It can be overwhelming to know and understand all the regulations that apply to the health care industry and to know which regulatory agency is responsible for the enforcement of certain requirements. Because it can get confusing, and because it’s so important that we understand who does what and why, I thought it was time to talk about regulations, to break down the regulatory agencies who govern and have oversight for health care and review why they’re important and how they impact each of us on a daily basis.

Regulation plays a major role in the health care industry and health care insurance coverage. The various regulatory bodies protect the public from a number of health risks and provide numerous programs for public health and welfare. Together, these regulatory agencies protect and regulate public health at every level. Health care regulations are developed and implemented not only by all levels of government (federal, state and local) but by private organizations as well.

Health care regulations and standards are necessary to ensure compliance and to provide safe health care to every individual who accesses the system. The health care regulatory agencies in turn monitor practitioners and facilities, provide information about industry changes, promote safety and ensure legal compliance and quality services.

Federal, state and local regulatory agencies often establish rules and regulations for the health care industry, and their oversight is mandatory. Some other agencies, such as those for accreditation, require voluntary participation but are still important because they provide rankings or certification of quality and serve as additional oversight, ensuring that health care organizations promote and provide quality care.

Here in Maryland, the Office of Health Care Quality (OHCQ) is the agency within the Department of Health & Mental Hygiene charged with monitoring the quality of care in Maryland’s 14,000 health care and community residential programs. OHCQ licenses and certifies the majority of the state’s health care facilities, uses the state and federal regulations that set forth minimum standards for provision of care and conducts surveys to determine compliance. OHCQ also educates providers, consumers and other stakeholders through written materials, presentations, its website, conferences and seminars.

Some other regulatory agencies that protect and regulate public health are:

The Centers for Medicare and Medicaid (CMS) oversee most of the regulations related directly to the health care system. CMS provides government-subsidized medical coverage through a number of programs:

Medicare for the elderly and disabled
Medicaid for lower-income individuals and families
State Children’s Health Insurance Program (SCHIP) for health insurance coverage for children under 19

CMS is also responsible for ensuring compliance to the Health Insurance Portability and Accountability Act (HIPAA). HIPAA, which works to reduce costs while protecting patients and providing better medical care, is a major piece of health care regulation and was instituted to improve the efficiency and effectiveness of the health care system.

The Agency for Healthcare Research and Quality (AHRQ) is another agency that falls under the U.S. Department of Health & Human Services (HHS). It conducts research aimed at improving the quality of health care, reducing costs and addressing patient safety and medical errors.

There are also several non-profit organizations that serve as watchdogs and accreditation institutions for health care in America:

The Joint Commission on Accreditation of Health Care Organizations (JCAHO) works to ensure that health Care organizations provide quality care. JCAHO employs a system in which health care organizations are examined and then given a score of 1-100, with higher scores being better. These scores are important to health care organizations as they are a factor when determining reimbursement from Medicare.
The National Committee for Quality Assurance (NCQA) ensures the quality of managed care plans. It was established in 1991 to provide standard and objective information about HMOs.

Other Public Health Regulation

In addition to the CMS programs, the HHS has many other regulatory departments that oversee other forms of public health regulation.

The Centers for Disease Control and Prevention (CDC) in Atlanta examines public health and warns of possible health threats from infectious diseases. The CDC monitors birth defects, disabilities, diseases and conditions, emergency preparedness and response, environmental health, genetics and genomics, health promotion, injury and violence, travelers’ health, vaccines and immunizations and workplace safety and health. The CDC is currently working closely with national, local and international health organizations, including the World Health Organization, to control the transmission of the Ebola virus.
The Food and Drug Administration (FDA) is the federal regulatory agency responsible for controlling the safety and effectiveness of the country’s drug supply for both humans and animals. The FDA regulates food safety, cosmetics, feed supply for animals, dietary supplements and biologics as well as the national blood supply, medical devices, food additives, product recalls and restaurant inspections.
The United States Agency for Toxic Substances and Disease Registry (ATSDR) monitors and regulates the effects of hazardous materials on public health. The ATSDR responds to hazardous material threats, educates the public on HAZMAT risks and encourages community members and organizations participation.
The Environmental Protection Agency (EPA), another federal agency, was created to protect human health and the environment through the writing and enforcing of regulations based on laws passed by Congress.

Essentially, all areas of health care, including but not limited to physicians, medical directors, health care computer technology companies, health care facilities and pharmaceutical companies, are subject to regulatory review and compliance. It is important that you recognize which regulations apply to you and seek clarification as needed in order to adequately comply with those regulations. Remember, the primary reason for health care regulation, while sometimes confusing, is to ensure that the care being provided by health care practitioners and health care facilities is safe and effective for all everyone who accesses the health care system.

Healthcare Regulations: Who Does What?