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 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?

Accepted Answer

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

Answer

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?

Accepted Answer

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

Answer

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?

Accepted Answer

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

Answer

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?

Accepted Answer

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

Answer

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.

CSP - Certified Specialty Pharmacist Practice Test

CSP - Certified Specialty Pharmacist Practice Test

CSP - Certified Specialty Pharmacist Regulatory and Compliance Issues Questions and Answers