Experts Discuss NOPR & CMS: Will PET Gain U.S. National Coverage for All Indications?
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Over the last year, the molecular imaging community has seen a flurry of activity since CMS reopened the case for a coverage expansion for the use of FDG PET for cancers and other indications not eligible for Medicare reimbursement. Study data released in the May 1, 2008, issue of the Journal of Clinical Oncology from the National Oncologic PET Registry (NOPR) showed a striking consistency of the impact of PET on referring physicians’ intended management plans, prompting the registry to formally ask CMS to reconsider a national coverage determination (NCD) on oncologic use of PET.
As a result, NOPR, which started collecting data in May 2006 in response to the CMS policy regarding CED for currently non-covered cancer indications, set out to address whether the impact of PET varied between cancers in its second year of analysis. NOPR researchers felt they had reached the moment of critical mass by confirming the effectiveness of PET in the monitoring of tumor activity across a wide range of cancers, with the most recent release of data from the registry published in the December 2008 issue of the Journal of Nuclear Medicine. The study results, collected from nearly 41,000 PET studies for staging, restaging or detecting suspected recurrences in patients with pathologically proven cancers conducted at 1,300 PET facilities across the United States, showed that when intended management was classified as treatment or non-treatment, physicians changed their intended management in 38 percent of cases. The data showed that one-third of older Americans undergoing PET for cancer types covered under Medicare’s CED policy had a major change in intended management, including type of treatment. (As of October 2008, 1,629 U.S. PET facilities are participating in NOPR, about 90 percent of all sites nationwide.)
Going into the new year, there were high expectations for CMS’ draft decision memo, but with its publication in January came a wave of disappointment and support—for while it proposed to remove a significant part of the CED requirement for PET scans in cancer and allow coverage for one PET scan to guide the initial treatment strategy, it stated CED would still be required for PET scans for subsequent treatment strategies.
While the efforts of CMS to develop an omnibus framework are speculated to help minimize the need to seek indication-by-indication decisions in the future, broad coverage is still the brass ring that could continue to be just out of physicians’ reach.
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- Barry Siegel, MD, co-chair of the NOPR Working Group and professor of radiology and chief of the division of nuclear medicine at Mallinckrodt Institute of Radiology in St. Louis;
- R. Edward Coleman, MD, member of the NOPR Working Group and director of the nuclear medicine division and vice-chairman of the department of radiology at Duke University Medical Center in Durham, N.C.; and
- Peter Conti, MD, PhD, board member and past president of SNM (the Society of Nuclear Medicine); professor of radiology, clinical pharmacy and biomedical engineering at the University of Southern California’s (USC) Keck School of Medicine, School of Pharmacy and School of Engineering, respectively; and director of the PET Imaging Science Center at USC’s Keck School of Medicine.
What was your initial reaction to CMS’ proposed decision against broad coverage?
Siegel: I believe there is no reason why PET shouldn’t be a part of the physician toolkit for managing patients with cancer in the same way that CT and MRI are. Doctors are capable of choosing which test is best for what clinical circumstance, especially when they are guided by what is best for their patients and not guided by financial incentives.
Coleman: I was disappointed with the proposed decision in that I thought we had submitted good data from the NOPR and the literature that would provide ample evidence for coverage of PET for all cancer indications, excluding diagnosis of breast cancer and prostate cancer. I can see where breaking the coverage framework into two categories—initial and subsequent treatment—can have some merit, but I don’t like that patients are limited to having one PET scan in a lifetime for initial treatment.
Conti: Of course I am disappointed it wasn’t opened up to broad coverage and the practice of medicine will ultimately play out for what is useful or not useful at this point. The micromanagement of this technology now in oncology is probably a bit old—they need to open it up and let us just practice medicine. To micromanage how we apply the technology to individual cancers and timing of disease is well beyond any other management approach within imaging for other technologies.
What could be prohibiting coverage expansion?
Siegel: To some extent, it’s a question of what is politically realistic and accomplishable in an environment where PET is being held up to much higher standards than were CT or MRI when they were approved for broad coverage. If those modalities were forced to go through the same indication by indication process now, there could be instances in which the evidence supporting broad coverage would be thin. It would have been better to base decisions on how the imaging tool works, a basic understanding of the physical principles, in the case of CT or MRI, or the biological principles, as in the case of PET, and how that relates to the detectability of cancer—but they didn’t do that. Yet, nonetheless, they have made a significant expansion in coverage for which I am very pleased. But I would have been happier and more comfortable if they had just said they would cover PET broadly.
Conti: There’s always a question whether people are going to abuse the technology—but this should be addressed by requiring credentialing and quality. Frankly, I don’t see how it is justified given the broad use of all other imaging modalities—why chastise this technology versus another? There are other expensive imaging modalities in other parts of medicine that don’t have this type of restriction. Perhaps it is because of our track record with non-coverage determinations and piecemeal expansion by CMS that seems to warrant continuing in this way.
What about the evidence?
Coleman: There is no way they could have used the data from NOPR to make the determination that they did. It seems like they fell back on the evidence-based medicine report from the Edmonton, Alberta, group to make their decision. Unfortunately, the literature isn’t all that convincing on the non-covered indications, especially to support treatment monitoring, recurrence detection and restaging. It’s a Catch-22. If they are not covered, they are not studied in the literature. But that is one advantage of NOPR—patient studies under NOPR will provide more data in the future.
What should we expect if the proposed decision remains as published?
Siegel: If coverage occurs as proposed, approximately 50 percent of what is now being done under NOPR would become routinely covered, which could be an increment of 20,000 to 25,000 additional PET scans per year. As far as coverage gaps are concerned, the NOPR investigators are in active communication with CMS and we are hoping to avoid coverage gaps; that we will have a modified NOPR in place that fulfills the somewhat more rigorous requirements in the NCD for the kind of data that CMS is going to want. But, we won’t know anything until the date they publish the final decision. We are getting ready and just waiting; eager to do anything we can do prevent a coverage gap.
Coleman: The issues to going forward are now what type of CED program is acceptable and will be instituted by CMS. Will this be initiated immediately when the present CED ends on or before April 6? We are hoping CMS will approve a CED that will provide coverage immediately so there is no gap in coverage, and that we can gather data for Medicare that will be helpful to prove subsequent evaluation for these cancers that are not currently covered.
Conti: I think [CMS] will stick with their decision and what will happen is the private sector will continue to move on as it already has, even though some Medicare patients will be denied coverage. It’s unfortunate that you will see more Medicare patients not have access to technology based on decisions that the agency is making rather than the physicians who take care of the patients. In any case, there will need to be clarification on the coverage gap between approvals. I am hoping that they will continue to at least collect more data on those non-covered indications to do further evaluation. We need to ask more relevant questions in those follow-up trials that will be helpful and we need to continue to move along in those directions that will ensure we get to broad coverage.
| SNM Recommends: PET Providers Take Action Now! |
| CMS’ new policy is effective on the day it is published. While NOPR and SNM have stated that they believe it is highly likely that a newly developed CED program will be in place by the date the coverage policy is published, the details of the final coverage policy will not be known until then. SNM has recommended that PET providers take the following information under advisement to be best prepared for the April 6 ruling date:
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