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Legislation Mandating Insurance Coverage for Biomarker Testing Introduced in Massachusetts


NEW YORK – Massachusetts could become the 10th US state to pass legislation requiring that certain insurance plans cover biomarker testing for patients when supported by medical and scientific evidence.

A pair of bills working their way through the Massachusetts Senate and House seek to mitigate coverage gaps for patients in the state, where currently some payors cover biomarker testing and some do not, said Marc Hymovitz, director of government relationships for Massachusetts at American Cancer Society Cancer Action Network (ACS CAN). "We put together legislation that will hopefully bridge those gaps and [lead to] clearer, understandable, and across-the-board insurance coverage policy when it comes to biomarker testing," he said.

The cancer advocacy organization worked with other non-cancer advocacy groups to develop the Senate and House bills, including the Michael J. Fox Foundation, the American Parkinson's Disease Association, and various rare disease organizations. "Biomarker tests are important for treating some cancers, but also for diseases like amyotrophic lateral sclerosis," said Hymovitz. "There's a really strong and growing coalition of patient advocacy groups" behind these bills.

Hymovitz said that the language of the two bills — S 689 sponsored by state Sen. Susan Moran, D-Plymouth and Barnstable District, and H 1074 sponsored by House Rep. Meghan Kilcoyne, D-12th Worcester District — is identical, except that the House bill mistakenly includes the word cancer in the title. "That was a drafting error," Hymovitz clarified. "The bills are disease agnostic and would apply to any disease that meets the criteria laid out in the bill for the biomarker testing."

The bills specify that insurers must cover biomarker testing if scientific or evidence-based medical recommendations support their use for diagnosing, treating, managing, or monitoring a disease. For example, if a biomarker test is indicated for such use and has the US Food and Drug Administration's approval or clearance, or if the FDA approves a drug for patients identified via a particular biomarker test, the bills would require insurers to cover such tests. The bills would also mandate coverage of tests included in nationally recognized clinical practice guidelines, consensus statements, and the Centers for Medicare & Medicaid Services' coverage determinations.

Since under the federal Employee Retirement Income Security Act (ERISA) law states can only place such requirements on state-regulated plans, these are the types of plans the bill addresses.

Hymovitz said ACS CAN is advocating for passage of the legislation hoping this will ease restrictive reimbursement for biomarker testing and broaden access for patients.

In a study published last year in Personalized Medicine, researchers examined how well 38 commercial coverage plans for multigene biomarker test panels aligned with the National Comprehensive Cancer Network's guidelines for four cancers — breast, non-small cell lung, melanoma, and prostate — and found that 71 percent of plans were more restrictive than the guidelines. About half the plans, or 52 percent, restricted the number of genes tested, and 63 percent restricted biomarker testing either in all types of cancer or select types.

"Doctors are using precision medicine to treat illnesses such as cancer," Hymovitz said. "It's great that we have these new advancements that can be less invasive, [and have] fewer side effects. But now the patient needs to get a biomarker test."

Insurance companies, meanwhile, have lobbied against similar bills ACS CAN has advanced in other states. It's still early in Massachusetts' legislative session, Hymovitz said, and payors have not yet come out specifically against the bill. He fully expects insurers will investigate the bill language closely and question it.

Still, Hymovitz believes payors who oppose these bills are not seeing the bigger picture. "Rather than blindly creating a treatment plan, we can tell in many cases whether or not they'll be effective. Biomarker tests can allow the practitioners to skip [therapies] that they know will be ineffective and get [patients] to the right, most effective treatment quickly," said Hymovitz. "It actually helps with healthcare costs."

To date, similar legislation has passed in Rhode Island, Illinois, Arizona, New Mexico, Louisiana, Kentucky, Georgia, Arkansas, and Maryland. However, California Gov. Gavin Newsom last October vetoed legislation mandating biomarker test coverage because he said the bill language lacked specificity.

ASC CAN has ambitions to pass these types of broad biomarker test coverage bills throughout the US and has succeeded in introducing legislation this year in Connecticut, Colorado, Florida, Maine, Nevada, New York, Ohio, Oklahoma, Texas, and again in California. The organization expects a bill will be introduced in Pennsylvania soon.

There's support for the biomarker test coverage provisions in these bills across the political spectrum, according to Hymovitz, including in deep Southern states like Louisiana and Kentucky, Midwestern states like Illinois, and Western states like Arizona. "It's quite clear that biomarker testing and precision medicine have the potential to help treat serious illnesses and even cure serious diseases that can impact any one of us, whether we're Democrats or Republicans or anywhere in between," Hymovitz said.

The bill in Massachusetts recently had a public hearing before the Senate Joint Committee on Financial Services, but the committee likely won't report on it until early fall, according to Hymovitz.