The National Oncologic PET Registry has successfully met the goal for which it was established and should be disbanded, the NOPR working group and others told CMS in response to an ongoing Medicare coverage analysis for positron emission tomography for diagnosing and managing solid tumors.

In comments due to the Medicare agency Oct. 12, the NOPR working group encouraged CMS to remove all remaining coverage-with-evidence-development (CED) requirements for oncologic PET imaging.

NOPR began collecting clinical data and sharing it with CMS as a requirement for Medicare coverage of certain oncologic PET scans in 2006.

In Oct. 4 comments, the World Molecular Imaging Society, which co-sponsors NOPR, heralded the registry as one of Medicare’s first CED projects, giving beneficiaries with less common types of cancer access to PET scans. The registry has collected data on over 230,000 scans since its inception, according to the group.

The National Oncologic PET Registry began in 2006 as one of Medicare’s first coverage-with-evidence-development projects.

In 2009, CMS ended the CED requirements for PET used during initial treatment strategy for most oncologic indications, but continued to require evidence gathering when the scans were used to inform subsequent treatment strategies. (See Also see "Oncology PET Scan Coverage Expands As CMS Lifts Some Data Mandates" - Medtech Insight, 13 April, 2009..)

Last month, CMS opened a national coverage reconsideration to address the remaining CED mandates at the request of the NOPR working group. (See Also see "News In Brief" - Medtech Insight, 17 September, 2012..)

“In light of the robust NOPR data collected since 2009, we are now convinced that there remains no clinical need to continue CED data collection” for fluorodeoxyglucose-PET (FDG-PET) oncologic indications, the NOPR working group said in Sept. 17 comments.

The working group acknowledged that there are still open questions about how best to sequence PET scans among other imaging services, but added it believes the research needed to answer such questions “would require a very different vehicle than the NOPR, and thus there is little benefit in continuing to maintain the existing CED requirements for oncologic FDG-PET.”

PET Seen As ‘Reasonable And Necessary’

The move to lift the CED restrictions is widely supported by industry, medical specialty societies and clinicians.

“We believe that the published peer-reviewed clinical research demonstrates that FDG-PET is reasonable and necessary for oncologic indications, and that CED data collection can be eliminated,” agreed Nathan Mark, chair of the nuclear medicine division at the Mayo Clinic in Rochester, Minn.

The Medical Imaging & Technology Alliance and the Council on Radionuclides and Radiopharmaceuticals submitted joint comments Oct. 11, arguing that eliminating the remaining CED requirements “will demonstrate consistency in [CMS] actions by following a similar path to the agency’s removal of CED requirements for most initial treatment planning procedures.”

Siemens Molecular Imaging wrote Oct. 12 that lifting the CED restrictions on PET imaging “will enable patients with all types of cancers to receive the benefits of PET imaging and not limit coverage to only the most common type cancers.” The company argued that limiting patient access to the imaging modality could increase costs by “subjecting patients to less effective courses of treatment and potentially unnecessary surgeries.”

Cost-Benefit Balance

In Oct. 11 joint comments, the American Society of Clinical Oncology and the American Society for Radiation Oncology said that oncologists should be free to choose among computed tomography, magnetic resonance imaging and PET as appropriate for their patients.

“CT, MRI and PET are critical in determining when patients have extensive disease that will not benefit from invasive, morbid and expensive therapy,” the societies said. “The wide array of toxic and often costly chemotherapeutic options, as well as radiation therapy, requires appropriate evaluation to determine when such treatments are benefitting patients, or when alternative therapy or supportive care may be appropriate.”

Richard Wahl, director of the nuclear medicine and PET center at Johns Hopkins School of Medicine in Baltimore, said filling out forms for the NOPR “is burdensome and wastes health care resources,” but he also argued that access to PET scans for patients with rarer cancers can be critical.

“More information about the status of cancers helps oncologists and radiation oncologists personalize therapies more effectively,” he said. “PET can help make the decision of whether a treatment is indicated, working or ineffective more rationally. Such rational decision making is essential to optimize the use of limited health care resources.”

CMS plans to issue a proposed decision memo by March 14, 2013, and finalize a decision by June 12.

CMS Urged To Lift All Evidence-Development Restrictions On PET For Solid Tumors

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