Alternatives to PAIN Act
- Bill Number
- H.R. 1227
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-02-12: 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
- 2026-07-10T08:05:36Z
AI-Generated Summary
Purpose of the Legislation
The "Alternatives to Prevent Addiction In the Nation Act" (Alternatives to PAIN Act), H.R. 1227, seeks to improve access to non-opioid drugs for managing pain under Medicare Part D. It aims to reduce financial barriers and administrative hurdles for these medications, encouraging their use over opioids to help prevent addiction and support safer pain treatment options.
Key Provisions
- Definition of Qualifying Drugs: Qualifying non-opioid pain management drugs are defined as medications or biological products that:
- Are approved by the Food and Drug Administration (FDA) for reducing postoperative pain or other acute (short-term) pain.
- Do not interact with the body's opioid receptors (meaning they are not opioids).
- Have no other therapeutically equivalent alternatives available and marketed in the U.S., as determined by the FDA's list of approved drug products.
- Cost no more than a monthly "specialty-tier" threshold set by the Secretary of Health and Human Services (HHS), based on wholesale acquisition cost for a month's supply.
- Cost-Sharing Adjustments: Starting January 1, 2026, for Medicare Part D plans:
- No deductible (the initial amount beneficiaries must pay before coverage begins) applies to these drugs.
- These drugs must be placed on the lowest cost-sharing tier (the level with the smallest out-of-pocket copay or coinsurance percentage) to minimize beneficiary costs.
- These rules also apply to low-income Medicare beneficiaries who receive extra help with premiums and cost-sharing.
- Prohibitions on Utilization Management:
- Prescription drug plans and Medicare Advantage plans with drug coverage (MA-PD plans) cannot require "step therapy" for these drugs starting January 1, 2026. Step therapy is a process where patients must first try a preferred (often cheaper) drug—such as an opioid—before getting the prescribed non-opioid.
- Plans also cannot impose "prior authorization," which is a requirement for patients or doctors to get plan approval before the drug is covered.
Significant Changes to Existing Law
- Amends Section 1860D-2 of the Social Security Act (governing Medicare Part D definitions and coverage) by adding a new paragraph (10) for cost-sharing treatment of qualifying drugs and updating references to include this provision.
- Adds a new paragraph (7) to Section 1860D-14 for low-income subsidy adjustments, ensuring consistent treatment.
- Modifies Section 1860D-4(c) by adding a new paragraph (8) to prohibit step therapy and prior authorization specifically for these drugs, while reordering existing paragraphs for clarity.
- These changes build on prior laws (e.g., from the Bipartisan Budget Act of 2018) but introduce targeted exceptions for non-opioid pain drugs, which were not previously addressed in this way.
Potential Impacts
- On Citizens: Medicare beneficiaries, particularly older adults or those with acute pain (e.g., after surgery), will face lower out-of-pocket costs and fewer delays in accessing non-opioid options. This could reduce reliance on opioids, lowering risks of addiction, overdose, and related health issues.
- On Government Agencies: The Centers for Medicare & Medicaid Services (CMS), part of HHS, will need to oversee plan compliance, update guidance on drug tiers and thresholds, and monitor implementation starting in 2026. This may increase administrative workload but support broader public health goals like the opioid crisis response.
- On International Relations: No direct impacts, as the bill focuses on domestic Medicare policy and U.S.-approved drugs.
Main Stakeholders Affected
- Medicare Beneficiaries: Primary beneficiaries, especially those needing pain relief without opioids.
- Healthcare Providers: Doctors and pharmacists who prescribe these drugs, benefiting from streamlined approvals.
- Pharmaceutical Manufacturers: Companies producing qualifying non-opioid drugs may see increased demand and sales.
- Insurance Plans: Part D and MA-PD plans must adjust formularies (lists of covered drugs), potentially affecting their costs and negotiation strategies with drug makers.
- Government Entities: HHS and CMS for enforcement; Congress for oversight of Medicare spending.
Notable Legal, Constitutional, or Political Implications
- Legal: Strengthens patient access rights under Medicare by limiting plan restrictions, aligning with FDA drug approval standards. It may lead to disputes over drug qualifications or cost thresholds, potentially resolved through administrative reviews or courts.
- Constitutional: No apparent challenges; the bill operates within Congress's authority to regulate federal programs like Medicare under the Spending Clause.
- Political: Bipartisan introduction (by Republicans and Democrats) signals broad support for opioid reduction efforts. It could influence future healthcare reforms by prioritizing non-addictive alternatives, though it raises questions about added costs to Medicare (estimated impacts would require Congressional Budget Office analysis) and plan flexibility in managing drug expenses.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. Miller-Meeks, Mariannette [R-IA-1]
Cosponsors (107)
Rep. Barragán, Nanette Diaz [D-CA-44], Rep. Kelly, Mike [R-PA-16], Rep. Panetta, Jimmy [D-CA-19], Rep. Miller, Carol D. [R-WV-1], Rep. Larson, John B. [D-CT-1], Rep. Malliotakis, Nicole [R-NY-11], Rep. Moulton, Seth [D-MA-6], Rep. Balderson, Troy [R-OH-12], Rep. Guest, Michael [R-MS-3], Rep. Clarke, Yvette D. [D-NY-9], Rep. Budzinski, Nikki [D-IL-13], Rep. Lieu, Ted [D-CA-36], Rep. Fleischmann, Charles J. "Chuck" [R-TN-3], Rep. Tenney, Claudia [R-NY-24], Rep. Peters, Scott H. [D-CA-50], Rep. Griffith, H. Morgan [R-VA-9], Rep. Auchincloss, Jake [D-MA-4], Rep. Thompson, Glenn [R-PA-15], Rep. Cohen, Steve [D-TN-9], Rep. Mann, Tracey [R-KS-1], Del. Norton, Eleanor Holmes [D-DC-At Large], Rep. Womack, Steve [R-AR-3], Rep. Salinas, Andrea [D-OR-6], Rep. Kiggans, Jennifer A. [R-VA-2], Rep. Brownley, Julia [D-CA-26], Rep. Dunn, Neal P. [R-FL-2], Rep. Pocan, Mark [D-WI-2], Rep. Scott, Austin [R-GA-8], Rep. Tokuda, Jill N. [D-HI-2], Rep. Moore, Gwen [D-WI-4], Rep. Aderholt, Robert B. [R-AL-4], Rep. Bilirakis, Gus M. [R-FL-12], Rep. Subramanyam, Suhas [D-VA-10], Rep. Costa, Jim [D-CA-21], Rep. Carter, Earl L. "Buddy" [R-GA-1], Rep. Khanna, Ro [D-CA-17], Rep. McGovern, James P. [D-MA-2], Rep. Kelly, Robin L. [D-IL-2], Rep. Mast, Brian J. [R-FL-21], Rep. Craig, Angie [D-MN-2], Rep. Vindman, Eugene Simon [D-VA-7], Rep. Vasquez, Gabe [D-NM-2], Rep. Bresnahan, Robert P. [R-PA-8], Rep. McGarvey, Morgan [D-KY-3], Rep. Fitzpatrick, Brian K. [R-PA-1], Rep. Davis, Donald G. [D-NC-1], Rep. Pfluger, August [R-TX-11], Rep. Garcia, Robert [D-CA-42], Rep. Steube, W. Gregory [R-FL-17], Rep. Weber, Randy K. Sr. [R-TX-14] and 57 more
Recent Actions
- 2025-02-12: 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.
- 2025-02-12: 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.
- 2025-02-12: Introduced in House
- 2025-02-12: Introduced in House
Bill Versions
- Alternatives to Prevent Addiction In the Nation Act — issued 2025-02-12 — PDF (6 pages)