Federal and State Regulations Flashcards
7 cards from real CCP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Federal and State Regulations flashcards as text
Which entity issues the National Provider Identifier (NPI) required for pharmacists billing Medicare and Medicaid?
Answer: CMS via the National Plan and Provider Enumeration System (NPPES)
CMS administers the NPPES, which issues NPIs to all covered healthcare providers, including pharmacists billing Medicare/Medicaid.
Under 42 CFR 483.45(f), a long-term care facility must act on a consultant pharmacist's drug regimen irregularity report within:
Answer: A timeframe established by facility policy and the attending physician's clinical judgment
Federal regulations require the facility to act on pharmacist irregularity reports in a timely manner based on clinical urgency, as defined by facility policy and the attending physician.
The Stark Law (Physician Self-Referral Law) prohibits a physician from referring Medicare patients to an entity for designated health services if:
Answer: The physician has any ownership interest or compensation arrangement with that entity
The Stark Law prohibits physician referrals for designated health services to entities in which the physician or immediate family member has a financial relationship, absent a specific exception.
Under USP Hazardous Drugs — Handling in Healthcare Settings, which engineering control is required for the receipt and storage of hazardous drugs?
Answer: Negative pressure room with at least 12 air changes per hour
USP requires hazardous drug storage areas to have negative pressure with at least 12 air changes per hour to prevent contamination of surrounding areas.
A consultant pharmacist identifies that a nursing home is billing Medicare Part A for a drug that is not medically necessary. The pharmacist's best course of action is to:
Answer: Report the finding to the attending physician, administrator, and, if unresolved, to the appropriate authority
The CCP must first report the potential fraud to the physician and administrator; if unresolved, escalation to the OIG or CMS is appropriate under federal fraud reporting obligations.
Under FDA regulations, a pharmacy that compounds drug products in anticipation of prescriptions without individual patient prescriptions may be regulated as an:
Answer: Outsourcing facility under Section 503B of the FD&C Act
Section 503B of the FD&C Act created the outsourcing facility category, allowing large-scale compounding in advance of prescriptions under FDA oversight and cGMP standards.
Which of the following best describes the 'corresponding responsibility' doctrine under DEA regulations for controlled substances?
Answer: A pharmacist shares legal responsibility for dispensing a controlled substance not issued for a legitimate medical purpose
The corresponding responsibility doctrine (21 CFR 1306.04) holds that a pharmacist who knowingly fills a controlled substance prescription not issued for a legitimate medical purpose is equally liable with the prescriber.