On April 3, the Centers for Medicare & Medicaid Services published a decision memorandum announcing significant easing of its coverage requirements for Positron Emission Tomography (PET) testing of solid tumors and myeloma. A minimally invasive diagnostic imaging procedure, PET uses a radioactive tracers to evaluate glucose metabolism in tumors and in normal tissue.
Medicare’s PET coverage has been the subject of considerable controversy and relatively frequent adjustment over the years. The new coverage policy, which elicited strong supportive comments from industry (e.g., AdvaMed) and professional societies (e.g., the American College of Radiology and the Society of Nuclear Medicine), came almost exactly one year after the initiation of a policy review requested by researchers participating in the National Oncologic PET Registry.
Three distinct aspects of the new policy – and the process by which it was developed – are worthy of discussion.
First, prior CMS PET tumor coverage analyses and policies utilized an analytical framework based on required cancer-by-cancer consideration of four possible applications: Diagnosis; Staging; Restaging; and Monitoring of response to therapy.
In the new policy, CMS adopted a simplified, two-category framework: Determination of initial treatment strategy and Assessment to determine the need for and content of a subsequent treatment strategy. This revision reflects CMS’ effort to adapt coverage policy to the evolving nature of clinical practice.
As stated in the memorandum:
“We received public input indicating that the previous coverage framework which required cancer-by-cancer consideration of diagnosis, staging, restaging and monitoring response to treatment was challenging for a variety of reasons. They commented that it was burdensome to implement and was not consistent with the cancer treatment community’s approach to cancer management. While that coverage framework was useful when introduced, we do not believe that it currently represents how physicians determine treatment for cancer patients. The treating physician’s dilemma is to determine how to initially treat the tumor and then, based on response, develop a subsequent strategy.“ (emphasis added)
Second, the new coverage policy represents a victory for and endorsement of the general principles of evidence-based medicine and the practical application of Medicare Coverage with Evidence Development. A careful reading of the coverage memorandum reveals a comprehensive and transparent process of data and opinion solicitation, review, and consideration; no interested party was excluded from participation; every comment received from outside CMS was (and remains) available for review by the public, and the bases for the resulting coverage policy decision are fully revealed.
While many in industry have viewed CED as a mechanism designed to limit or postpone coverage of high-cost diagnostics and therapeutics, CMS has consistently argued that the option is more permissive than restrictive – that it provides a mechanism to allow controlled coverage, and Medicare funding of clinical data collection, for promising new technologies which lack sufficient data to allow a positive coverage determination.
At least one ruling, the 2008 decision to provide coverage for artificial hearts under CED, speaks to CMS’ effort to promote continued development of a promising new technology that is distinctly not ready for prime time.
With regard to PET testing, Medicare coverage had been expanded (PDF) effective January 28, 2005, but with many indications covered only if the patient were enrolled in a qualifying clinical trial or data collection protocol.
But CMS did not, in this case, leave providers and industry wholly to their own devices; rather, CMS was a full participant in the data collection process, funding NOPR and recognizing the voluntary registry as an appropriate data collection mechanism under CED.
As mentioned previously, NOPR was the initiator of the most recent coverage policy review, and data from NOPR provided the most powerful support for the new and more permissive coverage guidelines. CMS support and funding for NOPR was thus critical to providing the evidentiary base for the expansion of PET coverage. An agency more interested in restricting the growth of PET testing might have left industry to conduct its own studies and registries – without a priori endorsement of data protocols.
Finally, the new policy does make PET coverage more readily available to patients and less administratively complicated or problematic for providers – it’s a clear step forward in the exploitation of the potential of a powerful diagnostic tool. As summarized by the Academy of Molecular Imaging:
“Under the NCD, Medicare will cover one FDG-PET study related to initial treatment decisions for patients with essentially all types of solid tumors that are either biopsy proven or are strongly suspected based on other diagnostic testing. Prostate cancer is excluded from this coverage, and certain coverage limitations remain for breast and cervical cancer and melanoma (see decision memo at here for a full explanation).”
“The following cancer indications are covered for subsequent treatment strategy evaluation: colorectal, esophageal, head and neck, lymphoma, non-small-cell lung, ovarian, cervical, breast, melanoma and myeloma. For all other cancers, PET coverage for subsequent treatment strategy evaluation requires participation in an approved Coverage with Evidence Development (CED) program. The NOPR Working Group expects that it will participate in this CED and that CMS will link these data to the Medicare claims database to track patient outcomes.”
The CED process remains in place for oncology indications that have not yet yielded data sufficient for an evidence-based coverage determination; CMS and the provider community remain engaged in a cooperative process.