Biomarker legislation could improve patient access in 2024

Panel biomarker testing can unlock some of the mysteries of treating patients so that they experience fewer side effects, better quality of life, longer survival rates and potentially, lower costs. At least 22 states are opening up, or looking at how to open up, access to it.

This past week, New York Governor Kathy Hochul signed Senate Bill 1196a/Assembly Bill 1673a into law, which directs all state-regulated health plans, including Medicaid, to cover comprehensive biomarker testing, thus clearing the path for more patients to access precision medicine treatments.

The new law means “biomarker testing for diagnosis, treatment, appropriate management or ongoing monitoring of a patient’s disease or condition when the test is supported by medical and scientific evidence,” is now required, according to a statement from the governor’s office.

“Biomarker testing has rapidly become an integral part of healthcare, as research has shown that it drastically improves outcomes for patients suffering from various illnesses and conditions, including different forms of cancer, arthritis, Parkinson’s and more,” said State Senator Roxanne Persaud in the announcement.

Fast becoming the standard of care 

Dr. Joel Diamond, CMO of Aranscia, told Healthcare IT News earlier this month that molecular diagnostics and broader payment will drive further adoption because they improve patient outcomes. 

“More and more, we are starting to see this as the standard of care,” he said. 

The Mayo Clinic is using algorithms to analyze multiple biomarkers to measure disease progression and improve care for chronic kidney and cardiovascular conditions. Late last year it announced efforts to develop AI-driven diagnostic testing for liver and neurologic diseases. 

The American Cancer Society Cancer Action Network said on its website that biomarker testing is key to unlocking precision medicine and that, in addition to New York, 12 states have already enacted legislation requiring coverage in both public and private insurance plans – Arizona, California, Georgia, Illinois, Kentucky, Louisiana, Maryland, Minnesota, New Mexico, Oklahoma, Rhode Island and Texas. 

Arkansas has enacted legislation requiring that commercial plans cover biomarker testing, and eight other states – Connecticut, Colorado, Florida, Massachusetts, Maine, Nevada, Ohio and Pennsylvania – introduced biomarker access bills this year.

Advancing health equity

ACS-CAN has campaigned to increase access to biomarker testing in 14 states, because it promises to achieve the triple aim of healthcare and can improve health equity.

“Communities that have been excluded, including communities of color, individuals with lower socioeconomic status, rural communities and those receiving care in non-academic medical centers are less likely to receive biomarker testing,” the organization said on its Ohio campaign page.

In addition to conserving medical resources and helping to ensure that patients are given tailored treatments, lawmakers were focused on the potential for broad biomarker testing to advance health equity, according to Pamela Hunter, a New York State Assembly member. 

“As medical capabilities progress and patients begin to see greatly improved health outcomes, we should strive to make the benefits of these new advancements as equitable as possible,” she said in a statement about New York’s new biomarker-testing coverage signed law.

ACS-CAN said studies have found broader biomarker testing results in substantial cost savings for payers by improving treatment precision and avoiding the costs of ineffective treatments.

“Improving coverage for and access to biomarker testing across insurance types is key to reducing health disparities,” the organization said in an FAQ on its Ohio campaign page.

Alzheimer’s is one disease where early diagnosis can lead to more effective dementia treatment, the Alzheimer’s Association said.

The organization recently joined 50 others, including the AACS-CAN, the ALS Association and the Arthritis Foundation, to expand comprehensive biomarker testing, according to a story Tuesday in the Dayton Daily News.

That association said Ohio House Bill 24 will advance the diagnosis of Alzheimer’s and other diseases for Ohioans by requiring Medicaid and state-regulated insurance plans to cover the cost of testing.

Ohio Medicaid already covers some biomarker testing, the story noted.

Treatments – there are two approved Alzheimer’s drugs and a third on the way – are aimed at patients beginning to experience forms of dementia, “making it important for people with those diseases to know sooner whether they have it,” according to Trey Addison, public policy director for Alzheimer’s Association Ohio.

“The sooner they get on treatment, the longer they can potentially live on their own, stay in the workforce and support themselves,” he said, according to the paper.

Andrea Fox is senior editor of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.