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See, for example, AMA Department of Young Physicians Services, Pain Management: Resources for Physicians (visited Dec. 3, 1998) <http://www.texnet.net/paincare/acute.htm> (stating that “[d]espite good intentions and genuine concern for patients’ comfort on the part of physicians, repeated evaluations of the state of pain therapy over the past 20 years suggest that many patients receive inadequate pain relief.”).+(stating+that+“[d]espite+good+intentions+and+genuine+concern+for+patients’+comfort+on+the+part+of+physicians,+repeated+evaluations+of+the+state+of+pain+therapy+over+the+past+20+years+suggest+that+many+patients+receive+inadequate+pain+relief.”).>Google Scholar

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See Bonica, J.J., Effective Pain Management for Cancer Patients (St. Paul: SIMS Deltec, Inc., 1994). According to John Bonica, “[d]ata contained in 11 reports, involving nearly 2,100 patients, published in the United States and several other countries reveals that in 70 percent of the patients managed with opioids and other drugs as well as anti-cancer therapy, the pain remained unrelieved in many instances until the death of the patient.” Id. See also Bernabel, R. Gatsonis, C. Mor, V., “Management of Pain in Elderly Patients with Cancer,” JAMA, 279 (1998): 1877–82 (reporting on a study of over 10,000 nursing home residents with cancer which found that, although pain is common among such residents, it is often untreated).Google Scholar

See Portenoy, R.K., “Opioid Therapy for Chronic Nonmalignant Pain: Clinicians' Perspective,” Journal of Law, Medicine & Ethics, 24 (1996): 294–309; see also AGS Panel on Chronic Pain in Older Persons, “The Management of Chronic Pain in Older Persons,” Journal of the American Geriatrics Society, 46 (1998): 635–51 (stating that opioids are often underprescribed for individuals with chronic nonmalignant pain in part because of “political and social pressures to control illicit drug use among people who take these medications for emotional rather than medical reasons” but that “addictive behavior among patients taking opioid drugs for medical indications appears to be very low”).Google Scholar

See Johnson, S.H., “Disciplinary Actions and Pain Relief: Analysis of the Pain Relief Act,” Journal of Law, Medicine & Ethics, 24 (1996): 319–27.Google Scholar

See Sontag, M., “A Comparison of Hospice Programs Based on Medicare Certification Status,” American Journal of Hospice & Palliative Care, Mar./Apr. (1996): at 32.Google Scholar

See Rhymes, J., “Hospice Care in America,” JAMA, 264 (1990): 369–72; see also AMA Young Physicians, supra note 2: The AMA's Council on Scientific Affairs in its 1995 report “Aspects of Pain Management in Adults,” identified the following barriers to optimal pain management:CrossRefGoogle Scholar

At the same time as we have become aware of the inadequacy of pain relief practices, our health care system is undergoing revolutionary changes. More and more of the insured population has moved into managed care. Over 70 percent of employees in medium and large organizations are enrolled in managed care plans, and the number of Medicare and Medicaid recipients in managed care is growing rapidly. See Findlay, S. Meyeroff, W.J., “Health Costs: Why Employers Won Another Round,” Business & Health, 14 (Mar. 1996): at 49–51; see also Office of Managed Care, Health Care Finance Administration, National Summary of Medicaid Managed Care Programs and Enrollment (Washington, D.C.: HCFA Office of Managed Care, Sept. 20, 1996); and Health Care Finance Administration, Monthly Medicare Managed Care Contract Report (Washington, D.C.: HCFA Office of Managed Care, Sept. 1, 1996).Google Scholar

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For example, a recent article regarding hospital-affiliated headache clinics stated that these facilities were often started before the managed care era and that, as managed care becomes more predominant, these clinics will have to document value in order to survive. See Green, M.W. Davis, D.W., “Hospital-Affiliated Headache Clinics in the Managed Care Era,” Headache, 36 (1996): 503–05.CrossRefGoogle Scholar

Ferrell, B.R. Griffith, H., “Cost Issues Related to Pain Management: Report from the Cancer Pain Panel of the Agency for Health Care Policy and Research,” Journal of Pain and Symptom Management, 9 (1994): at 222.CrossRefGoogle Scholar

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See id. at 227. This figure is based on then current reimbursements for home nursing visits in California under Medicare.Google Scholar

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Semmler v. Metropolitan Life Insurance Co., No. 119123/94, as reprinted in New York Law Journal, 25 (Nov. 17, 1997): at 25.Google Scholar

Patient controlled analgesia is the “use of a pump, programmed and monitored under the supervision of anesthesiologists or other trained physicians, which permits a patient to press a button to obtain pain medication intravenously as needed, within limits set by the physician.” Id.Google Scholar

Epidural narcotic administration is the “insertion of a catheter into the epidural space near the spine through which pain medication can be infused continuously and/or intermittently.” Id.Google Scholar

Id. The defendant’s Claims Issues Committee, including four physicians, determined that “a benefit allowance for additional visits by an anesthesiologist” in such cases would be a payment for services that are not medically necessary. Id.Google Scholar

At issue in this case was whether the determination would be evaluated on a “de novo standard or a more lenient arbitrary and capricious standard,” as desired by the defendant. The court ultimately applied the arbitrary and capricious standard. See id. Interestingly, an opinion by a federal district court regarding claimants governed by the Employment Retirement Income Security Act found that, under the same set of facts, the decision was not “arbitrary and capricious.” Semmler v. Metropolitan Life Insurance Co., 172 F.R.D. 86 (S.D.N.Y. Mar. 24, 1997), aff'd, 133 F.3d 907 (2d Cir.), cert. denied, 118 S. Ct. 2391 (1998).Google Scholar

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AGS Panel on Chronic Pain in Older Persons, supra note 5, at 636.Google Scholar

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Id. at 635–36. (emphasis added) (endnotes omitted).Google Scholar

See Caudill, M., et al., “Decreased Clinic Use by Chronic Pain Patients: Response to Behavioral Medicine Intervention,” Clinical Journal on Pain, 7 (1991): 305–10 (“The treatment of chronic pain is costly and frustrating for the patient, health care provider and health care system. This is due, in part, to the complexity of pain symptoms which are influenced by behavior patterns, socioeconomic factors, belief systems, and family dynamics as well as by physiological and mechanical components.”).Google Scholar

Zimm, A., “Tracking Elusive Sources of Pain More Difficult in Age of Cost Containment: Extensive Testing and Consultations with Specialists Often Required for Proper Diagnosis, Pain Experts Say,” Warfields, Sept. 9, 1996, at 9. In response to this concern by insurers and managed care plans, some pain specialists argue that “when it comes to pain, providing more can actually cost less.” This is especially true, advocates say, when costs are associated with obtaining a correct diagnosis. Id.Google Scholar

“Pain Control Innovations Abound, but Still no Voice of Authority: Report on Medical Guidelines and Outcomes Research,” available in 1997 WL 8623976 (Apr. 3, 1997) (hereinafter “Pain Control Innovations”); see also AGS Panel on Chronic Pain in Older Persons, supra note 5, at 637 (stating that “[a]mong those for whom the underlying cause [of pain] is not remediable or only partially treatable, a multidisciplinary assessment and treatment strategy is often indicated.”). There are data to show that multidisciplinary treatments for chronic pain yield better functional outcomes in the long run and are more cost effective than single discipline treatments at least for chronic, nonmalignant pain. See, for example, Flor, H. Fydrich, T. Turk, D., “Efficacy of Multidisciplinary Pain Treatment Centers: A Meta-Analytic Review,” Pain, 49 (1992): 221–30. However, there has been little evaluation of the cost effectiveness of pain clinics “based on acute and postoperative models of care or cancer pain programs.” See Ferrell, Griffith, supra note 13, at 230.Google Scholar

See “Finding the Right Care for Chronic Pain,” Business & Health, 14 (Fall 1996): at 17, adapted from Turk, D.C. Okifuji, A., “Multidisciplinary Approach to Pain Management: Philosophy, Operations, and Efficiency,” in Ashburn, M.A. Rice, L.J., eds., The Management of Pain (New York: Churchill Livingstone, 1998): 235–48.Google Scholar

Id.; see also “The Pain Coverage Conundrum,” Business & Health, 14 (Fall 1996): at 22 (stating that “pain clinics are perceived in many instances to be composed of quacks who overcharge and offer unproven and expensive therapies that take advantage of the system”).Google Scholar

“Pain Control Innovations,” supra note 33 (quoting Dr. Kutaiba Tabbaa, director of pain management at MetroHealth Medical Center, in Cleveland, Ohio). Pain experts also argue that “primary care physicians may not be well trained to diagnose and treat pain…. For one thing, they may not realize that pain may still be persistent even though diagnostic tests reveal nothing abnormal. Primary care physicians may even question whether patients with no detectable abnormality are malingering or mentally unstable.” “Finding the Right Care for Chronic Pain,” supra note 34, at 17 (quoting Dr. J. David Haddox, medical director of the Pain Rehabilitation Program at the Emory University Clinic, in Atlanta). However, some pain experts admit that even though managed care plans may be reluctant to approve psychiatric evaluations or referral to some specialists, they have an easier time approving some types of interventions. For example, managed care plans appear to be more willing to approve implantable analgesic pumps because the primary care physicians understand the devices and the need for them. See “Pain Control Innovations,” supra note 33 (quoting Dr. Tabbaa).Google Scholar

See “Pain Control Innovations,” supra note 33. One pain provider asserts that plans do not understand that treatment of chronic pain requires a “package” approach. In his experience, plans approve “some elements of multidisciplinary care and disapprove others,” which, he asserts, may not be effective in treating the patient. See “The Pain Coverage Conundrum, supra note 35.Google Scholar

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See Carey, T.S., et al., “The Outcomes and Costs of Care for Acute Low Back Pain Among Patients Seen by Primary Care Practitioners, Chiropractors, and Orthopedic Surgeons,” N. Engl. J. Med., 333 (1997): 913–17.Google Scholar

See Friedlieb, O.P., “The Impact of Managed Care on the Diagnosis and Treatment of Low Back Pain: A Preliminary Report,” American Journal of Medical Quality, 9 (Spring 1994): 24–29. Another argument for the benefit of clinical guidelines was made in a study of the impact of managed care on prescription drug use (not related to pain). Researchers found that members of health maintenance organizations (HMOs) were more likely to use prescription drugs at a greater rate than those who were not HMO members. The study suggested that, in some cases, intensive drug intervention in the ambulatory setting may not only improve a patient's well-being but also may result in a decrease in overall health care costs by avoiding expensive hospital care or surgery. The researchers further hypothesize that HMOs, by establishing rational guidelines for prescription drug use, may increase “both the effectiveness and the efficiency of care.” Specifically, they state that:Google ScholarGoogle Scholar

Hooper, Lundy & Bookman, Inc., “Senate Bills Introduced,” California Health Law Monitor, 5 (Mar. 31, 1997): 4–16.Google Scholar

Id. Although California Senate Bill 687 was subsequently modified and the pain provisions deleted, Senate Bill 402 remained focused on pain treatment and was passed and signed into law in October 1997.Google Scholar

Pear, R., “HMO's Fight Plan to Pay for Some Emergency Care,” New York Times, June 25, 1997, at A16.Google Scholar

Id. (quoting Dr.Saper, Joel R., director of the Michigan Head Pain and Neurological Institute in Ann Arbor, Michigan).Google Scholar

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See Curtis, J.R. Rubenfeld, G.D., “Aggressive Medical Care at the End of Life: Does Capitated Reimbursement Encourage the Right Care for the Wrong Reason?,” JAMA, 278 (1997): 1025–26 (casting doubt on the conclusions reached by Dr.Cher, Daniel Dr.Lenert, Leslie, in part because of “systematic incentives for hospitals to minimize billing for managed care patients and maximize billing for fee-for-service patients”).Google Scholar

See Jost, T.S., “Public Financing of Pain Management: Leaky Umbrellas and Ragged Safety Nets,” Journal of Law, Medicine & Ethics, 26 (1998): 290–307.Google Scholar

The senior medical director (SMD) was chosen because he/she would be most likely to have a sense of the importance of pain management and palliative care to the plan relative to other plan priorities, and to be knowledgeable about the plan's product lines. Other medical directors, although more likely to have detailed knowledge about pain management and palliative care, would be less likely to see the issue in the larger context of plan administration and plan products.Google Scholar

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When we began our study in 1997, there were fifty-eight Blue Cross Blue Shield Plans (BCBS Plans). As of January 1998, due to ongoing mergers throughout the United States, there were fifty-five. Id. This trend is consistent with published reports regarding the status of BCBS Plans. See, for example, Cain, H.P. II, “Proving the Policy Wonks Wrong,” Health Affairs, 15, no. 4 (1996): at 105–06 (stating “[t]he Blues system is changing rapidly. Fifteen years ago there were eighty Blue Cross and Blue Shield plans. The number now is sixty and dropping. Mergers and consolidations are underway all over the country.”).Google Scholar

BCBS refers to each of these fifty-five organizations as “Plans.” Each BCBS Plan offers a variety of “insurance products,” that is, HMOs, preferred provider organizations, traditional indemnity, and so forth.Google Scholar

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Palliative care is distinguished from pain management for terminally ill patients because it is considered to be somewhat broader in scope, encompassing not simply pain management but also other approaches to comforting patients at the end of life and helping them to cope with an impending death. The survey form defined palliative care as “comfort care and other non-aggressive treatment for patients who are terminally ill.”Google Scholar

Prior to initiating interviews, an exemption from institutional review board approval was obtained by the University of Maryland, Baltimore Institutional Review Board.Google Scholar

In addition, one plan director, speaking as a Medicare carrier, said that the issue had come to him in response to uncertainty over coverage (“loading of pumps by home nurse is not provided by Medicare, so it becomes cost to patient. Turfed problem to Medicare.”).Google Scholar

As regards the effort to develop guidelines or policies on pain management, specific responses included:Google Scholar

One SMD said it had come to his attention with regard to “off label use of neoplastic agents for supposedly palliative care.”Google Scholar

Other reasons why or how the issue came to the attention of SMDs include the following:Google Scholar

Other responses include:Google Scholar

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Specific responses include the following:Google Scholar

Blue Cross Blue Shield of Massachusetts, Medical Policy (Boston: Blue Cross Blue Shield of Massachusetts, June 1996, reviewed Feb. 1998).Google Scholar

Id. To explain the difference between coverage for Medicare beneficiaries and non-Medicare beneficiaries, the policy states that “Medicare policy is developed separately from BCBSMA [Blue Cross Blue Shield of Massachusetts] policy. While BCBSMA policy is based upon scientific evidence, Medicare policy incorporates scientific evidence with local expert opinion, and governmental regulations from HCFA [Health Care Financing Administration] … and the U.S. Congress.” Id. According to a medical director at BCBSMA, local expert opinions are also used to develop medical policy for non-Medicare policies.Google Scholar

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One respondent said that state law mandated coverage of pain management for a minimum of sixty days and because TENS units were not effective for chronic pain, the plan had made a decision not to cover it. A later conversation with this respondent indicated that the state law he was referring to did not explicitly mention pain management but had been interpreted to include pain management. More recently, he said, the plan's interpretation of the law had been revised.Google Scholar

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Evidence indicates that persons with more severe and chronic pain use health care at rates substantially above population means. See Von Korff, M., et al., “Chronic Pain and Use of Ambulatory Health Care,” Psychosomatic Medicine, 53 (1991): 61–79.Google Scholar

For example, in Maryland, as of June 1998, only seventeen physicians were certified by the American Board of Hospice and Palliative Medicine.Google Scholar

See WHO, Cancer Pain Relief and Palliative Care (Geneva: WHO Technical Report Series 804, 1990).Google Scholar

See Max, M.B., et al., Principles of Analgesic Use in the Treatment of Acute Pain and Cancer Pain (Skokie: American Pain Society, 3rd ed. 1992).Google Scholar

See Agency for Health Care Policy and Research, Clinical Practice Guideline Number 1: Management of Acute Pain (Rockville: Department of Health and Human Services, AHCPR Pub. No. 92–0022, 1992); Agency for Health Care Policy and Research, Clinical Practice Guideline Number 9: Management of Cancer Pain (Rockville: Department of Health and Human Services, AHCPR Pub. No. 94–0592, 1994); and Agency for Health Care Policy and Research, Clinical Practice Guideline Number 14: Management of Acute Low Back Pain (Rockville: Department of Health and Human Services, AHCPR Pub. No. 95–00642, 1994).Google Scholar

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See Jamison, R.N., “Comprehensive Pretreatment and Outcome Assessment for Chronic Opioid Therapy in Nonmalignant Pain,” Journal of Pain and Symptom Management, 11 (1996): at 231 (stating that guidelines currently exist on the use of opioid therapy for chronic nonmalignant pain but that “no empirical studies have been conducted to substantiate these guidelines”); and Justins, D., Book Review, “Pain Medicine: A Comprehensive Review,” Lancet, 347 (1996): 814 (asserting that there is a lack of “reports of proper randomized controlled trials of a great many of the treatments currently used for chronic pain”).Google Scholar

See AGS Panel on Chronic Pain in Older Persons, supra note 5. These include such interventions as educational programs, cognitive-behavioral therapy, exercise programs, acupuncture, TENS, chiropracty, and heat, cold massage, relaxation and distraction techniques.Google Scholar

See also Technology Evaluation Center, Blue Cross Blue Shield Association, Biofeedback (Chicago: TEC Assessment Program, Vol. 10, No. 25, Jan. 1996). In its official statement, the panel defines “biofeedback” as “a procedure intended to train a patient to control a physiological process (e.g., blood pressure).” The Technology Evaluation Center's (TEC) criteria for review include the following:Google Scholar

Technology Evaluation Center, Blue Cross Blue Shield Association, Acupuncture in the Treatment of Pain (Chicago: TEC Assessment Program, Vol. 11, No. 22, Jan. 1977). The statement goes on to say thatGoogle Scholar

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According to one report, “[t]he advantage of the pumps—which can cost $25,000 to implant in the patient's abdomen—is that only 1/300th of the amount of morphine usually given orally is required when it's delivered directly into the spine.” “Pain Control Innovations,” supra note 33.Google Scholar

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The American Geriatrics Society Panel on Chronic Pain in Older Persons made this point in the introduction to its recent clinical practice guideline on the management of chronic pain in older persons. The panel said, “Pain is an unpleasant sensory and emotional experience…. Unfortunately, there are no objective biological markers of pain. Therefore, the most accurate evidence of pain and its intensity is based on the patient's description and self-report.” AGS Panel on Chronic Pain in Older Persons, supra note 5, at 635.Google Scholar

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See Mor, V., “Hospice Fraud Alert,” Brown University Long-Term Care Quality Letter, 8 (Apr. 15, 1996): 4.Google Scholar

Id. The Office of Inspector General's focus on hospice was motivated by rapid growth in the size of the Medicare budget going to hospice providers and evidence of abusive billing practices. See also Shapiro, J.P., “Death Be Not Swift Enough: Fraud Fighters Begin to Probe the Expense of Hospice Care,” U.S. News & World Report, Mar. 24, 1997, at 34; and Franz, D., “Hospice Boom Is Giving Rise to New Fraud,” New York Times, May 10, 1998, at 1. Supporters of hospice have argued that it is difficult to predict the life expectancy of many patients and it is unfair to penalize hospices for predicting wrong. Moreover, this type of scrutiny may discourage physicians from earlier referrals to hospices so that patients may benefit in their last months from the services hospices have to offer.Google Scholar

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See Justins, supra note 93. In the year 2000, the American Board of Medical Specialties will also allow physicians board certified in psychiatry, neurology, and physical medicine and rehabilitation to subspecialize in pain management by meeting the requirements for the subspecialty established for anesthesiologists. However, the subspecialty is in pain management, not pain medicine, a significant difference according to pain treatment experts.Google Scholar

Id. For example, in 1997, California went to court to ban doctors from advertising certification by the American Academy of Pain Management (AAPM). AAPM was formed in 1988 “to issue credentials to multidisciplinary practitioners, including physicians, nurses, counselors, priests and social workers.” Walsh, D., “Judge Allows State Limits on Doctor Ads,” Sacramento Bee, May 24, 1997, at B4. The ban applied only to physicians. The California Medical Board had previously denied AAPM's application for recognition on the grounds that, among other things: “the academy gives a two-hour test consisting of 100 multiple-choice questions, while the state wants the 16 hours of testing required by the national specialties board” and “of the 5,000 practitioners certified by the academy as of April 1996, only approximately 1,000 had taken the test.” The judge who heard the case initially granted AAPM's request for a temporary restraining order (TRO) preventing the state from implementing the ban, but subsequently reversed his decision and refused to issue a preliminary injunction and dissolved the TRO. The decision was based in part on a 1990 statute that “sought to remedy situations in which ‘a physician who takes a weekend course can advertise [him or herself] as board certified in that specialty.’” Id.Google Scholar

Dunkin, A., “When Pain Itself is the Disease,” Business Week, Jan. 27, 1992, at 104.Google Scholar

See id. In 1992, there were just over 100 such certified facilities. Today, according to the Commission on Accreditation of Rehabilitation Facilities, there are just over 200. Id.Google Scholar

Id. In 1992, there were over 1,000 such facilities. Id.Google Scholar

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See “Pain Clinic Personalities,” Fibromyalgia Network: A Newsletter for People with Fibromyalgia Syndrome/Chronic Fatigue Syndrome, Jan. (1998): at 8.Google Scholar

Id. (based on an interview with Dr. Alan Spanos, a pain specialist in Chapel Hill, North Carolina).Google Scholar

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See, for example, Hadjistavropoulos, H.D. Ross, M. von Baeyer, C.L., “Are Physicians' Ratings of Pain Affected by Patients' Physical Attractiveness?,” Social Science and Medicine, 31 (1990): 69–72. A significant body of information indicates that both provider and patient sensitivity to pain may be a result of cultural bias. See, for example, Ferrell, B.R., “When Culture Clashes with Pain Control,” Nursing, 25 (1995): 90. These biases can enter into both treatment and coverage decisions.Google Scholar

Randal, supra note 49.Google Scholar