Medicare coverage decisions for new technologies are made at both national and regional levels.

While Medicare coverage is being considered at the national level (see http://www.weisenthal.org), the Medicare contractor for California (where almost all of the laboratories providing this service are located) has, after considerable deliberation, announced that what they term "Cell Culture Tumor Resistance" (CCTR) will henceforth be a covered service, effective December, 2000.

The announcement appears in Your Medicare Newsletter, Number 110, November 30, 2000. Copies of this newsletter are available through the following carrier website: http://www.medicarenhic.com.

Covered assay endpoints include: (1) Differential cell staining and microscope counting [DISC Assay]; (2) MTT Assay; (3) ATP Assay, and (4) Radiolabeled Thymidine assay. The latter assay endpoint had been previously announced as approved in the September, 2000 edition (Number 109) of Your Medicare Newsletter.

The carrier makes an important distinction between what the carrier terms cell culture tumor resistance (CCTR) assays and human tumor cell sensitivity (HTCS) assays. The former are used to identify drugs UNLIKELY to provide clinical benefit, while the latter assays are used to identify drugs which are LIKELY to provide clinical benefit.

From a technical point of view, CCTR (Medicare-covered) assays have the following general features:

1. Single (relatively high) drug concentrations are tested.
2. Usually only a single (DISC, MTT, ATP, or Thymidine) endpoint is used.
3. Only drugs commonly used (maximum of 7 drugs per tumor assay) in the treatment of the given neoplasm are tested.
4. Purpose is to identify drugs which are UNLIKELY to provide clinical benefit.

In contrast, HTCS (Medicare Non-covered) assays have the following general features:

1. 2 or more (both high and low) drug concentrations are tested.
2. Often 2 or more (DISC, and/or MTT, and/or ATP) endpoints are used.
3. Both commonly used and uncommonly-used (or new) drugs (typically 15 - 25 drugs and drug combinations are tested).
4. Purpose is to identify drugs which are LIKELY to provide clinical benefit.

To illustrate the difference between the CCTR and HTCS endpoints, I have analyzed our own data in previously-untreated ovarian cancer. The great majority of these patients are treated with platinum-based chemotherapy. The first figure shows patient survival as a function of whether the CCTR assay showed resistance or non-resistance, based on testing a single (high) drug concentration with only one (in this case, MTT) endpoint. The second figure shows patient survival as a function of whether the HTCS assays showed resistance, sensitivity, or an intermediate result, based on testing two drug concentrations with two different (in this case DISC and MTT) endpoints. It can be seen that both CCTR and HTCS assays provided useful prognostic information; however, the most extensive testing in the HTCS assay permitted more clear-cut distinctions to be made.

The cost of a CCTR assay alone (as performed by our own laboratory, for purpose of illustration) is approximately 1/3 the cost of a combined CCTR/HTCS assay designed to identify both inactive (covered service) and active (non-covered service) drugs.

It is possible for Medicare patients to receive both the covered service (CCTR) assay and the non-covered service (HTCS) assay. In the case where both assays are performed, approximately 1/3 of the total cost would be paid by Medicare, whereas the patient, with advance notification of Medicare non-coverage, would be personally responsible for paying 2/3 of the total cost of performing both assays.

I am continuing to pursue national Medicare coverage for both CCTR and HTCS. However, the practical reality is that Medicare coverage is now available for CCTR for a specimen from a Medicare patient obtained anywhere within the USA, but submitted for testing by one of the approved laboratories located within California.