HANDS Act

Bill Number

H.R. 5120

Origin Chamber

House

Congress

119th Congress, Session 1

Policy Area

Health

Status

Introduced

Latest Action

2025-09-03: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Armed Services, 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

2026-05-14T08:08:14Z

AI-Generated Summary

Purpose of the Legislation

The HANDS Act (H.R. 5120) aims to expand access to opioid overdose reversal drugs, such as naloxone, by requiring no-cost coverage under Medicare, Medicaid, and TRICARE programs. It focuses on preventive distribution from hospitals to at-risk patients upon discharge, helping to combat the opioid crisis by ensuring these life-saving medications are provided without financial barriers.

Key Provisions

• Coverage and Definition:
• Defines a "preventive opioid overdose reversal drug" as an intranasal or intramuscular opioid reversal medication (e.g., naloxone) provided by qualified clinical staff (physicians, nurse practitioners, physician assistants, or others as regulated) to inpatients or emergency department/ambulatory surgical center patients deemed at risk for overdose.
• The drug must be given at discharge or upon leaving the facility, along with instructions for use.
• Medicare Amendments (Titles XVIII of the Social Security Act):
• Adds coverage for these drugs as a preventive service starting January 1, 2026.
• Prohibits any cost-sharing (deductibles, copays, or coinsurance) for beneficiaries.
• Extends the no-cost requirement to Medicare Advantage plans.
• Medicaid Amendments (Titles XIX of the Social Security Act):
• Makes coverage mandatory for all state Medicaid plans and benchmark/alternative plans starting January 1, 2026.
• Includes these drugs in the list of covered medical assistance services.
• Applies drug rebate requirements (where manufacturers pay rebates to offset costs) and treats them as prescribed drugs for rebate purposes.
• Prohibits cost-sharing, including under alternative cost-sharing options.
• TRICARE Amendments (Title 10, U.S. Code):
• Requires coverage without cost-sharing for eligible beneficiaries starting January 1, 2026.
• Adopts the same definition from Medicare.
• Regulatory Guidance:
• The FDA must issue guidance within one year for state pharmacy, nursing, and medical boards to improve safe hospital-based dispensing and remove barriers.
• The Department of Health and Human Services (HHS) must issue billing guidance for hospitals within one year.
• Rule of Construction:
• Providers and facilities are not required to furnish these drugs; participation is optional.

Significant Changes to Existing Law

• Introduces a new mandatory benefit category for preventive opioid reversal drugs across Medicare, Medicaid, and TRICARE, which previously lacked specific no-cost coverage for hospital-based preventive distribution.
• Eliminates all forms of cost-sharing for these drugs, expanding on existing preventive service rules (e.g., no copays for certain vaccines or screenings under Medicare).
• Integrates rebate obligations under Medicaid's drug program, potentially reducing net costs to states and the federal government.
• Adds cross-references between programs (e.g., TRICARE using Medicare's definition), promoting consistency but not previously aligned.

Potential Impacts

• On Citizens: At-risk individuals (e.g., those treated for opioid-related issues in hospitals) gain free access to reversal drugs, potentially reducing overdose deaths by enabling take-home supplies with instructions. This could improve public health outcomes in communities affected by the opioid epidemic without adding personal costs.
• On Government Agencies: HHS, FDA, and the Department of Defense (for TRICARE) will incur administrative costs for issuing guidance and processing claims. Federal and state Medicaid programs may face higher upfront expenditures, offset partially by manufacturer rebates. Medicare's trust fund could see increased spending on these low-cost drugs.
• On Hospitals and Providers: Facilities like hospitals, critical access hospitals, rural emergency hospitals, and ambulatory surgical centers can distribute drugs without patient billing, easing administrative burdens, though implementation requires staff training and optional adoption.
• On International Relations: No direct impacts, as the bill focuses on domestic health programs.

Main Stakeholders Affected

• Beneficiaries: Medicare enrollees (65+ or disabled), Medicaid recipients (low-income individuals/families), and TRICARE users (military personnel, retirees, and families) at risk for opioid overdose.
• Healthcare Providers and Facilities: Physicians, nurse practitioners, physician assistants, and clinical staff in hospitals and surgical centers, who assess risk and distribute drugs.
• Government Entities: HHS (overseeing Medicare/Medicaid), FDA (guidance on dispensing), state Medicaid agencies, and the Department of Defense (TRICARE administration).
• Pharmaceutical Manufacturers: Required to provide rebates under Medicaid, potentially affecting pricing and supply chains for reversal drugs.
• State Regulatory Boards: Pharmacy, nursing, and medical boards, which must adapt to new guidance on safe distribution.

Notable Legal, Constitutional, or Political Implications

• Legal: Strengthens preventive care mandates under federal health programs by adding a targeted benefit, aligning with existing laws like the Affordable Care Act's emphasis on no-cost preventive services. The optional nature for providers avoids mandating private actions, reducing potential legal challenges. Rebate expansions ensure fiscal responsibility in public programs.
• Constitutional: No apparent issues; the bill operates within Congress's authority to regulate interstate commerce and spend on public welfare (e.g., under the Spending Clause), without infringing on state sovereignty beyond standard Medicaid requirements.
• Political: Addresses the ongoing opioid public health crisis through bipartisan-accessible measures (introduced by representatives from both parties), potentially influencing future drug policy debates by prioritizing harm reduction over restrictions. It may set a precedent for no-cost coverage of other emergency preventive medications.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Pettersen, Brittany [D-CO-7]

Cosponsors (3)

Rep. Kiggans, Jennifer A. [R-VA-2], Rep. Budzinski, Nikki [D-IL-13], Rep. Schrier, Kim [D-WA-8]

Recent Actions

• 2025-09-03: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Armed Services, 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.
• 2025-09-03: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Armed Services, 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.
• 2025-09-03: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Armed Services, 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.
• 2025-09-03: Introduced in House
• 2025-09-03: Introduced in House

Bill Versions

• Hospitals As Naloxone Distribution Sites Act — issued 2025-09-03 — PDF (10 pages)