CurrentAdvanced HealthPolicy N/A

General Drug Use Criteria for Prior Authorizations

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Establishes general coverage and prior authorization requirements for non-formulary medications and formulary medications requiring pre-approval when no drug-specific criteria exist for Advanced Health Oregon Health Plan members, including initial and renewal requests.

Policy Summary

PayerAdvanced Health

PolicyGeneral Drug Use Criteria for Prior Authorizations

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewMar 25, 2024

Next Review DateN/A

Key ActionSubmit chart notes dated within the previous 12 months for initial requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsChart note recency

MPR ≥80%Medication adherence threshold

5 daysMaximum fill gap

<21 yearsAge threshold

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CurrentAdvanced HealthPolicy N/A

General Drug Use Criteria for Prior Authorizations

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Policy Summary

PayerAdvanced Health

PolicyGeneral Drug Use Criteria for Prior Authorizations

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewMar 25, 2024

Next Review DateN/A

Key ActionSubmit chart notes dated within the previous 12 months for initial requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsChart note recency

MPR ≥80%Medication adherence threshold

5 daysMaximum fill gap

<21 yearsAge threshold

Initial pathway decision points

4Renewal pathway decision points

General Coverage Criteria

Initial Therapy

Covered for initial therapy when the applicable coverage pathway and all subsequent criteria are satisfied.

ALL of the following

ONE of the following coverage pathways
- The drug is prescribed for a condition funded by the Oregon Health Plan (OHP) consistent with the Health Evidence Review Commission (HERC) Prioritized List of Health Services.
- The member has a comorbid condition for which coverage is allowed.
- The member is younger than 21 years of age.
Chart notes are less than 12 months old.
OAR 410-120-1320(7) limits coverage up to 12 months. If the medication was previously approved, it may be approved for 1 month to allow time for a visit; if not previously approved, deny. Current chart notes are required.
The medication is listed in the treatment plan.
If not listed, deny as not meeting criteria.
The medication is not listed on the DESI Less-Than-Effective drug list.
Medications listed on the DESI Less-Than-Effective drug list are not covered under OHP per OAR 410-121-0420.
ONE of the following age-specific determinations
- The medication is not being used for impotency, erectile dysfunction, weight loss, cosmetic purposes, or as an herbal supplement.
- The member is 20 years of age or younger and the request is sent to MD review for medical appropriateness and medical necessity.
The medication is prescribed for an FDA-approved indication at the appropriate FDA-approved dose, or there is a substantial body of proof supporting its use to treat the covered condition.
If not, deny; off-label medication use is not a covered OHP benefit.
The medication is prescribed by, or in consultation with, an appropriate health care provider with expertise in treating the condition.
If not, forward to MD review to determine medical appropriateness.
The member has no contraindications to therapy according to FDA-approved labeling.
If contraindications are present, deny as not meeting criteria; medications must be prescribed consistent with the FDA-approved package insert.
The second-line requirement is satisfied
- The medication is not categorized as second-line therapy by FDA-approved labeling or national clinical guidelines.
- The medication is categorized as second-line therapy and the member has trialed and failed, or has a contraindication to, first-line therapy.
The member has trialed and failed all less-costly alternative therapies that are similar or identical to the requested therapy within the same drug class or therapeutic class.
If not, deny for failure to meet the less-costly rule or step-therapy requirement.
The member has been adherent to first-line therapies, defined as a Medication Possession Ratio (MPR) of at least 80% or no gaps between fills exceeding 5 days.
If not, deny; claims do not support a consistent fill history and first-line therapy use should be optimized.
ONE of the following fill or quantity-limit determinations
- The requested medication does not have a fill limit or quantity limit.
- The requested medication has a fill limit or quantity limit, and the prescriber has provided documentation that the medication is beneficial and clinical rationale explaining why other formulary alternatives cannot be used.
The medication is medically necessary and is not requested solely for patient convenience.
If requested for convenience rather than medical necessity, deny as not meeting criteria because convenience medications are not covered under OHP.

Continuation or Renewal Therapy

Covered for continuation or renewal therapy when all renewal requirements are satisfied.

ALL of the following

ONE of the following duration determinations
- The requested medication is being prescribed within the FDA-approved treatment duration.
- The medication is being prescribed outside the FDA-approved treatment duration and the member is younger than 21 years of age.
Documentation supports the medical necessity and ongoing use of the requested medication.
If not, deny and request a current evaluation supporting ongoing medical necessity.
Claims review supports adherence to prescribed medication therapy, defined as an MPR of at least 80% or no gaps between fills exceeding 5 days.
If adherence is not supported, deny as not meeting criteria.

Experimental, investigational, or off-label medication use is excluded from coverage under the Oregon Health Plan, including use in clinical trials or demonstration projects. Medications for which there is insufficient outcome data to indicate efficacy are also excluded.

For members age 21 or older, medications used for impotency, erectile dysfunction, weight loss, or cosmetic purposes, as well as herbal supplements, are not covered under the Oregon Health Plan. For members age 20 or younger, such requests are subject to MD review for medical appropriateness and medical necessity.

Medications requested for patient convenience rather than medical necessity are not covered under the Oregon Health Plan.

Medications listed on the DESI Less-Than-Effective drug list are not covered under the Oregon Health Plan, consistent with OAR 410-121-0420.

The patient-convenience exclusion applies whenever the requested medication is not medically necessary; such requests do not meet coverage criteria.

Medications not expected to significantly improve the member's basic health status are excluded from coverage. Services must be medically appropriate, and the least costly medication must be used when the anticipated outcome is essentially the same.

Operational Thresholds

Chart note recency

Required recencyChart notes must be less than 12 months old.

Initial request documentationChart notes within the past 12 months are required for an initial request.

Previously approved medicationIf chart notes are outdated for a previously approved medication, approval may be granted for 1 month to allow time for a visit.

Medication possession ratio

Adherence thresholdMedication possession ratio must be greater than or equal to 80%.

Claims reviewClaims must support adherence to prescribed or first-line medication therapy.

Failure to meet threshold

Prior Authorization Requirements and Denial Conditions

Prior Authorization

When General Drug Criteria Apply

Submit prior authorization requests under these general criteria when the medication is non-formulary or is formulary but requires pre-approval and has no specified drug-specific criteria.

The request must meet the basic principles established by Oregon Administrative Rule (OAR) for consideration of Advanced Health coverage.
These criteria apply to medications without specified drug use criteria.

Prior Authorization

Funded Condition and Medical Appropriateness

The requested medication must treat a condition funded for coverage under the Oregon Health Plan (OHP), consistent with the Health Evidence Review Commission (HERC) Prioritized List, and the service must be medically appropriate.

If the condition is not on the funded line, identify a qualifying covered comorbid condition or submit the request for a member younger than 21 for medical-necessity review under EPSDT.
Services that are not medically appropriate do not qualify for coverage.

Policy Framework

This policy establishes a general medical-necessity framework for non-formulary medications and formulary medications requiring prior authorization when drug-specific criteria are unavailable. Coverage considerations include treatment of an Oregon Health Plan-funded condition, FDA-consistent use, medical appropriateness, cost-effective therapy, and documented clinical need.

Defined Terms

EPSDT Services

ProgramEarly and Periodic Screening, Diagnosis and Treatment (EPSDT) Services, also known as Medicheck, are the Title XIX program of EPSDT services.

EligibilityEPSDT Services are for eligible clients under age 21.

PurposeEPSDT is a comprehensive child health program intended to assure access to medically necessary and medically appropriate health care services and items.

Adherence

Medication possession ratioAdherence includes a medication possession ratio greater than or equal to 80%.

Fill historyAdherence also includes no gaps between prescription fills exceeding 5 days.

Initial Request Criteria

Initial requests must meet all applicable Oregon Health Plan coverage, documentation, labeling, medical-necessity, cost, and adherence requirements.

Initial authorization requirements

Qualifying OHP coverage pathway
- The drug is prescribed for a condition funded by the Oregon Health Plan in a manner consistent with the HERC Prioritized List of Health Services.
- The member has a comorbid condition for which coverage would be allowed.
- The member is less than 21 years of age.under 21 years of age
Documentation and product requirements

Renewal Request Criteria

Renewal requests require current documentation of ongoing medical necessity and adherence.

Renewal requirements

Treatment duration
- The requested medication is prescribed within the FDA-approved treatment duration.
- Under-21 exception: If the medication is prescribed outside the FDA-approved treatment duration, the member is less than 21 years of age.under 21 years of age
Current evaluation and other documentation support medical necessity and ongoing use of the requested medication.

Alternative Therapy Requirements

Step	Requirement	Coverage outcome
1	Before approval, the member must try and fail first-line therapy when the requested medication is identified as second-line, unless first-line therapy is contraindicated or the request is referred for medical director review. The member must also try and fail all less-costly similar or identical alternatives in the same drug or therapeutic class.	Covered with criteria when the applicable step-therapy requirements are met.

Policy Summary

PayerAdvanced Health

PolicyGeneral Drug Use Criteria for Prior Authorizations

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewMar 25, 2024

Next Review DateN/A

Key ActionSubmit chart notes dated within the previous 12 months for initial requests.

SourceLink

On This Page

Coverage may be denied when claims do not support consistent adherence.

Fill gap

Maximum fill gapNo gap between prescription fills may exceed 5 days.

Adherence definitionA medication possession ratio of at least 80% or no fill gap exceeding 5 days meets the adherence definition.

Coverage impactA fill gap exceeding 5 days may result in denial when adherence is required.

Member age exception

Age exceptionThe member is under 21 years of age.

Funded-condition pathwayA request for a member under 21 may proceed when the medication is not otherwise prescribed for an Oregon Health Plan-funded condition or qualifying comorbid condition.

Excluded adult usesFor certain uses such as impotency, erectile dysfunction, weight loss, cosmetic purposes, or herbal supplements, members age 20 or under are sent for medical director review rather than automatically denied.

Prior Authorization

FDA-Consistent Prescribing

Prescribe the medication for an FDA-approved indication and consistent with FDA-approved labeling, including the package insert, dose, treatment duration, and contraindications.

Experimental, investigational, clinical-trial, demonstration-project, and off-label uses are excluded unless a qualifying exception applies.
The medication must have sufficient outcome data to indicate efficacy and be expected to significantly improve the member’s basic health status.

Documentation Required

Qualified Prescriber or Consultation

The medication must be prescribed by, or in consultation with, an appropriately qualified health care provider with expertise in treating the condition.

If the prescriber does not have the appropriate expertise or consultation is not documented, the request may be forwarded for medical director review of medical appropriateness.

Documentation Required

Current Chart Notes Required

Submit current clinical documentation with the request. Chart notes must be less than 12 months old and must support the requested therapy.

If notes are outdated, submit current chart notes; OAR 410-120-1320(7) limits coverage up to 12 months.
For a previously approved medication, a one-month approval may be issued to allow time for a visit; a medication not previously approved may be denied until current notes are submitted.

Documentation Required

Treatment Plan Documentation

The requested medication must be listed in the member’s current treatment plan. Requests without treatment-plan documentation do not meet criteria.

Include the treatment plan or chart documentation showing that the medication is part of the member’s planned treatment.

Denial Risk

Excluded Use or Product Category

Screen the request for products and uses excluded from coverage. A medication on the DESI Less-Than-Effective drug list does not meet criteria under OAR 410-121-0420.

For members age 21 or older, medications used for impotency, erectile dysfunction, weight loss, cosmetic purposes, or herbal supplements are not covered under OAR 410-121-0147.
For members age 20 or younger, these requests must be sent for medical appropriateness and medical-necessity review.

Denial Risk

FDA Labeling or Contraindication Issue

Confirm that the requested use matches FDA-approved labeling or is supported by a substantial body of proof for treatment of the covered condition, and that the dose and duration are appropriate.

Deny requests for off-label use when no qualifying coverage exception applies.
Deny or modify therapy when the requested dose or treatment duration is inconsistent with FDA-approved labeling.
Check for contraindications; therapy with a contraindication under FDA-approved labeling does not meet criteria.

Step Therapy

First-Line and Lower-Cost Alternatives

If FDA labeling or national clinical guidelines identify the requested medication as second-line therapy, document a trial and failure of, or contraindication to, first-line therapy before requesting approval.

A request may proceed when first-line therapy is not applicable (N/A).
Without a documented trial, failure, or contraindication, forward the request for medical director review or deny when criteria are not met.

Step Therapy

Less-Costly Alternatives

Document trial and failure of all less-costly alternative therapies that are similar or identical to the requested medication, including alternatives in the same drug or therapeutic class.

Use the least costly medication when the anticipated member outcome is essentially the same.
Failure to try and fail appropriate lower-cost alternatives does not meet the less-costly rule or step-therapy requirement.

Step Therapy

First-Line Adherence

Support adherence to first-line therapy with claims or other utilization evidence before requesting a non-first-line medication.

Adherence is established by a Medication Possession Ratio (MPR) of at least 80% or by no gap between fills exceeding 5 days.
If claims do not support consistent fill history, optimize first-line therapy before requesting the medication.

Documentation Required

Rationale for Limited-Use Medication

For a medication with a fill limit or quantity limit, the prescriber must document that the medication is beneficial and explain why other formulary alternatives cannot be used.

The rationale must address the member’s clinical need and the limitations of formulary alternatives.
If adequate rationale is not provided, use formulary alternatives without fill or quantity limits when appropriate.

Denial Risk

Convenience Medication

Do not request a medication solely for patient convenience. The request must demonstrate medical necessity.

Medications of convenience are not a covered OHP benefit and may be denied.

Documentation Required

Renewal Medical Necessity

For renewal requests, submit a current evaluation and documentation supporting the ongoing medical necessity and continued use of the requested medication.

If treatment continues beyond the FDA-approved duration, a member younger than 21 may proceed for review; otherwise, use outside the approved duration is not covered unless a qualifying exception applies.
Documentation must support the member’s current condition, benefit from therapy, and continued need.

Denial Risk

Renewal Criteria

Renewal requests must meet continuation requirements, including treatment duration, ongoing medical necessity, and adherence to the prescribed medication therapy.

Adherence is defined as MPR of at least 80% or no fill gap exceeding 5 days.
If criteria are met, approve for the requested duration or issue a modified approval with a specified number of fills and follow-up evaluation; otherwise deny.

Denial Risk

Condition Outside the Funded OHP Line

A request is at risk of denial when the condition is outside the OHP-funded line and there is no qualifying covered comorbid condition or applicable exception.

For an unfunded condition, assess whether coverage is allowed for a comorbid condition.
Requests for members younger than 21 must be evaluated under EPSDT for medical necessity and medical appropriateness before denial.

Denial Risk

Missing or Outdated Clinical Documentation

Deny or defer the request when required clinical documentation is missing or outdated, including current chart notes, treatment-plan documentation, or records supporting ongoing therapy.

Chart notes must be from the previous 12 months.
For a previously approved medication, a limited one-month approval may allow time for updated documentation; a new request without current notes does not meet criteria.

Denial Risk

Excluded Use or Product Category

Deny when the requested medication is used for an excluded purpose or product category for a member age 21 or older, or when the product is listed on the DESI Less-Than-Effective drug list.

Excluded uses include impotency, erectile dysfunction, weight loss, cosmetic purposes, and herbal supplements.
Members age 20 or younger require medical appropriateness and medical-necessity review for these uses.

Denial Risk

FDA Labeling or Contraindication Denial Risk

Deny when the request is off-label, uses a dose or duration inconsistent with FDA-approved labeling, or involves a contraindicated therapy without a qualifying exception.

The request must use an FDA-approved indication and comply with the FDA-approved package insert.
Experimental, investigational, clinical-trial, demonstration-project, and unsupported off-label uses are excluded from OHP coverage.
Contraindications identified in FDA-approved labeling must be addressed before approval.

Denial Risk

Step Therapy or Adherence Failure

Deny or refer for review when required step therapy has not been completed or claims do not support adherence to first-line therapy.

Document trial and failure of, or contraindication to, first-line therapy when the requested medication is second-line.
Document failure of all appropriate less-costly similar or identical alternatives.
First-line adherence requires MPR of at least 80% or no fill gaps exceeding 5 days.

Denial Risk

Insufficient Rationale for Limited-Use Drug

Deny a limited-use or quantity-limited medication when the prescriber has not provided adequate documentation that the medication is beneficial and a clinical rationale explaining why formulary alternatives cannot be used.

Direct the prescriber to use formulary alternatives without fill or quantity limits when appropriate.
The rationale must address both expected benefit and the clinical reason alternatives are unsuitable.

Denial Risk

Convenience Medication

Deny requests for medications prescribed for patient convenience rather than medical necessity because convenience medications are not a covered OHP benefit.

The request must demonstrate a medically necessary, clinically supported purpose.

Denial Risk

Renewal Criteria Not Met

Deny a renewal when the approved duration, ongoing medical necessity, adherence, or other continuation requirements are not met.

Submit a current evaluation supporting ongoing medical necessity and use.
For therapy beyond FDA-approved duration, members age 21 or older do not meet criteria unless a qualifying exception applies.
Claims must support adherence at an MPR of at least 80% or show no fill gap exceeding 5 days.

Claims review must support adherence to first-line or prescribed medication therapy.

Experimental or investigational use

Clinical-trial useUse of a medication in a clinical trial is considered experimental or investigational.

Other excluded usesDemonstration projects and other uses lacking sufficient outcome data to indicate efficacy are experimental or investigational.

Coverage statusExperimental and investigational use is excluded from Oregon Health Plan coverage.

Chart notes are less than 12 months old.less than 12 months old
If the medication was previously approved and the notes are outdated, a 1-month approval may be considered to allow time for a visit.
The medication is listed in the treatment plan.
The medication is not listed on the DESI Less-Than-Effective drug list.
For members age 21 or older, the medication is not being used for impotency, erectile dysfunction, weight loss, cosmetic purposes, or as an herbal supplement.

FDA labeling and medical appropriateness

The medication is prescribed for an FDA-approved indication and at the appropriate FDA-approved dose, or a substantial body of proof supports its use to treat the covered condition.
The medication is prescribed by, or in consultation with, an appropriate health care provider with expertise in treating the condition.
The member has no contraindication to therapy according to FDA-approved labeling.

Second-line therapy

If FDA-approved labeling or national clinical guidelines categorize the medication as second-line therapy, the member has tried and failed first-line therapy or has a contraindication to first-line therapy.
The medication is not categorized as second-line therapy by FDA labeling or national clinical guidelines.

Cost and adherence

The member has tried and failed all less-costly similar or identical alternative therapies within the same drug or therapeutic class.
Claims support adherence to first-line therapies, defined as a medication possession ratio of at least 80% or no gap between fills exceeding 5 days.MPR >= 80% or no fill gap exceeding 5 days

Fill or quantity limit

The requested medication does not have a fill or quantity limit.
For a medication with a fill or quantity limit, the prescriber has provided documentation that the medication is beneficial and clinical rationale explaining why other formulary alternatives cannot be used.

Medical necessity: The medication is not requested for patient convenience and is medically necessary.

If requirements are met, approve for the requested duration or issue a modified approval with a specified number of fills and follow-up evaluation.

Claims review supports adherence to prescribed medication therapy, defined as a medication possession ratio of at least 80% or no gaps between fills exceeding 5 days.MPR >= 80% or no fill gap exceeding 5 days

If requirements are met, approve for the requested duration or issue a modified approval with a specified number of fills and follow-up evaluation.