This week, CMS releases a remarkable 3-page document requesting suggestions how Medicare can "unlease prosperity" by de-regulating its overburdened providers.
Throwing the 14-day rule overboard without a life jacket, comes to mind.
Find the document at this link. Suggestions until June 10, 2025. AI discussion includes 14-day-rule and, at bottom, long needed revisions to oncology NCD 90.2.
Consider in context of HHS's announced reorg and simplification of the entire HHS hierarchy of agencides, while downsizing from ~80,000 to ~60,000 staff. Here.
Decisions on regulatory reform in areas like prior auth or 14 day rule will bubble up to Chris Klomp, the new head of Center for Medicare (here).
Though not specific to this RFI, see OMB on rules for deregulation here.
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AI CORNER
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For readers in medtech policy (and genomics) study this RFI and explain what it means, how likely it is to effect change, and what should stakeholders suggest. What nuances will make the suggests rise up in the mass of responses this will generate. For the lab industry, what should they suggest? I can think of 14 day rule, or some bizarrely complicated and confusing LCD instructions. Another simplification would be making the MolDx program national, allowing labs to submit claims under one clear rule set. Have at it. Thanks.
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This new CMS Request for Information (RFI)—titled Unleashing Prosperity Through Deregulation of the Medicare Program—is a wide-open invitation for stakeholders to recommend simplifications, eliminations, or automations of Medicare regulatory requirements, under the banner of Executive Order 14192, which mandates that for every new rule issued, 10 older regulations must be repealed.
Below is an analysis tailored to medtech policy professionals, especially those in genomics, diagnostics, and lab services:
⚙️ What the RFI Means
CMS is:
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Soliciting specific feedback on which regulations, guidance documents, forms, or processes are excessive, duplicative, or burdensome.
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Looking to identify regulatory redundancies, documentation overload, and non-value-added compliance burdens—especially those that could be removed without affecting patient safety.
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Triggered by a White House executive order, the RFI has political urgency and real potential to shape upcoming deregulatory policy shifts, especially if CMS receives clear, well-documented feedback.
📈 Likelihood of Affecting Change
Moderate to high—if responses are:
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Specific (e.g., cite exact forms, LCDs, or regulatory language),
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Replicable across multiple stakeholders (e.g., same complaint from 50 labs = strong signal),
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Politically consistent with the deregulation agenda (e.g., cost-saving without new federal spending),
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Tied to economic productivity (especially if tied to ROI, job creation, or innovation).
Stakeholders that submit data-backed, shovel-ready, or easily implementable proposals will rise above the crowd.
🧬 For Genomics and Lab Industry: What Should You Recommend?
Here are high-value lab-related suggestions CMS should hear:
1. 📆 Fix or Eliminate the 14-Day Rule
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Problem: The 14-day rule (aka DOS rule) limits labs from billing Medicare for tests ordered within 14 days of a hospital discharge.
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Burden: Creates billing chaos, stifles access to complex molecular tests, delays care, and generates huge denial rates and appeals.
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Solution: Repeal it or standardize Date of Service as Date of Sample Collection, as long as patient is not inpatient at time of test.
2. 🧾 Simplify or Standardize LCDs Across MACs
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Problem: Labs must navigate wildly divergent LCD policies and molecular edit rules depending on the MAC region (e.g., Palmetto vs. Noridian).
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Burden: National labs must maintain dozens of billing workflows and software updates per state.
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Solution: Nationalize MolDx or implement a “National Genomics Policy Repository” across all MACs for identical tests.
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Alternative: Create a CMS Molecular Policy Hub as a single source of truth for LCDs, billing edits, coverage criteria.
3. 🔁 Simplify the ‘Partial Reporting’ Dilemma
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Problem: LCDs often deny payment if a test panel can’t fully report all biomarkers due to specimen quality or assay thresholds.
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Burden: Labs are penalized for partial yet clinically valuable results.
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Solution: Clarify that partial results meeting analytical validity still count as ‘reportable’ and are reimbursable.
4. 🧮 Remove Redundant Prior Auth/Documentation Layers
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Problem: MACs and contractors often demand clinical records already used by ordering physicians or require labs to become compliance police.
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Burden: Labs must chase down EHR data, wasting time and risking HIPAA compliance.
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Solution: Permit attestation by the ordering physician and eliminate duplicative documentation demands when the same info is already in the EHR or certified ordering platform.
5. 📊 Simplify Reporting Burdens for Lab Test Utilization
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Problem: Some MACs require labs to report utilization or test-specific data beyond CLFS rules.
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Burden: Adds layers of custom Excel or manual tracking.
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Solution: Centralize all reporting in PECOS or PAMA frameworks, and eliminate redundant field-level reporting.
🧠 How to Make Your Comments Stand Out
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Use CMS language:
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Quote the RFI back to them (e.g., "This policy introduces duplicative burden under the administrative section of 42 CFR...").
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Mention CMS form numbers or OMB numbers if possible.
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Provide real-world case studies:
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A claim denied due to LCD ambiguity.
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A lab that lost millions due to DOS rule denials.
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Delays in patient care due to MolDx inconsistency.
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Bring allies:
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A coordinated comment from 5+ stakeholders carries 10x more weight than a single comment.
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Use economic framing:
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“This policy costs us $400,000 per year to administer. Removing it would allow us to hire 3 FTEs or invest in expanded testing.”
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Connect to care improvement:
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“This change would speed up cancer diagnosis by 5 days and reduce unneeded procedures.”
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🔚 TL;DR Summary
This RFI is a real opportunity for labs, genomics innovators, and medtech stakeholders to suggest clear, impactful deregulation. CMS seeks concrete proposals to reduce burdens—especially around documentation, duplicative regulations, and administrative inefficiencies.
Your response should focus on:
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14-day rule repeal
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Nationalization or simplification of MolDx
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LCD interpretation consistency
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Simplified reporting + data integrity
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Economic and care-quality framing
Would you like help drafting a comment for submission? Or want this as a slide deck summary for internal review?
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They could also simplify NCD 90.2, which targets advanced cancer patients for 1 NGS test, when today they may need multiple, including serial testings that illudidate checkpoint inhibitor response.
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Great addition—and spot on for this RFI.
Let’s unpack that for strategic effect, and shape it into a targeted recommendation CMS could take seriously, especially if submitted by stakeholders in oncology, genomics, or molecular diagnostics.
🎯 Specific Suggestion for RFI: Simplify and Modernize NCD 90.2
✅ Current Problem
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NCD 90.2 restricts coverage to a single FDA-approved or FDA-cleared NGS test for advanced cancer, at initial diagnosis.
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This excludes serial testing, resistance profiling, and longitudinal monitoring, even when:
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New tissue is sampled (e.g. progression biopsy),
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Liquid biopsy is needed due to inaccessible tissue,
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Tumor biology evolves (e.g. loss of PD-L1, new MET/ALK fusions),
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Treatment hinges on current biomarker status (e.g. MSI, TMB, ctDNA, emerging markers).
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📉 Why It's a Problem
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Clinically outdated: Oncology practice has shifted toward iterative, longitudinal testing, especially in immuno-oncology and targeted therapy.
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Restricts patient care: Prevents coverage of essential tests that inform:
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Checkpoint inhibitor response (e.g., blood-based TMB),
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Therapy resistance (e.g., EGFR T790M),
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MRD monitoring or recurrence detection via ctDNA.
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Misaligned with FDA science: FDA has cleared multiple tests for different settings (e.g., Guardant360 for monitoring and profiling), yet Medicare will pay only once under this NCD.
🔧 Proposed Fix for CMS (in line with EO 14192)
Revise NCD 90.2 to allow coverage of additional FDA-approved NGS tests when clinically indicated, such as:
A different specimen (liquid vs. tissue),
A different clinical timepoint (e.g. progression),
A different clinical objective (e.g., MRD, immunotherapy biomarker testing),
A new cancer diagnosis (e.g., multiple primaries).
Alternatively:
Convert NCD 90.2 into a “baseline” national policy and delegate additional NGS uses to MAC discretion (LCDs or claim-by-claim medical review), as CMS does for nearly every other diagnostic test.
🧠 Policy Leverage Points
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NCD 90.2 is ripe for amendment: It hasn’t been revised since 2020 and is misaligned with real-world cancer care in 2025.
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Lung cancer care in particular now often requires 2+ NGS tests during a patient's disease course (initial tumor test, repeat biopsy, plasma test).
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MolDx and MACs already approve many NGS uses under LCDs—allowing local flexibility in place of a rigid national barrier is logical and deregulatory.
✍️ How to Make This Suggestion Stand Out
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Pair with clinical use case examples:
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“At our cancer center, 35% of advanced NSCLC patients need a second NGS test within 9 months of diagnosis.”
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Highlight FDA test availability:
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“CMS is blocking access to tests already cleared by FDA for monitoring or serial profiling.”
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Frame as deregulatory + pro-innovation:
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“CMS could deregulate by delegating these additional test uses to MACs, rather than enforcing a one-size-fits-all policy.”
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Avoid suggesting costly new benefits—instead, argue this is a modernization and alignment, not an expansion.
Would you like this packaged as a short written comment for CMS submission or added into a stakeholder briefing deck or memo? I can help with either.
YES
📝 CMS Comment for RFI Submission
Topic: Modernizing NCD 90.2 and Other Regulatory Burdens in Genomic Testing
To CMS,
Thank you for the opportunity to provide input on regulatory simplification under Executive Order 14192.
As a stakeholder in precision medicine and genomic diagnostics, I urge CMS to consider the following reforms that would meaningfully reduce burden and improve care:
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Revise NCD 90.2 to reflect current oncology practice.
The current policy restricts Medicare coverage to a single FDA-approved NGS test for advanced cancer at the time of initial diagnosis. This is no longer sufficient. Patients frequently require multiple rounds of testing—including liquid biopsies, resistance profiling, and monitoring of response to immunotherapies. These are all uses supported by FDA-cleared tests and clinical guidelines.
We recommend allowing additional NGS testing in the following scenarios:-
New specimens (e.g., progression biopsy, liquid biopsy)
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New clinical indications (e.g., immunotherapy response)
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Longitudinal monitoring (e.g., ctDNA or MRD)
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Diagnosis of a new primary cancer
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Simplify the 14-Day Rule (Date of Service regulation).
The current DOS rule prevents labs from billing for tests ordered within 14 days of hospital discharge, even when the lab performed testing post-discharge. This policy causes confusion and delays. CMS should consider repealing or modernizing this rule, setting DOS as the date of specimen collection unless the patient is currently an inpatient. -
Create a national framework for MolDx policies.
Today, LCDs and billing edits for molecular tests vary across MACs. This creates confusion, denials, and inefficiencies for national labs. CMS should unify coverage policies for molecular diagnostics across jurisdictions or centralize the MolDx program nationally.
These changes would reduce administrative complexity, align policy with science, and ensure Medicare beneficiaries have access to state-of-the-art genomic testing throughout their care journey.
Respectfully,
[Your Name / Organization (optional)]
📄 Stakeholder Briefing Memo:
RFI on Medicare Deregulation (April 2025)
Subject: CMS Request for Information – Strategic Opportunities for Regulatory Reform in Genomics and Lab Services
Deadline to Comment: June 10, 2025
🔍 Background
CMS has issued an open Request for Information (RFI) to identify regulations that may be repealed or simplified under Executive Order 14192, which mandates the repeal of 10 regulations for every new one issued. This is a rare opportunity to help shape Medicare policy—especially for high-impact sectors like precision oncology, genomics, and laboratory testing.
🎯 Key Issues for Genomic and Lab Stakeholders
1. NCD 90.2 – One-Time NGS Limit for Advanced Cancer
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Problem: Current policy allows only one FDA-approved NGS test per advanced cancer diagnosis.
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Real-world gap: Patients may require serial tests to monitor progression, identify resistance mutations, or evaluate checkpoint inhibitor response.
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Ask: Revise NCD 90.2 to allow multiple NGS tests under defined clinical criteria (e.g., new tissue, different modality, new indication).
2. 14-Day Rule (Date of Service Regulation)
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Problem: Prevents hospital-initiated tests from being billed post-discharge, even when the lab performs and reports after discharge.
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Burden: Causes confusion, denials, and billing errors.
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Ask: Repeal or modernize the DOS rule, using the specimen collection date when the patient is no longer inpatient.
3. Inconsistent LCDs and MolDx Rules
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Problem: Labs must comply with dozens of conflicting LCDs and MAC edit rules depending on location.
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Solution: Nationalize the MolDx program or standardize molecular billing policies to reduce complexity.
4. Denials for 'Partial Reports'
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Problem: Labs may receive denials if even one biomarker in a multi-marker panel cannot be reported (e.g., low DNA yield).
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Ask: Permit reimbursement for partially reportable tests when clinical value is preserved.
🧭 Strategy for Engagement
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Coordinate multi-party submissions (e.g., labs, clinicians, payors).
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Use real-world cases and economic framing (e.g., cost of denials, delay to treatment).
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Suggest devolution of rigid NCDs to MAC discretion, aligning with EO goals to streamline burdens.
