CFO Regulatory Compliance & Legal Framework 2

Question 1

Under the FDA's regulatory framework, custom-fabricated orthoses are classified as which type of medical device?

Accepted Answer

Class I exempt devices

Answer

Most custom-fabricated orthoses are classified as Class I exempt devices under FDA regulations because they pose minimal risk.

Question 2

Which federal agency is primarily responsible for overseeing the billing and reimbursement practices of Medicare-participating orthotists?

Accepted Answer

CMS (Centers for Medicare & Medicaid Services)

Answer

CMS oversees Medicare and Medicaid reimbursement rules, including coverage policies and billing requirements for orthotists.

Question 3

A patient refuses to sign an Advance Beneficiary Notice (ABN) before receiving an orthosis that Medicare may not cover. What should the orthotist do?

Accepted Answer

Document the refusal and inform the patient they may be responsible for full payment

Answer

If a patient refuses to sign an ABN, the orthotist should document the refusal and notify the patient they bear financial responsibility if Medicare denies the claim.

Question 4

The National Supplier Clearinghouse (NSC) is responsible for which function related to orthotic practice?

Accepted Answer

Enrolling DMEPOS suppliers in Medicare

Answer

The NSC enrolls and monitors DMEPOS (Durable Medical Equipment, Prosthetics, Orthotics, and Supplies) suppliers participating in Medicare.

Question 5

Which law mandates that healthcare providers maintain the privacy of patient health information and sets standards for electronic transactions?

Accepted Answer

HIPAA (Health Insurance Portability and Accountability Act)

Answer

HIPAA establishes national standards for protecting patient health information (PHI) and governs electronic healthcare transactions.

(CFO) Certified Fitter Orthotics Practice Test

(CFO) Certified Fitter Orthotics Practice Test

CFO Regulatory Compliance & Legal Framework 2