In most of the United States, health insurance companies – not doctors – decide what pain medications should be prescribed to chronic pain sufferers. It’s a common practice that insurers use to control costs, but it leaves many patients in pain – forced to take drugs that are too often ineffective.
However, if legislation in three populous states — California, New York and New Jersey – gets the go-ahead, nearly half of America’s population of 314 million people will be protected against the common practice of “step therapy” medication.
Step therapy, also known as “fail first protocol,” is the requirement of many health insurers that the lowest cost medications be tried first by those suffering from chronic pain.
The cheapest drugs must ‘fail first’ before doctors can prescribe more costly medications. This continues — ‘stepping up’ one drug at a time based on cost — until a workable prescription is found.
Bills under review in all three states seek to give patients and physicians more clout in their preferred choice of medicine for sufferers.
Besides interfering with the doctor-patient relationship, critics say step therapy results in a lengthy and painful process, typically 30 days for each medication, before an effective prescription is found.
The system is said to save insurers 3 percent on prescription costs, a figure opponents argue is far offset by more frequent emergency room visits.
States Put Limits on Step Therapy
Thirteen states already have variations of step therapy legislation in place, including Texas, Florida and Illinois. In Louisiana, a step therapy bill was signed by Republican Gov. Bobby Jindal, who opted away from Harvard Medical School for a master’s degree in political science at Oxford, writing his thesis on needs-based health care.
Legislation stalled last year in California, home to nearly one out of every eight U.S.residents. But AB 369, authored by Assemblyman Jared Huffman (D-San Rafael), recently passed with a bi-partisan 60-15 vote in the Assembly.
The California bill represents a compromise. If signed by Democratic Gov. Jerry Brown, it will limit step trials to two. If both drugs fail, the doctor can then move to the medicine he or she thinks will best help the patient. AB 369 also prohibits insurers from requiring patients to try and fail first with non-FDA approved drugs.
The bill is sponsored by For Grace, a non-profit organization created 10 years ago by Cynthia Toussaint, who was injured during a ballet class in 1982. Toussaint subsequently developed Complex Regional Pain Syndrome (CRPS), a progressive condition often wryly referred to as the “Suicide Disease.”
She describes the main symptom of CRPS as “burning excruciating pain that feels as though I’ve been doused with gasoline and lit on fire.”
Toussaint longs for the day when there are “no steps” to getting the necessary medication for conditions like hers. “As a patient, I can tell almost immediately if a drug is going to be effective or not,” she said.
Insurers’ Fail First Policies Called Cruel
On the East Coast, New Yorkers are being encouraged to sign a petition in support of Assembly Bill 9397/Senate Bill 6464 by Assembly Member Matt Titone (D-Staten Island) and State Sen. Catharine Young (R-Olean).
“The effects of fail first are not just ridiculous – they are often cruel,” Titone said, recalling a time when ‘fail first’ was required by some insurers for women requesting birth control prescriptions.
“I have heard far too many stories from people who have been tortured – and I do not use that word lightly – by unnecessary and unwanted treatments.”
Provisions in the New York bill would permit a doctor to override an insurer’s step therapy requirements. The online petition was developed by Kathleen A. Arntsen, president and CEO of the Lupus Foundation of Mid and Northern New York, in part to provide legislators with more specific examples of suffering made worse by existing step therapy protocols.
Among the 500 signatures obtained at the recent New York State Fair in Syracuse, where the petition was launched, were many comments from Lupus sufferers. A Staten Island resident described amassing $28,000 in medical bills over two years “in large part due to my insurance not covering medications and new treatment and therapies.” She wrote that her long-time insurer wanted her to continue with a 50-year-old protocol which gave no relief.
Arntsen, who suffers from eight autoimmune diseases, takes 31 medications daily at a cost of $4,000 per month. Rather than eliminate step therapy, her goal is to make it “less-complicated, but with a clear and concise override process to give physicians back their power to prescribe the most appropriate treatment.”
In 1998, her insurance company required her to switch from a brand anti-malarial to a generic anti-malarial, resulting in “years of instability.” She is now on the original brand drug, Prednisone, and an off-label transplant drug.
Next door in New Jersey, Assembly Bill 3968 was authored by Assemblyman Herb Conway Jr., M.D. (D-Burlington, Camden), who is also an internal medicine specialist.
Its provisions require that no more than two pain medications be tried before the insurer be required to pay for the doctor-preferred meds, and that the duration of the two trials can be determined by the patient’s physician.
Testifying in June before the New Jersey Assembly’s Health and Senior Services Committee, chaired by Conway, was Alexey Salamkha, national program manager for the non-profit Global Health Living Foundation (GHLF).
Salamkha explained that the majority of GHLF’s 50,000 members suffer from arthritis, a condition he cited as “a frequent target of step therapy practices by insurance companies.”
He decries the irony of living in a time when treatment protocols are now available to stop the progression of such irreversible diseases as rheumatoid arthritis.
“Only after the disease has progressed – with no way to reverse permanent joint damage – will insurers agree to dual biologic therapy,” which he said nearly three-fourths of rheumatoid arthritis patients need.
“Disease progression equals disability. Inability to function within the family and community, and inability to work,” said Salamkha.
Elsewhere, Fail First Hurts has categorized step therapy bills as “stalled” in Missouri, North Carolina, Nebraska, Oregon and Washington, and “dead” in Idaho, Maine, New Mexico and Utah.
In the remaining 25 states, GHLF reports that fail first legislation has never been introduced.
A state-by-state overview of step therapy legislation can be found here.
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