Ohio Senate Medicaid Committee - 6-2-2026

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Thank you so much. Chair Romanchuk, Vice Chair Huffman, Ranking Member Liston, members of the Senate Medicaid Committee, thank you so much for this opportunity to testify in support of Senate Bill 387. My name is Willa Bluestone. I'm here on behalf of Ohio Life Sciences Association. We represent Ohio's thriving life sciences ecosystem, including our biotechnology, biopharmaceutical, medical device, medical technology, diagnostics, research, and advanced biomanufacturing organizations across the state. Senate Bill 387 would help to expand access to precision medicine tools that can improve patient access, access to patient care, reduce unnecessary medication trial and error, and support more informed prescribing decisions for Ohio Medicaid patients, especially those who are experiencing depression and anxiety. Pharmacogenomic, or PGX, testing evaluates how an individual's genetics impacts the way that they metabolize or respond to certain medications. For many patients, especially those who struggle with mental health conditions, finding the right medication can be a long, very arduous journey, involving multiple prescriptions, dosage changes, side effects, and delays in achieving the desired stability. A 2022 study published recently in the Journal of American Medical Association showed that the initial antidepressant remission rate is only about 30% with first-line treatment, so about 70% of individuals, more than 70% in fact, have to try additional medications to, again, achieve that desired relief from symptoms. We're very thankful for Senator Blessing's leadership on this and also the thoughtful and targeted approach that this bill takes. The guardrails that the bill sets up for prior authorizations for the MCOs allows those PAs, but requires that while they're established they have to show a clear path to treatment for individuals. As Ohio continues to strengthen its leadership in healthcare innovation, biotechnology and precision medicine, policies like Senate Bill 387 help to ensure that patients can benefit from the advances that are already being integrated into clinical care across the country. This legislation is ultimately about improving outcomes for Ohioans, those living with mental health conditions, and supporting our clinicians with additional evidence-based tools to make informed treatment decisions, all of which comes with significant cost savings. So Chairman Romanchuk, members of the committee, thank you for this opportunity. I'm happy to answer any questions you may have.

Thank you, Chairman. Thank you, Ms. Bluestone, for your testimony. I feel like this is one of these areas where there's been some changing technology as tests get better. but certainly at the beginning it wasn't clear that these tests would impact treatment decisions or outcomes. Obviously science is always moving forward. So I guess are you able to talk about sort of where things stand on these tests? And if not you, I know there's others, but then do you know what other states are doing with this? can you give sort of the big picture context on the mental health treatment genome testing type picture?

Great. Thank you.

Do you have separate testimony, each of you?

Chairman Romanchuk, Vice Chair Huffman, Ranking Member Liston, and the rest of the Senate Medicaid Committee. My name is Chris McDonald. I am here this morning on behalf of Myriad Genetics in support of Senate Bill 387. With me this morning, Dr. Renee Albers, my colleagues, PhD in Biomedical Sciences, and our Senior Medical Information Liaison. Also, Amanda Anglin, our licensed genetic counselor and medical policy manager. Excellent resources and experts in topics of discussion this morning. And we'll talk a little bit more about Mary Genetics. Mary Genetics is a leader in precision medicine testing in the realms of cancer, women's health, and mental health. The GeneSight test was developed right here in Ohio. Our lab is in Mason, Ohio, where we employ nearly 300 Ohioans. The GeneSight test came to be from collaboration between Cincinnati Children's Hospital and Investment Through Jobs Ohio. Now, the GeneSight test is a once-in-a-lifetime pharmacogenomic test that is ordered through a licensed clinician that also helps predict a patient's genetic makeup and helps us predict response to psychiatric medications. Additionally, clinicians receive the GeneSight report, and it helps them make more informed treatment decisions. And the evidence is compelling. A meta-analysis with high-level 1 evidence shows that clinicians with the access to the gene site test have a 41% greater likelihood of their patients receiving or achieving remission in depression compared to standard of care. Also, in the prime care trial, which was conducted by the U.S. Department of Veterans Affairs, which was the largest pharmacogenomics study done to date in mental health, showed that those patients also had a statistically significant improvement in remission for depression, also in standard of care. And then in terms of economic utility, there's been independent economic analyses that show that the Genesight test can save patients up to $1,200 per patient per year, after the test is conducted. And then lastly, Medicare has been covering Genesight for almost a decade, and it's been found to meet clinical utility as a reasonable and necessary benefit. So why is this bill necessary? Since April of 2023, Genesight has been priced and listed on the Ohio Medicaid fee-for-service schedule, meaning ODM has determined it as a covered service. Under Ohio law, managed Medicare organizations are required to provide a meaningful pathway to coverage for services on that schedule. ODM confirmed this writing in February of 2024, stating that MCOs are, quote, required to perform an individual analysis of medical necessity for each request, end quote, and must, quote, offer a potential pathway to coverage, end quote. So what has actually happened? Over the past two years, Myriad has submitted roughly 5,000 claims to Ohio managed MCOs. The number of claims approved, zero, 100% denial. That's not an individual medical necessity review. It's a blanket exclusion dressed up in the language of clinical judgment. And when Myriad did exactly what ODM advised, filed appeals, the response from at least one MCO was to terminate our contract, not just for Genesight, but for all the molecular tests that Myriad covers, including tests in oncology and women's health. Senators, this is what happens when there are no guardrails. A company follows ODM guidance, exercises its legal right to appeal, and an MCO responds by threatening to cut off thousands of Ohio Medicaid patients from cancer and women's health testing, too. So the chilling effect on other providers should concern members of this committee, especially giving the exponential rise in depression and anxiety diagnoses over the last five to seven years. Now, we understand the need for preauthorization and for determining medical necessity, but 5,000 denials without a single approval is not clinical review. It policy We also understand the focus and concern regarding cost This is a one patient test that reduces downstream Medicaid costs through fewer hospitalizations fewer ER visits, and fewer failed medication trial and error cycles that cost the system more time and more money that then should take the patients back to the community where they're working, productive, and hopefully thriving. Blanket denials is the expensive choice. Senate Bill 387 does not create a new entitlement. It enforces an obligation that already exists under Ohio law, that MCOs conduct genuine, individualized reviews and provide a real pathway to coverage for services ODM has already approved. It closes the loophole and it protects providers who are following the rules. Pharmacogenomic testing is covered under Medicare. It is covered under Ohio's own fee-for-service program, while denying coverage to Ohioans enrolled in Medicaid-managed care, often the most vulnerable patients in the state. We urge this committee to pass Senate Bill 387 and close that gap. Sincerely, we appreciate the invitation. We thank you for your time, and we do encourage questions, please.

Yes.

Thank you, Chairman. Yeah, I appreciate you guys coming in. I wanted to, I guess, get more details on some of the usage, because I think that there's specifics on which conditions this has the best evidence for. Are you able to talk a little bit about that? and then what that relates to the current claims and denials? It's my understanding that it's major depressive disorder, but maybe not some of the other mental health diagnoses that has the best evidence.

Philip, sure. I have a couple of question lines. But when you look at the 5,000 denials, are they, I mean, again, following the data would say major depressive disorder is the most useful. Do we know if the denials are submitted just for that? Or, you know, what's the breadth of use based on the claims that you're seeing?

I have a couple more lines of questions, but if you want to circle back around.

Thank you. So let me get this straight. and I know when you get into the mental health things, it can be a nebulous area. But what's not a nebulous area is cancer. So a doctor sees a patient, Medicaid patient, let's say, and determines that that Medicaid patient has cancer and that medical practice would say, treat that cancer as quickly as you can. We've discovered it, so we've got to treat it. But they've got to know the best way to treat it, and they know that you exist, and they know that for Medicaid, for Medicare, you are a place they can go to do this genetics testing to say to them, the best treatment for this particular patient, given their genetic makeup, is X. So when you get that request and you have the pre-authorization to do it, it is incumbent on you to do that immediately. If you don't react immediately to that doctor's request, you're delaying that treatment, correct?

So you do the test, and you send back to them, the best way to treat this is chemotherapy followed by radiation or whatever it comes out to be. And 100% of those have been denied?

Okay. Outside of the oncology. So they have been approving what I just described?

Yes. Thank you.

Thank you, Chairman. So I guess as I look at this particular test in mental health, I'm not seeing that there are major provider organizations or professional groups that recommend this as part of standard of care. Can you talk a little bit about it? I don't see psychiatrists or other mental health providers saying, hey, this is a test that should be done routinely. So am I wrong? Am I missing ones? Can you talk about where that stands and how that relates to this legislation and medical necessity determinations?

Senator Liston. Thank you. So a follow-up, certainly as we think about pharmacogenomic testing and saying, hey, there's some genes that seem best predictive, that to me sort of begs the question about the tests that are in the panels, right? Because you guys, Myriad, you know, have a pretty big market share, I think, in this space. But there are other companies that also make soda genomic testing. It's my understanding they're pretty variable. Are we able to speak to the consistency in what people might be ordering or what this bill might address in terms of, like, does this bill pay for any pharmacogenetics testing that might have mental health implications? Could the tests change? We might know the cost now, but if it's expanded with or without evidence, is this bill obligating Medicaid to then cover those variables as well?

Thank you. That was very helpful. I appreciate it.

Senator Huffman.

Yeah, so there is an FDA approval for the test. It falls under a lab-developed test, which recently was determined that the FDA doesn't have, like, specific coverage for, like, in that realm. So there's not, like, an FDA approval that the test goes through, similar to medications. But there is recognition, like I was saying, that FDA table of pharmacogenomics, they don't do it by specific condition. They do it by medication and gene association.

Sure, absolutely. Thank you for the question, Vice Chair Huffman. In that scenario, when you have indications that are not underscored by the clinical studies, most likely those would not be covered, and it would be no different than what we're doing today. These 5,000 claims that we had mentioned earlier, those test results are still being reported out, and clinicians and patients are still receiving benefit from those types of tests. So to answer your question directly, anything that potentially is outside of evidence-based data that we've collected over the last decade is likely won't be reimbursed to these types of companies. Nevertheless, the trend is that those reports will still be generated and clinicians and patients can still benefit from.

Thank you so much, Senator Huffman, for the question, and I hope I'm understanding correctly. So earlier I mentioned that Medicare has a longer list of conditions for which gene site would be considered medically necessary and appropriate. However, in the bill itself, one of the goals of the bill is to provide some guardrails and guidance around what the MCO would have to pay for. So in here, under Section 1, Part B, 1, the pharmacogenomic testing is ordered by a treating prescriber of a Medicaid enrollee who has been diagnosed with depression or anxiety.

No, thank you so much for the question. So the way the Medicare program works is there are national coverage determinations, or NCDs, which are essentially like medical policies that provide medical necessity criteria for certain tests. Laboratory testing oftentimes are covered by LCDs, local coverage determinations, and each MAC, Medicare Administrative Contractor, writes its own policies around what tests it's going to cover and what it won't. Ohio falls into the CGS MAC, which is part of the Moldex program. So us in Ohio, us Ohioans, we are in the CGS region. And so Moldex, the Moldex program established by Palmetto, is who writes our coverage determinations. So Genesight is covered under an LCD.

maybe no other you know other state but because Palmando has agreed to it in Ohio we would be required the way that laboratory testing works is it goes to the LCD where the laboratory resides So GeneCite is a sole source proprietary test offered by Myriad Genetics Our laboratory is in Mason Ohio Therefore all of the tests that are processed by Myriad at its GeneSight facility would be subject to the CGS LCD which is a Moldex LCD Okay.

Thank you for the question, Senator Huffman. I would not call this a biomarker bill. GeneCite is a biomarker test by definition and meets the definitions in most laws written for the coverage of biomarker tests. I don't think we need to sort of establish that the Medicaid program has already deemed this necessary. So, again, our goal isn't to get coverage of GeneCite. It's simply to enforce that the MCOs provide equivalent access to the patients who are enrolled in MCOs that the current fee-for-service program members have.

The majority of them, yes.

So back to Senator Wilson, you had asked about oncology testing. So while we don't offer oncology pharmacogenomic testing, the consequence of us following the procedures established for appealing the gene site tests was that then one large MCO in Ohio terminated our contract. Thus, we were not able to provide oncology services, genetic services, or women's health services to members who have that particular MCO plan. And so, again, while they're not oncology pharmacogenomic tests, it did hinder our ability to provide oncology genetic testing to those members.

To the extent that we have been able to, yes. We also, the typical process that we are instructed to follow is the appeals process. So that is our right as a provider to file grievance. We do it through the appeals process. We have received appeals responses that have indicated that certain MCOs do not consider the testing medically necessary in any scenario. So again, I think when Chris says this is a policy, unfortunately, again, if something is deemed not medically necessary in every circumstance, then there's not a pathway to provide equitable access to what the fee-for-service program offers.

I would say contracting is separate. So we're mostly contracted with the MCOs, and our goal through this legislation is not to force contracting. That's up to the individual MCO whether they contract with us or not, but rather to provide a pathway by which tests are considered medically necessary, such that zero out of 5,000 claims. That's a pretty definitive data point.

I imagine we did not attempt pre-authorization on all of them, but I would have to get back to you to be sure.

Correct.

Correct.

Correct.

Correct.

I may have bespoken because I know that for any that we appealed, certainly we did attempt prior authorization, and I can get the exact number of those on which we have attempted prior authorization, submitted claims, and then filed appeals.

In what way would you say that it's different?

Sure. So I think in all instances it is helpful for the clinician and the patient not to put undue burden on the ordering provider. And HIPAA, in general, instructs us to obtain the minimum necessary in order to, whether it's approve a test or whether it's to run a test. And what we have seen in some of the appeals responses is a request for additional documentation beyond what is considered reasonable and necessary. So the language in the bill attempts to provide reasonable guardrails around what an MCO might require to establish medical necessity. So we don't disagree that there should be information provided by the ordering clinician that establishes the medical necessity of the test, the reasons why they've ordered the test, the patient's condition for which they're ordering it, and how they might use the results. all of that information when submitted to the MCOs has still been deemed insufficient, which seems like an undue burden.

It's a fair question, and I don't know if I'm allowed to pose a question back, but I think what then is a laboratory to do if we are providing testing for patients in a critical disease state of mental health where the clinician, again, has deemed something medically necessary, the state says that it should be covered, and we have followed all of the processes outlined in terms of grievance and we have been punished, perhaps, by getting our contract terminated. So I think it's, I hear the question, but also what then, on the other side, and this may be back to you, what then should we do if we've exhausted our rights as a provider and we're still not seeing payment for any of the tests that are being ordered? No, I understand.

Are there any further questions? Seeing none, thank you so much for your testimony. Is there anyone here present that would like to testify on Senate Bill 387? Seeing none, is there any other business? Seeing none, we are adjourned.