March 15, 2000

Erica Bisguier-Reed, J.D.,M.P.H.
Hugh Hill, M.D., J.D.
HCFA/MS-S3-02-01
7500 Security Blvd.
Baltimore, MD 21244

Dear Ms. Reed and Dr. Hill:

The following is a summary of my understandings of our telephone discussion earlier today regarding HCFA's consideration of Human Tumor Assays:

1. There are 4 groups of formal requestors (Oncotech, Rational Therapeutics, Anticancer, and Larry Weisenthal). One or several of these requestors have expressed an intention to withdraw the coverage consideration request(s). I would like for HCFA to continue on its track of considering coverage of cell death assays. But I do not wish to serve as an impediment to allowing other requestor(s) to withdraw. And, from lessons learned with the review process to date, it may be more efficient, manageable, and effective to focus the scope of the request more narrowly.

2. There are two approaches which could be taken. The first approach would be to keep the existing requests on the table and for affected parties to ask HCFA to remove some of these requests from the scope of further review, leaving unchanged existing HCFA policies pertaining to these specific requests. The second approach would be for all requestors to withdraw all requests and for one or more requestor to re-submit a more focused request, which would then be evaluated and reviewed without consideration of the withdrawn formal requests. In this regard, there is a natural split along the respective lines of (1) cell proliferation assays versus (2) cell death assays. Additionally, it may be desirable to simplify the review by restricting the scope of the consideration request for either of the two groups of assays to less than the total universe of all human cancer types.

3. You indicated to me that it would be preferable, from your point of view, to follow the latter strategy, rather than the former strategy. I said that I would be willing to withdraw and resubmit, with the following understandings:

a. My resubmission would be very near term - hopefully within 6 weeks and certainly within 8 weeks. This is the time needed for me to prepare and defend a revised formal request for coverage, including providing HCFA with a complete set of photocopies of all relevant published scientific papers (including important publications since the time of the November MCAC meeting and important pre-existing publications which were not considered at the time of the previous review), as well as highly relevant, unpublished data from my own private practice (to address criticisms relating to evaluability rates and to address the issue of the degree to which the assay results are actually used in the real world to change and guide therapy in the Medicare population).

b. HCFA would have its Blue Cross/Blue Shield technology assessment contractor temporarily suspend its review, pending receipt of my revised formal request, which would then be forwarded to Blue Cross/Blue Shield, and also to other relevant reviewers. The formal, written reviews (external and internal) would then be submitted me for consideration and, if appropriate, written rebuttal prior to the future MCAC re-review. I should not need more than 10 days upon receipt of these reviews to read them and prepare and submit my rebuttal, if any. This written rebuttal would then be submitted to the MCAC at least one week prior to the actual meeting. I would have no objection if HCFA wished to first send my rebuttal to the outside reviewers, so that their counter-rebuttal(s), if any, could be included in the same mailing to the MCAC, along with my rebuttal, itself.

The above is based on the understanding that the issues relating to Human Tumor Assays and their applications in cancer medicine are extremely complex and historically controversial. These issues and relevant data defy both concise summary and simple argument. It is much better to have the major areas of contentiousness pre-argued in writing in advance of the meeting. The meeting itself, then, can consist of a very concise and straightforward oral summary of data and arguments on the part of both proponent(s) and critical reviewers, reserving the lion's share of time to committee deliberation and questioning. You made the relevant point that this is a meeting open to the public and last minute introduction of data and/or arguments by the public can certainly occur. This point is understood.

c. It is appreciated by HCFA that what prompted me to submit a formal request for coverage last August was the understanding that the issue was to be openly considered by an outside panel of qualified and independent reviewers, representing a broad cross section of laboratory medicine and clinical medicine (not just clinical oncology), and with the participation of patient and "industry" representatives. As I indicated in previous correspondence (paper and electronic), I therefore invested what was for me an enormous amount of time and money in participating in the review process.

While not without flaws, I found the system to be fundamentally superior to the closed, internal, and ultimately inscrutable reviews which are characteristic of the insurance industry (save for Blue Shield of California). If not a perfect system, it is a system which affords a reasonable opportunity for a proponent of a complicated technology to receive an open and fair review. Therefore, I asked for and received your assurance that my re-submitted formal request would be slated for formal MCAC review, as opposed to being decided by HCFA without formal MCAC review.

You proposed a timetable which would lead to an August, 2000 MCAC meeting to re-consider the revised coverage request. That would be acceptable, as would an even later (e.g. Fall, 2000 MCAC meeting). I have been doing this work on a full time basis for 20 years, and my concern is to have a good review, even more than to have an expeditious review. I represent non-proprietary, public domain technologies. The financial and regulatory implications of a positive Medicare coverage decision to me personally are far more likely to hurtful rather than helpful. As I have pointed out previously, I do not see a clamoring by ophthalmologists for Medicare to provide coverage for laser vision correction procedures.

This is not like stem cell transplantation therapy, where only a few patients could afford the cost, absent Medicare. There is a virtually unlimited number of Medicare cancer patients who can afford and do pay out of their own pockets the full retail cost of Human Tumor Assays (we are required to bill Medicare to obtain a denial before we are allowed to bill the patients, themselves; so you can document for yourselves the fact that TransAmerica/Medicare's non-coverage of our services does not prevent us from providing it to as many Medicare patients as we can handle - given that it requires 3 hours of my own personal time for each patient whose tumor we study). Rather, I am pressing for this simply because I am nauseated at the long-languishing current state of cancer chemotherapy and because I am certain that it can and will get much better once these technologies begin to receive more widespread application (also with greater resulting scrutiny and study).

4. Lastly, you agreed to be sensitive to "appearances" with respect to your wording in your announcement of the withdrawal of the requestors. I fully expect that both the MCAC and HCFA staff will come to agree that Human Tumor Assays are deserving of Medicare coverage for some and possibly many indications in cancer medicine. I would be (temporarily) withdrawing not because I agree that Human Tumor Assays are not worthy of coverage or, more plainly, because I fear defeat, but rather to facilitate HCFA's review of a very complex proposal and to allow other requestors the opportunity to withdraw, should any choose to do so. Among other things, I now have a better understanding of what HCFA and outside reviewers feel are key issues, and I can more specifically focus my bibliography and arguments to address these issues. My goal is simply to make a complex proposal and literature database as straightforward and clear as possible. It would appear that this goal would be facilitated by a withdrawal and re-submission. You agreed to phrase your announcement of the withdrawal, if forthcoming, in a way which would not be misconstrued by other cancer professionals, other insurance companies and agencies, by Medicare beneficiaries, and by the public at large.

If the above agrees with your understanding of the essence of our phone conversation, then I shall be enthusiastic in my agreement to proceed.

Sincerely yours,

Larry Weisenthal, M.D., Ph.D.