General Surgery Board Review Regulatory Frameworks & Compliance 5 — Questions and Answers
Question 1: Under FDA regulations, a Class III medical device used in surgery (e.g., a new vascular stent) requires which premarket approval pathway before commercial distribution?
- Premarket Approval Application (PMA) (Correct answer)
- 510(k) premarket notification
- De Novo classification request
- Humanitarian Device Exemption (HDE)
Correct answer: Premarket Approval Application (PMA)
Class III devices that support life or pose substantial risk of illness require a PMA, which demands valid scientific evidence of safety and effectiveness.
Question 2: The Physician Payments Sunshine Act requires manufacturers of drugs and medical devices to report payments and transfers of value to physicians to:
- CMS, which publishes the data in the Open Payments database (Correct answer)
- The OIG for inclusion in the NPDB
- The FTC for antitrust review
- The DEA for controlled substance monitoring
Correct answer: CMS, which publishes the data in the Open Payments database
The Sunshine Act (ACA §6002) requires applicable manufacturers to annually report physician payments and ownership interests to CMS, which publishes them in the Open Payments program.
Question 3: A hospital seeks Joint Commission accreditation. The Joint Commission's survey process is based on:
- Unannounced on-site surveys conducted approximately every 36 months (Correct answer)
- Annual announced inspections with a 90-day advance notice
- Biennial document review without on-site visits
- Quarterly audits triggered only by sentinel events
Correct answer: Unannounced on-site surveys conducted approximately every 36 months
The Joint Commission conducts unannounced full accreditation surveys approximately every 36 months, supplemented by random unannounced validation surveys.
Question 4: The two-midnight rule, implemented by CMS, distinguishes inpatient admissions (Part A) from observation services (Part B) based on:
- Whether the physician expects the patient to require hospital care spanning at least two midnights (Correct answer)
- Whether the patient is admitted through the emergency department
- Whether the total hospital stay exceeds 24 hours
- Whether a surgical procedure is performed during the stay
Correct answer: Whether the physician expects the patient to require hospital care spanning at least two midnights
Under the two-midnight rule, an inpatient admission is appropriate when the admitting physician expects the patient to need care crossing at least two midnights.
Question 5: A surgeon documents a procedure as 'laparoscopic cholecystectomy, converted to open.' For correct CPT coding, the surgeon should bill:
- The open cholecystectomy CPT code, as the completed procedure governs billing (Correct answer)
- Both the laparoscopic and open codes with a modifier
- Only the laparoscopic code because the procedure was initially attempted laparoscopically
- An unlisted procedure code because conversion is not separately defined
Correct answer: The open cholecystectomy CPT code, as the completed procedure governs billing
CPT coding rules require billing for the procedure actually completed; when a laparoscopic case is converted to open, the open procedure code is reported.
Question 6: Under the Americans with Disabilities Act (ADA), a hospital must provide reasonable accommodations to a surgeon with a disability unless doing so would:
- Cause undue hardship or pose a direct threat to patient safety that cannot be eliminated by reasonable accommodation (Correct answer)
- Require hiring additional support staff at any cost
- Change the essential functions of a surgical position
- Exceed a 15-employee threshold for the institution
Correct answer: Cause undue hardship or pose a direct threat to patient safety that cannot be eliminated by reasonable accommodation
The ADA requires reasonable accommodation but exempts employers from accommodations that impose undue hardship or where the individual poses a direct threat that cannot be mitigated.
Question 7: The Office of Inspector General (OIG) Corporate Integrity Agreement (CIA) is typically entered into by a health care provider as part of a settlement involving:
- Allegations of fraud or False Claims Act violations against federal health programs (Correct answer)
- Violations of the Joint Commission accreditation standards
- State medical board disciplinary proceedings
- OSHA workplace safety citations in the operating room
Correct answer: Allegations of fraud or False Claims Act violations against federal health programs
CIAs are negotiated between the OIG and providers settling civil fraud or FCA cases, imposing ongoing compliance monitoring obligations as a condition of continued Medicare/Medicaid participation.
General Surgery Board Review Regulatory Frameworks & Compliance 5
Under FDA regulations, a Class III medical device used in surgery (e.g., a new vascular stent) requires which premarket approval pathway before commercial distribution?