Access-to-Drugs Bill Gains Steam
Mari Velar, who has lupus and osteoporosis, has bones as fragile as butterfly wings.
To keep them from breaking, she depends on an IV drip of a bone-strengthening fluid, which costs a lot more than pills. Whenever she has a new plan or new doctor, she has to switch to the cheaper therapy until she begins to itch.
“In order to appease the doctor, I have to try the drug and show them the hives and prove to them that I cannot take the drug,” says the 54-year-old Tampa woman.
Florida Sen. Don Gaetz says that what happens to patients like Velar is an abuse of managed care. Gaetz, a Republican from the Panhandle town of Niceville, is sponsoring the “Right Medicine, Right Time Act” to fight it.
Senate Bill 784 is on Monday’s agenda of the Senate Health Policy Committee. It passed the Senate Banking and Insurance Committee unanimously on March 4.
At that hearing, Gaetz explained it this way: “Sometimes insurance companies disagree with doctors, and tell patients, ‘Before we’ll agree to you receiving this treatment or that medicine, you’ll have to fail first with one or more other interventions. Then we’ll see if we’ll cover the treatment your doctors have prescribed.’”
The bill has support from dozens of doctors’ associations and patient advocacy groups in a movement called Patient Access of Florida, funded by the pharmaceutical industry. It takes direct aim at the common industry practice of “step therapy,” in which plans cover drugs only if doctors follow the rules, prescribing what’s on the health plan’s preferred drug list, called a “formulary.”
If the first pill doesn’t work, they’re supposed to try another from the formulary, assuming there is one. If there are no appropriate drugs on the formulary, the doctor may be required to get “prior authorization” -- permission from a committee, or the medical director -- to prescribe a more expensive drug.
Patient Access of Florida’s website says this is unacceptable.
“Healthcare professionals have the expertise to know what is best for patients and must have access to a full range of therapeutic options to use as they see fit for their patients," it states. "They should not have to jump through burdensome bureaucratic hoops to secure the most appropriate therapy.”
Gaetz’s bill would require insurers and health plans to be cautious in setting too-strict limits on treatments, to do so only when there is medical justification and not just financial savings.
It would establish the Clinical Practices Review Commission, which would be dominated by physicians and operate out of the Department of Health. If a plan wanted to set up step therapy or other limits on coverage, it would have to show the commission that it was safe and justified by independent scientific evidence.
Another worry for the industry: The bill would make a plan legally liable if a patient were harmed by an unjustified limit on access to care.
Step therapy and the requirement for a prior authorization actually protect patients against prescribing errors, said Audrey Brown, president of the Florida Association of Health Plans.
“This is all in an effort to maintain patient health as well as prevent drug abuse and fraud,” she said.
And if the limits save money, that helps everyone, she said.
Paul Sanford, a lobbyist for large Florida insurers, warned that Gaetz's review board would be “another layer of costly, burdensome regulation that's not going to do much except slow things down and add cost to the system.”
Doctors say that the prior-authorization process may save money for the plan, but it shifts cost to the medical practice. It requires a lot of paperwork, faxing and hanging on the phone, waiting for approval, negotiating on behalf of patients.
Since doctors have no time to do all that, they say, they have to hire more staff to do it.
“I don’t think any physician or any practitioner is against cost-effective appropriate therapy,” said Dr. David Levin of Dunedin. “What we’re talking about today for the most part are exceptions.”
Certain specialists – those who treat cancer, mental illness and liver disease, among others – have a hard time dealing with step therapy and prior authorization, doctors say. That’s because the cheaper drugs, the older off-patent ones, may carry side-effects. Or they may not work as well as the new-line brand-name drugs.
Health plans change their drug lists frequently, said Dr. Levin, a specialist in rheumatoid arthritis. Each change in the list forces his patients to change drugs or pay a whopping bill. For some, a switch is okay, he says; for some it's dangerous.
“The drugs are not the same and the responses are not the same and the reactions, the adverse reactions, are not the same,” he said.
At a minimum, Dr. Levin says, plans should be required to let new members remain on the drugs that they are already taking, at least until they can work through the appeals process. The same grandfather clause should apply if the plan changes its drug list, he says.
Peggy Symonds of DeLand, who is in a Medicaid HMO, told senators that the search for savings sometimes backfires.
“It can take weeks of hospitalization to recover from exposure to the wrong drug, even briefly,” she said. “It’s happened to me.”
A staff analysis of Gaetz’s bill says the medical literature on the benefits and risks of access limits is inconclusive.
A House bill that addresses these issues but is less alarming to health plans because it doesn’t call for a review board is sponsored by Rep. Shawn Harrison, R-Tampa. It was referred to four committees, according to a legislative website, but none has taken it up yet.