Rarely during the recent upheavals concerning medical practice and management has a community of practitioners been so whipsawed by changes in reimbursement policy regarding one of its services. Positron emission tomography (PET) continues to be at the center of controversy regarding its payor coverage and reimbursement. Parties as diverse as manufacturers, patient advocacy groups, and government officials have joined physicians and scientists trying to argue a case to support widespread availability of this imaging tool.

The latest salvo in the ongoing struggle to gain payor acceptance concerns changes in the fee structure for fluorine 18-labeled deoxyglucose (FDG), the most common radiopharmaceutical employed for positron imaging. The 4 to 40 mCi dose of FDG is now (April 2002) reimbursed by the Centers for Medicare & Medicaid Services (CMS) at $475. This includes reimbursement for HCPCS C1775 and APC 1775; FDG is classified under the G code billing structure. A pro rata discount in 2002 may have brought reimbursement to $389, a reduction of approximately 18%. In addition to lowering the reimbursement rate for FDG, which retails for $500 to $600, CMS lowered its reimbursement for PET imaging at the close of 2001. PET imaging services (outpatient, hospital outpatient prospective payment system [HOPPS]) were reassigned to APC 0978, New Technology-Level IX ($1,250-$1,500), which resulted in a payment rate of $1,375 (down from $2,331 for 2001). However, last month, CMS announced it will cover a bundled fee of $1,850 per PET procedure, representing a contribution of $475 for FDG and $1,375 for imaging.

Table. codes for Medicare reimbursement of position emission tomography procedures.

These seeming losses to the PET imaging community are partially balanced by the introduction of new PET indications that qualify for reimbursement. The accompanying Table lists current reimbursement (a reimbursement code for recurrent breast cancer also will be released soon). Moreover, ongoing discussions at CMS may lead to acceptance of broader coverage for this medical technology.

At $1,850 per study, many imagers are indicating that the reimbursement level is too low and does not cover their own costs for performing and interpreting the study. The average outpatient PET imaging facility performs approximately 2.7 studies per day, representing a billable average of $4,995. A center that operates at this rate stands to bill approximately $1 million per year for 200 service days. Many estimates suggest that operating a PET center typically involves $1.5 to $2 million per annum. This includes physician fees, technician salaries, equipment depreciation, and many other direct and indirect costs. Consequently, even if 100% of CMS charges for PET services are collected, the average outpatient center loses any possibility of profit.

Clearly, this bleak scenario assumes an outpatient setting where CMS is the sole reimbursement source. The inpatient imaging setting and private payor reimbursement make the possibility of some degree of profitability more likely, however minimal. Clearly, there is no quick fix or resolution of this reimbursement conundrum.

Strategic Implementation

While reimbursement and coverage issues continue to play out and mature, what decisions should imagers make concerning their adoption of PET? Many new private, outpatient PET imaging centers have begun to operate around the country. Likewise, the retail price of FDG continues to slowly fall. Will the efficiencies of widespread PET availability drive the cost of performing a study low enough that some profitability will emerge? Will these outpatient centers have to accept a high proportion of cash-paying patients and not accept CMS or other payor reimbursement? Many of these issues perplex the entrepreneurial radiologist hoping to attract PET services to his or her practice.

PET continues to offer the possibility of diagnosing disease and the results of disease treatment more accurately than existing techniques such as CT or MRI. Particularly in the setting of oncology, PET represents a potentially powerful tool for meeting the needs of patients and those who care for them. PET utilization in the United States has languished for many disparate reasons. Perhaps the most important reason remains the lack of useful data concerning clinical outcomes and other clinical evidence of the effectiveness of PET.

The PET community deserves accolades for attempting to redress the current state of slim to minimal evidence to support the use of this technology. Payors continue to require clinical evidence of utility, metrics more difficult to demonstrate with an imaging tool than a therapeutic product. However, these are the standards currently being used by payors.

The economic issues surrounding PET reimbursement and coverage will lessen once clinical evidence of its utility becomes available. Payors such as CMS hold all technologies to common evaluation standards, and these standards apply to PET as well. Reimbursement for PET will stabilize, and potentially increase, once payors understand the contribution of this technology to disease management.

Seeking Balance

The PET community should seek a balance between coverage and reimbursement. Expanded coverage with lower reimbursement may not be the most appropriate path for this technology. Higher reimbursement with less expansive coverage may be a useful tactic to pursue while data are developed, studies are performed, and the usefulness of PET is communicated to patients and ordering physicians.

What remains of the future of molecular imaging and the hope of an expansion in clinical PET imaging? Much remains in this regard if appropriate evidence is obtained and appropriately interpreted. Much remains if clinical outcomes are tracked in clinical investigation that attempts to measure the technical features and diagnostic accuracy of the technique. Much also remains if PET is successfully integrated within the critical pathways and patient evaluation approaches that guide clinical trainees as well as advanced practitioners.

Reimbursement for PET imaging will not likely increase without demonstration of its overarching clinical utility. The installation of new PET imaging centers around the country may drive the cost of PET imaging down so that charges can represent the cost and reasonable profit. Overall, the future of PET lies in education. It lies in educating clinicians concerning its utility and payors concerning its cost-effectiveness.

Frank J. Papatheofanis, MD, MPH, PhD, is associate professor of radiology and director, Advanced Medical Technology Assessment and Policy Program, UCSD Comprehensive Cancer Center and Whitaker Institute of Bioengineering, University of California, San Diego.