Positron Emission Tomography (FDG) for Infection and Inflammation

Steve Phurrough, M.D., M.P.A.
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services 7500
Security Blvd., Mail Stop C1-09-06 Baltimore, MD 21244

RE: Comments on Proposed Decision for Positron Emission Tomography (FDG) for Infection and Inflammation (CAG-00382N)

Dear Dr. Phurrough:

GE Healthcare (GEHC) is providing comments to the Centers for Medicare and Medicaid Services (CMS) pertaining to the proposed decision to continue it’s national non-coverage decision of FDG-PET for infection and inflammation (CAG- 00382N).

GE Healthcare is a $17 billion unit of General Electric Company that is headquartered in the United Kingdom with expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery and biopharmaceuticals manufacturing technologies. GE Healthcare’s broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries.

On behalf of GEHC, I am writing to express disappointment in the conclusion of CMS that there is inadequate evidence to warrant a positive National Coverage Determination (NCD) for the use of PET for infection and inflammation. We believe FDG-PET provides physicians with an exceptionally valuable tool for diagnosing infection and inflammation for the indications evaluated by this proposed decision. While we acknowledge the concerns expressed by CMS in its proposed decision memorandum, GEHC believes that there is sufficient evidence in both the peer-reviewed scientific literature and the extensive clinical experience of investigators to support the issuance of an NCD that expands coverage at this time, particularly for the indications of chronic osteomyelitis, infection associated with hip arthroplasty, and fever of unknown origin.

In reconsidering an expansion of FDG-PET coverage, we caution CMS to refrain from implementing restrictive language that would require that FDG- PET totally replace conventional imaging including bone, leukocyte and/or gallium scintigraphy. Patients presenting with symptoms indicative of the conditions discussed in the NCA often represent complicated cases. Therefore, we suggest that CMS consider the role of PET as a replacement for OR as a follow-up to cases where conventional imaging is inconclusive.

In the absence of a decision to provide for expanded national coverage, we are encouraged by CMS’s request for comments concerning the potential for providing limited coverage for these indications by means of Coverage with Evidence Development (CED). If CMS cannot provide national coverage on the basis of existing evidence, we strongly encourage a CED registry similar to the National Oncologic PET Registry, or other means, which would enable CMS to acquire the data necessary to support the issuance of a favorable NCD on PET for infection and inflammation in the future.

In summary, GEHC believes that FDG-PET is clinically effective in diagnosing suspected chronic osteomyelitis, infection associated with hip arthroplasty, and fever of unknown origin, among many other infectious and inflammatory conditions. We strongly urge CMS to provide national coverage of PET for infection and inflammation, or establish a CED opportunity to provide CMS with the additional data it feels are necessary to support expansion of national coverage to include these indications in the future.

Should you have any questions or wish to discuss our comments further, please contact me at (262) 548-2088.

Sincerely,

Michael S. Becker
General Manager, Global Reimbursement

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Re: Comments on Proposed Decision for Positron Emission Tomography (FDG) for Infection and Inflammation (CAG-00382N)

Dear Dr. Phurrough:

On behalf of the Academy of Molecular Imaging (AMI), I am writing to express the AMI’s disappointment in the conclusion of CMS that there is inadequate evidence to warrant a positive National Coverage Determination (NCD) for the use of PET for infection and inflammation. While we recognize and understand the concerns expressed by CMS in its proposed decision memorandum, the AMI believes that there is sufficient evidence in both the peer-reviewed scientific literature and the extensive clinical experience of our investigators to support the issuance of an NCD at this time, particularly for the indications of chronic osteomyelitis, infection associated with hip arthroplasty, and fever of unknown origin.

Nevertheless, we are encouraged by CMS’s request for comments concerning the potential for providing limited coverage for these indications under the Coverage with Evidence Development (CED) paradigm. As the president of the AMI, I have direct knowledge of the highly effective collaboration of AMI with the Centers for Medicare & Medicaid Services (CMS) in the development and implementation of the National Oncologic PET Registry (NOPR), which has operated successfully pursuant to the innovate Coverage with Evidence Development (CED) paradigm since May 2006. If CMS does not believe a positive NCD can be issued on the basis of existing evidence, we strongly believe that - if feasible - a CED registry similar to the NOPR would enable CMS to acquire the data necessary to support the issuance of a favorable NCD on PET for infection and inflammation.

National Infection PET Registry (NOPR) Option

There are a number of advantages to the development of a National Infection PET Registry (“NOPR”), which we believe could operate in a manner similar to the current NOPR. For instance, CMS would have the assurance on the implementation level of the proven success of the NOPR in systematically acquiring PET scans for analysis. Additionally, the relevant potential stakeholders in such an endeavor (including the AMI, CMS, the NOPR, the American College of Radiology (ACR), and Society of Nuclear Medicine (SNM)) would bring to the project a level of prior familiarity with the implementation of a registry that would prove invaluable in enabling the NOPR to begin operation quickly and efficiently.

A CED for NOPR will, however, require the commitment of substantial technical and financial resources. To minimize such costs, the AMI would propose drawing upon the existing NOPR system as both a template and a foundation for the NOPR. From our experience in developing the NOPR, we believe that the costs of setting up a stand-alone second registry, developing data processing operations, registering sites, and gaining CMS recognition would outweigh any potential benefits of a distinct second registry. However, we do not believe that the existing NOPR study design will be entirely transferable to a registry for infection/inflammation imaging: for instance, entirely new pre-PET and post-PET forms would need to be developed and tested. Additionally, and in contrast to the NOPR, there are no single-site predecessor studies that conclusively demonstrate the feasibility of acquiring useful data in the setting of infection/inflammation. For this reason, we believe that many NOPR protocols would need to be developed de novo. The viability of a NOPR also depends on the availability of adequate funding. The NOPR is currently funded on a per-scan basis through the CMS CED. Based on the success of the NOPR, the NOPR Working Group intends to request that CMS lift its CED requirement on PET across all cancer types for diagnosis, staging, and restaging/suspected recurrence purposes. Should CMS issue a NCD for oncologic PET indications, as we hope that it will, the CED funding for these scans - and thus, a substantial portion of the funding for the NOPR - will disappear. While such an NCD would be welcome news for the thousands of Medicare cancer patients who will benefit from PET, it would leave NOPR with substantially fewer financial resources available to cover its overhead and operations costs. Although the NOPR expects to continue operating in order to gather data on PET for oncologic treatment monitoring, it is unclear whether the added financial burden of developing new protocols for PET for infection could be overcome if PET for infection were added to the NOPR framework. If CMS elects to pursue a CED for PET for infection using the NOPR as a foundation, we would strongly encourage CMS to recognize and incorporate these additional resource needs into its decision.

Conclusion

In summary, the AMI continues to believe that FDG-PET is clinically effective in diagnosing suspected chronic osteomyelitis, infection associated with hip arthroplasty, and fever of unknown origin, among many other infectious and inflammatory conditions. We strongly urge CMS to establish a CED for PET for infection and inflammation, as we believe that such a CED would provide CMS with the additional data it feels are necessary to support the issuance of an NCD for these indications. We appreciate your attention to this issue, and look forward to working closely with CMS to reach a positive determination on PET for infection and inflammation. If we can provide any additional information, please do let us know.

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January 14, 2008

Steve Phurrough, M.D., M.P.A.
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd., Mail Stop C1-09-06
Baltimore, MD 21244
Re: Proposed Decision for Positron Emission Tomography (FDG) for Infection and Inflammation (CAG-00382N)

Dear Dr. Phurrough:

I am writing to provide comments on the Proposed Decision of the Centers for Medicare & Medicaid Services (CMS), in which CMS proposes to continue its national non-coverage of Positron Emission Tomography (PET) for Infection and Inflammation. As my own research at the University of Pennsylvania has indicated, PET provides physicians with an exceptionally valuable tool for diagnosing infection and inflammation for the indications evaluated by this proposed decision. As you might imagine, I therefore found it unfortunate that CMS reached the conclusion that there does not yet exist sufficient data to support the issuance of a National Coverage Determination (NCD).

Despite this decision, however, I welcome the opportunity afforded by CMS to suggest research options that would permit for further data collection while providing coverage of PET for infection and inflammation to numerous Medicare beneficiaries whom I believe stand to benefit tremendously from this technology. Two research approaches in particular merit close consideration by CMS, as I outline briefly below.

One option is for CMS to institute a Coverage with Evidence Determination (CED) for PET for infection and inflammation, and employ an research design that emulates the existing National Oncologic PET Registry (NOPR). Having reviewed the preliminary results of the NOPR, which has now been operating for almost eighteen months, I believe that the registry approach could both serve the informational requirements of CMS and simultaneously provide coverage of PET to those who are most in need of the benefits it provides.Another innovative option is for CMS to approach the National Institutes of Health (NIH) and request the issuance of a Request for Application (RFA) for a multicenter trial of PET for infection on a national level. The obvious advantages of a multicenter trial include its prospective and randomized nature, its national scope, and the ability of CMS, NIH, and trial investigators to closely monitor implementation and controls. In short, such a study would provide CMS with significant confidence in the ultimate results, thereby providing strong evidence for a decision to grant or deny a national coverage determination.

In closing, I am heartened by the desire of CMS to seek new avenues for studying PET for infection and inflammation in greater depth, and I encourage CMS to adopt one or both of the options I have described above. If I can be of any further assistance, I would be happy to speak at your convenience. I look forward to working with CMS to develop and implement a strategy that will ultimately provide CMS with the confidence to implement a NCD on PET for infection and inflammation.

Abass Alavi, M.D., Ph.D. (Hon)
Director, Research Education
Professor, Department of Radiology

AA:akd

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I am a radiologist and fellowship trained nuclear radiologist. I have practiced for over two decades doing general radiology and nuclear medicine. I have reviewed the information you have provided and heard discussions at nucs mtgs I attend regularly. However, my opinion is mostly based on my clinical experience, and I want to comment only on the hip athroplasty issue. The currently used TPBS and IN-111 WBC scan are often inconclusive in my experience. Our orthopods usually order both to be done on successive days. TPBS is done day one with blood for WBC scan drawn before TcMDP injected for bone scan, pt returns that afternoon for delayed bone images, then reinjected with the labeled WBCs, and then pt returns the next morning for a dual isotope 4th phase of the TPBS and the IN-111 WBC imaging. This allows better correlation between bone scan and WBC scan. In doing FDG PET for 10yrs (the last 4 with PET/CT) for tumor imaging, I have seen the sensitivity of PET for incidental inflammatory changes in joints. I have found the CT side of the PET/CT to be CRITICAL in assessing the significance of the PET finding. Most references I have seen only comment on the PET component. Even when we do the low dose CT with the PET/CT there is enough detail to not only precisely anatomically localize the area of increased FDG uptake, but visualize some boney detail (of course beam hardening because of prothesis hinders the later). Based on my clinical experience I would definitely prefer a FDG PET/CT over the TPBS and In-111WBC scans. It would be useful to study this with PET/CT. I think it would also help to determine if the higher dose CT might help. This may take a multislice CT scanner (we use a 16 slic scanner). Since many studies are done by Nuclear Medicine doctors who don''t have CT training in imaging bone diseases, I don''t think we know the full potential of this side of the modality. Perhaps you only allow this to be done with PET/CT not with just PET imaging. Perhaps also, you should require the CT to be done in diagnostic mode, but bundle the payment as one exam. For refernce there are no sites in our area that only use PET, as all have PET/CT including the mobile vendors. I suggest you at least allow use of FDG PET/CT to further assess what combined power of both the PET and CT components may add to the existing inadequate approved studies used in the assessment of infected hip athroplasty. Thank you for reviewing my comments.

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