ABCS Regulatory Compliance & Legal Framework 3 — Questions and Answers
Question 1: The Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard most directly requires cosmetic surgery offices to:
- Report all needle-stick injuries to the FDA within 24 hours
- Implement an exposure control plan and provide hepatitis B vaccination to at-risk employees (Correct answer)
- Obtain separate malpractice insurance for bloodborne pathogen claims
- Submit annual infection rate data to the CDC
Correct answer: Implement an exposure control plan and provide hepatitis B vaccination to at-risk employees
OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030) requires employers to develop an exposure control plan and offer hepatitis B vaccination to all employees with occupational exposure risk.
Question 2: A cosmetic surgeon who delegates injectable procedures to an unlicensed medical assistant could face which legal consequence?
- Only a civil fine from the FDA
- Disciplinary action for supervising unlicensed practice of medicine (Correct answer)
- Mandatory retraining under federal law
- Automatic suspension of DEA registration only
Correct answer: Disciplinary action for supervising unlicensed practice of medicine
Delegating medical procedures to unlicensed personnel constitutes aiding in the unlicensed practice of medicine, subjecting the supervising physician to state medical board disciplinary action.
Question 3: When a cosmetic surgery complication results in patient death, the surgeon is legally required to:
- Contact the patient's next of kin within 72 hours and offer a refund
- Report the death to the state medical examiner or coroner as required by state law
- File a MedWatch report with the FDA only if a device was involved (Correct answer)
- Notify the American Board of Cosmetic Surgery within 30 days
Correct answer: File a MedWatch report with the FDA only if a device was involved
If a medical device was involved in or contributed to a death, the manufacturer and user facility must submit a MedWatch adverse event report to the FDA; independent practitioners in office settings also have voluntary reporting obligations.
Question 4: The doctrine of respondeat superior holds that a cosmetic surgery employer is vicariously liable for an employee's negligent acts when:
- The employee has a prior disciplinary history
- The negligent act occurred within the scope of employment (Correct answer)
- The employer failed to carry malpractice insurance
- The patient signed a waiver of liability
Correct answer: The negligent act occurred within the scope of employment
Respondeat superior imposes vicarious liability on an employer for an employee's tortious acts committed within the scope of their employment.
Question 5: Under HIPAA, a 'business associate agreement' (BAA) is required when a cosmetic surgery practice shares protected health information (PHI) with:
- Patients requesting their own records
- A third-party billing company that handles patient data (Correct answer)
- Another physician for treatment purposes only
- Insurance companies during claims adjudication
Correct answer: A third-party billing company that handles patient data
A BAA is required when PHI is disclosed to or used by a business associate—a third party that performs functions on behalf of the covered entity—such as a billing company.
Question 6: Which of the following best describes the legal standard for informed consent in cosmetic surgery under most U.S. state laws?
- The surgeon need only disclose risks they personally consider significant
- The surgeon must disclose all risks that a reasonable patient would consider material in making their decision (Correct answer)
- Written consent forms alone satisfy the informed consent requirement
- Verbal consent is legally equivalent to written consent in all states
Correct answer: The surgeon must disclose all risks that a reasonable patient would consider material in making their decision
Most states apply the 'patient-centered' or 'reasonable patient' standard, requiring disclosure of any risk that a reasonable patient would find material in deciding whether to undergo the procedure.
Question 7: The False Claims Act (FCA) allows private citizens to file qui tam lawsuits against cosmetic surgery practices that:
- Advertise misleading before-and-after photos to private-pay patients
- Submit fraudulent claims for reimbursement to federal healthcare programs (Correct answer)
- Refuse to accept Medicare assignment for elective procedures
- Charge fees above the Medicare physician fee schedule
Correct answer: Submit fraudulent claims for reimbursement to federal healthcare programs
The False Claims Act prohibits knowingly submitting false or fraudulent claims for payment to federal healthcare programs, and its qui tam provisions allow whistleblowers to file suits on the government's behalf.
ABCS Regulatory Compliance & Legal Framework 3
The Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard most directly requires cosmetic surgery offices to: