evekhm/cms_iom_500 huggingface dataset:
(Medicare Part D Manual)
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.
(Medicare Part D Manual)
 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.
(Medicare Part D Manual)
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)
(Medicare Part D Manual)
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).
(Medicare Part D Manual)
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
(Medicare Part D Manual)
 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.
(Medicare Part D Manual)
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.
(Medicare Part D Manual)
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)
(Medicare Part D Manual)
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
(Medicare Part D Manual)
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.
(Medicare Part D Manual)
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
(Medicare Part D Manual)
 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.