Mangalore Call Girls 👙 6297143586 👙 Genuine WhatsApp Number for Real Meet
Regulating Healthcare - Lecture A
1. 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/.
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)
2
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)
3
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)
4
5. Accreditation, Regulation, and
Professional Associations
• Nonprofit Accrediting Organizations
– The Joint Commission (TJC)
– URAC (formerly called Utilization Review
Accreditation Commission)
– National Committee for Quality Assurance
(NCQA)
• Regulatory Agencies
– Food and Drug Administration (FDA)
• Professional Associations
5
6. 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)
6
7. 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.
7
8. 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)
8
9. 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
9
10. 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
10
12. 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
12
13. 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
13
14. TJC Patient Safety Activities
• National Patient Safety Goals
• Universal Protocol
• Office of Quality Monitoring
• Speak Up™ Program
• Sentinel Event Policy
14
16. URAC
• Mission: “To promote continuous
improvement in the quality and efficiency
of healthcare management through
processes of accreditation, education, and
measurement”
• Has more than 30 accreditation and
certification programs for various types of
health care organizations
16
17. URAC Privacy & Security
Accreditation - 1
• Outlines best practices for maintaining
privacy and security of health information
• Allows organizations to demonstrate
compliance with privacy and security
requirements specified by:
– Health Insurance Portability and Accountability
Act (HIPAA)
– Health Information Technology for Economic and
Clinical Health Act (HITECH)
• See http://www.urac.org
17
18. URAC Privacy & Security
Accreditation - 2
• These health care organizations must
comply with HIPAA:
– Health plans: Health insurance companies,
employer-funded health plans, and
government programs that pay for health
care, such as Medicare or Medicaid
– Health care providers that conduct certain
tasks electronically
– Health care clearinghouses (organizations
that process health information)
18
19. 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 19
20. 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)
20
21. 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
areas. (FDA, 2016) 21
22. 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
22
23. 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)
23
24. 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
24
25. CMS – Medicaid and CHIP
• Medicaid and CHIP provide health care for
low income adults and children.
– Programs are administered by individual
states
25
26. 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
26
27. 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
27
28. 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
28
29. 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
29
30. American Board of Medical
Specialties (ABMS) - 2
• Member boards certify specialist
physicians
– Also subspecialists; for example, adolescent
medicine is a subspecialty of family medicine
30
31. 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
31
32. 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
32
33. 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
33
34. 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
34
35. 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
35
36. 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.
36
37. 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.
37
38. Introduction to Health Care
and Public Health in the U.S.
Regulating Health Care
Lecture a
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.
38
Notes de l'éditeur
Welcome to Introduction to Health Care and Public Health in the U.S.: Regulating Health Care. This is lecture a.
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.
The learning 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, classifications of laws, the court system, and the trial process
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.
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.
In this lecture, we’ll describe health care accreditation bodies, regulatory agencies, and professional associations.
We’ll begin by reviewing three nonprofit groups that accredit health care organizations. These are The Joint Commission, or TJC, URAC, which was originally known as the Utilization Review Accreditation Commission, and the National Committee for Quality Assurance or NCQA.
The following discussion will concern regulatory agencies, including the Food and Drug Administration, or FDA, a consumer protection agency that approves and regulates drugs and medical devices.
Finally, professional associations will be considered in terms of their role in boosting the quality of the medical profession.
This slide reviews the history of TJC, a nonprofit accrediting organization. More than 100 years ago, a medical doctor proposed a system to promote hospital reform based on outcomes management in patient care. It was called the “end-result” system. Under this system, hospitals tracked all of their patients long enough to determine whether the hospital treatment was effective. If it was not, hospital officials attempted to determine why, so similar cases could be treated successfully in the future.
This model of continuing to study and improve medical outcomes formed the basis for TJC, which accredits and certifies nearly 21,000 health care organizations and programs in the United States. The vision of TJC, is that: “All people always experience the safest, highest quality, best-value health care across all settings.”
In 1951, the Joint Commission on Accreditation of Hospitals was formed and begins accrediting health care organizations. In 1987, their name changed to the Joint Commission on Accreditation of Healthcare Organizations, or JCAHO. Many health care professionals are in the habit of using this name, so it is helpful to know this history.
In 2007, JCAHO simplified its name to The Joint Commission, or TJC.
In 1994, TJC founded Joint Commission International or JCI, which identifies, measures, and shares best practices in quality and patient safety across the world. To date, JCI has touched more than 90 countries.
Linked to TJC’s vision is its 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.”
TJC performs two functions to keep patients safe. Achieving accreditation signifies that an organization meets TJC’s standards for patient care. Accreditation is earned by an entire health care organization, such as a hospital or a long term care facility. Each organization accredited by TJC has to follow a procedure manual customized for that type of organization. Sample topics in the manual include emergency management, environment of care, human resources, and infection prevention and control.
The Joint Commission collects data for accreditation through on-site surveys and performance measurement. The Integrated Survey Process, or ISP, is an on-site survey that usually lasts at least three days and involves extensive meetings between TJC’s survey team and leaders of the health care organization being accredited.
Secondly, TJC requests that organizations submit data through a performance measurement system known as Outcome Research Yields Excellence, or ORYX. This tool is directly relevant to information technology professionals. Hospitals are required to collect and transmit data to TJC about patients with certain conditions. Treatments for these conditions are considered core measures of the health care organization’s performance and improvement.
A hospital might choose to provide data on various medical conditions, such as heart attack, or acute myocardial infarction, pneumonia, psychiatric care, children’s asthma, or stroke.
For each of these conditions, TJC requires the hospital to report on certain performance measures. For example, if a child is treated for asthma, the hospital must report whether certain drugs were given and whether the child was sent home with a management plan.
The second main function of TJC is certification. Certification is a designation that specific criteria, deemed essential to the provision of specific health care services, are in place. Any health care organization and any provider of health care staffing services can earn certification for programs or services that address certain chronic diseases. A chronic disease is one that exists over the long term, such as diabetes. Programs eligible for certification may be located within a medical center or in the community.
Patient safety is also a major focus of TJC. The National Patient Safety Goals program has created lists of tips for health care professionals to follow to prevent errors. For example, before administering a medication, a nurse should make sure he or she is administering medication to the correct patient by identifying the patient in two different ways, such as by name and birth date.
The Universal Protocol is a standard procedure for surgery teams to follow to avoid performing the wrong procedure, operating on the wrong body site, or even operating on the wrong person. Some of the steps include marking the correct site and taking a “time out” before surgery, when the team pauses to take stock and agree that their plans are appropriate.
The Joint Commission’s Office of Quality Monitoring is interested in the details of patient complaints. It does not resolve complaints, but it uses information from patients to identify possible noncompliance with accreditation or certification standards.
The Speak Up program encourages patients to help prevent medical errors by asking questions, educating themselves, and actively participating in their treatment.
Finally, TJC reviews how health care organizations respond to sentinel events. That term refers to an unexpected death, an unexpected serious physical or psychological injury, or the risk of such an event. These events need immediate investigation and response.
The second major nonprofit accrediting organization is URAC, which, as mentioned earlier, was originally chartered as the Utilization Review Accreditation Commission.
Its mission is “To promote continuous improvement in the quality and efficiency of health care management through processes of accreditation, education, and measurement.”
URAC is one of the fastest growing health care accreditation agencies, with more than 30 programs addressing multiple aspects of health care, including health care management, health care operations, health plans, pharmacy quality management, and providers. The accreditation process includes a review of policies and procedures, plus an on-site visit to the organization to determine that it is operating according to its stated policies and national standards.
In recent years, URAC has established an accreditation for accountable care organizations. Accountable care organizations, known as ACOs, are health care organizations characterized by a payment and care delivery model that ties payment to quality metrics to achieve reduced cost of care for an assigned population of patients.
URAC has more than 30 accreditation and certification programs for various types of health care organizations.
URAC offers privacy and security accreditation for health care organizations. This accreditation allows organizations to demonstrate that they are using the policies and procedures necessary to protect individual’s health information and comply with privacy and security requirements specified within HIPAA, and within the Health Information Technology for Economic and Clinical Health act, or HITECH act. The HITECH Act extends HIPAA privacy and security requirements to third-party organizations that have access to electronic health information.
Three groups in the health care market must comply with HIPAA requirements. These are:
Health plans, such as health insurance companies; company health plans; and Medicare and Medicaid.
Most health care providers must comply, assuming that they conduct certain tasks electronically.
The other group that must observe HIPAA regulations is health care clearinghouses, which are organizations that process health information.
HIPAA will be covered in more depth later in this unit.
The National Committee for Quality Assurance, or NCQA, is a non-profit organization focused on improving health care quality. NCQA offers accreditation for health plans, health plan contracting organizations that provide disease management and other services, and accountable care organizations.
The NCQA accreditation process includes an assessment of both clinical performance and consumer experience. The NCQA Healthcare Effectiveness Data and Information Set, known as HEDIS, assesses clinical performance through measurements of health care quality. The Consumer Assessment of Healthcare Providers and Systems Survey, known as CAHPS, invites consumers to report on their experiences in obtaining health care services through their health plan.
Another group of organizations that help keep the public safe are regulatory agencies. A regulatory agency is a public authority at the state or federal level that is established by legislative act to enforce standards in a specific field in the private sector. An agency’s rules have the force of law, and an agency can also act somewhat like a trial court, with the authority to conduct hearings and hand down judgments.
In the United States, health care focused agencies are part of the Department of Health and Human Services, or HHS. The goal of agencies within HHS is to promote health and provide consumer protection. In the health care field, the best-known example is the Food and Drug Administration, or FDA.
The FDA is a regulatory agency. It oversees the safety of eight categories of products: food; drugs; medical devices; vaccines, blood and biologic products; animal feed and veterinary drugs; cosmetics; radiation-emitting products; and tobacco products.
The FDA takes numerous actions to protect the public’s health. First and foremost, it regulates drugs by performing drug approvals, providing drug safety information, and alerting the public to actual and potential medication errors. It also helps drug companies and medical device companies speed up the development of new products. Finally, the FDA helps Americans get the accurate information they need in order to use medicines, devices, and foods to improve their health.
The Centers for Medicare and Medicaid Services, or CMS, is an agency within the U.S. Department of Health and Human Services responsible for the administration of several key federal health care programs. CMS regulates reimbursement for the provision of health care products and services for Medicare, Medicaid, and the Children’s Health Insurance Program, also known as CHIP.
Medicare is a federally funded health care program for individuals over 65 years of age, under 65 with certain disabilities, and individuals of all ages with permanent kidney failure that requires dialysis or a kidney transplant.
Medicaid and CHIP are programs designed to provide health care for low income adults and children. Both Medicaid and CHIP are administered by individual states within the USA.
The Office of the National Coordinator, commonly known as ONC, was established through an Executive Order in 2004, and was legislatively mandated in the Health Information Technology for Economic and Clinical Health, or HITECH, Act of 2009. ONC is the office within the Department of Health and Human Services that coordinates nationwide efforts to promote the adoption of electronic health records and to promote the electronic exchange of health information between care providers.
Professional associations are another group of organizations that work to keep health care safe. A professional association is a nonprofit organization of people who want to support a particular profession, the interests of individuals in that profession such as physicians or hospital administrators, and the interests of the public.
Most professional associations set requirements for entry into the profession and for maintaining membership. These requirements may include a license or certificate from a state or private authority. In most cases, entry and maintenance requirements are significant and involve testing, training, experience, and continuing education.
This lecture discusses four associations that are prominent in the health care field: the American Board of Medical Specialties, the American Hospital Association, the American Medical Association, and the American Nursing Association.
The American Board of Medical Specialties, or ABMS works in collaboration with 24 specialty Member Boards to maintain the standards for physician certification. The mission of the ABMS is 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.
Through the ABMS, physicians can become certified as a specialist in one or more fields. For example, if a physician is “board-certified in pediatrics,” this indicates that the physician has expertise in that field. This is different from a doctor’s state license, which sets the minimum competency required to practice in the state.
Some doctors also become certified in subspecialties. For example, adolescent medicine is a subspecialty of family medicine.
The vision of the American Hospital Association, or AHA, is of “a society of healthy communities where all individuals reach their highest potential for health.” The AHA has nearly 5,000 organizational members, including hospitals, health care systems, networks, and other providers. It also has 43,000 individual members.
A major emphasis of the AHA is advocacy, which means working to influence political and economic policies through activities such as lobbying and media campaigns. The AHA also provides an extensive resource center, a database of information about health planning and administration, an annual survey of U.S. hospitals, and other reports and studies.
The mission of the American Medical Association, or AMA, is to promote the art and science of medicine and improve public health. There are close to 225,000 members, primarily comprised of physicians who have a U.S. doctor of medicine degree, a U.S. doctor of osteopathic medicine degree, or a recognized international equivalent. Also eligible for membership are resident physicians and fellows, who have their medical degree but are still in training, and medical students.
Major activities of the AMA include educating physicians, advocating for the medical profession, and publishing medical journals.
The American Nurses Association, or ANA, is a nonprofit organization which represents the interests of the nation’s three point four million registered nurses.
The ANA’s areas of focus are:
Fostering high standards of nursing practice
Promoting a safe and ethical work environment
Bolstering the health and wellness of nurses
Advocating on health care issues that affect nurses and the public
This concludes lecture a of Regulating Health Care.
In summary, hospitals and other health care organizations are accredited by The Joint Commission, or 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.
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.