Arthritis Foundation Step Therapy Legislative Position Statement

Arthritis Foundation Position Statement on Step Therapy/Fail First

Issue

Step therapy is a practice used by insurers that requires people with arthritis to try lower-cost medications before permitting more expensive treatments, even when the doctor wants to prescribe them. In other words, more expensive and effective drugs can only be prescribed if the cheaper ones prove ineffective. Step therapy is not the same as generic substitution, which is when the brand name medication prescribed by a doctor is substituted with a generic version.

Background

"Step therapy," or "fail first," is the practice by insurers of requiring people to test the use of a lower-cost drug before permitting more expensive drugs. Step therapy is an established benefit management tool that is used by commercial carriers, self-insured employers, Medicare Advantage/Part D programs and Medicaid.

When a person changes insurers, or a drug they are currently taking is moved to a nonpreferred status, he or she may be put through the step therapy process again. Some step therapy protocols even impose these requirements on stable patients.

Arthritis Foundation Position

The Arthritis Foundation supports legislation that provides reasonable limitations on step therapy/fail first protocols and believes the following policies are essential to protect people:

  • Permit a physician to override the step therapy process when patients are stable on a prescribed medication.
  • Permit a physician to override step therapy if he or she expects the treatment to be ineffective based on the known relevant medical characteristics of the patient and the known characteristics of the drug regimen; if patient comorbidities will cause, or will likely cause, an adverse reaction by, or physical harm to, the patient; or is not in the best interest of the patient, based on medical necessity.
  • Require an expedited process of no more than 24 hours in cases of emergency.
  • Require health insurance plans to maintain step therapy approval and override request processes electronically.
  • Require health insurance plans to notify patients in writing if a step therapy override request is denied, the specific reason for the denial and how to conduct an appeal.
  • Prohibit insurers from requiring insured patients to fail a prescription medication more than once. Limit any single "step" of the step therapy protocol to a maximum of 60 days.
  • In circumstances where a patient is changing health insurance plans, the new plan may not require the person to repeat step therapy that was completed under a prior plan. This applies when that person is already being treated for a medical condition by a prescription medication, provided that the drug is appropriately prescribed and is considered safe and effective for the person's condition.
  • When a health insurance plan changes formulary design, the plan cannot limit or exclude coverage of a medication for a new plan member if the drug was previously approved for coverage by the plan for the person’s medical condition and the prescribing provider continues to prescribe the drug for the same medical condition.

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