HR-9823-119
Referred to the House Committee on Energy and Commerce.
Sponsored by Jake Auchincloss (D-MA)
What it does
This bill would require group health plans, individual and group health insurance issuers, and state Medicaid programs to cover Alzheimer's biomarker testing — including blood tests, tissue analysis, and genomic sequencing — used for early detection, diagnosis, treatment selection, or ongoing monitoring of Alzheimer's disease. It would prohibit insurers from applying more restrictive cost-sharing or prior authorization rules to these tests than to other covered medical services, ban step therapy requirements, and require prior authorization decisions within 72 hours (or 24 hours in urgent cases), with automatic approval if the deadline is missed. It would also direct the National Institutes of Health to commission annual reports from the National Academies of Sciences on the value of biomarker testing for three years.
Who benefits
The approximately 6.9 million Americans currently living with Alzheimer's disease, and the estimated 55 million people worldwide at risk, who would gain access to earlier and more precise diagnosis. Patients enrolled in Medicaid who currently lack coverage for these tests. Rural and underserved populations, explicitly named in the bill's equity provision. Caregivers and families who would benefit from earlier planning enabled by earlier diagnosis. Pharmaceutical companies whose FDA-approved Alzheimer's drugs (such as lecanemab and donanemab) require biomarker confirmation for eligibility. Diagnostic testing companies and clinical laboratories that develop and administer biomarker tests. Neurologists and geriatricians whose patients would have broader access to diagnostic tools.
Who is hurt
Private insurers and pharmacy benefit managers who would bear the cost of newly mandated coverage and face restrictions on prior authorization practices. Employers who sponsor self-funded group health plans and may see increased plan costs passed through to them. Taxpayers and federal and state governments, which would share the cost of expanded Medicaid coverage. Patients with other conditions competing for coverage mandates, if insurer cost increases lead to premium adjustments across the insured pool. Small businesses offering group health plans that may face higher premiums. States, which would be required to implement the Medicaid mandate and may bear a share of increased program costs.
Supporters argue
Supporters argue that FDA-approved Alzheimer's treatments such as lecanemab and donanemab require biomarker confirmation to determine patient eligibility, meaning that without covered testing, patients cannot access the treatments even when they have insurance. They contend that early detection through biomarker testing enables timely treatment that may slow cognitive decline, and that the current patchwork of coverage — where Medicare covers these tests but private insurance and Medicaid often do not — creates inequitable access based on insurance type rather than medical need. They further argue that the bill's prior authorization guardrails prevent coverage delays that can render time-sensitive diagnostic windows clinically meaningless.
Opponents argue
Opponents argue that mandating coverage of a broad and evolving category of biomarker tests — including whole genome and whole transcriptome sequencing — without a defined cost ceiling could impose significant and unpredictable costs on insurers, employers, and Medicaid budgets, ultimately raising premiums for all enrollees. They contend that the bill's definition of covered testing, which includes any test consistent with clinical practice guidelines or consensus statements, is broad enough to expand coverage well beyond currently validated tests, potentially incentivizing overutilization before clinical evidence fully matures. They further argue that the 72-hour prior authorization deadline and automatic-approval penalty remove insurers' ability to conduct meaningful medical necessity review, which could accelerate spending without proportionate health benefit.