CurrentFlorida BluePolicy N/A

Medicare Formulary Transition - Transition Program for Part D Drugs

Describes the Plan Sponsor's Medicare Transition Program governing temporary transition fills and processes for Part D drugs (including non-formulary drugs and drugs subject to PA/ST/QL) affecting Medicare members, including retail and long-term care settings.

Policy Summary

PayerFlorida Blue

PolicyMedicare Formulary Transition - Transition Program for Part D Drugs

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization or a medical necessity exception to continue coverage beyond the one-time temporary transition fill.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

90 daystransition window after member enrollment

>=1 monthmin transition supply (outpatient)

31 daysmin emergency supply (LTC)

108 dayslookback period

3 business daysnotice mailing timeframe

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Coverage and Transition Criteria

Initial Transition Coverage Criteria

Covered when ALL of the following are met for transition fills

Member eligibility and timing: Member is a Medicare Part D enrollee within the first 90 days of plan enrollment (including new members, newly eligible members, plan switchers, current members affected by negative formulary changes across contract years, and residents of long-term care facilities).within 90 days of enrollment or as specified for cross-year enrollments

Consistent with 42 CFR & 423.120(b)(3)

Drug applicability: Drug is a Part D drug that is non-formulary under the Plan Sponsor's formulary, or is on-formulary but subject to prior authorization (PA), step therapy (ST), or a quantity limit (QL) that would otherwise interrupt access to the member's current therapy.

Applies to non-formulary drugs and formulary drugs requiring PA/ST/QL per policy

Supply limits - outpatient: Provide at least a one-month supply (or the written amount if less) in outpatient/retail settings during the first 90 days of enrollment; when products cannot be broken or package/billing units exceed a month, provide a larger days' supply as needed.>= 1 month outpatient supply

Multiple fills permitted to achieve a month's supply when prescription written for less

Supply limits - LTC: Provide at least a one-month temporary fill consistent with LTC dispensing increments (with refills if needed) during the first 90 days of enrollment; after the transition period expires, provide an emergency supply for LTC residents (at least 31 days unless prescription/package limits apply) while an exception or PA is requested.>= 1 month initial LTC; 31 days emergency after transition

Refills allowed consistent with dispensing increment; larger days' supply permitted when smallest unit exceeds standard supply

Continuation beyond transition: Continuation of therapy beyond the temporary transition fill requires a medical necessity determination such as a formulary exception or prior authorization; extensions of the transition period may be granted case-by-case until a decision is reached or the member switches to an appropriate formulary alternative.

Extension available if exception/appeal unresolved at end of minimum transition period

Cross-contract-year rule: For current members affected by negative formulary changes across contract years, transition is available when the member has a history of paid claims within a designated lookback period (minimum 108 days) or via effectuating a transition prior to the new contract year.lookback >= 108 days

Program extended for enrollments with effective dates in November or December

Transition and Emergency Supply Coverage Criteria

Covered when conditions for transition or emergency supply are met per Plan Sponsor rules and CMS guidance

General transition eligibility: Member has a history of paid claim(s) for the drug within the Plan Sponsor's lookback period (minimum 108 days) or is impacted by negative formulary changes across contract years; re-enrolled or switching members are treated according to enrollment/effectuation dates.108 days

Includes effectuation prior to new contract year and lookback provisions

Emergency supply in LTC: If a member's transition period has expired and the member resides in a long-term care facility, supply an emergency quantity of the non-formulary Part D drug while an exception or prior authorization is requested; provide at least a 31-day supply unless the prescription or packaging prescribes a smaller amount, or provide a larger days' supply when smallest unit or billing unit exceeds 31 days.31 days; 90 days transition supply after enrollment

Applies even after initial transition period expires to allow time for exception or PA processing

The Plan Sponsor uses an automated Transitional Benefit Override (TBO) process in the RxCLAIM claims system to permit a one-time temporary transition fill during the first 90 days of a member’s enrollment. For outpatient settings this provides at least a one-month supply (or the written smaller amount), with larger day-supplies allowed when package or billing units prevent monthly dispensing. In long-term care (LTC) settings the system allows a temporary supply consistent with LTC dispensing increments (with refills as needed) during the same 90-day window. Quality Assurance personnel monitor claims to confirm the TBO processing is operating correctly, and case-by-case extensions of the transition period may be granted if an exception or appeal remains unresolved until the member switches therapy or a final determination is made.

Pharmacies may override certain Step Therapy (ST) and Prior Authorization (PA) edits during the transition process; however, the Plan Sponsor retains edits that cannot be overridden to: (1) prevent coverage of non-Part D drugs, and (2) promote safe utilization (for example, beneficiary-level opioid edits, FDA maximum dose quantity limits, and applicable early refill safety edits). These non-overridable edits are enforced at point-of-sale and remain subject to the plan’s exception and appeal processes.

Continuation and Discharge Supply

Continuation/Extension

Extensions and continuation

Extension during unresolved exception/appeal: Provide an extension of the transition period on a case-by-case basis when an exception request or appeal has not been processed by the end of the minimum transition period; extensions continue only until the member switches to an appropriate formulary alternative or a decision on the exception/appeal is made.

Plan Sponsor makes arrangements to continue necessary Part D drugs until resolution

Continuation at discharge

Continuity at discharge and during level-of-care changes

Outpatient supply at discharge: When a member is discharged to home (including in advance of discharge from a Part A stay), permit a full outpatient supply to continue therapy once any limited discharge supply is exhausted.

Available in advance of discharge from a Part A stay to prevent gaps in care

Refill override for admission/discharge: When a member is admitted to or discharged from a long-term care facility and lacks access to the remainder of a previously dispensed prescription, process a one-time override of 'refill too soon' edits for each impacted medication to permit access to necessary therapy.

Early refill edits are not used to limit appropriate and necessary access

Settings and Site-Specific Rules

Prior Authorization

Prior Authorization Required for Continuation / Transition Rules

Prior Authorization and Transition Continuation: Providers must request and obtain prior authorization if continuation of therapy is needed beyond the allowed transition fill or emergency supply. If a member has already received the one-time transition fill (or allowed days' supply) for a non‑formulary or utilization managed (UM) drug, claims will reject at point of sale unless authorization has been obtained. The Plan's RxCLAIM logic will allow the temporary transition supply during the first 90 days of enrollment (or as extended while an exception or appeal remains pending), but continuation past that period requires prior authorization.

Transition-period prior authorization/override: During the transition window the system permits a one-time temporary fill (retail) or temporary supply with refills as needed (LTC); overrides are limited to that transition supply. Providers must submit PA/exception requests promptly to avoid interruption.
Rejection after transition fill without authorization: Once the one-time transition fill or allowed days' supply has been paid, the RxCLAIM TBO logic will no longer allow claims for that drug and claims will reject unless an authorization is in place.
QA & monitoring: Quality Assurance Specialists and Audit representatives monitor TBO processing and claims to confirm proper operation of transition edits and overrides.

Documentation Required

Transition Notifications, Documentation, and Step Therapy

Member & Provider Transition Notices, Documentation, and Step Therapy: The Plan provides transition letters and QA documentation to support processing of transition fills and extensions when an exception or appeal is pending. Providers and facilities must include documentation of the transition fill, any emergency supply dispensed, and the status of exception/PA requests when submitting appeals or requests for extended transition. Members must be notified of the transition supply provided and of any actions needed to continue therapy (e.g., submission of an exception or PA request). Step therapy or other utilization management requirements still apply following the transition period; members may be subject to step therapy unless a valid exception or prior authorization has been approved. Extensions of the transition period are granted on a case‑by‑case basis only while an exception request or appeal remains unresolved.

Transition letter & QA documentation: Plan issues transition notifications and maintains QA oversight; providers should retain and submit documentation of transition fills and any communications relating to exception/appeal processing.
Member transition notice content: Notice must inform the member of the temporary supply provided, the length of that supply (retail: at least one month; LTC: at least one month with refills as needed; emergency LTC supply: at least 31 days), instructions for obtaining an exception or PA, and that continuation requires authorization after the transition period.
Step therapy considerations: If step therapy is required by the formulary after the transition, the member must meet step therapy criteria or receive an approved exception/PA to continue the non‑formulary regimen after the transition supply ends.

Provider Responsibilities and Overrides

Prior Authorization

PA required to continue therapy after transition

Prior authorization is required to continue coverage beyond the temporary transition fill for Part D drugs as defined by the Plan Sponsor; non-formulary drugs or drugs subject to PA/ST/QL will require medical review and authorization to continue beyond the transition supply.

Continuation beyond the temporary fill requires authorization or a medical necessity determination (exception/PA).
Medical review procedures for non-formulary requests are included and the Plan Sponsor will provide rationale if denied.

Prior Authorization

Override rules for PA/ST edits during transition

During the transition period pharmacies may override certain step therapy and prior authorization edits at point-of-sale, except for edits that prevent coverage of non-Part D drugs or that promote safe utilization; exception requests are to be processed expeditiously and PA/exception forms are made available upon request.

Pharmacies can override ST and PA edits during transition except edits to prevent non-Part D coverage or safety-promoting edits (e.g., opioid beneficiary-level edits, FDA dose limits).
Exception/PA forms are available via mail, fax, email, or the Plan Sponsor/PBM website and requests are processed expeditiously.

Step Therapy

Application of step therapy after transition fill

Step therapy requirements may be applied after the transition fill is satisfied; for protected-class drugs subject to PA/ST on new starts only, members who receive the initial transition fill are treated as current utilizers so new-start PA/ST no longer apply.

Protected-class drugs: initial transition fill renders member a current utilizer and new-start ST/PA requirements do not apply after that first fill.
General ST requirements can be enforced after the temporary fill has been provided.

Step Therapy

Step therapy override considerations during transition

Utilization management edits, including step edits, may be overridden during the transition to permit payment for non-formulary Part D drugs, subject to exceptions/appeals and except where safety-related hard edits apply.

Overrides do not apply to edits intended to prevent non-Part D coverage or to hard safety edits (e.g., FDA maximum dose limits).
Exception requests and appeals remain available and are processed expeditiously.

Documentation Required

Automated transition letters and QA monitoring

An automated daily transition letter report is produced and mailed to members (print vendor turnaround up to three business days from claim submit); Quality Assurance specialists review targeted samples of transition claims and mailings to confirm accuracy.

IT runs daily report and forwards to Print Vendor; letters mailed within three business days of claim submit date (vendor two-business day turnaround not to exceed three days).
QA targets samplings of transition claims and checks accuracy of transition mailings.

Documentation Required

Member transition notice — timing and required content

Send written transition notice to the member via U.S. first-class mail within three business days of the temporary transition fill submit date; the notice must explain the temporary nature of the supply, the right to request a formulary exception, instructions to satisfy utilization management or identify alternatives, and procedures for requesting an exception.

Include explanation of temporary nature, right to request formulary exception, instructions for satisfying UM requirements or finding formulary alternatives, and procedures to request an exception.
For LTC residents dispensed multiple supplies in ≤14-day increments, send notice within three business days of the first temporary fill submit date.

Denial Risk

Claims will reject after transition supply unless authorized

After the member has used the one-time transition fill (or up to the allowed day supply) for a non-formulary or utilization-managed Part D drug, claims for that drug will reject unless the member has obtained authorization or an approved exception.

TBO logic does not apply after the allowed day supply is used; subsequent claims will reject without authorization.
Providers should obtain authorization/exception to avoid claim rejection after the transition supply is exhausted.

Denial Risk

Denial risk for exceeding safety/quantity limits during transition

The Plan Sponsor may deny access to quantities or doses during transition when FDA safety limits or established clinical guidelines have been exceeded; before denial the sponsor verifies an initial transition supply was provided and that the member or prescriber was assisted in filing an exception or that an exception has been processed.

Denials may be based on FDA maximum recommended doses or other well-established clinical practice guidelines.
Prior to denial, verify initial transition supply provided up to the maximum limit and document assistance with exception filing or that an exception was processed.

Step Therapy Rules

Condition	How step therapy is applied after transition	Protected-class drugs / initial fill effect
Application timing
Step therapy (ST) and other utilization management requirements are applied after the transition fill has been satisfied; ST is not enforced at point-of-sale to prevent the temporary transition fill.
For protected-class drugs subject to PA or ST on new starts only, the Plan Sponsor treats members who receive the initial transition fill as current utilizers; therefore new-start PA/ST requirements no longer apply after the first allowed fill.

Override allowance during transition	Exceptions / hard edits	Processing expectations
Pharmacies may override step therapy (ST) and prior authorization (PA) edits at point-of-sale to permit payment for transition fills.
Overrides are not permitted for edits that prevent coverage of non-Part D drugs or for hard edits implemented to promote safe utilization (examples: beneficiary-level opioid edits, FDA maximum dose quantity limits, early refill hard edits).
An automated transition fill process exists that does not require the dispensing pharmacist to enter an override code; exception requests are to be processed expeditiously so members do not experience interruptions in therapy.

Supply and Quantity Limits

Non‑formulary Part D — minimum supply & refill/dispensing increments (outpatient & LTC)

Outpatient minimum supplyAt least a one-month supply (or written amount if less); larger days' supply allowed when package or billing unit prevents monthly dispensing

LTC initial supplyAt least a one-month temporary fill consistent with LTC dispensing increments; refills provided as needed

LTC refill/dispensing incrementsRefills in LTC permitted consistent with applicable dispensing increment (unless prescription written for less)

Emergency supply after transition (LTC)31-day emergency supply of non-formulary Part D drugs after transition period expires unless prescription written for less or packaging/billing unit requires larger days' supply

Packaging/billing unit exceptionsLarger days' supply permitted when smallest unit, multiple packages, or billing unit exceed a month (outpatient) or 31 days (LTC emergency)

Transition supply minimums

Outpatient transition minimumProvide at least a one‑month supply (or smaller if written); multiple fills allowed to reach one month during first 90 days of enrollment

LTC transition minimumProvide at least a one‑month temporary fill (or larger if packaging/billing unit requires) with refills per LTC dispensing increments during first 90 days

LTC emergency after transition expiresIf transition expires in LTC, supply at least a 31‑day emergency supply while exception/PA is requested (unless prescription written for less)

Transition lookback period

Lookback threshold>= 108 days (designated lookback period minimum used to identify prior paid claim history)

Cross‑year applicationLookback used to determine eligibility for transition when affected by negative formulary changes across contract years

Early effectuation optionProgram allows effectuation of a transition prior to new contract year for qualifying members (e.g., Nov/Dec enrollments)

Key Definitions

Formulary Exception (FE)

DefinitionAn exception process which defines when a non‑formulary medication is covered (or has a specific copay) under a closed formulary; may include step therapy, dose restrictions, therapeutic substitution, or continued coverage when coverage is being discontinued for reasons other than safety or withdrawal

When usedApplied when a non‑formulary drug requires coverage due to medical necessity or when utilization management would otherwise restrict access

OutcomeIf granted, the formulary exception permits coverage (and appropriate cost‑sharing) for a drug that is not on the formulary under standard rules

Prior Authorization (PA)

DefinitionA requirement that specific criteria be met before a drug is covered (or has a specific copay) under the prescription benefit; applied to medications selected for potential misuse, overuse, or clinical/economic concern

Application after transitionPrior authorization is required to continue coverage beyond the temporary transition fill; medical review and authorization may be needed for non‑formulary or UM drugs

ProcessingException/PA requests are processed expeditiously and forms/methods are made available by the sponsor (mail, fax, email, website)

Step Therapy (ST)

DefinitionA utilization management tool requiring use of one or more drugs in a step‑wise, graduated manner; protocols govern which claims adjudicate for a member

Application during transitionStep therapy requirements may be applied after the transition fill; for protected class drugs where PA/ST apply to new starts only, initial transition fill renders member a current utilizer so new‑start PA/ST no longer apply

Override rulesStep therapy edits may be overridden during the transition period to permit payment for non‑formulary Part D drugs except where safety/hard edits apply; exceptions processed expeditiously

Quantity Limit (QL) Exception

DefinitionA request that Medicare Part D sponsor‑approved clinical criteria be met before medication exceeding a defined quantity limit will be paid

When requiredSubmitted when a prescription exceeds the plan's established quantity limit; sponsor evaluates clinical justification against criteria

Relation to transitionTransition fills may be dispensed for less than the written amount due to QL safety edits, with refills allowed to achieve the temporary supply as appropriate

Emergency supply (LTC)

DefinitionAn emergency supply is a temporary provision of non‑formulary Part D drugs for LTC residents when the transition period has expired while an exception or prior authorization is requested

Minimum supplyProvide at least a 31‑day emergency supply (unless prescription written for less) or larger days' supply when packaging/billing unit requires

PurposeAllows time to request and obtain an exception or prior authorization to continue therapy without interruption

H5434	Contract identifier
S5904	Contract identifier
H1035	Contract identifier

OpenPayer

Medicare Formulary Transition - Transition Program for Part D Drugs

Coverage and Transition Criteria

Initial Temporary Fill

Continuation and Discharge Supply

Settings and Site-Specific Rules

Provider Responsibilities and Overrides

Step Therapy Rules

Supply and Quantity Limits

Contract Identifiers and Codes

Key Definitions

Program Background