MTM Regulatory Compliance & Ethical Standards 4 — Questions and Answers
Question 1: The Drug Enforcement Administration (DEA) Schedule II controlled substance regulations require that prescriptions be:
- Refillable up to five times within six months
- Written and signed by the prescriber with no electronic transmission permitted in most states
- Dispensed in no more than a 30-day supply under federal law (Correct answer)
- Renewed verbally by the prescriber over the phone
Correct answer: Dispensed in no more than a 30-day supply under federal law
Federal law does not mandate a 30-day supply limit for Schedule II; however, prescriptions must generally be written (or electronically prescribed where permitted) and cannot be refilled.
Question 2: In an MTM encounter, a patient discloses they are using an herbal supplement their prescriber is unaware of. What is the pharmacist's primary obligation?
- Advise the patient to stop the supplement immediately without consulting the prescriber
- Assess for drug-herb interactions, document findings, and communicate concerns to the prescriber with patient consent (Correct answer)
- Disregard the information as outside the scope of MTM services
- Report the supplement use to the patient's insurance plan
Correct answer: Assess for drug-herb interactions, document findings, and communicate concerns to the prescriber with patient consent
MTM pharmacists must evaluate all medications including supplements, document drug-herb interactions, and collaborate with prescribers to optimize therapy.
Question 3: The OBRA '90 mandate requires pharmacists to offer counseling to Medicaid patients. Which of the following is a key component of the prospective drug utilization review (ProDUR) required under OBRA '90?
- Performing annual comprehensive medication reviews for all Medicaid beneficiaries
- Screening for therapeutic duplication, incorrect dosage, and drug-disease contraindications before dispensing (Correct answer)
- Mandating pharmacist co-signature on all new Medicaid prescriptions
- Limiting Medicaid prescriptions to a 30-day supply
Correct answer: Screening for therapeutic duplication, incorrect dosage, and drug-disease contraindications before dispensing
OBRA '90's ProDUR requires pharmacists to review prescriptions before dispensing for issues such as therapeutic duplication, drug-disease contraindications, and dosage errors.
Question 4: Which ethical framework is MOST aligned with the pharmacist who makes MTM recommendations solely based on the greatest benefit for the greatest number of patients in a population health program?
- Deontological ethics
- Virtue ethics
- Utilitarian ethics (Correct answer)
- Principlism
Correct answer: Utilitarian ethics
Utilitarian ethics focuses on maximizing overall benefit for the largest number of people, which aligns with population-level decision-making.
Question 5: A CMS audit reveals that a Part D plan sponsor's MTM program enrolled patients who did not meet the required number of chronic conditions. This constitutes:
- A minor documentation error correctable by attestation
- Potential fraud and abuse requiring compliance investigation and corrective action (Correct answer)
- An acceptable deviation if overall program quality metrics were met
- A state pharmacy board matter outside CMS jurisdiction
Correct answer: Potential fraud and abuse requiring compliance investigation and corrective action
Enrolling ineligible beneficiaries in MTM and billing for services violates CMS requirements and constitutes potential fraud and abuse subject to civil monetary penalties.
Question 6: A pharmacist disagrees with the MTM platform's recommendation to close a medication-related problem as resolved when it is not. The MOST ethical course of action is:
- Follow the platform recommendation to maintain workflow efficiency
- Override the platform, document the clinical rationale, and escalate to supervisors if necessary (Correct answer)
- Resign from the MTM position to avoid complicity
- Report the platform vendor to CMS immediately
Correct answer: Override the platform, document the clinical rationale, and escalate to supervisors if necessary
Pharmacists bear professional and ethical responsibility for clinical documentation accuracy and must document their independent clinical judgment, escalating concerns through appropriate channels.
Question 7: Under the False Claims Act, a pharmacist who knowingly submits false MTM billing claims to a federal healthcare program may face:
- A warning letter and mandatory retraining only
- Civil monetary penalties and treble damages per false claim, plus potential exclusion from federal programs (Correct answer)
- License suspension limited to 90 days
- Criminal prosecution only if the amount exceeds $10,000
Correct answer: Civil monetary penalties and treble damages per false claim, plus potential exclusion from federal programs
The False Claims Act imposes civil monetary penalties of thousands of dollars per false claim plus treble damages, and offenders may be excluded from Medicare and Medicaid.
MTM Regulatory Compliance & Ethical Standards 4
The Drug Enforcement Administration (DEA) Schedule II controlled substance regulations require that prescriptions be: