Regulatory Compliance & Ethical Standards Flashcards
7 cards from real MTM practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Compliance & Ethical Standards flashcards as text
Under HIPAA's minimum necessary standard, which practice is most appropriate when sharing patient medication information?
Answer: Disclose only the information reasonably necessary to accomplish the intended purpose
HIPAA's minimum necessary standard requires covered entities to limit PHI disclosures to only what is reasonably necessary for the specific purpose.
A pharmacist conducting MTM discovers a patient is using a medication for an off-label indication not supported by evidence. The prescriber insists on continuing. What is the pharmacist's primary ethical obligation?
Answer: Document the concern, counsel the patient on risks, and respect the prescriber's clinical judgment
Pharmacists must document concerns, educate the patient, and collaborate with prescribers while respecting clinical autonomy unless clear harm is evident.
Which federal law specifically established the legal framework for Medicare Part D Medication Therapy Management programs?
Answer: Medicare Prescription Drug, Improvement, and Modernization Act of 2003
The Medicare Modernization Act of 2003 (MMA) created Medicare Part D and mandated MTM programs for targeted beneficiaries.
A patient refuses a recommended medication change during MTM despite documented risks. How should the pharmacist proceed?
Answer: Document the refusal, ensure the patient understands the risks, and respect patient autonomy
Patient autonomy is a core ethical principle; pharmacists must document refusals and ensure informed decision-making but respect the patient's right to refuse.
Which element is required in a Comprehensive Medication Review (CMR) under CMS Medicare Part D MTM guidelines?
Answer: An interactive, real-time consultation with the patient or caregiver
CMS requires CMRs to be interactive, real-time consultations conducted with the patient and/or caregiver, not asynchronous questionnaires.
Which ethical principle is MOST directly violated when a pharmacist accepts gifts from a pharmaceutical manufacturer in exchange for preferentially recommending their MTM-enrolled products?
Answer: Fidelity
Fidelity requires loyalty and keeping professional commitments; accepting gifts that bias recommendations breaches the duty of loyalty owed to patients.
Under CMS MTM eligibility criteria, a Part D plan sponsor must target beneficiaries who meet thresholds related to which three factors?
Answer: Multiple chronic diseases, multiple Part D drugs, and likely to incur annual drug costs above a threshold
CMS requires Part D plans to target MTM to beneficiaries with multiple chronic diseases, multiple Part D covered drugs, and expected drug costs above a CMS-set threshold.