1. McGivney, William T. PhD

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Coverage with Evidence Development (CED) is a policy proposed under the Medicare Program that would provide coverage for a health care technology with the stipulation that studies be performed to more conclusively define the safety/effectiveness profile of the technology for the specified indication.

WILLIAM T. MCGIVNEY,... - Click to enlarge in new windowWILLIAM T. MCGIVNEY, PHD, CEO of the National Comprehensive Cancer Network through the end of 2011, and before that Vice President for Clinical and Coverage Policy at Aetna Health Plans, is now Principal, McGivney Global Advisors.

The concept of CED is not new, but CED has never been widely implemented by the Medicare program. On May 16, the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) met at CMS to generally discuss the "evidentiary thresholds" that would trigger a CED analysis, be sufficient to establish CED for a technology, and allow extrapolation of CED evidence to other settings, practitioners, and indications.


An increasing use of CED by the Medicare program has significant implications for patients, providers, and innovator companies as CED would impact the introduction, diffusion, and overall use of drugs, biologics, devices, and procedures.


The concept of CED has been a point of some discussion since the 1980s when it was considered at the old government Office of Health Technology Assessment. In the early 1990s, it was a focus of discussion as the private insurance industry sought to address the demand for high-dose chemotherapy with bone marrow transplant in a number of tumor types, most especially in breast cancer.


Recently, consideration of the concept was elevated to more serious consideration by Sean Tunis, MD, during his tenure as the Chief Medical Officer for the Medicare Program. To date, the Medicare Program has applied the CED to eight to 10 technologies with varying degrees of rigor and impact.


In cancer care to date, the most significant application has been the development of a registry to track the use of positron emission tomography (PET) in the evaluation of solid tumors and to measure the impact of that PET use on clinician decisions about patient care.


Increasing and regular application of CED in establishing Medicare coverage raises a litany of issues impacting many constituencies. One such question is how one would select the technologies to be evaluated under CED. Further, there was much discussion and seeming confusion among MEDCAC members regarding what the term, "evidentiary threshold," meant in terms of CED and if one could establish a uniform set of criteria.


Sidebar conversations in the audience among those who had run coverage groups in large payer organizations indicated that most often it is a technology-by-technology call-almost "you know it when you see it."


For example, with serious and life-threatening illnesses in cancer, it is important to recognize that indeed patients, clinicians, and payers often should be willing to accept a lesser degree of certitude of effectiveness and a greater risk of harm given the compelling and closing nature of the illness.


Other important issues include potential long time frames (3-5 years) for the actual conduct of the CED studies and the role of observational outcomes databases and other study methods vs. the gold standard of the randomized controlled clinical trial. One MEDCAC member suggested that eventually all coverage decisions might be performed through CED processes.


Industry representatives raised the issue of more circumscribed availability and longer timeframes before valuable and innovative technologies might become generally available. While the focus of CED might be on procedures and devices, it is likely that expensive oncologic drugs and biologics will be in the spotlight. Given the rapid advances in oncology, is a three- to five-year time frame for study relevant in the life cycle of a biologic where new mechanisms of action are frequently introduced with second- and third-generation agents following on closely?


Further, as collaborations between academia and industry strategically develop mutation-directed agents, will CED become irrelevant for such agents; even for off-label use if the pertinent mutation is found to be prevalent and dominant in the additional tumor type? It is clear that the increased use of CED will impact access to and availability of drugs, biologics, devices, and procedures in cancer care. Will such impact be nurturing or stifling, or will the impact vary technology by technology?


So where are we? The meeting on May 16 seemed to be a forum held to legitimize the concept in a more public fashion. A CMS staffer indicated at the outset that the MEDCAC meeting was a first step in how CED will be approached at Medicare; opportunity for public comment on new CMS Guidance will be available in the coming months. Observations by this author strongly suggest that practicing clinicians and their representative associations, innovator companies and their associations, and, clearly, patient advocacy groups need to be more integrally involved in the evolution of this process.


The basic premise of coverage with evidence development is clear and correct-the development and accumulation of scientific evidence about technologies for specific indications is critical to the safer, more effective, and more efficient use of drugs, biologics, devices, and procedures in patients.


The balance that must be struck is achieving a CED process that also is safe, effective, and efficient in making innovative technologies available to patients in need in a timely fashion.


The diversity of disease entities, the rapidity of technological advancement, and the life-threatening nature of many of the diagnoses make cancer care the most challenging of applications for the CED paradigm.