Healthcare compliance consists of an organization’s complying with federal, state, and local healthcare laws. Federal healthcare compliance laws regulate public health, healthcare providers, health insurers, and eligibility for treatment and insurance.
What are the Federal Healthcare Compliance Laws?
Many of the major U.S. federal healthcare compliance laws are amendments to the largest and most well-known public health law in the United States is the Public Health Service Act (PHSA), passed in 1944. The Act established the authority of the federal government to quarantine individuals to prevent the introduction, transmission, and spread of communicable disease from foreign countries into the U.S.
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Some notable healthcare compliance amendments to the PHSA are those establishing or increasing federal funding for specific diseases and illnesses, and those providing funding for vulnerable populations, such as low-income, uninsured, homeless, and minor (children) individuals. These healthcare compliance amendments include:
- The National Cancer Act of 1971: This law amended the Public Health Service Act so as the federal government could more effectively carry out the national effort against cancer.
- The Ryan White CARE Act of 1990: The Ryan White CARE Act provides for the largest federally funded program in the United States for people living with HIV/AIDS. The Act provides for funding to improve availability of and access to care for low-income, uninsured, and under-insured people affected by HIV/AIDS and their families.
- The Health Center Consolidation Act of 1996: This law provides funding mechanisms for the country’s community health facilities, and healthcare for the homeless, health centers and health centers for public housing residents.
- The Children’s Health Insurance Program (CHIP): CHIP was signed into law in 1997 and provides federal matching funds to states to provide health coverage to children in families with incomes too high to qualify for Medicaid, but who cannot afford private coverage.
- The National Institute of Biomedical Imaging and Bioengineering Establishment Act of 2000 (NIBIB): The purpose of NIBIB was to integrate the physical and engineering sciences (i.e., physics) with the life sciences (i.e., chemistry, biology) to advance basic research and medical care
- Muscular Dystrophy Community Assistance Research and Education Amendments of 2001: These amendments provide for research with respect to the various forms of muscular dystrophy.
- Hematological Cancer Research Investment and Education Act of 2001: This Act allocated funding and establishes directed research and education programs targeted at blood cancer, including leukemia, lymphoma, and multiple myeloma.
- The Newborn Screening Saves Lives Act of 2007: This amendment to the PHSA established grant programs concerning newborn screening education and outreach, and established grant programs to coordinate follow-up care, after newborn screening is conducted.
What are Other Major Healthcare Compliance Laws?
Other healthcare compliance laws regulate the provision, quality, portability, privacy, and security of health services and/or information. These other major healthcare compliance laws include:
- Medicare and Medicaid: In 1965, President Lyndon Johnson signed the Social Security Amendments of 1965 into law, thus creating Medicare and Medicaid for elderly and low-income individuals.
- The Employee Retirement Income Security Act (1974): Most private sector health plans are covered by the Employee Retirement Income Security Act (ERISA). Among other things, ERISA provides protections for participants and beneficiaries in employee benefit plans (participant rights), including providing access to plan information.
- The Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA): Under COBRA, eligible employees and their dependents receive the continued benefits of health insurance coverage in the case that an employee loses his or her job or experiences a reduction of work hours.
- The Healthcare Quality Improvement Act (HCQIA) of 1986: HCQIA is a federal law that provides immunity for medical professionals and institutions during conduct (i.e., peer review) assessments. The law was enacted to healthcare providers from peer review-related lawsuits and to encourage physicians to file official complaints after encountering unprofessional and dangerous peer conduct.
- The Emergency Medical Treatment and Active Labor Act of 1986 (EMTALA): EMTALA applies to hospitals that accept Medicare patients, Under EMTALA, hospitals may not transfer or discharge patients needing emergency treatment, except if the patient consents to the transfer or discharge; when the patient is stabilized; or when the patient’s condition requires transfer to a hospital better equipped to administer treatment.
- The Newborns’ and Mothers’ Health Protection Act (the Newborns’ Act of 1996): The Newborns’ Act provides protections for mothers and their newborn children relating to the length of their hospital stays following childbirth.
- The Health Insurance Portability and Accountability Act of 1996 (HIPAA): HIPAA regulates insurance coverage in group and individual markets; contains provisions for combating waste, fraud, and abuse in healthcare insurance and delivery; and simplifies administration of health insurance by requiring national standards for the privacy and security of patient health information.
- The Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009: The HITECH Act was enacted in 2009, to promote the adoption and meaningful use of health information technology.
- The Patient Protection and Affordable Care Act of 2010 (The Affordable Care Act): The Affordable Care Act, which is the most significant healthcare reform legislation in modern America, made numerous changes to existing healthcare compliance law. The ACA modifies CHIP; expands Medicaid eligibility; requires health insurers to provide minimum essential coverage; requires employers of at least 50 full-time and/or full-time equivalent employees to offer affordable health care coverage that provides a minimum level of coverage, or pay a penalty; eliminates lifetime caps on insurance company medical benefits payments; and (among other things) requires insurers to offer health insurance policies on a “guaranteed issue” basis; that is, to offer insurance to any eligible applicant without regard to that person’s health status.
- The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA): MACRA created a quality payment program for Medicare that encourages providers to provide value over volume. MACRA streamlines multiple quality programs under a new Merit Based Incentive Payment System, with the acronym of “MIPS.”
- The 21st Century Cures Act: This law, signed in 2016, is designed to accelerate the discovery, development, and delivery of 21st century cures, by streamlining drug and device approval processes, and bringing treatments to market faster.