CurrentHealthPartnersPolicy N/A

Pharmacy prior authorization and step therapy criteria (Commercial Formulary)

Defines HealthPartners' prior authorization (PA) and step therapy (ST) rules for covered pharmacy products on the 2026 commercial formulary; applies to providers and members using the HealthPartners pharmacy benefit.

Policy Summary

PayerHealthPartners

PolicyPharmacy prior authorization and step therapy criteria (Commercial Formulary)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization or document required step-therapy failures, contraindication, or allergy per the referenced product-specific PA criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multipleindividual drug PA entries listed

links provideddrugs with separate detailed PA documents

20+drugs with reserved step therapy requiring inadequate response

1not eligible for coverage (explicit)

severalspecialist prescribing required

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria and Reservation Rules

General step therapy/PA conditions (V–Z entries)

Covered when ALL of the following general step therapy / prior authorization conditions (V–Z entries) are met:

The request is for a product listed in the formulary segment V–Z and subject to prior authorization or step therapy per the pharmacy benefit.

The prescriber documents that the medication is being used for an FDA‑approved indication unless the formulary entry or linked prior authorization policy specifies otherwise.

For products with a preferred alternative(s) listed, the member has had an inadequate response, intolerance, or contraindication to the required number of preferred alternatives (typically two), or the prescriber provides clinical rationale why preferred alternatives are not appropriate.

When the entry requires specialist prescribing or consultation (e.g., infectious disease, gastroenterology, neurology, cystic fibrosis center), the request includes documentation that the prescriber is the required specialist or that consultation has occurred.

For agents reserved for allergy-to-generic or allergy-to-preferred rules, documentation of a documented allergic reaction or intolerance to the equivalent generic/preferred product must be provided.

When culture, sensitivity, or other diagnostic testing is required by the product-specific criteria (for example, certain antibiotics), results supporting use are included.

For products with duration-limited initial approvals (e.g., 1–6 months), requests for renewal include documentation of clinical benefit and any objective measures required by the product-specific policy (for example, reduced parenteral nutrition volume, improved ambulation, decreased hospitalization frequency).

For long‑acting opioid products included in this segment: provider attestation is required that opioid therapy is being managed per standard opioid prescribing guidelines AND documentation of a recent adequate trial (minimum 30 days continuous) with a short‑acting opioid (or other product‑specific trial requirements) as specified in the product entry.

When a product is reserved for use only by or with consultation from a specialty center (e.g., cystic fibrosis treatment center), approvals are limited to quantities and renewal conditions specified (for example, one 28‑day package per month and annual specialist follow up).

Quantity limits, age limits, or episode supply limits noted in the product entry (for example, new IR opioid supply limits, tramadol pediatric age restrictions) must be met; if exceeded, the request should include clinical justification.

If a product is listed as not medically necessary (e.g., withdrawn or insufficient evidence), coverage is not available through HealthPartners unless a specific linked policy states otherwise.

Provider Requirements, Prior Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization (PA) is required for many products listed on the HealthPartners Drug List. Providers must request PA per HealthPartners prior authorization criteria before coverage at preferred copay/coinsurance will be granted.

Prior authorization required for many listed drugs — see product-specific PA criteria links in the Drug List.
Coverage at preferred cost-share may be denied without prior authorization.

Prior Authorization

Follow Referenced Prior Authorization Criteria and Links

Many product entries include direct links to HealthPartners’ product-level prior authorization criteria (webpage or PDF). Providers must follow the referenced PA document for required clinical criteria and submission instructions.

If a product lists a URL or PDF, submit documentation per that external PA criteria.
When no product-specific link is present, follow the general PA rules in this section and the HealthPartners public coverage criteria page.

Initial Authorization / Initiation Rules

Continuation / Renewal Rules

Step Therapy Rules and Summary Table

Step therapy summary	Preferred alternative(s)
Try and fail preferred alternatives before covering non-preferred product (number varies by drug)
Commonly 1–2 preferred formulary agents (see product-specific entry)

Product / category	Step therapy requirement
Products reserved for inadequate response to two preferred alternatives
Products reserved for documented allergic reaction to equivalent generic (brand approval requires documented allergy)
Products referencing external PA PDF/webpage for full step therapy details

Drug / scenario	Documentation required
General entries: documentation of prior trials or medical contraindication as specified per product
Some products require clinical literature showing benefit over preferred alternatives
Specialty products (e.g., Cayston, Nuzyra) require culture/specialist documentation per product notes

Requirement	When required / notes
Provider attestation that therapy is managed per standard opioid prescribing guidelines
Required for long‑acting opioids and some tramadol ER entries; attestation includes assessment and documentation of prior adequate short‑acting opioid trial (min 30 days)

External PA / link	Purpose
Product-specific PA PDFs/webpages referenced throughout list
Contains full prior authorization and step therapy criteria that providers must follow

What to document	Examples / rationale
Document prior trials and clinical response or documented contraindication/allergy to preferred/generic alternatives
For some agents, document objective clinical evidence (e.g., slit lamp exam for ophthalmic drugs; culture/sensitivity for antibiotics)

Default step path	Requirement
Step through two preferred alternatives
Unless documented contraindication or allergy to preferred products — then provide documentation of that contraindication/allergy

Requirement	Details
Trial and failure of preferred agents required
Number of required failures varies by product (commonly one or two); documented allergy to generic may substitute for failures

Follow referenced PA	Action for provider
When a product lists an external PA PDF or URL, follow that product-specific prior authorization document for full criteria
Submit documentation exactly as requested on the linked criteria (e.g., forms, lab results, specialist notes)

Product	Reserved / requirement
Tobramycin inhalation products (300 mg ampules, PAK)
Reserved for cystic fibrosis patients with documented Pseudomonas aeruginosa; prescribed/managed by CF treatment center; limited to one 56-count carton per 56 days; renewals require evidence of specialist follow-up and effectiveness

Formulary rule	Instruction
Try preferred alternatives per formulary before nonpreferred product
If product entry references a product-specific PA link, follow that link for exact step sequence and documentation requirements

Opioid attestation	Use case
Provider attestation required that opioid therapy is managed per standard opioid prescribing guidelines
Applies to long‑acting opioids and tramadol ER; includes verification of prior adequate short‑acting opioid trial (minimum 30 days) where specified

General ST note	Exceptions
Step therapy required for many products; some require allergy to generic or failure of preferred dosage form instead of standard failures
Exact number of required trials (1–3) and dosage-form steps are specified per product line or linked PA document

Documentation	Instruction
Document prior trials or documented contraindications as specified per product or linked PA document
Provide clinical rationale and any requested objective data (labs, imaging, culture results) when the PA link requires it

Pre-approval condition	Requirement
Prior trial/failure or documented contraindication/allergy required before non-preferred product coverage
Some drugs reference external PA PDFs for full criteria — follow those references for approval conditions and submission details

Required prior step	Alternative paths
Trial and failure of preferred alternatives as specified per product
Some products may instead require specialist prescribing or are reserved for patients with documented allergy/intolerance to preferred agents

Typical trials required	Notes
Trials of preferred alternatives commonly two (varies by product)
Document medical contraindication/allergy to preferred/generic equivalents if unable to trial preferred agents; submit supporting documentation per PA link

Quantity Limits and Dispensing Controls

inv-200: Cayston (aztreonam inhalation) quantity limit — one 28-day package

Quantity limitOne 28-day package per month

IndicationCystic fibrosis patients with Pseudomonas aeruginosa in the lungs

Prescribing/managementMust be prescribed and managed by specialists from a cystic fibrosis treatment center

inv-201: TOBRAMYCIN products quantity limit — one 56-count carton

Quantity limitOne 56-count carton per 56 days

Indication/siteUse in cystic fibrosis patients with Pseudomonas aeruginosa in the lungs

Prescribing/management

Site-of-Care and Specialty Prescribing Requirements

Note

Key Clinical Thresholds and Coding Values

inv-56: Parenteral nutrition volume for Gattex — >= 4L daily

Parenteral nutrition volume threshold>= 4L daily

Applies toGattex (teduglutide) coverage criteria for short bowel syndrome

Source contextUsed as a criterion for initial authorization in adults dependent on parenteral nutrition

inv-57: Parenteral nutrition duration for Gattex — dependent on PN for at least one year

Parenteral nutrition durationDependent on parenteral nutrition for at least one year

Applies toGattex (teduglutide) initial eligibility

Additional requirement

Definitions and Policy Terms

inv-152: Step Therapy (ST) — coverage approach definition

DefinitionStep Therapy (ST) is a coverage approach where members must try one or more specified medicines first; if not tried, prior approval is required for coverage at preferred cost-sharing.

PurposeEncourages use of preferred, lower-cost or first-line therapies before non-preferred agents are approved

ExceptionsMedical contraindication or documented allergy to preferred alternatives may allow bypass of step therapy

inv-153: Prior Authorization (PA) — pre-approval process definition

DefinitionPrior Authorization (PA) is a pre-approval process to confirm a medicine meets HealthPartners' criteria before it is covered under pharmacy benefits.

When usedMany drugs in the formulary require PA; product-specific criteria or external PA documents are referenced in the policy

Site-of-Care, Specialist Prescribing, and Biosimilar Rules

Note

Background and Scope

Background: This document provides administrative coverage rules for the HealthPartners commercial formulary, detailing how prior authorization (PA) and step therapy (ST) are applied to many prescription products. It is intended to guide providers and operational staff on the documentation and trial requirements that determine coverage under the plan.

Policy Summary

PayerHealthPartners

PolicyPharmacy prior authorization and step therapy criteria (Commercial Formulary)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization or document required step-therapy failures, contraindication, or allergy per the referenced product-specific PA criteria.

SourceLink

On This Page

Documentation Required

Opioid Attestation Required

Long-acting opioid products (and select other opioids such as tramadol ER) require a provider attestation that opioid therapy is being managed according to standard opioid prescribing guidelines. This includes documentation of an adequate recent trial of a short-acting opioid (minimum 30 days of continuous use) prior to initiating long-acting therapy.

Provider attestation required for long-acting opioids and tramadol ER/IR when longer supplies or chronic therapy requested.
Failure to include the attestation may result in denial of the PA request.

Prior Authorization

General Prior Authorization & Step Therapy Rules

General PA rules used across many products: brands may be reserved when generics exist (requires documented allergy/intolerance to generic); many specialty or high-cost agents are reserved for FDA-approved indications or for patients with inadequate response to preferred alternatives; clinical documentation and specialist prescribing may be required.

Brand products can be denied unless provider documents allergy or contraindication to generic.
Many agents require trials of one, two or three preferred alternatives before approval; documentation of prior trials must be submitted.
Specialist prescribing or consultation may be required for certain drugs (infectious disease, gastroenterology, CF center, etc.).

Step Therapy

Reserved for FDA Indications or After Preferred Failures

Some products are explicitly reserved for FDA-approved indications or only after failure of two (or more) preferred alternatives. Providers must document inadequate response to the required number of preferred agents or a medical contraindication/allergy.

Where a product is ‘reserved for FDA-approved indications,’ PA is only considered for those indications.
When a two-preferred-failure requirement is listed, include records showing trials and inadequate response or contraindication to those preferred agents.

Step Therapy

Step Therapy Failure & Documentation

Step therapy (ST) requirements are common. Approvals typically require documented inadequate response to required preferred alternatives or documentation of contraindication/allergy. Absence of trial documentation is a frequent denial trigger.

Document trials (start/stop dates, doses, clinical rationale for failure) of preferred agents as specified in the Drug List.
If ST requires a specific number (e.g., two or three), ensure documentation meets that threshold.
Denial is likely if prior trials or contraindication/allergy are not documented.

Prior Authorization

Gattex Prior Authorization & Documentation

Gattex (teduglutide) PA specifics: Reserved for adult short bowel syndrome (SBS) patients dependent on parenteral nutrition ≥4 L daily for ≥1 year and functionally impaired; initial approvals for three months; reauthorizations up to one year require documented reduction in parenteral nutrition volume.

Initial authorization: 3 months. Reauthorizations: up to 12 months with documentation of decreased parenteral nutrition requirements.
Doses up to 5 mg daily approved; other doses reviewed case-by-case.

Prior Authorization

PEGASYS Prior Authorization & Duration

PEGASYS (peginterferon alfa-2a) PA specifics: Prescribing by gastroenterology/hepatology/infectious disease specialists required; HCV and HBV treatment criteria apply. Required documentation includes HCV genotype and viral load for HCV, prior intolerance/adverse effects to Peg-Intron, and regimen alignment with HealthPartners coverage. Duration limits vary by indication.

Hepatitis B: covered up to 48 weeks.
Hepatitis C genotype 1: covered up to 48 weeks; genotypes 2 or 3: covered up to 24 weeks.
Must be used in combination with specified antiviral agents per criteria; submit genotype and viral load when applicable.

Documentation Required

Approval Durations & Reauthorization Documentation

Product-specific prior authorization criteria often include approval duration examples and renewal conditions. Initial approvals may be time-limited (e.g., 1–6 months) with reauthorization requiring documentation of clinical benefit.

Initial approval durations vary (examples: Cayston and Pulmozyme initial approvals 12 months; many specialty agents initial approvals 3–6 months).
Reauthorization commonly requires evidence of clinical benefit (clinic visit notes, documented effectiveness, reduced resource use).

Note

External Prior Authorization References

Some PA criteria reference external PDFs or HealthPartners coverage webpages. Providers must follow those external documents for submission requirements and clinical evidence standards.

When a product entry links to a PDF or coverage page, use that document as the operative PA criteria.
Contact HealthPartners if link content is unclear or inaccessible.

Prior Authorization

Tobramycin Prior Authorization & Quantity Limits

Tobramycin (inhaled/ampules) PA specifics: Reserved for cystic fibrosis patients with documented Pseudomonas aeruginosa; must be prescribed and managed by CF treatment center specialists. Quantity limits apply (e.g., one 28-day or one 56-count carton per specified interval). Initial approvals typically 12 months; renewals require documentation of clinic visit within last 12 months and effectiveness.

Approval limited to CF patients with documented Pseudomonas in lungs.
Prescribed/managed by CF center specialist; quantity limits (e.g., one 28-day package per month or one 56-count carton per 56 days) must be followed.
Renewals require documentation of patient seen within last 12 months and ongoing benefit.

Documentation Required

Required Clinical Documentation for Selected Products

Selected drugs require specialty documentation or diagnostic testing as part of PA: examples include culture & sensitivity for Nuzyra, cognitive testing for Namenda XR (moderate-to-severe Alzheimer’s), and clinic/exam documentation for ophthalmic agents. Pulmozyme and Cayston require CF center management and annual clinic documentation for renewals.

Include culture/sensitivity results where required (e.g., Nuzyra).
Provide cognitive testing or documentation of disease severity where requested (e.g., Namenda XR).
For ophthalmic or other specialist drugs, include specialist exam notes and rationale.

Denial Risk

Denial Risk for Brand When Generic Available

Certain branded drugs are subject to denial risk when an equivalent generic exists unless there is documented allergy/intolerance to the generic. Providers should submit documentation of allergy or a clinical rationale for brand use.

Document specific allergy or intolerance to the generic to support brand coverage.
Absence of such documentation is a common denial trigger.

Step Therapy

Dosage-Form & Example Step Therapy Requirements

Examples of dosage-form or step requirements: some formulations require prior trial of a preferred dosage form before coverage (e.g., sprinkle vs tablet). Talicia requires FDA-approved indication and failure of one first-line option (positive fecal antigen test or endoscopy).

Check product entry for dosage-form specific requirements and document trial of preferred form if required.
For Talicia: submit evidence of treatment failure to one first-line option (positive stool antigen test or endoscopy).

Denial Risk

Product-Specific Prescribing & Denial Triggers

Certain product policies have unique clinical or prescribing instructions (examples: Cayston and Pulmozyme require CF center management; Viberzi requires GI specialist prescribing and documented trials of conventional IBS-D therapies; Tramadol ER requires attestation and prior adequate trial of tramadol IR). Failure to meet these conditions may lead to denial.

Viberzi initial approvals limited to one month; one-year continuations require significant positive response documentation.
Tramadol ER: provider attestation required; documentation of prior adequate trial of tramadol IR; age/quantity limits may apply.

Must be prescribed and managed by specialists from a cystic fibrosis treatment center

inv-202: Tramadol immediate-release (new users) — 7-day supply first fill; 14-day per episode

Initial supply (new users)7-day supply for first fill

Per episode limit14-day supply per episode without prior authorization

Related requirementLonger therapy requires prior authorization with provider attestation

inv-203: IR opioids (including tramadol combinations) — 7-day initial; 14-day per episode

Initial supply limit7-day supply for first fill (new IR opioid users)

Per episode limit14-day supply per episode without prior authorization

Prior auth for longer therapyLonger therapy requires prior authorization with provider attestation of opioid management

inv-204: infusion center site-of-care requirement for select products

Site-of-care requirementSelected products (e.g., inhaled aztreonam, inhaled tobramycin formulations) must be prescribed and managed by specialists from a cystic fibrosis treatment center

Quantity/documentation linkQuantity limits and renewal documentation (specialist visit within 12 months) apply as specified per product

ExamplesCayston and Tobramycin inhalation products reference CF center management and specialist documentation

Parenteral nutrition on >=3 days per week

inv-58: Short-acting opioid adequate trial prior to long-acting opioid — minimum of 30 days continuous use

Minimum trial durationMinimum of 30 days continuous use of a short-acting opioid

PurposeAdequate short-acting opioid trial required prior to initiating long-acting opioid therapy or consideration of long-acting agents

Applies toLong-acting opioid prior authorization and attestations (e.g., morphine ER, hydrocodone ER, tapentadol ER)

inv-59: Testosterone deficiency threshold — < 300 ng/dL

Testosterone deficiency thresholdTotal testosterone < 300 ng/dL

Applies toTestosterone therapies (e.g., JATENZO, TLANDO) for FDA‑approved indications or gender dysphoria pathways

Related requirementAlso requires inadequate response or contraindications to preferred alternatives or other plan-specified criteria

inv-60: Somatuline initial approval duration — 6 months

Initial approval duration6 months (initial approval for Somatuline Depot / lanreotide acetate)

RenewalAnnual approvals thereafter for responders with demonstrated effect

PrerequisiteReserved for patients who have failed one somatostatin analogue or when surgery is not an option/not curative

inv-61: LDL threshold for Nexletol/Nexlizet — >= 70 mg/dL

LDL threshold>= 70 mg/dL

Applies toNexletol / Nexlizet prior authorization for lipid-lowering when inadequate response to high-intensity statin

Additional criteriaRequires inadequate response to ezetimibe or documented allergy/contraindication to ezetimibe; approvals given for one year

inv-62: Short-acting opioid trial duration (duplicate) — minimum of 30 days continuous use

Minimum short-acting opioid trialMinimum of 30 days continuous use

ContextRequired prior to coverage of certain long-acting opioids and for consideration of tapentadol ER/tramadol ER criteria

Provider actionProvider attestation that opioid prescribing follows standard guidelines is also required

inv-63: Tramadol IR initial supply — new users limited to 7-day supply first fill; total 14-day supply per episode without PA

Initial supply for new usersNew users limited to a 7-day supply for first fill

Per episode limitTotal 14-day supply per episode without prior authorization

PA/AttestationLonger therapy requires prior authorization with provider attestation to opioid prescribing guidelines

inv-64: Tobramycin quantity limit — up to one 56-count carton per 56 days

Quantity limitUp to one 56-count carton per 56 days

Applies toTobramycin inhalation products (300 mg/4 mL, 300 mg/5 mL ampules, TOBRAMYCIN PAK)

Prescribing/renewalRequires CF specialist management and annual documentation of clinic visit and medication effectiveness for renewal

inv-65: Tapentadol ER prior trial — requires trial and failure of two preferred products; prior short-acting opioid trial minimum 30 days

Prior trial requirementRequires trial and failure of two preferred products before coverage

Short-acting opioid prerequisitePrior short-acting opioid trial minimum 30 days is required for consideration

Provider attestationProvider must attest therapy is managed per standard opioid prescribing guidelines

inv-66: Opioid initial supply limit — 7-day initial; 14-day per episode

Initial supply limit7-day initial supply for new users

Per episode limit14-day supply per episode without prior authorization

ExtensionLonger therapy requires prior authorization with provider attestation and risk assessment

inv-67: Tramadol IR trial duration — minimum 30 days continuous use

Tramadol IR trial durationMinimum 30 days continuous use required as an adequate trial

ContextUsed to establish prior adequate trial before approving tramadol ER or other long-acting opioid formulations

Provider attestationProvider attestation of opioid guideline management is required for ER formulations

inv-68: Tramadol minimum age — 12 years

Minimum age12 years (tramadol reserved for adults and children 12 years and older)

ApplicabilityAge edit applies to tramadol formulations (IR and ER)

ReferenceAge restriction noted as a unique edit in tramadol criteria

ConsequenceCoverage at preferred copay/coinsurance may be denied unless prior authorization is obtained when PA rules apply

inv-154: Reserved — meaning in this policy

Meaning in this policy'Reserved' indicates the product is authorized only when the member has an inadequate response to preferred products or has a medical contraindication to preferred alternatives.

ImplicationTypically requires documentation of failed trials of preferred alternatives or evidence of contraindication/allergy

UsageFrequently used across multiple product entries to limit coverage to specific circumstances

inv-155: Reserved — for allergy to equivalent generic — definition

DefinitionReserved for patients with a documented allergic reaction to the equivalent generic: prior authorization required when member has documented allergy and brand is clinically necessary.

Common usageUsed to limit brand product coverage when generic alternatives exist unless allergy documented

Denial riskRequests may be denied if allergy to generic is not documented

inv-156: Inadequate response to preferred alternatives — definition

DefinitionInadequate response to preferred alternatives: evidence that the member failed therapeutic response to the specified number of preferred alternatives (commonly 1–3, varies by drug).

DocumentationProvider documentation of trial and failure or intolerance is required for PA/ST exceptions

Variable requirementNumber of required failed agents depends on product-specific criteria

inv-157: Reserved for patients with documented allergic reaction to equivalent generic/brand — definition

DefinitionReserved for patients with a documented allergic reaction to the equivalent generic/brand: coverage only when member cannot use standard generic/brand due to documented allergy.

ApplicationCommonly used across entries to restrict brand approvals absent documented allergy

Provider actionSubmit documentation showing allergic reaction to generic

inv-158: Inadequate response to preferred products — definition

DefinitionInadequate response to preferred products: prior trial(s) of one or more preferred alternatives without sufficient clinical response, typically specified as failure of two preferred products in many entries.

ImplicationTriggers eligibility for non-preferred agents when documented

EvidenceProvider notes or prior treatment records required to demonstrate inadequate response

inv-159: Reserved for documented allergic reaction to equivalent generic — definition

DefinitionReserved for patients with a documented allergic reaction to the equivalent generic: brand product may be approved only when allergy or intolerance to generic is documented.

Typical evidenceAllergy testing, provider attestation, clinical notes documenting reaction to generic

Policy effectAbsent documentation, requests likely denied or considered not medically necessary

inv-160: Reserved for inadequate response to a preferred alternative — definition (duplicate cluster)

DefinitionReserved for patients with an inadequate response to two preferred alternatives: coverage requires documented therapeutic failure or contraindication to two designated preferred alternatives before non-preferred product is approved.

DocumentationChart notes, prior prescriptions, or provider attestation required to show failures

ApplicabilityCommon across many product entries as step-therapy requirement

inv-161: Step Therapy — definition (duplicate)

DefinitionStep Therapy (ST): members must try specified preferred alternatives first; if not tried, prior approval is required for coverage at preferred cost-sharing.

GoalPromote use of clinically appropriate, lower-cost therapies before non-preferred treatments

ExceptionsMedical contraindication or documented allergy to preferred agents may exempt the member from ST

inv-162: Reserved for patients with a documented allergic reaction to the equivalent generic — definition (duplicate)

DefinitionReserved for patients with a documented allergic reaction to the equivalent generic: brand approval contingent on documented allergy/intolerance to generic.

Required evidenceProvider documentation indicating allergy or intolerance to generic alternative

Common usageUsed to limit coverage of brands when generics are available

inv-163: Reserved for patients with an inadequate response to two preferred alternatives — definition

DefinitionReserved for patients with an inadequate response to two preferred alternatives: coverage requires documented failure of two preferred agents or medical contraindication.

DocumentationPrior treatment records or provider attestation required

Policy impactCommon step-therapy pathway for many non-preferred drugs

inv-164: Treatment failure — definition

DefinitionTreatment failure: generally implies inadequate clinical response to prior therapy; in some entries defined by objective criteria (e.g., positive diagnostic test or failure of specified first-line therapy).

Evidence examplesPositive test results, documented lack of symptom improvement, or provider documentation of failure

Use in policyUsed to justify escalation to non-preferred or specialty therapies under PA/ST rules

inv-165: Provider attestation (opioids) — definition

DefinitionProvider attestation (opioids): a prescriber statement that therapy is being managed per standard opioid prescribing guidelines, including assessment and documentation of risk factors and prior adequate trials.

When requiredRequired for long-acting opioids and for ER formulations (e.g., tramadol ER, tapentadol ER)

ConsequenceLack of attestation may trigger denial of prior authorization

inv-166: Inadequate response — definition

DefinitionInadequate response: clinical failure to achieve desired therapeutic effect with a preferred dosage form or product, prompting step therapy exception or prior authorization.

DocumentationProvider notes describing persistent symptoms, lack of improvement, or adverse effects from prior therapy

Policy roleBasis for approving non-preferred or specialty agents under ST/PA rules

inv-167: Provider attestation — definition

DefinitionProvider attestation: a documented statement from the prescriber confirming management per required guidelines (e.g., opioid prescribing) and that prior trial criteria have been met.

ExamplesOpioid attestation for long-acting opioids; attestation of specialist management for CF therapies

Required evidenceSigned prescriber attestation or chart documentation accompanying PA request

inv-168: Step Therapy (ST) — definition (duplicate cluster)

DefinitionStep Therapy (ST): a utilization management approach where coverage for a nonpreferred product is reserved for patients with inadequate response to preferred alternatives or with contraindications to their use.

ProcessRequires trying preferred alternatives first; exceptions for contraindication/allergy

DocumentationProvider must supply evidence of prior trials or contraindication as specified per product