Public Financing of Pain Management: Leaky Umbrellas and Ragged Safety Nets

Journal of Law, Medicine and Ethics

Volumn 26, Issue 4, 1998, Pages 290-307

  Jost, Timothy S ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

DEATH AND EUTHANASIA; DRUG COST; ECONOMICS; GOVERNMENT; HEALTH CARE AND PUBLIC HEALTH; HEALTH INSURANCE; HOSPICE; HUMAN; INSURANCE; MEDICAID; MEDICARE; MENTAL STRESS; PAIN; PROFESSIONAL PATIENT RELATIONSHIP; REVIEW; UNITED STATES;

DEATH AND EUTHANASIA; HEALTH CARE AND PUBLIC HEALTH; MEDICAID; PROFESSIONAL PATIENT RELATIONSHIP;

DRUG COSTS; FEDERAL GOVERNMENT; HOSPICES; HUMANS; INSURANCE COVERAGE; MANAGED CARE PROGRAMS; MEDICAID; MEDICARE; PAIN; STRESS, PSYCHOLOGICAL; UNITED STATES;

EID: 0032228123     PISSN: 10731105     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1748-720X.1998.tb01677.x     Document Type: Article

References (211)

1. See K.R. Levit et al., "National Health Spending Trends in 1996," Health Affairs, 17, no. 1 (1998): at 43.
2. See Bureau of the Census, Statistical Abstract of the United States, 1997 (Washington, D.C.: U.S. Government Printing Office): tbls. 161, 165.
3. See Levit et al., supra note 1, at 42-43.
4. See U.S. Department of Health and Human Services, Health United States and Injury Chartbook, 1996-1997 (Washington, D.C.: U.S. Government Printing Office): tbl. 129 (hereinafter Health United States).
5. See B.R. Ferrell and H. Griffith, "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 223.
6. See Health United States, supra note 4, tbl. 90.
7. See Department of Health and Human Services, "Medicare and Medicaid Statistical Supplement," Health Care Financing Review, 17 (1996): tbl. 54.
8. See L.M. Bartnyska, M. Schactman, and J. Hidalgo, "Patterns in Maryland Medical Enrollment Among Persons with AIDS," Inquiry, 32 (1995): 184-95 ; and J. Green and P.S. Arno, "The 'Medicaidization' of AIDS: Trends in the Financing of AIDS in the New York and California Medicaid Programs," JAMA, 264 (1990): 1261-66.
9. See L.M. Bartnyska, M. Schactman, and J. Hidalgo, "Patterns in Maryland Medical Enrollment Among Persons with AIDS," Inquiry, 32 (1995): 184-95 ; and J. Green and P.S. Arno, "The 'Medicaidization' of AIDS: Trends in the Financing of AIDS in the New York and California Medicaid Programs," JAMA, 264 (1990): 1261-66.
10. 42 U.S.C. § 1396r-8(g)(1)(A) (1994).
11. See L.F. Post et al., "Pain: Ethics, Culture, and Informed Consent to Relief," Journal of Law, Medicine & Ethics, 24 (1996): at 349.
12. Agency for Health Care Policy and Research, Acute Pain Management: Operative or Medical Procedures and Trauma (Washington, D.C.: U.S. Government Printing Office, 1992): at 4.
13. See Post et al., supra note 10, at 354.
14. Assisted Suicide Funding Restriction Act of 1997, Pub. L. No. 105-12, 111 Stat. 23 (1997).
15. See W Breitbart, "Suicide Risk and Pain in Cancer and AIDS Patients," in C.R. Chapman and K.M. Foley, eds., Current and Emerging Issues in Cancer Pain: Research and Practice (New York: Raven Press, 1992): 49-65.
16. See Ferrell and Griffith, supra note 5, at 231.
17. Medicare briefly covered outpatient drugs under the Medicare Catastrophic Care legislation, but that program was repealed in 1990, a year after its adoption.
18. See 42 U.S.C. § 1395w-4 (1994). The most recent Medicare physician fee schedule was published at 62 Fed. Reg. 59,048 (1997).
19. See C.G. Kirschner et al., CPT 1998, Physicians' Current Procedural Terminology (Chicago: American Medical Association, 1998): at 9-27.
20. Telephone Interview with Dr. Philip Lippe, Executive Medical Director, American Academy of Pain Medicine (May 29, 1998); and Letter from Dr. Philip Lippe, for American Academy of Pain Management, to Bruce Vladeck, Director, Health Care Financing Administration (Mar. 7, 1994) (on file with author).
21. For a discussion of the problems that Medicare physician payment policy causes for pain management practice, see Committee on Care at the End of Life, M.J. Field and C.K. Cassel, eds., Approaching Death: Improving Caring at the End of Life (Washington, D.C.: National Academy Press, 1997): at 166; and D.E. Joranson, "Are Health-Care Reimbursement Policies a Barrier to Acute and Cancer Pain Management?," Journal of Pain and Symptom Management, 9 (1994): at 249. The 1997 report of the Physician Payment Assessment Commission acknowledged that evaluation and management services are undervalued compared with procedural or surgical codes. See Physician Payment Assessment Commission, Annual Report to Congress, 1997 (Washington, D.C.: ProPAC, 1997): at 279-80
22. For a discussion of the problems that Medicare physician payment policy causes for pain management practice, see Committee on Care at the End of Life, M.J. Field and C.K. Cassel, eds., Approaching Death: Improving Caring at the End of Life (Washington, D.C.: National Academy Press, 1997): at 166; and D.E. Joranson, "Are Health-Care Reimbursement Policies a Barrier to Acute and Cancer Pain Management?," Journal of Pain and Symptom Management, 9 (1994): at 249. The 1997 report of the Physician Payment Assessment Commission acknowledged that evaluation and management services are undervalued compared with procedural or surgical codes. See Physician Payment Assessment Commission, Annual Report to Congress, 1997 (Washington, D.C.: ProPAC, 1997): at 279-80
23. For a discussion of the problems that Medicare physician payment policy causes for pain management practice, see Committee on Care at the End of Life, M.J. Field and C.K. Cassel, eds., Approaching Death: Improving Caring at the End of Life (Washington, D.C.: National Academy Press, 1997): at 166; and D.E. Joranson, "Are Health-Care Reimbursement Policies a Barrier to Acute and Cancer Pain Management?," Journal of Pain and Symptom Management, 9 (1994): at 249. The 1997 report of the Physician Payment Assessment Commission acknowledged that evaluation and management services are undervalued compared with procedural or surgical codes. See Physician Payment Assessment Commission, Annual Report to Congress, 1997 (Washington, D.C.: ProPAC, 1997): at 279-80
24. See 42 U.S.C. § 1395x(s)(2)(A); 42 C.F.R. § 410.26 (1998); and Health Care Financing Administration, Medicare Carriers Manual, ¶ 2049.4 (HCFA Pub. 14, Aug. 1996) (hereinafter Medicare Carriers Manual).
25. 42 C.F.R. § 410.26(a). Even if drugs meet these criteria, Medicare will not cover them if they are under a proposed Food and Drug Administration order to withdraw approval because of suspected lack of efficacy. See 42 C.F.R. § 410.29(b).
26. See Medicare Carriers Manual, supra note 21, ¶ 2049.4.
27. See id. ¶ 15010, modified by transmittal no. 1566, [1997-1 Transfer Binder] Medicare and Medicaid Guide (CCH) ¶ 45,258 (May 1, 1997). See Office of Payment Policy, Bureau of Program Development, Health Care Financing Administration, Memorandum, "Policy Issues Flowing from the Carrier Medical Directors' Meeting," [1992-2 Transfer Binder] Medicare and Medicaid Guide (CCH) ¶ 40,375 (May 29, 1992) (discussing billing for injections).
28. See Office of Payment Policy, supra note 24.
29. See Balanced Budget Act, Pub. L. No. 105-33, § 4556(a), 111 Stat. 462-63 (1997) (to be codified at 42 U.S.C. § 1395u(o)). This provision was added as a cost-cutting measure by the 1997 Budget Act, and was effective January 1, 1998.
30. See K.B. Pace, "The Medicare Reimbursement Puzzle," CARING, May 1995, at 10-12. See also M.S. Uram, "A New Delivery System Makes Pain Control Easier," RN, 55 (1992): 46-50 (describing the operation of morphine infusion pumps).
31. See K.B. Pace, "The Medicare Reimbursement Puzzle," CARING, May 1995, at 10-12. See also M.S. Uram, "A New Delivery System Makes Pain Control Easier," RN, 55 (1992): 46-50 (describing the operation of morphine infusion pumps).
32. Durable medical equipment is covered under 42 C.F.R. § 410.38(a) (1998), although infusion pumps are not explicitly mentioned in these provisions.
33. See Health Care Financing Administration, Coverage Issues Manual, ¶ 60-14.A.4 (HCFA Pub. 6, Aug. 1996) (hereinafter Coverage Issues Manual).
34. See id.; and Medicare Carriers Manual, supra note 21, ¶ 2100.5.
35. Coverage Issues Manual, supra note 29, ¶ 60-14.B.3.
36. See id.
37. See id. ¶ 60-14.B; and Medicare Carriers Manual, supra note 21, ¶ 2100.5.
38. See S. Masoorli, "Home IV Therapy Comes of Age," RN, 59 (1996): 22-26 (describing the administration of the home infusion therapy Medicare benefit).
39. See 42 C.F.R. § 410.38(f) (1998).
40. See Coverage Issues Manual, supra note 29, ¶ 45-19.
41. See id. ¶ 60-20.
42. See id. ¶ 65-8.
43. See id. ¶ 35-46.
44. See 42 U.S.C. § 1395d(a)(1) (1994).
45. See Health United States, supra note 4, tbl. 88 (citing 1995 data).
46. See 42 U.S.C. § 1395x(b)(2); and 42 C.F.R. § 409.10(a)(5) (1998). Proposed regulations establishing prospective payment for outpatient hospital services would also permit hospitals to provide self-administered drugs, including pain medication, to patients being treated on an outpatient basis if the service is not advertised. See "Proposed Rule, Medicare Program; Prospective Payment for Hospital Services," 63 Fed. Reg. 47,552, 47,563-64 (proposed Sept. 8, 1998).
47. See 42 C.F.R. § 409.13(a).
48. See Health Care Financing Administration, Medicare Intermediary Manual, ¶ 3101.3 (HCFA Pub. 13, Aug. 1996).
49. See Coverage Issues Manual, supra note 29, ¶ 35.21.
50. See 42 U.S.C. § 1395x(e). See 42 C.F.R. § 482.25 (1998) for hospital certification regulations regarding pharmaceuticals.
51. Joint Commission on Accreditation of Healthcare Organizations, Comprehensive Accreditation Manual for Hospitals (Oakbrook Terrace: Joint Commission on Accreditation of Healthcare Organizations, 1996): at R.1.1.2.7.
52. See Health United States, supra note 4, tbl. 89.
53. See "Final Rule: Medicare Program; Changes to Hospital Inpatient Prospective Payment Systems and Fiscal Year 1999 Rates," 63 Fed. Reg. 40,962-63 (July 31, 1998); C.K. Cassel and B.C. Vladeck, Sounding Board, "ICD-9 Code for Palliative or Terminal Care," New Engl. J. Med., 335 (1996): 1232; and Committee on Care at the End of Life, supra note 20, at 165 (citing letter from Christine Cassel, M.D., Milbank Memorial Fund, dated July 20, 1996).
54. See "Final Rule: Medicare Program; Changes to Hospital Inpatient Prospective Payment Systems and Fiscal Year 1999 Rates," 63 Fed. Reg. 40,962-63 (July 31, 1998); C.K. Cassel and B.C. Vladeck, Sounding Board, "ICD-9 Code for Palliative or Terminal Care," New Engl. J. Med., 335 (1996): 1232; and Committee on Care at the End of Life, supra note 20, at 165 (citing letter from Christine Cassel, M.D., Milbank Memorial Fund, dated July 20, 1996).
55. See 42 U.S.C. §§ 1395d(a)(2), (f), 1395x(i).
56. See id. § 1395x(h).
57. See id. § 1395x(i). If admission within thirty days of hospital discharge is not medically appropriate, but the need for further medical care at a later point is predictable, the thirty-day period may be extended. See id. See also 42 C.F.R. § 409.30(b) (1994); and Health Care Financing Administration, Medicare Skilled Nurse Facility Manual, ¶ 212.3(B)(2) (HCFA Pub. 12, Aug. 1996).
58. See Department of Health and Human Services, supra note 7, tbl. 37.
59. 42 U.S.C. § 1395i-3(b)(2), (4)(A)(i).
60. 42 C.F.R. § 409.32(c).
61. See, for example, R. Bernabei et al., "Management of Pain in Elderly Patients with Cancer," JAMA, 279 (1988): at 1879 (more than a quarter of patients in sample nursing facilities who were in daily pain did not receive analgesia)
62. See 42 C.F.R. § 488.305 (1998).
63. See id. § 488.110(e)(3).
64. See id. § 488.105.
65. See id. § 488.115.
66. See Health Care Financing Administration, Resident Census and Conditions of Residents Form (HCFA Form 672, July 1995).
67. See Health Care Financing Administration, "Survey Procedures for Long Term Care Facilities," State Operations Manual (Transmittal 274, June 1995), at P-9.
68. Pain is one of the factors listed under the activities, incontinence, dental, and pressure sore resident assessment protocols, for example. See RAI 2.0 User's Manual, at C-30, C-58, C-71, C-73, C-76 (Oct. 1997).
69. See 62 Fed. Reg. 67,174, 67,194 (1997) (codified at 42 C.F.R. §§ 483.20, .315 (1998)).
70. See id. at 67,194.
71. Id.
72. See id.
73. See id. at 67,195.
74. See Committee on Care at the End of Life, supra note 20, at 168; and V. Bower, "The Right Way to Die: Despite Good Intentions, Some Hospices End up Bullying Patients Who Won't Pass Away Gracefully," Health, 23 (June 1991): 39-43.
75. See Medicare Payment Advisory Commission, Context for a Changing Medicare Program, Report to Congress (Washington D.C.: U.S. Government Printing Office, 1998): at 158. One recent study found that 82 percent of the random sample of hospices surveyed were Medicare certified. See M.-A. Sontag, "A Comparison of Hospice Programs Based on Medicare Certification Status," American Journal of Hospice and Palliative Care Mar./Apr. (1996): at 37.
76. See Medicare Payment Advisory Commission, Context for a Changing Medicare Program, Report to Congress (Washington D.C.: U.S. Government Printing Office, 1998): at 158. One recent study found that 82 percent of the random sample of hospices surveyed were Medicare certified. See M.-A. Sontag, "A Comparison of Hospice Programs Based on Medicare Certification Status," American Journal of Hospice and Palliative Care Mar./Apr. (1996): at 37.
77. See 42 U.S.C. § 1395x(dd) (1994).
78. See id. § 1395x(dd)(3); and 42 C.F.R. § 418.22 (1998).
79. See 42 U.S.C. § 1395d(a)(4), (d)(2), as amended by Pub. L. No. 105-33, § 4443, 111 Star. 423 (1997); and 42 C.F.R. §§ 418.24, .28. The election is for two periods of ninety days each, and then for successive sixty-day periods. See 42 U.S.C. § 1395d(2)(B) (as amended by Pub. L. No. 105-33, § 4443, 111 Stat. 423).
80. See 42 U.S.C. § 1395f(i); and 42 C.F.R. §§ 418.302-.309 (1998).
81. See 42 U.S.C. § 1396a(a)(13)(B) (as amended by Pub. L. No. 105-33, § 4711(a)(1), 111 Stat. 507-08 (1997)). This financing is discussed infra notes 97-101.
82. See Department of Health and Human Services, supra note 7, at 84.
83. See D.M. Gianelli, "Hospice Bill Could Improve End-of-Life Care," American Medical News, Feb. 24, 1997, at 10.
84. See Office of Inspector General, Department of Health and Human Services, Medicare Hospice Beneficiaries: Services and Eligibility (Chicago: Department of Health and Human Services, OEI-04-93-00270, 1997) (hereinafter Hospice Beneficiaries); Office of Inspector General, Department of Health and Human Services, Hospice Patients in Nursing Homes (Chicago: Department of Health and Human Services, OEI-05-95-00250, 1997) (hereinafter Hospice Patients); Office of Inspector General, Department of Health and Human Services, Hospice and Nursing Home Contractual Relationships (Chicago: Department of Health and Human Services, OEI-O5-95-00251, 1997) (hereinafter Contractual Relationships); Office of Inspector General, Department of Health and Human Services, Enhanced Controls Needed to Assure Validity of Medicare Hospice Enrollments (Washington D.C.: Department of Health and Human Services, A-05-96-00023, 1997); and Office of Inspector General, Department of Health and Human Services, "Medicare Advisory Bulletin on Hospice Benefits," 60 Fed. Reg. 55,721 (Nov. 2, 1995).
85. See Office of Inspector General, Department of Health and Human Services, Medicare Hospice Beneficiaries: Services and Eligibility (Chicago: Department of Health and Human Services, OEI-04-93-00270, 1997) (hereinafter Hospice Beneficiaries); Office of Inspector General, Department of Health and Human Services, Hospice Patients in Nursing Homes (Chicago: Department of Health and Human Services, OEI-05-95-00250, 1997) (hereinafter Hospice Patients); Office of Inspector General, Department of Health and Human Services, Hospice and Nursing Home Contractual Relationships (Chicago: Department of Health and Human Services, OEI-O5-95-00251, 1997) (hereinafter Contractual Relationships); Office of Inspector General, Department of Health and Human Services, Enhanced Controls Needed to Assure Validity of Medicare Hospice Enrollments (Washington D.C.: Department of Health and Human Services, A-05-96-00023, 1997); and Office of Inspector General, Department of Health and Human Services, "Medicare Advisory Bulletin on Hospice Benefits," 60 Fed. Reg. 55,721 (Nov. 2, 1995).
86. See Office of Inspector General, Department of Health and Human Services, Medicare Hospice Beneficiaries: Services and Eligibility (Chicago: Department of Health and Human Services, OEI-04-93-00270, 1997) (hereinafter Hospice Beneficiaries); Office of Inspector General, Department of Health and Human Services, Hospice Patients in Nursing Homes (Chicago: Department of Health and Human Services, OEI-05-95-00250, 1997) (hereinafter Hospice Patients); Office of Inspector General, Department of Health and Human Services, Hospice and Nursing Home Contractual Relationships (Chicago: Department of Health and Human Services, OEI-O5-95-00251, 1997) (hereinafter Contractual Relationships); Office of Inspector General, Department of Health and Human Services, Enhanced Controls Needed to Assure Validity of Medicare Hospice Enrollments (Washington D.C.: Department of Health and Human Services, A-05-96-00023, 1997); and Office of Inspector General, Department of Health and Human Services, "Medicare Advisory Bulletin on Hospice Benefits," 60 Fed. Reg. 55,721 (Nov. 2, 1995).
87. See Office of Inspector General, Department of Health and Human Services, Medicare Hospice Beneficiaries: Services and Eligibility (Chicago: Department of Health and Human Services, OEI-04-93-00270, 1997) (hereinafter Hospice Beneficiaries); Office of Inspector General, Department of Health and Human Services, Hospice Patients in Nursing Homes (Chicago: Department of Health and Human Services, OEI-05-95-00250, 1997) (hereinafter Hospice Patients); Office of Inspector General, Department of Health and Human Services, Hospice and Nursing Home Contractual Relationships (Chicago: Department of Health and Human Services, OEI-O5-95-00251, 1997) (hereinafter Contractual Relationships); Office of Inspector General, Department of Health and Human Services, Enhanced Controls Needed to Assure Validity of Medicare Hospice Enrollments (Washington D.C.: Department of Health and Human Services, A-05-96-00023, 1997); and Office of Inspector General, Department of Health and Human Services, "Medicare Advisory Bulletin on Hospice Benefits," 60 Fed. Reg. 55,721 (Nov. 2, 1995).
88. See Office of Inspector General, Department of Health and Human Services, Medicare Hospice Beneficiaries: Services and Eligibility (Chicago: Department of Health and Human Services, OEI-04-93-00270, 1997) (hereinafter Hospice Beneficiaries); Office of Inspector General, Department of Health and Human Services, Hospice Patients in Nursing Homes (Chicago: Department of Health and Human Services, OEI-05-95-00250, 1997) (hereinafter Hospice Patients); Office of Inspector General, Department of Health and Human Services, Hospice and Nursing Home Contractual Relationships (Chicago: Department of Health and Human Services, OEI-O5-95-00251, 1997) (hereinafter Contractual Relationships); Office of Inspector General, Department of Health and Human Services, Enhanced Controls Needed to Assure Validity of Medicare Hospice Enrollments (Washington D.C.: Department of Health and Human Services, A-05-96-00023, 1997); and Office of Inspector General, Department of Health and Human Services, "Medicare Advisory Bulletin on Hospice Benefits," 60 Fed. Reg. 55,721 (Nov. 2, 1995).
89. Balanced Budget Act, Pub. L. No. 105-33, §§ 4441-4449, 111 Stat. 422-24 (1997). These provisions are discussed in Gianelli, supra note 77, at 10.
90. See N. Christakis and J.J. Escarce, "Survival of Medicare Patients After Enrollment in Hospice Programs," New Engl. J. Med., 335 (1996): 172-77.
91. See id. at 174.
92. See S.G. Stolberg, "As Life Ebbs, So Does Time to Elect Comforts of Hospice," New York Times, Mar. 4, 1998, A1, A16; and Telephone Interview with Nicholas A. Christakis, M.D., Assistant Professor, University of Chicago School of Medicine, Department of Internal Medicine (Feb. 23, 1998).
93. See Interview with Bernice Wilson, Director, Ohio Hospice Association (Jan. 30, 1998). Another hospice director stated that, in some states, the median length of stay is down to eight days. See Interview with Samira Beckwith, President and Chief Operating Officer, Hope Hospice (Feb. 13, 1998).
94. This discussion is based largely on information provided by Bernice Wilson. See Interview with Bernice Wilson, supra note 83.
95. See id.
96. See Medicare Payment Advisory Commission, supra note 70, at 160.
97. See Interview with Bernice Wilson, supra note 83.
98. See P. Fish, "A Harder Better Death," Health, 11 (Nov.-Dec. 1997): 108-14; Stolberg, supra note 82, at A16; and Cassel and Vladeck, supra note 49, at 1232.
99. See Cassel and Vladeck, supra note 49, at 1232; and J. Lynn, Editorial, "Caring at the End of Our Lives," New Engl. J. Med., 335 (1996): at 202.
100. See J.P. Shapiro, "Death be Not Swift Enough: Fraud Fighters Begin to Probe the Expense of Hospice Care," U.S. News & World Report, Mar. 24, 1997, at 34-35; and Fish, supra note 88.
101. See Office of Benefits Integrity, Department of Health and Human Services, Memorandum BPO-B12, "Instructions for Regional Home Health Intermediary Medical Review of Hospice Claims to Determine Terminal Illness for Non-Cancer Diagnoses-ACTION" (Nov. 27, 1995).
102. See Interview with Bernice Wilson, supra note 83.
103. See id.
104. The State Medicaid Manual only requires hospice patients to waive Medicaid payment for treatment related to the terminal condition for which hospice care was elected or a related condition. See Health Care Financing Administration, State Medicaid Manual, ¶ 4305.2 (HCFA Pub. 45, Aug. 1996).
105. See Interview with Cherry Meier, Director of Public Relations, VITAS HealthCare Corp. (Jan. 22, 1998); and Interview with Bernice Wilson, supra note 83.
106. See "'Miracle' Drugs Tempt the Terminally Ill: Protease Inhibitors Complicate Hospice Guidelines," AIDS Alert, Dec. (1996): 137.
107. See 42 U.S.C. § 1396a(a)(13)(B) (as amended by Pub. L. No. 105-33, § 4711(a), 111 Stat. 507-08 (1997); and State Medicaid Manual, supra note 94, ¶ 4308.2.
108. See Hospice Patients, supra note 78, at 2.
109. See Contractual Relationships, supra note 78, at 4.
110. See Hospice Patients, supra note 78, at 9. A recent report from the Office of Inspector General (OIG) found that, in its sample of hospice patients in nursing homes, 29 percent were ineligible for the Medicare hospice benefit, compared with only 2 percent of hospice patients in the community. See Hospice Beneficiaries, supra note 78, at 4-5.
111. See Hospice Patients, supra note 78, at 9. A recent report from the Office of Inspector General (OIG) found that, in its sample of hospice patients in nursing homes, 29 percent were ineligible for the Medicare hospice benefit, compared with only 2 percent of hospice patients in the community. See Hospice Beneficiaries, supra note 78, at 4-5.
112. See Hospice Patients, supra note 78; Contractual Relationships, supra note 78; and "Special Fraud Alert: Fraud and Abuse in Nursing Homes Arrangements with Hospices," 63 Fed. Reg. 20,415 (1998).
113. See Hospice Patients, supra note 78; Contractual Relationships, supra note 78; and "Special Fraud Alert: Fraud and Abuse in Nursing Homes Arrangements with Hospices," 63 Fed. Reg. 20,415 (1998).
114. See Hospice Patients, supra note 78; Contractual Relationships, supra note 78; and "Special Fraud Alert: Fraud and Abuse in Nursing Homes Arrangements with Hospices," 63 Fed. Reg. 20,415 (1998).
115. See Interview with Sue Wells, Consultant, Wells Consulting Service, and Chair, National Hospice Organization's Managed Care Task Force (Jan. 28, 1998). See Pub. L. No. 105-33, § 4001, adding § 1853(h)(2), 111 Stat. 307-08, providing for payment to Medicare+Choice organizations for nonhospice services.
116. See Interview with Sue Wells, supra note 102.
117. See Health Care Financing Administration, Medicare Hospice Manual, ¶ 110 (HCFA Pub. 21, Aug. 1996); and Health Care Financing Administration, State Operations Manual, ¶¶ 2080-2087 (HCFA Pub. 7, Aug. 1996).
118. See Health Care Financing Administration, Medicare Hospice Manual, ¶ 110 (HCFA Pub. 21, Aug. 1996); and Health Care Financing Administration, State Operations Manual, ¶¶ 2080-2087 (HCFA Pub. 7, Aug. 1996).
119. See Interview with Bernice Wilson, supra note 83.
120. See Medicare Managed Care Contract Report (visited Dec. 15, 1998) 〈http://www.hcfa.gov/stats/mmcc1298.txt〉 (noting that, as of December 1, 1998, nearly 6.76 million Medicare beneficiaries are currently enrolled in risk-based managed care plans).
121. See Pub. L. No. 105-33, § 4001, 111 Stat. 323 (1997). See Prospective Payment Assessment Commission, Medicare and the American Health Care System: Report to Congress (Washington, D.C.: ProPAC, 1997): at 44.
122. See 42 C.F.R. §S 417.101(b), (d)(4), .102 (1998).
123. See Medicare Managed Care Contract Report, supra note 106 (noting that, as of December 1, 1998, 226, or over two-thirds, of Medicare risk-based health maintenance organizations and competitive medical plans covered outpatient drugs).
124. See M.R. Yessian and J.M. Greenleaf, "The Ebb and Flow of Federal Initiatives to Regulate Health Care Professionals," in T.S. Jost, ed., Regulation of the Healthcare Professions (Chicago: Heath Administration Press, 1997): at 169-98.
125. See 42 C.F.R. § 417.102(b).
126. For the proposed legislation to accomplish this result, see S. 1345, § 8, 105th Cong. (1997).
127. See 42 U.S.C. §§ 1395x(s)(2)(J), (O), (Q), (T) (1994), as amended through 1997.
128. See Health United States, supra note 4, tbl. 140.
129. See 42 U.S.C. §§ 1396a(a)(10)(A), 1396d(a) (1994).
130. See 3 Medicare and Medicaid Guide (CCH) ¶¶ 15,505-15,507 (1996). See also 42 C.F.R. § 440.120 (1998).
131. See 3 Medicare and Medicaid Guide (CCH) ¶¶ 15,505-15,507.
132. See Health United States, supra note 4, tbl. 141.
133. See R.F. Holcombe and J. Griffin, "Effect of Insurance Status on Pain Medication Prescription in a Hematology/Oncology Practice," Southern Medical Journal, 86 (1993): 151-56.
134. See 3 Medicare and Medicaid Guide (CCH) ¶¶ 15,550-15,660. One state drug utilization review (DUR) director reported to me that the state's program had discovered that the most frequently prescribed Medicaid covered drug in nursing facilities in its state was Darvocet, which apparently was being used in place of over-the-counter pain-relievers not covered by Medicaid.
135. See 42 U.S.C. § 1396o(a)(2), (3) (1994); and 42 C.F.R. §§ 447.53-.54 (1998). See Sweeney v. Bane, 996 F.2d 1384 (2d Cir. 1993) (upholding a New York law requiring Medicaid recipients to pay copayments for prescriptions). Services cannot be denied to a recipient who is unable to pay a copayment. See 42 U.S.C. § 1396o(e).
136. For 1997 data from Medicaid state charts, see 3 Medicare and Medicaid Guide (CCH), ¶¶ 15,550-15,660.
137. See id.
138. See 42 U.S.C. § 1396r-8(d) (1994).
139. For 1997 data from Medicaid state charts, see 3 Medicare and Medicaid Guide (CCH), ¶¶ 15,550-15,660.
140. See id.
141. See D.E. Joranson and A.M. Gilson, "Controlled Substances, Medical Practice, and the Law," in H.I. Schwartz, ed., Psychiatric Practice Under Fire (Washington, D. C.: American Psychiatric Press, 1994): 183-85 (discussing the problems caused by state laws limiting the quantities of controlled substances that may be dispensed).
142. See, for example, S.B. Soumerai et al., "A Critical Analysis of Studies of State Drug Reimbursement Policies: Research in Need of a Discipline," Milbank Quarterly, 71 (1993): 217-52.
143. See S.B. Soumerai et al., "Payment Restrictions for Prescription Drugs under Medicaid," New Engl. J. Med., 317 (1987)-550-56.
144. See id. at 552.
145. See id.
146. See S.B. Soumerai et al., "Determinants of Change in Pharmaceutical Cost Sharing: Does Evidence Affect Policy?," Milbank Quarterly, 75 (1997): at 12.
147. See General Accounting Office, Prescription Drugs: Automated Prospective Review Systems Offer Potential Benefits for Medicaid (Washington D.C.: General Accounting Office, GAO/AIMD-94-130, 1994): at 3.
148. See 42 U.S.C. § 1396r-8(g) (1994).
149. See id. § 1396r-8(g)(1)(A).
150. Id. See also 42 C.F.R. §§ 456.702, .703, .705, .709 (1998).
151. See 42 C.F.R. § 456.703.
152. See 42 U.S.C. § 1396r-8(g)(3)(C)(ii); and 42 C.F.R. § 456.711(b), (c), (d).
153. See 42 C.F.R. §§ 455.13-.16, .21; 456.3 (1998). See E.E. Lipowski and T. Collins, Medicaid DUR Programs, 1993 (Washington D.C.: American Pharmaceutical Association Foundation, 1993): at 7-8, 14-15.
154. A six-page survey was sent to all Medicaid DUR programs in early 1998, with the assistance of Leonard Tomlin of the Ohio Medicaid DUR Program and Sheryl Ingram of the Searle Group (which assists in surveying DUR programs). For purposes of the survey, pain medication was defined to include opiate agonists, opiate partial agonists, opiate antagonists, nonsteroidal antiinflammatory agents (including aspirin and salicylate compounds), and miscellaneous analgesics (acetaminophen and Tramdol).
155. Among the drugs identified as receiving special attention were: Ultram; ketorolac tromethamine (Toradol) and acetaminophen; butorphanol (Stadol Nasal Spray); carisoprodol (Soma); and nonsteroidal antiinflammatory drugs used in combinations or in high dosages. Another factor that raised particular concern is patients who received pain medication from more than one doctor or early refills.
156. Inappropriate prescribing was identified on the questionnaire in terms of therapeutic duplication, drug-disease contraindication, adverse drug-drug interactions, incorrect drug dosage, incorrect duration of drug treatment, or drug-allergy interactions. Potentially abusive prescribing was defined in terms of clinical abuse/misuse, including abuse, gross overuse, overutilization, or underutilization.
157. Electronic notifications were used by 15 of 21 programs where inappropriate prescribing was suspected, and by 14 of 21 where abusive prescribing was suspected.
158. Denial notifications were used by 10 of 21 programs for inappropriate prescribing and by 8 of 21 for abusive prescribing.
159. Written notifications were used by 23 of 27 programs for inappropriate prescribing and by 20 of 27 programs for abusive prescribing.
160. Written notifications were used by fourteen of the retrospective review programs for both inappropriate and abusive prescribing.
161. Fourteen of twenty-seven states took this approach.
162. Twelve of twenty-seven states took this approach.
163. One of the remaining programs had between 20 and 50; the other, between 50 and 100.
164. One of the remaining programs had between 20 and 50; another, between 50 and 100.
165. These may have been the programs most interested in responding to our survey, so it would be inappropriate to project that these results also reflect the nonresponding programs.
166. Apparently, states differ as to whether they have diagnostic information when they conduct drug utilization review, and further vary as to whether this information is available for prospective review, retrospective review, or both.
167. 42 C.F.R. § 456.711 (1998).
168. Another program noted that educational seminars on pain management were readily available, suggesting that it was not necessary for DUR programs to provide such education.
169. See Physician Payment Assessment Commission, supra note 107, at 26.
170. Federal law, however, prohibits states from requiring persons receiving qualified Medicare beneficiary benefits to enroll in a managed care entity. See 42 U.S.C. § 1396u-2(a)(2)(B) (1994).
171. See Pub. L. No. 105-33, §§ 4701-4703, 111 Stat. 489-95 (1997).
172. See S. Rosenbaum et al., Negotiating the New Health System: A Nationwide Study of Medicaid Managed Care Contracts (Washington D.C.: George Washington University, Center for Health Policy Research, Vol. 2, 1997): at 2-6, tbl. 2-1.
173. See id. at 2-6.
174. See Yessian and Greenleaf, supra note 110, at 179.
175. See id.
176. See 42 U.S.C. §§ 1396a(a)(10)(A), 1396d(a) (1994).
177. See K.R. Levit et al, "National Health Expenditures, 1996," Health Care Financing Review, 19, no. 1 (1997): at 199.
178. See Joranson, supra note 20, at 250 (citing T. Reutzel, "Hidden Costs: A Simulation for the Effect of a Public Aid Payment Lag on Community Pharmacies," Illinois Pharmacist, 53 (1991): 16-17, 23-25).
179. See T.S. Jost and S. Davies, Medicare and Medicaid Fraud and Abuse (St. Paul: West, 1998): §§ 1-1, 1-2.
180. See id. § 1-4.
181. See id. § 2-1.
182. See id. §§ 2-1 to -7. In particular, under an administrative sanction authority added in 1997, physicians and other providers must be excluded from participation in federal health care programs for at least five years if they are convicted of a felony "relating to the unlawful manufacture, distribution, prescription, or dispensing of controlled substances." Providers convicted of misdemeanor controlled substances violations may be excluded from federal health care programs. See 42 U.S.C. § 1320a-7(b)(3) (1994). Thus, even if a professional convicted of illegitimate prescribing of controlled substances is not convicted of health care fraud, he/she might be excluded from participation in government health care benefits programs.
183. See, for example, United States v. Sims-Robertson, Nos. 92-1076, 92-1080, 92-1082, 92-1090, 92-1094, 92-1096, 92-1115,1994 WL 12212 (6th Cir. 1994); United States v. Romano, 970 F.2d 164 (6th Cir. 1992); and United States v. Sblendorio, 830 F.2d 1382 (7th Cir. 1987).
184. See United States v. Hughes, 895 F.2d 1135, 1143 (6th Cir. 1990) (conviction of pharmacist for mail fraud upheld); and "Medifraud Druggist Placed on Probation," Chicago Tribune, Apr. 9, 1986, at C5.
185. See B. Kilby, "Pharmacist Convicted," Tulsa World, May 10, 1995, at 9.
186. See 18 U.S.C. § 1347 (1994).
187. See id. § 1035.
188. See id. § 1001.
189. See 42 U.S.C. § 1320a-7b(a) (1994).
190. See 31 U.S.C. § 3729(a)(2) (1994).
191. See 42 U.S.C. § 1320a-7a.
192. See United States v. Sidhu, 130 F.3d. 644 (5th Cir. 1997); Sblendorio, 830 F.2d at 1384; Sims-Robertson, 1994 WL 12212, at *2; "Medical Clinics, Michigan," National Association of Attorneys General, Medicaid Fraud Report (Washington, D.C.: National Association of Attorneys General, June 1995); and M. Lasalandra, "Docs Charged with Writing Prescriptions for Addicts," Boston Herald, Dec. 16, 1993, at 26.
193. See United States v. Sidhu, 130 F.3d. 644 (5th Cir. 1997); Sblendorio, 830 F.2d at 1384; Sims-Robertson, 1994 WL 12212, at *2; "Medical Clinics, Michigan," National Association of Attorneys General, Medicaid Fraud Report (Washington, D.C.: National Association of Attorneys General, June 1995); and M. Lasalandra, "Docs Charged with Writing Prescriptions for Addicts," Boston Herald, Dec. 16, 1993, at 26.
194. See Sims-Robertson, 1994 WL 12212; and Romano, 970 F.2d at 165.
195. See Sims-Robertson, 1994 WL 12212, at *2, *4; and Romano, 970 F.2d at 165.
196. See Sidhu, 130 F.3d at 647-48; Sims-Robertson, 1994 WL 12212, at *2; and "Physicians, Michigan," National Association of Attorneys General, Medicaid Fraud Report (Washington, D.C.: National Association of Attorneys General, July/Aug. 1993): at 22.
197. See M. Possley, "Druggist Dispenses Medicaid Fraud Story," Chicago Tribune, Dec. 8, 1985, at 1. See also General Accounting Office, Medicaid Drug Fraud: Federal Leadership Needed to Reduce Program Vulnerabilities (Washington, D.C.: General Accounting Office, HRD-93-118, 1993) (describing drug fraud schemes.)
198. See M. Possley, "Druggist Dispenses Medicaid Fraud Story," Chicago Tribune, Dec. 8, 1985, at 1. See also General Accounting Office, Medicaid Drug Fraud: Federal Leadership Needed to Reduce Program Vulnerabilities (Washington, D.C.: General Accounting Office, HRD-93-118, 1993) (describing drug fraud schemes.)
199. See Lasalandra, supra note 178.
200. See, authorities cited, supra note 178. In some cases, doctors have subsequently falsified records to support their prescribing. See "Physicians, California," National Association of Attorneys General, Medicaid Fraud Report (Washington, D.C.: National Association of Attorneys General, May 1994): at 14.
201. See M. Fuetsch, "Agents Say Mayfield Podiatrist Tried to Trade Drugs for Sex," Cleveland Plain Dealer, Jan. 26, 1995, at 48.
202. Sidhu, 130 F.3d. at 647.
203. See id. (admission of defendant Gifford on appeal).
204. See J. Irwin, "Dentist Faces Charges for Prescriptions: Patients Say He Ended Pain, Officials Disagree," Cincinnati Enquirer, July 12, 1997, at A1, A6.
205. Telephone Interview with Ben Bailey, Attorney, Bowles, Rice, McDavid, Graff, and Love (Mar. 17, 1998).
206. See Office of Inspector General, "Special Fraud Alert: Fraud and Abuse in Nursing Homes Arrangements with Hospices," 63 Fed. Reg. 20,415 (1998). The most recent OIG report on hospices, however, reveals that formal plans of care were found for 96 percent of hospice beneficiaries, and that, in 99 percent of the hospice records reviewed, documentation confirmed that the beneficiaries and their families were receiving care as indicated by the plans of care. See Hospice Beneficiaries, supra note 78, at 4.
207. See Office of Inspector General, "Special Fraud Alert: Fraud and Abuse in Nursing Homes Arrangements with Hospices," 63 Fed. Reg. 20,415 (1998). The most recent OIG report on hospices, however, reveals that formal plans of care were found for 96 percent of hospice beneficiaries, and that, in 99 percent of the hospice records reviewed, documentation confirmed that the beneficiaries and their families were receiving care as indicated by the plans of care. See Hospice Beneficiaries, supra note 78, at 4.
208. Interview with Dr. Steven Waldman, Member, Society for Pain Practice Management (June 9, 1998).
209. See, for example, M.K. Sparrow, License to Steal: Why Fraud Plagues America's Health Care System (Boulder: Westview Press, 1996) (describing the seriousness of the health care fraud problem).
210. See L. Messina, "Judge Blasts Agents' Behavior During Raid," Charleston Gazette, Sept. 30, 1997, at 1 (noting one case in which federal agents ordered patients in a waiting room "up against the wall," holding the doctor's nine-year-old, pajamaclad son at gun point while they searched the doctor's home and office). OIG special agents and Federal Bureau of Investigation agents are authorized to carry firearms while on duty.
211. See Medicare Payment Advisory Commission, supra note 70, at 162-64.