Policy and Procedure No: 93608 PHP Transition Process Title: Part D Transition Process Department: Pharmacy Services, Managed Care Effective Date: 1/1/2006 Supercedes Policy No: PH 8.0 Reviewed/Revised by: Molly Colombo, PharmD Review/Revision Date: 5/2013 Indicate any regulatory or accrediting standards or requirements addressed by this policy: California Florida DHCS AHCA NCQA AAAHC CMS Other Applicable Departments: All AHF Medical Nursing HCC Admin Public Health Managed Care Cross References: Purpose: To describe Positive Healthcare Partners policy and procedures that ensure that new and current PHP enrollees are provided continued Part D drug coverage and will have sufficient time to work with their health care providers to select a therapeutically appropriate formulary alternative or to request a formulary exception based on medical necessity when indicated. This policy is administered jointly with PHP s Pharmacy Benefits Manager (PBM) in a manner that is timely, accurate and compliant with all relevant CMS guidance and requirements as per 42 CFR 423.120(b)(3). Policy: This policy provides for: 1. An appropriate transition process for new and current PHP enrollees who received nonformulary Part D covered drugs; 2. Enrollees who are enrolled in PHP H5852 or H3132 will be evaluated for the medical necessity for a non-formulary drug during the transition period; 3. An expedited transition to therapeutically equivalent formulary drugs for enrollees who experience level of care changes; and 4. Non-formulary drugs offered during the transition process will include (a) Part D drugs that are not on PHP s formulary; and (b) Part D Drugs that are on PHP s formulary but require prior authorization or step therapy. 5. PHP will submit a copy of this Policy annually with its formulary submission and upon request to CMS. Definitions/Applicability: a) Transition Population i) PHP will maintain an appropriate transition process consistent with 42 CFR 423.120(b)(3) that includes a written description of how, for enrollees whose current drug therapies may not be included in their new Part D plan s formulary, it will effectuate a meaningful transition for: (1) new enrollees into prescription drug plans at the beginning of a contract year; (2) the transition of newly eligible Medicare beneficiaries from other coverage at the beginning of a contract year; (3) the transition of individuals who switch from one plan to another after the beginning of a contract year; - 1 -
(4) enrollees residing in long-term care (LTC) facilities; and (5) in some cases, current enrollees affected by formulary changes from one contract year to the next b) Transition Period i) PHP allows a minimum of 90 days from the start of coverage under a new plan. The 90 days are calculated from the member s Part D plan start date. PHP will extend its transition policy across contract years should a beneficiary enroll in a plan with an effective enrollment date of either November 1 or December 1 and need access to a transition supply. Procedure: 1) Implementation Statement: Partnership with PBM for Implementation of Transition Policies a) PHP implements transition policies in conjunction with the PBM at the pharmacy point of sale through the following mechanisms that are jointly maintained and monitored: (1) Claims Adjudication System: The Point of Sale transaction system operated by the PBM allows the provision of a temporary supply of non-formulary Part D drugs in order to accommodate the immediate needs of PHP enrollees, as well as to allow the enrollee and PHP sufficient time to work with the prescriber to make an appropriate switch to a therapeutically equivalent medication or to complete an exception request to maintain coverage of the existing drug prescription based on medical necessity reasons. (2) Edits During Transition: During an enrollee s transition period, the only edits that are enforced by the PBM s claims adjudication system are (1) edits to help determine Part B vs. Part D coverage (2) edits to help prevent coverage of non-part D drugs (i.e. excluded drugs); and (3) edits to help promote safe utilization of a Part d drug (i.e. quantity limits based on FDA maximum recommended daily dosing, early refill edits). The claims system also ensures that refills for transition prescriptions dispensed for less than the written amount due to quantity limits for safety purposes or drug utilization edits based on approved product labeling are provided. (3) Pharmacy Overrides at Point-Of-Sale: During enrollees transition periods, all edits (with the exception of those outlined in part b. above) associated with non-formulary drugs are automatically overridden by the PBM s claims adjudication system at the point-of-sale. (4) Electronic Messaging for Transition Fills (a) Until such time as alternative transactional coding is implemented in a new version of the HIPAA standard, PHP has implemented either: (i) appropriate system changes to achieve the goals of additional new messaging approved by the industry through NCPDP to address clarifying information needed to adjudicate a Part D claim, or (ii) alternative approaches that achieve the goals intended in the messaging guidance. b) PHP & the PBM ensure that step therapy and prior authorization edits other than those that are in place as described above are resolved at point-of-sale. Pharmacies can also contact the PHP pharmacy help desk during PHP business hours or the PBM pharmacy help desk after PHP business hours (24/7 coverage) for immediate assistance with point-of-sale overrides. c) PHP and the PBM will ensure that it will apply all transition processes to a brand-new - 2 -
prescription for a non-formulary drug if it cannot make the distinction between a brand-new prescription for a non-formulary drug and an ongoing prescription for a non-formulary drug at the point-of-sale. 2) Transition Fills for enrollees in Outpatient Settings a) In the retail setting, PHP will approve a one-time, temporary 30-day supply anytime during the first 90 days of enrollment beginning on the enrollee's effective date of coverage to enrollees requesting prescriptions at network pharmacies whether the drugs are non-formulary, require prior authorization, or are subject to step therapy. i) If the prescription is written for less than 30 days PHP will allow multiple fills to provide up to a total of 30 days supply of the drug. b) The Plan Pharmacist is available for prescriber consultation in order to assist in the determination of therapeutic equivalent transitions. c) PHP will apply appropriate cost-sharing amounts for the temporary supply of transition drugs provided. i) Cost-sharing for transition supplies for low-income subsidy eligible will never exceed the statutory maximum co-payments for the plan year. ii) Non-LIS enrollees will be charged cost-sharing based on one of PHP s CMS approved drug cost-sharing tiers. The cost-sharing will be consistent with cost-sharing for non-formulary drugs approved under a coverage exception. 3) Transition Fills for enrollees in Long Term Care Settings a) The PHP transition process takes into account the unique needs of residents of LTC facilities who may enroll in a new Part D plan. b) Residents of LTC facilities are more likely to be receiving multiple medications for which simultaneous changes could significantly impact the condition of the enrollee. c) In the long-term care setting: i) the transition policy provides for a 91 to 98 day fill consistent with the dispensing increment (unless the enrollee presents with a prescription written for less), with refills provided if needed during the first 90 days of a beneficiary's enrollment in a plan, beginning on the enrollee's effective date of coverage; ii) after the transition period has expired, the transition policy provides for a 31-day emergency supply of non-formulary Part D drugs (unless the enrollee presents with a prescription written for less than 31 days) while an exception or prior authorization is requested; and for enrollees being admitted to or discharged from a LTC facility, early refill edits 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. d) For enrollees being admitted to or discharged from a LTC facility, early refill edits 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. 4) Emergency Supplies and Level of Care Changes for Current Members a) An Emergency Supply is defined by CMS as a one-time fill of a non-formulary drug that is necessary with respect to current members in the LTC setting. Current members that are in need of a one-time Emergency Fill or that are prescribed a non-formulary drug as a result of a level of care change can be placed in transition via an NCPDP pharmacy submission clarification code. The Plan can also accommodate a one-time fill in these scenarios via a manual override at point-of-sale. b) Upon receiving a D.0 LTC claim transaction where the pharmacy submitted a Submission - 3 -
Clarification Code (SCC) value of 18, which indicates that the claim transaction is for a new dispensing of medication due to the patient s admission or readmission into an LTC facility, the PBM s claims adjudication system will recognize the current member as being eligible to receive transition supplies and will only apply the point-of-sale edits described above. In this instance, the Plan does not need to enter a point-of-sale override. 5) Transition Across Contract Years a) For current enrollees whose drugs are no longer on the Sponsor's formulary, or remain on the formulary but to which new prior utilization or step therapy restrictions are applied, Sponsor will effectuate a meaningful transition by either: (1) providing a transition process consistent with the transition process required for new enrollees beginning in the new contract year; or (2) effectuating a transition prior to the beginning of the new contract year. b) POS logic is able to accommodate option 1 by allowing current members to access transition supplies at the point-of-sale when their claims history from the previous calendar year contains an approved claim for the same drug that the member is attempting to fill through transition and the drug is considered a negative change from one plan year to the next. To accomplish this, POS looks for Part D claims in the member s claim history that were approved prior to January 1 of the new plan year, and that have the same HICL, Dosage Form, Product and Indicator values as the transition claim. c) Negative changes are changes to a formulary that result in a potential reduction in benefit to beneficiaries. These changes can be associated to removing the covered Part D drug from the formulary, changing its preferred or tiered cost-sharing status, or adding utilization management. The transition across contract year process is applicable to all drugs associated to mid-year and across plan-year negative changes 6) Transition Extension a) PHP will make arrangements to continue to provide necessary drugs to a member 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. b) PHP will 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. c) Until that transition is actually made, however, either through a switch to an appropriate formulary drug, or decision of an exception request, continuation of drug coverage is necessary, other than for drugs not covered under Medicare Part D. 7) General Transition Processes & Procedures a) PHP s transition process includes, but is not limited to: i) Analyzing the Transition Notification File provided daily by the PBM to determine which enrollees or prescribers require follow-up regarding the transition drug they have received. ii) Contacting identified enrollees when information is available 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. iii) Continuing education to increase staff capacity to respond to formulary exceptions requests. iv) Monitoring Call Center Activity, including PBM pharmacy help lines, to respond to calls from affected enrollees regarding the PHP transition process. v) Collaborating with Member Services, Chronic Care Management and Prescribers to continue to provide necessary drugs to a member by extending the transition period, on a case-by-case basis, if the enrollee s exception request or appeal has not been processed by - 4 -
the end of the minimum transition period. vi) Instructions to the member for a non-formulary transition fill. The instructions include, at a minimum, information which explains: (1) The transition supply provided is temporary and may not be refilled unless a formulary exception is approved; (2) The enrollee should work with PHP as well as his/her health care provider to identify appropriate therapeutic alternatives that are on the plan s formulary and that will likely reduce his or her costs; (3) The member s right to request a formulary exception; (4) The timeframes for processing the exception; (5) The member's right to request an appeal if PHP issues an unfavorable coverage determination; and, (6) PHP s procedures for requesting a formulary exception. 8) Transition Notices a) The PBM provides PHP a daily file called the Transition Notification File. The Transition Notification File, which contains claims data and other member information, provides PHP with all of the information needed to contact enrollees and providers regarding transition fills. b) PHP, through the use of a print vendor to aid in fulfillment, sends written notice via U.S. first class mail to enrollees within 3 business days of adjudication of a temporary fill. The notice includes (1) an explanation of the temporary nature of the transition supply the enrollee has received; (2) instructions for working with PHP and the enrollee s prescriber to identify appropriate therapeutic alternatives that are on the plan s formulary; (3) an explanation of the enrollee s right to request a formulary exception; and (4) a description of the procedures for requesting formulary exceptions. c) For long-term care residents dispensed multiple supplies of a Part D drug in increments of 14- days-or-less, consistent with the requirements under 43.154, the written notice will be provided within 3 business days after adjudication of the first temporary fill. d) PHP will ensure that reasonable efforts are made to notify prescribers of affected enrollees who receive a transition notice. e) PHP uses the CMS model Transition Notice via the file-and-use process (see Attachments I & II to this Policy for the 2012 models in use for both PHP contracts). 9) Public Notice of Transition Process a) The PHP transition process is published in plan enrollment materials, Plan Websites, as well as on the Medicare Prescription Drug Plan Finder. b) In addition, PHP will make available prior authorization or exceptions request forms upon request to both enrollees and prescribing physicians via a variety of mechanisms, including mail, fax, email, and on plan web sites. c) PHP will make its transition policy available to enrollees via link from Medicare Prescription Drug Plan Finder to web site and include in pre-and post-enrollment marketing materials as directed by CMS. 10) Provider and Patient Education a) PHP educates providers and enrollees concerning its formulary, program edits, and prior authorization. b) The CMS web site for CMS education is as follows: http://.cms.hhs.gov/prescriptiondrugcovconra/07_rxcontracting_marketing.asp#topofpage. - 5 -
References: Medicare Prescription Drug Benefit Manual, Chapter 6; CFR 423.120(b)(3) - 6 -
Attachment I (California_H5852 Transition Notice) - 7 -
Attachment II (Florida_H3132 Transition Notice) - 8 -