Step Therapy Protocols Must Be Established

On Feb. 28, 2018, Gov. Martinez signed SB 11 into law, which mandates certain actions in regards to step therapy protocols. As background, step therapy protocol means issuers require plan participants to use certain prescription drugs, other than prescription drugs recommended by participants’ health care providers, or to take prescription drugs in a certain order before plans provide coverage for recommended prescription drugs.

This bill requires insurers that require step therapy before providing prescription drugs to establish, implement and administer the step therapy protocol in accordance with industrywide clinical practice guidelines. Clinical review criteria must be based on clinical practice guidelines that do all of the following:

  • Recommend that prescription drugs subject to step therapy protocols be taken in specific order required by step therapy protocols
  • Are developed and endorsed by an interdisciplinary panel of experts that manage conflicts of interest
  • Are based on high-quality studies, research and medical practice
  • Are created by an explicit and transparent process that minimizes bias and conflicts of interest, explains relationships between treatment options and outcomes, rates quality of evidence used to support recommendations and considers relevant subgroups and preferences
  • Consider the needs of atypical populations and diagnoses

The law also outlines when participants should be able to request step therapy exceptions and specifies that plans must provide participants with decisions those exceptions within 72 hours (or within 24 hours in emergency situations).

This law will become effective for plans delivered, issued for delivery or renewed on or after Jan. 1, 2019.

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