|Robert E. Henkin, MD|
Traditionally, the role of declaring a device acceptable for clinical use has belonged to the Food and Drug Administration (FDA). The issuance of a 510(k) clearance has indicated to the medical community that a given device is acceptable for its intended clinical use. More recently, the Health Care Financing Administration (HCFA) has decided that it needs to decide what devices are suitable as well, even after FDA approval. This raises serious questions as to what the approval process is and will be for medical imaging devices.
The recently announced action of evaluating dual-head gamma cameras’ suitability for coincidence imaging (PET) marks a new step by HCFA into a dangerous area. Physicians and the FDA have traditionally held the responsibility for evaluating what technology works in a given clinical setting. Often, there is little literature or, in the case of PET, confusing literature about the clinical applications of various devices. The PET community is tremendously heterogeneous, encompassing devices that range in age from 15 or more years old to more current devices with varying detector materials. For some reason, HCFA thinks it is able to assess the clinical outcome of studies performed on these various devices on patient care, when the medical community has not been able to fully do so in a scientific fashion.
Multiple serious questions are raised by HCFA’s process. For medical imaging, the potential impact is significant. The variation in medical imaging devices throughout radiology is enormous. There are multislice computed tomographic scanners; there are open MR units, closed MR units, and MR units with varying field strength. This does not begin to get into the myriad of ultrasound devices that are also available on the market today. Likewise, the suitability of digital devices as compared to analog imaging for what are traditionally called plain film applications is not fully evaluated. HCFA recently approved additional reimbursement for digital mammography, yet there is little in the literature on which to base that decision.
The move by HCFA to classify which devices approved by the FDA as PET scanners are appropriate for clinical use has serious potential implications for patients. Smaller institutions that cannot acquire dedicated devices will be completely shut out of the market. The precedent of a third-party reimbursement group deciding what acceptable technology is has tremendous potential impact on rural, small, and inner-city hospitals as well. While many radiologists believe, for example, that open MRI is not the equivalent of traditional high field strength MRI in all clinical settings, it is up to the practitioner to decide what clinical setting the device should be used in. If dictated by the insurer, the entire scope of medical practice can be affected in a given community.
The real experts in medical imaging technology are those who interpret the images. Over the years, the marketplace has clearly shown that devices that do not measure up clinically do not survive. In the 1970s and 1980s, a myriad of companies produced CT scanners. Early MR devices came from various sources as well. The marketplace reduced the number of companies providing devices to a handful that proved to be reliable and clinically accurate. That same process should go forward for PET scanning. If dual-headed PET scanners do not serve the patients well, then they will not continue to be purchased by the imaging community. When patient volumes on dual-headed cameras grow significantly, the efficiencies of a dedicated PET scanner (not necessarily the diagnostic accuracy) dictate consideration of that device. However, the denial of service to patients who do not have ready access to any sort of PET imaging does more potential harm to the patients than good. We do not require that every CT scan be done on a multislice scanner, and neither should we dictate how PET scans should be done. To do so will disenfranchise patients who are unfortunate enough not to live near a dedicated PET unit.
Robert E. Henkin, MD Professor and Acting Chair, Department of Radiology, Loyola University Medical Center, Maywood, Ill