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MedDevice Alliance

Medical DevicesDiagnosticsSurgical Technology
24 provisions tracked
7 positive
8 negative
1 conflict
ConflictSec. CMS-2026-0156 · CMS Hospital Payment Policy

Hospital Outpatient Prospective Payment Update

Lower hospital outpatient payments could reduce device purchasing budgets. However, site-neutral policies may shift procedures to ASCs where some MedDevice members have stronger market share.

ACTION: Analyze net impact across device categories. Some members benefit from ASC shift while others lose from hospital budget cuts.
$14.2B in total OPPS payments (CY2027)
IndirectSec. CMS-2026-0089 · CMS Medicare Drug Price Negotiation

Medicare Part D Negotiation Methodology Update

Companion diagnostics tied to negotiated drugs may see volume shifts. Impact depends on whether negotiated prices reduce overall prescribing or shift to alternatives.

$4.8B estimated savings over 10 years
IndirectSec. CMS-2026-0178 · CMS IRA Drug Negotiation

IRA Drug Negotiation List Expansion (Round 3)

Companion diagnostics for listed drugs may see volume shifts. 4 MedDevice members manufacture diagnostics paired with newly listed therapies.

$8.6B combined annual revenue of listed drugs
IndirectSec. S-3156 · Legislative — Rural Health

Rural Hospital Preservation Act

Rural hospital infrastructure investment may increase medical device procurement, but smaller rural facilities have limited capital budgets for advanced equipment.

$3.8B over 5 years
PositiveSec. HR-5012 · Legislative — Medical Devices

Medical Device Innovation Act

Core legislative priority. 90-day breakthrough review and AI/ML framework directly benefit 12 of 18 MedDevice Alliance members. $200M grants fund next-gen device development.

ACTION: Lead Hill advocacy for committee markup. Coordinate member company innovation stories for congressional briefing. Engage Murray on HELP Committee scheduling.
$200M device innovation grants + regulatory modernization
PositiveSec. FDA-2026-D-0234 · FDA Regulatory Guidance

AI/ML-Based Medical Device Guidance

AI/ML framework benefits MedDevice members developing AI-assisted surgical and diagnostic systems. 8 members have AI device products that benefit from clearer pathway.

ACTION: Coordinate with HealthTech on joint public comments. Highlight AI diagnostic success stories for FDA consideration.
Regulatory framework — no direct funding