(Medicare Part D Manual)

 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.  Current Enrollees  - Part D sponsors that can identify objective information demonstrating that a meaningful transition has occurred (such as the adjudication of an exception request and/or evidence of a new prescription claim for a formulary alternative paid by the sponsor pr ior to the start of the new contract  year ) do not have to provide a transition supply in the new contract year for that beneficiary  as the next fill would either be a covered fill of the medication approved under the exception process or a covered fill of the formulary alternative that the enrollee transitioned to before the start of the new contract year .  However, lacking such documentation, the sponsor is expected to provide a transition supply in the new contract year and provide the corresponding trans ition notic e.  New Enrollees  - Part D sponsors  must extend their transition policies across contract years should a beneficiary enroll into a plan with an effective enrollment date of either November 1 or December 1 and need access to a transition supply.  For example, if a beneficiary enrolls effective December 1, in a plan whose transition policy affords a 90- day transition period for LTC enrollees and that beneficiary requires a transition supply in mid- December, the sponsor must offer a full 90- day tran sition period beginning December 1 and extending into the following contract year.  In addition, sponsors must send beneficiaries with a November 1 or December 1 effective enrollment date an ANOC as soon as practicable after the effective enrollment date.  This ANOC will still serve as advance notice of any formulary or benefit changes in the following contract year.  30.4.6 - Emergency Supply for Current Enrollees  in the LTC Setting  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Since, as a matter of general practice, LTC facility residents must receive their medications as ordered without delay, Part D sponsors must also cover emergency suppl ies of non- formulary Part D dru gs for LTC facility residents after the transition period.   During the first 90 days after enrollment, the enrollee will receive a transition supply  as described in section 30.4 .  However, to the extent that an enrollee in an LTC setting is outside his or her 90- day transition period, the sponsor must stil l provide an emergency supply of non-formulary Part D drugs while an exception or prior authorization request is being processed.  These emergency supplies of non- formulary Part D drugs must be for at least 31 days of medication, regardless of dispensing i ncrements, unless the prescription is written by a prescriber for less than 31 days.  In cases where the smallest available marketed package size is not available for less than a 31- day supply, the sponsor must still provide  an emergency supply when required.  Part D sponsors and their processors must determine how best to process claims in such cases.  Multiple 14- day or less supplies can be supplied for brand name drugs to meet a minimum of a 31- day emergency supply requirement.  A sponsor is not expected to provide more than a one -time 31 -day emergency fill of a particular drug per LTC stay.   30.4.7 - Level of Care Changes (Rev. 10, Issued: 02- 19-10, Effective/Implementation Date: 03- 01-10)  In addition to circumstances impacting new en rollees who may enter a plan with a medication list that contains non -formulary Part D drugs, other circumstances exist in which unplanned transitions for current enrollees could arise and in which prescribed drug regimens may not be on sponsor formularies .  These circumstances usually involve level of care changes in which a beneficiary is changing from one treatment setting to another.  For example, beneficiaries who enter LTC facilities from hospitals are sometimes accompanied by a discharge list of medi cations from the hospital formulary with very short term planning taken into account (often under 8 hours).  Similar situations may exist, for example, for beneficiaries who are discharged from a hospital to a home; for beneficiaries who end their skilled nursing facility Medicare Part A stay (where payments include all pharmacy charges) and who need to revert to their Part D plan formulary; for beneficiaries who give up hospice status to revert to standard Medicare Part A and B benefits; for beneficiaries who end an LTC facility stay and return to the community; and for beneficiaries who are discharged from psychiatric hospitals with drug regimens that are highly individualized.  For these unplanned transitions, beneficiaries and providers must clearly avai l themselves of sponsor exceptions and appeals processes.  CMS has streamlined the grievance, coverage determination, and appeals process requirements in order to ensure that beneficiaries receive quick determinations regarding the medications they need.  In all cases, CMS makes it clear that a Part D sponsor is required to make coverage determinations and redeterminations as expeditiously as the enrollees health condition requires.  Effective transition of care at time of discharge to home is a major conc ern in LTC. Ensuring appropriate medication reconciliation in the community is a safety issue, and requires pre -discharge planning. This optimally involves prescriptions being written and transmitted to the patients families in the week before discharge, to assure that the medications are obtained in advance of community discharge, to prevent a gap in care. The billing date may appear to overlap the skilled nursing home stay, but the medications, which may be dispensed by either the LTC or a retail pharmac y, are to be used in the home setting. While Part A does provide reimbursement for a limited supply to facilitate beneficiary discharge, beneficiaries must be permitted to have a full outpatient supply available to continue therapy once this limited supply is exhausted. This is particularly true for beneficiaries using mail- order pharmacy, home infusion therapy, or residing in rural areas where obtaining a continuing supply of drugs may involve certain delays. The current standard of care promotes caregiv ers receiving outpatient Part D prescriptions in advance of discharge from a Part A stay.   When an enrollee is admitted to or discharged from an LTC facility, he or she will not have access to the remainder of the previously dispensed prescription (through no fault of his or her own) and, therefore, sponsors must allow the enrollee to access a refill upon admission or discharge.  An early refill edit is a utilization management tool used to promote compliance and to prevent waste.  An early refill edit cann ot be used to limit appropriate and necessary access to an enrollee's Part D benefit.  For example, if a patient gets a prescription for 30 tablets for a 30 day supply (i.e., 1 tablet daily), but the prescriber changes the dose to 2 tablets daily after onl y 10 days, it would be inappropriate for a sponsor to deny as "too soon" a claim for a new prescription with the new dosage because the enrollee will not have enough medication to last until the originally scheduled refill date.   However, even with these protections, there may exist some period of time in which beneficiaries with level of care changes have a temporary gap in coverage while an exception is processed.  For this reason, CMS strongly encourages Part D sponsors to incorporate processes in their transition plans that allow for transition supplies to be provided to current enrollees with level of care changes.   30.4.8 - Edits for Transition Fills  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  A Part D sponsor must ensur e that an enrollee is able to obtain a temporary supply of non-formulary Part D drugs from a network pharmacy without unnecessary delays  in accordance with section 30.4.  Part D sponsors may only apply certain drug utilization management edits during a be neficiarys transition period.  Drug utilization management edits that are appropriate during a beneficiarys transition period include the following:    Edits to help determine Part A or  B vs. Part D coverage (see section 20.2) ;   Edits to prevent coverage of  non- Part D drugs (e.g. , excluded drugs such as a drug that may be used for sexual dysfunction, or formulary drugs being dispensed for an indication that is not medically accepted) (see sections 10.6 and 20) ; and    Edits to promote safe utilization of a Part D drug (e.g., a beneficiary -level opioid claim edit; quantity limits based on FDA maximum recommended daily dose such as APAP; early refill edits) (see section 30.2.2.2) .  CMS notes that although Part D sponsors may implement quantity limits that are based on approved product labeling during a beneficiarys transition period, to the extent that the prescription is dispensed for less than the written amount due to a plan edit, sponsors must still provide refills to  meet the  transition supply  requirement .  For example, if a beneficiary presents at a retail pharmacy with a prescription for 1 tablet per day for 30 days and a plan has a quantity limit edit in place that limits the days  supply to 14 per prescription for  safety purposes, the beneficiary would receive a 14 -day supply (consistent with the safety edit).  At the conclusion of the 14- day supply, the beneficiary should be entitled to another 16- day supply while he/she continues to pursue an exception with the P art D plan, or a switch to a therapeutic alternative that is on the plans formulary.   Irrespective of transition, all of these edits are subject to exceptions and appeals.  For example, if a quantity limit safety edit (based on an FDA  maximum recommended daily dose) results in the dispensing of a quantity that is less than indicated on the prescription and is less than the plan allowable days  supply (as determined by the prescribed daily dose), Part D sponsors must ensure that beneficiaries are made aware of this quantity limit and that an exception is required to obtain a greater quantity.  Part D sponsors must expeditiously process such exception requests so that beneficiaries will not experience unintended interruptions in medically necessary Part D drug therapies and/or will not inappropriately pay additional cost -sharing associated with multiple fills of lesser quantities when the originally prescribed doses of Part D drugs are medically necessary.   Beneficiary- level opioid point -of-sale claim edits  (and cumulative opioid MED edits, as noted in the guidance on safety edits in section 30.2.2.2) ma y be applied during transition.     If a beneficiary level point -of-sale opioid claim edit has been implemented, CMS expects the beneficiary to only be able to receive during a transition period the opioid dosage that has been determined to be medically necessary and appropriate, based upon the case management process.  In other words, if a sponsor currently has a beneficiary -level opioid claim edit in place in one of its Part D plans and the beneficiary enrolls in another one of the sponsors plans, or the sponsor has received information from the prior plan from which the beneficiary disenrolled and the sponsor is satisfied that the edit should be continued, the  sponsor may apply the edit during transition.   For new beneficiaries presenting with a prescription that represents ongoing therapy with a non-formulary opioid medication or a formulary opioid medication subject to PA or ST under the new plans utilizatio n management rules, a temporary supply can be provided during transition in accordance with this section, as long as the temporary transition fill does not exceed plan-level limits, cumulative opioid MED edits, or beneficiary -specific limits documented by the previous plan that the current plan also applied.  For non- formulary medications, the safety and dosing should be considered as part of the coverage determination process when such determinations are requested.  30.4.9 - Cost -sharing Considerations  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Starting in 2015, a Part D sponsor must charge cost sharing for a temporary supply of drugs provided under its transition process such that the following conditions are met:    For LIS  enrollees, a sponsor must not charge higher cost sharing for transition supplies than the statutory maximum copayment amounts.    For non- LIS enrollees, a sponsor must charge