When a new medication or product gets FDA approval, the CMS covers it on a provisional basis. However that’s not the case when a new PET tracer gets FDA approval. CMS automatically refuses to cover it without years of further study and proof of effectiveness.
That non-coverage ruling may soon change, thanks to a collaboration led by the Medical Imaging & Technology Alliance (MITA), which has been working with CMS and several other industry organizations to change the process. MITA officials said they hope that by changing the regulatory firewalls, PET tracer development will increase, also allowing CMS beneficiaries more timely access to PET scans with novel tracers. Research and development of new tracers has been stifled because of the approval process, experts say, and patients aren’t getting the benefit of FDA approved products.
CMS is taking public comments on the coverage proposal through August 10. It will render its decision by January 11, 2013, with the decision effective April 11, 2013.
The non-coverage decision history goes back to the early 2000s, according to MITA executive director Gail M. Rodriguez, PhD. Back then, “it was very novel. The technologies were new. CMS wasn’t sure what to do with it,” she said. “They thought to issue a broad coverage decision would be irresponsible, they’d need evidence.”
Since then, four PET tracers have been approved for PET imaging, including the most common fluorine-18 (F-18) FDG, plus rubidium-82 (Rb-82), nitrogen-13 (N-13) ammonia, and F-18 sodium fluoride (NaF).
However the medical landscape has changed, Rodriguez said. “To get something approved by the FDA is a different thing than 15 years ago. The quality of the evidence for safety and effectiveness by the FDA is quite a bit higher than it used to be. The clinical trials that are required to get a drug through the FDA require serious evidence.”
Last year, MITA undertook an effort to get CMS to reconsider their non-coverage decision. They put together a workshop with participants from CMS, the local insurance contractors, academics, policy makers, industry and think tanks, to figure out a way out of the impasse. This resulted in a formal request from MITA and four other organizations, asking CMS to reconsider.
Currently, new PET tracers are automatically not covered by CMS, which is rare for other new drugs and medical products. “Drugs are at least provisionally covered when approved by the FDA,” said Brian Abraham, senior policy director of MITA. “We didn’t ask for anything different than that.” If a new tracer comes out, he added, he’d anticipate getting provisional coverage for it, with CMS restricting its use only if there’s reason to believe it should be restricted. “Out of the gate we want it to be on the same playing field.”
Coverage and eligibility for reimbursement is generally up to the local CMS contractors, insurance companies around the country that handle the CMS payments.
“It’s up to them to cover on a local basis, so sometimes it’s staggered coverage when a new product comes out,” Abraham said. “By getting the reconsideration request hopefully approved, we hope it will be the same patterns with new tracers. We’re requesting the same consideration that other new products get.”
Times have changed since PET was developed, said Rodriguez, and PET imaging has made huge strides. “It’s a very established modality with lots of excellent published research behind it,” she said. Many factors led to the rise in PET imaging, like improvements in PET scanning equipment, corroboration of independent research on its value, and the ability to get physiologic information and anatomic information by combining with CT scans.
Abraham added that CMS realizes there will be a lot more newly FDA-approved PET tracers on the market in the near future. “We all realize it’s a different era and they don’t want things to be behind,” he said.
Several proprietary tracers are in the pipeline right now, including one just approved by Eli Lilly (Amyvid – florbetapir F-18) which detects beta amyloid plaque for Alzheimer’s disease. “This is important to make sure that Medicare beneficiaries have access to this in the future,” said Rodriguez.
There’s concern that the prior non-coverage of new tracers has affected the both research and development, and actual treatment, though that requires some speculation, said Rodriguez. “Our feeling is that it’s hindered the development process,” she said. “You may not be as willing to invest in those tracers if you don’t have the comfort of knowing it would be covered. It’s been a number of years since a novel PET tracer has been approved by the FDA, and I think that the non-coverage decision had something to do with it.”
To gather data to support a tracer’s benefits, the National Oncologic PET Registry (NOPA) was used, along with studies published with the data. This has helped convince CMS to cover some FDG indications. “We now have many indications covered for FDG because the data were most significant,” Rodriguez said. “The Journal of Clinical Oncology in 2008 showed that PET scan results changed the referring physician treating decision 36 percent of the time. That convinced CMS. That is the hard way to get coverage. Years had to go by.”
While the decision won’t be a slam dunk, Rodriguez said that she is encouraged. “We’ve been working with CMS and the coverage analysis group every step of the way,” she said. “They’ve been cooperative in helping to craft the best possible request and reasons for it.”