Commercial Formulary Prior Authorization and Step Therapy Coverage Criteria — Pharmacy & Specialty Drugs
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This document lists HealthPartners' commercial drug-list prior authorization (PA) and step therapy (ST) criteria for pharmacy and specialty drugs, explaining when PA/ST is required and linking to specific drug criteria. It affects providers and members covered under HealthPartners commercial pharmacy benefits.
No material clinical or coverage changes in this revision.
Coverage Criteria and Product-Level Rules
General PA criteria patterns
Coverage for listed drugs is conditional per drug-specific criteria
Many drug entries follow one of these recurring criteria patterns.
Drug-specific example: Abilify MyCite
Certain specialty products reference unique multi-point criteria
Extracted verbatim from listing.
Common PA criteria patterns (documented across multiple product entries in these chunks)
Entries in these chunks follow one of several common PA logic patterns:
Many single-tablet/genericable products use this pathway.
Some products specify one preferred alternative rather than two.
Used for specialized agents and those with external PA documents.
Explicit examples appear in the listing.
General PA coverage logic (segment)
Coverage reserved under one of these common conditions depending on product:
This segment lists drugs with one of these reservation logics applied.
Specialty drug criteria
Certain specialty agents have additional requirements
From CAYSTON entry.
General prior authorization conditions
Common conditional coverage language in this excerpt
Applies broadly across multiple listed products in the excerpt
Not medically necessary — deflazacort
Specific not medically necessary determination
Explicit NMN statement present for multiple deflazacort entries.
Dalfampridine (DALFAMPRIDINE ER) criteria
Dalfampridine approval logic
Contains time‑limited initial approval and renewal conditions.
Cystinosis ophthalmic product criteria
Cystinosis ophthalmic products
Monitoring requirement specified for renewals.
Opioid attestation requirement
Opioid-specific attestation
Specified for long-acting opioid products across the list.
Common prior authorization criteria (partial)
General prior authorization conditions appearing across listed products (partial list):
Many entries repeat these patterns; some drugs reference external PA PDFs for full criteria.
See linked product PDFs for full logic where provided.
Allergy or brand-equivalent reservation
Many products are covered only under specific reservation rules, for example:
Examples appear throughout the formulary listings.
Failure of preferred alternatives
Other products require prior trials or contraindications to preferred alternatives:
Examples include many topical, systemic, and specialty agents.
Gattex coverage criteria
Specialty agent (example) with condition-specific criteria:
Condition- and documentation-specific criteria.
Long-acting opioid PA criteria
Opioid-specific coverage requirement:
Applies to multiple long-acting opioid formulations listed.
General PA coverage criteria (H–I products)
Covered when the product-specific prior authorization reservation is met
Many entries reference external PA documents for full criteria and required documentation.
General coverage stance for listed drugs (I-L)
Coverage and PA stance for listed products (I-L) — conditions under which PA is granted or products are reserved
See linked product page for full criteria and required documentation.
Examples vary across listings.
Examples include multiple brand/generic pairs.
Examples reference specialty and oncology agents.
Standard coverage criteria (grouped)
Covered when ALL of the following are met (applies per-product as specified):
Many entries specify 'inadequate response to two preferred alternatives' or similar.
Several products point to external PDFs or coverage pages.
Applies to named long-acting opioids.
Allergy-based coverage
Covered when ALL of the following are met:
Frequently used for brand products where generic equivalent exists.
General reservation and step/failure criteria
Covered when the specific reservation condition for each product is met
Individual product entries specify exact requirements; see linked product-specific criteria where provided.
Nexletol/Nexlizet specific coverage conditions
Nexletol/Nexlizet specific coverage conditions
Reauthorization requires documentation of LDL reduction.
Long-acting opioid criteria
Long-acting opioids (multiple named products) coverage conditions
Applies to multiple long-acting opioids (e.g., morphine ER, hydromorphone ER, fentanyl patches).
Nuzyra specific coverage conditions
Nuzyra specific coverage conditions
See product-specific PDF for details.
Common coverage rules in excerpt
Common coverage rules appearing in this excerpt
Examples appear across the formulary.
Examples: numerous topical, systemic, and specialty agents.
Product‑specific examples exist in the listing.
See PEGASYS entry for specifics.
General coverage criteria patterns
Standard reservation/authorization rules observed in these entries:
Applies to multiple listed products.
Applies to many brand/generic pairs in list.
See Pulmozyme entry.
Relyvrio withdrawn 4/4/2024.
General coverage reservation rules
General reservation and PA patterns observed in this extract (applies per listed product as noted):
Specific products enumerate which of these apply; see individual product line.
General reserved-use and external-PA rules
Products covered only under specified reserved conditions or per linked PA criteria
See individual product line for exact wording.
Examples include topical and systemic agents.
Provider must follow linked PA document for clinical criteria and required documentation.
Specialty agent renewal logic.
Age/diagnosis-specific coverage
Products with gender/age/diagnostic-specific requirements
Applies to several testosterone products listed.
Product‑specific eligibility example.
Testosterone product criteria
Covered when ALL of the following (product-specific) requirements are met:
Applies to multiple testosterone formulations (gels, injections, pumps).
Tobramycin inhalation criteria
Covered when ALL of the following are met for Tobramycin ampules/PAK:
Site‑of‑care and quantity limits apply.
Tramadol ER criteria
Covered when ALL of the following (Tramadol ER / IR related) are met:
Attestation and age/quantity edits are required.
General reserved-use conditions
Covered when ANY of the following general reserved-use conditions apply (examples across multiple products):
Appears repeatedly for many brand products.
Documentation requirements vary by product.
Agamree is designated not medically necessary because the clinical evidence does not demonstrate superiority to less costly alternatives.
Certain topical ophthalmic antibiotics such as BESIFLOXACIN and BESIVANCE are reserved for treatment of MRSA infection, implying these agents are not authorized for other indications unless the MRSA-specific criteria are met.
Some products are limited to prescribing by specific specialists or within defined clinical programs; for example, CAYSTON must be prescribed and managed by clinicians at a cystic fibrosis treatment center as part of the coverage reservation.
Deflazacort is treated as not medically necessary because available evidence does not establish superiority to much less costly alternatives; brand formulations are only reserved when there is a documented allergic reaction to the equivalent generic.
The policy distinguishes brand and generic deflazacort: brand names (e.g., JAYTHARI, KYMBEE) are reserved only for patients with a documented allergic reaction to the equivalent generic; otherwise deflazacort is considered not medically necessary.
Several products are explicitly limited to FDA‑approved indications only; use outside FDA‑approved indications requires separate criteria or will not be covered under the reservation language.
Coverage for some devices or products is restricted to patients using compatible device ecosystems; for example, certain glucose sensors/transmitters are reserved for patients using a Medtronic insulin delivery device due to integrated functionality.
Brand deflazacort products (listed examples include JAYTHARI and KYMBEE) are considered not medically necessary absent documentation of allergy to the generic; brand coverage is limited to documented allergic reactions to the generic equivalent.
There are no blanket universal exclusions in this excerpt; instead, individual product entries may restrict coverage to FDA‑approved indications or other product‑specific reservation conditions.
For OCALIVA, HealthPartners notes that health care professionals should stop prescribing Ocaliva and refers clinicians to the Primary Biliary Cholangitis policy for additional direction.
For OXBRYTA the guidance states health care professionals should stop prescribing the product and that patients/caregivers should consult their clinician about stopping and selecting alternative therapy.
Requests for RELYVRIO will be denied because the product has been withdrawn from the market and is not eligible for coverage as of 4/4/2024.
Several listed products are reserved for FDA‑approved indications or require specialist prescribing; when a product is so reserved, other uses not meeting those requirements will not be approved.
Combination products (for example, SUMATRIPTAN‑NAPROXEN) are reserved for patients who have tried and failed the individual active ingredients given separately; coverage requires documentation of prior failure or allergy as specified.
Many formulary entries reference external prior authorization PDFs or HealthPartners coverage pages; providers must follow those linked PA documents for the detailed criteria and submission instructions.
Agamree is specifically listed as not medically necessary because there is insufficient evidence to establish superiority to less costly alternatives.
Deflazacort is reiterated as not medically necessary in multiple entries (including PYQUVI/PYQUVI‑related listings); brand formulations remain reserved only when a documented allergic reaction to the generic exists.
Deflazacort is repeatedly characterized as not medically necessary absent evidence of superiority; brand versions may be reserved solely for documented allergy to the generic equivalent.
Policy language for deflazacort appears in multiple product lines: the generic and brand formulations are considered not medically necessary except where brand use is justified by a documented allergic reaction to the generic.
Brand deflazacort coverage is limited: brand products are reserved only for members with a documented allergic reaction to the equivalent generic formulation; otherwise deflazacort is not eligible for coverage as not medically necessary.
For long‑acting opioid formulations, the policy requires a provider attestation that therapy is being managed per standard opioid prescribing guidelines and that the patient had an adequate recent trial (minimum of 30 days continuous use) of a short‑acting opioid prior to authorization.
PYQUVI (deflazacort listing) is noted as not medically necessary because evidence does not demonstrate superiority to less costly alternatives; brand coverage may be allowed only for documented allergy to generic equivalents.
Provider Requirements, Prior Authorization & Denial Risks
Prior authorization required for listed drugs
Many medicines listed on the HealthPartners drug list require prior authorization. Specific approval criteria differ by product and (where provided) must be followed per the HealthPartners prior authorization documents linked for individual drugs.
- Follow product-specific PA documents or linked HealthPartners URLs for full criteria.
General prior authorization requirement
Coverage of numerous branded or non‑preferred products is limited to patients with a documented allergic reaction to the equivalent generic, or to patients who have had an inadequate response to preferred alternatives; prior authorization is required to confirm these conditions.
- Provider must supply documentation of documented allergy to the generic or evidence of inadequate response to preferred agents when requested.
AUVI‑Q 0.1 mg specific PA requirements
AUVI‑Q 0.1 mg autoinjector is reserved for patients who meet all three specific criteria: prescribing by an allergist, patient weight between 7.5 kg and 10 kg, and a history of anaphylaxis; prior authorization must document these items.
- Prescriber specialty: allergist
- Patient weight: 7.5 kg–10 kg
- History of anaphylaxis documented in chart
Prior authorization general rule
Many entries require prior authorization and either reference product‑specific PA documents or reserve coverage for patients with documented allergic reactions or inadequate responses to preferred alternatives; providers must follow the referenced PA instructions for those products.
- If an external PA PDF/URL is listed, submit documentation per that product's linked criteria.
External PA documentation
Several products point to external HealthPartners prior authorization documents (PDFs or webpages); providers must consult and submit documentation according to those external PA criteria.
- Locate and follow the HealthPartners URL or PDF referenced in the formulary entry when filing the PA.
Prior authorization for non-preferred use
Many drugs are reserved for FDA‑approved indications or for patients who have had an inadequate response to preferred alternatives; prior authorization is required when used for non‑preferred indications or after failure of preferred therapies.
- Provide documentation of prior trials or contraindications to preferred alternatives as part of the PA.
External product-specific PA references
Some product entries refer to separate, product‑specific prior authorization documents hosted as external PDFs/webpages; providers must follow those external product‑specific PA references when requesting authorization.
- Submit supporting documentation exactly as required by the referenced product PA document.
Deflazacort coverage stance
Deflazacort (PYQUVI / brand formulations) is considered not medically necessary due to insufficient evidence of superiority; brand product coverage is reserved only for members with a documented allergic reaction to the equivalent generic.
- If requesting brand deflazacort, include documentation of a documented allergic reaction to the generic equivalent.
Prior authorization required for listed drugs
Prior authorization is required for many listed drugs and commonly requires documentation such as failure/inadequate response to two preferred products, medical contraindication to preferred alternatives, or specialist prescribing as specified per product.
- Provide evidence of trials and failures of preferred therapies (often two) when indicated in the product entry.
Follow product-specific PA links
When a product references a product‑specific PA webpage or PDF, providers must follow the full criteria and instructions on that linked page to obtain authorization.
- Attach any forms or required documentation listed on the product‑specific PA link.
External PA document required
Many products reference specific prior authorization criteria documents (URLs) that must be followed for approval; providers should consult the linked document and include required evidence when submitting the PA.
- Submit documentation per the HealthPartners linked PA criteria for that product.
Allergic reaction reservation
Several inhaled steroid or combination products are reserved for patients with a documented allergic reaction to the equivalent generic; prior authorization must include documentation of that allergic reaction.
- Provide chart notes or allergy testing evidence showing allergic reaction to the generic equivalent.
PA required for listed products
Prior authorization is required for listed products when they are reserved for patients with allergic reactions to preferred alternatives, medical contraindications, or after failure of preferred therapies; include documentation of those conditions in the PA request.
- Document inadequate response to preferred agents or medical contraindications as applicable.
Follow product-specific PA documents
Several products point to separate product‑specific PA documents provided via HealthPartners URLs (examples include HADLIMA, HAEGARDA, HARLIKU, HARVONI, HEMGENIX); providers must follow those external product PA documents when requesting authorization.
- Include any product‑specific forms or evidence required by the linked HealthPartners document.
PA required for listed products
Many listed products require prior authorization; individual drug entries specify product‑level criteria or external links which providers must follow when submitting requests.
- Check each formulary entry for product‑specific PA instructions or external link.
PA reserved for inadequate response or contraindication
Some products are reserved for FDA‑approved indications and require documentation that the member had an inadequate response to two preferred alternatives or has a medical contraindication to those alternatives; include that documentation in the PA.
- When two preferred failures are required, submit records showing the trials and outcomes.
General prior authorization rule
Many listed products require prior authorization when the patient has not tried and failed preferred alternatives or lacks a documented contraindication; long‑acting opioids additionally require provider attestation of opioid management and evidence of a prior adequate short‑acting opioid trial.
- For long‑acting opioids, include provider attestation and documentation of a minimum 30‑day continuous short‑acting opioid trial.
Product-specific prior authorization (linked)
Certain drugs include a linked product‑specific prior authorization criteria page or PDF that must be used; providers must follow those linked instructions and submit required documentation.
- Attach evidence exactly as requested on the linked PA PDF or web page.
PA required for allergy- or step-restricted products
Many listed products are reserved for patients with a documented allergic reaction to the equivalent generic or otherwise require prior authorization per the listed conditions or external PA links; providers must document the allergy or step failures when requesting coverage.
- Provide allergy documentation or prior therapy failure documentation as specified in the product entry.
PA for long-acting opioids
Long‑acting opioid formulations require prior authorization that includes a provider attestation the opioid therapy is managed per standard opioid prescribing guidelines and evidence of inadequate response to a recent adequate short‑acting opioid trial of at least 30 days continuous use.
- Provider attestation that care follows opioid prescribing guidelines
- Documentation of minimum 30 days continuous short‑acting opioid trial
PA with lab and prior therapy criteria (Nexletol/Nexlizet)
Nexletol and Nexlizet require prior authorization for FDA‑approved indications plus documentation that LDL remains >= 70 mg/dL despite standard therapy (high‑intensity statin) and inadequate response to ezetimibe or contraindication to ezetimibe; approvals are for one year with reauthorization contingent on LDL reduction attestation.
- Provide LDL result (>= 70 mg/dL) and prior therapy history (high‑intensity statin ± ezetimibe) in the PA.
Prior authorization required for listed products
Many listed products require prior authorization per HealthPartners and may reference linked PDF criteria for specific products; follow those links and submit required documentation when requesting authorization.
- If the formulary entry lists a linked PDF, use it to guide the PA submission.
PEGASYS prior authorization
PEGASYS prior authorization requires prescribing by gastroenterology, hepatology, or infectious disease specialists and, when used for HCV, must include HCV genotype and viral load and documentation of intolerance or adverse effects from prior Peg‑Intron; the regimen must meet HealthPartners coverage criteria.
- Include prescriber specialty and HCV genotype/viral load when applicable
- Document prior Peg‑Intron intolerance/adverse effects if claimed
PERPHENAZINE‑AMITRIPTYLINE prior authorization
Perphenazine‑amitriptyline is reserved for FDA‑approved indications and requires prior authorization when the patient has had an inadequate response to two preferred alternatives or has medical contraindications to their use.
- Provide documentation of two preferred therapy failures or contraindications.
PLAN B ONE‑STEP prior authorization
Plan B One‑Step requires prior authorization when the patient has significant side effects from two or more preferred alternatives or when a provider states the product is medically necessary for contraception.
- Document prior side effects to two or more preferred alternatives or include provider statement of medical necessity.
PYQUVI coverage stance
PYQUVI (deflazacort) is considered not medically necessary due to insufficient evidence of superiority; brand product coverage is reserved only for patients with a documented allergic reaction to the generic equivalent.
- Requests lacking documentation of the required allergy will be handled as not meeting criteria.
Authorization durations and links
Some products specify initial and re‑authorization durations (example: Reyvow initial authorization 6 months; re‑authorization 12 months); providers must request reauthorization and supply documentation per the product entry.
- Plan reauthorization submissions to meet the specified timeline and include required evidence.
Linked PA criteria
Certain products link to full prior authorization criteria pages or PDFs (e.g., Roctavian, Romidepsin, Romvimza); providers must follow those linked PA criteria and submit required documentation.
- Attach documentation requested on the linked product PA page when submitting the PA.
Somatostatin analogues PA requirement
Somatuline Depot and Somavert are reserved for patients for whom surgery is not an option or not curative and who have failed one somatostatin analogue; initial approvals are for six months with annual reauthorization for responders.
- Document prior somatostatin analogue failure and that surgery is not an option or not curative.
Talicia PA requirement
TALICIA is reserved for FDA‑approved indications and requires treatment failure to one first‑line option (treatment failure defined per product criteria such as positive fecal antigen or endoscopy); prior authorization must document that failure.
- Provide objective evidence of first‑line treatment failure (e.g., fecal antigen or endoscopy) as defined.
Tascenso ODT eligibility
Tascenso ODT 0.25 mg tablet is reserved for patients meeting all three criteria: age ≥10 years, weight ≤40 kg, and inability to take oral Gilenya capsules; prior authorization must document all three.
- Include patient age, weight, and rationale for inability to take oral capsule in the PA submission.
Allergy to generic required for brand coverage
Many branded products are reserved for patients with a documented allergic reaction to the equivalent generic; prior authorization must include documentation confirming the allergy to the generic.
- Supply allergy documentation (chart note or test result) when requesting branded product coverage.
Testosterone products prior authorization
Testosterone products require either a diagnosis of gender dysphoria OR an FDA‑approved indication with documented testosterone deficiency (< 300 ng/dL); some formulations also require inadequate response or contraindications to two or more preferred alternatives.
- Provide testosterone level (<300 ng/dL) or diagnosis of gender dysphoria, and documentation of prior therapy failures when required.
Tobramycin CF-specific prior authorization
Tobramycin inhalation products (300 mg ampules and PAK) are reserved for cystic fibrosis patients with Pseudomonas aeruginosa and must be prescribed and managed by specialists from a cystic fibrosis treatment center; quantity limits and renewal documentation (specialist visit within 12 months and evidence of effectiveness) are required.
- Prescriber should be a CF center specialist and include documentation of Pseudomonas aeruginosa and recent CF center visit for renewals.
Tramadol IR/ER prior authorization and edits
Tramadol ER requires prior authorization after a minimum 30 days continuous use of tramadol IR; it is reserved for adults and children 12 years and older and requires provider attestation that therapy is managed per standard opioid prescribing guidelines.
- Document minimum 30‑day continuous IR trial, patient age, and provide provider attestation per opioid prescribing guidelines.
Step therapy overview
Step therapy requires providers to document prior trials and failures of one or more preferred medicines before coverage of a step therapy drug will be approved; exceptions include documented allergy or medical contraindication to preferred agents.
- Include records of prior trials and reasons for discontinuation or failure when submitting a PA for a step therapy product.
Step therapy / failure requirements
Multiple products require documentation that the patient had an inadequate response to two preferred alternatives (or one preferred alternative for some agents) before prior authorization will be granted; providers must include trial history and outcomes in the PA.
- When two‑failure step rules apply, provide dates, medications, doses, and clinical rationale showing inadequate response.
Step therapy example
CAPLYTA is reserved for FDA‑approved indications and requires trial and failure of at least two formulary alternatives (risperidone, quetiapine, aripiprazole, olanzapine, ziprasidone, lurasidone) unless previously stable on Caplyta or prescribed by/with behavioral health consultation; prior authorization must document these trials or exception.
- Document trials and failures of the specified formulary alternatives or evidence of prior stability / behavioral health consultation.
Step/sequence requirement
Common step‑therapy patterns require trying and failing two preferred alternatives before coverage of many non‑preferred products; providers must submit evidence of those trials or documentation of contraindication/allergy.
- If medical literature evidence is required, include references or clinical data as noted in the product entry.
Prior authorization for listed drugs
Several products are reserved pending failure of preferred alternatives or as second‑line options; documentation of trials and failures (often two products) is required for prior authorization.
- Provide chart notes showing trials, durations, responses, and reasons for discontinuation to support PA requests.
External product-specific PA references
Some entries require providers to follow external PA documents and submit specified supporting documentation (e.g., specialist notes, lab values, culture/sensitivity results, or medical literature demonstrating superiority); providers must include those items to support approval.
- Examples: culture/sensitivity and infectious disease consult for Nuzyra; LDL and prior therapy attestation for Nexletol/Nexlizet; HCV genotype/viral load for PEGASYS.
Definitions and Key Terms
Initial Therapy Requirements and Durations
Ophthalmic initial approvals
When specified
Explicit initial approval duration.
Pulmozyme initial therapy
Pulmozyme initial approval
Specialist management required.
Initial therapy rules
Initial approval durations specified for some products
Applies to somatostatin analogues.
Initial therapy requirements
Initial approval conditions (general across products):
Common reservation reason.
Documentation of prior trials typically required.
Continuation and Renewal Criteria
Dalfampridine continuation
Continuation criteria when specified
Renewal timeline defined.
Cystinosis ophthalmic renewals
Ophthalmic cystinosis product renewals
Initial 3‑month approval then renewals up to 1 year.
Pulmozyme continuation
Renewal condition for Pulmozyme
Initial approval 12 months.
Continuation example
Example continuation rule present in extract:
Illustrative example of duration-based continuation.
Continuation therapy
Renewal terms where specified
Specialty agent continuation pattern.
Tobramycin renewal
Renewal requirements for Tobramycin inhalation products:
Initial approvals 12 months; quantity limits apply.
Step Therapy Rules and Required Trials
| Requirement | Notes / Examples |
|---|---|
| Try and fail preferred therapies before covering non-preferred or specialty agents | |
| Exceptions include documented allergy to the equivalent generic or medical contraindication to preferred alternatives |
| Requirement | Documentation expected |
|---|---|
| Document prior trials of specified preferred alternatives before approval | |
| Medical chart notes or prior therapy history showing inadequate response or intolerance to the preferred agent(s); literature support when superiority over preferred alternatives is claimed |
| Step | Example |
|---|---|
| Step 1: Confirm FDA‑approved indication and behavioral health consultation when required | |
| Example: CAPLYTA requires trial and failure of at least two formulary alternatives (risperidone, quetiapine, aripiprazole, olanzapine, ziprasidone, lurasidone) unless patient is previously stable or managed with behavioral health consultation |
| Requirement | Product-specific note |
|---|---|
| Require trial and inadequate response to specified alternatives (often two) prior to approval | |
| Example: BRIVIACT reserved for patients with inadequate response to two or more preferred seizure medications (one must be levetiracetam) |
| Requirement | Threshold / Count |
|---|---|
| Prior trials of a specified number of preferred formulary agents must be completed before approving a non-preferred product | |
| Examples: some drugs require two preferred alternatives; DEXLANSOPRAZOLE DR may require failure of three preferred alternatives |
| Requirement | Documentation / Exceptions |
|---|---|
| Documented trials and failures of preferred agents as specified per product | |
| Some products accept documented contraindication or prior stability on the requested medication as exceptions |
| Requirement | Coverage rule |
|---|---|
| Must have tried and failed two preferred alternatives (unless contraindicated) | |
| Applies across many long-acting opioid and non-opioid products; documentation of prior failures or medical contraindication required |
| Requirement | Provider attestation detail |
|---|---|
| Provider attestation that opioid therapy is managed per standard opioid prescribing guidelines | |
| Attestation must confirm management per guidelines and prior trial/failure where required (see long-acting opioid rules) |
| Requirement | Minimum prior trial |
|---|---|
| Provider attestation for long-acting opioids that a prior adequate trial of a short-acting opioid occurred | |
| Minimum prior trial duration: 30 days of continuous use of a short-acting opioid prior to long-acting opioid approval |
| Requirement | Scope |
|---|---|
| Trials of preferred alternatives are required before prior authorization approval for many products | |
| Applies to diverse drug classes; number of required prior alternatives varies by product (commonly one or two) |
| Requirement | Common rule |
|---|---|
| Trial and failure of preferred alternatives required prior to coverage for many products | |
| Documentation of inadequate response to one or two preferred alternatives (varies by product) or medical contraindication is expected |
| Requirement | Additional provider requirement |
|---|---|
| Provider attestation that therapy is managed per opioid prescribing guidelines | |
| For long-acting opioids, attestation must state prior short-acting opioid trial of minimum 30 days continuous use |
| Requirement | Coverage implication |
|---|---|
| Trial and failure of preferred alternatives before coverage of the listed product | |
| Where required, approval depends on documentation that preferred alternatives were tried and ineffective or not tolerated |
| Requirement | Exception |
|---|---|
| Trial and failure of preferred alternatives OR documented medical contraindication to preferred agents | |
| Some products accept medical contraindication in lieu of trials; specific products may require additional documentation |
| When prior authorization is required | Provider action |
|---|---|
| Prior authorization is required when step therapy failure criteria are met or when there is documented allergy/intolerance to preferred/generic alternatives | |
| Providers must submit documentation of prior trials, contraindications, or documented allergy to the preferred/generic alternative to support authorization |
| Requirement | Additional conditions |
|---|---|
| Failure of preferred alternatives or documented contraindication required; some products require specialist prescribing or specific monitoring | |
| Examples: certain specialty agents require prescribing by a specialist and documentation of monitoring or specialist visit for renewals |
| Requirement | Coverage note |
|---|---|
| Must have tried preferred alternatives unless there is a documented contraindication or allergy | |
| Where allergy to generic is documented, brand may be reserved for that patient with PA documentation |
| Requirement | Acceptable documentation |
|---|---|
| Documented trial and failure of preferred products OR documented contraindication to preferred products required prior to approval | |
| Acceptable supporting documentation includes chart notes, prior medication history, and provider attestation; some products require literature evidence or external PA forms |
Key Clinical Thresholds and Quantity/Code Notes
Product Quantity Limits and Dispensing Rules
Site-of-Care and Specialty Management Requirements
Background and Policy Scope
Step therapy is a utilization management approach that requires trying one or more preferred medicines first; a prior authorization or exception is needed when preferred agents have not been tried, and documentation of trials, failures, or contraindications must be submitted to support coverage of non‑preferred drugs.
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