At almost every turn, insurance payers, based on seemingly ignorant and unethical justifications, continue to undermine the quality of psychiatric care.
FROM THE EDITOR
I often think back with fondness about clinical psychiatric practice in the early 1990s, a time when I could meet with patients for an hour weekly when indicated, and prescribing was as simple as choosing the medication I felt was most appropriate for the patient sitting in front of me. I feel sad for psychiatrists who completed their residencies after the year 2000 and have only known the burdensome bureaucratic protocols that currently dictate our options for the treatment of our patients.
There are many old dirt roads I could drive you down related to this topic, but I will limit this editorial to 3:
1. The Medicare “drug formulary”
2. The loss of medication coverage when our patient changes health plans
3. The imposition of step therapy requirements by insurance companies
In clinical medicine, case reports have always provided the best vehicle for teaching, so I will share my experiences with patients over the past 5 years to exemplify these policies. These experiences are only examples of larger problems and trends, which regrettably contribute to physician burnout. The medication-related elements of these cases are factual; however, I have changed patient characteristics to ensure privacy.
Decision Does Not Concern the Medical Necessity...
“Tom” is a 65-year-old divorced man who had an onset of obsessive-compulsive disorder (OCD) and major depressive disorder (MDD) in his childhood years. I began treating him over 20 years ago, and after numerous and aggressive psychopharmacological trials he achieved significant symptom improvement in 2005 on sertraline 200 mg daily and ziprasidone 240 mg daily. Because of a medical comorbidity, he was eventually approved for disability.
At age 62, his health plan changed to Medicare, including Medicare Part D. Although Tom remained psychiatrically stable for 12 years on the combination of sertraline and ziprasidone, his first refill of the ziprasidone following the institution of Medicare coverage was denied because it was not FDA approved for OCD or MDD. I was quite familiar with this occurrence and I did my due diligence by filling out a prior authorization form. It was denied. I appealed the denial, which was also denied. I appealed the second denial, this time advancing my now 13-page expedited appeal to Maximus Federal Services in Pittsford, New York. I explained in great detail Tom’s lifelong history of OCD and MDD, the numerous failed medication trials, and the significant pain and suffering Tom lived with until the sertraline/ziprasidone combination provided symptom relief 12 years prior. Up to this point in my psychiatric career, I had never failed in my numerous prior authorization applications.
To my astonishment, the reply from Maximus Federal Services was:
“Geodon (ziprasidone) is requested for ongoing treatment of major depression and obsessive-compulsive symptoms, which are off- label (non-FDA approved) uses. You stated that the enrollee has been stabilized on this regimen and that discontinuation of treatment will result in a relapse of the noted conditions.
The Medicare-approved compendia do not contain any citations to support the use of the requested drug for treatment of the noted condition(s). Therefore, this drug is not being prescribed for a medically accepted indication as defined by Medicare law. Consequently, the noted drug is not eligible for coverage under Medicare Part D.”
Further, in their Explanation of Decision, they concluded:
“Our decision is the Plan is not required to cover Geodon. . . This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.”
I was befuddled! The next step of appeal they offered was an Administrative Law Judge Hearing at the Office of Medicare Hearings and Appeals. Tom’s elderly mother paid for the ziprasidone refills.
Subsequent to this frustrating precedent, I have had several denials of coverage of medications from Medicare, involving stable patients who were doing quite well on a chronic medication regimen but then, because they aged into their Medicare benefits, they lost coverage for their chronic but stable medication because it was not FDA approved for the prescribed diagnosis.
Patient Changed Health Plan, Chronic Coverage Denied
“Steve” is a 29-year-old single man who received a diagnosis of schizophrenia 7 years prior, at which time he was floridly psychotic with constant auditory hallucinations and paranoid delusions. After no symptom improvement over the next year with aggressive treatment with 4 different antipsychotic medications, he was hospitalized and treated with clozapine. Upon discharge, I gradually increased the clozapine dose, because of a lack of response, to his final maintenance dose of 800 mg by mouth at bedtime (with a 12-hour post dose serum clozapine level = 500 ng/mL). Over the following year, he significantly improved and has remained stable for the past 5 years, fully adherent with treatment. Although he continues with minimal daily auditory hallucinations, he understands them as a symptom of his schizophrenia, and he has learned to push them into the background and ignore them. Significantly, he has maintained the same full-time job for the past 4 years and lives independently with full functionality.
Early during the course of increased titration of the clozapine, Steve experienced sedation as a significant side effect. Ultimately, we began a trial of modafinil 200 mg by mouth twice a day, which significantly improved his daytime sedation and has allowed him to maintain full time employment. However, my first prescription for the modafinil was denied by his private health care plan because Steve did not have a diagnosis for the FDA-approved indications for modafinil of obstructive sleep apnea, narcolepsy, or shift work sleep disorder.
After my prior authorization was denied, I called the health care plan and requested a direct review with their pharmacist, which occurred 10 minutes later. The pharmacist agreed with my treatment plan of using the modafinil to manage the sedation from the clozapine. It was smooth sailing for the next 5 years; I simply filled out a 1-page prior authorization annually, which was always approved.
Two months ago, Steve’s employer changed to a new health care plan, and the modafinil refill was denied coverage because of its off-label use. I have filled out 2 prior authorizations so far, and both have been denied. I requested a peer-to-peer review, but the plan denied this, stating they required a detailed written prior authorization request after the 2 initial denials before my appeal could be elevated to a peer-to-peer review. I am awaiting the plan’s response to my written appeal, and Steve is paying full price for the modafinil.
Step 1, 2, 3 . . . Then Maybe We Will Approve That Drug
“Susan” is a 34-year-old married mother of 2, who has struggled with recurrent episodes of unipolar major depression beginning in her early 20s. She initially responded to psychotherapy and healthy lifestyle changes, but by her mid-20s her depression had worsened, and we initiated antidepressant medication with good effect. Despite medication compliance over time, her depressive episodes recurred and she was treated with courses of 4 different antidepressants from different classes over a 2-year period with only partial response.
After discussing treatment options, and for many clinical reasons, Susan and I agreed to augment her fluoxetine with brexpiprazole 1 mg orally every day. I provided her samples for the first month, and she had a good response. When she went to fill her first prescription at her pharmacy, it was denied coverage. Susan’s insurance company would only cover the brexpiprazole after documentation that she had failed trials of 2 other medications, which they listed as their required policy of so-called step therapy.
I could have lied, continuing to provide brexpiprazole samples, while telling Susan’s insurance company she was failing trials of the 2 required step therapy treatments, and eventually meet this insurance company’s step treatment failure. They would then allow coverage of the drug to which she responded. However, this is contrary to good medical practice, ethical behavior, and my general philosophy on life. Additionally, it would leave erroneous documentation in Susan’s medical record stating she failed trials of 2 step medications she never was really prescribed. I called the insurance company’s appeals department, was graciously transferred to one of the plan’s reviewing pharmacists, explained my clinical treatment plan, and the brexpiprazole was approved—a rare happy ending, albeit at the cost of lots of my time.
As I move toward the sunset of my career in clinical psychiatry, it saddens me to see how insurance companies—private, state, federal, Medicare, Medicaid, employer funded—have consistently obstructed physicians’ decision-making and treatment planning at every opportunity. It is exhausting, and it certainly contributes to physician burnout. Additionally, there is clear socioeconomic discrimination, as these policies are less expensive. Federal- and state-funded plans impose larger barriers to the treatment plans that the physician has determined to be best for their patient.
One of my primary frustrations with this process is exemplified by Tom and Steve’s stories: If we limit our prescribing to FDA-approved indications for medications, we will be in conflict with our oath to “do no harm” to our patients. The DSM diagnoses used for clinical trials’ inclusion criteria to demonstrate efficacy for FDA approval are actually mythological constructs in constant flux—although they do serve a useful purpose in creating a common language and approach to treating psychiatric disorders. An important paper highlighting this reality concluded that “only 11.8% of DSM-IV-TR diagnoses have an FDA-approved drug.”1 When DSM-5 was published in 2013, this percentage likely further decreased.
Ultimately, as experts in the field of psychiatry, we are being strong-armed by bureaucracies that use fictitious justifications to deny the implementation of our well-thought-through treatment plans for our patients. I have discussed this issue in detail in a previous editorial.2 Additionally, a good clinician is skilled at identifying patterns of symptoms that consistently improve when using an FDA-approved medication for an unrelated diagnosis. The perverse obstructionism of insurance payers, based on ignorant and unethical justifications, further serves to undermine the quality of care that we attempt to provide to our patients.
With regards to Susan’s story of mandated step therapy by her insurer, although I was ultimately able to bypass the 2 required step medications, that process took a significant amount of time. In the United States, the intrusion of mandated step therapies has created quite a hardship for physicians in all specialties. A recent article nicely explored the current status of this insurance practice, and how slowly states are passing laws that attempt to push back on this intrusion.3
Every day, medical literature articles appear documenting the contribution of the COVID-19 pandemic to physician burnout. Although this phenomenon is significant and pervasive, it is only one of many daily stressors contributing to physician burnout and the increasing incidence of retiring early from medical practice. I have reviewed 3 prescribing obstructions imposed intentionally by insurance payers that contribute to my own burnout; this has become more significant with each passing year. The difference is that COVID-19 is not willfully and consciously adding to my burnout, whereas the insurance companies are.
1. Devulapalli KK, Nasrallah HA. An analysis of the high psychotropic off-label use in psychiatric disorders: the majority of psychiatric diagnoses have no approved drugs. Asian J Psychiatr. 2009;2(1):29-36.
2. Miller JJ. “Off label” does not mean “off limits.” Psychiatric Times. 2019;36(10):5.
3. Krisberg K. Step therapy: Inside the fight against insurance companies and ‘fail first’ medicine. Medscape. Mar 26, 2021. https://www.medscape.com/viewarticle/948220 ❒