Regulatory Compliance & Standards Flashcards
7 cards from real CPT practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Compliance & Standards flashcards as text
Which L-code category is used to bill Medicare for lower-limb endoskeletal prosthetic systems?
Answer: L5600–L5999 range
L5600–L5999 codes cover endoskeletal (modular) lower-limb prosthetic systems for Medicare billing purposes.
A prosthetics facility must conduct a Corrective and Preventive Action (CAPA) process when which event occurs?
Answer: A product defect or quality nonconformance is identified
CAPA processes are triggered by identified defects, nonconformances, or quality failures to correct root causes and prevent recurrence.
State licensure laws for prosthetic technicians primarily serve which regulatory function?
Answer: Establishing minimum competency and scope-of-practice standards
State licensure laws define minimum competency requirements and scope-of-practice boundaries to protect public safety.
ISO 13485 is a quality management standard specific to which industry sector?
Answer: Medical device manufacturing and distribution
ISO 13485 specifies requirements for a quality management system specific to organizations involved in the design and manufacture of medical devices.
Under the Americans with Disabilities Act (ADA), a prosthetics practice must ensure which of the following for patients with mobility impairments?
Answer: Physical accessibility of the facility
The ADA requires places of public accommodation, including healthcare facilities, to provide physical accessibility to individuals with disabilities.
Which document must a prosthetics supplier have on file to demonstrate that a Medicare patient's device was medically necessary?
Answer: Certificate of Medical Necessity (CMN) or detailed written order
Medicare requires a Certificate of Medical Necessity or detailed written order from the treating physician to support medical necessity for prosthetic devices.
Which regulation governs proper disposal of sharp objects such as drills and saw blades used in prosthetic fabrication?
Answer: OSHA Bloodborne Pathogen Standard for sharps disposal
OSHA's Bloodborne Pathogen Standard requires proper sharps disposal containers and procedures to protect workers from percutaneous injury.