Regulating patient safety: The patient protection and affordable care act

University of Pennsylvania Law Review

Volumn 159, Issue 6, 2011, Pages 1727-1775

  Furrow, Barry R ^a,b  

^a Department of Law ^*  (United States)

^b DREXEL UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 79960178921     PISSN: 00419907     EISSN: 19428537     Source Type: Journal    
DOI: None     Document Type: Article

References (119)

1. INST. OF MED., TO ERR IS HUMAN: BUILDING A SAFER HEALTH SYSTEM (Linda T. Kohn et al. eds., 2000).
2. See CHARLES VINCENT, PATIENT SAFETY 25 (Wiley-Blackwell, 2d ed. 2010) (2006) ("Without doubt the publication of th[e IOM] report was the single most important spur to the development of patient safety, catapulting it into public and political awareness and galvanizing political and professional will at the highest levels in the United States.").
3. KRISTIN REED & RICK MAY, HEALTHGRADES, THE THIRTEENTH ANNUAL HEALTH-GRADES HOSPITAL QUALITY IN AMERICA STUDY 2 (2010), available at http://www.healthgrades.com/business/img/ HealthGradesHospitalQualityInAmericaStudy2010.pdf. The authors found that, while hospital quality had improved, the difference between the best ("5-star rated") and worst ("1-star rated") hospitals was significant. Id. at 11-12. For instance, the probability of dying in a 5-star hospital was roughly 70% lower than in a 1-star facility. Id. The authors concluded that of the more than 230,000 preventable deaths, over half could be attributed to four prevalent medical diagnoses: sepsis, pneumonia, respiratory failure, and heart failure. Id.
4. Christopher P. Landrigan et al., Temporal Trends in Rates of Patient Harm Resulting from Medical Care, 363 NEW ENG. J. MED. 2124, 2127 (2010).
5. E.N. De Vries et al., The Incidence and Nature of In-Hospital Adverse Events: A Systematic Review, 17 QUAL. & SAFETY HEALTH CARE 216, 216, 222 (2008).
6. OFFICE OF INSPECTOR GEN., U.S. DEP'T OF HEALTH & HUMAN SERVS., OEI-06-09-0090, ADVERSE EVENTS IN HOSPITALS: NATIONAL INCIDENCE AMONG MEDICARE BENEFICIARIES, at i-ii (2010), available at http://oig.hhs.gov/oei/reports/oei- 06-09-00090.pdf (determining that approximately 13.5 percent of Medicare hospital admissions suffered an adverse event, with an equal percentage experiencing temporary harm).
7. Sana M. Al-Khatib and her coauthors offer an illustrative example in the context of implantable cardioverter-defibrillators (ICDs), which in certain circumstances can prevent sudden cardiac death. Sana M. Al Khatib et al., Non-Evidence-Based ICD Implantations in the United States, 305 JAMA 43, 43 (2011). The authors divided the use of ICDs in hospital patients into two categories: those uses supported by practice guidelines (evidence-based ICDs) and those that were not (non-evidence-based ICDs). Id. They found that the "risk of in-hospital death was significantly higher in patients who received a non-evidence-based device than in patients who received an evidence-based device." Id. at 46. Despite the evident risk posed by the non-evidence-based ICDs, over 20% of patients in the study received such devices, with some hospitals using them more than 40% of the time. Id. at 43, 48.
8. Landrigan and his coauthors observe, Despite substantial resource allocation and efforts to draw attention to the patient-safety epidemic on the part of government agencies, health care regulators, and private organizations, the penetration of evidence-based safety practices has been quite modest. For example, only 1.5% of hospitals in the United States have implemented a comprehensive system of electronic medical records, and only 9.1% have even basic electronic record keeping in place; only 17% have computerized provider order entry. Physicians-in-training and nurses alike routinely work hours in excess of those proven to be safe. Compliance with even simple interventions such as hand washing is poor in many centers. Landrigan et al., supra note 5, at 2130 (citations omitted). For further insights, see also the astringent comments of Bruce Spitz and John Abramson: "What other industry would tolerate such disregard for professional standards? Who would buy their products? What would happen if we learned that defense contractors failed to follow production protocol 45 percent of the time and that ninety-eight thousand soldiers died annually because of the low quality of their equipment?" Bruce Spitz & John Abramson, When Health Policy Is the Problem: A Report from the Field, 30 J. HEALTH POL. POL'Y & L. 327, 329 (2005).
9. See Mark R. Chassin et al., The Urgent Need to Improve Health Care Quality, 280 JAMA 1000, 1002-03 (1998) (stating that "[l]arge numbers are injured [in part] because preventable complications of medical treatment are not averted").
10. See generally Barry R. Furrow, Data Mining and Substandard Medical Practice: The Difference Between Privacy, Secrets and Hidden Defects, 51 VILL. L. REV. 803, 810-18 (2006) (discussing privacy issues arising with the use of electronic medical records).
11. See, e.g., PHILLIP LONGMAN, BEST CARE ANYWHERE: WHY VA HEALTH CARE IS BETTER THAN YOURS 1-10 (2007) (confirming that the VA system excels at delivering high-quality, well-coordinated, and evidence-based care).
12. See DOUGLAS MCCARTHY ET AL., THE COMMONWEALTH FUND, PUB. NO. 1306, MAYO CLINIC: MULTIDISCIPLINARY TEAMWORK, PHYSICIAN-LED GOVERNANCE, AND PATIENT-CENTERED CULTURE DRIVE WORLD-CLASS HEALTH CARE 13-14 (2009), available at http://www.commonwealth.org/~/media/Files/Publications/Case%20Study/2009/Aug/ 1306-McCarthy-Mayo-case%20study.pdf (describing the structural and cultural pillars undergirding the Mayo Clinic's integrated model of health care delivery).
13. See JOHN E. WENNBERG, TRACKING MEDICINE: A RESEARCHER'S QUEST TO UNDERSTAND HEALTH CARE 4 (2010) ("Unwarranted variation in health care delivery - variation that cannot be explained on the basis of illness, medical evidence, or patient preference - is ubiquitous.").
14. See generally Angus Corbett et al., Does the Phenomenon of 'Sociological Citizenship' Provide a Pathway for Health Care Organizations to Navigate the Gap Between Expectations and Outcomes in Safety and Quality? 8-13 (Apr. 14, 2010) (unpublished manuscript presented at the Seventh International Conference in Organisational Behaviour in Health Care, University of Birmingham, UK), available at http://www.download.bham.ac.uk/hsmc/angus-corbett.pdf (discussing how implementing new and innovative oversight structures can improve patient safety and health).
15. See generally Barry R. Furrow, Regulating Patient Safety: Toward a Federal Model of Medical Error Reduction, 12 WIDENER L. REV. 1 (2005) (discussing the current regulatory structure of health care in the United States and proposing changes to strengthen federal regulation). A look at the website of the Agency for Healthcare Research and Quality (AHRQ) reveals dozens of menus and links to every aspect of the health care quality matrix.
16. AGENCY FOR HEALTHCARE RES. & QUALITY, http://www.ahrq.gov (last visited Mar. 15, 2011).
17. See generally BARRY R. FURROW ET AL., HEALTH LAW: CASES, MATERIALS AND PROBLEMS chs. 1, 4-6 (6th ed. 2008) for a discussion of the various regulatory initiatives. I have considered several dimensions of the patient safety problem in a series of articles. See Furrow, supra note 11;
18. Barry R. Furrow, Medical Mistakes: Tiptoeing Toward Safety, 3 HOUS. J. HEALTH L. & POL'Y 181 (2003);
19. Barry R. Furrow, Patient Safety and the Fiduciary Hospital: Sharpening Judicial Remedies, 1 DREXEL L. REV. 439 (2009); Furrow, supra note 16.
20. See, e.g., Thomas H. Lee, Pay for Performance, Version 2.0?, 357 NEW ENG. J. MED. 531, 531-32 (2007) (outlining some of the critical processes Geisinger promises to undertake to ensure patient safety).
21. TROYEN A. BRENNAN & DONALD M. BERWICK, NEW RULES: REGULATION, MARKETS, AND THE QUALITY OF AMERICAN HEALTH CARE 339 (1996).
22. Robert Wachter uses the phrase "flawless execution" in relation to medical practice. Robert M. Wachter, The End of the Beginning: Patient Safety Five Years After 'To Err Is Human,' HEALTH AFF. W4-534, W4-535 (2004), http://content.healthaffairs.org/cgi/reprint/hlthaff.w4.534v1. Wachter notes that as medicine has grown more complicated and sophisticated, the need for coordination has grown. Id. "It should come as no surprise, then, that without a culture, procedures, and technology focused on flawless execution, errors would become commonplace." Id.
23. See generally DEMOCRATIC POLICY COMM., THE PATIENT PROTECTION AND AFFORDABLE CARE ACT AS PASSED (2010), available at http://dpc.senate.gov/ healthreformbill/healthbill53.pdf (providing the Democratic Party's summary of PPACA's contents)
24. See Atul Gawande, Annals of Medicine: The Checklist, NEW YORKER, Dec. 10, 2007, at 86, 94 (comparing the culture change in test pilots during the 1950s - from brazen and unregulated to refined and systemized - to what is currently transpiring in medicine).
25. See, e.g., John E. Wennberg, Dealing with Medical Practice Variations: A Proposal for Action, HEALTH AFF., May 1984, at 6, 9-15 (contending that norms of medical practice allow for a "wide range of professional discretion" and thus can result in significant differences in how patients are treated);
26. Understanding of the Efficiency and Effectiveness of the Health Care System, DARTMOUTH ATLAS HEALTH CARE, http://www.dartmouthatlas.org (last visited Mar. 15, 2011) (using Medicare data to show "glaring variations in how medical resources are distributed and used in the United States").
27. The resistance of physicians to externally imposed standards and values is a recurrent theme in American health care. For an excellent summary and analysis of the reasons for this recalcitrance, see Sandra H. Johnson, Regulating Physician Behavior: Taking Doctors' "Bad Law" Claims Seriously, 53 ST. LOUIS U. L.J. 973, 973-75, 992-1008 (2009).
28. For a corroborating study of the benefit of basic procedures in reducing infections, see Peter Pronovost et al., An Intervention to Decrease Catheter-Related Bloodstream Infections in the ICU, 355 NEW ENG. J. MED. 2725, 2729-31 (2006). This study looked at one approach to reducing catheter-related bloodstream infections in sixty-seven hospitals. Id. at 2726, 2728. The five procedures implemented in this approach were "hand washing, using full-barrier precautions during the insertion of central venous catheters, cleaning the skin with chlorhexidine, avoiding the femoral site if possible, and removing unnecessary catheters." Id. at 2726. To increase use of these procedures, a number of steps were taken: [C]linicians [were educated] about practices to control infection and harm resulting from catheter-related bloodstream infections, a central-line cart with necessary supplies was created, a checklist was used to ensure adherence to infection-control practices, providers were stopped (in nonemergency situations) if these practices were not being followed, the removal of catheters was discussed at daily rounds, and the teams received feedback regarding the number and rates of catheter-related bloodstream infection at monthly and quarterly meetings, respectively.
29. For a copy of the checklist, see AGENCY FOR HEALTHCARE RESEARCH AND QUALITY, AHRQ PUB. NO. 09(10)-P013-2, FACT SHEET: ENDING HEALTHCARE-ASSOCIATED INFECTIONS 4 (2009), available at http://www.ahrq.gov/qual/haicusp.pdf.
30. National Targets and Metrics, U.S. DEPARTMENT HEALTH & HUM. SERVICES tbl.1, http://www.hhs.gov/ash/initiatives/hai/nationaltargets/index.html (last visited Mar. 15, 2011).
31. Map of Hospitals Participating in the "On the CUSP: Stop BSI" Project, ON THE CUSP: STOP HA1, http://www.onthecuspstophai.org/AbouStat-7954. html (last visited Mar. 15, 2011).
32. See, e.g., Michelle M. Mello, Of Swords and Shields: The Role of Clinical Practice Guidelines in Medical Malpractice Litigation, 149 U. PA. L. REV. 645, 653 (2001) (noting the varying quality of such guidelines, which are often drafted to meet the goals of the drafting organization).
33. See, e.g., id. at 176-78 (allocating hundreds of millions of dollars to the AHRQ). Dissemination has been happening for more than a decade. The ARHQ sponsors the National Guideline Clearinghouse, which reviews all guidelines for the quality of the evidence supporting them. NAT'L GUIDELINE CLEARINGHOUSE, http://www.guideline.gov (last visited Mar. 15, 2011) (describing the website as a "public resource for evidence-based clinical practice guidelines").
34. American Recovery and Reinvestment Act of 2009, Pub. L. No. 111-5, tit. VIII, 123 Stat. 115, 176-77 (2009); see also Comparative Effectiveness Research Funding, HHS.GOV/RECOVERY, http://www.hhs.gov/recovery/programs/cer/index.html (last visited Mar. 15, 2011) (showing research funding allocation among government entities). The Recovery Act created the Federal Coordinating Council for Comparative Effectiveness Research to organize such research across the federal government. Recovery Act § 804, 42 U.S.C.A. § 299b-8.
35. See, e.g., Mohammad N. Akhter & Richard A. Levinson, Editorial, Comparative Effectiveness Research and the Future Practice of Medicine, 101 J. NAT'L MED. ASS'N 1301, 1301 (2009) ("CER clearly has the potential to reshape major portions of the practice of medicine.").
36. See generally INST. OF MED., supra note 1, at 26-43.
37. Id.; see also Reducing Errors in Health Care: Translating Research into Practice, AGENCY FOR HEALTHCARE RES. & QUALITY, http://www.ahrq.gov/qual/ errors.htm (last visited Mar. 15, 2011) (disclosing categories of errors, including surgical errors).
38. For a discussion of the sources of physician resistance to CER and guidelines generally, see Richard S. Saver, Health Care Reform's Wild Card: The Uncertain Effectiveness of Comparative Effectiveness Research, 159 U. PA. L. REV. 2147 (2011). For a critique of practice guidelines,
39. see generally Harold C. Sox & Sheldon Greenfield, Quality of Care - How Good Is Good Enough?, 303 JAMA 2403 (2010).
40. See INST. OF MED., supra note 1, at 5-14 (summarizing the IOM's recommendations).
41. See Peter J. Pronovost et al., Improving the Value of Patient Safety Reporting Systems (discussing patient safety reporting systems and the need for data to identify and treat safety hazards), in 1 ADVANCES IN PATIENT SAFETY: NEW DIRECTIONS AND ALTERNATIVE APPROACHES 52, 52-53 (Kerm Henriksen et al. eds., 2008).
42. There are several reasons for such poor performance. Mandatory systems lack support from physicians, who are worried about liability, damage to reputation, and the hassle of any reporting system. See JILL ROSENTHAL ET AL., NAT'L ACAD. FOR STATE HEALTH POLICY, CURRENT STATE PROGRAMS ADDRESSING MEDICAL ERRORS: AN ANALYSIS OF MANDATORY REPORTING AND OTHER INITIATIVES 80-81 (2001) (discussing state-mandated adverse event reporting and barriers to such reporting even when mandated);
43. Bryan A. Liang, Dr. Arthur Grayson Distinguished Lecture in Law & Medicine, Promoting Patient Safety Through Reducing Medical Error: A Paradigm of Cooperation Between Patient, Physician, and Attorney, 24 S. ILL. U. L.J. 541, 555 (2000) (noting that because "patient safety medical error information" can be used in litigation, there is a "tremendous negative incentive" to report such errors).
44. THE JOINT COMM'N, SENTINEL EVENTS (SE), at SE-8 (2011), available at http://www.jointcommission.org/assets/1/6/2011-CAMH-SE.pdf. The Joint Commission stresses the advantages to hospitals that self-report, including early consultation with the Joint Commission during the hospital's development of its root-cause analysis and action plan. Id. at SE-8 to-9.
45. See John R. Clark, Leadership Series: Is Your Institution Leaving Patient Safety Information at the Bedside?, 5 PA. PATIENT SAFETY ADVISORY 109, 109 (2008), available at http://www.patientsafetyauthority.org/ADVISORIES/ AdvisoryLibrary/2008/Dec5(4)/documents/109.pdf ("Hospitals that are not capturing near-miss⋯ events are hurting their ability to identify and correct problems before they harm patients.").
46. See About the Joint Commission, JOINT COMMISSION, http://www. jointcommission.org/about-us/about-the-joint-commission-main.aspx (last visited Mar. 15, 2011) (describing the Joint Commission as a nonprofit organization accrediting and certifying U.S. health care organizations and programs).
47. In fact, the Joint Commission itself acknowledges this reality by including a disclaimer in its review of sentinel event data: "The reporting of most sentinel events to the Joint Commission is voluntary and represents only a small proportion of actual events. Therefore, these data are not an epidemiologic data set and no conclusions should be drawn about the actual relative frequency of events or trends in events over time." THE JOINT COMM'N, SENTINEL EVENT DATA: EVENT TYPE BY YEAR: 1995-FOURTH QUARTER 2010, at 4 (2011), available at http://www.jointcommission.org/assets/1/18/Event-Type-by- Year-1995-4Q2010(v2).pdf.
48. See Lisa Girion & Rong-Gong Lin II, Healthcare: Drastic Setback for OC Hospital, L.A. TIMES, Dec. 6, 2008, at 1, available at 2008 WLNR 23460341 (noting that the Joint Commission revocation of accreditation is a "rare occurrence").
49. See Press Release, Ctrs. for Medicare & Medicaid Servs., Eliminating Serious, Preventable, and Costly Medical Errors - Never Events (May 18, 2006), available at http://www.cms.hhs.gov/apps/media/press/release.asp?Counter=1863 (attributing the definition of "never events" to the NQF).
50. See Patient Safety Primers: Never Events, AHRQ PATIENT SAFETY NETWORK, http://psnet.ahrq.gov/primer.aspx?primerID=3 (last visited Mar. 15, 2011) ("Since the NQF disseminated its original Never Events list in 2002, 11 states have mandated reporting of these incidents whenever they occur, and an additional 16 states mandate reporting of serious adverse events (including many of the NQF Never Events)."). Some states, like Minnesota, require a root-cause analysis after such events are reported. Id.
51. Id.; see also MINN. STAT. ANN. § 144.7065 (West Supp. 2009) (requiring the reporting of certain adverse health care events to the state).
52. See Welcome to AHRQ's Patient Safety Organization Web Site, AGENCY FOR HEALTHCARE RES. & QUALITY, http://www.pso.ahrq.gov (last visited Mar. 15, 2011) (introducing the role played by Patient Safety Organizations (PSOs) within the Patient Safety Act and providing information about them).
53. See Frederick Levy et al., The Patient Safety and Quality Improvement Act of 2005: Preventing Error and Promoting Patient Safety, 31 J. LEGAL MED. 397, 407 (2010) (describing the Patient Safety Act's purposes and goals).
54. Patient Safety Organization Information, AGENCY FOR HEALTHCARE RES. & QUALITY, http://www.pso.ahrq.gov/psos/overview.htm (last visited Mar. 15, 2011).
55. See, e.g., Martin N. Marshall et al., The Public Release of Performance Data: What Do We Expect to Gain? A Review of the Evidence, 283 JAMA 1866, 1867 (2000) (reviewing studies that analyzed the impact of publicly releasing health care performance data and finding that consumer use was minimal at best);
56. Eric C. Schneider & Arnold M. Epstein, Use of Public Performance Reports: A Survey of Patients Undergoing Cardiac Surgery, 279 JAMA 1638 (1998) (assessing patient use of a publicly available report card listing hospital mortality rates for cardiac surgery and finding that patients rarely used such information when choosing between health care providers).
57. See M.N. Marshall & P.S. Romano, Impact of Reporting Hospital Performance, 14 QUALITY & SAFETY HEALTH CARE 77, 77 (2005) (noting the lack of evidence that public disclosure improves the quality of care, even though provider organizations are sensitive to the publication of such data).
58. See Ashish K. Jha et al., Care in U.S. Hospitals - The Hospital Quality Alliance Program, 353 NEW ENG. J. MED. 265, 271-72, 274 (2005) (noting the "hard work that lies ahead" in expanding and refining health care comparative data analyses).
59. Heart-Bypass Surgery: 50 Top-Rated Surgical Groups, CONSUMER REP., Oct. 2010, at 40, 40. Only subscribers of ConsumerReportsHealth.org have access to the full rankings and the detailed statistical information used to rank the surgical groups, but the top fifty groups are listed in the October 2010 edition of Consumer Reports. Id. For more background and a critical assessment of the rankings,
60. see Timothy G. Ferris & David F. Torchiana, Public Release of Clinical Outcomes Data - Online CABG Report Cards, 363 NEW ENG. J. MED. 1593 (2010).
61. VHA Directive 2005-049, Disclosure of Adverse Events to Patients (V.A. 2005), available at http://www.sorrywork.net/pdf/VA-Link.pdf.
62. The VA issued a revised directive in 2008. See VHA Directive 2008-002, Disclosure of Adverse Events to Patients (V.A. 2008), available at http://www.va.gov/vhapublications/ViewPublication.asp?pub-ID=1637.
63. STANDARDS IN SUPPORT OF PATIENT SAFETY AND MEDICAL/HEALTH CARE ERROR REDUCTION RI.1.2.2 (The Joint Comm'n 2001);
64. see also JOINT COMM'N RES., THE JOINT COMM'N, PATIENT SAFETY: ESSENTIALS FOR HEALTH CARE 88 (5th ed. 2009) ("[A] licensed independent practitioner or another caregiver responsible for a patient's care should explain all outcomes of care, including any unexpected outcomes of that care, to that patient/family. This standard specifically includes unanticipated outcomes that relate to sentinel events that are considered reviewable by the Joint Commission.").
65. 40 PA. CONS. STAT. ANN. § 1303.308(a) (West Supp. 2010). For a discussion of the origins of the Authority, see Stanton N. Smullens et al., Pennsylvania's Approach to Reducing Medical Error: The Story of the Patient Safety Authority, 12 WIDENER L. REV. 39, 45-52 (2005).
66. See Hospital Compare, U.S. DEPARTMENT HEALTH & HUM. SERVICES, http://www.hospitalcompare.hhs.gov (last visited Mar. 15, 2011) (enabling users to compare hospitals along various criteria).
67. For a fuller description, see Hospital Compare, CENTERS FOR MEDICARE & MEDICAID SERVICES, http://www.cms.gov/HospitalQualityInits/11- HospitalCompare.asp (last visited Mar. 15, 2011).
68. See Nursing Home Compare, MEDICARE.GOV, http://www.medicare.gov/NHCompare (last visited Mar. 15, 2001) (providing "detailed information about every Medicare and Medicaid-certified nursing home" in the United States).
69. See Robert A. Weinstein et al., Infection-Control Report Cards - Securing Patient Safety, 353 NEW ENG. J. MED. 225, 227 (2005) (arguing for the use of report cards that would allow patients to compare infection rates among hospitals).
70. See, e.g., Rachel M. Werner & David A. Asch, The Unintended Consequences of Publicly Reporting Quality Information, 293 JAMA 1239, 1240 (2005) (noting that consumers often do not utilize quality information when making health care decisions);
71. see also Mark A. Hall & Carl E. Schneider, Patients as Consumers: Courts, Contracts, and the New Medical Marketplace, 106 MICH. L. REV. 643, 688-89 (2008) (discussing consumers' problems in the medical market, including selecting doctors).
72. See, e.g., Judith H. Hibbard et al., Does Publicizing Hospital Performance Stimulate Quality Improvement Efforts?, HEALTH AFF., Mar.-Apr. 2003, at 84, 92-94 (discussing a study indicating that public disclosure of performance encourages quality improvement);
73. Dana B. Mukamel et al., Quality Report Cards, Selection of Cardiac Surgeons, and Racial Disparities: A Study of the Publication of the New York State Cardiac Surgery Reports, 41 INQUIRY 435, 443-44 (2004) ("[P]ublished quality rankings have both a direct effect and indirect effect, substituting at least partially for implicit signals for quality.").
74. But see Zoltan G. Turi, The Big Chill: The Deleterious Effects of Public Reporting on Access to Health Care for the Sickest Patients, 45 J. AM. C. CARDIOLOGY 1766, 1766-67 (2005) (raising skepticism about the claimed benefit of publicly reporting physician performance data and arguing that such reporting might even diminish health outcomes for the highest-risk patients).
75. For a debate on this issue, see Nadine Housri et al., Should Informed Consent for Cancer Treatment Include a Discussion About Hospital Outcome Disparities?, 5 PUB. LIBR. SCI. MED. 1413 (2008), available at http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.0050214. In this debate, Robert Weil acknowledges the difficulty of gathering reliable data but argues for a "principle of transparency," which demands that the data be disclosed to patients. Id. at 1415-16.
76. Furrow, Patient Safety and the Fiduciary Hospital, supra note 18, at 482.
77. Lucian L. Leape & Donald M. Berwick, Five Years After To Err Is Human: What Have We Learned?, 293 JAMA 2384, 2388 (2005) (citation omitted).
78. See E. HAAVI MORREIM, HOLDING HEALTH CARE ACCOUNTABLE: LAW AND THE NEW MEDICAL MARKETPLACE 3-12 (2001) (describing the relationship between tort suits and behavior change and explaining what needs to be altered to make health care providers more accountable).
79. See, e.g., CTRS. FOR MEDICARE & MEDICAID SERVS., DEVELOPMENT OF A PLAN TO TRANSITION TO A MEDICARE VALUE-BASED PURCHASING PROGRAM FOR PHYSICIAN AND OTHER PROFESSIONAL SERVICES 9-24 (Dec. 9, 2008), available at http://www.cms.gov/PhysicianFeeSched/downloads/PhysicianVBP-Plan-Issues-Paper. pdf (discussing performance-based program designs for Medicare).
80. Fiscal Year 2009 Quality Measure Reporting for 2010 Payment Update, CENTERS FOR MEDICARE & MEDICAID SERVICES, http://www.cms.gov/ HospitalQualityInits/downloads/HospitalRHQDAPU200808.pdf (last visited Mar. 15, 2011).
81. Centers for Medicare & Medicaid - CMS, PREMIER, http://www. premierinc.com/quality-safety/tools-services/safety/topics/guidelines/ cms-guidelines-4-infection.jsp (last visited Mar. 15, 2011).
82. See Rewarding Superior Quality Care: The Premier Hospital Quality Incentive Demonstration Fact Sheet, ALLIANCE FOR HEALTH REFORM (2006), http://www.allhealth.org/BriefingMaterials/HospitalPremierFS200602-175.pdf (explaining how hospitals will be scored and ranked based on quality measures);
83. see also Premier Hospital Quality Incentive Demonstration, CENTERS FOR MEDICARE & MEDICAID SERVICES, https://www.cms.gov/HospitalQualityInits/35- HospitalPremier.asp (last visited Mar. 15, 2011) (describing the initiative and linking to results of the project).
84. Rewarding Superior Quality Care, supra note 161.
85. Press Release, Ctrs. for Medicare & Medicaid Servs., CMS Updates the National Hospital Quality Measure Acute Myocardial Infarction Set for Discharges as of April 1, 2009 (Dec. 31, 2008), available at www.cms.gov/ HospitalQualityInits/Downloads/HospitalAMI-6FactSheet.pdf.
86. The Medicare Improvements and Extension Act of 2006, sec. 101(b), § 1848, 120 Stat. 2975, 2975-77, established PQRS. The PQRS was originally called the PQRI (Physician Quality Reporting Initiative). Press Release, Ctrs. for Medicare & Medicaid Servs., Physician Quality Reporting System and E-Prescribing Program (Nov. 3, 2010), available at http://www.cms.gov/apps/ media/press/factsheet.asp?Counter=3858.
87. Press Release, Ctrs. For Medicare & Medicaid Servs., supra note 165.
88. Hospital Inpatient Value-Based Purchasing Program, 76 Fed. Reg. 2454 (proposed Jan. 13, 2011) (to be codified at 42 C.F.R. pts. 422 and 480).
89. Press Release, Ctrs. for Medicare & Medicaid Servs., Affordable Care Act to Improve Hospital Care for Patients (Jan. 7, 2011), available at http://www.cms.gov/apps/media/press/release.asp?Counter=3893.
90. For a discussion of the full range of tools used by managed care plans in the 1980s and into the 1990s, see generally Barry R. Furrow, Managed Care Organizations and Patient Injury: Rethinking Liability, 31 GA. L. REV. 419 (1997).
91. See generally THE FRAGMENTATION OF U.S. HEALTH CARE: CAUSES AND SOLUTIONS (Einer R. Elhauge ed., 2010) (collecting essays on health care fragmentation, a situation where multiple decisionmakers make health care decisions which would be better handled by unified decisionmaking).
92. David A. Hyman, Health Care Fragmentation: We Get What We Pay For, in id. at 21, 21.
93. See generally Alain Enthoven, Curing Fragmentation with Integrated Delivery Systems: What They Do, What Has Blocked Them, Why We Need Them, and How to Get There from Here (defining and describing integration as the opposite of fragmentation and proposing ways to achieve greater integration), in THE FRAGMENTATION OF U.S. HEALTH CARE: CAUSES AND SOLUTIONS, supra note 186, at 61, 63-68, 77-85.
94. See, e.g., Atul Gawande, Testing, Testing, NEW YORKER, Dec. 14, 2009, at 34, 35-36. Gawande uses the United States Department of Agriculture farm demonstration projects as an example of a productive government role in a highly fragmented industry and explains that "[t]he government never took over agriculture, but the government didn't leave it alone, either. It shaped a feedback loop of experiment and learning and encouragement for farmers across the country." Id. PPACA, as Gawande notes, adopts much the same strategy of testing virtually every idea in health services research and evaluating the results constantly. Id. at 38, 40. He writes, "Government has a crucial role to play here - not running the system but guiding it, by looking for the best strategies and practices and finding ways to get them adopted, county by county." Id. at 38.
95. Id., § 1899(a)(1)(A), 42 U.S.C.A. § 1395jj j(a)(1)(A). See generally Elliott S. Fisher et al., Creating Accountable Care Organizations: The Extended Hospital Medical Staff, 26 HEALTH AFF. W44, w51-w53 (2007), http://content.healthaffairs.org/content/26/1/w44.full.pdf+html (arguing for the use of ACOs at the level of "extended hospital medical staff" as a way to better coordinate patient care);
96. Stephen M. Shortell & Lawrence P. Casalino, Health Care Reform Requires Accountable Care Systems, 300 JAMA 95, 97 (2008) (discussing the potential for ACOs to be designed to create value by improving patient outcomes while simultaneously reducing costs). Much of the formative work of ACOs can be traced to the Dartmouth Institute for Health Policy and Clinical Practice headed by Dr. Elliott Fisher and Dr. James Weinstein.
97. See Elliott S. Fisher et al., Fostering Accountable Health Care: Moving Forward in Medicare, 28 HEALTH AFF. W219, w220, w227 (2009), http://contenthealthaffairs.org/content/28/2/w219.full.pdf+html (proposing Medicare-payment reform through ACOs wherein coordination of patient care would be prioritized and financially rewarded);
98. see also The Brookings-Dartmouth Accountable Care Organization Learning Network, ACCOUNTABLE CARE ORG. LEARNING NETWORK, https://xteam.brookings.edu/ bdacoln/Documents/Network%20Overview.pdf (last visited Mar. 15, 2011) (providing resources on ACOs). The Medicare Payment Advisory Commission (MedPAC) has also provided extensive analysis of the ACO concept.
99. See MEDICARE PAYMENT ADVISORY COMM'N, REPORT TO CONGRESS: IMPROVING INCENTIVES IN THE MEDICARE PROGRAM 39-56 (2009), available at http://www.medpac.gov/documents/Jun09-EntireReport.pdf (developing an ACO model as a recommendation for reforming Medicare's health care delivery system).
100. See Timothy L. Greaney, Accountable Care Organizations - The Fork in the Road, 364 NEW ENG. J. MED. e1(1), e1(1)-(2) (2011), http://www.nejm.org/doi/pdf/ 10.1056/NEJMp1013404 (discussing the benefits and concerns surrounding the implementation of ACO reform measures).
101. See Mark McClellan et al., A National Strategy to Put Accountable Care into Practice, 29 HEALTH AFF. 982, 983 (2010) (discussing different ACO payment models).
102. See Stephen M. Shortell et al., How the Center for Medicare and Medicaid Innovation Should Test Accountable Care Organizations, 29 HEALTH AFF. 1293, 1294 (2010) (arguing that ACOs could result in more cost-effective health care in large part because of the increased coordination among clinician teams that ACOs would induce).
103. See Jeff Goldsmith, The Accountable Care Organization: Not Ready For Prime Time, HEALTH AFF. BLOG (Aug. 17, 2009), http://healthaffairs.org/blog/ 2009/08/17/the-accountable-care-organization-not-ready-for-prime-time (arguing that ACOs would create huge problems similar to those in the wake of the Clinton-era health care mergers and consolidations).
104. Congress mandated the DRG prospective payment system in 1982 to control Medicare costs. This system changes payment from a highly inflationary fee-for-service approach to an individual reimbursement mechanism, which divides inpatient admission cases into categories called diagnostic-related groups (DRGs). DRG Classification and Weighting Factors, 42 C.F.R. § 412.60 (2010). Medicare then pays hospitals a flat per-case charge based on the particular DRG. The goal is to reward efficient hospitals and create incentives for inefficient hospitals to improve. See generally Office of Inspector Gen., OEI-09-00-00200, MEDICARE HOSPITAL PROSPECTIVE PAYMENT SYSTEM: HOW DRG RATES ARE CALCULATED AND UPDATED (2001), available at http://oig.hhs.gov/oei/reports/oei- 09-00-00200.pdf.
105. See Health Policy Brief: Patient-Centered Medical Homes, HEALTH AFF., 1 (Sept. 14, 2010), http://www.healthaffairs.org/healthpolicybriefs/brief-pdfs/ healthpolicybrief-25.pdf ("Supporters [of health care reform] hope patient-centered medical homes will help refocus the U.S. health care system on the benefits of primary care.").
106. Robert A. Berenson et al., A House Is Not a Home: Keeping Patients at the Center of Practice Redesign, 27 HEALTH AFF. 1219, 1223 (2008). For more information about the implementation of medical homes and related national initiatives,
107. see generally National Initiatives Overview, NAT'L CENTER FOR MED. HOME IMPLEMENTATION, http://www.medicalhomeinfo.org/national (last visited Mar. 15, 2011).
108. John E. Wennberg & Philip G. Peters, Jr., Unwarranted Variations in the Quality of Health Care: Can the Law Help Medicine Provide a Remedy/Remedies?, 37 WAKE FOREST L. REV. 925, 928-30 (2002). PPACA defines "preference-sensitive care" as medical care for which the clinical evidence does not clearly support one treatment option such that the appropriate course of treatment depends on the values of the patient or the preferences of the patient, caregivers or authorized representatives regarding the benefits, harms and scientific evidence for each treatment option, the use of such care should depend on the informed patient choice among clinically appropriate treatment options.
109. Elie A. Akl et al., A Decision Aid for COPD patients Considering Inhaled Steroid Therapy: Development and Before and After Pilot Testing, BMC MED. INFORMATICS & DECISION MAKING 2 (May 15, 2007), http://www.biomedcentral. com/1472-6947/7/12. PPACA defines "patient decision aid" as "an educational tool that helps patients, caregivers or authorized representatives understand and communicate their beliefs and preferences related to their treatment options, and to decide with their health care provider what treatments are best for them based on their treatment options, scientific evidence, circumstances, beliefs, and preferences." PPACA sec. 3506, § 936(b)(1), 42 U.S.C.A. § 299b-36(b)(1). Under PPACA, patient decision aids: (A) shall be designed to engage patients, caregivers, and authorized representatives in informed decisionmaking with health care providers; (B) shall present up-to-date clinical evidence about the risks and benefits of treatment options in a form and manner that is age-appropriate and can be adapted for patients, caregivers, and authorized representatives from a variety of cultural and educational backgrounds to reflect the varying needs of consumers and diverse levels of health literacy; (C) shall, where appropriate, explain why there is a lack of evidence to support one treatment option over another; and (D) shall address health care decisions across the age span, including those affecting vulnerable populations including children.
110. For examples of decision aids for such diseases with treatment options, see Decision Aid Library, DARTMOUTH-HITCHCOCK, http://patients.dartmouth- hitchcock.org/shared-decision-making/decision-aid-library.html (last visited Mar. 15, 2011);
111. see also Patient Decision Aids, FOUND. FOR INFORMED MED. DECISION MAKING, http://www.informedmedicaldecisions.org/patient-decision-aids.html (last visited Mar. 15, 2011) (describing and listing patient decision aids).
112. See Michael J. Barry, Health Decision Aids to Facilitate Shared Decision Making in Office Practice, 136 ANNALS INTERNAL MED. 127, 127 (2002) ("Health decision aids are designed to facilitate shared decision making by helping patients and their physicians choose among reasonable clinical options." (citations omitted)).
113. See Letter from Douglas W. Elmendorf, Dir., Cong. Budget Office, to Orrin G. Hatch, U.S. Senator (Oct. 9, 2009), available at http://www.cbo.gov/ftpdocs/ 106xx/doc10641. The letter represented the CBO's official response to Senator Hatch's "request for an updated analysis of the effects of proposals to limit costs related to medical malpractice ('tort reform')." Id. at 1. The CBO began with the assumption that "[t]ort reform could affect costs for health care both directly and indirectly: directly, by lowering premiums for medical liability insurance; and indirectly, by reducing the use of diagnostic tests and other health care services when providers recommend those services principally to reduce their potential exposure to lawsuits." Id. The CBO estimated costs savings from various tort reforms, such as caps on noneconomic damages; caps on punitive damages; modification of the "collateral source" rule; more restrictive statutes of limitations; and replacement of joint-and-several liability with a fair-share rule limiting a defendant's liability to the percentage of the final award that was equal to his or her share of responsibility for the injury. Id. at 1-2. The CBO also estimated that such reforms would reduce medical malpractice premiums by about ten percent. Id. at 2. The CBO further calculated that in 2009 the direct costs to providers for medical malpractice liability, including premiums, awards, settlements, and administrative costs, would be around $35 billion, or roughly two percent of total health care expenditures. Id. A savings of ten percent in premiums plus costs would therefore, in the CBO's words, "reduce total national health care expenditures by about 0.2 percent." Id. at 2-3. This is hardly a significant savings. In addition, the CBO noted the possibility of measurable indirect savings from "reduced utilization of health care services," although particular reforms might have different effects on physician incentives. Id. at 3. Adding these savings to the reform savings would reduce total national health care spending by about half a percent, or approximately $11 billion in 2009. Id. Finally, the CBO noted that much uncertainty remains about the possible negative effect on health outcomes of limiting the rights of injured patients to sue for injuries from medical errors. Id. at 5. It noted that the studies are in conflict, ranging from an estimate that a 10% reduction in costs would increase the overall mortality rate by 0.2%, to an estimate of no serious adverse outcomes for patient health. Id. The tort reformers' hope that extensive reforms could be sold as cost reduction, as part of the overall PPACA package, was limited by this CBO analysis.
114. I do not address the problem of physician resistance to patient safety initiatives. For background on this problem, see Behaviors That Undermine a Culture of Safety, SENTINEL EVENT ALERT (The Joint Comm'n, Oakbrook Terrace, Ill.), July 9, 2008, available at http://www.jointcommission.org/assets/1/18/ SEA-40.pdf.
115. For a discussion of PPACA's failure to legislate any liability reforms, see Thomas L. Hafemeister & Joshua Hinckley-Porter, The Health Care Reform Act of 2010 and Medical Malpractice Liability: Worlds in Collision?, 64 SMU L. REV. (forthcoming Aug. 2011), available at http://ssrn.com/abstract=1755028. Hafemeister and Hickley-Porter explain, [S]ome have argued that because the PPACA does so little to directly address malpractice and malpractice litigation-related concerns, its enactment will actually result in an increase in the number of malpractice cases and related costs as its provisions come into effect. As more patient encounters occur per year as a result of more insured people seeking medical attention, as a matter of course the total number of adverse events may increase, resulting in a greater number of medical malpractice suits. In addition, because the number of available physicians will remain constant while the number of patients able to obtain medical care will increase, this may result in the time and energy of doctors being stretched to cover more patients, possibly resulting in an increased number of mistakes on the part of physicians. Id. (manuscript at 21) (citations omitted).
116. Pure outcome-based enterprise liability proposals have existed in the legal literature since the 1970s. See, e.g., Clark C. Havighurst & Laurence R. Tancredi, "Medical Adversity Insurance" - A No-Fault Approach to Medical Malpractice and Quality Assurance, 51 MILBANK MEMORIAL FUND Q. HEALTH & SOC'Y 125, 125-26 (1973) (proposing a no-fault system for handling unfavorable results of medical care);
117. Clark C. Havighurst, "Medical Adversity Insurance" - Has Its Time Come?, 1975 DUKE L.J. 1233, 1253-55 (1975) (describing a system that would create a schedule of compensable medical injuries in advance, regardless of fault, as opposed to a system with case-by-case adjudications for medical injuries);
118. Laurence R. Tancredi, Designing a No-Fault Alternative, 49 LAW & CONTEMP. PROBS. 277, 277 (1986) ("A no-fault compensation scheme should rank at the very top of a list of long-term solutions to the perceived crisis in medical malpractice."). For more recent scholarship,
119. see Philip G. Peters, Jr., Resuscitating Hospital Enterprise Liability, 73 MO. L. REV. 369, 369 (2008) ("No tort reform has more potential to improve the quality of medical care and to reduce the frequency of patient injuries than exclusive hospital enterprise liability.").