Introduction to Health Care

and Public Health in the U.S.

Regulating Health Care

Lecture a
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/.
 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 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 b) 2
 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 c)

3
 Accreditation, Regulation, and
Professional Associations
• Nonprofit Accrediting Organizations
– The Joint Commission (TJC)
– National Committee for Quality Assurance
(NCQA)
• Regulatory Agencies
– Food and Drug Administration (FDA)
• Professional Associations

4
 TJC History - 1

• 1910: The forerunner of TJC was called

the “end-result” system
• 1951: Joint Commission on Accreditation
of Hospitals (JCAH) is created and starts
accrediting health care organizations
• 1987: JCAH changed its name to Joint
Commission on Accreditation of
Healthcare Organizations (JCAHO)

5
 TJC History - 2

• 2007: Name simplified to The Joint

Commission (TJC); currently accredits and
certifies nearly 21,000 organizations and
programs in the USA
• 1994: Joint Commission International (JCI)
offers an international accreditation and
has touched more than 90 countries since
then.

6
 TJC’s Mission Statement

• “To continuously improve health care for

the public, in collaboration with other
stakeholders, by evaluating health care
organizations and inspiring them to excel
in providing safe and effective care of the
highest quality and value.”
(The Joint Commission, 2016)

7
 TJC Accreditation - 1

• TJC accreditation signifies an organization

meets TJC’s standards for patient care
• Accreditation is earned by an entire health
care organization (hospital, nursing home,
office-based surgery practice, etc.)
• Procedure manual: emergency
management, environment of care, HR,
infection prevention and control

8
 TJC Accreditation - 2

• Tools TJC uses to measure performance

– Integrated Survey Process (ISP): An in-person
visit to evaluate performance across an
organization
– Outcome Research Yields Excellence
(ORYX): System for health care organizations
to report information to TJC about patients
with certain conditions (core measure sets)
o The core measure sets reported depend on the
type and size of the organization
9
 ORYX: Core Measure Sets - 1

• Examples
– Heart attack
– Pneumonia
– Inpatient psychiatric care
– Children’s asthma
– Stroke

10
 ORYX: Core Measure Sets - 2

• Specific performance measures are

associated with each core measure set
– For example, the TJC looks at whether
children with asthma received certain drugs in
the hospital and were sent home with a
management plan

11
 TJC Certification

• TJC-accredited organizations and

providers of health care staffing services
can also earn certification for specific
programs or services
– For chronic diseases and conditions
o Examples: asthma, diabetes, heart failure
programs
– Programs can be within the medical center or
in the community

12
 TJC Patient Safety Activities

• National Patient Safety Goals

• Universal Protocol
• Office of Quality Monitoring
• Speak Up™ Program
• Sentinel Event Policy

13
 The National Committee for
Quality Assurance (NCQA)
• Accreditation body for:
– Health plans
– Health plan contracting organizations
– Accountable Care Organizations
– Accreditation process includes assessments
of clinical performance and consumer
experience
o Healthcare Effectiveness Data and Information Set
(HEDIS)
o Consumer Assessment of Healthcare Providers
and Systems (CAHPS) survey 14
 Regulatory Agencies

• Under the authority of Congress, federal

agencies enforce standards in a specific
field in the private sector
• Agencies create regulations, known as
“rules”, to carry out public policy
• The goal is consumer protection. Example:
Food and Drug Administration (FDA)

15
 FDA Overview

• Categories of FDA regulated products:

6.1 Figure: As part of Department of Health and Human Services, the FDA is charged with oversight of these
16
areas. (FDA, 2016)
 FDA Mission

• Protect public health

– Regulates drugs
o Performs drug approvals
o Provides drug safety information
o Spreads the message about medication errors

– Helps speed up product innovations

– Helps public obtain accurate, science-based
information

17
 Centers for Medicare &
Medicaid Services (CMS)
• Under U.S. Department of Health &
Human Services
• CMS regulates reimbursement for health
care products and services, including:
– Medicare
– Medicaid
– Children’s Health Insurance Program (CHIP)

18
 CMS - Medicare

• Federally funded health care program for

individuals who:
– Are over age 65
– Are under age 65 with certain disabilities
– Have permanent kidney failure requiring
dialysis or transplant

19
 CMS – Medicaid and CHIP

• Medicaid and CHIP provide health care for

low income adults and children.
– Programs are administered by individual
states

20
Office of the National Coordinator for
Health Information Technology (ONC)
• ONC a federal entity within the
Department of Health & Human Services
• Coordinates nationwide efforts to
implement and use electronic health
records
• Promotes the exchange of electronic
health information across care settings

21
 Professional Associations - 1

• Nonprofit organizations that support:

– A particular profession
– The interests of individuals engaged in that
profession
o Physicians
o Hospital administrators

– The public interest

22
 Professional Associations - 2

• Sets requirements:
– For entry into the profession
o May require license or certificate

– For maintaining membership in the profession

• Members generally have a significant
amount of education, training, or
experience

23
 American Board of Medical
Specialties (ABMS) - 1
• Mission: “to serve the public and the
medical profession by improving the
quality of health care through setting
professional standards for lifelong
certification in partnership with Member
Boards.”
• Board certification differs from licensure,
which sets minimum competency for
physicians
24
 American Board of Medical
Specialties (ABMS) - 2
• Member boards certify specialist
physicians
– Also subspecialists; for example, adolescent
medicine is a subspecialty of family medicine

25
 American Hospital
Association (AHA)
• Nearly 5,000 organizational members
• 43,000 individual members
• Major programs
– Advocacy
o Lobbying and media campaigns to influence political
and economic policies
– Resource center
o Database of information on health planning and admin.
– Annual survey of U.S. hospitals
– Reports and studies
26
 American Medical
Association (AMA)
• Nearly 225,000 members
– Physicians with an MD or DO degree, or a
recognized international equivalent
– Resident physicians and fellows
– Medical students
• Major programs
– Resources for physicians
– Advocacy
– Publishing medical journals
27
 American Nurses
Association (ANA)
• Nonprofit professional organization that
represents the interests of the USA’s 3.4
million registered nurses
• Focus areas
– Fostering high standards of nursing practice
– Promoting a safe and ethical work
environment
– Bolstering the health and wellness of nurses
– Advocating for nurses and the public
28
 Regulating Health Care
Summary – 1 – Lecture a
• Hospitals and other health care
organizations are accredited by TJC
• TJC also certifies specific health care
programs and conducts patient safety
activities
• URAC accredits and certifies a wide range
of health care organizations, and it has an
accreditation program for IT professionals

29
 Regulating Health Care
Summary – 2 – Lecture a
• Regulatory agencies such as the FDA
protect consumers by setting and
enforcing standards
• Professional associations establish
standards for their members to enhance
the safety and quality of health care

30
 Regulating Health Care
References – 1 – Lecture a
References
American Board of Medical Specialties. http://www.abms.org. Accessed January 26,
2017.
American Hospital Association. http://www.aha.org. Accessed January 26, 2017.
American Medical Association. http://www.ama-assn.org. Accessed January 26, 2017.
Center for Medicare & Medicaid Services. https://www.cms.gov/Medicare/Medicare-
General-Information/MedicareGenInfo/index.html. Accessed January 26, 2017.
Medicaid. https://www.medicaid.gov/. Accessed January 26, 2017.
Office of the National Coordinator. https://www.healthit.gov/newsroom/about-onc.
Accessed January 26, 2017.
Robeznieks A. AMA saw membership rise 3.2% in 2012. May 9, 2013.
http://www.modernhealthcare.com/article/20130509/NEWS/305099950. Accessed
January 26, 2017.
Regulatory agency (definition). Encyclopedia Britannica.
http://www.britannica.com/EBchecked/topic/496265/regulatory-agency. Accessed
January 26, 2017.

31
 Regulating Health Care
References – 2 – Lecture a
References
The Joint Commission.
http://www.jointcommission.org/facts_about_the_joint_commission/ Accessed
January 26, 2017.
The Joint Commission International. http://www.jointcommissioninternational.org/about-
jci/who-is-jci/. Accessed January 26, 2017.
U.S. Department of Health & Human Services. Health information privacy.
http://www.hhs.gov/hipaa/index.html. Accessed January 26, 2017.
U.S. Food and Drug Administration. http://www.fda.gov. Accessed January 26, 2017.
URAC. http://www.urac.org. Accessed January 26, 2017.

Charts, Tables, Figures

Figure 6.1: Part of Department of Health and Human Services, charged with oversight of
the areas displayed. http://www.fda.gov/. Accessed January 26, 2017.

32
 Introduction to Health Care
and Public Health in the U.S.
Regulating Health Care

Lecture b
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/.
 Affordable Care Act (ACA) - 1

• Comprehensive health care reform

• Passed by Congress and signed into law
by President Obama on March 23, 2010
• Supreme Court upheld ACA on June 28,
2012
• Health Insurance Marketplace began
October 1, 2013 – states had option to use
federal site or develop their own

34
 Affordable Care Act (ACA) - 2

• 20 million people gained insurance coverage

via the Affordable Care Act or “Obamacare”
– Expands coverage
o Individual mandates
o Private insurance that allows young adults to stay on
parents’ health insurance plans
o Medicaid expansion

– Requires plans to cover people with pre-existing

conditions
– Provides free preventive services

35
 State Medical Practice Acts

• Define the practice of medicine

• Regulate how medicine will be practiced
within the state
• Establish medical board
– Set standards
– Create process
– Investigate complaints

36
 Standards of Care

6.1 Figure: Diagram showing a few of the many sources that can contribute to a medical standard of care.
37
(OHSU, 2010)
 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

38
 Informed Consent Process - 1

• Physician or other health care professional

explains:
– Risks and benefits
– Other options, including no treatment
• Opportunity to ask questions and get
satisfactory, understandable answers

39
 Informed Consent Process - 2

• If desired, takes time to discuss the

situation with others
• Opportunity to communicate the decision
to physician or treatment team

40
 Informed Consent with
Shared Decision Making (SDM)
• SDM: Informed discussion between
providers and patient to help patient
decide among multiple acceptable health
care choices. Discussion must include
patient’s priorities and values.
• Decision aids facilitate SDM. Include
information on options, risks, benefits, and
can include a priority-setting activity and
coaching.
41
 Tort Law and Malpractice

6. 2 Chart: Diagram showing how Tort law is the part of private or civil law that deals with malpractice (OSHU,
42
2010).
 Elements of Malpractice

• Duty of reasonable care to the injured

party
• 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

43
 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

44
 “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

45
 Tort Law Reform - 1

• Pre-trial screening panels

– Reviews case at early stage and gives
opinion about merit
• Certificate of merit
– From qualified medical expert in order to file a
lawsuit
• Attorney fee limits
– Limits on percentage and/or total amount

46
 Tort Law Reform - 2

• Periodic payment
• Joint-and-several liability reform
– More than one defendant - limits amount that
can be recovered from each
• Caps on non-economic damages
– Limit payments for pain and suffering

47
 Tort Law Reform - 3

• Results Considered:
– Costs
– Frequency of malpractice claims
– Supply of health care services,
– Quality of care
– Need for physicians to practice so-called
defensive medicine
• The only tort reform that significantly
improved these results was the cap on
noneconomic damages
48
 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

49
 Innovative Tort Reform

• “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
50
 Fraud, Waste, and 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
51
 Federal Fraud and Abuse Laws

• False Claims Act

• Anti-Kickback Statute
• Stark Law
• Exclusion Statute
• Civil Monetary Penalties Law

52
 Regulating Health Care
Summary – 1 – Lecture b
• Laws that apply to health care are
numerous and complicated
• System is changing rapidly as a result of
the Affordable Care Act and tort reform
proposals

53
 Regulating Health Care
Summary – 2 – Lecture b
• 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

54
 Regulating Health Care
References – 1 – Lecture b
References
Agency for Health Care Research and Quality. Patient safety primer: never events.
https://psnet.ahrq.gov/primers/primer/3. Accessed January 27, 2017.
American Cancer Society. Informed consent. Updated 07/28/2014.
https://www.cancer.org/treatment/finding-and-paying-for-treatment/understanding-
financial-and-legal-matters/informed-consent/intro.html. Accessed January 27, 2017.
Code of Ethics for Emergency Physicians. (n.d.). Retrieved January 27, 2017, from
https://www.acep.org/Clinical---Practice-Management/Code-of-Ethics-for-Emergency-
Physicians/
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 January 27, 2017.
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/docs/default-source/contractor-
reports/Apr10_MedicalMalpractice_CONTRACTOR.pdf. Accessed January 27, 2017.

55
 Regulating Health Care
References – 2 – Lecture b
References
Nolo. Medical Malpractice Basics. http://www.nolo.com/legal-encyclopedia/medical-
malpractice-basics-29855.html. Accessed January 27, 2017.
Office of Inspector General. A Roadmap for New Physicians: Avoiding Medicare and Medicaid
Fraud and Abuse. https://oig.hhs.gov/compliance/physician-education/index.asp. Accessed
January 27, 2017.
Ohio State Bar Association. Law You Can Use: Ohio’s “Good Samaritan” Law Protects
Volunteers. Updated 2012.
https://www.ohiobar.org/General%20Resources/LawandYou/TLAY_Complete.pdf.
Accessed January 27, 2017.
US Department of Health and Human Services. New tools to fight fraud, strengthen Medicare
and protect taxpayer dollars. Updated February 11, 2013.
https://www.stopmedicarefraud.gov/newsroom/factsheets/medicare-fraud.html. Accessed
January 27, 2017.
US Department of Health and Human Services. 20 million people have gained health
insurance coverage because of the Affordable Care Act, new estimates show. March 3,
2016. http://www.hhs.gov/about/news/2016/03/03/20-million-people-have-gained-health-
insurance-coverage-because-affordable-care-act-new-estimates. Accessed January 27,
2017.

56
 Regulating Health Care
References – 3 – Lecture b
Charts, Tables, Figures
6.1 Figure: Diagram showing a few of the many sources that can contribute to a medical
standard of care. OHSU (2010).
6.2 Figure: Diagram showing how Tort law is the part of private or civil law that deals with
malpractice. OHSU (2010).

57
 Introduction to Health Care
and Public Health in the U.S.
Regulating Health Care

Lecture c
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/.

58
 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
59
 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

60
 HIPAA Covered Entities - 1

6.1 Figure: Flowchart for determining whether an entity is a HIPAA covered health provider or not. (CMS.gov,
61
nd.)
 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

62
 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

63
 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

64
 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
65
 Individually Identifiable
Information
• Information can be used to identify the
individual
– Physical or mental health condition
– Provision of health care
– Payment

66
 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
67
 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

68
 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

69
 HIPAA Enforcement
and 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
70
 HIPAA Enforcement
and 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

71
 Agency for Health Care
Research 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

72
 National Health Care
Quality Report
• Effectiveness
• Timeliness
• Efficiency
• Patient safety
• Access to care
• Patient centeredness

73
 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

74
 Regulating Health Care
Summary – 1 – Lecture c
• 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

75
 Regulating Health Care
Summary – 2 – Lecture c
• 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

76
 Regulating Health Care
References – 1 – Lecture c
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.

77
 Regulating Health Care
References – 2 – Lecture c
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.

78