Healthcare Regulatory Compliance

A federal law that prevents hospitals from transferring patients without providing a medical screening exam to ensure they are stable.

It ensures that individuals with health insurance plans can't be denied coverage or charged higher premiums for pre-existing conditions.

It's a set of regulations that require healthcare providers to use electronic health records (EHRs) to improve patient care and efficiency.

It's a law that sets national standards for protecting patient privacy and security of electronic health information.

It's a government program that provides health insurance to low-income Americans.

It's a government program that provides health insurance to people aged 65 and older or who have a disability.

It's a set of guidelines that hospitals must follow to participate in the Medicare and Medicaid programs.

It's a system of paying healthcare providers based on the quality of care they provide, rather than the quantity of services.

The FDA protects public health by ensuring the safety, efficacy, and security of medications, medical devices, food, cosmetics, and products that emit radiation. They also play a crucial role in national counterterrorism efforts, securing the food supply, and developing medical products to address public health threats.

The HRSA provides equitable healthcare to individuals who are geographically isolated or in need due to economic or medical vulnerability. Its programs support healthcare infrastructure, including training and distributing health professionals, providing financial assistance to healthcare providers, and advancing health initiatives.

The IHS is responsible for providing federal health services to American Indians and Alaska Natives. It's the primary federal health center provider for these populations, advocating for their health well-being.

The NIH is the primary U.S. medical research agency, supporting and conducting research to improve health and save lives. It supports both domestic and international research, trains aspiring young researchers, and promotes the sharing of medical knowledge.

The OIG works tirelessly to combat fraud, waste, and abuse in healthcare programs, specifically focused on improving the efficiency of Medicare, Medicaid, and other HHS programs. They are the largest inspector general's office in the federal government, overseeing Medicare and Medicaid.

A federal agency that leads public health efforts to advance behavioral health in the United States, aiming to reduce the impact of substance abuse and mental illness.

A system where a health plan manages costs, utilization, and quality of care for its members. It involves health plans paying for medical services.

The federal government regulates health plans sponsored by the private sector, while states regulate the business of insurance, which includes managed care organizations like HMOs.

The Employee Retirement Income Security Act of 1974 preempted states from regulating health plans offered by private sector employers, leaving insurance regulation to the states.

Almost all regulatory authority over health insurance remained with the states, except certain federal standards for HMOs that opted to operate under federal law.

If a private employer self-insures and contracts with an MCO, the plan is regulated by the state if the MCO bears the risk, but by federal law if the employer bears any risk.

The complex division of regulatory responsibilities between federal and state governments resulted from federal laws and court decisions.

Healthcare quality professionals work directly with HHS regional offices and state-level agencies on issues related to managed care.

The federal government sets minimum healthcare quality standards for providers participating in Medicare and Medicaid programs, ensuring patient safety and quality care.

CMS, or the Centers for Medicare and Medicaid Services, creates "Conditions of Participation" (CoP) and "Conditions for Coverage" (CfC) that healthcare organizations must meet to participate in Medicare/Medicaid.

A patient care institution, like a hospital, hospice, or nursing home, that participates in Medicare and receives reimbursement for services.

An agency providing diagnosis or therapy, but not sustained patient care, like a lab, clinic, or ambulatory surgery center.

The Social Security Act, initially for retirees and unemployed, was amended in 1965 to create Medicare and Medicaid, extending healthcare benefits to the elderly and low-income individuals.

HIPAA (Health Insurance Portability and Accountability Act) of 1996 mandated federal minimum requirements for state-regulated insurers and employer-sponsored plans, including managed care.

State laws and regulations governing managed care often draw inspiration from the National Association of Insurance Commissioners HMO Model Act, ensuring standardized practices.

The National Association of Insurance Commissioners (NAIC) publishes model laws to guide state regulations for various aspects of managed care, including quality assessment, provider credentialing, and network adequacy.

A federal database that tracks information about healthcare providers, including adverse actions and malpractice payments, primarily to protect patients.

The process by which a healthcare organization loses its ability to receive federal reimbursement for services after failing to meet required compliance standards.

A federal law requiring hospitals to provide a medical screening exam to all patients before transferring them, ensuring they are stable.

A federal law that sets national standards for protecting patient privacy and security of electronic health information.

A federal law that requires healthcare providers to use electronic health records (EHRs) to improve patient care and efficiency.

Guidelines that healthcare organizations must follow to qualify for Medicare and Medicaid reimbursements.

A payment system where healthcare providers are paid based on the quality of care they provide, encouraging better outcomes.

A data bank created to track Medicare and Medicaid providers, primarily to alert users about potential quality issues.

An official authorization or approval granted by a private organization, confirming adherence to specific standards. It's a voluntary process for organizations to demonstrate quality.

A recognition for meeting specific standards and qualifications within a field, granted by either private organizations or government agencies.

Programs that provide information about healthcare providers' quality to help employers, insurers, and patients make informed decisions.

A process of reviewing an entire healthcare organization's operations to ensure compliance with quality standards. It's like getting a comprehensive check-up for the whole organization.

A process of reviewing specific aspects of a healthcare organization's operations or care for a particular population or competency. It's like focusing on a specific area for an exam.

Federal regulations that mandate all laboratories conducting human testing must be certified to receive Medicare or Medicaid payments.

The requirement under the Mammography Quality Standards Act for all mammography facilities to be certified by the FDA.

An organization that performs laboratory inspections based on standards deemed equivalent or more stringent than CMS requirements. Their inspection satisfies CMS's requirement.

It involves healthcare quality professionals spending significant time, effort, and resources to comply with complex and ever-changing regulatory requirements. This often includes research, interpretation, and demonstration of compliance.

It's a comprehensive process where a private organization reviews an entire healthcare organization's operations to ensure compliance with quality standards. It's like a thorough check-up for the whole organization.

This type of certification focuses on evaluating specific aspects of a healthcare organization's operations or care for a particular population or competency. It's like focusing on a specific area for an exam.

This involves government agencies or private organizations recognizing organizations or individuals for meeting specific standards and qualifications within a field. It shows they meet the criteria for a particular skill or knowledge area.

Hospitals, hospices, or nursing homes that provide sustained patient care and participate in Medicare are considered 'providers.' They receive reimbursement for services they offer.

An official government publication that contains daily updates on rules, proposed rules, and notices of federal agencies and organizations.

A codification of rules published in the Federal Register, divided into 50 titles representing broad areas of federal regulation.

A publicly available document that outlines the annual priorities of selected federal agencies, helping healthcare quality professionals understand future directions for regulations.

A process where a private organization reviews an entire healthcare organization's operations to ensure compliance with quality standards.

A process of reviewing specific aspects of a healthcare organization's operations or care for a particular population or competency.

A federal database that tracks information about healthcare providers, including adverse actions and malpractice payments.

The 21st Century Cures Act, passed in 2016, aims to improve the flow and use of electronic health information, including promoting interoperability, stopping 'information blocking,' and enhancing the security and usability of health IT. It also provides clarity on HIPAA privacy rules and strengthens support for mental health and substance use services.

The U.S. Department of Health and Human Services (HHS) is a massive government agency with 11 divisions, including eight public health service agencies and three human services agencies. Its mission is to enhance the health and well-being of Americans by providing effective services and advancing research in medicine, public health, and social work. It works collaboratively with state and local governments to ensure these critical services reach individuals, families, and communities.

Interoperability in healthcare refers to the smooth exchange and use of electronic health information without any special effort from the user. It ensures seamless communication between different healthcare systems and providers.

Information blocking is the intentional or unintentional practice of restricting or delaying the access, exchange, or use of electronic health information. The Cures Act aims to prevent such practices to ensure smooth and uninterrupted flow of health data.

The Health Resources & Services Administration (HRSA) focuses on providing equitable healthcare to individuals in need, particularly those who are geographically isolated or facing economic or medical vulnerabilities. Its programs support healthcare infrastructure by training and distributing health professionals, providing financial assistance, and promoting health initiatives.

A division of the U.S. Department of Health and Human Services (HHS) that helps children, families, and communities thrive by providing programs and resources to promote well-being and development.

A division of HHS that promotes the well-being of older Americans and people with disabilities by providing support and resources to access community services.

A division of HHS that focuses on improving the quality of healthcare by researching and creating evidence-based practices to make healthcare safer, more effective, and affordable.

A division of HHS that protects public health by preventing exposure to harmful substances and mitigating the associated health risks, ensuring a safe environment for people.

A division of HHS that safeguards the nation from various health threats, from local outbreaks to international pandemics, working both domestically and globally to ensure the health security of the United States.

A division of HHS that oversees various health insurance programs, including Medicare, Medicaid, and the Children's Health Insurance Program (CHIP), to ensure the quality and accessibility of healthcare for millions of Americans.

A division of HHS that leads public health efforts to address substance abuse and mental illnesses across the country, striving to reduce the impact of these challenges and improve the well-being of individuals and communities.

A voluntary process by which a private organization reviews a healthcare organization's entire operations to ensure compliance with quality standards.

A process by which a private organization or government agency formally recognizes that an individual or organization has met established standards and qualifications for a specific competency or area of practice.

Accreditation is a voluntary process, while Certification is a formal recognition – often required by law.

Accreditation looks at the overall operations, while Certification focuses on specific areas like competency or patient populations.

CLIA regulations require all clinical laboratories performing tests on humans to be certified by CMS or accredited by a CMS-approved accrediting organization.

The Mammography Quality Standards Act requires all facilities providing mammography services to be certified by the FDA. This ensures the quality and safety of mammograms across the country.

Private organizations that provide oversight and standards for healthcare, often supplementing government regulators.

Continuous monitoring and adjustments within a healthcare organization to ensure compliance with federal and state regulations, accreditation standards, and contractual obligations.

State agencies responsible for enforcing healthcare regulations and ensuring compliance with state-specific laws.

Documents issued to organizations by state agencies that detail areas of non-compliance with healthcare regulations, requiring organizations to submit written corrective actions.

Private organizations like The Joint Commission that set standards for healthcare organizations and evaluate their adherence.

The process of regularly checking and improving a healthcare organization's compliance with regulations, standards, and contracts. It's like ongoing maintenance to ensure everything runs smoothly.

State-level agencies responsible for enforcing healthcare regulations that are specific to that state.

These are official documents sent to organizations that outline areas where they are not complying with healthcare regulations. They require the organization to explain how they will fix these issues.

They are like the 'gold standard' for healthcare organizations, providing external validation that the organization meets certain quality standards.

The process of reviewing an entire healthcare organization, looking at all aspects of their operations to ensure they meet specific quality standards.

It is the evaluation of specific parts of a healthcare organization's operations or care for a particular type of patient or skill.

A law passed in 2005 to create a framework for patient safety organizations, identify and reduce risks to patient safety, and report and analyze data related to near misses and patient safety events. It encourages a culture of safety through anonymous reporting, confidentiality, and legal protection for reporters.

Comprehensive health insurance reforms enacted in 2010 to transform the U.S. healthcare system. It aimed to improve affordability and accessibility, particularly for those with pre-existing conditions, and promote value-based care.

This Act, passed in 2015, established the Quality Payment Program, which impacts how healthcare providers are reimbursed through a merit-based incentive payment system and alternate payment models. It incentivizes quality over quantity of care.

A law passed in 2016 that aimed to improve the flow and use of electronic health information. This includes promoting interoperability, stopping "information blocking," and enhancing the security and usability of health IT.

The federal government regulates health plans sponsored by private employers, while states regulate the business of insurance, including managed care organizations (MCOs).

ERISA preempted states from regulating health plans offered by private sector employers, leaving insurance regulation to the states, creating a complex regulatory system.

Healthcare quality professionals work directly with HHS regional offices and state-level agencies on issues related to managed care.

The federal government plays a role in directing laws and regulations for managed care, ensuring cost containment, utilization control, and quality standards.

The FDA protects public health by ensuring the safety, efficacy, and security of drugs, medical devices, food, cosmetics, and radiation-emitting products. They also play a crucial role in national security by safeguarding the food supply and developing medical countermeasures against public health threats.

HRSA provides equitable healthcare to vulnerable individuals, especially those who are geographically isolated or economically or medically disadvantaged. They support healthcare infrastructure by training and distributing health professionals, providing financial assistance, and advancing health initiatives.

IHS is responsible for providing federal health services to American Indians and Alaska Natives. They serve as the primary federal health center provider and advocate for this population's well-being and health status.

NIH is the leading medical research agency in the U.S., conducting and supporting research to improve health and save lives. They fund research both domestically and internationally, train aspiring researchers, and promote the sharing of medical knowledge.

OIG is dedicated to combating fraud, waste, and abuse in healthcare programs, particularly Medicare and Medicaid. They oversee these programs to ensure efficiency and protect vulnerable populations from exploitation.

Interoperability refers to the seamless exchange and use of electronic health information between different systems and providers without any special effort from the user.

The process of ensuring that electronic health information can be easily shared and used between different healthcare systems and providers without any special effort from the user.

The intentional or unintentional practice of restricting or delaying access, exchange, or use of electronic health information.