors" - Pink Sheet, 30 March, 2011..

Coverage with evidence development has been sporadically used in general, and only twice in the area of pharmaceuticals and biologics, most recently for a genetic test that helps determine appropriate warfarin dosing Also see "CMS-Blessed Warfarin Genetic Testing Trial Aimed At Winning Over Payers and Docs" - Pink Sheet, 2 March, 2011.. Prior to that, it was used to collect data on colorectal cancer therapies. [Editor's Note: This story was updated Nov. 9, 2011 to clarify when CED has been used in the pharmaceuticals and biologics area.]

In 2009, the Medicare Payment Advisory Commission looked into whether CMS needs stronger statutory authority to pursue CED, as well as whether it has the funding to maintain it Also see "Funding, Authority Questions Hinder Coverage With Evidence Development" - Pink Sheet, 23 November, 2009..

CMS Sets The Stage For New Medicare "Coverage With Evidence Development" Guidance

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