Government Regulatory Agencies

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GOVERNMENT REGULATORY AGENCY•An organization that is responsible for the oversight

and administration of specific functions•May be established by either a national government

or a state government within the federal system

USDA (United States Department of Agriculture) •HUD (Housing and Urban Development) •IRS (Internal Revenue Service) •CDC (Centers for Disease Control) •FDA (Food and Drug Administration) •DEA (Drug Enforcement Agency) •FBI (Federal Bureau of Investigation) •INS (Immigration and Naturalization Service) •OSHA (Occupational Safety and Health Administration) •USGS (United States Geological Survey) •FAA (Federal Aviation Administration) •NHTSA (National Highway Traffic Safety Administration) •ATF (Bureau of Alcohol, Tobacco, and Firearms) •VA (Department of Veterans Affairs)

Government Regulatory Agencies

•This list points out the proliferation of government departments and agencies in the executive branch, all under the control of the President. •These are just a "drop in the bucket" of agencies necessary to help the President "enforce laws."

Government Regulatory Agencies•The heads of the departments usually have the title

of "Secretary" (except the head of the Justice Department who is called the Attorney General) and together they comprise the President's cabinet. •The current departments include: Agriculture;

Commerce; Defense; Education; Energy; Health and Human Services; Housing and Urban Development; Justice; Labor; State; Interior; Transportation; Treasury; and Veterans Affairs.

•Within each department are a number of agencies, services and programs that carry out its work. • As an example, the Department of Defense includes the

following agencies, plus many others: • Civilian Personnel Management Service • Defense Commissary Agency • Defense Prisoner of War/Missing in Action Office • Defense Threat Reduction Agency • National Imagery and Mapping Agency • National Security Agency

• Federal agencies administer enforceable regulations that impact healthcare.

• Regulations are mandatory laws or rules issued by a governing body. A regulatory standard is mandated by a governing agency and, if not complied with, may cause a facility to be in violation and liable for legal penalty.

• Not following regulations and standards set forth by federal agencies can also affect a healthcare organization's reimbursement, and that could make or break healthcare facilities that function with tight budgets.

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Healthcare regulatory agencies monitor health care practitioners and facilities, provide information about industry changes, promote safety and ensure legal compliance and quality services.

Some agencies, such as those for accreditation, require voluntary participation but are important because they provide rankings or certification of quality.

•Regulatory agencies and professional associations have one common goal: the provision of safe, appropriate, high quality care. •When violations of statutes or standards are observed, federal and state agencies can levy fines in amounts determined by severity of the infraction, number of like infractions found, and their level of concern for potential harm to workers or patients.•Some types of government agencies include:

• WHO is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends.• In the 21st century, health is a shared responsibility, involving

equitable access to essential care and collective defense against transnational threats.• WHO is reforming to be better equipped to address the increasingly

complex challenges of the health of populations in the 21st century. From persisting problems to new and emerging public health threats, WHO needs to be flexible enough to respond to this evolving environment.

•More than 7000 people from more than 150 countries work for the Organization in 150 WHO offices in countries, territories and areas, six regional offices and at the headquarters in Geneva, Switzerland.• In addition to medical doctors, public health specialists,

scientists and epidemiologists, WHO staff include people trained to manage administrative, financial, and information systems, as well as experts in the fields of health statistics, economics and emergency relief.

Department of Health and Human Services

• "It was once said that the moral test of government is how that government treats those who are in the dawn of life, the children; those who are in the twilight of life, the elderly; and those who are in the shadows of life, the sick, the needy and the handicapped."

- Hubert H. Humphrey

Department of Health and Human Services•The U.S. Department of Health and Human Services (HHS) is the U.S. government’s principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.

• The CDC is one of the major operating components of the Department of Health and Human Services. • CDC works 24/7 to protect America from health, safety and security

threats, both foreign and in the U.S. Whether diseases start at home or abroad, are chronic or acute, curable or preventable, human error or deliberate attack, CDC fights disease and supports communities and citizens to do the same.• CDC increases the health security of our nation. As the nation’s

health protection agency, CDC saves lives and protects people from health threats. To accomplish our mission, CDC conducts critical science and provides health information that protects our nation against expensive and dangerous health threats, and responds when these arise.

Role in the 21st Century:

– confronting global disease threats through advanced computing and lab analysis of huge amounts of data to quickly find solutions.• – tracking disease and finding out what is making people sick and

the most effective ways to prevent it.• – bringing new knowledge to individual health care and

community health to save more lives and reduce waste.• – fighting diseases before they reach our borders – detecting and

confronting new germs and diseases around the globe to increase our national security.• – nurturing public health - building on our significant contribution

to have strong, well-resourced public health leaders and capabilities at national, state and local levels to protect Americans from health threats.

Promoting healthy and safe behaviors, communities and environment

Developing leaders and training the public health workforce, including disease detectives

Taking the health pulse of our nation

Responsible for:• protecting the public health by assuring that foods are safe,

wholesome, sanitary and properly labeled; human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective• protecting the public from electronic product radiation• assuring cosmetics and dietary supplements are safe and properly

labeled• regulating tobacco products• advancing the public health by helping to speed product innovations

• helping the public get the accurate science-based information they need to use medicines, devices, and foods to improve their health.

Regulates:• foods, except for most meat and poultry products, which are

regulated by the U.S. Department of Agriculture• food additives• infant formulas• dietary supplements• human drugs• vaccines, blood products, and other biologics

• medical devices, from simple items like tongue depressors, to complex technologies such as heart pacemakers• electronic products that give off radiation, such as microwave ovens

and X-ray equipment• cosmetics• feed, drugs, and devices used for pets, farm animals, and other

animals• tobacco products

•Occupational Safety & Health Administration

"No one should have to sacrifice their life for their livelihood, because a nation built on the dignity of work must provide safe working conditions for its people." Secretary of Labor Thomas E. Perez

•Congress created OSHA to assure safe and healthful working conditions for working men and women by setting and enforcing standards and by providing training, outreach, education and assistance

• OSHA stands for the Occupational Safety and Health Administration, an agency of the U.S. Department of Labor. OSHA's responsibility is worker safety and health protection. The U.S. Congress created OSHA under the Occupational Safety and Health Act of 1970 (the OSH Act). Congress passed the law and established OSHA "to assure so far as possible every working man and woman in the nation safe and healthful working conditions and to preserve our human resources."

• OSHA began because, until 1970, there were no national laws for safety and health hazards.

• The mission of OSHA is to save lives, prevent injuries and protect the health of America's workers.

• To achieve this, federal and state governments work together with more than 100 million working men and women and eight million employers. Some of the things OSHA does to carry out its mission are:• developing job safety and health standards and enforcing them

through worksite inspections,• maintaining a reporting and recordkeeping system to keep track of job-

related injuries and illnesses, and• providing training programs to increase knowledge about occupational

safety and health

• This private, independent not-for-profit organization develops standards for healthcare facilities. Its representatives evaluate healthcare organizations and programs in the U.S. by conducting on-site surveys at least every three years. Failure to comply with its standards can result in the loss of accreditation by the federal and state governments. This, in turn, may cause the loss of millions of dollars in Medicare and Medicaid program payments. Unannounced surveys and direct observation and personal contact with everyone involved in patient care has brought the surveyors directly into the operating room and other procedure locations.

• The Joint Commission's surveys emphasize continuous improvement in the quality of patient care, and its standards may be incorporated by reference into federal, state and/or local statutes, and then become binding on healthcare facilities.

• The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services External Web Site Policy , is the nation’s medical research agency—making important discoveries that improve health and save lives.• NIH is the largest source of funding for medical research in the world,

creating hundreds of thousands of high-quality jobs by funding thousands of scientists in universities and research institutions in every state across America and around the globe.• NIH is made up of 27 Institutes and Centers, each with a specific

research agenda, often focusing on particular diseases or body systems. NIH leadership plays an active role in shaping the agency's research planning, activities, and outlook.

• Learn about the federal rule-making process and how to make your voice heard.• Become informed about the public policy and the

health policy issues currently under consideration at the federal level of government.• Check out the Federal Register. It is the very best

source of information about proposed new rules and changes to existing rules for federal programs. It is printed every day and contains all complete directions on where to send your comments and the deadlines for the public comment period.