HEALTH CAN'T WAIT

By: Nick Deleeuw for the Michigan State Medical Society

I. Introduction

The little things matter, but Chester’s impact is bigger than one might think. The Chesapeake Bay retriever is a good sized canine, with a bigger heart, and he’s an animal Julia Burk counts on in and around her northern Michigan home.

Julia – Jodi to friends – suffers from rheumatoid arthritis (RA), a debilitating autoimmune disease that causes an individual’s immune system to attack its own tissue. Typically, RA affects a patient’s joints. It’s been eating away at Jodi’s for years. She’s had her thumb fused, her wrist replaced, and endured three separate fusions in her neck as a result of the disease. Jodi, who makes her home in Bellaire, a small town north east of Traverse City, counts on her husband for love and support, her friends for prayer and understanding, and on Chester to keep her moving and active – from simple walks to snowshoeing during northern Michigan’s long winters.

That began to change a year ago when her condition progressed, and the medicine she’d been taking became ineffective. Her energy level dropped, her pain increased, and she became symptomatic in new parts of her body. It became too painful even to take Chester for a walk.

“That may not sound like a big deal to everyone else, but it’s a big deal to me,” said Jodi.

She’s a responsible patient invested in her own care, so she scheduled an appointment with her physician. She sat for an exam and all of the appropriate tests, and developed a new plan of care designed to keep her on her feet—and holding Chester’s leash. Medical science hasn’t found a cure for RA just yet, but it’s developed many effective treatments for patients with different physiologies, severity of symptoms, and disease progression.

Jodi’s physician prescribed a new medicine that would better treat her symptoms, and get her back on her feet. She had new hope—but then everything came screeching to a halt.

Her physician contacted the insurance company to ensure they’d cover the medicine she needed and determine if an approval was required— a process insurers call “prior authorization.” The physician documented her patient’s condition, her previous experiences and medications, and explained why she was requesting a new prescription.

A bureaucratic approval process that for many patients unnecessarily takes days or weeks has turned into a bureaucratic nightmare that has already kept Jodi Burk from effective treatment for more than a year.

Her insurer, OptumRx, declined to cover the medicine Jodi needed until she’d failed first to respond to a variety of other drugs—some of them even newer and more expensive—with more prominent places on the insurer’s formulary.

 

II. Prior Authorization and Step Therapy

Insurers claim that prior authorization requirements, including “fail first,” or “step therapy,” are designed to ensure patient safety and lower health care costs, but patients and physicians across the state are highlighting the urgent need for a patient-centered approach in health care that puts the needs of men and women like Jodi above bigger profits for insurers.

Betty Chu, MD, MBA, is a practicing OB-GYN and the Chief Medical Officer and Vice President of Medical Affairs at Henry Ford West Bloomfield Hospital.

“Physicians’ oath to "first do no harm" implies that we will act to assist our patients in whatever way possible, as quickly as possible,” said Doctor Chu, who also serves as the president of the Michigan State Medical Society. “Delays in care, once a decision has been made, lead to a diminishment of the doctor-patient relationship as patients learn ‘someone else’ they’ve never met is involved in the medical decision-making process.

“Doctors have a desire to help relieve our patients’ suffering as quickly as possible. The absence of a diagnosis via imaging, or the inability to receive a needed drug, interferes with the treatment plan and the physician's ability to heal.”

That third-party bureaucracy, physicians contend (and independent researchers agree), dramatically increases health care spending while allowing some of the state’s sickest patients’ underlying conditions to worsen, sometimes significantly. The more expensive (and, often more effective) the medicine or treatment, the more likely the insurer will require prior authorization. However, many less expensive treatments also get caught in the web of red tape because of insurers’ relationships with pharmacy benefit managers and the rebates or usage deals they cut to move one medicine or another up or down a formulary. The delays can cause patients’ underlying conditions to worsen, or new symptoms to arise.

A prior authorization demand sets physicians and their staffs off on a time-consuming and expensive quest as they navigate requirements that differ from insurer to insurer, and from product and plan to product and plan. Providers check formularies, move through step therapies, find the right forms, chronicle the patient’s medical history for insurance company bureaucrats, print and fill out paperwork, send faxes—sometimes only to learn that the authorization was denied, or that patients will have to try and fail to see improved health under less effective treatments for months or even years.

As maddening as the process is for Michigan physicians, it can be devastating for their patients.

Jodi Burk’s time trial still isn’t over. Before authorizing the medicine she needs, OptumRx has demanded that she try for two months each—and fail to experience improved health while taking—a long list of other prescriptions first. She’s one year and seven prescriptions into the bureaucratic swamp, and her health has continued to deteriorate.

“I am worthless as far as energy level,” said Jodi. “I hurt. I can’t sleep. I have gained thirty or forty pounds since this all started. This trial and error B.S. —it’s affected our whole household.

“The longer I stay on a drug that doesn’t work, the ramifications of that…I’m spending dollars on a different medication or a medical procedure. They’re not saving anything by doing this. Not at all.”

To the contrary. Burk’s health recently took a sharp turn for the worse, as symptoms moved to her lungs. While her disease most often affects the joints, in extreme progressions, it attacks internal organs as well.

“If that is what’s happened to my lungs, and I can attribute it to the last couple years, now all the problems I have with my lungs are on the back of (my insurance company).”

 

III. The Patient Crisis

Dozens of studies have been conducted over the last decade, examining the impact prior authorization has on patient outcomes. Each of them exposes a different level of patient devastation.

PharmExec.com examined a number of the studies and found that when a prior authorization requirement is placed between a patient and the medicine his or her physician prescribes, less than 30 percent of those patients end up with original prescription.[1]

In other words, more than 70 percent of patients whose prescriptions are tied up in bureaucratic red tape never get the medicine their doctor believes they need.

Staggeringly, 40 percent of these patients abandon their therapy.[2] Whether it’s because of ineffective alternative medicines pushed by insurers, worsening symptoms and other health outcomes, frustration with a broken system, lack of trust in the middlemen pulling the strings or a multitude of other reasons, four in 10 patients that experience prior authorization bureaucracy simply give up and walk away from treatment.

According to a host of studies, that’s when the problems really begin. Researchers have repeatedly identified an “economic backlash” created by prior authorization requirements that extends far beyond the estimated $31 billion in compliance costs borne by the nation’s physician community.[3]

Perhaps the most widely cited study, published in the Annals of Internal Medicine, pegged the cost of nonadherence to prescription medicines to the nation’s health care system at up to $289 billion each year.[4] More costly is the human toll. The study’s authors estimate nonadherence contributes to the deaths of 125,000 Americans each year.

Prior authorization and step therapy requirements are an unmistakable part of that deadly equation.  78 percent of physicians trace prescription and treatment non-adherence to prior authorization delays.[5]

They’re numbers that take physicians’ breath away—but they may be only the tip of the iceberg. A more recent study published in the Annals of Pharmacotherapy[6] pegged the costs of nonadherence in an entirely different stratosphere.

Researchers estimated the cost of prescription drug-related morbidity and mortality resulting from nonadherence and other medical therapy failures annually comes in as high as $672.7 billion, and at the cost of 275,689 lives.

“Prior authorization is potentially a deadly scenario,” said Mary Jo K. Voelpel, DO, FACOI, FACNM, a practicing hematologist and oncologist, and Associate Clinical Professor at Michigan State University’s College of Osteopathic Medicine.

Late last year, Doctor Voelpel witnessed PA’s devastating effects first hand, over the course of treating an elderly cancer patient who was failing conservative therapies.

“I requested an oral chemo that is known to be well tolerated in the elderly and creates transfusion independence and stability with good quality of life,” said Doctor Voelpel. “His insurance required prior authorization. We waited for approval and continued supportive care. He became critically ill about six weeks after we had requested the drug, and was hospitalized and died three days later. The next day the drug arrived via mail.

“These stories are endless and the time required to complete forms and answer queries is endless. With this particular case we submitted the genetic documentation of the need three times. This entire process spanned over three months. It became a win-win for the insurance company because they did not have to pay for his untimely death. Is this the way we practice medicine?”

Patient risk is an unmistakable and sometimes debilitating—or even deadly—“side effect” of insurance company prior authorization practices.

A recent survey released by the Michigan State Medical Society asked physicians across the state what kind of an impact PA bureaucracy had on their patients. Nearly three-in-four reported that PA delayed treatment for their typical patients by at least a day, but with an important and dangerous outlier.  Nearly 38 percent said they wait three days or longer to get even basic approvals for the medicines, tests, or treatments their patients need.[7]

So it isn’t surprising that another study found 92 percent of physicians claim that PA requirements had a negative impact on their patients’ health and wellbeing.[8]

Elizabeth Coffey is a 62 year old from Indian River battling a variety of health conditions. Her physician, Irene Kazmers, MD, identified an effective treatment that helped Coffey reclaim her life, but her insurer refuses to cover it. Instead, they are requiring her to take another drug with numerous serious side effects.

“Her insurer is requiring she be switched to an immunosuppressive drug that will increase her risk for infections and potentially fatal diseases like pneumonia,” said Doctor Kazmers, a Northern Michigan rheumatologist and member of the Michigan State Medical Society Liaison Committee with Third Party Payers. “She has no side effects from the safer medicine I’ve prescribed. As her doctor, I do not want her on a more risky, more dangerous drug, when this much-safer drug has been proven to do a fantastic job of completely controlling all of her disease symptoms.”

According to Doctor Kazmers, Coffey’s coverage request is going through a lengthy appeal process and her insurer has provided no indication how long they might take to make a decision.

“It would be medically wrong to switch her to the more dangerous drug for no good reason,” said Doctor Kazmers.

Coffey is equally matter of fact. “It makes me very angry and confused,” she said. “I don’t understand why they would want you to take something that may increase other costs (because of regular testing and additional treatment to address side effects). Before I had this medicine, I couldn’t do anything. I ached constantly. Within six weeks of starting the medicine Doctor Kazmers prescribed, the ache went away. I’ve even quit taking nighttime Tylenol—haven’t taken it for more than a year.”

Without approval from her insurer, Coffey relies on her physician’s supply of drug samples to provide the treatment she needs.

“I have to call the office to see if there are any samples available, then drive 40 minutes each way to pick them up,” said Coffey.

That’s hardly a sustainable approach.

What’s more, many of these sorts of delays are ultimately meaningless—even for insurers.

97.5 percent of all first-time prior authorization requests are eventually approved, according to the American Medical Association. In other words, insurers are delaying patients’ access to care for essentially no reason.[9]

Kevin O’Neill is the Vice President of Revenue Cycle at Henry Ford Health System (HFHS). His team helps connect the dots between area patients and the medicines and treatments prescribed by their physicians.

“Payers continue to increase prior authorization requirements, even for services that are approved for authorization over 95 percent of the time,” said O’Neill. “HFHS (alone) obtained over 200,000 payer prior authorizations for scheduled services in 2018, not including inpatient services where patients were admitted through the emergency department. This volume represents an increase of over 35 percent from 2016.”

According to O’Neill, after an initial request, payers can take up to 14 days to provide authorization.

“Delaying care can have significant negative impacts for a patient including both clinical and non-clinical and emotional issues,” he said.

 

IV. Health Can’t Wait

It’s no surprise then, that patients are demanding a fix. They’re clamoring for someone on the payer side of the equation to listen to them—to see them as a person, not a line item on a budget sheet.

“I would explain to my insurer—if they would listen—what my family has gone through and what I’ve gone through,” said Burk, the northern Michigan patient struggling to access the treatment she needs for rheumatoid arthritis. “Pain. Sleeplessness. No energy to participate. I would make plans with friends then have to cancel because I couldn’t do it. I want them to understand the mental anguish of being in pain all the time.

“Until someone has pain like this, and they can’t get away from it, you don’t understand. I was on a medicine for 10 years and it worked wonderfully. All of a sudden, (my insurer) says they aren’t covering it anymore. That’s a pretty nasty thing.”

That’s why providers and advocacy groups across Michigan have come together this spring to launch an unprecedented coalition push for meaningful change. Payers haven’t listened, so they’re taking their case to state policymakers.

Groups like the Michigan State Medical Society, Michigan Academy of Family Physicians, Michigan Radiological Society, Michigan Rheumatism Society, Michigan Society of Hematology & Oncology, Michigan Physical Therapy Association and many others, including patient advocacy groups, are on the ground at the state Capitol unveiling to lawmakers a reform push called Health Can’t Wait.

Physicians and other health care providers within each organization are advocating in Lansing on behalf of patients for a number of common sense reforms.

They’re demanding PA and step therapy requirements be remodeled to ensure clinical validity, reinserting the patient’s wellbeing into a process from which payers never should have excluded it. They’re also pushing for reforms to ensure continuity of care, transparency and fairness, timely access and administrative efficiencies to cut the wait times and diminish rampant prescription drug nonadherence, and for the creation of alternatives and exemptions for the patients who need them most.

“Eliminate prior authorization for physician and provider networks to reinforce quality of care,” said Doctor Chu. “Insurers are also going to need to improve feedback to providers regarding the rationale for claims denials in real time. Insurers need to adopt a 24/7 methodology to review prior authorization. Our health care facilities and patients are seeking answers quickly, and they’re not always doing it between nine and five.”

Elizabeth Coffey’s message to insurers is simple. “How dare you. This is my life and my body. My physician prescribed a drug that works. How dare you tell me I can’t take this when it’s safer than the one you’re trying to push on me. Who are you? You’re not a doctor.”

Michigan’s physicians and patient advocates believe Coffey’s is a message whose time has come.

 


[1] http://www.pharmexec.com/tackling-prior-authorization-challenge-critical-task-pharma

[2] http://www.pharmexec.com/tackling-prior-authorization-challenge-critical-task-pharma

[3] http://www.hii.iu.edu/the-prior-authorization-burden-in-healthcare/

[4] https://www.nytimes.com/2017/04/17/well/the-cost-of-not-taking-your-medicine.html

[5] https://healthpayerintelligence.com/news/prior-authorization-issues-contribute-to-92-of-care-delays

[6] https://www.pharmacytimes.com/contributor/timothy-aungst-pharmd/2018/06/does-nonadherence-really-cost-the-health-care-system-300-billion-annually

[7] MSMS 2017 SURVEY

[8] https://www.ama-assn.org/press-center/press-releases/survey-patient-clinical-outcomes-shortchanged-prior-authorization

[9] https://www.ama-assn.org/practice-management/sustainability/how-prior-authorization-hobbles-breast-cancer-care