Health Care and Anti-Fraud Regulations

Although some areas of business allow significant flexibility in how owners price, market, and provide services, health care is different. Federal and state governments have significant regulations on the health care market to protect patients, ensure fair pricing, and prevent surprise billing. This page contains resources for audiologists and speech-language pathologists about various federal regulations on health care and fraud reduction.

On this page:

• Self-Referral (Stark) Law
• Anti-Kickback Statute
• Exclusion Statute
• Civil Monetary Penalties
• False Claims Act (FCA)
• No Surprises Act
• Health Insurance Portability and Accountability Act (HIPAA)
• National Provider Identifier (NPI)
• Affordable Care Act (ACA)
• Emergency Medical Treatment and Active Labor Act (EMTALA)

Self-Referral (Stark) Law

The Self-Referral (Stark) Law prohibits clinicians from making referrals for designated health services (DHS) paid for by Medicaid and Medicare to an individual or business where they or an immediate family member (spouse, parent, child) have a financial interest. It also forbids the individual or business that receives the referral from sending these claims to Medicare, Medicaid, or another individual, business, or third-party payer. The law does contain a list of exceptions for some financial relationships that do not put the patient or the programs at risk for abuse or misuse. For more information see the Self-Referral (Stark) Law.

Anti-Kickback Statute

Anti-Kickback regulations apply to any services, devices, or medications billable to the Medicare or Medicaid programs. The law prohibits entities from rewarding or inducing patient referrals or other business through knowing and willful payment or remuneration. Put simply, you cannot pay someone or get a “kickback” to refer patients to you or your practice. While some areas of business allow rewarding referrals, this is an illegal practice in health care when billing federal programs. For more information see the Anti-Kickback Statute.

Exclusion Statute

The Exclusion Statue outlines when certain individuals and entities are excluded from participation in Medicare and state health care programs (e.g., Medicaid, Children’s Health Insurance Program [CHIP]). Exclusion applies to individuals and entities that are convicted of specific crimes such as patient abuse, health care fraud, license suspension or revocation, and several other criminal convictions. For more information see the Exclusion Statute.

Civil Monetary Penalties

The Civil Monetary Penalties law provides details on the cost for improper claim submission related to violations of the False Claims Act, Anti-Kickback Statute, Emergency Medical Treatment and Active Labor Act, and other anti-fraud legislation. For more information see the Civil Monetary Penalties.

False Claims Act (FCA)

The False Claims Act outlines provisions and penalties intended to prevent the government from being charged inappropriately for health care goods and services. The act makes it illegal for individuals or entities to (a) submit false or fraudulent claims to Medicare or Medicaid programs or (b) cause a false or fraudulent claim to be submitted. Financial and criminal penalties can be pursued against individuals or entities for being involved in improper claim submission. For more information see the False Claims Act (FCA).

No Surprises Act

The No Surprises Act was enacted to restrict surprise billing and ensure that good-faith estimates are provided for patients paying cash for health care goods and services. The act includes an independent dispute resolution (IDR) process to determine out-of-network payment amounts between health plans and providers or facilities. It also includes an IDR process for patients paying cash (out-of-pocket) and providers or facilities determining required payment amounts. The act also includes a process for appealing certain health plan decisions. For more information see the No Surprises Act.

Health Insurance Portability and Accountability Act (HIPAA)

The Health Insurance Portability and Accountability Act of 1996 (PL 104-191), also known as HIPAA, is a law designed to improve the efficiency and effectiveness of the nation’s health care system. It is intended to protect patients in several ways.

Two main elements of HIPAA apply to health care providers:

• Title I—Health Care Access, Portability, and Renewability
• Title II—Administrative Simplification

Title I protects health insurance coverage when someone loses or changes their job and addresses issues such as pre-existing conditions. Title II includes provisions for the privacy and security of health information under (a) the and (b) the Security Rule. Title I also specifies electronic standards for the transmission of health information and requires unique identifiers for providers (called the National Provider Identifier, or NPI). For more information see the Health Insurance Portability and Accountability Act (HIPAA).

National Provider Identifier (NPI)

The Health Insurance Portability and Accountability Act (HIPAA) established a simplification standard for claims processing known as the National Provider Identifier (NPI). Although the NPI was established under HIPAA, clinicians do not need to be HIPAA-covered entities to obtain an NPI. NPIs are now required on all claims and superbills so that patients can successfully submit claims to their health insurer for out-of-network reimbursement. For more information see National Provider Identifier.

Affordable Care Act (ACA)

The Affordable Care Act provides additional patient protections and expands access to health insurance through several measures. The Act precludes most insurance plans from excluding coverage of pre-existing conditions, expands coverage to young adults under their parents’ plan until the age of 26, offers health care marketplace insurance plans and subsidies for low-income individuals, offers options for states to expand their Medicaid programs, and supports innovation in health care delivery models. For more information see the Affordable Care Act (ACA).

Emergency Medical Treatment and Active Labor Act (EMTALA)

The Emergency Medical Treatment and Active Labor Act requires Medicare-participating hospitals that offer emergency services to provide a medical screening examination (MSE) when requested by a patient—regardless of their ability to pay. If an emergency medical condition (EMC) is identified, then the act also requires the hospital to provide stabilizing treatment; this includes patients who are in active labor. If the hospital is unable to provide the proper stabilizing care, then that hospital (and staff) must appropriately transfer the patient to a hospital that can stabilize their condition. The Act establishes penalties for hospitals who do not comply with these requirements. For more information see the Emergency Medical Treatment and Active Labor Act (EMTALA).