Testing for biomarkers in patients is the state of the art in assessing effectiveness of therapies.
The New York State legislature recently recognized that and passed a bill requiring health insurers, including Medicaid, to cover biomarker testing, a diagnostic tool for cancer and other medical conditions. The bill is expected to be signed by Governor Hochul.
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 or even physical characteristics like blood pressure or heart rate. They can be indicative of various conditions, such as cancer, cardiovascular diseases, neurological disorders or infectious diseases. Biomarker testing is also often employed to assess how a patient is responding to a particular treatment. Changes in biomarker levels can indicate the effectiveness of therapy, allowing for adjustments if needed.
Despite their clinically-demonstrated effectiveness, many insurers have restricted or even excluded coverage for biomarker testing or required prior authorization in ways that limited access to testing for many patients. As happened during the course of the legislative process in New York this year, insurers advanced several arguments:
- not all biomarker tests are medically necessary,
- only some have approval from the Food and Drug Administration,
- peer review of biomarker testing varies for different combinations of marker and disease or condition, and
- increases in required coverage will lead to increased costs for all insureds.
Ultimately, the New York law mandates coverage "when the test provides clinical utility to the patient as demonstrated by medical and scientific evidence," but in response to insurers comments, the law does not include "consensus statements" as an example of medical evidence that would trigger the coverage requirement.
Recent efforts to enact legislative changes like New York's have ramped up nationally—to date, nineteen States have passed legislation that either mandates health plans to provide coverage for biomarker testing or imposes restrictions on prior authorization requirements related to biomarker testing, and thirteen others, including New York, have active legislation on the topic.1
Some of the drivers behind these new laws have been patient groups American Cancer Society's Cancer Action Network, but trade organizations like NewYorkBIO have also been leaders in these campaigns. NewYorkBIO represents the life sciences industry in the State, and due to its connections to private bioscience companies, research institutions, and universities, it can build a broad support network for scientific advancements that advance public health.
Crowley Law is a proud member of NewYorkBIO; our dedication to assisting life science companies does not merely necessitate a vigilant approach to staying abreast of evolving legislation, but for being part of the life sciences community as it recognizes and advocates for new technologies that provide benefits to the public and the life science. We recognize that the dynamic nature of the industry demands a proactive mindset. To provide our clients with unparalleled legal support, we make it a priority to remain informed and well-versed in the latest legislative developments, so that our clients receive the most up-to-date legal guidance to thrive.
Footnote
1. See maps at https://aimedalliance.org/biomarker-testing-enacted-laws/.
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