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Damned If They Do, Damned If They Don't: The
Need for a Comprehensive Public Policy to Address the Inadequate Management of
by Amy J. Dilcher; 13
Annals of Health Law 81; Winter 2004. Posted 10/26/2004:
... I am dying in sustaining such a devouring pain. - Sophocles ... The CSA
permits pharmacists to dispense a controlled substance upon receiving oral
authorization of a prescribing health care provider in emergency situations. ...
In addition to the misconceptions surrounding opioid use, the philosophical
perspective of Western medicine unnecessarily perpetuates the inadequate
management of pain and the negative attitudes of health care providers toward
the use of opioids to treat pain. ... Limited prescription drug coverage,
government investigations of physician diagnoses, and hospice eligibility
requirements prevent Medicare and Medicaid beneficiaries from accessing pain
management services. ...
"Doctors feel damned if they do and damned if they don't ... . The enormous
confusion about pain has led to the hysteria around opiates." n1
I am dying in sustaining such a devouring pain. - Sophocles
Throughout history and across cultures, human beings have experienced pain. As
early as the fifth century B.C., Sophocles documented the experience of pain and
suffering in Philoctetes. Centuries later, the undertreatment of pain in the
United States is a public health epidemic despite the availability of treatment
for relieving most physical pain. n2 The [*82] prevalence of undertreated
moderate to severe pain is a persistent problem that affects more than fifty
million Americans, including individuals with chronic non-malignant conditions
and terminal illnesses. n3 The inadequate management of pain costs the United
States as much as $ 100 billion per year in health care expenditures, disability
payments, and lost productivity. n4
Narcotics in the morphine class, known as opioids, are safe and effective in the
treatment and management of pain. n5 However, for opioids to be truly useful,
they must be legally and practically accessible to medical professionals and
their patients as and when needed to provide satisfactory relief from pain. n6
Liberalizing the use of opioids would benefit a significant number of patients
suffering from acute and chronic pain; indeed, the Agency for Healthcare Policy
and Research, part of the Department of Health and Human Services, found that a
full eighty percent (or more) of cancer patients could have their pain
successfully managed by a combination of opioids and other analgesic drugs and
that only ten percent of such patients experienced pain so profound as to be
impervious to any sort of analgesic treatment. n7
This article synthesizes a number of perspectives regarding the [*83]
comprehensive regulation of pain management and demonstrates that the inadequate
treatment of pain results from a multitude of barriers, which includes
government pain policies, enforcement actions, attitudes, inadequate education,
and reimbursement policies. Part II of this article examines each of the
components that contribute to the inadequate management of pain and recent cases
involving the undertreatment of pain.
To date, efforts to improve pain management have been piecemeal and hence
incomplete. Part III argues that the only way to adequately address the pain
epidemic in this country is through a comprehensive public policy that addresses
all of the barriers to pain management. Part III further examines legislation
proposed in the 108th Congressional session, the Conquering Pain Act of 2003
("Act" or "CPA"). The CPA, while a noteworthy effort on the part of Congress to
promote more effective pain management, fails to adequately address some of the
most serious problems facing doctors and other front-line practitioners, notably
the fear of regulatory scrutiny.
Part IV offers recommendations for a more comprehensive policy - one that would
enhance the management of pain through the use of controlled substances. The CPA
should be amended to address problems with federal and state investigations and
enforcement actions of controlled substance laws, to require health care
providers and facilities to assess pain, to change Medicare and Medicaid
reimbursement policies that impact the management of pain, and to improve the
education of health care providers about the use of controlled substances to
II. Inadequate Pain Management in the United States
The undertreatment of pain in the United States is well-documented in scientific
literature. Almost thirty years ago, Dr. Richard Marks and Dr. Edward Sachar
researched the inadequate management of pain in the hospital setting. n8 Based
on structured interviews and chart reviews of thirty-seven inpatients
hospitalized at Montefiore Hospital and Medical Center in New York, 32% of the
patients exhibited ongoing severe distress from pain despite receiving narcotic
treatment. n9 The physicians also noted that 41% of the subjects remained in
moderate stress from pain, and 27% of the subjects complained of minimal
distress from pain, even though both groups received pain medication. n10 From
this data, the authors concluded that there "was clearly a general pattern of
undertreatment of pain with [*84] narcotic analgesics, leading to widespread
and significant patient distress." n11
Recent studies demonstrate that the inadequate management of pain remains a
problem in the United States. These studies have demonstrated continued
inadequacies in treatment (1) of those patient populations most likely to suffer
from chronic and acute pain, including terminally ill patients, n12 cancer
patients, n13 nursing home residents, n14 elderly individuals, n15 and chronic
pain patients, n16 and (2) in those medical environments where acute pain is
routine, such as the emergency room, n17 the post-operative unit, n18 and the
intensive care unit. n19
In a 1994 study of 1308 outpatients with metastatic cancer, more than two-thirds
exhibited pain. n20 While most of the patients who complained of pain received
some type of alleviative treatment, 36% reported that their pain was severe
enough to impair their ability function, affecting their enjoyment of life,
level of activity, ability to walk, sleep, and work, and [*85] relations with
others. n21 The study determined that 42% of the outpatients who exhibited pain
were not provided with adequate pain relief. n22 The inadequate treatment of
pain described in the study has many causes, each creating a separate barrier to
A. Fear of Regulatory Scrutiny as a Barrier to Pain Management
One of the primary barriers to pain management is fear of regulatory scrutiny.
n23 A 1991 survey of ninety Wisconsin physicians revealed that, due to fears of
regulatory inquiry, the majority of physicians (54%) prescribed fewer doses and
lesser quantities of pain medication, allowed fewer refills, or selected a
different drug than they otherwise would have. n24 In that same year, 40% of
physician members of the American Pain Society reported that concerns about
regulatory scrutiny, rather than medical considerations, led physicians to
"avoid prescribing opioids for chronic non-cancer pain patients." n25
The problem is no better today. A 2001 California survey showed that 40% of
primary care physicians reported that fear of investigation tempered their use
of opioids for patients with chronic non-malignant pain out of fear of
investigation. n26 As a consequence of self-protective medical restraint,
patients may be suffering needlessly simply because the regulatory environment
is unfriendly to aggressive pain management.
1. Federal Law
For centuries, the medical profession has utilized opium (from which morphine is
derived) to treat pain. n27 Despite the historical use of narcotics, opioids did
not become a target of federal regulation in the United States [*86] until the
early 1900s. The first attempt to regulate the distribution and marketing of
narcotics was the Pure Food and Drug Act of 1906. n28 In 1914, Congress twice
attempted to regulate narcotics with the Harrison Act n29 and the Narcotic Drugs
Import and Export Act. n30 In 1970, Congress repealed both of these laws and
enacted the Comprehensive Drug Abuse Prevention and Control Act, of which Title
II is known as the Controlled Substances Act ("CSA"). n31
In addition to the CSA, the Federal Food, Drug, and Cosmetic Act ("FDCA") n32
regulates the overall distribution or delivery of drugs. n33 The FDCA requires
that the Food and Drug Administration ("FDA") approve every new drug introduced
into interstate commerce. n34 The FDA has approved the use of many controlled
substances as safe and effective under the FDCA. n35
The FDA requires that all approved controlled substances be dispensed to
patients only by prescription. n36 Upon FDA approval of controlled substances
for use, health care providers may prescribe, and pharmacists may dispense,
these substances to patients in compliance with the CSA and state laws and
guidelines. While the FDCA and the CSA are the primary federal laws governing
the manufacture, distribution, and dispensing of controlled substances, they do
not regulate the practice of medicine. Medical, dental, nursing, and pharmacy
licenses are issued at the state level through licensure boards. n37
a. Categories of Controlled Substances
The CSA classifies narcotics and other controlled substances in five categories,
or schedules. The scheduling of controlled substances, overseen by the Drug
Enforcement Administration ("DEA"), FDA, and the National Institute on Drug
Abuse, is determined by several factors, including the potential for abuse, the
risk to public health, and the risk of psychological or physiological
Schedule I substances have a high potential for abuse and are not approved for
medical use. n39 Schedule I substances include heroin, marijuana, and lysergic
acid. n40 Neither retail pharmacies nor providers are authorized to dispense
Schedule I substances. These substances are available to health care providers
solely for investigational research, and a research protocol must be approved by
the FDA prior to registration with the DEA for handling Schedule I substances.
A drug is included in Schedule II if it meets three requirements: (1) a high
potential for abuse; (2) a currently accepted medical use in treatment in the
United States; and (3) the abuse of the drug may lead to severe psychological or
physical dependence. n42 Among Schedule II substances are fentanyl, morphine,
hydromorphone, oxycodone, and amphetamines. n43 In contrast to Schedule I
substances, health care providers are authorized to prescribe Schedule II
substances with certain limitations. n44 For example, unlike other prescription
drugs, which a pharmacist may dispense upon receiving a telephone or fax
prescription, a pharmacist generally may not dispense a Schedule II drug before
having received and reviewed an original, signed prescription. n45 Also unlike
other prescription drugs, a prescription for a Schedule II drug may not include
an authorization for refills. n46
[*88] Schedule III substances have a lower potential for abuse than substances
in Schedules I and II, are accepted for medical use, and may lead to low to
moderate physical dependence or a high psychological dependence. n47 Examples
include secobarbital, pentobarbital, and anabolic steroids. n48 Schedule IV
drugs have a low potential for abuse in comparison to Schedule III drugs, are
currently accepted medical for medical use, and may lead to limited physical or
psychological dependence in comparison to Schedule III substances. n49 Among
Schedule IV drugs are alprazolam, phenobarbital, triazolam, and fenfuramine. n50
Schedule V substances have a low potential for abuse relative to Schedule IV
substances, are currently accepted for medical use, and may lead to limited
physical and psychological dependence relative to the drugs in Schedule IV. n51
Examples include low doses of codeine and opium. n52
The CSA authorizes pharmacists to dispense Schedule III, IV, and V substances
pursuant to a written, fax, or telephone prescription from a health care
provider. n53 Schedule III and IV drugs are limited to five refills; there is no
refill limit for Schedule V drugs. n54
b. Prescription Requirements
The CSA and its implementing regulations establish mandatory prescription
requirements with which health care providers who intend to distribute or
dispense narcotics must comply. n55 The CSA imposes a general prohibition on the
distribution and dispensing of controlled substances in the United States, with
a few well-delineated exceptions. n56 Among the exceptions is a provision that
authorizes dispensing controlled substances pursuant to registration with the
Attorney General ("DEA registration"). n57 [*89] Under this exception, in
order to dispense n58 a controlled substance, a medical practitioner or
pharmacist must first be state-licensed, both to practice and to prescribe
controlled substances, and then must also successfully complete DEA
registration. n59 Health care providers need a DEA registration in order to
prescribe controlled substances, even if their state licenses allow them to
prescribe other prescription medication. A practitioner will generally be
approved for registration, unless the DEA determines that the issuance of the
registration is inconsistent with the public interest. n60 The DEA considers
five factors to determine whether registration is consistent with the public
(1) the recommendation of the appropriate State licensing board or professional
(2) the applicant's experience in dispensing, or conducting research with
respect to controlled substances;
(3) the applicant's conviction record under Federal or State laws relating to
the manufacture, distribution, or dispensing of controlled substances;
(4) compliance with applicable State, Federal, or local laws relating to
controlled substances; and
(5) such other conduct which may threaten the public health and safety. n61
If these five factors are satisfied, the DEA will grant registration and the
licensed health care provider will be authorized to prescribe or dispense
narcotics so long as it is for a legitimate medical purpose in the course of
professional practice. While the phrase "legitimate medical purpose" is not
defined under the CSA, the DEA may assess whether a controlled substance
provides a therapeutic benefit to the medical condition of the patient (i.e.,
the substances improve pain relief). n62 A prescription for a controlled
substance that is not intended to treat a medical condition (as when diverted to
street or recreational use) will be determined to have no legitimate medical
c. Penalties Under the CSA
In addition to registration requirements, the CSA establishes a range of
administrative, civil, and criminal penalties. The Attorney General, through the
DEA, is charged with implementing and enforcing the CSA. n64 The Attorney
General may suspend or revoke a provider's registration to distribute or
dispense a controlled substance if the provider has acted in a manner
inconsistent with the public interest. n65
In determining whether revocation or suspension of a registration is in the
public interest, the DEA may assess whether registrants' practices threaten the
"public health and safety" independently of whether the State suspended or
revoked their licenses to practice the healing arts or prescribe controlled
substances. n66 Thus, while the DEA must ensure that practitioners are in good
standing as state licensees before registering them, n67 it is not [*91]
required to wait until the practitioners' state licenses have been suspended or
revoked before withdrawing their DEA registrations. The DEA will, however,
consider practitioners' state licensing status as a factor in determining
whether to suspend or revoke registration. n68 The suspension or revocation of
DEA registration is a formidable penalty, first because it likely disrupts
providers' practices by precluding them in some cases from prescribing
medically-appropriate medication, and perhaps more onerously, because it may
constitute grounds for state disciplinary action.
Failure to comply with the CSA also subjects providers to potentially severe
civil and criminal penalties, including a civil fine of up to $ 25,000 n69 and,
for willful violators, up to one year in prison and a fine of up to $ 25,000.
n70 However, while the substantial penalties provided for by the CSA do serve as
a reminder that the federal government views DEA registration as a grave
responsibility, actual prosecution for abusive prescription of controlled
substances is often left to the states. n71
2. DEA Policies and Position Statements
Federal policy on the medical use of controlled substances is embodied not only
in the CSA and associated regulations, but also in DEA manuals and statements.
For example, the DEA recognized in its 1990 Physician's Manual that the use of
controlled substances to manage pain is a legitimate medical use and encouraged
physicians to prescribe, dispense or administer narcotics when used for a
legitimate medical purpose. n72
More recently, in 2001, the DEA joined with twenty-one pain and health
organizations to issue a joint statement on the use and abuse of pain medication
and physician reluctance to manage pain with controlled [*92] substances. n73
The statement was noteworthy, not only because it affirmed government support
for the legitimate use of prescription drugs for patients in pain, but also
because it was the first ever public collaboration between the DEA and
organizations supporting pain management. n74
Importantly, the statement recognized that the undertreatment of pain is a
serious problem in the United States that affects both chronic pain sufferers
and the terminally ill. The statement also recognized that there exists shared
responsibility between health care professionals, law enforcement, and
regulatory personnel, both for ensuring that controlled substances are available
to chronic and terminal patients and for assuring that pain control drugs are
not abused. Finally, the statement emphasized that while the prevention of drug
abuse is an important societal goal, it should not thwart pain management
efforts. n75 However, while the joint statement voices support for the use of
narcotics to manage pain, it fails to adequately address the reluctance of
health care providers to prescribe controlled substances for fear of federal
investigations and enforcement actions.
As noted above, the federal government takes seriously the mandate of the CSA
and has the authority to pursue significant penalties for its violation;
however, for all of the regulatory and prosecutorial power afforded by the CSA,
it is rare for the DEA to actually revoke a registration or pursue criminal
prosecution under the Act. While there are more than 950,000 practitioners
registered with the DEA to prescribe controlled substances, n76 the DEA revoked
only thirty practitioner registrations in 2002. n77 Nevertheless, the number of
DEA actions against health care providers is increasing. The thirty practitioner
revocations in 2002 represent a significant increase from the ten revocations in
2000 and the thirteen revocations in 2001. n78
[*93] When the DEA investigates a health care provider for violations of the
CSA it begins by investigating the provider's prescribing practices. The DEA may
initiate an investigation if it finds that a practitioner is prescribing
controlled substances in aberrantly high quantities, or if it receives a
complaint from a patient, pharmacist, or health care provider. n79 Under the CSA
and implementing regulations, the DEA has the power to conduct administrative
inspections for the purpose of completing a physical inventory of the controlled
substances on the premises and reviewing records and information concerning the
distribution of controlled substances by a health care provider. The DEA may
also inquire into any significant increases in the prescribing of controlled
substances. n80 As part of its investigation, the DEA may send undercover agents
to a provider's office to attempt to obtain prescriptions for controlled
DEA investigations can last several months, after which the DEA may take formal
action to suspend or revoke a health care provider's DEA registration or may
pursue criminal prosecution under the CSA. The DEA's investigatory and
prosecutorial powers are broad, far-reaching, and fearsome; the mere fact of
being investigated by the DEA, even without a subsequent finding of culpability,
can taint a practitioner's reputation and affect his practice. For example, in
1987 the DEA investigated Dr. Albert Brady, an oncologist from Portland, Oregon,
for prescribing high doses of the painkiller Dilaudid to a cancer patient in a
nursing home. n82 The DEA suspected that Dr. Brady was supplying Dilaudid to the
black market rather than to his patient. n83 Although the DEA ultimately
concluded that Dr. Brady was not illicitly prescribing Dilaudid, it nevertheless
notified the State Board of Medical Examiners, which fined Dr. Brady $ 5000 and
suspended his license for a month for overprescribing controlled substances. n84
Dr. Brady told the Journal of NIH Research that, as a result of this experience,
his two partners "changed their practice overnight and became reluctant to
prescribe sufficient doses of painkillers." n85
[*94] While Dr. Brady's case may not be typical, it illustrates the impact
that the DEA can have when it takes action, and the potentially chilling effect
a mere investigation can have, not only on a practitioner's future conduct, but
on the conduct of the entire medical profession. Indeed, recent federal
investigations targeting the abusive distribution and use of the painkiller
OxyContin have created a climate of fear surrounding the legitimate use of the
drug, and perhaps other controlled substances, for pain management. OxyContin, a
highly effective time-release pain medication, was introduced in 1995 and
quickly acquired a reputation as a miracle drug for those with severe and
chronic pain. n86 However, at the same time that OxyContin was helping patients
win the war on pain, it was being sold on the black market and used as an
illicit street drug. Consequently, over the past two years the DEA and the FDA
have closely examined the misuse and abuse of OxyContin and scrutinized
providers that prescribe the drug. Thus far, the DEA has relegated to the states
the task of prosecuting the inappropriate prescription of OxyContin. n87 Even
so, the fear of possible DEA prosecution, state prosecution, or state
de-licensing has stoked physicians' fears about using OxyContin, even where its
use would be medically appropriate. n88 Thus, doctors seem to be taking a more
conservative approach to prescribing effective painkillers, setting back
hard-won progress in the war against pain. n89 Any policy that purports to
improve pain management must address the issue of over-regulation of effective
pain medication at the expense of patient welfare.
It should be noted, though, that while the DEA has arguably over-regulated
OxyContin and other painkillers, illicit and improper prescription and use of
these drugs is a genuine problem. Doctors who abuse their authority to prescribe
controlled substances are probably few in number, but represent a legitimate
target for criminal prosecution. For instance, in United States v. Larson, a
physician was convicted of distributing a controlled substance and conspiracy to
distribute a controlled substance. n90 In affirming the conviction, the court
rejected the physician's argument that [*95] the Government was required to
present expert testimony to establish that the physician did not prescribe
controlled substances in the usual course of medical practice and that he or she
was acting other than for a legitimate medical purpose. n91 The court found that
the jury could make inferences from ordinary testimonial evidence and the facts
and circumstances surrounding the prescriptions. n92
The court determined that the evidence was sufficient to sustain Dr. Larson's
conviction. First, Dr. Larson prescribed excessive quantities of controlled
substances, he camouflaged the excess by spreading the quantities over multiple
prescriptions, and he charged a fee for each prescription. n93 Additionally, Dr.
Larson cautioned a "patient" about having his prescription filled repeatedly at
the same pharmacy. n94 Lastly, Dr. Larson used the street name for the drugs he
prescribed, including "reds" (seconal) and "speed" (methamphetimine). n95 The
court found that these facts and circumstances, without more, supported the
jury's determination that Dr. Larson was not acting for a legitimate medical
purpose or in the usual course of his professional practice.
Cases like Dr. Larson's, while rare, illustrate the type of conduct that the CSA
was intended to protect against. Despite the limited number of formal actions
against physicians for over-prescribing controlled substances for pain relief,
federal enforcement actions and the resulting penalties imposed against
physicians for prescribing drugs create a barrier to the adequate treatment of
pain. Stories like Dr. Brady's have had a chilling effect on physicians who
prescribe controlled substances to manage pain. Even though the chance of a
federal investigation involving prescriptions for controlled substances is quite
low, it should come as no surprise that physicians remain reluctant to prescribe
pain medication for fear of the potential penalties and the consequent loss of
professional standing and ability to earn a livelihood. n96 With so much at
stake, providers choose to undertreat pain instead of treating their patients as
they would like to. Any policy that is intended to improve pain management must
address the fear of regulatory scrutiny. This might include revising the
guidelines for DEA investigations and enforcement actions to include a safe
harbor provision [*96] that would immunize health care providers who, in good
faith, prescribe controlled substances for pain. n97
4. Federal Policies Strike a Balance Between the Control and Availability of
Although federal enforcement actions against physicians impede pain management,
David Joranson of the Pain & Policy Studies Group of the University of Wisconsin
Comprehensive Cancer Center, has suggested that the CSA, as a whole, represents
a "balanced" approach in which the availability of drugs to patients for pain
relief is balanced with the control of narcotics to prevent drug diversion and
abuse. n98 Few would challenge the notion that a balanced approach is both
desirable and necessary as a way to address and minimize the fears of health
care providers who limit prescriptions of opioids out of fear of regulatory
a. Aspects of Federal Policy That Enhance Pain Management
While the CSA penalizes those providers who abuse their authority to prescribe,
the CSA contains provisions which it can be implied that the use of narcotics is
promoted in order to better manage pain. For example, federal policy
specifically reflects the appropriateness of using narcotics to treat pain. This
should be viewed by health care providers as encouragement to prescribe pain
medication without fear of undue reprisals. It is also clear from the plain
language of the statute that Congress intended that the CSA not unduly restrict
practitioners from prescribing narcotics. n99 Section 801 of the CSA recognizes
that controlled substances "have a useful and legitimate medical purpose and are
necessary to maintain the health and general welfare of the American people."
The CSA further provides that psychotropic substances n101 should be controlled
in accordance with the drug schedules established under the CSA to ensure that
these substances are available for legitimate medical and scientific purposes.
n102 This is significant because psychotropic drugs, which are powerful mind-and
mood-altering substances, are frequently [*97] used in combination with
opioids to treat pain caused by nervous system damage. n103 Congressional
support for legitimate medical use of psychotropics, including for medical pain
management, suggests concomitant support for the legitimate medical use of
opioids to treat pain. Thus, Joranson's view that the CSA effectively balances
the need for effective pain treatment with the need to prevent drug abuse finds
unambiguous support in both the text and tenor of the statute; simply put, the
law is not intended to diminish the medical usefulness of opioids. It is in this
context that it becomes more important for federal regulators to be aware that
pain management is a fundamental part of medical practice.
There are other aspects of the CSA that are noteworthy because they support a
policy of effective pain management by allowing patients to have access to drugs
without overburdening the provider with administrative requirements:
. The CSA does not limit the quantity of drug prescribed or dispensed and avoids
using quantity or duration to determine the legitimacy of the physician's
treatment of the patient.
. There are no maximum doses identified under the CSA for controlled substances.
. The CSA does not limit the period of validity for a controlled substances
. The CSA does not limit the number of refills of a controlled substance
prescription for Schedules III, IV and V.
. The CSA permits pharmacists to dispense a controlled substance upon receiving
oral authorization of a prescribing health care provider in emergency
. Prescriptions for a Schedule II controlled substance may be transmitted via
facsimile provided that the original prescription is presented to the pharmacist
for review prior to dispensing the controlled substance. n105
These provisions promote the availability of controlled substances to patients
and thus enhance pain management.
b. Aspects of Federal Regulation That Impede Pain Management
While the CSA, taken as a whole, strikes a balance between preventing the
diversion of narcotics and making narcotics available to patients, there [*98]
are some provisions in federal policy that may impede pain management. n106 For
example, section 1306.7 of the regulations implementing the CSA provides:
This section is not intended to impose any limitations on a physician or
authorized hospital staff to administer or dispense narcotic drugs in a hospital
to maintain or detoxify a person as an incidental adjunct to medical or surgical
treatment of conditions other than addiction, or to administer or dispense
narcotic drugs to persons with intractable pain in which no relief or cure ...
has been found after reasonable efforts. n107
While the purpose of this section appears to have been to encourage pain
management by addressing provider concerns about regulatory scrutiny, the
regulation implies that opioids should be used only in narrowly defined
circumstances and only where other treatments have failed. n108 While there is
little debate that both non-pharmacologic alternatives and non-opioid
medications are valuable, the decision to use a particular treatment for pain
should be based on medical judgment, not governmental scrutiny. n109 The
regulation fails to reflect that the use of opioid analgesics is an important
part of medical practice and that opioids may be used effectively and safely to
relieve pain. Thus, the regulation impedes pain management. n110
Consider 42 U.S.C. 14,402 which provides that no provision of the Act should be
construed to discourage the use of drugs to alleviate pain, even if such use may
increase the risk of death, so long as the purpose in using the drugs is not to
cause death or to assist in the causing of death. n111 This section, with its
prohibitory reference to physician-assisted suicide, impedes the management of
pain with controlled substances because it perpetuates the erroneous belief that
opioids hasten death, even when used simply for pain management. The concern
reflected in this provision is that use of the medication will sedate the
patient into unconsciousness. While depressed respirations, sedation, and
confusion are potential side effects of opioid therapy, research reflects that
opioids do not hasten death when titrated appropriately. n112 Titration involves
the gradual increase of the amount of an opioid until a balance is reached
between pain relief and the adverse side [*99] effects of the medication,
i.e., sedation or respiratory depression. n113 As is currently written, the
provision creates a barrier to pain management. It should be amended to reflect
that opioids are not likely to hasten death when titrated appropriately.
B. State Regulation of Controlled Substances Is a Barrier to Pain Management
In addition to the federal government, individual states regulate the
prescription, dispensing, and administration of drugs and the regulation of the
medical, pharmacy, and nursing professions. Unlike federal policy, which is
relatively balanced, state regulation of controlled substances causes a number
of critical problems, n114 which have "the potential to interfere with decisions
about the care of individual patients that require medical expertise rather than
government dictum." n115 The draconian enforcement provisions in many state
regulations, coupled with a very real fear of the litigious environment for
health care providers, generally has curtailed the ability of providers to
prescribe drugs to manage pain. Indeed, many state policies have failed to
balance the control of pain medication prescriptions with the ability of
patients to obtain narcotics to control pain.
1. State Pain Policy Background
State pain policies may be prescribed not only by legislated statutes and
regulations but also through guidelines and regulations of medical,
pharmaceutical, or nursing boards. All fifty states have statutes and
regulations that govern controlled substances. Many of the states classify
controlled substances according to the schedules provided in the Federal CSA.
n116 Every state has adopted a form of the model Uniform Controlled Substances
Act. n117 All of the state laws permit prescriptions for controlled [*100]
substances, although, unlike federal law, most do not specifically recognize the
legitimate medical use of controlled substances. n118 Moreover, some states
restrict the physician's discretion by limiting the quantity of drug that can be
prescribed at one time, n119 limiting the validity of a controlled substance
prescription, n120 and prohibiting prescriptions issued to substance abusers or
requiring that such prescriptions be reported to a state agency. n121
Furthermore, several state policies contain antiquated provisions that confuse
the terms "physical dependence," "tolerance," and "addiction." n122 Addiction is
defined as a "psychological dependence on the use of substances for their
psychic effects and is characterized by compulsive use despite harm." Physical
dependence, on the other hand, is a "physiological state of neuroadaptation
which is characterized by the emergence of a withdrawal syndrome if the drug is
stopped or decreased abruptly or if an antagonist is administered." n123
Physical dependence is a foreseeable result of opioid use and is not, itself,
synonymous with addiction. n124 Physical tolerance is the "progressive decline
of the potency of an opioid with continued use." n125 It is due to physical
tolerance that patients require increasing doses of controlled substances to
achieve a consistent analgesic effect.
The regulation of professional practice in medicine, nursing, and pharmacy
occurs at the state level, n126 although federal agencies substantially affect
professional practices by denying or ending a provider's participation in
programs such as Medicare or revoking their registrations to prescribe
controlled substances. State agencies issue regulations that govern the specific
requirements for prescribing and dispensing controlled substances. n127 In
comparison to DEA regulations, state regulations [*101] governing the
prescribing and dispensing of controlled substances are often more stringent.
State laws authorize professional boards to license and discipline members of
the profession, to investigate complaints against licensees, to conduct
investigations and hold administrative proceedings, and to adopt regulations to
implement their statutory authority. n129 Board investigations of a licensee are
typically initiated by a complaint or by a referral from another agency. n130
Boards differ greatly as to the procedures used for inquiry and investigation
into complaints. Some professional boards are statutorily required to
investigate each complaint received; other boards may initiate proceedings at
their discretion. n131 The board investigations, often a form of administrative
review, n132 may result in disciplinary actions, which can range from a warning
or reprimand to a suspension or revocation of prescribing privileges or a
revocation of the provider's license. n133 After administrative requirements
have been exhausted, the provider may appeal the decision to the state courts.
n134 The criminal provisions of state controlled substance laws are enforced by
state and local law enforcement and, in some instances, the state's attorney
2. State Policies Are a Barrier to Pain Management
By contrast to federal law, state policies fail to strike a balance between
curtailing drug abuse and making pain management drugs available to those who
need them. State policies impede pain management in three critical [*102]
ways: (1) by failing to recognize the medical value and use of opioids; (2) by
using terminology that confuses physical dependence with addiction; and (3) by
restricting medical decisions. n136 While these critical areas are handled
differently by each state, certain commonalties are shared.
a. State Policies Fail to Recognize the Medical Value and Use of Opioids
Some state policies fail to recognize the medical value of opioids by implying
that controlled substances should be used as a last resort. For example, an
Arizona Medical Board guideline provides that the patient's symptoms must
clearly support a diagnosis that requires opioid therapy and that "all
reasonable alternative therapies have been explored." n137 A patient may be
excluded from opioid therapy if he has a history of chemical dependency, a major
psychiatric disorder, or a "chaotic social situation." n138 This guideline
impedes pain management because it requires that opioids be used only after
other alternative therapies have been explored. Furthermore, it implies that
opioids should not be used in certain patient populations, for example, those
patients with a history of chemical dependency or a major psychiatric disorder.
n139 The guideline fails to recognize that the use of opioid analgesics is an
important part of medical practice and that the use of controlled substances can
be a safe and effective way to manage pain for all patients. n140 Consequently,
the guideline fails to strike a balance between control and availability by
placing the prevention of drug abuse ahead of access to narcotics for pain
relief, and thereby interferes with pain management.
b. State Policies Confuse Physical Dependence with Addiction
State policies also fail to use terminology that distinguishes physical
dependence from addiction. For example, prior to being repealed, Maryland's
Controlled Substance Act defined a drug dependent person as one who was "in a
state of psychic or physical dependence, or both, arising from administration of
that controlled dangerous substance on a continuous basis." n141 In defining a
"drug dependent person," Maryland's Act [*103] inappropriately confused
psychological addiction with physical dependence. The World Health Organization
and others have made clear that physical dependence on opioids - the sudden
cessation of opioid drug therapy would result in withdrawal syndrome - is not
"drug dependence" but rather is "a behavioral pattern characterized by craving
for the drug and an overwhelming preoccupation with obtaining it." n142
Although physical dependence and tolerance occur in patients who take opioids
over a long period, studies have shown that psychological dependence is
extremely rare. n143 State pain policies should define abuse-related terms (i.e.
drug dependence) so as to avoid any confusion between psychological addiction
and physical dependence or tolerance. Undue anxiety about psychological
dependence on opioids has caused health care providers and patients to use
inadequate doses of opioids to treat pain. n144 In this way, Maryland impedes
pain management because it implies that the prevention of drug abuse is more
important than the availability of narcotics for pain relief.
c. State Policies Restrict Medical Decisions
State policies restrict medical decisions in at least three ways. First, a
number of state policies restrict providers from prescribing pain medication
based on patient characteristics such as age, diagnosis, prognosis, and a
history of drug abuse. For example, California's Controlled Substances Act
prohibits providers from prescribing or administering a controlled substance to
an "addict or habitual user." n145 This restriction preempts a health care
provider's medical discretion to treat pain in patients who are in the
restricted category. Medical research reflects that controlled substances can be
prescribed legitimately to individuals who are psychologically addicted to
opioids, provided that controlled substances are warranted by the individual's
medical condition. n146 California's Controlled Substances Act prohibition
substitutes government judgment for medical decision-making. As written,
California's provision fails to strike a balance by which the control of
narcotics is an equivalent priority to the availability of opioids for pain
relief and is thus a barrier to pain management.
Second, some state policies mandate that providers consult with at least
[*104] one other provider prior to issuing a prescription for the use of
controlled substance to treat intractable pain. For example, Colorado's Medical
Board Guidelines define intractable pain as "pain in which the cause cannot be
removed or otherwise treated and no relief or cure has been found after
reasonable efforts, including evaluation by one or more physicians specializing
in the treatment of the area of the body perceived as the source of the pain."
n147 While physician consultation is an important part of medical practice,
Colorado's mandate that one or more pain specialists evaluate the patient
appears to regulate medical decisions about pain management. The requirement
does not take into account the expertise of the prescribing physician or the
patient's needs, which could call for immediate attention. Federal policy is
appropriately silent on this issue, leaving the decision about whether
consultation is needed to the discretion of the physician. Colorado's guideline
fails to strike a balance between control of narcotics and the availability of
opioids for pain relief, and is thus a barrier to pain management.
Third, while federal law does not limit the quantity of drugs prescribed or
dispensed and avoids identifying a specific quantity or duration that it deems
to be legitimate, some state policies limit the amount of controlled substances
that can be prescribed or dispensed at one time in an attempt to control the
availability of narcotics and to prevent patients from becoming addicted to
controlled substances. For example, Delaware's Uniform Controlled Substance
Regulation limits the validity of a prescription for a Schedule II substance to
seven days from the original date of the prescription, except for Schedule II
prescriptions for the terminally ill or residents of long-term care facilities,
which are valid for up to sixty days from the issue date. n148 Delaware also
limits the quantity prescribed to one hundred dosage units, with an exception
being made for individuals with a medically documented terminal illness or
residents of long-term care facilities. n149
While these restrictions reflect an important goal of preventing abuse of
controlled substances, they may not be sufficient to meet the individual needs
of patients under all circumstances. State policymakers must realize the
real-life implications that a limitation on the quantity or the duration of
[*105] a prescription drug may have. For instance, patients may not have
access or transportation to a pharmacy to fill a prescription for pain
medication, the availability of which may not coincide with the duration of the
prescriptions. Also, the medical condition of a patient may limit the
individual's ability to go to doctor appointments or to a pharmacy to fill
prescriptions for pain medication. Further, some patients may live in rural
areas requiring them to travel long distances to health care providers and to
pharmacies. Delaware's restrictions are barriers to the management of pain
because such policies impede the availability of controlled substances to
patients suffering in pain.
3. Recent Developments in State Pain Policy
a. Intractable Pain Treatment Acts
Over the past ten years, several states have attempted to improve patient access
to pain management and address physician reluctance to prescribe opioids for
fear of disciplinary action by enacting Intractable Pain Treatment Acts ("IPTAs").
n150 These Acts immunize physicians from disciplinary action by state medical
boards provided that the physicians comply with certain requirements. For
example, Texas's IPTA prohibits a medical board from subjecting a physician to
disciplinary actions where, in the course of the physician's treatment of a
person for intractable pain, the physician prescribed or administered dangerous
drugs or controlled substances. n151 The Texas IPTA defines "intractable pain"
as a "pain state in which the cause of the pain cannot be removed or otherwise
treated and which in the generally accepted course of medical practice no relief
or cure of the cause of the pain is possible or none has been found after
reasonable efforts." n152 While the goal of IPTAs was to address physician
reluctance to prescribe opioids for the treatment of chronic pain due concern
about regulatory scrutiny, n153 "physicians in many states remain reluctant to
write such prescriptions." n154
[*106] Although IPTAs attempted to improve patient access to pain management
and mitigate physician reticence to prescribe opioids, IPTAs impede pain
management. First, the language in the IPTAs suggests that opioids are a last
resort and that the use of opioids is not considered part of ordinary medical
practice. n155 Second, IPTAs apply only to prescriptions of intractable pain,
not other types of pain where the source of pain is known and for which relief
can be achieved. n156 Third, the use of the term "intractable" implies that pain
that is not treatable, even though chronic pain can be treated. n157 Fourth,
IPTAs exclude pain patients who use drugs "nontherapeutically" (i.e., substance
abusers). n158 Fifth, IPTAs often impose additional requirements, such as
consultation with another physician and informed consent. n159 Given these
issues, IPTAs are not the "most direct or effective way to address the desirable
goal of relieving physician concern about regulatory scrutiny." n160
b. State Special Prescription Programs
Some states have adopted laws requiring that physicians complete special
prescription forms by using triplicate, duplicate, or single-copy state-issued
documents. n161 For example, New York requires that all prescriptions for
Schedule II substances be prepared by the physician in triplicate on an official
form prepared and issued by New York's Department of Health ("DPH"). n162 A
completed form identifies the patient, the prescribing physician, and details
regarding the use of the controlled [*107] substance. n163 One copy of the
form is retained by the physician, n164 a second copy by the pharmacist, n165
and a third copy of the prescription is filed with DPH. n166 The DPH is required
to retain its copy of the prescription for a period of five years, after which
the prescriptions must be destroyed. n167 Public disclosure of a patient's
identity, which is listed on a prescription for a Schedule II substance, is
expressly prohibited. n168
In Whalen v. Roe, a group of patients who regularly received prescriptions for
Schedule II drugs, doctors who prescribed the medication, and two associations
of physicians challenged New York's prescription requirements. n169 These groups
argued that the prescription requirements violated the right to privacy
protected by the Fourteenth Amendment because patients who required Schedule II
drugs declined treatment for fear that information contained on the
prescriptions would be misused and that physicians were reluctant to prescribe
these drugs for fear of regulatory scrutiny. n170 While the United States
Supreme Court recognized that there was a constitutionally protected zone of
privacy that included interests in avoiding disclosure of personal matters and
in making important personal decisions, it held that the law adequately
protected privacy (1) by limiting access to the information to authorized state
employees responsible for protecting the health of the community, and (2) by
providing for built-in protections from disclosure, such as the express
prohibition on disclosing the identity of a patient for whom a prescription for
a Schedule II controlled substance is written. n171 The Court further held that,
in contrast to a total prohibition on the use of Schedule II substances, the law
did not deprive the public of access to the drugs. n172 The Court upheld the
constitutionality of New York's prescription requirements, finding that the law
was the product of a rational legislative decision to minimize the abuse of
dangerous drugs and did not invade any right or liberty protected by the
Fourteenth [*108] Amendment. n173
Similar prescription requirements are often used by state health departments,
law enforcement agencies, and licensing boards, to monitor prescriptions of
Schedule II drugs for the purpose of detecting fraud and abuse. For instance,
Kentucky's prescription monitoring system assisted law enforcement in staging
"Operation Oxyfest," the state's largest drug-abuse raid to date, resulting in
the arrest of 252 people. n174 The extent to which prescription information is
tracked and monitored by state health departments or law enforcement agencies
varies greatly. n175 As of December 21, 2001, seventeen states monitor patients
who get prescriptions and the providers who prescribe the medication. n176
Research collected in the wake of Whalen v. Roe reflects that special
prescription monitoring programs continue to have a negative impact on
prescribing controlled substances for legitimate purposes. n177 In jurisdictions
with such monitoring programs, health care providers are reluctant to prescribe
pain medication because they fear that the completion of the special
state-issued forms will trigger an investigation into their prescribing habits
by the state health department or law enforcement agency. n178 Critics who
oppose prescription monitoring systems argue that they violate patients'
privacy, are costly, and harm those in need of medication by causing doctors to
prescribe fewer and less potent drugs. n179 For example, recent media reports
reflect that physicians attempt to evade electronic monitoring systems by
prescribing tranquilizers, which have greater potential side effects than
Schedule II medication and are generally not tracked by state electronic
monitoring systems. n180 Despite evidence that physicians avoid prescribing
controlled substances due to recently-enacted state prescription monitoring
programs, it is unlikely that courts will invalidate these programs. Relying on
Whalen v. Roe, courts will likely find that the special prescription monitoring
programs are a product of an orderly and rational legislative decision to
minimize the abuse of dangerous drugs and protect the health of the community.
n181 While state prescription [*109] monitoring programs provide an important
societal benefit of preventing drug diversion and drug abuse, a more balanced
approach is needed to address the accompanying reluctance of health care
providers to prescribe controlled substances to patients for legitimate medical
4. State Medical Board Actions
State medical boards negatively influence physician prescribing practices by
monitoring prescriptions and disciplining providers who, in the opinion of state
medical boards, "over-prescribe" controlled substances for pain management. n182
The case of Dr. Katherine Hoover illustrates the extent to which states
scrutinize providers who prescribe controlled substances and the potential
penalties that may result from such scrutiny.
In March 1994, Florida's state licensing agency filed an administrative
complaint alleging that Dr. Hoover, a board-certified physician in internal
medicine, had: (1) inappropriately and excessively prescribed Schedule II
controlled substances to seven of her patients, all of whom had been treated by
Dr. Hoover for chronic pain arising from non-cancerous conditions; and (2)
provided care that fell below the level of skill and treatment, which is
recognized by a reasonably prudent physician as being acceptable under similar
conditions and circumstances. n183 Dr. Hoover requested a formal hearing to
challenge the allegations. n184
At the hearing, two expert witnesses for the State opined that Dr. Hoover's
conduct fell below the standard of care because she prescribed excessive and
perhaps lethal amounts of narcotics. n185 The experts' opinions were based
solely on computer printouts from pharmacies where the physician's patients had
filled their prescriptions. n186 The printouts indicated only the quantity of
drug filled for each patient and only occasionally referred to the patient's
diagnosis. n187 Neither of the expert physicians specialized in the treatment of
chronic pain and both experts referred their [*110] patients to pain
management clinics. n188 Dr. Hoover provided detailed testimony as to her
treatment of each patient, the patients' progress under the prescribed
medication, and the appropriateness of the medication and amounts prescribed.
The hearing officer found that the agency failed to meet its burden of proof on
all charges. n190 The agency subsequently requested that the board of medicine
review the findings of fact and conclusions of law. n191 The board of medicine
accepted all of the agency's exceptions, amended the findings of fact in
accordance with the agency's suggestions, and found Dr. Hoover in violation of
Florida law. n192 The board's penalty included a reprimand, a $ 4000 fine, and
two years probation, in addition to required continuing medical education on
prescribing abusable drugs. n193 Dr. Hoover appealed the decision to the
District Court of Appeals of Florida. n194
The District Court reversed the medical board's decision. First, the court found
that the evidence was insufficient to support a breach of the standard of care.
n195 Second, the court determined that the hearing officer was entitled to give
greater weight to the testimony of Dr. Hoover and her expert witnesses where the
agency's physician experts did not examine the patients or regularly engage in
the treatment of chronic pain. n196 Third, the court concluded that the hearing
officer's finding that Dr. Hoover's prescriptions did not exceed the federal
guidelines for treatment of intractable pain in cancer patients (even though
none of the patients had cancer) was relevant and reasonable. n197
While at least one scholar has suggested that the Hoover case and others like it
support the argument that physicians who follow established medical practices
for treating pain with opioids should have nothing to fear from state regulatory
actions, n198 it is important to point out that Dr. Hoover was not vindicated
until appellate review was complete. It is therefore understandable that cases
like Dr. Hoover's, in which the state medical board's decision is ultimately
found to be erroneous, may provide little consolation to physicians who
prescribe controlled substances for pain [*111] management. Health care
providers who are wrongly accused of prescribing controlled substances in
violation of state law will likely endure negative publicity, loss of reputation
in the medical community, revocation of hospital privileges, and will likely
lose patients, time, and wages. Stories like Dr. Hoover's have had a chilling
effect on physicians who prescribe narcotics to manage pain. n199 Physicians are
reluctant to prescribe pain medication for fear of investigations and
disciplinary actions by the state professional licensing boards, which are often
triggered solely by the quantity of medication that a provider prescribes. With
the potential for sanctions, many providers choose to refer their patients to
other providers or pain management clinics for the treatment of pain to avoid
prosecutions by state medical boards. n200 This situation clearly impedes the
management of pain.
5. Law Enforcement
The enforcement of controlled substance laws by state medical boards, coupled
with criminal actions against health care providers, exacerbate health care
providers' reluctance to prescribe narcotics for pain management. While there
are only a few reported cases, anecdotal evidence suggests that doctors, nurses,
and other health care providers are distressed by potential criminal prosecution
for prescribing and/or administering pain medications to patients with terminal
illnesses. n201 Criminal actions against providers for prescribing pain
medication to patients, although rare, increase the reluctance to prescribe
opioids and thus impede pain management. n202
Between 1990 and 1998, few health care providers were convicted of criminal
charges associated with the management of pain. For example, Ann Alpers
identified six physicians who had been formally charged or indicted for homicide
between 1990 and 1998. n203 Of these, two physicians were acquitted, one pled
guilty and received community service, one was convicted of involuntary
manslaughter, a "lesser offense" in relation to homicide, one physician was
convicted of attempted first-degree murder, and one physician was convicted of
second-degree murder. Both murder [*112] convictions, however, were reversed
on appeal. n204 With respect to nurses, Alpers identified four nurses who
underwent criminal investigation for the management of pain, two of whom were
Since Alpers' article, the abuse of OxyContin and media attention regarding this
issue have escalated. Law enforcement officers in several states have brought
criminal actions against providers for over prescribing OxyContin to patients
who subsequently died. In February 2002, in the first case of its kind, a jury
found Dr. James F. Graves guilty of four counts of manslaughter, five counts of
unlawful delivery of a controlled substance, and one count of racketeering for
prescribing OxyContin to patients. n206 Prosecutors argued that Dr. Graves
recklessly wrote prescriptions to anyone willing to pay for an office visit
without asking the proper pre-prescribing questions, which they argued, led to
several patient deaths. n207 Dr. Graves argued that he followed medical
protocols and legitimately prescribed OxyContin and other pain medication to
patients he saw in his office, further asserting that patients would not have
died had they taken the medication properly. n208 While Dr. Graves plans to
appeal the verdict, he faces up to thirty years in prison. n209 In another case,
state prosecutors in Florida charged Dr. Denis Deonarine with first-degree
murder, a more serious crime than manslaughter, after his patient died from an
OxyContin overdose. n210
Because of increased focus on OxyContin, the reluctance of providers to
prescribe OxyContin and other pain medications will continue, if not intensify.
The reluctance of providers to prescribe narcotics for fear of criminal
sanctions fails to achieve a balance in state pain policy. Instead, the
prevention of abuse through enforcement actions overshadows efforts to improve
the availability of controlled substances to patients in pain. Commentators have
argued that the collective impact is to dissuade doctors [*113] from
aggressively treating pain. n211 These arguments are plausible notwithstanding
the dearth of decisional law on this issue, principally because of the increased
media focus on criminal investigations for OxyContin abuse coupled with the
specter of criminal investigations. Because these enforcement efforts have the
potential to impact provider livelihood and liberty, it should come as no
surprise that providers would choose to undertreat pain.
C. Attitudinal Barriers to Pain Management
The undertreatment of pain in the medical setting has sources that run far
deeper than reluctance [of health care providers] to provide adequate pain
Although the reluctance of health care providers to prescribe narcotics for fear
of criminal sanctions has exacerbated the problem of undertreatment of pain,
n213 underprescribing narcotics for pain is caused by a multitude of factors.
The attitudes of health care providers, patients and their families, and the
public at large, are among the factors that both create and perpetuate barriers
to pain management. For example, two major misconceptions about narcotics and
pain present barriers to the management of pain: (1) a fear that opioids cause
addiction, and (2) that the use of opioids can lead to terminal sedation. These
misconceptions perpetuate the underprescribing of narcotics to treat pain and
create barriers to proper and adequate treatment of pain. n214
Torture, despair, agony, and death are the symptoms of "opiophobia," a
well-documented medical syndrome fed by fear, superstition, and the war on
drugs. Doctors suffer the syndrome. Patients suffer the [*114] consequences.
Both health care providers and patients alike have been affected by what is
described as "opiophobia." n216 Opiophobia is the fear that the use of narcotics
causes drug addiction and drug abuse, and consequently is a factor that creates
a barrier to pain management. n217 The fear of addition to narcotics appears to
be based on the widespread misperception that physical dependence is equivalent
to addiction. Recent studies confirm that health care providers are reluctant to
prescribe, dispense, or administer opioids because they fear causing addiction
or contributing to the drug abuse problem. n218 For example, in a survey of 386
physicians in Texas, 25% of the respondents believed that any patient who is
given opioids for pain relief is at significant risk for addiction. n219 More
than 90% of physicians "believed that they must exercise caution when
prescribing potentially addictive medications to patients with chronic pain."
Fear of drug addiction and drug abuse is far greater for patients in chronic
pain in comparison to terminally ill individuals. n221 For example, in a survey
of 161 primary care physicians, 35% of the respondents were never willing to
prescribe Schedule II opioids on a twenty-four hour basis for patients with
chronic non-malignant pain, even after exhaustive evaluation and attempts at
treatment. n222 Two percent of the physicians were never willing to prescribe
Schedule III opioids (e.g., Tylenol with codeine) [*115] as needed for
patients with chronic and persistent non-malignant pain. n223 The surveyors
concluded that the reluctance of primary care physicians to prescribe opioids
for chronic non-malignant pain is connected to concerns about dependence,
tolerance, and addiction, and that primary care physicians were generally more
concerned about physical dependence, tolerance, and addiction than they were
about diversion for illegal use, regulatory scrutiny, or side effects. n224
Health care providers often confuse the terms physical dependence, tolerance,
and psychological dependence and "mistakenly interpret a satisfactory analgesic
drug effect as euphoria." n225 Despite provider fears, there is evidence that
patients treated with narcotics rarely become psychologically addicted to pain
medication. n226 For example, in 1980, researchers at Boston University Medical
Center reported that they had reviewed records of 11,882 hospital patients
treated with narcotics and found "only four cases of reasonably well documented
addiction in patients who had no history of addiction." n227 Similarly, a 1982
study of 10,000 burn victims who had received narcotic injections, most of them
for weeks or months, found no cases of drug abuse that could be attributed to
pain treatment. n228 These studies demonstrate that the legitimate use of
controlled substances is unlikely to cause psychological addiction to narcotics.
Scientific literature also supports the notion that the use of controlled
substances does not contribute to an increase in opioid abuse. In a recent
evaluation, researchers found that the medical use of opioids had increased
between 1990 and 1996, but there was no evidence of a corresponding increase in
abuse. n229 Misconceptions about opioids cause reluctance on the part of health
care providers to prescribe, dispense, or administer narcotics for pain relief,
particularly in chronic pain patients and are thus a barrier to the adequate
management of pain with controlled substances.
2. Fear That High Doses of Pain Medications Will Lead to Death
In contrast to chronic pain, the public at large and health care providers
generally support the use of controlled substances to comfort terminally ill
patients suffering in pain. n230 However, both health care providers and
patients have concerns that opioids may result in terminal sedation. As physical
tolerance develops, there is fear that higher doses of narcotics will slow the
patient's breathing to a point that the breathing ceases and the patient dies.
While this misconception is prevalent, n231 there is little empirical evidence
that a faster death ensues when opioids are used to manage severe pain in dying
patients. n232 In fact, when properly titrated, opioids are entirely safe.
Nevertheless, some providers are reluctant to prescribe opioids to terminally
ill patients for fear of terminal sedation.
Although appropriate titration generally does not result in terminal sedation,
it is difficult to determine the correct amount of drugs to administer.
Clinicians suggest that there is no maximal or optimal quantity of an opioid
analgesic drug for either chronic or cancer pain. n233 The appropriate dose is
one that relieves the patient's pain without causing adverse side effects. n234
In some instances, patients with severe cancer pain may require 1200 to 1800
milligrams of oral morphine per day, while other cancer patients may require a
greater dosage of intravenous morphine at 1000 to 4500 milligrams per hour. n235
Clinicians such as Dr. Michael Levy recommend that the "initial dose of a drug
should be based on the patient's [*117] level of pain and the efficacy of
prior analgesic therapy." n236 Subsequent drug therapy should be based on "a
continuing assessment of the efficacy of the therapy, with the dosage titrated
upward as needed." n237 Because opioids have no ceiling effect, the dose of pain
medication can be increased until pain relief is achieved or until the side
effects of the medication become intolerable. n238 Clinicians note that sedation
and cognitive impairment typically can be managed by allowing time for tolerance
to develop after drug therapy is initiated or after the dose is escalated, and
also by combining the use of non-opioid, non-sedating drugs with the use of
opioids. n239 Clinicians also recommend that opioids be administered at regular
intervals to prevent the recurrence of pain rather than administered as needed
by the patient. This practice reduces overall drug consumption and minimizes the
number of daily doses of medication. n240 The erroneous belief that opioids
cause terminal sedation makes health care providers reluctant to prescribe,
dispense, or administer narcotics for pain relief and thus presents a barrier to
the adequate management of pain with controlled substances.
3. Philosophy of Medicine
In addition to the misconceptions surrounding opioid use, the philosophical
perspective of Western medicine unnecessarily perpetuates the inadequate
management of pain and the negative attitudes of health care providers toward
the use of opioids to treat pain. n241 First, health care providers place great
weight in the objective approach to diagnosis. n242 This approach ultimately
fails because pain is subjective, not objective. n243 In order to assess pain,
health care providers must rely on first-person reports [*118] from patients.
n244 The subjectivity of pain interferes with its incorporation into modern
medicine. Although health care providers are taught to talk to patients about
pain and include pain assessment in the initial exam and health history, they
tend to put greater weight on objective tests. n245 Chronic non-malignant pain
challenges this approach given that objective tests cannot identify the source
of this type of pain.
Second, the causal basis of pain is often poorly understood. n246 Only within
the past thirty years has the health care community begun to understand how the
body perceives pain. n247 When health care providers do not know or understand
the causal basis for a medical condition, they frequently view the condition as
not real. n248 Doctors may treat patients' reports of pain as imaginary,
exaggerated, fraudulent, or merely psychological. n249
Third, health care providers view pain as a "mere" symptom of disease rather
than a separate phenomenon with a pathology of its own. As a result, pain
treatment may be given less emphasis in a patient's plan of care. n250 Other
treatment concerns, such as prolonging life and restoring health, may be viewed
as more important than pain management. With this mindset, pain has
traditionally not been studied in isolation. However, recently there has been a
focus on the comfort of patients, as evidenced by the increasing number of pain
specialists, pain centers, and palliative care. n251
Fourth, there often are no "magic bullets" to alleviate pain. n252 Because pain
has psychological, social, cultural, and spiritual components, no magic cure
exists to eliminate pain. Pain control is a complex problem that requires a
multi-disciplinary approach. n253 Despite clinicians' best intentions, pain and
symptom control is often inadequate because the entire healthcare system has
been designed around the cure of disease rather than palliation. n254 Fifth,
pain does not fit the expert knowledge model. While [*119] health care
providers are generally educated and trained to be experts on medical issues,
pain reverses the usual model of the doctor-patient relationship by placing the
knowledge and authority in the hands of patients, not health care providers.
For these reasons, the medical model results in negative attitudes on the part
of health care providers toward the use of opioids to treat pain, which
consequently results in the inadequate management of pain. Public policies to
improve the management of pain should allocate funds to medical, pharmacy, and
nursing schools for training and continuing education to address these issues.
4. Inadequate Education in the Areas of Pain Management
Inadequate education about pain management resulting in negative attitudes about
opioids is yet another factor that creates a barrier to pain management. In a
survey of 386 physicians in Texas, more than fifty percent erroneously believed
that drug addiction is a common result of the legitimate prescription of
controlled substances. n257 Further, approximately one-third of the respondents
incorrectly believed that increasing requests for analgesics indicated tolerance
to pain medication. They disagreed that almost all cancer patients suffer pain
and that almost all cancer patients should receive opioids to relieve chronic
Inadequate knowledge about pain management is not limited to physicians alone.
n259 A study of 305 emergency room nurses reported that forty-four percent of
the time, inadequate knowledge of pain management principles affected their
practice in the emergency department. n260 Because emergency room nurses screen
and classify individuals in the emergency room to determine the priority of
treatment, and are often the first health care providers to examine and/or
interview a patient experiencing pain, the knowledge base of emergency room
nurses has a profound impact on an emergency department's treatment of pain. The
researchers found that the emergency nurses did not understand the difference
between physical dependence, addiction, and tolerance. n261 The researchers
concluded that a [*120] "misunderstanding of these terms may lead emergency
room nurses to be overly concerned about addiction, which may lead to the
undertreatment of pain." n262
Health care providers who have an inadequate knowledge about the use of
controlled substances to manage pain are more reluctant to prescribe, dispense,
or administer opioids to manage pain. Accordingly, public policies to improve
the management of pain should include remedies to address the inadequate
knowledge of pain management. For example, the receipt of federal money by
professional schools and universities could be contingent upon compliance with a
requirement that they incorporate pain management and the use of controlled
substances to treat pain into their curricula. n263 Moreover, funds could be
allocated to academic institutions and professional schools for education about
pain management. n264 This would ensure that future health care providers
receive at least some exposure to pain management early in their careers.
Finally, DEA registration to prescribe controlled substances could be made
contingent on continuing medical education in the use of controlled substances
to manage pain. n265
D. Reimbursement For Pain Management Is a Barrier to Adequate Pain Management
In addition to education, the Medicare and Medicaid programs play a critical
role in pain relief in the United States. Since 1965, the federal government has
provided funding for health care through the Medicare and Medicaid Programs.
However, Medicare and Medicaid reimbursement policies often impede pain
management. n266 Limited prescription drug coverage, government investigations
of physician diagnoses, and hospice eligibility requirements prevent Medicare
and Medicaid beneficiaries from accessing pain management services.
1. Medicare Reimbursement
The Medicare program provides payment for services and medications for almost
all persons over the age of sixty-five, disabled persons under sixty-five years
of age, and persons with end-stage renal disease. n267 Medicare Part A provides
coverage for inpatient hospital care, n268 skilled nursing facilities, n269 and
hospice care n270 whereas Medicare Part B generally provides coverage for
physician services. n271 Medicare also reimburses providers for services such as
pain medication injections, n272 infusion pumps, n273 and electrical
[*122] In addition, Medicare Part B provides coverage for medication supplied
incidental to a physician's professional services and for those drugs that
cannot be self-administered. n275 However, Medicare does not provide payment,
for oral medication in an outpatient setting, including pain medication that is
supplied pursuant to a physician's prescription. n276 [*123] Consequently,
Medicare beneficiaries can be admitted to a hospital, skilled nursing facility,
or hospice, and receive Medicare coverage for care that may cost thousands of
dollars; however, the program will not cover a patient's monthly prescription
costs for oral pain medication, which may amount to several hundred dollars
every month. The high cost of oral pain medication is necessarily a problem for
elderly persons on fixed incomes who have several prescriptions. In 1996, for
example, the average annual out-of-pocket expense for medication per elderly
person was $ 405, a ninety-one percent increase in comparison to 1987. n277 When
seniors with limited budgets must decide which prescriptions to fill, they are
more likely to fill their prescriptions for blood pressure or diabetes
medication, rather than medicine for pain relief, which may they consider
non-essential medication. As such, Medicare's reimbursement policy for oral
medication impedes pain management for Medicare beneficiaries who are suffering
in pain and who are not in settings in which pain medication is reimbursed by
Medicare Part A also provides coverage for hospice services. n278 In 2001, the
total number of hospice users was 579,801. n279 Hospice benefits provide for the
management of terminal illness and related conditions, including pain relief. To
qualify for hospice benefits, a beneficiary must be considered "terminally ill"
and must voluntarily elect hospice care. n280 A beneficiary is considered
"terminally ill" if a physician certifies that the beneficiary has a life
expectancy of six months or less. n281 Once a beneficiary elects hospice care,
the individual must waive the right to Medicare payment for all curative
treatment for the terminal illness and related conditions. n282 In return, the
patient is eligible for a variety of [*124] palliative care services. n283
Many experts suggest that access to hospice care under Medicare is limited and
that enrollment in hospice often occurs too late. n284 From 1992 to 2002, for
instance, the number of hospice patients dying within one week of admission
increased from twenty-one percent to thirty percent. n285 Consequently, the data
suggest that patients are not receiving the totality of an important Medicare
benefit - at least six months of hospice services - that Congress intended the
terminally ill to receive.
In a 2002 report to Congress, the Medicare Payment Commission ("MedPac")
concluded that the difficulty in predicting the course of illness, even with
today's advanced technology, causes late enrollment in hospice programs. n286
Research suggests that only twenty percent of prognoses of terminal illness were
accurate and sixty-three percent overestimated the survival time of
beneficiaries. n287 Given the difficulty in predicting a patient's death, most
patients referred to hospice die within only three weeks of their admission to a
hospice. n288 Recognizing this, Congress [*125] recently amended the Social
Security Act to clarify that the certification of a terminal illness "shall be
based on the physician's or medical director's clinical judgment regarding the
normal course of the individual's judgment." n289 According to MedPac,
additional time may be required for the health care industry to familiarize
itself with this standard and apply it. n290
Another reason for delayed admissions to hospice care is physicians' concern
with investigations into Medicare certifications for patients who did not expire
as early as predicted. n291 Investigative agencies such as the Office of
Inspector General ("OIG") have conducted retrospective reviews of terminal
illness certifications. n292 Federal government audits of hospice certifications
deter physicians from making referrals to hospice at the appropriate time n293
because physicians do not wish to trigger OIG scrutiny of their medical practice
(with potential charges, including Medicare fraud, at issue). n294 Accordingly,
these investigations substitute retrospective governmental scrutiny for medical
judgment and are thus a barrier to the adequate management of pain.
Medicare payment rates for hospice services are yet another barrier to adequate
pain management. Hospice services for both Medicare and Medicaid are paid on
four prospective per diem rates, with each rate determined by the level of
service and whether it is provided on an inpatient or outpatient basis. n295
While beneficiaries are not precluded from receiving [*126] hospice services
in excess of six months, the hospice benefit is capped at a specific amount each
year regardless of the services provided. n296 In 1997, the OIG found that
hospice patients residing in nursing homes received fewer services than similar
patients who received hospice services in their homes, even though the
reimbursement rates for both types of patients were the same. n297 While hospice
payment rates are adjusted for inflation annually, the rates are based on
information from a Medicare demonstration project completed in the early 1980s
and are thus inconsistent with the costs that efficient hospices incur in
furnishing care to patients. n298 In its report to Congress, MedPac recommended
evaluating hospice payment rates to ensure that they are consistent with the
costs of providing appropriate care. n299
2. Medicaid Reimbursement
In addition to Medicare, a major payer of services, Medicaid is a joint federal
and state program also providing coverage for pain management. n300 The Medicaid
program provides coverage for health-related services for the poor and for
individuals over the age of sixty-five who are dually eligible for Medicaid.
n301 Because Medicaid is run by the states, Medicaid coverage policies for pain
management differ from state to state. In general, [*127] Medicaid provides
coverage for inpatient services, n302 outpatient care, n303 skilled nursing
facility care, n304 and physician services. n305
The most significant Medicaid issue is prescription drug coverage. Medicaid has
historically filled the gap in Medicare's lack of a prescription drug benefit by
providing coverage for drugs to beneficiaries. n306 Medicaid has also played a
"key role" in bridging the gaps in Medicare for those beneficiaries who are
dually eligible under both government programs. n307 However, the Medicaid
statute allows states to impose copayments on beneficiaries to limit coverage.
n308 Studies have shown that copayments of as little as one dollar per
prescription have led to a five to ten percent decline in drug use, including
both essential and nonessential drugs. n309
Federal law also permits states to limit the minimum or maximum quantities per
prescription or the maximum number of refills of the medication. n310 As of
1998, approximately half of the states imposed limits on the quantity of drugs
that could be dispensed and/or the number of refills per prescriptions. n311
More significantly, eight states limited the number of prescription refills a
recipient may obtain in one month, while other states limit the number of
dispensing fees that a pharmacist could receive in a month for filling a
particular recipient's prescriptions. n312 Because pain patients often require
frequent dosages of medication - upwards of thirty to fifty pills a day - these
limitations are likely to impede pain management. n313 Attempts to limit
Medicaid coverage of pain medication through restrictions on the quantity of
drugs have an adverse effect on pain management because patients are unable to
obtain the medication they need and are left to find either another source of
payment or to suffer in pain. n314
[*128] Because the Medicare and/or Medicaid programs may limit the ability of
patients to access controlled substances or hospice services for pain relief,
the programs are barriers to pain management. Any policy that purports to
improve pain management should: (1) eliminate the Medicare requirement that a
physician certify that an individual has six months or less to live and require
that physicians certify terminal illness by another standard to be determined by
Centers for Medicare and Medicaid Services with input from physicians; (2)
provide a safe harbor from federal and state fraud investigations for health
care providers and institutions who, in good faith, certify Medicare
beneficiaries for hospice services; (3) establish a requirement that OIG audits
of hospice care eligibility determinations are performed by physicians who
specialize in patients with terminal illness; (4) address Medicare payment rates
for hospice services; and (5) prohibit states from placing limitations on the
quantity of prescription drugs dispensed to Medicaid beneficiaries.
E. Civil Liability for the Undertreatment of Pain
While there are a multitude of barriers that impede adequate pain management,
until recently, there were no external incentives for providers to treat pain.
Traditionally, state medical boards have declined to pursue disciplinary actions
against health care providers for the undertreatment of pain. For example, the
family of an elderly man who died of lung cancer filed a complaint with the
Medical Board of California against a physician for failing to prescribe
adequate pain medication prior to his death. n315 While the Board's medical
consultant agreed that "the pain care was indeed inadequate," it concluded that,
"there is insufficient evidence at this time to warrant pursing further action."
n316 The family subsequently filed a lawsuit in California state court asserting
medical malpractice and elder abuse. n317
Today, however, the threat of civil liability is emerging as an incentive for
providers to treat pain. While there are only a few cases alleging the
undertreatment of pain as the basis for a medical malpractice claim, two recent
cases indicate that these actions may be on the rise. While health [*129] care
providers may need an incentive to provide pain medicine, in the current system
these providers are placed in a difficult position where both the treatment and
the overtreatment of pain may result in penalties. If they prescribe pain
medication to treat pain, they are subjecting themselves to potential
disciplinary or criminal actions. Under controlled substance laws, there is
clearly an incentive to avoid prescribing narcotics for pain relief, including
the potential for a reprimand, fines, suspension or revocation of the
professional licenses, criminal penalties, jail time, and loss of liberty.
However, if providers do not prescribe controlled substances, they may now face
administrative disciplinary actions by state medical boards, civil actions for
the undertreatment of pain, malpractice awards, increased insurance costs, and
publication of such information on databases available to various health care
entities and the public. The physician is forced to choose between the lesser of
two evils, notwithstanding his or her wishes to provide relief from pain.
An Oregon case, the only instance to date in which a state medical board
disciplined a health care provider for under-prescribing pain medication, may
signal a shift in attitudes toward imposing liability for undertreating pain. In
September 1999, the Oregon Board of Medical Examiners cited Dr. Paul Bilder, a
fifty-four year old pulmonary specialist, for unprofessional or dishonorable
conduct and gross or repeated acts of negligence for failing to adequately treat
six seriously ill or dying patients with pain medication from 1993 to 1998. n318
In at least three of the cases, Dr. Bilder purportedly failed to prescribe
controlled substances for pain relief for fear that pain medication would
suppress the respiratory drive of his patients despite medical research
reflecting appropriate titration of controlled substances does not depress
patient respirations. n319 In one case, for example, Dr. Bilder refused to
prescribe sedatives for a thirty-five year old woman with pulmonary disease and
instead prescribed a paralytic agent, which relaxes the breathing muscles to
accommodate the breathing tube. n320 Dr. Bilder refused to prescribe pain
medications or sedatives later that day [*130] when the patient became
restless and fought the ventilator. n321 When the woman subsequently pulled out
her breathing tube, Dr. Bilder failed to respond to requests to re-intubate the
patient. n322 While the Board did not suspend or revoke Dr. Bilder's license to
practice medicine, it required him to complete a one-year program in which
another pulmonary specialist worked with him to assess his practice and make
improvements; it also required him to attend a continuing medical education
course on physician-patient communication and to meet with a psychiatrist who
would give regular reports to the Board for at least one year. n323
Dr. Bilder's case demonstrates the extent to which providers' lack of knowledge
about the appropriate use of narcotics to manage pain may negatively impact
their use of narcotics to relieve pain or discomfort. Further, Dr. Bilder's
story sends a message to providers that state medical boards may impose
sanctions, pursuant to administrative actions, for undertreating pain.
Accordingly, both the treatment and undertreatment of pain may prospectively
result in penalties and the loss of external rewards (i.e., loss or suspension
of license, fines, etc.). Nevertheless, health care providers may continue to
perceive the potential penalties for undertreatment by medical boards less
onerous than those penalties imposed when a provider overtreats, given that
Oregon's medical board did not suspend or revoke Dr. Bilder's medical license
but merely imposed continuing medical education, physician mentoring, and
psychiatric visits. Accordingly, providers may continue to undertreat pain.
Aside from disciplinary actions, two other cases illustrate the potential civil
penalties that providers may face for undertreating pain. In Estate of Henry
James v. Hillhaven, a 1990 case, the court found a health care provider liable
for failing to treat pain appropriately. n324 Mr. James was admitted to
Hillhaven nursing home with less than six months to live as a result of prostate
cancer that had metastasized to his left femur and spine. Although a physician
had ordered doses of oral morphine elixir every three hours as needed for pain,
a Hillhaven nurse, based on her assessment that Mr. James was "addicted to
morphine," substituted a mild tranquilizer and delayed or withheld altogether
the administration of the oral morphine [*131] without the physician's
Mr. James' family filed a lawsuit alleging that the failure of the nurse and the
nursing home to ensure the proper administration of pain medication in
appropriate doses caused Mr. James to experience "inhuman treatment" inflicted
"without regard to the consequences and without care as to whether or not the
patient received analgesic relief and without care that the result and
procedures were torture of the human flesh." n326 During the trial, medical and
nursing experts testified about the proper standard of care for the
administration of opioid analgesics and specifically about the administration of
morphine for the relief of intractable pain. n327 In addition, a nurse
specializing in quality assurance for nursing homes testified that health care
institutions have an obligation to ensure that their health care providers
properly manage pain. n328 The jury awarded fifteen million dollars in damages
to the family of Mr. James, which was subsequently resolved by settlement among
the parties in an undisclosed amount. In his summary statement approving the
settlement, Judge Grant reiterated that Mr. James' family "does not allege that
the conduct of the defendants caused the death of [Mr. James], but only that the
conduct of the defendants caused [him] increased pain and suffering[.]" n329
It was not until eleven years after Hillhaven that a jury found another health
care provider liable for the undertreatment of pain. Bergman v. Eden Medical
Center is the first case in which a physician was held liable for elder abuse
under California's Bill of Patient's Rights for the undertreatment of pain based
on the physician's failure to prescribe sufficient medication for a terminally
ill patient. n330 William Bergman, eighty-five years old, presented to Eden
Medical Center in Northern California with complaints of severe back pain. n331
Mr. Bergman had [*132] recently lost weight and had been suffering pain from a
compression fracture of a spinal bone; a chest x-ray also revealed possible lung
cancer. n332 Dr. Wing Chin, an internal medicine specialist who had not
previously treated Bergman, admitted him to the hospital for tests and
prescribed intravenous Demerol, a narcotic for pain, to be given in twenty-five
to fifty milligram doses as needed. n333
Nurses at the hospital periodically asked Mr. Bergman to rate his pain on a
scale of one to ten and recorded his responses. All of the ratings in Mr.
Bergman's medical chart ranged from seven to ten, corresponding with moderate to
severe pain. However, progress notes recorded at other times by Dr. Chin and
respiratory therapists indicated that Mr. Bergman said he "felt okay" or that
his back pain was tolerable. n334 Mr. Bergman underwent a procedure to obtain
lung tissue - although not definitive, the results were suggestive of lung
cancer. Subsequently, Mr. Bergman chose to forego treatment for lung cancer and
returned home from the hospital for palliative care. n335 Upon discharge, Mr.
Bergman rated his pain a ten for which Dr. Chin prescribed Vicodin tablets, even
though Mr. Bergman could not swallow pills and even though this medication had
been ineffective for his back pain on previous occasions. n336 Mr. Bergman's
daughter complained that her father required stronger pain medication;
accordingly, Dr. Chin ordered a single injection of Demerol and a slow-release
patch containing fentanyl, a narcotic. n337 After three days at home, a hospice
nurse assessed Mr. Bergman's pain at level ten and called Dr. Chin to ask him to
prescribe liquid morphine. n338 According to court records, Dr. Chin did not
prescribe the morphine. n339 Later that afternoon, a doctor who had previously
treated Mr. Bergman prescribed a single dose of morphine, which brought him
immediate relief. Mr. Bergman died the next day. n340
Mr. Bergman's family sued both Eden Medical Center and Dr. Chin alleging
violation of California's Elder Abuse and Dependent Adult Civil Protection Act
Remedies, which allows patients to ask for painkillers of [*133] their choice.
n341 The act provides that "abuse" of an elder includes "neglect," which is
defined to include the failure to provide medical care for physical and mental
health needs. n342 It allows for both criminal prosecutions n343 and civil suits
n344 against those accused of elder abuse. It also allows a victim's family to
bring a lawsuit, even after the victim's death. n345 Because California's
malpractice laws do not allow pain and suffering for the deceased, Mr. Bergman's
family brought a lawsuit for elder abuse. n346
The jury found Dr. Chin liable for elder abuse and reckless negligence by not
giving Mr. Bergman enough pain medication. Although the jury awarded Mr.
Bergman's family $ 1.5 million in general damages, it did not find that Dr. Chin
acted with malice or that he had intentionally caused emotional distress that
would have supported an award of punitive damages. n347 Subsequently, the trial
judge reduced the $ 1.5 million damages to $ 250,000, applying California's
medical malpractice cap, n348 notwithstanding that the case had been
characterized as one of abuse rather than malpractice. In April 2002, Judge
Robert Hunter of the Superior Court of California for Alameda County denied
defense motions to set aside the verdict and demand a new trial. The court also
awarded attorney's fees to the plaintiff and applied a 1.5 multiplier to the fee
award to emphasize the importance of the case to the public interest. n349
The Bergman decision has had a tremendous impact on the management of pain in
California. n350 Reacting to the case, California passed legislation n351
requiring physicians to complete continuing medical education every four years.
As stated by Dr. Russell Portenoy, former president of the American Pain Society
and head of the pain management department of Beth Israel Medical Center in New
York City, the Bergman case also sends a wake-up call to physicians that there
are potential civil penalties for undertreating pain: "it begins to create the
reality of (punishment) ... for [*134] physicians who don't respond to
patients who have severe pain." n352
Professor Barry Furrow suggests that cases similar to Hillhaven and Bergman are
likely to continue and even increase in the near future given the number of
"politically savvy aging babyboomers with lower back pain," the sound scientific
evidence for the proper assessment of pain, and the proliferation of practice
management guidelines. n353 Furrow and other scholars have proposed that pain
management guidelines may be utilized as a tool by plaintiff's attorneys to
establish the standard of care for pain management. n354 Practice guidelines are
standardized suggestions based on a consensus of current medical research about
how to treat a particular medical condition. These guidelines assist health care
providers and guide patient decisions about managing a particular condition.
Prior to and including the time of the Hillhaven case, practice guidelines for
the management of pain did not exist, which would explain the absence of other
undertreatment cases. Proving negligent pain management has been difficult for
plaintiffs given the failure of the medical profession to implement pain
management standards. In 1992, the U.S. Department of Health and Human Services
Agency for Health Care Policy and Research ("AHCPR") released its Acute Pain
Management Guidelines, and in 1994, it released its Cancer Pain Management
Guidelines. n356 Other groups have since released guidelines for the management
of different types of pain, including peri-operative pain, n357 low back pain,
n358 and acute and chronic pain in sickle cell disease. n359 The Agency for
Health Care Policy and Research has also issued guidelines for a variety of
patient groups, including injured workers, n360 the elderly, n361 and long-term
care residents. n362 [*135] Clinical practice guidelines potentially offer an
authoritative and settled statement of what the standard of care should be for
the treatment of pain. n363 Elder abuse/neglect provisions similar to
California's Patient's Bill of Rights, under which the suit against Dr. Chin was
brought, combined with medical guidelines outlining proper treatment of pain in
sick and dying patients, offer ways to impose responsibility for failures in
pain and symptom management. n364
While cases premised on the undertreatment of pain are likely to continue, it is
unlikely that these cases alone will be sufficient to diminish physician
reluctance to manage pain with controlled substances given the factors that work
in concert to impede pain management. Consequently, a comprehensive solution
that addresses each of the barriers to pain management is needed to shift the
environment to one that treats pain adequately.
III. The Need for a Comprehensive Approach to Pain Management and the
Conquering Pain Act of 2003
There is a clear call for Congress to develop a comprehensive pain management
policy. Despite advances in technology, changes to state pain policies, and the
proliferation of practice guidelines for pain management, the inadequate
treatment of pain continues to be a significant problem in this country. The
problem is rooted in several causes: fear of disciplinary action and criminal
investigations; patient and provider attitudes; and inadequate reimbursement,
among others. To date, efforts to address this problem have treated only one or
two components of the problem.
These solutions, which are less than comprehensive, have failed to affect an
improvement in the management of pain. For example, while some state
legislatures have improved state laws and regulations (i.e, the creation of
IPTAs), inadequate pain management continues. Despite improvements in
reimbursement policies, pain management remains a problem. The key to [*136]
affecting an improvement is a coordinated course of action that addresses each
component that contributes to the inadequate management of pain. A comprehensive
approach addressing each barrier to pain management - federal and state laws;
federal and state investigation and enforcement of controlled substances laws;
patient and physician attitudes; inadequate education; and reimbursement
policies - is needed.
A promising plan introduced in the 108th Congress, the Conquering Pain Act of
2003 ("CPA"), is a significant attempt to address a number of the barriers to
pain management. n365 Similar versions of the bill were introduced in 1999 and
2001, but met an unceremonious demise, having been referred to House and Senate
committees and subcommittees but going no further. n366 Though disappointing, in
light of the myriad of political and financial issues that have confronted
Congress over the past four years, it is not surprising that the CPA has not
come to the forefront. n367 However, inadequate pain management continues to be
a problem with more than fifty million individuals currently suffer from chronic
pain, resulting in a cost of $ 100 billion dollars to society in lost
productivity and increased health care costs. n368 The management of pain
deserves Congress' attention now and the CPA is a noteworthy effort to address
the inadequate treatment of pain.
First and foremost, the CPA recognizes that untreated and undertreated pain is a
serious health problem in America. Congress has identified and focused on the
particular problem of undertreatment of pain and, in so doing, has recognized
not only the pain suffered by individual patients and the burdens suffered by
many providers but also the financial burdens placed on society. n369 Through
the Act, Congress also acknowledges that providers are inadequately trained in
pain management and that the treatment of pain is suboptimal because the medical
model focuses on a cure rather than on symptom management. n370 Because all of
these factors have been identified as contributing to the undertreatment of
pain, the CPA is more comprehensive than past legislative efforts and addresses
issues including, education, attitudes, regulation, and reimbursement.
A. Title I
Under Title I, section 102, the Secretary of Health and Human Services (the
"Secretary") is required, through the Agency for Health Research and Quality ("AHRQ"),
to ensure that health care facilities make available a website established by
AHRQ to all health care personnel providing care or services at the health care
facility. n371 The health care facilities would also be required to ensure that
the website is accessible to health care providers, patients, and families. n372
This provision specifically addresses the inadequate education of those involved
in pain management and will likely improve the knowledge of pain management
groups by ensuring that these groups have access to practice guidelines.
Section 102 of Title I requires the administrators of several federal government
programs, i.e., Medicare, Medicaid, the Public Health Service, and others, to
inform beneficiaries that they should "expect to have their pain assessed and
should expect to be provided with effective pain and symptom relief, when
receiving benefits under such program." n373 While this provision will create
patient expectations of pain assessment and pain relief, it falls short of
requiring providers to provide pain relief for beneficiaries of these programs.
Under section 103, the Secretary is required to provide funds for the
implementation of special education projects for providers, in as many states as
practicable, to improve the quality of pain and symptom management. n374 These
projects would place "an emphasis on improving pain and symptom management at
the end of life," and could also include efforts to increase the quality of
services delivered to chronic pain patients and the chronically ill for whom
pain may be a significant symptom. n375 This provision has the potential to
improve pain management by educating providers about the management of pain.
Section 104 requires Medicare + Choice plans to provide information to
beneficiaries about the "organization's coverage of pain and symptom [*138]
management" and to evaluate the plan's performance with respect to access to,
and quality of, pain and symptom management. n376 Similar to section 102 of
Title I, this provision creates patient expectations of pain assessment and pain
relief. However, it similarly falls short of providing a right to pain relief
for beneficiaries of these programs.
Under Section 105, the Surgeon General is required to prepare and submit to the
appropriate congressional committees a report concerning the state of pain and
symptom management in the United States, which includes a description of the
legal and regulatory barriers to the treatment of pain. n377 This provision is
important because it recognizes that multiple barriers including inadequate
education, patient differences, attitudes and stringent laws and regulations,
impede the management of pain. The report by the Surgeon General makes the
information available to both the appropriate congressional committees and to
the public and thus increases awareness regarding pain management. n378 However,
while the Surgeon General's report may ultimately lead to specific actions to
address barriers to appropriate pain management, the provision, as written,
falls short of taking specific action to remove the barriers to the management
B. Title II
Title II awards grants for the establishment of six "National Family Support
Networks in Pain and Symptom Management" to serve as national models for
improving access and quality of pain and symptom management. n379 The Networks
cater to chronic pain patients and individuals in need of pain management at the
end of life and provide assistance to family members and caregivers. Although
the provision attempts to improve patient access to pain management and
patient-physician communication by establishing six networks, it fails to
address physician fears of regulatory scrutiny. Consequently, even if patient
access and communication is improved, the physician's fear of investigations and
sanctions for overprescribing pain medication will perpetuate the inadequate
treatment of pain.
C. Title III
Section 301 of Title III of the CPA requires MedPac to conduct a study and
submit a report to appropriate congressional committees concerning the [*139]
reimbursement barriers to pain management. n380 Section 302 of Title III would
require the General Accounting Office to conduct a survey of public and private
health insurance providers, including managed care entities, to determine
whether reimbursement policies of these insurers inhibits access to pain and
symptom management of chronic pain patients. n381 Sections 301 and 302 recognize
that reimbursement and insurance policies present barriers to the management of
pain. However, the provisions fall short of taking specific action to improve
known reimbursement barriers to the management of pain, such as the prescription
drug benefit or the hospice eligibility requirement.
D. Title IV
Section 401 of Title IV requires the Secretary to establish an advisory
committee to make recommendations to the Secretary concerning a coordinated
federal agenda on pain and symptom management. n382 The advisory committee must
prepare and submit recommendations concerning the need for a federal agenda on
pain and symptom management to the Secretary. The committee will also report on
ways to better coordinate the activities of entities within the Department of
Health and Human Services and other federal entities charged with responsibility
for the delivery of health care services and research on pain and symptom
management. n383 Under section 402, the Secretary, with the assistance of the
Institute of Medicine, will be required to review research regarding legal and
regulatory barriers that impact patient access to pain and symptom management.
Title IV enhances pain management for several reasons. First, it recognizes that
various barriers, including federal and state legal and regulatory policies,
exist to impede the management of pain. Second, Title IV implies that the
medical use of opioids is appropriate and a legitimate professional practice.
Third, Title IV recognizes that a comprehensive policy and a coordinated effort
is necessary to improve the management of pain. However, while Title IV may
ultimately lead to specific actions to address barriers to pain management, the
provision, like the other provisions, falls short of taking specific action to
remove the barriers to the management of pain or to address the adverse impact
that federal and state enforcement of controlled substance laws has on the
management of pain.
E. Title V
Under Title V, the Secretary, acting through the Health Resources and Services
Administration awards grants for the establishment of five or more demonstration
projects to determine effective methods to measure improvement in the skills,
knowledge, attitudes, and beliefs of health care personnel in pain and symptom
management. Additionally, five or more demonstration projects that implement
care models for individuals at the end of life are authorized under the
provision. This provision, like Title I section 102, specifically addresses the
inadequate education of health care providers, patients, and families regarding
the management of pain and assists educators in determining how best to educate
providers. However, while Title V may lead to specific actions to educate
providers about pain management, this provision, as written, does not advance
specific action to address the inadequate education of providers.
The Conquering Pain Act of 2003 is an admirable effort by Congress to address
the inadequate management of pain. It raises the public's awareness of this
issue and recognizes that multiple barriers impede pain management.
Additionally, the CPA acknowledges that a coordinated and comprehensive effort
is required to adequately address the management of pain. As such, it devotes
valuable federal resources, namely time and funds, to further research this
issue. However, despite its attempts, the Act does not go far enough to attack
the problem because it fails to adequately address several significant issues
that are known to impede the management of pain.
A. Investigations and Enforcement
Adding a provision that addresses the barriers created by government
investigations and the enforcement of controlled substance laws would strengthen
the CPA. The proposed law does not contain any provisions that address this
issue, even though the fear of regulatory scrutiny is a primary barrier to pain
management. Health care providers are reluctant to relieve the pain of their
patients even if they know it might be the best course of action. The reticence
on the part of providers is understandable given the severity of the potential
penalties: loss or revocation of license, fines, jail time, and loss of liberty.
The CPA should support the notion that effective pain management can be achieved
and that those who provide appropriate pain management have little to fear from
[*141] The Act could achieve this goal in two ways. n385 First, the CPA should
be amended to provide a "safe harbor," like those found in the state Intractable
Pain Treatment Acts that immunize health care providers and health care
institutions that prescribe, dispense, or administer controlled substances for
the purpose of relieving pain when the provider or institution demonstrates
compliance with an established practice guideline. Compliance with an applicable
practice guideline for pain management would provide a defense in an
administrative, civil, or criminal action under the CSA.
Second, the CPA should also be amended to address the problems with federal
investigations and enforcement actions. Generally speaking, federal and
particularly state investigations and enforcement actions for overprescribing
pain medications are triggered by the quantity of drug prescribed to a patient,
rather than a qualitative review of the patient's condition, the length of the
drug therapy, and the patient's response to drug therapy. For this reason, the
CPA should require the DEA and states to follow specific guidelines for
investigations and enforcement of controlled substance laws. These guidelines
should be determined with input from investigators and health care providers who
prescribe controlled substances to manage pain. For example, neither federal nor
state investigations should be triggered solely by the quantity of drug
prescribed. Both federal and state investigators should be trained in the
appropriate use of controlled substances. Further, investigators should be
required to have both quantifiable and qualifiable information and documentation
prior to bringing charges against any health care provider or institution for
overprescribing controlled substances, and should be required to review patient
medical records. This would create a presumption that the provider is acting in
the best interest of the patient, which is consistent with the goal of managing
pain. Investigators should also be required to consult with an expert in pain
management to evaluate the patient's medical records. On the other side,
providers and institutions should ensure that they have diligently and
sufficiently documented their assessments, telephone conversations with
patients, and the medical necessity of prescriptions for narcotics. Adequate
documentation should be utilized to refute charges of overprescribing narcotics
and to demonstrate compliance with the standard of care established by practice
B. Health Care Facility Inspection Requirements
The CPA should be amended to require that health care institutions that [*142]
participate in federal government health care programs assess and adequately
provide pain relief for beneficiaries of those federal programs. While the CPA,
as written, would create patient expectations of pain assessment and pain
relief, it falls short of requiring health care facilities to provide pain
relief for beneficiaries of these programs. The CPA should provide civil money
penalties and other punishments for health care facilities who fail to comply
with this requirement. The providers who demonstrate compliance with an
established practice guideline for the management of pain necessarily would
demonstrate compliance with the requirement.
The CPA should be amended to address four well-documented reimbursement barriers
to pain management. n386
First, Congress should amend the hospice provision in the Medicare Act to
eliminate the requirement that a physician certify that an individual has six
months or less to live. Instead, the Act should require that physicians certify
terminal illness by another standard to be determined by Centers of Medicare and
Medicaid Services with input from physicians and other health care providers.
The difficulty of predicting the course of illness or time of death makes the
physician certification of terminal illness requirement unworkable.
Consequently, hospice admissions are often delayed, and patients are not
receiving the full hospice benefit (i.e., six months) that Congress intended
them to receive.
Second, Congress should provide a safe harbor from federal and state fraud
investigations for health care providers and institutions who have, in good
faith, certified Medicare beneficiaries for hospice services. Congress should
expressly require that OIG audits of hospice care eligibility determinations are
performed by physicians who specialize in patients with terminal illness.
Physicians' concerns about investigations of their certifications of terminal
illness for hospice services delay admissions of Medicare beneficiaries to
hospice care and impede pain management.
Third, Congress should require that the Centers for Medicare and Medicare
Services evaluate Medicare payment rates for hospice services in light of
MedPac's recommendations, and report to Congress with the results of the
evaluation on specific date. Currently, hospice rates are based on information
obtained from the early 1980's, which is outdated and thus inconsistent with the
costs that efficient hospices incur in furnishing care to [*143] patients.
Fourth, Congress should include a provision in the CPA amending the Medicaid
statute to prohibit states from placing limitations on the quantity of
prescription drugs dispensed to Medicaid beneficiaries. As previously discussed,
coverage limitations on the quantity of prescription drugs impedes pain
While the CPA contains provisions that would improve the education of patient,
families, and providers, it should go further to combat the problem of
inadequate pain management. For example, the CPA should be amended to make the
receipt of federal money by professional schools and universities contingent
upon compliance with a requirement that schools incorporate pain management and
the use of controlled substances into their curricula. This would ensure that
future health care professionals attending federally funded schools are, at the
very least, exposed to pain management earlier in their careers. Moreover,
Congress should allocate funds to provide grants to academic institutions and
professional schools to provide pain management education. Further, Congress
should make DEA registration to prescribe controlled substances contingent upon
continuing medical education on the use of controlled substances to manage pain.
The CPA and the proposed revisions, taken together, represent a comprehensive
policy addressing the multiple components that impede the management of pain.
Given the fifty million patients who exhibit pain in America and the exorbitant
costs related to untreated pain, Congress should reintroduce the CPA with the
Despite progress in the medical community's understanding of how to treat pain,
health care providers continue to underprescribe opioids to manage pain. This
practice is a result of several factors, including fear of disciplinary and
enforcement actions; negative attitudes of health care providers, patients, and
the public about the use of controlled substances to treat pain; inadequate
education in pain management; and Medicare and Medicaid reimbursement policies.
Recent decisions holding physicians accountable for the inadequate treatment of
pain are insufficient to change the reluctance of health care providers to
prescribe controlled substances to manage pain. Until this point, efforts to
improve the pain management problem have been piecemeal and have consequently
failed to achieve an improvement in the management of pain.
A comprehensive public policy that addresses the multiple barriers is [*144]
needed to address the inadequate management of pain in America. While the
Conquering Pain Act of 2003 is a commendable effort to improve pain management,
it fails to adequately address several significant issues that are known to
impede the management of pain. Congress should pass the CPA in accordance with
the proposed revisions in this congressional session. Only then will it be
possible for the millions of patients who suffer in pain to obtain adequate pain
management. Society will benefit from a policy that adequately addresses pain
management through decreased health care spending and disability and worker's
compensation costs, and increased productivity. It is for these reasons that
there is a need for Congress to develop and implement a comprehensive policy
such as the CPA with the proposed revisions to put an end to the epidemic of
pain that currently exists in this country.
n1. Statement of Dr. Scott Fishman, Chief of the Division of Pain Medicine at
the University of California at Davis Medical Center, regarding Bergman v. Eden
Med. Ctr., No. H205732-1 (Alameda County Ct. filed June 13, 2000), the first
case in which a physician was held liable for elder abuse for undertreating a
n2. Michael J. Reynolds, Note, Morphine or Malpractice: Should Courts Recognize
a Legal Duty to Prescribe Opiates for Treating Chronic Pain, 15 St. John's L.
Comment 79, 79 (2000). See also Darlene Fujimoto, Regulatory Issues in Pain
Management, 17 Clinics in Geriatric Med. 537, 537 (2001) (identifying inadequate
pain assessment and treatment as a "significant public health problem in elderly
patients, even in those suffering from cancer pain"); D.E. Joranson et al., Pain
& Policy Studies Group, Univ. of Wis. Comprehensive Cancer Ctr., Achieving
Balance in Federal and State Pain Policy: A Guide to Evaluation i (July 2000)
("It is well understood that inadequate management of pain is a serious health
problem in the United States."), available at http://www.medsch.wisc.edu/painpolicy;
Press Release, U.S. Drug Enforcement Administration (DEA), DEA to Join Pain
Advocates in Issuing Statement on Prescription Pain Medications (Oct. 23, 2001),
available at http://www.usdoj.gov/pubs/pressrel/prl102301.html.
n3. Reynolds, supra note 2, at 79.
n4. Melanie Thernstrom, Pain, The Disease, N.Y. Times, Dec. 16, 2001, 6
(Magazine), at 66 (estimating total costs of chronic pain add up to more than $
100 billion annually); Reynolds, supra note 2, at 79 (estimating that the costs
of chronic pain total "over $ 70 billion per year in health care spending and
lost productivity"); Press Release, American Pain Society, American Pain Society
Urges Congress to Preserve Patient Access to Pain Medications (Dec. 11, 2001),
at www.ampainsoc.org/whatsnew/121101.html ("Pain is one of the most common
reasons people consult a physician, yet it frequently is inadequately treated,
leading to enormous social cost in the form of needless suffering, lost
productivity, and excessive health care expenditures.").
n5. Joranson et al., supra note 2, at 3; Reynolds, supra note 2, at 80;
Fujimoto, supra note 2, at 537. For the purposes of this article, the term
"narcotic" is synonymous with the terms "opioid," "pain medication," "controlled
substance," and "morphine."
n6. Fujimoto, supra note 2, at 537 (arguing that widespread perception that
regulatory policies prohibit use of opioids to treat pain is a significant
factor causing prescribers to inadequately relieve cancer pain and to undertreat
or refuse to prescribe opioids for chronic pain).
n7. Vincent Perron & Ronald S. Schonwetter, Assessment and Management of Pain in
Palliative Care Patients, 8 Cancer Control 15, 18 (2001) (noting that around the
clock dosing, using other forms of treatment in addition to pain medication, and
using noninvasive routes of administration provide good pain control for eighty
percent of patients). See also Michael H. Levy, Pharmacologic Treatment of
Cancer Pain, 335 New Eng. J. Med. 1124, 1127 (1996) ("Analgesic drugs should be
scheduled at intervals that prevent the recurrence of pain and minimize the
number of daily doses."). Analgesia means the absence of pain without a loss of
consciousness. See The American Heritage Steadman's Medical Dictionary (27th ed.
n8. Richard M. Marks & Edward J. Sachar, Undertreatment of Medical Inpatients
with Narcotic Analgesics, 78 Annals of Internal Med. 173, 173 (1973).
n9. Id. at 175.
n11. Id. at 176.
n12. Ezekiel J. Emanuel et al., The Practice of Euthanasia and Physician
Assisted Suicide in the United States, 280 JAMA 507, 510 (1998); SUPPORT
Principal Investigators, A Controlled Trial to Improve Care for Seriously Ill
Hospitalized Patients, 274 JAMA 1591, 1595 (1995).
n13. Charles S. Cleeland et al., 330 New Eng. J. Med. 592, 592 (1994) (noting
that forty-two percent of outpatients with recurrent or metastatic cancer with
complaints of pain were not provided with adequate pain relief). See also Levy,
supra note 7, at 1124.
n14. Wendy M. Stein, Pain in the Nursing Home, 17 Clinics in Geriatric Med. 575,
576 (2001) (estimating the prevalence of pain in nursing home residents ranges
from forty-five to eighty percent). See also Brian A. Ferrell et al., Pain in
the Nursing Home, 38 J. Am. Geriatric Soc'y 409, 411 (1990) (concluding that as
many as eighty percent of nursing home residents experience pain).
n15. Brian A. Ferrell, Pain Management in Elderly People, 29 J. Am. Geriatric
Soc'y 64, 64 (1991) (revealing that twenty-five to fifty percent of elders
living in the community reported complaints of pain).
n16. See generally Myra Glajchen, Chronic Pain: Treatment Barriers and
Strategies for Clinical Practice, 14 J. Am. Bd. of Fam. Prac. 211 (2001).
n17. Paula Tanabe & MaryBeth Buschmann, Emergency Nurses' Knowledge of Pain
Management Principles, 26 J. Emergency Nursing 299, 299 (2000) (noting that
seventy-eight percent of all patients that arrived at the emergency department
presented with pain as an initial symptom).
n18. Harry Owen et al., Post-operative Pain Therapy: A Survey of Patients'
Expectations and Their Experiences, 41 Pain 303, 305 (1990). See also Bernardo
Ng et al., Ethnic Differences in Analgesic Consumption for Postoperative Pain,
58 Psychosomatic Med. 125, 128 (1996).
n19. Ben A. Rich, An Ethical Analysis of the Barriers to Effective Pain
Management, 9 Cambridge Q. of Healthcare Ethics 54, 54 (2000) (noting fifty
percent of intensive care unit patients suffered from moderate to severe pain
during the last days of life, citing SUPPORT Principal Investigators, A
Controlled Trial to Improve Care for Seriously Ill Hospitalized Patients, 274
JAMA 1591, 1591-98 (1995)).
n20. Cleeland et al., supra note 13, at 592.
n23. David E. Joranson & Aaron M. Gilson, State Intractable Pain Policy: Current
Status, Am. Pain Soc'y Bull., March/April 1997, at http://www.ampainsoc.org/pub/bulletin/mar97/policy.htm.
n24. David E. Weissman et al., Wisconsin Physicians' Knowledge and Attitudes
About Opioid Analgesic Regulations, 90 Wis. Med. J. 671, 671 (1991), at
n25. David E. Joranson et al., Pain Management, Controlled Substances, and State
Medical Board Policy: A Decade of Change, 23 J. Pain & Symptom Mgmt. 138, 139
(2002) (describing a 1990 survey of oncologists in which eighteen percent of the
respondents reported excessive regulation of opioids as one of the top four
barriers to pain management).
n26. Michael Potter et al., Opioids for Chronic Nonmalignant Pain: Attitudes and
Practices of Primary Care Physicians in the UCSF/Stanford Collaborative Research
Network, 50 J. Fam. Prac. 145, 148 (2001).
n27. Roselyne Rey, The History of Pain 42-43 (Louise Elliot Wallace et al.,
trans., Harvard University Press ed. 1995).
n28. Pure Food and Drug Act of 1906, Pub. L. No. 59-384, 34 Stat. 768
(prohibiting the interstate commerce of adulterated drugs) (repealed by Food,
Drug, and Cosmetic Act, ch. 627, 52 Stat. 1040-1059 (1938)).
n29. Harrison Narcotics Act of 1914, Pub. L. No. 63-223, 38 Stat. 785 (repealed
1970); United States v. Brandenburg, 155 F.2d 110, 111 (3d Cir. 1946):
Under ... the statute, it is unlawful for any person to sell, barter, or
exchange or give away certain drugs (including [morphine]), except in pursuance
of a written order on a form issued for that purpose by the Secretary of the
Treasury. An exception is made to "the dispensing or distribution of any of the
drugs ... to a patient by a physician ... in the course of his professional
n30. Narcotic Drugs Import and Export Act of 1914, Pub. L. No. 63-230, 38 Stat.
275 (repealed 1970).
n31. Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. No.
91-513, 84 Stat. 1242 (codified as amended in scattered sections of 21 U.S.C.).
n32. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301-99 (2000). See also 21
U.S.C.A. 301-99 (West 2003).
n33. 21 U.S.C. 351-60. See also 21 U.S.C.A. 351-60.
n34. 21 U.S.C. 355 (2000). See also 21 U.S.C.A. 355.
n35. See, e.g., Laurence Hammack, OxyContin, Roanoke Times, 2001, at http://www.roanoke.com/archives
(noting that the FDA approved the use of 10 mg, 20 mg, and 40 mg
extended-release tablets of OxyContin).
n36. 21 C.F.R. 290.1 (2003).
n37. See, e.g., N.Y. Pub. Health Law 3310.1 (McKinney 2002) (requiring licensure
prior to dispensing controlled substances).
n38. 21 U.S.C. 811(c) (2000) (directing the Attorney General to consider: (1)
the drug's actual or relative potential for abuse; (2) scientific evidence of
its pharmacologic effect; (3) the state of current scientific knowledge
regarding the drug; (4) the drug's history and current pattern of abuse; (5) the
scope, duration, and significance of abuse; (6) any risk to the public health;
(7) the psychic or physiological dependence liability; and (8) whether the
substance is an immediate precursor of a substance that is already controlled).
n39. 21 U.S.C. 812(b)(1) (2000). See generally 21 U.S.C. 812(b)(1)-(6), (c).
n40. 21 C.F.R. 1308.11(c)(11), (d)(18)-(19) (2003).
n41. See 21 C.F.R. 1301.18(a) (2003).
n42. 21 U.S.C. 812(b)(2).
n43. 21 U.S.C. 812(c) Schedule II (b)(6); 21 C.F.R. 1308.12(b)(1)(12),
(14)-(15), (d)(1) (2003).
n44. 21 U.S.C. 829(a) (2000). See generally 21 U.S.C. 829(a)-(b).
n45. 21 C.F.R. 1306.11(a) (2003).
n46. 21 C.F.R. 1306.12 (2003) (forbidding refills on Schedule II drugs); 21
C.F.R. 1306.22(a) (2003) (permitting up to five refills on Schedule III and IV
n47. 21 U.S.C. 812(b)(3).
n48. 21 C.F.R. 1308.13(c)(1)(ii)-(iii), (f)(1) (2003).
n49. 21 U.S.C. 812(b)(4).
n50. 21 C.F.R. 1308.14(c)(1), (42), (48), (d)(1) (2003).
n51. 21 U.S.C. 812(b)(5).
n52. 21 C.F.R. 1308.15(c)(1), (5) (2003).
n53. 21 U.S.C. 829(b); 21 C.F.R. 1306.21(a) (2003).
n54. 21 C.F.R. 1306.22(a)(1) (2003).
n55. 21 U.S.C. 842(a)(1) (2000). See also 21 U.S.C.A. 842(a)(1) (West 2003). See
generally 21 U.S.C. 842(a)-(c).
n56. 21 U.S.C. 841(a)(1) (2000) (prohibiting any person from knowingly or
intentionally creating, distributing, or dispensing, or possessing with the
intent to distribute or dispense, a controlled substance).
n57. 21 U.S.C. 822(b). See also 21 U.S.C.A. 841(a)(1) (West 2003). See generally
21 U.S.C. 822(a)-(d).
n58. The term "dispense" means "to deliver a controlled substance to an ultimate
user or research subject by, or pursuant to the lawful order of, a practitioner,
including the prescribing and administering of a controlled substance." 21 USC
n59. 21 U.S.C. 822(a)(2); 21 C.F.R. 1301.11, .13 (2003). See also 21 U.S.C.
822(d), 21 C.F.R. 1301.22-.24 (2003) (permitting and specifying conditions for a
waiver of registration).
n60. 21 U.S.C. 823(f) (2000). See also 21 U.S.C.A. 823(f) (West 2003).
n61. 21 U.S.C. 823(f).
n62. See, e.g., Murray J. Walker, Jr., M.D., 55 Fed. Reg. 5306 (Dep't Justice,
Feb. 14, 1990) (hearing on registration revocation) (finding physician
prescribed opioids to patients and undercover DEA agents for "no legitimate
n63. Id. An important ongoing debate is whether the use of controlled substances
for physician-assisted suicide ("PAS") is a legitimate medical purpose under the
CSA. In 2001, the U.S. Attorney General issued an interpretive rule that
prohibited the prescribing, administering, or dispensing controlled substances
for the purposes of assisting suicide. See Dispensing of Controlled Substances
to Assist Suicide, 66 Fed. Reg. 56,608 (Nov. 9, 2001). The rule was aimed at
overruling Oregon's PAS law and specifically allowed for the revocation of DEA
registration of any health care provider who participated in assisted suicide
using controlled substances. Id. In response, the State of Oregon filed suit in
federal court seeking a preliminary injunction to prevent the federal government
from invalidating the state's PAS law. See Oregon v. Ashcroft, 192 F. Supp. 2d
1077, 1079 (D. Or. 2001). The court granted Oregon's motion for summary judgment
and issued a permanent injunction preventing enforcement of the rule. Id. at
1093. The Department of Justice appealed, and the case is presently pending
before the Ninth Circuit Court of Appeals. See Compassion News: Ashcroft v.
Oregon Archive, at http://www.compassionindying.org/ashcroft<uscore>archive.php.
An affirmance of the injunction would insure that states retain their
traditional authority to define what constitutes a legitimate medical purpose of
controlled substances, see U.S. v. Evers, 643 F.2d 1043, 1048 (5th Cir. 1981),
and would insulate Oregon health care providers from the onerous fear of federal
prosecution for prescribing controlled substances for assisted suicides.
n64. 21 U.S.C. 871(b) (2000).
n65. 21 U.S.C. 824(a) (2000). See also 824(c) (requiring an order to show cause
and a hearing before the Attorney General before a registration may be denied,
revoked or suspended); 21 U.S.C.A. 824 (West 2003).
n66. H.R. Rep. No. 106-378, at 4 (1999), available at 1999 WL 816955. See, e.g.,
Hugh I. Schade, M.D., 60 Fed. Reg. 56,354 (denial of application) (Dep't Justice
Nov. 8, 1995) (denying registration to a physician whose conduct objectively
threatened "public health and safety" when he prescribed potentially lethal
amounts of Darvocet to a depressed patient who used them to commit suicide);
Samuel Fertig, M.D., 49 Fed. Reg. 6577 (denial of application) (Dep't Justice
Feb. 22, 1984) (denying registration to a physician who prescribed massive
quantities of controlled substances to several young individuals who used them
in lethal overdoses, ruling that the physician "was responsible, directly or
indirectly, for the deaths of several young people" and that the application
must be denied to protect "public health and safety").
n67. Jose R. Castro, M.D, 62 Fed. Reg. 16,189 (denial of application) (Dep't
Justice Apr. 4, 1997) ("The DEA does not have statutory authority under the
Controlled Substances Act to issue or maintain a registration if the applicant
or registrant is without state authority to handle controlled substances in the
state in which he conducts business.").
n68. 21 U.S.C. 824(a)(3). The CSA was enacted to establish a uniform national
standard for the control and availability of narcotics, and a system of
enforcement and penalties that is independent of State law. H.R. Rep. No.
106-378, pt. 1, at 2 (1999) (House Comm. on the Judiciary, considering the Pain
Relief Promotion Act of 1999, HR 2260 (1999)). See also Hugh I. Schade, M.D., 60
Fed. Reg. at 56,356 (denying application for registration even though the
physician had a valid license to practice medicine in the state of California).
n69. 21 U.S.C. 842(c)(1)(A) (2000). See also 21 U.S.C.A. 842(c)(1)(A) (West
n70. 21 U.S.C. 842(c)(2)(A). Penalties are even more severe for practitioners
found to have abused their prescribing authority. Illicit distribution, use of a
false registration number, and falsifying DEA registration records are each
punishable by imprisonment of up to four years and fines of up to $ 30,000. 21
n71. See, e.g., Anne Alpers, Criminal Act or Palliative Care? Prosecutions
Involving Care of the Dying, 26 J.L. Med. & Ethics 308, 312-15 (1998)
(cataloging state medical board disciplinary actions taken against physicians in
assisted dying cases).
n72. DEA, U.S. Dept. of Justice (DOJ), Physician's Manual: An Informational
Outline of the Controlled Substances Act of 1970 (1990).
n73. DEA Press Release, supra note 2.
n75. Id. In fact, DEA Administrator Asa Hutchinson urged a policy that:
Protects the appropriate use of opioid pain relievers for patients who need them
while also preventing abuse and diversion of drugs ... . We don't want to cause
patients who have legitimate needs for these medications, to be discouraged or
afraid to use them. And we don't want to restrict doctors and pharmacists from
providing these medications when appropriate ... .
n76. DEA, DOJ, Registrant Population: Summary, at http://www.deadiversion.usdoj.gov/drugreg/pop/summary.htm.
n77. DEA, DOJ, Registrant Actions: 2002, at http://www.deadiversion.usdoj.gov/fed<uscore>regs/actions/2002/index.html.
n78. DEA, DOJ, Registrant Actions: 2000, at http://www.deadiversion.usdoj.gov/fed<uscore>regs/actions/2000/index.html;
DEA, DOJ, Registrant Actions: 2001, at http://www.deadiversion.usdoj.gov/fed<uscore>regs/actions/2001/index.html.
n79. See, e.g., Hugh I. Schade, M.D., 60 Fed. Reg. at 56,355 (reporting that the
DEA began an investigation of Dr. Schade after receiving information that Dr.
Schade had purchased quantities of controlled substances in "in excess of
average U.S. and California practitioners").
n80. 21 C.F.R. 1316.03(c), (e) (2003).
n81. U.S. v. Rosen, 582 F.2d 1032, 1032 n.2 (5th Cir. 1978).
n82. Jacob Sullum, No Relief in Sight, Reason, Jan. 1998, at
n85. Id. See also Hugh McIntosh, 83 J. Nat'l Cancer Inst. 1282, 1283 (1991)
(describing the case of Dr. Ronald H. Blum, associate director of the Kaplan
Cancer Center at New York University, in which, after Dr. Blum endured an
eighteen month investigation and incurred $ 10,000 in legal fees, the DEA
dismissed all charges).
n86. Tanya Alberts & Damon Adams, OxyContin Crackdown Raises Physician, Patient
Concerns, Amednews.com, June 25, 2001, at http://www.amednews.com/2001/prl10625.html
(noting physician fears of DEA and licensure actions are growing in light of
n87. See infra text accompanying notes 199-209.
n88. Alberts & Adams, supra note 86.
n90. United States v. Larson, 507 F.2d 385, 390 (9th Cir. 1974).
n91. Id. at 387.
n94. Id. at 387-88.
n95. Id. at 388.
n96. Ann M. Martino, In Search of a New Ethic for Treating Patients with Chronic
Pain: What Can Medical Boards Do?, 26 J.L. Med. & Ethics 332, 337 (1998)
(arguing that physicians have perversely strong incentives to undertreat chronic
pain, leading to the syndrome of "opiophobia," the fear of prescribing
n97. See infra Part IV.A.
n98. Joranson et al., supra note 2, at 3.
n99. 21 U.S.C. 801 (2000). See also 21 U.S.C.A. 801 (West 2003).
n100. 21 U.S.C. 801 (listing Congress' findings and declarations).
n101. Psychotropics are "drugs that affect psychic function, behavior, or
experience." Taber's Cyclopedic Medical Dictionary 1632 (Clayton L. Thomas ed.,
1993). Psychotropics include antidepressants, anti-anxiety medications,
anticonvulsants, antipsychotics, lithium, and sleeping pills.
n102. 21 U.S.C. 801(1).
n103. Joyce M. Black & Esther Matasarran-Jacobs, Luckmann and Sorensen's
Medical-Surgical Nursing: A Psychophysiologic Approach 321 (1993).
n104. Joranson et al., supra note 2, at 29.
n105. 21 C.F.R. 1306.11(a) (2003).
n106. 21 C.F.R. 1306.7 (2003).
n107. 21 C.F.R. 1306.7.
n108. See Joranson et al., supra note 2, at 26.
n111. 42 U.S.C. 14402 (2000).
n112. See infra text accompanying notes 228-238. See generally Susan Anderson
Fohr, The Double Effect of Pain Medication: Separating Myth from Reality, 1 J.
Palliative Med. 315 (1998) (discussing fear from the potential side effects of
n113. Russell K. Portenoy, Opioid Therapy for Chronic Nonmalignant Pain:
Clinicians' Perspective, 24 J.L. Med. & Ethics 296, 298 (1996). See also
Glajchen, supra note 16, at 215 (noting patients usually develop tolerance to
these side effects within one week to ten days of drug therapy); Levy, supra
note 7, at 1128.
n114. Joranson et al., supra note 2, at 4.
n116. Cf. Mass. Gen. Laws ch. 94(c), 2 (2001) (establishing the five controlled
substances schedules under the CSA and adding a sixth schedule for all
prescription drugs not included in the fifth schedule).
n117. See Unif. Controlled Substances Act 1994 (setting forth, in the References
& Annotations, a table of jurisdictions where either the 1970, 1990 or 1994
version of the Act has been adopted). The original Uniform Controlled Substances
Act was drafted by the National Conference of Commissioners on Uniform State
Laws in 1970. The Commissioners subsequently revised the Act in 1990 and again
amended it in 1994 to reflect research regarding the use of narcotics to manage
pain. See generally http://www.nccusl.org.
n118. Joranson et al., supra note 2, at 490.
n119. Del. Reg. 40-700-021 (2001) (prohibiting more than 100 dosage units to be
dispensed at one time), reprinted in Joranson et al., supra note 2, at 110.
n120. Del. Reg. 40-700-021 (requiring prescriptions for Schedule II and III
drugs to be filled within seven days of the original date of the prescription).
n121. Cal. Health & Safety Code 11156 (West 2001) (prohibiting prescriptions for
controlled substances to be issued to an "addict or habitual user").
n122. See Md. Code Ann., Crimes & Punishments art. 27, 277 (2001) (repealed by
Acts 2002, ch. 26, 2, eff. Oct. 1, 2002) .
n123. Fujimoto, supra note 2, at 545.
n124. Id. (quoting Fed'n of State Med. Bds. of U.S., Inc., Model Guidelines for
the Use of Controlled Substances of the Treatment of Pain (May 1998)).
n125. Perron & Schonwetter, supra note 7, at 20.
n126. Cf. United States v. Evers, 643 F.2d 1043, 1048 (5th Cir. 1981)
(commenting that the Federal Food, Drug, and Cosmetic Act was not intended to
regulate the practice of medicine).
n127. See, e.g., Wash. Admin. Code 246-840-421 (2002) (setting forth
requirements for advanced nurse practitioners to qualify for prescriptive
authority of Schedule II through Schedule V substances); Wash. Admin. Code
246-887-020 (2002) (providing documentation requirements for pharmacists); Wash.
Admin. Code.246-919-600 (dispensing requirements for physician prescriptions of
controlled substances); Wash. Admin. Code 246-919-800 (setting forth guidelines
for using opioids to treat pain).
n128. Joranson et al., supra note 2, at 19, 20.
n129. E.g., W. Va. Code 30-3-7 (2002).
n130. See, e.g., W. Va. Code 30-3-14 (2002) (recognizing that the medical board
may initiate disciplinary proceedings against physicians upon receipt of
information from peer review committees or complaints from citizens, physicians,
n131. See, e.g., W. Va. Code 30-3-14 (2002) (granting discretion to the medical
board to initiate disciplinary proceedings against physicians based on
information from peer review committees or complaints from citizens, physicians,
n132. See generally Med. Bd. of Ca. Reg. tit. 16, 1361 (2002) (board
disciplinary actions resolved pursuant to Administrative Procedure Act).
n133. See, e.g., La. Rev. Stat. Ann. 37:1285A(6) (West 2002) (explaining that
the medical board may suspend or revoke any license or impose probation when
controlled substances are prescribed for an illegitimate medical purpose).
n134. See, e.g., Wash. Rev. Code 34.05.510 (2003); Wash. Admin. Code 246-10-706
(2002); W. Va. Code 30-3-14 (2002).
n135. See, e.g., Del. Code Ann. tit. 16, 4796 (2002).
n136. Joranson et al., supra note 2, at 4.
n137. 31 Az. State Bd. of Med. Examiners, Guidelines for Prescribing Controlled
Substances (revised June 2003), available at http://www.bomex.org/Regulatory/policy/7<uscore>policy.asp.
n139. Joranson et al., supra note 2, at 26.
n141. Md. Code Ann., Crimes & Punishments 277 (2001) (repealed by Acts 2002, ch.
26, 2, eff. Oct. 1, 2002) (emphasis added).
n142. Joranson et al., supra note 2, at 24.
n145. Cal. Health & Safety Code 11156 (West 2001).
n146. Yael Swica & William Breitbart, Treating Pain in Patients with AIDS and a
History of Substance Abuse, 176 W. J. Med. 33, 33-39 (2002).
n147. Colo. Med. Bd., Policy 10-14, Guidelines for Prescribing Controlled
Substances for Intractable Pain (1996) (emphasis added).
n148. Del. Reg. 40-700-021 (2001). See also Conn. Gen. Stat. 21a-251(b) (2003)
(explaining that Connecticut's Controlled Substances Act restricts the quantity
of Schedule II controlled substances that can be prescribed within seven-days of
the order entry; however, the seven-day period may be extended for another seven
days with the prescribing practitioner's signature).
n149. Del. Reg. 40-700-021.
n150. Tex. Rev. Civ. Stat. Ann. art. 4495c (Vernon 2001) (adopted by Acts 1989,
71st leg., 1st C.S., ch. 5, 1, eff. Nov. 1, 1989).
n151. Tex. Rev. Civ. Stat. Ann. art. 4495c, 3, 5.
n152. Tex. Rev. Civ. Stat. Ann. art. 4495c, 2(3) (emphasis added).
n153. Joranson et al., supra note 2, at 495 (asserting that the primary goal of
IPTAs was to address physician reluctance to prescribe opioids for the treatment
of chronic pain by providing immunity from discipline by state medical boards).
Joranson suggests that the IPTAs also may have alerted state regulators and law
enforcement officials to the use of opioids for intractable pain. Id.
n154. California Initiative Attempts to Reassure Physicians Who Prescribe
Opioids, Alcoholism & Drug Wkly., Feb. 15, 1999, available at 1999 WL 9620110.
n155. Joranson & Gilson, supra note 23 (identifying risks of IPTAs). See, e.g.,
Cal. Bus. & Prof. Code 2241.5(b) (West 2002); Colo. Rev. Stat. 12-36-117(1.5)(b)
(2002); Minn. Stat. 152.125 (2002) (subdivision 1); Mo. Rev. Stat. 334.105.2(2)
(2002); N.D. Cent. Code 19-03.3-01(2) (2002); Ohio Rev. Code Ann. 4731.052(C)
(West 2002); Or. Rev. Stat. 677.470(2) (2002); R.I. Gen. Laws 5-37.4-2(B)
(2002); Tex. Rev. Civ. Stat. Ann. art. 4495(c), 2(3); W. Va. Code 30-3A-1(3)
n156. Joranson & Gilson, supra note 23. See also Tex. Rev. Civ. Stat. Ann. art.
4495(c), 2(3) (providing the type of pain to which Texas's IPTA applies).
n157. Joranson et al., supra note 2, at 495; Joranson & Gilson, supra note 23.
See, e.g., Tex. Rev. Civ. Stat. Ann. art. 4495(c), 2(3) (defining intractable
n158. Joranson et al., supra note 2, at 495; Joranson & Gilson, supra note 23.
See, e.g., Cal. Bus. & Prof. Code 2241.5(e); Mo. Rev. Stat. 334.106(3); N.D.
Cent. Code 19-03-3-05 (2002).
n159. Joranson et al., supra note 2, at 495; Joranson & Gilson, supra note 23.
See, e.g., Cal. Bus. & Prof. Code 2241.5(b); Colo. Rev. Stat. 12-36-117(1.5)(b);
Ohio Rev. Code Ann. 4731.052; Or. Rev. Stat. 677.474(3) (2002).
n160. Joranson et al., supra note 2, at 495; Joranson & Gilson, supra note 23.
n161. See N.Y. Pub. Health 3338(2) (Consol. 2001); N.Y. Comp. Codes R. & Regs.
tit. 10, 80.67, 80.71 (2003).
n162. N.Y. Pub. Health 3338(2); N.Y. Comp. Codes R. & Regs. tit. 10, 80.67,
n163. N.Y. Pub. Health 3332(2)(a)-(d) (Consol. 2001); N.Y. Comp. Codes R. & Regs.
tit. 10, 80.71.
n164. N.Y. Pub. Health 3331(6) (Consol. 2001).
n165. N.Y. Pub. Health 3333(4) (Consol. 2001); N.Y. Comp. Codes R. & Regs. tit.
10, 80.73(c)(2) (2003).
n166. N.Y. Pub. Health 3331(6); N.Y. Comp. Codes R. & Regs. tit. 10,
n167. N.Y. Pub. Health 3379(3) (Consol. 2001).
n168. N.Y. Pub. Health 3371 (Consol. 2001); N.Y. Comp. Codes R. & Regs. tit. 10,
n169. Whalen v. Roe, 429 U.S. 589, 595 (1977).
n170. Id. at 599.
n171. Id. at 598-602.
n172. Id. at 602-03 (recognizing, however, that the concern about disclosures of
identity information discouraged the use of Schedule II substances).
n173. Id. at 606.
n174. Melody Peterson & Barry Meier, Few States Track Prescriptions as a Method
to Bar Overdoses, N.Y. Times, Dec. 21, 2001, available at www.nytimes.com.
n175. Joranson et al., supra note 2, at 491.
n176. David Brushwood, Maximizing the Value of Electronic Monitoring Programs,
31 J.L. Med. & Ethics 41 & n.13 (2003).
n177. Joranson et al., supra note 2, at 491 (citations omitted).
n178. Id. at 30.
n179. Peterson & Meier, supra note 174.
n181. Cf. Brushwood, supra note 176, at 43 (noting the uncertainty of whether
the widespread dissemination of information under electronic prescription
monitoring programs would alter the Supreme Court's view of the impact of such
programs on the privacy interests of patients).
n182. Reynolds, supra note 2, at 2 (advocating that chronic pain patients should
utilize tort law medical malpractice actions against physicians who under
prescribe opioid medications).
n183. Hoover v. Agency for Healthcare Admin., 676 So. 2d 1380, 1381 (Fla. Dist.
Ct. App. 1996).
n185. Id. at 1382.
n186. Id. at 1381.
n188. Id. at 1382.
n189. Hoover, 676 So. 2d at 1382-84.
n190. Id. at 1382.
n195. Hoover, 676 So. 2d at 1385.
n196. Id. at 1384.
n197. Id. at 1383.
n198. Reynolds, supra note 2, at 85-86.
n199. Id. at 86.
n200. Hoover, 676 So. 2d at 1382.
n201. Marilyn Frank-Stromborg & Anjeanette Christensen, A Serious Look at the
Undertreatment of Pain: Part I, 5 Clinical J. of Oncology Nursing No. 5, 235,
n202. Alpers, supra note 71, at 311.
n203. Id. (estimating that at least thirteen physicians have been investigated
by law enforcement for their management of pain in patients with end-stage
disease, none of whom were formally indicted or prosecuted).
n204. Id. Cf. Frank-Stromborg & Christensen, supra note 201, at 235 (stating
that hospital administrators are alarmed by the possibility that physicians may
be criminally prosecuted for administering pain medications to dying patients).
n205. Alpers, supra note 71, at 311.
n206. Tanya Albert, Florida Physician Guilty of Manslaughter in OxyContin Case,
Am. Med. News, Mar. 11, 2002, available at http://www.ama-assn/org/sci-pubs/amnews/pick<uscore>02/prl20311.html.
The fact that a physician was convicted on a criminal charge of manslaughter is
likely to have an effect on how physicians treat patients with chronic pain. Id.
According to B. Eliot Cole, M.D., Continuing Medical Education Director at the
American Academy of Pain Management, "every one of these headlines probably
makes 10,000 doctors wish they had gone to law school." Id.
n211. E.g., Alpers, supra note 71, at 324-25.
n212. Martino, supra note 96, at 334 (citing David B. Morris, Pain's Dominion:
What We Make of Pain, Wilson Q., Sept. 22, 1994, at 3).
n213. Id. at 332.
n214. Patricia M. Clark, Pharmacologic Pain Management in the Elderly Cancer
Patient, Medscape Conference Coverage of the 26th Congress of the Oncology
Nursing Society, May 17-20, 2001, available at www.medscape.com/viewarticle/418569
(noting patient beliefs about pain can be barriers to the management of pain).
See also David E. Joranson & Aaron M. Gilson, Pharmacists' Knowledge of and
Attitudes Toward Opioids: Pain Medication in Relation to Federal and State
Policies, 41 J. Am. Pharmaceutical Assoc. 213, 217 (2001). In a 2001 survey of
pharmacists, Joranson and Gilson concluded that the incorrect knowledge and
inappropriate attitudes of some pharmacists could contribute to a failure to
dispense valid prescriptions for opioid analgesics to patients in pain. Id.
n215. Sullum, supra note 82.
n216. John P. Morgan, American Opiophobia: Customary Underutilization of Opioid
Analgesics, 5 Advances in Alcohol & Substance Abuse 163, 163-73 (1986).
n217. See Sullum, supra note 82. Sullum states that opiophobia is a result of
deeply routed prejudices and that Americans have always had mixed feelings about
drugs. Id. To deal with our ambivalence, we tend to divide drugs into neat
categories: good and bad, legal and illegal, therapeutic and recreational. We
are not comfortable with drugs that straddle categories, as the opioids do. The
discomfort is strengthened by historical experience, ranging from Civil War
veterans hooked on morphine to middle-class housewives hooked on
over-the-counter remedies in the years before the Harrison Narcotics Act of
n218. David E. Joranson et al., Trends in Medical Use and Abuse of Opioid
Analgesics, 283 JAMA 1710, 1710 (2000).
n219. Sharon M. Weinstein et al., Physicians' Attitudes Toward Pain and the Use
of Opioid Analgesics: Results of a Survey from the Texas Cancer Pain Initiative,
93 S. Med. J. 479, 482 (2000).
n221. See generally Jamie H. Von Roenn et al., Physician Attitudes and Practice
in Cancer Pain Management: A Survey from the Eastern Cooperative Oncology Group,
119 Annals of Internal Med. 121 (1993) (surveying health care practitioners to
determine the amount of knowledge about cancer pain and to determine the methods
of pain control being used by physicians), available at http://www.annals.org/cgi/content/full/119/2/121.
n222. Michael Potter et al., Opioids for Chronic Nonmalignant Pain: Attitudes
and Practices of Primary Care Physicians in the UCSF/Stanford Collaborative
Research Network, 50 J. Fam. Prac. 145, 147-48 (2001).
n223. Id. at 147.
n224. Id. (assessing pharmacists' attitudes toward the legality of prescribing
opioids and finding that only seventy-five percent of pharmacists considered
prolonged prescribing for cancer pain to be lawful and acceptable medical
n225. Weinstein et al., supra note 219, at 479.
n226. Fujimoto, supra note 2, at 545-46 (citing Samuel Perry & George Heidrich,
Management of Pain During Debridement: A Survey of US Burn Units, 13 Pain 267
n227. Sullum, supra note 82 (citing Jane Porter & Herschel Jick, Addiction Rare
in Patients Treated with Narcotics, 302 New Eng. J. Med. 123 (1980)).
n228. Sullum, supra note 82.
n229. Joranson et al., supra note 218, at 1712 (noting that the the incidence of
drug addiction for patients taking opioids is less than one percent). See also
Tanabe & Buschmann, supra note 17, at 299.
n230. Von Roenn et al., supra note 219.
n231. Joranson et al., supra note 2, at 27. Courts, likely relying on the
opinions of health care providers, have reinforced the erroneous belief that
opioids cause respiratory depression and hasten death. For example, in Vacco v.
Quill, the United States Supreme Court held that New York's ban on assisted
suicide did not violate the Equal Protection Clause of the Fourteenth Amendment.
See 521 U.S. 793, 796 (1997). See also concurring op. Washington v. Glucksberg,
521 U.S. 702 (1997) (O'Connor, J., concurring). In a concurring opinion, Justice
O'Connor, joined by Justices Ginsberg and Breyer, stated that the provision of
pain-relieving medications to a patient that hastened death would not violate
the state laws prohibiting assisted suicide. Id. at 737. Justice O'Connor wrote
that "a patient who is suffering from a terminal illness and who is experiencing
great pain has no legal barriers to obtaining medication, from qualified
physicians, to alleviate that suffering, even to the point of causing
unconsciousness, and hastening death." Id. at 736-37. She further stated, "there
is no dispute that dying patients ... can obtain palliative care, even when
doing so would hasten their deaths." Id. at 737-38. While these statements
support the use of opioids for pain management, they do not reflect the
empirical evidence on this subject, which demonstrates that opioids, if
appropriately titrated, do not generally result in terminal sedation.
n232. Fohr, supra note 112, at 315-28.
n233. Glajchen, supra note 16, at 214; Levy, supra note 7, at 1126.
n234. Levy, supra note 7, at 1126.
n235. Id. (citations omitted) (stating generally that dosage levels in cancer
patients exceed those of patients with chronic pain).
n238. Glajchen, supra note 16, at 214-15 (noting that side effects of narcotics
in patients with cancer or chronic pain include sedation, confusion, nausea,
vomiting, and constipation, the most common side effect among such patients).
n239. Id. at 215 (noting that patients usually develop tolerance to these side
effects within one week to ten days of drug therapy); Levy, supra note 7, at
n240. Glajchen, supra note 16, at 214 (stating that regular intervals reduce
overall drug consumption); Levy, supra note 7 (explaining that scheduled
intervals minimize the number of daily doses).
n241. David B. Resnik et al., The Undertreatment of Pain: Scientific, Clinical,
Cultural, and Philosophical Factors, 4 Med. Health Care Phil. 277, 282 (2001)
(stating that the philosophy behind modern medicine - the scientific approach to
health and disease - plays a key role in explaining why health care providers
n243. Id. at 278.
n244. Id. at 283.
n246. Id. at 284.
n247. Resnick et al., supra note 241, at 279.
n248. Id. at 284.
n249. Id. at 278.
n251. Mitchell Max et al., Am. Pain Soc'y, Treatment of Pain at the End of Life:
A Position Statement From the American Pain Society, at http://www.ampainsoc.org/advocacy/treatment.htm.
n252. Resnick et al., supra note 241, at 285.
n254. Max et al., supra note 251 (citing U.S. Pub. Health Serv., Agency for
Health Care Policy & Research, Pub. No. 94-0592, Management of Cancer Pain:
Clinical Practice Guideline No. 9 (1990)).
n255. Resnick et al., supra note 241, at 285.
n256. Id. See also infra Part IV.D.
n257. Weinstein et al., supra note 219, at 485.
n259. Tanabe & Buschmann, supra note 17, at 299-305 (stating that emergency room
nurses may not have a good understanding of the management of pain with drugs,
or of issues such as risk of addiction).
n260. Id. at 303-04.
n261. Id. at 304 (noting that only sixty-one percent of questions in this areas
were answered correctly).
n263. See infra Part IV.D.
n264. See infra Part IV.D.
n265. See infra Part IV.D.
n266. This article touches upon the most significant reimbursement issues
impacting pain management in the Medicare and Medicaid programs. For a
comprehensive discussion of reimbursement issues related to pain management in
the Medicare and Medicaid programs, see Timothy Jost, Public Financing of Pain
Management: Leaky Umbrellas and Ragged Safety Nets, 26 J.L. Med. & Ethics 290,
291 (1998). For a discussion of managed care reimbursement of pain management,
see Dianne E. Hoffman, Pain Management and Palliative Care in the Era of Managed
Care: Issues for Health Insurers, 26 J.L. Med. & Ethics 267, 267 (1998).
n267. 42 U.S.C. 1395c (2000).
n268. 42 U.S.C. 1395d(a)(1) (2000) (providing coverage for inpatient hospital
care "up to 150 days during any spell of illness minus 1 day for each day of
such services in excess of 90 received during any preceding spell of illness.").
Inpatient hospital coverage includes drugs, 42 U.S.C. 1395x(b)(2) (2000), 42
U.S.C.A. 1395x(2) (West 2003), 42 C.F.R. 409.10(a)(5) (2003), but a hospital
admission solely for the purpose of administering a drug which has not been
determined "reasonably necessary" is not covered. Ctrs. for Medicare & Medicaid
Servs. (CMS), Dep't of Health & Human Servs. (DHHS), Medicare Intermediary
Manual 3101.3, available at http://www.cms.hhs.gov/manuals (last modified Nov.
26, 2003). However, Medicare provides payment for four weeks of inpatient
hospitalization for pain rehabilitation. CMS, DHHS, Coverage Issues Manual 35-21
[hereinafter CMS Coverage Issues Manual], available at http://www.cms.hhs.gov/manuals
(last modified Nov. 26, 2003). Additionally, Medicare will provide payment for
an outpatient hospital pain rehabilitation program provided that the patient's
pain is attributable to a physical cause, the usual methods of treatment have
not been successful in alleviating the pain, and a significant loss of ability
by the patient to function independently has resulted from the pain. Id. at
n269. 42 U.S.C. 1395d(a)(2) (providing coverage for up to 100 days of during any
spell of illness post-hospital extended care services). See 1395x(i) (defining
post-hospital extended care and services).
n270. 42 U.S.C. 1395d(d) (explaining hospice care election and waiver of
n271. 42 U.S.C. 1395k(a)(2)(B) (2000); 42 C.F.R. 410.10 (2003). See also 42
U.S.C.A. 1395k(a)(2)(B) (West 2003).
n272. Medicare Part B covers drugs that are administered incidental to a
physician's professional services that cannot be self-administered and that are
commonly furnished in a physician's office or clinic without charge or included
in a physician's bill. 42 C.F.R. 410.26 (2003). Generally, injections satisfy
this requirement. Injections are not covered, however, if standard medical
practice indicates that the administration of the medication by mouth is
effective and is an accepted or preferred method of administration. CMS Coverage
Issues Manual, supra note 268, at 2049.2.
n273. Jost, supra note 266, at 292. Infusion pumps are covered under the durable
medical equipment benefit.
42 C.F.R. 410.38 (2003).
n274. 42 C.F.R. 410.38(f). A transcutaneous electrical nerve stimulation
("TENS") is a type of electrical nerve stimulator that is attached to the
surface of the patient's skin over the peripheral nerve to be stimulated. CMS
Coverage Issues Manual, supra note 268, at 60-20. Medicare pays for a TENS unit
that is determined to medical necessary and that is ordered by the beneficiary's
physician or a specialty physician on referral from the beneficiary's physician
and the written order is furnished to the supplier before the delivery of the
unit to the beneficiary. 42 C.F.R. 410.38(f)(1), (2). See also CMS Coverage
Issue Manual, supra note 268, at 45-19 (identifying requirements for
transcutaneous electrical nerve stimulation for acute post-operative pain); id.
at 60-20 (explaining coverage of TENS for chronic pain under the durable
n275. 42 U.S.C. 1395k(a)(2)(B) (providing Medicare Part B coverage for medical
and other health services); 42 U.S.C. 1395x(s)(2) (defining "medical and other
health services" to include drugs which are not usually self-administered by the
patient); 42 C.F.R. 410.26 (explaining Medicare Part B coverage for drugs); CMS,
DHHS, Medicare Carriers Manual 2049, available at http://www.cms.hhs.gov/manuals
(last modified Nov. 26, 2003).
n276. On November 25, 2003, after months of contentious negotiations between
House and Senate conferees, Congress approved a bill that will assist Medicare
beneficiaries to pay for the costs of outpatient prescription drugs. See
Congress Approves Drug Benefit Bill, Sending Legislation to President Bush, BNA
Health Plan & Provider Rep. (BNA, Inc., Washington, D.C.), Dec. 3, 2003, at 1223
[hereinafter BNA Report]. See also Medicare Prescription Drug, Modernization and
Improvement Act of 2003, Pub. L. No. 108-173, available at http://thomas.loc.gov.
Although the drug benefit will begin in 2006, a prescription drug discount card
will be made available beginning the spring of 2004. BNA Report at 1223. The
bill is estimated to cost $ 395 million over the next 10 years. Id. The full
drug benefit will require beneficiaries to pay an estimated $ 35 monthly premium
and a $ 250 annual deductible for the drug benefit. Id.
Prior to this bill, signed by President George W. Bush on December 8, 2003,
Medicare Part B did not provide payment or medication in an outpatient setting.
See Medicare Prescription Drug, Improvement and Modernization Act of 2003, Pub.
L. No. 108-173 (2003). Thus, prior to this Act, where a physician gave a patient
pills or other oral medication, such medication was excluded from coverage since
the form of the drug given to the patient was usually self-administered. See CMS
Coverage Issues Manual, supra note 268, at 2049.2. In addition, oral drugs
incident to physician services were considered self-administered and, thus, were
not covered under Medicare Part B. Id. at 2049.2. See also 42 C.F.R. 410.27
In 1988 and 1994, initial congressional attempts to provide a Medicare
prescription benefit failed. See, e.g., The Medicare Catastrophic Act of 1988,
Pub. L. No. 100-360, 102 Stat. 683, repealed by Medicare Catastrophic Repeal Act
of 1989, tit. II, Pub. L. No. 101-234; American Health Security Act of 1994,
H.R. 3960, 103rd Cong. (1994). A few years later, the 106th Congress introduced
several bills that proposed to provide a Medicare prescription drug benefit.
See, e.g., Seniors Prescription Insurance Coverage Equity (SPICE) Act of 1999,
H.R. 2782, S. 1480, 106th Cong. (1999). See also Amy J. Dilcher, Congress
Proposes to Expand Medicare to Include Coverage for Outpatient Prescription
Drugs, at www.law.uh.edu/healthlawperspectives/Medicare/20000518Congress.html
(summarizing prescription drug legislation). In the 107th Congressional session,
Congress introduced at least twenty-three bills that would have provided a
Medicare prescription benefit or addressed Medicare's lack of coverage for
prescription drugs by alternative means. None of these bills passed. Although
The Medicare Modernization and Prescription Act of 2002, which proposed to
provide a voluntary prescription drug coverage under the Medicare program,
passed in the House, it ultimately died in the Senate. See The Medicare
Modernization and Prescription Act, H.R. 4954, 107th Cong. (2002).
n277. DHHS, Health and Injury Chartbook, at 12 & tbl.119 (2001). A recent study
by the Commonwealth Fund found that the average Medicare enrollee in
Medicare+Choice plan (Medicare's private plan option) will spend approximately $
512 in out-of-pocket expenses for prescription drugs in 2003. Cf. Marsha Gold &
Lori Achman, The Commonwealth Fund, Issue Brief No. 667, Average Out-of-Pocket
Health Care Costs for Medicare+Choice Enrolless Increase 10 Percent in 2000
(Aug. 2003) (noting the increase in out-of-pocket expenses from 1999-2003), at
n278. 42 U.S.C. 1395d(a)(4) (2000) (explaining scope of benefits).
n279. Hospice Ass'n of Am., Hospice Facts & Statistics 1 (Nov. 2002) (citing
CMS, Office of the Actuary, Ctr. for Health Plans & Providers (Oct. 2002),
available at http:www.nahc.org/Consumer/hpcstats.html.
n280. 42 U.S.C. 1395d(d).
n281. 42 C.F.R. 418.22(b) (2003); 42 C.F.R. 418.20 (2003) (describing election
periods); 42 C.F.R. 418.22 (providing requirements for certification of terminal
n282. 42 U.S.C. 1395d(d)(2)(A); 42 C.F.R. 418.24(d) (2003) (stating that
election for hospice benefit requires waiver of all other Medicare benefits).
The individual may revoke the election at any time. 42 U.S.C. 1395d(d)(B)(i); 42
C.F.R. 418.28(a) (2003).
n283. 42 C.F.R. 418.202 (2003). Covered hospice services include nursing care,
medical social services, physicians' services, counseling, home health aid
services, physical, occupational, and speech therapy. Id.
n284. See generally David E. Joranson, Are Health-Care Reimbursement Policies a
Barrier to Acute and Cancer Pain Management?, 9 J. Pain & Symptom Mgmt. 244
(1994), available at http://www.medsch.wisc.edu/painpolicy/publicat/94jpsma.htm.
Short-term admissions result in increased health care costs to the hospice. Id.
n285. Medicare Payment Advisory Comm., Medicare Beneficiaries' Access to
Hospice, Report to the Congress, at 6 (May 2002). A delay in admission to
hospice care has serious implications. For instance, patients in the last six
months of life are likely to need pain management services, particularly those
with terminal illness. Beneficiaries who remain in environments other than the
hospice setting (for example, community, skilled nursing facilities, home health
agencies) often do not receive appropriate management of pain because the focus
in those systems is on providing curative treatment as compared to palliative
care in hospice settings. Since beneficiaries who elect the hospice benefit must
waive payment for all curative treatment, hospices are in the unique position to
be able to focus solely on the comfort level of the patients in their dying
n286. Id. (concluding that one of the main causes of late referrals to hospice
included the difficulty of making prognoses of death within six months).
n288. Jost, supra note 266, at 294 (citations omitted). Professor Jost suggests
that the declining length of stay is a result of several factors. Increased
pressure is being placed on doctors to refrain from referring patients to
hospices until death is almost certain. Id. Additionally, Medicare hospital
reimbursement, "which both discourages hospitals from admitting patients until
their condition is grave and encourages hospitals to discharge patients as
rapidly as possible, making it tempting for discharge planners to make a quick
home health referral rather than a more time-consuming hospice referral." Id.
Further, advances in technology often permit patients to remain in the community
with symptoms controlled for a much longer time than previously, followed by a
swift death when treatments finally fail. Id. Finally, other Medicare providers
such as SNFs and home health agencies, may be reluctant to refer patients to
hospices until the patient is in the final stages of dying because the hospice
benefit is exclusive of other Medicare services. Id.
n289. Benefits Improvement and Protection Act (BIPA) of 2000, Pub. L. No.
106-554, 114 Stat. 2763 (2000) (amending 1814(a)(7) of the Social Security Act,
Subtitle C, 322).
n290. Medicare Payment Advisory Comm., supra note 285, at 7.
n291. Jost, supra note 266, at 295-95.
n292. Jost, supra note 266, at 295. See also Office of the Inspector Gen. (OIG),
DHHS, Pub. No. A-05-97-00015, OIG Audit, Beneficiary Hospice Eligibility at
Samaritan Care, Inc., Southfield, Michigan, (Sept. 11, 1998), available at
http://oig.hhs.gov/oas/reports/region5/5970015.pdf; OIG, DHHS, Pub. No.
A-02-94-01030, OIG Audit, Review of Hospice Beneficiary Eligibility at Hospicio
en el Hogar de Manati (June 9, 1995), available at http://oig.hhs.gov/oas/reports/region2/29401030.pdf.
n293. See, e.g., OIG, DHHS, Pub. No. A-04-95-0211, OIG Audit, Operation Restore
Trust, Review of Hospice Eligibility at the Hospice of the Florida Suncoast,
Inc. (Aug. 1996), available at http://oig.hhs.gov/oas/reports/region4/4900211.pdf
(recommending recoupment of $ 8.9 million relating to beneficiaries who the OIG
determined were not eligible for Medicare hospice benefits). The Health Care
Financing Administration (HCFA) (now the Centers for Medicare and Medicaid
Services) subsequently agreed to reassess the OIG's findings. HCFA, DHHS,
Management Report on Final Action for Fiscal Year 1999, Section VI (1999),
available at http://www.hhs.gov/of/reports/account/acct99/sect6/sect6<uscore>5.html;
HCFA, DHHS, Management Report on Final Action for Fiscal Year 2000 (2000),
available at http://www.hhs.gov/of/reports/account/acct00/sect6/sect6b.html.
n294. Jost, supra note 266, at 295.
n295. 42 U.S.C. 1395f(i) (2000); 42 C.F.R. 418.302-0.309 (2003). See also 42
U.S.C.A. 195f(i) (West 2003).
n296. For fiscal year ending October 31, 2001, the hospice cap amount was $
16,650.85. See Palmetto GBA, Change in Hospice Payment Rates, Update to the
Hospice Cap, Revised Hospice Wage Index and Hospice Pricer, available at http://www.palmettogba.com;
Memorandum from Thomas E. Hamilton, CMS Director of the Disabled and Elderly
Health Programs Group, to all Associate Regional Administrators of the Division
of Medicaid and State Operations 1-2 (date not provided) (establishing Medicare
payment rates for FY 2002). Section 1814(i)(1)(C)(ii) of the Social Security Act
provides for an annual increase in the payment rates for hospice care services.
See 42 U.S.C. 1395f. Section 1814(i)(2)(B) of the Act provides for an annual
increase or decrease in the hospice cap amount. See 42 U.S.C. 1395f. Should a
beneficiary receive hospice services that exceed the capped amount, Medicare
will not pay additional hospice services. See 42 U.S.C. 1395f. For FY 2001, the
average number of hospice days utilized was 49.9 days per client. See Hospice
Ass'n of Am., supra note 279.
n297. OIG, DHHS, Pub. No. OEI-05-95-00250, Hospice Patients in Nursing Homes
(Sept. 1997), available at http://oig.hhs.gov/oei/reports/oei-05-95-00250.pdf.
According to its FY 2003 work plan, the OIG plans to follow up its examination
of the financial implications of Medicare hospice payments for nursing home
residents. See OIG, DHHS, OIG Work Plan 2003, available at http://oig.hhs.gov/publications/docs/workplan/2003/2cms%20FY03.pdf.
n298. Medicare Payment Advisory Comm., supra note 285, at 7.
n299. Id. at 8.
n300. 42 U.S.C. 1396a (2000). See also 42 U.S.C.A. 1396a (West 2003).
n301. Dual eligibility means that the beneficiary is eligible to receive
benefits under both the Medicare and Medicaid programs. See www.cms.hhs.gov/dualeligibles/bbadadef.asp.
n302. 42 U.S.C. 1396d(a)(1) (2000). See also 42 U.S.C.A. 1396d(a)(1) (West
n303. 42 U.S.C. 1396d(a)(2). See also 42 U.S.C.A. 1396d(a)(2).
n304. 42 U.S.C. 1396d(a)(4). See also 42 U.S.C.A. 1396d(a)(4).
n305. 42 U.S.C. 1396d(a)(5). See also 42 U.S.C.A. 1396d(a)(5).
n306. Kaiser Comm'n on Medicaid & the Uninsured, Henry J. Kaiser Family Found.,
A Prescription Drug Benefit in Medicare: Implications for Medicaid and
Low-Income Medicare Beneficiaries 2 (Sept. 2003).
n307. Id. at 1.
n308. 42 U.S.C. 1396o(a)(2), (3) (2000); 42 C.F.R. 447.53-54 (2003) (providing
that services cannot be denied to a recipient who is unable to pay a copayment);
42 U.S.C. 1396o(e). As of 1998, twenty-seven states imposed copayments on
prescriptions, which ranged from $ 0.50 to $ 3.00 per prescription. Jost, supra
note 266, at 297.
n309. Jost, supra note 266, at 297.
n310. 42 U.S.C. 1396o(a)(2), (3); 42 C.F.R. 447.53-.54 (2003).
n311. Jost, supra note 266, at 297.
n313. Id.; Joranson et al., supra note 2, at 495.
n314. Jost, supra note 266, at 297.
n315. Compassion in Dying Fed'n, Undertreating Pain Can Amount to Elder Abuse
(Feb. 3, 2000), available at http://www.compassionindying.org/releases/elderabuse.html;
Susan Okie, Doctor's Duty to Ease Pain at Issue in California Lawsuit, Wash.
Post, May 8, 2001, at A3, available at http://www.washingtonpost.com/wp-dyn/health/A51818-2001May6.html.
For a description of this case, see infra text accompanying notes 330-53.
n316. Okie, supra note 315, at A3.
n317. Bergman v. Eden Med. Ctr., No. H205732-1 (Alameda County Ct. filed June
13, 2002). See also Barry R. Furrow, Pain Management and Provider Liability: No
More Excuses, 29 J.L. Med. & Ethics 28, 28 (2001).
n318. See Or. Bd. of Med. Examiners, Guide to Licensing Action Report (Aug. 14,
2003), available at www.bme.state.or.us/licensactionrpt.html (lists legal
actions that have been taken by the Oregon Board of Medical Examiners). See also
Erin Hoover Barnett, Case Marks Big Shift in Pain Policy, Oregonian, Sept. 2,
1999. Oregon's disciplinary action against Dr. Bilder comes more than one and a
half years after a national nonprofit patient advocacy group, Compassion in
Dying, called upon all fifty states medical boards and the Federation of State
Medical Boards to penalize physicians who failed to give adequate pain control
to terminally ill patients. Medical Boards Urged to Penalize Docs Who Give
Little Pain Relief to Dying, Med. & Health, Jan. 19, 1998, available at 1998 WL
n319. Barnett, supra note 318.
n322. Id. An on-call physician eventually reinserted the breathing tube.
n323. Or. Bd. of Med. Examiners, supra note 318 available at www.bme.state.or.us;
Barnett, supra note 318.
n324. Robyn S. Shapiro, Health Care Providers' Liability Exposure for
Inappropriate Pain Management, 24 J.L. Med. & Ethics 360, 361 (1996) (describing
the unreported decision of Estate of Henry James v. Hillhaven Corp., No. 89CVS64
(Super. Ct. Div. N.C. Nov. 20, 1990)).
n330. Bergman v. Eden Med. Ctr., No. H205732-1 (Alameda County Ct. filed June
13, 2000). Dr. Chin was not the first physician sued under the California Elder
Abuse Act for inadequate treatment. In May 2000, a physician at a nursing home
was found liable for elder abuse for concealing a patient's bedsore, opposing
her hospitalization when it was medically necessary, and then withdrawing from
her case shortly before her death. Mack v. Soung, 95 Cal. Rptr. 2d 830, 835-36
(Ct. App. 2000). Like Bergman, the case was premised on the fact that the
California Elder Abuse Act covers the failure to provide medical care for health
needs. Cal. Welf. & Inst. Code 15610.57 (West 2003).
n331. Okie, supra note 315, at A3. See Matthew Yi, Doctor Found Reckless for Not
Relieving Pain, $ 1.5 Million Jury Verdict for Family of Cancer Patient Who Went
Home to Hayward to Die, S.F. Chron., June 14, 2001. See also Janice Lynch, Will
California Court Find Elder Abuse in Case of Inadequate Pain Management?, at
http://ww.mywhatever.com/cifwriter/content/19/abcd1592.html; James Hattori,
Doctor Found Guilty of Elder Abuse (June 12, 2001), available at http://www.cnnsf.com/storyofweek.html.
n332. Okie, supra note 315, at A3.
n338. Okie, supra note 315, at A3.
n341. Cal. Health & Safety Code 15600-15675 (West 2001).
n342. Cal. Health & Safety Code 15610.57.
n343. Cal. Welf. & Inst. Code 15656.
n344. Cal. Welf. & Inst. Code 15657-15657.3.
n345. Cal. Welf. & Inst. Code 15657.3(c)-(d).
n346. Lynch, supra note 331; Hattori, supra note 331.
n347. Yi, supra note 331; Matthew Yi, Elder Abuse Verdict Challenges Physicians
on Pain: Doctors Must Balance Relief Against Addiction, S.F. Chron., June 15,
n348. Cal. Civ. Code 3333.2(b) (West 2001).
n349. Yi, supra note 331; Hattori, supra note 331.
n350. Yi, supra note 331; Hattori, supra note 331.
n351. Cal. Bus. & Prof. Code 2190 (West 2002) (codifying Bill AB 487, which was
enacted Jan. 1, 2002).
n352. Yi, supra note 331.
n353. Furrow, supra note 317, at 30.
n354. Shapiro, supra note 324, at 362; Furrow, supra note 317, at 31.
n355. Furrow, supra note 317, at 31.
n356. Agency for Health Care Policy & Research, DHHS, Pub. No. 92-0032, Acute
Pain Management: Operative or Medical Procedures & Trauma, Clinical Practice
Guideline (1992); Agency for Health Care Policy & Research , DHHS, Pub. No.
94-0592, Management of Cancer Pain, Clinical Practice Guideline (1994).
n357. Am. Soc'y of Anesthesiologists, Practice Guidelines for Acute Pain
Management in the Perioperative Setting (1995), at http//:www.asahq.org/publications/AndServices/pain.html.
n358. Inst. for Clinical Sys. Improvements, Adult Low Back Pain (1999) (revised
May 2001), at http//:www.guideline.gov.html.
n359. Am. Pain Soc'y, Guideline for the Management of Acute and Chronic Pain in
Sickle Cell Disease (1999), at www.guideline.gov.
n360. Wash. State Dept. of Labor & Indus., Guidelines for Outpatient
Prescription of Oral Opiods for Injured Workers with Chronic, Noncancer Pain
(2000), at http//:www.guideline.gov/summary.
n361. The Management of Persistent Pain in Older Persons, 50 J. Am. Geriatric
Soc'y 205, 205 (2002), available at http://www.guideline.gov/summary.
n362. Am. Med. Dirs. Ass'n., Chronic Pain Management in the Long-Term Care
Setting (1999), at htttp://www.guideline.gov/summary.
n363. Furrow, supra note 317, at 32.
n364. For instance, the Commonwealth of Pennsylvania charged Alterra Assisted
Living, Inc. ("Alterra"), an assisted living facility, with three felony counts
of neglect and one misdemeanor count of neglect. See Hearing Transcript,
Commonwealth of Pennsylvania v. Alterra Assisted Living, Inc.,
CR-0000702-01(Centre County 2002) (preliminary hearing testimony of the State's
expert witness, Marie Boltz, R.N.). One felony count against Alterra was based,
in part, on allegations that it failed to provide adequate pain management to
one resident. Id. After a three-day preliminary hearing, all charges against
Alterra were dismissed. Id. (District Justice's order dated Jan. 31, 2002).
n365. The Conquering Pain Act of 2003, S. 1278, H.R. 2507, 108th Cong. (2003).
n366. The Conquering Pain Act of 1999, S. 941, H.R. 2188, 106th Cong. (1999);
The Conquering Pain Act of 2001, S. 1024, H.R. 2156, 107th Cong. (2001).
n367. While other pressing issues have occupied Congress' time, it does not
necessarily follow that there is a lack of interest in these bills. To the
contrary, Congress spent a good deal of time over the last session evaluating
one impediment to adequate pain management - Medicare reimbursement policies of
prescription drugs. This resulted in the passage of the Medicare Prescription
Drug, Improvement and Modernization Act of 2003. See Pub. L. No. 108-173 (2003).
n368. Glajchen, supra note 16, at 211-18.
n369. S. 1278; H.R. 2507.
n370. S. 1278 2(6)-(7) ; H.R. 2507 2(6)-(7).
n371. S. 1278 tit. I, 101(a) H.R. 2507 tit. I, 101(a) ("Websites in existence
... may be used if such websites meet the requirements of this section."). The
website at www.guideline.gov, which is organized and managed by the Agency on
Health Care Research, will likely meet the requirements of this section.
n372. S. 1278 tit. I, 101(c)(2)(A)-(C); H.R. 2507 tit. I, 101(c)(2)(A)-(C).
n373. S. 1278 tit. I, 102(a); H.R. 2507 tit. I, 102(a). Government health
programs include the Medicare and Medicaid program under Titles XVIII and XIX of
the Social Security Act, programs through the Public Health Service Act, the
Indian Health Service, the Federal Employee Benefits Program, the Civilian
Health and Medical Program of the Uniformed Services (CHAMPUS), and other
programs administered by Secretary of Health and Human Services. See S. 1278
tit. I, 102(b)(1)-(7); H.R. 2507 tit. I , 102(b)(1)-(7).
n374. S. 1278 tit. I, 103; H.R. 2507 tit. I, 103.
n375. S. 1278 tit. I, 103; H.R. 2507 tit. I, 103.
n376. S. 1278 tit. I, 104(a)(1), (2)(C); H.R. 2507 tit. I, 104(a)(1), (2)(C).
n377. S. 1278 tit. I, 105(1); H.R. 2507 tit. I, 105(1).
n378. S. 1278 tit. I, 105; H.R. 2507 tit. I, 105.
n379. S. 1278 tit. II, 201(a); H.R. 2507 tit. II, 201(a). Congress would
allocate $ 18 million toward this effort. See S. 1278 tit. II, 201(e); H.R. 2507
tit. II, 201(e).
n380. S. 1278 tit. III, 301(1); H.R. 2507 tit. III, 301(1).
n381. S. 1278 tit. III, 302(a); H.R. 2507 tit. III, 302(a).
n382. S. 1278 tit. IV, 401(a); H.R. 2507 tit. IV, 401(a).
n383. S. 1278 tit. IV, 401(e); H.R. 2507 tit. IV, 401(e).
n384. S. 1278 tit. IV, 402(a)(3); H.R. 2507 tit. IV, 402(a)(3).
n385. Frank-Stromborg & Christensen, supra note 201, at 236.
n386. The absence of a prescription drug benefit was formerly a reimbursement
barrier, but Congress has recently addressed this issue with the passage of the
Medicare Prescription Drug, Improvement and Modernization Act of 2003. See Pub.
L. No. 108-173 (2003).