(Medicare Part D Manual)

 The proposed change on its face in the context of substantially discouraging enrollment by certain beneficiary groups.    The impact of the proposed change on the formulary as a whol e to ensure the formulary continues to satisfy the minimum formulary requirements established by CMS.   Because these additional types of change requests will require more extensive review by CMS, Part D sponsors must not implement such changes until they r eceive explicit notification of approval from CMS and must not issue any beneficiary notices of such forthcoming changes prior to receiving explicit and affirmative CMS approval.  30.3.4 - Provision of Notice Regarding Formulary Changes  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07- 18-08)  Part D sponsors must provide notice of formulary changes as outlined in the following sections.  Additionally, for formulary maintenance changes (described in section 30.3.2), CMS will not require Part D  sponsors to wait for approval before sending notice of a proposed formulary change to required parties.  For these changes, a Part D sponsor may choose to provide notice to CMS and other required parties at the same time.  Part D sponsors will provide not ice to CMS via the HPMS system, which will also require plans to specify the intended effective date.  Although sponsors may provide notice to all required parties prior to receiving CMS approval, sponsors might prefer to wait so that they do not risk sending notice of a change that is subsequently disapproved by CMS.  For formulary non- maintenance or other changes (described in section 30.3.3.3), Part D sponsors must not issue any beneficiary notices until CMS has explicitly approved the non- maintenance change.   30.3.4.1 - Beneficiary Notice Requirements  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Prior to making any  negative formulary change during the contract year , a Part D sponsor must either:    Provide direct written notice to affected enrollees at least 60 days prior to the date the change becomes effective; or    At the time an affected enrollee requests a refill of the Part D drug, provide such enrollee with a 60 day supply of the Part D drug under the same terms as previously allowed and written notice of the formulary change.   If a beneficiary is not affected by a formulary change (in other words, exempted from a formulary change), notice is not required.   The written notice must contain the following information:   The name of the affected covered Part D drug;    Whether the Part D sponsor is removing the covered Part D drug or changing its preferred or tiered cost -sharing status;    The reason why the Part D sponsor is removing such covered Part D drug from the formula ry, or changing its preferred or tiered cost -sharing status;    Alternative drugs in the same therapeutic category or class or cost -sharing tier and expected cost -sharing for those drugs; and    The means by which enrollees may obtain a coverage determination under 42 CFR 423.566 or exception under 42 CFR 423.578.  As an alternative to providing written notice, Part D sponsors may provide such notice electronically if, and only if, an enrollee affirmatively elects to receive such notice electronically.   30.3.4.2 - Notice for Other Entities  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Prior to making any  negative formulary change during the contract year , a Part D sponsor must provide at least 60 days  notice to CMS, State Pharmaceutical Assistance Programs (as defined in 42 CFR 423.454), entities providing other prescription drug coverage (as described in 42 CFR  423.464 (f)(1), authorized prescribers, network pharmacies, and pharm acists prior to the date such change becomes effective.   To the extent possible, sponsors may elect to provide State Pharmaceutical Assistance Programs, entities providing other prescription drug coverage (as described in 42 CFR 423.464(f)(1), authorized prescribers, network pharmacies, and pharmacists an annual notice providing information on the sponsors formulary change policy (i.e., length of notice, methods of communication with beneficiaries, and any electronic notices providers may receive at the point -of-sale regarding formulary status) and the sponsors Web site where these entities can verify the formulary status of particular drugs.   30.3.4.3 - Provision of Notice Regarding Formulary Changes Subsequent to Removal from the Market  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Part D sponsors may immediately remove from their formularies covered Part D drugs deemed unsafe by the FDA or removed from the market by their manufacturer without meeting the advance notice requirements specified in this section.  However, Part D sponsor s must provide retrospective notice of any such formulary changes to affected enrollees, CMS, State Pharmaceutical Assistance Programs (as defined in 42 CFR 423.454), entities providing other prescription drug coverage (as described in 42 CFR  423.464 (f)(1), authorized prescribers, network phar macies, and pharmacists consistent with the requirements set forth in this section.  CMS expects that this retrospective notice will occur as soon as possible to inform enrolled beneficiaries of potential safety concerns surrounding medications they are ta king, especially those beneficiaries who may have a 90 day supply and will not interact with the pharmacy for an extended period.  In instances where there has been an announcement of a market withdrawal, but the withdrawal has not yet taken place, Part D sponsors may opt to either remove the drug immediately with a retrospective notice to affected enrollees or provide an advance notice.  CMS expects Part D sponsors to consider all pertinent information available from the FDA related to the withdrawal.   30.3.4.4 - Notice Requirements for Pending Formulary Changes  (Rev. 2, Issued:  07- 18-08; Effective/Implementation Date:  07- 18-08)  When a Part D sponsor notifies CMS of a formulary change in HPMS, the change is assigned a prospective effective date.  Durin g the period of time between when a Part D sponsor has notified CMS of a prospective change and the actual effective date of that change, Part D sponsors must ensure appropriate beneficiary protections are implemented should a beneficiary who has not been notified of the change present with a new prescription for the drug whose formulary status is changing.   For maintenance changes outlined in section 30.3.3.2, the Part D sponsor must implement the beneficiary notice requirements contained in section 30.3.4.1 (i.e., 60 days of advance written notice before implementing the change for the individual).  For example, assume on March 1st, a Part D sponsor notifies CMS via HPMS that it is removing a brand name drug from its formulary due to the availability of a new generic.  The sponsor indicates the effective date for this formulary change will be May 1st.  If a beneficiary were to present on April 1st with a new prescription for the brand name drug pending removal, the Part D sponsor would provide written notic e of the change and not implement the change until June 1st, in order to provide the full 60 days of advance notice to that beneficiary.   A Part D sponsor may elect to provide written notice to all of its enrollees of a pending formulary maintenance change in lieu of notifying only the affected enrollees.  Such an approach would satisfy the beneficiary notice requirements in section 30.3.4.1 because all enrollees, including affected enrollees would receive advance notice of a formulary change.  In addit ion, it would preclude the plan from needing to extend the formulary change effective date for those enrollees who present with a new prescription for the drug between the date when a Part D sponsor notifies CMS of a prospective change and the actual effec tive date of that change.  However, Part D sponsors are still required to provide advance written notice of a formulary change and a 60 day -supply of the drug whose formulary status is changing to those beneficiaries who enroll in the plan after the initia l advance formulary change notice, as described above.   For non- maintenance changes outlined in section 30.3.3.3, the Part D sponsors must not implement the formulary change for a beneficiary who presents with a new prescription for a pending formulary dru g.  In accordance with our non- maintenance formulary change policy, enrollees currently taking the affected drug must be exempt from the formulary change for the remainder of the contract year.  For example, assume on March 1st, a Part D sponsor notifies CMS via HPMS it is removing a drug from its formulary with no replacement.  CMS approves the change.  The sponsor indicates the effective date for this formulary change will be May 1st.  If a beneficiary were to present on April 1st with a new prescription for the drug pending removal, the Part D sponsor would not implement this change for the beneficiary for the remainder of the contract year.   30.3.5 - Formulary Change Notice in Advance of Upcoming Contract Year  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  Enrollees must receive an annual notice of change (ANOC) by September 30th  prior to the upcoming contract year.  The ANOC is intended to outline benefit changes for the upcoming year including changes in cost -sharing and drug tier structures.  Because the upcoming years formulary is viewed as a new formulary, Part D sponsors are not required to identify specific drug changes impacting enrollees in their explanation of benefits, or provide a 60- day notice of changes for the upcoming years formulary.  However, enrollees must receive a comprehensive or abridged formulary with the ANOC, which will provide enrollees with at least 90 days to review the new formulary to determine if their  medications are covered and whether the cost -sharing for their covered medications will change in the upcoming contract year.   30.4 - Transition  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  A Part D sponsor must provide for an appropriate transition process for certain enrollees who are prescribed Part D drugs that represent ongoing therapy with that drug, but  that are non-formulary .  The purpose of providing a transition supply is to promote  continuity of care and avoid interruptions in drug therapy while a switch to a therapeutically equivalent drug or the completion of an exception request to maintain coverage of an existing drug based on medical necessity reasons can be effectuated .  The t ransition policy must satisfy the requirements in the following sections.  For the purposes of transition requirements in section  30.4, CMS defines non- formulary Part D drugs to mean: (1) Part D drugs that are not on a sponsors formulary, (2) drugs previously approved for coverage under an exception once the exception expires, and ( 3) Part D drugs that are on a sponsors formulary but require prior authorization or step therapy , or that have an approved QL lower than the beneficiarys current dose, under a plans utilization management requirements.  This is because  a formulary drug whose access is restricted via UM  requirements is essentially equivalent to a non- formulary Part D drug to the extent that the relevant UM requirements are not met for a particular enrollee.   However, if the plans QL is equal to an FDA maximum dose limit, plans do not have to allow doses greater than this limit as part of a transition supply.  30.4.1 - Transition Requirements  (Rev. 18, Issued: 01- 15-16, Effective:  01-15-16; Implementation:  01-15-16)  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.