Drug Cost Assistance Program Regulations

c t DRUG COST ASSISTANCE ACT DRUG COST ASSISTANCE PROGRAM REGULATIONS PLEASE NOTE This document, prepared by the Legislative Counsel Office, is an office consolidation of this regulation, current to September 1, 2024. It is intended for information and reference purposes only. This document is not the official version of these regulations. The regulations and the amendments printed in the Royal Gazette should be consulted on the Prince Edward Island Government web site to determine the authoritative text of these regulations. For more information concerning the history of these regulations, please see the Table of Regulations on the Prince Edward Island Government web site (www.princeedwardisland.ca). If you find any errors or omissions in this consolidation, please contact: Legislative Counsel Office Tel: (902) 368-4292 Email: legislation@gov.pe.ca Part 1 Drug Cost Assistance Program Regulations Section 1 c DRUG COST ASSISTANCE ACT Chapter D-14.1 DRUG COST ASSISTANCE PROGRAM REGULATIONS Pursuant to section 21 of the Drug Cost Assistance Act R.S.P.E.I. 1988, Cap. D-14.1, Council made the following regulations: PART 1 Interpretation and Application 1. Definitions In these regulations, (a) “Act” means the Drug Cost Assistance Act R.S.P.E.I. 1988, Cap. D-14.1; (b) “agreement” means the agreement referred to in section 12 of the Act between the Minister and the Prince Edward Island Pharmacists Association or the Minister and a participating pharmacy; (c) “eligible cost” means the cost or portion of the cost of a benefit that is reimbursable under a program; (d) “health card” means a health card as defined in the Provincial Health Number Act R.S.P.E.I. 1988, Cap. P-27.01; (e) revoked by EC382/22; (e.1) “nurse practitioner” means a nurse practitioner authorized under the Regulated Health Professions Act R.S.P.E.I. 1988, R-10.1, to practise as a nurse practitioner in the province; (f) “prescriber” means a person who is authorized to prescribe drugs under an enactment or an Act of the Parliament of Canada; (g) revoked by EC382/22; (h) “spouse” means an individual who, in respect of another person, (i) is married to the other person, (ii) has entered into a marriage with the other person that is voidable or void, or (iii) is not married to the other person but is cohabiting with the other person in a conjugal relationship. (EC367/14; 382/22; 317/23) c t Current to: September 1, 2024 Page 3 Part 2 Section 2 Drug Cost Assistance Program Regulations 2. Submission of claim to other payors first Where, in respect of a benefit, an eligible person is covered by third-party insurance or a prescribed benefit plan or program not established under the Act, the eligible person or participating pharmacy shall submit a claim for the benefit to the third-party insurer or administrator of that plan or program, as the case may be, before submitting a claim under these regulations. (EC367/14; 796/24) PART 2 Seniors Drug Program 3. Definition In this Part, “program” means the Seniors Drug Program. Program established There is hereby continued as a program under the Plan entitled the Seniors Drug Program. (EC367/14) 4. Eligibility criteria A resident is eligible for benefits under the program if the resident (a) has attained the age of 65 years; and (b) is entitled to payment for basic health service benefits under the Health Services Payment Act R.S.P.E.I. 1988, Cap. H-2 and the Hospital and Diagnostic Services Insurance Act R.S.P.E.I. 1988, Cap. H-8. Cessation of eligibility and coverage An eligible person ceases to be eligible for benefits under the program, and the person’s coverage ceases, (a) on the day the person leaves the province to establish residence in another province or country; and (b) on the day the person ceases to be an entitled person under the Health Services Payment Act and the Hospital and Diagnostic Services Insurance Act. (EC367/14) 5. Payment of eligible cost of benefit The program shall pay to or on behalf of an eligible person the eligible cost of a benefit, subject to subsection (2), (3) or (4), as applicable, and any requirements set out in the formulary, in accordance with these regulations and the terms of the agreement or, where there is no agreement, as determined by the Minister. Co-payment For any benefit dispensed, an eligible person who is not covered by a contract of third-party insurance is responsible for payment of (a) the lesser of (i) the first $7.69 of the amount of a dispensing fee charged by the participating pharmacy, or (ii) the dispensing fee charged by the participating pharmacy; and Page 4 Current to: September 1, 2024 t c Part 3 Drug Cost Assistance Program Regulations Section 6 (b) the lesser of (i) the actual cost of the drug, or (ii) the first $8.25 of the cost of the drug. Idem For any benefit dispensed, an eligible person who is covered by a contract of third-party insurance is responsible for payment of the lesser of (a) twenty per cent of the sum of the amounts calculated under clauses (2)(a) and (b); and (b) the balance owing after reimbursement for the benefit by the person’s third-party insurer. Exception (4) Notwithstanding subsections (2) and (3), where the benefit dispensed is a benefit designated in the formulary for which a co-payment not exceeding $5.00 is payable, an eligible person is responsible for payment of $5.00. (EC367/14; 317/23) PART 3 Diabetes Drug Program 6. Definition In this Part, “program” means the Diabetes Drug Program. Program established There is hereby established a program under the Plan entitled the Diabetes Drug Program. (EC367/14) 7. Enrolment A resident, or another person on behalf of a resident, may apply to the Administrator in the form approved by the Administrator for enrolment in the program. Eligibility criteria A resident is eligible to be enrolled in the program if the resident (a) is diagnosed by a medical practitioner or nurse practitioner as having diabetes; and (b) is entitled to payment for basic health service benefits under the Health Services Payment Act and the Hospital and Diagnostic Services Insurance Act. Review of application On receipt of an application made in accordance with subsection (1), the Administrator shall review the application and may enrol or re-enrol the applicant in the program if the Administrator is satisfied that the applicant meets the requirements for enrolment set out in subsection (2). Cessation of eligibility An eligible person ceases to be eligible for benefits under the program, and the person’s coverage ceases, c t Current to: September 1, 2024 Page 5 Part 4 Section 8 Drug Cost Assistance Program Regulations (a) on the day the person leaves the province to establish residence in another province or country; or (b) on the day the person ceases to be an entitled person under the Health Services Payment Act and the Hospital and Diagnostic Services Insurance Act. (EC367/14; 382/22) 8. Payment of eligible cost of benefit The program shall pay to or on behalf of an eligible person the eligible cost of a benefit, subject to subsection (2), (3) or (4), as applicable, and any requirements set out in the formulary, in accordance with these regulations and the terms of the agreement or, where there is no agreement, as determined by the Minister. Co-payment For any benefit dispensed, an eligible person who is not covered by a contract of third-party insurance is responsible for payment of (a) the first $10 of the cost of each 10 ml. vial of insulin dispensed; (b) the first $11 of the cost of each prescription of oral diabetes medications dispensed; (b.1) the first $20 of the cost of each unit of glucagon dispensed; (c) the first $11 of the cost of each 50-count box of urine testing strips dispensed; (d) for blood testing strips, (i) the first $11 of the cost of 100 blood testing strips dispensed every 25 days, and (ii) the full cost of any additional blood testing strips dispensed in that 25-day period; and (e) the first $20 of the cost of each package of cartridges, prefilled syringes or prefilled pens of diabetes medication dispensed. Idem For any benefit dispensed, an eligible person who is covered by a contract of third-party insurance is responsible for payment of the lesser of (a) twenty per cent of the applicable amount specified in clauses (2)(a) to (c), subclause (2)(d)(i) and clause (2)(e); and (b) the balance owing after reimbursement for the benefit by the person’s third-party insurer. Exception (4) Notwithstanding subsections (2) and (3), where the benefit dispensed is a benefit designated in the formulary for which a co-payment not exceeding $5 is payable, an eligible person is responsible for payment of $5. (EC367/14; 727/20; 382/22; 317/23) PART 4 Family Health Benefit Drug Program 9. Definitions In this Part, (a) “dependant” means a child Page 6 Current to: September 1, 2024 t c Part 4 Drug Cost Assistance Program Regulations Section 10 (i) who is younger than 19 years of age and does not have a spouse, or (ii) who is younger than 25 years of age and is a full-time student at a post-secondary institution and does not have a spouse; (b) “household” means an applicant, the applicant’s spouse and their dependants or, if the applicant does not have a spouse, the applicant and the applicant’s dependants; (c) “income”, subject to section 47, means the net income as reported by the applicant and the applicant’s spouse, if the applicant has a spouse, on line 23600 of the applicant’s and spouse’s annual income tax returns for the preceding taxation year as filed with and verified by the Canada Revenue Agency; (d) “program” means the Family Health Benefit Drug Program. Program established There is hereby established a program under the Plan entitled the Family Health Benefit Drug Program. (EC367/14; 382/22) 10. Enrolment A resident, on behalf of the resident’s household, may apply to the Administrator in the form approved by the Administrator for enrolment or re-enrolment in the program. Idem A dependant may be enrolled in only one household. Eligibility criteria A household is eligible to be enrolled or re-enrolled in the program if (a) all the members of the household named on the application (i) are residents, and (ii) are entitled to payment for basic health service benefits under the Health Services Payment Act and the Hospital and Diagnostic Services Insurance Act; (b) the household meets the criteria respecting income set out in Schedule A to these regulations; and (c) the household provides the required information respecting the income of the household, or sufficient information to enable the Administrator to obtain the information pursuant to subsection 8(2) of the Act. Cessation of eligibility A household or a member of a household ceases to be eligible for enrolment in the program, and the household’s or member’s coverage under the program, as the case may be, ceases, (a) on the day that the household or member of the household leaves the province to establish residence in another province or country; (b) on the day that the member or members of the household cease to qualify as entitled persons under the Health Services Payment Act and the Hospital and Diagnostic Services Insurance Act; or (c) on the day there are no longer any dependants in the household. Review of application On receipt of an application made in accordance with subsection (1), the Administrator shall review the application and may enrol or re-enrol the household in the program if the c t Current to: September 1, 2024 Page 7 Part 5 Section 11 Drug Cost Assistance Program Regulations Administrator is satisfied that the household meets the requirements for enrolment set out in subsection (3). Effect of enrolment Each member of a household enrolled under subsection (5) is an eligible person. Program year Enrolment in the program is valid for a term of one year from the date of enrolment or re-enrolment, as the case may be. (EC367/14) 11. Payment of eligible cost of benefit The program shall pay to or on behalf of an eligible household the eligible cost of a benefit, subject to subsection (2), (3) or (4), as applicable, and any requirements set out in the formulary, in accordance with these regulations and the terms of the agreement or, where there is no agreement, as determined by the Minister. Co-payment For any benefit dispensed, a person in an eligible household who is not covered by a contract of third-party insurance is responsible for payment of the dispensing fee charged by the participating pharmacy. Idem For any benefit dispensed, a person in an eligible household who is covered by a contract of third-party insurance is responsible for payment of the lesser of (a) twenty per cent of the dispensing fee charged by the dispensing pharmacy; and (b) the balance owing after reimbursement for the benefit by the person’s third-party insurer. Exception Notwithstanding subsections (2) and (3), where the benefit dispensed is a benefit designated in the formulary for which a co-payment not exceeding $5.00 is payable, an eligible person is responsible for payment of the lesser of $5.00 and the amount that would be payable under subsection (2) or (3). (EC367/14; 317/23) PART 5 High-Cost Drug Program 12. Definitions In this Part, (a) “dependant” means a child (i) who is younger than 19 years of age and does not have a spouse, or (ii) who is younger than 25 years of age and is a full-time student at a post-secondary institution and does not have a spouse; (b) “high-cost drug” means a high-cost drug specified as such in the formulary; (c) “household income”, subject to section 47, means the total of the amounts claimed by the applicant and the applicant’s spouse, if the applicant has a spouse, on line 23600 of Page 8 Current to: September 1, 2024 t c Part 5 Drug Cost Assistance Program Regulations Section 13 the applicant’s and spouse’s annual income tax returns for the preceding taxation year as filed with and verified by the Canada Revenue Agency, less a deduction from income of $3,000 for each dependant; (d) “program” means the High-Cost Drug Program. Program established There is hereby established a program under the Plan entitled the High-Cost Drug Program. (EC367/14; 382/22) 13. Enrolment A resident may apply to the Administrator in the form approved by the Administrator for enrolment or re-enrolment in the program. Eligibility criteria A resident is eligible to be enrolled or re-enrolled in the program if the resident (a) is entitled to payment for basic health service benefits under the Health Services Payment Act and the Hospital and Diagnostic Services Insurance Act; (b) meets the clinical criteria for treatment with a high-cost drug as specified in the formulary; and (c) provides the required household income information, or sufficient information to enable the Administrator to obtain the information pursuant to subsection 8(2) of the Act. Review of application On receipt of an application made in accordance with subsection (1), the Administrator shall review the application and may enrol or re-enrol the applicant in the program if the Administrator is satisfied that the applicant meets the requirements for enrolment or re-enrolment set out in subsection (2). Cessation of eligibility An eligible person ceases to be eligible for benefits under the program (a) on the day the person leaves the province to establish residence in another province or country; or (b) on the day the person ceases to be an entitled person under the Health Services Payment Act and the Hospital and Diagnostic Services Insurance Act. Program year Enrolment in the program is valid for a term of one year from the date of enrolment or re-enrolment, as the case may be. (EC367/14) 14. Payment of eligible cost of benefit The program shall pay to or on behalf of an eligible person the eligible cost of a benefit, subject to subsection (2) or (3), as applicable, and any requirements set out in the formulary, in accordance with these regulations and the terms of the agreement or, where there is no agreement, as determined by the Minister. Co-payment For any benefit dispensed, an eligible person who is not covered by a contract of third-party insurance is responsible for payment of c t Current to: September 1, 2024 Page 9 Part 6 Section 15 Drug Cost Assistance Program Regulations (a) the dispensing fee charged by the participating pharmacy; and (b) the lesser of (i) the applicable amount set out in Schedule B based on the eligible person’s household income, and (ii) the remaining cost of the benefit. Idem For any benefit dispensed, an eligible person who is covered by a contract of third-party insurance is responsible for payment of the lesser of (a) the sum of (i) twenty per cent of the dispensing fee charged by the participating pharmacy, and (ii) twenty per cent of the applicable amount set out in Schedule B based on the eligible person’s household income; and (b) the balance owing after reimbursement for the benefit by the person’s third-party insurer. (EC367/14; 317/23) PART 6 Catastrophic Drug Program 15. Definitions In this Part, (a) “catastrophic costs” means the sum of (i) the price paid by the household that does not exceed the maximum reimbursable price for a drug or supplies listed in the formulary and dispensed for the purposes of this program, and not reimbursed under a program under another enactment or an Act of the Parliament of Canada, by a provider of third-party insurance or by another person, and (ii) the dispensing fee to the maximum approved in the agreement and not reimbursed under a program under another enactment or an Act of the Parliament of Canada, by a provider of third-party insurance or another person; (b) “dependant” means a child of the applicant or the applicant’s spouse, if the applicant has a spouse, (i) who is younger than 19 years of age and does not have a spouse, or (ii) who is between the ages of 19 and 25, is a full-time student, and does not have a spouse; (c) “household”, subject to section 47, means (i) the applicant, (ii) the applicant and the applicant’s spouse, (iii) the applicant and the applicant’s dependants, or (iv) the applicant, the applicant’s spouse and their dependants, as the case may be; (d) “income”, subject to section 47, means the combined income of , the applicant and the applicant’s spouse, if the applicant has a spouse, as set out in the applicant’s and Page 10 Current to: September 1, 2024 t c Part 6 Drug Cost Assistance Program Regulations Section 16 spouse’s income tax returns for the preceding tax year as filed with and verified by the Canada Revenue Agency, calculated as set out in Schedule C to these regulations; (e) “maximum reimbursable price” means the maximum reimbursable price for a drug product as defined in the Drug Product Interchangeability and Pricing Act R.S.P.E.I. 1988, Cap. D-15; (f) “program” means the Catastrophic Drug Program. Program established There is hereby established a program under the Plan entitled the Catastrophic Drug Program. (EC367/14) 16. Enrolment A resident may apply on behalf of the resident’s household to the Administrator in the form approved by the Administrator for enrolment or re-enrolment of the household in the program. Idem A dependant may only be enrolled in one household. Eligibility criteria An applicant and the applicant’s household are eligible to be enrolled or re-enrolled in the program if (a) the applicant and the other members of the household are residents; (b) the applicant and the other members of the household are entitled to payment for basic health service benefits under the Health Services Payment Act and the Hospital and Diagnostic Services Insurance Act; and (c) the applicant provides the required information respecting income, or sufficient information to enable the Administrator to obtain the information pursuant to subsection 8(2) of the Act. Review of application On receipt of an application made in accordance with subsection (1), the Administrator shall review the application and may enrol or re-enrol the applicant and the applicant’s household in the program if the Administrator is satisfied that the applicant and the household meet the requirements for enrolment set out in subsection (3). Effect of enrolment The applicant and each member of the applicant’s household enrolled under subsection (4) are eligible persons under the program. Cessation of eligibility An eligible person ceases to be eligible for benefits under the program, and the person’s coverage under the program ceases, (a) on the day the person leaves the province to establish residence in another province or country; or (b) on the day the person ceases to be an entitled person under the Health Services Payment Act and the Hospital and Diagnostic Services Insurance Act. Program year The program year runs from July 1 to June 30. (EC367/14) c t Current to: September 1, 2024 Page 11 Part 7 Section 17 Drug Cost Assistance Program Regulations 17. Payment of eligible cost of benefit The program shall pay to or on behalf of a member of a household enrolled under section 16 the eligible cost of a benefit, subject to subsection (2) and any requirements set out in the formulary, in accordance with these regulations and the terms of the agreement or, where there is no agreement, as determined by the Minister. Eligible costs Before any benefit is dispensed under the program, the catastrophic costs incurred by a household in each program year shall exceed a specified percentage of the income of the household for that year as set out in Schedule D to these regulations, subject to pro-ration. Credit toward eligible costs An eligible person who pays a premium attributable to coverage for prescription drugs under a contract or plan of third-party insurance is entitled to a deduction from income equal to the premiums paid, up to a maximum of $2,500 per household, subject to pro-ration. Payment of cost of benefits When a household has incurred the catastrophic costs determined in accordance with subsections (2) and (3), the program shall pay to or on behalf of a member of the household the eligible cost of benefits not reimbursable in respect of that member under a contract of third-party insurance for the balance of the program year. (EC367/14; 755/18) PART 7 Financial Assistance Drug Program 18. Definition, program In this Part, “program” means the Financial Assistance Drug Program. Program established There is hereby established a program under the Plan entitled the Financial Assistance Drug Program. (EC367/14) 19. Eligibility criteria An individual is entitled to benefits as an eligible person under the program if the individual is in receipt of social assistance in the form of financial assistance under the Social Assistance Act R.S.P.E.I. 1988, Cap. S-4.3 or assured income under the Supports for Persons with Disabilities Act R.S.P.E.I. 1988, Cap. S-9.2. Cessation of eligibility An eligible person ceases to be eligible for benefits under the program, and the person’s coverage ceases, if the person ceases to be entitled to social assistance in the form of financial assistance under the Social Assistance Act or assured income under the Supports for Persons with Disabilities Act. (EC367/14; 382/22) Page 12 Current to: September 1, 2024 t c Part 8 Drug Cost Assistance Program Regulations Section 20 20. Payment of eligible cost of benefit The program shall pay to or on behalf of an eligible person the eligible cost of a benefit, subject to any requirements set out in the formulary, in accordance with these regulations and the terms of the agreement or, where there is no agreement, as determined by the Minister. (EC367/14) PART 8 Child in Care Drug Program 21. Definition, program In this Part, “program” means the Child in Care Drug Program. Establishment of program There is hereby established a program under the Plan entitled the Child in Care Drug Program. (EC367/14) 22. Eligibility criteria A person for whom the Director of Child Protection has developed a plan of care under the Child Protection Act R.S.P.E.I. 1988, Cap. C-5.1, is entitled to benefits under the program. Cessation of eligibility A person ceases to be eligible for benefits under the program, and the person’s coverage ceases, when the person is no longer the subject of a plan of care under the Child Protection Act. (EC367/14) 23. Payment of eligible cost of benefit The program shall pay to or on behalf of an eligible person the eligible cost of a benefit, subject to any requirements set out in the formulary, in accordance with these regulations and the terms of the agreement or, where there is no agreement, as determined by the Minister. (EC367/14) PART 9 Nursing Home Drug Program 24. Definition, program In this Part, “program” means the Nursing Home Drug Program. Establishment of program There is hereby established a program under the Plan entitled the Nursing Home Drug Program. (EC367/14) 25. Eligibility criteria A resident is entitled to benefits under the program if the individual c t Current to: September 1, 2024 Page 13 Part 10 Section 26 Drug Cost Assistance Program Regulations (a) is determined to be entitled to financial assistance under the Long-Term Care Subsidization Act R.S.P.E.I. 1988, Cap. L-16.1; and (b) is entitled to payment for basic health service benefits under the Health Services Payment Act and the Hospital and Diagnostic Services Insurance Act. Cessation of eligibility An eligible person ceases to be eligible for benefits under the program, and the person’s coverage ceases, (a) on the day the person is no longer entitled to financial assistance under the Long-Term Care Subsidization Act; (b) on the day the person leaves the province to establish residence in another province or country; or (c) on the day the person ceases to be an entitled person under the Health Services Payment Act and the Hospital and Diagnostic Services Insurance Act. (EC367/14) 26. Payment of eligible cost of benefit The program shall pay to or on behalf of an eligible person the eligible cost of a benefit, subject to any requirements set out in the formulary, in accordance with these regulations and the terms of the agreement or, where there is no agreement, as determined by the Minister. (EC367/14) PART 10 Smoking Cessation Drug Program 27. Definition, program In this Part, (a) “program” means the Smoking Cessation Drug Program; (b) “program year” means the term of one year from the date of a person’s enrolment in a smoking cessation program through Health PEI. Establishment of program There is hereby established a program under the Plan entitled the Smoking Cessation Drug Program. (EC367/14; 542/19) 28. Eligibility criteria A resident is entitled to benefits under the program if the resident (a) is enrolled in a smoking cessation program through Health PEI; and (b) is entitled to payment for basic health service benefits under the Health Services Payment Act and the Hospital and Diagnostic Services Insurance Act. Cessation of eligibility in a program year (1.1) An eligible person ceases to be eligible for benefits under the program in a program year and the person’s coverage ceases for that program year on the day the person ceases to be enrolled in a smoking cessation program through Health PEI. Page 14 Current to: September 1, 2024 t c Part 11 Drug Cost Assistance Program Regulations Section 29 Cessation of eligibility An eligible person ceases to be eligible for benefits under the program, and the person’s coverage ceases, (a) on the day the person leaves the province to establish residence in another province or country; or (b) on the day the person ceases to be an entitled person under the Health Services Payment Act and the Hospital and Diagnostic Services Insurance Act. (EC367/14; 542/19) 29. Payment of eligible cost of benefit Subject to any requirements set out in the formulary, the program shall pay to or on behalf of an eligible person the eligible cost of a benefit in accordance with these regulations and the terms of an agreement, or where there is no agreement, as determined by the Minister. (EC367/14; 542/19) PART 11 Sexually Transmitted Infection Drug Program 30. Definitions In this Part, (a) “program” means the Sexually Transmitted Infection Drug Program; (b) “program month” means thirty days from the date of registration in the program; (c) “sexually transmitted infection” means chlamydia or gonorrhoea. Establishment of program There is hereby established a program under the Plan entitled the Sexually Transmitted Infection Drug Program. (EC367/14; 382/22) 31. Eligibility criteria A person is entitled to benefits under the program if the person is (a) diagnosed by a medical practitioner or nurse practitioner as having a sexually transmitted infection; or (b) identified as a sexual contact of a person diagnosed by a medical practitioner or nurse practitioner as having a sexually transmitted infection. (EC367/14;382/22) 32. Payment of eligible cost of benefit The program shall pay to or on behalf of an eligible person the eligible cost of a benefit per program month, subject to any requirements set out in the formulary, in accordance with these regulations and the terms of the agreement or, where there is no agreement, as determined by the Minister. (EC367/14) c t Current to: September 1, 2024 Page 15 Part 12 Section 33 Drug Cost Assistance Program Regulations PART 12 Substance Use Harm Reduction Drug Program 33. Definitions In this Part, (a) “Program” means the Substance Use Harm Reduction Drug Program established under this Part; (b) “substance” means alcohol or an opiate. (EC367/14; 382/22) 34. Establishment of program There is hereby established a program under the Plan entitled the Substance Use Harm Reduction Drug Program. Eligibility criteria A resident is entitled to benefits under the Program if (a) a medical practitioner or nurse practitioner recommends drug therapy for the resident for substance dependency; and (b) the resident is entitled to payment for basic health service benefits under the Health Services Payment Act and the Hospital and Diagnostic Services Insurance Act. Cessation of eligibility An eligible person ceases to be eligible for benefits under the Program and the person’s coverage ceases on the earliest day that (a) the person leaves the province to establish residence in another province or country; (b) a medical practitioner or nurse practitioner no longer recommends drug therapy for the person for substance dependency; or (c) the person ceases to be entitled to payment for basic health service benefits under the Health Services Payment Act and the Hospital and Diagnostic Services Insurance Act. Transitional A person who was enrolled in the Opioid Replacement Therapy Drug Program as it was established under this Part on May 31, 2022, is deemed to be enrolled in this Program on and after June 1, 2022, until the person ceases to be eligible for benefits under subsection (3). (EC367/14; 382/22) 35. Benefits The benefits under the Program include drug therapy for substance dependency. Eligible cost payable Subject to any requirements set out in the formulary, the Program shall pay to or on behalf of an eligible person the eligible cost of the benefit claimed. (EC367/14; 382/22) Page 16 Current to: September 1, 2024 t c Part 13 Drug Cost Assistance Program Regulations Section 36 PART 13 Insulin Pump Program 36. Definitions In this Part, (a) “dependant” means a child of a person or the person’s spouse, who (i) is under 19 years of age and does not have a spouse, or (ii) is 19 years of age or over but under 25 years of age, is a full-time student and does not have a spouse; (b) “household” means a person, the person’s spouse, if the person has a spouse, and any dependants; (c) “household income” means the total income of the persons in a household, other than any dependents, calculated in accordance with Schedule E; (d) “program” means the Insulin Pump Program established under this Part; (e) “year” in relation to the program, means a period of 12 months commencing on the date of enrolment or anniversary of enrolment of a person, as the case may be. One household (1.1) For the purpose of this Part, no person may be considered to be part of more than one household and spouses shall be considered part of the same household unless the administrator is satisfied they are separated in accordance with section 47. Establishment of program There is hereby established a program under the Plan entitled the Insulin Pump Program.(EC367/14; 382/22) 37. Application A resident may apply to the Administrator for enrolment in the program on behalf of a person who meets the criteria set out in subsection (2), or that person may apply on his or her own behalf. Eligibility criteria A resident is entitled to benefits under the program if the resident has been diagnosed by a medical practitioner or nurse practitioner as having Type 1 diabetes and (a) revoked by EC796/24; (b) has been assessed by a diabetes heath care team and registered in the Insulin Pump Therapy Program through Health PEI; and (c) is entitled to payment for basic health service benefits under the Health Services Payment Act and the Hospital and Diagnostic Services Insurance Act. Cessation of eligibility An eligible person ceases to be eligible for benefits under the program, and the person’s coverage ceases on the earliest day the person, (a) revoked by EC796/24; (b) ceases to be registered in the Insulin Pump Therapy Program through Health PEI; c t Current to: September 1, 2024 Page 17 PART 13.1 Section 38 Drug Cost Assistance Program Regulations (c) leaves the province to establish residence in another province or country; or (d) ceases to be an entitled person under the Health Services Payment Act and the Hospital and Diagnostic Services Insurance Act. (EC367/14; 727/20; 382/22; 796/24) 38. Program benefits The benefits under the program include (a) one insulin pump of a type approved in the formulary, every five years; and (b) the annual supplies approved in the formulary and required for the operation of the insulin pump set out in Schedule G, but do not include insulin or blood testing strips. Amount payable to or on behalf of eligible person Subject to any requirements set out in the formulary, the program shall pay to or on behalf of an eligible person (a) in respect of a benefit described in clause (1)(a), a percentage of the eligible cost of the benefit claimed, based on the eligible person’s household income, as set out in Schedule F; and (b) in respect of a benefit described in clause (1)(b), a percentage of the eligible cost of the benefit claimed, based on the eligible person’s household income, as set out in Schedule F, to the maximum aggregate amount for the supply per year set out in Schedule G, subject to proration. (EC367/14; 382/22) PART 13.1 Ostomy Supplies Program 38.1 Definitions In this Part, (a) “dependant” means a child of a person or the person’s spouse, who (i) is under 19 years of age and does not have a spouse, or (ii) is 19 years of age or over but under 25 years of age, is a full- time student and does not have a spouse; (b) “household” means a person, the person’s spouse, if the person has a spouse, and any dependants; (c) “household income” means the total income of the persons in a household, other than any dependents, calculated in accordance with Schedule E; (d) “program” means Ostomy Supplies Program established under this Part. One household (1.1) For the purpose of this Part, no person may be considered to be part of more than one household and spouses shall be considered part of the same household unless the administrator is satisfied they are separated in accordance with section 47. Page 18 Current to: September 1, 2024 t c PART 13.1 Drug Cost Assistance Program Regulations Section 38 Program established There is hereby established a program under the Plan entitled the Ostomy Supplies Program. (EC755/18; 382/22) 38.2 Application A resident, or another person on behalf of a resident, may apply to the Administrator in the form approved by the Administrator for enrolment in the program. Eligibility criteria A resident is eligible to be enrolled in the program if the resident (a) has a permanent abdominal stoma; and (b) is entitled to payment for basic health service benefits under the Health Services Payment Act and the Hospital and Diagnostic Services Act. Enrolment On receipt of an application made in accordance with subsection (1), the Administrator shall review the application and may enrol the applicant in the program if the Administrator is satisfied that the applicant meets the requirements for enrolment set out in subsection (2). Eligibility ceases An eligible person ceases to be eligible for benefits under the program, and the person's coverage ceases on the earliest day the person, (a) leaves the province to establish residence in another province or country; or (b) ceases to be an entitled person under the Health Services Payment Act and the Hospital and Diagnostic Services Insurance Act. Program year Subject to subsection (6), the program year commences July 1 in a year and ends June 30 in the following year. Initial program year The program commences January 1, 2019, and runs for an initial partial program year, ending June 30, 2019. (EC755/18; 382/22) 38.3 Program benefits The benefits under the program include the supplies specified in the formulary that are required for the maintenance of an abdominal stoma and the collection of bodily waste. Amount payable to or on behalf of eligible person Subject to any requirements set out in the formulary, the program shall pay to or on behalf of an eligible person a percentage of the eligible cost of the benefit claimed, based on the eligible person’s household income, as set out in Schedule F, to a maximum aggregate of $2,400 in a program year, subject to proration. (EC755/18; 382/22) c t Current to: September 1, 2024 Page 19 PART 13.1 Section 38 Drug Cost Assistance Program Regulations PART 13.2 Diabetes Glucose Sensor Program 38.4 Definitions In this Part, (a) “dependant” means a child of a person or the person’s spouse, who (i) is under 19 years of age and does not have a spouse, or (ii) is 19 years of age or over but under 25 years of age, is a full-time student and does not have a spouse; (b) “household” means a person, the person’s spouse, if the person has a spouse, and any dependants; (c) “household income” means the total income of the persons in a household, other than any dependents, calculated in accordance with Schedule E; (d) “Program” means Diabetes Glucose Sensor Program established under this Part. One household For the purpose of this Part, no person may be considered to be part of more than one household and spouses shall be considered part of the same household unless the administrator is satisfied they are separated in accordance with section 47. (EC382/22) 38.5 Program established There is hereby established a program under the Plan entitled the Diabetes Glucose Sensor Program. Eligibility criteria A resident is eligible to be enrolled in the Program if the resident is (a) diagnosed by a medical practitioner or nurse practitioner as having diabetes; (b) reliant on an insulin pump or multiple daily injections of insulin to manage the diabetes; and (c) entitled to payment for basic health service benefits under the Health Services Payment Act and the Hospital and Diagnostic Services Insurance Act. Eligibility ceases An eligible person ceases to be eligible for benefits under the Program, and the person’s coverage ceases, on the earliest day the person (a) leaves the province to establish residence in another province or country; or (b) ceases to be an entitled person under the Health Services Payment Act and the Hospital and Diagnostic Services Insurance Act. Program year Subject to subsection (5), the program year commences July 1 in a year and ends June 30 in the following year. Initial program year The Program commences June 1, 2022 and runs for an initial partial program year, ending June 30, 2022. (EC382/22) Page 20 Current to: September 1, 2024 t c Part 14 Drug Cost Assistance Program Regulations Section 39 38.6 Benefit The benefits under the Program include a glucose sensor of a type approved in the formulary. Amount payable to or on behalf of eligible person Subject to any requirements set out in the formulary, the Program shall pay to or on behalf of an eligible person the eligible cost of a benefit claimed to a maximum aggregate of $2,400 in a program year, subject to proration. Co-payment, no third party insurance For any benefit dispensed, an eligible person who is not covered by a contract of third-party insurance is responsible for the co-payment set out in the second column opposite the household income range in the first column in which the eligible person’s household income falls in the following table: Household Income C o-payment $0 to $20,000 $0.00 $20,001 to $40,000 $10.00 $41,001 to $50,000 $20.00 $50,001 to $100,000 $60.00 $100,001 or greater $80.00 Co-payment, third party insurance For any benefit dispensed, an eligible person who is covered by a contract of third-party insurance is responsible for a co-payment equal to the lesser of (a) twenty per cent of the co-payment amount specified in subsection (2) that would be payable if the eligible person was not covered by a contract of third-party insurance; and (b) the balance owing after reimbursement for the benefit by the person’s third-party insurer. (EC382/22) PART 14 Program Administration 39. Benefits dispensed in province All benefits, except those provided to an eligible person who has been referred for medical care outside the province, shall be dispensed only within the province unless otherwise authorized by the Minister. Presentation of health card An eligible person shall present the person=s health card when requesting benefits from a pharmacy or other provider of a benefit. (EC367/14) 40. Payment of difference in price For any benefit dispensed, the relevant program is not responsible for payment of any difference in price between a benefit price as determined by the Minister with reference to the formulary, and the price of a comparable but more expensive product chosen by the eligible person, unless the more expensive product has been specifically authorized in accordance with c t Current to: September 1, 2024 Page 21 Part 14 Section 41 Drug Cost Assistance Program Regulations section 3 of the Interchangeable Drug Product Substitution Regulations under the Pharmacy Act. (EC367/14) 41. Professional service fee limits In dispensing a benefit under a program, a participating pharmacy shall not charge a dispensing fee higher than the fee set in the agreement or, if the agreement does not set a fee, as determined by the Minister. (EC367/14) 42. Requirements for submission of claim by pharmacy Where a participating pharmacy provides a benefit to an eligible person, the pharmacy shall, within 90 days of providing the benefit, submit a claim to the appropriate program in the form required by the Administrator and supply the following information: (a) the identification number of the participating pharmacy as assigned by the Plan; (b) the health number of the eligible person; (c) the drug identification number of the benefit dispensed; (d) the quantity dispensed; (e) the intended duration of the therapy, stated in days; (f) the date the benefit was dispensed; (g) the prescription number; (h) the dispensing fee charged; (i) the total amount charged for the benefit; (j) whether the prescription was new or a repeat of a previous prescription; (k) the identification number of the prescriber, as assigned or confirmed by the Plan; (l) the identification number of the dispensing pharmacist, as assigned or confirmed by the Plan; (m) in the case of a claim in printed form, the name and address of the participating pharmacy and the signature of its authorized agent; (n) the amount or amounts previously paid by the eligible person; and (o) any further information or other requirements the Administrator considers necessary in order to assess the claim and make payment. Assessment of claims The Administrator shall assess claims submitted to the Plan with respect to their validity and determine whether payment should be made under the Plan. Resubmission of rejected claim Where a claim is rejected by the Administrator, a participating pharmacy may submit it again for reconsideration, with amendment or explanation not later than 90 days from the date on which the benefit was provided. Incorrect payment Where the Administrator issues payment for a claim in respect of which the benefit was not actually provided, the participating pharmacy that submitted the claim shall within 90 days submit a reversal of the claim, and the amount of the incorrect payment shall be recovered by the Administrator by deduction from payment of other claims submitted by that pharmacy. (EC367/14) Page 22 Current to: September 1, 2024 t c Part 14 Drug Cost Assistance Program Regulations Section 43 43. Requirements for submission of claim by eligible person An eligible person who receives a benefit under a program for which a claim has not been submitted under section 42 may, within six months of the date of receiving the benefit, submit a claim for direct reimbursement to the Administrator in the form required by the Administrator together with the following information: (a) the prescription number; (b) the drug identification number of the benefit dispensed; (c) the quantity dispensed; (d) the identity of the prescriber; (e) the total cost of the prescription; (f) an itemized receipt from the non-participating pharmacy; and (g) the health number of the eligible person. Payment to eligible person Where a benefit is provided to an eligible person in the circumstances set out in subsection (1), the amount payable for the benefit shall be paid directly to the eligible person. Payment by person Where a participating pharmacy is unable to (a) confirm the eligibility of a person under a program; (b) confirm the drug or supply being dispensed is a benefit; or (c) successfully submit a claim to the Administrator electronically, the pharmacy may directly charge the person for the cost of the dispensed item, and the person may submit a claim to the Plan in accordance with subsection (1). (EC367/14) 44. Payment to participating pharmacy The payment to a participating pharmacy for benefits dispensed to an eligible person under a program shall be at the rate specified in the agreement or as set by the Minister by order under the Drug Product Interchangeability and Pricing Act, less the amount of any co-payment required under these regulations. Effect of payment Where a participating pharmacy submits a claim for benefits in accordance with section 43 and is paid an amount under the Plan, the payment is payment in full of the claim and no other claim, except for the required co-payment, shall be made against any other person or organization. (EC367/14) 45. Extemporaneous preparations A compounded preparation prescribed by a prescriber is a benefit for the purposes of these regulations, subject to any requirements or restrictions of the formulary, if (a) the preparation is compounded by a pharmacist; (b) the preparation as compounded does not duplicate the formulation of a manufactured drug product that is currently available; and (c) the active ingredients of the preparation as compounded are, in the opinion of the Administrator, of therapeutic benefit in the concentrations provided and the recommended manner of use. (EC367/14) c t Current to: September 1, 2024 Page 23 Part 14 Section 46 Drug Cost Assistance Program Regulations 46.

Application for variation in enrolment An eligible person may apply to the Administrator in the form approved by the Administrator to vary the terms of the person’s enrolment in a program for which the person continues to be eligible where there has been a material change in the person’s circumstances, including, but not limited to, a change in (a) income; (b) marital status; or (c) number of dependants. Information required An applicant under subsection (1) shall provide to the Administrator any information, including any relevant documents or records, required by the Administrator to establish the applicant’s change in circumstances. Review of application On receipt of an application made in accordance with subsection (1), the Administrator shall review the application and may vary the terms of the applicant’s enrolment if the Administrator is satisfied that the applicant’s change in circumstances is established. Notification The Administrator shall notify an applicant under this section of the Administrator’s decision under subsection (3) and, where the Administrator determines that the requirements for a variation have not been met, the reasons for that determination, within 14 days. When variation is effective A variation of an applicant’s terms of enrolment under this section takes effect on the date specified by the Administrator. (EC367/14) 47. Establishing breakdown of marriage or relationship An applicant may establish that the applicant is separated from the applicant’s spouse by submitting a statutory declaration, in the form approved by the Minister, with an application for enrolment or a variation in the terms of enrolment, confirming there has been a breakdown of the marriage, within the meaning in the Divorce Act (Canada), or the spouses are no longer cohabiting in a conjugal relationship. Review of application On receipt of an application made in accordance with subsection (1), the Administrator shall review the application and may, if the Administrator is satisfied that the spouses are separated, vary the terms of the applicant’s enrolment, or enrol the applicant without requiring the production of the income information of the applicant’s spouse. Grounds for refusal, etc. Where, after review of an application under subsection (2), the Administrator determines that the spouses are not separated, the Director may refuse to enrol the applicant or to vary the terms of the applicant’s enrolment as specified in the application, as the case may be. Notification The Administrator shall notify an applicant under this section of the Administrator’s decision under subsection (2) or determination under subsection (3) and, where the Administrator is not satisfied that the spouses are separated, of the reasons for the decision, within 14 days. Page 24 Current to: September 1, 2024 t c Part 14 Drug Cost Assistance Program Regulations Section 48 Effect of separation Where the Administrator is satisfied that an applicant is separated from the applicant’s spouse, the spouse’s income shall not be considered in respect of the applicant’s enrolment or terms of enrolment in a program. (EC367/14; 755/18; 796/24) 48. Appeal A person who is aggrieved by a decision or determination of the Administrator under subsection 10(5), 13(3), 16(4), 46(3) or 47(2) or (3) may appeal that decision or determination to the Minister in accordance with section 17 of the Act. (EC367/14) 49. Transitional A person who was in receipt of benefits under the Seniors Drug Program under the Drug Cost Assistance Act General Regulations (EC511/97) immediately prior to the coming into force of these regulations is deemed to be enrolled in the Seniors Drug Program under these regulations. Idem A person who was in receipt of benefits under or was enrolled in the following programs as they existed immediately prior to the coming into force of these regulations is deemed, on the coming into force of these regulations, to be a person enrolled in the equivalent program under these regulations: (a) the Diabetes Drug Program; (b) the Family Health Benefit Drug Program; (c) the High-Cost Drug Program; (d) the Catastrophic Drug Program; (e) the Financial Assistance Drug Program; (f) the Child in Care Drug Program; (g) the Nursing Home Drug Program; (h) the Smoking Cessation Drug Program; (i) the Sexually Transmitted Infection Drug Program; (j) the Opioid Replacement Therapy Drug Program. (EC367/14) 50. Schedules adopted Schedules A to G are hereby adopted and form part of these regulations. (EC367/14) 51. Revocation The Drug Cost Assistance Act General Regulations (EC511/97) are revoked. (EC367/14) 52. Commencement These regulations come into force on July 1, 2014. c t Current to: September 1, 2024 Page 25 Drug Cost Assistance Program Regulations Schedule A Schedule A Criteria for coverage under the Family Health Benefit Drug Program: Number of Dependants Income (as defined in section 9) 1 Less than $24,800 2 Less than $27,800 3 Less than $30,800 4 Less than $33,800 more than 4 Add $3,000 per each additional dependant (EC367/14) c t Current to: September 1, 2024 Page 27 Schedule B Drug Cost Assistance Program Regulations Schedule B HIGH COST DRUG PROGRAM CO-PAYMENT Household Income Ranges Co-Payment $0 – $14,000 $7 $14,001 - $15,999 $25 $16,000 – $17,999 $32 $18,000 - $19,999 $40 $20,000 - $21,999 $48 $22,000 - $23,999 $57 $24,000 - $25,999 $68 $26,000 - $27,999 $79 $28,000 - $29,999 $91 $30,000 - $31,999 $103 $32,000 - $33,999 $117 $34,000 - $35,999 $131 $36,000 - $37,999 $146 $38,000 - $39,999 $162 $40,000 - $41,999 $179 $42,000 - $43,999 $197 $44,000 - $45,999 $216 $46,000 - $47,999 $235 $48,000 - $49,999 $255 $50,000 - $51,999 $287 $52,000 - $53,999 $320 $54,000 - $55,999 $355 $56,000 - $57,999 $392 $58,000 - $59,999 $430 $60,000 - $61,999 $470 $62,000 - $63,999 $512 $64,000 - $65,999 $555 $66,000 - $67,999 $600 $68,000 - $69,999 $647 Page 28 Current to: September 1, 2024 t c Drug Cost Assistance Program Regulations Schedule B $70,000 - $71,999 $695 $72,000 - $73,999 $745 $74,000 - $75,999 $797 $76,000 - $77,999 $850 $78,000 - $79,999 $905 $80,000 - $81,999 $962 $82,000 - $83,999 $1,020 $84,000 - $85,999 $1,080 $86,000 - $87,999 $1,142 $88,000 - $89,999 $1,205 $90,000 - $91,999 $1,270 $92,000 - $93,999 $1,337 $94,000 - $95,999 $1,405 $96,000 - $97,999 $1,475 $98,000 - $99,999 $1,547 $100,000 - $109,999 $1,684 $110,000 - $119,999 $1,893 $120,000 - $129,999 $2,109 $130,000 - $139,999 $2,334 $140,000 - $149,999 $2,568 $150,000 - $159,999 $2,825 $160,000 - $169,999 $3,108 $170,000 - $179,999 $3,418 $180,000 - $189,999 $3,760 $190,000 - $199,999 $4,136 $200,000 - $399,999 $6,204 $400,000 - $599,999 $7,755 $600,000 - $799,999 $9,048 $800,000 - $999,999 $10,179 ≥ $1,000,000 $11,310 (EC367/14; 317/23) c t Current to: September 1, 2024 Page 29 Schedule C Drug Cost Assistance Program Regulations Schedule C Calculation of income for the purposes of the Catastrophic Drug Program: Income is the total of the incomes of the applicant and the applicant’s spouse, if the applicant has a spouse, as shown on the applicant’s and spouse’s tax return for the previous taxation year, calculated as follows: Income = Line 15000 (total income) less Line 21000 (split pensions amount) less Line 21400 (child care expenses) less Line 22000 (support payments made) (EC367/14; 382/22) SCHEDULE D CATASTROPHIC DRUG PROGRAM ELIGIBLE COSTS Income Eligible Costs (as a percentage of total costs) $0 - $19,999 3.00% $20,000 - $29,999 3.25% $30,000 - $39,999 3.50% $40,000 - $49,999 3.75% $50,000 - $59,999 4.00% $60,000 - $69,999 4.25% $70,000 - $79,999 4.50% $80,000 - $89,999 4.75% $90,000 - $99,999 5.00% $100,000 - $109,999 5.25% $110,000 - $119,999 5.50% $120,000 - $129,999 5.75% $130,000 - $139,999 6.00% $140,000 - $149,999 6.25% ≥ $150,000 6.50% (EC367/14; 317/23) Page 30 Current to: September 1, 2024 t c Drug Cost Assistance Program Regulations Schedule E Schedule E For the purposes of the Insulin Pump Program, the Ostomy Supplies Program and the Diabetes Glucose Sensor Program, the income of a person in a household, other than a dependant, shall be based on the amounts reported on the specified lines of the person’s income tax return for the preceding tax year, as filed with and verified by the Canada Revenue Agency, calculated as follows: Line 15000 (total income) less Line 21000 (split income) less Line 21400 (child care expenses) less Line 22000 (support payments made) (EC367/14; 755/18; 382/22) c t Current to: September 1, 2024 Page 31 Schedule F Drug Cost Assistance Program Regulations Schedule F For the purposes of the Insulin Pump Program and the Ostomy Supplies Program the percentage of the eligible cost of a benefit claimed that is covered based on an eligible person’s household income is as follows: Household Income Percentage Covered of Eligible Cost of Benefit Claimed $0 to $20,000 100% $20,001 to $40,000 95% $41,001 to $50,000 90% $50,001 to $100,000 70% $100,001 or greater 60% (EC367/14; 755/18; 727/20; 382/22) Page 32 Current to: September 1, 2024 t c Drug Cost Assistance Program Regulations Schedule G Schedule G Annual supplies covered as eligible insulin pump program costs under the Insulin Pump Program: • infusion sets - to a maximum of 140 per year • insulin reservoirs - to a maximum of 140 per year • site inserters - a maximum of 1 replacement inserter per year • skin adhesive wipes - to a maximum of 150 per year • sterile transparent dressings - to a maximum of 200 per year (EC367/14) c t Current to: September 1, 2024 Page 33