Policy Changes, Faster Testing Turnaround Needed to Improve Precision Lung Cancer Care Access: Robert Kratzke, MD

In part 2 of his interview with The American Journal of Managed Care^® (AJMC^®), Robert Kratzke, MD, of the University of Minnesota, highlighted how Minnesota’s biomarker testing mandate, which took effect in January 2025, has helped virtually eliminate genomic testing coverage denials and improve access to precision therapies for patients with lung cancer.

Based on these experiences, he called for similar policies nationwide, along with faster sequencing turnaround times and operational strategies such as reflex testing to ensure patients receive timely, biomarker-driven care.

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 Institute for Value-Based Medicine® event on June 23, 2026.

This transcript has been lightly edited for clarity.

AJMC: Getting from biopsy to an actionable result involves many moving parts. Where do you see the biggest operational challenges, and how do you view liquid biopsy fitting alongside tissue testing rather than replacing it?

Kratzke: My understanding, it doesn't come up too much in our discussions, but since its passage, is that we have not had any denials for coverage for the liquid biopsy or the tissue next-generation sequencing (NGS). I think that's the heart of the matter: the law mandates that coverage in the state cannot deny necessary genomic testing on cancer patients in general, not just lung cancer.

The state cannot control everything that CMS does. It does cover state-covered Medicaid, but my understanding is it doesn't necessarily cover Medicare. But that being said, I've not had a Medicare denial either in years for NGS testing. I'm told that people still face this problem in other places, but some of us were talking the other night; it's probably been 5 years since I saw any kind of denial, but certainly not in the last 2 years. I think that that's just great for patients.

In lung cancer, more than maybe almost any other cancer, except leukemia, we need to know that NGS result before we can embark on therapy. If there's a denial for coverage, that is so frustrating because the patient has an active cancer. We often have a very, very effective treatment at this day and age, and instead we're filing paperwork. So, it's been a great blessing to work in Minnesota for that.

AJMC: Minnesota's biomarker testing mandate took effect in January 2025 and is often cited as one of the most comprehensive in the country. What does the testing access landscape look like in your practice?

Kratzke: Similar rules or laws should, frankly, be nationwide. Certainly, CMS should adopt that as their policy. I'm not casting them as the bad guy in this, but we really should have uniform access to all of our testing platforms. Once again, it's not a “nice to have”; it's a “need to have” for lung cancer and for a number of other cancers. Just like you wouldn't decline authorization of an X-ray for a broken bone, the fact that anybody has to struggle to get this testing done is a shame.

I do think, going back to your question, not Minnesota-specific, but one thing that many of us have argued for and argued about is that we really should also have reflex testing. Like I said, at the University of Minnesota, if the pathology comes back and it says lung cancer, it gets sent to the molecular medicine lab. I know that some institutions regretfully feel that that's maybe self-referral, and they feel uncomfortable with that, but that certainly has expedited our workup and delivery of good care to our patients, knowing that the sequencing data is often available, usually available, to the medical oncologist when they first see the patient because that has been sent off as soon as the biopsy came back.

AJMC: Lastly, if you could change one thing to improve access to biomarker testing or lung cancer care, what would it be?

Kratzke: For several years now, the technology has been readily available to do the sequencing in 24 hours to 48 hours through nanopore microfluidics, I think, technology, and it's even commercially available and used in Europe on some cases of cancer and rare infectious diseases.

So, what I'm saying is for many of our patients, for all of our patients, we order genomic sequencing on a tissue sample or liquid biopsy, and then we wait for 10 days or 7 days or 2 weeks for the result to come back. The technology exists for a test, not unlike, for example, a prostate-specific antigen (PSA), where we get a PSA result back within a day, certainly, and even sometimes within hours.

The technology exists currently; it's not esoteric to get sequencing data back within 24 hours, and that is what I would like to see. That is, I'm sure, what we will see in the coming next few years, that a patient I see, I can say, “Well, we're going to send off this, let's say, blood test, and I'll talk to you, give you a call in a day or 2, and we'll see what the results are.”

Along those lines, the 14-day rule for Medicare and ordering of tests and sometimes inhibiting our ability to order genomic tests on inpatients is a shame and an embarrassment, and that really needs to be changed as well. Maybe that's a whole other political discussion, but that needs to go away.

It's an exciting time to treat lung cancer. I'm older, so in my years of practice and research, it has gone from a survival rate for stage 4 lung cancer of 1 year now to most of our patients living 3, 4, or 5 years, and many of them living 10 years or more. I think we just have to keep pushing to get these state-of-the-art treatments to our patients.