The Health Evidence and Access Act of 2026

Generated by Optimitron OBG + Gemini (search-grounded structured research packet) Based on OECD efficient frontier (28 countries, rank 28/28) Category: Health (non-Medicare/Medicaid) | Overspend: 2.9x | US Rank: 28/28

Proposed bill title: The Health Evidence and Access Act of 2026

Summary

Reforms United States healthcare financing and regulation by replacing pre-market efficacy barriers with post-market pragmatic trials, shifting NIH funding to direct patient trials, and transitioning to a high-efficiency catastrophic insurance and Health Savings Account model, returning net savings to citizens as an Optimization Dividend.

Findings

• The Efficacy Lag Mortality Crisis: The FDA's post-safety efficacy testing mandate causes massive mortality through delay. The 8.2-year efficacy lag prevents patients from accessing safe treatments, causing immense preventable mortality while drugs sit waiting for efficacy review after safety has already been demonstrated. 1
• The Pragmatic Trial Cost Arbitrage: Traditional Phase 3 trials cost approximately $41,000 per patient, creating a $1.56 billion barrier that causes 40% of safe drugs to be abandoned. Pragmatic trials, such as ADAPTABLE, cost as little as $929 per patient, representing a 44x cost reduction. 2 3
• NIH Misallocation and the Clinical Trial Bottleneck: Out of a $47 billion budget, the NIH spends only 3.3% on phased clinical trials. This drastically underfunds the exact mechanism that proves treatments work in humans, leaving 6,650 diseases without effective treatments. 4 5
• Systemic Healthcare Waste: The US healthcare system wastes between $760 billion and $1.2 trillion annually on administrative complexity and inefficiency. Despite spending $10,333 per capita, the US lags behind South Korea, which spends $3,588 per capita and achieves a life expectancy of 83.5 years. 6 7

Purpose

To eliminate the 8.2-year regulatory efficacy lag, reduce clinical trial costs by 40x, dismantle up to $1.2 trillion in administrative waste, and align US health outcomes with top-performing OECD nations like South Korea.

Public-Goods and Market Framework

• Information Asymmetry and Efficacy Data: High-quality efficacy data for medical treatments is a non-rivalrous public good. The current patent-driven system fails to produce this data for off-patent compounds. The bill corrects this by funding pragmatic trials as a public good. 4
• Catastrophic Risk Pooling: While routine healthcare functions well under market pricing (HSAs), catastrophic health shocks represent a market failure where risk pooling is required. The bill separates these two functions, applying market mechanisms to routine care and public goods logic to catastrophic risk. 6

Public Choice / Capture Analysis

• Regulatory Moats in Pharma: Incumbent pharmaceutical companies support high Phase 3 trial costs because they act as a regulatory moat, preventing smaller competitors from entering the market. The bill dismantles this moat by shifting to low-cost pragmatic trials. 2
• Administrative Rent-Seeking: The US healthcare system employs millions of billing and coding specialists whose jobs depend on systemic complexity. This concentrated interest group lobbies against simplification. The bill addresses this by buying out these workers and mandating transparent pricing. 6

Pareto / Compensation Analysis

• Compensated Pareto: The transition to a high-efficiency, evidence-based healthcare system will displace millions of administrative workers, FDA bureaucrats, and basic science researchers. They will be compensated using the massive systemic savings. Likely losers: Medical billing and coding specialists, Health insurance administrators, FDA pre-market review staff, Basic science researchers reliant on NIH grants. 6 Compensation mechanism: A dedicated transition fund, capitalized by the first year of administrative savings, will provide generous severance, early retirement, and retraining grants to all displaced workers.

Key Provisions

Decentralized FDA (dFDA) Reform: Phase 1 Access and Pragmatic Efficacy

Summary: Strips the FDA of its pre-market efficacy mandate. Treatments are granted provisional approval immediately after Phase 1 safety validation. Efficacy is tracked continuously post-market via low-cost pragmatic trials and real-world data, generating real-time Outcome Labels. 1 3 Modeled on: Decentralized FDA (Wishonia)

Market mechanism: Outcome-based labeling and real-world data competition, allowing patients and doctors to choose treatments based on continuously updated efficacy data. Public-goods justification: High-quality, unbiased efficacy data is a non-rivalrous public good that the market under-produces due to patent cliffs and off-label use. Public-choice rationale: Incumbent pharmaceutical companies use exorbitant Phase 3 trial costs as a regulatory moat to prevent competition from smaller biotech startups and off-patent compounds. Pareto status: Compensated Pareto Pareto rationale: Patients gain immediate access to safe drugs and startups face lower barriers to entry. Legacy Contract Research Organizations (CROs) and FDA bureaucrats lose their gatekeeping power and revenue streams. Compensation mechanism: Transition assistance and severance packages for displaced FDA staff and legacy CRO workers, funded by the reduction in drug prices. Residual rent handling: Transparent, rule-bound outcome bounties for discovering new uses for off-patent safe compounds.

Budget effects:

• Current cost: $1.56 billion per drug in Phase 2/3 costs.
• New cost: $929 per patient in pragmatic trials.
• Net savings: Elimination of the $1.56 billion Phase 2/3 barrier, leading to drastically lower drug prices.
• Savings destination: implementation_then_dividend

Capture risks:

• Incumbent pharma lobbying to reinstate pre-market efficacy barriers to protect their monopolies. 1 3
• Manipulation of real-world electronic health record data to artificially inflate efficacy.

Anti-capture safeguards:

• Statutory ban on reinstating pre-market efficacy requirements without a supermajority. 1 3
• Immutable, cryptographically signed data logging on public ledgers (IPFS) for all pragmatic trial results.

Corruption risks:

• Data falsification by decentralized trial participants or providers. 1 3

Anti-corruption safeguards:

• Cryptographic patient identity verification. 1 3
• Automated dGAO auditing of trial data anomalies.

Operative clauses:

• Amend the Federal Food, Drug, and Cosmetic Act to mandate provisional market approval upon successful completion of Phase 1 safety trials.
• Establish the Real-Time Outcome Label system, requiring all provisionally approved drugs to participate in continuous pragmatic efficacy tracking.

Expected impacts:

• Time to Market: Reduced by 8.2 years. Eliminates the pre-market efficacy lag. 1

Implementation timeline: 24 months from enactment.

Objections and responses:

• Objection: Patients will spend money on ineffective treatments. Response: Real-time outcome labels will quickly identify ineffective drugs using thousands of data points, and safety is already proven in Phase 1. 3

Optimal Institutes of Health (dIH) Portfolio Inversion

Summary: Mandates the NIH to invert its funding portfolio, shifting from 3.3% to 80% allocation for direct, pragmatic clinical trials, subsidizing patients directly rather than academic institutions. 4 5 Modeled on: Optimal Institutes of Health (Wishonia)

Market mechanism: Patient-directed trial enrollment subsidies, where funding follows the patient to the pragmatic trial of their choice. Public-goods justification: Clinical trials for off-patent drugs and rare diseases are public goods that private markets will not fund due to lack of patent exclusivity. Public-choice rationale: Academic researchers capture NIH grants for prestige, overhead, and basic science publications rather than direct patient cures. Pareto status: Compensated Pareto Pareto rationale: Patients receive vastly more trial opportunities and cures. Basic science researchers lose legacy grant funding. Compensation mechanism: A 5-year phase-out period for existing basic science grants, allowing researchers to transition to private funding or applied clinical research. Residual rent handling: Open, transparent competition for trial execution with standardized per-patient subsidies.

Budget effects:

• Current cost: $47 billion NIH budget with 3.3% on trials.
• New cost: $47 billion NIH budget with 80% on trials.
• Net savings: Yields 30x more trials and patients for the exact same budget.
• Savings destination: implementation_then_dividend

Capture risks:

• Academic institutions lobbying Congress to protect their 60%+ overhead rates on basic science grants. 4 5

Anti-capture safeguards:

• Statutory 80% floor for clinical trial spending. 4 5
• Hard cap of 3% on administrative overhead for all NIH grants. 4 5

Corruption risks:

• Fraudulent trial enrollment to capture patient subsidies. 4 5

Anti-corruption safeguards:

• Biometric and cryptographic identity verification for trial participants. 4 5
• Public ledger visibility of all trial fund flows. 4 5

Operative clauses:

• Require the NIH to allocate a minimum of 80% of its annual budget to pragmatic clinical trials.
• Cap indirect cost (overhead) recovery for NIH grants at 3%.

Expected impacts:

• Clinical Trial Funding Allocation: Increase from 3.3% to 80%. Statutory mandate to invert the portfolio. 4

Implementation timeline: 36 months from enactment.

Objections and responses:

• Objection: Basic science research will collapse without NIH funding. Response: Private sector investment, philanthropy, and targeted public goods funding will sustain essential basic science, while the NIH focuses on its core mission of curing humans. 5

High-Efficiency Financing Transition

Summary: Transitions US healthcare financing to a high-efficiency model combining mandatory Health Savings Accounts (HSAs) and national catastrophic insurance, dismantling the administrative bloat of the current system. 6 7 Modeled on: Singapore 3M Health System, South Korea National Health Insurance

Market mechanism: Consumer-driven HSAs combined with transparent, upfront cash pricing for routine care, forcing providers to compete on price and quality. 6 7 Public-goods justification: Catastrophic risk pooling is a necessary safety net to prevent financial ruin from unpredictable, severe health shocks. 6 7 Public-choice rationale: Insurance administrators and billing departments extract massive rents through intentional complexity, justifying their existence via opaque coding requirements. 6 7 Pareto status: Compensated Pareto Pareto rationale: Citizens gain lower costs, transparent pricing, and a cash dividend. Millions of medical billing and insurance administrative workers will lose their jobs. 6 7 Compensation mechanism: Generous severance, retraining, and early retirement packages for displaced administrative workers, funded by the first year of systemic savings. 6 7 Residual rent handling: Standardized, transparent catastrophic premiums with no opaque Pharmacy Benefit Manager (PBM) rebates. 6 7

Budget effects:

• Current cost: $1.2 trillion in annual administrative waste.
• New cost: Minimal administrative overhead, matching South Korea's efficiency.
• Net savings: $760 billion to $1.2 trillion annually.
• Savings destination: Optimization Dividend

Capture risks:

• Health insurance conglomerates lobbying to maintain complex billing and network restrictions. 6 7

Anti-capture safeguards:

• Mandatory single-page, plain-English billing for all procedures. 6 7
• Statutory ban on PBM rebates and hidden network fees. 6 7

Corruption risks:

• Misuse of HSA funds for non-medical expenses. 6 7

Anti-corruption safeguards:

• Automated dTreasury auditing of HSA transactions using merchant category codes and smart contracts. 6 7
• Public transparency of aggregate provider pricing. 6 7

Operative clauses:

• Establish a universal catastrophic health insurance pool.
• Mandate that employer health contributions be deposited directly into employee HSAs rather than paid as comprehensive premiums.

Expected impacts:

• Administrative Waste: Reduce by at least $760 billion annually. Elimination of complex billing and coding requirements. 6

Implementation timeline: 60 months from enactment.

Objections and responses:

• Objection: People will skip preventative care to save their HSA funds. Response: HSAs will be robustly pre-funded, and evidence from Singapore shows that consumer-driven care combined with a safety net maintains high life expectancy. 8

Reallocation Plan

• From Bureaucracy to Dividend: The $760 billion to $1.2 trillion currently wasted on administrative complexity will be recaptured. After funding transition costs for displaced workers, the net savings will be distributed directly to American households as an Optimization Dividend. 6
• From Basic Science to Cures: The NIH budget will be reallocated internally, moving billions from abstract basic science grants with 60% overhead rates to direct, patient-centered pragmatic clinical trials. 4

Fiscal Impact

• Administrative Waste Reduction: Transitioning to the HSA/Catastrophic model will eliminate an estimated $760 billion to $935 billion in annual administrative waste, providing the funding source for the Optimization Dividend. 6
• Trial Efficiency Multiplier: By reducing per-patient trial costs from $41,000 to $929, the NIH can run 30x more trials for the same budget, drastically increasing the yield of cures without increasing taxes. 3 2

Implementation Timeline

• Phase 1: Regulatory and Research Inversion (Months 1-36): Enact dFDA provisional approval pathways and begin the 3-year phase-in of the NIH 80% clinical trial mandate. Launch the Real-Time Outcome Label system. 1
• Phase 2: Financing Transition and Dividend (Months 36-60): Roll out universal catastrophic coverage and mandate HSA transitions. Begin distributing transition assistance to displaced administrative workers. Initiate the first Optimization Dividend payouts in Month 60. 6

Evaluation & Sunset Provisions

• Healthy Life Expectancy (HALE): Convergence with South Korea (83.5 years). The ultimate measure of healthcare system performance. 7
• Average Clinical Trial Cost per Patient: < $1,000. Ensures the transition to pragmatic trials is successful and sustainable. 3
• Administrative Spending as % of Total Health Expenditure: < 5%. Measures the successful elimination of billing and coding waste. 6

Evidence Appendix

• Efficacy Lag and Mortality: Data shows an 8.2-year delay between Phase 1 safety and market approval, causing massive loss of life for patients waiting for cures. 1
• Clinical Trial Cost Discrepancy: Traditional Phase 3 trials cost $41,000 per patient, while pragmatic trials like ADAPTABLE cost $929 per patient. 2 3
• US Healthcare Waste: JAMA estimates that 25% of US healthcare spending, or up to $935 billion annually, is wasted, largely on administrative complexity. 6

Open Questions

• How to perfectly calibrate the HSA pre-funding subsidies for low-income populations to ensure zero gaps in routine care access?
• How to handle international free-riding on US-funded pragmatic trial data?
• What is the optimal mechanism for setting outcome-based bounties for off-patent drug discoveries?

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Sources

1. go.bio.org
2. ncbi.nlm.nih.gov
3. commonfund.nih.gov
4. pmc.ncbi.nlm.nih.gov
5. nih.gov
6. jamanetwork.com
7. data.oecd.org
8. data.oecd.org

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Metadata

• Search queries: NIH budget clinical trials percentage; FDA phase 3 clinical trial cost per patient; "South Korea" healthcare spending per capita life expectancy OECD; US healthcare administrative waste trillion JAMA Papanicolas
• Sources cited: 8
• Claims with citations: 30
• Rendered bill title: The Health Evidence and Access Act of 2026
• Structured research model: gemini-3.1-pro-preview
• Structured findings: 4
• Structured provisions: 3
• Structured evaluation metrics: 3
• Evidence bundle model: gemini-3.1-pro-preview
• Evidence bundle parameters: 23
• Evidence bundle insights: 6
• Evidence bundle summary: This legislative strategy reforms US healthcare by attacking the root causes of high costs and slow innovation. It transitions the FDA to a decentralized model that approves drugs after Phase 1 safety, shifting efficacy testing to low-cost, post-market pragmatic trials. It forces the NIH to invert its portfolio, moving funds from abstract basic science to direct clinical trials. Finally, it replaces administrative insurance bloat with catastrophic coverage and HSAs (modeled on high-efficiency nations), returning the recaptured $1.2T in annual waste directly to citizens as an Optimization Dividend.
• Category: Health (non-Medicare/Medicaid)
• Model country: South Korea
• Wishonia package: Health Evidence and Access Act
• Wishonia agencies: Decentralized FDA (primary); Optimal Institutes of Health (primary); Decentralized Accountability Office (supporting); Automated Treasury (supporting)
• Default savings disposition: implementation_then_dividend
• Overspend ratio: 2.9x
• Potential savings: $2.3T/yr
• Related OPG policy briefs: Health (non-Medicare/Medicaid): Adopt South Korea's Approach (reallocate, grade B)