Palliative and Supportive Care (2014), 12, 515– 518.

# Cambridge University Press, 2014 1478-9515/14

doi:10.1017/S1478951514000091

Insurance company denial of payment and enforced

changes in the type and dose of opioid analgesics for
patients with cancer pain

1 2 1
KIMBERSON TANCO, MD, † SOFIA E. BRUERA, JD, † AND EDUARDO BRUERA, MD
1
Department of Palliative Care and Rehabilitation Medicine, The University of Texas MD Anderson Cancer Center,
Houston, Texas
2
Blizzard & Nabers LLP, Houston, Texas
(RECEIVED November 5, 2013; ACCEPTED January 13, 2014)

ABSTRACT

Opioids are the mainstay of treatment for moderate to severe cancer pain. The variations in
average monthly cost can make it difficult for most patients to procure them without adequate
insurance coverage. There are increasing numbers of denials of payment and statements made
by insurance agents and other sources regarding inappropriate opioid use, resulting in severe
pain and emotional distress for cancer patients and their families. This case series describes five
events where the insurer was a major barrier to opioid access.
KEYWORDS: Cancer pain, Opioid analgesic, Insurance denial, Barriers to pain management,
Insurance coverage

INTRODUCTION
American patients pay the highest prices for medi-
cations in the world (Bartlett & Steele, 2004;
OECD, 2005). As a result, most patients need insur-
ance coverage to afford their prescribed medications.
More than 80% of patients with cancer develop se-
vere pain requiring opioid analgesics before death
(Nerseyan & Slavin, 2007; Levy & Samuel, 2005).
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-Put-
tini et al., 2012; Bruehl et al., 2013). In recent weeks,
our outpatient supportive care center experienced an
unprecedented number of events where an insurance
company refused to pay and/or recommended chan-
†These authors contributed equally to this manuscript.
Address correspondence and reprint requests to: Kimberson
Tanco, Department of Palliative Care and Rehabilitation
Medicine, Unit 1414, The University of Texas MD Anderson
Cancer Center, 1515 Holcombe Boulevard, Houston, Texas
77030. E-mail: kctanco@mdanderson.org
515
ges 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 re-
sulted from these denials and provide some rec-
ommendations 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 im-
mediately 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 com-
pany. However, in the meantime, the patient
516
had already experienced several days of severe
pain and emotional distress.
2. The insurer informed a patient who was receiv-
ing a 125-mg 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 sec-
ondary to running out of opiates. Furthermore,
both the patient and family were concerned
about statements made by the insurance com-
pany and their local pharmacist to the effect
that she had been “taking too many painkillers.”
The supportive care team provided intense psy-
choeducational 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-re-
lease 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 con-
siderable 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 me-
thadone due to its lower cost.
4. An insurance company limited the monthly pre-
scription of 240 tablets for a patient with good
pain control on immediate-release hydromor-
phone 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 quan-
tity limit, only 60 tablets were filled. The patient
experienced emotional distress due to the possi-
bility 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 preauthoriza-
tion for a patient on slow-release oxycodone
60 mg every 8 hours with immediate-release
oxycodone 10– 20 mg every 2 hours and in-
formed the patient to “make due” with his avail-
able opiates. He had an old prescription for
Tanco et al.
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 de-
crease pain intensity, restore levels of function, and
improve quality of life for adults with chronic pain
(Portenoy & Lesage, 1999; Vallerand & Nowak,
2010). Uncontrolled pain, on the other hand, creates
needless suffering and eventually increases health-
care costs (Stewart et al., 2003; Berger et al., 2004;
Craig & Strassels, 2010).
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 func-
tion, 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,
2011). Furthermore, patients experience an emo-
tional burden even with appropriately prescribed
opioid regimens due to prevailing concerns about ad-
diction, untoward side effects, tolerance, and scru-
tiny from regulatory bodies, payor sources, and
even family members (Greenwald & Narcessian,
1999; Ballantyne & Mao, 2013; Hampton, 2004;
Loder et al., 2003).
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 influ-
ences 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
Insurance company denial of payment
the South pay 27.8% more than those in the North-
east, and patients in the South and West also pay
more (Craig & Strassels, 2010).
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 cov-
erage and shows that insurers are increasingly ag-
gressively 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 mech-
anism often used to delay necessary pain manage-
ment is the requirement of preauthorization (events
4 and 5) (Schatman, 2011). In all our cases, this resul-
ted in severe pain and/or emotional distress and gen-
erated 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, 2012). In
1974, Congress passed the Employee Retirement In-
come 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, 1999).
Consequently, most insurers could deny payment
for a medication or treatment only if the patient’s pol-
icy 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, phys-
ician 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 pro-
filing (Peeno, 2004). The results have been cata-
strophic, as seen from the present case series.
Unfortunately, the remedies for denials of necess-
ary 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 pro-
cess 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 suf-
517
fered injury or emotional distress as a result of in-
surer denials. In those instances, many patients are
forced to turn to litigation.
Litigating denial-of-coverage claims is a complica-
ted 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). Dama-
ges recoverable under these causes of action are lim-
ited 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 dama-
ges—are not available under employer-based cover-
age claims. This decision dealt a devastating blow
to patients’ rights and the ability of physicians to pro-
vide proper and adequate medical treatment.
Our experience with the five events presented
here and the current status of legal and regulatory is-
sues regarding insurance claims suggest that pallia-
tive care teams should take certain actions when
prescribing opioids for cancer pain. Patients and
their caregivers should be provided counseling re-
garding 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, 2009; Ehret et al., 2006; Pear-
son & Woosley, 2005).
Our previous experience has shown that patients
treated by palliative care teams undergo minimal de-
viation from prescribed practice with appropriate
education about medications (Nguyen et al., 2013).
The only likely long-term resolution of this important
issue of deviations in treatment caused by interfer-
ence by insurers would be major changes in legis-
lation and/or regulation of the ability of insurance
companies to interfere with the management of can-
cer pain.
518
CONFLICTS OF INTEREST
The authors have no conflicts of interest to declare.
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