Guide for pharmacy benefits for First Nations and Inuit: Non-Insured Health Benefits

1.1 Terms and conditions of services

To be eligible for payment, providers must adhere to the NIHB program's terms and conditions. These are detailed within the NIHB Billing Agreement (available within the NIHB Pharmacy Provider Enrolment Package) and the Pharmacy Claims Submission Kit, both available on the Express Scripts Canada NIHB provider and client website.

It is the pharmacist's responsibility to verify benefit eligibility for the client, at the time of dispensing, to ensure that no limitations under the program will be exceeded, and to ensure compliance with NIHB benefit criteria and policies.

2.1 Drug Benefit List

The NIHB program maintains a formulary called the Drug Benefit List which includes eligible drugs and other health products primarily used in a home or ambulatory setting. The Drug Benefit List is available online on the Express Scripts Canada NIHB provider and client website. The list is updated regularly, and significant listing changes are communicated via provider newsletters and bulletins (available on the Express Scripts Canada NIHB provider and client website) and NIHB program updates.

A prescription or recommendation from a health professional as defined in section 3.12 Prescriber policy for pharmacy benefits is required for any listed drug or eligible health product to be processed as a benefit under the NIHB program.

Products considered for, or currently listed on, the Drug Benefit List must meet the minimum criteria. Drugs must be legally available for sale in Canada and demonstrate evidence of therapeutic efficacy, safety and incremental benefit in proportion to the incremental cost. Only drugs with a notice of compliance will be considered.

Decisions on drug and pharmacy benefits are based on the judgment of recognized health professionals, consistent with the best practices of health services delivery and evidence-based standards of care.

The review process for drugs that are considered for inclusion as a benefit under the NIHB program varies depending on the type of drug submitted.

Submissions for new chemical entities, new combination drugs and existing chemical entities with new indications must be sent to Canada's Drug Agency (CDA-AMC). Clinical and pharmacoeconomic reviews are coordinated by the CDA-AMC's Reimbursement Review processes and forwarded to expert review committees for recommendations on formulary listing. These recommendations are forwarded to participating drug plans, including the NIHB program, for consideration. The NIHB program makes listing decisions based on CDA-AMC expert committee recommendations and other specific relevant factors, such as mandate, priorities and resources.

Submissions for line extensions, generics and all other submissions are reviewed internally or by the Drugs and Therapeutics Advisory Committee. Generics are considered for inclusion on the Drug Benefit List after assessment through the pan-Canadian Generic Tiered Pricing Framework (TPF) and based on provincial interchangeability lists and other relevant factors.

Should you have any questions regarding the Drug Benefit List, please contact the NIHB Call Centre at Express Scripts Canada toll-free at 1-888-511-4666 for providers.

2.2 Open benefits

Open benefits are products listed on the Drug Benefit List which do not require prior approval. However, some products may have coverage conditions regarding age, quantity, frequency or dose.

There are 2 types of open benefits:

1. Benefits which do not require prior approval and have no conditions regarding age, quantity, frequency or dose.
2. Benefits which do not require prior approval but have conditions regarding age, quantity, frequency or dose. Requests for coverage outside those conditions require prior approval and are reviewed on a case-by-case basis.

2.3 Limited use benefits

Limited use benefits are products listed on the Drug Benefit List which have specific criteria for coverage as a benefit under the NIHB program.

Although most limited use benefits require prior approval using the "Limited Use Benefit Request Form," some limited use benefits do not require prior approval as the electronic claims adjudication system verifies prerequisite drug therapy automatically. The electronic claims adjudication system has the capacity to automatically adjudicate a number of medications by verifying prerequisite drug therapy for limited use criteria. Limited use benefits and the criteria for their coverage are identified in the Drug Benefit List.

2.4 Exceptions

Exception products are not listed on the Drug Benefit List. These products may be approved in special circumstances upon receipt of a completed Exception Drugs Request Form from the licensed prescriber when:

• the prescription is for a recognized clinical indication and dose which is supported by published evidence or authoritative opinion
• there is significant evidence that the requested product is superior to products already listed as program benefits
• a client has experienced an adverse reaction with a best price alternative product, and a higher-cost alternative is requested by the prescriber
• there is supporting evidence that available alternatives are ineffective or contraindicated

Personal preference alone does not justify coverage of an exception.

2.5 Exclusions

Certain products are excluded from the NIHB program as recommended by Canada's Drug Agency's expert review committee or the NIHB Drugs and Therapeutics Advisory Committee because published evidence does not support the clinical value or cost of the product relative to existing therapies, or there is insufficient clinical evidence to support coverage.

Exclusions are products not listed on the Drug Benefit List and not available through the exception or appeal processes. These include certain therapies for particular conditions which fall outside of the NIHB mandate.

Examples of categories of products* that are not considered for coverage under the program under any circumstances are as follows:

• anti-obesity drugs
• household products (for example, regular soaps and shampoos)
• cosmetics
• alternative therapies, including glucosamine and evening primrose oil
• megavitamins
• investigational or experimental products
• drugs for travel
• hair growth stimulants
• impotence drugs
• opioid containing cough preparations

*Note: List of excluded products is not exhaustive and may be modified as necessary.

2.6 Prior approval

In addition to limited use benefits, some products not listed on the Drug Benefit List may be considered for coverage under special circumstances, with prior approval.

If a client is prescribed a product that requires prior approval, the provider must contact the Drug Exception Centre and provide details about the prescription, prescriber, client and pharmacy. To complete the prior approval process, the Drug Exception Centre may also fax an Exception or Limited Use Benefit Request Form to the prescriber for completion. Providers may also submit claims and prior approval requests through their NIHB web account, found on the Express Scripts Canada NIHB provider and client website.

The time that it takes the Drug Exception Centre to review prior approval requests depends on the time it takes for the prescriber to provide any needed information. Providers should be aware that a representative from the Drug Exception Centre may call them directly to discuss the request or to collect any necessary information. When approval is granted, a confirmation letter with the applicable dates and prior approval details will be faxed or mailed to the provider. Pharmacy providers are advised to retain the confirmation letter, if applicable, for billing purposes.

A prior approval does not override the requirement to adhere to program policies for claim submissions, including pricing and reimbursement guidelines.

Prior approvals are entered electronically in the claims processing system. The date of dispense, if known, should be provided to the analyst so that it can be reflected in the prior approval.

Please refer to the Pharmacy Claims Submission Kit, found on the Express Scripts Canada NIHB provider and client website, for more information on obtaining prior approvals.

2.7 Formulary for chronic renal failure

Clients with chronic renal failure are eligible to receive a list of supplemental benefits that are not included on the Drug Benefit List, but may be required on a long-term basis. These supplemental benefits are provided when provincial or territorial renal programs are not available to NIHB clients.

New clients that require products on the special formulary will be identified for coverage through the usual prior approval process. Once the client is confirmed as eligible, coverage will automatically be extended to all products in the special formulary for as long as needed.

2.8 End-of-life care formulary

Clients who are diagnosed with a terminal illness and are near the end of life will be eligible to receive a list of supplemental benefits that are not included on the Drug Benefit List.

When the Drug Exception Centre is informed that a client requires end-of-life care, an end-of-life care formulary application form will be generated and faxed to the prescriber. Once this form is completed and submitted, the client will be eligible for all products on the End-of-life care formulary if the following criteria are met:

• the client is not receiving care in a provincially covered hospital or long-term care facility

  and

• the client has been diagnosed with a terminal illness or disease which is expected to be the primary cause of death within 6 months or less

Once approved, the client will be eligible for all products on the End-of-life care formulary for 6 months, without the need for further prior approval. If coverage is required beyond the initial 6 months, an additional 6 months may be granted upon receipt of a new End-of-Life Care Formulary Application Form request.

For clients awaiting approval, providers may dispense an initial emergency course of treatment of up to a 14-day supply. For detailed information, see section 3.6 Emergency supply process.

2.9 Formulary for adjunct medications used during active cancer treatment

The NIHB program has established a formulary to streamline access to adjunctive (non-chemotherapy) products frequently used by clients undergoing active cancer treatment. These clients will be eligible to receive a list of supplemental benefits that are not included on the Drug Benefit List. Clients approved for oral chemotherapy drugs are automatically approved for access to all the products in this formulary. Additionally, clients approved for 1 of these products for a cancer-related indication are automatically approved for access to all other products in this formulary.

Clients are automatically enrolled for a period of 6 months. If the cancer treatment is of a longer duration, access to the formulary will be granted to align with the treatment duration. If treatment duration is not known, and the treatment plan extends beyond 6 months, access to this formulary may be extended upon request.

2.10 Formulary for medically necessary nutrition products

The NIHB program has established a formulary for clients who require medically necessary nutrition products. The formulary includes the following products: thickening agents, infant formulas and nutritional supplements for children, youth and adults. The program only provides coverage for products that have demonstrated benefit as part of managing a medical condition. For example, variations of these products labelled as "organic" are not included in this formulary.

Nutritional supplements remain as a part of other special formularies, specifically Formulary for chronic renal failure, Formulary for adjunct medications used during active cancer treatment, and End-of-life care formulary.

2.11 Back-order items and shortages

NIHB works closely with federal and provincial partners as well as distributors to monitor drug shortages. In response to shortages, NIHB has the ability to make policy changes and review product listings to ensure other drugs are made eligible for reimbursement. The program may remove the prior approval requirements from alternative drugs, reimburse compounded therapies or add temporary coverage for new products.

Please see section 3.4.1.2 Back-order products and extemporaneous mixtures for more information. Pharmacy providers may also consult the Drug Benefit List for the list of pseudo-DINs created to help mitigate the shortages.

2.12 Drug Utilization Review program

A Drug Utilization Review (DUR) program, which is part of the point of sale or online adjudication system, provides an analysis of both previous claims data and current claims data to ensure that providers are advised of potential drug-related problems or interactions. Messages are returned to pharmacists to alert them of the potential problems. The purpose of DUR is not to replace professional judgment or individualized client care in the delivery of healthcare services, but to enhance them with additional information.

For more information on the DUR program, please refer to the Pharmacy Claims Submission Kit available on the Express Scripts Canada NIHB provider and client website.

2.13 Client safety initiatives

The NIHB program no longer restricts clients to a sole prescriber or prescriber group for drugs of concern, under the Client Safety Program (NIHB-CSP). Other client safety measures, detailed below (from section 2.13.1 to 2.13.4.4), remain in place.

3.1 Best price alternative

The NIHB program covers the lowest cost equivalent drug, which is often a generic product. Generic products are considered for inclusion on the NIHB formulary based on provincial interchangeability lists and other relevant factors.

The NIHB program will reimburse only the best price (lowest cost) alternative product in a group of interchangeable drugs. Pharmacists must follow their provincial or territorial pharmacy legislation and policies to identify interchangeable products and to select the lowest-priced brand. The program may not necessarily reimburse at the cost listed in the provincial drug plan formulary.

3.2 "No substitution" claims

The NIHB program will consider reimbursement for a higher-cost interchangeable product when a client has experienced an adverse reaction with a lower-cost alternative. In such circumstances, the prescriber must provide NIHB with:

• a completed and signed Side Effect Reporting Form: 'Report of suspected adverse reactions to health products in Canada'
• the prescription indicating "No substitution" or "No sub". Verbal authorization of 'no substitution' is not accepted by NIHB

Upon receipt, the pharmacist will forward a copy of the prescription to NIHB for review. The prescriber is responsible for submitting the form to the Canada Vigilance Program. Forms can be obtained by calling the Canada Vigilance Program toll-free at 1-866-234-2345, by downloading a copy of the Side Effect Reporting Form, or by photocopying a copy from the Compendium of Pharmaceuticals and Specialties.

The Side Effect Reporting Form will not need to be resubmitted for renewals or new prescriptions of the same drug for the client, although a prescription indicating "No sub" will still be required. Verbal authorization of 'no substitution' is not accepted by the NIHB program.

3.3 Prescription quantities

The program reimburses 100-day supply of chronic medications unless otherwise indicated by the prescriber. This ensures that certain medications required for long-term maintenance therapy are prescribed and dispensed efficiently.

The default maximum allowed dollar threshold for claims adjudication without a prior approval is $1999.99. Providers require a prior approval for claims that are over $1999.99. The NIHB program may set a different maximum dollar threshold for specific products. Providers will be notified of these exceptions. Please contact the NIHB Call Centre at Express Scripts Canada toll-free at 1-888-511-4666 for related questions.

3.4 Extemporaneous mixtures

3.5 Non-medicated emollients

Non-medicated emollient cream bases are a limited use benefit as described below:

• for the treatment of skin conditions in children aged 18 and under, prior approval is not required (pseudo-DIN 99000385)
• for the treatment of atopic dermatitis or psoriasis in clients aged 19 and over, prior approval is required (pseudo-DIN 09991668)

The NIHB program considers reimbursements for non-medicated emollients when prescribed in accordance with section 3.12 Prescriber policy for pharmacy benefits.

Please note that NIHB may reimburse the cost of any non-medicated emollient cream provided the cost does not exceed that of the per gram cost of Glaxal Base (454 g). Clients are eligible for up to 454 g per month. If a client requires a larger quantity, providers may contact the Drug Exception Centre for prior approval. Non-medicated emollient creams are subject to the short-term dispensing policy and reimbursement is based upon the unit cost per gram of the largest commercially available pack size (for example, 454 g). See section 3.3.1 Short-term dispensing for more information.

3.6 Emergency supply process

The NIHB program has a provision allowing providers to dispense products requiring prior approval on an emergency basis.

When an eligible product requiring prior approval is required by an NIHB client on an emergency basis and the criteria for automated prior approval have not been met (for example, a claim is submitted online and a prior approval is not electronically granted as indicated by the generated Canadian Pharmacist Association (CPhA) message), a provider may dispense an initial emergency course of treatment of up to a 14-day supply. This only applies if access to the Drug Exception Centre is not possible (for example, due to unforeseen system issues, on statutory holidays and outside regular hours of operation). In such situations, an emergency dispense may be provided without prior approval. The provider must then resubmit the request for authorization through the prior approval process as soon as the Drug Exception Centre is available during regular business hours so that it can be reviewed for emergency supply coverage.

After an emergency dispense, providers must follow the usual prior approval process to dispense the balance of the prescription. If authorization is granted for the remainder of the prescription, the:

• pharmacist will receive a prior approval or special authorization confirmation with details of the approved products by mail or fax (provider preference)
• prior approval number must then be included on the subsequent submitted claim. Claim submissions for products dispensed as an emergency supply during regular hours of operation of the Drug Exception Centre are subject to recovery

3.7 Refusal to fill (dispense) fee

A pharmacy provider in British Columbia, Saskatchewan, or Manitoba may decide not to dispense a prescription when a claim has been returned through the Drug Utilization Review and it is deemed to be in the best interest of the client. In these cases, a fee equal to the provider's usual and customary fee may be charged to the NIHB program through the refusal to fill (dispense) fee. The provider is advised to resubmit the original claim and use the 'UL' intervention code, along with the original information on their claim. Please refer to the Pharmacy Claims Submission Kit available on the Express Scripts Canada NIHB provider and client website for more information.

3.8 Trial Rx Program

The Trial Rx Program is intended to help determine if a client can tolerate a specific drug without experiencing side effects. This program is only applicable to electronic claims using the EDI system for British Columbia and Saskatchewan with or without a verified prior approval number. Under the Trial Rx Program, clients receive a 7-day supply of a new drug to determine if it is tolerated. Please refer to the Pharmacy Claims Submission Kit, available on the Express Scripts Canada NIHB provider and client website, for details on adjudicating Trial Rx Program claims.

3.9 Manual claims submission

Providers who do not have access to the Internet may contact the NIHB Call Centre at Express Scripts Canada toll-free at 1-888-511-4666 to request a copy of the forms required to submit a manual claim for products which require a prior approval or special authorization. Please refer to the Pharmacy Claims Submission Kit, available on the Express Scripts Canada NIHB provider and client website, for detailed information on how to submit manual claims, including forms required and necessary information.

Drugs with potential problematic use require close monitoring by health care providers, such as prescribers and pharmacists, to maximize safety and effectiveness and minimize the risk of harm and diversion. In order for the program to provide coverage for these drugs appropriately, information about drug claims must be received in an accurate and timely manner. The adjudication system for the NIHB program, Health Information and Claims Processing Services (HICPS) ensures this by adjudicating claims in real time. In order to ensure client safety and program integrity, all claims for methadone, buprenorphine/naloxone (Suboxone and generics), opioids, benzodiazepines or stimulants must be adjudicated at the point of sale. Provider manual claims and client reimbursement will not be permitted for these drugs.

3.10 Reversals for prescribed product not picked up by client

When a client has not picked up a prescription within 30 days, the original paid claim must be reversed and resubmitted for payment of only the dispensing fee.

The submission of a claim for a dispensing fee where the client has not picked up a prescribed product, which can be reinserted to inventory, only applies to products with a dispensing fee dollar value.

Where the product is an eligible compound and reinsertion into the pharmacy's inventory is not possible, Express Scripts Canada pays the provider for both the product and dispensing fee. Therefore, a reversal is not necessary. The Drug Utilization Review program is not affected.

Please refer to the Pharmacy Claims Submission Kit, available on the Express Scripts Canada NIHB provider and client website, for details on adjudicating reversals.

3.11 Balance billing

When submitting claims, providers are required to submit the usual and customary dispensing fee to the NIHB program according to their NIHB Pharmacy Billing Agreement. Providers are also required to update the usual and customary dispensing fees in their system based on the agreed upon dispensing fees.

The maximum dispensing fees accepted by the program are negotiated by the NIHB program. Any usual and customary dispensing fee exceeding the allowable maximum is not to be charged to NIHB clients.

3.12 Prescriber policy for pharmacy benefits

To be eligible for reimbursement, all prescriptions must meet the following conditions:

• the prescribers must be licensed by and in good standing with the respective governing body or province in which they practice
• the prescription has been written in accordance with federal and provincial legislation
• the prescription falls within the health professional's scope of practice, as defined by the relevant provincial and territorial regulations

In addition, the NIHB program accepts client-specific written recommendations for the National Association of Pharmacy Regulatory Authorities (NAPRA) Schedule II, III, unscheduled (non-prescription) drugs and other eligible health products when they fall within the health care provider's scope of practice.

The NIHB program requires providers to maintain documentation related to claims submitted as a result of a health professional's recommendation. At a minimum this must include the following information:

• date
• name and date of birth of the client
• proper name, common name, or brand name of the recommended drug, and the quantity thereof
• dosage
• signature of the health professional

Claims submitted according to this policy will be reimbursed for the drug cost and dispensing fee according to NIHB reimbursement policies. All claims are subject to claims verification.

3.13 Pharmacist-led tobacco use reduction services in the Atlantic region

NIHB reimburses for pharmacist-led tobacco reduction services (also known as smoking cessation) in the Atlantic region in cases where coverage for comparable services by provincial or territorial programs, or through private insurance, is not available.

For professional pharmacy services, NIHB will reimburse the lesser of:

• fees as set by a provincial or territorial public plan
• fees as set by a pharmacy association (such as a provincial or territorial fee guide)
• fees as set by the pharmacy which are charged to any client obtaining such a service (including clients without coverage)

  or

• the NIHB maximum fee

3.14 Administration of Shingrix and Sublocade

The NIHB program reimburses pharmacy providers for administration of Shingrix and Sublocade by injection. The amount reimbursed depends on the province or territory of the provider and is listed in section 3.14.1 Table 7: Reimbursement for injection administration.

Providers can submit for reimbursement using pseudo-DIN 96100008 under the following conditions:

• the product is being administered by either an employee of the pharmacy provider or by a health professional contracted by the provider to administer injections

  and

• the product has been reimbursed by NIHB

The NIHB program requires providers to maintain the following information:

• client name
• name of product administered
• service date
• name and signature of the person administering the product
• client signature

Submitting a claim for the administration of Sublocade must be done separately from the claim for dispensing it. Claims for the injection administration fee must contain the following information:

• the professional service fee in the 'item cost' field
• the ID number of the health professional providing the service in the 'prescriber ID' field
• the reference code of the health professional providing the service in the 'prescriber ID reference code' field

The 'dispensing fee' field should remain empty (zero dollars). The administration of injectable products other than Shingrix or Sublocade is currently not eligible for reimbursement using this pseudo-DIN.

In Quebec, providers are required to use pseudo-DIN 01111061 for administration of Shingrix by a pharmacist, and 01111062 for administration of Shingrix by a non-pharmacist. Providers in Quebec should refer to the agreement between Indigenous Services Canada and Association québécoise des pharmaciens propriétaires (AQPP) for further details.

3.15 Health Canada's Special Access Program (SAP)

NIHB will consider, on a case-by-case basis, claims for drugs available through Health Canada's Special Access Program (SAP). Drugs considered for release by the Special Access Program include pharmaceutical, biologic, and radio-pharmaceutical products not approved for sale in Canada. Drugs used for psychedelic-assisted therapies approved through Health Canada's Special Access Program will not be considered for coverage as they are exclusions to the NIHB program.

Providers should follow the usual process for prior approval of pharmacy benefits and contact the Drug Exception Centre to submit requests. The Drug Exception Centre will validate requested costs using manufacturer receipts or invoices; adjustments may be needed based on the exchange rate. Where the drug has been supplied to pharmacies at no cost, NIHB will consider requests for reimbursement of the dispensing fee alone. Where the Special Access Program drug is compounded into an extemporaneous mixture, it will be billed using the Special Access Program pseudo-DIN and the dispensing fee will be adjusted according to the extemporaneous mixture reimbursement policy.

Clients who have paid for drugs received through the Special Access Program may submit requests for reimbursement to NIHB using the Client Reimbursement Form, available on the Express Scripts Canada NIHB provider and client website. These requests will be reviewed by the Drug Exception Centre for approval prior to reimbursement. Where the client reimbursement process is followed, NIHB will consider reimbursing based on the manufacturer receipt, at the current exchange rate, and documentation of dispensing of the drug by the physician, in lieu of an official pharmacy receipt, where applicable.

4.1 Coordination of benefits

Persons eligible for benefits under the NIHB program are required to access other public or private health plans or provincial or territorial programs for which they are eligible before accessing NIHB benefits. Pharmacy providers must confirm with each client whether other coverage exists, and a claim must be submitted to the other party first for processing. Once this party processes the claim, the provider may then submit any remaining balance to NIHB.

5.1 Client eligibility

The provider must verify that the individual is eligible for benefits under Indigenous Services Canada's NIHB program and identify any other benefit coverage available to the client, if applicable.

To be eligible, a client must be a resident of Canada, and one of the following:

• a First Nations individual who is registered according to the Indian Act (commonly referred to as a "Status Indian")
• an Inuk recognized by one of the Inuit land claim organizations as outlined in Inuit client eligibility for NIHB
• a child less than 2 years old, whose parent is an NIHB-eligible client

Refer to the Who is eligible for the NIHB program webpage or contact the NIHB regional office for information.

More detailed information about client identification and eligibility can be found in section 4 of the Pharmacy Claims Submission Kit, available on the Express Scripts Canada NIHB provider and client website.

5.2 Privacy statement

Indigenous Services Canada's NIHB program has a responsibility to protect personal information under its control in accordance with the Privacy Act and its related Treasury Board privacy policy and directives and is responsible for ensuring the personal information collected is limited to that which is necessary to administer the program.

For more information, please contact Indigenous Services Canada's Access to Information and Privacy (ATIP) Coordinator at 819-997-8277 or atiprequest-aiprpdemande@rcaanc-cirnac.gc.ca. You also have the right to file a complaint with the Privacy Commissioner of Canada if you think your personal information has been handled improperly.

5.3 Appeal process

Persons eligible for the NIHB program have the right to appeal the denial of coverage for a product, except for those that are identified as exclusions or insured services. If a client seeks information about the appeal process, pharmacy providers may direct them to the online appeal procedures or to the appropriate First Nations and Inuit Health Branch regional office.

5.4 Provider Claim Verification Program

As part of the NIHB program's risk management activities, Indigenous Services Canada has mandated its claims processor to maintain a set of pre-payment and post-payment processes, including claim verification activities.

This function incorporates the review of claims against records to confirm compliance with the terms and conditions of the NIHB program. If under any circumstances it is found that a provider has inappropriately billed the program, claim payments will be recovered; either by direct payment from the provider or withheld from future provider claim statements.

Detailed information about the Provider Claim Verification Program and procedures can be found in section 6 of the Pharmacy Claims Submission Kit available on the Express Scripts Canada NIHB provider and client website.

6.1 Short-term dispensing questions and answers for providers