Health Insurers Use Pre-emptive Strike on Legislative Mandate in Florida

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OLDWICK, N.J. — In a pre-emptive strike on a legislative
mandate, major health insurers in Florida have agreed to pay for what
could be costly care for members diagnosed with cancer who participate
in clinical trials.

The "Clinical Trials Compact," negotiated by Florida state Sen. Don Gaetz, a Republican and chairman of the Senate Health Regulation Committee, ensures that cancer patients receive continued benefits while being treated with experimental drugs and other therapies, according to a statement from the committee earlier this month.

Participating insurers are Blue Cross and Blue Shield of Florida, Humana, Aetna, Cigna, UnitedHealthcare, Vista Healthplans and AvMed Health Plans. The compact involves fully insured commercial group health business.

Companies wanted to avoid a legislative mandate, said Dr. Jonathan Gavras, vice president and chief medical officer for the Florida Blues, the largest health insurer in the state. There was a move toward legislation to eventually cover all phases of these cancer clinical trials, he said.

Before, some insurers discontinued coverage of routine care if a patient entered an investigational protocol, which discouraged many from participating but these clinical trials could potentially cure their disease, the committee’s statement said.

For most insurance policies, phase I and phase II trials, in particular, are almost always excluded from coverage under investigational/experimental language, Gavras said.

Jerry Flanagan, health care policy director for the California-based Consumer Watchdog, with offices in Washington, D.C., said it’s likely legislators were threatening a mandate. Cancer patients in Florida are getting a short-term victory but "without a clear law on the books that requires this treatment, the insurance companies are free to back away from their promise in the future."

Gavras, however, said the companies will adhere to the agreement, and that it would be difficult to back out because all of the competitors must agree to do so.

Meanwhile, these types of voluntary agreements seem to have flown under the radar nationally.

Florida became the fifth state to use a compact for cancer clinical trials. The other states with similar agreements are Georgia, Michigan, Nebraska and New Jersey, the latter of which dates back to 1999, according to Patrick Dyer, a spokesman for The Leukemia and Lymphoma Society.

According to a report by the Council for Affordable Health Insurance, a mandate requires an insurer or health plan to cover common — but sometimes uncommon — providers, benefits and patient populations. Benefit mandates, for example, include mammograms but also acupuncture and wigs. Mandates make coverage more expensive because they require insurers to pay for care people previously paid for on their own, CAHI said.

The health insurers "have indicated that the compact will not increase premium costs for whomever is paying the premium," Sen. Gaetz said.

The compact covers phase II, III and IV clinical trials, which must be approved by the National Institutes of Health, National Cancer Institute, the Food and Drug Administration or performed by a Florida-accredited school of medicine, nursing or pharmacy or licensed children’s speciality hospital. The routine services that will continue to be provided include all health care covered by the patient’s insurer absent the clinical trial and services for the "reasonable and necessary care" arising from trials, including diagnosis and treatment of drug complications, according to the committee’s statement.

Humana Inc. (NYSE: HUM) said it was instrumental in bringing about the voluntary agreement on cancer care costs. The Kentucky-based health insurer has about 350,000 commercial members in Florida.

Humana was able "to support a multipayer effort in Florida to provide health insurance coverage for patients participating in clinical trials for cancer and avoid a legislative mandate," said Dr. Jill Sumfest, Humana’s south and central Florida market medical officer. "We would also like to see a statewide registry of patients in clinical trials that tracks outcomes."

The voluntary cancer trials coverage compact doesn’t extend to Medicare members, said the company, a top seller of private Medicare plans for seniors in the United States. The Centers for Medicare and Medicaid Services sets coverage policy for Medicare beneficiaries.

Mandates tend to not be clinically oriented or necessarily appropriate, which usually translates to higher premiums, Gavras said. With the compact, treatment can be cost effective because it’s aimed at appropriate trials done in reputable centers, he said.

Compact participants will now cover expenses related to the trial, such as hospitalization and some nursing care, which were previously excluded, Gavras said. The drugs, medical devices or therapies would still be paid for by whomever is sponsoring the trial, he said.

According to Dyer, 30 states and the District of Columbia require coverage of routine care costs for patients enrolled in clinical trials, and "there is definitely momentum to have these costs covered."

Contact the author Fran Matso Lysiak, senior associate editor, BestWeek at: [email protected]

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