Controversy on Medication Coverage – “step therapy” (also known as “fail first”)

Insurance Industry Opposes Physician’s Choice of Medication for Pain Relief

The best or just the cheapest?

Before I define “step therapy,” let me introduce Forgrace.org, a nonprofit organization “Dedicated to Ensuring the Ethical and Equal Treatment of All Women in Pain.”   Based in Los Angeles, the organization was formed in 2002 by John Garrett, Executive Director, and his partner Cynthia Toussaint, an accomplished ballerina who has suffered with CRPS (and later fibromyalgia) for 26 years. Thanks to their leadership advocating for health care reform in California, today they announce that

For Grace and HAAF’s bill, AB 1144, was heard by the California Assembly Health Committee in Sacramento yesterday (April 21) and it passed overwhelmingly with a vote of 14-2.  There was strong opposition from the health insurance industry – and this effort will be an uphill climb as we move the bill along to the Senate.

Also, today, ABC News national covered the issue of “step-therapy” (also known as “fail first”) along with our bill, that if signed by Gov. Schwarzenegger, will abolish this unethical prescription practice that negatively impacts women in pain.  Ms. Toussaint pitched this story, consulted and interviewed for it.

Because of its importance to every single one of my patients whose lives hang by the constant threat of an indifferent refusal by insurance carriers to continue providing medication that they require, I am posting almost the entire ABC News article titled “Patients Irate With Insurers’ ‘Fail First’ Policy“ by Dan Childs

What Is Step Therapy?

The basic idea behind step therapy is to start with the most cost-effective and safest treatment, progressing to more costly or risky therapy only if the current treatment is not effective. In theory, proponents say, the strategy both minimizes risks to the patient and keeps overall costs under control.

Robert Zirkelbach, spokesman for America’s Health Insurance Plans, said that when it comes to the bigger picture, step therapy is a key element in making the country’s health care system more efficient by creating a standard system of care from state to state. He said that this saves costs, and it also ensures that patients get access to therapies that have been proved to be medically effective.

“We see individuals with the exact same illnesses get drastically different treatment depending on where they live,” he said. “Right now there is no correlation between the money being spent and the health outcomes being advanced. Our goal is to help guide the patient.”

Dr. Forest Tennant, head of the Veract Intractable Pain Clinic and editor of the trade magazine Practical Pain Management, is also Cook’s doctor. He agreed that in theory, step therapy is not a bad strategy. And he added that doctors have traditionally employed a form of step therapy, in which they would gradually increase the dose of a given medication for a patient who was not responding until they were able to achieve the desired effect.

Doctors Employ Different ‘Step Therapy’

And even when it comes to designing a course of treatment, Tennant agreed that a cheaper approach is preferable, as long as it works for the patient.

“Given the cost of some of the medications I prescribe, I also want the patient to try the cheaper medication first.”

But he said that the step therapy used by the health insurance industry is different in that it may actually place a preferred therapy out of reach of a patient. Particularly vulnerable may be pain patients like Cook and Toussaint, who have experienced success with a given medication but are switched to a different drug by an insurer.

“What we have today is a situation where a patient is knocked around in the system, usually after they’ve already tried something that works for them but which they can’t have,” he said. “All of a sudden, the drug that they have been taking for quite some time is pulled away from them — because it is more expensive, usually.

The Best — or Just the Cheapest?

According to data collected in 2006 by the health care analytics company Verispan, the drugs for which step therapy is most commonly used are anti-ulcer medications, with 58 percent of health insurance plans using step therapy for this class. The data also reveal that antidepressants are the fourth most common drugs subject to step therapy, with 45 percent of plans subjecting these to step therapy. Twenty-six percent of plans use step therapy for pain drugs, according to Verispan, and other drugs including heart medications and antipsychotics are also on the list.

Zirkelbach argued that in most cases, patients are allowed to switch drugs if the recommended option is not working for them, and if the drug that the patient is switching to is supported by medical evidence.

“If there is a good medical reason to switch to drug A versus drug B, health plans typically allow that to happen,” he said.

But he noted that how long a patient is required to stay on a given medication before making a switch varies from case to case. Doctors who prescribe a drug that is unapproved by the insurance company risk receiving what Tennant calls a “tantrum letter” from insurance companies.

“The insurance companies hire auditing firms, and they demand to know why I prescribe [patients] certain drugs,” he said.

The net effect, Tennant said, is a grave imposition on the doctor-patient relationship.

“I have to say [to patients], ‘I can’t tell you what you should take. I can only get you to get what your insurance can pay for, and I’ll design a regimen,'” he said. “For the expensive medicine, the doctor no longer chooses what he wants.”

And according to a Thomson Reuters study published in the February issue of The American Journal of Managed Care, step therapy may actually be more expensive for insurance companies, at least when it comes to patients receiving medication for high blood pressure.

Step Therapy May Not Be Cheaper

In the study, which was sponsored by Pfizer, researchers looked at insurance claims for 11,851 people with employer-sponsored health coverage that incorporated a step therapy protocol for high blood pressure drugs. These patients’ claims were compared with those of 30,882 patients on similar medication who did not participate in a step therapy program.

What the researchers found was that the group of patients treated for hypertension under the step therapy program had 3.1 percent lower drug costs. But these savings appear to have been wiped out by the apparent increase in hospital admissions and emergency room visits. Over two years, the step therapy patients incurred $99 more in healthcare costs per quarter, on average, than the control group.

Hope for Step Therapy?

If indeed California passes anti-step therapy legislation, it would not be the first to do so. New Jersey already prohibits such plans. And even the Centers for Medicare and Medicaid Services may be considering regulations to limit step therapy by health plans available to Medicare patients.

But Robert Taketomo, president and CEO of the Glendale, Calif.-based managed care contracting services organization Ventegra, warned that if such legislation passed in the state, patients may find that other parts of their coverage will be cut back to compensate.

“As long as healthcare is a benefit, and not a right, then measures such as step therapy are important means of preserving pharmacy benefits,” he said. “If step therapy were to be prohibited through legislative means, there are other means through which a payor — whether they be government, health insurer or employer — could limit their cost exposure in pharmacy.

“These could include removal from formulary, increases in copayment, addition of deductibles (and increasing them), or ‘carving out’ pharmacy altogether and just cover medical expenses.”

Tennant said he believes the true solution to the problem does not lie with new laws.

“There has to be some goodwill meeting of the minds for the people who practice medicine, those who need the help, and the people who are paying for it,” he said. “Most of the [insurance companies] are trying to develop formularies comprehensive enough to get the job done without compromising patient care too much.”

But Cook said that as long as her insurance adheres to a step therapy policy, she and other pain patients will worry about her medication one day becoming unaffordable.

“We all know that our lives could change at a moment’s notice if the insurance companies say, ‘Change,'” she said.

To view some of Ms. Toussaint’s presentation to the media, including her “fail first” experiences… on the second page of their “Videos” go here.

Her focus has now shifted to bringing a single-payer, universal health care plan to all in California which will provide a model for the rest of the country.

For My Home Page, click here:  Welcome to my Weblog on Pain Management!