Robert (Bob) R. Hearn, Member of the Firm in the Health Care & Life Sciences and Litigation & Business Disputes practices, in the firm’s St. Petersburg office, was interviewed for the July issue of Laboratory Economics Compliance & Policy Report on biomarker legislation and insurance coverage.
Following is an excerpt:
Since 2021, 17 states have enacted laws requiring insurance companies to cover biomarker testing and a handful of others have introduced such measures. An American Cancer Society survey of more than 300 oncology providers found that 66% reported the insurance coverage for biomarker testing is a moderate or significant barrier to appropriate testing for their patients.
Colorado in early June 2024 became the latest state to sign biomarker coverage legislation into law. Pennsylvania is close to passing a biomarker bill. Laboratory Economics Compliance & Policy Report recently spoke with Robert Hearn, an attorney with Epstein, Becker & Green, about what’s behind the push to increase mandated coverage.
What was the impetus behind seeking legislative action on the issue of payer coverage of biomarker testing?
The impetus is that there is good scientific evidence that these types of tests really help identify certain types of cancers in ways that are significant to their clinical management. You’ve also got the pharmaceutical industry behind the new laws because many of their recent cancer drugs require that certain types of tests be performed either before or during their administration.
Many new cancer drugs have true companion diagnostic tests associated with them or there is a strong recommendation that certain types of NGS or hybrid biomarker testing be performed before the drugs are administered to determine propriety or expected efficacy or to monitor side effects during treatment. [In fact, more than 60% of oncology drugs launched in the past five years require or recommend biomarker testing before use].
These drugs are also incredibly expensive. And, while biomarker testing isn’t cheap, the cost is less than giving someone the wrong chemotherapy or autoimmune drug for months before the physician realizes it’s not working and has hurt the patient.
On top of that, a lot of the tests are for diseases that touch a lot of people, such as cancer, and there are emotional elements associated with them. There are a number of strong, well-established advocacy groups, such as the American Cancer Society, that are behind these legislative efforts. It’s an interesting combination of stakeholders.
Are the measures that have passed similar or are there key differences?
The main difference is the scope of the various state laws. Some laws are Medicaid-oriented only, some are Medicaid and commercial pay and some are commercial pay only. For example, the Colorado law that just passed only mandates coverage for specified tests by commercial plans. It doesn’t apply to the state Medicaid plan. A lot of that is driven by what the state Medicaid plans can afford.
Almost all the laws have some kind of medical necessity criteria that have to be met for mandatory coverage, but they can vary on specifics. The laws can also vary in the ranges of target diseases that are covered and how those target diseases are defined. Generally, there are biomarker tests that are associated with lots of conditions. Oncology is a primary one, but there are also tests for things like autoimmune disorders.
