CMC Regulatory Compliance & Legal Framework 5 — Questions and Answers
Question 1: A cardiac device manufacturer recalls a pacemaker model due to a software defect. Under FDA regulations, this recall is classified as Class I if:
- The defect causes minor inconvenience only
- The defect could cause serious adverse health consequences or death (Correct answer)
- The device is cosmetic in nature
- The recall is initiated voluntarily without FDA involvement
Correct answer: The defect could cause serious adverse health consequences or death
FDA Class I recalls involve products with a reasonable probability of causing serious adverse health consequences or death.
Question 2: Under state medical practice acts, a cardiologist's license can be suspended for conduct that most directly violates:
- A hospital's internal dress code policy
- Professional standards of care or ethical conduct (Correct answer)
- A billing dispute with a private insurer
- Disagreement with a hospital committee decision
Correct answer: Professional standards of care or ethical conduct
State medical boards have authority to discipline physicians for violations of professional standards of care and ethical conduct.
Question 3: A patient with stable angina refuses a recommended angioplasty after being fully informed of risks and benefits. The cardiologist should:
- Proceed with the procedure for the patient's benefit
- Respect the refusal and document it, offering alternative management (Correct answer)
- Seek a court order to override the refusal
- Transfer the patient to another facility immediately
Correct answer: Respect the refusal and document it, offering alternative management
A competent patient's informed refusal must be respected; the physician should document it and discuss alternative treatment options.
Question 4: The Health Care Quality Improvement Act (HCQIA) provides immunity to peer review participants when the review is conducted:
- Anonymously without notifying the reviewed physician
- In good faith, with reasonable effort to obtain facts, and with adequate notice and hearing procedures (Correct answer)
- Only by hospital administrators, not fellow physicians
- Under direct CMS supervision
Correct answer: In good faith, with reasonable effort to obtain facts, and with adequate notice and hearing procedures
HCQIA immunity requires peer review to be conducted in good faith with adequate fact-finding and due process procedures for the reviewed physician.
Question 5: A cardiology practice wants to share de-identified patient outcome data for a quality improvement publication. Under HIPAA, de-identification requires:
- Removing only the patient's name
- Removing all 18 HIPAA identifiers or applying a statistical expert determination (Correct answer)
- Obtaining patient consent for each record
- IRB approval in all cases
Correct answer: Removing all 18 HIPAA identifiers or applying a statistical expert determination
HIPAA's Safe Harbor method requires removing all 18 specified identifiers, while the Expert Determination method requires statistical verification of non-identifiability.
Question 6: When a cardiologist is named in a malpractice lawsuit, the National Practitioner Data Bank (NPDB) must be queried or reported to in which scenario?
- Any time a patient files a complaint with the hospital
- When a malpractice payment is made on behalf of the physician (Correct answer)
- When the physician receives a negative peer review
- When the physician changes hospital affiliations voluntarily
Correct answer: When a malpractice payment is made on behalf of the physician
Malpractice payments made on behalf of a physician must be reported to the NPDB regardless of admission of liability.
Question 7: A hospital's cardiac surgery program has a 30-day mortality rate significantly above the national benchmark. CMS may respond by:
- Automatically suspending the program's Medicare billing
- Initiating a quality improvement review and potentially imposing conditions or terminating the program's Medicare participation (Correct answer)
- Requiring only a written explanation from the program director
- Reporting the program to The Joint Commission only
Correct answer: Initiating a quality improvement review and potentially imposing conditions or terminating the program's Medicare participation
CMS has authority to conduct quality reviews and, in serious cases, impose conditions of participation or terminate Medicare participation for persistently poor outcomes.
CMC Regulatory Compliance & Legal Framework 5
A cardiac device manufacturer recalls a pacemaker model due to a software defect.
Under FDA regulations, this recall is classified as Class I if: