Fallon HealthCommercial Clinical Policy

Pharmacy Form

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Pharmacy

Indications

(1) Member’s age is less than 18 years of age 2. Member is partially responsive to the original prescribed dose 3. Member previously demonstrated a suboptimal response to a lower rounded down dose 4. Member has a history of rapidly fluctuating body weight (i.e., weight gain of at least 10% body weight in a one month time period within the past 6 months) 5. Member is clinically unstable and at high risk for hospitalization if the requested medication produces a suboptimal response 6. Member is being treated for an oncology indication with a curative goal (i.e. adjuvant, neoadjuvant) 7. Member's laboratory values indicate that a dose reduction will result in a suboptimal response All other reasons not referenced in this policy are not considered medically necessary. Please refer to our website (https://fallonhealth.org/providers/pharmacy) for the most up-to-date criteria. IX. Prescription process Pharmacies should process member prescriptions through the claims adjudication system at the point of service. When there is a generic version of a brand-named drug or an interchangeable biosimilar drug for a biologic drug available, the pharmacies will automatically give the member the generic or interchangeable biosimilar version unless the prescribing physician states that the member must have the brand-named drug only (Generic Drug Law St.1976, C.470, Sec.13). There are some medications where the brand may be preferred over the generic. These are usually noted as “Brand Preferred” or in a Generic Tier on our formulary. Prescriptions written for Fallon Health members must conform to the Fallon Health formulary. If the prescribed drug is not a preferred formulary drug or requires utilization management, the pharmacist may call the provider to discuss a substitution or send notification by fax that the prescribed drug requires prior authorization. The pharmacist will not provide a substitution without the physician’s approval. If the physician feels that there is no clinically appropriate substitution, they should follow the prior authorization request procedure described below to request approval for the medication. It is recommended that every effort be made to utilize formulary medications before requesting non-formulary products. Fallon Health provides prior authorization approval criteria for most medications listed on the formulary that require prior authorization. If the medication is urgently needed, the pharmacy may provide up to a three-day supply for Community Care members at the member’s expense. If the request is approved, the member may be reimbursed by Fallon Health. For ACO members, the pharmacy may provide a 72-hour emergency supply to the member at usual cost-sharing. Pharmacy Revised January 2026 Fallon Health Provider Manual | 11 Prescribing with OptumRx How do I get started with ePrescribe with OptumRx? 
(2) ePrescribe – Add the OptumRx profile in your electronic medical record (EMR) system using the following information: OptumRx Mail Service, 2858 Loker Ave East, Suite 100, Carlsbad, CA 92010; NC PDP ID = 0556540; PID = P00000000020173. 2. Call an OptumRx pharmacist at 1-800-791-7658 3. Fax a completed form to OptumRx at 1-800-491-7997 Prescribing for specialty medications with OptumRx* 1. Phone – 1-855-427-4682 2. Address – P.O. Box 2975, Mission, KS 66201 3. Fax (for prescription submissions only – no PAs) – 1-877-342-4596 *Specialty pharmacies also include: UMass, Harvard Vanguard Medical Associates Specialty Pharmacy at Atrius Health, Berkshire. Note that these pharmacies may be limited to certain plans only. The following information is necessary and mandatory by Massachusetts law when documenting prescriptions: 1. Correct spelling of name and address of member 2. Name and address of physician 3. Physician registration number (DEA) 4. Date of writing the prescription 5. Name, dosage and strength of medication 6. Directions of usage 7. Number of refills allowed Other information that ensures a speedier processing of prescriptions includes the member’s date of birth and home telephone number. We recommend that providers utilize e-prescribing whenever possible. X. Prior Authorization Request Policy Prior authorization is required for any medication exceeding the cost threshold ($20000 for most medications (Community Care only) or $100 for compounds) and any medication noted with a “PA, ” “QL,” or “ST” on the Fallon Health formulary. A PA is also required for a drug that exceeds our Opioid Management Strategy limits and for formulary exception requests. Before we will pay for these medications, the provider must fill out a Fallon Health prescription prior authorization form and Fallon must approve the request. Pharmacy Revised January 2026 Fallon Health Provider Manual | 13 Prior authorization request procedure Fallon Health collaborates with OptumRx (Fallon's Pharmacy Benefit Manager) and Prime Therapeutics Management (Prime) to implement our prior authorization process. For all lines of business, OptumRx reviews pharmacy benefit drugs (patient self-administered drugs, including oral medications and Commercial/Medicaid member diabetic testing supplies). Prime Therapeutics Management (Prime) reviews medical benefit drugs (physician-administered drugs, including home infusion). Important Information regarding the Massachusetts Standard PA Form and Community Care plan members. (This is not applicable to ACO members) Please review the criteria posted on the Online Formulary prior to completing the PA form or submitting an ePA and provide all relevant data for each part of the criteria. If there is no specific field for the data on the PA form, please use the "Additional information pertinent to this request" field. For Community Care member PA requests, you must use the state- mandated standard PA form, or otherwise use ePA or telephone. Please use the Online Formulary to determine which medications require Utilization Management (UM). Each drug with UM includes a link to the criteria, ePA, and fax form. Example: Patient-administered drugs (pharmacy benefit) Our process offers you two ways to submit a prior authorization request for patient self-administered drugs: • Electronic prior authorization tool (ePA) • Call or fax Electronic prior authorization tool (ePA) Fallon and OptumRx have made submitting PAs easy, quick, and convenient. ePA is a secure and easy method for submitting, managing, tracking PAs, step therapy and non- formulary exception requests. It enables a faster turnaround time of coverage determinations for most PA types and reasons. • Request clinical questions through your integrated EHR or the ePA website. • Answer patient-specific clinical questions electronically and submit for review. For more information about OptumRx prior authorizations, please refer to https://professionals.optumrx.com/prior-authorization.html or to our provider webpage. Pharmacy Revised January 2026 Fallon Health Provider Manual | 14 Call or fax To serve you quickly and efficiently, we have separate phone and fax numbers for our Community Care and ACO plans. To determine which phone or fax number to use, find the member's plan name on their ID card and locate it in the chart below. When faxing, please use the form in the drug link on the Online Drug Formulary. Line of business Phone Fax Mail Commercial • Community Care 1-844-720-0035 1-844-403-1029 Optum Prior Authorization Department P.O. Box 2975 Mission, KS 66201 Medicaid ACO • Fallon 365 Care • Berkshire Fallon Health Collaborative • Fallon Health-Atrius Health Care Collaborative 1-844-720-0033 1-844-403-1029 Optum Prior Authorization Department P.O. Box 2975 Mission, KS 66201 Physician-administered drugs (medical benefit) Our process offers you two ways to submit a prior authorization request for physician- administered drugs: • Electronic prior authorization web portal • Call or fax Electronic prior authorization web portal Fallon and Prime have made submitting PAs easy, quick, and convenient through the GatewayPA.com . website. Please click "New Provider Access Request" under the "Sign In" box to request access. Call or fax • Call: 1-800-424-1740 • Fax: 1-888-656-6671 For more about our Medical Rx program, please refer to our Provider webpage. If the prior authorization is approved, the provider will be notified by fax. If the prior authorization is not approved, the provider will be notified through a phone call, followed by fax; citing denial reasons, Pharmacy Revised January 2026 Fallon Health Provider Manual | 15 alternative medications if indicated, a reference to the guideline, protocol or other similar criterion on which the denial decision is based, and information on the appeal process. Please note: To facilitate the process, we recommend reviewing the criteria documents that are available on the Fallon Health website. The criteria can be found on the Physicians and providers area of the Fallon Health website, www. fallonhealth.org, in the “Pharmacy” section, under the “Online Drug Formulary.” Clinical review criteria are also available to all practitioners upon request. For Community Care member PA requests, you must use the state-mandated standard PA form. A link to the standard PA form is provided in the "PA form" column. Please review the criteria posted on our website prior to completing the PA form and provide all relevant data for each part of the criteria. If there is no specific field for the data on the PA form, please use the "Additional information pertinent to this request" field. PAs are usually completed within 2 business days of receiving a complete form. For ACO members, PA forms are not restricted to the state mandated standard form. In fact, this standard form should not be used for Medicaid members. Drug-specific PA forms and general PA forms are available on the MassHealth website. Please review the criteria posted on the MassHealth website prior to completing the PA form and provide all relevant data for each part of the criteria. Fallon’s website will link to the formulary and criteria on MassHealth’s website. Although the PA forms are posted on MassHealth’s website, PAs must be submitted to Fallon’s partners of Optum (pharmacy benefit medications) or Prime (medical benefit medications). PAs are reviewed within 24 hours of receipt of a complete PA form for Medicaid-ACO and within 2 business days of a completed form for Community Care. Why Complete and Timely Pharmacy Prior Authorization (PA) Submissions Matter In today’s healthcare environment, timely access to medications is critical to patient outcomes. One of the most impactful ways providers can support this goal is by submitting complete and clinically thorough prior authorization (PA) requests and responding promptly to any requests for additional information. Regulatory Requirements Drive Timely Reviews Regulatory bodies such as CMS, NCQA, and various state agencies mandate strict turnaround times for pharmacy PA reviews, many of which are within 24 or 72 hours. These timeframes are designed to ensure patients receive timely decisions regarding their medication access. When we request additional information, it is with these regulatory deadlines in mind. If the necessary information is not received within the required timeframe, we are obligated to deny the request due to insufficient documentation. Avoiding Delays Through Complete Initial Submissions A common pattern we observe is that denied initial PA requests are quickly followed by appeals. While appeals are a valid part of the process, they often have longer turnaround times than initial reviews. This delay can result in interrupted or postponed access to medications for members. Pharmacy Revised January 2026 Fallon Health Provider Manual | 16 Submitting a complete and clinically supported PA request from the start is the best way to avoid unnecessary delays and denials. This includes: • Answering all questions thoroughly. • Providing clinical rationale when answering questions or listing alternative therapies. • Including relevant documentation such as chart notes, lab results, and treatment history. Clinical Oversight Is Key We’ve also noted that some PA requests or responses to additional information are completed by non-clinical staff, which can lead to incomplete or inaccurate submissions. This often results in denials that could have been avoided with proper clinical input. Best practice: Ensure that staff handling PA submissions have clinical knowledge or that requests are escalated to clinical team members when appropriate. Tips for Successful PA Submissions • Be proactive: Submit all relevant clinical documentation with the initial request. • Be responsive: Reply to requests for additional information as quickly and thoroughly as possible keeping in mind the short turnaround times for initial PA reviews. • Be specific: When listing alternative therapies or explaining why a drug cannot be used, include a clear clinical rationale. • Be collaborative: Ensure coordination between administrative and clinical staff to avoid gaps in information. The Bottom Line Complete and timely PA submissions not only help meet regulatory requirements, they also reduce delays, minimize denials, and most importantly, support better patient care. We appreciate your partnership in ensuring that members receive the medications they need without unnecessary barriers. For more information on our Pharmacy PA process visit our website: https://fallonhealth.org/en/providers/pharmacy/pharmacy-prior-authorization Our formulary and clinical criteria may also be accessed from our website: https://fallonhealth.org/en/providers/pharmacy/online-drug-formulary XI. Non-Covered Items Community Care only Exclusions: Medications/conditions listed above under “Related Exclusions” are not a covered benefit. Non-Formulary: Medications not on the formulary are considered non formulary and are not covered. If the medications on our formulary are not appropriate for your patient’s condition, there is a formulary exception request process available. The prescriber must support the request by providing clinical information and a statement that provides justification for supporting the need for the non-formulary drug to treat the condition, including a statement that all covered formulary drugs on any tier will be or have been ineffective, would not be as effective as the non-formulary drug, or would have adverse effects. This request must be Pharmacy Revised January 2026 Fallon Health Provider Manual | 17 approved by Fallon Health before we will pay for the drug. This follows the standard PA process. MassHealth ACO only If you believe it is medically necessary for the patient to take a drug that is not listed on our formulary, you can submit a prior authorization that will be reviewed by a clinician and, if approved, Fallon will cover the drug. If the prior authorization request is denied, you and your patient receive denial information. XII. Diabetic Supplies Community Care Plan with Rx Insulin Prescription copayment, deductible and/or coinsurance per 30 day supply Insulin syringes (includes needles) Prescription copayment, deductible and/or coinsurance per 30 day supply Blood glucose meter Covered in full Blood glucose test strips Prescription copayment, deductible and/or coinsurance per 30 day supply Blood ketone test strips Prescription copayment, deductible and/or coinsurance per 30 day supply Spring-powered lancet device Prescription copayment, deductible and/or coinsurance applies Lancets Prescription copayment, deductible and/or coinsurance per 30 day supply Urine glucose test strips Prescription copayment, deductible and/or coinsurance per 30 day supply Urine ketone test strips Prescription copayment, deductible and/or coinsurance per 30 day supply Insulin pens (includes pre- filled insulin pen cartridges; needles sold separately) Prescription copayment, deductible and/or coinsurance per 30-day supply Insulin pen needles Prescription copayment, deductible and/or coinsurance per 30-day supply Prescribed oral medications that influence blood sugar levels Prescription copayment, deductible and/or coinsurance per 30-day supply Pharmacy Revised January 2026 Fallon Health Provider Manual | 18 Community Care Prior authorization is required for blood glucose meters and supplies that are non-preferred brands, continuous or require adaptive features. • Blood glucose meters are limited to Accu-Chek® glucose meters and test strips manufactured by Roche. Plan members can obtain an Accu-Chek® glucose meter at network pharmacies. • Continuous blood glucose monitors are limited to the Freestyle Libre System. Members may obtain Freestyle Libre at network durable medical equipment suppliers or pharmacies. • Members with a demonstrated need, including having a severe visual impairment or impaired manual dexterity, may require a blood glucose meter with adaptive features, such as an integrated voice synthesizer or integrated lancing device. Prior authorization is required. • Quantities of blood glucose test strips in excess of 150 per 30-day supply require PA • Other diabetic supplies noted on formulary as requiring a PA MassHealth ACO Prior authorization is required for blood glucose meters and supplies that are non-preferred brands, continuous or require adaptive features. • Preferred blood glucose meters covered are limited to FreeStyle or Precision Xtra glucose meters and test strips manufactured by Abbott. You can obtain a FreeStyle or Precision Xtra glucose meter at network pharmacies by providing the pharmacy with the following information: RxBIN: 610020 Group #: 99992432 ID # ERXMASSHEAL or by calling Abbott Diabetes Care at 1-866-224-8892 with Offer Code A35ABII0. FreeStyle can also be ordered by signing up at ChooseFreeStyle.com with Offer Code A35ABII0. • Test strip quantities over 100 per month and other brand meters and test strips require prior authorization. • Continuous blood glucose monitors may be obtained at network durable medical equipment supplies or pharmacies. Prior authorization applies. • Members with a demonstrated need, including having a severe visual impairment or impaired manual dexterity, may require a blood glucose meter with adaptive features, such as an integrated voice synthesizer or integrated lancing device. Diabetic supply procedure 1. Provider fills out Fallon Health prior authorization form if necessary and follows above prior authorization procedure. 2. The physician writes a prescription for the diabetic supply. 3. The member fills the prescription at a Fallon Health contracted pharmacy. The retail pharmacy collects any applicable copayment. Pharmacy Revised January 2026 Fallon Health Provider Manual | 19 XIII. Injectables Injectables are defined as sterile medications given with the aid of a needle/syringe and administered parenterally. Certain medications may be supplied by a Fallon Health- contracted pharmacy for patient self-use. Other medications are obtained by the contracted health care provider for in-office use. Many injections require prior authorization. Note: Call the Pharmacy Service Department Service Line (1-866-275-3247, prompt 5, prompt 2) for any questions regarding whether a medication can be self administered or must be administered in the office. Refer to the following sections above for more information: Infusions of certain drugs (Home Infusion) Specialty Prescription Drugs Medical Drug Wastage Program Injectable supply procedure A. Injectable medication to be self-administered (or by a family member) at home: 1. Provider fills out Fallon Health prior authorization form if necessary and follows above prior authorization procedure. 2. Provider writes prescription to the applicable pharmacy. 3. The member receives the prescription. A co-payment is charged. B. Injectable medication to be administered in the physician office: 1. Provider fills out Fallon Health prior authorization form if necessary and follows above prior authorization procedure. 2. Provider supplies the medication from their own stock and bills Fallon Health directly for both the medication and the administration of the medication. XIV. Transitional Medications Process Community Care: Fallon has a medication continuity of care (or transition) policy. This is for drugs requiring Prior Authorization (PA) or Step Therapy. Fallon allows a 30-day supply of medication for newly enrolled members who have already been prescribed the medication and on which the member is stable, upon documentation by the member’s prescriber. Fallon does not apply any greater deductible, coinsurance, copayments or out-of-pocket limits than would otherwise apply to other drugs covered by the plan. This ensures that the member does not experience any delay in accessing the drug prescribed by their health care provider while the PA or Step Therapy request is being reviewed. After this transition period, if a PA or Step Therapy is not granted, the appropriate requirements need to be met.. Pharmacy Revised January 2026 Fallon Health Provider Manual | 20 MassHealth ACO Step Therapy: Fallon has a step therapy medication continuity of care (or transition) policy for new members. Step therapy include step drugs and PA drugs with an embedded step requirement. This includes pharmacy and medical benefit drugs with step. Fallon will allow a 30-day supply of step therapy medication for newly enrolled members within the first 30 days of their enrollment. This will ensure that the enrollee does not experience any delay in accessing the drug prescribed by their health care provider, including a drug administered by infusion, while the exception request is being reviewed. After this transition period, if an exception is not granted, the appropriate step requirements will need to be met. MassHealth ACO General Transition: For new members, Fallon Health has a 30-day continuity of care policy to minimize disruption of care and ensure uninterrupted access to medically necessary services. This applies to all newly enrolled MassHealth ACO members. During the initial 30 days of enrollment, we will allow a temporary 30-day transition fill for drugs if members have already been taking the drug previously and the drug has Prior Authorization, quantity limit, or step therapy requirements. This allows members to work with their provider to change to a drug on our formulary or to request a Prior Authorization. Members will receive a letter explaining the temporary fill and actions the member needs to take. We also allow a temporary fill for an out of network pharmacy. This allows the member to contact Customer Service to locate a pharmacy near them that is in our network and to have the prescription transferred. Members will receive a letter explaining the temporary fill and actions they need to take. In addition to the above, we also allow a 72-hour emergency supply to be filled at network pharmacies when a Prior Authorization request is pending resolution. Pharmacy Revised January 2026 Fallon Health Provider Manual | 21 Fallon Medicare Plans (Fallon Medicare Plus, NaviCare, Summit ElderCare PACE, and Fallon Health Weinberg PACE) I. Formulary The Fallon Health Medicare Plan formularies can be found on the Fallon Health website, www.fallonhealth.org in the Physicians and providers area, in the “Pharmacy” section, under Online Drug Formulary. Any medication requiring utilization management will be designated with: PA for prior authorization; ST for Step Therapy; QL for Quantity Limit. Fallon Health will notify practitioners whenever there is a change in the formulary. These notifications are by direct mailings and through the Connection newsletter. Fallon Medicare plans have a formulary drug list that includes medications from every drug class except for certain medications excluded by Medicare. These excluded medications are the member’s responsibility and include the following: • Agents when used for anorexia, weight loss, or weight gain* • Agents when used to promote fertility. • Agents when used for cosmetic purposes or hair growth • Agents when used for the symptomatic relief of cough and colds • Prescription vitamins and mineral products, except prenatal vitamins and fluoride preparations • Nonprescription drugs (Note: certain OTC medications are covered for Navicare and PACE) • Covered outpatient drugs which the manufacturer seeks to require as a condition of sale that associated tests or monitoring services be purchased exclusively from the manufacturer or its designee • Agents when used for the treatment of sexual or erectile dysfunction, unless such agents are used to treat a condition other than sexual or erectile dysfunction, for which the agents have been approved by the Food and Drug Administration. *Note: weight-loss agents may be available for NaviCare members under the Medicaid benefit. If a member receives their health care coverage through an employer group, their formulary may include more covered prescription drugs than those normally covered by Medicare Part D. Pharmacy Revised January 2026 Fallon Health Provider Manual | 22 II. New-to-Market Policy Fallon Health follows a new-to-market medication evaluation policy and usage determination for medications newly approved by the FDA. Fallon Health has a waiting period of up to 180 days for all new medications, in order to ensure enough time to determine true dosing parameters, side-effect profiles, drug-drug interactions, drug- disease state interactions, and age-related issues. Medications or new indications of medications that fall within one of the following classes of clinical concern, antidepressants, antipsychotics, anticonvulsants, Antineoplastics, immunosuppressive or Antiretrovirals, will be subject to the expedited review process. This process involves evaluation and usage determination for the preceding medications within 90 days of approval by the FDA. During this period, a physician can request the medication via the prior authorization process. III. Utilization Management Utilization management includes Prior Authorization, Quantity Limits, and Step Therapy as described below. Prior Authorizations Coverage of certain formulary medications is based on medical necessity. For these drugs, a prior authorization* is required from the plan. They are noted on the formulary as “PA.” We will review the prior authorization request according to our criteria for medical necessity. Quantity and duration limits To further ensure patient safety, Fallon Health has established quantity and duration-of- use limits for a specific list of medications. The limits and duration will appear as “QL” on the online formulary. If a physician would like an exception to this rule for a specific member, they can submit a completed prior authorization request form*. This form must state the medical reason why more doses are needed, as well as the duration that is needed. Quantity limits are based upon the Food and Drug Administration’s maximum recommendation doses. Step-therapy There are certain medications for which patients will be required to have previously used or be unable to take certain other formulary medications. This is called step-therapy. They are noted on the formulary as “ST”. If a physician would like an exception to this rule for a specific member, they can submit a completed prior authorization request form*. This form must state the medical reason why the preferred drugs would not be appropriate for this patient. *Instructions for submitting a PA, as well as ePA, phone, and fax numbers is located on our website, www.fallonhealth.org, in the Physicians and providers section, under “Pharmacy”. Pharmacy Revised January 2026 Fallon Health Provider Manual | 23 IV. Drug Utilization Review We conduct prospective and retrospective drug utilization reviews for all of our members to make sure they are getting safe and appropriate care. These reviews are especially important for members who have more than one doctor who prescribe medications. These reviews are conducted each time a prescription is filled by a member and on a regular basis by reviewing our records. Examples of these reviews include the following: • Possible medication errors • Duplicate drugs treating same condition • Age-gender related issues • Drug-drug interactions • Drug-disease state interactions • Drug allergies • Drug dosage errors • Over-usage of narcotic drugs V. Opioid Edits and Management Program There are several opioid safety edits and programs for the Fallon Medicare plans. This impacts all Fallon Medicare members: Fallon Medicare Plus, NaviCare, Summit ElderCare PACE, and Fallon Health Weinberg PACE. The criteria used to identify members potentially at risk or for the point of sale pharmacy edits are not intended as prescribing limits. They are used to identify members that may be at risk for opioid overuse. The edits are not a substitute for your professional judgement and do not mean that you cannot prescribe over these limits. You need to attest that the identified medications and doses are intended and medically necessary for the member. Please be aware that network pharmacies, Fallon Pharmacy Department, our MTM vendor (Clarest Health), and/or our Opioid Drug Management vendor and PBM (Optum Rx) may outreach to you for your assistance in resolving these safety edits and opioid management cases. Please assist us in meeting the expectation that prescribers respond to pharmacy outreach related to opioid safety alerts in a timely manner, including educating their on-call staff. Some of these issues can be completed directly with the retail pharmacy by attesting that the medications and doses are intended and medically necessary for the member. If you need to submit a Coverage Determination or an Exception request, please call 844- 657-0494 (please call 844-722-1701 for Fallon Health Weinberg PACE) or Fax 844-403-1028. Pharmacy Revised January 2026 Fallon Health Provider Manual | 24 Below is a summary of the programs: Point of Sale (POS) opioid safety edits CMS requires certain prospective safety edits. These edits will occur when the member is filling the prescription at the pharmacy. These edits require resolution. The pharmacist at the pharmacy may override some of the edits with appropriate codes, may need to consult with the provider, and may need to inform the provider that a prior authorization is required. Since these are safety edits, they will still apply during a member’s transition period; meaning, the claims will still reject with the edits and require resolution. Buprenorphine for medication-assisted treatment (MAT) is not included in the safety edits. Hospice/palliative care, cancer-related pain, sickle cell disease, and LTC members are excluded from the safety edits. Members have Coverage Determination and Appeal rights under this program. The edits include: • Soft edit for concurrent opioid and benzodiazepine use – pharmacy can override • Soft edit for duplicative long-acting (LA) opioid therapy – pharmacy can override • Soft edit for concurrent opioid and prenatal vitamins use – pharmacy can override • Soft edit for concurrent opioid and Medication Assisted Therapy (MAT) use – pharmacy can override • Care coordination edit at 90 morphine milligram equivalents (MME) and 2 prescribers – pharmacy can override only after consultation with the prescriber, documentation of the discussion, and if the prescriber confirms intent (the opioids and/or day supply is intended and medically necessary for the member), using an override code that indicates the prescriber has been consulted. • Hard edit for a 7-day supply limit for initial opioid fills (opioid naïve) with a 120-day look-back. This will require a prior authorization to be submitted. Provider needs to attest that the opioids and/or day supply is intended and medically necessary for the member. Member is considered opioid naïve if there are no opioid claims in the past 120 days. Medication Therapy Management (Not applicable to PACE programs) We are also including special eligibility criteria into our Medication Therapy Management Program (MTMP). In addition to traditional MTMP eligibility, members are also eligible for MTM if they have been identified as an At-Risk Beneficiary (ARB) under a Drug Management Program (DMP). Comprehensive Addiction and Recovery Act of 2016 (CARA) - Drug Management Program (DMP) This is a comprehensive opioid management program required under the Comprehensive Addiction and Recovery Act of 2016 (CARA). This is a retrospective DUR program to identify members at risk for frequently abused drugs and conduct case management. Frequently abused drugs are defined by CMS as opioids and benzodiazepines. Pharmacy Revised January 2026 Fallon Health Provider Manual | 25 Buprenorphine for medication-assisted treatment (MAT) is not included in the 90 MME accumulations. The program excludes members with cancer pain, palliative/hospice care, sickle cell disease, and in LTC. Dual/Low Income Subsidy (LIS) members are limited in ability to change plans to avoid intervention once identified as at-risk. Criteria for identification into the program include any of the below: • Members with opioid pharmacy claims equal to or greater than 90 MME and 3+ opioid prescribers and 3+ opioid dispensing pharmacies • Members with opioid pharmacy claims equal to or greater than 90 MME and 5+ opioid prescribers • Members with any MME level and 7+ opioid prescribers or 7+ opioid dispensing pharmacies • Members identified as having a history of opioid-related overdose are also included in the DMP The Drug Management Program includes case management and clinical outreach to providers to determine if the member is at risk for opioid overutilization, notifications to the member, potential lock-in restrictions to specific provider(s), pharmacy(ies), and/or at the drug level. Members have appeal rights under this program. Alternative pain management options There are ways to manage pain that do not involve prescription opioids. Some of these options may work better and have fewer risks and side effects. Depending on the type of pain the patient is experiencing, options may include: • Over-the-counter medications such as ibuprofen (Motrin®), acetaminophen (Tylenol®) or naproxen (Aleve®). • Prescription-strength anti-inflammatory medications such as celecoxib (Celebrex®), diclofenac (Voltaren®), and etodolac (Lodine®). • Some prescription non-opioid medications that target pain-producing nerves, such as gabapentin (Neurontin®) and pregabalin (Lyrica®). • Injectable and topical therapies. • Chiropractor services, physical and other therapies, heat or cold compresses, exercise, acupuncture and cognitive behavioral therapy. Note: In most cases, only the generic versions of the above drugs are covered; OTCs are not covered for Fallon Medicare Plus; and PA may be required. Medicare covers Opioid Treatment Programs (OTPs) for opioid use disorder (OUD) treatment. Services are provided to people with Medicare Part B (Medical Insurance). For information on your patient’s benefits related to treatment for prescription drug abuse, including medication assisted treatment, mental health and counseling services, call Fallon Health Provider Relations. Pharmacy Revised January 2026 Fallon Health Provider Manual | 26 VI. Prescription Process Pharmacies should process member prescriptions through the claims adjudication system at the point of service. When there is a generic version of a brand-named drug or an interchangeable biosimilar drug for a biologic drug available, the pharmacies will automatically give the member the generic or interchangeable biosimilar version unless the prescribing physician states that the member must have the brand-named drug only (Generic Drug Law St.1976, C.470, Sec.13). There are some medications where the brand may be preferred over the generic. These are usually listed in a Generic Tier on our formulary. Prescriptions written for Fallon Health members must conform to the Fallon Health formulary. If the prescribed drug is not a preferred formulary drug, the pharmacist may call the provider to discuss a substitution or send notification by fax that the prescribed drug requires prior authorization. The pharmacist will not provide a substitution without the physician’s approval. If the physician feels that there is no clinically appropriate substitution, they should follow the prior authorization request procedure described below to request approval for the medication. It is recommended that every effort be made to utilize formulary medications before requesting non-formulary products. Fallon Health provides prior authorization approval criteria for medications listed on the formulary that require prior authorization. If the medication is urgently needed, the pharmacy may contact Fallon to request a transition fill while the PA is being processed. Prescribing with OptumRx How do I get started with ePrescribe with OptumRx? 
(3) Correct spelling of name and address of member 2. Name and address of physician 3. Physician registration number (DEA) 4. Date of writing the prescription 5. Name, dosage and strength of medication 6. Directions of usage 7. Number of refills allowed Other information that ensures a speedier processing of prescriptions includes the member’s date of birth and home telephone number. We recommend that providers utilize e-prescribing whenever possible. VII. Prior Authorization Request Policy Prior authorization is required for any medication noted with a “PA”, “QL”, or “ST” on the Fallon Health formulary. A PA may also require for a drug that exceeds our Opioid Management Strategy limits and for formulary exception requests. Before we will pay for these medications, the provider must fill out a Fallon Health prescription prior authorization form and Fallon must approve the request. Prior authorization request procedure Fallon Health collaborates with OptumRx (Fallon's Pharmacy Benefit Manager) and Prime Therapeutics Management (Prime) to implement our prior authorization process. For all lines of business, OptumRx reviews pharmacy benefit drugs (patient self-administered drugs, including oral medications and member diabetic testing supplies). (See note below regarding Medicare glucose monitors and test strips.) Prime Therapeutics Management (Prime) reviews medical benefit drugs (physician-administered drugs, including home infusion). Please use the Online Formulary to determine which medications require Utilization Management (UM). Each drug with UM includes a link to the criteria, ePA, and fax form. Pharmacy Revised January 2026 Fallon Health Provider Manual | 29 Example: Patient-administered drugs (pharmacy benefit) Our process offers you two ways to submit a prior authorization request for patient self-administered drugs: • Electronic prior authorization tool (ePA) • Call or fax Electronic prior authorization tool (ePA) Fallon and OptumRx have made submitting PAs easy, quick, and convenient. ePA is a secure and easy method for submitting, managing, tracking PAs, step therapy and non- formulary exception requests. It enables a faster turnaround time of coverage determinations for most PA types and reasons. Using ePA, you can: • Request clinical questions through your integrated EHR or the ePA website. • Answer patient-specific clinical questions electronically and submit for review. For more information about OptumRx prior authorizations, please refer https://professionals.optumrx.com/prior-authorization.html or to our provider webpage. Call or fax To serve you quickly and efficiently, we have separate phone and fax numbers for our Medicare plans. To determine which phone or fax number to use, find the member's plan name on their ID card and locate it in the chart below. When faxing, please use the form in the drug link on the Online Drug Formulary. Pharmacy Revised January 2026 Fallon Health Provider Manual | 30 Line of business Phone Fax Mail Medicare • Fallon Medicare Plus • NaviCare 1-844-657- 0494 1-844-403- 1028 Optum Prior Authorization Department P.O. Box 2975 Mission, KS 66201 PACE Summit ElderCare 1-844-657- 0494 1-844-403- 1028 Optum Prior Authorization Department P.O. Box 2975 Mission, KS 66201 Fallon Health Weinberg- PACE 1-844-722- 1701 1-844-403- 1028 Optum Prior Authorization Department P.O. Box 2975 Mission, KS 66201 Physician-administered drugs (medical benefit) Our process offers you two ways to submit a prior authorization request for physician- administered drugs: • Electronic prior authorization web portal • Call or fax Electronic prior authorization web portal Fallon and Prime Therapeutics Management (Prime) have made submitting PAs easy, quick, and convenient through the GatewayPA.com website. Please click "New Provider Access Request" under the "Sign In" box to request access. Call or fax • Call: 1-800-424-1740 • Fax: 1-888-656-6671 For more about our Medical Rx program, please refer to our Provider webpage Medicare glucose monitors and related testing supplies (including test strips and CGMs) for Medicare, NaviCare, and PACE plans are reviewed by our partner, OptumRx. Please use the Optum contact information above to submit these PA requests. Pharmacy Revised January 2026 Fallon Health Provider Manual | 31 Please note: To facilitate the process, we recommend reviewing the criteria documents that are available on the Fallon Health website. The criteria can be found on the Physicians and providers area of the Fallon Health website, www.fallonhealth.org, in the “Pharmacy” section under the Online Drug Formulary. Clinical review criteria are also available to all practitioners upon request. Routine requests are processed within 72 hours from the date of request. Urgent/emergency requests are processed within 24 hours of the date of request. Requests are reviewed in the order of arrival, with the exception of emergency medications, which are reviewed according to the urgency of the clinical situation. Please note that urgent requests may require more information and the reviewing pharmacist may need to reach out to the office. Please remember that an urgent request must be decided within 24 hours and you must be available to answer any extra questions during this time, otherwise, the request may be denied. The same applies to a standard request that is submitted on a Friday. Please submit urgent requests only when the patient’s health is truly in jeopardy. If the prior authorization is approved, the provider will be notified by fax. If the prior authorization is not approved, the provider will be notified through a phone call, followed by written notification (fax or mail). The notification will cite denial reasons, alternative medications if indicated, a reference to the guideline, protocol or other similar criterion on which the denial decision is based, and information on the appeal process. Why Complete and Timely Pharmacy Prior Authorization (PA) Submissions Matter In today’s healthcare environment, timely access to medications is critical to patient outcomes. One of the most impactful ways providers can support this goal is by submitting complete and clinically thorough prior authorization (PA) requests and responding promptly to any requests for additional information. Regulatory Requirements Drive Timely Reviews Regulatory bodies such as CMS, NCQA, and various state agencies mandate strict turnaround times for pharmacy PA reviews, many of which are within 24 or 72 hours. These timeframes are designed to ensure patients receive timely decisions regarding their medication access. When we request additional information, it is with these regulatory deadlines in mind. If the necessary information is not received within the required timeframe, we are obligated to deny the request due to insufficient documentation. Avoiding Delays Through Complete Initial Submissions A common pattern we observe is that denied initial PA requests are quickly followed by appeals. While appeals are a valid part of the process, they often have longer turnaround times than initial reviews. This delay can result in interrupted or postponed access to medications for members. Pharmacy Revised January 2026 Fallon Health Provider Manual | 32 Submitting a complete and clinically supported PA request from the start is the best way to avoid unnecessary delays and denials. This includes: • Answering all questions thoroughly. • Providing clinical rationale when answering questions or listing alternative therapies. • Including relevant documentation such as chart notes, lab results, and treatment history. Clinical Oversight Is Key We’ve also noted that some PA requests or responses to additional information are completed by non-clinical staff, which can lead to incomplete or inaccurate submissions. This often results in denials that could have been avoided with proper clinical input. Best practice: Ensure that staff handling PA submissions have clinical knowledge or that requests are escalated to clinical team members when appropriate. Tips for Successful PA Submissions • Be proactive: Submit all relevant clinical documentation with the initial request. • Be responsive: Reply to requests for additional information as quickly and thoroughly as possible keeping in mind the short turnaround times for initial PA reviews. • Be specific: When listing alternative therapies or explaining why a drug cannot be used, include a clear clinical rationale. • Be collaborative: Ensure coordination between administrative and clinical staff to avoid gaps in information. The Bottom Line Complete and timely PA submissions not only help meet regulatory requirements, they also reduce delays, minimize denials, and most importantly, support better patient care. We appreciate your partnership in ensuring that members receive the medications they need without unnecessary barriers. For more information on our Pharmacy PA process visit our website: https://fallonhealth.org/en/providers/pharmacy/pharmacy-prior-authorization Our formulary and clinical criteria may also be accessed from our website: https://fallonhealth.org/en/providers/pharmacy/online-drug-formulary Pharmacy Revised January 2026 Fallon Health Provider Manual | 33 VIII. Part B Drugs In accordance with federal regulations, Fallon Medicare members are covered, with a required co-payment (if applicable to the plan), for the following mandated medications: Note: The following Medicare mandated medications are not applied to the Medicare Part D accumulators. Covered drugs include: • Drugs that usually aren’t self-administered by the patient and are injected or infused while you get physician, hospital outpatient, or ambulatory surgical center services • Insulin furnished through an item of durable medical equipment (such as a medically necessary insulin pump) • Other drugs patients take using durable medical equipment (such as nebulizers) that were authorized by our plan • The Alzheimer’s drug, Leqembi® (generic name lecanemab), which is administered intravenously. In addition to medication costs, patients may need additional scans and tests before and/or during treatment that could add to overall costs. • Clotting factors patients give themselves by injection if they have hemophilia • Transplant/immunosuppressive drugs: Medicare covers transplant drug therapy if Medicare paid for the organ transplant. Patients must have Part A at the time of the covered transplant, and patients must have Part B at the time they get immunosuppressive drugs. Medicare Part D drug coverage covers immunosuppressive drugs if Part B doesn't cover them • Injectable osteoporosis drugs, if patients are homebound, have a bone fracture that a doctor certifies was related to post-menopausal osteoporosis, and can’t self-administer the drug • Some antigens: Medicare covers antigens if a doctor prepares them and a properly instructed person gives them under appropriate supervision • Certain oral anti-cancer drugs: Medicare covers some oral cancer drugs patients take by mouth if the same drug is available in injectable form or the drug is a prodrug (an oral form of a drug that, when ingested, breaks down into the same active ingredient found in the injectable drug) of the injectable drug. As new oral cancer drugs become available, Part B may cover them. If Part B doesn’t cover them, Part D does. • Oral anti-nausea drugs: Medicare covers oral anti-nausea drugs patients use as part of an anti-cancer chemotherapeutic regimen if they’re administered before, at, or within 48 hours of chemotherapy or are used as a full therapeutic replacement for an intravenous anti-nausea drug • Certain oral End-Stage Renal Disease (ESRD) drugs covered under Medicare Part B • Erythropoiesis-stimulating agents: Medicare covers erythropoietin by injection if patients have End-Stage Renal Disease (ESRD) or need this drug to treat anemia related to certain other conditions. (such as Epogen®, Procrit®, Retacrit®, Epoetin Alfa, Aranesp®, Darbepoetin Alfa, Mircera®, or Methoxy polyethylene glycol-epoetin beta) • Intravenous Immune Globulin for the home treatment of primary immune deficiency diseases Pharmacy Revised January 2026 Fallon Health Provider Manual | 34 • Parenteral and enteral nutrition (intravenous and tube feeding) • We also cover some vaccines under Part B and most adult vaccines under our Part D drug benefit. IX. Diabetic Supplies Fallon Medicare Plans with Part D Fallon Medicare Plans without Part D Insulin Prescription copayment per 30 day supply Not covered Insulin syringes (includes needles) Prescription copayment per 30 day supply Not covered Blood glucose meter Covered in full Covered in full Blood glucose test strips Covered in full Covered in full Blood ketone test strips Covered in full Covered in full Spring-powered lancet device Covered in full Covered in full Lancets Covered in full Covered in full Urine glucose test strips Covered in full Covered in full Urine ketone test strips Covered in full Covered in full Insulin pens (includes pre- filled insulin pen cartridges; needles sold separately) Prescription copayment per 30 day supply Not covered Insulin pen needles Prescription copayment per 30 day supply Not covered Prescribed oral medications that influence blood sugar levels Prescription copayment per 30 day supply Not covered Coverage of Blood Glucose Meters will be limited to Accu-Chek® glucose meters and test strips manufactured by Roche. Plan members can obtain an Accu-Chek® glucose meter at network pharmacies. Pharmacy Revised January 2026 Fallon Health Provider Manual | 35 Continuous blood glucose monitors are limited to the Freestyle Libre System. Members must obtain Freestyle Libre at network pharmacies. A prior authorization is required for blood glucose meters and supplies that are non- preferred brands, continuous, require adaptive features or for test strip quantities over 5 per day. Members with a demonstrated need, including having a severe visual impairment or impaired manual dexterity, may require a blood glucose meter with adaptive features, such as an integrated voice synthesizer or integrated lancing device. Prior authorization is required. The following diabetic supplies require prior authorization through Fallon Health: • Non-preferred test strips (Preferred test strips are Accu-Chek products) • Quantities of blood glucose test strips in excess of 150 per 30-day supply • Blood glucose meters with adaptive features, such as an integrated voice synthesizer or integrated lancing device • Continuous blood glucose monitors. Our preferred therapeutic or non-adjunctive continuous glucose monitors are Freestyle Libre monitors and supplies. Members obtain Freestyle Libre monitors and supplies at network pharmacies. • Other diabetic supplies noted on formulary as requiring a PA Diabetic supply procedure 1. Provider fills out Fallon Health prior authorization form if necessary and follows above prior authorization procedure. 2. The physician writes a prescription for the diabetic supply. 3. The member fills the prescription at a Fallon Health-contracted. The member pays any applicable copay or co-insurance. Pharmacy Revised January 2026 Fallon Health Provider Manual | 36 X. Injectables Injectables are defined as sterile medications given with the aid of a needle/syringe and administered parenterally. Certain medications may be supplied by a Fallon Health contracted pharmacy for patient self-use. Other medications are obtained by the contracted health care provider for in-office use. Many injections require prior authorization. For Fallon Medicare members with Medicare Part D prescription coverage, some injectable medications are covered under the member’s Medicare Part B benefits. Note: Call the Pharmacy Service Department Service Line (866-275-3247, option 5, option 2) for any questions regarding whether a medication can be self-administered or must be administered in the office. Injectable supply procedure A. Injectable medication to be self-administered (or by a family member) at home: 1. Provider fills out Fallon Health prior authorization form if necessary and follows above prior authorization procedure. 2. Provider writes prescription. 3. The member fills the prescription at a Fallon Health-contracted pharmacy. A copayment is charged. B. Injectable medication to be administered in the physician office: 1. Provider fills out Fallon Health prior authorization form if necessary and follows above prior authorization procedure. 2. Provider supplies the medication from their own stock and bills Fallon Health directly for both the medication and the administration of the medication. XI. Transitional Medications Process The transitional process is for Fallon Medicare members who are new to Fallon Health, new to F a l l o n Medicare, or experience a negative formulary change from one year to the next. This process is designed to provide temporary medication coverage for Fallon Health non-formulary or UM-required medications until a prior authorization can be obtained by the prescriber. The qualifying member can obtain a one month’s temporary supply of medications (within the first 108 days of their enrollment) at a copayment cost. A letter will be sent to both the patient and the provider indicating that the transition fill was temporary and providing the process to request an exception, coverage determination, or to substitute a preferred formulary medication. Pharmacy Revised January 2026 Fallon Health Provider Manual | 37 XIII. Medication Therapy Management (MTM) Program Our Medication Therapy Management Program is not a benefit but is a free service to eligible members that is designed to help members learn more about their medications and how they affect their health and well-being. We want our members to have all the information they need about their medications. This program is not applicable to PACE members. Fallon Health, in partnership with our Medication Therapy Management (MTM) vendor, Clarest Health, would like to remind you of this program to improve our Fallon Medicare Plus and Navicare HMO members’ engagement in the CMS Comprehensive Medication Review (CMR). The CMR rate is a CMS Part D Star measure. The CMR assists patients in understanding their medications, so that they are more active in their healthcare. The CMR includes an interactive discussion with a clinical pharmacist and can identity side effects a patient may be experiencing or be able to assist with finding a less expensive medication. The review also includes OTC products (including vitamins, minerals, and herbal supplements) that are sometimes not brought to your attention. Once the CMR is compete, the patient and you will receive a summary of the discussion items, any recommendations, and a medication list. We hope that you will find this information valuable in your conversations with your patient. If your patients are eligible for the MTM program, they will receive a welcome letter and a phone call from Clarest Health. Please recommend that your patients participate in this valuable, free opportunity. Who is eligible for the MTM Program? 
(4) What does the member receive as an MTM Program participant? 

Effective Date

NA

Last Reviewed

NA

Original Document

  Reference



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Community Care and MassHealth ACO Plans • I. Formulary • II. New-to-Market Policy • III. Utilization Management • IV. Drug Utilization Review • V. Opioid Management Program • VI. Infusions of Certain Drugs (Home Infusion) • VII. Specialty Prescription Drugs • VIII. Medical Drug Wastage Program • IX. Prescription Process • X. Prior Authorization Request Policy • XI. Non-Covered Items • XII. Diabetic Supplies • XIII. Injectables • XIV Transitional Medications Process

Fallon Medicare Plans • I. Formulary • II. New-to-Market Policy • III. Utilization Management • IV. Drug Utilization Review • V. Opioid Edits and Management Program • VI. Prescription Process • VII. Prior Authorization Request Policy • VIII. Part B Drugs • IX. Diabetic Supplies • X. Injectables • XI. Transitional Medications Process • XII. Medication Therapy Management (MTM) Program

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Community Care and ACO plans

I. Formulary Community Care: The Fallon Health on-line formulary can be found on the Fallon Health website— www.fallonhealth.org—in the physicians and providers section, under “Pharmacy”. Fallon Health will notify practitioners whenever there is a change in the formulary. These notifications are by direct mailings and through the Connection newsletter.

Fallon Health has a formulary drug list that includes medications from every drug class except for those medications specified in the evidence of coverage document that each member receives. These e x c l u d e d medications are the member’s responsibility and include the following:

Related Exclusions: Medications/conditions listed below are not a covered benefit: • Drugs/conditions that are specifically excluded from the formulary • Drugs for which no prescription is required by law, unless specifically included on the formulary • Vitamins and minerals, whether or not a prescription is required (except certain pre-natal vitamins available through the Fallon Health Oh Baby! Program or certain vitamins or minerals included under the ACA preventive medications.) • Devices for birth control that are not on the Fallon Health formulary • Drugs that are investigational or that have not been approved for general sale and distribution by the U.S. Food and Drug Administration • Drugs that are not listed in the Fallon Health formulary (except as approved through the Fallon Health exception process) • Drugs that are not used or prescribed in accordance with FDA-approved labeling (unless compendia supported), including, but not limited to: unapproved doses, unapproved duration of therapy and unapproved indications. (This does not include the off-label uses of covered prescription drugs used in the treatment of HIV/AIDS or cancer when used in accordance with state law. This also does not include bone marrow transplants for breast cancer as required by state law.) • Drugs that require prior authorization, if prior authorization is not received • Drugs used for cosmetic purposes or to enhance athletic performance, or for other non-covered conditions, unless otherwise included in the formulary for that condition. • Drugs used for weight loss (including appetite suppression, obesity, and overweight) whether FDA-approved for weight loss or as off-label use for weight loss. • Drugs used for weight loss (including appetite suppression, obesity, overweight)

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and associated comorbidities (example: Wegovy) • Drugs that do not meet Fallon medical criteria • Non-emergency prescriptions obtained at a non-network pharmacy • Medications used for preference or convenience • Medications that are new to the market that have not been reviewed by Fallon for safety and adverse events. These medications are not covered by Fallon until they have been reviewed and guidelines for their use have been developed. This could take up to 180 days post-marketing. • Replacement of more than one lost/mishandled medication per benefit period • Prescription drugs that are a combination of a covered prescription item and an item that is specifically excluded, such as vitamins, minerals, or medical foods. • Bio-identical hormone replacement therapy. • Tier cost-sharing exceptions. • The following are not covered benefits: o Topical emollients o Medical wound dressings for maintenance or long term care of a condition o Work-required vaccines • The following Prescription Proton Pump Inhibitors: Prevacid (brand name capsules), Protonix (brand name), Zegerid, Prilosec(brand name) and others not on the Fallon formulary • The following non-sedating antihistamines: Allegra, Allegra ODT, cetirizine HCl, Clarinex, Claritin, Claritin Reditabs, fexofenadine HCl, Xyzal and Zyrtec. • Vimovo • Medical marijuana • Duexis (ibuprofen/famotidine) • Omeclamox (amoxicillin/clarithromycin/omeprazole) Therapy Pack • Vascepta (icosapent ethyl) • Liptruzet (atorvastatin/ezetimibe) • Diclegis (doxylamine/pyriodoxine) • Acticlate (doxycycline Hyclate) • Jublia (efinaconazole soln) • Durlaza (aspirin 162.5mg) • Cuprimine (penicillamine) capsules • Glumetza (metformin) tablets • Fortamet (metformin SR 24h osmotic) tablets • Sernivo (betamethasone dipropionte spray emulsion) 1.5% Spray • Bonjesta (doxylamine/pyridoxine) • Yosprala (aspirin/omeprazole) • Ybuphen (ibuprofen 600mg & acetaminophen 500mg)

Only medications on our formulary are covered. Medications not on the formulary are considered non-formulary and are not covered. There is a formulary exception process for medications not on our formulary. Please see the “Non Covered Items” section below under the Prior Authorization section.

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Medications for Chronic Conditions:

Certain medications to treat chronic conditions are covered with no or limited cost-sharing. Fallon annually selects at least one generic drug (if available), and one brand name drug used to treat each of the four conditions: • diabetes (insulin); • asthma; and • the two most prevalent heart conditions among members Please refer to the Fallon formulary at https://fallonhealth.org for more information.

MassHealth ACO (Berkshire Fallon Health Collaborative, Fallon 365 Care, Fallon Health-Atrius Health Care Collaborative) Fallon Health ACO plans follow the MassHealth Unified Formulary. All Massachusetts Medicaid managed care organizations (MCOs) will follow MassHealth’s pharmacy drug coverage and criteria. The drugs or services listed below are excluded: • Fertility medications • Over-the-counter medications that are not included on the MassHealth list of covered drugs • Medications that are experimental or that have not been approved for general sale and distribution by the U.S. Food and Drug Administration • Drugs prescribed for purposes that are not medically necessary, for example, cosmetic purposes, to enhance athletic performance, or for non-covered services/conditions • Non-emergency prescriptions filled at a pharmacy that is not in Fallon’s network • Drugs used for erectile dysfunction If you believe it is medically necessary for the patient to take a listed drug, you can submit a prior authorization that will be reviewed by a clinician and, if approved, Fallon will cover the drug. If the prior authorization request is denied, you and your patient receive denial information.

II. New-to-Market Policy Fallon Health follows a new-to-market medication evaluation policy and usage determination for medications newly approved by the FDA. Fallon Health has a waiting period of up to 180 days for all new medications, in order to ensure enough time to determine true dosing parameters, side-effect profiles, drug-drug interactions, drug- disease state interactions, and age-related issues.

III. Utilization Management Utilization management includes Prior Authorization, Quantity Limits, and Step Therapy as described below.

Prior authorizations Coverage of certain formulary medications is based on medical necessity. For these drugs, a prior authorization* is required from the plan. They are noted on the formulary as “PA”. We will review the prior authorization request according to our criteria for medical necessity.

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Quantity and duration limits To further ensure patient safety, Fallon Health has established quantity and duration of use limits for a specific list of medications. The limits and duration noted on the formulary as “QL.”. If a physician would like an exception to this rule for a specific member, they can submit a completed prior authorization request form*. This form must state the medical reason why more doses are needed, as well as the duration that is needed. Quantity limits are based upon the Food and Drug Association’s maximum recommended doses.

Per Massachusetts state law, certain contraceptives may be available for up to a 12-month supply.

Step-therapy There are certain medications for which patients will be required to have previously used or be unable to take certain other formulary medications. This is called step-therapy. They are noted on the formulary as “ST”. If a physician would like an exception to Step Therapy for a specific member, they can submit a completed prior authorization request form*. This form must state the medical reason why the preferred drugs would not be appropriate for this patient.

*Instructions for submitting a PA, as well as ePA, phone, and fax numbers is located on our website, fallonhealth.org, in the Physicians and providers section, under “Pharmacy”.

IV. Drug Utilization Review We conduct drug prospective and retrospective utilization reviews for all of our members to make sure they are getting safe and appropriate care. These reviews are especially important for members who have more than one doctor who prescribe medications. These reviews are conducted each time a prescription is filled by a member and on a regular basis by reviewing our records.

Examples of these reviews include the following:

• Possible medication errors • Duplicate drugs treating same condition • Age-gender related issues • Drug-drug interactions • Drug-disease state interactions • Drug allergies • Drug dosage errors • Over-usage of narcotic drugs

V. Opioid Management Program Opioid painkillers provide needed relief to those with acute or chronic pain. But given their potential for harm, and the very real – and pervasive – problem of misuse and abuse, ensuring appropriate use is more critical now than ever before.

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Community Care

Our standard opioid management program is aligned with the “CDC Clinical Practice Guideline for Prescribing Opioids for Pain” issued by the Centers of Disease and Prevention (CDC) in November 2022 and includes:

Inappropriate Drug Therapy Combinations The pharmacy may need to contact the prescriber to resolve these issues: • Opioids & Medication Assisted Treatment (MAT): reject for an opioid claim secondary to a MAT drug (includes only buprenorphine- combination products) • Opioids & Benzodiazepine: reject for an opioid drug if the member has an existing claim for a benzodiazepine and vice versa • Opioids & Prenatal Vitamin: reject for an opioid drug if the member has an existing claim for a prenatal vitamin claim and vice versa

Inappropriate opioid quantities or dosing The pharmacy may need to contact the prescriber to resolve these issues: • Members already on opioids: reject for a cumulative Short Acting Opioid/Long Acting Opioid dose check for >90 MME/day • Members new to opioids: reject for a cumulative Short Acting Opioid/Long Acting Opioid dose check for >50 MME/day • Members new to opioids: reject for Short Acting Opioid prescriptions for >7 day supply • Members new to opioids: reject for a Long Acting Opioid with no paid claim for a Short Acting Opioid The following requires prior authorization from the prescriber: • Members already on opioids: Prior Authorization required for a cumulative Short Acting Opioid/Long Acting Opioid dose check for

180 MME*/day

Therapeutic Dose Limit The pharmacy may need to contact the prescriber to resolve this issue: • Cumulative acetaminophen dose check (with opioid-containing drugs) >4 grams/day (reject) Refill Threshold • This edit narrows the refill window for Schedule II-V controlled drugs to a 90% threshold at retail pharmacy and 84% at mail order.

Opioid Management Edits The following require prior authorization from the prescriber if exceeding the limit: • Members new to opioids: Short Acting Opioids maximum 50 MME/day • Members new to opioids: Short Acting Opioids 7 days supply limit • Members already on opioids: Short Acting Opioids maximum 90 MME/day.

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• All members: use of Short Acting Opioids required before Long Acting Opioids • All members: Quantity Limits on all Long Acting Opioids based on FDA maximum dosing frequency (i.e. once daily) • All members: Maximum 2 opioid fills within a 60-day time period

Pediatric (≤19 years of age) Edits The following require prior authorization from the prescriber if exceeding the limit: • All pediatric members: PA required for all opioid containing cough and cold medications • Pediatric members new to opioids: 3 days supply limit

MassHealth ACO: Our standard opioid management program for Medicaid ACO is aligned with MassHealth’s program. Please refer to the table below for Fallon Health ACO initiatives, thresholds and dose limits.

Edit Summary Drug-drug interaction Soft edit: drug-drug interaction between opioids and benzodiazepines Drug-drug interaction Soft edit: concurrent use of opioids and medication assisted treatment for addiction (MAT) Drug-drug interaction Soft edit: concurrent use of opioids and prenatal vitamins will trigger soft edit reject Drug-drug interaction Soft edit: concurrent use of opioids and antipsychotics will trigger soft reject edit 180 MME limit for Opioid regimens Prior authorization will be required if a member’s opioid regimen exceeds 180 MME/day. Members with sickle cell disease, cancer, or a history of a diagnosis indicating palliative care treatment are exempt. 7 day supply initial fill Treatment naïve member (no opiate claims in the last 120 days) will have a soft reject if attempting to fill > 7 day supply. Members with sickle cell disease, cancer, or a history of a diagnosis indicating palliative care treatment are exempt. Duplicate Long-Acting Opioids For any combination of 2 or more long-acting opioids, if there is greater than 2 months of duplicate claims in a member’s claims history the opioid will require prior authorization Duplicate Short-acting Opioids For any combination of 2 or more short-acting opioids, powders, and combination products, if there is greater than 2 months of duplicate claims in a member’s claim’s history Concurrent Therapy with Opioid Dependence Agents Prior authorization is required if a member is stable on any buprenorphine product used for substance use disorder and is attempting to fill a long-acting opioid (for any length of time), a short- acting opioid for more than a 7 day supply, or short-acting opioid(s) for more than 7 days of therapy in the last 30 days. “Stability” is defined as: 1. Buprenorphine/naloxone film or tablet, Zubsolv, or Bunavail: 60 days of therapy within the last 90 days 2. Probuphine (buprenorphine implant): history in the past 210 days. 3. Sublocade: ≥ 56 days of therapy in the last 84 days Quantity Limit & Quantity limit for short Claims for specified short-acting opioids over a dosage limit (120MME) and being used as monotherapy (no claim for a long acting opioid agent

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acting opioids without long acting opioids within the last 30 days) will reject at the pharmacy as prior authorization required. Concurrent Opioid and Benzodiazepines Hard Edit: Drug – 60 day overlap of opioid and benzo within last 90 days; one-way edit where only benzo will reject. Therapeutic Dose Hard Reject: Cumulative acetaminophen dose check (APAP); > 4 gram of acetaminophen containing products will trigger a hard reject edit Therapeutic Dose Hard Reject: Cumulative dose check of aspirin (>4GM) and ibuprofen (>3.2GM). Concurrent Therapy Concurrent use of opioids and MAT (medication assisted treatment for addiction); opioid post MAT (e.g. Suboxone) will trigger soft reject edit

*Morphine Milligram Equivalents are a way to compare different opioid medications based on their strength as compared to morphine.

When patients fill a prescription for an opioid (a covered drug that is a narcotic substance contained in U.S. Drug Enforcement Administration Schedule II), they may choose to obtain a fill in a lesser quantity than the full amount prescribed. If they do, they may then choose to later obtain the remainder of the prescribed fill. They will not be responsible for any copayment amount beyond the amount that would normally apply if they obtained the entire fill at once. Pain management alternatives to opioid products If you are interested in pain management alternatives to opioid products for your patients, there are many non-opioid medications and treatments available. These include, but are not limited to, those listed below. Non-opiate medication treatment options (Please note that some medications require PA or may have other utilization management restrictions): • NSAIDs • Topical Analgesic • Cox-II Inhibitors • Skeletal Muscle Relaxants • Anti-Depressants • Anti-Convulsant • Corticosteroids

Please refer to our formulary for further information about our prescription drug formulary and prior authorization requirements.

Non-medication, non-surgical treatment modalities: • Chiropractic care • Physical therapy services • Behavioral health providers with pain management-related specialties, such as cognitive behavioral therapy, pain management and treatment of chronic pain.

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These services may require prior authorization or may be subject to benefit limitations or may not be covered for all plans.

Additional medications and treatments are available which may also serve as pain management alternatives to opioid products. These include other medications, certain other types of therapies, treatment by certain types of non-behavioral health specialists, certain types of surgery, and certain types of injections. Some of these additional medication services may require prior authorization or may be subject to benefit limitations; see our prescription drug formulary for further information.

VI. Infusions of certain drugs (Home Infusion) Fallon prefers infusions of certain drugs to be given by home infusion. Please refer to the Medical benefit formulary on our website for the drugs included in this program. Home infusions are provided by Fallon preferred home infusion providers. For outpatient hospital administration, the first doses may be given at facility of choice by the physician; all subsequent doses are preferred to be given by home infusion. Our home infusion service program will outreach to the member and provider to help determine if home infusion is the best option for the member or if there are exceptions that would require the member to receive the infusion in the hospital outpatient setting. Please note: certain members’ benefits may have a preferred infusion suite (rather than home infusion) for certain drugs.

VII. Specialty Prescription Drugs Patients requiring certain specialty medicines must use OptumRx Specialty Pharmacy* to get their medicine. Fallon may allow a one-time fill of a specialty drug at a local pharmacy; after the one-time fill, the patient will receive a letter and call to set up delivery of the drug through the specialty pharmacy network. Please refer to our Provider webpage for more information.

Select Specialty Chemotherapy drugs (Community Care only): Patients will be required to first try six 15 day fills (so 6 half fills) of a new medication before they can fill 30 days at a time. This applies to only oncology specialty medications.

*Specialty pharmacies also include: UMass, Harvard Vanguard Medical Associates Specialty Pharmacy at Atrius Health, Berkshire.. Note that these pharmacies may be limited to certain plans only.

VIII. Medical Drug Wastage Program Community Care and ACO members are partnered with Prime Therapeutics for a medical drug wastage program. As part of the prior authorization process, Prime Therapeutics will require dose rounding for infused drug products to the nearest lowest vial size if within +/- 10% of the original prescribed dose ("the Recommended Dose") unless the following medical necessity criteria are met: Provider indicates the recommended dose may result in a suboptimal outcome due to one of the following:

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  1. Member’s age is less than 18 years of age
  2. Member is partially responsive to the original prescribed dose
  3. Member previously demonstrated a suboptimal response to a lower rounded down dose
  4. Member has a history of rapidly fluctuating body weight (i.e., weight gain of at least 10% body weight in a one month time period within the past 6 months)
  5. Member is clinically unstable and at high risk for hospitalization if the requested medication produces a suboptimal response
  6. Member is being treated for an oncology indication with a curative goal (i.e. adjuvant, neoadjuvant)

  7. Member's laboratory values indicate that a dose reduction will result in a suboptimal response All other reasons not referenced in this policy are not considered medically necessary. Please refer to our website (https://fallonhealth.org/providers/pharmacy) for the most up-to-date criteria.

    IX. Prescription process Pharmacies should process member prescriptions through the claims adjudication system at the point of service. When there is a generic version of a brand-named drug or an interchangeable biosimilar drug for a biologic drug available, the pharmacies will automatically give the member the generic or interchangeable biosimilar version unless the prescribing physician states that the member must have the brand-named drug only (Generic Drug Law St.1976, C.470, Sec.13).

    There are some medications where the brand may be preferred over the generic. These are usually noted as “Brand Preferred” or in a Generic Tier on our formulary. Prescriptions written for Fallon Health members must conform to the Fallon Health formulary. If the prescribed drug is not a preferred formulary drug or requires utilization management, the pharmacist may call the provider to discuss a substitution or send notification by fax that the prescribed drug requires prior authorization. The pharmacist will not provide a substitution without the physician’s approval. If the physician feels that there is no clinically appropriate substitution, they should follow the prior authorization request procedure described below to request approval for the medication.

    It is recommended that every effort be made to utilize formulary medications before requesting non-formulary products. Fallon Health provides prior authorization approval criteria for most medications listed on the formulary that require prior authorization. If the medication is urgently needed, the pharmacy may provide up to a three-day supply for Community Care members at the member’s expense. If the request is approved, the member may be reimbursed by Fallon Health.

    For ACO members, the pharmacy may provide a 72-hour emergency supply to the member at usual cost-sharing.

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Prescribing with OptumRx How do I get started with ePrescribe with OptumRx? First, add the OptumRx profile in your EMR system to send the prescription directly to OptumRx. Make sure to verify your EMR software is certified for e-prescribing controlled substances (EPCS) to comply with the 1/1/2020 requirement of eRx for all controlled substances.

Check the Fallon member’s benefit plan for current prescription coverage and price. Identify possible medication alternatives. If necessary, submit a prior authorization request using your preferred electronic prior authorization portal—CoverMyMeds or Surescripts, for example. Then submit the e-prescription to OptumRx. For more help on successfully submitting a prescription to OptumRx, please visit https://professionals.optumrx.com/resources/manuals-guides/successful-prescription- submission.html.

Mail order pharmacy The following are rules that pertain to ordering medications from mail order pharmacy. Please review these rules to make sure you know what your patients are receiving, and how much the prescription costs. Please note that some medications may not be available from mail order or may be limited in day supply per state laws.

Please note: Mail Order Pharmacy program is not available to all members. Please check the Evidence of Coverage for specific benefit coverage. Fallon Health ACO members are not enrolled in the Mail Order Pharmacy programs.

How to order medications through mail order Listed below are a few reminders to ensure that the mail order process goes smoothly for your patients: • First-time prescriptions are not candidates for mail order. It’s advisable to write new prescriptions for a one-month supply for pickup at a local pharmacy. This ensures that your patient gets the prescription quickly and allows you time to determine the medicine’s effect before ordering larger quantities. • Please be sure to include the dosage, physician signature, name and address. • Members can mail in the prescription via a pre-paid envelope. Members must obtain a prescription from their physician. The prescription must include the dosage, physician signature, name and address. o Members must complete the Mail Service Enrollment form. • The prescription must be written for a 90-day supply. Maintenance medications (e.g., for diabetes and high blood pressure) are best. These are more suited to the larger quantity and mailing timeframes (usually within 5 business days).

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• Please review the prescription and its destination (mail order vs. retail) with your patient. Once your patient receives the medication, it can’t be returned. Federal and state laws prohibit it, and the member will be charged the prescription copayment.

You have three options for prescribing with OptumRx Home Delivery (mail order):

  1. ePrescribe – Add the OptumRx profile in your electronic medical record (EMR) system using the following information: OptumRx Mail Service, 2858 Loker Ave East, Suite 100, Carlsbad, CA 92010; NC PDP ID = 0556540; PID = P00000000020173.
  2. Call an OptumRx pharmacist at 1-800-791-7658
  3. Fax a completed form to OptumRx at 1-800-491-7997 Prescribing for specialty medications with OptumRx*
  4. Phone – 1-855-427-4682
  5. Address – P.O. Box 2975, Mission, KS 66201

  6. Fax (for prescription submissions only – no PAs) – 1-877-342-4596

    *Specialty pharmacies also include: UMass, Harvard Vanguard Medical Associates Specialty Pharmacy at Atrius Health, Berkshire. Note that these pharmacies may be limited to certain plans only.

    The following information is necessary and mandatory by Massachusetts law when documenting prescriptions:

  7. Correct spelling of name and address of member
  8. Name and address of physician
  9. Physician registration number (DEA)
  10. Date of writing the prescription
  11. Name, dosage and strength of medication
  12. Directions of usage

  13. Number of refills allowed

    Other information that ensures a speedier processing of prescriptions includes the member’s date of birth and home telephone number.

    We recommend that providers utilize e-prescribing whenever possible.

    X. Prior Authorization Request Policy Prior authorization is required for any medication exceeding the cost threshold ($20000 for most medications (Community Care only) or $100 for compounds) and any medication noted with a “PA, ” “QL,” or “ST” on the Fallon Health formulary. A PA is also required for a drug that exceeds our Opioid Management Strategy limits and for formulary exception requests. Before we will pay for these medications, the provider must fill out a Fallon Health prescription prior authorization form and Fallon must approve the request.

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Prior authorization request procedure Fallon Health collaborates with OptumRx (Fallon's Pharmacy Benefit Manager) and Prime Therapeutics Management (Prime) to implement our prior authorization process. For all lines of business, OptumRx reviews pharmacy benefit drugs (patient self-administered drugs, including oral medications and Commercial/Medicaid member diabetic testing supplies). Prime Therapeutics Management (Prime) reviews medical benefit drugs (physician-administered drugs, including home infusion).

Important Information regarding the Massachusetts Standard PA Form and Community Care plan members. (This is not applicable to ACO members) Please review the criteria posted on the Online Formulary prior to completing the PA form or submitting an ePA and provide all relevant data for each part of the criteria. If there is no specific field for the data on the PA form, please use the "Additional information pertinent to this request" field. For Community Care member PA requests, you must use the state- mandated standard PA form, or otherwise use ePA or telephone.

Please use the Online Formulary to determine which medications require Utilization Management (UM). Each drug with UM includes a link to the criteria, ePA, and fax form. Example:

Patient-administered drugs (pharmacy benefit) Our process offers you two ways to submit a prior authorization request for patient self-administered drugs: • Electronic prior authorization tool (ePA) • Call or fax Electronic prior authorization tool (ePA) Fallon and OptumRx have made submitting PAs easy, quick, and convenient. ePA is a secure and easy method for submitting, managing, tracking PAs, step therapy and non- formulary exception requests. It enables a faster turnaround time of coverage determinations for most PA types and reasons. • Request clinical questions through your integrated EHR or the ePA website. • Answer patient-specific clinical questions electronically and submit for review.

For more information about OptumRx prior authorizations, please refer to https://professionals.optumrx.com/prior-authorization.html or to our provider webpage.

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Call or fax To serve you quickly and efficiently, we have separate phone and fax numbers for our Community Care and ACO plans. To determine which phone or fax number to use, find the member's plan name on their ID card and locate it in the chart below. When faxing, please use the form in the drug link on the Online Drug Formulary.

Line of business Phone Fax Mail Commercial • Community Care 1-844-720-0035 1-844-403-1029 Optum Prior Authorization Department P.O. Box 2975 Mission, KS 66201 Medicaid ACO • Fallon 365 Care • Berkshire Fallon Health Collaborative • Fallon Health-Atrius Health Care Collaborative 1-844-720-0033 1-844-403-1029 Optum Prior Authorization Department P.O. Box 2975 Mission, KS 66201

Physician-administered drugs (medical benefit) Our process offers you two ways to submit a prior authorization request for physician- administered drugs: • Electronic prior authorization web portal • Call or fax

Electronic prior authorization web portal Fallon and Prime have made submitting PAs easy, quick, and convenient through the GatewayPA.com . website.

Please click "New Provider Access Request" under the "Sign In" box to request access. Call or fax • Call: 1-800-424-1740 • Fax: 1-888-656-6671

For more about our Medical Rx program, please refer to our Provider webpage.

If the prior authorization is approved, the provider will be notified by fax. If the prior authorization is not approved, the provider will be notified through a phone call, followed by fax; citing denial reasons,

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alternative medications if indicated, a reference to the guideline, protocol or other similar criterion on which the denial decision is based, and information on the appeal process.

Please note: To facilitate the process, we recommend reviewing the criteria documents that are available on the Fallon Health website. The criteria can be found on the Physicians and providers area of the Fallon Health website, www. fallonhealth.org, in the “Pharmacy” section, under the “Online Drug Formulary.” Clinical review criteria are also available to all practitioners upon request.

For Community Care member PA requests, you must use the state-mandated standard PA form. A link to the standard PA form is provided in the "PA form" column. Please review the criteria posted on our website prior to completing the PA form and provide all relevant data for each part of the criteria. If there is no specific field for the data on the PA form, please use the "Additional information pertinent to this request" field. PAs are usually completed within 2 business days of receiving a complete form. For ACO members, PA forms are not restricted to the state mandated standard form. In fact, this standard form should not be used for Medicaid members. Drug-specific PA forms and general PA forms are available on the MassHealth website. Please review the criteria posted on the MassHealth website prior to completing the PA form and provide all relevant data for each part of the criteria. Fallon’s website will link to the formulary and criteria on MassHealth’s website. Although the PA forms are posted on MassHealth’s website, PAs must be submitted to Fallon’s partners of Optum (pharmacy benefit medications) or Prime (medical benefit medications). PAs are reviewed within 24 hours of receipt of a complete PA form for Medicaid-ACO and within 2 business days of a completed form for Community Care.

Why Complete and Timely Pharmacy Prior Authorization (PA) Submissions Matter

In today’s healthcare environment, timely access to medications is critical to patient outcomes. One of the most impactful ways providers can support this goal is by submitting complete and clinically thorough prior authorization (PA) requests and responding promptly to any requests for additional information.

Regulatory Requirements Drive Timely Reviews Regulatory bodies such as CMS, NCQA, and various state agencies mandate strict turnaround times for pharmacy PA reviews, many of which are within 24 or 72 hours. These timeframes are designed to ensure patients receive timely decisions regarding their medication access. When we request additional information, it is with these regulatory deadlines in mind. If the necessary information is not received within the required timeframe, we are obligated to deny the request due to insufficient documentation.

Avoiding Delays Through Complete Initial Submissions A common pattern we observe is that denied initial PA requests are quickly followed by appeals. While appeals are a valid part of the process, they often have longer turnaround times than initial reviews. This delay can result in interrupted or postponed access to medications for members.

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Submitting a complete and clinically supported PA request from the start is the best way to avoid unnecessary delays and denials. This includes: • Answering all questions thoroughly. • Providing clinical rationale when answering questions or listing alternative therapies. • Including relevant documentation such as chart notes, lab results, and treatment history. Clinical Oversight Is Key We’ve also noted that some PA requests or responses to additional information are completed by non-clinical staff, which can lead to incomplete or inaccurate submissions. This often results in denials that could have been avoided with proper clinical input. Best practice: Ensure that staff handling PA submissions have clinical knowledge or that requests are escalated to clinical team members when appropriate.

Tips for Successful PA Submissions • Be proactive: Submit all relevant clinical documentation with the initial request. • Be responsive: Reply to requests for additional information as quickly and thoroughly as possible keeping in mind the short turnaround times for initial PA reviews. • Be specific: When listing alternative therapies or explaining why a drug cannot be used, include a clear clinical rationale. • Be collaborative: Ensure coordination between administrative and clinical staff to avoid gaps in information.

The Bottom Line Complete and timely PA submissions not only help meet regulatory requirements, they also reduce delays, minimize denials, and most importantly, support better patient care. We appreciate your partnership in ensuring that members receive the medications they need without unnecessary barriers.

For more information on our Pharmacy PA process visit our website: https://fallonhealth.org/en/providers/pharmacy/pharmacy-prior-authorization Our formulary and clinical criteria may also be accessed from our website: https://fallonhealth.org/en/providers/pharmacy/online-drug-formulary XI. Non-Covered Items

Community Care only Exclusions: Medications/conditions listed above under “Related Exclusions” are not a covered benefit.

Non-Formulary: Medications not on the formulary are considered non formulary and are not covered. If the medications on our formulary are not appropriate for your patient’s condition, there is a formulary exception request process available. The prescriber must support the request by providing clinical information and a statement that provides justification for supporting the need for the non-formulary drug to treat the condition, including a statement that all covered formulary drugs on any tier will be or have been ineffective, would not be as effective as the non-formulary drug, or would have adverse effects. This request must be

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approved by Fallon Health before we will pay for the drug. This follows the standard PA process.

MassHealth ACO only If you believe it is medically necessary for the patient to take a drug that is not listed on our formulary, you can submit a prior authorization that will be reviewed by a clinician and, if approved, Fallon will cover the drug. If the prior authorization request is denied, you and your patient receive denial information.

XII. Diabetic Supplies

Community Care Plan with Rx Insulin Prescription copayment, deductible and/or coinsurance per 30 day supply Insulin syringes (includes needles) Prescription copayment, deductible and/or coinsurance per 30 day supply Blood glucose meter Covered in full Blood glucose test strips Prescription copayment, deductible and/or coinsurance per 30 day supply Blood ketone test strips Prescription copayment, deductible and/or coinsurance per 30 day supply Spring-powered lancet device Prescription copayment, deductible and/or coinsurance applies Lancets Prescription copayment, deductible and/or coinsurance per 30 day supply Urine glucose test strips Prescription copayment, deductible and/or coinsurance per 30 day supply Urine ketone test strips Prescription copayment, deductible and/or coinsurance per 30 day supply Insulin pens (includes pre- filled insulin pen cartridges; needles sold separately) Prescription copayment, deductible and/or coinsurance per 30-day supply Insulin pen needles Prescription copayment, deductible and/or coinsurance per 30-day supply Prescribed oral medications that influence blood sugar levels Prescription copayment, deductible and/or coinsurance per 30-day supply

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Community Care Prior authorization is required for blood glucose meters and supplies that are non-preferred brands, continuous or require adaptive features. • Blood glucose meters are limited to Accu-Chek® glucose meters and test strips manufactured by Roche. Plan members can obtain an Accu-Chek® glucose meter at network pharmacies. • Continuous blood glucose monitors are limited to the Freestyle Libre System. Members may obtain Freestyle Libre at network durable medical equipment suppliers or pharmacies. • Members with a demonstrated need, including having a severe visual impairment or impaired manual dexterity, may require a blood glucose meter with adaptive features, such as an integrated voice synthesizer or integrated lancing device. Prior authorization is required. • Quantities of blood glucose test strips in excess of 150 per 30-day supply require PA • Other diabetic supplies noted on formulary as requiring a PA

MassHealth ACO Prior authorization is required for blood glucose meters and supplies that are non-preferred brands, continuous or require adaptive features. • Preferred blood glucose meters covered are limited to FreeStyle or Precision Xtra glucose meters and test strips manufactured by Abbott. You can obtain a FreeStyle or Precision Xtra glucose meter at network pharmacies by providing the pharmacy with the following information: RxBIN: 610020 Group #: 99992432 ID # ERXMASSHEAL or by calling Abbott Diabetes Care at 1-866-224-8892 with Offer Code A35ABII0. FreeStyle can also be ordered by signing up at ChooseFreeStyle.com with Offer Code A35ABII0. • Test strip quantities over 100 per month and other brand meters and test strips require prior authorization. • Continuous blood glucose monitors may be obtained at network durable medical equipment supplies or pharmacies. Prior authorization applies. • Members with a demonstrated need, including having a severe visual impairment or impaired manual dexterity, may require a blood glucose meter with adaptive features, such as an integrated voice synthesizer or integrated lancing device. Diabetic supply procedure

  1. Provider fills out Fallon Health prior authorization form if necessary and follows above prior authorization procedure.
  2. The physician writes a prescription for the diabetic supply.
  3. The member fills the prescription at a Fallon Health contracted pharmacy. The retail pharmacy collects any applicable copayment.

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XIII. Injectables Injectables are defined as sterile medications given with the aid of a needle/syringe and administered parenterally. Certain medications may be supplied by a Fallon Health- contracted pharmacy for patient self-use. Other medications are obtained by the contracted health care provider for in-office use. Many injections require prior authorization. Note: Call the Pharmacy Service Department Service Line (1-866-275-3247, prompt 5, prompt 2) for any questions regarding whether a medication can be self administered or must be administered in the office.

Refer to the following sections above for more information: Infusions of certain drugs (Home Infusion) Specialty Prescription Drugs Medical Drug Wastage Program

Injectable supply procedure A. Injectable medication to be self-administered (or by a family member) at home:

  1. Provider fills out Fallon Health prior authorization form if necessary and follows above prior authorization procedure.
  2. Provider writes prescription to the applicable pharmacy.
  3. The member receives the prescription. A co-payment is charged. B. Injectable medication to be administered in the physician office:
  4. Provider fills out Fallon Health prior authorization form if necessary and follows above prior authorization procedure.

  5. Provider supplies the medication from their own stock and bills Fallon Health directly for both the medication and the administration of the medication.

    XIV. Transitional Medications Process

    Community Care:

    Fallon has a medication continuity of care (or transition) policy. This is for drugs requiring Prior Authorization (PA) or Step Therapy. Fallon allows a 30-day supply of medication for newly enrolled members who have already been prescribed the medication and on which the member is stable, upon documentation by the member’s prescriber. Fallon does not apply any greater deductible, coinsurance, copayments or out-of-pocket limits than would otherwise apply to other drugs covered by the plan.

    This ensures that the member does not experience any delay in accessing the drug prescribed by their health care provider while the PA or Step Therapy request is being reviewed. After this transition period, if a PA or Step Therapy is not granted, the appropriate requirements need to be met..

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MassHealth ACO Step Therapy:

Fallon has a step therapy medication continuity of care (or transition) policy for new members. Step therapy include step drugs and PA drugs with an embedded step requirement. This includes pharmacy and medical benefit drugs with step.

Fallon will allow a 30-day supply of step therapy medication for newly enrolled members within the first 30 days of their enrollment. This will ensure that the enrollee does not experience any delay in accessing the drug prescribed by their health care provider, including a drug administered by infusion, while the exception request is being reviewed. After this transition period, if an exception is not granted, the appropriate step requirements will need to be met.

MassHealth ACO General Transition:

For new members, Fallon Health has a 30-day continuity of care policy to minimize disruption of care and ensure uninterrupted access to medically necessary services. This applies to all newly enrolled MassHealth ACO members. During the initial 30 days of enrollment, we will allow a temporary 30-day transition fill for drugs if members have already been taking the drug previously and the drug has Prior Authorization, quantity limit, or step therapy requirements. This allows members to work with their provider to change to a drug on our formulary or to request a Prior Authorization. Members will receive a letter explaining the temporary fill and actions the member needs to take. We also allow a temporary fill for an out of network pharmacy. This allows the member to contact Customer Service to locate a pharmacy near them that is in our network and to have the prescription transferred. Members will receive a letter explaining the temporary fill and actions they need to take.

In addition to the above, we also allow a 72-hour emergency supply to be filled at network pharmacies when a Prior Authorization request is pending resolution.

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Fallon Medicare Plans (Fallon Medicare Plus, NaviCare, Summit ElderCare PACE, and Fallon Health Weinberg PACE)

I. Formulary The Fallon Health Medicare Plan formularies can be found on the Fallon Health website, www.fallonhealth.org in the Physicians and providers area, in the “Pharmacy” section, under Online Drug Formulary. Any medication requiring utilization management will be designated with: PA for prior authorization; ST for Step Therapy; QL for Quantity Limit.

Fallon Health will notify practitioners whenever there is a change in the formulary. These notifications are by direct mailings and through the Connection newsletter.

Fallon Medicare plans have a formulary drug list that includes medications from every drug class except for certain medications excluded by Medicare. These excluded medications are the member’s responsibility and include the following: • Agents when used for anorexia, weight loss, or weight gain* • Agents when used to promote fertility. • Agents when used for cosmetic purposes or hair growth • Agents when used for the symptomatic relief of cough and colds • Prescription vitamins and mineral products, except prenatal vitamins and fluoride preparations • Nonprescription drugs (Note: certain OTC medications are covered for Navicare and PACE) • Covered outpatient drugs which the manufacturer seeks to require as a condition of sale that associated tests or monitoring services be purchased exclusively from the manufacturer or its designee • Agents when used for the treatment of sexual or erectile dysfunction, unless such agents are used to treat a condition other than sexual or erectile dysfunction, for which the agents have been approved by the Food and Drug Administration.

*Note: weight-loss agents may be available for NaviCare members under the Medicaid benefit.

If a member receives their health care coverage through an employer group, their formulary may include more covered prescription drugs than those normally covered by Medicare Part D.

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II. New-to-Market Policy Fallon Health follows a new-to-market medication evaluation policy and usage determination for medications newly approved by the FDA. Fallon Health has a waiting period of up to 180 days for all new medications, in order to ensure enough time to determine true dosing parameters, side-effect profiles, drug-drug interactions, drug- disease state interactions, and age-related issues. Medications or new indications of medications that fall within one of the following classes of clinical concern, antidepressants, antipsychotics, anticonvulsants, Antineoplastics, immunosuppressive or Antiretrovirals, will be subject to the expedited review process. This process involves evaluation and usage determination for the preceding medications within 90 days of approval by the FDA. During this period, a physician can request the medication via the prior authorization process.

III. Utilization Management Utilization management includes Prior Authorization, Quantity Limits, and Step Therapy as described below.

Prior Authorizations Coverage of certain formulary medications is based on medical necessity. For these drugs, a prior authorization* is required from the plan. They are noted on the formulary as “PA.” We will review the prior authorization request according to our criteria for medical necessity.

Quantity and duration limits To further ensure patient safety, Fallon Health has established quantity and duration-of- use limits for a specific list of medications. The limits and duration will appear as “QL” on the online formulary. If a physician would like an exception to this rule for a specific member, they can submit a completed prior authorization request form*. This form must state the medical reason why more doses are needed, as well as the duration that is needed. Quantity limits are based upon the Food and Drug Administration’s maximum recommendation doses.

Step-therapy There are certain medications for which patients will be required to have previously used or be unable to take certain other formulary medications. This is called step-therapy. They are noted on the formulary as “ST”. If a physician would like an exception to this rule for a specific member, they can submit a completed prior authorization request form*. This form must state the medical reason why the preferred drugs would not be appropriate for this patient.

*Instructions for submitting a PA, as well as ePA, phone, and fax numbers is located on our website, www.fallonhealth.org, in the Physicians and providers section, under “Pharmacy”.

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IV. Drug Utilization Review We conduct prospective and retrospective drug utilization reviews for all of our members to make sure they are getting safe and appropriate care. These reviews are especially important for members who have more than one doctor who prescribe medications. These reviews are conducted each time a prescription is filled by a member and on a regular basis by reviewing our records. Examples of these reviews include the following: • Possible medication errors • Duplicate drugs treating same condition • Age-gender related issues • Drug-drug interactions • Drug-disease state interactions • Drug allergies • Drug dosage errors • Over-usage of narcotic drugs

V. Opioid Edits and Management Program There are several opioid safety edits and programs for the Fallon Medicare plans. This impacts all Fallon Medicare members: Fallon Medicare Plus, NaviCare, Summit ElderCare PACE, and Fallon Health Weinberg PACE. The criteria used to identify members potentially at risk or for the point of sale pharmacy edits are not intended as prescribing limits. They are used to identify members that may be at risk for opioid overuse. The edits are not a substitute for your professional judgement and do not mean that you cannot prescribe over these limits. You need to attest that the identified medications and doses are intended and medically necessary for the member. Please be aware that network pharmacies, Fallon Pharmacy Department, our MTM vendor (Clarest Health), and/or our Opioid Drug Management vendor and PBM (Optum Rx) may outreach to you for your assistance in resolving these safety edits and opioid management cases. Please assist us in meeting the expectation that prescribers respond to pharmacy outreach related to opioid safety alerts in a timely manner, including educating their on-call staff. Some of these issues can be completed directly with the retail pharmacy by attesting that the medications and doses are intended and medically necessary for the member. If you need to submit a Coverage Determination or an Exception request, please call 844- 657-0494 (please call 844-722-1701 for Fallon Health Weinberg PACE) or Fax 844-403-1028.

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Below is a summary of the programs:

Point of Sale (POS) opioid safety edits CMS requires certain prospective safety edits. These edits will occur when the member is filling the prescription at the pharmacy. These edits require resolution. The pharmacist at the pharmacy may override some of the edits with appropriate codes, may need to consult with the provider, and may need to inform the provider that a prior authorization is required. Since these are safety edits, they will still apply during a member’s transition period; meaning, the claims will still reject with the edits and require resolution. Buprenorphine for medication-assisted treatment (MAT) is not included in the safety edits. Hospice/palliative care, cancer-related pain, sickle cell disease, and LTC members are excluded from the safety edits. Members have Coverage Determination and Appeal rights under this program.

The edits include: • Soft edit for concurrent opioid and benzodiazepine use – pharmacy can override • Soft edit for duplicative long-acting (LA) opioid therapy – pharmacy can override • Soft edit for concurrent opioid and prenatal vitamins use – pharmacy can override • Soft edit for concurrent opioid and Medication Assisted Therapy (MAT) use – pharmacy can override • Care coordination edit at 90 morphine milligram equivalents (MME) and 2 prescribers – pharmacy can override only after consultation with the prescriber, documentation of the discussion, and if the prescriber confirms intent (the opioids and/or day supply is intended and medically necessary for the member), using an override code that indicates the prescriber has been consulted. • Hard edit for a 7-day supply limit for initial opioid fills (opioid naïve) with a 120-day look-back. This will require a prior authorization to be submitted. Provider needs to attest that the opioids and/or day supply is intended and medically necessary for the member. Member is considered opioid naïve if there are no opioid claims in the past 120 days.

Medication Therapy Management (Not applicable to PACE programs) We are also including special eligibility criteria into our Medication Therapy Management Program (MTMP). In addition to traditional MTMP eligibility, members are also eligible for MTM if they have been identified as an At-Risk Beneficiary (ARB) under a Drug Management Program (DMP).

Comprehensive Addiction and Recovery Act of 2016 (CARA) - Drug Management Program (DMP) This is a comprehensive opioid management program required under the Comprehensive Addiction and Recovery Act of 2016 (CARA). This is a retrospective DUR program to identify members at risk for frequently abused drugs and conduct case management. Frequently abused drugs are defined by CMS as opioids and benzodiazepines.

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Buprenorphine for medication-assisted treatment (MAT) is not included in the 90 MME accumulations. The program excludes members with cancer pain, palliative/hospice care, sickle cell disease, and in LTC. Dual/Low Income Subsidy (LIS) members are limited in ability to change plans to avoid intervention once identified as at-risk.

Criteria for identification into the program include any of the below: • Members with opioid pharmacy claims equal to or greater than 90 MME and 3+ opioid prescribers and 3+ opioid dispensing pharmacies • Members with opioid pharmacy claims equal to or greater than 90 MME and 5+ opioid prescribers • Members with any MME level and 7+ opioid prescribers or 7+ opioid dispensing pharmacies • Members identified as having a history of opioid-related overdose are also included in the DMP

The Drug Management Program includes case management and clinical outreach to providers to determine if the member is at risk for opioid overutilization, notifications to the member, potential lock-in restrictions to specific provider(s), pharmacy(ies), and/or at the drug level. Members have appeal rights under this program.

Alternative pain management options There are ways to manage pain that do not involve prescription opioids. Some of these options may work better and have fewer risks and side effects. Depending on the type of pain the patient is experiencing, options may include: • Over-the-counter medications such as ibuprofen (Motrin®), acetaminophen (Tylenol®) or naproxen (Aleve®). • Prescription-strength anti-inflammatory medications such as celecoxib (Celebrex®), diclofenac (Voltaren®), and etodolac (Lodine®). • Some prescription non-opioid medications that target pain-producing nerves, such as gabapentin (Neurontin®) and pregabalin (Lyrica®). • Injectable and topical therapies. • Chiropractor services, physical and other therapies, heat or cold compresses, exercise, acupuncture and cognitive behavioral therapy.

Note: In most cases, only the generic versions of the above drugs are covered; OTCs are not covered for Fallon Medicare Plus; and PA may be required.

Medicare covers Opioid Treatment Programs (OTPs) for opioid use disorder (OUD) treatment. Services are provided to people with Medicare Part B (Medical Insurance). For information on your patient’s benefits related to treatment for prescription drug abuse, including medication assisted treatment, mental health and counseling services, call Fallon Health Provider Relations.

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VI. Prescription Process Pharmacies should process member prescriptions through the claims adjudication system at the point of service. When there is a generic version of a brand-named drug or an interchangeable biosimilar drug for a biologic drug available, the pharmacies will automatically give the member the generic or interchangeable biosimilar version unless the prescribing physician states that the member must have the brand-named drug only (Generic Drug Law St.1976, C.470, Sec.13). There are some medications where the brand may be preferred over the generic. These are usually listed in a Generic Tier on our formulary.

Prescriptions written for Fallon Health members must conform to the Fallon Health formulary. If the prescribed drug is not a preferred formulary drug, the pharmacist may call the provider to discuss a substitution or send notification by fax that the prescribed drug requires prior authorization. The pharmacist will not provide a substitution without the physician’s approval. If the physician feels that there is no clinically appropriate substitution, they should follow the prior authorization request procedure described below to request approval for the medication. It is recommended that every effort be made to utilize formulary medications before requesting non-formulary products. Fallon Health provides prior authorization approval criteria for medications listed on the formulary that require prior authorization. If the medication is urgently needed, the pharmacy may contact Fallon to request a transition fill while the PA is being processed.

Prescribing with OptumRx

How do I get started with ePrescribe with OptumRx? First, add the OptumRx profile in your EMR system to send the prescription directly to OptumRx. Make sure to verify your EMR software is certified for e-prescribing controlled substances (EPCS) to comply with the 1/1/2020 requirement of eRx for all controlled substances.

Check the Fallon member’s benefit plan for current prescription coverage and price. Identify possible medication alternatives. If necessary, submit a prior authorization request using your preferred electronic prior authorization portal—CoverMyMeds or Surescripts, for example. Then submit the e-prescription to OptumRx.

For more help on successfully submitting a prescription to OptumRx, please visit https://professionals.optumrx.com/resources/manuals-guides/successful-prescription- submission.html .

Mail order pharmacy The following are rules that pertain to ordering medications from mail order pharmacy. Please review these rules to make sure you know what your patients are receiving, and how much the prescription costs. Please note that some medications may not be available from mail order or may be limited in day supply per state laws.

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How to order medications through mail order Listed below are a few reminders to ensure that the mail order process goes smoothly for your patients: • First-time prescriptions are not candidates for mail order. It’s advisable to write new prescriptions for a one-month supply for pickup at a local pharmacy. This ensures that your patient gets the prescription quickly and allows you time to determine the medicine’s effect before ordering larger quantities. • Please be sure to include the dosage, physician signature, name and address. • Members can mail in the prescription via a pre-paid envelope. Members must obtain a prescription from their physician. The prescription must include the dosage, physician signature, name and address. o Members must complete the Mail Service Enrollment form. o Medicare members must complete the Medicare Part D Mail Service Enrollment form (only need to do this with the first order) • The prescription must be written for a 90-day supply. Maintenance medications (e.g., for diabetes and high blood pressure) are best. These are more suited to the larger quantity and mailing timeframes (usually within 5 business days). • For certain Medicare plans, up to 100-day supply is allowed on Tier 1 medications. Please write for 100-day supply for Tier 1 medications whenever appropriate. This is not applicable to PACE plans. • Please review the prescription and its destination (mail order vs. retail) with your patient. Once your patient receives the medication, it can’t be returned. Federal and state laws prohibit it, and the member will be charged the prescription copayment.

You have three options for prescribing with OptumRx Home Delivery (mail order): • ePrescribe – Add the OptumRx profile in your electronic medical record (EMR) system using the following information: OptumRx Mail Service, 2858 Loker Ave East, Suite 100, Carlsbad, CA 92010; NC PDP ID = 0556540; PID = P00000000020173. • Call an OptumRx pharmacist at 1-800-791-7658 • Fax a completed form to OptumRx at 1-800-491-7997

Prescribing for specialty medications with OptumRx* • Phone – 1-855-427-4682 • Address – P.O. Box 2975, Mission, KS 66201 • Fax (for prescription submissions only – no PAs) – 1-877-342-4596

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*Specialty pharmacies also include: UMass, Tufts, Berkshire. The above contact information is ONLY for OptumRx. Please contact the other specialty pharmacies directly.

The following information is necessary and mandatory by Massachusetts law when documenting prescriptions (written and oral).

  1. Correct spelling of name and address of member
  2. Name and address of physician
  3. Physician registration number (DEA)
  4. Date of writing the prescription
  5. Name, dosage and strength of medication
  6. Directions of usage

  7. Number of refills allowed Other information that ensures a speedier processing of prescriptions includes the member’s date of birth and home telephone number.

    We recommend that providers utilize e-prescribing whenever possible.

    VII. Prior Authorization Request Policy Prior authorization is required for any medication noted with a “PA”, “QL”, or “ST” on the Fallon Health formulary. A PA may also require for a drug that exceeds our Opioid Management Strategy limits and for formulary exception requests. Before we will pay for these medications, the provider must fill out a Fallon Health prescription prior authorization form and Fallon must approve the request.

    Prior authorization request procedure Fallon Health collaborates with OptumRx (Fallon's Pharmacy Benefit Manager) and Prime Therapeutics Management (Prime) to implement our prior authorization process. For all lines of business, OptumRx reviews pharmacy benefit drugs (patient self-administered drugs, including oral medications and member diabetic testing supplies). (See note below regarding Medicare glucose monitors and test strips.) Prime Therapeutics Management (Prime) reviews medical benefit drugs (physician-administered drugs, including home infusion).

    Please use the Online Formulary to determine which medications require Utilization Management (UM). Each drug with UM includes a link to the criteria, ePA, and fax form.

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Example:

Patient-administered drugs (pharmacy benefit) Our process offers you two ways to submit a prior authorization request for patient self-administered drugs: • Electronic prior authorization tool (ePA) • Call or fax

Electronic prior authorization tool (ePA) Fallon and OptumRx have made submitting PAs easy, quick, and convenient. ePA is a secure and easy method for submitting, managing, tracking PAs, step therapy and non- formulary exception requests. It enables a faster turnaround time of coverage determinations for most PA types and reasons.

Using ePA, you can:

• Request clinical questions through your integrated EHR or the ePA website. • Answer patient-specific clinical questions electronically and submit for review.

For more information about OptumRx prior authorizations, please refer https://professionals.optumrx.com/prior-authorization.html or to our provider webpage.

Call or fax To serve you quickly and efficiently, we have separate phone and fax numbers for our Medicare plans. To determine which phone or fax number to use, find the member's plan name on their ID card and locate it in the chart below.

When faxing, please use the form in the drug link on the Online Drug Formulary.

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Line of business Phone Fax Mail Medicare • Fallon Medicare Plus • NaviCare 1-844-657- 0494 1-844-403- 1028 Optum Prior Authorization Department P.O. Box 2975 Mission, KS 66201 PACE Summit ElderCare 1-844-657- 0494 1-844-403- 1028 Optum Prior Authorization Department P.O. Box 2975 Mission, KS 66201 Fallon Health Weinberg- PACE 1-844-722- 1701 1-844-403- 1028 Optum Prior Authorization Department P.O. Box 2975 Mission, KS 66201

Physician-administered drugs (medical benefit) Our process offers you two ways to submit a prior authorization request for physician- administered drugs:

• Electronic prior authorization web portal • Call or fax

Electronic prior authorization web portal Fallon and Prime Therapeutics Management (Prime) have made submitting PAs easy, quick, and convenient through the GatewayPA.com website.

Please click "New Provider Access Request" under the "Sign In" box to request access.

Call or fax • Call: 1-800-424-1740 • Fax: 1-888-656-6671

For more about our Medical Rx program, please refer to our Provider webpage

Medicare glucose monitors and related testing supplies (including test strips and CGMs) for Medicare, NaviCare, and PACE plans are reviewed by our partner, OptumRx. Please use the Optum contact information above to submit these PA requests.

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Please note: To facilitate the process, we recommend reviewing the criteria documents that are available on the Fallon Health website. The criteria can be found on the Physicians and providers area of the Fallon Health website, www.fallonhealth.org, in the “Pharmacy” section under the Online Drug Formulary. Clinical review criteria are also available to all practitioners upon request.

Routine requests are processed within 72 hours from the date of request. Urgent/emergency requests are processed within 24 hours of the date of request. Requests are reviewed in the order of arrival, with the exception of emergency medications, which are reviewed according to the urgency of the clinical situation.

Please note that urgent requests may require more information and the reviewing pharmacist may need to reach out to the office. Please remember that an urgent request must be decided within 24 hours and you must be available to answer any extra questions during this time, otherwise, the request may be denied. The same applies to a standard request that is submitted on a Friday. Please submit urgent requests only when the patient’s health is truly in jeopardy.

If the prior authorization is approved, the provider will be notified by fax. If the prior authorization is not approved, the provider will be notified through a phone call, followed by written notification (fax or mail). The notification will cite denial reasons, alternative medications if indicated, a reference to the guideline, protocol or other similar criterion on which the denial decision is based, and information on the appeal process.

Why Complete and Timely Pharmacy Prior Authorization (PA) Submissions Matter

In today’s healthcare environment, timely access to medications is critical to patient outcomes. One of the most impactful ways providers can support this goal is by submitting complete and clinically thorough prior authorization (PA) requests and responding promptly to any requests for additional information.

Regulatory Requirements Drive Timely Reviews Regulatory bodies such as CMS, NCQA, and various state agencies mandate strict turnaround times for pharmacy PA reviews, many of which are within 24 or 72 hours. These timeframes are designed to ensure patients receive timely decisions regarding their medication access. When we request additional information, it is with these regulatory deadlines in mind. If the necessary information is not received within the required timeframe, we are obligated to deny the request due to insufficient documentation.

Avoiding Delays Through Complete Initial Submissions A common pattern we observe is that denied initial PA requests are quickly followed by appeals. While appeals are a valid part of the process, they often have longer turnaround times than initial reviews. This delay can result in interrupted or postponed access to medications for members.

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Submitting a complete and clinically supported PA request from the start is the best way to avoid unnecessary delays and denials. This includes: • Answering all questions thoroughly. • Providing clinical rationale when answering questions or listing alternative therapies. • Including relevant documentation such as chart notes, lab results, and treatment history. Clinical Oversight Is Key We’ve also noted that some PA requests or responses to additional information are completed by non-clinical staff, which can lead to incomplete or inaccurate submissions. This often results in denials that could have been avoided with proper clinical input. Best practice: Ensure that staff handling PA submissions have clinical knowledge or that requests are escalated to clinical team members when appropriate.

Tips for Successful PA Submissions • Be proactive: Submit all relevant clinical documentation with the initial request. • Be responsive: Reply to requests for additional information as quickly and thoroughly as possible keeping in mind the short turnaround times for initial PA reviews. • Be specific: When listing alternative therapies or explaining why a drug cannot be used, include a clear clinical rationale. • Be collaborative: Ensure coordination between administrative and clinical staff to avoid gaps in information. The Bottom Line Complete and timely PA submissions not only help meet regulatory requirements, they also reduce delays, minimize denials, and most importantly, support better patient care. We appreciate your partnership in ensuring that members receive the medications they need without unnecessary barriers.

For more information on our Pharmacy PA process visit our website: https://fallonhealth.org/en/providers/pharmacy/pharmacy-prior-authorization Our formulary and clinical criteria may also be accessed from our website: https://fallonhealth.org/en/providers/pharmacy/online-drug-formulary

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VIII. Part B Drugs In accordance with federal regulations, Fallon Medicare members are covered, with a required co-payment (if applicable to the plan), for the following mandated medications:

Note: The following Medicare mandated medications are not applied to the Medicare Part D accumulators.

Covered drugs include: • Drugs that usually aren’t self-administered by the patient and are injected or infused while you get physician, hospital outpatient, or ambulatory surgical center services • Insulin furnished through an item of durable medical equipment (such as a medically necessary insulin pump) • Other drugs patients take using durable medical equipment (such as nebulizers) that were authorized by our plan • The Alzheimer’s drug, Leqembi® (generic name lecanemab), which is administered intravenously. In addition to medication costs, patients may need additional scans and tests before and/or during treatment that could add to overall costs. • Clotting factors patients give themselves by injection if they have hemophilia • Transplant/immunosuppressive drugs: Medicare covers transplant drug therapy if Medicare paid for the organ transplant. Patients must have Part A at the time of the covered transplant, and patients must have Part B at the time they get immunosuppressive drugs. Medicare Part D drug coverage covers immunosuppressive drugs if Part B doesn't cover them • Injectable osteoporosis drugs, if patients are homebound, have a bone fracture that a doctor certifies was related to post-menopausal osteoporosis, and can’t self-administer the drug • Some antigens: Medicare covers antigens if a doctor prepares them and a properly instructed person gives them under appropriate supervision • Certain oral anti-cancer drugs: Medicare covers some oral cancer drugs patients take by mouth if the same drug is available in injectable form or the drug is a prodrug (an oral form of a drug that, when ingested, breaks down into the same active ingredient found in the injectable drug) of the injectable drug. As new oral cancer drugs become available, Part B may cover them. If Part B doesn’t cover them, Part D does. • Oral anti-nausea drugs: Medicare covers oral anti-nausea drugs patients use as part of an anti-cancer chemotherapeutic regimen if they’re administered before, at, or within 48 hours of chemotherapy or are used as a full therapeutic replacement for an intravenous anti-nausea drug • Certain oral End-Stage Renal Disease (ESRD) drugs covered under Medicare Part B • Erythropoiesis-stimulating agents: Medicare covers erythropoietin by injection if patients have End-Stage Renal Disease (ESRD) or need this drug to treat anemia related to certain other conditions. (such as Epogen®, Procrit®, Retacrit®, Epoetin Alfa, Aranesp®, Darbepoetin Alfa, Mircera®, or Methoxy polyethylene glycol-epoetin beta) • Intravenous Immune Globulin for the home treatment of primary immune deficiency diseases

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• Parenteral and enteral nutrition (intravenous and tube feeding) • We also cover some vaccines under Part B and most adult vaccines under our Part D drug benefit.

IX. Diabetic Supplies

Fallon Medicare Plans with Part D Fallon Medicare Plans without Part D Insulin Prescription copayment per 30 day supply Not covered Insulin syringes (includes needles) Prescription copayment per 30 day supply Not covered Blood glucose meter Covered in full Covered in full Blood glucose test strips Covered in full Covered in full Blood ketone test strips Covered in full Covered in full Spring-powered lancet device Covered in full Covered in full Lancets Covered in full Covered in full Urine glucose test strips Covered in full Covered in full Urine ketone test strips Covered in full Covered in full Insulin pens (includes pre- filled insulin pen cartridges; needles sold separately) Prescription copayment per 30 day supply Not covered Insulin pen needles Prescription copayment per 30 day supply Not covered Prescribed oral medications that influence blood sugar levels Prescription copayment per 30 day supply Not covered

Coverage of Blood Glucose Meters will be limited to Accu-Chek® glucose meters and test strips manufactured by Roche. Plan members can obtain an Accu-Chek® glucose meter at network pharmacies.

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Continuous blood glucose monitors are limited to the Freestyle Libre System. Members must obtain Freestyle Libre at network pharmacies.

A prior authorization is required for blood glucose meters and supplies that are non- preferred brands, continuous, require adaptive features or for test strip quantities over 5 per day. Members with a demonstrated need, including having a severe visual impairment or impaired manual dexterity, may require a blood glucose meter with adaptive features, such as an integrated voice synthesizer or integrated lancing device. Prior authorization is required.

The following diabetic supplies require prior authorization through Fallon Health: • Non-preferred test strips (Preferred test strips are Accu-Chek products) • Quantities of blood glucose test strips in excess of 150 per 30-day supply • Blood glucose meters with adaptive features, such as an integrated voice synthesizer or integrated lancing device • Continuous blood glucose monitors. Our preferred therapeutic or non-adjunctive continuous glucose monitors are Freestyle Libre monitors and supplies. Members obtain Freestyle Libre monitors and supplies at network pharmacies. • Other diabetic supplies noted on formulary as requiring a PA

Diabetic supply procedure

  1. Provider fills out Fallon Health prior authorization form if necessary and follows above prior authorization procedure.
  2. The physician writes a prescription for the diabetic supply.
  3. The member fills the prescription at a Fallon Health-contracted. The member pays any applicable copay or co-insurance.

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X. Injectables Injectables are defined as sterile medications given with the aid of a needle/syringe and administered parenterally. Certain medications may be supplied by a Fallon Health contracted pharmacy for patient self-use. Other medications are obtained by the contracted health care provider for in-office use. Many injections require prior authorization. For Fallon Medicare members with Medicare Part D prescription coverage, some injectable medications are covered under the member’s Medicare Part B benefits.

Note: Call the Pharmacy Service Department Service Line (866-275-3247, option 5, option 2) for any questions regarding whether a medication can be self-administered or must be administered in the office.

Injectable supply procedure

A. Injectable medication to be self-administered (or by a family member) at home:

  1. Provider fills out Fallon Health prior authorization form if necessary and follows above prior authorization procedure.
  2. Provider writes prescription.

  3. The member fills the prescription at a Fallon Health-contracted pharmacy. A copayment is charged.

    B. Injectable medication to be administered in the physician office:

  4. Provider fills out Fallon Health prior authorization form if necessary and follows above prior authorization procedure.

  5. Provider supplies the medication from their own stock and bills Fallon Health directly for both the medication and the administration of the medication.

    XI. Transitional Medications Process The transitional process is for Fallon Medicare members who are new to Fallon Health, new to F a l l o n Medicare, or experience a negative formulary change from one year to the next. This process is designed to provide temporary medication coverage for Fallon Health non-formulary or UM-required medications until a prior authorization can be obtained by the prescriber. The qualifying member can obtain a one month’s temporary supply of medications (within the first 108 days of their enrollment) at a copayment cost. A letter will be sent to both the patient and the provider indicating that the transition fill was temporary and providing the process to request an exception, coverage determination, or to substitute a preferred formulary medication.

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XIII. Medication Therapy Management (MTM) Program Our Medication Therapy Management Program is not a benefit but is a free service to eligible members that is designed to help members learn more about their medications and how they affect their health and well-being. We want our members to have all the information they need about their medications. This program is not applicable to PACE members.

Fallon Health, in partnership with our Medication Therapy Management (MTM) vendor, Clarest Health, would like to remind you of this program to improve our Fallon Medicare Plus and Navicare HMO members’ engagement in the CMS Comprehensive Medication Review (CMR). The CMR rate is a CMS Part D Star measure.

The CMR assists patients in understanding their medications, so that they are more active in their healthcare. The CMR includes an interactive discussion with a clinical pharmacist and can identity side effects a patient may be experiencing or be able to assist with finding a less expensive medication. The review also includes OTC products (including vitamins, minerals, and herbal supplements) that are sometimes not brought to your attention. Once the CMR is compete, the patient and you will receive a summary of the discussion items, any recommendations, and a medication list.

We hope that you will find this information valuable in your conversations with your patient.

If your patients are eligible for the MTM program, they will receive a welcome letter and a phone call from Clarest Health. Please recommend that your patients participate in this valuable, free opportunity.

Who is eligible for the MTM Program? Members who are: Enrolled in a Medicare Part D plan AND meet the characteristics of at least one of the following groups:

• Group 1: o Taking at least eight Part D maintenance drugs, AND o Have three or more chronic conditions,* AND o Are spending an annual amount as determined by CMS on Part D prescriptions • Group 2: o Are at-risk beneficiaries (ARBs) - that is, members with an active coverage limitation under a Drug Management Program (DMP)

  • Qualifying chronic conditions include: Alzheimer’s disease, Bone disease-arthritis (including osteoporosis, osteoarthritis, and rheumatoid arthritis), Chronic congestive heart failure (CHF), Diabetes, Dyslipidemia, End-stage renal disease (ESRD), Human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), Hypertension,

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Mental health (including depression, schizophrenia, bipolar disorder, and other chronic/disabling mental health conditions), Respiratory disease (including asthma, chronic obstructive pulmonary disease (COPD), and other chronic lung disorders).

**Morphine Milligram Equivalents are a way to compare different opioid medications based on their strength as compared to morphine.

What does the member receive as an MTM Program participant? Enrolled members will receive at least one comprehensive, interactive phone consultation with a clinical team member and one or more quarterly medication reviews. The purpose of the phone consultation is to gather information to conduct a comprehensive medication review. The medication review is not intended to interfere with the care already provided by doctors. The medication review may include:

• Checking for drug-to-drug interactions, including interactions with over-the- counter medications • Offering solutions that may reduce any side effects from medications • Identifying less expensive medication alternatives • Presenting ways to simplify medication regimens • Monitoring medications and medical conditions (such as high blood pressure, high cholesterol or diabetes) to be sure members are getting the most out of their medications

We'll give members and their providers a written summary of the review, a list of their medications, and a list of any recommendations made by the pharmacists. We encourage the member to complete the MTM review prior to their yearly check-up. They can use the summary to discuss their drug therapy with their provider.

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