Iowa legislation would allow exceptions from step-therapy protocols

Two years ago, when Cynthia Heaton - a nurse in Iowa City - took a different job, she had no idea the nightmare her new health insurance company would soon put her family through.

Her son, Michael, has multiple chronic illnesses, Asperger's syndrome - a form of autism - asthma, ADHD and Gastroesophageal reflux disease (GERD). He's on numerous medications and the family spent years finding the right combination of drugs that interacted with one another properly and also managed his symptoms.

The family tried generics and different versions of them at her original insurance company's request, only to find they did not work before moving to newer, name brand medications.

But the time already spent trying those medications that did not work was not considered under the new insurance plan.

"We had to do the process all over again," she said.

It's a practice called step therapy - patients must start with the most cost-effective or safest drug, moving to more costly or risky therapy only after those treatments fail. It's a way for insurers to control costs and minimize risks.

And the vast majority of the time, it makes sense for an insurer to ask doctors and patients to go through the process. But there are instances when exemptions are needed, advocates say.

For example, after Michael Heaton was forced to go back to drugs the family knew wouldn't work, two of them interacted poorly with one another and caused him to have coughing spells. Because Michael has asthma, doctors first thought he needed a stronger inhaler or a dose of steroids.

But he kept coughing. After several months, they put Michael under to get a better look at his lungs. That's when they found that the coughing had nothing to do with his asthma. The drug mixture had caused multiple stomach ulcers to form, which were producing acid reflux and causing him to cough.

"I was so angry," Heaton said. "We decided that we'd pay out of pocket before we changed prescriptions again."

That experience is what brought her to Des Moines this past Wednesday along with about a dozen other Iowans to talk with legislators and urge them to vote in favor for a pair of bills - Senate File 436 and House File 233 - that soon will come to the floors for debate.

The legislation would allow exceptions from step-therapy protocols when inappropriate. It would give the patient immediate coverage of the prescribed drug if there is proper documentation.

It's supported by the Brain Injury Alliance of Iowa, National Alliance of Mental Illness, Iowa Pharmacy Association and the Iowa Medical Society, among other provider and advocacy groups. Wellmark Blue Cross Blue Shield and Amerigroup Iowa are against the bill.

"Although this legislation is well-intended, almost everything being proposed is already covered by existing federal and state laws or regulations. Additional legislation could create a confusing overlap of these regulations," Wellmark said in a statement. "As examples, the Affordable Care Act already regulates the processes for developing step therapy protocols and the state laws in Iowa provide members with rights to challenge denials of coverage for prescription drugs.

"In addition, Wellmark already administers its step therapy protocols to ensure that members are not forced to try and fail on drugs simply because they switched health plans."

The insurer added it has been involved in discussions with the bill's advocates to address concerns while ensuring that health plans can continue to administer appropriate, scientifically based step therapy programs.

"In terms of step therapy, these protocols are understandable to have set for the usual patient," said Dr. Michael Brooks, a rheumatologist at the Physicians' Clinic of Iowa who also went to Des Moines this past week. "But there is enough in the way of unusual patients or patients with conditions that make it difficult to follow a set pattern, that we are unable to provide the best care."

Brooks has one patient whom he has been working with for more than a year to find medications to properly mitigate arthritis symptoms. But then the patient switched insurance companies and the insurer had a different set of preferred medications, so the patient wasn't allowed to stay on the drugs.

Brooks has the medical records and the often yearslong history with patients. It's important that insurers allow for exemptions so that health care professionals can properly care for their patients, he said - especially when being taken off a working medication could harm a patient or stop progress, such as in the case of patients who suffer from seizures or a mental illness.

Brooks said physicians understand drug costs are high and insurers are trying to contain them. But the system needs to be altered, he said.

"We need the ability to, in an expedited way, get answers within a reasonable amount of time," he said.