New York’s Biomarker Law is a Promise Unkept—It’s Time for Enforcement
As a 14-year survivor of Triple Negative Breast Cancer and a Black woman leading a national breast cancer patient advocacy organization, I celebrated when New York took an important step forward by enacting a law that requires coverage for biomarker testing. The aim was to ensure patients can access precise diagnostics that guide early detection and modern cancer treatments. While we made progress in theory, many New Yorkers still haven’t felt that progress in practice.
New York’s biomarker testing law requires all state-regulated health plans, including Medicaid, to cover biomarker tests when specific scientific standards are met, such as U.S. Food and Drug Administration approval, CMS national coverage determinations, Medicare administrative contractor local coverage determinations, clinical guidelines, or peer-reviewed evidence. Under this law, patients should have access to the latest biomarker testing methods that deliver clinically accurate, personalized treatment options, but the reality is this: insurer policies remain unclear, coverage gaps exist, and the letter of the law is not always followed.
While I am fortunate to be thriving and to have benefited from the science behind transformative breast cancer diagnostics and treatments, I also understand the harsh realities of unequal access, having heard more stories about coverage denials and barriers than I can count.
For Black women, these barriers to access can mean life or death. The statistics are more than just numbers; they highlight failures in our current system. Black women face a 38% higher breast cancer mortality rate than any other racial or ethnic group in the U.S. Black patients also have the lowest five-year survival rate among all races and ethnicities at any stage, any age and any sub-type. While Black women are just as likely to carry hereditary breast cancer mutations as white women, they participate much less in genetic counseling and testing.
Biomarker testing shifts us from “one-size-fits-all” medicine toward personalized care that can help close these gaps. Customized and effective treatment regimens are developed by identifying specific biomarkers. That includes biomarkers linked to Triple Negative Breast Cancer, a particularly aggressive form that is more difficult to treat and affects Black women at nearly three times the rate of White women.
Yet, we are allowing insurers to gatekeep this technology.
While New York is among 23 states with a biomarker testing law, not all state laws are equal. Mississippi will become the 24th state on July 1, when its comprehensive and forward-thinking law takes effect. Mississippi will require insurers to provide written explanations for denials and grant its Department of Insurance the authority to conduct audits to ensure compliance.
Additional states are implementing further measures to ensure compliance. State Departments of Insurance, including Georgia and Nevada most recently, have issued bulletins clarifying coverage requirements and indicating that regulators are closely monitoring insurer behavior.
It is the duty of New York regulators to issue clear, official guidance to insurers and to ensure that plans that do not comply are properly managed. The New York State Department of Financial Services, which oversees the private and commercial insurance markets, should take similar steps to rein in noncompliant plans. Medicaid must also support precision medicine and diagnostics by reducing administrative burdens and modernizing coding and reimbursement systems, as other biomarker states have done, to better serve patients and providers and to improve efficiency throughout the healthcare system. Increasing transparency in coverage policies will also help patients and providers understand their rights and challenge unfair denials.
The impact of biomarker testing is clear. A 2023 survey by the American Cancer Society of cancer patients and survivors found that 77% of those who underwent biomarker testing reported it provided valuable information that improved their treatment. More than half said it increased their chances of recovery.
While I advocate nationally for Black breast cancer patients, biomarker testing offers similar benefits across many diseases. For individuals with diabetes, lupus, rheumatoid arthritis, as well as lung and colorectal cancers, biomarker testing helps identify the most effective treatment tailored to each patient. The result is better health and less suffering caused by ineffective or delayed care.
The biomarker testing law promised access to precision medicine for millions of New Yorkers. That promise still exists, but it won’t be fulfilled without action. By implementing clear enforcement measures, the Department of Financial Services and Medicaid can ensure that all state-regulated insurers provide comprehensive and equal access to biomarker testing, as the law requires.
There is no good reason for New Yorkers to wait any longer.
Ricki Fairley is Co-Founder and CEO of TOUCH, The Black Breast Cancer Alliance.
