CPT Regulatory Compliance & Standards 2 — Questions and Answers
Question 1: Which federal agency oversees the registration and regulation of prosthetic devices as medical devices in the United States?
- Centers for Medicare & Medicaid Services (CMS)
- Food and Drug Administration (FDA) (Correct answer)
- Occupational Safety and Health Administration (OSHA)
- Department of Veterans Affairs (VA)
Correct answer: Food and Drug Administration (FDA)
The FDA regulates prosthetic devices as medical devices under the Federal Food, Drug, and Cosmetic Act.
Question 2: Under OSHA standards, which hazard communication element must be present on all containers of hazardous chemicals used in a prosthetics lab?
- Material Safety Data Sheet inside the container
- GHS-compliant label with pictograms and signal word (Correct answer)
- Manufacturer's telephone number only
- Employee signature acknowledging hazard awareness
Correct answer: GHS-compliant label with pictograms and signal word
OSHA's Hazard Communication Standard (HazCom 2012) requires GHS-compliant labels including pictograms, signal words, and hazard statements on all hazardous chemical containers.
Question 3: A prosthetics facility that bills Medicare must enroll in which program to obtain a National Provider Identifier (NPI)?
- State Medicaid enrollment portal
- PECOS (Provider Enrollment, Chain, and Ownership System) (Correct answer)
- FDA device registration database
- ABC credentialing system
Correct answer: PECOS (Provider Enrollment, Chain, and Ownership System)
Medicare requires providers to enroll through PECOS and obtain an NPI before submitting claims for reimbursement.
Question 4: Which classification does the FDA assign to most custom-fabricated prosthetic limbs?
- Class I (General Controls)
- Class II (Special Controls) (Correct answer)
- Class III (Premarket Approval)
- Class IV (Investigational Device)
Correct answer: Class II (Special Controls)
Most prosthetic limbs are classified as Class II medical devices, subject to special controls and typically requiring 510(k) clearance for new products.
Question 5: Under HIPAA, which type of information requires the strictest protection in a prosthetics practice?
- Billing codes used for reimbursement
- Protected Health Information (PHI) (Correct answer)
- Manufacturer warranty documentation
- Technician training records
Correct answer: Protected Health Information (PHI)
HIPAA's Privacy and Security Rules mandate strict safeguards for Protected Health Information (PHI), which includes any identifiable patient health data.
Question 6: The ABC Code of Professional Responsibility primarily applies to which individuals in a prosthetics setting?
- Insurance billing staff only
- Credentialed practitioners and technicians (Correct answer)
- Administrative receptionists
- Device manufacturers exclusively
Correct answer: Credentialed practitioners and technicians
The ABC Code of Professional Responsibility applies to credentialed practitioners and technicians, outlining ethical and professional conduct standards.
Question 7: When a prosthetic device causes an unexpected serious injury, the facility is required to report it to the FDA under which program?
- MedWatch / Medical Device Reporting (MDR) (Correct answer)
- OSHA 300 Log incident report
- Joint Commission sentinel event report
- CMS quality improvement report
Correct answer: MedWatch / Medical Device Reporting (MDR)
The FDA's Medical Device Reporting (MDR) regulation requires facilities to report device-related serious injuries or deaths through the MedWatch reporting system.
CPT Regulatory Compliance & Standards 2
Which federal agency oversees the registration and regulation of prosthetic devices as medical devices in the United States?