1. Introduction to Healthcare and 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.

2. Regulating Healthcare Learning 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) 2 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c

3. Affordable Care Act (ACA) Major reworking of healthcare financing and delivery Phased in from 2010 through 2018 Court challenges pending 3 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c

4. 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 4 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c

5. Titles of the ACA I.Quality, Affordable Healthcare for All Americans II.The Role of Public Programs III.Improving the Quality and Efficiency of Healthcare IV.Prevention of Chronic Disease and Improving Public Health V.Healthcare Workforce 5 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c

6. Titles of the ACA (cont’d) VI.Transparency and Program Integrity VII.Improving Access to Innovative Medical Therapies VIII.Community Living Assistance Services and Supports Act (CLASS Act) IX.Revenue Provisions X.Reauthorization of the Indian Healthcare Improvement Act 6 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c

7. ACA Timeline (HealthCare.gov, nd.) 7 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c

8. 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 8 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c

9. 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) 9 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c

10. 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 10 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c

11. 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 11 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c

12. 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). 12 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c

13. 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 13 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c

14. 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 14 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c

15. “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 15 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c

16. 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 16 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c

17. 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 17 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c

18. 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 18 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c

19. 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 19 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c

20. 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 20 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c

21. Federal Fraud and Abuse Laws False Claims Act Anti-Kickback Statute Stark Law Exclusion Statute Civil Monetary Penalties Law 21 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c

22. 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 22 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c Regulating Healthcare Summary – Lecture c

23. 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.http://www.psnet.ahrq.gov/primer.aspx?primerID=3 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. http://www.cancer.org/acs/groups/cid/documents/webcontent/003014-pdf.pdf 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. http://www.emergencycareforyou.org/EmergencyManual/Default.aspx?id=200 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.http://www.ama- assn.org/ama/pub/physician-resources/legal-topics/patient-physician-relationship-topics/informed-consent.page Federation of State Medical Boards. A guide to the essentials of a modern medical practice act. 10 th ed. 2003. http://www.fsmb.org/pdf/2003_grpol_Modern_Medical_Practice_Act.pdf. Accessed April 10, 2011. http://www.fsmb.org/pdf/2003_grpol_Modern_Medical_Practice_Act.pdf 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.http://www.fsmb.org/pdf/2009_state_of_states.pdf 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.http://virtualmentor.ama-assn.org/2004/12/mhst1-0412.html 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.http://www.medpac.gov/documents/Apr10_MedicalMalpractice_CONTRACTOR.pdf Nolo. Medical malpractice basics. http://www.nolo.com/legal-encyclopedia/medical-malpractice-basics-29855.html. Accessed April 11, 2011.http://www.nolo.com/legal-encyclopedia/medical-malpractice-basics-29855.html 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. http://oig.hhs.gov/fraud/PhysicianEducation 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. http://www.ohiobar.org/Pages/LawYouCanUseDetail.aspx?itemID=477 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.http://www.healthcare.gov/news/factsheets/new_tools_to_fight_fraud.html US Department of Health and Human Services. Understanding the Affordable Care Act. http://www.healthcare.gov/law/introduction/index.html. Accessed April 10, 2011. http://www.healthcare.gov/law/introduction/index.html Regulating Healthcare References – Lecture c 23 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c

24. 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). Regulating Healthcare References – Lecture c 24 Health IT Workforce Curriculum Version 3.0/Spring 2012 Introduction to Healthcare and Public Health in the US Regulating Healthcare Lecture c 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. http://www.healthcare.gov/law/timeline/index.htmlhttp://www.healthcare.gov