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
The CMS Competitive Bidding Program for durable medical equipment primarily impacts prosthetics suppliers by doing which of the following?
Answer: Setting competitive reimbursement rates in selected geographic areas
The CMS Competitive Bidding Program establishes reimbursement rates through a bidding process among eligible suppliers in designated competitive bidding areas.
A prosthetics technician discovers that a batch of laminated sockets has delamination defects. Under a quality management system, the first required action is to:
Answer: Quarantine and tag the nonconforming product to prevent use
Nonconforming products must be identified, segregated, and tagged to prevent unintended use, as required by quality management standards such as ISO 13485.
Which standard specifically governs the mechanical testing of lower-limb prostheses to verify structural integrity?
Answer: ISO 10328
ISO 10328 specifies structural testing procedures for lower-limb prostheses, including static and cyclic load tests to verify durability.
A facility's fraud and abuse compliance program should include which core element to be considered effective under OIG guidelines?
Answer: Written policies, training, and an internal reporting mechanism
OIG guidance states that an effective compliance program must include written standards, employee training, and a mechanism for reporting suspected violations.
When a prosthetics company acquires another practice, which regulatory requirement must be addressed regarding existing Medicare supplier agreements?
Answer: The new owner must enroll separately in PECOS and obtain a new supplier number
Medicare supplier numbers and billing agreements are not automatically transferable; new owners must complete a fresh PECOS enrollment.
Which type of warranty documentation must a prosthetics supplier provide to a Medicare beneficiary at the time of device delivery?
Answer: A written warranty statement outlining repair and replacement rights
Medicare requires suppliers to provide beneficiaries with a written warranty statement at delivery, explaining their rights to repair or replacement.
An accreditation survey by ACHC or The Joint Commission evaluates a prosthetics organization primarily on its:
Answer: Adherence to quality and safety standards across clinical and operational areas
Accreditation surveys assess compliance with quality and safety standards covering clinical practice, patient rights, staff competency, and operational processes.