How to request a step therapy exception and when the plan must answer

A step therapy exception is the prescriber's statement that the required drug is contraindicated, likely to cause harm or expected to be ineffective. Medicare Part D decides within 72 hours of that statement (24 expedited). Texas, New York and Louisiana allow the plans their laws cover 72 hours before a missed deadline counts as a grant.

Which rule covers a step therapy exception request?

The plan type decides which rule covers a step therapy exception request, because Medicare Part D, Medicare Advantage, individual and small group plans, state-regulated commercial plans and employer plans each follow a different one.

• Medicare Part D treats a step therapy waiver as a formulary exception, because 42 CFR 423.578(b) counts a step therapy requirement as formulary use.
• Medicare Advantage may apply step therapy to Part B drugs only to new administrations, using at least a 365-day lookback period, and only after its pharmacy and therapeutics committee reviews and approves the program (42 CFR 422.136).
• Non-grandfathered individual and small group plans providing essential health benefits must offer a standard and an expedited exception process (45 CFR 156.122(c)).
• State-regulated commercial plans follow their state's step therapy law where one exists, and Texas, New York and Louisiana are the worked examples below.
• Employer plans also follow the federal claims rule for urgent claims.

State laws reach only some of those plans. Texas's drug subchapter excludes the child health plan program, Medicaid managed care and Medicaid (Texas Insurance Code chapter 1369). New York's law applies to insurers, HMOs, the Essential Plan, Medicaid managed care plans and Child Health Plus, and it excludes self-insured plans, Medicaid fee-for-service and Medicare (New York DFS step therapy Q&A).

What must the prescriber's statement say?

The prescriber's statement must show one of the grounds each rule lists, and the common ones are that the required drug is ineffective, contraindicated or likely to cause harm.

• Part D: the alternatives required by step therapy have been ineffective or are likely to be, or have caused or are likely to cause an adverse reaction or other harm (42 CFR 423.578(b)(5)).
• Texas: the plan must grant a request that includes the prescriber's written statement, with supporting documentation, saying the required drug is contraindicated, will likely cause an adverse reaction or physical or mental harm, or is expected to be ineffective based on the patient's known clinical characteristics and drug regimen.
• New York: the supporting rationale and documentation must demonstrate one of the listed grounds, the first two being that the required drug is contraindicated or will likely cause an adverse reaction or harm, or is expected to be ineffective based on the insured's known clinical history, condition and drug regimen.
• Louisiana: the override must be granted expeditiously when the prescriber, using sound clinical evidence, shows that the preferred treatment was ineffective, is reasonably expected to be ineffective, or is contraindicated or likely to cause harm, or that the patient already has a positive outcome on the drug under the current or immediately preceding plan (Louisiana's step therapy statute).

A Part D supporting statement does not produce an automatic favorable decision. The supporting statement is the prescriber's letter of medical necessity, and how to fax a letter of medical necessity covers sending one.

Which form does the plan require?

The form depends on the plan type: a Part D plan cannot require a specific form for a written request, and Texas requires the standard form NOFR002 for a step therapy exception.

CMS says that a prescriber who asks a Part D plan to waive a prior authorization or other utilization management requirement is asking for an exception and must submit a statement meeting 42 CFR 423.578(b)(5). CMS's guidance counts any verbal or written statement indicating that the drug is medically necessary as the supporting statement, and an incomplete one still counts as received and starts the timeframe (CMS coverage determination and appeals guidance). A Part D plan may require a written statement after an oral one, with additional supporting medical documentation.

In Texas the prescriber submits the request on the standard form the insurance commissioner prescribes under Insurance Code section 1369.304, the Standard Prior Authorization Request Form for Prescription Drug Benefits, NOFR002. The form is for requests by fax or mail, it covers prior authorization, formulary exceptions, quantity limit overrides and step-therapy exceptions, and Section IX must be completed for a step-therapy exception. New York's Q&A and the Louisiana statute name no standard form.

How long does the plan have to decide a step therapy exception?

A plan decides a standard step therapy exception within 72 hours and an expedited one within 24 hours in every plan type in the table, and the point where the clock starts differs by plan type. The clock starts when the plan receives the supporting statement under Part D, the supporting rationale and documentation in New York, and the request in every other row.

The table sets each plan type's standard and expedited decision time beside its official source.

Exigent circumstances under the individual and small group rule include a health condition that may seriously jeopardize the enrollee's life, health or ability to regain maximum function, and a current course of treatment using a non-formulary drug.

What happens when the plan misses the deadline or says no?

A plan that misses the deadline loses the decision in Texas, New York and Louisiana, because each state's law treats the silence as a grant.

• Texas: a request the plan does not deny within 72 hours of receipt is considered granted, and the window is 24 hours when the request states that the prescriber reasonably believes denial makes the patient's death or serious harm probable.
• New York: failing to decide within the required time results in a deemed override, and the plan must decide within the 72 hours (24 if urgent) whether or not it needs more information.
• Louisiana: if the plan fails to meet the timelines, the override request is considered approved.

After a denial, Texas treats the denial of an exception request as an adverse determination that can be appealed under Insurance Code chapter 4201. A plan providing essential health benefits that denies a standard or expedited exception must have a process for the prescriber to ask an independent review organization to review the original request and the denial (45 CFR 156.122(c)). The steps after a denial are in what to do when a prior authorization is denied.

What delays a step therapy exception?

A step therapy exception is delayed by the wrong form, a missing supporting statement, an urgent request that is not marked urgent, and, in New York, an urgent request sent without the rationale and documentation.

• The wrong form in Texas, where the prescriber submits the request on the standard form and Section IX of NOFR002 must be completed for a step-therapy exception.
• No supporting statement under Part D, where the plan may toll the timeframe by up to 14 calendar days after receipt of an exception request while it waits for the statement (42 CFR 423.568(b)).
• An urgent request not marked urgent: Texas applies its 24-hour window only when the request states the prescriber's reasonable belief that denial makes the patient's death or serious harm probable, and Louisiana applies its 24 hours where exigent circumstances exist. How to request an expedited prior authorization covers marking a request urgent.
• A New York urgent request without the rationale and documentation, because the 72 hours (24 if urgent) run from receipt of them and the clock starts only when they arrive.

How do formulary exceptions, quantity limits and Medicaid drug authorizations compare?

Formulary exceptions, quantity limit overrides, Medicaid managed care drug authorizations and employer plan claims each have their own rule.

• Formulary and tiering exceptions at Part D plans use the same exception-request clocks, and how to fax a formulary exception request covers the Part D mechanics and the pharmacy benefit manager routes.
• Quantity limit overrides go on the same Texas form, NOFR002, beside step therapy exceptions and formulary exceptions.
• Medicaid managed care outpatient drug authorizations have their own paragraph in the timeframe rule, which points to the notice described in section 1927(d)(5)(A) of the Social Security Act (42 CFR 438.210(d)(3)).
• Employer plans follow the federal claims rule: a claim that a physician with knowledge of the claimant's medical condition determines involves urgent care is treated as an urgent care claim, whatever the state law (29 CFR 2560.503-1).

How do you fax a step therapy exception securely and receive the answer?

A prescriber faxes a step therapy exception securely by sending the plan's form and the supporting statement together from a HIPAA fax service that signs a BAA, with a fax number of the practice's own on the request for the plan's answer. Fax Pigeon's plans all carry a BAA signed at signup, and on a paid plan the practice's own number receives the plan's decision in a shared inbox with roles and assignment. Every delivered fax gets delivery proof showing when the pages reached the plan, a record worth keeping in Texas, New York and Louisiana, where a missed deadline counts as a grant. A cover sheet is optional.

* Official sources (the eCFR, CMS, the Texas Legislature, the Texas Department of Insurance, the New York Department of Financial Services, the Louisiana Legislature) were read on October 26, 2026. Fax Pigeon prices and plan terms as of October 26, 2026.