Clinical Pharmacy Determinations

These types of requests require clinical information and cannot be overridden by the MedImpact Help Desk. Requests should be initiated by faxing the appropriate pharmacy determination form to MedImpact. Expedited requests for pharmacy determinations for medications that are urgently needed may be initiated by phone. All pharmacy determinations shall be completed within timelines established by State and Federal regulations.

The following information tells 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
   1. Reason for the request
       
2. Clinical pharmacy determinations fall into one of the categories below. PrimeWest Health, in conjunction with our contracted pharmacy benefits manager (PBM), will develop a list of medications requiring clinical pharmacy determinations. This list will change over time based on current use and prescription patterns. This list is located in the Pharmacy section. 
3. 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 shall develop and administer 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.
   5. 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.)

3. 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.)
4. 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 the 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 will follow MN Stat. sec. 62Q.525 relating to coverage and payment for off-label drug use authorizations

4. Coverage of non-formulary drugs for mental illness and emotional disturbances: PrimeWest Health will approve 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 the 2023 DHS Families and Children contract, section 6.1.40.10)
   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.
5. 72-hour emergency supply: Providers or pharmacies may request an emergency supply of medication by calling the PBM Pharmacy Help Desk at 1-800-788-2949 and requesting the emergency supply. This would be expected in rare instances. An appropriate use would be requesting opioids after surgery or fracture. Approval of a 72-hour emergency supply does not replace the need for prior authorization or guarantee approval. If a provider seeks an emergency supply, it is still at the discretion of the pharmacy to fill the supply.

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. All pharmacy determinations shall be completed and decisions returned to members and attending health care providers within timelines established by MN Statutes and Rules, DHS contract, and 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 will be 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 will maintain a Provider Manual section 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 will use 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 as outlined in PrimeWest Clinical Review Process Flow, Medicare Part D, and Medicare WRAP Exception Process.
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 the necessary time frame to meet timeliness requirements, the request will be denied and appropriate notices will be sent.
   4. Excluded drugs as defined by CMS and DHS will be denied as such when requested for the excluded indications.
   5. Authorization will not be required when PrimeWest Health is the secondary carrier. For example, if the primary insurance requires brand name medication, PrimeWest Health will enter an authorization to approve brand name medication rather than require a coverage determination.

Review of Requests for Pharmacy Determinations: The pharmacy review team will use evidenced-based clinical guidelines to review pharmacy determination requests following PrimeWest Health’s adopted criteria and guidelines. The clinical guidelines are based on primary literature, governmental associations, peer reviewed medical guidelines, and have received Pharmacy and Therapeutics (P&T) Committee approval. When a request for a pharmacy determination is received, clinical review may discuss treatment options, the member’s clinical history, and previous drug treatment with the treating practitioner. Clinical review may also request medical records for peer review prior to making a decision.

Potential Denials: Potential denials will be reviewed by a clinical pharmacist and a delegated physician expert or PrimeWest Health Medical Director prior to making a final denial decision. The PrimeWest Health pharmacy clinical review shall authorize the following non-formulary requests if supported by a health care provider’s statement of need:

1. Prescriptions related to the direct treatment of oncology and Acquired Immune Deficiency Syndrome (AIDS) patients
2. Requests for specific brand name drugs based on practitioner determination that a generic alternative is not acceptable
3. Requests for specific brand name drugs based on practitioner determination that previous treatment with formulary drugs failed
4. Requests for a medication where there is no formulary alternative to requested prescription
5. Medications used to treat mental illness or emotional disturbances

Response to Physician Request for Pharmacy Determination

PrimeWest Health and/or its delegated PBM are responsible for notifying members and providers of approved pharmacy determinations. An approval response will be faxed back to the practitioner as soon as possible once a complete request has been received, not to exceed timelines established by Minnesota Statutes, Rules, and regulations. Established turn-around times are as follows:

PrimeWest Health and/or its delegated PBM send the member and requesting provider a letter of approval. PrimeWest Health and its delegated entities shall be responsible for mailing any Denial, Termination, or Reduction (DTR) of Service notices to members and practitioners that are required by Minnesota Statutes, Rules, and regulations, including but not limited to, MN Stat. Chap. 62M. Denial notices shall include Appeal rights and follow the format required by DHS as outlined in MN Stat. Chap. 62M and related regulations. All denials will include a written or verbal notice to the practitioner and servicing facility that includes the following information:

1. Outcome of the review
2. Reason for the outcome, including a brief explanation of why the patient does not meet the criteria established by the clinical guidelines
3. Re-direction to potential formulary alternatives
4. Statement telling how the practitioner can Appeal or submit additional information that may be helpful or relevant to the case for review

For more information, please see the PrimeWest Health formulary exception process web page.

Formulary Exceptions

For members sensitive or unresponsive to the formulary medication or who have a known contraindication to all of the formulary choices in that therapeutic class, have the prescriber complete the appropriate formulary exception form and have the prescriber fax the form to MedImpact, PrimeWest Health’s clinical pharmacy reviewer. Please visit our website for specific forms and criteria.

Pharmacy Claims Screening

Paid Claims: Some DUR conflict codes are posted for informational purposes only and allow the claim to be paid.

Denied Claims: If a claim is denied for payment based on a DUR conflict code, the pharmacist’s professional judgment will need to be used to decide whether or not to fill the prescription. If it is in the member’s best medical interest to fill the prescription, the denial may be Appealed.

Drug Formulary

PrimeWest Health has adopted MedImpact’s formularies for its selected populations. The formularies are developed and approved by a P&T Committee, which is an independent panel of physicians and pharmacists representing various practice disciplines. The P&T Committee meet no less than quarterly to review the current formularies. Different populations adhere to different formularies, as shown below.

The OTC formulary is different for F&C, MinnesotaCare, MSC+, SNBC, and PrimeWest Senior Health Complete/Prime Health Complete members as it has been tailored to address the specific needs and coverage status of each demographic group. The OTC formulary for F&C, MinnesotaCare, MSC+ only, and SNBC only is different from the OTC formulary for MSC+ with Medicare, SNBC with Medicare, PrimeWest Senior Health Complete/Prime Health Complete. The wraparound formulary is a list of medications that a traditional Medicare Part D formulary would not cover, but PrimeWest Health has made available to its PrimeWest Senior Health Complete/Prime Health Complete members and MSC+ and SNBC members with Medicare. It generally consists of medications from the following classes:

1. OTC items
2. Vitamins
3. Cough and cold products

When providing any prescription drug service to a member, the pharmacy shall comply with the Drug Formulary. When a non-formulary product is prescribed, the claim will reject with NCPDP reject code 70 “NDC Not Covered.” The pharmacy should make an effort to contact the prescribing provider to ask if the prescription can be changed to a formulary product.

Drug Utilization Review (DUR)

MedImpact will alert the pharmacy through the online system in situations that include, but are not limited to, the following:

1. Drug regimen compliance screening
2. Drug-drug interaction screening
3. Drug inferred health state screening
4. Dosing/duration screening
5. Drug-age caution screening
6. Drug-sex caution screening
7. Duplicate prescription screening
8. Duplicate therapy screening
9. Greater than four grams/day acetaminophen screening
10. Morphine Equivalent Dose (MED) daily limits

The pharmacy is responsible for reviewing any claim where there is a DUR rejection from the online adjudication system. Pharmacists should use their professional judgment to follow up with patients and counsel them regarding the DUR messages.

Pharmacy Audit

Suspected Fraud, Waste, and Abuse

For suspected fraud, waste, or abuse by a member, prescribing provider, or a pharmacy, notify the PrimeWest Health Compliance Coordinator at:

PrimeWest Health
3905 Dakota St
Alexandria, MN 56308

Phone: 1-320-763-4135 or 1-888-588-4420 (toll free) (ask to speak with the Corporate Compliance Officer)

Inspection of Records and Audit per MedImpact’s Pharmacy Network Agreement

Maintenance of Records

The pharmacy shall maintain records that comply with State and Federal law, rules, and regulations regarding prescription drug services provided to members

Inspection Rights

During the term of agreement and for two years following termination of the agreement for any reason, MedImpact has the right to inspect all records of the pharmacy related to PrimeWest Health claims.

Pharmacy Audit

Audits are conducted in compliance with Federal and State laws to ensure the privacy and confidentiality of all patient records. PrimeWest Health may delegate MedImpact to conduct audits of its contracted network of pharmacy providers. Audits are performed to verify the integrity of claims submitted to PrimeWest Health and payments to the pharmacy. The pharmacy will provide auditors access to pharmacy records, including invoices and prescription files, related to prescription drug services provided under its Pharmacy Network Agreement. MedImpact may use these records to compare the online claims with the hard copies of prescriptions and other documentation. For additional information related to audits, please refer to the MedCare^® Pharmacy Networks Policies and Procedures Manual.

There are several situations that could precipitate an audit request to MedImpact on PrimeWest Health’s behalf:

1. Notification by a benefit sponsor or member of suspected fraudulent activity (see below)
2. Pharmacy exceeds the normal profile in one or more audit profile categories
3. Routine area audit of pharmacies in a specific geographic location

Fraudulent Activity

Based on the claims submission requirements, the following are examples of unacceptable and, in some cases, fraudulent practices:

1. Billing for a quantity of a legend drug that is greater than the quantity prescribed
2. Billing for a higher-priced drug when a lower-priced drug was prescribed and dispensed to the member
3. Dispensing a brand name drug, billing for the generic, and then charging the member for the difference
4. Billing for a legend drug without a prescription
5. Submitting a claim with an NDC other than the NDC on the package from which the drug was dispensed
6. Dispensing a smaller quantity than was prescribed in order to collect more than one professional dispensing fee. If a patient requests a smaller amount, a notation should be made on the hard copy of the prescription.
7. Billing more than once per month for maintenance drugs for members in nursing facilities. A maintenance drug is a drug ordered on a regular, ongoing, scheduled basis. This limitation does not apply to treatment medications (e.g., topical preparations) or drugs ordered with a stop date of less than 30 days.

In addition, pharmacies must comply with MN Stat. sec. 152.11, which describes general prescription requirements for controlled substances, restrictions on release and use of Federal registration numbers, dispensing orphan drugs, and limits on the quantity of opiates prescribed.

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Updated_10/11/2023