Medicare coverage of PET scans for oncology indications will be less restrictive under a national coverage determination finalized April 3.

CMS is removing coverage-with-evidence-development (CED) requirements for one-time use of positron emission tomography scans during early diagnosis or pre-treatment staging for several solid tumor cancers, including brain, pancreatic, testicular, thyroid and small cell lung cancer. But for PET scans used to restage a patient or to monitor therapy in the same variety of cancers, the agency largely maintains data-collection mandates.

The final national coverage determination updates a 2005 policy and marks the first time CMS has reconsidered a national coverage policy based on evidence gathered through a CED program.

For the most part, the decision mirrors the Medicare agency's Jan. 6 proposal (¹ Also see "CMS Proposes To Require Less Data Collection For Cancer PET Coverage" - Medtech Insight, 12 January, 2009., p. 7).

However, CMS decided to remove CED requirements for PET scans that monitor the progression of ovarian cancer; the move responds to groups who argued that ongoing PET scans are especially important in tracking ovarian cancer because it is so difficult to detect in its early stages (² Also see "Cancer Specialists Seek Fewer Restrictions On Medicare Coverage For PET" - Medtech Insight, 9 February, 2009., p. 19). Single scans during the initial phase are also covered without CED.

The ruling also adds coverage for PET scans in both the initial and subsequent treatment phases of the blood cancer myeloma, "distinct from our coverage determination regarding solid tumors," CMS writes.

Imaging Groups Herald Decision

The decision will save thousands of dollars for patients who would otherwise have to pay out-of-pocket for PET scans, said R. Edward Coleman, chief of nuclear medicine at Duke University Hospital, in an April 4 statement by the American College of Radiology. "It will also allow more providers to offer this life-saving care," he added.

Medical Imaging & Technology Alliance managing director Ilyse Schuman called the decision "a major step forward in the war on cancer."

Under the decision, PET coverage falls into a two-part framework for initial and subsequent treatment, replacing a more complicated, four-part system that included separate cancer-by-cancer coverage determinations for diagnosis, staging, restaging and monitoring. In the new system, diagnosis and staging map to "initial" treatment, and restaging and monitoring map to "subsequent" treatment.

"We believe this simpler framework is consistent with the practice of medicine and is more easily understood by physicians and patients," CMS says.

Some commenters had hoped CMS would cover multiple scans in the initial treatment stage if needed for accuracy, but the agency stuck with its plan to cover only one early-stage scan, noting that this is "consistent with the current evidence base."

The new policy also lifts data collection requirements for PET scans to stage newly diagnosed cervical cancer "subsequent to conventional imaging that is negative for extra-pelvic metastasis." Coverage with evidence requirements remains for other cervical scan uses.

In keeping with its proposal, CMS removes coverage altogether for PET in the initial treatment phase of prostate cancer and continues to require CED during the subsequent treatment phase.

Registries Will Continue To Collect Some Data

While PET scans in some cancers are proven to influence the direction of cancer treatment, CMS found the evidence is not strong enough to broadly remove the CED requirement for PET use during the subsequent phase of treating other cancers.

"Anticancer therapy is risky and arduous," CMS writes. "The treatments are often toxic and disfiguring. Thus the beneficiary may be harmed or killed if treatment is based on diagnostic modalities which have not been rigorously evaluated with respect to their impact on patient-centered outcomes."

Where CED is required, CMS expects providers to collect outcomes data for PET scans in cancer treatment through the National Oncologic PET Registry (NOPR), created in 2005. CMS will also consider registry proposals from other agencies.

- Monica Hogan (m.hogan@elsevier.com)

Oncology PET Scan Coverage Expands As CMS Lifts Some Data Mandates

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