July 21, 1999
Conference call with Oncotech representatives. HCFA requested information on test methodology, e.g. applicability for different tumor types and drugs.
August 4, 1999
Letter to Oncotech accepting formal request.
September 2, 1999
Received materials to consider coverage for the Ex Vivo Apoptopic (EVA®) assay.
September 3, 1999
Received formal request for cell culture drug resistance testing (CCDRT).
Placed call to Dr. Robert Nagourney to confirm the materials Rational Therapeutics submitted were to be considered for a formal request for Medicare coverage.
October 4, 1999
Referral to Medicare Coverage Advisory Committee (MCAC) panel. MCAC will meet on November 15 and 16, 1999.
October 7, 1999
Human Tumor Assay Systems (HTAS) information packets sent to MCAC Laboratory and Diagnostic Services Panel and requestors.
November 15/16, 1999
MCAC Laboratory and Diagnostic Services Panel meets and discusses HTAS.
December 8, 1999
MCAC Executive Committee (EC) Panel meets to evaluate specialty panels' recommendations for ratification. EC does not ratify recommendations developed on November 16 regarding HTAS.
January 2000
HCFA arranges with Blue Cross Blue Shield Association for a technology assessment on HTAS to be completed before next tentatively scheduled MCAC Laboratory and Diagnostics Services panel meeting.
February 9, 2000
Frank Kiesner, Oncotech President, meets with HCFA staff regarding the coverage process. Discussion included potential outcomes of a formal withdrawal of his company's request for a National Coverage Decision (NCD). HCFA stated that it would be within their discretion to either move forward with the NCD or to accept the requestor's withdrawal. However, HCFA explained that it would only consider withdrawing this request for a NCD if all the requestors decided to formally withdraw from the process.
March 1, 2000
EC meets and discusses interim procedural guidelines developed by its subcommittee, created for use in the specialty panel proceedings.
March 13, 2000
HCFA staff conduct a conference call with requestor Dr. Larry Weisenthal.
March 23, 2000
HCFA receives formal withdrawal notices from each requestor, with at least one noting an intention to resubmit a formal request in the future.
HCFA decides to accept withdrawals and not move forward with a NCD on HTAS and not to hold another MCAC panel meeting on HTAS at this time.
April 13, 2000
HCFA formally acknowledges, in letters to each of the requestors, receipt of requestors' withdrawals and announces its intention, after careful consideration to neither make a NCD on HTAS at this time, or to bring HTAS to MCAC Laboratory and Diagnostics Services panel.
