chapter 3
LEGAL AND REGULATORY ANALYSIS
PART TWO
4/23/22
Enterprise RM Defined
Definition relates to function in organization:
Firstly, it is a business decision-making process used to identify and manage the risks across the continuum of an organization’s structure and function;
Secondly, it is a discipline that engages professionals;
Thirdly, it is a practice that embraces organizational risk identification, analysis, mitigation, monitoring, and evaluation
RISK DOMAINS
Operational Risks
Strategic Risks (Technology, Hazard & Human Capital Risks)
Legal and Regulatory Risks
Financial Risks
WHAT IS HEALTH POLICY
Public policies are authoritative decisions made in the legislative (congressional), executive (presidential), or Judicial (courts, including the Supreme Court) branches of government that are intended to direct or influence the actions, behaviors, or decisions of others (Longest, 2002)
WHAT IS HEALTH POLICY
When public policies pertain to or influence the pursuit of health, they become health policies. Thus health policy can be defines as “the aggregate of principles, stated or unstated that …characterize the distribution of resources, services, and political influences that impact on the health of the population” (Miller, 1987, p. 15).
WHAT IS HEALTH POLICY
Health policies can be used as regulatory tools and they may call upon the government to prescribe and control the behavior of a particular target group by monitoring the group and imposing sanctions if it fails to comply
WHAT IS HEALTH POLICY
Federally funded quality improvement organizations, for instance, develop and enforce standards concerning appropriate care under the Medicare program
State insurance departments across the country regulate health insurance companies in an effort to protect customers from excessive premiums, mendacious practices, and defaults on coverage in case of financial failure of an insurance company
WHAT IS HEALTH POLICY
Some health policies are self-regulatory. For example, physicians set standards of medical practice, and schools of public health decide which courses should be part of their graduate programs in public health
Health policies can also be used as allocative tools
Legislation to regulate:
Drugs
Devices, etc.
Impact of Health Care Costs/Insurance
STATUTES, STANDARDS, AND REGULATIONS
What differentiate Health Care Law from Rules and Regulation?
Is there any relationship between Law, Rules and Regulation; and Risk Management?
What is Health Policy?
STATUTES, STANDARDS, AND REGULATIONS
Healthcare is one of the most heavily regulated of all sectors of commerce and many of the rules we live by, such as federal and state laws, are legislative mandates
Others reflect regulatory requirements imposed by various government-sponsored programs-Medicare being chief among them
Others are more or less self-imposed to conform to various government and private initiatives
STATUTES, STANDARDS, AND REGULATIONS
Healthcare professional should familiarize themselves with at least the basic elements of key status and regulations; keeping current with changes in the law or regulation will help identify, and correct defects in compliance
REGULATORY AGENCIES
The federal Department of Health and Human Services (HHS), and its components agencies, is the chief overseer of healthcare-related legislative and regulatory matters at the federal level
REGULATORY AGENCIES
HHS oversees, through one or more of its eleven agencies and their dozens of constituents divisions and departments (that designed a far-reaching array of programs designed to ensure that essentially all elements of the healthcare industry provide services and goods that are beneficial and safe
THE HHS AGENCIES ARE:
Office of the Secretary (OS)
Administration for Children & Family (ACF)
Administration on Aging (AoA)
Agency for Healthcare Research & Quality (AHRQ)
Agency for Toxic Substances & Disease (ATSDR)
Centers for Disease Control & Prevention (CDC)
Centers for Medicare & Medicaid Services (CMS)
Food & Drug Administration (FDA)
THE HHS AGENCIES ARE:
Health Resources & Services Administration (HRSA)
Indian Health Service (HIS)
National Institute of Health (NIH)
Office of Inspector General (OIG)
Substance Abuse & Mental Health Services Administration (SAMHSA)
MEDICARE REGULATIONS
Regulations are conditions of participation in Medicare and any other services in healthcare; noncompliance might result not only in loss of the facility’s Medicare or Medicaid provider agreement, but in loss of license, permit, etc.
CONCLUSION
Healthcare organizations are subject to mandatory review and disclosure requirements and may also participate in voluntary accreditation and inspection programs that apply to either the organization as a whole or to specialized areas within the industry
CONCLUSION
The push to obtain better data about the quality of care services that the medical community provides has placed greater focus on accreditation, licensure, and certification bodies
CONCLUSION
Therefore, our legal responsibilities are our ethical obligations:
Knowledge of federal and state regulations pertaining to area of your business (occupational health and etc.)
Knowledge of the American with Disabilities Act, associated guidelines, and Affirmative Action and Equal Employment Opportunity legislation
Knowledge of all aspects of medical record-keeping practices in compliance with your practice, state law, and standards of practice
Knowledge of current legal trends related to negligence and malpractice cases in your professional field and setting
CONCLUSION
The Regulatory Affairs division is responsible for keeping abreast of current federal regulations and government policies that affect an agency's day to day operations as well as its long term business planning. The regulatory staff is often the first to learn of regulatory changes that have both direct and indirect effects on the home health and hospice industry. This up to the minute tracking of key regulatory events enables members to stay ahead of the curve in a rapidly changing health care environment.