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State-Regulated Illinois Health Plans Subject to Biomarker Test Coverage Mandate Starting 2022

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Illinois State Capitol Building, Springfield, Illinois.jpg

NEW YORK – Illinois Gov. J.B. Pritzker last Friday signed a bill into law that will require state-regulated plans to cover evidence-backed biomarker testing for patients.

Similar bills are popping up in state legislatures around the country. While doctors and patient advocates are optimistic that the enactment of HB1779 in Illinois is a positive move toward mitigating growing disparities in accessing precision medicine, it remains to be seen if insurers will respond to the change by increasing premiums or implementing other strategies to rein in test utilization.

The changes due to the enacted bill, HB1779, would impact all private health insurance plans overseen by the Illinois Department of Insurance, including plans for state and local government employees, as well as plans offered by public schools, by small employers, individual plans, and Medicaid. Starting next year, insurers managing these plans must cover biomarker testing to diagnose, treat, or monitor patients when it is supported by US Food and Drug Administration-approved drug or test labeling; a Centers for Medicare & Medicaid Services national coverage determination; broadly accepted clinical practice guidelines; consensus statements; professional society recommendations; evidence published in peer-reviewed journals that meet nationally recognized standards; and biomedical compendia.

Although the coverage mandate is both disease- and diagnostic technology-agnostic, the near-term impact of the law may be most visible among cancer patients, who based on rapidly advancing research can now benefit from a growing list of drugs based on biomarkers driving their tumors. Biomarker testing "is becoming absolutely essential in most malignancy types," said Sheetal Kircher, an associate professor of hematology and oncology at Northwestern University's Feinberg School of Medicine. "It's not a luxury. It's no longer something that we think of only for our most advanced cancer patients."

For example, last year, the FDA approved osimertinib (AstraZeneca's Tagrisso) as an adjuvant treatment for EGFR-mutated non-small cell lung cancer, necessitating EGFR testing for lung cancer patients at diagnosis. Similarly, data presented at this year's American Society of Clinical Oncology's annual meeting, researchers presented compelling data on the benefit of olaparib (Merck/AstraZeneca's Lynparza) in early-stage breast cancer patients with BRCA1/2 mutations, which spurred many oncologists to consider whether biomarker testing guidelines should be updated to recommend testing all breast cancer patients for such mutations.

"The utilization of biomarkers has become more important … in how we treat a patient, where at the time of diagnosis we need biomarkers to make decisions and we need them quickly," said Kircher.

She reflected that the broad scope of the Illinois law — that it does not specify coverage for certain diseases, biomarkers, or testing technology — is appropriate given how quickly genomic medicine is changing. "It's nearly impossible for insurers to be able to keep up with policy when the science is changing so fast in terms of the development of new biomarkers and new techniques to try to find different biomarkers," said Kircher, who testified before Illinois legislators earlier this year in support of the coverage mandate in HB1779.

She noted a variety of reasons for why her patients may encounter delays in receiving biomarker-informed treatment. There may be logistical delays in terms of getting access to records and biological materials, for example, when patients move their care from a local practice to an academic facility like Northwestern. Then there are insurance-related delays, where doctors and support staff must appeal coverage denials multiple times or await prior authorization for drugs and biomarker testing, which can hold up patients' treatment plans.

That latter difficulty can be more readily addressed with policy changes, Kircher noted. "There will inherently be some delays that by the nature of cancer [care], we can't control," she said. "With these policies, we are trying to mitigate undue delays, controllable delays, things that we can influence and impact."

Although the new law in Illinois doesn't stipulate payors must cover a particular type of testing, it requires they cover testing that is "conducted in an efficient manner" and that "provides the most complete range of results" without requiring multiple biopsies or other delays in care. In cancer, next-generation sequencing panels fit these stipulations. Commercially available NGS panels can detect changes in dozens to hundreds of genes from a single blood or tissue sample and identify biomarkers predictive of treatment response.

At the federal level, CMS has granted national coverage to FDA-approved NGS-based companion tests that determine whether advanced or refractory cancer patients are likely to respond to certain treatments based on biomarkers in their tumors. However, many commercial payors haven't aligned their policies with the federal government outside of their Medicare advantage plans. In fact, there is a lot of variability among commercial payors when it comes to covering large NGS panels, particularly panels that gauge more than 50 genes.

While in recent years insurance coverage for biomarker testing has improved, the variability in payors' policies make them difficult for healthcare providers and patients to navigate. In addition to ordering NGS testing from commercial labs, Northwestern also conducts such analysis in-house for cancer patients — and Kircher noted she has experienced insurance challenges with both internally conducted and outsourced tests.

In addition to her research responsibilities, she spends two days a week seeing patients. A full-time physician's assistant and nurse help manage her practice, but the team spends a significant amount of time dealing with insurers' coverage denials and prior authorizations. "From an efficiency standpoint, the administrative burdens are really high," Kircher reflected. "It takes us away from just caring for patients, which is what we are trained to do and want to be doing."

Insurance coverage for biomarker testing also "varies based on the individual patient's cancer type and the specifics of their case," agreed Hilary Goeckner, who manages state and local policy campaigns for the advocacy organization American Cancer Society Cancer Action Network, or ACSCAN. She is hopeful that the changes resulting from HB1779 will help improve biomarker test access for patients under small employer plans or state Medicaid programs, which tend to have worse coverage compared to large employer-sponsored plans and Medicare.

Last year, the patient advocacy group LUNGevity did an analysis of state Medicaid policies around comprehensive biomarker testing — defined as testing for all biomarkers that current clinical guidelines recommend for a particular type of cancer — and found that around 60 percent of states did not have specific coverage policies on such testing, though around 40 percent of states did cover it.

Currently, most commercial labs offer financial assistance, and some academic medical centers with in-house biomarker tests eat the cost of testing for underinsured or uninsured patients. And while some patients are paying out of pocket when their insurer refuses to cover such testing, the unpredictability and inconsistency in insurers' policies are contributing to widening healthcare access disparities in this country.

Despite evidence that biomarker testing improves outcomes in NSCLC patients, for example, not all patients have access to guidelines-backed testing. According to one analysis by the MYLUNG consortium, less the 50 percent of advanced NSCLC patients were tested for all five biomarkers for which there are FDA-approved treatment options and less than 40 percent received testing for multiple biomarkers on an NGS panel. Studies have also found race-based differences in lung cancer biomarker testing.

While there are multiple reasons for these disparities, oncologists and patient advocates on the ground cite insurance coverage among the biggest roadblocks to equitable access to biomarker testing and precision medicine. "If we don't pass these [laws] to ensure that plans are covering biomarker testing when it's necessary, you're just going to see the disparities in access and cancer outcomes grow as some patients are able to pay out of pocket and others are left behind," said Goeckner.

Insurers, on the other hand, have been worried about increasing costs due to greater use of genetic testing, and many have implemented prior authorization policies or enlisted lab-benefit managers to control spending. Several insurer organizations objected in principle to the biomarker testing coverage mandate in HB1779 but didn't testify during hearings for the bill. Among the objectors listed to HB1779 on the Illinois General Assembly website are the Illinois Life & Health Insurance Council, or ILHIC, and BlueCross BlueShield of Illinois.

Laura Minzer, president of ILHIC, estimated that around 25 percent of Illinois' privately insured population have a state-regulated plan that would have to comply with the new law. "Health insurance coverage mandates, however well-intended, make it more difficult to manage premiums for those with individual/family and small employer plans," Minzer said.

The Illinois General Assembly didn't conduct a cost-impact analysis for HB1779, and the requirements for commercial insurers don't kick in until next year. As such, it remains to be seen how insurers offering state-regulated plans will adjust their policies in light of the new law, and particularly whether the changes will impact insurers' costs and impact patients' premiums. 

Most commercial insurers have already submitted their policies and premium rate information this year for approval by the state's Department of Insurance, according to Minzer. While some insurers may decide to amend their premium rates in light of the new law, "the more likely scenario is for those plans to wait until 2023, when there is a better understanding of utilization and costs associated with covering the biomarker testing per the mandate," she said.

Meanwhile, similar bills to expand biomarker testing coverage or do away with prior authorizations for cancer genetic testing are being introduced in state legislatures around the country.

In June, Louisiana Gov. John Bel Edwards signed a bill into law that among other things would require state-regulated plans to cover a variety of genetic tests for cancer patients including somatic and germline analysis, next-generation sequencing, whole-exome and -genome sequencing, and pharmacogenomic analysis. The law, which also goes into effect next year, would still allow insurers in Louisiana to design coverage policies that include medical necessity criteria and are subject to annual deductibles, coinsurance, and copayment provisions.

A bill in California, SB535, would amend the state insurance code to restrict prior authorizations for biomarker testing for advanced cancer patients. A similar bill in Massachusetts has been referred to the Joint Committee on Healthcare Financing.

In Illinois, HB1779 initially contained language seeking to do away with prior authorization language, but legislators nixed this in favor of focusing on broadening biomarker test coverage. ACSCAN pushed for this change, according to Goeckner, who added that the organization doesn't advocate for across-the-board elimination of prior authorization for any medical intervention but focuses on improving coverage policies.

"We will continue to advocate to make sure that patients are able to get the treatments they need. But our first priority on this issue was to have the coverage requirement," she said. "If you look just at the prior authorization piece without also having a coverage requirement, plans could just choose to stop covering the testing if they were prohibited from using prior authorization."

At Northwestern, meanwhile, Kircher finds payors' utilization management tools, such as prior authorizations, often delay her cancer patients' ability to access oral cancer medications and even biomarker testing. Even when treatments or biomarker tests are covered, she still needs to garner prior authorization from the insurer, which can delay care.

"The barrier isn't just with coverage — it's once we get through coverage, [making sure that] obtaining prior authorization, or any sort of utilization review practices are timely and efficient, is really important," she said. "Coverage is irrelevant if we can't still access the drug or test because of restrictive prior authorization or through cost prohibitive copays. Those are all barriers."

The enactment of HB1779 is a good start in Kircher's view, but she suggested the need to further track the impact of insurers' various mechanisms for controlling utilization. "Implementation [of this bill's provisions] will need to be closely followed to make sure it is actually removing the barriers to getting biomarker testing or if it reveals other barriers that also need to be addressed like prior authorization or copays," she said.

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