By Kurt Woock

A host of PET tracers are set to hit the market soon. Increasingly, diagnostic tools such as these must meet the threshold of demonstrating measurable outcomes demanded by outcome-based reimbursement models. Just how to do that, however, remains a question mark that stands between the products and their widespread use. Tasked with furthering the conversation, 52 representatives from the Centers for Medicare and Medicaid Services (CMS), the Agency for Healthcare Research and Quality, the Food and Drug Administration, the National Institutes of Health, the American College of Radiology, the Radiological Society of North America, the Society of Nuclear Medicine and Molecular Imaging, and other stakeholders met for an Endpoints Workshop in Baltimore in November.

At the meeting, hosted by the Medical Imaging & Technology Alliance (MITA), the representatives discussed possible frameworks for CMS coverage of emerging PET procedures and how coverage might apply to various subspecialties. Thus far, PET tracers have operated under a different set of coverage rules than most other items or services. The status, presumptive noncoverage, means that CMS has restricted coverage on the use of any PET procedure unless the agency specifically covers for a certain use or indication. This policy differs from most others in that items or services generally have coverage at the time they are approved by the FDA for marketing, with the provision that CMS later can place specific restrictions on coverage. In order for the new PET tools to be available to more people, this policy will need to be changed.

Gail-5 hi-resGail Rodriguez, PhD, Executive Director, MITA

Gail Rodriguez, PhD, executive director of MITA, pointed out the crux of the challenge: “The key message is that diagnostics are different. It’s easy to track the success of a therapy—it works or it doesn’t.” According to Rodriguez, CMS has started to identify more and more endpoints, such as the reduction of mortality, by which to judge the effectiveness of treatments. But endpoints for therapies don’t have clear parallels in diagnostics. “Tracking whether a diagnostic contributes to a reduction of mortality is extremely difficult and time-consuming,” she said. “CMS agrees, but then we need to have the conversation; ‘Well, what are the right endpoints?’ We need to find the appropriate standard by which we judge diagnostic imaging, starting with PET. We need to provide a reasonable evidentiary threshold.”

For the Endpoints Workshop, MITA brought in methodological experts, who helped guide participants through the fundamental definitions of diagnostic endpoints, as well as health economic considerations. After that, attendees divided into groups by expertise and disease state. Brian Abraham, director of policy for MITA, said the three specialties relevant to PET—oncology, neurology, and cardiology—met separately and came up with their own ideas on recommendations that were put forward. “The general consensus of all three groups was: diagnosis should result in lower radiation doses; one of the diagnostic endpoints should be the determination to stop treatment if it has been effective or if it has not been successful; the decision not to treat. Those main points had the most resonance with CMS.”

A first step toward removing restrictions to access to PET procedures recently occurred. In mid-December, CMS proposed to remove the national non-coverage decision for PET for FDA approved oncologic applications. If the decision is finalized, local Medicare Administrative Contractors (MACs) may determine coverage for new oncologic agents within their respective jurisdictions for PET.

Another key step is to publish the proceedings from the Endpoints Workshop. CMS could then use the proceedings paper as a piece of evidence to help codify their guidelines. Rodriguez said she anticipates MITA will continue to stay active bringing people together. “We are good conveners. We’re asking the hard questions, and people feel comfortable in these forums.”