In understanding regulatory agencies the differences between regulation and legislation needs defining. Legislation is the law that has been passed by a voting process and regulation is the responsibility of the regulatory board appointed to enforce laws once the law is passed; it sets forth rules on how the laws are to be implemented and to what degree. In health care the Department of Health and Human Services (HHS) has the predominant responsibility to enforce legislation that impacts the health and well-being of Americans. Under the umbrella of HHS there are 13 regulatory agencies tasked with setting rules on the enforcement of the legislation passed by lawmakers.
Regulatory Agencies
Two of the most influential regulatory agencies within HHS are the United States Food and Drug Administration (FDA) and the Center for Medicare and Medicaid Services (CMS), these two agencies have substantial influence on every aspect of health care delivery. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, medical devices, drugs, vaccines, blood products and biologics. In addition, they monitor medical errors and adverse reactions and reporting such to providers, (U.S. Department of Health and Human Services, 2011). CMS controls the Medicare program and works in collaboration with state governments to oversee Medicaid, and the State Children 's Health Insurance Program (SCHIP). In addition to these responsibilities, CMS dispenses criteria from the Health Insurance Portability and Accountability Act of 1996 (HIPAA), surveys and certifies quality standards in long-term care facilities, and clinical laboratories, (Centers for Medicare and Medicaid Services). The proportion of national health spending sponsored by both federal, state, and local governments was 45% in 2010, a significant source of revenue depended on by providers of health care, (Centers for Medicare
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