Provider Guide for Pharmacy Benefits

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This guide provides information on the Health Canada Non-Insured Health Benefits (NIHB) Program and policies relevant to pharmacy providers. It explains the extent and limitations of the NIHB Program's drug and pharmacy benefits by describing the important elements of each associated policy. It also lists website addresses to provide pharmacy providers quick access to related forms and more detailed Program information.

The guide is intended to supplement the information contained in the  Pharmacy Claims Submission Kit, published by ESI Canada, which explains the process for pharmacy providers to submit claims for payment of services rendered to eligible Clients.

Table of Contents

• 1.0 Introduction
• 2.0 Benefit Description and Conditions
  • 2.1 Terms and Conditions of Services
  • 2.2 Drug Benefit List
  • 2.3 Open Benefits
  • 2.4 Limited Use Benefits
  • 2.5 Drug Utilization Review and Potential Overuse/Abuse
• 3.0 Policies
  • 3.1 Lowest Cost Equivalent Drug
  • 3.2 Extemporaneous Mixtures
  • 3.3 Methadone
  • 3.4 Short-Term Dispensing Policy
  • 3.5 Overriding Codes
  • 3.6 Emergency Supply Process
  • 3.7 Refusal to Fill Fee
  • 3.8 Trial R_x Program
• 4.0 Prior Approval
• 5.0 Payment and Reimbursement
  • 5.1 Co-ordination of Benefits
  • 5.2 Dispensing and Claims Submission
• 6.0 Exceptions
• 7.0 Exclusions
• 8.0 Appendices
  1. Glossary of Key Terms
  2. Client Eligibility
  3. Privacy Statement
  4. Appeal Process
  5. Audit Program

1.0 Introduction

Health Canada's Non-Insured Health Benefits (NIHB) Program provides a limited range of medically necessary health-related goods and services to eligible registered First Nations and recognized Inuit, when these goods and services are not already provided through private insurance plans, provincial or territorial health and social programs, or other publicly funded programs.

NIHB Program benefits include a specified range of prescription drugs and over-the-counter medications; dental and vision care; medical supplies and equipment; short-term crisis intervention mental health counselling; and transportation to access medically required health services that are not available on the reserve or in the community of residence. The Program also covers provincial health premiums for eligible clients in British Columbia.

This Provider Guide to Pharmacy Benefits explains the policies under which the NIHB Program will reimburse pharmacy goods and services provided to eligible clients. As policies and procedures evolve, the guide is updated accordingly and pharmacy providers are advised of these changes through the Program's newsletters and bulletins.

Providers are advised to read and retain the most current version of the guide to ensure continued compliance with their NIHB provider agreement. In the event of a contradiction between document versions, the provisions of the Health Canada web-posted guide will prevail.

2.0 Benefit Description and Conditions

The pharmacy or drug component of the NIHB Program covers drugs and over-the-counter medications that are included on the NIHB drug benefit list and prescribed by a health professional, licensed to prescribe in a given provincial jurisdiction, such as a physician.

Eligible pharmacy benefits are based on policies established by Health Canada to provide eligible clients with access to benefits not otherwise available under federal, provincial, territorial or private health insurance plans. This includes 'open benefits' which are listed on the NIHB drug benefit list and do not require prior approval, and 'limited use benefits' which are on the drug benefit list and may be eligible for coverage, if the criteria for coverage are met. Qualified and legally licensed pharmacists may also provide eligible clients emergency and other necessary services identified for the NIHB Program, provided that these services are rendered within policy criteria for frequency limitations, prescription quantities, and the emergency supply process.

Pharmacy benefits are covered in accordance with the mandate of the NIHB Program. Clients of the NIHB Program do not pay deductibles or co-payments.

2.1 Terms and Conditions of Services

To be eligible for payment of services rendered, pharmacy providers must adhere to the terms and conditions of the NIHB Program. These are detailed within section 5.4 of the  Pharmacy Claims Submission Kit, including the procedures for verifying Client eligibility and submitting NIHB benefit claims.

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

2.2 Drug Benefit List

Health Canada maintains an up-to-date NIHB drug benefit list of eligible drugs that are primarily used in a home or ambulatory setting. The drug benefit list indicates to prescribers and pharmacy providers which drug products are eligible NIHB benefits. It is a tool to encourage providers to select the most optimal and cost-effective drug therapy. Pharmacy providers should regularly review the list to ensure that they continue to be aware of the drug benefits included.

Drugs considered for, or currently listed on, the drug benefit list must meet minimum criteria. For example, they must be legally available for sale in Canada with a Notice of Compliance. The drugs must also demonstrate evidence of therapeutic efficacy, safety, and incremental benefit in proportion to incremental cost.

NIHB Program drug benefits are based on the judgement of recognized health professionals, consistent with the best practices of health services delivery and evidence-based standards of care.

The review process for drug products 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 drug products and existing chemical entities with new indications, must be sent to the Canadian Agency for Drugs and Technologies in Health (CADTH). Clinical and pharmacoeconomic reviews are coordinated by the Common Drug Review (CDR) Directorate and forwarded to the Canadian Expert Advisory Committee (CEDAC) for recommendations on formulary listing. These recommendations are forwarded to participating drug plans, including the NIHB Program, for consideration. The NIHB Program and other drug plans make listing decisions based on CEDAC recommendations and other specific relevant factors, such as mandate, priorities, client safety and resources.

Submissions for line extensions, generics and all other submissions are reviewed internally or by the Federal Pharmacy and Therapeutics Committee. Generic drug products are considered for inclusion on the formulary based on provincial interchangeability lists and other relevant factors.

2.3 Open Benefits

Open benefits are drugs listed on the NIHB drug benefit list that do not have established criteria, gender or age limitations, or prior approval requirements. This means that, in most cases, pharmacy providers may submit claims for dispensing 'open benefit' drugs without receiving pre-approval.

Open benefits may include specific eligible items in the following categories:

• prescription drugs;
• over-the-counter medications;
• injectable drugs, including injectable allergy serums;
• extemporaneous mixtures;
• drug delivery devices, as required, to deliver medications for certain conditions;
• recognized non-oral contraceptive devices; and
• therapeutic vitamins and minerals.

A prescription from a licensed practitioner is required for any listed drug to be processed as a benefit under the NIHB Program. The practitioner must be in good standing with the appropriate governing body, province or territory in which they practice, and the prescription must be written in accordance with the applicable provincial or territorial prescriber guidelines. Practitioners include, but are not limited to, medical doctors, medical specialists, dentists, and nurse practitioners.

2.4 Limited Use Benefits

Certain drug products may be inappropriate for general listing, but have value in specific circumstances. These may be recommended as 'limited use benefits' for the NIHB Program in one of three categories: those which do not require prior approval, such as multivitamins and pre- and post-natal vitamins (with age or gender limitations); those which require prior approval; and those which have a quantity and frequency limit.

To be eligible for payment for dispensing 'limited use benefits', pharmacy providers must adhere to the following eligibility criteria and obtain prior approval when required.

In the first category, age or gender limitations restrict the eligibility of the drug product for NIHB benefit. For example, multivitamins are benefits for children up to six years of age, and pre- and post-natal vitamins benefit women of childbearing age.

Drugs in the second category are considered for limited use benefits against specific criteria. For example, a product may have proven to be effective, but is associated with predictable severe adverse effects. These benefits require prior approval by the NIHB Drug Exception Centre to be eligible for the NIHB Program.

Benefits that have a quantity and frequency limit do not require prior approval as long as the maximum quantity of the drug is not exceeded within a specified period of time. For example, NIHB clients are eligible to receive a three-month supply of smoking cessation products over a one-year period. This is renewable only 12 months from the day the initial prescription was filled.

2.5 Drug Utilization Review and Potential Overuse/Abuse

Drug use evaluation is a means of improving the quality of client care, enhancing therapeutic outcomes, and reducing inappropriate pharmaceutical expenditures. Health Canada established an independent advisory body of licensed health care professionals to provide advice and recommendations in support of a comprehensive drug evaluation program. Among its objectives, the Drug Utilization Evaluation Advisory Committee provides recommendations to improve prescribing, dispensing, and the use of drugs among First Nations and Inuit Clients.

All NIHB claims are subject to the drug utilization review process to ensure that pharmacy providers are advised of potential drug-related problems or interactions. For example, an 'NE' code will warn the pharmacy provider of potential overuse or abuse of specified drug entities, such as the use of three or more different opioid drug entities.

As per professional judgement, providers may use an intervention code to override these messages. In these instances, the providers must document the nature of their intervention directly on the prescription hard copy or on the electronic patient profile, and retain the documented intervention as supporting documentation for audit purposes.

3.0 Policies

The following policies impact the benefits under which the NIHB Program will reimburse pharmacy goods and services provided to eligible clients. As policies and procedures evolve, the guide is updated accordingly. Pharmacy providers are advised of these changes through the Program's newsletters and bulletins.

3.1 Lowest Cost Equivalent Drug

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

The policy of the Program is to reimburse only the best price (lowest cost) alternative product in a group of interchangeable drug products. Pharmacists must follow their provincial or territorial pharmacy legislation and policies to identify interchangeable products and to select the lowest-priced brand.

If the client cannot take the lowest cost equivalent drug as a result of an adverse reaction to it, the NIHB Program may consider coverage of interchangeable products. In such circumstances, pharmacy providers must seek prior approval from the NIHB Program.
To do so, pharmacists should acquire from the prescriber a completed and signed Health Canada Report of suspected adverse reaction due to drug products marketed in Canada form, as well as the prescription with 'No Substitution' or 'No Sub' written on it by hand. A copy of the form and prescription should then be sent by the pharmacy provider to NIHB for review.

3.2 Extemporaneous Mixtures

To be eligible under the NIHB Program, extemporaneous mixtures must have at least one ingredient listed on the drug benefit list and must not duplicate the formulation of commercially manufactured drug products. Mixtures that contain exception or 'limited use' drugs must receive prior approval by the NIHB Drug Exception Centre; those that contain ingredients excluded from the Program will not be eligible for coverage.

For more information, please contact the Provider Claims Processing Call Centre at 1-888-511-4666 to speak with an ESI Representative.

3.3 Methadone

Methadone used for the treatment of addictions does not require prior approval, but there are strict requirements for the preparation and submission of such claims. For example, Pseudo-DIN 00908835 must be used for methadone compounded for treatment of opioid dependency.

When billing methadone treatment, the NIHB Program has specific requirements for drug cost, mark-up, and dispensing fees. This applies to both witnessed and carried doses.

The methadone dispensing fee will be paid by the dose when the usual and customary fee is the pharmacy provider's usual dispensing fee up to an NIHB maximum, using the following formula: ((usual and customary fee × 1.5) / 7 days + $3.80) per dose. Claims are to be transmitted the same day the service is provided.

For claims filled on the same day, the electronic claims adjudication system will allow a single transaction up to a maximum seven-day supply or more than one transaction for a combination of up to a maximum seven-day supply. Pharmacy providers should be aware that the NIHB will only pay claims from one provider per day and only if the total "days supply" has elapsed from a previous date of service.

3.4 Short-Term Dispensing Policy

The NIHB Program implemented a Short-Term Dispensing (STD) policy to address a significant increase in the frequency of short-term dispensing of chronic use medications. The new policy established compensation criteria for short-term fills of chronic use medications when medically necessary. The Program will compensate pharmacists up to one usual and customary dispensing fee every 28 days, up to the regional maximum of the Program. If these medications are dispensed daily, the Program will compensate 1/28^th of the usual and customary dispensing fee, up to the Program regional maximum.

The Program expanded the STD policy on July 15^th, 2012 to also include anticonvulsants, antidepressants, antipsychotics, benzodiazepines and stimulant medications. When short-term dispensing is medically necessary, the Program will compensate pharmacists up to one usual and customary dispensing fee every seven days, up to the Program regional maximum, for the aforementioned medications. If these medications are dispensed daily, the Program will compensate 1/7^th of the usual and customary dispensing fee, up to the Program's regional maximum. When these medications are dispensed less frequently than every seven days, such as once a month, the pharmacist will be entitled to one full dispensing fee, up to the Program regional maximum.

For more information regarding the NIHB Program's STD policy, please visit the Health Canada website at the following address: http://www.hc-sc.gc.ca/fniah-spnia/nihb-ssna/provide-fournir/pharma-prod/faq-foq-eng.php, as noted in the NIHB Fall 2012 newsletter.

3.5 Overriding Codes

When pharmacy providers decide to override a reject message with an intervention code, they must complete and retain the appropriate documentation on the nature of the intervention directly on the prescription or on any hard or electronic version of the patient file. To avoid the recovery of claim payment during the claims verification and audit process, proper documentation of any intervention is required. This may include:

• date of the intervention;
• summary of the intervention by the pharmacy provider;
• documented communication with the physician, caregiver, and/or patient; and
• reason for early refill (medication lost, destroyed, stolen, physician changed dosage, or patient going out of town for a period greater than the days supply remaining of the current refill).

If a provider uses an intervention code to override a drug utilization review reject message for "fill too soon," the prescription or client profile at the pharmacy must contain specific documentation citing the reason why the prescription was refilled early.

3.6 Emergency Supply Process

When a drug requiring prior approval is needed on an emergency basis and the criteria for automated prior approval have not been met (i.e., a claim is submitted on-line and prior approval is not electronically granted, as indicated by the generated CPhA message) and/or access to the NIHB Drug Exception Centre is not possible (i.e., statutory holidays and after hours of operation), a pharmacist may dispense an initial course of treatment (maximum four days supply).
If the item is eligible for auto prior approval, but did not meet the criteria, the provider may  resubmit the rejected claim with applicable intervention code to initiate the prior approval process as soon as possible so that the NIHB Drug Exception Centre can review the request for NIHB emergency supply coverage. Refer to the  Pharmacy Claims Submission Kit for information on how to re-submit a request.

After an emergency dispense, providers must follow the usual prior approval process to dispense the balance of the prescription. If a prior approval is granted for the remainder of the prescription, the pharmacist will receive a prior approval number and details of the approved benefit by mail, fax or e-mail. The prior approval number must then be included on the subsequent submitted claim.

3.7 Refusal to Fill Fee

A pharmacy provider in British Columbia, Saskatchewan, or Manitoba may decide not to fill or refill a prescription when a claim has been rejected 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 providers usual and customary fee may be charged to the NIHB Program.  The provider is advised to use the 'UL' intervention code on his claim.

3.8 Trial R_x Program

In British Columbia and Saskatchewan, the NIHB Program may cover the dispensing fee associated with the provision of a small initial quantity of a 'trial drug' (seven-day supply) that is included under the Trial Prescription Program. To be applicable for reimbursement, the client must not have used the drug in the past two years.

4.0 Prior Approval

Some items not listed on NIHB Drug Benefit List, as well as 'limited use benefits', may be considered for NIHB Program coverage under special circumstances, with prior approval.

Prior approvals may be generated automatically by the electronic claims adjudication system when a claim is submitted. The claim may also be rejected if the criteria for automated prior approval have not been met. If rejected, the provider may resubmit the claim electronically to have the prior approval request reviewed by the NIHB Drug Exception Centre (DEC). 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.

Prior approvals may also be obtained by contacting the NIHB Drug Exception Centre. In these instances, the Drug Exception Centre will require details about the prescription, the prescriber, and the pharmacist. The Drug Exception Centre may also need a copy of the completed exception or limited use drug request form from the prescriber stating the exceptional medical need for the drug to complete the PA process.

Prior approval requests or rejected claims submitted to the Drug Exception Centre may take a few days to review, depending on the time it takes for the licensed prescriber to provide any needed information. When approval is granted, a confirmation letter with the applicable dates and prior approval details may be faxed or mailed to the provider.

Prior approvals are entered electronically on the claims processing system. The date of dispense should be indicated to the analyst so it can be reflected in the prior approval. Pharmacy providers are advised to retain the confirmation letter, if applicable, for billing purposes and/or to validate any discrepancies. When submitting the claim, providers must be sure to include the date of service (dispense date).

5.0 Payment and Reimbursement

5.1 Co-ordination of Benefits

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

Claims submitted for NIHB clients who no longer have coverage with another plan must be supported by a letter from the client or from the provider on behalf of the client.

5.2 Dispensing and Claims Submission

Upon entering the Pharmacy Provider Agreement with the NIHB Program, pharmacy providers are advised to read and retain an up-to-date  Pharmacy Claims Submission Kit. This Kit outlines all of the accountability rules and obligations for providers to ensure that they have the information they need to dispense prescriptions to NIHB clients and submit claims for payment.

There are a few obligations that bear repeating in this guide. Pharmacy providers, for example, have one year from the date of service to secure payment, and completion of the days supply field with the appropriate number of days of treatment is mandatory for all claims submitted electronically and on NIHB pharmacy claim forms. The following policies also carry important requirements for providers:

• The provider should submit claims for payment for the acquisition cost of products on the drug benefit list which were provided, and the lesser of: (i) the Usual and Customary Professional Fee (dispensing fee) and (ii) any maximum for such fees as set out in any regional schedules for professional fees referred to in the  Pharmacy Claims Submission Kit.
  Please note that Pharmacists may be required to provide evidence of pricing information related to non-NIHB clients on a periodic basis in order to verify usual and customary dispensing fees and product costs (AAC or DC).
• When accessing benefits through the NIHB Program, eligible clients may not directly or indirectly benefit from special promotions or incentives, including coupons, discounts, points or rebates in the form of cash and/or goods that may be offered by providers. To the extent permitted by such promotions and applicable law, the coupons, discounts or rebates should be applied to the NIHB claim.
• When a client has not picked up a prescription, the original paid claim must be reversed and resubmitted for payment of just the dispensing fee".  This is applicable only to drugs with a dispensing fee dollar value.

6.0 Exceptions

Exceptions are items that are not listed on the drug benefit list, but which may be considered on a case-by-case basis with written medical justification and prior approval. For example, a non-listed drug may be approved under special circumstances, when an Exception Drugs Request Form is received from the attending physician or dentist that lists supporting evidence that available alternatives are ineffective or toxic.

Exceptions are also considered when there is significant evidence that the requested drug is superior to drugs already listed as Program benefits or the client has experienced an adverse reaction with a best-price alternative drug.

Pharmacy providers should refer to the prior approval section of this guide and follow its procedures to proceed with 'exceptions'.

7.0 Exclusions

Exclusions are items that are not listed on the drug benefit list and do not apply to the exception process. These items are not considered for coverage under the NIHB Program and cannot be appealed. They include anti-obesity drugs, household products, cosmetics, hair growth stimulants, and megavitamins, among other items.

The Common Drug Review and Federal Pharmacy and Therapeutics Committee recommend that the NIHB not cover 'exclusion' items because published evidence does not support the clinical value or cost of the drug relative to existing therapies, or there is insufficient clinical evidence to support coverage.

8.0 Appendices

A. Glossary of Key Terms

• CDR: Common Drug Review
• FNIHB: First Nations and Inuit Health Branch at Health Canada
• FP&T: Federal Pharmacy and Therapeutics Committee
• HICPS: Health Information and Claims Processing Services
• NIHB: Non-Insured Health Benefits
• Notice of Compliance (NOC): A firm may not market its product until it has been reviewed for safety and effectiveness and approved by the issuance of a notice of compliance under the Food and Drug Regulations.
• Dispensing Fee: Usual and Customary Professional Fee

B. Client Eligibility

To be eligible for NIHB Program benefits, a person must be a Canadian citizen and have the following status:

• is a registered Indian, recognized by INAC, according to the Indian Act; or
• an Inuk recognized by one of the following Inuit Land Claim organizations - Nunavut Tunngavik Incorporated, Inuvialuit Regional Corporation, Makivik Corporation. For an Inuk residing outside of their land claim settlement area, a letter of recognition from one of the Inuit land claim organizations and a birth certificate are required; or
• an infant, less than age one (1), whose parent is an eligible client; and
• is currently registered or eligible for registration, under a provincial or territorial health insurance plan; and
• is not otherwise covered under a separate agreement with federal, provincial or territorial governments.

To facilitate verification, pharmacy providers should provide the following client identification information in each claim:

• surname (under which the client is registered);
• given names (under which the client is registered);
• date of birth (dd/mm/yyyy); and
• client identification number.

It is recommended that pharmacy providers ask clients to present their identification card upon each visit to ensure that client information is entered correctly and to protect against mistaken identity.

For recognized Inuit clients, one of the following identifiers is required:

1. Government of the Northwest Territories health plan number, which begins with the letter "T" and is followed by 7 digits. This number is valid in any region of Canada and is cross-referenced to the First Nations and Inuit Health Regional Office Client identification number.
2. Government of Nunavut health plan number, which is a 9-digit number starting with a "1" and ending with a "5". This number is valid in any region of Canada and is cross-referenced to the FNIH client identification number.
3. FNIHB Client Identification Number (N-Number), which begins with the letter "N" and is followed by 8 digits. This is a client identification number issued by the First Nations and Inuit Health Branch at Health Canada to recognized Inuit clients.

For eligible First Nations clients, one of the following identifiers is required:

1. Indian and Northern Affairs Canada registration number, which is a 10-digit number.  Also known as the Department of Indian Affairs and Northern Development Treaty or Status number, this registration number is the preferred method of identifying First Nations clients.
2. Band Number and Family Number, where applicable.
3. FNIHB Client Identification Number (B-Number), which begins with the letter "B" and is followed by 8 digits.

For infants under one year of age who are not yet registered with Indian and Northern Affairs Canada or applicable Inuit associations, pharmacy providers must submit the first claim for manual processing. Subsequent claims may be submitted for this infant via point of service with the parent's primary identifier in the client identification number field and the infant's identifiers in the surname, given name, and birth date fields.

More detailed information about client eligibility is included in section 6.1 of the  Pharmacy Claims Submission Kit.

C. Privacy Statement

The NIHB Program respects an individual's right to control who has access to their personal information and the purpose for which that information will be used.

When a request for benefits is received, the Program collects, uses, discloses and retains an individual's personal information according to the applicable federal privacy legislation. The information collected is limited to only the information needed for the Program to provide and verify benefits and to ensure that claims paid are in accordance with its terms and conditions.

As a federal government program, NIHB must comply with the Privacy Act, the Canadian Charter of Rights and Freedoms, the Access to Information Act, applicable Treasury Board policies and guidelines, and the Health Canada Security Policy.

D. Appeal Process

Persons eligible for the NIHB Program have the right to appeal the denial of a benefit with the exception of items that are identified as exclusions or insured services. If a client seeks information about the appeal process, pharmacy providers may direct them to the on-line appeal procedures, or to the appropriate Health Canada regional office.

E. Audit Program

The NIHB provider audit program ensures that the NIHB Program is accountable for the expenditure of public funds. The Health Information and Claims Processing Services (HICPS) contractor performs this audit function by verifying paid claims against pharmacy records to confirm that the claims have been billed in compliance with the terms and conditions of the NIHB Program.

Detailed information about audit procedures and the responsibilities of pharmacy providers for these audits are included in section 8.0 of the  Pharmacy Claims Submission Kit.