CurrentFlorida BluePolicy N/A

Medicare Formulary Transition

Defines the Plan Sponsor's Medicare Part D transition program procedures for providing temporary supplies of non-formulary or utilization-managed Part D drugs (including retail and long-term care settings), notification, system logic, extensions, cross-year transitions, and quality assurance consistent with CMS requirements.

Policy Summary

PayerFlorida Blue

PolicyMedicare Formulary Transition

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionEnsure claim history (minimum 108 days lookback) is available to support transition at contract year start for current members.

POLICY UPDATE CHANGES

No material clinical or coverage changes to policy.

90 daysTransition eligibility window

1 monthRetail minimum temporary supply

31 daysLTC emergency supply min

108 daysCross-year lookback min

Coverage Summary

This policy defines the Plan Sponsor's Medicare Part D transition program to ensure eligible Part D members receive temporary transition supplies of non-formulary or utilization-managed Part D drugs in both retail and long-term care (LTC) settings, provide required member and prescriber notifications, implement RxCLAIM Transitional Benefit Override (TBO) system logic at point-of-sale, manage extensions and cross-year transitions, and perform quality assurance consistent with CMS requirements. The program covers one-time temporary fills (generally at least a one month's supply in retail and LTC unless prescription written for less), LTC emergency supplies (minimum 31 days after the transition period), a 90-day transition eligibility window for new enrollees, cross-year lookback and transition methods (including a minimum 108-day paid claim lookback), notification timing and content, system processing rules that avoid pharmacist override requirements for permitted transition fills, and case-by-case transition extensions pending exception/appeal decisions.

Medical-Necessity / Transition Criteria

General Transition Eligibility / Application

Transition benefit applies when ALL of the following are met:

Affected Members: Member is a Medicare Part D enrollee of the Plan Sponsor (includes new members, newly eligible members, members switching plans after contract year start, current members affected by negative formulary changes, residents of LTC facilities, and re-enrolled members).
Applicable Drugs: Drug is a Part D drug that is non-formulary or a Part D drug that is on the formulary but requires prior authorization (PA), step therapy (ST), or has a quantity limit (QL) lower than the beneficiary's current dose.
Transition Timing: Claim occurs during the member's transition period: within first 90 days of member's enrollment (beginning on effective date of coverage), or for current members affected by formulary changes, per lookback/history rules.90 days
Lookback/history rules for current members addressed separately.

Retail (Outpatient) Transition Fill Rules

Covered when ALL of the following are met:

One-time temporary fill is allowed to provide at least a one month's supply unless prescription written for less; multiple fills permitted to provide at least a month supply if written for less.1 month
Larger days' supply exceptions: Larger days' supply permitted when: (i) smallest unit available exceeds a month's supply, (ii) multiple packages required to achieve therapeutic dose and exceed a month's supply, or (iii) billing unit greater than package size and exceeds a month's supply.
Post-fill authorization requirement: Transition allowed anytime during the first 90 days of member's enrollment; after allowed transition fill (or allowed days supply) TBO logic will not permit additional paid transition fills unless member has obtained authorization.90 days
Further fills require authorization.

Long-Term Care (LTC) Transition Fill Rules

Covered when ALL of the following are met:

Temporary LTC fill: Temporary fill of at least a one month's supply, consistent with dispensing increment (unless prescription written for less), with refills provided as needed, during the first 90 days of enrollment.1 month; 90 days
Emergency supply after transition period: at least 31 days (unless prescription <31 days) or larger days' supply when smallest unit, packaging, or billing unit exceeds 31 days.31 days
Override of early refill edits for admission/discharge: For admission or discharge from LTC, early refill edits are not used to limit access; one-time override of 'refill too soon' edits is processed as needed.

Transition Across Contract Years / Current Members

Transition for current members affected by formulary changes is provided when ANY of the following are met:

Lookback-based transition at start of new contract year: Providing a transition process at the start of the new contract year when member has history of paid claim(s) for the drug within a designated lookback period which is a minimum of 108 days.minimum 108 days
Effectuate transition prior to new contract year: Effectuating a transition prior to the beginning of the new contract year.
Extension for late-year enrollments: Program extended across contract years if member enrolls with effective enrollment date of November 1 or December 1 and needs access to a transition supply.Nov 1 or Dec 1 effective date

Transition Extensions and Appeals

Transition extension applies when ALL of the following are met:

Pending exception or appeal: Member's exception request or appeal has not been processed by the end of the minimum transition period.
Case-by-case extension until resolution or switch: Extension is provided on a case-by-case basis until member has switched to an appropriate formulary drug or a decision on the exception request has been made.

Protected Class and New vs Ongoing Therapy Treatment

Rules applied as follows:

POS inability to distinguish new vs ongoing: When point-of-sale cannot distinguish new from ongoing therapy, transition processes apply to brand-new prescriptions.
Protected class treatment after initial fill: For protected class drugs subject to PA or ST on new starts only, if initial fill is allowed due to inability to determine current use at POS, member is treated as current utilizer and PA/ST new-start requirements do not apply after the first fill.

Edits, Safety Limits, and Denials During Transition

Edits and denials may occur under these rules:

POS coverage determination edits: Point-of-sale logic determines Part A/B vs Part D coverage; edits prevent coverage of non-Part D drugs and promote safe utilization (e.g., opioid beneficiary-level edits, FDA-based QL edits).
Pharmacy override ability for ST/PA: Pharmacies can override ST and PA edits for transition fills except edits that prevent coverage of non-Part D drugs or those that promote safe utilization as described.
Denial when safety limits exceeded: Plan Sponsor may deny access to quantities or doses during transition where FDA safety limits or P&T-established safety limits are exceeded, but only after verifying initial transition supply provided and member/prescriber assisted in filing an exception or exception processed.

Notices and Communication Requirements

Notices required when ALL of the following are met:

Member written notice timing: Written notice via U.S. first-class mail to member within three (3) business days of temporary transition fill submit date (for LTC residents dispensed multiple supplies of <=14-day increments, within three business days of first temporary fill submit date).3 business days
Notice contents: Notice must include: explanation of temporary nature; instructions to work with Sponsor/prescriber to satisfy UM or find alternatives; explanation of right to request formulary exception; description of procedures for requesting an exception.
Prescriber notification efforts: Reasonable efforts to notify prescribers via cover letter and confidential patient profile sent by U.S. first-class mail.

Provider Actions & Operational Requirements

Documentation Required

Maintain claim/history evidence for cross-year transitions

Ensure claim history is maintained to support transition across contract years; current-member transitions rely on paid claim history within a minimum 108-day lookback to effectuate a transition at the start of the new contract year.

Minimum 108-day paid claim lookback for cross‑year transitions

Prior Authorization

Obtain authorization after transition fill if additional supply needed

After the one-time transition fill or allowed days supply has been provided, additional paid fills require that the member obtain prior authorization or a formulary exception because the Transitional Benefit Override (TBO) logic no longer applies once the allowed transition supply has been used.

Billing Rule

Point-of-sale transition processing via RxCLAIM

Process transition claims at point-of-sale using the RxCLAIM system's Transitional Benefit Override (TBO) logic so appropriate non-formulary or utilization-managed Part D drugs will adjudicate as transition fills automatically; the system applies specific POS messaging explaining paid or rejected claims and does not require a pharmacist to enter override codes for permitted transition fills.

Documentation Required

Send transition notices

Send written transition notices to members and notify prescribers: mail the member notice via U.S. first-class mail within three (3) business days of the temporary transition fill submit date (for LTC residents dispensed ≤14‑day increments, within three business days of the first temporary fill submit date); make reasonable efforts to notify prescribers by sending a cover letter and confidential patient profile via U.S. first-class mail.

Mail member notice within 3 business days of transition fill submit date
Send prescriber cover letter and confidential patient profile by U.S. first-class mail

Denial Risk

Denial possible when safety limits exceeded

Denials may occur if FDA-established or P&T-established safety limits (e.g., maximum dose or quantity limits) are exceeded during transition; before denying access to quantities or doses, the Plan Sponsor must verify an initial transition supply was provided up to the maximum limit and document that the member or prescriber was assisted in filing an exception or that an exception has been processed.

Billing Rule

Override early refill edits for LTC admission/discharge

For LTC admissions or discharges, early refill ('refill too soon') edits are not used to limit access; process a one-time override of the refill-too-soon edit for each impacted medication as needed to prevent gaps in therapy.

One-time override of early refill edits upon LTC admission or discharge to ensure continuity of therapy

Definitions & Background

The Plan Sponsor is committed to maintaining a Transition Program that adheres to CMS Part D goals and regulations: ensuring eligible Part D members promptly receive temporary transition supplies of non-formulary or utilization-managed drugs and providing members sufficient time to work with prescribers to switch to formulary alternatives or obtain prior authorization or formulary exceptions. The Program is administered consistent with applicable CMS regulations and manual guidance.

Formulary Exception (FE): Process defining when a Non-formulary medication is covered (or has specific copay) under a closed formulary design, including step therapy, dose restrictions, therapeutic substitution, or continued coverage when coverage discontinued for reasons other than safety or manufacturer withdrawal.

Prior Authorization (PA): Requirement that specific criteria be met before the drug is covered due to potential misuse/overuse or economic/clinical concern.

Quantity Limit (QL) Exception: Request requiring Medicare Part D sponsor–approved clinical criteria to be met before medication requesting more than the defined quantity limit will be paid.

Step Therapy (ST): Utilization management tool requiring use of one or more drugs in a step-wise manner for cost or quality reasons.

RxCLAIM System: Claims processing system designed for on-line, real-time adjudication of prescription drug claims at point-of-sale; contains TBO logic for transition processing.

Transitional Benefit Override (TBO): Logic in RxCLAIM used to process transition claims for non-formulary Part D drugs so transition fills pay without pharmacist override.

42 CFR 423.120(6)(3)	Medicare Part D transition requirements reference
42 CFR 423.154	Part D transition notice and LTC requirements
42 CFR 423.578(b)	Cost sharing and transition coverage regulations
CMS Prescription Drug Benefit Manual: Chapter 6	CMS guidance

OpenPayer

Medicare Formulary Transition

Coverage Summary

Medical-Necessity / Transition Criteria

Provider Actions & Operational Requirements

Regulatory & Code References

Definitions & Background

Medicare Determinations

Revision History