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CMS Proposes New Coverage Policy for PET

Butcher, Lola

doi: 10.1097/01.COT.0000346856.69617.4e
Notes on Reimbursement

Convinced that positron emission tomography (PET) helps oncologists make treatment decisions for their patients, the Centers for Medicare & Medicaid Services is proposing a new framework for paying for initial PET scans for Medicare patients with cancer.

That good news for oncologists and their patients is tempered, however, by uncertainty as to how CMS plans to pay for follow-up scans in the near future.

Like private payers, CMS has been skeptical that PET was an expensive technology that cost more than it was worth.

Three years ago, the agency introduced a novel approach—covering PET scans for Medicare patients who were enrolled in the National Oncologic PET Registry (NOPR)—and the data collected changed CMS's opinion.

The new proposal to expand permanently the use of PET is noteworthy because it marks the first time that the agency's coverage with evidence development (CED) policy has led to a national coverage decision.

The action is also important because many private insurers, who generally have not paid for PET scans that were covered via the CED initiative, will follow CMS's lead.

Aetna, for example, considers national coverage decisions by CMS to be part of its evidence review when developing its coverage policy.

“We will be interested to see what comes out of the public comment period on the proposed PET revisions and will review the final CMS decision when it is announced this spring,” said Wendy Morphew, an Aetna spokesperson.

In the time since the NOPR was established in 2006, Medicare has paid for PET scans for nearly 130,000 patients, noted Barry A. Siegel, MD, Co-Chairman of the National Oncologic PET Registry.

After analyzing one year of NOPR data, Dr. Siegel, Chief of the Division of Nuclear Medicine at Washington University School of Medicine, and his fellow researchers found that oncologists changed their treatment decisions nearly 37% of the time based on the results of a patient's PET scan.

“The data demonstrates that PET/CT has impacted treatment management of many cancer patients significantly,” said Johnathon Myers, CRA, CNMT, Diagnostic Services Director at Kansas City Cancer Centers, which owns three PET/CT systems.

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Reimbursement Limited

Because of that, CMS proposes—beginning in April—to start paying for one scan to help with initial treatment decision-making for patients with a wide range of solid tumors. (CMS already covers PET scans in some circumstances—See “CMS's Proposal for PET Scan Reimbursement” box, showing the current and proposed policies.)

That one-scan limit of PET use worries Mr. Myers and his colleagues at more than 1,350 PET centers that contributed data to the NOPR.

“What CMS is proposing is a positive first step; however, for many tumor types, they are only covering scans for the initial diagnosis or staging,” he said. “Many of these patients will undergo treatment and need to be re-imaged after a cycle or a regimen and subsequent PET/CT imaging will need to be performed.”

CMS had sought public comments on its proposal through February 5. “We're really hoping that the oncology community and the oncology professional organizations will see this as an important opportunity to comment and suggest to Medicare that they would endorse even broader coverage than CMS has suggested,” Dr. Siegel said in an interview at the end of January.

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Future of NOPR?

CMS has said that, for cancers currently covered only via participation in NOPR, coverage with evidence development will still be required for PET scans for subsequent treatment strategies. The agency believes the current evidence is not adequate to justify coverage for PET scans in guiding subsequent treatment.



However, how that evidence will be collected is not yet clear—something that concerns him, Dr. Siegel said. “What happens to NOPR on April 5—does it stop dead in the water? Is the coverage for all these other things dead until someone comes forward with NOPR-2—or with some other study design?”

The NOPR working group is chaired by Bruce Hillner, MD, Professor of Internal Medicine at Virginia Commonwealth University. In addition to Dr. Siegel, other co-chairs are R. Edward Coleman, MD, Director of Nuclear Medicine at Duke University Health System; and Anthony F. Shields, MD, Professor of Cancer Biology at Wayne State University and the Barbara Ann Karmanos Cancer Institute.

They believe that NOPR data provides evidence that oncologists use PET to manage treatment through the course of a patient's disease (see “Oncologists Use PET to Make Treatment Decisions” table) and collecting more of the same data will not advance knowledge.

“We don't think that just collecting data in the same way we're doing it for these remaining indications makes any sense,” Dr. Siegel said. “We've already got thousands of patients in each cell. What we need is a totally different type of data collection to drill down and get the things that CMS says it would really like to know.”

He said that beyond the issue of collecting additional data to support reimbursement for follow-up scans, the hope is that CMS will make a technical correction that addresses one particular problem in its new proposal.

By limiting initial treatment evaluation coverage to a single scan, CMS's proposal creates a problem in situations in which an oncologist, after seeing the original scan and other data, decides a patient should have radiation or chemoradiation therapy instead of surgery. That requires a second scan with the patient in a different position to plan the radiation treatment. Currently, CMS is paying for those repeat scans, and Dr. Siegel said he hopes the agency will be convinced to continue that.

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