More States Adopt Step Therapy Limitations While Federal Protections Remain Elusive

June 14, 2022

Tennessee and Kentucky are the latest states to enact step therapy reform, joining more than two dozen others in protecting commercially insured patients from the harmful practice. Federal officials, meanwhile, are leaving some seniors vulnerable.

Step therapy, also known as “fail first,” requires patients’ care to begin with their health plans’ most-preferred drug. Often patients must fail multiple medications before getting approval for the one their doctor initially prescribed. The practice can lead to preventable and costly consequences, including delayed access to optimal treatments and worsening symptoms. 

State Level Reforms   

While the bill signed into law by Tennessee Governor Bill Lee in May does not eliminate step therapy, it sets guardrails to enable patient access to medically necessary treatments.  

The new policy establishes clinical review criteria and strengthens the appeals process to ensure an exception if, among other criteria, the medication is contraindicated or expected to be ineffective. It also makes exceptions if the patient has previously tried and failed a medication or if a patient is stable on a current medication. 

Noting the urgency associated with ensuring a patients’ access to the best medication, the Tennessee law also requires the insurer, health plan or utilization review organization to grant or deny a step therapy exception request within 72 hours. That period drops to 24 hours in the event of an emergency. 

Medicare Advantage Allows Step Therapy 

Despite the harms caused by insurers’ use of the cost savings tactic, in 2019, the Centers for Medicare and Medicaid Services allowed Medicare Advantage plans to implement step therapy for Part B drugs.  

Medicare Part B covers medications that are administered in a doctor’s office or outpatient clinic. Nearly a third of patients covered by Medicare have an Advantage plan, so the policy change had wide-reaching implications on seniors’ access to their preferred treatment. 

The move drew the ire of both patient advocacy and professional medical organizations, including the American Academy of Ophthalmology. The organization called on CMS to “move swiftly to reinstate the step therapy prohibition.” Despite the requests from AAO and others, CMS has yet to change its approach.  

Vision Patients’ Step Therapy Perils 

For patients with vision conditions like diabetic retinopathy or age-related macular degeneration step therapy is particularly concerning. Delays in starting an effective treatment could lead to irreversible vision loss. 

Administratively, multi-fail protocols create an unnecessary burden for health care providers. And, perhaps most concerning, step therapy puts payers – as opposed to health care providers – in charge of patients’ treatment decisions. 

For some patients with vision conditions, quickly starting an effective treatment can be the difference between sight and blindness. Until the federal government changes its course, step therapy will continue to delay seniors’ access to the drugs they need, when they need them. 

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