Formulary Exception Process

When a medication is prescribed that is not listed in the formulary, a Formulary Exception request is required. This process must also be followed for certain Pharmacy Utilization Management programs. Providers should complete the appropriate form in these situations.

Prime Health Complete (HMO SNP) requests

• Request for Medicare Prescription Drug Coverage Determination
• Request for Redetermination of Medicare Prescription Drug Denial

PrimeWest Senior Health Complete (HMO SNP) requests

• Request for Medicare Prescription Drug Coverage Determination
• Request for Redetermination of Medicare Prescription Drug Denial

Families and Children, MinnesotaCare, Minnesota Senior Care Plus (MSC+), and Special Needs BasicCare (SNBC) requests

• Minnesota Uniform Form for Prescription Drug Prior Authorization (PA) Requests and Formulary Exceptions
• OxyContin Prior Authorization (PA) Form
• Opioid Program Override Form

Below is information on how to use our pharmaceutical management procedures. It explains our limits, information that is needed to support an exception request, and our process for generic substitutions, therapeutic interchange, and step therapy protocols.

Clinical pharmacy determinations

1. Clinical pharmacy determination requests can be initiated by members or providers but require the prescribing health care provider to validate the need for the exception prior to any approval being granted. At a minimum, the following information must be provided:
   1. Member name
   2. Member date of birth
   3. Health care provider name
   4. Health care provider phone number
   5. Health care provider fax number
   6. Drug requested
   7. Diagnosis pertaining to request
   8. Previously tried drugs
   9. Reason for the request
2. If the same clinical pharmacy determination request is received more than once, the duplicate request will be processed as an Appeal.
3. Clinical pharmacy determinations fall into one of the categories below. PrimeWest Health, in conjunction with our contracted pharmacy benefits manager (PBM), develops a list of medications requiring clinical pharmacy determinations. This list will change over time based on current use and prescription patterns. This list is available for providers on the PrimeWest Health website.
   1. Prior Authorization: Medications requiring prior authorization are on the PrimeWest Health formulary; however, they require that specific medical information such as medical diagnoses or laboratory results be submitted by the prescribing health care provider prior to approval being granted and the drug being paid under the pharmacy benefit for a PrimeWest Health member. PrimeWest Health allows members or providers to initiate a formulary exception request; however, health care providers with prescribing privileges as a result of their licensure status must validate requests for pharmacy determinations before they will be approved.
   2. Quantity Limitations: Quantity limitations describe the maximum and/or minimum quantity to be dispensed. The dispensing limitation may be defined by the number of days supplied or the dispensed medication units supplied.
   3. Step Therapy: Step Therapy is a use requirement for drugs that have been identified as the frequent subject of actual or potential misuse, overuse, or inappropriate use that could be of clinical and economic concern. Step Therapy is a series of criteria that must be met to move to the next step. In Step Therapy, the first step will be automated (electronic edit). If the member meets the requirements in the initial Step Therapy criteria, then the requested medication will be covered. If the member does not meet the Step Therapy electronic edit, a pharmacy determination evaluation must be initiated by the health care provider for the medication to be paid under the member's prescription benefit.
   4. Formulary Exception: A formulary exception is a request for a medication that is not included in the PrimeWest Health formulary. The PBM has and administers a process to grant exceptions to the formulary if the preferred medication is contraindicated, or the requested drug has been demonstrated to provide maximum benefit to the member, in accordance with MN Rules part 4685.0700, subp. 3.
      1. On behalf of the member, the health care provider may request an override for a non-formulary medication to be paid under the member's prescription benefit and provide specific clinical information to justify the request. PrimeWest Health members will have no coverage for non-formulary medications unless a formulary exception has been granted.
      2. PrimeWest Health will promptly grant an exception to its drug formulary when the health care provider prescribing the drug for a member indicates that one of the following applies:
         • The formulary drug causes an adverse reaction in the member
         • The formulary drug is contraindicated for the member
         • The health care provider demonstrates, through submission of clinical documentation, that the prescription drug must be dispensed as written (DAW) to provide maximum medical benefit to the member (MN Stat. sec. 62Q.527, subd. 4.)
4. Dispense as Written (DAW): DAW allows the prescribing provider to request that the brand name product be dispensed instead of an equivalent generic without passing an ancillary charge to the member. The claim must be submitted with a DAW of “1” to override the pricing and to provide payment for the brand name product. If DAW “1” is used in processing a claim, the written prescription must contain documentation of the “DAW” order from the prescribing provider. If the prescription is telephoned in, the pharmacist must manually write on the written prescription document “Dispense as Written.” (Formulary exceptions must be submitted to the PBM for review to see if they meet criteria on an individual basis.)
   1. An exception to this policy is when a generic drug has a higher net cost to the PrimeWest Health member than the brand name drug. When this occurs, PrimeWest Health may prefer the brand name drug over the generic until the generic product is available at a reduced cost. When PrimeWest Health prefers the brand over the generic, the prescriber is not required to write “DAW” on the prescription or enter “Brand Medically Necessary” in the “Prescriber note to Pharmacy” field. When a new generic drug becomes available, use our NDC Search or call the PrimeWest Health Provider Contact Center to determine if the generic drug is under authorization requirements.
   2. Coverage for off-label use: The PBM follows MN Stat. sec. 62Q.525 relating to coverage and payment for off-label drug use authorizations.
5. Coverage of non-formulary drugs for mental illness and emotional disturbances: PrimeWest Health approves antipsychotic drugs prescribed to treat emotional disturbance or mental illness, regardless of the formulary, if the prescribing health care provider certifies in writing that the prescribed drug will best treat the member’s condition. This procedure is in accordance with MN Stat. sec 62Q.527. (Note: If the prescribed drug has been removed from the formulary due to safety reasons, this provision does not apply in accordance with DHS Families and Children contract requirements.)
   1. No added copays or fees will be imposed on the member.
   2. Authorization is generally granted for one year, and then recertification is needed.

Requesting and Processing Clinical Pharmacy Determination

1. The treating health care provider must validate all requests for clinical pharmacy determinations in writing or through submission of patient medical records to certify medical necessity.
2. Requests should be initiated by faxing the applicable coverage determination form to the PBM.
   1. Expedited requests for pharmacy determinations for medications that are urgently needed may be initiated by phone.
   2. Formulary exception forms and criteria for pharmaceutical Utilization Management programs are available on the PrimeWest Health website 24 hours a day for providers to reference.
   3. A duplicate pharmacy determination request will be processed as an Appeal.
3. All medical pharmacy determinations shall be completed and decisions returned to members and attending health care providers within timelines established by MN Statutes and Rules, as described in PrimeWest Health Policy and Procedure CC06: Service Authorization and Policy and Procedure UM13: Notices of Denials, Terminations, or Reductions (DTRs) of Services.
4. All requests will be processed as received.
   1. The PBM clinical reviewers do not make a determination of urgency.
   2. If the request does not specify “Urgent” or “Expedited,” it is handled as a standard request.
5. In accordance with MN Stat. sec. 62M.09, subd. 5, PrimeWest Health will apply only clinically accepted criteria for pharmacy determinations.
   1. These criteria are reviewed for appropriateness on a yearly basis during the annual utilization management review by PrimeWest Health’s Quality and Care Coordination Committee (QCCC).
   2. PrimeWest Health maintains online information for providers dedicated strictly to the pharmacy benefit so that providers will be aware of all billing and clinical criteria and benefit limits applied to the PrimeWest Health pharmacy benefit.
   3. Specific criteria are made available to members and providers upon request.
6. The PBM uses evidenced-based clinical guidelines to review pharmacy determination requests following PrimeWest Health’s adopted criteria and guidelines and/or as described in the Delegation Agreement.
   1. The clinical guidelines are based on relevant findings of government agencies, medical associations, national commissions, peer-reviewed journals and authoritative compendia, and the approval of the PBM’s Pharmacy and Therapeutics (P&T) Committee.
   2. Appropriately licensed pharmacists and physicians are involved in the review process where necessary.
7. When a request for a pharmacy determination is received, the PBM may discuss treatment options, the member’s clinical history, and previous drug treatment with the treating health care provider. The PBM may request medical records for peer review prior to making a decision.
8. The PBM will make one of the following determinations after reviewing requests for pharmacy determinations:
   1. Approved – after documentation is provided showing that the request meets established criteria
   2. Denied – after all necessary information is reviewed and the request does not meet the criteria for approval. The physician has final determination about whether a request is denied or approved.
   3. More Information Needed – the health care provider will be notified of the information needed. If the information is not received within seven business days, the request will be denied and appropriate notices will be sent.
   4. Prior Authorization Not Required – the requested drug is a covered benefit or already has a prior authorization in place.
9. If PrimeWest Health is secondary coverage, and the primary requires a brand name drug, an authorization will be entered without the supporting documents required from the health care provider.
10. PrimeWest Health will cover 72-hour supply of covered outpatient drugs in emergency situations. This override can be sought by calling the PBM Pharmacy Help Desk at 1-800-788-2949 (toll free) and requesting an emergency 72-hour override.
11. New information received after a pharmacy determination request is denied will be processed as a new pharmacy determination request. A duplicate request will be processed as an Appeal.
12. To Appeal a pharmacy determination denial:
    1. For Medical Assistance (Medicaid) members, submit the Appeal request via the provider web portal.
    2. For Medicare members, fax the Appeal request to the PBM at 1-858-790-6060.

Please call the PrimeWest Health Provider Contact Center with any questions or for assistance with PrimeWest Health Utilization Management programs.

PW_2011_232
Updated_07/19/2022