CMS Publishes Coverage Evidence Development Guidance Comments
called its April 2005 draft guidance doc.pdf ”Factors CMS Considers in Making a Determination of Coverage with Evidence Development.” Now, you tell me what that means. Right. I thought so. It means nothing to most people. What it really means, however, is: “How CMS (overseers of Medicare) plans to decide when current clinical evidence supports coverage, and how to improve clinical evidence when coverage is not unconditionally supported.” As you probably know, CMS is obliged to provide coverage under Medicare for certain therapies, when such therapies are deemed to be reasonable and necessary for diagnosis or treatment of disease. Unconditional coverage is provided when “the evidence is adequate to conclude that the item or service improves net health outcomes for all patients with a particular clinical condition.” The draft guidance is a precursor to a future formal CMS guidance that will describe ways in which CMS will make this “reasonable and necessary” determination for coverage decisions. The 15-page draft is an exciting document for proponents of evidence-based medicine, since CMS proposes to promote collection of evidence in a variety of ways that will support clinical decision-making (and Medicare coverage) for individual patients. The document is brief and, aside from the title, clearly written and worth perusing.
CMS was apparently keen on inviting public commentary on its ideas. Two and half months later, they’ve published these comments. To save you the trouble of reading through all 400+ pages, I’ll highlight some of what Pharma and Biotech wrote (you’re quite welcome).
In all, 15 pharma/biopharma companies and their respective industry organizations submitted comments. While there was some expressed enthusiasm for incorporating additional elements of evidence-based medicine into CMS’ coverage determinations, there was also concern that CED is a thinly veiled euphemism for CMS attempts to limit Medicare coverage.
Bayer came right out and expressed their skepticism: “We are sensitive to the Agency’s attempt to ensure that Medicare provides payment for items and services under conditions that help assure significant net benefits…. Nevertheless, we remain skeptical of this approach and the Agency’s ability to meet the minimum standards for coverage as required by Congress in drafting the Social Security Act.” Such skepticism was conveyed in other ways by other drug companies. Here’s a typical comment: “Sanofi-aventis recommends that CMS clarify in the guidance that CED will be used only if the criteria to open a national coverage determination are met and only when that process would otherwise have resulted in a determination of noncoverage. For example, CMS should make clear that CED will not be used to limit coverage that is provided pursuant to specific provisions in the Medicare statute.”
Many of the comments were much more critical, challenging CMS’ statutory authority to employ CED in its coverage decisions. For instance, Amgen: “We recommend revising the Draft Guidance so that the scope is more clearly defined and the Draft Guidance is used in a way that is consistent with CMS statutory authority. CMS should provide assurance that the Draft Guidance will not interfere with the accepted statutory framework of reasonable and necessary for coverage of drugs and biologicals. We believe that some aspects of the Draft Guidance are unclear in this regard.” And, again, Bayer: “According to the Draft Guidance, the Agency derives the statutory authority to link coverage decisions to the collection of additional data from 42 U.S.C. § 1862(a)(1)(A). Upon review, Bayer is unpersuaded that the CED approach as articulated by CMS complies with the statutory requirement that Medicare limit its payment to items and services that are “reasonable and necessary” for the treatment of illness or injury.” And Johnson & Johnson: “While we recognize CMS’ underlying statutory authority to determine which items and services are “reasonable and necessary” for Medicare beneficiaries,…CMS should recognize that a guidance document does not have the same standing as a regulation promulgated under the Administrative Procedure Act [which provides for off-label use of cancer drugs, for instance–FJC]. And from Merck: “The rationale for CED is neither entirely clear nor consistent, and the tie to the reasonable and necessary statutory requirement is indirect. CMS stipulates that a service may be reasonable and necessary only when a provider collects and reviews data at the time the service is delivered. This is arguably the very protocol of good, standard, medical practice.” Finally, from Sanofi-Aventis: “The U.S. Congress has designated the FDA as the agency in charge of ensuring that drugs and devices are not brought to market until they have been proven to be safe and effective (and an assessment of side effects is inherent in making a determination regarding whether or not a drug is safe enough to be marketed to the public). We do not believe that CMS has the resources to duplicate FDA’s mission. If a product has been approved by the FDA as safe and effective, CMS should rely on that decision, as the agency has done in the past, and should instead concentrate its resources on ensuring that beneficiaries have the same access to FDA-approved products as do patients not on Medicare.”
I will be sure to keep an eye on this developing Guidance and will keep you informed. My initial reaction is that CMS has in Mark McClellan a leader who is not interested in waiting for things (i.e. statutes) to happen. He intends to make them happen, and he wants CMS to be a leader in defining what constitutes good clinical practice (in the medical, not regulatory, sense), akin to UK’s NICE. Will he succeeed in his lofty goals? He clearly will face obstacles from industry.
