The Safe Step Act amends ERISA to require every group health plan and any issuer offering coverage in connection with such a plan to implement a formal exceptions process for medication step therapy protocols. The statute sets substantive grounds for approving exceptions (ineffectiveness, contraindication, risk of harm, stability on current therapy, functional impairment, or other Secretary‑determined reasons), mandates specific procedural features for requests, and imposes strict decision deadlines including an expedited 24‑hour track for urgent cases.
Beyond the review process, the bill forces operational changes: plans must use standard forms (paper and electronic), permit prescribers or designated representatives to act on a patient’s behalf, guarantee a granted exception for at least one year, and report detailed exception and appeals data (including PBM identities) annually to the Secretary. The Department of Labor must issue implementing regulations within six months and the rule applies to plan years beginning at least six months after enactment — a federal compliance and reporting burden that will affect self‑insured employers, insurers, PBMs, prescribers and patients alike.
At a Glance
What It Does
The bill requires group health plans and group market issuers to operate a clear exceptions process for any medication step therapy protocol, including defined grounds for approval and procedural safeguards. It imposes a 72‑hour maximum for routine decisions, a 24‑hour maximum for expedited (urgent) requests, a one‑year minimum coverage period for approved exceptions, and annual reporting to the Secretary.
Who It Affects
ERISA‑governed employer‑sponsored group health plans, health insurance issuers offering group coverage, pharmacy benefit managers that service those plans, prescribing clinicians who request exceptions, and patients (especially those on ongoing or specialty therapies). Employers that self‑insure and third‑party administrators will face the principal operational changes.
Why It Matters
The Act establishes a uniform federal floor for step therapy exceptions across large employer plans and group market issuers, increasing transparency into PBM arrangements and utilization management decisions. For compliance teams, it creates time‑sensitive workflows, new reporting obligations, and potential financial exposure if plans do not process exceptions within statutory deadlines.
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What This Bill Actually Does
The Safe Step Act writes a mandatory exceptions pathway into ERISA for any group health plan or group insurer using step therapy. The law does two broad things: first, it defines when a plan must grant an exception (for example, prior therapies were ineffective, a required therapy is contraindicated, switching would cause harm, or the patient is stable on a non‑preferred drug); second, it prescribes how plans must run the review process.
Plans must accept exception requests from patients or from prescribers acting on their behalf, provide a standard request form available both on paper and electronically, and allow a designated third‑party representative to act for the enrollee.
The Act sets tight deadlines: most exception requests must receive an eligibility decision within 72 hours of receipt or within 72 hours of receiving any additional information the plan asks for; requests that threaten life, health, function, or cause severe unmanaged pain must be processed on an expedited track with decisions and any requests for more information completed within 24 hours. If a plan approves an exception, it must cover the requested drug under the plan’s normal cost‑sharing rules for at least one year.
The statute also clarifies that a policy is covered whether or not the plan labels it ‘step therapy’. Operationally, plans cannot ask for more documentation than the Secretary permits as strictly necessary, and must include clear criteria in plan materials and on websites explaining how exception decisions are made.
The law requires annual reporting to the Secretary (starting within three years) on counts of exception requests by statutory reason, approvals and denials, appeals and reversals, how many requests required additional information, who submitted the requests (patient vs. prescriber and prescriber specialty), medical conditions tied to certain denials, and the identities of entities providing PBM services. The bill also bars plan contracts with third parties from preventing the plan from obtaining the information needed to satisfy reporting requirements.
Finally, the Department of Labor must issue final regulations through notice‑and‑comment within six months of enactment, and the new rules apply to plan years beginning at least six months after the law takes effect.
The Five Things You Need to Know
The bill requires routine exception decisions within 72 hours of an initial request (or within 72 hours after receipt of any additional information requested by the plan).
For requests where delay could jeopardize life, health, function, or cause severe unmanaged pain, plans must make an expedited determination and either decide without additional information or request needed materials and resolve the claim within 24 hours.
A granted exception must be honored for at least one year, during which the plan must cover the requested drug under the plan’s established cost‑sharing terms.
Plans and issuers must use a standard request form available in paper and electronic formats, permit prescribers or designated third‑party representatives to act on a patient’s behalf, and limit documentation requests to what the Secretary deems strictly necessary.
Plans and issuers must report annually to the Secretary (beginning not later than three years after enactment) counts of requests by statutory exception reason, approvals/denials, appeals and reversals, requests for additional information, prescriber specialty, medical conditions tied to adverse‑reaction exceptions, and the entities providing PBM services; the Secretary must publish analyses to Congress.
Section-by-Section Breakdown
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Short title
Names the statute the "Safe Step Act." This is purely formal but signals that subsequent provisions create a single, cohesive package addressing step therapy exception procedures within ERISA‑governed group coverage.
Mandated exceptions process
Adds a new ERISA section requiring any group health plan or group market issuer using step therapy to implement a clear, prompt and transparent exceptions process. Practically, plans must accept exception requests from participants or prescribers, evaluate them against statutory criteria, and — if the criteria are met — cover the requested medication under the plan’s cost‑sharing framework.
Enumerated grounds for granting exceptions
Lists six grounds that obligate plans to approve an exception: failure of prior treatments (including same pharmacologic class), risk of severe or irreversible harm from delay, contraindication or likely adverse reaction, impairment of function, stability on current therapy with prior approval, and a catch‑all for Secretary‑designated circumstances. For compliance teams, this creates objective categories to apply during reviews and limits arbitrary denials, but some criteria (like clinician judgement and peer‑reviewed evidence) will require protocols for clinical documentation and adjudication.
Process features, submission formats, expedited review, and duration
Specifies operational requirements: standard forms in paper and electronic formats; ability to submit by either medium; clear disclosure of required information and decision criteria in plan materials and on websites; prohibitions on requiring unnecessary documentation; and allowance for a patient representative to file on behalf of an enrollee. It also prescribes decision timeframes (72 hours routine; 24 hours expedited) and mandates a minimum one‑year coverage period for any approved exception, forcing plans to implement tracking systems to manage reauthorization and cost‑sharing flow for approved exceptions.
Definition and scope clarification
Defines ‘medication step therapy protocol’ as any utilization management policy that requires trying preferred alternatives before approving non‑preferred drugs, and makes clear the law applies regardless of whether the plan labels a policy as ‘step therapy.’ That broad definition pulls within scope programs that might otherwise escape notice by relabeling or packaging utilization rules differently.
Reporting, contract transparency, rulemaking, and effective date
Requires annual reporting to the Secretary on granular exception metrics (approval/denial counts, appeals, reversals, PBM identities, prescriber specialties, and medical conditions tied to adverse‑reaction exceptions). Plans cannot contract away the data the law requires them to report. The Department of Labor must complete notice‑and‑comment rulemaking within six months, and the substantive obligations apply to plan years beginning at least six months after enactment. These scheduling and reporting provisions create immediate compliance deadlines for IT, vendor contracts and PBM agreements.
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Explore Healthcare in Codify Search →Who Benefits and Who Bears the Cost
Every bill creates winners and losers. Here's who stands to gain and who bears the cost.
Who Benefits
- Patients on stable or specialty therapies — The one‑year exception and expedited pathway reduce interruptions for patients who are clinically stable on non‑preferred drugs and limit lapses while appeals or administrative reviews occur.
- Prescribing clinicians — The statute formalizes a clinician‑driven exception route, allowing prescribers to supply clinical rationale directly and to request expedited reviews when delay would harm the patient.
- Patient advocates and disability communities — The law codifies functional and clinical grounds (including activities of daily living and occupational function) for exceptions, which advocacy groups can use to press for approvals and standardized processes.
- Employers concerned with workforce stability — Faster access to appropriate medications and a one‑year guarantee can reduce productivity losses due to therapeutic disruption or unmanaged symptoms.
Who Bears the Cost
- Self‑insured employers and group health insurers — They must implement new workflows, hire or reassign staff to meet 24/72‑hour windows, develop standard forms and IT interfaces, and potentially pay higher drug costs if exceptions increase utilization of non‑preferred drugs.
- Pharmacy benefit managers (PBMs) and third‑party administrators — The bill forces greater transparency (identifying PBM entities in reports), constrains contract terms that would block data flow, and increases administrative work to support exception adjudications and reporting.
- Plan compliance and operations teams — Compliance, legal and benefits operations will bear the burden of revising plan documents, summary materials and websites, coordinating with vendors, and preparing for DOL rulemaking and annual data submissions.
- Department of Labor — The DOL must complete expedited notice‑and‑comment rulemaking within six months and set up systems to receive, analyze and publish annual reports, creating a new regulatory and oversight workload.
Key Issues
The Core Tension
The central dilemma is between patient access and system integrity: the Act prioritizes rapid, clinician‑informed access to non‑preferred drugs to prevent harm and preserve function, but doing so reduces utilization controls that payers use to manage costs and can create significant administrative and financial burdens for plans, PBMs and employers; the bill leaves it to regulators to draw the line between necessary documentation and burdensome proof requirements.
The Safe Step Act addresses a real access problem by forcing plans to adjudicate exceptions quickly, but it creates practical implementation tensions. Plans must balance speed (statutory 24/72 hour clocks) with careful clinical review; overly rigid workflows risk improper approvals, while excessive documentation demands conflict with the bill’s prohibition on requesting more than what the Secretary deems strictly necessary.
Determining what qualifies as ‘strictly necessary’ will be a central battleground in the upcoming rulemaking.
The reporting mandate increases transparency into PBM relationships and exception outcomes, yet it also creates new compliance and data‑integration burdens. Plans that outsource pharmacy functions will need contractual changes and technical solutions to extract granular counts, appeals trajectories, prescriber specialties and PBM identifiers.
The statute prohibits contracts that block data transfer for reporting, but enforcing that prohibition may require audits and additional resources at both agency and plan levels. Finally, the one‑year minimum approval period protects patients against churn but could raise plan drug spend and premiums if exceptions substantially increase utilization of higher‑cost therapies; measuring net clinical benefit versus cost will depend on the quality of the data plans and the Secretary publish.
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