The question of adequate palliative care to ameliorate the pain and suffering of

individuals with a terminal illness is infused at every level with legal issues

and concerns. One impetus for current efforts to improve such care has been the

attempt to create a constitutional right to physician-assisted suicide for

individuals who face an agonizing death. At the same time, clinical studies have

begun to show that pharmacological and other options are available to relieve

most of the pain that often accompanies a final illness.(1)

In federal courts in New York and Washington, proponents of physician-assisted

suicide contended that individuals have a constitutionally protected liberty

interest in deciding the time and manner of their own deaths and a right to a

physician's assistance in achieving death. Eventually, the United States Supreme

Court ruled unanimously that there was no such constitutional right,(2) thereby

upholding the states' power to make physician-assisted suicide a criminal

offense.

Several of the justices found it significant that New York and Washington

imposed no legal impediments to adequate pain management for the terminally ill.

For example, in her concurring opinion, Justice Sandra Day O'Connor noted:

The parties and amici agree that in these States 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.(3)

For Justice O'Connor, the fact that terminally ill individuals could, under

existing state laws, receive the pain relief necessary to alleviate their

suffering undermined the most compelling argument for physician-assisted

suicide. Justice Ruth Bader Ginsburg expressed her full agreement with Justice

O'Connor.(4)

Justice Steven Breyer was even more explicit, conceding that a strong argument

could be made for a constitutional right to "die with dignity," a right that

would include "the avoidance of unnecessary and severe physical suffering."(5)

But, like Justice O'Connor, he noted that "the laws of New York and Washington

do not prohibit doctors from providing patients with drugs sufficient to control

pain despite the risk that those drugs could themselves kill."(6)

Justices John Paul Stevens and David Souter also included adequate palliative

care as one of the serious issues confronting the terminally ill and suggested

that barriers to such care might require reconsideration of the decisions in the

physician-assisted suicide cases.(7)

Whether the dicta of those five justices will eventually become the basis for

the Supreme Court's finding a constitutional right to adequate palliative care

must await an appropriate future court case. In the meantime, the availability

of medications for adequate pain management remains a contentious issue under

federal and state laws.

Numerous clinical studies have shown that opioids are an important component of

any pain-management regimen for the terminally ill. But opioids are tightly

regulated under the federal Controlled Substances Act,(8) and state regulatory

authorities carefully monitor and sometimes challenge the opioid prescription

practices of physicians subject to their authority. Such license-revocation or

suspension proceedings invariably end up in state courts.

The Bazelon Center seeks to identify legal barriers to palliative care,

including pain management, for individuals with a terminal illness and to assess

whether litigation is an appropriate means of eliminating or lowering the

barriers. Two issues are the focus of initial inquiries: 1) administration of

the Medicare Hospice Benefit and 2) state regulatory oversight of the use of

opioids in pain management.

The Medicare Hospice Benefit is available to terminally ill Medicare recipients

who have a prognosis of six months or less to live and who waive their right to

"curative" treatment under Medicare. Both of those conditions have evoked

criticism, but the six-month rule has been the most contentious.(9)

Congress added the hospice benefit to Medicare by 1982 amendments to the Social

Security Act, apparently without giving much thought to the six-month

requirement. At the time, the hospice movement was just becoming established in

this country, and the patients most likely to choose hospice were those with

advanced malignant diseases. Some, but not all, cancers follow a fairly

predictable trajectory from the diagnosis of a terminal condition(10) to death.

However, making an accurate prognostication for any individual with a

nonmalignant terminal condition, such as congestive heart failure, chronic

obstructive pulmonary disease or dementia, is extremely difficult, because the

pace of dying is affected by many factors over a substantial period of time.(11)

Neither the legislation nor its implementing regulations provide any significant

guidance on application of the six-month rule.

It is not clear whether a 6-month prognosis means that nearly all patients (more

than 99%) should expire within 6 months or that 10% or even 50% of patients

might still be alive at 6 months (the latter being akin to the usual way of

thinking in terms of median survival). Depending on the extent to which hospices

might be forced to bear excessive costs when patients live beyond 6 months, . .

. this lack of definition can have profound effects on the potential hospice

population.(12)

Two other factors have exacerbated the difficulty in administration of hospice

benefit. First, in 1995, the Office of Inspector General of the Department of

Health & Human Services (HHS) undertook an investigation into allegations of

fraud in connection with the operation of the Medicare hospice benefit.(13) The

investigation looked askance at any hospice with more than a few patients who

survived longer than six months after being certified eligible.

One consequence of the investigation was a precipitous drop in hospice

enrollment, indicated by a greatly reduced increase in hospice payments in 1996

"due in part to a lower rate of patient enrollment, after the Office of

Inspector General found that some hospices were inappropriately enrolling

patients by making inaccurate life expectancy determinations."(14)

Another possible impact of the inquiry was a drop in the average length of

Medicare recipients' stay in hospices. While the number of Medicare

beneficiaries enrolling in hospice increased by 42% between 1994 and 1997, their

average length of stay in hospice declined by 10 days. The decline was

attributed in part to the investigation because doctors had become reluctant to

certify patients for the hospice benefit until death was imminent.(15)

Oddly, HHS has not attempted to recover money improperly paid to the offending

hospices. Such proceedings would provide an avenue for hospices to challenge the

inspector general's interpretation of the six-month rule.

One thing is certain: the publicity surrounding the investigations has made

doctors reluctant to certify and hospices reluctant to accept Medicare patients

until there is no question that death will ensue in fewer than six months and

often quite a bit sooner. The effect has been to deprive Medicare recipients and

their families of the full range of services available under the hospice

benefit, including the development of an appropriate pain-management plan and

the time necessary to tie up the loose ends of one's life.

A second issue related to the hospice benefit is concern that inconsistent

criteria are being applied to assess compliance with the six-month rule. The

Health Care Financing Administration (HCFA) contracts with private entities,

each responsible for a geographical region, to carry out many of the tasks

associated with administering Medicare. These "Fiscal Intermediaries" (FIs)

receive requests for payments from hospices for services provided to Medicare

beneficiaries, evaluate the hospices' compliance with applicable statutory and

regulatory requirements, and authorize payments for the services provided. The

various FIs have adopted local medical review policies for evaluating whether a

person diagnosed with a terminal, nonmalignant illness has six months or fewer

to live. Since the jurisdiction of each FI is geographical, two individuals in

identical stages of a terminal illness can be evaluated differently because of

where they live. A court could well conclude that the hospice benefit is being

administered in an arbitrary and capricious manner, a classic ground to

invalidate administrative actions.

However, litigation cannot address two issues related to inadequate pain

management for the terminally ill: the adequacy of medical education and the

attitudes of those involved in the dying process. An American Medical

Association survey revealed that only five of 126 medical schools in the country

required a separate course on the care of the dying and only 26 percent of 7,048

residency programs surveyed offered training on the medical aspects of care at

the end of life as a regular part of the curriculum.(16)

The attitudinal problem relates to fears on the part of patients, their families

and physicians that the use of opioids in the quantities required to alleviate

the pain of a final illness will lead to addiction. These fears are rooted in

misconceptions about the nature of addiction and the legitimate medical use of

opioids. For example, those who abuse drugs such as opioids do so for the "high"

they experience. Yet one survey showed that more than 85% percent of cancer

patients experienced dysphoria rather than euphoria when opioids were

administered to treat their pain.(17) Attitudes, however, do not have to be well

grounded to interfere with proper palliative care.

Apart from those considerations, physicians often encounter significant

regulatory barriers when they use opioids to treat pain. Two facts delineate the

conundrum faced by physicians engaged in pain management for the terminally ill.

First, opioids, and particularly morphine, are the most effective drugs for

alleviating the pain experienced by people in their final illnesses. Second,

opioids are a major focus of efforts to curb drug abuse. Consequently,

physicians who use opioids to treat pain are often scrutinized closely by

federal or state regulators.

Opioids are among the drugs listed under Schedule II of the Controlled

Substances Act as having a high potential for abuse that may lead to severe

psychological or physical dependence, even while having a currently accepted

medical use in treatment.(18) This tension drives the regulatory problems that

face physicians using opioids to alleviate the pain accompanying terminal

illness.

The Drug Enforcement Agency (DEA) is the federal enforcement agency charged with

preventing the illegal use and abuse of controlled substances. But when a

physician who prescribes a controlled substance in the course of professional

practice, he or she is outside the DEA's enforcement authority.(19) The

responsibility for policing prescriptions of these drugs in the course of

professional practice rests with state regulatory authorities, such as state

medical boards.

State regulation of prescription practices has not been as benign as the federal

government's. Until 1970, states' anti-drug laws, more often than not, were

driven by perceptions of abuse rather than the realities of medical need.

Beginning in 1970, all states replaced their drug control laws with legislation

based on a model called the Uniform Controlled Substances Act (UCSA) that was

designed to bring more consistency to drug control policies.(20)

While the UCSA achieved a degree of consistency among the states, it had two

significant shortcomings. First, unlike the federal Controlled Substances Act,

the UCSA did not expressly acknowledge the acceptable medical uses of controlled

substances. Second, the UCSA left each state to work out its own definition of

"addict." In some states, the effect has been to equate drug addiction with drug

dependence and/or habitual drug use, two conditions that describe the terminally

ill patient whose pain is managed with opioids.

The result has been policies and practices in some states that deter or unduly

restrict the ability of a physician legitimately to prescribe the dosage of

opioids that terminally ill patients need for pain relief. For example, some

states have restricted the number of dosage units that can be dispensed at one

time. This causes many patients to ration drugs for fear of running out before a

prescription can be refilled; it also costs patients additional dispensing fees.

Other states require physicians to use multiple-copy prescription forms provided

by state agencies. These forms increase physicians' record-keeping burdens and

have been found to discourage the prescribing of the drugs that require such

forms.(21)

While motivated by the states' desire to reduce drug abuse, such restrictions

weigh most heavily on people suffering from the pain that accompanies a final

illness. For example, in a 1993 study of 897 physicians caring for cancer

patients, 86 percent reported that most patients with cancer were

under-medicated for pain. Another study a year later disclosed that patients

with nonmalignant diseases received less adequate pain treatment than patients

with cancer.

One of the significant impediments is physicians' fear that prescribing an

adequate quantity of opioids will result in an investigation. . . .Even members

of state medical boards do not have a clear understanding of what is legally and

medically acceptable in using opioids to treat pain.(22)

Efforts to reverse these trends began in the early 1990s and have begun to show

some progress. For example, the Federation of State Medical Boards, working in

cooperation with the Pain and Policy Studies Group at the University of

Wisconsin and others, has sponsored a series of educational workshops for

members of state medical boards.(23) During the same period, an increasing

number of states have enacted intractable pain laws or their medical boards have

issued guidelines for physicians using opioids to treat intractable pain.(24)

While these actions hold the promise of relaxing the regulatory restrictions

that physicians perceive on their opioid prescription practices, fears and

inhibitions that have built up over the years will not vanish overnight.

Moreover, state medical boards are not the only entities that pose a threat to

physicians who prescribe opioids in appropriately large quantities to alleviate

the pain of a final illness. State prosecutors and other actors in the criminal

justice system can also be a threat.

For example, a special panel of forensic professionals was appointed in Volusia

County, Florida, after the a District Medical Examiner and his associate were

suspended for identifying 19 deaths for further investigation because of high

blood levels of opioids.(25) The panel reported that none of the deaths

warranted further investigation, although some had been attributed to homicide

and all had been labeled suspicious. In most of the cases, the panel found that

the "toxic" levels of morphine to which the medical examiner attributed death

were based on an assumption that the deceased had been "pharmacologically

naive," a term that describes individuals not previously treated with opiate

narcotics, such as morphine, for pain. In fact, the 19 deceased individuals in

Volusia County had either died in hospices where they had been given opioids in

appropriately large doses to manage the pain of their terminal illnesses or had

died in intensive care units of hospitals from severe trauma after being sedated

with opioids for severe pain.

The panel of forensic professionals was unanimous in concluding that none of the

deaths warranted further investigation. It criticized the original autopsy

reports for failing to consider the clinical treatment of the deceased prior to

death and basing conclusions solely on levels of opioids in the blood at the

time of death. While the panel vindicated the treatment of the 19 deceased

individuals prior to death, it does not require much imagination to understand

the chilling effect the initial autopsy reports must have had on physicians

engaged in pain management in Volusia County.

As a further example, some nurses at a nursing home in eastern Maryland faced

criminal charges because an autopsy disclosed that a patient at the home had

opioids in her body at the time of death. The patient, a 90-year-old woman with

congestive heart failure, had suffered a stroke and had an irregular heart beat,

a fever and a seizure in the days preceding her death. Apart from the presence

of opioids in her body, the autopsy disclosed that the patient had suffered an

acute stroke and had an acute infection prior to death. Yet the local prosecutor

brought criminal charges, including conspiracy to commit first degree murder,

against three nurses, based solely on the presence of the opioids. While those

charges never went to trial,(26) the prosecutor's action sent a chill through

health care professionals in nursing homes throughout Maryland.

The Bazelon Center believes that unduly restrictive state medical board policies

on the prescription of opioids and unfounded criminal charges or other punitive

actions against health care professionals engaged in appropriate pain management

are legitimate targets for preventive litigation.

One difficulty with a state medical board's actions against a particular

physician, or the types of inquiries or criminal charges described above in

Florida and Maryland, is that they do not always get the public notice that they

should. For the most part, they are publicized, if at all, in the local

community or among members of the affected health care community. Only if such

incidents come under the light of public scrutiny are they likely to be

challenged and shown to be what they are: a serious threat to the ability of

terminally ill patients to get the palliative care and appropriate pain

management they need to ease the burdens of a final illness.

A plethora of problems continues to inhibit the ability of health care

professionals to provide adequate palliative care, including effective pain

management, to people with terminal illnesses. These problems range from

outdated attitudes about the use of opioids, fostered by unfounded concerns

about addiction, and inadequate training of physicians, to unnecessarily

restrictive regulatory policies. Litigation is not a panacea that will cause all

the problems to disappear. However, when the problems arise in a context in

which the legal process likely will be directly or indirectly implicated,

properly targeted litigation can be a needed antidote to assure terminally ill

individuals that they can receive appropriate palliative care.

© Copyright 1999 Judge David L. Bazelon Center for Mental Health Law, Washington

D.C

ENDNOTES

1. See, e.g., Approaching Death: Improving Care at the End of Life, p. 5

(Institute of Medicine, 1997); R.A. Burt, Constitutionalizing Physician-Assisted

Suicide: Will Lightning Strike Thrice, 35 Duquesne Law Rev. 159, 166-69 (1996).

2. Vacco v. Quill, 117 S.Ct. 2293 (1997); Washington v. Glucksberg, 117 S.Ct.

2258 (1997).

3. Vacco v. Quill, 117 S.Ct. at 2303.

4. Id., 117 S.Ct. at 2310.

5. Id., 117 S.Ct. at 2311.

6. Id.

7. Washington v. Glucksberg, 117 S.Ct. 2290 (Souter), 2308 (Stevens).

8. Pub. L. No. 91-513, 21 United States Code § 801 et seq., as amended.

9. There is not always a clear demarcation between curative and palliative

medicine. For example, surgical procedures are the paradigm of curative

medicine, but some surgery can serve a palliative purpose. See G.P. Dunn,

Surgery and Palliative Medicine: New Horizons, 1 Journal of Palliative Medicine

215 (1998). Even the requirement that a person be "terminally ill" to be

eligible for the Medicare hospice benefit has been criticized. E.g., J. Lynn,

Geriatricians, Public Policy, and Practice Standards for the Care of the Dying,

43 Journal of American Geriatrics Society 553 (1995); J. Lynn. F.E. Harrell, F.

Cohn, M.B. Hamel, N. Dawson & A.W. Wu, Defining the "Terminally Ill:" Insights

from SUPPORT, 35 Duquesne L. Rev. 311 (1996).

10. "Terminal condition," as used in the text, means that the particular disease

or condition will no longer respond to attempts to bring about a cure.

11. J. Lynn, J.M. Teno & F.E. Harrell, Accurate Prognostications of Death:

Opportunities and Challenges for Clinicians, 163 Western Journal of Medicine

250, 251 (1995).

12. J.A. Rhymes, Hospice Care-Too Little, Too Late? 43 Journal of American

Geriatric Society pp. 557-58 (1995). It should be noted that an incorrect

six-month prognosis does not affect the length of a particular Medicare

patients's in hospice. The Medicare statute allows indefinite hospice treatment

for an eligible Medicare patient once that patient opts for the hospice benefit.

42 United States Code § 1359d(a)(4).

13. "HHS Inspector General Issues Hospice Advisory," a news release from the

Office of the Inspector General, October 10, 1995.

14. Medicare Payment Advisory Commission, Health Care Spending and the Medicare

Program: A Data Book, p. 114 (July 1998).

15. E. Twitchell, Medicare Hospice Patient Count Up 42%, But Length of Stay Down

by 10 days, Home Health Line Extra, August 24, 1998. The report was based on

data from 21 states and Puerto Rico.

16. K.M. Foley, Competent Care for the Dying Instead of Physician-Assisted

Suicide, 336 New England Journal of Medicine 54, 55-56 (1997).

17. K.M. Foley, The Relationship of Pain and Symptom Management to Patient

Requests for Physician-Assisted Suicide, 6 Journal of Pain & Symptom Management

289, 291-92 (1991).

18. 21 United States Code § 812(b)(2).

19. D.E. Joranson & A. Gilson, Controlled Substances, Medical Practice, and the

Law, in Psychiatric Practice Under Fire: The Influence of Government, the Media

and Special Interests on Somatic Therapies, pp. 173-94 (H.I. Schwartz, ed.

1994). The authors note that a physician's prescription practices might

constitute terrible medicine, the grossest form of medical misconduct or

malpractice and still not be subject to DEA jurisdiction as along the

prescriptions in question were issued in the course of professional practice.

20. D.E. Joranson & A. Gilson, supra note 19. The discussion in the text of the

USCA is based principally on this source.

21. D.E. Joranson & A. Gilson, supra note 19.

22. C.S. Hyman, Pain Management and Disciplinary Action: How Medical Boards Can

Remove Barriers to Effective Treatment, 24 Journal of Law, Medicine & Ethics 338

(1996).

23. D.E. Joranson & A.M. Gilson, State Intractable Pain Policy: Current Status,

7(2) American Pain Society Bulletin 7-9 (1997). The 125 state medical board

members represented 20 percent of all state medical board members nationwide.

24. D.E. Joranson & A.M. Gilson, supra note 23.

25. The information reported in the text about the Volusia County situation is

from a letter, dated July 30, 1998, to Joan E. Wood, M.D., Acting District 7

Medical Examiner, from Stephen J. Nelson, M.D., who chaired the panel of

forensic professionals.

26. The charges against one of the nurses were dropped for lack of evidence. The

two other nurses, however, committed an error in judgment that proved quite

costly. On the day before the elderly patient's death, she was in great distress

because of dyspnea. There was no written order in her chart authorizing the

administration of opioids. So the two nurses "borrowed" medicine from another

patient and gave it to the dying elderly woman. It was that "borrowed" medicine

that was found in that patient's body at the autopsy. In exchange for the

prosecutor's dropping all charges, including conspiracy to murder, in the

original indictments, the two nurses entered guilty pleas to a charge of

administering a controlled substance without proper authorization. They served

30 days in jail, were fined and subsequently lost their nursing licenses for

their error in judgment. However, the charge to which they entered their guilty

pleas was far removed from the original charge of conspiracy to commit first

degree murder. (This information about the Maryland nursing home incident was

provided by Dr. Timothy J. Keay, a Soros Faculty Scholar in the Geriatrics

Division of the Department of Family Medicine at the University of Maryland

School of Medicine in Baltimore.)

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