Federal Government Broadens Reimbursement of PET Scans for Cancer Treatment Follow-up

The recent decision by the Centers for Medicare & Medicaid Services (CMS) to broaden coverage of fluorine-18 fluo­­rodeoxyglucose positron emission tomography (FDG-PET) imaging in patients who have been treated for tumors has been welcomed by many in the oncology community, although the decision is not without its critics.

CMS stated in the June 11, 2013, Decision Memo that the agency will cover 3 FDG-PET scans for guiding antitumor treatment strategy after the initial anticancer therapy has been completed, to determine whether there are any distant metastases that were not found in initial staging studies. This includes patients with all forms of cancer, including prostate cancer, breast cancer, and testicular cancer. The CMS deemed that it is up to local Medicare administrative contractors (MACs) to decide whether they will cover any additional FDG-PET scans on these patients.

The CMS will also cover FDG-PET scanning for the determination of initial treatment strategy for most types of solid tumors, with the sole exceptions being prostate cancer, the initial diagnosis of cervical cancer, the initial diagnosis and/or staging of axillary lymph nodes in women with breast cancer, and the initial staging of regional lymph nodes in people with melanoma.

All of this is in line with what officials at the National Oncologic PET Registry (NOPR), which previously had been tasked with collecting data on PET imaging of cancers, had requested.

“One of the arguments from day 1 has been that by drilling down to the level of each tumor type and each tumor indication, you reach a point where you make it impossible to reach a decision about use of the tool unless the overarching goal is not to pay for it,” Barry Siegel, MD, cochair of the NOPR, told Oncology Practice Management. “But at the same time, the fact that something is covered doesn’t mean we should assume that doctors will foolishly use it in cases where it’s not useful…. What the CMS has done is set a policy that allows doctors to use their discretion and to use the tool intelligently to answer clinical questions.”

Walter J. Curran, Jr, MD, Executive Director of the Winship Cancer Institute and Associate Vice President, Woodruff Health Sciences Center, Emory University, Atlanta, Georgia, has a different point of view.

“While I believe that PET is an integral part of the initial staging of patients with most solid tumors, the data don’t necessarily support that it makes a difference in second-line and subsequent therapy with what would be at that point patients with incurable solid tumors,” Dr Curran said. “And at a time when there are increasing constraints for healthcare spending, the cost implications of the CMS’ decision could be significant.”

Details of the June 11 Decision Memo

Part of the purpose of the Decision Memo was to help determine ways to curb PET use, which increased from 35.9% to 53.6% between 1999 and 2006, and which exposes patients to significant amounts of radiation.

The lead author of the Decision Memo was Louis B. Jacques, MD, Director, Coverage and Analysis Group, CMS. Other authors included Tamara Syrek Jensen, JD, Deputy Director, Coverage and Analysis Group, CMS, and James Rollins, MD, PhD, Director, Division of Items and Devices, CMS.

They ended the requirement that had been in place since 2006 for PET scans of solid tumors to be included in the NOPR. They concurred with Dr Siegel and his colleagues at the NOPR that the existing database provides sufficient information on PET studies’ effects on intended clinical management. None of the comments received by the CMS during the initial and second comment periods on their proposed Decision Memo opposed ending the gathering of this information.

In contrast, the CMS received 175 comments that opposed the portion of its March 2013 proposed Decision Memo suggesting coverage be granted only to 1 postcancer treatment FDG-PET scan. This included opposition from the NOPR, with Dr Siegel and his colleagues opining that the 1-scan limit is not evidence-based.

The authors of the CMS Decision Memo gave significant weight to the information gleaned from data in the NOPR while also examining other studies published before January 2013 and taking into consideration reviews of the utility of FDG-PET by Blue Cross and Blue Shield Association’s Technology Evaluation Center and by a team in the United Kingdom. The reviewers concluded that PET should not be used for surveillance and that the jury is out on whether PET improves health outcomes—other than, the UK review authors concluded, for non–small-cell lung cancer, restaging Hodgkin’s lymphoma, staging/restaging colorectal cancer, and the detection of solitary pulmonary nodules.

Data from the NOPR show that FDG-PET changes doctors’ self-reported management in 35% to 40% of patients, the CMS authors concluded. It has not been demonstrated to lead to actual changes in management or outcomes. “Nevertheless, NOPR-derived re­sults have informed our considera­tion of the evidence base for covering FDG-PET imaging for this oncologic indication,” they wrote in the Decision Memo. “…In the setting of anticancer treatment, we believe that the choices made by treating physicians, in many instances, change the patient’s experience of illness. Therefore, we have largely accepted the persuasiveness of the NOPR report [delivered to the CMS committee in April 2013], except where we believe there is other evidence available to better support an alternative conclusion.”

The authors of the Decision Memo also discuss each form of solid tumor separately, and give the nod to coverage of FDG-PET for every type, both for initial treatment strategy (formerly diagnosis and staging) and for subsequent treatment strategy (formerly restaging and monitoring response to treatment) with a few exceptions, including noncoverage of PET for the initial treatment strategy in prostate cancer.

The most controversial area was whether CMS should cover FDG-PET for subsequent antitumor treatment strategy of prostate cancer, with 7 of 30 comments on this particular indication requesting noncoverage. Despite the comments to the contrary, the authors of the Decision Memo were “convinced that FDG-PET/CT imaging’s selective use in assessing progression of prostate cancer does provide valuable additional information for managing treatment decisions,” and that physicians use appropriate judgment in determining when to use FDG-PET for treatment-planning purposes.

The CMS team also acknowledged that some patients and their physicians might wish to have more than 3 FDG-PET scans after initial treatment to help determine whether their second-line or further therapies have been successful. Therefore, they decided to permit local MACs to make autonomous decisions about further coverage.

Potential Problems with the Decision

Dr Curran noted that while FDG-PET scanning at the time of a locoregional-only recurrence could help physicians determine whether surgical or radiotherapeutic salvage would be indicated, that there are many scenarios in which CT is more appropriate than FDG-PET.

“If a patient has several metastatic sites from a commonly occurring tumor such as colorectal cancer, breast, or lung cancer, CT scanning is probably sufficient to help the oncologist determine if the treatment is working or not,” Dr Curran said.

His colleague at the Winship Cancer Institute, Suresh S. Ramalingam, MD, Professor and Director, Division of Medical Oncology, calls for well-designed clinical trials to define the role of FDG-PET in posttreatment

“[But] I’m concerned that the present decision by CMS could make the conduct of such studies very difficult. [And as a result] our patients could [continue to] be exposed to unnecessary stress and anxiety from abnormal results that might not make a difference in their overall outcome,” Dr Ramalingam told Oncology Practice Management. “Results from FDG-PET also can lead to abandoning effective therapies prematurely. I see a lot of patients referred from the community that have been told a certain standard therapy has stopped working solely based on the results of FDG uptake without any change in tumor size. This concerns me deeply—we don’t know if an increase in FDG uptake represents treatment resistance when the tumor size is unchanged.”

The Chief Medical Officer of the American Society of Clinical Oncology (ASCO), Richard L. Schilsky, MD, said ASCO and Dr Curran have a similar point of view in terms of wanting evidence-based decisions and wise resource use—“we [just] have a different emphasis.”

“ASCO felt the original position of the CMS—that only 1 posttreatment scan would be covered—was too limiting. We can certainly conceive of many clinical scenarios in which more than 1 PET scan would be helpful for a physician in determining the best subsequent course of treatment for a patient,” Dr Schilsky said. “At the same time, ASCO has come out quite strongly in other venues, including the Choosing Wisely campaign of the American Board of Internal Medicine Foundation, in advocating against routine posttreatment surveillance scans unless they are going to be used to influence key treatment decisions.”

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