CMS takes comments on expanding coverage for nine specific cancers, but it appears wider coverage faces an uphill battle.

A Centers for Medicare and Medicaid Services advisory panel took testimony in August on expanding coverage of nine specific cancers by PET scanning.

In the face of clinical data that radiology experts say support the use of positron emission tomography (PET) scans for diagnosis and treatment of some cancers, a US Medicare panel is still doubtful about expanding coverage for the procedure to include all cancers.

On August 20, the Centers for Medicare and Medicaid Services’ Medicare Evidence Development and Coverage Advisory Committee reviewed a request from the National Oncologic PET Registry (NOPR) to expand coverage of scans beyond brain, cervical, bladder, small-cell lung, ovarian, testicular, prostate, kidney, and pancreatic cancers. Medicare currently approves PET scans for these nine cancers, but requires patients to register with NOPR, which has collected clinical data about treatment decisions from approximately 23,000 cancer patients nationwide.

Clinical investigators have reported that physicians changed the intended course of treatment of more than one in three cancer patients after PET scans were performed. The underlying question, however, is whether doctors are making all the right decisions and if they actually are improving patient outcomes, for which there is still not enough data.

“I understand the quandary,” said Leonard Berlin, MD, chair of the Department of Radiology at Rush North Shore Medical Center in Skokie, Ill, and professor of radiology at Rush University Medical College in Chicago. “I’m not at all insensitive to the other side of the argument. Outcome data is great if you have the time to collect it. In the meantime, patients are dying sooner than they have to.”

In a study published by Virginia Commonwealth University scholar Bruce Hillner, MD, in the March 24 Journal of Clinical Oncology, clinical investigators said they were surprised by the impact of PET findings on patients who originally were planned to have a biopsy. The procedure was avoided in about three-quarters of those patients post-PET, they reported.

“It saves a lot of biopsies, and that’s better for patients, better for society, and, in the long run, it saves costs,” Berlin noted.

Robert Saunders, director of nuclear medicine at the Mayo Clinic, Rochester, Minn, hailed the use of PET in his public comments to the CMS panel.

Saunders said Mayo has enrolled more than 300 patients in the NOPR since May 2006 and the evidence is clear: “We are in complete agreement with the National Oncologic PET Registry’s recently released report and recommendations that data collection requirements end and that coverage be extended to all oncologic indications for diagnosis, staging, and restaging/recurrence.”

David Mankoff, MD, PhD, professor of nuclear medicine at the University of Washington in Seattle, agreed the NOPR data strongly support the impact of PET scans on physician decision-making.

“Across the board for different indications and cancers, the use of PET made minor changes in therapy in 30% to 40% of patients undergoing imaging studies,” he said.

The intent of the NOPR study was not to determine the efficacy of cancer treatment but to find out whether PET helped refine decisions for that treatment. Rather than document cancer patients’ diagnoses, response to treatment, or survival rate, it explored the pre-PET scan impressions of the stage and extent of disease and plans for treatment. A post-PET questionnaire then asked oncologists if their proposed plan of treatment changed based on the scan results.

“The value of PET imaging for all forms of cancer has been demonstrated widely at this point in time,” said Robert Atcher, PhD, MBA, president of the Society of Nuclear Medicine.

However, CMS has expressed concern that there is too little data to indicate if the scans would have a similar impact on the treatment for other types of cancer, and there is a clash between the data supportive of the technique and traditional assessment. The Medicare panel’s discomfort with expanding PET coverage also was fed by an independent analysis by outside experts, which questioned how changing physician decisions could affect patient outcomes.

Mankoff acknowledges it will be challenging to ease those concerns for Medicare policymakers. “It’s a tough study because we’re doing the diagnostic work that’s going to change the response to treatment,” he said. “Effective diagnostic tests and ineffective therapy won’t change patient outcome.”

He said the greatest benefit of PET for patients, in addition to the procedure being noninvasive, is that it detects biochemical changes in tumors to provide entirely different information than anatomically based imaging.

“Right now, when we treat a tumor, we’re looking for changes in size. We’re looking for the tumor to shrink as an efficacy of clinical therapy,” he said. “In some cases, the tumor cells can go away and leave scar tissue behind, but the functional metabolism of the tumor can change.”

For example, the standard of care in lymphoma cases now is to use PET scans to determine if the tumor mass is scar tissue or still cancer. PET also is used for lymphoma restaging for earlier determination of efficacy of treatment.

“Some people call it an assessment of futility,” Mankoff explained. “If it’s not working, move on to another therapy.”

The accuracy of PET far exceeds that of x-ray and CT in determining whether a cancer is responding to treatment because the isotopes concentrate at the tumor site for a more accurate measure, some experts argue. This gives the oncologist an earlier opportunity to change chemotherapeutic drugs if the patient is not responding.

Proponents argue patients have already benefited from the expanded use of PET.

“Countless patients with the cancer types now under consideration for approval have benefited from this technology,” Ken Manning, COO of Trident Medical Imaging, Gwinnett, Ga, offered to the panel.

“These results are not unique to specific cancer types, nor are they the results of a particular provider. On the contrary, virtually all cancer types can be accurately imaged by FDG-PET, and can be performed conveniently in comfortable outpatient settings just as well as in tertiary care university hospital settings. Additionally, several data suggest that utilizing PET results in much more cost-effective care by eliminating unnecessary/inappropriate procedures, thereby saving Medicare and taxpayers countless dollars.”

Although Berlin recognizes outcome data is needed, he said it shouldn’t be a reason to postpone expanded Medicare coverage. “Why wait for patients to die or live to decide if it’s beneficial? It’s a difficult decision, but if it were my loved one, my mother, my wife, or my child, or if I’m on a therapeutic agent for cancer and told it is not responding, I don’t want to wait for the data to allow a change in treatment,” he said.

Atcher, the new SNM president, commented that PET can assess early the spread or recurrence of cancer and the impact of intervention.

“Perhaps most importantly, the fact that these studies can upstage or downstage a patient, materially change their treatment options, and identify patients who are not responding to chemotherapy provides the potential for saving substantial sums in treatment costs.”

Dominic Smith, marketing vice president for nuclear medicine for Philips Healthcare, said it is now up to the imaging industry and its clinical partners to answer lingering questions before the CMS panel meets again in January.

“We’re just getting the feedback from the [panel’s] initial response,” he said. “It was a high bar, but that’s where PET has a role to play. We’re waiting now and having dialogue with our clinical partners.”

In addition to changing the way cancer is monitored and treated, many believe PET technology can help relieve both economic and emotional burdens for patients.

Some comments to CMS revolve around the accuracy of PET versus x-ray and CT.

“By selecting the right treatment for the right patient at the right time, we can potentially save billions in health care costs for cancer patients,” Atcher said.

“From the imaging economics perspective, if any device can actually help patients not go through expensive and uneventful therapy, it can,” Smith said, noting that a PET scan costs an average of $1,100 compared to $40,000 for radiation therapy that may or may not work.

He said patients don’t want to wonder if their treatment is effective, and PET can answer their biggest fear: “How do you know the cancer is really gone?”

“Can we give a green light to a patient and tell them it’s in remission? That’s what people want to hear. They want to hear it worked,” Smith emphasized. “Ultimately, as we move into the use of these tools, we’ll be able to help people understand that they are cured. It’s one more tool in the ongoing war against cancer.”

Verina Palmer Martin is a contributing writer for Axis Imaging News. For more information, contact