Reducing Coverage Barriers, Testing Delays Could Further Improve Lung Cancer Outcomes: Robert Kratzke, MD
Robert Kratzke, MD, calls for a national biomarker testing mandate, emphasizing that timely genomic testing is essential for precision lung cancer care.
In part 2 of an interview with The American Journal of Managed Care®, Robert Kratzke, MD, professor of medicine at the University of Minnesota, reported that at his institution, coverage denials for genomic testing, whether liquid biopsy or tissue-based next-generation sequencing (NGS), have essentially disappeared.
Kratzke's comments build on points he made during the panel discussion, “Precision in Practice: Implementing Biomarker Testing in Lung Cancer,” at the Minneapolis Regional
Much of the recent decline in coverage denials is due to Minnesota's biomarker testing mandate, which took effect in January 2025 and requires the state to cover necessary genomic testing for patients with cancer. Kratzke noted that it applies to state Medicaid but does not necessarily bind Medicare directly. Even so, he said he has not seen a Medicare denial in roughly 5 years and none in the past 2.
He considered this essential for patients with lung cancer, who depend on NGS results before treatment can begin. Consequently, the mandate helps reduce coverage denials, which delay patients from receiving an already available effective therapy.
Kratzke argued similar rules should be adopted nationwide, with CMS establishing uniform policy so testing access is not determined by geography. He compared withholding genomic testing to denying an X-ray for a broken bone, framing comprehensive biomarker testing as a "need-to-have," not a "nice-to-have."
Regarding operational challenges, Kratzke highlighted the value of reflex testing: at the University of Minnesota, a pathology result confirming lung cancer automatically triggers a molecular medicine lab workup, even though some institutions avoid this over self-referral concerns. This head start means sequencing data is often ready by the time the oncologist first sees the patient, he explained.
Overall, his top wish for improving access to biomarker testing and treatment for patients with lung cancer is faster turnaround. Nanopore microfluidic sequencing already exists and could deliver 24- to 48-hour results, similar to how prostate-specific antigen (PSA) tests return quickly, yet patients with lung cancer often wait 7 to 14 days. He also flagged Medicare's 14-day inpatient testing rule as an obstacle that should be eliminated.
Kratzke closed on an optimistic note, pointing to major survival gains in stage 4 lung cancer, from about 1 year historically to now commonly 3 to 5 years, with some patients surviving 10 or more years.
“I think we just have to keep pushing to get these state-of-the-art treatments to our patients,” he concluded.





