Florida State Senator Wants Clinical Trial Claims Covered

A powerful Florida state senator wants insurance companies and HMOs to stop denying coverage of routine medical treatment, such as doctor’s visits and X-rays, for Florida cancer patients participating in clinical trials.

And if the insurers won’t do it voluntarily, Sen. Don Gaetz says he’ll introduce a bill in the next legislative session that forces them to, according to Health News Florida, an online news service.

Gaetz, who chairs the Senate Committee on Health Regulation, called industry lobbyists to his office in the Capitol last week to lay down their options: work with him now to draft a voluntary agreement requiring coverage or battle him in the Legislature this spring when he pushes the bill.

“My preference is we try to approach this issue and achieve a voluntary compact,” Gaetz told the insurance, teaching hospital, cancer society and pharmaceutical lobbyists who attended the meeting. “Failing that, we will sponsor legislation. I want you to know that we will. We have to.”

Deputy Insurance Commissioner Mary Beth Senkewicz, who also attended, said about 2 million Floridians are covered by policies that leave them at financial risk when they enter clinical trials, which are tests of experimental drugs and treatments that patients can try after standard treatments have not worked. Such trials are sponsored by pharmaceutical companies, medical research organizations, and federal agencies.

One of the companies that excludes the coverage is the state’s largest insurer, Blue Cross and Blue Shield of Florida, which has a 28.4 percent market share of insured patients in the state.

Gaetz, R-Niceville, succeeded in passing a bill last year against the fierce opposition of Blue Cross and several other insurers. The bill required them to pay doctors outside their network directly when they treat Blue Cross members, instead of routing the payments through the patients. The fight between the doctors and insurers was so fierce it reminded many of the malpractice insurance reform disputes in the early years of this decade.

Gaetz is known for his tenacity, said Senkewicz. “He can get stuff passed. I wouldn’t bet against him,” she said.

Senkewicz, who reviewed the filings of the 10 largest carriers in the state, named several other companies that don’t cover patients during clinical trials: AvMed, Vista Health Plan and Connecticut General Life. Together they account for 11 percent of the insured market.

United Health Care Insurance, the second-largest insurance carrier in the state with 14.5 percent market share, does provide coverage. So does Aetna Health, the third-largest carrier with nearly 14 percent market share.

The Senate Health Regulation Committee produced a report showing 23 states require routine coverage for those enrolled in clinical trials. Four states have signed special agreements with insurers to provide coverage. That’s the route Gaetz prefers, he said.

But if that doesn’t work, Gaetz could add a mandate _ a requirement for coverage _ to the 50 or so that already exist in Florida law for such services as chiropractor visits and cervical-cancer screenings.

Mandates don’t apply to workers’ coverage from large employers that self-insure. They affect policies sold mostly to individuals and small employers; about 4 million Floridians are covered under state-regulated policies, Senkewicz said.

Gaetz said he’s not asking companies to cover anything that they don’t already cover for their members before they enter clinical trials.

Dr. Michael Good, interim dean of the University of Florida College of Medicine, who sat in on the meeting by telephone, said that clinical trials benefit not only the individual but all cancer patients by increasing knowledge of what works.

“We need to make sure that patients are comfortable in entering trials and they are not dissuaded because of real or perceived concerns with their health coverage,” Good said.

Gaetz said he became familiar with the issue while campaigning for the state Senate seat. A former school superintendent, Gaetz said he met a teacher he had once hired who was battling cancer with experimental treatment. When she informed the insurance company of her efforts, she told Gaetz, she lost her coverage.

Gaetz said he knows a Panama City prostate cancer patient who hasn’t told his insurer that he’s participating in a clinical trial. If it finds out and cuts off his coverage, Gaetz said, the man would “dedicate his fortune” to fighting the decision. “This gentleman has a sizable fortune and it would be an extraordinary and unfortunate court case, I think, for all concerned,” Gaetz said.

The Florida Department of Financial Services has received just two complaints regarding health insurance coverage for patients in clinical trials, according to the Senate brief.

But a program meant to settle disputes between HMOs and their members has fielded 52 grievances in the last three years. Nineteen of those complaints were either settled before the Statewide Provider and Subscriber Assistance Panel heard the case or favored the patient.

“I think good law starts with a human need,” Gaetz said.