1. Introduction to Health Care and Public Health in the U.S.
Regulating Health Care
Welcome to Introduction to Health Care and Public Health in the U.S.: Regulating Health Care. This is lecture e.
The component, Introduction to Health Care and Public Health in the U.S., is a survey of how health care and public health are organized and how services are delivered in the U.S. It covers public policy, relevant organizations and their interrelationships, professional roles, legal and regulatory issues, and payment systems. It also addresses health reform initiatives in the U.S.
Lecture e
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.
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Health IT Workforce Curriculum Version 4.0

2. Regulating Health Care Learning 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)
The Objectives for Regulating Health Care are to:
Describe the role of accreditation, regulatory bodies, and professional associations in health care in the U.S.
Describe the basic concepts of law in the U.S.: the legal system, sources of law, classification of laws, the court system, and the trial process.

3. Regulating Health Care Learning 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)
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.

4. Regulating Health Care Learning 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)
Describe key components of the Health Insurance Portability and Accountability Act, or HIPAA, and current issues concerning privacy and patient safety in the U.S.
And, discuss the need for quality clinical documentation for use of the health record as a legal document, communication tool, and a key to prove compliance for health care organizations.

5. The Health Record
Summarizes a patient’s health conditions and care activities
Historically existed on paper but have become increasingly digitized
Serves as a
Communication and quality enhancement tool
Legal record of the care provided
This lecture discusses the health record as a communication tool and legal document to demonstrate compliance with laws, rules, regulations, accreditation, and internal policies.
Health records are documents that summarize a patient’s health conditions and care activities. Historically, health records were recorded on paper, but over the past few decades, health records have become increasingly digitized. The terms “electronic medical record” and “electronic health record” are largely synonymous, however, the use of the term “electronic health record” is frequently used to denote that the health record is multi-disciplinary in nature.
The health record is, first and foremost, a tool for communication among members of the health care team. It is important that documentation in the health record be complete and accurate. When all components of the health record are used, such as clinical documentation, lab reports, x-rays, surgical reports, and consult reports, the patient has the best chance of receiving high-quality health care.
Health IT Workforce Curriculum Version 4.0

6. The Health Record as Tool for Patient Safety
Providing care based on a full understanding of a patient’s current and past conditions is a key element of safe care
Information in the health record is monitored for accuracy and completeness
The health record is used to manage risk and improve care
Safe patient care necessitates that all care providers have a complete and accurate picture of the patient’s current and past medical conditions. From admission to discharge, whether in an acute care facility, outpatient setting, long-term care, or any other health care system, the information that is documented in the health record is carefully monitored for accuracy and completeness.
After the patient leaves a health care system, the health information management department, or HIMD, continues to assess the completeness of the electronic record. In an electronic health record that includes scanned paper documents, the quality of the scanning process and filing of the documents in the correct area of the record will affect future use of the scanned information.
When an error or incident occurs, an incident report is generated and the risk management department reviews and addresses the incident.
Health care organizations provide ongoing education to care providers regarding best practices in clinical documentation. Education is also provided regarding areas of identified clinical documentation deficiencies or inaccuracies so that they can be avoided. With improved documentation quality, patient safety and health care quality also improve.

7. The Health Record as a Legal Record
Considered the business record for a health care organization
Also a legal record
Admissible in a court of law
Substantiates quality of care provided
In any health care organization, the health record is considered the business record for the organization. As the business record of the organization, the health record holds key information for decision making, both administrative and clinical. The health record will be used for many purposes, such as analyzing the quality of care given a patient, processing claims for reimbursement, conducting research, and planning of resource needs.
As such, it is also the legal record. Information documented in the health record can be used in a court of law as evidence to substantiate the quality of the treatment given to the patient. Therefore, health care organizations must consider the importance of clinical documentation as it relates to the legal health record.

8. Governance of Health Record
Federal and State Laws, Regulations, and Rules
The Joint Commission and other voluntary accreditation
Medical staff bylaws
The components of the health record are governed by many different external agencies. These may include federal and state laws, regulations, and administrative rules. Voluntary accreditation, such as by The Joint Commission, introduces requirements for documentation in the health record. At the health care facility level, medical staff bylaws also provide direction for completion and maintenance of documentation in the health record.
It is difficult to keep abreast of all the changes occurring in health record policies. Facilities must develop compliance plans to make sure that external and internal rules are followed. The director of a health information management department must stay up to date on legislative and accreditation changes that affect requirements for documentation in the health record. Key areas of focus include medical coding, reimbursement laws and regulations, and privacy of patients’ health information.
Clinical departments within a health care organization must monitor new laws and regulations for their respective areas. In addition, each facility should also have an oversight committee, department, and/or director to ensure overall compliance with documentation requirements.

9. Quality Clinical Documentation for Legal Purposes
Hand-written documentation
Illegibility introduces malpractice risk
Electronic documentation
Mistakes can be made, but the legibility of health record content is improved
More detailed notes
“What isn’t documented isn’t done”
Hand-written documentation may be illegible, and mistakes can be made when interpreting the provider’s intentions about treatment. When mistakes occur because of illegible handwriting, the health care facility is at risk for malpractice claims in a court of law. Although mistakes can still be made in an electronic documentation system, illegibility of handwriting will not occur.
Clinical documentation will not protect a health care organization from litigation unless the content is thorough enough to communicate with the members of the health care team about the treatment. Therefore, the health record must provide clear and honest reflections of the care needed or given to patients.
There is an old adage, “What isn’t documented isn’t done.” If the health record does not indicate what is actually done for the patient, the health record as a legal document does not hold up in court.

10. Quality Clinical Documentation to Avoid Fraud and Abuse Accusations
Clinical documentation improvement programs support high-quality documentation
Train providers
High-quality documentation supports accurate coding and reimbursement
Accurate coding is needed to avert accusations of fraud and abuse
No legitimate individual provider or health care organization wants to be accused of fraud or abuse. Examples of fraud or abuse include billing for a higher level of service than was provided, or billing for a service that was not provided. Ethical standards must be upheld for reporting claims for reimbursement at all levels of health care. This is best done by developing clinical documentation improvement programs, in which providers are trained to provide high-quality documentation in the health record.
Reimbursement of claims is based on documentation in the health record. A “coding specialist” reviews the health record and provides code numbers that are then linked to a payment system for the payer responsible for the claim.

11. OIG Compliance Program Tips - 1
The Seven Fundamental Elements of an Effective Compliance Program
Implementing written policies, procedures and standards of conduct
Designating a compliance officer and compliance committee
Conducting effective training and education.
Developing effective lines of communication
Compliance programs have been a focus of health care organizations since the late 1990s, when the U.S. Office of the Inspector General, or OIG, began a campaign against fraud and abuse in health care for the Medicare and Medicaid programs. The fight against fraud and abuse has escalated in the past few years. Those who report fraudulent practices, called “whistleblowers,” are protected.
The issues of fraud and abuse are complicated. Compliance programs within health care organizations broadly focus on all external rules, regulations, laws, accreditation guidelines, internal medical staff bylaws, and department compliance responsibilities. The location of the compliance program depends on the organization. For example, it may operate under a separate department, within risk management, or in the quality department.
The Office of the Inspector General provides training on compliance issues. There are seven fundamental elements of an effective compliance program. Four are shown here and there are three on the next slide.

12. OIG Compliance Program Tips - 2
The Seven Fundamental Elements of an Effective Compliance Program
Conducting internal monitoring and auditing
Enforcing standards through well-publicized disciplinary guidelines
Responding promptly to detected offenses and undertaking corrective action
OIG compliance education videos:
Conducting internal audits is an important aspect of compliance monitoring. Staff should be made aware of applicable disciplinary actions through well-published guidelines, and when an offense is noted, organizations must respond promptly to take corrective action.
 The issues of compliance are broad, deep, and rooted in the quality of health care. The OIG Health Care Fraud Prevention and Enforcement Action Team, or "HEAT“, provides helpful training videos that include a thorough discussion of compliance.

13. Corporate Integrity Agreements - 1
A comprehensive CIA includes requirements to:
Hire a compliance officer/appoint a compliance committee
Develop written standards and policies
Implement a comprehensive employee training program
Retain an independent review organization to conduct annual reviews
Corporate Integrity Agreements incorporate the principles of a corporate compliance program. These agreements are voluntary unless the organization is found to have issues of fraud or abuse. When that happens, the OIG will require a comprehensive Corporate Integrity Agreement. The comprehensive agreement is outlined on this slide and the next slide.

14. Corporate Integrity Agreements - 2
A comprehensive CIA includes requirements to:
Establish a confidential disclosure program
Restrict employment of ineligible persons
Report overpayments, reportable events, and ongoing investigations/legal proceedings
Provide an implementation report and annual reports to OIG on the status of the entity's compliance activities
Examples of Corporate Integrity Agreements can be found on the OIG website, which is listed in the References section of this presentation.

15. Compliance Beyond Fraud and Abuse
HIPAA Privacy and Security Rules
What is the plan for appropriate release of PHI?
How is the tracking of release occurring?
Who is responsible for breach notification?
What training is being done?
Is there a team reviewing policies and procedures?
Compliance programs, when broadly applied to a health care organization, are concerned with more than just fraud and abuse. A comprehensive compliance program takes into consideration all rules, regulations, and laws. For example, organizations must follow the policies and procedures of HIPAA pertaining to the release of personal health information, or PHI and the security of data.
The health information management department manages requests for PHI after the patient leaves the facility. Requests may come from patients, lawyers, other health care providers, and other entities. Department personnel are trained in the most up-to-date rules relating to the release of information.
The business office releases health information when needed for claim payment. Sometimes nursing stations release information upon discharge to an extended-care facility. Therefore, several departments may be releasing PHI and need to be well trained about HIPAA policies.
Tracking the release of personal health information must be systematic and transparent. Breaches in security need to be tracked as well. Humans make mistakes, and information may be sent to the wrong patient or third party. When a facility knows this has happened, it must follow relevant policies and procedures as established in the corporate compliance plan.
Likewise, large breaches of data must be reported to the Department of Health and Human Services. For example, a large data breach includes loss of a laptop containing the PHI of 500 or more patients. There are policies and procedures for notifying individual patients when privacy is breached.
All department managers and key personnel must review policies and procedures to address any issues related to the release of information. Although general HIPAA training is mandated for all personnel, additional in-depth training is needed in high-risk areas where breaches could occur. Those areas of risk must be identified and training must be ongoing to ensure compliance.

16. Regulating Health Care Summary – 1 – Lecture e
The health record is the business and legal record for a health care organization
The health record is the communication tool for the health care team
Clinical documentation is used to assure high quality care of the patient, as well as to provide information for decision-making, reimbursement and medical coding
This concludes lecture e of Regulating Health Care.
The following are the key concepts to remember about this lecture:
The health record is the business and legal record for a health care organization
The health record is the communication tool for the health care team
Clinical documentation is used to assure high quality care of the patient, as well as to provide information for decision-making, reimbursement and medical coding

17. Regulating Health Care Summary – 2 – Lecture e
Thorough and complete clinical documentation protects health care organization from the risk of fraud, abuse, and malpractice claims
Compliance programs are important to assure correct procedures to follow related to regulations, rules, laws, accreditation, and internal policies
HIPAA privacy and security rules need to be included in compliance plans
Thorough and complete clinical documentation protects health care organization from the risk of fraud, abuse, and malpractice claims.
Compliance programs are important to assure the correct procedures are followed related to regulations, rules, laws, accreditation, and internal policies
HIPAA privacy and security rules need to be included in compliance plans

18. Regulating Health Care Summary - 1
Health Care accrediting and certification organizations
The U.S. legal system
Laws governing health care privacy and security rules
This also concludes the unit Regulating Health Care. In summary, this unit discussed the following:
Organizations such as The Joint Commission accredit and/or certify health care organizations. Regulatory agencies under the authority of Congress issue rules that protect the public. Organizations including The Joint Commission and the Agency for Health Care Research and Quality provide initiatives and resources for patient safety and quality improvement.
The legal system in the U.S. is made up of many courts, where a neutral arena is used for parties to dispute issues.
The laws governing health care are complicated and ever changing. Health Care providers are responsible for following standards of care, obtaining informed consent from patients, and avoiding fraud, waste and abuse.
Compliance with HIPAA privacy and security rules are high priority in health care delivery.

19. Regulating Health Care Summary - 2
The clinical documentation in the health record supports quality health care, administrative and business operations of the organization, and provides the basis for legal proof of care that assures compliance with laws, rules, and regulations as well as professional standards of care
The clinical documentation in the health record supports quality health care, administrative and business operations of the organization, and provides the basis for legal proof of care that assures compliance with laws, rules, and regulations as well as professional standards of care.

20. Regulating Health Care References – 1 – Lecture e
 American Health Information Management Association. Accessed January 30, 2017.
American Health Information Management Association. Accessed January 30, 2017.
American Health Information Management Association. Accessed January 30, 2017.
Bayes, N., Newby, J, Seggern, J, Valerius J. Medical Insurance An integrated claims process approach 5th edition, McGraw Hill Companies: New York
Davis, N. Revenue Cycle Management Best Practices, 2011, AHIMA Press: Chicago
Health Care Compliance Program Tips Accessed January 30, 2017.
 LaTour & Eichenwald, Health Information Management, concepts, Principles, and Practice, Third Edition, 2010 AHIMA Press: Chicago
References slide. No audio.

21. Regulating Health Care References – 2 – Lecture e
 Office of the Inspector General. Accessed January 30, 2017.
Office of Inspector General. A Roadmap for New Physicians: Avoiding Medicare and Medicaid Fraud and Abuse. Accessed January 30, 2017.
Centers for Medicare and Medicaid. Accessed January 30, 2017.
Corporate integrity agreements. Accessed January 30, 2017.
References slide. No audio.

22. Introduction to Health Care and Public Health in the U. S
Introduction to Health Care and Public Health in the U.S. Regulating Health Care Lecture e
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.
No Audio.