February 5, 1999

ATTENTION: Mitchell I. Burken, MD
Office of Clinical Standards and Quality
Coverage Advisory Group
Room S3-02-01
7500 Security Boulevard
Baltimore, MD 21244-1850

Dear Dr. Burken:

The National Electrical Manufacturers Association (NEMA) would like to submit this letter as its comments on the proceedings of the PET Town Hall Meeting, which took place on Wednesday, January 20 and Thursday, January 21, 1999.

NEMA is the largest U.S. trade association representing and serving America's electroindustry. The Diagnostic Imaging and Therapy Systems Division of NEMA represents manufacturers of x-ray imaging, CT, radiation therapy equipment, diagnostic ultrasound, magnetic resonance systems and medical imaging informatics systems, as well as nuclear medicine imaging devices. The Nuclear Section of NEMA's Diagnostic Imaging and Therapy Systems Division comprises over 90% of the manufacturers of nuclear medicine imaging devices.

NEMA wishes to commend HCFA for holding this Town Hall meeting as a mechanism to open up a dialogue between HCFA, the clinical community, manufacturers and patients. We believe that all critical stakeholders should be able to participate in order to ensure a fair, open and scientifically - based Medicare coverage process. We appreciate this opportunity to provide comments.

As a follow up to the Town Hall meeting, we would like to express our deep concerns about the current status of Medicare coverage for PET. At present, Medicare reimbursement for PET is limited to lung cancer diagnosis and staging.

A number of presentations were given at the meeting dealing with:

We want to state first that the data presented at the meeting compellingly demonstrated the efficacy of the use of PET in a cost-effective manner for the above-listed applications. The data in the studies presented was well-organized and cross referenced to patient management tracks. The clinical trials which were discussed were comprised of cancer and dementia patients which were imaged by PET and other modalities. Moreover, the data which was presented, when compared with other modalities in imaging trials using the same patients, yielded clear evidence of specific clinical indications in which PET was superior to CT and other imaging modalities.

The PET community has performed a wide range of cancer studies, as indicated above. It is critical to note that the benefits of the use of PET are recognized by a broad range of providers in the clinical community, including surgeons, oncologists, radiologists and nuclear medicine physicians. All of these specialties recognize the unique sensitivity of PET and endorse its use in the staging and detection of cancer.

The cost-effectiveness of PET was shown by such measures as avoidance of surgery, and the early staging of disease. The use of PET scanning greatly facilitated the ability of clinicians to avoid costly and unnecessary surgeries, and instead permitted them to use more prudent and effective patient management alternatives, such as radiation and chemotherapeutic treatment. The "quality of life" improvements in patients' lives were convincingly demonstrated by the presentations of surviving cancer patients. Thus, we firmly believe that the current quantity and quality of the data across multiple cancer types sufficiently establishes the cost-effectiveness of PET and its strong, positive impact on health outcomes. PET should therefore receive coverage for these well - defined indications.

Some of the commenters at the workshop proposed that randomized, clinical trials be conducted for PET. In view of the strength of current, clinical evidence, it would be wholly unnecessary and wasteful to conduct such trials. Randomized trials are appropriate for drug-type studies, but are less efficient for studying diagnostic tests. In the PET trials presented, one population was studied comparing PET and CT imaging--for example, patients suspected of having recurring colorectal cancer. This type of trial requires significantly fewer patients to yield statistically significant results than a randomized trial where PET is studied on one population and CT is used on another. It may be impossible to get human subjects committees to approve trials. One reason for this is because of the significant body of literature which currently exists about PET, which reflects the extent of clinical research on PET which has been ongoing for the past 10 years. Therefore, a blinded trial may not be able to be done.

In addition, the proposal for establishment of minimum performance statndards for PET would be inappropriate. Over the years in which PET data has been accumulated, this data has been produced by various PET scanning devices with different performance capabilities. However, even with those variations in performance, these clinical studies have demonstrated the advantages of PET in caring for oncology patients.

Patient management is a matter lying distinctly within the practice of medicine and should be left to the exercise of judgement by the physician. In fact, the needs of physicians in clinical practice do and should determine the appropriate standards of performance of medical devices; not some arbitrarily imposed standard which does not take into account the realities in which medicine is practiced today.

The technology of PET is an evolving one, and therefore clinicians will gravitate toward the use of more effective technology as the state-of-the-art becomes more sophisticated. The manufacturers and clinicians have been and will continue to be advocates of prudent quality control procedures to ensure consistent high quality diagnostic imaging performance by PET devices.

At the meeting, Dr. Bagley posed the following questions which he stated would need to be addressed before a favorable coverage decision could be made:

  1. Will the modality yield information which is going to be useful in making clinical decisions (clinical utility for treatment strategy).
  2. Is the information translatable for use in the oucome of the patient, for example, what benefit does the diagnosis confer--what does early diagnosis allow to happen
  3. Is the information which was produced something that the clinician was willing to rely upon.
  4. Is the technology a replacement for older technology, additive to it or optional.

Clearly, the data presented at the workshop fully address these questions and we wish to reply to them point by point.

First, the clinicians presented convincing data showing that PET scanning provided essential clinical information which enabled them to determine, for example, multiple metastases of cancer in the body. This information proved key to deciding whether surgery was indicated in the particular patient , or whether such surgery would be futile and ineffective in the treatment of the disease.

Second, to address the benefits conferred by use of PET scans, the diagnostic information which was provided in the cancer studies presented was used directly in guiding the clinical decision-making process for cancer treatment, for employing surgery, or chemotherapy and radiation treatment. In many instances, as a result of the sensitivity of PET, needless surgery was avoided.

With respect to patient outcomes, the use of PET produced significant and positive results. These included avoidance of the cost and trauma of surgical procedures, in favor of more effective therapies. The early diagnosis capability afforded by PET allowed patients to commence appropriate treatment at an earlier point, thus enhancing their survivability and quality of life.

Finally, the presentations demonstrated that PET can play a valuable role as an additional tool in the clinical armamentarium in the diagnosis of recurrent disease and staging of disease. As well, it adds a new dimension in the treatment of cancer, in that it can obviate the need to perform repetitive CT scans in certain specific instances. Thus PET serves both a complementary as well as an additive role when compared with CT. It should be recognized that this is due in large part because CT is a morphological modality, while PET is a metabolic one.

Conclusion

In view of the weight of the evidence presented over the two days of the workshop, PET should receive HCFA approval for coverage of carefully defined indications. The absence of a favorable coverage decision will cause serious adverse consequences for treatment of patients with cancer, and certain types of dementia.

Patients will face dangerous risks of remaining untreated as a result of a failure to detect disease in the absence of PET. They will be compelled to undergo costly, traumatic surgery which is totally unnecessary due to the known and accepted value of PET in the diagnosis of disease. Denial of Medicare reimbursement will deprive thousands of patients from access to this imaging modality which has given life and hope to so many people.

NEMA urges HCFA to recognize the strong endorsement of use of PET by the medical community for the clinical applications presented in these studies, and render a favorable decision on Medicare coverage accordingly. The pressing needs of the medical community and Medicare patients should not be delayed any further and should be addressed now by promptly approving coverage for this powerful diagnostic tool.

If you have any questions, or need further information, please feel free to contact me at (703) 841 - 3248.

Sincerely,

Richard Eaton,
Industry Manager,
NEMA Nuclear Section