Health Tech Investment Act
- Bill Number
- H.R. 6197
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-11-20: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- Last Updated
- 2026-05-12T08:05:45Z
AI-Generated Summary
Purpose of the Legislation
The Health Tech Investment Act (H.R. 6197) aims to update Medicare payment rules to better support innovative healthcare technologies, specifically those using artificial intelligence (AI) and machine learning. It ensures that certain algorithm-based services receive fair and timely reimbursement under Medicare's Outpatient Prospective Payment System (OPPS), which is a method for paying hospitals a fixed amount for outpatient services based on predefined categories.
Key Provisions
- Special Payment Rules for Algorithm-Based Services: Starting January 1, 2026, Medicare must assign qualifying algorithm-based healthcare services to a "new technology ambulatory payment classification" (a temporary category for emerging technologies to cover their higher costs until enough data is collected). This assignment is based on costs submitted by the service's manufacturer, including invoice prices, subscription fees, staff time, overhead, and other related expenses.
- Duration and Adjustments: The Secretary of Health and Human Services (HHS) must adjust this classification as needed but cannot remove the service from it until at least five years have passed or sufficient claims data exists to shift it to a standard category.
- Expanded Eligibility: The bill modifies the criteria for new technology classifications to include algorithm-based services that are performed alongside other procedures (e.g., as an add-on) but require extra resources. These services must be distinct procedures with a clear start, middle, and end.
- Definition of Algorithm-Based Healthcare Service: This refers to services delivered through devices approved or cleared by the Food and Drug Administration (FDA) that use AI, machine learning, or similar software to produce clinical results (e.g., for screening, diagnosing, or treating diseases). HHS can expand this in consultation with relevant groups.
- Codification of Software-as-a-Service Payments: Effective January 1, 2023, the bill locks in an existing HHS policy from 2022 that allows OPPS payments for software delivered as a subscription service (like cloud-based tools), preventing future changes without congressional action.
Significant Changes to Existing Law
- Amends Section 1833(t) of the Social Security Act to explicitly include algorithm-based services in OPPS new technology rules, which previously focused more on devices and procedures without tailored provisions for AI/software.
- Broadens eligibility for new technology payments to cover adjunctive or concurrent AI services, addressing gaps where such technologies might not qualify under current "distinct procedure" requirements.
- Codifies a 2022 regulatory policy on software-as-a-service payments, making it statutory law rather than an administrative rule that could be altered.
Potential Impacts
- On Government Agencies: HHS and the Centers for Medicare & Medicaid Services (CMS) will need to update application processes, review manufacturer cost submissions, and monitor data for reclassifications, potentially increasing administrative workload but streamlining payments for new tech.
- On Citizens: Medicare beneficiaries (primarily older adults and disabled individuals) may gain better access to cutting-edge AI-driven diagnostics and treatments in outpatient settings, as ensured payments could encourage hospitals to adopt these technologies without financial disincentives.
- On International Relations: Minimal direct impact, though it could indirectly boost U.S. competitiveness in global health tech innovation by supporting domestic AI development.
Main Stakeholders Affected
- Healthcare Providers: Hospitals and outpatient facilities benefit from clearer reimbursement paths for AI-integrated services, reducing financial risks in adopting new technologies.
- Technology Manufacturers: Companies developing FDA-approved AI and machine learning tools gain predictable Medicare payments based on their submitted costs, encouraging investment in health innovations.
- Medicare Beneficiaries: Patients relying on Medicare for outpatient care could see improved service quality and availability of advanced tools for disease management.
- HHS and CMS: As overseers, they must implement and enforce the new rules, consulting with organizations like medical associations.
Notable Legal, Constitutional, or Political Implications
- Legal: Strengthens Medicare's framework for reimbursing digital health innovations without altering broader OPPS structures, potentially setting precedents for future AI regulations in healthcare. It requires HHS to consult external groups, promoting transparency.
- Constitutional: No apparent challenges; the bill exercises Congress's authority over federal spending and health programs under the Spending Clause.
- Political: Bipartisan sponsorship (from both parties) signals broad support for health tech investment, which could influence future budgets or innovation policies. It avoids controversy by focusing on payment equity rather than mandating technology use.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (7)
Rep. Peters, Scott H. [D-CA-50], Rep. Van Duyne, Beth [R-TX-24], Rep. Schneider, Bradley Scott [D-IL-10], Rep. Obernolte, Jay [R-CA-23], Rep. Craig, Angie [D-MN-2], Rep. Vindman, Eugene Simon [D-VA-7], Rep. Bynum, Janelle S. [D-OR-5]
Recent Actions
- 2025-11-20: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2025-11-20: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2025-11-20: Introduced in House
- 2025-11-20: Introduced in House
Bill Versions
- Health Tech Investment Act — issued 2025-11-20 — PDF (6 pages)