S-3064-119
Read twice and referred to the Committee on Finance.
Sponsored by Steve Daines (R-MT)
What it does
This bill would amend Medicare Part D (the prescription drug benefit) to require that certain non-opioid drugs used to treat chronic pain be covered without a deductible and placed on the lowest available cost-sharing tier. It would also prohibit Medicare Part D plans from requiring prior authorization or step therapy — meaning plans could not require patients to try cheaper or alternative drugs before covering these non-opioid pain medications.
Who benefits
Medicare Part D enrollees who suffer from chronic pain conditions and currently use or would use non-opioid pain medications — estimated at millions of seniors and disabled Americans. Patients who have previously been denied coverage or delayed treatment due to prior authorization or step therapy requirements. Physicians and prescribers who would face fewer administrative hurdles. Manufacturers of non-opioid pain drugs, who would gain a guaranteed, unrestricted market among Medicare enrollees. Pharmacies that dispense these medications may see increased volume.
Who is hurt
Medicare Part D insurance plans and pharmacy benefit managers (PBMs), which would lose tools they use to manage drug costs and formulary design. Taxpayers and the Medicare program broadly, as removing cost-sharing and utilization controls could increase federal spending. Medicare enrollees generally, if reduced plan cost controls lead to higher premiums over time. Manufacturers of opioid pain medications, who may face reduced demand as non-opioid alternatives become more accessible. Generic or lower-cost alternative drug manufacturers whose products could be bypassed if step therapy is prohibited.
Supporters argue
Supporters argue that prior authorization and step therapy requirements force chronic pain patients — many of them elderly or disabled — to endure bureaucratic delays and to try drugs that may be less effective or carry greater risks before accessing the treatments their doctors have already determined are appropriate. They contend that expanding access to non-opioid pain management directly addresses the opioid crisis by removing financial and administrative barriers that may push patients toward opioid-based alternatives, and that placing these drugs on the lowest cost-sharing tier ensures that out-of-pocket costs do not deter patients from filling medically necessary prescriptions.
Opponents argue
Opponents argue that prior authorization and step therapy are essential tools that Medicare Part D plans use to ensure cost-effective prescribing, prevent unnecessary utilization, and keep premiums affordable for all enrollees. They contend that mandating zero-deductible, lowest-tier coverage for an entire drug category — without requiring evidence of comparative effectiveness — could significantly increase program costs, and that the Congressional Budget Office has previously found that removing utilization management tools in Medicare Part D raises federal spending, ultimately burdening taxpayers and potentially increasing premiums for the broader Medicare population.
Constitutional context
Congress has broad authority to structure Medicare under the Taxing and Spending Clause (Art. I, §8, cl. 1), and NFIB v. Sebelius (2012) affirmed wide latitude to set conditions on federal benefit programs. No significant constitutional challenge is apparent here, as the bill modifies an existing federal program rather than compelling private action or imposing conditions on states.
Checks and balances
Congress gains authority by mandating specific coverage and pricing rules for Medicare Part D plans; HHS and CMS would implement and enforce the requirements, subject to judicial review of agency rulemaking under the post-Loper Bright standard of independent statutory interpretation.
Historical precedent
The Inflation Reduction Act of 2022 similarly restructured Medicare Part D cost-sharing, including caps on out-of-pocket drug costs for seniors, establishing a precedent for Congress directly mandating Part D plan design.