CurrentCDPHPPolicy H5938

Medicare Formulary Transition

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This policy governs the Plan Sponsor and PBM process for providing temporary transition supplies of non-formulary Part D drugs, including drugs subject to prior authorization, step therapy, or quantity limits, for Medicare Part D members in retail and long-term care settings.

Policy Summary

PayerCDPHP

PolicyMedicare Formulary Transition

Policy CodePolicy H5938

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionWork with the member to switch to an appropriate formulary alternative or submit a prior authorization or formulary exception request based on medical necessity.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

90 daysInitial transition period

1 month+Outpatient transition supply

31 daysLTC emergency supply

108 daysPaid-claim lookback

3 business days

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CurrentCDPHPPolicy H5938

Medicare Formulary Transition

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Policy Summary

PayerCDPHP

PolicyMedicare Formulary Transition

Policy CodePolicy H5938

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionWork with the member to switch to an appropriate formulary alternative or submit a prior authorization or formulary exception request based on medical necessity.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

90 daysInitial transition period

1 month+Outpatient transition supply

31 daysLTC emergency supply

108 daysPaid-claim lookback

3 business days

Transition notice deadline

Transition Benefit Coverage Criteria

Eligibility for transition benefit

Transition coverage applies when both an eligible member circumstance and an applicable Part D drug circumstance are present.

ALL of the following

Eligible member circumstance
- Member is a new Part D enrollee following the annual coordinated election period.
- Member is newly eligible for Medicare and is transitioning from other coverage.
- Member switches from one Part D plan to another after the start of the contract year.
- Member is affected by a negative formulary change across contract years.
- Member resides in a long-term care facility.
Applicable drug circumstance
- Drug is a Part D drug that is not on the Plan Sponsor's formulary.
- Drug is on the formulary but requires prior authorization.
- Drug is on the formulary but requires step therapy.
- The approved quantity limit is lower than the member's current dose.

Transition supply by setting

The transition supply depends on the dispensing setting and applies during the initial enrollment period unless otherwise stated.

ANY of the following

In an outpatient or retail setting, provide at least a month's supply during the first 90 days of enrollment, beginning on the effective date of coverage.At least 1 month's supply; first 90 days
If the outpatient prescription is written for less than a month's supply, permit multiple fills to provide at least a month's supply.At least 1 month's supply
In an LTC setting, provide at least a month's supply, or a larger non-breakable supply, with refills as needed and consistent with the applicable LTC dispensing increment during the first 90 days of enrollment.At least 1 month's supply; first 90 days

Transition extensions and contract-year continuity

Transition access may continue when an exception or appeal is unresolved and may carry across contract years in specified circumstances.

ANY of the following

Continue necessary Part D drug access on a case-by-case basis when an exception request or appeal has not been processed by the end of the minimum transition period, until the member switches to an appropriate formulary drug or an exception decision is made.
For a current member affected by a negative formulary change, provide a transition process at the start of the new contract year when the member has paid claim history for the drug within a designated lookback period.Minimum 108 days of paid claim history
For a current member affected by a negative formulary change, effectuate the transition before the beginning of the new contract year.
Extend the transition program across contract years when the member enrolls with an effective date of November 1 or December 1 and needs access to a transition supply.

Operational Timeframes and Supply Limits

Initial transition period

DurationFirst 90 days of enrollment

Start dateBeginning on the member's effective date of coverage

Applicable settingsOutpatient and long-term care settings

Outpatient transition supply

Minimum supplyAt least a month's supply

Prescription written for lessMultiple fills are permitted to provide at least a month's supply

Non-breakable products

Provider and Plan Sponsor Actions

Prior Authorization

Act After a Temporary Transition Fill

After a temporary transition fill, work with the member to switch to an appropriate therapeutically equivalent formulary drug or submit the applicable prior authorization or formulary exception request. The Plan Sponsor may extend transition access case by case when an exception or appeal remains unresolved.

Review the temporary-fill notice and coordinate the next step before the transition period ends.
Use the available PA or formulary exception process when a formulary alternative is not appropriate.

Documentation Required

Document Medical Necessity for an Exception

Support a formulary exception by documenting medical necessity for the requested non-formulary drug. Identify formulary alternatives that the member has tried and failed, or explain why available alternatives are contraindicated, likely to be less effective, or likely to cause an adverse reaction or other harm.

Key Terms

Formulary Exception (FE)

DefinitionAn exception process that defines when a non-formulary medication is covered, or has a specific copay, under a closed formulary prescription drug benefit design

Covered circumstancesMay address dose restrictions, step therapy, therapeutic substitution, or continued coverage after a non-safety formulary discontinuation

Part D contextApplies to non-formulary medication coverage under the prescription drug benefit

Prior Authorization (PA)

DefinitionA requirement that specific criteria be met before a drug is covered or has a specific copay under a prescription benefit

Why appliedMedications may be selected because of actual or potential misuse, overuse, or inappropriate use

Policy Summary

PayerCDPHP

PolicyMedicare Formulary Transition

Policy CodePolicy H5938

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionWork with the member to switch to an appropriate formulary alternative or submit a prior authorization or formulary exception request based on medical necessity.

SourceLink

On This Page

After the LTC transition period expires, provide a 31-day emergency supply of a non-formulary Part D drug, or a larger non-breakable supply, while an exception or prior authorization is requested.At least 31 days

A larger days' supply is permitted when the smallest unit, required packages, or billing unit exceeds a month's supply

LTC transition supply

Minimum supplyAt least a month's supply

Non-breakable productsA larger days' supply is permitted when the product cannot be broken and its unit, package, or billing requirements exceed a month's supply

Refills and dispensingRefills are provided as needed, consistent with the applicable LTC dispensing increment; a prescription written for less is honored

LTC emergency supply

Supply after transition period31-day emergency supply of non-formulary Part D drugs

Prescription written for lessThe supply may be less than 31 days when the prescriber writes the prescription for less

PurposeAllows time to request an exception or prior authorization

Contract-year lookback

Minimum lookback108 days of paid claim history

ApplicabilitySupports transition for current members affected by negative formulary changes across contract years

Timing optionTransition is provided at the start of the new contract year or effectuated before the new contract year begins

Cross-contract-year paid-claim lookback

Minimum period108 days

Evidence requiredA history of paid claims for the drug within the designated lookback period

UseSupports a transition process at the start of the new contract year for affected current members

Initial LTC transition period

Duration90 days after enrollment

SettingLong-term care facility

Coverage during periodTransition supply of non-formulary Part D drugs

LTC emergency supply

Minimum supplyAt least 31 days of medication

Eligibility timingAvailable after the member's transition period has expired while an exception or prior authorization is requested

ExceptionsA shorter prescription or non-breakable product, package, or billing-unit characteristics may require a different days' supply

Member transition notice

Notice deadlineWithin three business days of the temporary transition-fill submit date

Mailing methodWritten notice is sent by U.S. first-class mail

LTC multiple suppliesFor LTC residents receiving 14-day-or-less increments, notice is sent within three business days of the first temporary-fill submit date

Non-model Transition Notice CMS review

CMS review period45 days

Notice typeNon-model Transition Notice

Submission purposeMarketing review by CMS

Document the diagnosis and relevant treatment history.
Explain why each applicable formulary alternative is ineffective or clinically inappropriate.

Unsupported block type: step_therapy

Unsupported block type: billing_rule

Unsupported block type: denial_risk

Unsupported block type: prior_auth

Prior Authorization

Coordinate Level-of-Care Transitions

Coordinate exception or prior-authorization requests when a member changes level of care, including a move into or out of an LTC facility. During these unplanned transitions, work promptly with the Plan Sponsor to maintain access to medically necessary Part D therapy.

Identify medications affected by the setting change and submit the required request.
Use the expedited process when the member's health condition requires it.
Coordinate any refill-too-soon override when the member cannot access the remainder of a prior supply.

Unsupported block type: billing_rule

Note

Follow Up on the Transition Notice

After a transition notice is issued, work with the member and prescriber to satisfy utilization-management requirements or identify an appropriate covered formulary alternative. Submit supporting PA or exception materials promptly; request forms are available to members and prescribers by mail, fax, email, and the Plan Sponsor or PBM website.

The written notice is sent within three business days of the temporary-fill submission date, including for applicable LTC 14-day-or-less dispensing increments.
Review the notice's temporary-fill explanation, alternative-therapy instructions, exception rights, and exception-request procedures.
Respond to follow-up requests from the Plan Sponsor and provide the prescriber's supporting documentation.
Coordinate with the Plan Sponsor when a prescriber notification or confidential patient profile identifies the affected drug and reason for notice.

Unsupported block type: denial_risk

Concern addressedThe concern may be clinical, economic, or both

Quantity Limit (QL) Exception

DefinitionA request requiring approved clinical criteria to be met before a medication exceeding the defined quantity limit is paid

Who may requestThe enrollee, the enrollee's appointed representative, a physician, or another authorized prescriber

Benefit contextThe request applies under the enrollee's prescription benefit for a Medicare Part D drug

RxCLAIM System

DefinitionA claims processing system designed for online, real-time adjudication of prescription drug claims

Processing pointPoint of sale

Policy useSupports real-time processing of prescription claims and transition-benefit logic

Step Therapy (ST)

DefinitionA utilization management tool requiring use of one or more drugs in a step-wise, graduated manner

PurposeUsed for cost or quality reasons

Response to inadequate responseIf the member does not respond satisfactorily, progressively more or different therapy may be prescribed as needed

Utilization Management (UM)

DefinitionEvaluation of the medical necessity, appropriateness, and efficiency of health care services, procedures, and facilities

Governing standardEvaluation is performed under the provisions of the applicable health benefits plan

Alternate termSometimes called utilization review

Transition extension

DefinitionContinued access to necessary Part D drugs after the minimum transition period

When availableProvided case by case when an exception request or appeal has not been processed by the end of the minimum transition period

End pointContinues until an appropriate formulary drug is selected or an exception decision is made

Emergency supply

DefinitionA supply of a non-formulary Part D drug provided to an LTC resident after the normal transition period

Pending processProvided while an exception or prior authorization is requested

Minimum amountAt least 31 days unless the prescription or product characteristics require otherwise

Re-enrolled member

DefinitionA member who leaves one plan, enrolls in a different plan, and later re-enrolls in the original plan

Transition treatmentTreated as a new member for purposes of receiving transition benefits

Applicable dateThe re-enrollment date in the original plan is used to apply transition benefits

Level-of-care change

DefinitionA change from one treatment setting to another

Potential impactMay create an unplanned transition requiring access to a prescribed regimen that is not on the formulary

Examples of supportMembers and prescribers must use the Plan Sponsor's exceptions and appeals processes, with determinations processed as expeditiously as the member's health condition requires