CMC Regulatory Compliance & Legal Framework 2 — Questions and Answers
Question 1: Under HIPAA's Minimum Necessary Standard, a cardiac nurse accessing a patient's full medical history to schedule a stress test is:
- Compliant, as all records may be needed
- Non-compliant, only information necessary for scheduling should be accessed (Correct answer)
- Compliant if the patient provided verbal consent
- Non-compliant only if the records are printed
Correct answer: Non-compliant, only information necessary for scheduling should be accessed
The Minimum Necessary Standard requires accessing only the PHI needed for the specific task, not the entire record.
Question 2: A hospital's cardiac catheterization lab wants to participate in a multi-site clinical trial. Which federal regulation governs the protection of human research subjects?
- HIPAA Privacy Rule
- The Common Rule (45 CFR 46) (Correct answer)
- EMTALA
- The Stark Law
Correct answer: The Common Rule (45 CFR 46)
The Common Rule (45 CFR Part 46) establishes federal standards for protecting human subjects in research, including IRB oversight.
Question 3: A physician refers a cardiac patient to a diagnostic imaging center in which the physician holds a financial interest. This arrangement may violate:
- EMTALA
- The Anti-Kickback Statute only
- The Stark Law (Correct answer)
- HIPAA
Correct answer: The Stark Law
The Stark Law prohibits physician self-referrals for designated health services, including imaging, when a financial relationship exists.
Question 4: Which accrediting body sets standards for cardiac catheterization laboratory quality and safety in the United States?
- FDA
- The Joint Commission (TJC) (Correct answer)
- CMS only
- OSHA
Correct answer: The Joint Commission (TJC)
The Joint Commission accredits and certifies healthcare organizations including cardiac cath labs, setting safety and quality standards.
Question 5: When a patient with chest pain arrives at an emergency department, EMTALA requires the hospital to:
- Obtain insurance verification before evaluation
- Provide a medical screening examination regardless of ability to pay (Correct answer)
- Transfer the patient immediately to a cardiac center
- Contact the patient's cardiologist first
Correct answer: Provide a medical screening examination regardless of ability to pay
EMTALA mandates a medical screening examination for all individuals presenting to an ED regardless of payment ability.
Question 6: A cardiac care unit implements a new protocol using an AI-based arrhythmia detection device. This device must receive clearance from:
- The Joint Commission
- The FDA's Center for Devices and Radiological Health (CDRH) (Correct answer)
- CMS
- The American Heart Association
Correct answer: The FDA's Center for Devices and Radiological Health (CDRH)
The FDA's CDRH regulates medical devices including AI-based diagnostic tools through the 510(k) or PMA pathway.
Question 7: A cardiologist documents a procedure with a higher complexity code than was actually performed to increase reimbursement. This is an example of:
- Bundling
- Upcoding (Correct answer)
- Downcoding
- Unbundling
Correct answer: Upcoding
Upcoding is billing for a higher-level service than was provided, constituting Medicare/Medicaid fraud.
CMC Regulatory Compliance & Legal Framework 2
Under HIPAA's Minimum Necessary Standard, a cardiac nurse accessing a patient's full medical history to schedule a stress test is: