CSP - Certified Specialty Pharmacist Regulatory and Compliance Issues 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?

Accepted Answer

The Anti-Kickback Statute (AKS)

Answer

The Health Insurance Portability and Accountability Act (HIPAA)

Answer

The Drug Supply Chain Security Act (DSCSA)

Answer

The Stark Law (Physician Self-Referral Law)

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?

Accepted Answer

Measuring, monitoring, and reporting on clinical outcomes and patient satisfaction.

Answer

Offering financial incentives to prescribers for detailed clinical notes.

Answer

Establishing a marketing program to attract patients from competing pharmacies.

Answer

Compounding non-sterile preparations for off-label indications.

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?

Accepted Answer

Ensuring receipt of the product's transaction information, history, and statement.

Answer

Sending a sample from the shipment to the manufacturer for quality verification.

Answer

Reporting the National Drug Code (NDC) of all received products to the FDA.

Answer

Storing the product in a separate, quarantined area for 24 hours before dispensing.

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?

Accepted Answer

Document the incident and the risk assessment; no formal notification is required.

Answer

Notify the patient and the media within 60 days.

Answer

Report the incident to the Office for Civil Rights (OCR) immediately.

Answer

Offer complimentary credit monitoring to the affected patient for one year.

Question 5

Which of the following activities by a specialty pharmacy is the clearest example of potential healthcare fraud?

Accepted Answer

Billing an insurer for a brand-name drug using a 'Dispense as Written' code when the generic equivalent was dispensed.

Answer

Enrolling an eligible patient in a manufacturer's copay assistance program to lower their out-of-pocket cost.

Answer

Conducting a clinical intervention to switch a patient to a more cost-effective, preferred drug on the formulary.

Answer

Calling a patient for a refill reminder a few days before their medication is due to run out.

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?

Accepted Answer

Ensuring the 340B-acquired drugs are dispensed only to individuals who are eligible patients of the covered entity.

Answer

Charging all patients the same acquisition cost for the medication.

Answer

Using a separate wholesaler for 340B drug purchases than for its own GPO purchases.

Answer

Reporting all 340B dispensing activity to the state board of pharmacy on a monthly basis.