H.R. 1227: Alternatives to PAIN Act
Sponsor
Mariannette Miller-Meeks
Republican · IA-1
Bill Progress
Latest Action · Feb 12, 2025
Referred to 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. for review
Why it matters
Congress is weighing new ways to reduce opioid use while making newer non-opioid pain treatments easier for Medicare patients to get starting in 2026.
H.R. 1227 would change Medicare Part D rules so some non-opioid pain medicines get better insurance treatment than they do now. If a drug qualifies, Medicare drug plans could not apply the Part D deductible to it, and the drug would have to be placed on the plan's lowest cost-sharing tier. That means patients would likely pay less out of pocket for these drugs than they do today.
The bill also targets two common insurance barriers: step therapy and prior authorization. Under this proposal, Medicare drug plans could not require a patient to use an opioid first before getting a qualifying non-opioid pain drug, and they could not require prior approval before covering that drug. Supporters will argue this is a direct response to concerns that insurance rules can push patients toward cheaper opioid options even when a non-opioid drug may be appropriate.
But the bill is narrower than it may sound. It applies only to non-opioid pain drugs that meet several tests: they must be FDA-approved for postoperative or other acute pain, must not work on opioid receptors, must lack a therapeutically equivalent marketed alternative, and must stay under a set monthly price ceiling tied to Medicare's specialty-tier threshold. In practice, that means the bill appears aimed at a relatively small set of newer brand-name pain treatments, not the full universe of non-opioid pain care.
Politically, the measure fits into a larger bipartisan push to address addiction risk without cutting off pain treatment. The appeal is easy to understand: reduce incentives that may steer patients to opioids. The harder question is whether lowering cost-sharing and blocking utilization controls for a select class of drugs will raise Medicare spending or favor a small number of manufacturers. That tradeoff is likely to be central as the bill moves through committee.
What does H.R. 1227 do?
No deductible for qualifying pain drugs
Starting in plan year 2026, Medicare Part D plans could not make patients meet their deductible before coverage begins for qualifying non-opioid pain drugs.
Lowest cost-sharing tier required
Plans would have to place qualifying non-opioid pain drugs on the lowest cost-sharing tier they use, which should reduce copays or coinsurance.
No opioid-first requirement
Plans could not force a patient to try an opioid before getting coverage for a qualifying non-opioid pain drug.
No prior authorization allowed
Plans could not require advance approval before covering a qualifying non-opioid pain drug.
Applies to low-income subsidy enrollees too
The same deductible and low cost-sharing protections would also apply to Medicare Part D beneficiaries who receive low-income assistance.
Strict rules define which drugs qualify
Only drugs for acute pain that are FDA-approved, do not act on opioid receptors, have no therapeutically equivalent marketed alternative, and stay below a set monthly price threshold would qualify.
Who benefits from H.R. 1227?
Medicare patients with acute pain
They could get faster and cheaper access to certain non-opioid pain medicines after surgery or other short-term pain episodes.
Older adults at risk of opioid dependence or side effects
They may have an easier path to pain treatment options that avoid opioid receptors and may reduce exposure to opioids.
Low-income Medicare beneficiaries
They would receive the same protection from deductibles and high cost-sharing for qualifying drugs, helping limit out-of-pocket costs.
Manufacturers of qualifying non-opioid pain drugs
Their products could become more attractive because plans would have to cover them on favorable terms and could not use common access restrictions.
Who is affected by H.R. 1227?
Medicare Part D plans
They would lose flexibility to use prior authorization, step therapy, deductibles, and higher tiers for this class of drugs.
Taxpayers and the Medicare program
If more beneficiaries use higher-cost brand drugs, overall Medicare spending could rise, though the bill does not estimate the impact.
Pharmacy benefit managers and plan administrators
They would have fewer tools to manage utilization and negotiate around these products.
Patients currently steered toward opioids first
Their treatment pathway could change because plans would no longer be allowed to require opioid use before coverage of a qualifying non-opioid option.
H.R. 1227 Common Questions
When would Medicare stop applying the Part D deductible to certain non-opioid pain drugs?
Starting with plan years beginning on or after January 1, 2026, Medicare Part D plans could not apply the deductible to qualifying non-opioid pain management drugs under the Alternatives to PAIN Act (Sec. 2).
Can Medicare Part D plans require an opioid first before covering a non-opioid pain drug?
No. Under the Alternatives to PAIN Act, Part D and MA-PD plans may not require an enrollee to use an opioid before receiving a qualifying non-opioid pain management drug (Sec. 3).
Does H.R. 1227 ban prior authorization for non-opioid pain drugs in Medicare?
Yes, for qualifying non-opioid pain management drugs. According to H.R. 1227 Sec. 3, Part D and MA-PD plans may not require prior approval before the drug is furnished.
What are the rules for a pain drug to qualify under the Alternatives to PAIN Act?
It must be FDA-approved for postoperative or other acute pain, not act on opioid receptors, have no therapeutically equivalent marketed alternative in the U.S., and stay under the monthly specialty-tier cost threshold (Sec. 2).
How much can a qualifying non-opioid pain drug cost and still qualify under H.R. 1227?
Its wholesale acquisition cost for a monthly supply cannot exceed the monthly specialty-tier cost threshold set by the HHS Secretary, according to H.R. 1227 Sec. 2.
Will Medicare have to put qualifying non-opioid pain drugs on the lowest copay tier?
Yes. Under the Alternatives to PAIN Act (Sec. 2), qualifying non-opioid pain management drugs must be placed on the plan's lowest cost-sharing tier.
Does the Alternatives to PAIN Act apply to low-income subsidy Medicare beneficiaries?
Yes. The deductible and low cost-sharing protections for qualifying drugs also apply to low-income individuals under Medicare Part D, under the Alternatives to PAIN Act (Sec. 2).
Which Medicare plans would be barred from step therapy and prior authorization for qualifying pain drugs?
Prescription drug plans and MA-PD plans would be barred from those requirements for qualifying non-opioid pain management drugs under H.R. 1227 Sec. 3.
Does H.R. 1227 apply to chronic pain drugs or only acute pain drugs?
Only acute pain drugs qualify. According to H.R. 1227 Sec. 2, the drug must have an FDA-approved indication for postoperative pain or another form of acute pain.
Can a non-opioid pain drug qualify if there is already a therapeutically equivalent version sold in the U.S.?
No. Under the Alternatives to PAIN Act (Sec. 2), a drug does not qualify if another therapeutically equivalent drug or product is already sold or marketed in the United States.
Based on H.R. 1227 bill text
HR1227 Legislative Journey
House: Committee Action
Feb 12, 2025
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.
About the Sponsor
Mariannette Miller-Meeks
Republican, Iowa's 1st congressional district · 5 years in Congress
Committees: Veterans' Affairs, Energy and Commerce
View full profile →
Cosponsors (80)
This bill has 80 cosponsors: 40 Democrats, 40 Republicans, reflecting bipartisan support. Cosponsors represent 32 states: Alabama, Arkansas, Arizona, and 29 more.
Nanette Barragán
Democrat · CA
Mike Kelly
Republican · PA
Jimmy Panetta
Democrat · CA
Carol Miller
Republican · WV
John Larson
Democrat · CT
Nicole Malliotakis
Republican · NY
Seth Moulton
Democrat · MA
Troy Balderson
Republican · OH
Michael Guest
Republican · MS
Yvette Clarke
Democrat · NY
Nikki Budzinski
Democrat · IL
Ted Lieu
Democrat · CA
Committee Sponsors
Ways and Means Committee
11 of 45 committee members cosponsored
Energy and Commerce Committee
16 of 54 committee members cosponsored
38 Republicans across these committees haven't cosponsored yet. Mobilize their constituents
H.R. 1227 Quick Facts
- Committee
- Ways and Means
- Chamber
- House
- Policy
- Health
- Introduced
- Feb 12, 2025
Referred to 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. for review
Feb 12, 2025
Official Sources
Official bill text, cosponsors, actions, and status for the Alternatives to PAIN Act in the 119th Congress.
CMS overview of the Medicare Part D benefit that this bill amends, including formulary guidance and plan information.
FDA announcement of the first drug in the class this bill targets: a non-opioid for moderate to severe acute pain, approved January 2025.
The bill uses Orange Book therapeutic equivalence ratings to determine which drugs qualify; a drug with an equivalent already marketed does not qualify.
FDA draft guidance encouraging sponsors to develop non-opioid analgesics for acute pain, the same drug category this bill covers.
The bill extends its deductible and cost-sharing protections to low-income Medicare beneficiaries eligible for Extra Help.
Official CMS guidance for the 2026 Part D benefit structure, including the $615 deductible and $2,100 out-of-pocket cap that this bill interacts with.
The federal statute this bill directly amends to add a new paragraph (10) exempting qualifying non-opioid drugs from deductibles and placing them on the lowest tier.
Who is lobbying on H.R. 1227?
3 organizations lobbying on this bill
VERTEX PHARMACEUTICALS INCORPORATED | 4 |
VERTEX PHARMACEUTICALS INCORPORATED | 4 |
AMERICAN SOCIETY OF ANESTHESIOLOGISTS | 2 |
Showing 1-3 of 3 organizations
H.R. 1227 Bill Text
“To amend title XVIII of the Social Security Act to ensure appropriate access to non-opioid pain management drugs under part D of the Medicare program.”
Source: U.S. Government Publishing Office
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