Thursday, May 15, 2025

HHS Advice on De-regulation: Now Comment on All of HHS & De-regulation

 A few weeks ago, Medicare issued a call for ideas on how Medicare can  rapidly decrease regulatory burdens.  The input is open until June 10.

This week, all of HHS asks for about the same thing - how any part of HHS can kill burdensome regulations.

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There are some special webpages for deregulation like here and here.   

For example, AHA has already submitted 100 ways to deregulate on May 12 - here.

ACLA submitted deregulatory ideas to OMB, April 10, 12 pp.  here.

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See an RFI for "the market for digital health products for Medicare beneficiaries."

https://public-inspection.federalregister.gov/2025-08701.pdf   (click link at top after 5/16).

See the Medicare simplification request, from April 22, open til June 10.

https://www.discoveriesinhealthpolicy.com/2025/04/cms-asks-for-ways-to-simplify-its.html

Although it goes in a different direction, you might also like to see this week's announcement of new directions and goals for CMMI - here.

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Here's an AI take on the HHS-wide deregualtory request from May 14.

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AI CLIENT MEMORANDUM
TO: Health Industry Clients
FROM: [Your Law Firm], Senior Partner, Healthcare Regulatory Practice
RE: HHS Request for Public Comment on Massive Deregulatory Initiative under Executive Orders 14192 and 14219
DATE: May 15, 2025

Overview

On May 14, 2025, the U.S. Department of Health and Human Services (HHS), under Secretary Robert F. Kennedy Jr., issued a sweeping Request for Information (RFI) as part of what is described as the largest deregulatory effort in the Department’s history. The initiative is aligned with President Trump’s Executive Orders 14192 (“Unleashing Prosperity Through Deregulation”) and 14219 (“Ensuring Lawful Regulation and Implementing the President’s Department of Government Efficiency Deregulatory Agenda”).

The RFI invites all stakeholders—including healthcare providers, payers, state agencies, technology firms, and patient advocates—to submit proposals to eliminate, streamline, or radically modify HHS regulations, policies, guidance documents, and reporting requirements.

Deadline for submissions: July 14, 2025, 11:59 PM ET

Context and Legal Basis

Executive Order 14192 mandates a “10-for-1” deregulatory model—for every new regulation issued, at least 10 existing regulations must be repealed, and the net cost of all new regulations must be significantly less than zero.

Executive Order 14219 compels agencies to identify regulations that are:

  • Unconstitutional or legally dubious,

  • Rooted in unlawful legislative delegation,

  • Inconsistent with statutory authority,

  • Imposing unjustified economic burdens,

  • Stifling innovation or small business,

  • Or otherwise exceeding executive power.

These actions are being coordinated through OIRA (Office of Information and Regulatory Affairs) and integrated into a new Unified Regulatory Agenda.

What HHS Is Asking From You

HHS seeks detailed stakeholder input on how specific regulations should be:

  • Modified, rescinded, or repealed;

  • Replaced with less burdensome alternatives (state or private-sector analogs encouraged);

  • Updated to reflect technological advancement or better regulatory alignment.

Submissions should ideally include:

  • Regulation citation or title;

  • Responsible HHS office or program;

  • Statutory authority for proposed changes;

  • Detailed cost-benefit analysis (preferably consistent with OMB Circular A-4 and HHS economic guidance);

  • Real-world implementation examples or data.

Questions HHS Wants Addressed

  1. Which HHS rules are unconstitutional, unauthorized, or overly burdensome under E.O. 14219?

  2. What rules interfere with reversing chronic disease trends (E.O. 14212)?

  3. Which regulations are confusing, outdated, technologically obsolete, or duplicative?

  4. Are there less burdensome alternatives used by states or the private sector?

  5. Are any HHS rules inconsistent with other executive orders (e.g., E.O. 14151, 14154)?

  6. What are the estimated cost savings of proposed repeals?

Strategic Considerations for Industry Clients

  • This is a real opportunity to influence policy rollback. The Kennedy-led HHS appears serious about publishing stakeholder proposals directly into the Federal Register as draft rules or notices.

  • Target regulations that impede innovation, such as legacy reporting requirements, burdensome IT documentation standards, or overlapping state/federal licensure rules.

  • Use economic data and clinical case studies to frame deregulatory asks. The more “shovel-ready” your proposal, the better.

  • If your organization operates under both CLIA and FDA, this is an ideal forum to challenge overlapping regulatory burdens on lab-developed tests or RUO products.

  • Be aware: this is not a grant solicitation or funding opportunity, and HHS disclaims any obligation to respond individually.

Next Steps for Clients

  1. Identify top 3–5 HHS regulations that are costly, obsolete, or duplicative for your organization.

  2. Work with counsel or your compliance office to articulate statutory authority and suggest precise modifications or repeal language.

  3. Submit your proposal before July 14 at www.regulations.gov/deregulation, under docket AHRQ–2025–0001.

  4. Consider whether you want your organization’s name to appear on the record or to submit anonymously.

Conclusion

This RFI opens a window into the new regulatory strategy of the Trump Administration and Secretary Kennedy’s HHS. It is designed to rapidly unwind large portions of the administrative state—and healthcare stakeholders who submit thoughtfully supported proposals could have an outsized role in shaping which regulations survive and which do not.

We strongly encourage your compliance, legal, and policy teams to participate.

Let us know if you would like our firm’s assistance in developing or reviewing your submission.

Prepared by:
[Name]
Senior Partner, Healthcare Regulatory Practice
[Your Law Firm]

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I also asked Chat GPT to directly compare the April CMS regulation RFI with the brand new HHS-wide deregulation RFI.

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CLIENT MEMORANDUM
TO: Health Industry Clients
FROM: [Your Law Firm], Senior Partner – Healthcare Regulatory Practice
RE: Comparison of April 15 and May 14, 2025 Federal Deregulatory RFIs from CMS and HHS
DATE: May 15, 2025

Overview

In April and May 2025, two significant deregulation Requests for Information (RFIs) were issued by the Department of Health and Human Services (HHS). While both respond to Executive Order 14192, “Unleashing Prosperity Through Deregulation,” they differ in scope, target agencies, policy rationale, and deregulatory ambition. This memo compares:

  • April 15 CMS RFI: Focused solely on Medicare-related regulations.

  • May 14 HHS-wide RFI: Broad call to deregulate all HHS divisions, including FDA, CDC, NIH, and CMS.

Key Differences

CategoryApril 15 CMS RFIMay 14 HHS-Wide RFI
Issuing AgencyCenters for Medicare & Medicaid Services (CMS)Department of Health and Human Services (HHS)
Target ScopeOnly Medicare program regulationsEntire HHS portfolio (CMS, FDA, NIH, CDC, AHRQ, etc.)
DeadlineJune 10, 2025July 14, 2025
Submission Portalcms.gov/medicare-regulatory-relief-rfiregulations.gov/deregulation
Legal Authority CitedEO 14192 (10-for-1 repeal of regulations)EO 14192 and EO 14219 (lawful regulation mandate); references also EO 14212 (chronic disease), 14151, 14154, 14168, 14213
Tone and FramingEfficiency, administrative simplification, provider reliefSweeping deconstruction of the administrative state, restoring constitutional authority, and “Making America Healthy Again”
Stakeholder TargetsMedicare providers, Medicare Advantage plans, Part D plans, suppliersEntire U.S. public: health plans, providers, state and local agencies, faith-based orgs, researchers, food producers, technology companies, etc.
Topics of InquirySpecific burdens in Medicare rules: reporting, documentation, duplicative requirements, cross-agency conflictsEntire HHS regulation universe: unconstitutional rules, burdensome mandates, outdated tech, conflicting EO alignment, innovation barriers
Preferred Submission FormatCMS Form #s and OMB Control #s requested for clarityLegal citations, economic estimates, and pre-drafted NPRM/DFR content encouraged
Deregulatory Metric10 regulations repealed for every new one proposed; net cost of all new regs < $0Same 10-for-1 repeal rule, but also a constitutional test, national interest test, and innovation test for all HHS rules

Strategic Insights

  1. CMS RFI = Practical, Bottom-Up
    The April 15 CMS RFI is a relatively conventional deregulatory effort. It encourages providers and plans to highlight inefficiencies in Medicare’s Conditions of Participation, reporting rules, and documentation burdens. It focuses on administrative simplification and Medicare-specific cost relief.

  2. HHS RFI = Ideological, Top-Down
    The May 14 RFI goes much further. It frames federal regulation as constitutionally suspect and economically harmful, and openly aims to dismantle major portions of the administrative state. It invites public participation in rewriting the regulatory role of HHS itself—from the FDA’s drug and device policies to NIH research protections and beyond.

  3. Cross-Submission Opportunity
    Stakeholders with concerns that span both Medicare and other programs (e.g., Medicaid, FDA clinical trial requirements, LDTs, digital health tools) may submit parallel comments to both RFIs. HHS encourages submissions that can be directly adopted into the Federal Register.

  4. Political Climate Caution
    The May 14 RFI’s constitutional language (e.g., “unlawful delegations of power,” “deconstructing the administrative state”) is ideologically charged and could face resistance in courts, Congress, or the next administration. Submissions should be grounded in cost-benefit analysis and statutory clarity, regardless of tone.

Recommendations for Clients

  • Medicare-Only Clients: Focus your resources on the April 15 CMS RFI. Identify specific Medicare reporting/documentation rules that duplicate private payer policies or state mandates.

  • Broad-Scope Clients (e.g., diagnostics, life sciences, health tech): Prepare submissions for the May 14 HHS RFI. Address overlapping FDA/CLIA/LDT burdens, 21st Century Cures Act conflicts, or outdated regulatory assumptions.

  • Format Matters: Wherever possible, cite OMB Control Numbers (CMS RFI) or propose draft regulatory language (HHS RFI). Quantify burdens and potential savings.

  • Review Past Submissions: Both RFIs build on Trump-era 2020 RFIs. Review past deregulatory ideas and update them for 2025.

Please let us know if you would like assistance drafting or reviewing RFI submissions or identifying high-impact regulatory targets.