NEW YORK – Medicare administrative contractors Novitas and First Coast Service Options have postponed the implementation dates of two final local coverage determinations that rescinded coverage for nine genetic tests for oncology.
The decisions, posted earlier this month, were set to go into effect on Feb 23., but the implementation dates have since been updated with a new effective date of April 24. In a statement, Interpace Biosciences said the delay is intended to give the incoming presidential administration time to fully review the proposed changes, reevaluate the supporting clinical evidence, and fully assess the potential negative impact on patient care if the policy comes into effect.
The firm previously said it would stop offering its PancraGen test on Feb. 7 as a result of the decisions and that the "impending loss" of Medicare reimbursement would necessitate the restructuring of the business.
As a result of the delayed implementation of the final LCDs, Interpace Biosciences President and CEO Tom Burnell said in its statement that the company will use the extra time to work with the incoming administration to "further demonstrate that there has not been any new evidence to justify non-coverage, which would effectively remove this test from the market."
Other tests affected by the LCDs are Castle Biosciences' DecisionDx-SCC test; Pacific Edge Diagnostics' Cxbladder Detect, Enhanced Cxbladder Detect, Cxbladder Monitor, and Cxbladder Triage assays; Clinical Genomics' Colvera; and the University of Pittsburgh Medical Center's ThyroSeq Cancer Risk Classifier and PancreaSeq Genomic Classifier.
The final LCDs were the result of more than two years of coverage changes after Novitas and FCSO issued draft LCDs in 2022 and allowed for public comment. The finalized LCDs, released in June 2023, were much longer and included coverage terms not mentioned in the draft decisions that sparked outcry from industry stakeholders who said the public had not been allowed the chance to provide feedback on the changes.
Both MACs later rescinded their final decisions and reposted them as draft LCDs with a two-month public comment period. Many of the comments expressed concern that the new coverage criteria would limit access to necessary genetic tests and harm patients.
One of the key provisions under issue was the requirement that covered molecular tests must be endorsed by the National Comprehensive Cancer Network's compendium or guidelines, the Clinical Genome Resource, or the Memorial Sloan Kettering Cancer Center-sponsored Oncology Knowledge Base. The final LCDs have removed that requirement.