State of Maryland Step Therapy Protocol Exception Process
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Process governing how providers request exceptions to step therapy requirements for members covered under Maryland fully insured plans or Maryland self-insured non‑ERISA plans administered by Banner Health and Aetna, with prior authorization review by CVS Caremark.
No material clinical or coverage changes in this revision.
Step Therapy Exception Criteria
Step therapy exception criteria
Requested medication may be covered when ANY of the following are met and documented:
Step Therapy Exception Criteria
- Contraindication or adverse reaction: The step therapy drug is contraindicated or will likely cause an adverse reaction to the insured.
- Expected ineffectiveness: The step therapy drug is expected to be ineffective based on the known clinical characteristics of the insured and the known characteristics of the prescription drug regimen.
- Clinical stability on current therapy: The insured is stable on a prescription drug prescribed for the medical condition under consideration while covered under the policy of the insurer or under a previous source of coverage.
Prior same‑class trial discontinued
- While covered under the policy of the insurer or a previous source of coverage, the insured has tried a prescription drug that is in the same pharmacologic class or has the same mechanism of action as the step therapy drug.
- That prescription drug was discontinued by the prescriber due to lack of efficacy or effectiveness, diminished effect, or an adverse event.
Requested medications subject to step therapy may be approved if the provider documents that any one of the specified exception criteria is met. These criteria include: (1) the step therapy drug is contraindicated or likely to cause an adverse reaction for the patient; (2) the step therapy drug is expected to be ineffective given the patient’s clinical characteristics; (3) the patient is clinically stable on an alternative prescription for the condition while covered under this or prior coverage; or (4) the patient previously tried a drug in the same pharmacologic class (or with the same mechanism of action) and it was discontinued by the prescriber because of lack of efficacy, diminished effect, or an adverse event.
What Providers Must Do
Submit PA form to CVS Caremark
If a formulary medication requires step therapy, the provider must request an exception by completing and submitting the applicable prior authorization (PA) form to CVS Caremark for review. The PA form can be obtained by contacting the CVS Caremark Prior Authorization Department or via the CVS Caremark website link provided in the policy.
- Complete the applicable PA form for the member's plan.
- Submit the PA form to CVS Caremark Prior Authorization Department for review.
Clinical grounds to bypass step therapy
Exception to step therapy may be granted when documentation shows the patient meets any one of the listed clinical grounds: contraindication or likely adverse reaction to the step drug; expected ineffectiveness based on clinical characteristics; clinical stability on the current medication; or prior trial of a same‑class drug discontinued for lack of efficacy, diminished effect, or an adverse event.
- Step therapy drug is contraindicated or will likely cause an adverse reaction.
- Step therapy drug is expected to be ineffective based on known clinical characteristics.
- Patient is clinically stable on an alternative prescription for the condition.
- Patient previously tried a same‑class drug that was discontinued by the prescriber due to lack of efficacy/effectiveness, diminished effect, or an adverse event.
Complete and submit PA form with supporting documentation
Providers must complete and submit the applicable prior authorization (PA) form and include supporting clinical documentation that demonstrates one of the exception considerations listed in the policy.
- Attach clinical evidence showing contraindication, likely ineffectiveness, patient stability on current therapy, or prior same‑class therapy failure/adverse event.
- Use the PA form obtained from CVS Caremark and submit it to the CVS Caremark Prior Authorization Department.
Requests may be denied if criteria not met or information insufficient
CVS Caremark will review the information submitted and may deny the request if the documentation does not meet the exception requirements or if medical necessity criteria are not satisfied.
- Insufficient or incomplete documentation supporting an exception ground may result in denial.
- Meeting exception grounds is required; medical necessity requirements may still apply and affect the decision.
Operational Step-Therapy Requirements
| Requirement | Details |
|---|---|
| Submit prior authorization (PA) form to CVS Caremark | |
| Provider must complete and submit the applicable PA form to CVS Caremark to request an exception to step therapy | |
| Provide supporting clinical documentation demonstrating one of the exception criteria | |
| Exception criteria: 1) step therapy drug contraindicated or likely to cause an adverse reaction; 2) step therapy drug expected to be ineffective given patient clinical characteristics; 3) patient is clinically stable on an alternative prescription drug; 4) patient previously tried a same‑class drug that was discontinued by the prescriber due to lack of efficacy/effectiveness, diminished effect, or an adverse event |
Key Terms
Policy Background
Step therapy is a utilization management tool that requires patients to try preferred, typically lower‑cost medications before covering alternative or higher‑cost agents. Exceptions to step therapy are available when clinical documentation shows one of the defined grounds for bypass (for example, contraindication, likely ineffectiveness, clinical stability on another agent, or prior same‑class therapy failure), and must be requested through the prior authorization process administered by CVS Caremark.
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