Corporate Integrated Health Management Policy Title Number Current Effective Date Original Effective Date Replaces Cross Reference Medicare Part D Transition – CY 2015 CP.IHM.PH.006.v1.1 January 1, 2015 Purpose To ensure compliance with 42 CFR 423.120 (b) (3) regarding providing an appropriate transition process for members prescribed Part D drugs that are not on the plan’s formulary or Part D drugs on the formulary but require prior authorization or step therapy. Scope Applies to PREMERA and its subsidiaries and affiliates (“Premera” or the “Company”) and first tier, downstream and related entities for Medicare Advantage members with a prescription drug (Part D) benefit. Policy In compliance with CFR 423.120 (b) (3), Premera Blue Cross Medicare Advantage Plans (PBC) will maintain an appropriate transition process that includes a written description of how, for members whose current drug therapies may not be included in their new Part D plan’s formulary, it will effectuate a meaningful transition for: (1) the transition of new members into the prescription drug plan at the beginning of the contract year; (2) the transition of newly eligible Medicare members from other coverage at the beginning of a contract year; (3) the transition of individuals who switch from one plan to another after the start of the contract year; (4) members residing in long-term care (LTC) facilities; and (5) in some cases, current members affected by formulary changes from one contract year to the next. Transition supplies will be provided to allow the member and provider time to discuss alternatives and/or submit documentation for prior authorization review. 05/30/13 CP.IHM.PH.006.v1.0 N/A The transition policy will apply to non-formulary drugs, meaning both: (1) Part D drugs that are not on the formulary, and (2) Part D drugs that are on the formulary but require prior authorization or step therapy under the PBC utilization management rules. PBC will ensure procedures for medical review of non-formulary drug requests and when appropriate, a process for switching new Part D plan enrollees to therapeutically appropriate formulary alternatives failing an affirmative medical necessity determination. At point-of-service if PBC is not able to distinguish between a brand new non-formulary drug and an ongoing prescription for a non-formulary drug then both will be treated the same in the transition process. If a prescription is dispensed for less than the written amount due to a plan edit, such as quantity limits for safety purposes or drug utilization edits based on approved product labeling, PBC will provide refills for that transition supply. After members receive their Annual Notice of Change (ANOC) material, PBC will effectuate an appropriate and meaningful transition for current members whose drugs are Premera Blue Cross is an Independent Licensee of the Blue Cross Blue Shield Association 029331 (10-2014) Corporate Integrated Health Management Policy no longer on the formulary or have had new utilization management (UM) edits applied, by providing a transition process that is consistent with the transition process required for new members. PBC will provide a temporary supply of the Part D drug, if not medically contraindicated, and provide the members with a notice that they must either switch to an appropriate formulary drug or request an exception or coverage determination. If a member enrolls with PBC with an effective date of either November 1 or December 1 and requires access to a transition supply, PBC will extend the transition policy across the contact years. IMPLEMENTATION: PBC claims processing system capabilities will allow a one time, temporary supply of non-formulary Part D drugs, as described above, to accommodate the immediate needs of a member as well as to allow PBC and/or members time to work with the prescribing provider to switch to an appropriate therapeutically equivalent Part D drug or to complete an exception request to maintain coverage of an existing drug based on medical necessity. In order to assure that new members are able to leave a pharmacy with a temporary supply of non-formulary Part D drugs without unnecessary delays, PBC will utilize claims messaging that provides the pharmacy with a prior authorization code that can be used at point-of-service to override step-therapy and prior authorization edits during transition except for edits that are in place: (1) to determine Part B vs. Part D coverage; (2) to prevent coverage of non-part D drugs (i.e. excluded drugs); and (3) to promote safe utilization of a Part D drug (e.g., quantity limits based on FDA maximum recommended daily dose; early refill edits). PBC cost-sharing for a temporary supply of drugs provided under the transition process will never exceed the statutory maximum co-payment amounts for low-income subsidy (LIS) eligible enrollees. For non-LIS enrollees, PBC charges the same cost sharing for non-formulary Part D drugs provided during the transition that would apply for nonformulary drugs approved through a formulary exception in accordance with § 423.578(b) and the same cost sharing for formulary drugs subject to utilization management edits provided during the transition that would apply once the utilization management criteria are met. For members whose transition period has expired, this policy also establishes drug classes in situations which would allow members to continue established therapy upon prior authorization review request (non-formulary, prior authorization, step-therapy and quantity limit). PBC will send a written notice via U.S. First Class mail to each member within three (3) business days of a temporary transition fill. The notice will include the following elements: (1) an explanation that the transition supply provided is temporary and may not be refilled unless a formulary exception is approved; (2) instructions for the member to work with PBC and their prescriber to identify appropriate therapeutic alternatives that are on the formulary; (3) an explanation of the member’s right to request a formulary exception, and the member’s right to request an appeal if PBC issues an unfavorable Premera Blue Cross is an Independent Licensee of the Blue Cross Blue Shield Association Corporate Integrated Health Management Policy decision; and (4) a description of the procedure for requesting a formulary exception. For long-term care residents dispensed multiple supplies of a Part D drug in increments of 14 days or less, the written notice will be provided within 3 business days after adjudication of the first temporary fill. PBC will use the Centers for Medicare and Medicaid Services (CMS) model transition letter via the file-and-use process or submit a non-model Transition Notice to CMS for 45 day marketing review. PBC will also make reasonable attempts to notify prescribers of affected enrollees who receive a transition notice. PBC will provide point-of-sale notification to pharmacists, so that they can notify members about transition supplies, using current billing transaction response claims messaging following National Council for Prescription Drug Programs (NCPDP) 5.1 standards. When alternative transactional coding is implemented in a new version of the HIPAA standard, PBC will implement the appropriate system changes to incorporate any new additional messaging approved by the industry through NCPDP. Information regarding PBC transition is provided to members in pre-enrollment marketing materials, post-enrollment materials and website. PBC will make the transition policy available to members on our website that will also allow CMS to establish a link to the policy from the Medicare Prescription Drug Plan Finder website. PBC prior authorization or exception request forms are available upon request to both members and prescribing physicians in a variety of mechanisms that include mail, fax, email, and on the PBC website. PROCEDURE: For patients using retail pharmacies: 1. For new members, PBC transition policy will provide a 30-day fill (unless the prescription is written for less than 30 days), with multiple refills as necessary for up to a 90 day supply during the first 90 days of a members enrollment with PBC, beginning on the members effective date of coverage. 2. An enrollee’s transition period will be extended as needed on a case-by-case basis to the extent that their exception request or appeal has not been processed by the end of the minimum transition period. Until the transition is made, through a switch to an appropriate formulary drug, or a decision is made regarding an exception request, continuation of coverage is necessary unless the drug is not covered under Part D. 3. This temporary transition supply does not apply to CMS restricted drug categories and excluded drugs. PBC will not cover these drugs during the transition. The following are examples of commonly excluded categories not covered under Medicare Part D: • cough and cold preparations • erectile dysfunction (ED) drugs (Viagra, Cialis, Levitra, and Caverject) • vitamins, except prenatal vitamins • over-the-counter (OTC) drugs Premera Blue Cross is an Independent Licensee of the Blue Cross Blue Shield Association Corporate Integrated Health Management Policy For patients residing in a Long-Term Care Facility (as defined by CMS) In the long-term care setting: (1) the transition policy will provide for a 98 day fill consistent with the dispensing increment (unless the prescription is written for less), with refills provided if needed during the first 90 days of a beneficiary’s enrollment in the plan, beginning on the enrollee’s effective date of coverage; (2) after the transition period has expired, the transition policy provides for a 34-day emergency supply of nonformulary Part D drugs (unless the enrollee presents with a prescription written for less than 34 days) while an exception or prior authorization is requested; and (3) for enrollees being admitted to or discharged from an LTC facility, early refills are not used to limit appropriate and necessary access to their Part D benefit, and such enrollees are allowed to access a refill upon admission or discharge. 1. This temporary transition supply does not apply to CMS restricted drug categories and excluded drugs. PBC will not cover these drugs during the transition. The following are examples of commonly excluded categories not covered under Medicare Part D: • cough and cold preparations • erectile dysfunction (ED) drugs (Viagra, Cialis, Levitra, and Caverject) • vitamins, except prenatal vitamins • over-the-counter (OTC) drugs Post New Member Transition Continuation of Therapy: CRITERIA: 1. The medication was filled during the new member transition period. AND one of the following: 2. The medication is in one of the following CMS protected drug classes. • Anticonvulsants • Antidepressants • Antipsychotics • Anti-HIV • Immune Suppressants • Antineoplastics (Oncology) 3. The medication falls into one of the following USPDI drug classes: • Antiarrythmic Agents • Antiglaucoma Agents 4. Medical rationale that it is unsafe for the member to change to a preferred alternative. Violations of Policy Violations of this policy may be grounds for disciplinary action. The level of discipline is at the discretion of the Company, and may include any of the following: (1) verbal Premera Blue Cross is an Independent Licensee of the Blue Cross Blue Shield Association Corporate Integrated Health Management Policy Exception Process Laws, Regulations & Standards warning; (2) written warning; (3) suspension; (4) termination; and (5) restitution. Any exception to this Policy must be approved in advance by the VP, Pharmacy, Contracting and Consulting. References: 1. Medicare Prescription Benefit Drug Manual, Chapter 6- Part D Drugs and Formulary Requirements, Section 30.4-Transition, Rev.10, 02-19-10 2. 42 CFR 423.120 (b)(3) Controls The Compliance & Ethics Department and Pharmacy Department are responsible for ensuring that Premera is in compliance with this Policy through routine audits of transition fills. Policy Owner Chad Murphy, VP, Pharmacy, Contracting and Consulting Contact Any questions regarding the contents of this Policy or its application should be directed to Customer Service at 1-888-850-8526. TTY users should call 711. 08/04/14; 07/08/14; 05/13/14; 05/30/13 Approval Dates Approval IHM Programs Committee Print Name Chelle Moat, MD, Chair Signature Committee approval on file Date 05/13/14 Premera Blue Cross is an Independent Licensee of the Blue Cross Blue Shield Association
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