CSP - Certified Specialty Pharmacist Regulatory and Compliance Issues Questions and Answers — Questions and Answers
Question 1: A specialty pharmacy proposes to place a pharmacy-employed nurse liaison inside a large neurology clinic. The nurse's role would be to assist clinic staff with prior authorizations and patient education for any of the clinic's patients, regardless of which pharmacy they use. In return, the clinic agrees to send all of its specialty prescriptions to that pharmacy. This arrangement MOST likely violates which federal law?
- The Health Insurance Portability and Accountability Act (HIPAA)
- The Drug Supply Chain Security Act (DSCSA)
- The Anti-Kickback Statute (AKS) (Correct answer)
- The Stark Law (Physician Self-Referral Law)
Correct answer: The Anti-Kickback Statute (AKS)
The Anti-Kickback Statute (AKS) is a federal criminal law prohibiting the exchange of anything of value to induce or reward the referral of federal health care program business. Providing a 'free' employee to a prescriber's office constitutes remuneration intended to induce referrals, which is a classic example of a potential AKS violation. HIPAA deals with patient privacy, DSCSA with drug supply chain integrity, and the Stark Law with physician self-referral to entities where they have a financial interest.
Question 2: A specialty pharmacy is seeking URAC accreditation and is developing its Patient Management program. A core component of these standards requires the pharmacy to have documented processes for which of the following activities?
- Offering financial incentives to prescribers for detailed clinical notes.
- Establishing a marketing program to attract patients from competing pharmacies.
- Measuring, monitoring, and reporting on clinical outcomes and patient satisfaction. (Correct answer)
- Compounding non-sterile preparations for off-label indications.
Correct answer: Measuring, monitoring, and reporting on clinical outcomes and patient satisfaction.
URAC's Specialty Pharmacy Accreditation standards place a strong emphasis on demonstrating value and quality through patient-centered care. A fundamental requirement of the Patient Management (PM) standards is that the pharmacy must have a structured program to measure, monitor, analyze, and report on key performance metrics, including patient satisfaction, quality of life, and clinical outcomes.
Question 3: In accordance with the Drug Supply Chain Security Act (DSCSA), what is a mandatory action for a specialty pharmacy upon receiving a shipment of a prescription drug?
- Sending a sample from the shipment to the manufacturer for quality verification.
- Ensuring receipt of the product's transaction information, history, and statement. (Correct answer)
- Reporting the National Drug Code (NDC) of all received products to the FDA.
- Storing the product in a separate, quarantined area for 24 hours before dispensing.
Correct answer: Ensuring receipt of the product's transaction information, history, and statement.
The DSCSA requires dispensers, including pharmacies, to only accept prescription drugs that are accompanied by product tracing documentation, often called the '3Ts': Transaction Information (TI), Transaction History (TH), and Transaction Statement (TS). This documentation must be stored for six years and is crucial for tracing the drug's path through the supply chain to prevent counterfeit or illegitimate products from reaching patients.
Question 4: A specialty pharmacy employee accidentally sends an email containing a patient's PHI to an incorrect recipient. The pharmacy immediately contacts the recipient, confirms the email was deleted, and performs a risk assessment. The assessment concludes there is a low probability of compromise because the recipient is a known business associate under a BAA who acted in good faith and did not further disclose the information. According to the HIPAA Breach Notification Rule, what is the pharmacy's required action?
- Notify the patient and the media within 60 days.
- Document the incident and the risk assessment; no formal notification is required. (Correct answer)
- Report the incident to the Office for Civil Rights (OCR) immediately.
- Offer complimentary credit monitoring to the affected patient for one year.
Correct answer: Document the incident and the risk assessment; no formal notification is required.
An impermissible disclosure of PHI is presumed to be a breach unless the covered entity can demonstrate a 'low probability that the PHI has been compromised' through a documented, four-factor risk assessment. If the assessment concludes a low probability of compromise, the event is not considered a reportable breach, and notification to the patient or HHS is not required. However, the entity must maintain documentation of the incident and the risk assessment that led to this conclusion.
Question 5: Which of the following activities by a specialty pharmacy is the clearest example of potential healthcare fraud?
- Billing an insurer for a brand-name drug using a 'Dispense as Written' code when the generic equivalent was dispensed. (Correct answer)
- Enrolling an eligible patient in a manufacturer's copay assistance program to lower their out-of-pocket cost.
- Conducting a clinical intervention to switch a patient to a more cost-effective, preferred drug on the formulary.
- Calling a patient for a refill reminder a few days before their medication is due to run out.
Correct answer: Billing an insurer for a brand-name drug using a 'Dispense as Written' code when the generic equivalent was dispensed.
Fraud involves intentional deception for financial gain. Billing for a more expensive brand-name product when a cheaper generic was dispensed is a form of upcoding and a clear violation. The other options describe legitimate, and often required, functions of a specialty pharmacy: utilizing patient assistance programs, performing clinical management, and promoting adherence.
Question 6: A specialty pharmacy has a contract pharmacy relationship with a 340B-covered entity. To maintain compliance and prevent diversion, what is the most critical responsibility of the pharmacy?
- Ensuring the 340B-acquired drugs are dispensed only to individuals who are eligible patients of the covered entity. (Correct answer)
- Charging all patients the same acquisition cost for the medication.
- Using a separate wholesaler for 340B drug purchases than for its own GPO purchases.
- Reporting all 340B dispensing activity to the state board of pharmacy on a monthly basis.
Correct answer: Ensuring the 340B-acquired drugs are dispensed only to individuals who are eligible patients of the covered entity.
The core principle of the 340B program is to provide discounted drugs to eligible patients of covered entities. Diversion, a major compliance violation, occurs when a 340B-purchased drug is provided to an individual who does not meet the HRSA definition of an eligible patient. The covered entity is ultimately responsible, but the contract pharmacy must have systems in place to ensure 340B drugs are not diverted.
CSP - Certified Specialty Pharmacist Regulatory and Compliance Issues Questions and Answers
A specialty pharmacy proposes to place a pharmacy-employed nurse liaison inside a large neurology clinic.
The nurse's role would be to assist clinic staff with prior authorizations and patient education for any of the clinic's patients, regardless of which pharmacy they use.
In return, the clinic agrees to send all of its specialty prescriptions to that pharmacy.
This arrangement MOST likely violates which federal law?
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