Improvements to New York Health Insurance: Biomarker Testing
Testing for biomarkers in patients is the state of the art in assessing the effectiveness of therapies. These tests enable healthcare providers to gain a deeper understanding of a patient’s disease and predict their response to treatment, making them a crucial tool in personalized medicine.
New York Legislature Takes Action
The New York State legislature recently recognized the importance of biomarker testing and passed a bill requiring health insurers, including Medicaid, to cover this type of diagnostic tool. The bill is expected to be signed by Governor Hochul, marking a major step forward for patient access to precision diagnostics.
What Is Biomarker Testing?
Biomarker testing involves the measurement and analysis of specific molecules, substances, or characteristics in the body that can provide information about a biological or pathological process, disease presence, or treatment response.
Biomarkers can include:
-
Proteins
-
Enzymes
-
Genetic material (DNA or RNA)
-
Hormones
-
Metabolites
-
Physical characteristics (e.g., blood pressure or heart rate)
This testing is commonly used to evaluate conditions such as cancer, cardiovascular disease, neurological disorders, and infectious diseases. It also helps clinicians monitor treatment response and make timely therapy adjustments.
Insurance Industry Pushback
Despite their proven effectiveness, many insurers have historically restricted or excluded coverage for biomarker testing. In some cases, they required prior authorizations that created barriers for patients. During the legislative debate in New York, insurers raised several concerns, including:
-
Not all biomarker tests being medically necessary
-
Limited FDA approval for certain tests
-
Variability in peer-reviewed evidence based on disease and biomarker
-
Fears that expanded coverage would raise healthcare costs overall
Clinical Utility as the Legal Standard
In response to these concerns, the New York law requires insurers to cover biomarker testing only when “the test provides clinical utility to the patient as demonstrated by medical and scientific evidence.” However, the legislation specifically excludes “consensus statements” as standalone evidence that would trigger the coverage requirement.
A National Trend in Biomarker Access
New York is not alone in this effort. Legislative momentum is building nationwide:
-
19 U.S. states have enacted laws requiring biomarker test coverage or limiting prior authorization barriers.
-
13 additional states, including New York, have active legislative proposals in progress.
This wave of reform reflects a growing consensus that patients deserve access to timely and relevant diagnostic technologies.
Industry Advocacy and Support
The push for expanded access has been driven by both patient advocacy groups, such as the American Cancer Society’s Cancer Action Network, and industry organizations like NewYorkBIO. The latter represents New York’s life sciences sector and helps advance research, innovation, and public health policy.
Crowley Law’s Role in the Life Sciences Ecosystem
Crowley Law is a proud member of NewYorkBIO. Our commitment to serving the life sciences industry extends beyond legal support, we actively engage with the scientific community, policymakers, and stakeholders to help shape a regulatory environment that supports innovation and patient care.
We understand the pace and complexity of biotech law, and we remain vigilant in tracking and interpreting changes in legislation that impact our clients.
Partner with Crowley Law
Whether you’re a biotech startup or an established diagnostics provider, we offer strategic legal guidance grounded in industry insight. Our firm helps clients adapt to evolving legal landscapes while staying focused on scientific progress.
Contact Crowley Law today at (908) 540-6901 to discuss your projects, goals, and how we can support your success.
