Biomarker Testing Laws: How Are They Helping?

Welcome to The Breastcancer.org Podcast, the podcast that brings you the latest information on breast cancer research, treatments, side effects, and survivorship issues through expert interviews, as well as personal stories from people affected by breast cancer. Here’s your host, Breastcancer.org Senior Editor, Jamie DePolo.

Jamie DePolo: Hello, thanks for listening. Several organizations, including the American Cancer Society and the LUNGevity Foundation, through the No One Missed campaign, are working to pass laws to require insurance coverage for biomarker testing for people with cancer. The No One Missed campaign is being expanded to include breast cancer. 

Our guest is Joanna Fawzy Doran, a cancer rights attorney, author, speaker, and CEO of Triage Cancer, a national nonprofit organization providing free education on the legal and practical issues that may affect people diagnosed with cancer and their caregivers. Joanna has spent more than 27 years working on behalf of people with cancer. She joins us to talk about the problems people may have getting biomarker testing covered and how the new laws are helping.  

Joanna, welcome to the podcast.

Joanna Fawzy Doran, Esq: Thank you so much for having me.

Jamie DePolo: To start, I feel like I need to explain what biomarkers are, just so everybody has some idea of what we’re talking about.

In the broadest sense, they’re anything in your body that can be measured, like your heart rate or your blood pressure. In cancer it’s features of the cancer – like a certain genetic mutation that’s in the cancer cells or the presence of a certain protein – that control how the cancer behaves. Doctors use biomarkers to help make decisions about treatments. In breast cancer, hormone receptors and HER2 receptors are two common biomarkers that I believe all breast cancers are tested for, at least as far as I understand. 

I also want to point out that there are many different names for biomarkers, including tumor markers and molecular markers, and sometimes people use them interchangeably and they may not mean the same thing when somebody’s using them.

So, now that we have all that out of the way, I have to admit, Joanna, I’m confused because I thought that many types of cancers were always tested for certain biomarkers, so I’m not sure I understand what these new laws are covering. And then I read a February 2024 story, in The Washington State Standard, it was about a woman who was diagnosed with breast cancer. 

The story said her insurance covered almost all her tests except her biomarker test, singular, one test, which cost her $300. I have no idea what this test was and the story didn’t say. I don’t expect you to know, you’re not an oncologist, you’re a lawyer, but I was just so puzzled because I was like, what biomarker test could this be? This woman has been diagnosed with early-stage disease. So, Joanna, please help me, help us understand what these laws are potentially covering or what they would like to cover. 

Joanna Fawzy Doran, Esq: That’s a good question and it is confusing because the laws that are being passed at the state level to improve access to biomarker testing are all very different. And I think even stepping back and starting from the place that prior to these laws there weren’t any specific laws that said that biomarker tests must be covered. But it’s important to keep in mind that science moves faster than the law, so we often have new tests, new treatments that don’t have a specific law that says insurance companies have to cover X test, X treatment. 

And in that case it doesn’t necessarily mean that insurance companies aren’t required to cover those new tests and treatments, just because there isn’t a specific law. And so the legal standard that insurance companies need to look at is, is a particular treatment or a test medically necessary for a patient. And in that case they should be covering that care.

So, when we talk about the law and we talk about coverage and insurance, the things that are most important are the words. Language matters when we’re talking about the law. So how we define biomarker testing under the law depends on who wrote the law. 

And so when we say a biomarker test wasn’t covered for that particular patient in that story, you’re right, we don’t know what that test was specifically, because it could’ve been a lot of different things. My guess is that it was actually a test that was looking at her particular tumor and seeing if the genetic makeup of that tumor made her eligible for a particular type of treatment. And so what we are seeing on the science side, and you’re right I’m not an oncologist, I’m a lawyer, but on the science side we’re seeing new tests for tumors or certain types of cancer that give us information. And that information is really helpful to healthcare teams in determining which is the best treatment for that particular patient based on the biomarkers of their particular cancer. That is often referred to as precision medicine where, or targeted therapy.

Jamie DePolo: Personalized medicine.

Joanna Fawzy Doran, Esq: Personalized medicine. So, there’s lots of terms even there to describe it. And so these biomarker tests that are giving us information about that individual’s genetic makeup of their tumor allow us to narrow down the treatment options that are best for them, based on their particular cancer, and so in doing that we know a couple of things. We don’t have to try treatments that don’t work for that particular patient, and that also has a cost savings involved with it beyond just the benefit to the patient.

And so when insurance companies are looking at this, even though there is an additional cost for the testing, it could potentially end up saving the insurance company money where they don’t have to pay for a treatment that doesn’t end up working for a patient and then have to try something else. And so there’s actually a financial rationale to this whole conversation as well.

But when we talk about the law, as I mentioned, definitions matter. So, each law might define biomarker testing differently, which means it could be hereditary genetic testing or it could be tumor-specific testing. It could be next-generation sequencing or whole-genome sequencing. So, there’s lots of different types of tests that fall into this umbrella term of biomarker testing, which is why we don’t know exactly which test wasn’t covered by her particular insurance company in that story. 

Jamie DePolo: Okay. Okay, that makes sense.

Are the laws really aimed at, as you described, that science moves faster than the law, is it aimed at new kinds of tests? Because I guess I haven’t heard, and again I’m just going back from my limited experience, say that somebody had difficulty getting a hormone receptor status test for breast cancer covered, because that just, that’s been around for so long and it’s so helpful. So, I’m wondering if it’s the newer kinds of things like now if the tumor, its PD-L1 status that could affect, like are you a candidate for immunotherapy? So, I’m wondering if it’s more the stuff that’s come out, say, in the last 10 years that they’re really aimed at? 

Joanna Fawzy Doran, Esq.: I would say that the concern where we’re trying to address the concern by passing new laws, is around the newer testing. Because it takes time for the law to catch up with the science and often insurance companies look at those new types of tests and they think, well, is it going to be valuable? Is it cost-effective for us to be covering this particular test? So, it takes a while for the evidence to grow, to show the effectiveness of the test and why insurance companies should be covering it. 

But I do want to stress that if a healthcare provider has said, it’s important for my patient to receive access to this test, so that I can make some decisions about what treatment options are available to this particular patient, and I believe it’s medically necessary for this patient to get access to the test, it doesn’t necessarily require that there be an additional law that specifically says a patient should get access to the test. The fact that it’s medically necessary and that there’s evidence to that and the healthcare team can provide that evidence, an insurance company should be covering it. 

Jamie DePolo: Okay. Now, the laws have only been passed in certain states, and I want to make sure I understand this, they apply to state-regulated plans. So, if somebody has what’s called a self-funded insurance plan, and I’m going to ask you to explain what that is, these laws may not apply, is that correct? 

Joanna Fawzy Doran, Esq: That is true. So, there’s a few pieces there to unpack. So, we do only have laws in about 20 states now that are requiring insurance coverage of biomarker testing. That could mean different things, as we discussed, how each one of those laws define biomarker testing is different. Some list all the potential things that could be covered under biomarker testing, some just use the term biomarker testing, so it’s very broad. That can actually be helpful because as the science advances it doesn’t require that every potential type of test in the future get listed in the law. So, that broad umbrella can sometimes be very helpful, but it’s harder when you’re then trying to show that something falls under that particular broad umbrella. So, there are pros and cons to broad language in the law. 

The second piece is that each one of those state laws applies to different types of plans at the state level. So, in some states the law might only apply to private insurance and that includes individual health insurance plans as well as employer-sponsored health insurance plans. Some states only include Medicaid, some states include both, some states include state employee health insurance plans, included as well. So, every one of the state laws define which types of plans it applies to. But even where there is a law that covers those employer-sponsored health insurance plans, if the employer is self-funded or self-insured, those are two terms that mean the same thing, then the state law isn’t going to apply to them. And there’s a couple of reasons why. 

So, if an employer buys their health insurance from a private insurance company, that means that they’re insured. So, they’re going to a company and they’re saying we want to offer a policy to all of our employees, that’s referred to as an insured or a funded plan. When an employer says we don’t want to do that. We actually just want to set aside a pool of money and we’re going to pay directly for the healthcare costs of our employees. That’s referred to as a self-insured or a self-funded plan. But what’s tricky about that, is that the employer isn’t usually the one who’s handling the claims and approving them and writing the checks to providers. They usually hire a third-party company to do that for them, and who they usually hire is an insurance company.

Jamie DePolo: Oh, that’s very confusing.

Joanna Fawzy Doran, Esq: It is. Because what you might have as an employee is a health insurance card that has the logo of an insurance company on it, but what you actually have is a self-insured plan and that insurance company isn’t directly paying for the claims, they’re literally just handling the paperwork for the employer. So, you actually have to find out if you have an insured or a self-insured plan so that you understand how these laws apply specifically to you. And this is just one example of the types of laws. 

There are lots of situations in the cancer community where these self-insured or self-funded plans don’t benefit from those state level protections. And the reason why is there’s a federal law called ERISA, which basically says states are allowed to preempt this federal law, meaning states can’t require these specific plans to comply with these state level requirements that they cover specific things. 

Jamie DePolo: Okay. So, somebody would probably ask, like, their HR person to figure out if it’s a self-funded plan or not? 

Joanna Fawzy Doran, Esq: Yes. So, there’s a couple of tips, because your HR person won’t always know or maybe, you know, you don’t even have an HR person directly. 

Jamie DePolo: Right.

Joanna Fawzy Doran, Esq: So you know, talking to your employer to see if you have a self-insured or self-funded plan is step one. You can call the insurance company or the number on your insurance card to ask that question, and you want to make sure actually to do both and that the answers match. 

Jamie DePolo: Oh, geez.

Joanna Fawzy Doran, Esq: And then the third kind of clue that you have a self-funded plan is if somewhere on your insurance card it says, this company does claims processing only and bears no financial responsibility. So, some version of that language, you know it’s kind of cryptic and you know why we’re supposed to know what that means, but that is generally the clue that it’s a self-funded plan. 

Jamie DePolo: Okay, thank you for that.

So, from your perspective, are the new laws helping people and…or are there any downsides to them? Because previously you said if something is medically necessary it should be covered by insurance, you know, if your healthcare providers can prove that this is medically necessarily, it should be covered. So, part of me is wondering is there any downside to the laws that now that they’re passed could it hurt anyone? 

Joanna Fawzy Doran, Esq: That’s a great question and from a legal perspective there’s two sides to the argument. One side could argue if it’s medically necessary for people to get access to these tests, we don’t need additional laws to say that these insurance companies or plans should actually be covering the tests. Because if it’s already medically necessary they really should be already. The flip side of that argument is, it doesn’t hurt to make sure that we are establishing that insurance companies and these plans must cover these biomarker tests. 

You know, there are definitely two sides of that argument and both are completely valid, and there’s no one right answer, but I do think that it can be very helpful to have specific laws that ensure insurance companies are covering. Because it’s just one more tool in our toolbox, so to speak, to ensure that people are getting access to the care that they need.

Jamie DePolo: Okay. Now, I’m wondering too, a lot of the new tests are focused on markers for metastatic disease to help doctors see, is the treatment working, is the cancer shrinking, are there, you know, is the cancer sort of mutating and now all of a sudden it has this specific genetic mutation, which may make this person eligible for a clinical trial or something else? So, is it mainly people with metastatic disease that you see in your experience that are benefiting from this or is it really the whole gamut? 

Joanna Fawzy Doran, Esq: I think it’s really the whole gamut. I think there are definitely some specific benefits to biomarker testing when someone has advanced disease or a recurrence, because it can, again, provide the healthcare team with some additional information that is useful in making treatment decisions. But in terms of the way the law is written. it does, most of the state laws apply across the board, not to specifically patients with metastatic disease. 

Jamie DePolo: Okay. And where are we today with these laws? Are more likely to pass? I feel like I heard a lot about it at the end of 2023, in the beginning of 2024, now we’re at the end of 2024 and I’m not hearing so much about it, so I’m just curious.

Joanna Fawzy Doran, Esq: I think that’s a good point. There has been a lot of effort in the cancer community to propose these state laws and to advocate for them and there have obviously been some successes, which is why we are where we are today. But many of these laws only went into effect this year or are very recent and so we don’t even necessarily have great data on, are people actually benefitting from these laws? Or, you know, are there still situations where people are being denied coverage?

So, it’s too new to have that level of information, so we really only have anecdotal situations. And I think it’s important to keep in mind as well that, you know, I say all the time if all we needed was a law to solve a problem we wouldn’t need lawyers and we wouldn’t need law enforcement because just having the law is really only step one. Now we have to make sure people know the law exists and that means patients, it means providers, it means insurance companies, too, also need to know that this law exists. 

And just because the law exists doesn’t mean everybody’s going to follow it. And so that’s why it’s so important for people to know what the law says and what their rights are and then how you actually go about enforcing your right if you come across a situation where insurance companies are denying coverage for something that you are entitled to.

Jamie DePolo: Well, and that’s the perfect lead in to my last question, which is probably the most important question. So, what are the options if somebody’s insurance carrier denies coverage for a biomarker test that the person’s doctor says is medically necessary? What should they do?

Joanna Fawzy Doran, Esq: Depending on the type of insurance coverage someone has and what state they’re in, based on these additional legal protections, they first want to understand what are their rights to appeal. And regardless of what type of insurance you have, you have the right to appeal that denial of coverage. The process depends on what type of insurance you have. But if you have an individual or an employer-sponsored health insurance plan, you not only have a right to an internal appeal, where you basically go back to the insurance company and say please reconsider. But if they still say no, then you get to go outside the insurance company to an independent entity, where they decide whether or not the care that’s been prescribed by your healthcare team is medically necessary. 

And if they decide that it is, that’s binding on the insurance company and they have to follow that decision. So that external appeals process is something that I call the best kept secret of our healthcare system. Because even though the people who do file external appeals are successful, on average, 50 percent of the time, there is data that shows, just from 2021, that there were 48 million claims denied by individual health insurance plans sold through the marketplace. So 48 million claims were denied, 99.9 percent of them were not appealed. 

Jamie DePolo: Oh, wow. 

Joanna Fawzy Doran, Esq: So, only .1 percent of people are actually appealing. And we’re not even talking about external appeals, we’re just saying to the first level of appeal, 99.9 percent of people are taking no for an answer. This is an example of where the advocacy community fought hard for a legal protection for consumers, but no one is taking advantage of it. 

Jamie DePolo: Right.

Joanna Fawzy Doran, Esq: So, and that is partly because patients don’t know they have this right, but also providers, and many providers really go above and beyond for patients and they’re filing those appeals on behalf of patients. So, some of these patients don’t even know that their providers are taking those extra steps for them, and then really only if it’s denied again do patients end up finding out. But if those providers and patients don’t know about the external appeals process, it makes sense that no one’s actually using it. 

But it’s a really seriously missed opportunity and contributes to two of the biggest problems we see in the cancer community, where patients aren’t getting access to the care that’s prescribed by their healthcare team, or they’re paying for it out-of-pocket when their insurance company likely should have, so that’s contributing to financial hardship.

Jamie DePolo: Right. I have a question about the internal appeal. If your provider does that for you, is that considered your internal appeal? And then if it gets denied again, would you then file the internal appeal? And do you have to file the internal appeal before you do the external appeal?

Joanna Fawzy Doran, Esq: All great questions. So, it doesn’t, you and your provider aren’t separate in that process.

Jamie DePolo: Okay.

Joanna Fawzy Doran, Esq: So, if your provider is doing it for you it’s as if you are doing it. So, generally you do have to exhaust the internal appeals process before you get access to the external appeal, but there’s an exception to that. Well, there’s two good exceptions.

One is if the insurance company doesn’t respond within 30 days to your internal appeal then you can move on to external appeal. The second is if waiting to hear from the insurance company is basically dangerous to your health, you could potentially file an urgent appeal. And in that case, you could file an internal and an external appeal at the same time, urgently, and get a response back within 72 hours. 

So, depending on the patient and the type of care that they need, denying access to the biomarker test does also mean that treatment can’t move forward until the biomarker test is done. If getting access to the biomarker test is necessary for someone to get access to specific treatment, delaying access to the biomarker test and a response from the insurance company, is also going to delay access to that treatment. So, in that case filing it urgently would speed up the insurance company’s response to the biomarker test, and then would improve somebody’s ability to get access to treatment in a more timely fashion. 

Jamie DePolo: Okay. And does someone’s provider have to certify, say, that this care, this treatment, is necessary to save life? Is that required for that?

Joanna Fawzy Doran, Esq: It’s not a specifically required certification, but it is important to the appeal. So, we encourage patients who are filing their appeal themselves to work with their healthcare team because the healthcare team is going to be the key to sharing the information about why it’s medically necessary to get access to that particular treatment or test. You know they prescribed it for a particular reason and that reason needs to be included in the appeal. And so sometimes that means sharing medical records, sometimes it’s about sharing research studies that have been done, or clinical guidelines, or any other medical background to explain why it’s medically necessary someone get access to that particular care.

Jamie DePolo: Okay. And then one final question, if somebody did want to file an external appeal where do they go? How do you find who to send that to? 

Joanna Fawzy Doran, Esq: That is also a good question. Theoretically, when an insurance company denies coverage, they’re supposed to include information about someone’s external appeal rights. So, maybe on the back of that letter in small print, in light font, it might have that information, but it is supposed to be there. And so usually someone can follow the very clear steps that are included in that letter about how to access an appeal, external appeal. 

But if, for some reason, they don’t have that letter anymore or they can’t find that information they can always start with their state department of insurance and look for the information on external appeals, whether they’re calling or they’re looking for that online. On Triage Cancer’s website, we have state-specific resources and the contact information for external appeals is there for every state.

Jamie DePolo: Oh, perfect, perfect.

Joanna, thank you so much. This is so helpful. I know we didn’t answer all the specific questions, but I think the appeal process for denial of coverage for biomarker testing, which seems to be the most important thing right now, that was very helpful. The explanation was very helpful. I appreciate your time, as always.

Joanna Fawzy Doran, Esq: Well, thank you so much and we appreciate you sharing the information.

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