- Minnesota Governor Mark Dayton has signed a bill into law that allows patients and providers to execute overrides on payer step therapy programs for prescription drug treatments in certain clinical situations.
HF 3196 requires payers to bypass their established step therapy protocols when providers can meet one of three criteria indicating a patient’s need for a prescription drug that would not ordinarily be covered out of sequence.
Overrides are required when a drug included in the sequence is likely to create an adverse reaction to a health plan member. Adverse reactions include allergic reactions, physical or mental health impairments, or decreases in day-to-day mobility.
Payers must also approve overrides when health plan members previously had a trial of required step therapy drugs covered by their current plan, or previous health plan, and the trial led to positive healthcare outcomes. Coverage will be mandatory even when the previous patient trial was discontinued by a provider or phased out of health plan coverage.
However, the law does not prohibit health plans from requiring enrollees to try another drug or pharmacological alternative.
Payers considering adding or changing step therapy procedures must continue to cover a therapy if the patient is currently experiencing positive outcomes on the drug, even if the new step therapy plan would prevent the patient from receiving coverage without trying other options.
Providers may initiate these outcomes-based overrides by providing health plans with enrollee and drug information explaining when step therapy drugs would create adverse patient reactions.
In addition to the override provisions, the law requires payers to share the methodologies behind step therapy protocols. All protocols must be developed using using evidence-based practice guidelines, FDA labeling/information, and manufacturer's prescribing labels.
Payers will be required to post step therapy override information on their health plan’s website for both providers and enrollees, and must offer clinical review criteria for covered prescription drugs at the request of health plan enrollees.
Health plans are required to respond to step override requests and override denials within five days. In urgent cases, health plans have 72 hours to respond to override requests.
The legislation is likely to bring benefits to patients, said the National Psoriasis Foundation (NFP).
"HF 3196 preserves the patient and provider relationship, which is where treatment decisions should be made," said Patrick Stone, Vice President of Government Relations and Advocacy at NPF.
"Treating psoriatic disease is unique and complex. What might work for one patient may not work for another. HF 3196 allows patients the ability to access the therapies that their health care provider knows will best treat their disease when they are initially prescribed."
Other states have also implemented laws that make it possible for patients to circumvent step therapies in medically necessary cases.
In Illinois, providers and enrollees can request step therapy overrides from any health plan if current prescriptions have produced strongly positive clinical outcomes.
Illinois’s law also creates a step therapy process that requires health plans to deny or approve requests with 72 hours. Expedited requests require health plans to make step therapy decisions within 24 hours.
In Mississippi, providers can request step therapy overrides when fail-first protocols and initial drug treatments do not create positive patient outcomes.
Leading payer organizations have expressed a willingness to improve and streamline prior authorizations by working with providers and stakeholders to create better procedures. However, the impact of more restrictive step therapy legislation on long-term outcomes and payer costs remains to be seen.