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Perspective |
1 Foley Hoag, LLP, 155 Seaport Blvd., Boston, MA 02210-2600.
2 Mallinckrodt Institute of Radiology, Washington University School of Medicine,
St. Louis, MO.
3 HealthTech, San Francisco, CA.
4 Department of Internal Medicine, Virginia Commonwealth University, Richmond,
VA.
5 Karmanos Cancer Institute, Wayne State University, Detroit, MI.
6 Department of Radiology, Duke University School of Medicine, Durham, NC.
Received September 1, 2006; accepted after revision November 8, 2006.
M. J. Lindsay and B. P. Carey represent the Academy of Molecular Imaging,
whose member organizations include GE Healthcare, Siemens Medical Solutions,
and Philips Medical Systems, among many other companies with financial
interests in PET. They also represent the Radiology Corporation of
America.
OBJECTIVE. The purpose of this article is to review the recent expansion of Medicare coverage for 18F-FDG PET for certain cancer indications under the Centers for Medicare & Medicaid Services' new Coverage with Evidence Development (CED) policy and to describe the specific operational mechanics of the National Oncologic PET Registry (NOPR).
CONCLUSION. The NOPR will make possible a more accurate assessment of the actual influence of PET on patient management across a wide spectrum of cancer indications. By linking access to PET for virtually all Medicare beneficiaries to the collection of clinically valuable evidence, the NOPR represents the cutting edge of the CED approach.
Keywords: cancer • National Oncologic PET Registry • nuclear medicine • oncologic imaging • PET • PET/CT
In January 2005, the Centers for Medicare & Medicaid Services (CMS) announced that it would expand Medicare coverage for PET with 18F-FDG for the diagnosis and management of patients with malignancies. The decision followed many years of incremental expansion of Medicare coverage for oncologic applications of PET and included the novel requirement that prospective clinical and demographic data be collected on Medicare beneficiaries receiving PET examinations under this policy. After a lengthy period of project design and regulatory review by multiple Department of Health and Human Services (DHHS) agencies, the National Oncologic PET Registry (NOPR) went into operation in May 2006. The NOPR is sponsored by the Academy of Molecular Imaging and administered by the American College of Radiology (ACR) through the American College of Radiology Imaging Network.
The NOPR is a nationwide prospective Internet-based registry and a centerpiece of CMS's new "Coverage with Evidence Development" (CED) approach, under which the agency links Medicare coverage of certain promising technologies to the collection of prospective data. The NOPR bridges an informational gap that historically has limited CMS coverage for FDG PET and will provide, for the first time, nearly comprehensive coverage for oncologic applications. CMS had declined to cover FDG PET for many of the less prevalent cancer types and indications because the peer-reviewed literature provided insufficient evidence that those specific applications improved health outcomes. In the absence of coverage by either Medicare or private payers, researchers at academic institutions have been unable to develop the clinical data necessary to show to CMS that broader coverage is warranted. Under CED, CMS conditions coverage of a particular item or service on the collection of specific clinical data; those data, in turn, assist the agency in evaluating whether the item or service is "reasonable and necessary" [1]—the legal threshold for coverage under Medicare. CMS plans to use registries similar to the NOPR to assess other new technologies under its CED approach.
This article describes the recent history of PET coverage under Medicare, the broad policy goals of CED, and the specific operational mechanics and anticipated clinical benefits of the NOPR.
Incremental Expansion of Medicare Coverage for FDG PET
PET is a minimally invasive molecular imaging method used to evaluate physiology and biochemistry in both healthy subjects and in patients with diseases such as cancer, ischemic heart disease, and some neurologic disorders. The primary radiopharmaceutical used in clinical PET for oncologic imaging is FDG. Images obtained with this tracer provide both qualitative and quantitative information about the regional distribution of glucose metabolism. Most malignancies have greater glucose utilization than do normal tissues and accordingly exhibit greater FDG uptake [2]. Studies comparing the diagnostic performance of PET to that of CT have shown that PET is more accurate in detecting most cancers [3]. In addition, integrated PET/CT is rapidly replacing conventional PET as the preferred method for oncologic imaging; the combined information from the fused PET and CT images is more accurate than that available with either PET or CT alone [4]. The NOPR will include data from both conventional PET and PET/CT.
In contrast to other widely used imaging technologies such as CT and MRI, which have been covered by Medicare for general oncologic applications since their introduction, CMS has approached expanded coverage for PET cautiously. In a series of National Coverage Decisions (NCDs) beginning in 1998, CMS has evaluated the clinical utility of PET on a cancer-by-cancer and indication-by-indication basis. CMS's specific rationale for this approach reflects the growing trend among payers to impose more explicit and stringent evidentiary requirements on the coverage process. Under pressure from Congress to make coverage decisions more predictable and transparent, in the late 1990s the agency instituted significant changes to the national coverage process [5]. Under the revised NCD framework, CMS covers a particular item or service only after the agency determines it to be "reasonable and necessary for the diagnosis or treatment of illness or injury" [1]. CMS's core consideration in making that judgment is whether available evidence supports the conclusion that the item or service "improves net health outcomes" [6].
Under the NCD process, CMS has extended national coverage for FDG PET only in response to coverage requests that include clinical data sufficient to justify its use for a specific cancer type or indication. CMS issued its first coverage decision for FDG PET in January 1998, approving payment for the characterization of an indeterminate solitary pulmonary nodule and for the initial staging of suspected metastatic non-small cell lung cancer [7]. In July 1999, the agency extended coverage to include restaging of suspected recurrent colorectal cancer, staging and restaging of lymphoma when used as an alternative to gallium scintigraphy, and evaluating the recurrence of melanoma before surgery when used as an alternative to gallium scintigraphy [7]. In July 2001, in response to a request for broad coverage of FDG PET, CMS began covering diagnosis, staging, and restaging for melanoma, lymphoma, and non-small cell lung, esophageal, colorectal, and head and neck cancers. In the same NCD, however, CMS declined to cover FDG PET for many other requested indications, citing insufficient supporting clinical data [6]. CMS extended coverage to certain breast cancer indications in October 2002, to a specific thyroid cancer indication in October 2003, and to a specific cervical cancer indication in January 2005 [7].
Requests for broader coverage of FDG PET have been based on the premise that increased glucose metabolism is a fundamental characteristic of malignant cells [2] and that FDG PET is therefore useful for the detection of all cancers. CMS has been unwilling to accept this premise in the absence of data specific to individual tumor types. The agency's reticence has created a "catch-22": The lack of broad coverage for FDG PET has acted as a check on its clinical adoption for noncovered applications, which has inhibited research into its clinical utility. In particular, academic researchers have been unable to obtain the clinical data necessary to show that FDG PET is "reasonable and necessary" for a broad range of cancer types and indications. The National Institutes of Health have been largely unwilling to fund clinical trials to evaluate the diagnostic performance of FDG PET, and industrial sponsors have provided only limited support for such research. In addition, it is unlikely that trials capable of generating robust data on the performance of FDG PET for certain rare cancers and narrow indications will ever be performed. As the result of CMS's incremental, application-specific approach, FDG PET has remained not covered for numerous cancer types and indications [8]. CMS and NOPR investigators hope to resolve this evidentiary dilemma by making coverage conditional on the collection of clinical data.
Coverage with Evidence Development
The CED approach bridges the information gap between the "reasonable and necessary" standard under the NCD process and the dearth of clinical data supporting coverage for certain promising technologies and services. CMS believes that conditioning coverage on the collection of data is especially appropriate when "a particular medical intervention has yet to conclusively show an improvement in health outcomes, but existing information clearly suggests the intervention may provide an important benefit" [6]. For example, after a major multicenter trial suggested additional clinical indications for implantable cardioverter defibrillators (ICDs), CMS issued an NCD in 2005 making expanded coverage for ICDs conditional on the creation of a national ICD data registry [9, 10]. Significantly, CMS conceives of CED not as a departure from the NCD process but rather as an adjunct policy to the agency's traditional coverage-granting authority. "Rather than waiting for definitive studies to be completed to address all key questions related to whether the use of a particular technology is reasonable and necessary," under CED, the agency can "provide coverage along with an assurance that appropriate data will be collected to ensure that the item or service is reasonable and necessary and to answer specific, important remaining questions" [6].
Although the primary purpose of CED is to equip the agency to reach more-informed payment determinations, the new data are also expected "[to] assist doctors and patients in better understanding the risks, benefits, and costs of alternative diagnostic and treatment options... [and] help to ensure that individual patients are receiving care that is reasonable and necessary given their specific clinical situation" [6]. Further, CED will stimulate important derivative research. By paying for items and services that previously were not covered, CED will enable academic institutions to undertake their own investigations of the items or services under study, thus engendering more robust prospective data than are produced through CED alone.
The NOPR is one of the first examples of CED in action. In the NCD announcing the DHHS authorization of a PET registry, CMS explained that in coupling Medicare coverage with a data collection requirement, the registry would influence patient management and improve health outcomes by enabling "physicians [to] appropriately evaluate the PET scan results in the context of critical relevant clinical information" [6]. Were it not for the creation of the NOPR, "CMS would have continued adding coverage for specific clinical use of FDG PET in cancer as each of these potential uses was shown through well-designed clinical trials to influence patient management and alter patient outcomes" [7]. As a result, "many Medicare beneficiaries with cancer would not have the benefit of more definitive evidence on the specific circumstances in which PET has clinical utility" [7].
By linking coverage to the collection of clinical data, the NOPR brings together federal health care administrators, physicians, researchers, and industry in a collaborative effort to improve health outcomes. As one of "a small group of high-priority pilot efforts on topics for which there is substantial agreement that better evidence would be valuable in expanding access to specific technologies and services" [6], CMS views the NOPR as a demonstration project for CED and for its evidence-based medicine framework more broadly.
Mechanics of the National Oncologic PET Registry
Detailed information on the NOPR is available on its Website [8]. Medicare beneficiaries who are referred for PET for an oncologic indication that is either not currently covered or not specifically not covered by Medicare are eligible to participate. The primary scientific objective of the registry is to assess the effect of PET on referring physicians' intended patient management across the spectrum of the expanded cancer indications [11]. Several previous studies have evaluated the impact of FDG PET on the management of patients with cancer [11-18]. The study by Hillner et al. [11], which reported that PET altered management in approximately 60% of cases, served as the prototype for the NOPR.
Because DHHS does not consider the submission of data to the NOPR by individual PET facilities and referring physicians to constitute research, the facility is not required to obtain institutional review board (IRB) approval to participate in the registry. As the NOPR operations manual explains, "[the] only entity engaged in research is the registry itself (i.e., NOPR)" [8]. The ACR IRB has approved the use of data collected by the NOPR for research purposes. Both patients and referring physicians are considered research subjects, however, and must therefore provide informed consent before their data can be used for research. Either before or on arrival at a PET facility, each patient receives a standard NOPR information document describing the registry and requesting that the patient provide oral consent for the use of identified data for research purposes. If the patient withholds consent, the identified data are still collected by the PET facility, sent electronically to the NOPR, and submitted to CMS; however, the data are not used for research. In such cases, CMS nevertheless pays for the PET scan.
A schema illustrating the operation of the NOPR is shown in Figure 1. Participating PET facilities use a secure, Internet-based application to register patients referred for NOPR-eligible indications and to submit other required information to the NOPR database. Before the PET examination, the referring physician must complete a pre-PET form providing, among other data, the following information: the specific reason for the PET referral, the cancer type (if known) and an assessment of the working stage, the patient's performance status, the physician's intended management plan for the patient if PET were not available, and whether the referring physician is also the treating physician [8]. This form must be returned to the PET facility, and the PET facility staff must enter the data into the registry no later than the day of the PET examination.
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After the PET examination is performed and the PET report is entered into the database, the referring physician must complete an indication-specific post-PET form to assess the physician's intended patient management in light of the PET findings. The post-PET form also solicits consent from the referring physician to allow the response data to be used for research purposes. Physicians who elect to withhold consent nevertheless must submit all of the required data elements as a condition of reimbursement by CMS; however, those data are excluded from the research data set used by NOPR investigators. When all of the required forms have been entered into the NOPR database, the registry notifies the PET facility that it can submit its claim to CMS. In order for the case to be eligible for reimbursement by Medicare, all required data must be entered into the registry within 30 days of the PET examination [8].
The NOPR began accepting patient registrations on May 8, 2006. The initial implementation of the NOPR was marked by minor difficulties, including security concerns with unencrypted health information in e-mail communications, programming errors, and some ambiguity of specific items on the pre- and post-PET forms. These problems have been addressed, and the NOPR investigators and staff have continued to educate referring physicians and PET facilities in response to many patient-specific questions (e.g., questions regarding eligibility). Notably, unwillingness of referring physicians to complete the required pre- and post-PET forms has not been a significant problem. As of January 31, 2007, 1,421 PET facilities nationwide were participating in the registry, and complete data for 21,597 patients had been submitted. Patients and referring physicians have consented to the use of data for research purposes in approximately 92% and 96% of cases, respectively.
Clinical Benefits of the NOPR
The NOPR provides patients, physicians, and payers with more robust data about the impact of FDG PET on patient management and, ultimately, net health outcomes. By facilitating direct comparisons between referring physicians' pre-PET and post-PET patient management plans, the NOPR will make possible a more accurate assessment of the actual influence of PET on patient management across a wide spectrum of cancer indications. The anticipated benefits of such an analysis are threefold: First, as indicated, the clinical data submitted to the registry will permit CMS to better evaluate whether PET is reasonable and necessary for specific cancer types and indications for the purpose of coverage determinations. Second, "systematic, protocol-driven data has the potential to increase the likelihood of improved health outcomes. These additional data may alter the course of patient treatment based on the best available evidence and may lead a physician to reconsider the use of the item or service or otherwise alter a patient's management plan, potentially improving health outcomes" [6]. Third, and more generally, the data collected through the NOPR will enable investigators to better analyze the value of FDG PET in improving cancer diagnosis and designing treatment.
The NOPR will equip CMS to refine its coverage policy for FDG PET. If the agency concludes, based on the evidence developed under the registry, that PET is "reasonable and necessary" for a particular cancer or indication, it can remove the registry requirement and cover that indication unconditionally. In addition, outside researchers can submit proposals to NOPR and CMS to link the NOPR data to Medicare claims data, thus allowing them to study the long-term impact of FDG PET on net health outcomes. The results of such studies will, in turn, inform patient management. As is the case with any large registry, the accuracy of the data submitted to the NOPR depends on the submissions of referring physicians. Busy clinicians or their designees (e.g., nurse practitioners) may not always take the few minutes necessary to complete the forms accurately. Further, the data collected by the NOPR on physicians' intended patient management may or may not reflect actual management. Notwithstanding these limitations, the NOPR will afford physicians, researchers, and CMS significant insight into the effect of PET on patient management. With CED, CMS has expanded its role in the care of Medicare patients from that of making payment determinations for specific items and services to informing patients and physicians of the clinical benefits of new technologies. "As the pace of the introduction of a broader range of diagnostic tools and therapeutic interventions quickens," the agency explains, "the demand for better information about their effectiveness for particular types of patients becomes even more urgent. Better evidence will help doctors and patients get the most benefits at the lowest possible cost in our increasingly complex and individualized health care system" [6]. By linking access to PET for virtually all Medicare beneficiaries to the collection of clinically valuable evidence, the NOPR represents the cutting edge of this new approach.
Acknowledgments
We thank the many individuals who have contributed to the development of the National Oncologic PET Registry (NOPR). Without their contributions, the NOPR would not have come to fruition, nor would it have achieved such apparent early success. These contributors include individuals at the Academy of Molecular Imaging, American College of Radiology, American College of Radiology Imaging Network, Society of Nuclear Medicine, American Society of Clinical Oncology, and the Centers for Medicare & Medicaid Services.
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