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Under section 63 of the Prescription and Catastrophic Drug Insurance Act, the Lieutenant-Governor in Council makes the following Regulation:

CITATION AND DEFINITIONS

Citation

1This Regulation may be cited as the General Regulation - Prescription and Catastrophic Drug Insurance Act.

Definitions for the purposes of the Act and this Regulation

2The following definitions apply in the Act and this Regulation.

“co-payment” means the portion of the total cost of an entitled service that is required to be paid by a member of the Plan at the time a benefit is provided or that is not reimbursed to a member of the Plan, except an amount under subsection 22(2).(quote-part)

“income” means the total income in the year immediately preceding the current year, or, if the total income for that year is not available, the income of the year prior to that year, as declared on Line 150 of an individual’s income tax return less any elected split-pension amount as declared on Line 116.(revenu)

Definitions for the purposes of this Regulation

3The following definitions apply in this Regulation.

“Act” means the Prescription and Catastrophic Drug Insurance Act.(Loi)

“actual acquisition cost” means the unit price of a drug to a participating provider, based on reasonable and customary purchasing practices, which is calculated by deducting from the total amount paid or payable to purchase the drug, excluding franchise fees and shipping charges, the value of any price reduction.(coût d’achat réel)

“brand name product” means the drug for which the first notice of compliance has been issued in respect of a particular active ingredient or combination of particular active ingredients, the drug’s strength and the drug’s dosage form.(produit de marque)

“controlled drug” means a controlled drug as defined in Part G of the Food and Drug Regulations under the Food and Drugs Act (Canada).(médicament contrôlé)

“extemporaneous preparation” means a drug compounded by a provider that does not duplicate the formulation of a manufactured drug.(préparation extemporanée)

“manufacturer’s list price” means the unit price of a drug as provided by a manufacturer to the Minister and published by the Minister, excluding any markup for distribution and the value of any price reduction.(prix courant du fabricant)

“maximum allowable price” means the unit price of a drug determined by the Minister in accordance with subsection 30(1) of the Act.(prix maximal autorisé)

“narcotic” means a narcotic as defined in the Narcotic Control Regulations under the Controlled Drugs and Substances Act (Canada).(stupéfiant)

“notice of compliance” means the notice of compliance issued for a drug under the Food and Drug Regulations under the Food and Drugs Act (Canada).(avis de conformité)

“original product” means a drug that(produit original)

(a) is the brand name product, and

(b) is or was marketed in Canada by the drug’s innovator or a person acting under a licence granted by the drug’s innovator before the issuance of any subsequent notice of compliance for another drug having the same active ingredient or combination of active ingredients.

“pharmaceutical alternative” means a drug that contains the same therapeutic moiety as another drug but (substitut pharmaceutique)

(a) different salts, esters or complexes of that moiety, or

(b) in a different dosage form or strength.

“pharmaceutical equivalent” means a drug that contains identical amounts of identical medicinal ingredients as another drug in a similar dosage form.(équivalent pharmaceutique)

“price reduction” means a rebate, an allowance, a refund, free goods or any other similar advantage granted to a participating provider by a manufacturer or pharmaceutical distributor in respect of the purchase of a drug and includes(réduction de prix)

(a) a discount, unless the discount is for prompt payment that is made within 30 days after the drug is delivered to the participating provider and that does not exceed 2% of the net purchase price, and

(b) a delayed payment, unless the payment is made within 120 days after the drug is delivered to the participating provider, in which case the delayed payment is deemed to be a profit of 1.5% of the net purchase price per month.

“reasonable and customary purchasing practices” means purchasing sufficient quantities to satisfy anticipated sales of a drug and maintenance of appropriate inventory levels based on generally accepted business principles.(pratiques d’achat raisonnables et courantes)

“targeted substance” means a targeted substance as defined in the Benzodiazepines and Other Targeted Substances Regulations under the Controlled Drugs and Substances Act (Canada).(substance ciblée)

GOVERNANCE

Duties of the Director

4For the purposes of subsection 6(2) of the Act, the Director shall perform the following duties:

(a) inform the Advisory Committee with respect to information relating to the Plan;

(b) evaluate the Plan; and

(c) inform the public with respect to the Plan.

Information relating to an entitled person

5For the purposes of subsection 6(4) of the Act, the personal information and personal health information is as follows:

(a) the identification number of the family unit; and

(b) in relation to each member of the family unit, the member’s

(i) name,

(ii) Medicare number,

(iii) address,

(iv) date of birth,

(v) date of death, if applicable, and

(vi) gender.

Duties of the Plan Administrator

6For the purposes of section 7 of the Act, the Plan Administrator shall perform the following duties:

(a) support the evaluation of Plan funding;

(b) process claims;

(c) assess subsidies and collect premiums;

(d) determine eligibility for the Plan;

(e) determine whether a member of the Plan is eligible for an entitled service referred to in paragraph 29(2)(b) of the Act;

(f) provide for the administration with respect to entitled services;

(g) manage communications; and

(h) store, analyse and report on Plan data.

Agreements

7(1)For the purposes of subsection 8(2) of the Act, the Minister may enter into agreements for the following purposes:

(a) to establish an entitlement to benefits or a subsidy;

(b) to establish an obligation to pay an amount under the Act or this Regulation and the amount owing;

(c) to identify a situation in which information was not provided or was provided incorrectly;

(d) to establish a person’s permanent residence; or

(e) to evaluate the Plan.

7(2)For the purposes of subsection 8(2) of the Act, the Minister may enter into agreements with the following entities:

(a) the Minister of Employment and Social Development Canada;

(b) the Minister of Social Development; and

(c) the regional health authorities as defined in the Regional Health Authorities Act.

Advisory Committee

8(1)The Advisory Committee shall be composed of

(a) a minimum of five and a maximum of nine voting members, including

(i) a representative of employees,

(ii) a representative of employers,

(iii) a representative of the insurance industry,

(iv) a representative of pharmacists, and

(v) a representative of medical practitioners, and

(b) two non-voting members as follows:

(i) the Director; and

(ii) an employee of the Plan Administrator.

8(2)A voting member of the Advisory Committee shall be appointed for a maximum term of three years and may be reappointed for one additional term.

8(3)The Minister shall appoint from among the voting members of the Advisory Committee a Chair for a maximum term of three years and a Vice-Chair for a maximum term of two years.

8(4)The Minister may appoint an alternate member to act in the place of a member of the Advisory Committee, appointed by the Minister under subsection 10(1) of the Act, who is unable to act for any reason.

8(5)A vacancy on the Advisory Committee does not impair the capacity of the Advisory Committee to act.

8(6)A member of the Advisory Committee is entitled to be reimbursed for accommodation, meal and travel expenses reasonably incurred in connection with his or her duties on the Advisory Committee in accordance with the Board of Management Travel Policy guidelines, as amended.

Meetings of the Advisory Committee

9(1)The Advisory Committee shall meet at least once in every fiscal year.

9(2)The Chair, or in his or her absence, the Vice-Chair, shall preside at meetings of the Advisory Committee.

9(3)If the Chair and Vice-Chair are absent from a meeting of the Advisory Committee, the voting members present may elect from among themselves a person to preside at the meeting.

9(4)A majority of the voting members of the Advisory Committee present at a meeting constitutes a quorum and, in the event of a tie, the person presiding at the meeting shall cast the deciding vote.

9(5)The Advisory Committee shall ensure that minutes of each of its meetings are taken and that the minutes, once certified and approved by the Advisory Committee, are submitted to the Minister.

Conflict of interest of a member of the Advisory Committee

10(1)A member of the Advisory Committee has a conflict of interest if, in the opinion of the Chair,

(a) the member has an interest in the matter, distinct from an interest arising from his or her functions as a member,

(b) the member has a direct or indirect pecuniary interest in the matter,

(c) a person who is related to the member by blood or marriage has an interest in the matter, or

(d) the member is an officer, employee or agent of a corporation, an unincorporated association or other association of persons that has an interest in the matter.

10(2)If a member of the Advisory Committee has a real or potential conflict of interest, the member shall disclose to the Advisory Committee the nature and extent of the interest either in writing or by requesting to have it entered in the minutes of a meeting of the Advisory Committee.

10(3)A member of the Advisory Committee shall disclose a real or potential conflict of interest

(a) at the meeting at which the matter giving rise to the conflict of interest is considered, or

(b) if the member does not have a conflict of interest at the time described in paragraph (a), at the first meeting that is held after the conflict of interest arises.

10(4)If, in the opinion of the Chair, a member of the Advisory Committee has a conflict of interest, the Chair may exclude the member from the meeting or limit the participation of the member at the meeting.

Matters referred to the Advisory Committee

11For the purposes of subsection 10(2) of the Act, the financial and other matters are as follows:

(a) premium rates;

(b) subsidy rates;

(c) the maximum co-payment under the Plan;

(d) the minimum requirement under paragraph 36(1)(b); and

(e) cost management strategies.

EARLY ENROLMENT

Voluntary membership

12(1)For the purposes of subsection 12(8) of the Act, notice shall be provided by registered mail.

12(2)The notice under subsection (1) shall be deemed to have been received by the person to whom it was sent on the earlier of the fifth day after mailing and the day its receipt was acknowledged in writing by the person to whom it was sent.

Information provided by an entitled person

13(1)For the purposes of subsection 13(2) of the Act, the information to be provided is as follows:

(a) in relation to each member of the family unit, the member’s

(i) name,

(ii) Medicare number,

(iii) date of birth,

(iv) gender,

(v) marital or cohabitation status, and

(vi) current drug coverage;

(b) in relation to each dependant in the family unit, whether the dependant is a person with a disability;

(c) the address, phone number and email address of the family unit; and

(d) the preferred official language of the family unit.

13(2)An entitled person shall provide the information referred to in subsection (1) within 30 days after the Director makes the request.

13(3)For the purposes of subsection 13(3) of the Act, an entitled person shall make the statement on a form provided by the Minister that includes the following information:

(a) an undertaking to notify the Director of any change that would affect eligibility of the entitled person within 30 days after the change;

(b) an undertaking to notify the provider who provides an entitled service to the entitled person of all of his or her drug coverage; and

(c) an undertaking to repay a benefit or a portion of a benefit for which the entitled person is not eligible.

Premiums and co-payments for voluntary members

14(1)For the purposes of subsection 15(1) of the Act, premiums are set as follows:

(a) at the request of an entitled person, by taking into account the income level of the family unit and the composition of the family unit in accordance with Schedule A, or

(b) in any other case, $2,000 annually per member of the Plan.

14(2)For the purposes of paragraph (1)(a), a dependant is only a member of a family unit that obtains coverage for that dependant under the Plan.

14(3)An entitled person who requests that his or her premium be set under paragraph (1)(a) shall provide the Director with the following information in relation to each member of the family unit other than a dependant:

(a) social insurance number; and

(b) an authorization to the Minister under subsection 241(5) of the Income Tax Act (Canada) to obtain information directly from the Canada Revenue Agency.

14(4)The premium under subsection (1) shall be paid on or before the last day of the month preceding the first full month in which the member of the Plan is entitled to benefits.

14(5)If a member of the Plan provides banking information to the Plan Administrator, the premium under subsection (1) may be paid by preauthorized payment.

14(6)For the purposes of subsection 15(2) of the Act, a member of the Plan may apply for a reimbursement by regular mail or electronic transmission on a form provided by the Minister within 12 months after the date the overpayment was made.

14(7)A member of the Plan shall pay a co-payment of 30% of the total cost of an entitled service that is provided to the member to a maximum of $30.

14(8)Despite subsection (7), a member of the Plan referred to in subsection 22(2) shall pay a co-payment of 30% of the total cost, including the dispensing fee, the markup and the cost of the lowest cost pharmaceutical equivalent or pharmaceutical alternative to a maximum of $30.

14(9)A member of the Plan who has an approval under subsection 29(4) of the Act for a brand name product shall pay a co-payment of 30% of the total cost, including the dispensing fee, the markup and the cost of the brand name product to a maximum of $30.

MEMBERS OF THE PLAN

Certificate of private individual drug insurance

15For the purposes of section 17 of the Act, the certificate of insurance shall contain the following information:

(a) the names of the parties to the contract;

(b) the contract number;

(c) the names of other insured persons under the contract, if applicable;

(d) the identification number of the insured, if applicable; and

(e) a statement, in respect of each insured person under the contract, indicating that the contract meets the minimum requirements under the Act and this Regulation.

Mandatory membership

16(1)For the purposes of subsection 18(5) of the Act, proof of drug coverage shall be provided to the Director by regular mail or electronic transmission.

16(2)For the purposes of subsection 18(9) of the Act, the Director shall be notified by regular mail or electronic transmission on a form provided by the Minister.

Private group drug insurance

17For the purposes of subsection 20(1) of the Act, an entitled person shall not be required to obtain or maintain private group drug insurance provided by an insurer in the following circumstances:

(a) the entitled person takes a leave of absence of at least three months from his or her employment for medical reasons;

(b) the entitled person is on parental leave;

(c) the entitled person is at least 65 years of age; or

(d) the entitled person is retired from employment with the employer who is offering private group drug insurance.

Information provided by or relating to an entitled person

18(1)For the purposes of subsection 21(2) of the Act, the information to be provided is as follows:

(a) in relation to each member of the family unit, the member’s

(i) name,

(ii) Medicare number,

(iii) date of birth,

(iv) gender,

(v) marital or cohabitation status, and

(vi) current drug coverage;

(b) in relation to each dependant in the family unit, whether the dependant is a person with a disability;

(c) the address, phone number and email address of the family unit;

(d) the preferred official language of the family unit;

(e) in relation to a member of the family unit,

(i) a change of address,

(ii) a change in marital or cohabitation status,

(iii) a change in circumstances,

(iv) a period of absence from the Province that exceeds a temporary absence from the Province as provided for in subsection 3(4) of the General Regulation under the Medical Services Payment Act, and

(v) a change in drug coverage.

18(2)An entitled person shall provide the information referred to in subsection (1) on or before April 1, 2015, or within 30 days after the change or absence occurs.

18(3)For the purposes of subsection 21(3) of the Act, an entitled person shall make the statement on a form provided by the Minister that includes the following information:

(a) an undertaking to notify the Director of any change that would affect eligibility of the entitled person within 30 days after the change; and

(b) an undertaking to repay a benefit or a portion of a benefit for which the entitled person is not eligible.

PROVIDERS

Participating providers

19For the purposes of subsection 22(1) of the Act, a provider may participate in the Plan by providing the Director with the following information:

(a) the provider’s name, the business name of the pharmacy, the store number of the pharmacy and the name of the owner of the pharmacy;

(b) the licence or accreditation number of the provider;

(c) the phone number, fax number and email address of the provider;

(d) the mailing and physical address of the provider;

(e) the signing authority of the provider for claim submissions;

(f) payment information of the provider;

(g) the software vendor of the provider; and

(h) any change to the information provided in paragraphs (a) to (g) and the effective date of the change.

Information provided by non-participating providers

20When a provider who is not participating in the Plan provides an entitled service that is a drug to a client, the provider shall provide to the client the following information:

(a) the prescription number and the number of refills;

(b) the name, licence number and address of the prescriber;

(c) the name, physical address and licence or accreditation number of the provider;

(d) the drug name, strength and form;

(e) the drug identification number assigned by Health Canada or the product identification number assigned by the Director;

(f) the intervention or exception code;

(g) the quantity and day supply of the drug;

(h) the total cost, including a breakdown of the cost as follows:

(i) the dispensing fee;

(ii) the markup;

(iii) the drug cost; and

(iv) any other costs; and

(i) the date of service and the date the drug was dispensed.

Information provided by participating providers

21(1)When a participating provider provides an entitled service that is a drug to a member of the Plan, the participating provider shall provide to the member the following information:

(a) the prescription number, the number of refills and the transaction number;

(b) the name of the prescriber and the prescriber identification number assigned by the Director;

(c) the name and physical address of the participating provider and the participating provider identification number assigned by the Director;

(d) the drug name, strength and form;

(e) the drug identification number assigned by Health Canada or the product identification number assigned by the Director;

(f) the intervention or exception code;

(g) the quantity and day supply of the drug;

(h) the amount of the co-payment;

(i) the total cost, including a breakdown of the cost as follows:

(i) the dispensing fee;

(ii) the markup; and

(iii) the drug cost; and

(j) the date of service and the date the drug was dispensed.

21(2)When a participating provider provides a brand name product that has a pharmaceutical equivalent or a pharmaceutical alternative to a member of the Plan who does not have an approval under subsection 29(4) of the Act for the brand name product, the participating provider shall provide to the member the following information:

(a) that the amount that the Plan pays to a participating provider under the Plan shall not exceed the maximum allowable price of the lowest cost pharmaceutical equivalent or pharmaceutical alternative; and

(b) that the member shall pay the difference in price between the actual acquisition cost of the brand name product and the maximum allowable price of the lowest cost pharmaceutical equivalent or pharmaceutical alternative if the member elects to receive the brand name product.

Sale to member of the Plan by participating provider

22(1)For the purposes of section 25 of the Act, a participating provider shall not charge a member of the Plan an amount that is greater than the amount determined under subsection 27(2) of the Act.

22(2)Despite subsection (1), when a prescription is for a brand name product that has a pharmaceutical equivalent or a pharmaceutical alternative and the member of the Plan does not have an approval under subsection 29(4) of the Act for the brand name product, the member shall pay the difference in price between the actual acquisition cost of the brand name product and the maximum allowable price of the lowest cost pharmaceutical equivalent or pharmaceutical alternative if the member elects to receive the brand name product.

22(3)A participating provider shall not require a member of the Plan to pay an amount, in addition to a co-payment or an additional charge under subsection (2), as a condition to providing a benefit.

Claims by participating providers

23(1)If a participating provider charges a member of the Plan an amount for an entitled service that is equal to the amount determined by the Minister in accordance with section 25 of the Act, the participating provider is not required to submit a claim to the Director under subsection 27(1) of the Act.

23(2)For the purposes of subsection 27(1) of the Act, a claim by a participating provider shall be accompanied by the information as provided for in the pharmacy claim standard of the Canadian Pharmacists Association.

23(3)A participating provider shall submit a claim in electronic format within three months after the date an entitled service was provided to the member of the Plan or in non-electronic format within one year after the date an entitled service was provided to the member of the Plan.

Reassessment of claims

24(1)A participating provider may request a reassessment of a claim by resubmitting a claim in electronic format within three months after the date an entitled service was provided to the member of the Plan or in non-electronic format within one year after the date an entitled service was provided to the member of the Plan.

24(2)The Minister may conduct a reassessment of a claim and adjust the amount that he or she is required to pay to a participating provider if an error or omission exists with regard to the claim.

Amount to be paid to a participating provider

25(1)The following classes of entitled services are established:

(a) Class A drugs; and

(b) Class B drugs.

25(2)For the purposes of subsection 27(2) of the Act, if a benefit provided by a participating provider is a Class A drug, the amount to be paid to the participating provider is the sum of the following amounts:

(a) an amount that is equal to or less than the manufacturer’s list price;

(b) a dispensing fee of up to $10.50; and

(c) up to 8% of the manufacturer’s list price.

25(3)For the purposes of subsection 27(2) of the Act, if a benefit provided by a participating provider is a Class B drug, the amount to be paid to the participating provider is the sum of the following amounts:

(a) an amount that is equal to or less than the maximum allowable price;

(b) a dispensing fee of up to $10.50; and

(c) up to 8% of the maximum allowable price.

25(4)Despite subsections (2) and (3), the amount to be paid to a participating provider if a benefit provided by the participating provider is an extemporaneous preparation, is the sum of the following amounts:

(a) an amount that is equal to or less than the actual acquisition cost of each ingredient; and

(b) a dispensing fee of up to $15.75.

25(5)Despite subsections (2) to (4), the amount to be paid to a participating provider if a benefit provided by the participating provider is a drug used to treat opioid dependence, is the sum of the following amounts:

(a) an amount that is equal to or less than the maximum allowable price; and

(b) a dispensing fee of up to $9.50.

Frequency of dispensing

26(1)A dispensing fee shall be paid to a participating provider in the following circumstances:

(a) the amount of the drug provided to a member of the Plan is a continuous 28-day supply; or

(b) the amount of the drug provided to a member of the Plan is at least a one-day supply and either

(i) the member’s drug therapy cannot be managed if the amount of the drug provided to the member is a continuous 28-day supply, or

(ii) the drug is used to treat opioid dependence.

26(2)Despite subsection (1), if a drug is classified according to the anatomical therapeutic chemical classification system, a dispensing fee shall be paid to the participating provider in the following circumstances:

(a) the amount of the drug provided to a member of the Plan is a continuous 60- or 90-day supply according to the drug’s classification;

(b) the amount of the drug provided to a member of the Plan is a continuous 30-day supply and the member has not received the drug in the past 12 months; or

(c) the amount of the drug provided to a member of the Plan is at least a one-day supply and the member’s drug therapy cannot be managed if the amount of the drug provided to the member is a continuous 60- or 90-day supply.

Restrictions and conditions on days supply

27(1)A member of the Plan is not entitled to reimbursement and a participating provider is not entitled to payment under the Plan in respect of a drug if the amount of the drug provided exceeds a 100-day supply unless the dosage regimen of the drug requires that it be administered at an interval that exceeds a 100-day supply.

27(2)Despite subsection (1), a member of the Plan is not entitled to reimbursement and a participating provider is not entitled to payment under the Plan in respect of a narcotic, a controlled drug or benzodiazepine or another targeted substance if the amount of the drug provided exceeds a 35-day supply.

27(3)A member of the Plan is not entitled to reimbursement and a participating provider is not entitled to payment under the Plan

(a) in respect of a refill of a prescription that is dispensed on the same day as a fill or refill of the same prescription, or

(b) in respect of a refill of a prescription unless 80% of the previous days’ supply has elapsed.

BENEFITS

Formulary

28(1)A request under subsection 29(4) of the Act shall be made on a form provided by the Minister and signed by a provider or medical practitioner.

28(2)For the purposes of subsection 29(4) of the Act, the information to be provided is as follows:

(a) the name, form, strength and treatment schedule of the drug;

(b) whether the request is for an approval of a brand name product when a pharmaceutical equivalent or a pharmaceutical alternative is available;

(c) clinical information that outlines the request of the member of the Plan;

(d) outcome measures to support continued use and to stop treatment;

(e) supporting laboratory tests and objective clinical measures;

(f) details of previous treatment with other therapies or products, if applicable;

(g) details of availability of the drug to the member of the Plan from other sources; and

(h) supporting published data and evidence for use.

List of prices

29(1)The list established under subsection 30(1) of the Act shall be published by the Minister on the Department of Health website.

29(2)The Minister may vary the unit price of a drug that is an entitled service if the proposed price is not higher than the price in another Canadian jurisdiction and one or more of the following conditions exists:

(a) the manufacturer provides documentation indicating that a different unit price should be established;

(b) the manufacturer’s list price for the original product has changed;

(c) the original product is no longer marketed in Canada or another product with similar ingredients, strength and form has received a notice of compliance;

(d) it is justified having regard to market conditions; or

(e) it is justified in the public interest having regard to the safety of members of the Plan, access to the drug or costs to the Plan.

Entitlement to benefits

30For the purposes of subsection 31(2) of the Act, a member of the Plan may be entitled to a benefit if entitled services as defined in the Medical Services Payment Act are authorized under subsection 2(2) or 2(3) of that Act.

Exceptions

31For the purposes of paragraph 32(c) of the Act, a benefit shall not be provided

(a) in a nursing home as defined in the Nursing Homes Act from the limited supply of drugs referred to in paragraphs 21(h) or (i) of the General Regulation under that Act, or

(b) in a correctional institution as defined in the Corrections Act.

Evidence of membership

32For the purposes of subsection 33(1) of the Act, a member of the Plan shall provide his or her valid identification card issued by the Director as evidence of membership in the Plan.

Reimbursement for entitled services

33For the purposes of subsection 34(1) of the Act, a member of the Plan shall submit a claim for reimbursement within one year after the date an entitled service was provided to the member.

Restrictions

34For the purposes of section 35 of the Act, the Director may limit the maximum number of providers or the quantity of benefits that may be provided to a member of the Plan in the following circumstances:

(a) there is documentation indicating that the member filled prescriptions from more than one prescriber for duplicate therapy;

(b) there is documentation indicating that the member has filled prescriptions at more than one provider for duplicate therapy;

(c) in the opinion of the member’s attending physician, the member is abusing or misusing a drug resulting in danger to the health of the member or unnecessary cost to the Plan; or

(d) there is documentation indicating that the member has filled prescriptions for amounts of a drug that are not within recommended dosing for the drug.

FUNDING

Premiums

35(1)For the purposes of subsection 36(1) of the Act, premiums shall be paid on or before the last day of the month preceding the first full month in which the member of the Plan is entitled to benefits.

35(2)If a member of the Plan provides banking information to the Plan Administrator, premiums may be paid by preauthorized payment.

35(3)For the purposes of subsection 36(4) of the Act, a member of the Plan may apply for a reimbursement by regular mail or electronic transmission on a form provided by the Minister within 12 months after the date the overpayment was made.

MINIMUM REQUIREMENTS

Private group drug insurance

36(1)For the purposes of paragraph 40(f) of the Act, the following are minimum requirements:

(a) there shall be no annual or lifetime maximum coverage under the contract; and

(b) an insured person shall not be required to pay, in respect of each insured person under the contract, more than

(i) $2,000 per year in co-payments and deductibles for drugs that are entitled services, or

(ii) $30 as a co-payment for each drug that is an entitled service if the contract does not include deductibles.

36(2)An insurer who provides private group drug insurance under a contract or policy that offers more than one option shall ensure that

(a) at least one option meets the requirements under subsection (1) and section 40 of the Act, and

(b) an insured person is permitted to choose an option that meets the requirements under subsection (1) and section 40 of the Act at least once a year or within 60 days after a birth, an adoption, a change in marital or cohabitation status or a death in the insured person’s family unit.

Certificate of private group drug insurance

37For the purposes of section 41 of the Act, the certificate of insurance shall contain the following information:

(a) the names of the parties to the contract;

(b) the contract or policy number;

(c) the names of other insured persons under the contract or policy, if applicable;

(d) the identification number of the insured, if applicable; and

(e) a statement, in respect of each insured person under the contract, indicating that the contract meets the requirements under subsection 36(1) and section 40 of the Act or that an option that does not meet the requirements was chosen.

Information provided by the insurer

38For the purposes of section 42 of the Act, the information to be provided is as follows:

(a) the names of the parties to a contract;

(b) the primary drug insurance carrier;

(c) the contract or policy number;

(d) the names of other insured persons under the contract or policy, if applicable;

(e) the identification number of the insured, if applicable;

(f) the coverage period of the contract or policy; and

(g) any private group drug insurance offered to the public.

Cancellation of an insurance contract

39An insurer shall notify the Director of a cancellation of a private group drug insurance contract or policy 30 days before the effective date of the cancellation on a form provided by the Minister.

ENFORCEMENT

Notice of non-compliance

40(1)For the purposes of subsection 50(2) of the Act, the Minister shall serve the notice of non-compliance

(a) in the manner in which personal service may be made under the Rules of Court, or

(b) by registered mail to the person’s latest known address.

40(2)Service by registered mail shall be deemed to have been effected five days after the date the notice of non-compliance is deposited in the mail.

40(3)For the purposes of subsection 50(3) of the Act, the notice of non-compliance shall include the following information:

(a) the name of the person who has violated or failed to comply with a provision of the Act or regulations;

(b) the provision of the Act or regulations and the date on which the violation or failure to comply occurred;

(c) the amount of the administrative penalty that may be imposed; and

(d) information with respect to the person’s right to make written submissions.

Notice of administrative penalty

41(1)For the purposes of subsection 53(2) of the Act, the Minister shall serve the notice of administrative penalty

(a) in the manner in which personal service may be made under the Rules of Court, or

(b) by registered mail to the person’s latest known address.

41(2)Service by registered mail shall be deemed to have been effected five days after the date the notice of administrative penalty is deposited in the mail.

41(3)For the purposes of subsection 53(3) of the Act, the notice of administrative penalty shall include the following information:

(a) the name of the person required to pay the administrative penalty;

(b) the provision of the Act or regulations and the date on which the violation or failure to comply occurred;

(c) the amount of the administrative penalty;

(d) when and how the administrative penalty shall be paid; and

(e) information with respect to the person’s right to request a review of the Minister’s decision.

Maximum amount of administrative penalty

42The maximum amount of an administrative penalty is $500.

APPEALS

Appeal Committee

43(1)The Appeal Committee shall be composed of five members, including

(a) a medical practitioner with experience in critical appraisal or health technology assessment,

(b) a pharmacist with experience in critical appraisal or health technology assessment, and

(c) a member who has never been a health care provider as defined in the Personal Health Information Privacy and Access Act.

43(2)A member of the Appeal Committee shall be appointed for a maximum term of three years and may be reappointed for one additional term.

43(3)The Minister shall appoint from among the members of the Appeal Committee a Chair for a maximum term of three years.

43(4)The Minister may appoint an alternate member to act in the place of a member of the Appeal Committee, appointed by the Minister under subsection 60(1) of the Act, who is unable to act for any reason.

43(5)A vacancy on the Appeal Committee does not impair the capacity of the Appeal Committee to act.

Notice of appeal and information

44(1)A person may appeal a decision of the Director that is within the scope of subsection 60(2) of the Act to the Appeal Committee by serving a notice of appeal to the Chair within six months after receiving the decision of the Director.

44(2)The notice of appeal of a decision of the Director regarding eligibility for the Plan or exemption from the Plan shall include the following information:

(a) the name, date of birth and gender of the appellant;

(b) the preferred official language of the appellant;

(c) supporting documentation indicating all of the appellant’s drug coverage; and

(d) the reasons for the appeal.

44(3)The notice of appeal of a decision of the Director made under subsection 29(4) of the Act shall include the following information:

(a) the name, date of birth, gender and Plan identification number of the member of the Plan;

(b) the preferred official language of the member of the Plan;

(c) the name, address, phone number, fax number, licence number and signature of the prescriber;

(d) the name, form, strength and treatment schedule of the drug;

(e) clinical information that outlines the request of the member of the Plan;

(f) outcome measures to support continued use and to stop treatment;

(g) supporting laboratory tests and objective clinical measures;

(h) details of previous treatment with other therapies or products, if applicable;

(i) supporting published data and evidence for use; and

(j) any other information requested by the Chair that is relevant to the appeal.

44(4)The notice of appeal of a decision of the Director made under section 35 of the Act shall include the following information:

(a) the name, date of birth, gender and Plan identification number of the member of the Plan;

(b) the preferred official language of the member of the Plan;

(c) the name, address, phone number, fax number, licence number and signature of the prescriber; and

(d) supporting documentation indicating that the restriction is not appropriate in the circumstances, including a written statement from the prescriber, if applicable.

Grounds of appeal

45A member of the Plan may appeal a decision of the Director made under subsection 29(4) of the Act on the following grounds:

(a) the drug requested cannot be provided or reimbursed to the member from any other source;

(b) the drug requested has been authorized for sale and use in Canada by Health Canada; and

(c) the drug requested

(i) if approved, would be an exception to the cases, conditions or criteria specified on the Plan Formulary,

(ii) is a brand name product and the member has a documented hypersensitivity reaction to an inactive ingredient in the pharmaceutical equivalents and the pharmaceutical alternatives of the brand name product,

(iii) was previously listed in the Plan Formulary or in the New Brunswick Prescription Drug Program Formulary under the Prescription Drug Payment Act, or

(iv) is a drug for which no recommendation has been made and no advice has been given by the Canadian Agency for Drugs and Technologies in Health, the pan-Canadian Oncology Drug Review or the Atlantic Common Drug Review with respect to listing the drug in the Plan Formulary or that is not expected to be considered for funding in the six months following service of the notice of appeal and

(A) there is no alternative listed in the Plan Formulary,

(B) there is scientific evidence for the use being requested supporting the clinical effectiveness and the cost-effectiveness of the drug,

(C) without the drug, there is a significant risk of serious harm to the life, health or recovery of the member of the Plan, and

(D) in the opinion of the prescriber, the drug is medically necessary and will prevent substantial morbidity or mortality.

Notice of hearing

46(1)The Chair shall set a date for the hearing of the appeal, which shall not be later than 90 days after the date the notice of appeal was received by the Chair.

46(2)The Chair shall serve a notice of the hearing on the appellant and the Director that indicates the date, time and place of the hearing at least ten days before the date set for the hearing or within such shorter period as the Chair considers appropriate if the parties consent.

Conduct of hearings

47(1)A hearing of the Appeal Committee shall be conducted by a hearing panel consisting of three members of the Appeal Committee.

47(2)One member of the hearing panel shall be the Chair who shall preside at the hearing.

47(3)At the hearing of an appeal, the parties to the appeal have the right to attend and to make representations and to present evidence respecting the appeal either personally or through counsel.

47(4)The hearing panel has the same power that The Court of Queen’s Bench of New Brunswick has for the trial of civil actions with respect to compelling witnesses to give evidence under oath or in any other manner.

47(5)The hearing panel may receive in evidence any statement, document, record, information or thing that, in the opinion of the hearing panel, is relevant to the matter before it, regardless of whether the statement, document, record, information or thing is given or produced under oath or would be admissible as evidence in a court of law.

47(6)With the consent of the parties, the hearing panel may determine the appeal based on the written representations of the parties without a hearing.

47(7)Personal information and personal health information received by the hearing panel is confidential and shall not be disclosed to any other person unless the disclosure is required for the purposes of the appeal or the person to whom the information relates consents to the disclosure.

47(8)No appeal proceedings shall be deemed to be invalid by reason of any defect in form or any technical irregularity.

Decisions of the Appeal Committee

48(1)After hearing an appeal or receiving written submissions, the hearing panel may allow the appeal or confirm or vary the decision of the Director.

48(2)A decision made by a majority of the members of the hearing panel is a decision of the Appeal Committee.

48(3)The decision of the Appeal Committee, with reasons, shall be in writing and signed by the Chair and shall be forwarded to the parties within 30 days after the date of the hearing.

Conflict of interest of a member of a hearing panel

49(1)A member of a hearing panel has a conflict of interest if, in the opinion of the Chair,

(a) the member has an interest in the matter, distinct from an interest arising from his or her functions as a member,

(b) the member has a direct or indirect pecuniary interest in the matter,

(c) a person who is related to the member by blood or marriage has an interest in the matter, or

(d) the member is an officer, employee or agent of a corporation, an unincorporated association or other association of persons that has an interest in the matter.

49(2)If a member of a hearing panel has a real or potential conflict of interest, the member shall disclose to the Appeal Committee the nature and extent of the interest in writing and may recuse himself or herself from hearing the appeal.

49(3)If, in the opinion of the Chair, a member of the hearing panel has a conflict of interest, the Chair may prohibit the member from hearing the appeal.

Remuneration and compensation

50(1)A member of a hearing panel who is not a full-time employee of the Public Service, as defined in the Public Service Labour Relations Act, is entitled to remuneration of $300 for each hearing.

50(2)The Chair of the Appeal Committee who sits on a hearing panel and who is not a full-time employee of the Public Service, as defined in the Public Service Labour Relations Act, is entitled to remuneration of $350 for each hearing.

50(3)A member of the Appeal Committee is entitled to be reimbursed for accommodation, meal and travel expenses reasonably incurred in connection with his or her duties on the Appeal Committee in accordance with the Board of Management Travel Policy guidelines, as amended.

COMMENCEMENT

Commencement

51(1)Subject to subsection (2), this Regulation comes into force on April 1, 2014.

51(2)Sections 15 to 18 and 35 to 39 come into force on April 1, 2015.

SCHEDULE A

Gross Income Levels		Annual Premium
Individual	Single with children/couple with or without children

$26,360 or less	$49,389 or less	$ 800
$26,361 to $50,000	$49,390 to $75,000	$1,400
$50,001 to $75,000	$75,001 to $100,000	$1,600
Over $75,000	Over $100,000	$2,000

2014-27 - General

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