Navitus-managed Liberty Medicare Advantage Part D formulary administration, prior authorization and exception processes
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Describes Navitus-managed Liberty Medicare Advantage Part D formulary administration, prior authorization and exception processes, and member/provider procedures for formulary issues; applies to Liberty Medicare Advantage members and Navitus as the Part D vendor.
No material clinical or coverage changes in this revision.
Coverage criteria and processing rules
Formulary inclusion and review
Formulary coverage decisions are made to comply with CMS Part D requirements and internal committee review.
CMS may require more than two drugs when additional drugs present unique therapeutic advantages.
Formulary changes require client approval or committee/CMS mandate before implementation.
Defined by Title XVIII and 42 CFR 423.100.
PA and exception adjudication
Coverage determinations for prior authorizations and exceptions follow CMS Part D adjudication timeframes and documented outreach rules.
All determinations are made within required timeframes; outreach documented.
Classification may remain as initially reported if reclassification would impact TAT.
If information is not received prior to TAT, the case may be closed or denied based on available supporting statement information.
Coverage and exception processing
Coverage determinations, formulary exceptions, and prior authorization requests are processed per defined timeframes and documentation requirements; approvals or denials follow medical necessity criteria and CMS guidance.
Expedited vs standard TATs apply (24h/72h).
Expedited = 24 hours TAT.
Subsequent requests within 60 days processed as a redetermination.
If approval duration is extended, the enrollee must receive written notice at least 60 days prior to the new termination date.
Formulary Transition and Transitional Coverage
Transitional coverage and communications are applied for new members and for current members affected by negative formulary changes.
Example classes include antidepressants, anticonvulsants, antipsychotics, and HIV/AIDS medications.
Goal timeline for transition processing typically occurs 3–6 months post-implementation; overrides, Talking Points, and Customer Care communications support member triage.
Overrides and communications are documented in the transition report and client 'Talking Points'.
Affected members receive at least 60 days' notice; system messaging and pharmacy fax blasts may be used.
Drugs for which payment would be made under Medicare Part A or Part B are excluded from Part D coverage. Per the Medicare statutory and regulatory definition of a Part D drug, a drug prescribed to a Part D–eligible individual is not considered a covered Part D drug if payment for that drug "is available (or would be available but for the application of a deductible) under Part A or B" for that beneficiary. Consequently, medications payable under Parts A or B must be processed under those benefits and are not eligible for Part D coverage decisions or authorization under this policy.
Denials are issued when the applicable medical necessity, formulary, or statutory criteria are not met. Written denial notifications use the CMS model denial notice and must include the specific criteria supporting the decision (including formulary formulation/strength as applicable), compendia or FDA recommendations relied upon, and plan/CMS coverage criteria. Common denial reasons include: not medically necessary, ineligible benefit requested, Medicare Part D excluded drug, Medicare Part B benefit, and other plan exclusions. For tiering exceptions, a denial will be rendered when a required supporting statement is not supplied or when supplied information fails to demonstrate medical necessity.
When applying mandatory formulary transition rules, Navitus may exempt stabilized members in selected therapeutic categories from forced transition; however, exemptions do not apply to medications for which an FDA-designated A-rated generic exists. In other words, branded products that have an A-rated equivalent generic available (or an equivalent chemical entity at an equal or lower tier) are not eligible for P&T-authorized transition exemptions. FDA-recalled products are likewise handled as exceptions to standard implementation procedures.
Coverage may be denied when items or services are not reasonable and necessary for diagnosis or treatment as defined under Medicare rules. Determinations that a drug is not reasonable and necessary (not medically necessary) can trigger an adverse determination. Tiering exception requests are evaluated against specified criteria; where requested cost-sharing relief conflicts with plan tier structure or permitted scenarios, the request may be denied in accordance with those rules.
If Navitus requests a supporting statement or supplemental information and that information is not provided, the request will be tolled for 14 calendar days. If the supporting statement is not received within that period, a denial will be rendered. Where the supporting statement is received but further information is required, Navitus will perform one outreach attempt (via fax) to obtain the additional documentation; failure to receive the information before the applicable TAT will result in case closure or denial based on the information on file.
A determination that a drug is not medically necessary constitutes an adverse determination and can result in denial of coverage or payment. Adverse determinations include any unfavorable decision about whether to provide or pay for a Part D drug, decisions about tiering or formulary exceptions, or findings that prior authorization or other utilization management requirements have not been satisfied.
Codes and identifiers used in reporting
| GPI | Generic Product Indicator (identifier included in Transition Report when available) |
| NDC | National Drug Code (included in Transition Report when available) |
What providers must submit and expected timelines
Prior authorization review and timeframes
Prior authorization requests are reviewed against preestablished criteria and determinations are rendered within CMS timeframes: expedited decisions within 24 hours and standard decisions within 72 hours of receipt. Outreach for missing information is documented and all determinations are made within these required timeframes regardless of whether additional information is received.
- Review against preestablished criteria on receipt.
- Expedited: determination within 24 hours from time of request.
- Standard: determination within 72 hours from time of request.
- Outreach attempts documented; provider notified via fax when additional information is needed.
Prior authorization duration and overrides
Standard prior authorizations are approved for one year unless clinically inappropriate or a different CMS-approved duration applies. When an approval is granted an override is entered into the claim processing system effective the decision date; pharmacies may request backdating of overrides and the pharmacy will be notified of an approved coverage determination when a rejected claim occurs within 30 days.
- Standard PA duration: one year (unless clinically inappropriate or different CMS criteria).
- Overrides are entered into the claim system as of the decision date and can be backdated if requested by the pharmacy.
- Pharmacy notified of approved coverage determination when there is a rejected claim within 30 days.
Impact of negative formulary changes on prior authorization
Negative formulary changes may add or more aggressively apply utilization management (e.g., Prior Authorization, Step Therapy, Quantity Limits), which can trigger prior authorization processes per plan design; affected members are notified and transition options may be provided.
- Negative changes include removal, tier increases, or added utilization criteria such as PA, step therapy, or quantity limits.
- All negative formulary changes and alternatives are approved by the P&T Committee prior to implementation (with limited exceptions).
- Affected members receive at least 60 days' notice and transition options/overrides may be provided.
Step therapy exception classification
Requests to bypass step therapy will be classified as step therapy exceptions only when documentation clearly requests a waiver of one or more CMS‑approved utilization management criteria; documentation must explicitly indicate the requester is asking for that waiver.
- Navitus will classify prior authorization and step therapy requests as exceptions only if documentation clearly requests waiver of CMS‑approved UM criteria.
Step therapy duration
Standard step therapy approvals and step therapy exception approvals are granted for the lifetime of the therapy (lifetime approval).
- Standard step therapy and step therapy exception requests: approved for lifetime.
Step therapy addition with formulary changes
Step therapy may be newly implemented as part of negative formulary changes; when applied, affected members are notified at least 60 days in advance and alternatives and transition options (including potential transitional coverage) are provided.
- Step therapy addition is treated as a negative formulary change and approved by P&T prior to implementation.
- Members affected by such changes are notified at least 60 days in advance and communications list alternatives and transitional coverage details.
Required documentation and submission
If information required to approve a prior authorization or formulary exception is missing, the requestor will be notified of the specific information needed; additional supporting information may be supplied orally or in writing, but when PA criteria require supplemental documentation oral information will not be accepted. If a supporting statement is not received, Navitus will toll the request for 14 calendar days and perform one fax outreach for additional necessary information.
- Notify requestor of specific missing information; accept oral or written information unless PA criteria require documentation (then oral information not accepted).
- If supporting statement not received, toll request for 14 calendar days from receipt.
- If further information is needed after a supporting statement, perform one fax outreach; if not received before TAT the case is closed based on available supporting statement.
Appointment of Representative and prescriber initiation
When a coverage determination request is submitted by someone other than the enrollee or prescriber, Navitus must attempt to obtain a CMS‑1696 Appointment of Representative (AOR) form or equivalent; if unobtainable Navitus will reach out to the prescriber to initiate the request and use the prescriber initiation date/time as the received date/time to avoid dismissal.
- Obtain CMS‑1696 AOR form or equivalent written notice to verify appointed representative.
- If AOR unavailable, contact prescriber to initiate; if prescriber initiates, use that initiation date/time as the received date/time.
- If unable to obtain AOR or prescriber initiation within 5 business days, the request will be dismissed and written notification provided.
Transition report contents
Transition reports must include member identifiers, complete provider information, and drug identifiers (GPI or NDC) along with drug name, carrier/plan name, formulary type and other fields necessary to support communications and overrides.
- Include: member name/address, DOB, member ID, language code, complete provider information.
- Include: GPI or NDC for the transition medication, drug name, carrier and plan name, formulary type, combined family and carrier ID and person code.
- Use the Transition Report to generate written communications and to support transitional overrides.
Denial triggers — missing or inadequate supporting information
Denials will be rendered when supporting information is not supplied within the required timeframes (including the 14‑day tolling period) or when the information supplied fails to meet medical necessity criteria; denial notices will state the criteria used for the denial.
- A denial will be rendered if supporting information is not supplied upon request or within the tolling period.
- If information supplied within the required timeframe fails to meet medical necessity, a denial will be issued.
- Denial notifications will include the criteria used (formulary criteria, compendia/FDA recommendations, Medicare/CMS plan criteria) and use the CMS model denial notice.
Denial triggers — failure to provide requested support
A denial will be rendered when supporting information requested by Navitus is not supplied upon request and/or if all information supplied within the required timeframe fails to meet medical necessity criteria as outlined in Parts C & D guidance.
- Navitus tolls for 14 calendar days; if supporting statement still not provided, decision and notification occur within the expedited (24h) or standard (72h) timeframe as applicable.
- Denial will explicitly explain if denial was due to lack of prescriber supporting statement when applicable.
Triggers for adverse determination
Adverse determination triggers include drugs not on the formulary, drugs determined not to be medically necessary, drugs furnished by an out‑of‑network pharmacy, items otherwise excluded under statute, untimely coverage determinations, tiering or formulary exception denials, disputes over cost sharing, or failure to meet prior authorization or UM requirements.
- Examples of adverse determination triggers: non‑formulary status, not medically necessary, out‑of‑network pharmacy, statutory exclusions, untimely determinations, UM requirement failures.
Policy background and scope
Medicare Part D covers prescription drugs as defined by Title XVIII and implementing regulations; however, drugs for which payment would be made under Medicare Part A or Part B are explicitly excluded from Part D. Navitus administers Liberty Medicare Advantage Part D formulary and coverage decisions to meet CMS Part D requirements, including formulary composition and protected-class obligations, review of new molecular entities and protected-class drugs, and coordination with the plan sponsor and P&T committees to ensure coverage decisions comply with statute and CMS guidance.
Key definitions used in this policy
Continuation and transitional fill rules
Continuation during transition
Transitional fills and overrides are used to maintain therapy for members during formulary changes.
Overrides aim to align with desired member notice periods (eg when 60-day notice is desired a 90-day override is recommended); overrides are goaled to prevent unnecessary rejections and support access while alternatives are considered.
Step therapy rules and exceptions
| Policy Element | Details |
|---|---|
| Step therapy exceptions processing | Requests to bypass step therapy are classified as exceptions only when documentation clearly indicates the beneficiary, authorized representative, or provider is requesting a waiver of CMS‑approved utilization management criteria; Navitus pharmacists process these requests per the PA/exception timeframes and outreach rules (including tolling if supporting statement not received). |
| Approval when medical necessity established | An approval will be granted when the submitted supporting information/statement demonstrates medical necessity as defined by the applicable criteria. Outreach for missing supporting statements will be conducted and the request may be tolled (see timelines). |
| Tolling and outreach for missing information | If the supporting statement is not received, Navitus will toll the request for 14 calendar days from receipt; notification is sent on or immediately after the 14th day and the decision notification will be sent within the applicable TAT (24 hours for expedited, 72 hours for standard) from the decision date. |
| Policy Element | Standard Duration |
|---|---|
| Standard step therapy approvals | Standard step therapy and step therapy exception requests will be approved for lifetime. |
| Prior authorization duration (context) | For context, standard prior authorizations are approved for one year unless clinically inappropriate; protected class drugs approved for one year. (Auto‑adjudication may continue if member is adherent with no gap >180 days.) |
| Policy Element | Requirement / Process |
|---|---|
| Implementation as part of negative formulary changes | Step therapy may be newly applied or made more aggressive as part of negative formulary changes (including removal, tier increase, or added utilization criteria); such changes and appropriate alternatives are approved by the Navitus P&T Committee (or the client's P&T Committee) prior to implementation except limited exceptions (e.g., branded drugs with A‑rated generics, FDA recalls). |
| Member notification and transition | If members are affected by a negative formulary change, Navitus notifies members at least 60 days in advance and provides communications listing affected medications, reasons, common alternatives, transitional coverage tier and period, and contact information; transitional overrides may be provided to avoid point‑of‑sale rejections. |
| P&T approval requirement | All negative formulary changes (including additions of step therapy) and appropriate alternatives are approved by the Navitus P&T Committee (or the client's P&T Committee) prior to implementation, subject to the stated limited exceptions. |
Quantity limit handling and exception outcomes
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