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Learn about healthcare regulation in the US, including laws, quality care, and the Affordable Care Act. Explore legal aspects, malpractice, and patient consent.
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Introduction to Healthcareand Public Health in the US Lecture c Regulating Healthcare This material (Comp1_Unit6c) was developed by Oregon Health and Science University, funded by the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology under Award Number IU24OC000015.
Regulating HealthcareLearning Objectives • Describe the role of accreditation, regulatory bodies, and professional associations in healthcare in the US. (Lecture a) • Describe the basic concepts of law in the United States: the legal system, sources of law, classification of laws, the court system, and the trial process. (Lecture b) • Describe legal aspects of medicine involving the Affordable Care Act, professional standards in healthcare, medical malpractice, Tort reform, and Medicare and Medicaid Fraud and Abuse (Lecture c) • Describe key components of the Health Insurance Portability and Accountability Act (HIPAA) and current issues of privacy and patient safety in the US (Lecture d) • Discuss the need for quality clinical documentation for the use of the health record as a legal document, communication tool and a key to prove compliance for healthcare organizations. (Lecture e) Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c
Affordable Care Act (ACA) • Major reworking of healthcare financing and delivery • Phased in from 2010 through 2018 • Court challenges pending Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c
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 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c
Titles of the ACA • Quality, Affordable Healthcare for All Americans • The Role of Public Programs • Improving the Quality and Efficiency of Healthcare • Prevention of Chronic Disease and Improving Public Health • Healthcare Workforce Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c
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 Healthcare Improvement Act Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c
ACA Timeline (HealthCare.gov, nd.) Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c
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 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c
Standards of Care 6.5 Figure: Diagram showing a few of the many sources that can contribute to a medical standard of care. (OHSU, 2010) Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c
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 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c
Informed Consent Process • Physician or other healthcare 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 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c
Tort Law and Malpractice 6. 6 Chart: Diagram showing how Tort law is the part of private or civil law that deals with malpractice (OSHU, 2010). Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c
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 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c
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 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c
“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 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c
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 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c
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 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c
NewerTort 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 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c
InnovativeTort 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 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c
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 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c
Federal Fraud and Abuse Laws • False Claims Act • Anti-Kickback Statute • Stark Law • Exclusion Statute • Civil Monetary Penalties Law Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c
Regulating HealthcareSummary – Lecture c • The laws that apply to healthcare are numerous and complicated • The system is changing rapidly as a result of the Affordable Care Act and tort reform proposals • Still, healthcare providers must: • Obtain informed consent from their patients • Act consistently with reasonable standards of care • Avoid Medicare/Medicaid fraud, waste, and abuse Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c
Regulating HealthcareReferences – Lecture c References Agency for Healthcare Research and Quality. Patient safety primers: never events. http://www.psnet.ahrq.gov/primer.aspx?primerID=3. Accessed April 10, 2011. American Cancer Society. Informed consent. Updated August 10, 2010. http://www.cancer.org/acs/groups/cid/documents/webcontent/003014-pdf.pdf. Accessed April 11, 2011. American College of Emergency Physicians Foundation. Emergency manual: legal issues—Good Samaritan laws. http://www.emergencycareforyou.org/EmergencyManual/Default.aspx?id=200. Accessed April 11, 2011. American Medical Association. Physician resources: patient physician relationship topics—informed consent. http://www.ama-assn.org/ama/pub/physician-resources/legal-topics/patient-physician-relationship-topics/informed-consent.page. Accessed April 11, 2011. Federation of State Medical Boards. A guide to the essentials of a modern medical practice act. 10th ed. 2003. http://www.fsmb.org/pdf/2003_grpol_Modern_Medical_Practice_Act.pdf. Accessed April 10, 2011. Federation of State Medical Boards. State of the states: physician regulation 2009. http://www.fsmb.org/pdf/2009_state_of_states.pdf. Accessed April 11, 2011. Kinney ED. The origins and promise of medical standards of care. Virtual Mentor: American Medical Association Journal of Ethics. 2004;6(12). http://virtualmentor.ama-assn.org/2004/12/mhst1-0412.html. Accessed April 11, 2011. Mello MM, Kachalia A. Evaluation of options for medical malpractice system reform: a report to the Medicare Payment Advisory Commission (MedPAC). January 29, 2010. http://www.medpac.gov/documents/Apr10_MedicalMalpractice_CONTRACTOR.pdf. Accessed April 11, 2011. Nolo. Medical malpractice basics. http://www.nolo.com/legal-encyclopedia/medical-malpractice-basics-29855.html. Accessed April 11, 2011. Office of Inspector General. A roadmap for new physicians: avoiding Medicare and Medicaid fraud and abuse. http://oig.hhs.gov/fraud/PhysicianEducation. Accessed April 11, 2011. Ohio State Bar Association. Law you can use: Ohio’s “Good Samaritan” law protects volunteers. October 22, 2006. http://www.ohiobar.org/Pages/LawYouCanUseDetail.aspx?itemID=477. Accessed April 11, 2011. US Department of Health and Human Services. New tools to fight fraud, strengthen Medicare and protect taxpayer dollars. January 24, 2011. http://www.healthcare.gov/news/factsheets/new_tools_to_fight_fraud.html. Accessed April 11, 2011. US Department of Health and Human Services. Understanding the Affordable Care Act. http://www.healthcare.gov/law/introduction/index.html. Accessed April 10, 2011. Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c
Regulating HealthcareReferences – Lecture c Charts, Tables, Figures 6.5 Figure: Diagram showing a few of the many sources that can contribute to a medical standard of care. OHSU (2010). 6. 6 Chart: Diagram showing how Tort law is the part of private or civil law that deals with malpractice. OHSU (2010). Images Slide 7: Screenshot of the Affordable Care Act (ACA) Timeline. HealthCare.gov (nd.). http://www.healthcare.gov/law/timeline/index.html. Retrieved Nov. 2011 from the HealthCare.gov website, http://www.healthcare.gov. Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c