The CAP strongly opposed the health insurer Highmark’s new credentialing requirements for next-generation sequencing (NGS) testing that imposes independent third-party validation of NGS results and/or variants of uncertain significance interpretation. The CAP is concerned with the burdens placed on NGS testing laboratories to require meritless new credentialing requirements.

In a November 14 letter, the CAP asked Highmark to stop this requirement as its not based on scientific basis and presents a conflict of interest. “The purported scientific basis for the use of this proposed proficiency testing methodology is contrived, misapplied, and misrepresented, and further confounded by an apparent conflict of interest. For these reasons, we believe this new requirement would not only fail to improve patient care but would distract laboratories from clinically relevant aspects of testing that could improve quality. Therefore, we request that Highmark abandon this requirement,” the CAP said in the letter.

Specifically, the CAP disagrees with the recommendation for the Center for Genomic Interpretation (CGI) to validate laboratory standards and the assertion that certifications from the CAP and CLIA are insufficient guarantees of quality from high-complexity laboratories.

Highmark said in an August letter to 18 high-complexity laboratories that requirements under CLIA and CAP accreditation are “necessary but are not sufficient guarantees of quality from high-complexity labs.”

The CAP is a deemed accreditor on behalf of the Centers for Medicare and Medicaid Services (CMS), under the CLIA law, with a longstanding and respected record of serving the public by overseeing the quality of laboratory operations and proficiency testing. CAP Accreditation Checklists consist of 21 discipline-specific documents including Molecular Pathology. The first CAP Molecular Pathology Checklist (MOL) was published by the CAP in 1993 and the NGS section of the MOL checklist was first introduced to the laboratory community in 2012.

The CAP has requested a meeting with Highmark to further discuss its policy.