Health Care Law and Regulations week 9
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Chp23.CF.HA610.pptxChapter 23
Improving Patient Safety and Quality of Health Care
Improving Patient Safety and Quality of Health Care
“These are complicated issues… It is important we resolve them right because there is only one goal here: patient care and doctor power. That’s what has made America’s health care system great. And that’s where we have to end up. And if it takes a day or two longer, if it takes a week or two longer, if it takes a month longer, that is not the issue.”
—Rep. Nancy Johnson
Lecture Overview
Principles and Applications
Malpractice Framework
National Database for Patient Safety Research
Risk-Risk Calculus
Institute of Medicine and Food and Drug Administration Reforms
Prevention of Medical Errors and Adverse Events
Source: Hammaker, D. K., & Knadig, T. M. with Tomlinson, S.J. (2017). Antitrust regulation of health care providers. In Health care management and the law: Principles and applications (pp. 487-497). (2nd Ed.) Burlington, MA: Jones & Bartlett Learning.
Principles and Applications
An important development in health law over the last decade has been the growing emphasis on patient safety, quality of health care, and the availability of information about provider safety and quality for consumers.
Most Americans will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences.
Evidence suggests that Americans receive lower quality care than the residents of other developed nations
Malpractice Framework (1 of 2)
Hospital’s quality management committee learns that a medical error or adverse event has occurred, they question:
What are the implications for payment?
What is the appropriate course of action?
Who needs to know?
Trend Toward Enterprise Liability
The malpractice framework, which is primarily designed to apportion blame to individual health care providers, has failed to adequately address patient safety problems.
Some have suggested moving toward an enterprise liability model, in which financial liability is imposed on hospitals as opposed to individuals, although a breach of duty would remain a predicate for liability.
Poorly Designed Systems
There is widespread agreement that the root cause of most medical errors is poorly designed systems.
The tremendous complexity of health care delivery systems makes hospitals highly susceptible to both technological and human error.
Market Competition
The federal government sought to determine how to reconfigure the multiple levels of the health care system so as to improve patient care.
In response, Congress appropriated $50 million annually for patient safety research to be conducted by the federal Agency for Healthcare Research and Quality.
Malpractice Framework
National Database for Patient Safety Research (1 of 5)
The Agency for Healthcare Research and Quality grants funding for research on:
Health info tech
Patient safety
Pharmaceutical outcomes
Prevention and care management.
Health Information Technology
The Joint Commission could implement a system for reporting medical errors. The Joint Commission currently requires reporting of sentinel events, which are not the same as preventable medical errors.
Hospitals that do not comply with accreditation requirements risk losing Medicare insurance funding
National Database for Patient Safety Research (2 of 5)
Health Information Technology (Continued)
Today, more than half the states have some form of mandatory disclosure law for medical errors.
In Pennsylvania, the State Health Care Cost Containment Council Imposes penalties for failures to report medical errors, publishes each hospital’s rate of infection, requires hospitals to disclose specific hospital-acquired infections, and requires reporting of serious events to both the state and to patients directly affected by the medical error.
National Database for Patient Safety Research (3 of 5)
Patient Safety Organizations
Patient safety organizations have arisen to contract with health care providers to review and analyze patient safety reports and make recommendations for improving the quality of health care, which includes:
Collecting and analyzing patient safety work product
Developing and disseminating information to improve patient safety
Maintaining procedures to preserve the confidentiality and security of patient safety work product
Providing feedback and assistance to minimize patient risks and medical errors
Utilizing patient safety work product to encourage a culture of safety by health care providers
National Database for Patient Safety Research (4 of 5)
Payment Incentives
Medicare, as well as several private health insurers, such as Aetna and WellPoint, have moved to end payments to hospitals for treatment that results from serious medical errors.
Providers of other private health insurance are now banning payments for only the gravest of mistakes, such as:
Administration of incompatible blood
Infants discharged to the wrong person
Medication errors that result in death or disability
Surgeries on the wrong limbs
It is most likely only a matter of time before the health insurance industry also stops paying for some of the more common and less clear problems that Medicare insurance is tackling.
National Database for Patient Safety Research (5 of 5)
Pharmaceutical Outcomes
Every 5 to 10 years, major legislation addresses pressing issues concerning the federal Food and Drug Administration.
Sometimes, reform is motivated by the perception that the FDA is not getting new drugs to market as efficiently as possible. Other times, the leading concern is that the FDA is not protecting the public from the risks of drugs as effectively as it might.
Patients make a risk-risk assessment: they decide whether the potential risk of a therapeutic option outweighs the risk of a given disorder.
Risk-Risk Calculus (1 of 3)
This risk-risk proposition was evident when Elan Pharmaceutical withdrew Tysabri, a multiple sclerosis therapy, from the market because of a rare and serious potential side effect. Multiple sclerosis patients with limited therapeutic options organized, made their voices heard, and demanded a return of Tysabri to the market.
Although not every negative care outcome is a result of negligence, or even an entirely preventable error, providers of health insurance maintain that the no-pay policies will help improve patient safety and reduce health care costs.
While patients want to be warned of known risks, they also understand their disease and want, even demand, the right to choose their own therapies.
Risk-Risk Calculus (2 of 3)
Evidence-Based Guidelines
The lack of standardized, universally accepted treatment guidelines, firmly supported by scientific evidence, is a significant obstacle to the prevention of medical errors.
Moreover, nearly all of these adverse events could be prevented with simple clinical processes in place.
Example: Evidence suggests that using chlorhexidine to clean the skin prior to placing a central venous catheter can cut the risk of catheter related bloodstream infections in half with minimal, if any, increase in costs.
Risk-Risk Calculus (3 of 3)
Evidence-Based Guidelines (Continued)
The tools available for learning about drugs and their effectiveness include:
Drug coverage, including tiered benefits by the health care industry based on proven effectiveness.
Drug utilization management programs that influence prescribing
Electronic data on prescription use and patient outcomes
Internet resources for consumers of health care to understand their use of prescription drugs
Institute of Medicine and Food and Drug Administration Reforms (1 of 5)
The reforms recommended by the Institute of Medicine and proposed by the FDA fall into four main categories:
Balancing drug safety against access to innovative treatments
More effective use of prescribed drugs
Need to balance industry user fees and federal appropriations
Post-marketing drug surveillance
Need to Balance Industry User Fees and Federal Appropriations
Total user fees exceed $2.2 billion per year, accounting for more than half of the FDA resources for drug regulation.
While FDA critics claim this has affected drug safety, the rate at which drugs have been withdrawn from the market has not increased since user fees were implemented.
The increase in FDA resources has resulted in important public health benefits, including a reduction in drug review time, which is estimated to save 180,000 to 210,000 lives year.
Institute of Medicine and Food and Drug Administration Reforms (2 of 5)
Balancing Drug Safety with Access to Innovative Treatments
The FDA has authority to help assure drug safety, including the ability to:
Impose special requirements for prescribers, such as documentation of laboratory testing that would be monitored by the FDA
Limit direct-to-consumer marketing
Mandate post-marketing drug surveillance
Require special medication guides for patients
Restrict which physicians can prescribe a drug, for instance, restricting certain therapeutic classes to oncologist or cardiologist prescribers.
Critics believe such steps strengthen the FDA’s enforcement authority.
Institute of Medicine and Food and Drug Administration Reforms (3 of 5)
Post-Marketing Drug Surveillance
A fundamentally better system for post-marketing drug surveillance could help avoid increased costs and reduced access due to drug-by-drug regulation, with the development of better risk information based on actual experience with every new drug.
While the United States obtains innovative drugs two to three years ahead of its European counterparts, Europe has a compulsory drug surveillance system.
The FDA relies on its Adverse Event Reporting System, which involves the investigation of voluntary adverse event reports from health care providers, pharmaceutical firms, and consumers of health care.
Institute of Medicine and Food and Drug Administration Reforms (4 of 5)
More Effective Use of Prescribed Drugs
While it has been proposed that a regulatory entity be formed that is separate from the FDA pre-marketing review process, this possibility has generally been rejected.
Achieving a balanced approach to the assessment of risks and benefits would be greatly complicated, or even compromised, if two separate agencies were working in isolation from one another.
More effective use of drugs could be promoted by augmenting FDA resources with the rapidly growing array of electronic resources related to drug use.
Institute of Medicine and Food and Drug Administration Reforms (5 of 5)
Prevention of Medical Errors and Adverse Events
While some still claim adverse events are an inherent risk in receiving health care, the consensus is that medical errors should not be tolerated.
States are increasingly requiring health care professionals to report adverse events, with harsh penalties for non-reporting.
Transparency and public disclosure of medical errors are gradually becoming mandatory.
The financial disincentives for medical errors also are becoming more significant, as Medicare insurance and the health insurance industry refuse to compensate care associated with adverse events.
Management and Law Issues
Should the federal government support the states and begin mandating the use of generally accepted clinical procedures approved by the Agency for Healthcare Research and Quality in all acute-care hospitals, not just those receiving Medicare insurance funding, in an effort to decrease health care costs?
