Laws and Regulations Applicable to Medicare

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The page below is a sample from the LabCE course Medicare Compliance for Clinical Laboratories (retired 2/17/2021). Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Laws and Regulations Applicable to Medicare

  • Social Security Act:
    • Includes Medicaid and Medicare rules and regulations.
  • Anti-kickback 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 Medicare 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 improperly or inappropriately using a patient's confidential health information.
    • Requires health care providers to keep a patient's confidential information secure.
    • Provides for standardized electronic formats for all health care transactions.