Regulatory Compliance & Legal Framework Flashcards

A cosmetic surgeon performs an off-label use of an FDA-approved filler. Under FDA regulations, this practice is:

Answer: Generally permissible as part of the physician's medical judgment, though the FDA may not promote it

The FDA regulates drug and device manufacturers, not the practice of medicine; physicians may use approved products off-label based on their professional judgment, though the FDA cannot promote such uses.

Which accreditation body is specifically recognized for accrediting office-based surgical facilities where ABCS-certified surgeons commonly practice?

Answer: American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF)

AAAASF is a widely recognized accreditation body for ambulatory and office-based surgical facilities, and ABCS-certified surgeons practicing in these settings commonly seek AAAASF accreditation.

When a patient threatens to post negative online reviews unless a refund is issued, the cosmetic surgeon's ethically and legally safest response is to:

Answer: Address the patient's concerns through proper channels without conditioning resolution on review removal

Conditioning refunds on retraction of reviews can constitute consumer protection violations; the ethically proper approach is to address legitimate concerns through standard dispute resolution without coercive bargaining.

The Consolidated Omnibus Budget Reconciliation Act (COBRA) is most relevant to a cosmetic surgery practice when:

Answer: The practice terminates an employee who had employer-sponsored health insurance

COBRA requires employers with 20 or more employees to offer continuation of group health coverage to employees (and their dependents) who lose coverage due to qualifying events such as termination.

A cosmetic surgeon who owns a medical spa and directs non-physician staff to perform laser hair removal in a state where this is considered the practice of medicine is most likely violating:

Answer: State laws prohibiting the corporate practice of medicine and unlicensed practice

Many states prohibit the corporate practice of medicine and require that medical acts be performed by licensed practitioners; directing unlicensed staff to perform laser procedures that constitute medical practice violates these state statutes.

Under the ADA (Americans with Disabilities Act), a cosmetic surgery practice that is a place of public accommodation must:

Answer: Make reasonable modifications to policies and ensure physical accessibility for patients with disabilities

Title III of the ADA requires places of public accommodation, including medical offices, to make reasonable modifications to policies and procedures and ensure physical accessibility for individuals with disabilities.

A cosmetic surgeon who receives a cash payment above $10,000 from a patient for a procedure is required to:

Answer: Report the payment to the IRS on Form 8300 within 15 days

IRS Form 8300 must be filed within 15 days for cash transactions exceeding $10,000 received in the course of trade or business, including payments to medical practices.