U.S. Health and Human Services, Healthcare Finance Administration, Medicare Advisory Committee Finds Personalized Cytometric Profiling Clinically Useful

Even prior to completion of the landmark LRF CLL4 randomized clinical trial showing improved one year survival among CLL patients whose treatments were guided by DiSC Assay personalized cytometric profiling, a two-day national Medicare Advisory Committee meeting was held in Baltimore, Maryland, USA to consider personalized cytometry as performed using several human tumor assay systems. 

Following in-depth pro and con presentations by Drs. Weisenthal and Bosanquet, and also by other physicians and scientists, by the NCI, FDA, HCFA, ASCO, by outside consultants, and by cancer patients, the eleven voting members of the expert panel voted support for cell culture drug resistance testing as a covered service for Medicare beneficiaries.  By unanimous vote, the panel singled-out CLL as a special category in which the highest level of clinical utility was demonstrated.  Most of the data in support of cytometric profiling in the setting of CLL derived from studies performed and published by Drs. Bosanquet and Weisenthal, using the DiSC Assay. 

The testimony, deliberations, and committee findings can all been viewed in the published meeting transcript, which is linked below.

Links to the HCFA Transcript

VOLUME ONE OF THREE

This section consists of introductions by HCFA and by the FDA.  It also includes data presentations by physicians and scientists in support of cytometric profiling and by cancer patients.  At the end of the volume are comments by a regional Medicare contract insurance company and by ASCO. (Please note: A major typographical error occurs in this volume of the transcript. On page 137, line 15: "18 percent" should actually read "80 percent."

VOLUME TWO OF THREE

The section contains presentations by the NCI, by two outside consultants, and by the HCFA staff.

VOLUME THREE OF THREE

This section contains deliberations by the Medicare Coverage Advisory Committee based upon data and testimony.   It includes individually-stated opinions by each of the 13 panel members and votes on specific positions and recommendations by the eleven voting members.