Regulating patient safety: the Patient Protection and Affordable Care Act.

• Author: Furrow, Barry R.

INTRODUCTION I. STANDARDIZING GOOD MEDICAL PRACTICES A. Quality Priorities and Measurement B. Research on Outcomes and Outcome Measures C. Evidence-Based Practices II. TRACKING ADVERSE EVENTS IN HOSPITALS A. Sentinel Events and the Joint Commission B. "Never Events". C. Patient Safety Organizations III. DISCLOSING PROVIDER PERFORMANCE A. Disclosing Adverse Events to Patients: The Veterans Administration and Joint Commission Models B. PPACA and Disclosure 1. Physician Compare 2. Infection Compare IV. REFORMING PAYMENT SYSTEMS A. "Never Events". B. Hospital-Acquired Infections C. Premier Hospital Quality Initiative D. Reporting Hospital Quality Data for Annual Payment Update Program E. Physician Quality Reporting System (PQRS) F. General Quality Indicators G. Insurance Exchange Mandates V. COORDINATING AND INTEGRATING CARE A. Center for Medicare and Medicaid Innovation B. Health Care Innovation Zones C. Accountable Care Organizations D. Performance-Based Care Coordination E. Payment Bundling F. Patient-Centered Medical Homes (PCMHs) VI. EXPANDING PROVIDER RESPONSIBILITY A. Explicit Liability Provisions in PPACA 1. Decision Aids 2. Liability-Reform Demonstration Projects B. Streams of Liability Risk Under PPACA 1. Physician Liability 2. Institutional Liability CONCLUSION INTRODUCTION

Patient injury is a predictable feature of health care, particularly in hospitals, in the United States and elsewhere. Since publication of the Institute of Medicine (IOM) report To Err Is Human in 2000, (1) patient safety has come to the forefront of U.S. health care. The IOM's projection of 44,000 to 98,000 deaths per year due to hospital errors, and hundreds of thousands of avoidable injuries and extra days of hospitalization, (2) fueled the patient-safety movement in the United States. (3) Ten years after the IOM report, the level of adverse events in hospitals has not improved in any major way. A recent HealthGrades analysis of Medicare data estimates that more than 230,000 hospital deaths from 2007 to 2009 could have been prevented within the Medicare population alone. (4) A study of ten North Carolina hospitals concluded that the rate of patient harm from medical care had not decreased substantially over a six-year period ending in December 2007. (5)

Analysis of patient safety rests on four basic propositions. First, patient injury (ranging from minor injuries to death) is a recurring feature of health care and negatively affects roughly one in every ten patients, according to a systematic review of the literature. (6) Findings by the Inspector General within the Medicare context support this estimated patient-injury rate. (7) As these statistics attest, patient injury eludes easy solutions.

Second, physicians (and the hospitals in which they practice) all too often continue to practice bad medicine in spite of what is known about good medical practice. (8) While hospital care is indeed complicated, it is also poorly coordinated and poorly managed in many hospitals. (9) Hospital policing of adverse events remains inadequate, (10) even though tools, such as computer programs, can ferret out ineffective and dangerous care and its causes. (11) Some health care systems function very well in coordinating care and improving outcomes, with the Veterans Administration (VA) hospitals serving as the prime example, (12) and private systems like the Mayo Clinic exemplifying an integrated model with seamless coordination of patient care. (13) The challenge is learning from their successes and applying them to other hospitals across the United States.

Third, medical practice too often ignores effective practices. (14) More research is needed to understand both what works in modern medicine and what barriers exist to adopting new practices. Fourth, regulatory tools need to be expanded in order to force more integration and coordination in health care delivery. (15)

The field of patient safety has grown in the United States as a subspecialty within health law and policy over the past fifteen years. (16) Patient safety efforts have included both private market-based initiatives and state and federal regulatory initiatives to reduce the problems outlined above. The general strategies can be summed up in six major regulatory categories:

(1) Standardizing Good Medical Practices. This method tries to reduce medical practice variation by promoting best practices, practice guidelines, and research on what works and is cost-effective.

(2) Tracking Adverse Events in Hospitals. Collection of adverse event data is expanding at the state and federal levels, since both health care providers and regulators need data in order to select the most serious problem areas for repair.

(3) Disclosing Provider Performance. Disclosure of adverse events can occur at three levels: (a) induced disclosure of hospital adverse events and "near misses" to state regulators and quasi-regulators like the Joint Commission; (17) (b) disclosure by the provider of adverse events to patients; and (c) publication of performance data about relative risks by private/public agents, designed for purchaser use.

(4) Reforming Payment Systems. These strategies include creating a range of financial incentives for providers to promote safety, through "pay for performance" initiatives, including bonuses and docking reimbursement for failures to meet minimum standards as well as using insurance exchanges to promote quality and safety improvements.

(5) Coordinating and Integrating Care. This strategy is the largest and most innovative category of federal health care reform, which promotes several new models for integrating health care delivery in the fragmented U.S. system.

(6) Expanding Provider Responsibility. This strategy includes implementing legislative requirements for disclosure, expanded fiduciary duties, and corporate-system responsibility for bad outcomes. (18) There are also emerging examples of providers who market safety, such as Geisinger Health System's guarantee that certain safety procedures will be undertaken during cardiac surgery. (19)

Many of these initiatives represent real progress, but the culture of hospitals and the structure of payment have meant that these admirable reform efforts have moved at a glacial pace. As Troyen Brennan and Donald Berwick observed fifteen years ago, "Variation in practice runs rampant beyond the bounds of common sense. Hospitals and doctors continue to perpetrate harms in their work, albeit unintended ones. And it is no easier now to cause an alcoholic surgeon to stop operating than it was forty years ago." (20) Little has changed since they stated their critique.

On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act (PPACA). (21) This Act is a major attempt to improve access to health care by expanding coverage through Medicaid and by reforming the private insurance market. Quality is also an important focus of PPACA--it promotes disease management, care coordination, new payment models, value-based purchasing initiatives, and the use of comparative effectiveness research. PPACA offers a strong regulatory push toward the goal of "flawless execution," the health care equivalent of zero defects in industrial production. (22)

The passage of PPACA promises to take patient safety to the next level of regulatory intensity in American health care delivery, in part through the infusion of money into patient-safety research and into payment reforms in particular. PPACA has an astonishing variety of provisions aimed at improving the quality of the U.S. health care system, reducing errors, and generally promoting patient safety. (23) These provisions include new centers, demonstration projects, and funding awards for a wide range of quality improvement initiatives. (24) The Act sets out an ambitious research agenda for the United States and provides funding and other incentives to accomplish its goals. It establishes a mandate of continuous, data-driven testing of the performance of health care professionals and facilities. It also launches "demonstration projects" through which the federal government funds particular forms of health care or health care delivery systems with a requirement that their performance be studied, often with the intent of examining their potential for wider adoption. (25)

PPACA contains numerous provisions that fund research and disseminate findings to providers about what works. Some provisions define health care quality and its measures, while others attempt to generate new research findings on outcomes and best practices in the clinical setting. Still other provisions mandate broad dissemination of these findings to providers and consumers of health care through websites and other media. Finally, payment strategies will be expanded and tested to determine how the Medicare payment system can better promote best practices and outcomes.

1. STANDARDIZING GOOD MEDICAL PRACTICES

   The culture of medicine is constructed around the challenges presented by individual patients and the need for individual provider judgment--as well as the perceived need, at times, for clinical heroism. This culture values "expert audacity," the insight of a brilliant clinician in solving a diagnostic puzzle. (26) By contrast, improvement of health care generally requires system-wide improvements--reducing medical practice variation by figuring out what works, synthesizing these findings into clinical practice guidelines and best practices, and then applying them to ensure effective treatments. Studies of American medicine have found large practice variation around the country, (27) and it is clear that modern medicine still lacks validation for many treatment modalities. Yet diffusion of good practice is a slow process often resisted by physicians. (28)

   Tools are already available to improve clinical performance. One obvious example is a checklist. (29) Atul Gawande writes about the tension...