CSP Regulatory Compliance 4

Question 1

Why can't a Medicare Part D beneficiary use a manufacturer copay coupon for a specialty drug?

Accepted Answer

It may induce purchases of federally reimbursed items, which implicates the Anti-Kickback Statute

Answer

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?

Accepted Answer

Grants from bona fide independent charity patient assistance foundations

Answer

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?

Accepted Answer

60 days after identification

Answer

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)?

Accepted Answer

Federal health care programs will not pay for items or services furnished by excluded individuals

Answer

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?

Accepted Answer

Designated health services (DHS)

Answer

Outpatient prescription drugs are designated health services, so physician self-referral to pharmacies they have financial relationships with is restricted.

CSP - Certified Specialty Pharmacist Practice Test

CSP - Certified Specialty Pharmacist Practice Test

CSP Regulatory Compliance 4