Regulatory Compliance Flashcards
7 cards from real CSP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Compliance flashcards as text
Why can't a Medicare Part D beneficiary use a manufacturer copay coupon for a specialty drug?
Answer: It may induce purchases of federally reimbursed items, which implicates the Anti-Kickback Statute
OIG considers manufacturer copay coupons for federal health care program beneficiaries potential remuneration under the Anti-Kickback Statute.
Which option is generally allowed under OIG guidance to help Medicare patients afford high-cost specialty drug cost-sharing?
Answer: Grants from bona fide independent charity patient assistance foundations
Independent charity PAPs that meet OIG safeguards, such as no donor control over patient selection, are an accepted route for help.
Under the Affordable Care Act, how long does a provider have to report and return an identified Medicare or Medicaid overpayment?
Answer: 60 days after identification
Identified overpayments must be reported and returned within 60 days, or they may become False Claims Act liabilities.
Why does a specialty pharmacy check employees against the OIG List of Excluded Individuals/Entities (LEIE)?
Answer: Federal health care programs will not pay for items or services furnished by excluded individuals
Employing excluded individuals can lead to civil monetary penalties and repayment of federal program claims.
Under the Stark Law, outpatient prescription drugs fall into which category?
Answer: Designated health services (DHS)
Outpatient prescription drugs are designated health services, so physician self-referral to pharmacies they have financial relationships with is restricted.
What liability does the federal False Claims Act impose for knowingly submitting false claims?
Answer: Up to treble damages plus per-claim civil penalties
The False Claims Act allows up to three times the government's damages plus inflation-adjusted civil penalties per false claim.
What is the CMS timeframe for a standard Part D coverage determination on a drug request?
Answer: 72 hours after receiving the request
Part D plans must decide standard coverage requests within 72 hours and expedited requests within 24 hours.