Safe Step Act

The Safe Step Act was introduced in the 119th Congress on September 18, 2025, by Senator Murkowski (R-AK) with 42 cosponsors. It has advanced only to a committee hearing stage (March 19, 2026) with no markup or floor vote scheduled. The bill amends ERISA to require group health plans and issuers to implement a 'clear, prompt, and transparent' exception process for patients to bypass step therapy protocols under specific circumstances (e.g., previous failure of the required step drug, expected adverse reaction, or extended delay in step therapy completion). The bill authorizes zero dollars in federal spending—it is a regulatory mandate on private health plans, not a government appropriation. The funding source is entirely private-sector compliance: insurers and their PBMs must absorb the cost of building and adjudicating exception requests. There is no direct revenue for any public company; the effect is a cost burden and a reduction in the ability to steer patients to lower-cost drugs. Structural winners and losers: The primary losers are managed care organizations with large PBM operations—UnitedHealth (Optum Rx), Cigna (Evernorth), and CVS Health (Aetna + Caremark). These entities rely on step therapy to maximize rebate revenue from drug manufacturers. Weakening step therapy reduces rebate capture and increases pharmacy trend. Humana is less exposed due to its Medicare Advantage focus. Pharmaceutical and biotech companies that manufacture drugs typically placed second or third in step therapy protocols (e.g., AbbVie, Amgen, Bristol-Myers Squibb) would benefit structurally if patients can bypass lower-cost generics, but the bill does not directly name any drug or company—the benefit is diffuse across brand drug portfolios. No ticker is included for pharma because the link is indirect and requires multiple inferential steps. The companion bill HR 5509 is identical and sits in House committee, which slightly increases passage odds, but the 119th Congress is already past the midpoint; without markup by mid-2026, the bill likely dies and must be reintroduced in the 120th Congress (2027). Timeline: The bill requires committee markup in Senate HELP, full Senate vote, companion passage in the House, and Presidential signature. None of these steps are imminent. A realistic passage window is 2027–2028 if reintroduced. Investors should watch for HELP committee markup or inclusion of step therapy language in broader health package legislation—that would accelerate odds.