Medical Ethics, Legal and Regulatory Issues 6 Flashcards

A patient enrolled in a clinical trial for a new glaucoma drop reports experiencing blurred vision and eye pain. The investigator believes these are unrelated to the study drug. According to research ethics regulations, what is the most appropriate action?

Answer: Document the adverse event and report it to the IRB per protocol requirements regardless of the investigator's opinion

All adverse events must be documented and reported to the Institutional Review Board (IRB) per protocol requirements, regardless of the investigator's assessment of causation. The IRB — not the individual investigator — determines whether events are related to the study drug. This protects human subjects and maintains research integrity.

Under the Anti-Kickback Statute, which of the following arrangements between an ophthalmology practice and an optical dispensary would most likely constitute a violation?

Answer: The ophthalmologist receives a per-referral fee from an independent optical shop for every patient sent there

Receiving a per-referral fee (payment tied directly to the number of patient referrals) is a textbook violation of the federal Anti-Kickback Statute. It creates a financial incentive that can improperly influence medical decision-making. The in-office optical shop with disclosure may qualify under a Stark Law exception; the employed optician and one-time grant do not involve remuneration for referrals.

A 14-year-old patient presents alone requesting treatment for an eye infection. The parent cannot be reached. In most U.S. states, under which condition may the ophthalmic team legally treat this minor without parental consent?

Answer: Under the emergency exception, if delaying treatment would result in significant harm

The emergency exception to informed consent allows treatment of a minor without parental consent when a delay to obtain consent would result in significant harm or a medical emergency. An untreated eye infection that could threaten vision or spread to surrounding structures may qualify. Otherwise, parental or guardian consent is required for minor patients in most jurisdictions.

A patient requests that a specific notation — one they believe is inaccurate — be removed entirely from their medical record. Under HIPAA, what is the healthcare provider's correct response?

Answer: Allow the patient to submit a written amendment request, and if denied, include the patient's written disagreement in the record

HIPAA grants patients the right to request amendments to their records, but providers may deny the request if the information is accurate and complete. If denied, the patient must be allowed to submit a written statement of disagreement, which is appended to the record. Removing or altering accurate entries or destroying records violates both HIPAA and medical record integrity laws.

An ophthalmology practice bills Medicare for a comprehensive eye exam (92004) but the documentation only supports an intermediate exam (92002). The billing staff argues this is a 'minor rounding up' and unlikely to be audited. This practice is best described as:

Answer: Upcoding, which constitutes Medicare fraud under the False Claims Act

Billing for a higher-level service than what is documented and supported is called 'upcoding' and is a form of Medicare fraud under the False Claims Act (FCA). The FCA imposes civil penalties of up to three times the overpayment plus per-claim fines, and intentional upcoding can trigger criminal prosecution. The dollar amount and audit probability are irrelevant — the act of submitting a false claim is itself the violation.

A COT discovers that a colleague has been reusing single-use disposable contact lens trial fitting sets to save the practice money, a practice the office manager quietly condones. The COT is ethically and legally obligated to:

Answer: Report the practice internally and, if unresolved, escalate to the state medical board or FDA, as it violates patient safety regulations

Reusing FDA-cleared single-use devices violates federal regulations (21 CFR) and creates documented infection and cross-contamination risks. Allied health professionals, including COTs, have an ethical duty under their scope of practice guidelines and patient safety obligations to escalate unsafe practices — first through internal channels, and then to external regulatory authorities (state medical board, FDA MedWatch) if the problem is not corrected. Manager approval does not override regulatory or ethical obligations.