Laws and regulations that govern laboratories from Medicare Compliance for Clinical Laboratories, presented by MediaLab

Introduction: Laws and Regulations

Laws and regulations that govern laboratories

Social Security Act:
- Medicare and Medicaid laws are in this act.
- Medicare rules and regulations come under this act.
Antikickback laws:
- Provide criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit or receive money or favors for referrals of tests or services that will be paid for by the Medicare or Medicaid programs.
False Claims Act:
- Provides criminal penalties for knowingly or willingly filing a false claim to a government program.
Self Referral (Stark) laws and regulations:
- Identify financial relationships that have the potential to result in directed referral to one or both of the individuals or entities involved.
- Prohibit the referral of patients or tests between related entities unless certain conditions are met.
Health Insurance Portability and Accountability Act (HIPAA)
- Prohibits health care providers and payers from improper or inappropriate use of a patient's confidential health information
- Requires health care providers to insure that a patient's confidential information is kept secure
- Provides for standardized electronic formats for all health care transactions

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