New Florida Law Extends Biomarker Testing to More Floridians

A growing number of people diagnosed with cancer, Alzheimer’s disease and autoimmune diseases benefit from biomarker testing – a type of genetic test that can help physicians determine how to best treat their patients. A state law that went into effect Jan. 1, 2025, extends this important service to more Floridians.

The bill, named HB 885, was signed by Gov. Ron DeSantis in June. It requires coverage for biomarker testing when supported by scientific and medical evidence under Florida Medicaid and state-employee health insurance plans. The section of the bill covering Medicaid recipients went into effect Oct. 1, 2024.

Biomarker testing involves analyzing blood or tumor samples to identify specific genes or proteins that play a role in a particular disease. Knowing each patient’s genetic profile can help doctors select treatments that have a better chance of success. For example, women who carry BRCA gene mutations are often prescribed a “targeted” medication that addresses that gene mutation.

Personalized medicine has revolutionized cancer care and is rapidly spreading into other types of medical conditions, says Susan Harbin, senior government relations director for the American Cancer Society Cancer Action Network (ACS CAN) in Florida. The organization led efforts to pass the legislation.

Biomarker testing “is new and evolving. Unfortunately, the insurance plan coverage hasn’t kept up with the science,” Harbin says. “We have situations where a provider may be recommending a certain test, or it gets denied, or there are questions on whether the test is covered. It creates confusion for the patient.”

According to Harbin, about 60% of all cancer drugs approved in the last five years carry instructions requiring or recommending biomarker testing before use. Without such testing, patients may not receive the most effective drugs. Testing can help doctors dispense with treatment that won’t work. It’s also used to monitor how a treatment is working.

“We want to make sure that once something becomes the standard of care, it should be covered,” she says. “These biomarkers are providing information to physicians about whether treatments are going to be effective for a particular type of cancer, what treatments won’t work. It helps patients avoid treatments that won’t help. Quality of life is something we are concerned about as well.”

Before​ passage of the law, there was wide disparity regarding coverage of biomarker testing, Harbin says. In general, coverage of biomarker testing in Florida “was not as comprehensive as the guidelines put forward by the National Comprehensive Cancer Network. We were far under what the standard was.”

Biomarker testing can cost anywhere from a few hundred to a few thousand dollars, Harbin says. With the cost of co-pays and premiums, that may make biomarker testing unaffordable for people who are paying out-of-pocket. However, research indicates that appropriate use of biomarker testing can save money for insurance by helping doctors and patients avoid ineffective therapies.

Growing use of biomarker testing

Biomarker testing is becoming more useful for other conditions besides cancer. The Alzheimer's Association of Florida lobbied for passage of the legislation, citing the growing role of genetics in the disease. For example, a recent study showed that people who carry two copies of the APOE4 gene mutation have a 60% chance of developing Alzheimer’s disease by age 85.

The legislation will make it easier for physicians to order tests such as spinal taps and PET scans of the brain to help diagnose Alzheimer’s disease and start patients on therapies early in the course of the disease, when they have a better chance of being effective.

Moreover, blood tests to diagnose Alzheimer’s disease are being developed. The legislation will pave the way for coverage of such a test, should one become available.

“Most of the current applications right now are in oncology and autoimmune diseases,” Harbin says. "But there is so much research helping right now. Precision medicine looks to be the future for lots of different therapies … The way we drafted the bill, it’s not cancer specific. As more tests and therapies emerge, they should also be covered once they are supported by science.”

A good first step

The bill could expand coverage of biomarker testing to thousands of Floridians who would otherwise have to pay out of pocket for the service. However, the law stops short of requiring coverage for private market health plans, such as those offered on the Affordable Care Act marketplace. It does not cover Medicare recipients because Medicare is regulated by the federal government. (Many Medicare health plans cover biomarker testing.) Many private health insurance plans cover biomarker testing when deemed medically necessary; however, it is not mandated by federal or state law.

The Florida law does not cover members of state-regulated private health insurance plans, which could include tourism, hospitality and agriculture employees who aren’t offered coverage through an employer. 

“We have a lot of people enrolled in Medicaid in Florida – more than 5​ million people. Most are children and pregnant women,” Harbin says. “When it comes to state employee health plans, there are between 300,000 and 400,000 members.

“We would love this requirement to extend to private plans this doesn’t capture. That is something we are continuing to work on.”

Harbin says the American Cancer Society Cancer Action Network in Florida will monitor how well the legislation is working and will provide continuing advocacy and education to make sure qualifying Floridians can access biomarker testing. The Florida Medicaid program and the Division of State Group Insurance program has outlined a process for patients and providers to request authorization for biomarker testing. The law stipulates that state insurance plans shall only cover tests if scientific evidence indicates they will medically benefit the patient.

The legislation marks a rare victory for health care rights for consumers in Florida. The ACS first introduced the bill in 2023, but it floundered. In 2024, the legislation drew the support of first lady Casey DeSantis, who is a cancer survivor.

“The landscape in Florida, when it comes to passing laws that look like a new insurance mandate or requirement, is not something we’ve seen happen in Florida for many years,” Harbin says. “This past session, we worked on education, and the governor and his wife have been highlighting cancer research and innovation and putting more money into these types of programs. That helped elevate this issue.”