Opinion: Insurance Companies Use Medically and Fiscally Irresponsible Formularies

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Receipt of an unsolicited communication that a sweepstakes award has been won may con some people (especially, but not limited to, those underprivileged or undereducated as to legalities), but can’t fool all of the people all of the time. The names of the organizations and products involved are often marketing tool inventions, which imply special personal benefit, but neither actually warrantee nor subsequently provide delivery of the product that their advertisements suggest.

Offerings with the suffix “for you” or “for life,” perhaps, should be suspect, especially when incorporated into the name of an insurance company’s medical insurance product. Less obvious are insurance products that call themselves by the same acronym as that utilized by a university in the region. One might perceive this as an attempt to suggest a relationship with that university and, thus, achieve additional insurance company credibility. When quality issues are subsequently raised (e.g., insurance company patient care directions), that university appears to quickly distance itself.

Practicing Medicine without a License?

Examination of insurance company utilization of formularies provides clear guidance as to whom they are committed. Off-label prescriptions are often denied reimbursement, unless the insurance company demands such use, the latter often in lieu of an alternative medication that is FDA approved for that indication. Insurance companies claim their formularies have been designed by physicians and pharmacists, but refuse to identify those individuals and provide no documentation of such derivation or even scrutiny.

When the fallacies of their formularies and the significant patient hazard and actual damage they impose are documented, insurance companies (at least in this area [Pennsylvania]) refuse to even acknowledge the querying communication. They refuse to make their medical director available to discuss the issue (be educated) and refuse to identify who actually constructed their formulary. They remain mute, even when presented with evidence-based rebuttal of their formulary direction mandates and expressed concern regarding how their promotion of illogical and unsafe medications appears to constitute insurance company practice of medicine without a license.

Even if the insurance company considers its formulary a way to reduce its payouts, this approach is still fiscally irresponsible. It demands utilization of medications or modalities that are ineffective, create additional morbidity or are actually inaccessible to the patient.

The associated mortality related to some of the formulary directions perhaps could be considered cost savings, if one were to consider the insurance company decisions as that diabolical. Some formulary demands might superficially appear reasonable, until one actually examines them. Typical is a promotion of medications with the side effect of producing drowsiness. This is a dangerous method and actually does not induce restorative sleep.^1,2 It just reduces the patient’s cognitive abilities and increases their risk of falls and other injuries.

Appeals

Some insurance companies have an “appeals process” called “peer to peer.” Although one rarely does have the opportunity to discuss the issues with an actual peer (a physician in the same subspecialty), that “peer” typically indicates they don’t have the authority to deviate from the formulary and they and the insurance company refuse to provide access to those with the authority. Most communications involve the “peer” stating the party line, perhaps listening to an evidence-based rebuttal of the insurance company’s formulary directions, but then simply denying the request—saying it deviates from the required formulary. One intriguing example of this was when an insurance company “peer” recommended use of an antidepressant to treat arthritis—in a patient with ulcers—for whom the actual request was for celecoxib.

Mandating use of multiple medications ineffective for an indication simply increases expense, an apparently illogical approach—unless the insurance company plans to totally block access to the appropriate medication under any circumstance—with the hope that all involved will give up and the insurance company won’t have to pay for the patient’s treatment.

Some formulary problems derive from insurance company advisors’ lack of familiarity with the pertinent literature. Insurance companies typically deny access to medications that represent combinations. Refusal to allow more convenient forms of medications may superficially seem cost effective, but it makes medical care more complicated. An increase in the number of individual pills or medications a patient must take compromises compliance and increases the risk for erroneous consumption—with associated morbidity and associated increased expenses. Even if those risks and expenses did not outweigh the perceived cost savings, the insurance company refusals are based on the often untested assumption that the response to combination medications is equivalent to the sum of their components.

Case in Point

Arthrotec (the combination product containing misoprostol and diclofenac) exemplifies such irresponsible interference with patient care. It combines (actually coats) a non-steroidal anti-inflammatory drug with an agent (misoprostol) that greatly reduces the ulcer risk. Recall that 1–2% of individuals over age 51 (that age was the lower limit in the pertinent study) are hospitalized (not just acquire) for ulcers every year and that individuals with arthritis often require long-term use of such agents.^1,2 Twenty to forty percent of long-term users will be hospitalized.

The combination product’s efficacy in greatly reducing that risk has been clearly demonstrated.^3,4 The timing of the outer layer’s (misoprostol) dissolution allows it to prepare the stomach by increasing gastric blood flow, and buffering and reducing acid production at the precise time when the coated diclofenac (the anti-inflammatory component) is exposed. Use of misoprostol alone to prepare the stomach requires timed administration and requires significantly more of the misoprostol to be effective.⁵ So replacement of the combined product by its components requires the same diclofenac dose, but requires significantly more misoprostol—three ante-meal and one nightly misoprostol dose—to achieve the same reduction of ulcer risk.^3-5 Thus, replacement by its components not only significantly complicates the patient’s medication regimen (requiring five or six, rather than one or two pills and special attention to the timing of doses), it actually incurs greater expense. Misoprostol is the expensive component of the medication, and the cost of three or four misoprostol is greater than that of one or two of the combined product. Denying that product not only compromises compliance and patient safety, but actually incurs greater expense, thus making said denial fiscally irresponsible.

Medically & Fiscally Detrimental

When insurance companies were required to spend 93% of premiums on actual healthcare provision, one company then listed its advertising expenses as a healthcare provision cost. Although insurance company formularies possibly may not represent similar behavior, some certainly don’t seem adherent to the scientific and evidence-based approach that defines contemporary medical care and actually work to the detriment of all involved. So when a product is offered by such an insurance company as “for you,” the patient or “for life,” is that representation an oxymoron?

Bruce Rothschild, MD, is professor of medicine at Northeast Ohio Medical University and provides rheumatology services at the Indiana Regional Medical Center. He is a Fellow of the American College of Physicians, the ACR and the Society of Skeletal Radiology and was elected to the International Skeletal Society.

References

1. Roth AJ, McCall WV, Liguori A. Cognitive, psychomotor and polysomnographic effects of trazodone in primary insomniacs. J Sleep Res. 2011 Dec;20(4):552–558.
2. Rothschild BM. To sleep, perchance to dream: Restoration of normal sleep physiology versus sedation in management of sleep disorders and fibromyalgia. The Rheumatologist. 2015 Jun;9(6):67.
3. de Melo Gomes JA. The safety of Arthrotec in patients with rheumatoid arthritis or osteoarthritis: An assessment of the upper gastrointestinal tract by endoscopy. Scand J Rheumatol Suppl. 1992;96:23–31.
4. Goldstein JL, Larson LR, Yamashita BD. Prevention of nonsteroidal anti-inflammatory drug-induced gastropathy: Clinical and economic implications of a single-tablet formulation of diclofenac/misoprostol. Am J Manag Care. 1998 May;4(5):687–697.
5. Silverstein FE, Graham DY, Senior JR, et al. Misoprostol reduces serious gastrointestinal complications in patients with rheumatoid arthritis receiving nonsteroidal anti-inflammatory drugs. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 1995 Aug 15;123(4):241–249.