Component 1: Introduction to Health Care and Public Health in the U.S. Unit 6: Regulating Health Care Lecture 3 This material was developed by Oregon Health & Science University, funded by the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology under Award Number IU24OC000015.

Objectives of This Lecture List major provisions of the Affordable Care Act (health care reform law) Discuss sources of professional standards in health care Review medical malpractice law Explain proposals for tort reform Describe laws designed to combat Medicare and Medicaid fraud, waste, and abuse Component 1/Unit 6-3 Health IT Workforce Curriculum Version 2.0/Spring 2011

Affordable Care Act (ACA) Major reworking of health care financing and delivery Phased in from 2010 through 2018 Court challenges pending Component 1/Unit 6-3 Health IT Workforce Curriculum Version 2.0/Spring 2011

Health IT Workforce Curriculum Version 2.0/Spring 2011 ACA Elements Better access to insurance Health care quality improvement Improved public health Health care workforce training Increased Medicaid and Medicare payments Overall system change http://www.healthcare.gov/law/introduction Component 1/Unit 6-3 Health IT Workforce Curriculum Version 2.0/Spring 2011

Health IT Workforce Curriculum Version 2.0/Spring 2011 Titles of the ACA Quality, Affordable Health Care for All Americans The Role of Public Programs Improving the Quality and Efficiency of Health Care Prevention of Chronic Disease and Improving Public Health Health Care Workforce Component 1/Unit 6-3 Health IT Workforce Curriculum Version 2.0/Spring 2011

Titles of the ACA (cont’d) Transparency and Program Integrity Improving Access to Innovative Medical Therapies Community Living Assistance Services and Supports Act (CLASS Act) Revenue Provisions Reauthorization of the Indian Health Care Improvement Act Component 1/Unit 6-3 Health IT Workforce Curriculum Version 2.0/Spring 2011

Health IT Workforce Curriculum Version 2.0/Spring 2011 ACA Timeline http://www.healthcare.gov/law/timeline/index.html Component 1/Unit 6-3 Health IT Workforce Curriculum Version 2.0/Spring 2011

State Medical Practice Acts Define the practice of medicine Regulate how medicine will be practiced within the state Establish medical board Set standards for licensing physicians Create process for disciplining physicians Investigate complaints about physicians Component 1/Unit 6-3 Health IT Workforce Curriculum Version 2.0/Spring 2011

Health IT Workforce Curriculum Version 2.0/Spring 2011 Standards of Care What would a reasonably prudent person do in similar circumstances? Component 1/Unit 6-3 Health IT Workforce Curriculum Version 2.0/Spring 2011

Health IT Workforce Curriculum Version 2.0/Spring 2011 Informed Consent Requirement that patient be fully informed and give consent to treatment Process of communication between doctor and patient Required legally and ethically Absence can result in liability Battery Negligence Historically, liability for lack of informed consent was based on a legal theory of battery, that is an unlawful touching of another person. However, now, most cases concern the issue of whether the patient was adequately informed rather than the issue of whether the touching was unauthorized. Therefore, most informed consent cases are brought under a theory of negligence. Component 1/Unit 6-3 Health IT Workforce Curriculum Version 2.0/Spring 2011

Informed Consent Process Physician or other health care professional explains: The risks and benefits of the proposed treatment Other options, including no treatment Patient has opportunity to ask questions and get satisfactory, understandable answers If desired, patient takes time to discuss the situation with others Patient has opportunity to communicate the decision to physician or treatment team Component 1/Unit 6-3 Health IT Workforce Curriculum Version 2.0/Spring 2011

Tort Law and Malpractice Component 1/Unit 6-3 Health IT Workforce Curriculum Version 2.0/Spring 2011

Elements of Malpractice The defendant had a duty of reasonable care to the injured party The defendant did not meet the minimum standard of care or failed to obtain informed consent Failure to meet the standard of care was the proximate cause of the injury The injury resulted in damages Component 1/Unit 6-3 Health IT Workforce Curriculum Version 2.0/Spring 2011

Statute of Limitations Time limit for filing a lawsuit Short as 6 months Long as 4 years Discovery rule Time limit starts when the malpractice is discovered, rather than when it was allegedly committed Component 1/Unit 6-3 Health IT Workforce Curriculum Version 2.0/Spring 2011

Health IT Workforce Curriculum Version 2.0/Spring 2011 “Good Samaritan” Laws Apply in emergencies Protect people who do not have an obligation to help Rescuer must use common sense Rescuer must not act beyond expertise and capabilities Component 1/Unit 6-3 Health IT Workforce Curriculum Version 2.0/Spring 2011

Health IT Workforce Curriculum Version 2.0/Spring 2011 Tort Law Reform Pre-trial screening panels Panel reviews case at an early stage and gives an opinion about merit Certificate of merit Patient must present certificate from qualified medical expert in order to file a lawsuit Attorney fee limits Limits on percentage and/or total amount Component 1/Unit 6-3 Health IT Workforce Curriculum Version 2.0/Spring 2011

Tort Law Reform (cont’d) Periodic payment Allows insurers to pay damage awards in smaller payments over time Joint-and-several liability reform When there is more than one defendant, limits the amount that can be recovered from each Caps on non-economic damages Limit payments for pain and suffering Component 1/Unit 6-3 Health IT Workforce Curriculum Version 2.0/Spring 2011

Health IT Workforce Curriculum Version 2.0/Spring 2011 Newer Tort Law Reforms Pre-determined non-economic damages Administrative compensation systems (“health courts”) Neutral expert witnesses Knowledgeable hearing officers Disclosure-and-offer programs Mistakes are admitted Compensation is offered Component 1/Unit 6-3 Health IT Workforce Curriculum Version 2.0/Spring 2011

Innovative Tort Reform (cont’d) “Safe harbor” for adherence to practice guidelines based on the latest medical research More evidence needed to assess newer reform proposals Affordable Care Act authorizes $50 million in grants for projects that evaluate the effectiveness of newer tort reform proposals Component 1/Unit 6-3 Health IT Workforce Curriculum Version 2.0/Spring 2011

Health IT Workforce Curriculum Version 2.0/Spring 2011 Fraud, Waste, Abuse Office of Inspector General (OIG) protects integrity of Medicare, Medicaid, other government programs Fraud: intentional misrepresentation or concealment of relevant facts Waste: unnecessary costs as a result of poor management, practices, or controls Abuse: excessively or improperly using government resources Component 1/Unit 6-3 Health IT Workforce Curriculum Version 2.0/Spring 2011

Federal Fraud and Abuse Laws False Claims Act Anti-Kickback Statute Stark Law Exclusion Statute Civil Monetary Penalties Law Component 1/Unit 6-3 Health IT Workforce Curriculum Version 2.0/Spring 2011

Health IT Workforce Curriculum Version 2.0/Spring 2011 Summary The laws that apply to health care are numerous and complicated The system is changing rapidly as a result of the Affordable Care Act and tort reform proposals Still, health care providers must: Obtain informed consent from their patients Act consistently with reasonable standards of care Avoid Medicare/Medicaid fraud, waste, and abuse Component 1/Unit 6-3 Health IT Workforce Curriculum Version 2.0/Spring 2011