ModifiedHealth NetPolicy CP PMN.255

No Coverage Criteria, Recent Label Changes Pending Clinical Policy Update

Governs authorization review for preferred drug list (PDL) medications that lack drug-specific coverage criteria or whose clinical policies are pending updates due to recent label changes; applies to Medicaid line(s) of business and providers requesting pharmacy- or medical-benefit drug coverage.

Policy Summary

PayerHealth Net

PolicyNo Coverage Criteria, Recent Label Changes Pending Clinical Policy Update

Policy CodePolicy CP PMN.255

Change TypeMultiple material additions and clarifications

Effective DateDec 1, 2020

Next Review Date

Key ActionSubmit prior authorization with diagnosis and supporting clinical documentation and confirm the drug is on the formulary for pharmacy-line requests.

SourceLink

POLICY UPDATE CHANGES

added requirement for diagnoses

added requirement that request is for a formulary drug

added requirement that request is not for a benefit excluded use

Added bypass of preferred agent and combination products redirection for certain mental health settings (Appendix E states)

Added Nevada step therapy limits: for typical/atypical antipsychotic or anticonvulsant medications, step therapy is limited to one PDL drug

Clarified redirection to two preferred FDA-approved drugs applies when requested is not first-line therapy

Added clarification for non-preferred PDL drugs that requires failure of two preferred PDL drugs

Added disclaimer that medical management techniques beyond step therapy are not allowed for members in NV per SB 439

Added depression and transplant to list of continuity of care programs

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Coverage Criteria

Initial Therapy (Pharmacy Benefit)

Initial Approval — Pharmacy Benefit: Labeled use without drug-specific coverage criteria or pending clinical policy updates (ALL of the following must be met):

Initial Pharmacy Criteria: 1) Request is for a PDL drug; 2) Request is not for a benefit-excluded use (e.g., cosmetic); 3) All requests for non-PDL drugs under the pharmacy benefit should be reviewed against CP PMN.16 (Request for Medically Necessary Drug Not on the PDL); 4) Requested drug either (a) does not have a drug-specific clinical policy, or (b) has a drug-specific clinical policy pending updates due to recent label changes (e.g., new indications, age expansions, new dosing) within the last 6 months; 5) Condition is FDA-indicated and approved OR diagnosis supported by NCCN Drug Information/Biologics Compendium level of evidence 1, 2A, or 2B; 6) Generic is preferred, if available; 7) If the requested drug is not first-line, failure of an adequate trial of at least two preferred FDA-approved or standard-of-care drugs at maximum indicated doses is required when such agents exist, unless one of the following applies: (a) clinically significant adverse effects or all are contraindicated; (b) request is for a product for treatment associated with cancer in a State with regulations against step therapy in certain oncology settings (Appendix E); or (c) request is for a member in a State with limitations on step therapy in certain settings (Appendix F); 8) If request is for a non-preferred PDL drug, failure of two preferred PDL drugs at maximum indicated doses is required unless exceptions above apply; 9) For combination products or alternative dosage form/strength, medical justification supports inability to use the individual products concurrently or alternative formulations (or oncology/state exceptions apply); 10) If applicable, prescriber has taken necessary measures to minimize any risk associated with a boxed warning in the product label; 11) Member has no contraindications to the prescribed agent per the prescribing information; 12) Dose does not exceed the FDA-approved maximum recommended dose for the relevant indication, or the requested dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Approval duration: duration of request or 6 months (whichever is less)

Initial Therapy (Medical Benefit)

Initial Approval — Medical Benefit: Labeled use without drug-specific coverage criteria or pending clinical policy updates (ALL of the following must be met):

Initial Medical Criteria: 1) Request is not for a benefit-excluded use (e.g., cosmetic); 2) Requested drug either (a) does not have a drug-specific clinical policy, or (b) has a drug-specific clinical policy pending updates due to recent label changes; 3) Condition is FDA-indicated and approved OR diagnosis supported by NCCN level 1, 2A, or 2B; 4) Generic is preferred, if available; 5) If the requested drug is not first-line, failure of an adequate trial of at least two preferred FDA-approved or standard-of-care drugs at maximum indicated doses is required when such agents exist, unless one of the following applies: (a) clinically significant adverse effects or all are contraindicated; (b) request is for a product for treatment associated with cancer in a State with regulations against step therapy in certain oncology settings (Appendix E); or (c) request is for the treatment of a member in a State with limitations on step therapy in certain settings (Appendix F).

Approval duration: duration of request or 6 months (whichever is less)

Continuation Therapy

Continued Therapy — Pharmacy or Medical Benefit (ALL of the following must be met):

Continued Therapy Criteria: 1) Member currently receiving medication via Centene benefit OR member has previously met initial approval criteria OR state or health plan continuity of care programs apply with documentation that the member has received this medication for at least 30 days (where applicable); 2) Member is responding positively to therapy; 3) If request is for a dose increase, the new dose does not exceed the FDA-approved maximum recommended dose for the relevant indication OR the new dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Approval duration: duration of request or 12 months (whichever is less)

Non‑FDA‑approved indications that are not specifically addressed by this policy are excluded from coverage unless the requestor provides sufficient documentation of efficacy and safety in accordance with the off‑label use policy CP.PMN.53 (Medicaid) or other applicable evidence‑of‑coverage documents.

As of the 4Q 2023 annual review the policy explicitly states that requests for uses that are benefit‑excluded will not be covered.

Indications or diagnoses that have been demonstrated to be unsafe or ineffective are not authorized for coverage under this policy.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Requirement

Prior Authorization Required: Prior authorization is required for applicable PDL drugs and for pharmacy‑benefit requests reviewed under this policy. Pharmacy-line requests must be for formulary (PDL) drugs. All requests for non‑PDL drugs under the pharmacy benefit should be reviewed against CP PMN.16 (Request for Medically Necessary Drug Not on the PDL) or medication‑specific prior authorization criteria when available.

Pharmacy-line requests must be for formulary/PDL drugs (4Q2021 addition).
All non‑PDL pharmacy requests should be evaluated per CP PMN.16.

Step Therapy

Step Therapy / Preferred Agent Requirements and Redirection Rules

Step therapy and redirection rules apply when the requested drug is not first‑line. When applicable, prescribers must document trials and failures of required preferred agents. For non‑preferred PDL drugs, failure of two preferred PDL drugs is required when such agents exist, at maximum indicated doses, unless there is documented contraindication, clinically significant adverse effects, or a state regulatory exception. Redirection to preferred FDA‑approved or standard‑of‑care drugs generally requires trials of two preferred agents; exceptions include oncologic indications and states with redirection prohibitions.

Initial Therapy Criteria (Pharmacy)

Initial Therapy (Pharmacy)

Initial Approval — Pharmacy Benefit: Labeled use without drug-specific coverage criteria or pending clinical policy updates (ALL of the following must be met):

Continuation Therapy Criteria

Continuation Therapy

Continued Therapy — Pharmacy or Medical Benefit (ALL of the following must be met):

Approval duration: duration of request or 12 months (whichever is less)

Step Therapy Rules and Exceptions

Exception type	When allowed / Documentation required	Reference
Adverse effect to preferred agents	Allowed when member experienced clinically significant adverse effects to one or more preferred FDA‑approved or standard‑of‑care agents; provider must document adverse reaction in chart notes or other clinical records.	Policy: failure/exception criteria for step therapy; see criteria allowing exceptions for clinically significant adverse effects (chunks 6, 9).
Contraindication to preferred agents	Allowed when all preferred agents are contraindicated for the member; documentation of contraindication required (e.g., problem list, clinical notes, lab results).	Policy: step therapy exceptions include contraindications to preferred agents (chunks 6, 9).
State-specific prohibitions or limits (Appendix E)	Bypass of redirection/step therapy allowed for requests associated with cancer in states listed in Appendix E (states with regulations against redirections in cancer); include documentation that member qualifies under the state-specific setting (e.g., stage/condition described in Appendix E).	Appendix E: states with regulations against redirections in cancer (see chunk 14).
State-specific limitations in certain mental health settings (Appendix F)	Bypass allowed for mental health settings in Appendix F states (e.g., Arkansas); provider must document the clinical setting and diagnosis supporting the exception.	Appendix F: states with limitations against redirections in certain settings (chunk 14).
Nevada-specific limits (Appendix F)	For typical/atypical antipsychotic or anticonvulsant medications in Nevada, step therapy is limited to one PDL drug; requests should document compliance with Nevada limits and any applicable state law; medical management beyond step therapy (including quantity management) is not allowed per NV SB 439 where applicable.	Nevada limits and SB 439 disclaimer described in Appendices/References (chunks 14, 19).

Redirection scenario	Redirect to	When bypass/limit applies (state notes)
Requested drug is not first-line therapy	Redirect to two preferred FDA‑approved or standard‑of‑care agents (adequate trials at maximum indicated doses).	Clarification: redirection to two preferred FDA‑approved drugs applies when requested is not first-line therapy (chunk 20). Exceptions per Appendix E/F may apply (chunks 6, 14).
Requested drug is a non-preferred PDL drug	Require failure of two preferred PDL drugs when such agents exist, unless an exception (adverse effects, contraindication, or state-specific prohibition) applies.	Policy clarification: non-preferred PDL drugs require failure of two preferred PDL drugs (chunk 20); exceptions per Appendices E/F (chunks 6, 14).
Member located in Appendix E state with oncology redirection prohibition	No redirection to preferred agents for applicable oncology indications described in Appendix E; approve based on documentation supporting applicability of the oncology exception.	Appendix E lists states and oncology settings where redirection is prohibited (chunk 14).
Member located in Appendix F state with mental health setting limitation (e.g., AR)	Bypass redirection to preferred agents for specified mental health indications per Appendix F; provider must document diagnosis/setting.	Appendix F includes states with limitations against redirections in certain settings, e.g., AR (chunk 14); policy added bypass for such states (chunk 19).
Member located in Nevada for antipsychotic/anticonvulsant requests	Limit step therapy to one PDL drug (i.e., redirection limited); follow Nevada-specific requirement and do not apply additional medical management beyond step therapy where prohibited by SB 439.	Nevada-specific limit: step therapy limited to one PDL drug for typical/atypical antipsychotic or anticonvulsant medications; SB 439 disclaimer (chunks 14, 19).

Site of Care

Note

Applicable sites of care

Applicable sites of care include office, infusion center, hospital outpatient, and home — the policy applies to both pharmacy and medical benefit requests, with separate medical‑benefit criteria where formulary/PDL language does not apply.

Site settings: office, infusion center, hospital outpatient, home.

Definitions

Preferred Drug List (PDL) medication — definition

DefinitionPreferred Drug List (PDL) medication — a formulary-listed drug subject to pharmacy management (a drug on the plan formulary/PDL).

When this policy appliesPDL drugs that lack drug‑specific coverage criteria or have drug‑specific clinical policies pending updates due to recent label changes (e.g., new indications, age expansions, dosing changes).

Related review actionAll pharmacy-line non‑PDL drugs should be reviewed against CP PMN.16 (Request for Medically Necessary Drug Not on the PDL).

State-specific regulatory limitations — definition

DefinitionState-specific regulatory limitations that prohibit or limit redirection/step therapy — statutory or regulatory provisions in certain states that restrict use of step therapy or redirection to preferred agents in specified clinical settings (see Appendices E and F).

Background

This policy provides a pathway for a case‑by‑case medical necessity review when a Preferred Drug List (PDL) medication lacks drug‑specific coverage criteria or when a drug’s labeling has recently changed and clinical policy updates are pending. It applies to both pharmacy‑ and medical‑benefit requests and is intended to guide prior authorization decisions, taking into account continuity‑of‑care provisions and state‑specific step‑therapy exceptions (see Appendices E and F and related references).

Policy Summary

PayerHealth Net

PolicyNo Coverage Criteria, Recent Label Changes Pending Clinical Policy Update

Policy CodePolicy CP PMN.255

Change TypeMultiple material additions and clarifications

Effective DateDec 1, 2020

Next Review Date

Key ActionSubmit prior authorization with diagnosis and supporting clinical documentation and confirm the drug is on the formulary for pharmacy-line requests.

SourceLink

On This Page

If requested drug is not first‑line: document failure of an adequate trial of at least two preferred FDA‑approved or standard‑of‑care drugs at maximum indicated doses, unless contraindicated or adverse effects occur.
For non‑preferred PDL drugs: failure of two preferred PDL drugs is required unless exception applies.
Redirection bypass exists for states with regulations against redirections in cancer or certain mental health settings (see Appendices E/F).
For members in Nevada, step therapy for typical/atypical antipsychotic or anticonvulsant medications is limited to one PDL drug (Appendix F).

Documentation Required

Required Clinical Documentation and Diagnosis

Required documentation must be submitted to support that the member meets all approval criteria. Requests must include the member's diagnosis and relevant clinical information to justify use and any exceptions to step therapy.

Provider must submit office chart notes, relevant lab results, prior treatment history, and any supporting practice‑guideline or peer‑reviewed literature for off‑label uses.
Requests must include the member's diagnosis (added 4Q2021).
Use of patient copay/discount cards does not constitute medical necessity and is not acceptable justification.

Denial Risk

Denial Triggers and Benefit‑Excluded Uses

Denial Triggers / Benefit‑Excluded Uses: Requests will be denied when the requested use is benefit‑excluded, when required supporting documentation is missing, or when criteria (including step‑therapy requirements) are not met.

Explicit denial for benefit‑excluded uses (e.g., cosmetic) — added 4Q2023.
Risk of denial if documentation (office notes, labs, prior therapy trials, diagnosis) is incomplete or missing.
Denial if required trials of preferred agents or PDL preferred agents are not documented and no acceptable exception applies.
Non‑FDA approved indications require sufficient documentation of efficacy/safety per off‑label use policies (CP.PMN.53) or evidence of coverage documents; otherwise they may be denied.