Pain Management and Palliative Care in the Era of Managed Care: Issues for Health Insurers

Email Comments of Michael Chamberlain, M.D., Medical Director, Blue Cross Blue Shield of Maine (July 15, 1998) (on file with author).

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.”).

Committee on Care at the End of Life, Field M.J. Cassel C.K. , eds., Approaching Death: Improving Care at the End of Life (Washington, D.C.: National Academy Press, 1997): At 5.

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).

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”).

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

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

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:

○ Factors related to health care professionals

○ inadequate knowledge of analgesic pharmacology and pain therapy

○ poor pain assessment

○ concern about regulatory oversight

○ fear of patient addiction

○ concern about the side effects of analgesics

○ concern about development of tolerance to analgesics

○ Factors related to patients

○ reluctance to report pain

○ reluctance to take pain medications

○ Factors related to the health care system

○ low priority given to pain management

○ inadequate or inappropriate provisions for reimbursement

○ restrictive regulation of therapeutic agents that are controlled substances.

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).

Joranson D.E. , “Are Health-Care Reimbursement Policies a Barrier to Acute and Cancer Pain Management?,” Journal of Pain and Symptom Management, 9 (1994): 244–53.

Wolf S.M. , “Physician-Assisted Suicide in the Context of Managed Care,” Duquesne Law Review, 35 (1996): At 471 (footnotes omitted).

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.

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.

See id.

See id.

See id.

Id. at 226.

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

See id. at 228.

See id. at 225.

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

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.

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.

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.

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).

See New York Law Journal, supra note 21.

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

Id. at 635.

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

See Caudill M. , “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.”).

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.

“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.

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.

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”).

“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).

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.

Rutherford A. , ed., The Anesthesia Answer Book (Rockville: United Communications Group, 1997): At 16701.

See Carey T.S. , “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.

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:

Studies have suggested that prescribing guidelines adopted by organized approaches used by HMOs are usually more appropriate than those implicitly followed by communitybased practitioners. Most current non-HMO prescribing practices are based on informal and often haphazard continuing education and, not infrequently, on information that is colored by nonscientific considerations.

Weiner J.P. Watch Data , “Impact of Managed Care on Prescription Drug Use,” Health Affairs, 10, no. 1 (1991): At 53.

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

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.

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

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

Committee on Care at the End of Life, supra note 3, at 31.

See, for example, Randal J. , “Hospice Services Feel the Pinch of Managed Care,” Journal of the National Cancer Institute, 13 (1996): 860–62.

See Becker S. Pristave R.J. , “Managed Care and the Provision of Hospice Care,” Managed Care Quarterly, 3 (1995): 39–43.

Wolf , supra note 11, at 471.

Randal , supra note 49, at 869.

See id.

“Study Hints HMOs' Dying Elderly Suffer Less,” Baltimore Sun, Sept. 24, 1997, at C1 (discussing Cher D.J. Lenert L.A. , “Method of Medicare Reimbursement and the Rate of Potentially Ineffective Care of Critically Ill Patients,” JAMA, 278 (1997): 1001–07).

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 Cher Daniel Dr. Lenert Leslie Dr. , in part because of “systematic incentives for hospitals to minimize billing for managed care patients and maximize billing for fee-for-service patients”).

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

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.

See Blue Brand Facts: The Blue Cross and Blue Shield System (updated Jan. 1998) <http://www.bluecares.com/blue/Blue_Brand_Facts/facts_sheet.html>.

See id.

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.”).

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.

See id.

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.”

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

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.”).

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

• “working with local Institute exploring provision of guidelines, network of pain management centers as well as direct patient care”;

• “developed policies on which pain management techniques are good and worthwhile and also on drug utilization tracking”;

• “developed policies; ongoing monitoring of pain management programs”; and

• “reviewed hospice policy and procedure; reviewed infusion company's policy and procedure and persuaded the company to change their policies and procedures.”

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

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

• brought to our attention by “case managers and pharmacists with individual cases”;

• “increase in denial of individual claims”;

• “state legislative attention, pain provider in state putting pressure on legislators to establish centers of excellence for pain management”;

• “hospice conference: After assuming charge of oncology, I went to conference and learned about issues of long term care and pain”;

• “increasing number of requests/inquiries by physicians seeking pain management programs for patients”;

• “at a meeting of medical directors we discussed a concern about how we handle pain management”;

• “patients who had outstripped medical community for getting services but still needed help; behavioral/mental health services were carved out and contracted to another company which required defining pain management—whether covered and where patient fits”; and

• “medical review on patient who requested benefits for pain management.”

Other responses include:

• “developed case management ‘catastrophic’ program to deal with people with special needs”;

• “on-going monitoring”;

• conducted “internal research about what is covered and what is utilized”;

• “established individual payment arrangements with [provider] groups, practices, centers, etc.”;

• “threw problem back to case management; have tried to get addicted patients into pain programs but have had no success”;

• “developed a response to abusers—some have been placed on automatic 100% review; pain clinic personnel seem to be a particular problem”; and

• “are looking at each case individually through case management—looked at and decided not to cover as routine benefit.”

Additional specific responses include the following:

• “develop pain management provider network”;

• “develop policies; e.g., three med[ication] injections for acute pain then reevaluate; are referring to center for excellence in pain management and specialists—evaluating outcomes”;

• “develop policies—e.g., chiropractic care; development of pain management centers or at least guidelines specifying who, what and how to help; education of providers”;

• “establish a working group; physician management groups which hold discussions of alternative methods of care”;

• “create Centers of Excellence for chronic pain management, network of experts; educate oncologists about chronic pain management” [ideas of SMD, no plan agreement on this];

• “hire a consultant, develop policies; develop a pain management program for patients with chronic pain”;

• “establish a working group; want to develop and establish guidelines and then policies”;

• “education of patients, families, and physicians for undermedicating”;

• “continue work of symposium and state experts to develop a comprehensive pain program”;

• “maybe create a Center of Excellence”; and

• “right now [we] send out notices to all physicians the patient is getting prescriptions from, but feel a lot more education of physicians needs to be undertaken. Next step might be to start denying claims.”

Specific responses include the following:

• “wrote letters to providers alerting them to the problem—response was positive”;

• “reaching out to MDs, limiting members to one prescribing physician and one pharmacy; high users identified”;

• “track records and abuses; look for trends”;

• “developed policies; quality management looked for stricter flags to alert us to developing problem”;

• “developed a policy that patient receive a certified letter telling them how many narcotics the Plan will cover and that is all they receive”;

• “addiction was included in Symposium discussion about the pain continuum”;

• “developed pain management program”; and

• “talked to pharmacy about monitoring prescribing patterns and notifying medical director; physician education.”

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

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.

Blue Cross Blue Shield of Massachusetts, Medical Policy (Boston: Blue Cross Blue Shield of Massachusetts, Dec. 1996, reviewed Jan. 1998).

Specific responses include:

• “epidurals except for cancer”;

• “physical therapy”;

• “just about any alternative therapy”;

• “comprehensive pain management programs”;

• “cupping; other exotic techniques; home electric stimulators like PENS [percutaneous electrical nerve stimulation]”;

• “questionable pain management centers”;

• “electrical stimuli to spinal cord”;

• “Aim 100 nerve stimulator”;

• “implanted nerve stimulators—policy is being reviewed”;

• “hypnosis as anesthesia”;

• “Porlou—an injection into spine; purposely irritating substance to create inflammation and formation of scar tissue which is supposed to relieve back pain”;

• “magnet therapy devices”;

• “trigger point therapy”;

• “neuro-musculoskeletal H-waves”;

• “chiropracty”;

• “hypnosis; massage therapy”;

• “chronic methadone usage”;

• “alternative medicine”;

• “hypnosis”; and

• “none of the holistic alternatives”.

For example, respondents stated:

• “cover for a few ICD9 codes, otherwise lack of scientific validation, policy decision in past”;

• “policy developed after review of literature established a lack of scientific validation of effectiveness”;

• “BCBS Association says experimental”;

• “a medical review committee looked at the scientific efficacy and found that behavioral interventions failed the test”;

• “no good evidence that biofeedback helps with pain”; and

• “following recommendation of technology evaluation center of BCBS that does not recommend coverage.”

Other responses include:

• “stress management is not a health or medical intervention”; and

• “do not have a credentialed network of providers.”

Other similar responses include:

• “acupuncture is considered investigational, it's a standing policy; contracts written to not open up questionable practices”;

• “never covered; no sufficient medical literature to show effectiveness”;

• “unproved technology”; and

• “no scientific evidence of benefit.”

For example:

• “given NIH [National Institutes of Health] report, will be re-reviewing acupuncture”; and

• “not requested; no proof of effectiveness; changing because of NIH study.”

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.

Rutherford , supra note 38, at 16707.

“The Pain Coverage Conundrum,” supra note 35.

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

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

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

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

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).

See “Pain Control Innovations,” supra note 33.

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”).

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.

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: 1) The technology must have final approval from the appropriate government regulatory bodies; 2) The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes; 3) The technology must improve the net health outcome; 4) The technology must be as beneficial as any established alternatives; and 5) The improvement must be attainable outside the investigational settings.

See id. at 1–2.

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 that

The studies in which needles are inserted in places other than those prescribed by the meridian maps from Chinese medicine are the most consistent. Among these studies, there is little evidence that acupuncture, as it is traditionally practiced, is effective as a treatment of pain….

The remaining two control conditions, low- or no-needle insertion and low stimulation have findings that are more provocative. Five of the 9 studies that used low-or no-needle insertion controls reported positive findings. The only study using a low stimulation control reported positive findings even on a measure of catecholamine activity. There are at least two possible explanations for these findings. It is possible that certain components of acupuncture, in particular, the needle insertion to a specified depth followed by stimulation, are effective, but the location does not have to follow the meridian maps of energy flow from Chinese medicine. Alternatively, it is possible that subjects in pain trials are aware of whether or not a needle is inserted and, thus, needle insertion is a key component to unbinding the subject and stimulating effects based on expectancy or bias.

Those well-controlled trials that report efficacy were generally smaller than the studies reporting negative findings. None of the 4 studies with a study population of greater than 100 reported positive findings. The largest sample for a study with positive findings was 48. The fact that smaller studies are more likely to provide positive support for the efficacy of acupuncture, while larger studies do not, suggests that possible influences of weaknesses in the study design or random differences that do not hold up with more data.

Id. at 1–2.

See National Institutes of Health Consensus Development Statement, Acupuncture (Nov. 3–5, 1997) <http://www.consensus.nih.gov> (visited 14 Dec. 1998).

Technology Evaluation Center, Blue Cross Blue Shield Association, Transcutaneous or Percutaneous Electrical Nerve Stimulation in the Treatment of Chronic and Postoperative Pain (Chicago: TEC Assessment Program, Vol. 11, No. 21, Jan. 1997). The TEC Panel justified its conclusion as follows:

There is a large body of research on the efficacy of TENS for a variety of pain conditions, but relatively few controlled studies. Four published studies compared TENS with a placebo (e.g., sham TENS), a known active intervention (e.g., exercise, splint), or no treatment in patients who had chronic pain. Eleven studies of similar design assessed the efficacy of TENS in the treatment of postoperative pain. Although there is a large body of uncontrolled research that describes favorable results using TENS for pain management, the majority of controlled studies reported that, compared to placebo, known active intervention, or no treatment, TENS had no significant benefit. With the exception of two studies that suggest that TENS might reduce postoperative pain through a placebo effect, each of the few studies that contradict this basic conclusion had either mixed results or important methodological shortcomings. No controlled study provided consistent findings across multiple outcomes that TENS reduced pain experiences compared to appropriate control conditions.

Id. at 1. However, the assessment further stated that, as it was going to press, “a major research project on TENS was being planned. The proposed project is to be conducted by the Health Outcomes Institute, with funding from EMPI, a manufacturer of TENS devices. Two phases are planned: An outcomes study using data from several Blue Cross and Blue Shield Plans and a prospective evaluation of efficacy.” Id.

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.

Rutherford , supra note 38, at 16705.

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.

Rutherford , supra note 38, at 16701.

Ferrell Griffith , supra note 13, at 222.

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

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.

Portenoy , supra note 5, at 296.

Blue Cross & Blue Shield of Massachusetts, Medical Policy (Boston: Blue Cross & Blue Shield of Massachusetts, Jan. 1997, reviewed Feb. 1998).

Letter from Carla Alexander, M.D., Assistant Professor of Medicine and Director of Palliative Care, University of Maryland Medical Systems, to Hoffmann Diane E. , J.D., M.S. Professor of Law, University of Maryland School of Law (July 24, 1998) (on file with author).

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.

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.

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

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.

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

Hendler N. Talo S. , “Role of the Pain Clinic,” in Foley K.M. Payne R.M. , eds., Current Therapy of Pain (Toronto: B.C. Decker, 1989): At 23.

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

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

See Bernabel Gatsonis Mor , supra note 4.

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.

Randal , supra note 49.