Approximately 197 groups and individuals have voiced their opposition to CMS' national proposal to cover only one positron emission tomography scan during the lifetime of a cancer patient who has completed initial anticancer therapy.

The opposition appeared in comments responding to CMS’ March 13 proposed decision memo on national Medicare coverage of F¹⁸ fluorodeoxyglucose positron emission tomography (FDG PET) for solid tumors. (See Also see "Reimbursement In Brief" - Medtech Insight, 18 March, 2013..)

Currently, there are no restrictions on the number of FDG PET scans a doctor can order during subsequent management of patients with solid tumors. The agency is now proposing to offer national Medicare coverage for only a single scan intended to guide a physician’s decisions after a patient has completed initial anticancer therapy. The proposal had only one supporter, America's Health Insurance Plans, which urged CMS to go even further and not cover any PET scans at all for solid tumors.

Most comments were extremely negative about CMS’ new proposal for restricting the number of allowable scans. "We very strongly oppose the proposal," the National Oncologic PET Registry (NOPR) wrote. "Such a strict and broad-based limit is neither clinically or scientifically warranted nor administratively desirable, and should not be finalized."

CMS suggested that without the proposed restriction, PET scans could be performed for purposes the agency does not support, such as routine surveillance. “Medicare generally does not cover diagnostic testing used for routine screening or surveillance,” the proposal noted.

While the agency does not want national coverage for more than one post-therapy scan, its proposal would give local Medicare administrative contractors discretion to cover additional scans, except in cases of prostate cancer.

But the NOPR Working Group is having none of it. The group, which initiated the national coverage reconsideration in the first place with the aim of ending the current coverage-with-evidence-development data collection requirement, said it understands CMS’ concerns about potential unnecessary use of imaging. (See Also see "CMS Urged To Lift All Evidence-Development Restrictions On PET For Solid Tumors" - Medtech Insight, 22 October, 2012..) However, the one-scan limitation for subsequent treatment strategy evaluations “is an excessively blunt approach that does not reflect the data or current clinical practice,” NOPR wrote in April 11 comments.

As cancer outcomes have improved in recent years, “decisions as to the optimal treatment strategy have evolved into a series of decision points during the patient’s care,” NOPR said. “These multiple decisions should be informed by the best diagnostic information available. Where CMS has established that the evidence demonstrates that FDG PET is reasonable and necessary in assisting physicians to make informed decisions as to patient management, it is arbitrary and unreasonable to limit the use of FDG PET to a single baseline study and a single post-treatment examination.”

A comment submitted March 27 by an individual who did not supply her title simply said, “You have to be kidding! Limiting PET scans to two per person per life?” She added sarcastically, “OK, so you are only allowed to get and recover from cancer once, ‘cause it never recurs. Get real!”

CMS’ proposed changes to the FDG PET coverage policy also include ending the requirement that registry data be collected when the scans are performed, since enough PET registry evidence has been gathered by now to drop the requirement. NOPR’s request for this change is why CMS opened the FDG PET coverage policy in the first place and the public comments mostly support this part of the CMS proposal.

NOPR Suggests An Alternative

As an alternative to the national limit on the number of scans that will be covered by Medicare, NOPR requested that CMS nationally cover FDG PET for oncologic indications without restriction, but allow local contractors the discretion to set frequency limitations as medically reasonable. At the same time, the group suggested, CMS should reiterate its policy not to cover FDG PET and other advanced imaging for surveillance, and include both “a clear definition of what constitutes a surveillance scan” and a statement of intent to monitor claims for improper surveillance uses.

“By establishing that the appropriate default status of FDG PET is coverage (rather than limited coverage), CMS would convey an important message to local contractors,” NOPR explained. “While [Medicare administrative contractors] would retain their prerogative to impose frequency limits, a policy of national coverage would indicate to MACs that any frequency limits should not be automatically set at N=1, but rather should be established – if at all – with sensitivity as to the specific type of cancer and its established treatment protocol.”

In a joint comment, the World Molecular Imaging Society and four other major professional societies supported the idea of unrestricted national coverage of FDG PET for oncologic indications paired with local contractor discretion to set frequency limits.

Among many additional organizations weighing in against the post-treatment one-scan limit were the Medical Imaging & Technology Alliance, representing manufacturers of advanced imaging equipment; the American Society for Radiation Oncology and the American Society of Clinical Oncology, which submitted a joint comment; and numerous chiefs, chairs, directors and other medical leaders from major cancer centers throughout the U.S.

The lone voice on the opposite side of the debate was America’s Health Insurance Plans, the national trade association for the health insurance industry. In a brief comment submitted April 12, the group said that while CMS found adequate evidence that PET scans guide physician management of cancer patients, this alone is not a good reason to cover the procedure.

“It is well known that providers’ anecdotal experience in guiding their decision-making is often found to be flawed when their experience is subjected to a scientific study,” AHIP wrote. Rather than “default to coverage,” CMS should withhold coverage “until appropriate scientific evidence is available to demonstrate the clinical value of the testing,” AHIP recommended.

The group also recommended against allowing regional Medicare contractors to make their own coverage decisions regarding PET for solid tumors, arguing that allowing different local decisions “creates inconsistency and does not promote evidence-based decision making.”

Prostate Cancer Non-Coverage

CMS is also proposing that FDG PET for subsequent treatment strategy for Medicare patients with prostate cancer be nationally non-covered. The cancer type was the one exception to the proposal’s coverage of one post-treatment scan. CMS’ justification was that the available evidence does not support the usefulness of PET for patients who have completed initial prostate cancer treatment.

“We respectfully disagree,” NOPR wrote. The registry’s leadership, along with MITA and several professional societies, argued that the use of FDG PET to assess men with castrate-resistant prostate cancer, in particular, has become increasingly important with the advent of new but expensive therapies for this patient subset.

Based on evidence in peer-reviewed published articles not cited in CMS’ coverage proposal, the World Molecular Imaging Society and its partners, including the American College of Radiology, stated they “strongly believe that CMS should include the use of FDG PET in the specific case of patients with castrate-resistant metastatic prostate cancer.”

CMS Proposal To Limit Number Of PET Scans For Cancer Patients Sparks Outcry

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