Relief of Chronic Pain Act of 2025

Bill Number

S. 3064

Origin Chamber

Senate

Congress

119th Congress, Session 1

Policy Area

Health

Status

Introduced

Latest Action

2025-10-28: Read twice and referred to the Committee on Finance.

Last Updated

2026-06-25T12:18:23Z

AI-Generated Summary

Purpose

The Relief of Chronic Pain Act of 2025 aims to improve access to non-opioid medications for treating chronic pain under Medicare Part D, the program's prescription drug benefit. It seeks to reduce financial barriers and administrative hurdles, encouraging the use of safer alternatives to opioids amid the ongoing opioid crisis.

Key Provisions

• Definition of Qualifying Drugs: Establishes criteria for "qualifying non-opioid chronic pain management drugs." These are non-opioid medications or biologics (biological products like vaccines or proteins) approved by the Food and Drug Administration (FDA) for chronic pain conditions. They must not target opioid receptors in the body, have no therapeutically equivalent alternatives available in the U.S. (per FDA's drug equivalence list), and cost no more than a monthly specialty-tier threshold (a cap set by the Secretary of Health and Human Services).
• Covered Chronic Pain Conditions: Includes pain lasting over three months from conditions such as diabetic peripheral neuropathic pain, endometriosis, fibromyalgia, musculoskeletal pain, neuropathic pain, post-herpetic neuralgia, and trigeminal neuralgia.
• Cost-Sharing Adjustments: Starting January 1, 2026, for qualifying drugs under Medicare Part D:
• No deductible (the initial amount beneficiaries must pay before coverage begins) applies.
• Drugs must be placed on the lowest cost-sharing tier (the level with the smallest out-of-pocket copay or coinsurance percentage) to minimize patient costs.
• Protections for Low-Income Beneficiaries: Extends the same no-deductible and lowest-tier rules to low-income individuals eligible for Medicare Part D subsidies.
• Ban on Utilization Management Tools: Prohibits prescription drug plans (PDPs) and Medicare Advantage plans with drug coverage (MA-PD plans) from requiring:
• Step therapy: A process where patients must try a preferred (often cheaper) drug, like an opioid, before accessing the prescribed non-opioid.
• Prior authorization: Approval from the plan before the drug can be covered, which can delay treatment.
• Effective Date: All changes apply to plan years beginning on or after January 1, 2026.

Significant Changes to Existing Law

• Amends Section 1860D-2 of the Social Security Act (governing Part D definitions and cost-sharing) by adding a new paragraph (10) for treatment of qualifying drugs, explicitly waiving deductibles and mandating lowest-tier placement.
• Updates Section 1860D-14 (low-income subsidies) with conforming changes, including a new paragraph (7) to align protections for qualifying drugs.
• Modifies Section 1860D-4 (plan requirements) by adding a new paragraph (8) that bans step therapy and prior authorization specifically for these drugs, building on prior reforms like those in the 2018 Bipartisan Budget Act (which addressed other utilization management issues but not this targeted prohibition).
• These changes expand on existing Part D rules by carving out exceptions for non-opioid chronic pain treatments, without altering broader opioid coverage policies.

Potential Impacts

• On Beneficiaries: Medicare enrollees (primarily seniors and people with disabilities) with chronic pain may face lower out-of-pocket costs and faster access to treatments, potentially reducing reliance on opioids and improving quality of life. This could benefit millions affected by listed conditions.
• On Government Agencies: The Centers for Medicare & Medicaid Services (CMS) will need to define the specialty-tier cost threshold, monitor compliance, and update guidance for plans, possibly increasing administrative oversight but aligning with federal efforts to combat opioid misuse.
• On Health Plans and Providers: Part D plans must adjust formularies (lists of covered drugs) and processes, which could raise short-term costs for plans but encourage broader adoption of non-opioid options.
• On International Relations: Minimal direct impact, though it supports U.S. public health goals that could influence global pharmaceutical standards or opioid export policies indirectly.
• Overall, the bill promotes a shift toward non-addictive pain management, potentially lowering long-term healthcare costs from opioid-related complications like addiction and overdoses.

Main Stakeholders Affected

• Medicare Beneficiaries: Especially those with chronic pain conditions, including older adults and low-income individuals who rely on Part D for drug coverage.
• Pharmaceutical Manufacturers: Companies producing qualifying non-opioid drugs (e.g., for fibromyalgia or neuropathic pain) may see increased demand and market access.
• Prescription Drug Plans and Insurers: PDPs and MA-PD plans must comply with new coverage mandates, affecting their cost structures and utilization review processes.
• Healthcare Providers: Doctors and pain specialists gain flexibility in prescribing without insurance barriers, streamlining patient care.
• Government Entities: Congress, CMS, and the FDA, which will enforce definitions and thresholds.

Notable Legal, Constitutional, or Political Implications

• Legal: Strengthens patient protections under the Social Security Act by limiting plan discretion in drug management, potentially reducing litigation over coverage denials. It relies on FDA approvals for drug qualifications, ensuring evidence-based criteria without overstepping agency authority.
• Constitutional: No apparent challenges; the bill involves congressional spending power for Medicare benefits, a well-established federal role in healthcare.
• Political: Bipartisan sponsorship (by Senators Daines, R-Montana, and Cantwell, D-Washington) highlights cross-party support for opioid alternatives. It advances national anti-opioid initiatives (e.g., aligning with the SUPPORT Act of 2018) but may face debate over added costs to the Medicare Trust Fund or plan burdens, influencing future drug pricing reforms. Referred to the Senate Finance Committee, passage could set precedents for targeted drug access in entitlement programs.

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

Sponsor

Sen. Daines, Steve [R-MT]

Cosponsors (5)

Sen. Cantwell, Maria [D-WA], Sen. Tillis, Thomas [R-NC], Sen. Sheehy, Tim [R-MT], Sen. Marshall, Roger [R-KS], Sen. Kaine, Tim [D-VA]

Recent Actions

• 2025-10-28: Read twice and referred to the Committee on Finance.
• 2025-10-28: Introduced in Senate

Bill Versions

• Relief of Chronic Pain Act of 2025 — issued 2025-10-28 — PDF (7 pages)