stappa schreef op 26 mei 2015 22:44:
But until you do get the coverage limitation lifted, does the LCD restrict you to testing only 1200 patients?
No. First of all, one must understand that the substantial majority of the patients we test are not covered under Medicare, but are instead covered by private health insurance in the U.S. Second, the 1200 Medicare patient figure in the LCD is only an estimate, not a limit. Our Medicare administrator's main concern is that we use our best efforts to enroll patients into and complete our new clinical utility trial, which is also in MDxHealth's best interest.
The LCD identifies both 2-year and 3-year expected time periods for completion of the MDxHealth clinical assessments. Will the coverage limitations last this long and, if so, what are the implications for MDxHealth?
Once we complete the interim analysis for our PASCUAL trial, targeted for the first half of 2015, we expect to open up general enrollment into our Registry to all interested sites.
The PASCUAL trial may take another 1-2 years to complete, but given the quite low burden on the doctors to participate in the Registry while the trial is ongoing, we expect broad Registry participation throughout the U.S. by current and prospective urology clients.
The Registry provides for coverage of all Medicare patients outside of the PASCUAL study until it is completed.