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1 Consultant, SBH Group, 200 Winding Way, Ovilla, TX 75154.
2 Massachusetts General Hospital, Boston, MA.
Received October 25, 2004;
accepted after revision March 7, 2005.
Address correspondence to S. Halliday. Sue Halliday has been a paid
consultant to PETNET Pharmaceticals, Inc.
Abstract
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CONCLUSION. Clearly, the fusion of PET and CT into one piece of equipment will present challenges for years to come. It is important for providers to be involved with all of the administrators, managers, referring and interpreting physicians, and the payer communities in their market to clearly understand individual payer business practices and to identify opportunities to educate and influence changes in payment and coverage policies.
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According to the Society of Nuclear Medicine (SNM), by the end of 2004 more than 400 PET/CT systems will have been sold to hospital nuclear medicine, CT, or radiation therapy departments, and outpatient radiology facilities and physician practices. Many dedicated PET scanners are now being replaced with advanced technology PET/CT systems, and most of the new purchases are for PET/CT systems. With the improved diagnostic accuracy of PET/CT systems, we anticipate that referring physicians will gain more confidence in the results offered by PET examinations and will value the excellent anatomic correlation now available. The added investment in PET/CT technology will strengthen PET referrals and allow some dedicated PET centers to add diagnostic CT procedures to their mix of services. The challenges lie in marketing this combined technology to the referral community; providing physician coverage; obtaining preauthorization for the procedures; appropriately staffing PET/CT systems; correctly interpreting the procedures, and, most importantly, staying on top of the billing and collection issues.
On May 6, 2004, a group of 20 radiologists and nuclear medicine physicians gathered at a session titled "PET/CT Unplugged" during the 104th ARRS annual meeting. It was clear from the discussion that the blending of these two technologies will present many opportunities and many challenges to administrators, managers, referring and interpreting physicians, and the payer community.
Marketing and Education for PET/CT
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Once the added benefit of a dedicated PET/CT system becomes apparent, providers are challenged to direct patients to the most appropriate technology. Facilities should consider writing policies to provide guidance as to which patients should undergo PET versus PET/CT procedures. Without education or experience, it is difficult for many referring physicians to determine which technology might be most appropriate for a particular patient. It is likely that referring physicians will differentiate results of PET from PET/CT in their final reports and find PET/CT to be superior. They may begin to seek out sites that have PET/CT systems for certain indications, or in some cases, for all their patients.
Many metropolitan markets have a large number of PET providers. Sites using PET/CT systems are trying to emphasize the advantage of the combined technology to the referring physician community and private payers to influence and build referrals. Sites with PET-only systems are likely to be at a competitive disadvantage going forward.
Physician and Technologist Coverage for PET/CT
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Diagnostic CT procedures without contrast fall under the category of tests that require general supervision, the same designation as PET scan procedures. Diagnostic CT scans with contrast fall under the category of tests that require direct supervision. Direct supervision means a physician must be present in the office suite and immediately available to furnish assistance and direction throughout the procedure. The physician does not have to be present in the scan room.
Thus, no direct physician coverage is required at a PET/CT site that does not perform diagnostic CT scans with contrast. There are physician-owned PET/CT sites that do not perform separate diagnostic CT procedures at all and only report CT findings as they correlate anatomically with the PET findings. Some sites have language in their final reports stating that the results from the CT portion of the procedure are used only for anatomic correlation and attenuation correction. Many questions have been raised about how to reference the CT portion of the PET/CT procedure and how best to use the information available. No consensus has yet evolved, and each center needs to establish a consistent policy for its own practice.
At the May 6, 2004, ARRS meeting in Miami, several physicians expressed concern about downplaying the CT data as nondiagnostic. Is there a significant liability for interpreting physicians who ignore the CT data? This subject will continue to be debated by nuclear medicine physicians and radiologists until a consensus is reached.
The fusion of PET with CT has created unique staffing challenges. The SNM reports that there are fewer than 5,000 technologists certified in both radiology and nuclear medicine and fewer than 200 technologists certified in nuclear medicine and CT to staff the 400 PET/CT machines in the United States. The American Society of Radiologic Technologists (ASRT) and the Society of Nuclear Medicine Technologist Section (SNMTS) have designed curricula for supplementary CT and PET training. The curricula are designed to address skills each technologist will need to become competent in both PET and CT. The curricula are available on the ASRT Web site at www.asrt.org and the SNM Web site at www.smn.org. Current staffing requirements are governed by state regulations and licensing requirements. Conservatively, anyone operating a PET/CT system should determine applicable state law.
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Oncology indications account for the largest percentage of reimbursed clinical PET studies. With the recent approval of FDG PET for the differential diagnosis of frontotemporal dementia and Alzheimer's disease, it is expected the volume of PET brain studies will increase. CMS had assigned a complicated set of G codes for each PET indication except the one covered CPT code for myocardial viability. In an updated announcement from CMS dated February 11, 2005 [1], CMS intends to transition billing for all brain, cardiac, and oncology PET from G codes to CPT codes. CMS will continue to issue instruction and guidance documents over the next several months related to this transition. The implementation date for this transition is April 4, 2005. CMS also is planning to conduct a PET Registry project as outlined in the recently released National Coverage Determination (NCD) update [2].
There are CPT codes available that do not use the CMS-designated G codes for billing PET procedures to private payers. Neither the G codes nor the CPT codes have technical component relative value units. CMS-contracted carriers are responsible for establishing the technical component payment for all PET studies and, under the Hospital Outpatient Prospective Payment System (HOPPS), PET is assigned to an Ambulatory Payment Classification (APC) category. There is an additional charge for the PET radiopharmaceutical. Many contracted carriers include the payment for the radiopharmaceuticals in the technical component allowable and, under HOPPS, each radiopharmaceutical is assigned a payment under a designated APC category.
Private payers also must set the technical component payment levels for all PET procedures. The majority of private payers established their payment rates based on the Medicare allowable in their state or regional market. This pattern was fairly consistent until recently when many of the saturated markets began to see a decline in reimbursement due to a number of PET providers willing to negotiate for lower reimbursement to attract volume.
When providers began adding or upgrading to PET/CT technology, the majority of the sites did not increase their charge for a PET scan even though the cost of the combined systems was considerably higher. There were no billing codes that distinguished the fusion technology. In addition, if sites are performing appropriately ordered and indicated diagnostic CT procedures, they are billing with the appropriate CPT codes.
On November 15, 2004, six new PET and PET/CT CPT codes were published in the Federal Register [3]. CMS designated these new codes with status indicator "Inot valid for Medicare purposes." These new CPT codes are designated for tumor imaging, and CPT codes 78811, 78812, and 78813 will replace CPT code 78810. There are three new PET/CT codes: 78814, 78815, and 78816. These new codes are designed to indicate a PET scan performed on a dedicated PET scanner or a dual-technique PET/CT scanner. The SNM made a very strong case for CMS to consider using these new CPT codes in comment letters to Administrator McClellan dated September 23, 2004, and January 14, 2005, in response to the Physician Fee Schedule (PFS) and the PFS final rule, respectively [4]. The new codes are described in Table 1. It is likely that most private payers will begin to use these new codes. CMS chose not to publish the technical component relative value units, and, thus, providers and payers continue to establish fee and payment schedules based on historical billing and payment practices.
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Some Blue Cross plans do not cover esophageal and thyroid cancer. Recently, the majority of Blue Cross plans began covering breast cancer, but coverage has not expanded to include monitoring response to therapy. Although some of the private payers cover more indications than CMS, this is in limited markets and has occurred primarily due to the efforts of providers working with plan medical directors and soliciting the help of the referring physicians. This strategy does work but takes time and repeated follow-up. For most PET and PET/CT centers, private payers account for at least 50-60% of procedure volume. Medicare covers approximately 40 million lives [4]. Blue Cross and Blue Shield provide coverage for over 88 million people [5]. As of October 2004, approximately 200 million lives were insured by 10 major payers (Fig. 1).
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Many private payers rely on technology evaluations to support their coverage decisions. Although there has been no formal technology evaluation for PET/CT, at least one private payer has issued a policy statement indicating "PET/CT is considered investigational, experimental, and unproven." In addition, some private payers have entered into contractual relationships with radiology management organizations like MedSolutions and National Imaging Associates to manage the utilization of their high-end imaging technologies such as MRI, MR angiography, CT, nuclear cardiology, and PET. These radiology management organizations have established sophisticated programs that are marketed to payers showing how they can help manage their "out-of-control" costs for radiology services. These groups assume the responsibility of establishing utilization review and management guidelines for each imaging technique designed to direct patients to the most clinically appropriate technology based on the information provided by the referring physician. It is extremely important for PET and PET/CT providers to be aware of the contracting strategies and clinical guidelines established by these groups. There are situations where these organizations preauthorize and refer procedures to the most cost-effective providers in a market, without regard for the technical advantage of PET/CT. Self referral is also a concern with PET and PET/CT. In Western Pennsylvania, a major payer has designated PET services to be provided by hospitals only.
It is clear that the fusion of two distinct procedures, PET and CT, into one piece of equipment will present challenges for years to come. Radiology and nuclear medicine communities and their professional organizations are aware of these challenges and will address many of these issues in a timely manner. It is also important for providers to be involved with all of the payers in their market to clearly understand individual payer business practices and to identify opportunities to educate and influence changes in payment and coverage policies.
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403, 405, 410, et
al.
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