General Surgery Board Review Regulatory Frameworks & Compliance 4 — Questions and Answers
Question 1: A surgeon performs a 'never event' — a wrong-site surgery. Under current CMS policy, this event is:
- Non-reimbursable; CMS will not pay for care related to the preventable error (Correct answer)
- Reportable to the FDA under mandatory device reporting
- Subject to immediate license revocation by the medical board
- Covered under the AKS safe harbor for quality improvement
Correct answer: Non-reimbursable; CMS will not pay for care related to the preventable error
CMS designates certain serious reportable events (formerly 'never events') as non-reimbursable; hospitals cannot bill Medicare or Medicaid for care resulting from wrong-site surgery.
Question 2: The Joint Commission's Universal Protocol is designed to prevent wrong-site, wrong-procedure, and wrong-patient surgeries. The three core components are:
- Pre-procedure verification, site marking, and a time-out (Correct answer)
- Informed consent, pre-anesthesia check, and post-op debriefing
- Surgical safety checklist, WHO sign-in, and sign-out
- H&P review, imaging confirmation, and team briefing
Correct answer: Pre-procedure verification, site marking, and a time-out
The Joint Commission Universal Protocol requires a pre-procedure verification process, marking of the operative site, and a time-out immediately before the procedure starts.
Question 3: Under OSHA's Bloodborne Pathogens Standard, surgical employers must offer hepatitis B vaccination to employees with occupational exposure:
- At no cost to the employee, within 10 working days of initial assignment (Correct answer)
- After a documented needlestick injury only
- On a voluntary basis with cost-sharing between employer and employee
- Only if the employee tests seronegative for hepatitis B antibodies
Correct answer: At no cost to the employee, within 10 working days of initial assignment
OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030) mandates that employers provide hepatitis B vaccination free of charge within 10 working days of initial assignment to occupational exposure.
Question 4: The Health Care Quality Improvement Act (HCQIA) provides peer review immunity to hospitals when conducting professional review actions, provided the action is taken:
- In the reasonable belief it furthers quality health care, with adequate notice and hearing procedures (Correct answer)
- Only after a formal malpractice verdict has been rendered
- In response to a complaint filed with the state licensing board
- Exclusively through a Joint Commission-accredited process
Correct answer: In the reasonable belief it furthers quality health care, with adequate notice and hearing procedures
HCQIA grants immunity for professional review actions that meet four criteria: reasonable belief the action furthers quality care, reasonable effort to obtain facts, adequate notice and hearing, and reasonable belief the action was warranted.
Question 5: A hospital's compliance officer discovers upcoding on surgical claims submitted over three years. Under the False Claims Act, the statute of limitations for the government to bring a civil action is generally:
- Six years from the violation, or three years from when the government knew or should have known, whichever is later (up to 10 years) (Correct answer)
- Two years from the date of the last fraudulent claim
- Five years from the date of discovery by the OIG
- One year from the internal audit finding
Correct answer: Six years from the violation, or three years from when the government knew or should have known, whichever is later (up to 10 years)
The FCA's statute of limitations is the later of 6 years from the violation or 3 years after the government learns of it, but no more than 10 years total.
Question 6: Which CMS regulation requires hospitals to have a governing body that assumes full responsibility for determining, implementing, and monitoring policies governing the hospital's total operation?
- The CMS Conditions of Participation, §482.12 (Governing Body) (Correct answer)
- The Sarbanes-Oxley Act
- The Joint Commission Leadership Standard LD.04.01.01
- HIPAA Administrative Safeguards
Correct answer: The CMS Conditions of Participation, §482.12 (Governing Body)
CMS CoP §482.12 requires hospitals to have a governing body legally responsible for the conduct of the hospital, including establishing policies and ensuring executive leadership accountability.
Question 7: A surgical resident observes an attending billing for a procedure performed by the resident without meaningful attending supervision. The most appropriate first action under federal compliance obligations is to:
- Report the concern through the hospital's compliance hotline or compliance officer (Correct answer)
- Refuse to participate in any further cases with that attending
- Notify the patient directly of the billing discrepancy
- File a qui tam lawsuit immediately without internal reporting
Correct answer: Report the concern through the hospital's compliance hotline or compliance officer
Effective compliance programs require internal reporting channels; residents should first use the compliance hotline or officer before considering external reporting pathways.
General Surgery Board Review Regulatory Frameworks & Compliance 4
A surgeon performs a 'never event' — a wrong-site surgery.
Under current CMS policy, this event is: