PET on a Leash: Reimbursement Developments and Challenges

The operative phrase for PET reimbursement circa 2013 may be “cautiously optimistic.” The Centers for Medicare & Medicaid Services (CMS) is providing a bit more slack in reimbursement for imaging professionals towing the payer line. However, even with new reimbursement available for relatively broad cancer applications, other major issues need to be hashed out, particularly for dementia imaging, before PET could be considered out of the woods.

The two newest changes in reimbursement are the final CMS decision to expand coverage for FDG-PET for oncologic use as of June 11 and the July 3 draft decision for coverage with evidence development (CED) for diagnostic amyloid imaging of the brain in cases of cognitive decline, suspected Alzheimer’s disease and similar neurodegenerative disorders. A 30-day period for comment on amyloid imaging was opened and a final decision is expected in October. 

Make way for oncologic PET

The decision regarding cancer imaging is more of a boon because it effectively opens up the use of FDG-PET for a wide variety of oncologic applications, including prostate cancer, and it ends the National Oncologic PET Registry (NOPR) with the exception of sodium fluoride bone imaging, for which data collection under CED is still required. 

Essentially all applications of FDG-PET for cancer imaging are covered across the U.S. Physicians should be aware that the scan count returned to zero as of June 11, so previous scans for patients already in the system will not be included in quotas.

“The final landscape that we have ended up with is that oncologic PET is now covered for a single scan for what CMS calls initial treatment strategy,” explains Barry A. Siegel, MD, chief of the division of nuclear medicine at Washington University in St. Louis in Mo., and NOPR chair. The definition includes diagnosis and initial staging of cancer. “It is also nationally covered for three scans per cancer for subsequent treatment strategy, which would include treatment monitoring during a course of chemotherapy or radiation therapy, when a treatment change is being considered, for restaging of cancer at the completion of therapy and for suspected recurrence. It does not include surveillance.”

After patients have reached this limit, it is up to local Medicare administrative contractors (MACs) and their medical directors, who will have sole discretion for coverage or non-coverage decisions for additional scans. 

Is there wriggle room with MACs?

It worked well with some new cancer tracers to haggle with MACs regarding what should and should not be covered, notes Gary L. Dillehay, MD, professor of radiology at Northwestern Memorial Hospital in Chicago. 

“Once you get a local carrier that is a little more liberal, you say, ‘look in New York they are paying for things so why don’t you do the same thing?’ Local MAC medical directors get together and talk to each other several times a year,” says Dillehay. “Sometimes with some consensus they sort of even out the playing field and become more generous in their decisions.” 

Just as physicians can discuss patterns of approval with local carriers, they also can bring up patterns of denial for procedures that clinicians deem necessary. However, they face regulation when it comes to who can and cannot authorize a scan. The referring physician should authorize the scan, which requires some cooperation and coordination between physicians to create a united front for better coverage. 

On the minds of many physicians is how new data will be collected for national review. 

There is no set repository for CMS or local Medicare contractors to track how many scans a patient has had at another institution and pre-certification may come into play, but there have been no promises. Substantial information needs to be included in reports to pave the way for smoother approval and appeals. 

“With Medicare advantage plans and commercial insurers, most of them do pre-authorization, so if you try to do the fourth subsequent treatment strategy scan, you will know more or less in advance if the insurance company is going to pay for it,” says Siegel. “With traditional Medicare, at least up to now, they do not do pre-certification. But they have been talking about it for the last two years. Therefore if I believe that a scan is medically necessary and go ahead and do it, I have no guarantee that I can convince Medicare to pay for that scan.”

In terms of additional applications of FDG-PET, imaging for infection and inflammation could be in the hopper for CMS coverage approval, according to Siegel. A request for this coverage was submitted four years ago to no avail, but expanding evidence may make it more salient. 

Amyloid imaging caught in the crosshairs 

If CED for amyloid imaging of the brain is announced in October, CMS would require patients receiving a scan to be  part of an eligible clinical trial that provides proof-positive evidence of improved outcomes. Coverage of amyloid PET imaging would be limited to studies that clear up ambiguous cases where Alzheimer’s disease is not easily differentiated from other neurological disorders such as frontotemporal dementia. Coverage would be halted indefinitely after the first scan.

“The worst thing about all this is unfortunately this particular product is probably more useful in patients in the non-Medicare population—patients younger than 65,” says Dillehay, who explains that commercial insurers follow the general guidelines of CMS and if CMS is not paying, chances are, neither will insurers. 

“That’s a problem,” says Dillehay. “This will change if we ever get an effective therapy, because then you’ll need to know which patients might benefit from some of the drugs that they’re proposing to stop the amyloid deposition and hopefully reverse it, but that is obviously down the road a pace.” 

Appropriate use and outcomes research

“We are always looking for the cost basis and the appropriateness of what we do,” says George M. Segall, MD, chief of nuclear medicine service at the VA Palo Alto Health Care System. The VA does not bill Medicare, so little has changed at his practice, but Segall has been a representative for the Society of Nuclear Medicine and Molecular Imaging (SNMMI) and other organizations in the development of appropriate use. 

“The problem for diagnostic imaging is that it is only indirectly tied to patient outcomes,” explains Segall. “We can have a test that is very accurate in making a diagnosis that we believe has intrinsic value, but if it doesn’t affect patient management or if it doesn’t affect patient outcomes it makes it appear that the test itself has no value. It’s difficult when reimbursement decisions are based on outcomes evidence to demonstrate that accurate diagnostic imaging results have an effect on outcomes.”

A major question on the minds of clinicians is how they will provide the evidence needed to secure coverage for amyloid imaging. They will need to provide data that patient outcomes will be improved and that they will be used appropriately. 

As these decisions begin to blaze a wider path for PET, physicians need to remain focused on lobbying with CMS and negotiating with commercial insurance providers.