General Surgery Board Review Regulatory Frameworks & Compliance 5

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?

Accepted Answer

Premarket Approval Application (PMA)

Answer

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:

Accepted Answer

CMS, which publishes the data in the Open Payments database

Answer

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:

Accepted Answer

Unannounced on-site surveys conducted approximately every 36 months

Answer

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:

Accepted Answer

Whether the physician expects the patient to require hospital care spanning at least two midnights

Answer

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:

Accepted Answer

The open cholecystectomy CPT code, as the completed procedure governs billing

Answer

CPT coding rules require billing for the procedure actually completed; when a laparoscopic case is converted to open, the open procedure code is reported.

General Surgery Board Review Practice Test

General Surgery Board Review Practice Test

General Surgery Board Review Regulatory Frameworks & Compliance 5