The 'Safe Step Act' Mandates 72-Hour Approvals for Step Therapy Exceptions, Protecting Patient Access to Needed Drugs

If you’ve ever had your insurance company tell you, “No, you can’t have the drug your doctor prescribed; you have to try this cheaper one first,” then you’ve run into “step therapy.” It’s a common cost-saving practice, but when it forces you onto a medication that doesn't work or actively harms you, it’s frustrating—and sometimes dangerous. The Safe Step Act aims to fix that by forcing group health plans and insurers to create a mandatory, quick-fire exception process when step therapy protocols fail.

When the Safety Net Becomes a Trip Hazard

This bill amends the Employee Retirement Income Security Act (ERISA) to ensure that if your employer-sponsored health plan uses step therapy, you now have a clear, legally defined path to skip the required steps. The core idea is simple: if the first drug in the sequence isn’t right for you, the plan has to cover the drug your doctor actually wants you to take. This isn't just about convenience; it’s about preventing serious harm. The bill lists specific criteria that, if met, require the insurer to grant the exception. For example, if previous required treatments (or even drugs in the same class) haven’t worked, or if delaying the correct treatment would cause “severe or irreversible harm” or worsen your condition, the plan must approve the exception.

This also covers practical, real-world situations. Say you’re a construction worker whose prescribed drug causes side effects that make it unsafe for you to operate heavy machinery. The bill stipulates that if the required drug “prevents you from safely doing your job or your daily activities,” that’s grounds for an exception. Crucially, if you’re already stable on a drug because you successfully used it under a previous plan, you won’t have to restart the step therapy gauntlet just because you switched jobs.

The 72-Hour Clock Starts Now

One of the biggest wins for busy people is the strict timeline for decisions. For a standard exception request, the plan or insurer has just 72 hours to either approve the medication or ask for strictly necessary additional information. If your situation is urgent—meaning delaying treatment could seriously jeopardize your life or health, or cause severe pain—that timeline shrinks dramatically to 24 hours. This rapid turnaround is designed to prevent the kind of bureaucratic delays that can turn a manageable condition into a crisis while you wait for paperwork to clear. Once an exception is approved, the plan must cover the drug for at least one year.

Plus, the bill addresses the cost issue. If your exception is approved, the cost-sharing (your copay or deductible) for the new, preferred drug must be the same as it would have been for the initially required, cheaper drug at the start of the plan year. This prevents insurers from approving the exception only to slap you with a massive copay, effectively making the drug unaffordable anyway.

Holding the Insurers Accountable

This legislation doesn't just change the rules of the game; it requires the players to show their work. Group health plans and insurers must now report detailed annual data to the Secretary of Labor. This includes how many exception requests they received for each reason (e.g., previous failure, urgency, job impact), how many they approved, and how many denials were overturned on appeal. This mandatory reporting is a big deal because it increases transparency. The Secretary of Labor is then required to take all that data and create a public report summarizing the trends. For the first time, we'll get a clear, public view of exactly how often insurers are saying no, and why.

This reporting requirement also puts pressure on Pharmacy Benefit Managers (PBMs) and third-party administrators, as plans are explicitly forbidden from signing contracts that prevent them from collecting the data needed to comply. While this means added administrative lift and compliance costs for the insurance industry, the benefit for patients is clear: faster access to necessary medication and a reduction in the red tape that currently forces people to struggle through ineffective treatments.