Commercial Formulary Prior Authorization and Step Therapy Coverage Criteria
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Defines HealthPartners commercial pharmacy prior authorization (PA) and step therapy (ST) requirements for medications on the 2026 formulary; applies to prescribers and members under the HealthPartners commercial pharmacy benefit.
No material clinical or coverage changes in this revision.
Coverage & Prior Authorization Criteria
General PA/ST conditions (documented across entries)
Coverage and prior-authorization/step-therapy conditions vary by drug; common conditions across the drug list include:
Derived from multiple product entries
General Step Therapy / PA Criteria
Covered when meeting product-specific step therapy or prior authorization criteria as stated below:
Some products require external PA documents or specialist involvement.
Provider attestation required for long‑acting opioid approvals.
General coverage condition patterns (C–CY)
Coverage is product-specific; common covered‑when rules include:
Repeated pattern across many entries.
Common brand-exception pathway.
Some agents require specialist management and renewal documentation.
CAPLYTA
CAPLYTA (example product-level criteria):
From the CAPLYTA entry in the drug list.
CAYSTON
CAYSTON (aztreonam inhalation) specific criteria:
Initial approvals provided for 12 months; renewals require CF center visit within last 12 months and documented effectiveness.
CHOLBAM
CHOLBAM specific criteria:
Patient weight required to verify dose; initial authorization 6 months; reauthorization when liver function improves and annually thereafter if effective.
Not medically necessary / restricted brand
Examples of explicit not‑medically‑necessary or restricted‑brand stances:
Explicit NMN statement in the formulary entries.
Dalfampridine ER criteria
Dalfampridine ER (Ampyra) initial and continuation criteria example:
Initial authorization limited to 6 months.
Provider documentation required for renewal.
Topical diclofenac criteria
Topical diclofenac examples:
Per diclofenac topical entry.
General step therapy/prior authorization logic
Products are covered only under the following generalized conditions (applies variably by product):
Some products require documentation of benefit in the literature or specialist prescribing.
EMSAM specific criteria
EMSAM (selegiline transdermal) high‑step requirement:
Exact trial history must be documented.
Fidaxomicin
FIDAXOMICIN (DIFICID) coverage conditions:
Document prior vancomycin therapy and diagnosis.
Long-acting opioid (fentanyl) criteria
Long‑acting fentanyl and similar opioid criteria:
Attestation required for coverage of long‑acting opioid products.
Standard authorization criteria
Standard authorization criteria (typical required elements):
Some drugs reference external PA PDFs for full criteria.
Gattex criteria
Gattex (teduglutide) coverage specifics:
Reauthorizations require documented reduction in parenteral nutrition volume and are provided up to one year.
General product-level PA and step therapy rules
General product-level prior authorization and step therapy rules (examples):
Follow linked PA documents for product-specific details.
Not medically necessary — deflazacort (brand)
Exceptions and explicit not‑medically‑necessary stance:
Explicit statement in the formulary.
Lanreotide (Somatuline Depot) approval conditions
Lanreotide (Somatuline Depot) approval conditions:
Product-specific duration and failure requirement.
General Step Therapy / Prior Authorization
General step therapy / prior authorization pattern applied to many products:
Per repeated entries across the formulary.
Long‑acting opioid PA requirement
Long‑acting opioid prior authorization requirement (planwide pattern):
Applies to long‑acting opioid products listed in the formulary.
General product-specific coverage criteria (examples)
Common product-specific coverage criteria patterns (examples):
Common requirement across many entries.
Repeated pathway across the formulary.
Follow linked PA documents for full product criteria.
Per Nexletol/Nexlizet entries.
Per Nuzyra entry.
General Step Therapy / Prior Authorization criteria
General Step Therapy / Prior Authorization criteria (summary):
See individual product link for full criteria; some products require provider attestation or specialty prescriber.
General step therapy/prior authorization criteria (P–R list)
Common step therapy/prior authorization patterns in P–R segment:
Many entries reference external PA PDFs or pages for product‑specific details.
Pulmozyme (site-specific coverage conditions)
Pulmozyme (dornase alfa) site‑specific coverage conditions:
Site‑of‑care and renewal requirements noted.
Rebif (MS biologic) criteria
Rebif (interferon beta‑1a) criteria (MS biologic example):
Per Rebif entries in the formulary.
General prior authorization and step therapy logic (R–S excerpt)
General prior authorization and step therapy logic (R–S excerpt):
Specific counts, specialty requirements and timeframes are product‑specific and detailed in linked PA PDFs.
General coverage criteria patterns (partial)
General coverage patterns (partial) — recurring authorization conditions:
Product‑level PA PDFs may add additional, specific criteria.
Initial coverage and PA trigger conditions
Initial coverage and PA trigger conditions (examples):
Some entries specify different counts (e.g., three NSAIDs) or require literature support.
Provider documentation required.
Failure to meet these conditions requires PA or may result in denial.
Prescriber specialty criteria
Prescriber specialty requirements (examples):
Specialty involvement and documentation often required for approval and renewals.
Drug-specific multi-criteria example
Drug-specific multi‑criteria example (Viberzi):
Multi‑item indication‑specific step/diagnostic criteria.
General Step Therapy / Prior Authorization criteria (W–Z excerpt)
General W–Z step therapy / prior authorization criteria (summary):
Some products specify variant rules (e.g., different counts or specialist requirements).
Opioid attestation
Opioid attestation requirement (planwide pattern):
Applies where product text explicitly references long‑acting opioid requirements.
Generic allergy exception
Allergy / generic substitution exceptions:
Provider documentation required for brand exception approvals.
Examples of products listed as not medically necessary in the policy reflect explicit determinations based on insufficient evidence of superiority to less costly alternatives. For instance, Agamree is identified as not medically necessary because clinical evidence does not demonstrate advantage over lower‑cost options; such NMN designations are applied when the document-level criteria indicate lack of supportive evidence for the branded product versus available alternatives.
Many product entries are limited to FDA‑approved indications or otherwise reference an external prior authorization (PA) criteria document that providers must follow. The policy repeatedly points to product‑specific HealthPartners PA webpages or PDFs (links provided inline) as the definitive source of detailed PA requirements and exclusions; approval depends on satisfying those external criteria.
CAYSTON (aztreonam inhalation) coverage is restricted: it is reserved for patients with cystic fibrosis who have documented Pseudomonas aeruginosa in the lungs, must be prescribed and managed by specialists from a cystic fibrosis treatment center, and is quantity‑limited to one 28‑day package per month. Initial approval periods and renewal documentation (CF center visit within the last 12 months and demonstrated effectiveness) are required as specified in the PA guidance.
The branded formulation of deflazacort is designated not medically necessary in this policy because the document states there is insufficient evidence that the brand offers superiority compared with much less costly alternatives; the brand may only be considered when a member has a documented allergic reaction to the equivalent generic.
Several branded products are explicitly reserved for use only when there is a documented allergic reaction to the equivalent generic or when literature demonstrates clinical benefit over preferred alternatives. The policy flags brand‑only coverage pathways when an allergic‑to‑generic exception is required and otherwise reserves brand use pending appropriate documentation.
Prior authorization and step therapy prerequisites are applied widely: non‑preferred or branded products are typically covered only when the member has had an inadequate response to one or two preferred alternatives, or when there is a documented medical contraindication or documented allergic reaction to the equivalent generic. Some products require additional documentation or provider attestations per the referenced PA criteria.
The policy restates that certain branded products will be considered not medically necessary absent a documented allergic reaction to the generic equivalent (for example, branded deflazacort/EMFLAZA). Where a brand is NMN, coverage may only be allowed if the PA documentation supports a generic allergy exception.
Some product entries are limited to specific patient populations. For example, low‑dose liraglutide 0.6 mg is reserved for members with type 2 diabetes, and other entries impose age, weight, or device‑use restrictions as part of the coverage conditions described in the policy.
For certain agents the policy directs prescribers to stop use or to consult a disease‑specific policy: for example, guidance on Ocaliva directs health care professionals to discontinue prescribing Ocaliva and to see the Primary Biliary Cholangitis policy for further information; the PA entry includes this clinical advisory rather than routine PA approval language.
Similarly, the document includes a clinical advisory for Oxbryta stating health care professionals should stop prescribing the product and that patients should consult their health care professional about treatment changes; such advisories are noted alongside PA routing where applicable.
The policy records that Relyvrio is not eligible for coverage because it has been withdrawn from the market; requests for a withdrawn product will be denied. Relatedly, several entries explicitly limit coverage to FDA‑approved indications or to narrow patient groups.
Many entries specify coverage only for FDA‑approved indications and add step/failure requirements or specialist prescriber conditions. When the policy states a product is reserved for FDA‑approved uses, off‑label use is generally not covered unless the linked product‑specific PA document explicitly allows it.
Narrow eligibility examples recur throughout the listing: common scenarios include products reserved for patients who have failed defined numbers of preferred agents (commonly two), products restricted to specific diagnoses or age groups, and products that require specialist prescribing or documented diagnostic test results to meet PA criteria.
Vistogard (uridine triacetate) approvals are limited to approved emergency uses after fluorouracil/capecitabine overdose or specific early‑onset, severe toxicities per the FDA regimen; the policy explicitly states that approvals will not be granted for non‑emergent treatment of adverse reactions because this may diminish efficacy.
Where a combination product contains multiple active ingredients that can be used separately, the policy often requires a prior trial of the individual active ingredients given separately before authorizing the combination product. This step‑through approach applies when the PA text specifies trying individual components (or preferred formulations) prior to coverage of the listed product.
The policy lists Agamree as not medically necessary because the document indicates insufficient evidence that the product is superior to less costly alternatives; this rationale underlies NMN determinations for select branded agents when comparative effectiveness is not established.
Brand products that are reserved for allergy or failure exceptions are not covered when those exceptions are not documented. The policy consistently states branded product use without evidence of a documented allergic reaction to the equivalent generic or without meeting step therapy failure criteria will not meet PA approval.
This document reiterates that branded deflazacort is considered not medically necessary because of insufficient evidence of superiority; brand coverage is limited to documented allergy to generic equivalents.
The policy specifically names EMFLAZA (brand deflazacort) as not medically necessary under standard formulary review because evidence does not demonstrate superiority relative to less costly alternatives; brand exceptions require documented allergy to generic.
The policy repeats the NMN stance for branded deflazacort formulations: absent a documented allergic reaction to the equivalent generic, branded deflazacort will be considered not medically necessary and not eligible for coverage.
Vistogard PA language includes nuance: coverage is reserved for specific emergent uses (approved dosing/regimen) and for life‑threatening toxicities within defined time windows; non‑emergent uses for chemotherapy adverse reactions are explicitly not approved and therefore are not eligible for routine PA coverage.
Where clinically appropriate, the policy requires a prior trial of the active ingredients administered separately before approving a combination or branded product. This requirement is applied when the PA text specifies trying individual components or preferred dosage forms first, with documentation of inadequate response or contraindication needed to support progression to the requested product.
What Providers Must Do
Prior authorization required
Medications listed on the HealthPartners commercial drug list require prior authorization; coverage will not be provided unless the product-specific PA criteria are met and PA approval is obtained.
Follow referenced PA criteria
Follow the product-specific HealthPartners prior authorization criteria or linked PA PDFs/coverage pages cited in each drug entry; approvals depend on satisfying those external criteria.
Opioid attestation requirement
For long-acting opioids and tramadol ER, the provider must attest that therapy is being managed per standard opioid prescribing guidelines; lack of this attestation may prevent approval.
- Attestation must confirm opioid guideline–based management.
Prior authorization requirement (general)
Many listed products are reserved for FDA‑approved indications or require documented failure of preferred alternatives, documented allergy to an equivalent generic, or specialist prescribing per the product-specific PA language.
Long-acting opioid attestation
Long‑acting opioid requests require prior authorization plus a provider attestation that therapy is managed per standard opioid prescribing guidelines and evidence of an adequate recent trial (minimum 30 days continuous) with a short‑acting opioid.
- Adequate short‑acting opioid trial defined as minimum 30 days continuous use.
Refer to HP public coverage criteria
Some products (for example, CRYSVITA) direct providers to the HealthPartners public coverage criteria webpages or linked PA PDFs; providers must consult and meet those external criteria for approval.
PA for generic allergy or failure of preferred alternatives
When a product is reserved for use only with documented allergic reaction to the equivalent generic, providers must supply documentation of the allergic reaction; absence of this documentation may result in denial.
- Brand use permitted only when documented allergic reaction to generic is present per the product entry.
Prior authorization required for listed products
Prior authorization is required for the many listed products; follow the product-specific PA criteria or linked PDFs for the detailed conditions that must be met for approval.
General prior authorization requirements
Providers must meet general PA requirements across many entries, which commonly include documentation of allergic reaction to equivalent generic, inadequate response to preferred alternatives (commonly two), or a documented medical contraindication.
Prior Authorization required for listed products
Prior authorization is required for the listed products; consult the HealthPartners product-specific PA criteria cited in the drug list entries for approval requirements.
Prior authorization required for listed products
Many products require prior authorization and may link to external PA criteria documents; PA is often reserved for FDA‑approved indications when the member has failed preferred alternatives or has contraindications.
Prior authorization required for listed drugs
Many listed drugs require prior authorization and are reserved for patients with inadequate response to preferred alternatives, documented allergic reactions to generics/biosimilars, or other specified conditions; see linked PA webpages for full criteria.
Long-acting opioid PA requirement
Long‑acting opioids require prior authorization and a provider attestation confirming guideline-based management plus documentation of an adequate recent trial (minimum 30 days continuous) of a short‑acting opioid; missing the attestation or trial evidence may result in denial.
- Attestation and documentation of ≥30 days continuous short‑acting opioid trial required.
Prior authorization required for listed products
Prior authorization is required for the listed products; many entries include links to product‑specific PA criteria pages or PDFs that providers must follow.
Prior authorization required
Prior authorization is required; many listed products are reserved for patients who have failed preferred alternatives or who meet other specified PA conditions—follow the linked PA criteria for product-level details.
Prior authorization required for many R–S products
Many R–S section products require prior authorization; criteria vary by product and commonly include failure of preferred alternatives, documented allergy to generic, or referenced external PA PDFs.
PA for FDA-approved indications with step/failure requirements
Some products are reserved for FDA‑approved indications and require documented inadequate response to preferred alternatives or documented contraindications as specified in the product PA language.
Prior authorization required for listed products
Many listed products require prior authorization with product-specific criteria; providers must supply the documentation specified in the linked PA documents for approval.
Tramadol ER and general reserved-use PA
Tramadol ER requires prior authorization with a provider attestation that therapy is managed per opioid prescribing guidelines and documentation of an adequate prior trial (minimum 30 days continuous) of tramadol immediate release; age and quantity limits also apply per the entry.
- Tramadol ER: attestation + ≥30 days continuous trial of tramadol IR; reserved for adults and children ≥12.
External PA document references
Many entries reference external prior authorization PDFs or product-specific PA forms/links; providers must follow those external documents and supply required documentation as specified.
Prior authorization required
Prior authorization is required for the products listed; consult the product entries and linked PA criteria for the specific conditions that must be satisfied for coverage.
Step therapy requirement
Providers must document trials of required preferred alternatives (step therapy) before requesting coverage; if alternatives have not been tried, the provider must request PA and supply documentation of trials or contraindications.
- Step therapy requires trying one or more other medicines first; approval requires documentation of those trials or exceptions.
General step therapy rule
Step therapy commonly reserves non‑preferred products for patients with an inadequate response to one or two preferred products, or for those with documented allergies or medical contraindications; follow product-specific step requirements.
Step therapy / trial/failure requirements
Numerous products are reserved for patients who have tried and failed specified numbers of preferred alternatives (commonly one or two); providers must document the required trials and failures in the PA request.
- Some entries require documentation in the medical literature when claiming clinical benefit over preferred alternatives.
Step therapy general rule
Coverage of many branded products is contingent on documented inadequate response to one or more preferred alternatives (often two) or a documented contraindication/allergy; providers must document trials/failures as specified.
Multiple drugs subject to step therapy
Multiple drugs are subject to step therapy requiring trial/failure of one or two preferred products (commonly two) before non‑preferred product approval; providers must document those trials or provide medical contraindication/allergy evidence.
PA for FDA-approved indications with step/failure requirements
Step therapy typically requires trial and inadequate response to two preferred alternatives (or one for some products) prior to approval of a non‑preferred agent; providers must document the specific number of failed alternatives per product entry.
General step therapy rule
Step therapy rules commonly require trial and inadequate response to one or more preferred alternatives (sometimes two) or documented contraindication/allergy before approval of the listed product; providers must provide that documentation.
Step therapy: failure of preferred alternatives
Step therapy typically requires failure/inadequate response to two preferred alternatives (or more where specified); for some products (e.g., EMSAM) documented trials may be more extensive—providers must supply the exact trial history.
- EMSAM requires failure of multiple antidepressants (at least three SSRIs, one SSNRI, and one other antidepressant) unless previously stable.
Step therapy: inadequate response to preferred alternatives
Step therapy frequently requires documenting inadequate response to two preferred alternatives; providers must either document those trials or provide evidence of medical contraindication or allergy as specified per product.
Step therapy requirement
Step therapy is applied broadly across many drugs; providers must document prior trials or contraindications as specified or follow linked PA criteria when requesting authorization.
Step therapy failure requirements
Step therapy commonly requires trial and inadequate response to one or two preferred alternatives prior to coverage of non‑preferred products; documentation of those trials must be included in the PA.
Step therapy trial/failure requirements
Step therapy trial/failure requirements include trials of preferred agents (often one or two alternatives) before non‑preferred products are approved; some entries specify what constitutes treatment failure and may require diagnostic evidence.
- Example: Talicia requires test-confirmed treatment failure per its criteria.
General step therapy rule
Step therapy is broadly applied: many drugs are reserved for patients with inadequate response to one or two preferred alternatives or documented contraindications/allergies; providers must document prior trials or exceptions.
Step therapy rule
Step therapy generally requires failure/inadequate response to two preferred alternatives prior to coverage of the non‑preferred product, unless product-specific language indicates otherwise; providers must document those failures or contraindications.
External PA criteria documentation
Some product entries reference external prior authorization criteria documents; providers must consult and satisfy those external PA documents and include required evidence with the PA request.
Required supporting documentation
Medical documentation must be provided to show prior inadequate response to preferred products or medical contraindications/allergies; some products additionally require literature evidence of clinical benefit or provider attestations.
- Documentation of prior trials/failures or contraindications is required per product-specific criteria.
CHOLBAM dosing and follow-up documentation
CHOLBAM requires patient weight to verify dosing; initial authorizations are for six months and reauthorization requires improvement in liver function and annual demonstration of efficacy.
- Dose verification via patient weight is required.
- Initial authorization 6 months; reauthorization based on liver function improvement.
CAYSTON renewal documentation
CAYSTON renewals require documentation that the patient has been seen within the last 12 months at the cystic fibrosis treatment center and that the medication is effective; initial approvals are provided for 12 months and quantity limited to one 28-day package per month.
- Prescribed/managed by CF treatment center specialists.
- Renewal: CF center visit within last 12 months + effectiveness documentation.
Ophthalmic cystinosis documentation
For cystinosis ophthalmic products (CYSTADROPS, CYSTARAN) initial approvals are for three months and renewals require documentation of clinical treatment effect, such as slit‑lamp exam notes.
- Initial approvals: 3 months; renewals require clinical treatment-effect documentation.
Topical diclofenac documentation
Diclofenac 1.5% topical solution requires prior failure of Voltaren 1% topical gel and a significant clinical rationale or literature support showing improved outcomes over the preferred product.
- Prior failure of Voltaren 1% gel required.
Documentation of superiority required when reserved for allergy
When a branded product is reserved due to allergy to the generic, providers must document in the medical record the allergic reaction to the equivalent generic; documentation of superiority in the literature may also be required for some reserved uses.
- Documentation of allergic reaction to equivalent generic required when specified.
- Literature documenting clinical benefit may be required for some products.
Gattex documentation
Gattex initial approvals granted for three months require documentation of parenteral nutrition dependence (≥4 L daily for at least one year); reauthorization requires demonstration of reduction in parenteral nutrition volume.
- Parenteral nutrition dependence threshold: ≥4 L daily and ≥1 year.
- Reauthorization requires documented reduction in parenteral nutrition volume.
Follow external PA criteria
Follow the external product‑specific PA criteria pages or PDFs linked in many drug entries; providers must supply the documentation specified in those external documents for PA approval.
Opioid attestation specifics
Provider attestation is required for long‑acting opioids confirming management per standard opioid prescribing guidelines and documentation of an inadequate response to a recent adequate short‑acting opioid trial (minimum 30 days); include attestation and trial details in the PA.
- Attestation should document guideline‑based management and the ≥30‑day short‑acting opioid trial.
Clinical documentation and test results
Clinical documentation and test results (e.g., culture and sensitivity for Nuzyra, HCV genotype/viral load for Pegasys) must be provided when required by product-specific PA criteria.
- Provide culture/sensitivity, genotype, viral load, or other test results when specified by product PA.
Nexletol/Nexlizet LDL documentation
For Nexletol/Nexlizet approvals, providers must document baseline LDL ≥ 70 mg/dL and inadequate response or contraindication to high‑intensity statins and ezetimibe; reauthorizations require documentation of LDL reduction per provider attestation.
- Baseline LDL ≥ 70 mg/dL required.
- Documentation of prior statin/ezetimibe therapy failure or contraindication.
Required supporting documentation for specialty agents
Providers must supply required supporting documentation for specialty agents (prior trials, allergic reactions to preferred generics, specialist management) as specified in product PA entries; missing documentation may lead to denial.
- Specialist management/annual visits and effectiveness documentation required for some inhaled cystic fibrosis agents.
Follow linked PA documents for required documentation
When external PA PDFs are linked, follow those documents and provide the documentation they specify (e.g., prior trial/failure, specialty prescriber, diagnosis, lab results) when submitting the PA request.
Tobramycin inhalation documentation
For inhaled tobramycin formulations in cystic fibrosis, providers must document Pseudomonas aeruginosa in the lungs, specialist prescription/management by a CF treatment center, and quantity limited to one 56‑count carton per 56 days; renewals require annual CF center visit documentation and effectiveness.
- Document Pseudomonas aeruginosa infection and CF center specialist management.
- Quantity limit: one 56‑count carton per 56 days; renewals require annual visit and effectiveness documentation.
Required documentation for PA
Provider attestation documenting management per opioid prescribing guidelines and documentation of an adequate trial of preferred dosage forms (e.g., 30 days for tramadol IR) or documented contraindication/allergy to preferred generics is required for opioid and other PA requests.
- IR opioid new users: 7‑day first fill; 14‑day total per episode unless PA obtained with attestation and risk assessment.
Required supporting documentation
Clinical documentation should demonstrate inadequate response to preferred alternatives (commonly two) or medical contraindication; literature documenting clinical benefit over preferred alternatives is required for some products.
Opioid attestation
For long‑acting opioids, provider attestation that therapy is managed per standard opioid prescribing guidelines and that the patient had an adequate recent trial (minimum 30 days continuous) of a short‑acting opioid is required; include this attestation with the PA request.
- Adequate trial defined as minimum 30 days continuous short‑acting opioid use.
Prior authorization required for coverage
Coverage requires meeting HealthPartners prior authorization criteria for medicines listed on the drug list; lack of PA approval will prevent coverage.
Failure to meet step therapy prerequisites
Requests may be denied if the patient has not had the required inadequate response to preferred alternatives or lacks documentation of medical contraindication or allergy as specified in the product PA.
- Failure to document required step therapy trials is a common reason for denial.
CAYSTON approval restrictions
CAYSTON approvals are limited to cystic fibrosis patients with Pseudomonas aeruginosa, prescribed and managed by CF treatment center specialists, quantity limited to one 28‑day package per month; initial approval 12 months and renewals require documentation of CF center visit and effectiveness—requests outside these conditions may be denied.
- Initial approvals: 12 months; annual renewal requires CF center visit within last 12 months and effectiveness documentation.
Not covered without documented allergy to generic
Deflazacort brand is considered not medically necessary due to insufficient evidence of superiority; coverage is reserved only for patients with a documented allergic reaction to the equivalent generic.
- Brand considered not medically necessary except when documented generic allergy exists.
Dalfampridine ER authorization requirements
Dalfampridine ER (Ampyra) approvals require neurologist prescribing, baseline walking ability (able to walk 25 feet), physician attestation of walking difficulty, dose limit 10 mg twice daily, initial approval for six months, and continuation requires documented ambulation improvement.
- Neurologist prescriber required.
- Initial approval 6 months; continuation requires documented ambulation improvement.
Failure to document trials of required preferred alternatives
Failure to document trials of required preferred alternatives (for example, EMSAM requires inadequate response to at least three SSRIs AND one SSNRI AND one other antidepressant) may trigger denial.
- Exact trial counts must be documented per product (EMSAM example shown).
Long-acting opioid attestation and trial
Long‑acting opioids require provider attestation of guideline‑based management and an adequate recent trial (minimum 30 days continuous) with a short‑acting opioid; missing attestation or trial evidence may result in denial.
Common triggers for denial
Common triggers for denial include lack of documentation of allergic reaction to the equivalent generic, no documented inadequate response to required number of preferred alternatives (commonly two), or missing specialist/diagnostic evidence when required.
- Examples: missing Pseudomonas documentation for inhaled tobramycin; no documented trials for step therapy.
Not medically necessary — deflazacort (brand)
Deflazacort (brand/EMFLAZA) will be considered not medically necessary due to insufficient evidence of superiority; PA requests for brand without documented generic allergy may be denied.
Failure to meet step therapy trials
Requests may be denied if the member has not tried and failed the required number of preferred alternatives (commonly two) or lacks documented medical contraindications to preferred products.
Opioid attestation and prior short-acting trial
Requests for long‑acting opioids may be denied without a provider attestation that therapy is managed per opioid prescribing guidelines and documentation of an inadequate trial (minimum 30 days) of a short‑acting opioid.
Nexletol/Nexlizet LDL and prior therapy requirement
Nexletol/Nexlizet requests may be denied if baseline LDL is < 70 mg/dL or if there is no documentation of inadequate response or contraindication to high‑intensity statins and ezetimibe.
- Baseline LDL ≥ 70 mg/dL and prior statin/ezetimibe failure/contraindication must be documented.
Product withdrawn — not eligible
Relyvrio has been withdrawn from the market and is not eligible for coverage; PA requests for Relyvrio will be denied.
Allergic reaction to generic required for some products
Coverage may be denied if documentation does not support a documented allergic reaction to the equivalent generic when that is the reserved PA criterion; providers must include allergy documentation when requested.
Failure of preferred therapies required for some products
Coverage may be denied if the member has not had an inadequate response to preferred alternatives when the PA states the product is reserved for inadequate response to two preferred alternatives; include trial/failure documentation in the PA.
Common triggers for denial
Prior authorization denials may be triggered when required documentation—such as specialist management, Pseudomonas infection for inhaled tobramycin products, age or quantity limits, or opioid management attestations—is not provided.
- Example: inhaled tobramycin requires Pseudomonas documentation and CF center specialist management.
Tramadol ER attestation
Failure to attest that tramadol ER therapy is being managed per standard opioid prescribing guidelines and to document an adequate prior trial (minimum 30 days continuous use of tramadol IR) may result in denial.
- Tramadol IR trial minimum: 30 days continuous use.
IR opioid quantity limits
New users of immediate‑release opioids are limited to a 7‑day supply for the first fill and 14‑day total per episode; longer therapy requires prior authorization with provider attestation and opioid risk assessment documentation.
- IR opioid new-user limits: 7‑day first fill; 14‑day total per episode.
Failure to meet step requirements
Requests may be denied if the patient has not had an inadequate response to the required number of preferred alternatives (commonly two) or lacks documented medical contraindication; include trial/failure documentation in the PA.
No documented allergy to generic
Requests for brand formulations may be denied without documentation of a documented allergic reaction to the equivalent generic when the policy reserves the product for such patients.
Initial Therapy / Authorization Rules
Initial therapy rules (product-specific)
Initial therapy rules (product‑specific):
See product‑specific PA links.
Initial therapy — select opioids
Initial therapy — select opioids:
Applies to long‑acting opioid products.
Initial therapy durations
Initial therapy durations (examples):
Renewals require documentation of clinical treatment effect.
Continuation requires documented ambulation improvement.
Lanreotide initial therapy
Lanreotide initial therapy:
Per Somatuline Depot entry.
Initial therapy examples
Initial therapy examples (selected specialty products):
Per Nuzyra entry.
Per NUPLAZID entry.
Initial authorization patterns
Initial authorization patterns (general):
Consult linked PA pages for full product criteria.
Initial therapy requirements (general)
Initial therapy requirements (general):
Per formulary guidance.
Tramadol initial therapy
Tramadol initial therapy specifics:
IR opioid supply limits for new users also apply (7‑day first fill; 14‑day total per episode).
Continuation / Reauthorization Rules
Specified continuation rules
Specified continuation requirements (examples):
Per CYSTADROPS/CYSTARAN entries.
Per dalfampridine entry.
Lanreotide continuation therapy
Lanreotide continuation:
Requires documented response.
Continuation therapy examples
Continuation therapy examples:
Per NUPLAZID entry.
Per Nexletol/Nexlizet entries.
Selected continuation rules
Selected continuation rules (example):
Per Reyvow entry.
Continuation rules (examples)
Continuation example (Viberzi):
Per Viberzi entry.
Step Therapy Tables & Rules
| Requirement | Details |
|---|---|
| Members must try preferred alternatives before coverage of non-preferred products | |
| Step therapy commonly requires trial and inadequate response to one or two preferred products (often two) prior to coverage |
| Requirement | Details |
|---|---|
| Documented trial and failure of preferred alternatives | |
| Coverage requires documentation of inadequate response to required preferred agents or documentation of medical contraindication/allergy per product-specific criteria |
| Requirement | Details |
|---|---|
| Brand use reserved until preferred alternatives fail | |
| Many branded products are reserved for patients with documented failure/contraindication to preferred alternatives or documented allergy to the equivalent generic |
| Requirement | Details |
|---|---|
| Trial and failure of two alternatives or prior stability | |
| Example (Caplyta): tried and failed at least 2 formulary alternatives OR previously stable on the medication |
| Requirement | Details |
|---|---|
| Prior trials or allergy/contraindication required | |
| Entries frequently reserve coverage for patients who have tried specified numbers of preferred alternatives or who have documented allergy/contraindication to preferred/generic equivalents |
| Requirement | Details |
|---|---|
| Trial and documented failure of preferred alternatives | |
| Multiple products require documented inadequate response to preferred options (commonly two) before non-preferred product will be approved |
| Requirement | Details |
|---|---|
| Trial and failure required | |
| Many non-preferred agents require prior trial and inadequate response to preferred alternatives prior to coverage |
| Requirement | Details |
|---|---|
| Trial and failure or contraindication/allergy | |
| Coverage contingent on failure of preferred therapies or documentation of allergy/medical contraindication to preferred/generic alternatives |
| Requirement | Details |
|---|---|
| Two preferred alternative requirement | |
| Step therapy typically requires trial and inadequate response to two preferred alternatives (or one for some products) before approving non-preferred agents |
| Requirement | Details |
|---|---|
| Specialty prescriber or lab requirement for some drugs | |
| Certain products (e.g., inhaled tobramycin) require prescribing/management by specialists and specific documentation (Pseudomonas in lungs) and quantity limits |
| Requirement | Details |
|---|---|
| Document trials or follow product-specific PA link | |
| Providers must document prior trials of preferred agents or follow the referenced product-specific prior authorization criteria/links for approval |
| Requirement | Details |
|---|---|
| Opioid attestation requirement | |
| Long-acting opioids require provider attestation that therapy is managed per opioid prescribing guidelines and evidence of an adequate recent trial (minimum 30 days continuous) of a short-acting opioid |
| Requirement | Details |
|---|---|
| Applied broadly to many drugs | |
| Step therapy rules are applied across many listed products; providers must document prior trials, contraindications, or follow linked PA criteria as specified |
| Requirement | Details |
|---|---|
| Document prior trials or specialty prescriber | |
| Coverage may require documentation of prior therapy trials and inadequate response or prescribing by a specialty provider depending on product-specific criteria |
| Requirement | Details |
|---|---|
| Must document trials/failures or contraindications | |
| Many products require documentation of failed preferred therapies or documented allergy/contraindication before coverage of non-preferred agents |
| Requirement | Details |
|---|---|
| Specialist prescription and annual documentation for renewals | |
| Certain specialty products (e.g., inhaled tobramycin) require specialist management and annual documentation of effectiveness for renewals |
| Requirement | Details |
|---|---|
| Step through preferred alternatives unless contraindication | |
| Coverage is reserved until patient has inadequate response to preferred alternatives or a documented medical contraindication/allergy |
| Requirement | Details |
|---|---|
| Trial and failure of preferred therapies or documented contraindication/allergy | |
| Providers must document inadequate response to preferred therapies (commonly two) or document medical contraindication/allergy; some products additionally require evidence of clinical benefit or specific tests per linked PA documents |
Clinical Thresholds & Coding Notes
Quantity & Supply Limits
Prescribing & Site-of-Care Requirements
Background & Rationale
Step therapy is a utilization management approach that requires members to try specified preferred alternatives before coverage of non‑preferred medications. Prior authorization enforces these requirements by requiring documentation of prior trials, documented contraindications, or other product‑specific criteria before coverage is approved.
Key Definitions
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.