CSP Regulatory Compliance 4 — Questions and Answers
Question 1: Why can't a Medicare Part D beneficiary use a manufacturer copay coupon for a specialty drug?
- Coupons violate HIPAA
- Medicare already covers 100% of specialty drugs
- It may induce purchases of federally reimbursed items, which implicates the Anti-Kickback Statute (Correct answer)
- Coupons are allowed only for generic drugs
Correct 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.
Question 2: Which option is generally allowed under OIG guidance to help Medicare patients afford high-cost specialty drug cost-sharing?
- Routine pharmacy waivers of all copays
- Manufacturer coupons processed as secondary coverage
- Rebating the copay to the patient in cash
- Grants from bona fide independent charity patient assistance foundations (Correct answer)
Correct 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.
Question 3: Under the Affordable Care Act, how long does a provider have to report and return an identified Medicare or Medicaid overpayment?
- 60 days after identification (Correct answer)
- 30 days after the claim was paid
- 6 months after the audit
- 1 year after the date of service
Correct answer: 60 days after identification
Identified overpayments must be reported and returned within 60 days, or they may become False Claims Act liabilities.
Question 4: Why does a specialty pharmacy check employees against the OIG List of Excluded Individuals/Entities (LEIE)?
- To verify DEA registration
- Federal health care programs will not pay for items or services furnished by excluded individuals (Correct answer)
- To confirm state pharmacist licensure
- To meet USP <800> training requirements
Correct 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.
Question 5: Under the Stark Law, outpatient prescription drugs fall into which category?
- Exempt ancillary services
- Durable medical equipment only
- Designated health services (DHS) (Correct answer)
- Non-covered items
Correct 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.
Question 6: What liability does the federal False Claims Act impose for knowingly submitting false claims?
- Only license suspension
- Single damages with no penalties
- Criminal penalties only
- Up to treble damages plus per-claim civil penalties (Correct answer)
Correct 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.
Question 7: What is the CMS timeframe for a standard Part D coverage determination on a drug request?
- 72 hours after receiving the request (Correct answer)
- 24 hours
- 14 calendar days
- 30 calendar days
Correct answer: 72 hours after receiving the request
Part D plans must decide standard coverage requests within 72 hours and expedited requests within 24 hours.
