MCQ Quiz: Federal Regulation of Pharmacy Practice: Antitrust and Fraud

Beyond clinical duties, pharmacists operate within a complex legal framework designed to ensure fair competition and prevent fraudulent activities, particularly within federal healthcare programs like Medicare and Medicaid. Understanding these laws, a core part of the Principles of Pharmacy Law and Ethics course “, is essential for every practicing pharmacist to avoid serious legal and financial penalties. This quiz will test your knowledge of key federal statutes like the Sherman Antitrust Act, the False Claims Act, and the Anti-Kickback Statute.

1. The primary purpose of federal antitrust laws in the context of pharmacy is to:

• a. Set the prices for all prescription drugs.
• b. Protect competition by prohibiting monopolies and unreasonable restraints on trade.
• c. Regulate the storage of controlled substances.
• d. Mandate that pharmacists must counsel patients.

Answer: b. Protect competition by prohibiting monopolies and unreasonable restraints on trade.

2. A group of independent pharmacy owners in the same town meet and agree to all charge the same dispensing fee. This is a per se violation of the Sherman Antitrust Act known as:

• a. A tying arrangement
• b. A boycott
• c. Price fixing
• d. A monopoly

Answer: c. Price fixing

3. The federal law that prohibits knowingly submitting a false or fraudulent claim to a federal healthcare program like Medicare or Medicaid is the:

• a. Anti-Kickback Statute
• b. Stark Law
• c. False Claims Act
• d. Robinson-Patman Act

Answer: c. False Claims Act

4. Which of the following would be an example of pharmacy fraud?

• a. Billing for a brand-name medication but dispensing the generic.
• b. Submitting a claim for a prescription that was never dispensed to the patient.
• c. Billing for a non-existent “ghost” patient.
• d. All of the above.

Answer: d. All of the above.

5. The federal Anti-Kickback Statute prohibits:

• a. Providing any gifts to physicians, regardless of value.
• b. Knowingly and willfully offering or receiving anything of value to induce or reward referrals for federally funded healthcare services.
• c. Charging a patient a copay.
• d. Dispensing generic drugs.

Answer: b. Knowingly and willfully offering or receiving anything of value to induce or reward referrals for federally funded healthcare services.

6. The “Principles of Pharmacy Law and Ethics” is a core course in the curriculum.

• a. True
• b. False

Answer: a. True

7. A pharmaceutical company offers a pharmacist a lavish, all-expenses-paid vacation in exchange for switching patients to their brand-name drug. This is a potential violation of the:

• a. False Claims Act
• b. Anti-Kickback Statute
• c. Sherman Antitrust Act
• d. HIPAA

Answer: b. Anti-Kickback Statute

8. The key difference between fraud and abuse is that fraud requires:

• a. A financial loss.
• b. The involvement of a pharmacist.
• c. Intent.
• d. A federal healthcare program.

Answer: c. Intent.

9. A group of competing pharmacies agree to not accept a new insurance plan because its reimbursement rates are too low. This is an example of:

• a. Price fixing
• b. A group boycott
• c. A tying arrangement
• d. A legal business practice

Answer: b. A group boycott

10. “Waste” in healthcare is best described as:

• a. The intentional deception for financial gain.
• b. The overutilization of services that results in unnecessary costs.
• c. Disposing of expired medications properly.
• d. A billing practice that is inconsistent with sound medical practice.

Answer: b. The overutilization of services that results in unnecessary costs.

11. Understanding these federal laws is a key component of which course?

• a. PHA5703 Principles of Pharmacy Law and Ethics
• b. PHA5104 Sterile Compounding
• c. PHA5176 Drug Delivery Systems
• d. PHA5244 Principles of Evidence-Based Practice

Answer: a. PHA5703 Principles of Pharmacy Law and Ethics

12. The Stark Law specifically deals with:

• a. Pharmacist referrals.
• b. Physician self-referrals for designated health services paid for by Medicare.
• c. Antitrust violations.
• d. Controlled substance prescriptions.

Answer: b. Physician self-referrals for designated health services paid for by Medicare.

13. A pharmacy consistently dispenses a 30-day supply of medication but bills the insurance for a 90-day supply. This is an example of:

• a. A sound business practice.
• b. A violation of the False Claims Act.
• c. A legal loophole.
• d. A common billing error that is not a violation.

Answer: b. A violation of the False Claims Act.

14. A key role of a pharmacist is to have a compliance program in place to prevent, detect, and report fraud, waste, and abuse.

• a. True
• b. False

Answer: a. True

15. A pharmacy that requires a patient to buy a bottle of the pharmacy’s own brand of vitamins in order to get their blood pressure medication filled is potentially engaging in:

• a. A tying arrangement.
• b. A group boycott.
• c. Price fixing.
• d. Good patient care.

Answer: a. A tying arrangement.

16. The “qui tam” or whistleblower provision is a key feature of which law?

• a. The Anti-Kickback Statute
• b. The Stark Law
• c. The Sherman Antitrust Act
• d. The False Claims Act

Answer: d. The False Claims Act

17. A pharmacist who reports their employer for systematically fraudulent billing practices may be protected and rewarded under which provision?

• a. The Stark Law
• b. The “qui tam” provision of the False Claims Act.
• c. The Robinson-Patman Act.
• d. There is no such protection.

Answer: b. The “qui tam” provision of the False Claims Act.

18. A pharmaceutical manufacturer cannot offer a coupon or copay card to a Medicare Part D beneficiary because it could be viewed as:

• a. A violation of the Anti-Kickback Statute.
• b. A good marketing practice.
• c. A way to lower healthcare costs.
• d. A requirement under the MMA of 2003.

Answer: a. A violation of the Anti-Kickback Statute.

19. Which of the following is an example of pharmacy “abuse”?

• a. Routinely dispensing medications in excessive quantities.
• b. Billing for services that are not medically necessary.
• c. Both a and b.
• d. Neither a nor b.

Answer: c. Both a and b.

20. A pharmacist’s professional ethics require them to act with honesty and integrity, which aligns with avoiding fraud, waste, and abuse.

• a. True
• b. False

Answer: a. True

21. A “safe harbor” regulation related to the Anti-Kickback Statute describes:

• a. A payment practice that is illegal.
• b. A payment practice that is exempt from prosecution under the statute.
• c. A safe place to store medications.
• d. A type of pharmacy.

Answer: b. A payment practice that is exempt from prosecution under the statute.

22. An agreement between two competing pharmacies to divide up the geographic market (e.g., “you take the north side of town, I’ll take the south”) is an illegal:

• a. Market allocation.
• b. Tying arrangement.
• c. Boycott.
• d. Business merger.

Answer: a. Market allocation.

23. The penalties for violating the False Claims Act or Anti-Kickback Statute can include:

• a. Large fines.
• b. Exclusion from participating in federal healthcare programs.
• c. Imprisonment.
• d. All of the above.

Answer: d. All of the above.

24. A pharmacist who suspects FWA should:

• a. Ignore it.
• b. Report it through their company’s compliance program or to the appropriate authorities.
• c. Confront the person they suspect directly.
• d. Participate in the activity.

Answer: b. Report it through their company’s compliance program or to the appropriate authorities.

25. The Robinson-Patman Act is an antitrust law that primarily addresses:

• a. Group boycotts.
• b. Monopolies.
• c. Price discrimination.
• d. Price fixing.

Answer: c. Price discrimination.

26. A pharmacy billing for a more expensive brand of test strips but dispensing a cheaper, different brand is an example of:

• a. A cost-saving measure.
• b. Fraud.
• c. A smart business practice.
• d. A legal substitution.

Answer: b. Fraud.

27. The pharmacist’s role in promoting public health includes ensuring the integrity of the healthcare payment system.

• a. True
• b. False

Answer: a. True

28. An agreement between a brand and generic manufacturer where the brand company pays the generic company to delay the release of its generic drug is known as:

• a. A “pay-for-delay” or “reverse payment” agreement.
• b. A standard business practice.
• c. A pro-competitive action.
• d. A way to lower drug costs.

Answer: a. A “pay-for-delay” or “reverse payment” agreement.

29. Which of the following is NOT an antitrust concern?

• a. Two pharmacies competing on price.
• b. Two pharmacies agreeing on what price to charge.
• c. A single pharmacy chain controlling 95% of the market in a region.
• d. A group of pharmacies agreeing not to do business with an insurance plan.

Answer: a. Two pharmacies competing on price.

30. The principles of pharmacy law are foundational to understanding these regulations.

• a. True
• b. False

Answer: a. True

31. The “intent” standard for the Anti-Kickback Statute means that ____ purpose of the payment was to induce referrals.

• a. the sole
• b. the primary
• c. one
• d. an accidental

Answer: c. one

32. A pharmacy offering free delivery service to all its patients is generally considered:

• a. A violation of the Anti-Kickback Statute.
• b. A permissible and competitive business practice.
• c. An antitrust violation.
• d. A form of fraud.

Answer: b. A permissible and competitive business practice.

33. The OIG (Office of Inspector General) is the primary enforcement agency for:

• a. The Sherman Antitrust Act.
• b. Federal fraud and abuse laws like the Anti-Kickback Statute.
• c. The Controlled Substances Act.
• d. The Food, Drug, and Cosmetic Act.

Answer: b. Federal fraud and abuse laws like the Anti-Kickback Statute.

34. A key part of a pharmacy’s compliance program is:

• a. Conducting internal monitoring and auditing.
• b. Establishing written standards and procedures.
• c. Providing training and education to employees.
• d. All of the above.

Answer: d. All of the above.

35. A pharmacist providing a nominal gift (e.g., a free pill box) to a patient is:

• a. A clear violation of the Anti-Kickback Statute.
• b. Generally considered acceptable and not a violation.
• c. An example of fraud.
• d. An antitrust concern.

Answer: b. Generally considered acceptable and not a violation.

36. The False Claims Act applies only to Medicare claims.

• a. True
• b. False

Answer: b. False

37. The fundamental purpose of antitrust law is to protect:

• a. Businesses from competition.
• b. Competition itself, for the benefit of consumers.
• c. The government from lawsuits.
• d. Large corporations.

Answer: b. Competition itself, for the benefit of consumers.

38. The pharmacy law course PHA5703 provides the basis for understanding these complex regulations.

• a. True
• b. False

Answer: a. True

39. Which of the following would likely NOT be considered waste?

• a. Dispensing a 90-day supply of a new opioid prescription for acute pain.
• b. Dispensing a 90-day supply of a statin for a patient with stable dyslipidemia.
• c. Automatically refilling all prescriptions without checking if the patient still needs them.
• d. Using a more expensive brand-name drug when a generic is therapeutically equivalent and preferred by the patient’s plan.

Answer: b. Dispensing a 90-day supply of a statin for a patient with stable dyslipidemia.

40. An active learning session covering pharmacy law is part of which course?

• a. PHA5703 Principles of Pharmacy Law and Ethics
• b. PHA5163L Professional Skills Lab 3
• c. PHA5781 Patient Care I
• d. PHA5782C Patient Care 2

Answer: a. PHA5703 Principles of Pharmacy Law and Ethics

41. The False Claims Act includes provisions for ______, where the government can recover up to three times its damages plus penalties.

• a. single damages
• b. double damages
• c. treble damages
• d. punitive damages only

Answer: c. treble damages

42. A pharmacist’s professional and ethical obligations go hand-in-hand with legal compliance.

• a. True
• b. False

Answer: a. True

43. A P&T committee meeting where drug costs are discussed in the context of clinical efficacy is an application of:

• a. Antitrust law
• b. Pharmacoeconomics
• c. Fraud and abuse law
• d. Dispensing law

Answer: b. Pharmacoeconomics

44. A pharmacist who knowingly fails to reverse a claim for a prescription that was not picked up by the patient could be violating the:

• a. False Claims Act
• b. Sherman Antitrust Act
• c. Stark Law
• d. HIPAA

Answer: a. False Claims Act

45. “Abuse” can include billing for services that are not medically necessary, even if no deception was intended.

• a. True
• b. False

Answer: a. True

46. A “per se” violation in antitrust law means that:

• a. The action is always legal.
• b. The action is illegal on its face, without any need to prove it harmed competition.
• c. The action must be proven to have harmed competition.
• d. The action is only illegal in certain states.

Answer: b. The action is illegal on its face, without any need to prove it harmed competition.

47. Understanding these laws is critical for pharmacists in what roles?

• a. Community pharmacy ownership and management.
• b. Hospital pharmacy administration.
• c. Managed care and PBMs.
• d. All of the above.

Answer: d. All of the above.

48. An active learning session on pharmacy law is part of which course?

• a. PHA5703 Principles of Pharmacy Law and Ethics
• b. PHA5163L Professional Skills Lab 3
• c. PHA5781 Patient Care I
• d. PHA5782C Patient Care 2

Answer: a. PHA5703 Principles of Pharmacy Law and Ethics

49. The overall goal of fraud, waste, and abuse laws is to:

• a. Make pharmacy practice more difficult.
• b. Protect the financial integrity of federal and state healthcare programs.
• c. Increase healthcare costs.
• d. Limit patient access to care.

Answer: b. Protect the financial integrity of federal and state healthcare programs.

50. The ultimate reason for a pharmacist to understand antitrust and fraud laws is to:

• a. Be able to find loopholes.
• b. Practice legally and ethically, protecting both their patients and their license.
• c. Pass the MPJE.
• d. Both b and c.

Answer: d. Both b and c.