CSC Regulatory Frameworks & Compliance 5 — Questions and Answers
Question 1: Under the CMS Hospital Readmissions Reduction Program (HRRP), which cardiac condition is included as a tracked readmission measure?
- Atrial fibrillation
- Aortic stenosis
- Acute Myocardial Infarction (AMI) (Correct answer)
- Hypertensive urgency
Correct answer: Acute Myocardial Infarction (AMI)
CMS tracks 30-day risk-standardized readmission rates for Acute Myocardial Infarction, Heart Failure, and CABG surgery under the HRRP, with financial penalties for excess readmissions.
Question 2: A pharmaceutical representative provides a cardiologist with a research grant funded directly by the drug manufacturer. Under AHA conflict-of-interest guidelines for clinical guideline writing, this cardiologist should:
- Disclose the relationship but may vote on all recommendations
- Be excluded from all guideline writing activities
- Disclose and be recused from voting on recommendations related to that manufacturer's products (Correct answer)
- Participate freely as research grants are not considered conflicts
Correct answer: Disclose and be recused from voting on recommendations related to that manufacturer's products
AHA and ACC COI policies require disclosure of relevant relationships and recusal from voting on specific recommendations related to the funding company's products.
Question 3: The FDA's Breakthrough Device Designation, as applied to a novel cardiac monitoring wearable, is intended to:
- Automatically approve the device without standard trials
- Expedite the development and review process for serious conditions (Correct answer)
- Grant permanent marketing approval before clinical data is available
- Exempt the device from post-market surveillance requirements
Correct answer: Expedite the development and review process for serious conditions
Breakthrough Device Designation expedites development, assessment, and review while maintaining the FDA's standard for safety and effectiveness evidence.
Question 4: Under CMS's Conditions of Participation for Surgical Services, a hospital performing cardiac catheterization must ensure that a qualified physician is available to perform which function?
- Anesthesia administration for all cases
- Emergency surgical backup for complications (Correct answer)
- Interpretation of all post-procedure imaging
- Real-time supervision of all nursing staff
Correct answer: Emergency surgical backup for complications
CMS and ACC/SCAI standards require that cardiac catheterization programs have arrangements for emergency surgical backup to manage life-threatening complications such as perforation or dissection.
Question 5: A hospital's cardiac surgery program is being evaluated under The Joint Commission's National Patient Safety Goals. Which NPSG is most directly applicable to preventing wrong-site cardiac surgery?
- NPSG 01.01.01: Patient Identification (Correct answer)
- NPSG 07.01.01: Hand Hygiene
- NPSG 15.01.01: Suicide Risk Reduction
- NPSG 02.03.01: Critical Test Reporting
Correct answer: NPSG 01.01.01: Patient Identification
NPSG 01.01.01 requires use of at least two patient identifiers, which is the foundation of preventing wrong-patient and wrong-site procedures including cardiac surgery.
Question 6: Under Stark Law (Physician Self-Referral Law), a cardiologist who owns interest in an ambulatory cardiac monitoring center must:
- Divest all ownership before treating any Medicare patients
- Comply with applicable exceptions such as the in-office ancillary services exception if applicable (Correct answer)
- Obtain prior authorization from CMS for all referrals
- Refer patients only through a neutral third-party coordinator
Correct answer: Comply with applicable exceptions such as the in-office ancillary services exception if applicable
Stark Law prohibits self-referral to entities in which the physician has a financial interest but provides specific statutory exceptions, such as the in-office ancillary services exception, when conditions are met.
Question 7: The ACC's CardioSmart patient decision aid tools align with which regulatory and quality framework?
- FDA drug labeling requirements
- CMS Shared Decision Making requirements under the Affordable Care Act (Correct answer)
- OSHA workplace safety standards
- DEA controlled substance monitoring programs
Correct answer: CMS Shared Decision Making requirements under the Affordable Care Act
The ACA and subsequent CMS rules promote shared decision making, and CardioSmart tools are designed to support these requirements by helping patients make informed choices about cardiac treatments.
CSC Regulatory Frameworks & Compliance 5
Under the CMS Hospital Readmissions Reduction Program (HRRP), which cardiac condition is included as a tracked readmission measure?