Healthcare Compliance
The Healthcare Compliance Experts
Health Insurance Portability and Accountability Act (HIPAA) - Privacy, Security, and Breach Notification Rules
-
HIPAA Privacy Rule: Establishes standards for the protection of individually identifiable health information, including requirements for the use and disclosure of health information by covered entities and their business associates.
-
HIPAA Security Rule: Sets forth standards for the security of electronic protected health information (ePHI), including administrative, physical, and technical safeguards.
-
HIPAA Breach Notification Rule: Requires covered entities to notify individuals, the Department of Health and Human Services (HHS), and, in some cases, the media, following a breach of unsecured protected health information (PHI).
Health Information Technology for Economic & Clinical Health Act (HITECH Act)
-
Expands on HIPAA's privacy and security provisions and establishes requirements for the adoption of electronic health records (EHRs) and the protection of ePHI.
-
​Provides incentives for the meaningful use of EHRs by healthcare providers and strengthens penalties for non-compliance with HIPAA regulations.
Affordable Care Act (ACA)
-
Contains provisions related to healthcare fraud and abuse, including the establishment of the Health Care Fraud Prevention and Enforcement Action Team (HEAT) to combat fraud and improper payments in Medicare and Medicaid.
False Claims Act (FCA)
-
Imposes liability on individuals or entities that knowingly submit false or fraudulent claims to government programs, including Medicare and Medicaid.
Stark Law (Physician Self-Referral Law
-
Prohibits physicians from referring patients for certain designated health services to entities with which they have a financial relationship, unless specific exceptions apply.
Anti-Kickback Statute (AKS)
-
​Prohibits offering, paying, soliciting, or receiving remuneration in exchange for referrals of federal healthcare program business.
Medicare Access and CHIP Reauthorization Act (MACRA)
-
Reforms Medicare payment systems and promotes the use of quality-based payment models, such as the Merit-based Incentive Payment System (MIPS) and Alternative Payment Models (APMs).
Controlled Substances Act (CSA)
-
​Regulates the manufacture, distribution, and dispensing of controlled substances, including prescription drugs with potential for abuse.
Drug Supply Chain Security Act (DSCSA)
-
​Regulates the manufacture, distribution, and dispensing of controlled substances, including prescription drugs with potential for abuse.
Clinical Laboratory Improvement Amendments (CLIA)
-
Establishes quality standards for laboratory testing and requires clinical laboratories to be certified by the Centers for Medicare and Medicaid Services (CMS).
Federal Food, Drug, and Cosmetic Act (FDCA)
-
Regulates the safety, effectiveness, and labeling of drugs, medical devices, cosmetics, and food products.