PACS Regulatory Framework & Requirements 2 — Questions and Answers
Question 1: Under the Employee Retirement Income Security Act (ERISA), which entity primarily regulates self-funded employer health plans?
- State insurance commissioners
- The U.S. Department of Labor (Correct answer)
- Centers for Medicare & Medicaid Services
- The Office of Personnel Management
Correct answer: The U.S. Department of Labor
ERISA grants the U.S. Department of Labor primary regulatory authority over self-funded employer-sponsored health plans, preempting most state insurance laws.
Question 2: Which CMS regulation requires Medicare Advantage plans to make prior authorization decisions within 72 hours for expedited (urgent) requests?
- 42 CFR Part 422 (Correct answer)
- 45 CFR Part 156
- 42 CFR Part 438
- 29 CFR Part 2590
Correct answer: 42 CFR Part 422
42 CFR Part 422 governs Medicare Advantage plans and mandates that expedited organization determinations, including prior authorization, be resolved within 72 hours.
Question 3: What does the term 'gold carding' refer to in the context of prior authorization reform legislation?
- Automatic denial of high-cost services
- Exempting providers with high approval rates from PA requirements (Correct answer)
- Requiring gold-standard clinical evidence for PA approvals
- Expedited PA processing for gold-tier health plans
Correct answer: Exempting providers with high approval rates from PA requirements
Gold carding laws exempt providers who demonstrate consistently high prior authorization approval rates from needing to obtain PA for certain services.
Question 4: Which federal law prohibits health plans from placing more restrictive prior authorization requirements on mental health and substance use disorder benefits compared to medical/surgical benefits?
- HIPAA Privacy Rule
- Mental Health Parity and Addiction Equity Act (MHPAEA) (Correct answer)
- Affordable Care Act Section 1557
- Americans with Disabilities Act
Correct answer: Mental Health Parity and Addiction Equity Act (MHPAEA)
MHPAEA requires that treatment limitations, including prior authorization requirements, for mental health and substance use disorder benefits be no more restrictive than those applied to medical/surgical benefits.
Question 5: A state law requires health insurers to provide prior authorization decisions within 3 business days for non-urgent requests. A fully-insured commercial plan in that state must comply because:
- ERISA preempts all state PA timelines
- Fully-insured plans are subject to state insurance regulation (Correct answer)
- CMS mandates state law compliance for all commercial plans
- ACA prohibits state-specific PA timelines
Correct answer: Fully-insured plans are subject to state insurance regulation
Fully-insured commercial health plans are regulated by state insurance law, so state-mandated PA timelines apply to them, unlike self-funded ERISA plans.
Question 6: Under the CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F), by what date must impacted payers implement FHIR-based Prior Authorization APIs?
- January 1, 2026 (Correct answer)
- January 1, 2027
- January 1, 2025
- July 1, 2026
Correct answer: January 1, 2026
CMS-0057-F requires impacted payers (Medicare Advantage, Medicaid, CHIP, and QHP issuers) to implement FHIR-based Prior Authorization APIs by January 1, 2026.
Question 7: Which accreditation standard requires health plans to have a written policy specifying the clinical criteria used to make prior authorization decisions?
- NCQA UM Standards (Correct answer)
- Joint Commission ORYX requirements
- ISO 9001 healthcare guidelines
- URAC telehealth standards
Correct answer: NCQA UM Standards
NCQA Utilization Management standards require health plans to maintain written clinical criteria policies used for prior authorization and other utilization management decisions.
Under the Employee Retirement Income Security Act (ERISA), which entity primarily regulates self-funded employer health plans?