General Surgery Board Review Regulatory Frameworks & Compliance 3 — Questions and Answers
Question 1: The False Claims Act (FCA) imposes liability on individuals or entities that submit fraudulent claims to federal health care programs. The FCA's 'qui tam' provision allows:
- Private individuals to file suit on behalf of the government and share in any recovery (Correct answer)
- The Department of Justice to prosecute without evidence of intent
- CMS to withhold payment pending an investigation
- State attorneys general to impose criminal penalties
Correct answer: Private individuals to file suit on behalf of the government and share in any recovery
The FCA's qui tam provision enables whistleblowers (relators) to file suit in the government's name and receive 15–30% of any resulting recovery.
Question 2: A hospital's compliance program is auditing surgical billing. Which document published by the OIG provides guidance on billing risk areas specific to surgical services?
- OIG Work Plan (Correct answer)
- CMS Conditions of Participation
- The Joint Commission Surgical Checklist
- American College of Surgeons Statement on Patient Safety
Correct answer: OIG Work Plan
The OIG Work Plan identifies compliance risk areas and audit priorities for federal health care programs, including surgical billing concerns.
Question 3: Under HIPAA, a 'covered entity' includes which of the following?
- Health care providers who transmit health information electronically (Correct answer)
- Medical device manufacturers
- Pharmaceutical companies
- Health information technology vendors with no direct patient contact
Correct answer: Health care providers who transmit health information electronically
HIPAA covered entities include health care providers that transmit PHI electronically, health plans, and health care clearinghouses.
Question 4: The Anti-Kickback Statute (AKS) is violated when remuneration is offered to induce referrals of items or services covered by federal health care programs. The AKS differs from the Stark Law in that AKS:
- Requires proof of intent and applies to all health care providers, not just physicians (Correct answer)
- Is a civil statute that requires no showing of intent
- Applies only to physician self-referrals
- Is enforced exclusively by the FDA
Correct answer: Requires proof of intent and applies to all health care providers, not just physicians
Unlike the strict-liability Stark Law, the AKS is an intent-based criminal statute that applies broadly to any person offering or receiving remuneration to induce federal program referrals.
Question 5: A surgeon is asked to use an implant supplied by a company in which she holds equity. Which compliance framework primarily governs this financial conflict of interest in a Medicare context?
- The Stark Law and its device-implant exception criteria (Correct answer)
- The Medical Device Amendments to the FDCA
- The Safe Medical Devices Act (SMDA)
- USP device labeling regulations
Correct answer: The Stark Law and its device-implant exception criteria
The Stark Law governs physician financial relationships with entities providing designated health services to Medicare patients, including implantable devices, subject to specific exceptions.
Question 6: When a surgical instrument is found to cause patient injury and the manufacturer issues a safety alert, the hospital is required under the Safe Medical Devices Act (SMDA) to report serious device-related adverse events to:
- The FDA via MedWatch or mandatory reporting (Correct answer)
- The Joint Commission only
- The state health department only
- The device manufacturer without FDA notification
Correct answer: The FDA via MedWatch or mandatory reporting
The SMDA requires hospitals to report device-related serious injuries to the manufacturer and device-related deaths to both the FDA and the manufacturer.
Question 7: CMS Conditions of Participation (CoPs) for hospitals require that surgical patients receive a pre-operative assessment documented by:
- A licensed practitioner within 30 days before surgery, updated within 24 hours pre-operatively (Correct answer)
- A registered nurse within 48 hours of admission
- An anesthesiologist at least 72 hours before any elective procedure
- The operating surgeon on the day of surgery only
Correct answer: A licensed practitioner within 30 days before surgery, updated within 24 hours pre-operatively
CMS CoPs require a history and physical completed within 30 days prior to surgery, with an update performed within 24 hours before the procedure.
General Surgery Board Review Regulatory Frameworks & Compliance 3
The False Claims Act (FCA) imposes liability on individuals or entities that submit fraudulent claims to federal health care programs.
The FCA's 'qui tam' provision allows: