Tessa Quinn
Hospitals are among the most regulated environments in the United States, with numerous regulatory bodies monitoring health procedures, treatments, and operations. These regulatory agencies ensure hospitals meet federal, state, and local laws, standards, and requirements. Some of the key regulatory agencies include the Department of Health and Human Services (HHS), the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the Federal Communications Commission (FCC). These agencies oversee various aspects of hospital operations, from patient treatment programs and reimbursements to the safety and effectiveness of medical products and services. Additionally, hospitals are regulated through certification requirements, such as those set by The Joint Commission, and federal laws governing patient treatment and reimbursement criteria.
| Characteristics | Values |
|---|---|
| Regulatory bodies for hospitals | The Joint Commission, Det Norske Veritas Healthcare, the Center for Improvement in Healthcare Quality, the Healthcare Facilities Accreditation Program, and the Organ Procurement and Transplantation Network (OPTN) |
| Regulatory body for hospital construction | Department of Housing and Urban Development (HUD), Department of Buildings, Facility Guidelines Institute for Design and Construction (FGI) |
| Regulatory body for hospital equipment | Centers for Medicare and Medicaid Services (CMS), Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA) |
| Regulatory body for hospital telecommunications | Federal Communications Commission (FCC) |
| Regulatory body for hospital emergency helicopters | Federal Aviation Administration (FAA) |
| Regulatory body for hospital ambulances and mobile clinics | Department of Transportation's Emergency Medical Services (DOT) |
| Regulatory body for hospital finances | Internal Revenue Service (IRS), Treasury Department, Securities and Exchange Commission (SEC), Federal Bureau of Investigations |
| Regulatory body for hospital patient rights | Federal Trade Commission (FTC) |
| Regulatory body for hospital quality of care | Centers for Disease Control and Prevention, Agency for Healthcare Research and Quality (AHRQ), National Committee for Quality Assurance, Hospital Quality Alliance, National Quality Forum |
| Regulatory body for hospital research | HHS, HIPAA Privacy Rule, Health Information Technology for Economic and Clinical Health (HITECH) Act |
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What You'll Learn
The US Department of Health and Human Services (HHS)
The Office of the Secretary (OS) is HHS’s chief policy officer and general manager and is responsible for administering and overseeing the organization, its programs, and its activities. The Deputy Secretary and a number of Assistant Secretaries and Offices support the OS.
HHS includes the Agency for Healthcare Research and Quality, which aims to produce evidence to make healthcare safer, more accessible, equitable, and affordable, and to ensure that this evidence is understood and used. The Centers for Disease Control and Prevention is also part of HHS and is responsible for protecting the public health of the nation by providing leadership and direction in the prevention and control of diseases and other preventable health conditions, as well as responding to public health emergencies.
Another division within HHS is the Administration for Children & Families, which promotes the economic and social well-being of families, children, individuals, and communities through educational and supportive programs in partnership with states, tribes, and community organizations.
HHS also includes the Agency for Toxic Substances and Disease Registry, which works to prevent exposure to toxic substances and the adverse health effects and diminished quality of life associated with exposure to hazardous substances from waste sites, unplanned releases, and other sources of environmental pollution.
HHS is subject to Section 508, a law that states that whenever the federal government develops, procures, maintains, or uses ICT, employees and members of the public with disabilities must have the same or comparable access as those without disabilities.
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The Food and Drug Administration (FDA)
The FDA's primary focus is on enforcing the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, such as Section 361 of the Public Health Service Act. The FDA's regulatory scope extends beyond food and drugs, encompassing the regulation of lasers, cell phones, and condoms.
In terms of drug advertising regulation, the FDA requires that companies may only advertise or promote a drug for its specific indicated or medical use. Additionally, advertisements must present a "fair balance" between the benefits and risks (side effects) of the drug. The FDA oversees the advertising of prescription drugs, while the Federal Trade Commission (FTC) regulates over-the-counter (OTC) drugs.
The FDA also plays a role in approving new drug therapies. For instance, the 2024 New Drug Therapy Approvals report highlights drug approvals expected to significantly impact public health. Furthermore, the FDA works collaboratively with other federal agencies, including the Department of Agriculture, the Drug Enforcement Administration, Customs and Border Protection, and the Consumer Product Safety Commission.
The FDA is led by the commissioner of food and drugs, who is appointed by the president with the Senate's advice and consent. The commissioner reports to the secretary of health and human services. The FDA has an extensive presence across the United States, with 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico.
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The Centers for Medicare and Medicaid Services (CMS)
CMS has several other responsibilities, including administrative simplification standards from the Health Insurance Portability and Accountability Act of 1996 (HIPAA), quality standards in long-term care facilities (commonly known as nursing homes), and oversight of HealthCare.gov. CMS actively inspects and maintains a 5-Star Quality Rating System for nursing homes across the United States.
In addition, CMS is committed to encouraging the development and use of evidence-based medicine through regulatory incentives and partnerships with various organizations. CMS's Coverage with Evidence Development protocol, clinical trials policy, and use of registries support this work. They collaborate with entities such as the Agency for Healthcare Research and Quality (AHRQ) and the National Committee for Quality Assurance to develop and implement quality measures.
CMS also plays a role in accelerating progress in healthcare delivery. While CMS primarily regulates reimbursement for healthcare products and services, it shares an interest with other agencies like the Food and Drug Administration (FDA) in the safety and effectiveness of pharmaceuticals, medical devices, and healthcare services. CMS has proposed initiatives like the Transitional Coverage for Emerging Technologies (TCET) pathway to improve access to innovative treatments.
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The Internal Revenue Service (IRS)
The IRS's duties include providing tax assistance to taxpayers, addressing erroneous or fraudulent tax filings, and overseeing benefits programs such as the Affordable Care Act. It was established to collect the revenue required to fund the federal government, with the remaining funds sourced from the US Customs and Border Protection and the Federal Reserve. The IRS has faced criticism and opposition over its methods, constitutionality, and the broader principle of taxation.
The origins of the IRS can be traced back to 1862, when the Office of Commissioner of Internal Revenue was established to assess the nation's first income tax to fund the American Civil War. This temporary measure funded a significant portion of the Union's war expenses. In 1913, the Sixteenth Amendment to the US Constitution was ratified, authorizing Congress to impose a tax on income, which led to the creation of the Bureau of Internal Revenue.
The Bureau underwent a reorganization in 1952 following incidents of tax evasion and bribery among its employees. This reorganization decentralized functions to new district offices, replacing the collector's offices with civil service directors. In 1953, the Bureau was renamed the Internal Revenue Service, and it has since undergone numerous reforms, particularly in the 1990s.
In recent years, the IRS has faced challenges such as budget cuts, staffing reductions, outdated technology, and low morale, which have impacted the enforcement of tax laws. Despite these issues, the agency processed over 271.4 million tax returns during the 2023 fiscal year, collecting approximately $4.7 trillion, which accounts for about 96% of the operational funding for the federal government.
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The Environmental Protection Agency (EPA)
In the United States, the Environmental Protection Agency (EPA) is responsible for protecting public health and the environment. It was established in 1970 by President Richard Nixon, who made the environment a policy priority from 1969 to 1971. The EPA was created through an executive reorganization that consolidated the environmental responsibilities of the federal government under one agency. This included merging pollution control programs from various departments, such as the combination of pesticide programs from the Agriculture and Interior departments.
The creation of the EPA was a response to increasing public concern about the impact of human activity on the environment in the 1950s and 1960s. Senator James E. Murray introduced the Resources and Conservation Act (RCA) in 1959, which would have established a Council on Environmental Quality. However, the bill did not pass Congress. The publication of Rachel Carson's best-selling book, "Silent Spring" in 1962, further alerted the public to the detrimental effects of human activity on the environment. The burning Cuyahoga River in Cleveland, Ohio, in 1969, led to a national outcry and criminal charges against major steel companies, highlighting the need for an agency dedicated to environmental protection.
The EPA's work encompasses a range of initiatives, including remediating contaminated sites, ensuring clean drinking water, and promoting the use of electric vehicles. The agency also conducts research and provides educational resources to the public, such as webinars on understanding drinking water safety. The EPA's staff consists of engineers, scientists, environmental protection specialists, legal experts, public affairs professionals, financial analysts, and information technologists. They work together to address environmental challenges and find solutions that benefit the American people and the environment.
One example of the EPA's involvement in environmental protection is the case against Monsanto, a company accused of causing glyphosate-related non-Hodgkin's lymphoma. In 2017, litigation revealed emails suggesting that Monsanto had influenced research conducted by academics and that an EPA official had tried to prevent a review of glyphosate, the main ingredient in Monsanto's product Roundup. This case highlighted the importance of the EPA's role in regulating and holding accountable companies that may pose environmental and health risks.
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Frequently asked questions
The Department of Health and Human Services (HHS) is the US hospital regulatory agency. It comprises multiple divisions and agencies within the US Public Health Service and three human services agencies. The Centers for Medicare and Medicaid Services (CMS) is another regulatory agency that falls under HHS.
Here are some examples of regulatory agencies outside the US:
- National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria
- Ministry of Health and Care Services (HOD) in Norway
- Drug Regulatory Authority of Pakistan (DRAP)
- Ministry of Health, also known as el Ministerio de Salud, in Panama
- Health Sciences Authority (HSA) in Singapore
- Ministry of Health & Medical Services in Fiji
- Romanian Ministry of Health (MS)
The US hospital regulatory agency, HHS, has multiple functions, including:
- Conducting vital, life-saving research to protect and support Americans
- Ensuring the safety and effectiveness of pharmaceuticals, medical devices, and healthcare services
- Creating regulations or "rules" to help the government carry out public policy
- Promoting the economic and social well-being of families, children, individuals, and communities
