Companion Diagnostics: Will the Final Guidance Resolve Anything?

Glen Freiberg, RAC
Glen P. Freiberg, RAC

The CDRH 2013 Strategic Priorities indicates that the companion diagnostic final guidance will be published by the end of March. Without specific linkage to reimbursement, the guidance will not solve a main problem it attempts to address.
The reason is that even with a cleared or approved companion diagnostic, plus therapy labeling that requires an FDA-approved or -cleared companion diagnostic, there is nothing stopping CLIA-certified labs from creating LDTs to qualify patients for the subject therapies. Unique CPT codes requiring verification of the cleared or approved diagnostic for reimbursement would resolve this. And since there is already a CMS/FDA concurrent coding/product approval program in place, this would not be a major leap in cooperation.
Many of the comments to FDA thus far have been typical in their protection of traditional turf. The pathologists don’t want to do anything differently, and FDA does not have LDT regulation in the 2013 strategic objectives. So, the approach FDA has taken will standardize the diagnostic testing for certain personalized medicine trials, but that same approach will not protect patients post-approval, in that it relies on labeling alone.
Eventually, HHS will need to help FDA and CMS make some decisions about the dual nature of diagnostic testing in the United States. We either need the FDA diagnostic system or we don’t – the EU IVD Directive merits a good, hard look for potential adoption by U.S. regulators. Unless and until HHS can show that EU patients are at risk compared to our diagnostic patients, less diagnostic regulation needs to be further considered. However it goes, safety and effectiveness needs consistent standards and regulation.
---Glen Paul Freiberg, RAC
    RCQ Consulting
    Rancho Santa Fe, CA