CMS ruling could be fatal to gamma camera PET

Jul 16, 2001

The National Electrical Manufacturers Association is hosting a conference call of nuclear medicine companies today to discuss the impact of a recent U.S. government decision to approve reimbursement for only those PET studies conducted on dedicated PET scanners.

No one expects an easy solution, if indeed one can be found at all. The Centers for Medicare and Medicaid Services (CMS), the new name for the Health Care Financing Administration (HCFA), said June 29 that gamma camera-based PET systems will not be on the list of new clinical PET applications eligible for Medicare reimbursement.

The ruling stunned nuclear medicine providers and vendors, who had hoped that CMS would adopt test-related payment standards. Instead, the agency stepped into equipment-standards territory that is usually the purview of the Food and Drug Administration.

The NEMA conference call will include companies such as ADAC, GE Medical Systems, Marconi Medical Systems, and possibly CTI. They hope to adopt strategies to oppose the decision, a difficult proposition.

"The manufacturers are upset, and what we will do is develop strategy over the next week or so," said Richard Eaton, NEMA's industry manager for diagnostic imaging and therapy systems. "We believe CMS set a very dangerous precedent [by] basing its decision on design characteristics. CMS does not have the experience, and its authority to evaluate equipment is questionable at best. This is the province of the FDA. Evaluating medical devices is a very complicated task."

PET studies are usually conducted on dedicated PET scanners, but in the past few years some nuclear medicine vendors have developed coincidence-detection upgrades for gamma cameras that enable them to be used to image fluorodeoxyglucose (FDG), the most common PET radioactive tracer. The debate is whether gamma camera PET images are of sufficient quality relative to those of dedicated PET systems.

"CMS appears to be intent upon finding a very simplistic formula for defining what is good PET and what is bad PET," Eaton said. "How it is used in clinical practice has a greater bearing on the quality of images produced."

Dr. Sean Tunis, director of the CMS coverage and analysis group that issued the memorandum, took issue with the charge that CMS was treading on FDA territory.

"There is nothing unusual about how we approached the decision regarding PET," Tunis said. "The [reimbursement] coverage requirements for PET were supported by studies based mostly on full-ring [dedicated PET] scanners. With existing information it was already clear that gamma cameras did not perform as well as full-ring scanners."

Tunis said studies showed that gamma cameras equipped for PET missed a significant number of lesions in the studies submitted to CMS.

"We would apply that framework to any technology," he said. "PET may be one of the first examples of diagnostic technology where CMS decided to cover a subset of systems within an FDA-approved category," implying that CMS may take a similar approach in looking at other modalities.

Overstepping its authority?

Some clinicians believe CMS overstepped its bounds.

Dr. Robert Lull is chair of nuclear medicine at the University of California, San Francisco, and immediate past chair of the Society of Nuclear Medicine Government Relations Committee. He is livid at what he sees as unwarranted interference.

"This represents a new kind of intrusion by the new HCFA," Lull said. "How far are they going to carry this concept? Are they going to decide what kind of CT scanner we can use, and use that as an excuse for not paying?

"This is an area of clinical decision-making HCFA [CMS] shouldn't be involved in. We feel strongly that doctors should be making these decisions, not HCFA," Lull said. "On the other hand, some people make mistakes and miss significant lesions. What is needed is a good quality-assurance program. It's not the instrument, it's how you interpret the study results."

Lull and others pointed out that some older dedicated PET scanners produce images worse than the newer gamma cameras. Then there is the always-political issue of cost.

"This will have a disproportionate impact on smaller community and inner-city practices," said Steve Atkinson, director of PET marketing for ADAC and chair of the industry council of the Academy of Molecular Imaging, which has created a lobbying arm.

The new ruling keeps in place reimbursement for previous indications using coincidence gamma cameras, including non-small cell lung cancer, solitary pulmonary nodules, colorectal tumors, lymphoma staging, and recurrence of melanoma. But it said the cameras must have:

Crystal at least 5/8-inch thick.
Techniques to minimize or correct for scatter.
Digital detectors and iterative reconstruction.

The agency will cover dedicated scanners using bismuth germanate (BGO), sodium iodide (NaI) or "new crystal detector technologies that are equal or superior in performance," such as ADAC's gadolinium silicate (GSO) detector or CTI's lutetium oxyorthosilicate (LSO) detectors, which are sold as part of a system marketed by both Marconi and Siemens.

CMS will review the limitations on gamma cameras after Dec. 31, 2002, saying that coverage will be provided for gamma cameras if they "demonstrate performance equivalent to or better than the full-ring PET systems."

The clear implication is that gamma cameras may be dropped from coverage altogether, which means manufacturers and the National Institutes of Health are unlikely to fund gamma camera PET studies that might convince CMS to cover cameras.

"This will definitely have an impact on clinical practice," said William Uffelman, a spokesman for the Society of Nuclear Medicine. "A number of institutions have purchased new cameras in the fall with the expectation they would be able to provide PET diagnostic services to patients, and this puts a monkey wrench in this. Nobody had any inkling this would be what you got."

On the other hand, dedicated PET centers stand to benefit. One Southern California PET center business manager, who did not want to be identified, was "ecstatic." And Wayne Webster, Positron's vice president for marketing and sales, said, "I was not surprised. The issue of whether gamma cameras were good PET scanners went away about a year ago. When you try to use something for what it is not designed, it didn't work very well."

By Robert Bruce
AuntMinnie.com contributing writer
July 17, 2001

HCFA expands covered uses for PET, but hedges on coincidence cameras, April 12, 2001

HCFA broadens Medicare coverage for PET, December 18, 2000

Dedicated PET and hybrid PET are equally accurate for assessing lung cancer, October 25, 2000

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