CPT Regulatory Compliance & Standards 2

Question 1

Which federal agency oversees the registration and regulation of prosthetic devices as medical devices in the United States?

Accepted Answer

Food and Drug Administration (FDA)

Answer

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?

Accepted Answer

GHS-compliant label with pictograms and signal word

Answer

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)?

Accepted Answer

PECOS (Provider Enrollment, Chain, and Ownership System)

Answer

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?

Accepted Answer

Class II (Special Controls)

Answer

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?

Accepted Answer

Protected Health Information (PHI)

Answer

HIPAA's Privacy and Security Rules mandate strict safeguards for Protected Health Information (PHI), which includes any identifiable patient health data.

(CPT) Certified Prosthetic Technician Practice Test

(CPT) Certified Prosthetic Technician Practice Test

CPT Regulatory Compliance & Standards 2