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Market Research in the Healthcare Field with Expertise in Medical Imaging and Radioisotopes
Bio-Tech Systems, Inc. - 4167 West Pinecrest Circle - Las Vegas, Nevada 89121 phone: (702) 456-7608 - fax: (702) 456-2189
Rising Demand for PET Despite Reimbursement PressureSept 3, 2008
Expanded use of PET in oncology coupled with effective use of the National Oncologic PET Registry (NOPR) has added substantially to procedure volume. Although the dominant focus of PET is still in oncology, applications in cardiology are increasing, including rubidium PET studies for myocardial perfusion. Myocardial viability studies with PET are also benefiting from fast, multi-slice PET-CT’s suitable for cardiac imaging. PET scanners have continued to improve in image quality and performance and the technological success of PET-CT has increased PET's functionality with radiologists, making the images easier to interpret in a familiar format. It has also reduced imaging time significantly while enhancing the economics of PET, making it more comparable to other modalities such as CT and MRI. Changes in PET Reimbursement
Growth of PET procedures is significant in light of recent reductions in reimbursement and the financial pressures experienced by many PET providers. Reimbursement limitations have been most severe for outpatient imaging centers and mobile PET providers, since they are not able to distribute overhead as flexibly as hospital imaging departments. The hospitals also have had more time to adjust to the lower reimbursement, since the current HOPPS rate (Hospital Outpatient Prospective Payment System) was implemented about two years ago. Now all providers must accept the same reduced reimbursement. PET reimbursement was modified in 2008, consolidating the allowable charges for the imaging procedure and the radiopharmaceutical into one fixed fee, which is now $1,057. In 2007, PET-CT reimbursement was $950 and the FDG could be billed separately at about $200 plus delivery cost. The proportionate cost of a radiation safety officer and ancillary business costs could also be included. Therefore, users could add $250-$300 on the average to the base reimbursement of $950. However, in 2008, these options were eliminated and replaced with a single fixed fee of $1,057. Private insurance still pays $2,000-$2,200 per study, which helps balance the lower Medicare reimbursement. Although, private insurance payments may eventually be adjusted downward to match Medicare, these changes have not been implemented yet. There are currently nine approved cancer indications for PET-CT scans. These standards allow for diagnosis, staging and restaging of treatment with some limitations. CMS has also reassigned the PET-CT ambulatory payment codes (APC’s) from a “new technology category” to a payment code applicable to established modalities. Therefore, CMS has decided that PET no longer justifies special treatment with respect to reimbursement as a new technology, but has become mature enough to stand on its own similar to MR and CT. Unfortunately, CMS is still restricting coverage for PET to certain approved indications, which limits the procedures that can be performed One would expect that CMS will eventually treat PET more equitably with “open coverage” similar to MR and CT. This would allow referring physicians more latitude in requesting PET scans with more confidence that the charges will be approved. Initial Results from the National Oncologic PET Registry (NOPR)
Under Medicare’s Coverage with Evidence Development policy, PET and PET-CT became covered services for previously noncovered cancer indications if prospective registry data were collected. The National Oncologic PET Registry (NOPR) was developed to meet these coverage requirements and to assess how PET affects care decisions. Initial results were published in the Journal of Clinical Oncology (Volume 26, Number 13, May 1, 2008).Impact of PET in Reducing Biopsies
Analysis of the results of the National Oncologic PET Registry revealed that PET was associated with a change in patient management in almost three quarters of the cases reported. The study group was surprised by the impact of PET on patients with a pre-PET plan of biopsy. In approximately three quarters of these patients, a biopsy was avoided. Failure to follow through with a tissue biopsy in patients with a negative PET study may reflect overconfidence in PET results. However, major strengths of the NOPR data are the large sample size, the completeness of the data, and the national scale.A prior study found that one key benefit of PET was the referring physician’s impression that all noninvasive diagnostic options had been exhausted. In this study, referring physicians, in more than three quarters of cases, indicated that PET enabled them to avoid additional tests and procedures. However, the group concluded that prospective comparisons of different sequencing approaches of CT and PET or PET-CT in cancer patients are needed. The Road toward Open Coverage for PET
One objective of the NOPR was to demonstrate that PET should be treated similar to other imaging modalities, such as CT and MR, for reimbursement purposes. These modalities provide “open coverage” where a referring physician can request a scan for any medically justifiable purpose without being restricted to a set of approved indications. Although the list of approved indications for PET has increased, there are still many cancers that are not covered, even though the NOPR has provided a window for these less common cases.The NOPR has demonstrated that referring physicians can be trusted to utilize PET responsibly in managing their patients and that quality of care can be improved with the information derived from PET. The NOPR observation that biopsy can be avoided in a large number of cases with PET attests to the fact that it fulfills one of the major goals of medical imaging, i.e., to reduce the number of invasive studies by accurately characterizing the tissue in vivo. It appears that CMS has accepted this reality by reclassifying PET from the “new technology” category to an established modality similar to CT and MR. In addition, by reducing reimbursement, it has limited the financial exposure for CMS. However, it is necessary to overcome the final hurdle and allow open coverage. This would allow PET to be used more widely, offsetting the high fixed costs and providing sounder incentives for providers of PET services. Expanded Applications for PET in Oncology
The clinical opportunities for PET are continuing to improve as more clinicians gain experience and are able to integrate PET more effectively with available treatment modalities. Education of referring physicians is still required; however, the visibility of PET is improving, bringing it closer to the surface when diagnostic options are being considered. Although reimbursement uncertainties still exist, there is more confidence that the process can be managed for the benefit of the patient.Notwithstanding the increase in approved indications, PET providers believe that there are many patients who could benefit from PET that are not being referred for the procedure. Bringing the radiologist into the loop with PET-CT has helped, since all PET procedures are generally preceded by one or more anatomical imaging procedures, such as CT or x-ray. Radiologists who perform these procedures are in a good position to recommend subsequent PET studies if a suspicious lesion or mass is observed. Patient education is also helping to raise the level of awareness of PET, particularly where it might eliminate more invasive studies. A good example is the growth of breast cancer procedures with PET. About 9% of all PET imaging in 2007 was for breast cancer (130,000 procedures) with the volume increasing. This has allowed the use of PET for staging patients with distant metastasis or restaging-patients with local, regional recurrence or metastasis as an adjunct to standard imaging modalities. PET is also being utilized to monitor tumor response to treatment to determine if therapy should be changed-as an adjunct to standard imaging modalities. However, diagnosis of, or surgical planning for breast cancer is still not covered by Medicare, which is a limitation. PET Scanning for Prostate Cancer
It was previously presumed that PET imaging of prostate cancer was not effective because it is a slow growing cancer and is often not responsive to FDG in its early states. However, if the cancer is poorly differentiated and has a high Gleason score (high level of cancer activity) at the time of initial presentation, then there is high clinical suspicion of metastasis. Also, if it is post-prostatectomy and there is a rising PSA level, there is disease, but one may not know where it is or how far it has spread. In these cases, PET–FDG can be helpful. In the NOPR program, 11% of the studies were for prostate cancer. The Registry has helped to better articulate which patients would be most likely to benefit from FDG-PET based on Gleason score, PSA levels or a combination of these two. This is significant because of the high incidence of prostate cancer and the difficulty of managing the more advanced cases.Bone Scanning with Sodium Fluoride
A number of active PET centers are performing bone scans with sodium fluoride. This agent has been available for some time and is a natural product of the FDG production process, but is still not reimbursed by Medicare. The agent is actually a bit less expensive than FDG and produces much higher quality images than traditional SPECT images. CMS is now considering setting up a registry similar to the NOPR that would allow the use of sodium fluoride for bone scanning within registry guidelines. Since the volume of bone scans is large, it could expand PET's role significantly in this area.Infection Imaging
Another registry opportunity is infection imaging with PET. FDG is taken up by metabolically active tissue and can be used to highlight sources of infection. PET-CT also provides anatomical guidelines that help in assessing the degree and extend of infection, which can be used for effective diagnosis and treatment.
There are currently no approved in vivo infection imaging agents. There was one SPECT in vivo agent that was introduced briefly in 2005, but it was withdrawn because of unanticipated side-effects. This has discouraged other developments with SPECT infection imaging agents. Since FDG is safe and well tolerated, it overcomes the problems experienced with SPECT agents and would help in its acceptance once physicians become familiar with the procedure.Since the registry approach has been used successfully to reimburse new PET procedures, it can be extended to infection imaging with approval from CMS. There is a large group of patient candidates that could be enlisted in the study and many referring physicians would also participate. Prospects for Integrating Diagnostic CT with PET-CT
One of the promising aspects of PET-CT is its potential to deliver diagnostic CT scans simultaneously with functional PET imaging. In practice, most facilities have opted to use the CT portion of the hybrid modality to perform attenuation correction for PET imaging and provide anatomical guidelines to aid in identifying the structures seen in the PET image. Generally, if diagnostic-quality CT images are required, a separate scan is ordered.Since the CT portion of the PET-CT is available for diagnostic use, it offers the advantage of increasing reimbursement in cases where a CT scan is ordered in conjunction with the PET-CT. Performing a diagnostic CT in conjunction with the PET-CT is certainly possible, but there are differing opinions as to whether the two protocols can be merged effectively in all cases without introducing artifacts or compromises in the quality the scans. Researchers from Duke University Medical Center in Durham, NC, have developed and implemented a set of protocols for obtaining diagnostic-quality PET and CT images in one session on a PET-CT scanner. They presented the results of their work at the Academy of Molecular Imaging (AMI) meeting recently. Advantages of Simultaneous Diagnostic CT and PET
With the proper protocol, patients only have to undergo one imaging session, while referring physicians are provided with a diagnostic CT report interpreted by a radiologist specializing in cross-sectional imaging, as well as a PET report provided by a nuclear medicine specialist.In addition, clinicians receive the high quality anatomic definition and a high degree of image registration with the PET-Diagnostic CT (PET-DCT). In developing the protocols, the team set its objectives on producing both CT and PET images with a minimum sacrifice in quality for either modality. However, performing PET-DCT requires more technology and support than conventional PET imaging and requires nursing support and technologists cross trained in both PET and CT. Artifacts Introduced
In researching this subject with other nuclear physicians experienced with PET, the response was far from unanimous. There are some advantages in having a simultaneous diagnostic CT and PET-CT scan in cases where the physician sees some uptake and is not sure whether it is in a blood vessel or a lymph node. In these cases, adding contrast will help. It also helps to distinguish bowel uptake. However, many patients have had a contrast study before coming to PET, which is the reason the PET scan is requested initially. Although the physician may gain 5% in diagnostic accuracy, the procedure may introduce artifacts.There is also the question as to which part of the contrast is going to be optimized, (oral or IV), and whether the contrast is optimized for the head and neck, the chest/meditational area, or abdomen. Each body segment has a different protocol in diagnostic CT. Therefore, the combined protocol is not straightforward. For instance, there may be a lesion in the abdomen discovered in the baseline study that cannot be resolved. Since this might be an abdominal node or physiological condition in the bowel, one can reason that using oral contrast in the follow-up study might reveal something useful. But the routine use of contrast in every study would probably be a waste of resources in addition to subjecting the patient to a high radiation dose. Overlap of CT Contrast and FDG
Although IV contrast media does not interfere with FDG, it can cause artifacts when the CT is used for attenuation correction because it will respond as it the contrast is a hard, dense structure. Therefore, the PET system may overcompensate and incorrectly indicate a lesion. Special training is necessary so that the physician reading the scan knows what kind of artifacts to expect.Performing the CT scan after the PET is preferable in most cases because of more targeted contrast and an optimized protocol for the particular area of the body being studied. For example, if a physician is studying a patient with lung cancer and there is nothing suspicious in the abdomen, then there is no benefit in utilizing oral contrast in the abdomen and pelvic area. Instead the focus would be on the mediastinum. However, if the case in question is colon cancer, then the patient would require oral contrast rather than IV contrast. Therefore, the decision to use contrast must be made on a case-by-case basis. Improvements in Scanner Performance
Notwithstanding market uncertainties, scanner manufacturers are continuing to make large investments in new technology to improve image resolution and reduce imaging time. This should make it easier to interpret PET images and improve diagnostic sensitivity, which should increase confidence in the value of PET imaging. The new technology is also encouraging replacement of older scanners and stimulating users to upgrade to newer high-performance systems with state of the art multi-slice CT's . This has raised the average price for a new scanner from $1.6 million to about $1.8 million.Simultaneously, the market for refurbished systems has increased as many users take a more conservative approach to the high cost of financing new PET systems. The increased availability of older units taken in trade has also helped. In 2007, 17% of the units ordered were refurbished (38 out of a total of 219). In 2006, the proportion of refurbished systems rose to 25%, with orders for 67 systems out of a total of 268 units. This trend will continue and provide more opportunity for to provide PET services at a cost that is compatible with individual budgets. by Marvin Burns
Sept 3, 2008 BIO-TECH SYSTEMS, INC., founded in 1980, provides clients with market research services in the healthcare field. This focuses on strategic planning, market research and development of new business opportunities. Bio Tech specializes in product and market evaluation where technical insight is important as well as the ability to communicate with many levels of management and end-users. One objective is to assess technological risk and target new products and services effectively in order to generate the best market response. Bio-Tech's expertise is in medical imaging and radioisotope products covering a broad range of diagnostic and therapeutic applications. For further details and information, please visit us at: Related Reading:
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