[gdpawel]

Scott Gottlieb stated in the Forbes article that most of the new rates are being based on the work of "one" Medicare contractor, Palmetto GBA.

Efficacy doesn’t mean proof that treatment decisions are changed; efficacy means that you prove that patient “outcomes” are improved as a result of the changed treatment decisions. It hasn’t been proven to improve outcomes and that is what is meant by “efficacy” in this context.

The standard used to judge the utility of laboratory and radiographic tests has always been “acceptable accuracy of clinical correlations” and “clinical utility.” Demanding (for demanding sake) proof of “efficacy” as opposed to proof of “accuracy” is completely unprecedented for laboratory tests in cancer (you just don’t make up another criteria for the sake of making it up).

Cancer is a disease which has always been managed on the basis of “best evidence” and not on the basis of “conclusive evidence,” which is lacking in virtually all situations in clinical oncology, including those situations in which clinical trials to identify the best treatment for the “average” patient have been performed and published and meta-analyzed.

Back in 1999, the Medicare Advisory Panel concluded that cell culture assay tests (functional cytometric profiling) offered “clinical utility.” After listening to detailed clinical evidence, the Medicare Coverage Advisory Committee found that these assay systems can aid physicians in deciding which chemotherapies work best in battling an “individual” patient’s form of cancer.

Although Medicare had been reimbursing for the cell culture drug “resistance” part of the tests since 2000, it wasn’t until the beginning of 2006 that they abandoned the artificial distinction between “resistance” testing and “sensitivity” testing and provided coverage for the whole FDA-approved kit. Their decision had been made that the assay is a perfectly appropriate medical service, worthy of coverage on a non-investigational basis.

Until Palmetto GBA came along in 2010!

Even though the new Medicare contractor, Palmetto GBA, arbitrarily reversed positions to reimburse the assays, the previous CMS administrator for Medicare, NHIC, let the cat out of the bag. They cannot try to put it back in. Previous Medicare contractors for California made the determination that chemoresponse assays qualified as a Medicare covered service, with the decision that the assays were a perfectly appropriate medical service, worthy of coverage on a "non-investigational" basis. Too many patients know about something the cancer establishment tried to keep under a breadbox for too many years.

It was Medicare contractor Palmetto GBA, which is a subsidiary of Blue Cross/Blue Shield of South Carolina, that provides coverage for several states, unexpectedly posted a notice on its web site that it would no longer pay for Roche's Avastin medication for treating breast cancer after January 29, 2010. But Palmetto GBA did an embarassing about face and rescinded its decision.

Palmetto GBA also provides coverage in Ohio, West Virginia, Nevada, California and Hawaii, apparently acted too hastily. Some have said that Palmetto did not go through the usual motions before posting its decision, which was quickly scrubbed from its web site, and allow for public comment. And its action annoyed officials at the Centers for Medicare & Medicaid Services (CMS), since Roche's Genentech unit is appealing the decision by the FDA, which assured patients that Medicare would continue to cover Avastin while the appeals process played out.

Did Palmetto's indiscriminate action, without having an extensive, transparent tech assessment of the evidence annoy officials at CMS? No! Did Palmetto GBA do an embarassing about face and rescind its decision? No! CMS allowed Palmetto GBA to arbitrarily and capriciously stop reimbursements to cancer patient services. Business is business, but at a certain point, business is also about people and cancer business is about cancer patients.

It looks like Novitas Solutions, Inc. (formerly Highmark Medicare Services) has arbitrarily made the decision, like Palmetto, GBA did in California, to discontinue Medicare payment for chemoresponse assays done in Pennsylvania.

The rationale for the non-coverage decision is totally bogus. It's a shame.

According to this same Dr. Scott Gottlieb, former senior official at CMS, CMS doesn't have a single oncologist on staff, yet since the year 2000, they've issued 165 restrictions and directives on the use of cancer drugs and diagnostic tools. And CMS has radically expanded its authorization for use of cancer drugs by putting off-label decision making in the hands of compendia writers in the private sector, many of whom are on the payrolls of the companies that make the drugs.