INTRODUCTION
American patients pay the highest prices for medications in the world (Bartlett & Steele, Reference Bartlett and Steele2004; OECD, 2005). As a result, most patients need insurance coverage to afford their prescribed medications. More than 80% of patients with cancer develop severe pain requiring opioid analgesics before death (Nerseyan & Slavin, Reference Nersesyan and Slavin2007; Levy & Samuel, Reference Levy and Samuel2005). Uncontrolled pain is one of the main fears for cancer patients and their families. Opioid analgesics are highly effective agents, but the choice of type, route, and dose needs to be highly personalized (Sarzi-Puttini et al., Reference Sarzi-Puttini, Vellucci and Zuccaro2012; Bruehl et al., Reference Bruehl, Apkarian and Ballantyne2013). In recent weeks, our outpatient supportive care center experienced an unprecedented number of events where an insurance company refused to pay and/or recommended changes in the opioid regimen for patients with pain due to metastatic cancer. The purpose of the present manuscript is to report on the series of events that resulted from these denials and provide some recommendations for managing such events.
1. The insurance agent contacted a patient, who had achieved good analgesic control with slow-release oxycodone 20 mg every 8 hours and immediate-release oxycodone 10 mg every 4 hours. His wife was told that he was taking “too much medication” and was directed to immediately contact their physician to switch to a fentanyl patch. Thereafter, his slow-release oxycodone was reduced to every 12 hours, and they contacted the supportive care center to change his opioid. Reassurance and counseling were undertaken, and they agreed to take the slow-release oxycodone 30 mg every 12 hours with immediate-release oxycodone, as this was apparently acceptable to the insurance company. However, in the meantime, the patient had already experienced several days of severe pain and emotional distress.
2. The insurer informed a patient who was receiving a 125-µg fentanyl patch every 72 hours and hydromorphone 8 mg every 4 hours as needed that she could not fill her opiate prescription prior to the last day. The denial remained in force for 12 more days, and she developed severe uncontrolled pain and opioid withdrawal secondary to running out of opiates. Furthermore, both the patient and family were concerned about statements made by the insurance company and their local pharmacist to the effect that she had been “taking too many painkillers.” The supportive care team provided intense psychoeducational intervention to address some of the cognitive and emotional issues raised. At this time, the denial was lifted, and she was again able to fill her opiate prescriptions.
3. An insurance company denied coverage for a patient on slow-release oxycodone 20 mg/day and informed her that she had to try slow-release morphine at a dose of 30 milligrams twice a day, which she found to be much less effective. Upon arrival at the supportive care center, she was in severe pain and was experiencing considerable emotional distress related to that pain. Due to the demonstrated failure of the morphine, the insurance company was now willing to cover slow-release oxycodone, but only with an extremely high copayment. At this point, opioid rotation was conducted to methadone due to its lower cost.
4. An insurance company limited the monthly prescription of 240 tablets for a patient with good pain control on immediate-release hydromorphone 4 mg every 4 hours around the clock with 2 mg every 2 hours as needed. Due to a “no-exceptions” rule with respect to the quantity limit, only 60 tablets were filled. The patient experienced emotional distress due to the possibility of running out of hydromorphone. The supportive care center nurses worked to obtain a preauthorization and won two appeals lasting 3–4 hours/day for three days, and a one-time exception was finally approved. His wife was able to switch insurance companies to prevent recurrence of the same setback.
5. An insurance company required a preauthorization for a patient on slow-release oxycodone 60 mg every 8 hours with immediate-release oxycodone 10–20 mg every 2 hours and informed the patient to “make due” with his available opiates. He had an old prescription for sustained-release oxycodone 10 mg at home and had to reduce his dose to 20 mg b.i.d. He experienced severe worsening of his pain over the next two days before preauthorization was approved.
DISCUSSION
Opioids are the mainstay of treatment for moderate to severe cancer pain and have been shown to decrease pain intensity, restore levels of function, and improve quality of life for adults with chronic pain (Portenoy & Lesage, Reference Portenoy and Lesage1999; Vallerand & Nowak, Reference Vallerand and Nowak2010). Uncontrolled pain, on the other hand, creates needless suffering and eventually increases healthcare costs (Stewart et al., Reference Stewart, Ricci and Chee2003; Berger et al., Reference Berger, Dukes and Oster2004; Craig & Strassels, Reference Craig and Strassels2010).
A wide variation in interpersonal response to opioids exists. Therefore, opioid treatment needs to be personalized. Different intrinsic and extrinsic patient factors—including physiologic organ function, presence of adverse effects, pharmacogenetics, and other potential drug interactions, as well as pharmacokinetics and pharmacodynamics—make it crucial to not change opioids without appropriate evaluation and follow-up. One of the most common reasons for denial of pain management services is a lack of knowledge of their clinical efficacy (Schatman, Reference Schatman2011). Furthermore, patients experience an emotional burden even with appropriately prescribed opioid regimens due to prevailing concerns about addiction, untoward side effects, tolerance, and scrutiny from regulatory bodies, payor sources, and even family members (Greenwald & Narcessian, Reference Greenwald and Narcessian1999; Ballantyne & Mao, Reference Ballantyne and Mao2013; Hampton, Reference Hampton2004; Loder et al., Reference Loder, Witkower and McAlary2003).
A personalized approach to opioid treatment can result in a wide variance in average monthly cost. Based on reports on long-acting opioids, average monthly equianalagesic cost ranges from $17 per month for a 15-mg daily dose of methadone to $1,031 per month for a 160-mg daily dose of sustained-release oxycodone (Consumer Reports, 2012). The average minimum wage in the United States is approximately $7.25 an hour (United States Department of Labor, 2013); if averaged over an 8-hour workday, this amounts to $1,334 a month. This striking disparity between average monthly income and average monthly cost for opioids would be a huge burden for patients without adequate insurance coverage. The area of residence also influences out-of-pocket prices, as patients in rural areas have been found to pay 5.4 to 7.5% more than patients in urban areas for analgesics. With regard to the four regions of the United States, patients in the South pay 27.8% more than those in the Northeast, and patients in the South and West also pay more (Craig & Strassels, Reference Craig and Strassels2010).
One of our most striking findings was that five of these events occurred in the same clinic and that this had been experienced less often in the past. This is indicative of a growing trend of refusal of coverage and shows that insurers are increasingly aggressively interfering with the medical care of these patients. In these cases the insurer was the major barrier and actively blocked patient access to opioids by delaying the refill (event 2), limiting the number of prescriptions (event 4), suggesting that they were taking too much (event 1), and even recommending changing the type of opioid (event 1). Another mechanism often used to delay necessary pain management is the requirement of preauthorization (events 4 and 5) (Schatman, Reference Schatman2011). In all our cases, this resulted in severe pain and/or emotional distress and generated great concern among patients and family members.
It is estimated that about 55% of Americans are covered by employer-based healthcare plans (USCB, 2008; DeNavas-Walt & Smith, Reference DeNavas-Walt and Smith2012). In 1974, Congress passed the Employee Retirement Income Security Act (ERISA, 1994) to create a uniform regulatory scheme for employment-based insurance. At that time, only 4% of employees were enrolled in managed healthcare plans, while the remaining 96% had traditional indemnity plans (Gabel, Reference Gabel1999). Consequently, most insurers could deny payment for a medication or treatment only if the patient's policy specifically excluded that treatment. By the early 2000s, these statistics had reversed, with the vast majority of workers then being enrolled in managed care. After managed care became predominant, physician autonomy regarding decisions in patient care waned. Denials from insurers at first reflected those treatments that were not “medically necessary.” More recent tactics include disease management, restrictive protocols, cost shifting, and physician profiling (Peeno, Reference Peeno2004). The results have been catastrophic, as seen from the present case series.
Unfortunately, the remedies for denials of necessary patient treatment and the harm resulting from these decisions are few and far between given the current status of the law. Enactment of the Patient Protection and Affordable Care Act (ACA) in March 2010 increased the appeals process requirements by providing internal and external procedures against claim denials, with decisions that can take up to 60 days to be made (Public Heath Service Act [PHSA], §2719, 42 U.S.C. 300gg–19, 2010). This appeals process is one of the ways that patients may attempt to obtain treatment that has been denied; however, it does not provide remedies for patients who have suffered injury or emotional distress as a result of insurer denials. In those instances, many patients are forced to turn to litigation.
Litigating denial-of-coverage claims is a complicated issue that lawyers, the courts, and legislators have grappled with over the past few decades. In 2004, the U.S. Supreme Court decision in Aetna Health Inc v. Davila effectively eliminated a patient's ability to recover damages resulting from an ERISA insurer's denial of treatment (Aetna Health Inc. v. Davila, 2004). ERISA was enacted to provide exclusive remedies for its members. Section 502(a) provides a member with two forms of redress: he or she can sue (1) to “recover benefits due to him under the terms under his plan” and (2) to “enforce rights under the terms of the plan” (29 USC §1132). Damages recoverable under these causes of action are limited to the cost of the benefit due, declaratory relief preventing denial of benefits, and, in some instances, costs and attorney's fees (29 USC §1132). However, consequential damages or punitive damages are not permissible, essentially preventing injured patients such as Davila to be made whole. State legal remedies such as the Texas Health Care Liability Act (THCLA), which provides a wider range of damages—including economic losses, noneconomic damages for pain and suffering, and punitive damages—are not available under employer-based coverage claims. This decision dealt a devastating blow to patients' rights and the ability of physicians to provide proper and adequate medical treatment.
Our experience with the five events presented here and the current status of legal and regulatory issues regarding insurance claims suggest that palliative care teams should take certain actions when prescribing opioids for cancer pain. Patients and their caregivers should be provided counseling regarding potential denial of payment or even requests to change the opioids. In cases where denial occurs, patients can be treated with lower-cost opioids like methadone. Unfortunately, methadone is not a good option for every patient, particularly those on CYP450 inhibitors or inducers, particularly CYP3A4 and CYP2B6, and those predisposed to QT prolongation (Strouse, Reference Strouse2009; Ehret et al., Reference Ehret, Voide and Gex-Fabry2006; Pearson & Woosley, Reference Pearson and Woosley2005).
Our previous experience has shown that patients treated by palliative care teams undergo minimal deviation from prescribed practice with appropriate education about medications (Nguyen et al., Reference Nguyen, Rhondali and De la Cruz2013). The only likely long-term resolution of this important issue of deviations in treatment caused by interference by insurers would be major changes in legislation and/or regulation of the ability of insurance companies to interfere with the management of cancer pain.
CONFLICTS OF INTEREST
The authors have no conflicts of interest to declare.
