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Amendments L.A. Care Health Plan Revised 11/2015 lacare.org LA1478 11/15

16.0 Pharmacy Overview L.A. Care s prescription drug formulary is designed to support the achievement of positive member health outcomes through the administration of pharmacy benefits including: high-quality, cost-effective pharmaceuticals and supplies. The goal of the drug formulary is to provide a comprehensive list of covered pharmaceutical benefits that enhances the prescribing practitioners and pharmacists ability to deliver optimal drug therapy to L.A. Care members. Navitus Health Solutions (Navitus) is the Pharmacy Benefits Management (PBM) vendor which administers pharmacy benefits to L.A. Care members. L.A. Care utilizes a closed formulary. Prescribing practitioners are requested to prescribe medications included on the formulary whenever possible. Formulary status and applicable utilization management edits such as prior authorization requirements, step-therapy, quality limits, and exceptions for drugs may be found on the L.A. Care website at http://www.lacare.org/providers/pharmacy/ formulary. Note: L.A. Care Covered and L.A. Care Covered Direct members are responsible for pharmacy copayments that may vary according to the metal level of their plan and percentage of Federal Poverty Level. Role of Navitus Health Solutions L.A. Care contracts with Navitus, a pharmacy benefit management vendor, to administer pharmacy benefits for its members. Prescriptions of covered outpatient drugs may be filled at network pharmacies throughout Los Angeles County that are contracted with Navitus. Pharmacy Quality and Oversight Committee (PQOC) The PQOC Committee is responsible for oversight of the formulary development process administered by the contracted Pharmacy Benefit Manager (PBM). The PQOC s role is to review and evaluate drugs and drug therapies to be added to, or deleted from the formulary, and to review new medical technologies or new applications of existing technologies and recommend for benefit coverage, based on medical necessity. Additionally, the PQOC provides a peer review forum for L.A. Care s clinical policies, provider communication strategies, pharmaceutical quality programs/outcomes, and specialty drug distribution options. The PQOC meets quarterly to review the clinical direction of the pharmacy benefit, including but not limited to the following: formulary and utilization management positions, review and approval of policies and procedures, evaluation of outcomes for clinical programs; and, recommendations on communications to providers and members. L.A. Care encourages prescribing practitioners and pharmacists to provide suggestions and comments for consideration of formulary additions and changes. Suggestions and comments may be made by completing the L.A. Care Health Plan Formulary Drug Review Request Form. This form is found on the L.A. Care website or by clicking on the following link: http://www.lacare.org/sites/default/files/universal/ formulary_review_request.pdf. 2

Prescription Drug Prior Authorization Request Prior Authorization (PA) requirements are placed on certain medications to increase appropriate utilization, promote treatment and step-therapy protocols, actively risk manage drugs with serious side effects, and influence the process of managing costs. Drugs with a PA requirement are designated on the formulary with a PA indicator. Navitus processes pharmacy PA s for L.A. Care. The PA criteria and the length of the PA approval follow State and Federal regulations. A response from Navitus regarding PA requests may include a notice of action letter in the form of an approval, denial or request for additional information to make a determination of medical necessity. Decisions will be made within two business day unless there is mutual agreement between the clinical reviewer and the prescribing provider indicating that it is clinically appropriate for the review time to be extended. Expedited PA requests may be made by the prescribing provider when there is a serious risk to the patient s life, health, function, the request is for appropriately prescribed pain medications for terminally ill patients, or when medically necessary. Most decisions will be made within one business day unless there is mutual agreement between the clinical reviewer and the prescribing provider indicating that it is clinically appropriate for the review time to be extended. Prescribers may access information regarding the formulary and the specific PA criteria and forms online at www.navitus.com under the for providers section or have them faxed by Navitus Customer Care to the prescriber s office. Prescribers will need their NPI to access this portal. Drugs requiring PA and other forms may also be found on the L.A. Care website at www.lacare.org. Click on for providers and you will see the formulary and pharmacy section where the PA form is posted. Pain Medication for the Terminally Ill L.A. Care's PBM will follow the standard coverage determination time requirements of 24 hours or one business day for patients identified as terminally ill by their provider. This applies when responding to any request by the provider for pain medication. If a decision is not made within 72 hours, the requested treatment shall be deemed authorized. The provider shall contact the L.A. Care Pharmacy Department at 1-866-522-2736 within one business day of proceeding with the deemed authorized treatment and provide the following information so treatment can begin: confirm the 72 hour timeframe has expired, provide member identification, notify L.A. Care of the prescribing provider or providers performing the treatment; and, notify L.A. Care of the facility or location where the treatment was or is to be is rendered. Prescribing providers may also call Navitus Customer Care for additional information on the PA process at 1-844-268-9787 for L.A. Covered and L.A. Care Covered Direct. Obtaining Coverage Prior authorization questions or information regarding the prior authorizations process may be obtained by the following: 3

Telephone: Calling Navitus Customer Care at 1-844-268-9787 for L.A. Covered and L.A. Care Covered Direct and providing all required information. Fax: Providers may fax fully completed and signed PA form to Navitus Health Solutions 24/7 at 1-855-878-9210 for L.A. Covered and L.A. Care Covered Direct. Navitus will provide an authorization number specific for the medical need for all approved requests. Denied requests may be appealed on behalf of the member (please see Appeals and Grievance below). The prescriber must provide information to support the appeal on the basis of medical necessity. Appeals and Grievances If you would like to discuss a decision for a coverage determination denial with a clinical reviewer, prescribing providers may call Navitus Health Solutions at 1-844-268-9787 for L.A. Covered and L.A. Care CoveredDirect. If you believe that this determination is not correct, you have the right to appeal the decision on behalf of the member by filing an appeal with L.A. Care. For additional information on appeals on behalf of a member, please call L.A. Care at 1-866-522-2736. You may also submit a copy of the denial notice and a brief explanation of your concern with any other relevant information to the address below or fax it to L.A. Care at 1-213-438-5748. L.A. Care Health Plan Attn: Appeals and Grievance Department 1055 West 7th Street, 10th Floor Los Angeles, CA 90017 For questions related to the formulary, prior authorizations, step-therapy, quantity limit, or therapeutic interchange, please call Navitus at 1-844-268-9787 for L.A. Covered and L.A. Care Covered Direct. Non-Formulary Agents Any generic or proprietary drug name not found in the formulary listing, or any formulary updates published by L.A. Care, shall be considered a non-formulary drug. Coverage for non-formulary agents may be applied for by a prescribing provider using the Prior Authorization (PA) process described above. Each request will be reviewed on individual patient need. Approval will be given if a documented medical need exists. The following basic guidelines are used: use of formulary drugs is contraindicated in the patient; patient has failed an appropriate trial of formulary or related agents; choices available in the formulary are not suited for the present patient care need, and the drug selected is required for patient safety; and, use of a formulary drug may provoke an underlying condition, which would be detrimental to patient care. Step-Therapy Step Therapy (ST) is administered to help increase appropriate utilization of certain drugs and influence the process of managing costs when there are multiple effective drugs to treat a medical condition. ST drugs are designated on the formulary with an ST indicator. Drugs listed as ST require one or more prerequisite first step drugs to be tried before progressing to the second step drug. 4

L.A. Care uses ST to promote cost-effective pharmaceutical management when there are multiple effective drugs to treat a medical condition. Drugs that are listed in the Formulary as Step Therapy require one or more prerequisite first step drugs to be tried before progressing to the second step drug. When a prescription for a Step Therapy drug is filled at the dispensing pharmacy, the pharmacy benefits claims processor will search past claims for the first step drugs. If medically necessary, a ST drug can be obtained without first trying a first step drug by submitting a completed PA form with documentation of the medical need for consideration. Each request will be reviewed on an individual member need. Procedures and timeframes will follow our PA process. The following basic guidelines are used: The use of the first step drug is contraindicated in the patient, The first step drug is not suited for the present patient care need, and the drug selected is required for patient safety; and, The use of the first step drug may provoke an underlying condition which would be detrimental to patient care. Quantity Limits L.A. Care has identified a select number of medications that are subject to quantity limits. A quantity limit establishes the maximum amount of medication that L.A. Care will cover within a defined period of time. If a member has a medical condition that requires a quantity of medication that exceeds our limit, a written request on a PA form will be required with documentation of medical need for consideration. Procedures and timeframes will follow the PA process. Generic Substitution When available, FDA approved generic drugs are to be used in all situations, unless otherwise specifically indicated. Brand name drugs may be prescribed as a covered benefit, but members may be responsible for the cost difference between the brand name drug and the generic substitution. Greater economy is realized through the use of generic equivalents. This policy is not meant to preclude or supplant any State statutes that may exist regarding the use of generic or brand name drugs. All drugs that are or become available generically are subject to review for inclusion in the formulary. Drug products approved for generic substitution are reviewed and updated periodically based on the evaluation of clinical literature and available pharmacokinetic principles of the drug products. If a prescribing provider determines that there is a medical need for the brand name equivalent and it is not covered, a request for coverage may be made using the PA process. How to Use the Formulary In the formulary listing, FDA approved generic drug product names are presented in lower case letters. The common proprietary (branded) name is capitalized next to the generic name in parenthesis. Drugs that only come in brand name formulations are listed by the proprietary (branded) name. To view a copy of our formulary and more information about covered brand name and generic equivalent drugs, quantity limits and the Step Therapy (ST) medication list, please visit our website at http://www. lacare.org/providers/pharmacy/formulary. 5

Therapeutic Interchange L.A. Care may use Therapeutic Interchange to promote rational pharmaceutical therapy when evidence suggests that outcomes can be improved by substituting a drug that is therapeutically equivalent but chemically different from the prescribed drug. Improved outcomes include, but are not limited to: enhanced compliance, superior side effects or risk profiles, clinically superior results, and equivalent clinical results at a reduced cost. Therapeutic Interchange protocols are never automatic. A pharmacist may not substitute or alternate a therapeutically equivalent drug for a prescribed drug without the knowledge and authorization of the prescribing practitioner. Drugs may be considered for Therapeutic Interchange if they are: high risk, high volume, high cost; and, overused in routine conditions In designing Therapeutic Interchange protocols, the following drug characteristics are considered: efficacy, dosage formulation, safety, cost; and, pharmacoeconomic variables. Product and Over-the-Counter Medication Coverage Select products for the treatment and monitoring of diabetes and categories of over-the-counter (OTC) medications are available as a covered benefit, and may be prescribed by providers as an alternative to prescription drugs. Diabetes Treatment and Monitoring The following products are covered for treatment and monitoring of diabetes by L.A. Covered and L.A. Care Covered Direct : blood glucose monitors (including those designed to assist the visually impaired) (preferred brand is Abbott Products), blood glucose test strips (preferred brand is Abbott Products), Ketone urine test strips, lancets and lancet puncture devices, injectable medications (including insulin), disposable needles and syringes, Glucagon, insulin syringes, pumps and supplies, pen delivery systems, podiatric devices to prevent or treat diabetes related conditions; and, visual aides, excluding eyewear, to assist the visually impaired with proper dosing of insulin. L.A. Covered and L.A. Care Covered Direct - OTC Covered Medications Select categories OTC medications are covered under L.A. Covered and L.A. Care Covered Direct formularies. They include, but are not limited to the following with a written prescription by prescriber: aspirin to reduce the risk of heart attack, folic acid supplements for pregnant women to reduce the risk of birth defects, 6

fluoride supplements for children to reduce the risk of tooth decay, iron supplements for children, all FDA-approved over-the-counter tobacco cessation products such as nicotine patches, nicotine gum, nicotine lozenges (Note: Tobacco cessation products requiring a prescription are also covered. Please refer to the formulary); and, emergency contraception. Devices L.A. Care provides coverage on the pharmacy benefit for the following devices for L.A. Covered and L.A. Care Covered Direct members: spacers; and, peak flow meters Excluded Medications L.A. Care Health Plan does not cover the following medications on its pharmacy benefit: experimental or investigational drug products, or any drug product used in an experimental or investigational manner, unless it is accepted for use by professionally recognized standards of practice and authorized as necessary, weight-loss medications, except as medically necessary for morbid obesity, infertility agents, drugs or medications for cosmetic purposes, dietary or nutritional supplements, except when medically necessary or for the treatment of phenylketonuria, compounded medications with formulary alternatives or those with no FDA-approved indications, non self-administered injectable drug products are not covered unless otherwise specified in the formulary listing; and, foreign drugs or drugs not approved by the United States Food & Drug Administration are not covered. Note: Please refer to the formulary listings for a comprehensive list of covered products and OTC medications for L.A. Covered and L.A. Care Covered Direct. Specialty Pharmacy L.A. Care has specific policies for use of specialty drugs and therapies to treat chronic and complex conditions. These are often high cost pharmaceuticals, and may require special handling by the manufacturer and/or the FDA, and their effectiveness is driven by coordinated clinical support for the member. Most of these therapies require a Prior Authorization, and some of these therapies must be dispensed by L.A. Care s preferred specialty pharmacy. This is to insure the patient achieves the optimal clinical benefit from the prescribed therapy. Coverage of specialty drugs is based upon the member's formulary and pharmacy benefit coverage. To learn more about specialty drug access and coverage determination for these drugs and therapies, prescribing providers and pharmacies may call Navitus Customer Care at 1-844-268-9787 for L.A. Care Covered and L.A. Care Covered Direct. 7

Opioid Overutilization Monitoring As part of its clinical programs, opioid overutilization is reviewed by L.A. Care and Navitus to reduce potentially inappropriate and harmful use of opioid drugs. Patient specific reports are generated when criteria are met during a predefined time period, and the reports are supplied to the appropriate providers. The information shared with providers enables clinical interventions deemed necessary by the provider to address opioid overutilization. Additionally, the program implements improved Drug Utilization Review (DUR) controls including: safety controls at pharmacy during dispensing [e.g. preventing unsafe daily doses of acetaminophen (APAP) and opioids], improved use of formulary management (e.g. step therapy, quantity limits); and, concurrent and retrospective DUR programs and case management. Note: Overutilization is defined as a daily dose of APAP exceeding 4 grams for a total of 30 days or more during the measurement period, or use of opioids with a cumulative daily Morphine Equivalent Dose (MED) exceeding 120 mg for at least 90 consecutive days. Patients in hospice and/or with clinically necessary pain management are excluded. Mail Order Prescriptions L.A. Care offers members the option of getting up to a 90-day supply of select maintenance medications mailed to their home or alternate address through our prescription mail order program. Please remember to write a 30-day supply, as well as a 90-day supply plus refills prescription, for their maintenance medications. Mail order service is provided by WellDyneRx. Additional information may be found under at https://www.lacare.org/providers/ provider-resources/provider-forms. WellDyneRx accepts new prescriptions from prescribers by phone or fax 24 hours a day, 7 days a week. WellDyneRx Phone: 1-866-490-3326 WellDyneRx Fax: 1-888-830-3608 E-Prescribing/Electronic Health Records L.A. Care strongly encourages all prescribing practitioners to adopt e-prescribing and electronic health records. E-prescribing allows providers to: enhance formulary compliance, verify alternatives and generic substitutions, check drug quantity limits, avoid drug-drug interactions/medication errors; and, improve patient safety (reduce adverse drug events). The final year for eligible providers to adopt electronic health records (EHR) and receive an incentive from the Centers for Medicare and Medicaid Services (CMS) is 2016. For more information about the EHR incentive program, providers may go to the CMS website at http://www.cms.gov/regulations-and-guidance/ Legislation/EHRIncentivePrograms. Please refer to L.A. Care s HITEC-LA website at www.hitecla.org for information to assist you with adopting E-Prescribing/EHRs. 8

Pharmacy Locations Improving member health and providing the best possible service and convenient access to safe and costeffective medication is important to L.A. Care. A large number of pharmacies are available to members across Los Angeles County. The network includes most all major chain drug stores, retailers, grocers and community pharmacies. To search the pharmacy network, please visit http://www.lacare.org/members/ member-tools/find-pharmacy. Contact L.A. Care Health Plan Pharmacy and Formulary Department Physicians and pharmacists are highly encouraged to direct any suggestions, comments or formulary additions to L.A. Care via e-mail to Pharmacyandformulary@lacare.org or by mail to the following address: L.A. Care Health Plan ATTENTION: Senior Director, Enterprise Pharmacy 1055 W. 7th Street, 10th Floor Los Angeles, CA 90017 9