(Medicare Part D Manual)

A Part D sponsors transition process i s necessary with respect to the transition of : (1) new enrollees into prescription drug plans following the annual coordinated election period; (2) newly eligible Medicare beneficiaries from  other coverage; (3) enrollees who switch from one plan to another after the start of the contract year; (4) current enrollees affected by negative formulary changes (as defined in section 30.3.3.1) across contract years; and (5) enrollees residing in LTC facilities  (see section 30.4.6) .  See Appendix E for a listing of multiple scenarios when beneficiaries may be eligible for a transition fill under this guidance.   A Part D sponsors transition process must address situations in which an individual first presents at a network pharmacy with a prescription for a drug that is non- formulary, and should be presumed to be unaware of what is covered by the plan or of the sponsors exceptions process for providing access to Part D drugs that a re not covered.   A beneficiarys transition period begins with the date of each enrollment.  CMS receives frequent questions about who constitutes a new enrollee , and who constitutes a current enrollee affected by negative formulary changes, who are  entitled to a transit ion fill.  CMS believes these questions should first be considered in the context of the purpose of the transition policy.  The purpose of the transition policy  is to address situations when an enrollees ongoing drug therapy (whether the Part D sponsor is  able to actually ascertain ongoing therapy or not) could be potentially interrupted by a drug being non- formulary.  Thus, an enrollee who stays with the same contract number but changes PBPs is potentially entitled to a transition fill because the enrolle e could experience a negative formulary change .  However, just because a member s drug therapy could potentially be interrupted does not mean that the member will necessarily receive a transition fill.  In this example, for instance, the formulary may not have changed (which means there have also been no addition of utilization management edits).  Also, in some cases, the sponsor may have the claims history for the member from the just prior PBP , and thus, the sponsor may be able to determine that the membe r is not taking a non- formulary medication.  In other words, the sponsor may be able to determine at the POS that there will be no interruption in medication therapy for the member, and therefore the member is not eligible for a transition fill.   30.4.2 - General Transition Process  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07- 18-08)  Part D sponsors must ensure that they have provided their enrollees who have used a transition benefit with the appropriate assistance and information necessa ry to enable them to better understand the purpose of the transition.  Steps that sponsors should consider to ensure a meaningful transition include:    Analyzing claims data to determine which enrollees require information about their transition supply.    Contacting those enrollees to ensure they have the necessary information to enable them to switch to a formulary product or as an alternative to pursue necessary prior authorizations or formulary exceptions.   Increasing call center capacity, including phar macy help lines, to respond to an anticipated increase in call volume from affected enrollees regarding the sponsors transition process.   Making arrangements to continue to provide necessary drugs to an enrollee by extending the transition period, on a ca se-by-case basis, if the enrollees exception request or appeal has not been processed by the end of the minimum transition period.  30.4.3 - New Prescriptions Versus Ongoing Drug Therapy (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  CMS is aware that it may be difficult for Part D sponsors to distinguish between new prescriptions for non -formulary Part D drugs and refills for ongoing drug therapy involving non -formulary Part D drugs.  CMS believes a  minimum of a 108 day look -back  (consistent with other reviews)  is typically needed to adequately document  ongoing drug therapy.  Although Part D sponsors may be able to access prior drug claims history for an enrollee of an affiliated plan, or  may attempt to follow up with presc ribing physicians and pharmacies to ascertain the status of a prescription presented during the transition period, CMS clarifies that if a sponsor is unable to make this distinction at the point of sale, the sponsor is  required to provide the enrollee with a transition fill.  In other words, for transition purposes, a brand -new prescription for a non-formulary drug will not be treated any differently than an ongoing prescription for a non-formulary drug when a distinction cannot be made at the point of sale .  Generally, a sponsor may apply any CMS approved PA or ST after the transition fill has been satisfied if the sponsor determines that the tra nsition fill was the first fill.  However, for protected class drugs that are subject to PA or ST on new starts only , in ac cordance with section 30.2.5, if a sponsor allows an initial fill because it cannot determine at the point of sale that an enrollee is not currently taking the protected class drug (during transition or otherwise), the sponsor shall treat such en rollees as currently taking the drug.  Therefore, any protected class PA  or ST  requirements for new starts are no longer applicable after the first fill has been provide d.  30.4.4 - Transition Timeframes and Transition Supply  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Within the first 90 days of coverage under a new plan, plans must provide a transition  supply when the beneficiary requests a non- formulary drug.  This 90 day timeframe applies to retail, home infusion, long -term care, and mail -order pharmacies.  CMS believes it makes sense to both limit and define the amount of time during which a transition process is applicable.  Thus, plans are required to provide a temporary fill anytime during the first 90 days of a bene ficiarys enrollment in a plan.  However, since certain enrollees may join a plan at any time during the year, this requirement applies beginning on such  an enrollees first effective date of coverage instead of  to the first 90 days of the plan year.  If a n enrollee leaves a plan and re -enrolls during the original 90 day transition period, the transition period begins again with the new effective date of enrollment, because it is possible that the enrollees drug therapy changed while the enrollee was not w ith the plan and that therapy could be potentially interrupted.  However, if there is no gap in coverage, there is no new transition period.  30.4.4.1 - Timeframe and  Transition Supply  in the Retail Setting  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  In the retail setting, the transition fill of non- formulary Part D drugs  must be for at least 30 days, unless the prescription is written by a prescriber for less than 30 days . Part D sponsors  must allow multiple fills to provide at least 30 days of medication in accordance with 42 CFR 423.120(b)(3)(iii)(A).  If the smallest available mar keted package size exceeds  a 30 day supply , the sponsor must still provide  a transition supply when required.  Part D sponsors and their processors must determine how to process claims in such cases.   30.4.4.2 - Timeframe and Transition Supply  in the Long Term Care Setting  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  The transition supply  of non- formulary Part D drugs for a new enrollee in a n LTC facility must be for at least 91 days , and may be up to at least 98 days to be consistent with the applicable dispensing increment in the LTC setting (unless a lesser amount is actually prescribed by the prescriber).  Part D sponsors must allow multiple fills if needed to provide the full amount of medication prescribed, in accordance with 42 CFR 423.120(b)(3)(iii)(B ).  If the smallest available marketed package sizes do not align with this timeframe, the sponsor must still provide  a transition supply when required.  Part D sponsors and their processors must determine how to process claims in such cases.   CMS is requiring up to a 91-  to 98- day transition supply given that many LTC pharma cies and facilities must dispense brand name medications in 14- day or less increments.  Also , sponsors must honor multiple fills of non- formulary Part D drug s as necessary during the entire length of the transition period.   CMS is permitting Part D sponsor s the option of sending required transition fill notices to network long term care pharmacies.  In sending enrollees residing in LTC facilities a model transition notice via U.S. mail within 3 business days  of adjudication of the transition fill, Part D sponsors may instead elect to send the beneficiary transition notice to the LTC pharmacy serving the beneficiarys LTC facility.  The LTC pharmacy must then ensure delivery of the notice to the beneficiary within 3 business days of adjudication of the fill.   Part D sponsors electing this option must update their existing transition policy to specifically address that:   1. The sponsor maintains documentation of the LTC pharmacies willingness to be delegated transition notice responsibilities; and   2. The sponsor ma intains a fully functional electronic communication process with the LTC pharmacy once a transition fill has occurred (within 3 business days).   3. The LTC pharmacy will maintain a process that demonstrates notice has been provided to the beneficiary (or his/ her representative) within the 3 -day period.  This option must be in place prior to the start of the contract year; otherwise, the Part D sponsor must continue to provide notice directly to the beneficiary (or his/her designated representative) via U.S. ma il.  30.4.4.3 - Transition Extension  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07- 18-08)  A Part D sponsor may need to make arrangements to continue to provide necessary drugs to an enrollee via an extension of the transition period, on a  case -by-case basis, to the extent that his or her exception request or appeal has not been processed by the end of the minimum transition period.  It is vital that sponsors give affected enrollees clear guidance regarding how to proceed after a temporary fill is provided, so that an appropriate and meaningful transition can be effectuated by the end of the transition period.  Until that transition is actually made, however, either through a switch to an appropriate formulary drug, or a decision is made regarding an exception request, continuation of drug coverage is necessary, other than for drugs not covered under Part D.  30.4.5 - Transition Across Contract Years (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  After enrollees r eceive their ANOC i n a given year, CMS expects sponsors to select at least  one of the following two options for effectuating an appropriate and meaningful transition for enrollees whose drugs will be affected by negative formulary  changes in the upcoming year :   Provide a transition process for current enrollees at the start of the new contract year .  In order to prevent coverage gaps, sponsors choosing this option are expected to provide a transition supply of the requested prescription drug beginning January 1 and provide enrollees with the required transition notice; or    Effectuate a transition for current enrollees prior to the start of the new contract year .  In effectuating this transition, sponsors must aggressively work to (1) prospectively transitio n current enrollees to a therapeutically equivalent formulary alternative; and (2) adjudicate any requests received for exceptions to the new formulary prior to the start of the contract year  (consistent with chapter 18, section 30.2.2, available at https://www.cms.gov/Medicare/Appeals -and-Grievances/MedPrescriptDrugApplGriev/Downloads/Chapter18.zip ).  However, if sponsors have not successfully transitioned affected enrollees to a therapeutically equivalent formulary alternative or adjudicated an exception request prior to January 1 , they will be expected to provide a transition supply beginning January 1 and the required transition notice .  If a sponsor approves an exception request pursuant to this section, the sponsor must authorize payment prior to January 1 of the new contract year.