While there is an RFI for deregulatory ideas to CMS, and for deregulatory ideas to all of HHS (open to June 10 and July 10, respectively) - AHA and OMB have already submitted deregulatory ideas to OMB.
AHA here. ACLA here. 18pp and 12pp, respectively.
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I asked for a Chat GPT comparison.
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Here is a detailed comparative analysis of the American Clinical Laboratory Association (ACLA) and the American Hospital Association (AHA) submissions in response to the Administration’s deregulatory RFI (2025), with an emphasis on the ACLA letter and then a structured contrast with AHA’s approach.
ACLA: Focused, Targeted Deregulation in Laboratory Policy
The ACLA letter is a highly focused, technically detailed, and policy-savvy document aimed squarely at regulatory barriers unique to clinical laboratories. It speaks the language of CMS rulemaking and OMB cost-benefit review, while laying out eight specific deregulatory proposals, most of which are highly actionable within current agency authority.
Core Themes of ACLA’s Strategy:
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PAMA Reform (CLFS Rates):
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ACLA sharply critiques CMS’s implementation of PAMA Section 216 and calls for rate freezes and updated data collection windows.
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It frames the issue using statutory interpretation (e.g., CMS may reduce but not must reduce) and budgetary facts (CLFS cuts already exceeded CBO projections by $1.5B in just 3 years).
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Medical Necessity Documentation:
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Urges CMS to formally recognize test requisition forms (TRFs) as valid documentation — citing inconsistency among MACs and referencing MolDX precedent.
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Prior Authorization and Date of Service:
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Focuses on misuses of CMS’s “date of service” rule as a denial tactic.
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Seeks amendments to 42 CFR §§ 414.510 and 422.122 to clarify payment pathways and prevent retroactive denials.
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National Coverage Determinations (NCDs):
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Proposes a streamlined process for NCD reconsiderations that expand (rather than narrow) coverage — aimed at unlocking innovation backlog.
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Coding and NCCI Manual Conflicts:
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Calls for deletion of several burdensome and contradictory clauses in the NCCI Policy Manual that conflict with AMA CPT guidance.
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Seeks to align CMS with the official HIPAA code set source (CPT), asserting that CMS edits that deviate from CPT guidance should not stand.
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Electronic Signatures:
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Proposes a modernization of signature policy, arguing that HL7v2-based lab orders from EHRs inherently reflect physician intent.
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ICD-10 Excludes Notes:
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Argues that these create systematic denials of legitimate claims, especially when multiple ICD-10 codes apply.
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CPT Licensing Fees:
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Raises a broader issue of monopolistic pricing — that CMS mandates CPT codes but does not regulate AMA’s licensing fees — a rare deregulatory push on public-private cost imposition under HIPAA.
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AHA: Broad, Systems-Level Deregulatory Agenda
By contrast, the AHA submitted an expansive and multi-faceted 100-point deregulatory agenda, organized into four domains: Billing/Admin, Quality, Telehealth, and Workforce.
Key Characteristics of the AHA Letter:
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Breadth Over Depth: The AHA letter is sweeping, aimed at reducing system-wide friction across all sectors of hospital operations — billing, regulation, safety, staffing, etc.
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Pragmatic Framing: Focuses on financial instability (40% hospitals with negative margins) and massive admin overhead ($1T/year) to justify relief.
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Policy Recommendations Include:
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Repeal of CMMI Mandatory Models like TEAM and IOTA.
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Rollback of CMS’s 2024 Information Blocking Disincentive Rule.
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Codification and rapid implementation of Interoperability and Prior Auth Rule (CMS-0057-F).
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Elimination of duplicative and outdated reporting (e.g., sepsis bundle, COVID-19 vax stats, 42 CFR Part 2 behavioral health privacy).
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CMS survey reform, including virtual low-risk complaint surveys.
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Major telehealth expansions including origin site, modality, and provider type.
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HIPAA updates, such as removing breach notices for events under 500 persons.
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Comparative Insights: ACLA vs. AHA Approaches
| Theme | ACLA Approach | AHA Approach |
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| Tone & Style | Technical, regulatory detail, aimed at CMS/OMB staffers | Advocacy-forward, sweeping, politically inflected |
| Focus | Lab-specific deregulatory pain points, especially CLFS and coverage coding | Entire hospital ecosystem: payment, surveys, workforce, quality, IT |
| Primary Regulatory Targets | CMS (CLFS, NCDs, PAMA, NCCI), HHS (HIPAA) | CMS, HHS, CMMI, OSHA, FTC, EPA |
| Use of Executive Order 14219 Framework | Strong alignment: cites each action under EO-defined categories like “not based on best reading of statute” or “excessive cost” | Implicit use; themes align but less explicitly cited |
| Actionability | Focused, rule-by-rule roadmap of actionable CMS revisions | Big-picture policy wishlist — some requiring Congress, many needing interagency coordination |
| Innovation Framing | Emphasizes how flawed regulation suppresses diagnostics R&D and precision medicine | Innovation cited more generally, especially in payment models and digital care delivery |
Shared Ground and Divergence
Shared Ground:
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Criticism of Prior Authorization Abuse: Both criticize MA plans for using prior auth to obstruct care, especially retroactive denials.
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Telehealth Support: Both want telehealth regulations updated to reflect post-pandemic realities (origin site, behavioral health, hospice, etc.).
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Regulatory Overhead: Both highlight administrative burden detracting from patient care.
Divergence:
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Lab-Centric Issues: ACLA uniquely targets CPT license fees, Excludes Notes logic errors, and the misalignment of NCCI with CPT — none of which appear in AHA’s list.
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Payment Models: AHA squarely attacks mandatory CMMI bundles (TEAM, IOTA); ACLA does not engage payment reform beyond CLFS.
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Workforce & Accreditation: AHA’s list is heavy on workforce de-bureaucratization (e.g., NPs, surveys, OSHA), not relevant to ACLA’s world.
Conclusion
For a lab industry audience, the ACLA letter provides a precise deregulatory roadmap tailored to actual operational friction points in laboratory medicine — from pricing mechanisms (PAMA) to coding conflicts (NCCI/CPT), to coverage hurdles (prior auth). It is tightly written, strategically framed in EO 14219 language, and well-suited to OMB deliberations.
In contrast, AHA’s letter serves as a maximalist deregulatory manifesto, collecting long-standing frustrations across a fragmented hospital landscape into a single political and economic narrative. While both documents seek relief from regulatory burdens, ACLA is surgical, AHA is systemic.
Let me know if you’d like a one-page version, a chart-only summary, or a redline to use in briefings.
