The federal role in reducing hospital-acquired conditions: Are Medicare reimbursement incentives enough?

Columbia Journal of Law and Social Problems

Volumn 42, Issue 1, 2008, Pages 1-41

  Deutsch, Rachel ^a  

^a NONE

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EID: 58049180887     PISSN: 00101923     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (172)

1. R. Monina Klevens et al., Estimating Health Care-Associated Infections and Deaths in U.S. Hospitals, 2002, 122 PUB. HEALTH REP. 160, 164 (2007); Lucian L. Leape & Donald M. Berwick, Five Years After To Err Is Human: What Have We Learned? 293 JAMA 2384 (2005).
2. Leape & Berwick, supra note 1.
3. 42 U.S.C. § 1395ww(d)(4XD) (2008), discussed infra Part III.A.
4. See, e.g., Chantal Worzala et al., Challenges and Opportunities for Medicare's Original Prospective Payment System, 22 HEALTH AFF. 175 (2003) (discussing the tensions and unintended consequences of using Medicare to achieve health policy goals).
5. See, e.g., Joanna M. Shepherd, Tort Reforms Winners and Losers: The Competing Effects of Care and Activity Levels, 55 UCLA L. REV. 905, 922-23 (2008) (applying law and economics analysis to predict the results of tort reform on physicians incentives to provide quality care and to perform risky procedures).
6. § 1395ww(d)(4)(A). This system is intended to group together patients whose care is expected to require similar resources. Worzala et al., supra note 4, at 176.
7. Actual payments are calculated by weighting the DRG with standardized amounts representing labor, non-labor, and capital costs, subject to other adjustments such as area wage index and outlier costs. See BARRY R. FURROW ET AL., THE LAW OF HEALTH CARE ORGANIZATION AND FINANCE 373-74 (2004).
8. Hospital-Acquired Conditions, Including Infections, 71 Fed. Reg. 24,100 (Apr. 25, 2006).
9. See, e.g., Barry R. Furrow, Regulating Patient Safety: Toward a Federal Model of Medical Error Reduction, 12 WIDENER L. REV. 1, 11-12 (2005); Meredith B. Rosenthal, Nonpayment for Performance? Medicare's New Reimbursement Rule, 357 NEW ENG. J. MED. 1573 (2007); David A. Hyman & Charles Silver, You Get What You Pay For: Result- Based Compensation For Health Care, 58 WASH. & LEE L. REV. 1427, 1480 (2001).
10. § 1395ww(d)(4)(D).
11. See Reporting of Hospital Quality Data for Annual Hospital Payment Update, 73 Fed. Reg. 23,643 (Apr. 30, 2008) ("Linking a payment incentive to hospitals' prevention of avoidable or preventable HACs [hospital-acquired conditions] is a strong approach for encouraging high quality care.").
12. Preventable Hospital-Acquired Conditions (HACs), Including Infections, 73 Fed. Reg. 48,477 (Aug. 19, 2008). (publishing and discussing final CMS rule on Hospital- Acquired Condition reimbursement changes). Several of these conditions are infections, but the remaining are medical conditions such as pressure ulcers and injuries due to patients falling. The scope of the rule is thus "hospital-acquired conditions," with hospitalacquired infections as a subset.
13. § 1395ww(d)(4)(D); Deficit Reduction Act of 2005, Pub. L. 109-171 § 5001(c), 120 Stat. 4, 30 (2006); Hospital-Acquired Conditions, Including Infections, 72 Fed. Reg. 47,200 (Aug. 22, 2007). Evidence-based guidelines are discussed infra Part IV. For a helpful comparison of the concept of evidence in the worlds of law and medicine, see John M. Eisenberg, What Does Evidence Mean? Can the Law and Medicine be Reconciled?, 26 J. HEALTH POL. POL'Y & L. 369 (2001).
14. § 1395ww(d)(4).
15. COMM. on QUALITY of HEALTH CARE in AM., INST. of MED., TO ERR IS HUMAN (Linda Kohn et al. eds., 2000) [hereinafter IOM Report]. The IOM is a branch of the National Academy of Sciences.
16. Id. at 26. The IOM report uses "error" to encompass both failures of execution and failure to choose an appropriate course of action for the problem at hand. Id. at 54. It is not synonymous with hospital acquired infection.
17. Leape & Berwick, supra note 1, at 2384.
18. Medical malpractice suits allow patients to recover only if they can prove a causal connection between a physician's lapse in applying treatment protocols and their resulting injury. Some scholars advocate moving toward an enterprise liability model, in which financial liability is imposed on hospitals rather than doctors, although a physician's breach of duty remains a predicate for liability. See Kenneth S. Abraham & Paul C. Weiler, Enterprise Medical Liability and the Evolution of the American Health Care System, 108 HARV. L. REV. 381 (1994). While malpractice suits provide remuneration and vindication for some patients, few consider malpractice liability alone to be an effective legal tool for preventing medical errors. See, e.g., Michelle M. Mello et al., Fostering Rational Regulation of Patient Safety, 30 J. HEALTH POL. POL'Y & L. 375, 386-89 (2005) (discussing the inadequacy of tort law to address patient safety because there is scant evidence that tort system sends effective deterrence signal to physicians and courts lack healthcare expertise).
19. IOM report, supra note 15, at 157.
20. Leape & Berwick, supra note 1, at 2385; Lucian L. Leape, Foreword: Preventing Medical Accidents: Is "Systems Analysis" the Answer?, 27 AM. J.L. & MED. 145, 145-46 (2001).
21. COMM. on QUALITY of HEALTH CARE in AM., INST. of MED., CROSSING the QUALITY CHASM (2001) [hereinafter Quality Chasm]. The report contained a number of specific recommendations for changes at the microsystem level, where a small team of clinicians operates; but the suggestions for change at the level of the hospital itself were far less concrete. See Donald M. Berwick, A User's Manual for the IOM's 'Quality Chasm' Report, 21 HEALTH AFF. 80 (2002) (summarizing the key points, as well as the strengths and weaknesses, of the report).
22. Leape & Berwick, supra note 1, at 2385; AHRQ Profile: Advancing Excellence in Healthcare, AHRQ Publication No. 00-P005, March 2001. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/about/profile.htm (last visited Sept. 6, 2008). The agency was initially created as the Agency for Health Care Policy and Research, but reauthorized in 1999 as AHRQ. Healthcare Research and Quality Act of 1999, Pub. L. No. 106-129 § 2(b)(2), 113 Stat. 1653, 1670 (1999). AHRQ is discussed in more detail infra, Part V.
23. Patient Safety and Error Reduction Act: Hearing on S. 2738, 106th Cong. 146 Cong. Rec. S5241-02 (2001) (statement of Sen. Jeffords) (predicting the need for additional funding for medical error reduction).
24. Hyman & Silver, supra note 9, at 1430 (2001). But see Bruce Vladeck, If Paying for Quality is Such a Bad Idea, Why is Everyone for It?, 60 WASH. & LEE L. REV. 1345, 1350 (2004) (arguing that frustration with the current payment system, coupled with the tendency to seek grand solutions to intractable health care problems, underpins the fervor for Pay-for-Performance).
25. Meredith B. Rosenthal & R. Adams Dudley, Pay-for-Performance: Will the Latest Payment Trend Improve Care?, 297 JAMA 740 (2007).
26. Id. (acknowledging that most Pay-for-Performance programs currently fall short of expectations, and highlighting key factors to better align incentives with the goal of improving quality); Karen Milgate & Sharon Bee Cheng, Pay-For-Performance: The Med- PAC Perspective, 25 HEALTH AFF. 413, 415 (2006). MedPAC, which advises Congress on Medicare payment policy, has advocated incorporating Pay-for-Performance into Medicare reimbursement since 2003.
27. Charles N. Kahn III et al., Snapshot of Hospital Quality Reporting and Pay-for- Performance Under Medicare, 25 HEALTH AFF. 148, 151 (2006). In the Premier Hospital Quality Incentive Demonstration, a CMS project, hospitals that fall in the top ten percent on certain quality measures will receive 2% bonuses, while low performers are penalized. Hospitals in the bottom 10% are penalized by 2% while hospitals in the next lowest decile are penalized 1%. In a different model, the Medicare Payment Advisory Commission (MedPAC) has recommended setting aside 1-2% of total Medicare payments into a pool that is used to reward hospitals for both quality improvement and achievement. Milgate & Cheng, supra note 26, at 415. This represents an implicit penalty on lower performing hospitals because payment are reduced by 1-2% overall. Kahn et al., supra at 153.
28. Hyman & Silver, supra note 9, at 1448.
29. Id. at 1457-58.
30. 42 U.S.C. § 1395ww(d)(4)(D) (2008).
31. Urinary tract infections often occur among patients with indwelling catheters. Indwelling urinary catheters account for 80% of hospital-acquired urinary tract infections, and up to 40% of all hospital-acquired infections. Heidi L. Wald & Andrew M. Kramer, Nonpayment for Harms Resulting from Medical Care, 298 JAMA 2782, 2783 (2007).
32. Vascular catheter infections occur when bacteria invades a patient's bloodstream as a result of contamination of the site where an intravenous line has been inserted into the patient's vein. See Michele L. Pearson et al., Guideline for Prevention of Intravascular Device-Related Infections, 24 AM. J. INFECTION CONTROL 262 (1996).
33. Pressure ulcers, also called decubitus ulcers, occur when patients remain in one position too long. The pressure reduces blood flow to the skin, causing the tissue to die and skin to break down. Courtney H. Lyder, Pressure Ulcer Prevention and Management, 289 JAMA 223 (2003). See Michael Stockham, "This Might Sting a Bit": Policing Skin Care in Nursing Facilities by Litigating Fraud, 87 CORNELL L. REV. 1041 (2002) (advocating False Claims Act litigation to enforce appropriate skin care and pressure ulcer prevention in nursing homes).
34. Hospital-Acquired Conditions, Including Infections, 72 Fed. Reg. 47,217 (Aug. 22, 2007).
35. Hypoglycemia (low blood glucose levels) and hyperglycemia (elevated blood glucose levels) may be complications of diabetes or side effects of certain medications. The CMS rule as finally published prohibits reimbursement of comas resulting from these conditions, which can be avoided by routine testing of blood glucose levels. Preventable Hospital-Acquired Conditions (HACs), Including Infections, 73 Fed. Reg. 48,475 (Aug. 19, 2008).
36. These include infections following (often elective) orthopedic surgeries to repair the spine, shoulder and elbow, and infections following coronary artery bypass graft surgery. Preventable Hospital-Acquired Conditions (HACs), Including Infections, 73 Fed. Reg. 48,477 (Aug. 19, 2008).
37. Deep vein thrombosis (DVT) occurs when a blood clot forms in a vein, usually in the leg. When the clot migrates to the lung, it is known as pulmonary embolism (PE), which can be fatal. 73 Fed. Reg. 48,480 (Aug. 19, 2008).
38. This is because, until now, CMS has not required hospitals to record whether secondary diagnoses are "present on admission" so there was no nationwide data to differentiate hospital-acquired from community-acquired infections. See Hospital-Acquired Conditions, Including Infections, 72 Fed. Reg. 24,716, 24,718 (May 3, 2007) (inviting comment on a list of thirteen proposed hospital-acquired conditions).
39. See, e.g., Hospital-Acquired Conditions, Including Infections 72 Fed. Reg. at 24,719; Comment Letter, Medicare Payment Advisory Commission "MedPAC") (June 11, 2007) at 18. For example, conditions such as "object left in patient during surgery" is likely to be associated with a higher average charge simply because surgeries are high cost.
40. Hospital-Acquired Conditions, Including Infections, 72 Fed. Reg. 47,205 (Aug. 22, 2007).
41. Chunliu Zhan et al., Medicare Payment for Selected Adverse Events: Building the Business Case for Investing in Patient Safety, 25 HEALTH AFF. 1386, 1388-89 (2006) (assessing how much Medicare pays, under the DRG prospective payment system, for five hospital-acquired conditions, and how much of the additional costs incurred by those conditions must be absorbed by the hospital).
42. Id. at 1389. Postoperative sepsis occurs when a patient contracts a bacterial infection during surgery and the immune system reacts by going into overdrive. It can lead to organ failure and death if not treated quickly. See Medline Plus: Sepsis, U.S. NAT'L LIB. of MED. & NAT'L INST. of HEALTH, http://ww.nlm.nih.gov/ medlineplus/sepsis.html (last visited Sept. 16, 2008).
43. 42 U.S.C. § 1395ww(d)(4XD)(ii)(1); Hospital-Acquired Conditions, Including Infections, 72 Fed. Reg. at 24,718. ICD-9-CM (International Classification of Diseases, Clinical Modification) is the official system to assign codes to diagnoses and hospital treatments. Classification of Disease, Functioning, and Disability, NAT'L CTR. FOR HEALTH STATISTICS, http://www.cdc.gov/nchs/icd9.htm (last visited Sept. 16, 2008).
44. Hospital-Acquired Conditions, Including Infections, 72 Fed. Reg. 47,209 (Aug. 22, 2007) (stating that ventilator-associated pneumonia is not represented by a unique ICD-9-CM code, although there are twenty-seven codes for pneumonia which in some cases may be hospital acquired); Changes to the ICD-9-CM Coding System, 73 Fed. Reg. 23,579 (Apr. 30, 2008) (including ventilator-associated pneumonia as a distinct code). The agencies also created a new code for vascular catheter-associated infections, allowing CMS to select that harmful and frequent infection for inclusion. Hospital-Acquired Conditions, Including Infections, 72 Fed. Reg. at 47,211.
45. See Changes to the ICD-9-CM Coding System, 73 Fed. Reg. 23,579 (Apr. 30, 2008). The ICD-9-CM Coordination and Maintenance Committee is co-chaired by the National Center for Health Statistics ("NCHS") and the Centers for Medicare and Medicaid Services CMS. In the spring and fall of each year, the committee holds public meetings to discuss proposed coding changes, consulting with organizations such as the American Hospital Association and the American Health Information Management Association. Changes must be approved by the agencies and are published on the CMS and NCHS websites in May of each year, five months before they take effect.
46. Hospital-Acquired Conditions, Including Infections, 72 Fed. Reg. at 47,201 ("We are only selecting those conditions where, if hospital personnel are engaging in good medical practice, the additional costs of the hospital-acquired condition will, in most cases, be avoided."); Preventable Hospital-Acquired Conditions (HACs), Including Infections, 73 Fed. Reg. 48,474 (Aug. 19, 2008) ("the statute does not require that a condition be "always preventable" . . . but rather that it be "reasonably preventable" which necessarily implies something less than 100 percent.").
47. Wald & Kramer, supra note 31, at 2783.
48. Comment Letter, Association for Professionals in Infection Control and Epidemiology ("APIC") (June 11, 2007) [hereinafter APIC Comment Letter]. APIC and a number of other health care organizations endorsed selection of these conditions while cautioning against immediate adoption of the other infections. All Comment Letters can be found at http:/www.cms.hhs.gov/ eRulemaking/ECCMSR/itemdetail.asp?filterType=dual,%20date &filterValue= 90%7Cd&filterByDID=&sortByDID=l&sortOrder=ascending&itemID=CMS 1201453&intNumPerPage=10.
49. In 2006, there were 764 reported cases of Medicare patients who had an object left inside them during surgery; 45 reported cases of air embolisms; and only 33 reported cases of incompatible blood transfusions. Hospital-Acquired Conditions, Including Infections, 72 Fed. Reg. 47,206-07 (Aug. 22, 2007).
50. Staphylococcus aureus is a bacteria that can cause serious infection, especially those strains that are immune to treatment with antibiotics. See infra note 52. Ventilator-associated pneumonia refers to pneumonia that develops in patients who require mechanical assistance to breathe.
51. Staphylococcus aureus septicemia affected 29,500 Medicare patients in 2006; 92,586 Medicare patients developed pneumonia as a secondary diagnosis (although it is not clear that all were on ventilators). Hospital-Acquired Conditions, Including Infections, 72 Fed. Reg. at 24,721-22.
52. MRSA is the most frequent cause of skin and soft tissue infections reported at hospital emergency rooms in the United States. It can invade the tissue to become a severe, and sometimes fatal, condition. R. Monina Klevens et al., Invasive Methicillin- Resistant Stapylococcus aureas Infections in the United States, 298 JAMA 1763, 1763-64 (2007).
53. Hospital-Acquired Conditions, Including Infections, 72 Fed. Reg. at 24,718.
54. Hospital-Acquired Conditions, Including Infections, 72 Fed. Beg. 47,201 (Aug. 22, 2007).
55. Comment Letter, Society for Healthcare Epidemiology of America ("SHEA") (June 11, 2007) [hereinafter SHEA Comment Letter]; Comment Letter, American Hospital Association ("AHA") (June 4, 2007) [hereinafter AHA Comment Letter].
56. Comment Letter, Texas Hospital Association (June 4, 2007) at 2; SHEA Comment Letter, supra note 55, at 3; AHA Comment Letter, supra note 55, at 16; Comment Letter, Hospital and Health System Association of Pennsylvania (June 11, 2007) at 7.
57. SHEA Comment Letter, supra note 55, at 3.
58. Comment Letter, Ohio Hospital Association (June 8, 2007) at 4. "Unfunded mandate" refers to a regulatory scheme that requires hospitals to introduce expensive innovations without providing additional funds to offset that cost.
59. See, e.g., Comment Letter, California Hospital Association (June 12, 2007) at 12; AHA Comment Letter, supra note 55, at 16.
60. SHEA Comment Letter, supra note 55, at 8; APIC Comment Letter, supra note 48, at 8; Comment Letter, Michigan Hospital Association (June 8, 2007) at 19.
61. Hospital-Acquired Conditions, Including Infections, 72 Fed. Reg. 47,216 (Aug. 22, 2007).
62. Hospital-Acquired Conditions, Including Infections, 72 Fed. Reg. at 47,203.
63. See SHEA Comment Letter, supra note 55, at 3; APIC Comment Letter, supra note 48, at 3. These guidelines have not been updated since 1981. Hospital-Acquired Conditions, Including Infections, 72 Fed. Reg. 47,204.
64. Hospital-Acquired Conditions, Including Infections, 72 Fed. Reg. 47,204.
65. Hospital-Acquired Conditions, Including Infections, 72 Fed. Reg. 24,719.
66. Comment Letter, New Jersey Hospital Association (June 11, 2007) at 1; SHEA Comment Letter, supra note 55, at 4-5.
67. SHEA Comment Letter, supra note 55, at 4; APIC Comment Letter, supra note 48, at 4; AHA Comment Letter, supra note 55, at 16.
68. AHA Comment Letter, supra note 55, at 16.
69. Hospital-Acquired Conditions, Including Infections, 72 Fed. Reg. 47,204 (Aug. 22, 2007). CMS acknowledged but did not respond to suggestions that CMS should continue to reimburse for patients whose diagnoses qualify them as high-risk for developing pressure ulcers (such as quadriplegia, wasting syndrome, and advanced AIDS).
70. Rosenthal, supra note 9, at 1574-75. The Greater New York Hospital Association urged CMS to "develop a risk-adjusted model for evaluating hospital ulcer rates." See Comment Letter, Greater New York Hospital Association (June 11, 2007) at 14.
71. Quality Chasm, supra note 21, at 181.
72. Id. at 182.
73. Id. These include blended or bundled methods of payment for providers (covering multiple providers so that some elements of care can efficiently substitute for others, e.g. home care for office visits, id. at 188), multiyear contracts (providing longer relationships between payers and providers to encourage collaborative investments in quality), risk adjustment (so that providers and payers benefit financially from improved quality), and alternative approaches for addressing the capital requirements necessary to improve quality.
74. Robert A. Berenson, Separating Fact From Fiction: A New Role for Health Affairs, 26 HEALTH AFF. 1528, 1529 (2007) (urging Health Affairs to lead in ensuring health policy debates are not based on misuse or distortion of evidence, and citing Pay-for-Performance as an example of marketing an old and unsuccessful idea as the newest innovation).
75. Id.
76. See William M. Sage, Pay-for-Performance: Will It Work in Theory?, 3 IND. HEALTH L. REV. 305, 311 (2006) (arguing that the Pay-for-Performance "movement" lacks a coherent theory or purpose beyond frustration with current payment systems and a quality improvement objective); Vladeck, supra note 24, at 1351.
77. Seth W. Glickman et al., Pay-for-Performance, Quality of Care, and Outcomes in Acute Myocardial Infarction, 297 JAMA 2373 (2007). Researchers analyzed the differences in treatment of acute myocardial infarction (heart attack) between hospitals that applied financial incentives and a control group. They found improvement in both groups, but no greater improvement in the P4P group. This has not stopped P4P advocates and CMS officials from characterizing the Premier demonstration as a success. See Berenson, supra note 74.
78. Rosenthal & Dudley, supra note 25, at 742.
79. See Mark R. Laret, UCSP MED. CTR, Letter to the Editor, 25 HEALTH AFF. 287 (2004); Dennis S. O'Leary, JOINT COMM'N on the ACCREDITATION of HEALTHCARE ORGS., Letter to the Editor, 25 HEALTH AFF. 288 (2004).
80. Milgate & Cheng, supra note 26, at 415.
81. For example, if bonuses are tied to surgical outcomes, it may shift attention away from nonsurgical interventions oriented towards prevention.
82. Vladeck, supra note 24, at 1357-58.
83. Stephanie S. Teleki et al., Will Financial Incentives Stimulate Quality Improvement? Reactions from Frontline Physicians, 21 AM. J. MED. QUAL. 367, 371 (2006). An assessment of a Pay-for-Performance program launched by a private PPO (preferred provider organization) found no modification of physician practice in response to financial incentives. Many physicians perceive financial incentives as a "take-away and give-back masquerading as a bonus" since the bonuses do not add to the health plan's total payments for care. Physicians reacted with anger and suspicion to the health plan's use of financial incentives to improve quality.
84. Vladeck, supra note 24, at 1370.
85. Id. at 1365; Quality Chasm, supra note 21, at 181 ("Recognition of professional accomplishment and innovation is a strong motivator of improvement."). Vladeck, who led the Health Care Financing Administration (the predecessor of the Centers for Medicare and Medicaid Services) during the Clinton Administration, also identifies ethical problems with Pay-for-Performance. If Medicare identifies a level of quality care that is high enough to justify additional incentive payments, it seems morally indefensible to continue any payments to those hospitals that fail to meet that threshold. Yet, excluding hospitals from participation because they fall below certain (possibly disputed) indicators of quality could have a negative impact on Medicare beneficiaries' access to care. Id. at 1361-62. In contrast, Vladeck considers the binary nature of the new CMS rule on hospital-acquired conditions to be a virtue. Interview with Bruce Vladeck, Interim President, Univ. of Medicine and Dentistry of N.J, (Nov. 29, 2007).
86. Furrow, supra note 9, at 11.
87. Zhan et al., supra note 41.
88. Id. at 1388.
89. Id. at 1391.
90. Central-line infections are a subset of vascular catheter-associated infections, which are listed in the new CMS rule. Vascular catheters are inserted into blood vessels; central lines are catheters inserted into one of the major veins.
91. Richard P. Shannon et al., Economics of Central-Line Associated Bloodstream Infections, 21 AM. J. MED. QUALITY 7S, 14S (Supp.) (2006). The study examined government and private payers; it found no significant distinction in magnitude of financial loss when comparing Medicare and other payers. Id. at 15S.
92. See infra Part IV.D.
93. Kaveh G. Shojania & Jeremy M. Grimshaw, Evidence-Based Quality Improvement: The State of the Science, 24 HEALTH AFF. 138 (2005) (arguing that not only clinical decisions but also quality improvement efforts should be based on scientific evidence of effectiveness). Clinical guidelines are the mechanism for diffusing evidence-based knowledge about best treatment practices.
94. Id. at 141.
95. See Lars Noah, Medicine's Epistemology: Mapping the Haphazard Diffusion of Knowledge in the Biomedical Community, 44 Ariz. L. Rev. 373, 422 (2002) (noting that conflicts of interest may taint clinical guidelines, which may be authored by specialty medical societies or insurance companies).
96. Id. at 397 ("[P]eer review in the publication process cannot guarantee the accuracy or validity of the reported research.").
97. Dave Quiros et al., Attitudes Toward Practice Guidelines Among Intensive Care Unit Personnel, 36 HEART & LUNG: J. OF ACUTE & CRITICAL CARE 287 (2007).
98. Id. Hospitals struggle, often unsuccessfully, to ensure that clinicians wash their hands before touching patients. See Atul Gawande, On Washing Hands, 350 NEW ENG. J. MED. 1283 (2004) (describing the ongoing, unsuccessful, efforts of his hospital's infection control staff to promote consistent hand-washing by clinical staff); Didier Pittet et al., Hand Hygiene Among Physicians: Performance, Beliefs, and Perceptions, 141 ANN. INTERNAL MED. 1 (2004) (finding a 57% hand-washing compliance rate and noting factors that were associated with adherence and nonadherence).
99. Richard Grol & Michel Wensing, What Drives Change? Barriers to and Incentives for Achieving Evidence-Based Practice, 180 MED. J. AUSTL. S57, S59 (2004) (proposing that barriers and incentives affecting absorption of clinical guidelines be analyzed at the level of the patient, physician, and innovation itself, with reference to the organizational, social, political and economic context).
100. Jeremy M. Grimshaw and Martin P. Eccles, Is Evidence-Based Implementation of Evidence-Based Care Possible?, 180 MED. J. AUSTL. S50 (2004).
101. Shojania & Grimshaw, supra note 93, at 141.
102. See id.
103. Andrew D. Auerbach et al., The Tension Between Needing to Improve Care and Knowing How to Do It, 357 NEW ENG. J. MED. 608 (2007).
104. Lucian L Leape et al., What Practices Will Most Improve Safety?, 288 JAMA 501, 505-06 (2002).
105. Id.
106. Id. at 506; see Thomas R. McLean, The 80-Hour Week, 26 J. LEGAL MED. 339 (2005) (concluding that one implication of reduced physician hours will be greater reliance on "physician extenders" - healthcare workers with less training, such as respiratory therapists, physical therapists, and physician assistants); Jennifer F. Whetsell, Changing the Law, Changing the Culture: Rethinking the "Sleepy Resident" Problem, 12 ANNALS HEALTH L. 23 (2003) (analyzing New York's restrictions on resident hours); Dori Page Antonetti, A Dose of Their Own Medicine: Why the Federal Government Must Ensure Healthy Working Conditions for Medical Residents and How Reform Should Be Accomplished, 15 CATH. U. L. REV. 875 (2002).
107. Auerbach et al., supra note 103, at 608.
108. See Eli N. Perencevich et al., Raising Standards While Watching The Bottom Line: Making a Business Case for Infection Control, 28 INFECTION CONTROL & HOSP. EPIDEMIOLOGY 1121 (2007) (discussing the need to make a "business case" to hospital administrators to gain approval for new infection control programs; including cost-benefit analysis to project future savings to be gained by introducing effective programs).
109. Comment Letter, Ohio Hospital Association (June 8, 2007) at 3.
110. Perencevich et al., supra note 108, at 1121; Marly Christenson et al., Improving Patient Safety: Resource Availability and Application for Reducing the Incidence of Health care-Associated Infection, 27 INFECTION CONTROL & HOSP. EPIDEMIOLOGY 245 (2006) (reporting a descriptive study of the resources, infrastructure, and procedures used by infection control departments to combat hospital-acquired conditions, within a network of nonprofit community-based hospitals).
111. Christenson et al., supra note 110, at 248.
112. Id. at 247.
113. Perencevich et. al., supra note 108, at 1129. Grimshaw & Eccles, supra note 100, at S50 (indicating that less than one-third of studies report the costs of the implementation program).
114. Allen Dobson et al., The Cost-Shift Payment 'Hydraulic': Foundation, History, and Implications, 25 HEALTH AFF. 22, 25 (2006) (positing cost-shifting as an integral part of the health care financing system).
115. Id.; Paul B. Ginsburg, Can Hospitals and Physicians Shift the Effects of Cuts in Medicare Reimbursement to Private Payers?, HEALTH AFF. W3-472 (2003) (web exclusive) (explaining the economic basis for cost shifting and how it fluctuates under different market conditions).
116. Dobson et al., supra note 114, at 26.
117. Id. at 27-28; Ginsburg, supra note 115, at W3-478.
118. Vanessa Fuhrmans, Insurers Stop Paying for Care Linked to Errors; Health Plans Say New Rules Improve Safety and Cut Costs; Hospitals Can't Dun Patients, WALL ST. J., Jan. 15, 2008, at Dl.
119. Hospital-Acquired Conditions, Including Infections, 72 Fed. Reg. 47,201 (Aug. 22, 2007).
120. Fuhrmans, supra note 118.
121. Leape & Berwick, supra note 1, at 2387.
122. Id. at 2388.
123. 42 U.S.C. § 299 (1999).
124. See Stockham, supra note 33, at 1057.
125. See § 299a-l (noting deletion of prior provision "related to dissemination of research, demonstration projects, and evaluations"); Reauthorization of the Agency for Health Care Policy and Research: Hearing before the Subcomm. on Health and Env't of the H. Comm. on Commerce, 106th Cong. 24 (1999) (testimony of John M. Eisenberg, Administrator, Agency for Health Care Policy and Research).
126. Agency for Health Care Research and Quality, AHRQ Portfolios of Research (2005), http://www.ahrq.gov/fund/portfolio.htm.
127. Joel L. Weissman et al., Error Reporting and Disclosure Systems: Views from Hospital Leaders, 293 JAMA 1359, 1365 (2005).
128. IOM Report, supra note 15, at 86-88.
129. Compliance with JCAHO accreditation requirements satisfies Medicare's conditions for participation.
130. JCAHO requires reporting of "sentinel events," and the reporting system is hindered by the broad definition of "sentinel events," which is not coextensive with that of preventable medical error. A sentinel event is defined as "an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof." Joint Commission on the Accreditation of Health Care Organizations, Sentinel Event Policy and Procedures, http://www.jointcommission.org/SentinelEvents/Policy and Procedures/se-pp.htm (last visited Sept. 16, 2008). JCAHO is also notoriously reluctant to actually withdraw accreditation, making its " requirements" somewhat toothless. Of 3,000 sentinel events reported between 1995 and 2004, only 63% were reported by the accredited organizations, with the remainder reported by the media or other sources. Leigh Ann Lauth, The Patient Safety and Quality Improvement Act of 2005: An Invitation for Sham Peer Review in the Health Care Setting, 4 IND. HEALTH L. REV. 151 (2007); see also Maxine M. Harrington, Revisiting Medical Error: Five Years After the IOM Report, Have Reporting Systems Made A Measurable Difference?, 15 HEALTH MATRIX 329, 360 (2005) (discussing the lack of a uniform definition of medical error, and the disincentives for disclosure embedded in many reporting systems); Furrow, supra note 9, at 13-14. But see Michelle M. Mello et al., Fostering Rational Regulation of Patient Safety, 30 J. HEALTH POL. POL'Y & L. 375 (2005) (discussing the pluralistic regulatory environment for patient safety, and crediting JCAHO with becoming interested in patient safety before To Err Is Human was published and surmising that the standards are at least somewhat helpful).
131. Harrington, supra note 130, at 362. As of November 2006, twenty-five states had some form of mandatory disclosure law. Dayna C. Nicholson & Lynsey A. Mitchel, A Medical Error Happened: Now What? The Implications for Medical Errors Heat Up, 1 J. HEALTH Care COMPLIANCE 5 (2008). For example, Pennsylvania's statute requires reporting of serious events to both the state and to patients, and imposes penalties for failures to report medical errors. It also requires hospitals to disclose specific hospital-acquired infections and publishes each hospital's rate of infection; includes whistleblower protection that allows health care workers to anonymously report events; and immunizes documents provided to the state's health care authority from discovery in most litigation. Medical Care Availability and Reduction of Error Act, 40 PA. STAT. ANN. § 1303 (2002); see Barry R. Furrow, Medical Mistakes: Tiptoeing Towards Safety, 3 HOUS. J. HEALTH L. & POL'Y 181, 213-216 (2003) (discussing Pennsylvania's law). PENNSYLVANIA HEALTH CARE COST CONTAINMENT COUNCIL, HOSPITAL-ACQUIRED INFECTIONS in PENNSYLVANIA (2006), http://www.phc4.org/ reports/hai/05/docs/hai2005report.pdf; see also Michael M. Peng et al, Adverse Outcomes From Hospital-Acquired Infection in Pennsylvania Cannot Be Attributed to Increased Risk on Admission, 21 AM. J. MED. QUALITY 17S (2006).
132. Harrington, supra note 130, at 364-66; Furrow, supra note 131, at 204; Weissman et al., supra note 127, at 1369 (discussing a recent survey of hospital administrators finding that over two-thirds believed that mandatory, non-confidential reporting systems discouraged honest reporting of errors and led to a greater number of lawsuits; twentythree percent thought the reporting requirements in their state were unclear).
133. The "report card" that the Pennsylvania Health Care Containment Council publishes, based on the information hospitals are required to disclose, is one example. See PENNSYLVANIA HEALTH CARE COST CONTAINMENT COUNCIL, supra note 131; Kristin Madison, Regulating Health Care Quality In an Information Age, 40 U.C. DAVIS L. REV. 1557, 1590-91 (2007) (discussing information imperfections in the health care market, and citing Pennsylvania's statute as an example of a market-facilitating regulatory approach, in contrast to market-displacing or market-channeling regulations).
134. A national public-private partnership aimed at increasing voluntary hospital reporting of quality data is also premised on consumer use of healthcare data. See Voluntary Hospital Quality Data Reporting, 73 Fed. Reg. 23,643 (Apr. 30 2008) (describing a partnership between a plethora of acronym-identified agencies and organizations including CMS, AHRQ, AARP, AMA, AFL-CIO, to make data available on the Hospital Compare website, to be used by consumers selecting hospitals).
135. The Health Care Infection Control Practices Advisory Committee (HICPAC), which advises HHS and the CDC on infection control, recently evaluated mandatory reporting statutes. HICPAC found no evidence that public disclosure of infection rates were effective in reducing hospital-acquired infections. HICPAC declined to recommend for or against public reporting, but established best-practice guidelines for states choosing to implement disclosure statutes (such as selecting appropriate patient populations for monitoring; choosing process and outcomes measures; risk adjustment; and validation of data). Linda McKibben et al., Guidance on Public Reporting of Health care-Associated Infections: Recommendations of the Healthcare Infection Control Practices Advisory Committee, 33 AM. J. INFECT. CONTROL 217 (2005). As for market efficiency, a few informed consumers who diligently shop for quality can theoretically influence the market even if most remain uninformed. But health care is hardly a conventional product. The health care market's segregation along geographic, diagnosis-related, and demographic lines reduces the spillover effect of a minority of sophisticated quality-shoppers. Madison, supra note 133, at 1620-21.
136. Judith H. Hibbard & Jacquelyn J. Jewett, Will Quality Report Cards Help Consumers?, 16 HEALTH AFF. 218, 220-21, 225 (1997). The quality information that consumers describe as most salient in the abstract is not always the information they actually consider when choosing health plans. Consumers appear to rely more on patient satisfaction rates, which they can comprehend, than they do on more objective (but often baffling) clinically-based data. Although this research analyzes report cards for helping consumers choose insurers, rather than medical providers, cognitive biases are likely to similarly undermine the utility of provider report cards. See William Sage, Regulating Through Information: Disclosure Laws and American Health Care, 99 COLUM. L. REV. 1701, 1728-30 (1999) (citing studies showing that large proportions of English-speaking patients are unable to comprehend standard health-related materials; that Medicare beneficiaries mostly lack the knowledge to make informed decisions between coverage options; and that people dismiss health information when they are healthy but over-emphasize it when they are ill).
137. 42 U.S.C. § 299b-21 et. seq.; see, e.g., 151 Cong. Rec. H6673, H6677 (daily ed. July 27, 2005) (statement of Rep. Brown) ("The consequences of reporting medical errors can be onerous, which deters some who commit or witness medical errors from documenting them. This legislation is intended to overcome that obstacle. To reduce the number of medical errors, we need to understand what causes them and address those causes. Accurate and complete information on medical errors is the first step.").
138. Patient Safety and Quality Improvement Act of 2005, Pub. L. No. 109-41, 119 Stat. 424 (2005); § 299b-21 et. seq.; see Charles M. Key, A Review of the Patient Safety and Quality Improvement Act of 2005, 18 J. Health L. 20 (2005); Robert A. Kerr-, The Patient Safety and Quality Improvement Act of 2005: Who Should Pay for Improved Outcomes?, 17 HEALTH MATRIX 319, 329-31 (2007) (noting that the PSQIA does not provide funding for PSOs, and prevents HMOs from sponsoring PSOs; the author argues that pharmaceutical companies should fund PSOs).
139. § 299b-22. With a few exceptions, patient safety work product is not subject to discovery or subpoena in state, federal, civil or criminal proceedings; nor is it admissible in disciplinary proceedings conducted by state professional bodies. For further discussion on how legal liability deters health care providers from sharing quality and safety information, and the function of the PSQIA, see Bryan A. Liang, Collaborating on Patient Safety: Legal Concerns and Policy Requirements, 12 WIDENER L. REV. 83 (2005).
140. Sage, supra note 136, at 1771 (citing a lag in communications and data management in healthcare compared to other industries, regulatory interventions that discourage innovation, and "competitively sheltered hegemony of the medical profession").
141. The government has estimated that 100 PSOs will apply for certification over an initial three year period. See Agency Information Collection Activities, 73 Fed. Reg. 9337 (Feb. 20, 2008) (inviting comment on AHRQ's proposed request to the Office of Management and Budget to begin collecting information from PSOs in order to certify them pursuant to PSQIA).
142. §299b-23. This statute states, The Secretary shall facilitate the creation of, and maintain, a network of patient safety databases that provides an interactive evidence-based management resource for providers, patient safety organizations, and other entities. The network of databases shall have the capacity to accept, aggregate across the network, and analyze nonidentifiable patient safety work product voluntarily reported by patient safety organizations, providers, or other entities. This information "shall be used to analyze national and regional statistics, including trends and patterns of health care errors." Id.
143. On April 21, 2008, the AHRQ extended the period for members of the public to comment on its proposal regarding the forms by which PSOs could apply for certification. Agency Information Collection Activities, 73 Fed. Reg. 21349 (Apr. 21, 2008).
144. § 299b-23 ("The Secretary shall assess the feasibility of providing for a single point of access to the network for qualified researchers for information aggregated across the network and, if feasible, provide for implementation.").
145. See supra Part IV.C.
146. COMM. on REVIEWING EVIDENCE to IDENTIFY HIGHLY EFFECTIVE CLINICAL SERVICES, INST. of MED., KNOWING WHAT WORKS in HEALTH CARE (Jill Eden et al. eds., 2000).
147. Id. at 3, 33.
148. Id.
149. Id. at 6-7.
150. This is one of six grants AHRQ has provided to evaluate systems-related best practices. See Dwight McNeill et al., Beyond the Dusty Shelf: Shifting Paradigms and Effecting Change, in ADVANCES in PATIENT SAFETY: FROM RESEARCH to IMPLEMENTATION, Vol. 3, at 384. Agency for Health care Research and Quality, AHRQ Publication No. 05-0021-3, 2005.
151. See Michigan Health & Hospital Association, KeyStone: ICU, http://www.mha.org/mha-app/keystone/icu-overview.jsp (last visited Aug. 27, 2008). CMS rule covers central-line infections, which are a subset of vascular catheter infections.
152. See Peter Provonost et al., An Intervention to Decrease Catheter-Related Bloodstream Infections in the ICU, 355 NEW ENG. J. M ED. 2725, 2726 (2006) (describing the Keystone intervention and its clinical results). The five procedures are hand-washing, using full barrier precautions when inserting catheters into central lines, cleaning the skin with chlorhexidine, avoiding the femoral vein, and removing catheters as soon as they became clinically unnecessary.
153. Id. at 2726-27.
154. Atul Gawande, The Checklist, THE NEW YORKER, Dec. 10, 2007, at 91-92. The Keystone intervention prompted systems-level changes even before it was fully implemented. When the study was initiated, only 19% of Michigan ICUs stocked the antiseptic that clinical guidelines recommend using to disinfect the skin before inserting the catheter, in their central line kits. Within six weeks of the letter inviting hospitals to participate in the project and detailing the clinical guidelines, 64% of ICUs included the antiseptic, chlorhexidine, in the kits. Provonost et al., supra note 152, at 2729.
155. Provonost et. al., supra note 152, at 2725. This reduction refers to the mean rate. The reduction in the median rate of infection was from 2.7 to 0.
156. Id. at 2729-31.
157. Id. at 2729.
158. Id. at 2730.
159. Id. at 2731.
160. Id. at 2730.
161. Unfortunately, plans by Johns Hopkins researchers to extend the Keystone project to hospitals in New Jersey and Rhode Island were recently halted by the Office for Human Research Protections. The agency determined that recording the results of the intervention amounted to a modification in medical care that, without informed consent from patients, violated research ethics. Atul Gawande, A Lifesaving Checklist, N.Y. TIMES, Dec. 30, 2007, at 8. Protecting the dignity and privacy of individuals involved in research is vital; hopefully the project can quickly adapt and receive authorization to proceed in additional states.
162. See Gawande, supra note 154, at 92.
163. Donald Berwick, a leading authority on patient safety, has called for AHRQ's budget to be "billionized." See, e.g., Berwick, supra note 21, at 88.
164. See AHRQ Justification of Estimates for Appropriations Committees, FY 2008, available at http://ahrq.gov/about/cj2008/cj2008.pdf; National Institutes of Health, NIH Budget, httpy/www.nih.gov/about/budget.htm (last visited Aug. 27, 2008).
165. The budget request for FY 2007 included less than six million dollars for general patient safety research. FY 2008 includes a fifteen million dollar increase in this section of the budget, but it is entirely earmarked for a Personalized Health Care Initiative. AHRQ, supra note 164.
166. AHRQ, supra note 164.
167. Leape & Berwick, supra note 1, at 2385.
168. See Nicolas P. Terry, To HIPAA, a Son: Assessing the Technical, Conceptual, and Legal Frameworks for Patient Safety Information, 12 WIDENER L. REV. 133 (2005) (hypothesizing that patient safety advocates may be drawn to solutions that can be implemented quickly, and noting that health information technology initiatives are the only health care reform proposals to gain bipartisan support in recent years).
169. Shojania & Grimshaw, supra note 93, at 141, 149 n.8; see J.D. Kleinke, Release 0.0: Clinical Information Technology in the Real World, 17 HEALTH AFF. 23 (1998); Ross Koppel et al., Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors, 293 JAMA 1197 (2005) (finding that a leading CPOE system frequently increased the risks of medication errors).
170. See Robert L. Wears & Marc Berg, Computer Technology and Clinical Work: Still Waiting for Godot, 293 JAMA 1261 (2005) (arguing that because technology does not stand alone but rather interacts with people and routines in the health care environment, health information technology must be integrated into a larger organizational change framework).
171. McNeill et al., supra note 150, at 392.
172. Id. at 384.