Introduction to Health Care and Public Health in the U.S.

1. Introduction to Health Careand Public Health in the U.S. Regulating Health Care Lecture d This material (Comp 1 Unit 6) 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 90WT0001. This work is licensed under the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/4.0/.

2. Regulating Health CareLearning Objectives - 1 • Describe the role of accreditation, regulatory bodies, and professional associations in health care in the U.S. (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)

3. Regulating Health CareLearning Objectives - 2 • Describe legal aspects of medicine involving the Affordable Care Act, professional standards in health care, medical malpractice, Tort reform, and Medicare and Medicaid Fraud and Abuse (Lecture c)

4. Regulating Health CareLearning Objectives - 3 • Describe key components of the Health Insurance Portability and Accountability Act (HIPAA) and describe efforts to promote patient safety in the U.S. (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 health care organizations. (Lecture e)

5. Health Insurance Portability and Accountability Act (HIPAA) • Improves “portability” of health insurance • Employer plans may not limit coverage due to pre-existing conditions • If health insurance is lost, improves access to a group health plan • Protects from discrimination based on health status • Establishes requirements for the exchange of personally identifiable health information

6. HIPAA Privacy & Security • Privacy requirements • What health information must be protected https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html • Security requirements • How to protect health information https://www.hhs.gov/hipaa/for-professionals/security/laws-regulations/index.html

7. HIPAA Covered Entities - 1 6.1 Figure: Flowchart for determining whether an entity is a HIPAA covered health provider or not. (CMS.gov, nd.)

8. HIPAA Covered Entities - 2 • Health care providers • Health plans • Insurance companies • Health maintenance organizations (HMOs) • Company insurance plans • Government agencies that pay for health care

9. HIPAA Covered Entities - 3 • Health care clearinghouses • Billing services • Repricing companies • Community health management information systems • Value-added networks and switches that perform clearinghouse functions

10. Business Associates • Entities that are engaged to assist covered entities in delivering health care services • Business Associate Agreement (BAA) • Must also comply with HIPAA rules

11. HIPAA Privacy Rule • Applies to protected health information (PHI) • Applies to all forms or medium • Individually identifiable health information • Name/address • Phone number • E-mail address • SSN • Photograph

12. Individually Identifiable Information • Information can be used to identify the individual • Physical or mental health condition • Provision of health care • Payment

13. Privacy Rule Requirements • Notify patients of rights • Allow patients to see their medical records • Implement and train employees on privacy procedures • Designate individual to be responsible for seeing that procedures are adopted and followed • Keep patient records secure

14. HIPAA Security Rule • Requires covered entities to use security measures to protect health information • Does not specify which technology must be used • Establishes minimum federal standards • State laws may require more rigorous safeguards

15. HIPAA Security Rule:General Guidelines • Covered entities must: • Ensure confidentiality, integrity, and availability • Anticipate threats and protect against them • Protect against impermissible uses or disclosures • Ensure workforce compliance

16. HIPAA Enforcementand Penalties - 1 • The Office of Civil Rights within the U.S. Department of Health and Human Services enforces HIPAA compliance • The HITECH Act extends privacy and security rules, provides for enhanced enforcement https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/combined-regulation-text/omnibus-hipaa-rulemaking/index.html

17. HIPAA Enforcementand Penalties - 2 • HIPAA Omnibus Rule, 2013 • Stringent requirements regarding notification of health information breach to the Department of Health and Human Services • Increased fines and penalties • Enhanced patient control of health information

18. Patient Safety - 1 • Regulation is an important mechanism used to improve patient safety • Landmark 1999 report (To Err is Human) • 44,000 to 98,000 people die in hospitals each year as a result of preventable medical mistakes • Mistakes cost hospitals $17 billion to $29 billion yearly

19. Patient Safety - 2 • The 1999 To Err is Human Report: • Individual errors are not the main problem • Faulty systems, processes, and other conditions lead to preventable errors

20. Medical Mistakes Today • Errors can result in medical malpractice lawsuits • 61% of doctors are sued at some point • Medical malpractice payouts totaled over $3 billion dollars in 2014 • Suffering from medical errors: not measurable

21. The Joint CommissionSafety Initiatives - 1 • Sentinel Event Policy • Unexpected death, unexpected serious physical or psychological injury, or the risk of such an event • Patient Safety Advisory Group • Panel of experts who recommend National Patient Safety Goals • Also address newly developing safety issues

22. The Joint CommissionSafety Initiatives - 2 • Universal Protocol for Preventing Wrong Site, Wrong Procedure and Wrong Person Surgery • Pre-surgery verification • Site marking • “Time out” before an incision is made • The Speak Up Initiative • Encourages patients to participate in their care • Free patient education materials

23. Agency for Health CareResearch and Quality (AHRQ) • Part of U.S. Department of Health and Human Services. • www.AHRQ.gov • Improve safety and quality of care • Investing in research • Creating tools to put the results into practice • Generating measures and data used by providers and policymakers

24. National Health Care Quality Report • Effectiveness • Timeliness • Efficiency • Patient safety • Access to care • Patient centeredness

25. AHRQ: Health IT • Develops and disseminates information • Toolkits and educational materials are available to capture best practices in the use of technology • Research funding opportunities are also available

26. Regulating Health CareSummary – 1 – Lecture d • Patient privacy and safety are high priorities for all people employed in the health care industry • HIPAA has rules for the privacy and security of patient health information • The Joint Commission supports initiatives for reducing medical errors

27. Regulating Health CareSummary – 2 – Lecture d • Patient safety is an important focus for health care improvement • The Agency for Health Care Research and Quality is an important source of information regarding care improvement through the effective use of health IT

28. Regulating Health CareReferences – 1 – Lecture d References Agency for Health Care Research and Quality. 2014 National Health Care Quality Report. http://www.ahrq.gov/research/findings/nhqrdr/nhqdr14/index.html. Accessed January 27, 2017. Agency for Health Care Research and Quality. Health information technology portfolio. https://healthit.ahrq.gov/. Accessed January 27, 2017. Centers for Medicare and Medicaid Services. Are you a covered entity? https://www.cms.gov/Regulations-and-Guidance/Administrative-Simplification/HIPAA-ACA/AreYouaCoveredEntity.html. Accessed January 27, 2017. HIPAA Business Associates. http://www.hhs.gov/hipaa/for-professionals/covered-entities/index.html. Accessed January 27, 2017. Institute of Medicine. To Err is Human: Building a Safer Health System. November 1, 1999. http://www.nationalacademies.org/hmd/Reports/1999/To-Err-is-Human-Building-A-Safer-Health-System.aspx. Accessed January 27, 2017. Medical Liability. http://www.amednews.com/article/20100816/profession/308169946/2/. Accessed January 27, 2017.

29. Regulating Health CareReferences – 2 – Lecture d References Medical Malpractice Payout Analysis. Diederich Healthcare. http://www.diederichhealthcare.com/the-standard/2015-medical-malpractice-payout-analysis/. Accessed January 27, 2017. Office of Civil Rights. http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/data/enforcement-highlights/index.html Accessed January 27, 2017. The Joint Commission. http://www.jointcommission.org. Accessed January 27, 2017. US Department of Health and Human Resources. Health information privacy. http://www.hhs.gov/hipaa/index.html. Accessed January 27, 2017. Charts, Tables, Figures 6.1 Figure: Adapted from https://www.cms.gov/Regulations-and-Guidance/Administrative-Simplification/HIPAA-ACA/Downloads/CoveredEntitiesChart20160617.pdf. CMS (nd.) Acquired from http://www.cms.gov. Last accessed January 27, 2017.

30. Introduction to Health Careand Public Health in the U.S.Regulating Health CareLecture d 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 90WT0001.