Ontario Drug Benefit Act
Loi sur le régime de médicaments de l’Ontario

ONTARIO REGULATION 201/96

GENERAL

Consolidation Period: From April 1, 2014 to the e-Laws currency date.

Last amendment: O. Reg. 20/13.

This Regulation is made in English only.

SKIP TABLE OF CONTENTS

CONTENTS

   

Sections

 

Definitions

1

 

Eligible Persons

2

 

Trillium Program

3-8.-10

 

Conditions for Designation of Listed Drug Products

11-12.0.2

 

Conditions to Continue to be a Designated Listed Drug Product

12.1

 

Establishing Criteria

12.2

 

Amounts Paid by Executive Officer

13-17

 

Limits on Amounts Paid by Executive Officer

18-20

 

Co-payment

20.1-20.3

 

Amount Charged to Person Other Than Executive Officer

21-22

 

Miscellaneous

23-30

Table

Annual out-of-pocket expense to be exceeded to become eligible for trillium drug program (in $500 increments)

 

Schedule 2

 

Definitions

1.  (1)  In this Regulation,

“drug cost amount” means the quantity of a drug product multiplied by the drug benefit price of the drug product;

“extemporaneous preparation” means a drug or combination of drugs prepared or compounded in a pharmacy according to a prescription;

“Ministry” means the Ministry of Health and Long-Term Care;

“modified release dosage form” means a dosage form of a product that is formulated to control the level of the drug in the blood over a shorter or longer period of time than a conventional dosage form;

“original product” means the original source of a drug product in a particular strength and dosage form;

“spouse” means a person,

(a) to whom the person is married, or

(b) with whom the person is living in a conjugal relationship outside marriage, if the two persons,

(i) have cohabited for at least one year,

(ii) are together the parents of a child, or

(iii) have together entered into a cohabitation agreement under section 53 of the Family Law Act;

“unit” means a gram, millilitre, tablet, capsule or other appropriate unit of a listed drug product in a particular dosage form and strength. O. Reg. 201/96, s. 1; O. Reg. 324/96, s. 1; O. Reg. 336/96, s. 1; O. Reg. 375/96, s. 1; O. Reg. 508/96, s. 1 (1); O. Reg. 110/97, s. 1; O. Reg. 299/97, s. 1; O. Reg. 612/98, s. 1; O. Reg. 72/99, s. 1; O. Reg. 332/99, s. 1; O. Reg. 401/99, s. 1; O. Reg. 588/99, s. 1; O. Reg. 69/00, s. 1; O. Reg. 202/00, s. 1 (1); O. Reg. 366/00, s. 1; O. Reg. 584/00, s. 1; O. Reg. 16/01, s. 1; O. Reg. 172/01, s. 1 (1); O. Reg. 358/01, s. 1; O. Reg. 64/02, s. 1; O. Reg. 214/02, s. 1; O. Reg. 395/02, s. 1; O. Reg. 88/03, s. 1; O. Reg. 334/03, s. 1; O. Reg. 60/04, s. 1; O. Reg. 184/04, s. 1; O. Reg. 321/04, s. 1; O. Reg. 12/05, s. 1; O. Reg. 191/05, s. 1; O. Reg. 334/05, s. 1; O. Reg. 484/05, s. 1 (1); O. Reg. 645/05, s. 1 (1); O. Reg. 55/06, s. 1 (1); O. Reg. 202/06, s. 1; O. Reg. 459/06, s. 1 (1, 2); O. Reg. 320/07, s. 1.

(1.1)  The functions and powers of the executive officer set out in subsection 1.1 (2) of the Act include the power,

(a) to hold competitions for the purpose of selecting drug products that may be listed or continue to be listed as designated drug products on the Formulary or for any other purpose under the Act;

(b) to use the results of such competitions in exercising any of the executive officer’s powers under the Act, including designating or continuing to designate a drug product as a listed drug product under section 19 of the Act or removing such a designation under section 20 of the Act; and

(c) to enter into agreements that contain, among other things, provisions with respect to volume discounts and payments to the Minister of Finance. O. Reg. 356/08, s. 1.

(1.2)  The executive officer shall not, under section 16 of the Act, make the Act apply in respect of a drug that is a drug product described in subsection 12 (9) of this Regulation, unless the conditions set out in that subsection are met. O. Reg. 20/13, s. 1.

(2)  For the purposes of subsection 1 (2) of the Act,

“therapeutic substitution” means the substitution of a drug that contains chemically different active ingredients that are considered to be therapeutically equivalent, without authorization from a person authorized to prescribe drugs within the scope of his or her practice of a health profession. O. Reg. 459/06, s. 1 (3).

(3)  The executive officer may enter into agreements for the purposes of carrying out his or her functions under clause 1.1 (2) (a) of the Act. O. Reg. 459/06, s. 1 (3).

(4)  The executive officer may, in writing, delegate his or her authority under clause 1.1 (2) (c), (f) or (g) of the Act or subsection 1 (3) of this Regulation to any person employed in the Ministry. O. Reg. 459/06, s. 1 (3).

(5)  For greater clarity, the power of the executive officer under clause 1.1 (2) (f) of the Act to negotiate agreements includes the power to enter into such agreements that have been negotiated. O. Reg. 459/06, s. 1 (3).

(6)  Revoked: O. Reg. 220/10, s. 1 (2).

(7)  For the purposes of subsection 1.4 (2) of the Act,

“Association” means the Ontario Pharmacists’ Association. O. Reg. 459/06, s. 1 (3).

(8)  For greater certainty, a benefit provided as a professional allowance before July 1, 2010 is a rebate and is not a professional allowance unless the manufacturer providing the benefit and the person receiving it report to the executive officer the amount of professional allowance paid or received in the same manner as provided in Schedule 3 of this Regulation as it read before July 1, 2010. O. Reg. 220/10, s. 1 (3).

(9), (10)  Revoked: O. Reg. 220/10, s. 1 (3).

(11)  For the purposes of section 11.5 of the Act, a “rebate” does not include the value of a benefit that is provided in accordance with ordinary commercial terms that meet all of the following conditions:

1. The benefit is provided in the ordinary course of business in the supply chain system of listed drug products that are designated as interchangeable under the Drug Interchangeability and Dispensing Fee Act between any of a manufacturer, a wholesaler, an operator of a pharmacy or a company that owns, operates or franchises pharmacies.

2. The value of the benefit is set out in a written agreement between any of a manufacturer, a wholesaler, an operator of a pharmacy and a company that owns, operates or franchises pharmacies.

3. The benefit relates to an ordinary commercial relationship that is any of the following:

i. A prompt payment discount.

ii. A volume discount.

iii. A distribution service fee.

4. The total value of any benefits does not exceed 10 per cent of the value of the listed drug products based on the drug benefit price in the Formulary and the number of units dispensed by a pharmacy and reimbursed under the Act.

5. A person who receives the benefit reports to the executive officer, if required by the executive officer to do so, the net selling price of the drug products representing the drug benefit price less the value of the benefits received. O. Reg. 220/10, s. 1 (4).

(12)  For the purposes of section 11.5 of the Act, a “rebate” does not include the value of a benefit provided in accordance with ordinary commercial terms with respect to a listed drug product that is not interchangeable where the ordinary commercial terms are a discount for prompt payment. O. Reg. 220/10, s. 1 (4).

Eligible Persons

2.  (1)  Subject to subsections (2) and (3), the following classes of persons who are insured persons under the Health Insurance Act are designated as eligible classes of persons for the purposes of section 2 of the Act:

1. Persons who are receiving a professional service referred to in paragraph 1, 2, 3, 4, 5, 6, 8 or 9 of subsection 2 (7) of the Home Care and Community Services Act, 1994 that is provided or arranged by a community care access centre as defined in subsection 1 (1) of Ontario Regulation 386/99 (Provision of Community Services) made under that Act.

2. Persons who reside in homes licensed under section 5 of the Homes for Special Care Act.

3. Persons who are eligible for a pension under Part I of the Old Age Security Act (Canada).

4. Persons who have attained 65 years of age.

5. Residents of long-term care homes under the Long-Term Care Homes Act, 2007.

6., 7. Revoked: O. Reg. 104/10, s. 1 (2).

O. Reg. 201/96, s. 2 (1); O. Reg. 252/09, s. 1; O. Reg. 104/10, s. 1.

(2)  A person is not a member of the class of persons referred to in paragraph 3 of subsection (1) until the first day of the month for which the person first receives payment of the pension. O. Reg. 201/96, s. 2 (2).

(3)  A person is not a member of the class of persons referred to in paragraph 4 of subsection (1) until the latest of,

(a) the first day of the month following the month the person attains 65 years of age;

(b) the day that is five years earlier than the day the executive officer receives all the information required by the executive officer to confirm that the person has attained 65 years of age and that the person has been an insured person under the Health Insurance Act since the beginning of the five-year period; and

(c) the day the person becomes an insured person under the Health Insurance Act. O. Reg. 201/96, s. 2 (3); O. Reg. 459/06, s. 2 (1).

(4)  Information received by the Minister before October 1, 2006 shall be deemed to have been received by the executive officer. O. Reg. 459/06, s. 2 (2).

Trillium Program

3.  (0.1)  In this section and in sections 4, 4.1 and 4.2,

“fiscal period” means the 12-month period that begins on August 1 of every year and ends on the following July 31;

“quarter” means, in relation to a fiscal period, a three-month period that begins on August 1, November 1, February 1 or May 1. O. Reg. 374/99, s. 1 (1).

(1)  In addition to the classes listed in subsection 2 (1), persons who meet the following qualifications are designated as an eligible class of persons for the purposes of section 2 of the Act:

1. A person must be an insured person under the Health Insurance Act.

2. A person must be a member of a household unit whose members have collectively spent, in any quarter of a fiscal period, the amount determined in sections 4, 4.1 and 4.2, or more, on allowable expenses.

3. In order to become eligible, an application to become enrolled must be made to the executive officer on behalf of the person’s household unit and the executive officer must be satisfied that the members of the household unit have collectively spent the amount determined in accordance with sections 4, 4.1 and 4.2, or more, on allowable expenses in any quarter in a fiscal period. O. Reg. 201/96, s. 3 (1); O. Reg. 83/98, s. 1 (2); O. Reg. 374/99, s. 1 (2); O. Reg. 69/00, s. 2 (1, 2); O. Reg. 156/05, s. 1 (1); O. Reg. 459/06, s. 3 (1).

(2)  A person becomes a member of the class of eligible persons referred to in subsection (1) after the beginning of each quarter of a fiscal period only once the members of his or her household unit have spent the amount determined under sections 4, 4.1 and 4.2 on allowable expenses and the person ceases to be a member of the class at the end of the quarter. O. Reg. 374/99, s. 1 (3); O. Reg. 69/00, s. 2 (3).

(3)  Subject to subsection (3.1), an application under paragraph 3 of subsection (1) shall be made in the form provided by the executive officer and must include,

(a) receipts for allowable expenses as required by the form;

(b) information evidencing annual net income as required by the form;

(b.1) information evidencing the annual amount of income from the Universal Child Care Benefit program of the Government of Canada as required by the form;

(b.2) information evidencing the annual amount of taxable income withdrawn from Canadian Registered Disability Saving Plans as required by the form; and

(c) completion of the consents required by the form. O. Reg. 156/05, s. 1 (2); O. Reg. 459/06, s. 3 (2); O. Reg. 556/06, s. 1; O. Reg. 94/09, s. 1.

(3.1)  Every application made under paragraph 3 of subsection (1) shall be deemed to be renewed every year, effective as of the first day of the fiscal period, unless,

(a) the executive officer confirms that no claims for payment were submitted to the Health Network mentioned in section 23 on behalf of any member of the household unit for one fiscal period;

(b) the member of the household unit that made the application on behalf of the household unit notifies the executive officer that all members of the household unit withdraw the general consent required by the application form; or

(c) the member of the household unit that made the application requests that the executive officer terminate the enrolment of all members of the household unit. O. Reg. 156/05, s. 1 (2); O. Reg. 459/06, s. 3 (3-5).

(3.2)  If a person’s application is not renewed for one of the reasons set out in subsection (3.1), the person may reapply to be enrolled by completing the application form required by paragraph 3 of subsection (1) in accordance with subsection (3). O. Reg. 156/05, s. 1 (2).

(3.3)  The member of the household unit that made the application shall notify the executive officer in writing of any change in the unit’s circumstances or membership that results in a member of the household unit ceasing to be a member of the eligible class of persons, or of any other changes that may affect the calculation of the unit’s allowable expenses under section 4, 4.1 or 4.2. O. Reg. 156/05, s. 1 (2); O. Reg. 459/06, s. 3 (6).

(4)  Subject to subsections (6), (8) and (9), the following expenses are allowable expenses for the purposes of paragraph 2 of subsection (1):

1. The cost, including the dispensing fee, of the following products that are to be used by a member of the household unit other than a member who is an eligible person:

i. A listed drug product, subject to subsection (4.1).

ii. a product that is a facilitated access drug product funded under the Ontario Drug Benefit Program.

iii. A listed substance.

iv. A drug listed in Schedule F or G of the Food and Drugs Act (Canada) that meets the criteria set out in subsection (5).

v. A nutritional product or a diabetic testing agent that is funded under the Ontario Drug Benefit Program.

vi. An extemporaneous preparation that is a designated pharmaceutical product.

vii. A product listed in Schedule 2.

viii. A product to which the Act has been made to apply, under section 16 of the Act, in respect of the supply of the product for a member of the household unit.

2. A co-payment paid upon the purchase of a product that is referred to in paragraph 1 and is to be used by a member of the household unit who, at the time the product is purchased, is an eligible person.

3. An insurance premium paid to insure a member of the household unit against the cost of any products referred to in paragraph 1, up to a maximum premium of,

i. $100 a year for a household unit of one, or

ii. $200 a year for a household unit of two or more. O. Reg. 201/96, s. 3 (4); O. Reg. 336/96, s. 2 (1); O. Reg. 507/96, s. 1 (1); O. Reg. 508/96, s. 2 (2); O. Reg. 69/00, s. 2 (4-6); O. Reg. 459/06, s. 3 (7-9).

(4.1)  A listed drug product for which clinical criteria are specified under section 23 of the Act shall not be an allowable expense unless the product is supplied in circumstances that meet the clinical criteria. O. Reg. 336/96, s. 2 (2).

(5)  For the purposes of subparagraph iv of paragraph 1 of subsection (4), the cost of a drug referred to in subparagraph iv of paragraph 1 of subsection (4) is an allowable expense if,

(a) the executive officer has been informed by a physician that the proper treatment of the patient requires the administration of the drug; and

(b) the executive officer, on the advice of a panel of experts appointed for this purpose, recommends the use of the drug based on clinical criteria that relate to the patient’s case. O. Reg. 201/96, s. 3 (5); O. Reg. 507/96, s. 1 (2); O. Reg. 508/96, s. 2 (3); O. Reg. 459/06, s. 3 (10, 11).

(6)  The cost of a product referred to in paragraph 1 of subsection (4) shall not be an allowable expense if,

(a) the product was not prescribed by a member of a health profession acting within the scope of his or her practice; or

(b) the product is for use by a member of the household unit who, at the time the product is purchased, is not an insured person under the Health Insurance Act. O. Reg. 201/96, s. 3 (6); O. Reg. 69/00, s. 2 (7).

(7)  For the purposes of clause (6) (a),

“health profession” means a health profession as defined in the Regulated Health Professions Act, 1991. O. Reg. 201/96, s. 3 (7).

(8)  If the cost of a product referred to in paragraph 1 of subsection (4) or part of the cost of that product, has been, or may be, reimbursed under the Ontario Health Insurance Plan or under an insurance plan or by an employer or a third party acting on behalf of an employer, the cost or part of that cost that may be reimbursed shall not be an allowable expense. O. Reg. 73/04, s. 1.

(9)  An insurance premium shall not be an allowable expense if,

(a) the premium is to insure a member of the household unit who is an eligible person or who is not an insured person under the Health Insurance Act; or

(b) the premium is for travel insurance for travel outside Canada. O. Reg. 201/96, s. 3 (9); O. Reg. 69/00, s. 2 (8).

(10)  An application submitted to the Minister before October 1, 2006 shall be deemed to have been submitted to the executive officer for the purposes of this section. O. Reg. 459/06, s. 3 (12).

4.  (1)  Subject to sections 4.1 and 4.2, the amount referred to in paragraphs 2 and 3 of subsection 3 (1) is equal to a quarter of,

(a) with respect to a household unit whose annual net income is $100,000 or less, the amount indicated in the Table to this Regulation; and

(b) with respect to a household unit whose annual net income exceeds $100,000, an amount equal to the sum of,

(i) $500, and

(ii) 4.5 per cent of the annual net income that exceeds $20,000,

less, where applicable,

(iii) $100 for a household unit of two,

(iv) $150 for a household unit of three, or

(v) $200 for a household unit of four or more. O. Reg. 201/96, s. 4 (1); O. Reg. 374/99, s. 2; O. Reg. 69/00, s. 3 (1).

(2)  Subject to subsections (4) and (5), a household unit’s annual net income shall be determined based on each member’s annual net income for his or her most recent taxation year. O. Reg. 83/98, s. 2 (1); O. Reg. 69/00, s. 3 (2).

(3)  For the purposes of this section, a member’s most recent taxation year is the member’s taxation year that ended before the beginning of the fiscal period in respect of which an application is made under paragraph 3 of subsection 3 (1) or renewed under subsection 3 (3.1). O. Reg. 156/05, s. 2 (1).

(4)  For the fiscal period that begins on April 1, 1997 and ends on July 31, 1998, the members of a household unit may elect to determine the household unit’s annual net income based on each member’s annual net income for the taxation year immediately preceding the members’ most recent taxation year. O. Reg. 83/98, s. 2 (1); O. Reg. 69/00, s. 3 (3).

(5)  The members of a household unit may elect to determine the household unit’s annual net income based on each member’s annual net income for the taxation year immediately following the members’ most recent taxation year if the election would result in a difference of 10 per cent or more in the unit’s annual net income. O. Reg. 83/98, s. 2 (1); O. Reg. 69/00, s. 3 (4).

(6)  In the case of an election under subsection (5), if the relevant taxation year of a member of a household unit is not complete on the day the application to be enrolled is made or the day upon which the executive officer receives the member’s written notification of his or her election, whichever is later, the member’s annual net income for that taxation year shall be determined using the sum of,

(a) the member’s income from the beginning of the taxation year until the day of the application or the executive officer’s receipt of the notification of election; and

(b) an estimate of the member’s income from the day of the application or the executive officer’s receipt of the notification of election until the end of the taxation year. O. Reg. 156/05, s. 2 (2); O. Reg. 459/06, s. 4 (1).

(6.1)  For the purposes of subsection (6), a written notification submitted to the Minister before October 1, 2006 shall be deemed to have been submitted to the executive officer. O. Reg. 459/06, s. 4 (2).

(7)  An estimate under clause (6) (b) shall be determined by multiplying the number of days remaining in the member’s taxation year by the member’s average daily income for the month immediately preceding the day of the application or receipt of notification. O. Reg. 156/05, s. 2 (2).

(8)  Revoked: O. Reg. 83/98, s. 2 (3).

(9)  In this section,

“annual net income” means the amount indicated on line 236 of the Notice of Assessment issued under the Income Tax Act (Canada) for the relevant taxation year or, if no Notice of Assessment has been issued, the amount that would appear on that line had the Notice of Assessment been issued, in either case minus both,

(a) the amount of income from the Universal Child Care Benefit program of the Government of Canada that was reported or that should have been reported on line 117 of the relevant Canadian income tax return, and

(b) the amount withdrawn from Canadian Registered Disability Saving Plans that was reported or that should have been reported on line 125 of the relevant Canadian income tax return;

“relevant taxation year” means, with respect to a person, the person’s most recent taxation year, or such other taxation year, as may be determined in accordance with subsections (2), (3) and (4). O. Reg. 83/98, s. 2 (4); O. Reg. 556/06, s. 2; O. Reg. 94/09, s. 2.

4.1  (1)  The amount referred to in paragraphs 2 and 3 of subsection 3 (1) as determined under subsection 4 (1) shall be increased in accordance with subsection (2) if,

(a) the amount is being determined with respect to the second, third or fourth quarter of a fiscal period; and

(b) in the quarter immediately preceding the quarter in respect of which eligibility is being determined, the members of the person’s household unit spent less on allowable expenses than the amount determined under subsection 4 (1). O. Reg. 374/99, s. 3; O. Reg. 69/00, s. 4 (1); O. Reg. 156/05, s. 3.

(2)  The amount of the increase under subsection (1) shall be determined in accordance with the following formula:

A ꞊ B – C

where,

A is the amount of the increase,

B is the amount determined under subsection 4 (1) that the members of the person’s household unit are required to have collectively spent on allowable expenses in order to be part of the eligible class of persons referred to in subsection 3 (1), and

C is the amount that the members of the person’s household unit actually spent on allowable expenses in the previous quarter of the fiscal period.

O. Reg. 374/99, s. 3; O. Reg. 69/00, s. 4 (2).

4.2  (1)  If the application made under paragraph 3 of subsection 3 (1) in any given fiscal period requests that eligibility begin after the beginning of the period, the amount referred to in paragraphs 2 and 3 of subsection 3 (1) that must be spent on allowable expenses in each remaining quarter of the fiscal period shall be determined in accordance with subsection (2). O. Reg. 156/05, s. 4.

(2)  The amount referred to in paragraphs 2 and 3 of subsection 3 (1) shall be determined in accordance with the following formula:

A ꞊ B × (C/D)

where,

A is the amount that the members of the person’s household unit must have collectively spent on allowable expenses where subsection (1) applies,

B is the amount determined under subsection 4 (1),

C is the number of days from the day eligibility begins to the end of the fiscal period, and

D is the total number of days in the fiscal period.

O. Reg. 374/99, s. 3; O. Reg. 69/00, s. 5.

5.  (1)  For the purposes of sections 3 and 4, two persons are members of the same household unit if,

(a) they are spouses of each other;

(b) they share a residence and,

(i) one is a parent, grandparent or other ancestor of the other or the legal guardian of the other, and

(ii) one is dependent for support, either wholly or partly, on the other; or

(c) they are each members of the same household unit with a third person under clause (a) or (b). O. Reg. 201/96, s. 5 (1); O. Reg. 69/00, s. 6 (1-3); O. Reg. 334/05, s. 2 (1).

(2)  Revoked: O. Reg. 69/00, s. 6 (4).

(3)  Revoked: O. Reg. 69/00, s. 6 (4).

(4)  For the purposes of this section, spouses who cease to live together because of a breakdown in their marriage or relationship are not members of the same household unit. O. Reg. 69/00, s. 6 (5); O. Reg. 334/05, s. 2 (2).

(5)  Despite clause (1) (b), a person is a member of the same household unit as a parent, grandparent or other ancestor or is a member of the same household unit as his or her legal guardian even if they do not share a residence so long as the person,

(a) is a student;

(b) is dependent for support, either wholly or partly, on the parent, grandparent, ancestor or legal guardian; and

(c) elects to be part of the household unit of the parent, grandparent or other ancestor or legal guardian. O. Reg. 201/96, s. 5 (5); O. Reg. 69/00, s. 6 (6).

(6)  A student shall not elect to be part of the household unit of a parent, grandparent or other ancestor or of a legal guardian under clause (5) (c) if,

(a) the student has elected to be part of the household unit of another parent, grandparent, ancestor or legal guardian upon whom the student is dependent for support, either wholly or partly; or

(b) the person shares a residence with another parent, grandparent, ancestor or legal guardian upon whom the student is dependent for support, either wholly or partly. O. Reg. 201/96, s. 5 (6); O. Reg. 69/00, s. 6 (6).

6.  An individual who is not part of the same household unit as another person pursuant to section 5 shall constitute a household unit for the purposes of sections 3 and 4. O. Reg. 69/00, s. 7.

7.  Revoked: O. Reg. 459/06, s. 5.

7.1  Revoked: O. Reg. 484/05, s. 2.

7.2  Revoked: O. Reg. 459/06, s. 5.

8.-10.  Revoked: O. Reg. 459/06, s. 5.

Conditions for Designation of Listed Drug Products

11.  (1)  A strength and dosage form of a product that has been submitted for designation as an interchangeable product under the Drug Interchangeability and Dispensing Fee Act shall not be designated as a listed drug product unless the manufacturer submits the information required under section 12 and the following conditions are met:

1. If the original product is a listed drug product, the drug benefit price of the product proposed to the executive officer under clause 12 (1) (d) must be,

i. less than or equal to 25 per cent of the drug benefit price of the original product as set out in the Formulary on the date the product is first proposed for designation as a listed drug product, or

ii. if the drug benefit price of the original product has been reduced by more than 20 per cent in the 24-month period before the date on which the product is proposed for designation as a listed drug product, less than or equal to 25 per cent of the drug benefit price of the original product as set out in the Formulary immediately before the drug benefit price of the original product was first reduced.

2. If the original product was but is no longer a listed drug product, the drug benefit price of the product proposed to the executive officer under clause 12 (1) (d) must be less than or equal to 25 per cent of the drug benefit price of the original product that was set out in the Formulary immediately before its removal.

3. Revoked: O. Reg. 220/10, s. 2 (3).

4. In addition to the applicable conditions under paragraphs 1 and 2, if applicable, and if required by the executive officer, the manufacturer of the product shall enter into an agreement with the executive officer that specifies any volume discount or other amount that may be payable by the manufacturer to the Minister of Finance, and shall agree that the executive officer may make public the following information, and that information only, with respect to the agreement:

i. The name of the manufacturer.

ii. The subject-matter of the agreement.

iii. The fact of entering into or terminating the agreement. O. Reg. 459/06, s. 6; O. Reg. 559/06, s. 1 (1); O. Reg. 355/08, s. 1 (1); O. Reg. 356/08, s. 2; O. Reg. 220/10, s. 2 (1-4).

(1.1)  For the purposes of paragraphs 1 and 2 of subsection (1), all references to “25 per cent” shall be read as “35 per cent” in the case of a drug product that is not a solid dosage form. O. Reg. 220/10, s. 2 (5).

(2)  Paragraphs 1 and 2 of subsection (1) do not apply where there is evidence satisfactory to the executive officer that the product would be the only drug product of its type that has been proposed to be designated as interchangeable with an original drug product. O. Reg. 559/06, s. 1 (2); O. Reg. 220/10, s. 2 (6).

(3)  Where the circumstances described in subsection (2) exist, the executive officer may, in the executive officer’s sole discretion, negotiate an agreement in respect of the product with the manufacturer for any drug benefit price, but in no case may the interchangeable product be priced higher than the original product. O. Reg. 559/06, s. 1 (2).

(4)  For greater certainty, where the executive officer and the manufacturer cannot agree as to a drug benefit price under subsection (3), the executive officer shall not list the drug product. O. Reg. 559/06, s. 1 (2).

(5)  Upon the application of the manufacturer, the executive officer may re-designate a drug product that was designated on the Formulary before December 31, 2007, and whose designation was removed by either of the amendments to the Formulary known as Update 8 to Edition 40, effective January 15, 2008, or Update 8A to Edition 40, effective January 17, 2008, subject to the following:

1. The submission requirements set out in subsection 12 (1) shall be deemed to have been met with respect to the product.

2. The conditions for continued listing set out in section 12.1 must be met with respect to the product.

3. The criteria established by the executive officer under section 12.2 must be met with respect to the product. O. Reg. 355/08, s. 1 (2).

(6)  Revoked: O. Reg. 220/10, s. 2 (8).

(7)  Despite paragraphs 1 and 2 of subsection (1), during the three-month period provided for in paragraph 4 of subsection (8), the drug benefit price of a product that meets the conditions set out in subsection (8) must be less than or equal to 50 per cent of the drug benefit price of the original product on the date the product is first proposed for designation as a listed drug product. O. Reg. 220/10, s. 2 (9).

(8)  The conditions referred to in subsection (7) are the following:

1. The product is first proposed for designation as a listed drug product on or after April 1, 2012 and has not been designated as a listed drug product at any other time.

2. The manufacturer of the product has submitted evidence satisfactory to the executive officer that the manufacturer, or another manufacturer of a product that is interchangeable with the original product, has successfully challenged the patent of the original product with the result that the manufacturer’s product can be sold in Canada earlier than if the patent had expired or if the challenge had not been brought.

3. The manufacturer has not entered into any arrangement, other than a cross-licensing agreement, with the manufacturer of the original product with respect to the product that is proposed for designation as a listed drug product, including any first-to-market arrangement or delayed-entry arrangement.

4. The manufacturer agrees that the exception set out in subsection (7) no longer applies three months after the first product of any manufacturer that is interchangeable with the original product becomes a listed drug product, at which time the drug benefit price shall be as set out in subsection (1) or any other applicable provision of this Regulation. O. Reg. 220/10, s. 2 (9).

12.  (1)  A strength and dosage form of a drug product shall not be designated as a listed drug product unless the manufacturer of the drug product submits to the executive officer,

(a) either,

(i) evidence that Health Canada has approved the product for sale in Canada, a copy of the product’s drug notification form issued by Health Canada and, subject to subsection (2), a copy of the product monograph approved by Health Canada, or

(ii) evidence that an application has been made to Health Canada to approve the product for sale in Canada, and evidence satisfactory to a panel of experts established for the purpose that the product meets at least one of the following criteria:

A. The product is a new chemical entity that is effective for the treatment of an immediately life-threatening disease or other serious disease for which it offers substantial improvements on significant outcomes, including improved efficacy, safety and tolerability and quality of life over other available drug therapies in Canada, or for which no treatment or no other effective drug therapy is currently available in Canada.

B. The product is a new chemical entity that would have, if designated as a listed drug product, the effect of saving or creating efficiencies for the Government of Ontario, an average of at least $2,500,000 per year for the first three years the product is marketed in Ontario.

C. The product is a new chemical entity that would have, if designated as a listed drug product, the effect of saving the Ontario Drug Benefit Program an average of at least $250,000 per year for the first three years the product is marketed in Ontario;

(b) a letter authorizing the executive officer to gain access to all information with respect to the product in the possession of Health Canada, the Patented Medicine Prices Review Board established under section 91 of the Patent Act (Canada), the government of any province or territory in Canada or the Canadian Agency for Drugs and Technologies in Health and authorizing the executive officer to disclose any information with respect to the product in the possession of the Ministry to Health Canada, the Patented Medicine Prices Review Board, the government of a province or territory in Canada or the Canadian Agency for Drugs and Technologies in Health;

(c) an estimate of the net costs to the Ontario Drug Benefit Program in a three-year period;

(d) the proposed drug benefit price of the product;

(e) evidence that the manufacturer is able to supply the product at the proposed drug benefit price in a quantity sufficient to meet the anticipated demand for the product;

(f) certification in writing that no rebate as defined in subsection 11.5 (15) of the Act has been provided to a person listed in subsection 11.5 (1) of the Act with respect to the product contrary to the Act since Health Canada approved the product for sale in Canada;

(g) Revoked: O. Reg. 27/97, s. 1 (3).

(h) clinical studies and, if available, other clinical evidence of the product’s therapeutic effectiveness or efficacy and of the product’s safety, including any information that relates to adverse drug reactions and any existing clinical studies comparing the product’s therapeutic effectiveness or efficacy and the product safety to that of other products or treatments; and

(i) evidence demonstrating the benefit of the product in relation to the cost of the product and to alternative products or treatments. O. Reg. 201/96, s. 12 (1); O. Reg. 27/97, s. 1 (1-3); O. Reg. 495/00, s. 2 (1, 2); O. Reg. 338/03, s. 1; O. Reg. 645/05, s. 2; O. Reg. 459/06, s. 7 (1-4); O. Reg. 320/07, s. 2 (1).

(2)  If Health Canada has not approved a product monograph for a drug product, the manufacturer of the drug product may, instead of submitting a copy of the product monograph as required under clause (1) (a), submit to the executive officer the following information:

1. Pharmaceutical information.

2. Information with respect to the product’s clinical pharmacology.

3. Information as to the product’s indications and clinical use.

4. A list of any contra-indications, warnings or precautions in the use of the product and of possible adverse reactions to its use.

5. A list of symptoms of an overdose of the product and information as to the treatment of an overdose.

6. Information with respect to the dosage and administration of the product.

7. Information regarding the availability of dosage forms for each strength of the product marketed in Canada. O. Reg. 201/96, s. 12 (2); O. Reg. 495/00, s. 2 (3); O. Reg. 459/06, s. 7 (5).

(3)  A manufacturer may satisfy the condition set out in clause (1) (h) for a strength of a drug product by submitting the clinical evidence referred to in clause (1) (h) for another strength of the same dosage form of the drug product, if the evidence is sufficient for the purposes of evaluating the therapeutic effectiveness or efficacy and the safety of both the strengths of the dosage form of the product. O. Reg. 201/96, s. 12 (3).

(3.1)  A manufacturer may satisfy the condition set out in clause (1) (h) for a format of a drug product by submitting the clinical evidence referred to in clause (1) (h) for another format of the drug product, if the evidence is sufficient for the purposes of evaluating the therapeutic effectiveness or efficacy and safety of both the formats of the product. O. Reg. 495/00, s. 2 (4).

(4)  A manufacturer may satisfy the condition set out in clause (1) (h) for a drug product by submitting to the executive officer the clinical evidence referred to in clause (1) (h) with respect to another product and submitting evidence that satisfies the executive officer that the two products are bioequivalent. O. Reg. 201/96, s. 12 (4); O. Reg. 495/00, s. 2 (5); O. Reg. 459/06, s. 7 (6).

(5)  Subsection (4) does not apply if the drug product that the manufacturer seeks to have designated is the drug product of a drug for which there exists a listed drug product. O. Reg. 201/96, s. 12 (5).

(6)  Subsection (1) does not apply to a drug product that is proposed to be designated as an interchangeable product under the Drug Interchangeability and Dispensing Fee Act. O. Reg. 201/96, s. 12 (6); O. Reg. 355/08, s. 2.

(7)  If required by the executive officer, the manufacturer of the product shall enter into an agreement with the executive officer that specifies any volume discount or other amount that may be payable by the manufacturer to the Minister of Finance, and shall agree that the executive officer may make public the following information, and that information only, with respect to the agreement:

1. The name of the manufacturer.

2. The subject-matter of the agreement.

3. The fact of entering into or terminating the agreement. O. Reg. 459/06, s. 7 (7).

(8)  Despite subclause (1) (a) (ii), but subject to subsection (6), a product may not be designated as a listed drug product until evidence that satisfies subclause (1) (a) (i) is also received. O. Reg. 459/06, s. 7 (7).

(8.1)  It is a condition of being listed as a listed drug product that the manufacturer must not have provided a rebate as defined in subsection 11.5 (15) of the Act to a person listed in subsection 11.5 (1) of the Act with respect to the product contrary to the Act since Health Canada approved the product for sale in Canada. O. Reg. 320/07, s. 2 (2).

(9)  A strength and dosage form of a drug product that contains oxycodone as the only active ingredient and that is a long-acting product that has been formulated in a solid dosage form for oral administration shall not be designated as a listed drug product unless the following conditions are met:

1. There must be evidence satisfactory to the executive officer that the drug product exhibits one or more physiochemical properties that, when compared to drugs without the property or properties, make the drug product,

i. significantly more difficult to alter, break, crush, chew, dissolve or otherwise manipulate in such a way that it could be misused, abused or put to an intended use that is different than the use for which it is prescribed, or

ii. significantly less effective and less likely to be misused, abused or put to an intended use that is different than the use for which it is prescribed, if the product is altered, broken, crushed, chewed, dissolved or otherwise manipulated.

2. The evidence referred to in paragraph 1 must be demonstrated by,

i. in vitro testing,

ii. in vivo testing,

iii. another form of testing of equivalent reliability, or

iv. a combination of any of the forms of testing mentioned in subparagraphs i to iii. O. Reg. 20/13, s. 2.

(10)  In clause (1) (a),

“Government of Ontario” includes all ministries of the Government of Ontario, all programs and agencies funded by the Government of Ontario and all agencies that are established by Ontario statute or regulation but are not necessarily funded by the Government of Ontario. O. Reg. 459/06, s. 7 (7).

12.0.1  An agreement that was entered into under this section as it existed before October 1, 2006 continues in force until it expires according to its terms. O. Reg. 459/06, s. 8.

12.0.2  (1)  A drug product that is a private label product shall not be designated as a listed drug product. O. Reg. 220/10, s. 3.

(2)  In this section,

“private label product” includes a drug product in respect of which,

(a) the manufacturer applying for the designation of the product as a listed drug product does not directly fabricate the product itself, and,

(i) is not controlled by a person that directly fabricates the product, or

(ii) does not control the person that directly fabricates the product, and

(b) either,

(i) the manufacturer does not have an arm’s-length relationship with a wholesaler, an operator of a pharmacy or a company that owns, operates or franchises pharmacies, or

(ii) the product is to be supplied under a marketing arrangement associating the product with a wholesaler or one or more operators of pharmacies or companies that own, operate or franchise pharmacies. O. Reg. 220/10, s. 3.

Conditions to Continue to be a Designated Listed Drug Product

12.1  (1)  The following conditions must be met in order for a designated listed drug product to continue to be designated as a listed drug product:

1. The manufacturer of the product shall give the executive officer notice of any change made to the product, including a formulation change, and of any change in the ownership of the manufacturer.

2. The product must be authorized for sale under the Food and Drugs Act (Canada).

3. The manufacturer of the product must continue to be able to supply the product at the drug benefit price in a quantity that is sufficient to meet the demand for the product.

4. Where the manufacturer was a party to an agreement to which this paragraph, as it read before October 1, 2006, applied, the manufacturer shall continue to be a party to that agreement until it expires according to its terms.

5. Subject to paragraphs 6.1 and 6.2, if the product has been designated as interchangeable under the Drug Interchangeability and Dispensing Fee Act the drug benefit price of the product may not be more than the price that could be proposed to the executive officer under section 11.

6. Revoked: O. Reg. 220/10, s. 4 (2).

6.1 Paragraph 5 does not apply with respect to a product that has been designated as interchangeable with an original product where there is evidence satisfactory to the executive officer that,

i. the product is the only drug product of its type that is designated as interchangeable with an original drug product, and has been so designated for at least two years, and

ii. removing the product’s listing would result in significant patient safety or access concerns, or significant increased costs to the Government of Ontario.

6.2 Paragraph 5 does not apply with respect to a product that has been designated as interchangeable with an original product where the manufacturer of the interchangeable product has submitted evidence satisfactory to the executive officer of substantial raw material cost increases or substantial direct manufacturing cost increases, and the executive officer is satisfied that the criteria established under section 12.2 have been met establishing that it is in the public interest that the interchangeable product be listed at a higher drug benefit price.

7. If required by the executive officer, the manufacturer of the product shall enter into and remain a party to an agreement with the executive officer that specifies any volume discount or other amount that may be payable by the manufacturer to the Minister of Finance, and shall agree that the executive officer may make public the following information, and that information only, with respect to the agreement:

i. The name of the manufacturer.

ii. The subject-matter of the agreement.

iii. The fact of entering into or terminating the agreement.

8. If required by the executive officer, the manufacturer of a product that has been designated as interchangeable under the Drug Interchangeability and Dispensing Fee Act shall inform the executive officer of the price that the manufacturer receives for the product, net of the value of any ordinary commercial terms. O. Reg. 459/06, s. 9; O. Reg. 559/06, s. 2 (1, 2); O. Reg. 320/07, s. 3 (1-4); O. Reg. 355/08, s. 3 (1-3); O. Reg. 220/10, s. 4 (1-4).

(2)  For greater certainty, the conditions set out in subsection (1) apply whether the designation as a listed drug product or as an interchangeable product under the Drug Interchangeability and Dispensing Fee Act took place before, on or after July 1, 2010. O. Reg. 459/06, s. 9; O. Reg. 220/10, s. 4 (5).

(3)  Where the circumstances described in paragraph 6.1 or 6.2 of subsection (1) exist, the executive officer may, in the executive officer’s sole discretion, negotiate an agreement with the manufacturer for any drug benefit price, but,

(a) in no case may the interchangeable product be priced higher than the original product, unless,

(i) the manufacturer has submitted detailed information to the executive officer demonstrating why the product should be priced higher than the original product, and

(ii) the executive officer considers such a price to be in the public interest, having regard to the matters set out in subsection 22 (2) of the Act and to anything else the executive officer considers relevant; and

(b) in respect of a product for which the only applicable circumstances are those set out in paragraph 6.1 of subsection (1), if the circumstance set out in subparagraph 6.1 i of subsection (1) no longer applies, the drug benefit price of the product shall revert to a price that is less than or equal to 25 per cent of the drug benefit price of the original product as set out in the Formulary on the date that the product was first proposed for designation as a listed drug product. O. Reg. 220/10, s. 4 (6).

Establishing Criteria

12.2  Pursuant to subsection 1.1 (9) of the Act, it is provided that,

(a) the executive officer has the power to establish criteria that must be met for the purposes of paragraph 6.2 of subsection 12.1 (1) in order to establish that it is in the public interest to list a drug product at a higher drug benefit price; and

(b) the executive officer shall publish those criteria on the Ministry website. O. Reg. 355/08, s. 4.

Amounts Paid by Executive Officer

13.  (1)  For the purposes of paragraph 2 of subsection 6 (1) of the Act, the drug benefit price of a listed drug product is the price set out opposite the listed drug product in the Formulary. O. Reg. 201/96, s. 13 (1); O. Reg. 459/06, s. 10 (1).

(2)  For the purposes of paragraph 3 of subsection 6 (1) of the Act, the mark up on the drug benefit price of a listed drug product is 8 per cent of the drug benefit price. O. Reg. 201/96, s. 13 (2); O. Reg. 459/06, s. 10 (2).

(3)  Revoked: O. Reg. 459/06, s. 10 (3).

(4)  For the purpose of subclause 6 (2) (c) (i) of the Act, the dispensing fee for a listed drug product is the fee set out in Column 2 of the Table to this subsection opposite the description of the pharmacy in which the listed drug product is dispensed.

TABLE

Item

Column 1

Description Of Pharmacy

Column 2

Dispensing Fee

1.

Pharmacy other than a pharmacy provided for in item numbers 2, 3 or 4

$8.83

2.

Pharmacy located in a postal code with the second figure of 0 or with a score on the Ministry of Health and Long-Term Care’s Rurality Index for Ontario of more than 40, and one of the following conditions is met:

$9.93

 

    1. There is no other pharmacy within 5 kilometres.

 
 

    2. The nearest other pharmacy is no more than 5 kilometres away and is the only other pharmacy in a 5 kilometre radius.

 
 

    3. The nearest other pharmacy is at least 5 kilometres away but no more than 10 kilometres

 

3.

Pharmacy located in a postal code with the second figure of 0 or with a score on the Ministry of Health and Long-Term Care’s Rurality Index for Ontario of more than 40, and the nearest other pharmacy is at least 10 kilometres away but no more than 25 kilometres

$12.14

4.

Pharmacy located in a postal code with the second figure of 0 or with a score on the Ministry of Health and Long-Term Care’s Rurality Index for Ontario of more than 40, and the nearest other pharmacy is at least 25 kilometres away

$13.25

O. Reg. 220/10, s. 5.

(5)  Despite subsection (4), for the purposes of subclause 6 (2) (c) (i) of the Act, the dispensing fee for a listed drug product that is dispensed from one of the following locations or systems shall be the amount set out in item 1 of the Table to that subsection, without regard to item 2, 3 or 4.

1. A remote dispensing location within the meaning of the Drug and Pharmacies Regulation Act.

2. An automated pharmacy system that is operated in or by a public hospital within the meaning of the Public Hospitals Act, or another dispensing system operated in or by such a hospital that is substantially similar to a remote dispensing location mentioned in paragraph 1. O. Reg. 228/11, s. 2.

14.  (1)  For the purposes of subsections 4 (5), 6 (3) and (4) of the Act, the acquisition cost of a listed drug product supplied for an eligible person is the amount calculated by,

(a) determining, in accordance with subsection (2), the amount payable by the operator of the pharmacy to the manufacturer or wholesaler of the listed drug product for a shipment or order of the product, a portion of which was supplied for the eligible person;

(b) dividing the amount determined under clause (a) by the number of units of the listed drug product purchased from the manufacturer or wholesaler; and

(c) multiplying the unit cost determined under clause (b) by the number of units of the product or drug supplied for the eligible person. O. Reg. 201/96, s. 14 (1); O. Reg. 459/06, s. 11 (1).

(2)  The amount payable referred to in clause (1) (a) shall be the full amount payable for a shipment or order of a listed drug product less any amount charged for shipping and handling of the listed drug product. O. Reg. 459/06, s. 11 (2).

(3)  The operator of a pharmacy may submit a claim for payment in accordance with subsection 6 (3) of the Act where the executive officer is satisfied that,

(a) Revoked: O. Reg. 559/06, s. 3 (2).

(b) the operator of a pharmacy is unable to acquire an interchangeable drug product and must dispense the original product or an interchangeable product with a higher drug benefit price. O. Reg. 559/06, s. 3.

15.  (1)  The drug benefit price of a drug for which there is not a listed drug product, and to which the executive officer has made the Act apply under section 16 of the Act, shall be the price agreed to by the manufacturer and the executive officer. O. Reg. 459/06, s. 12.

(2)  The amount that the executive officer shall pay under subsection (1) shall be the amount as determined in section 6 of the Act and, if applicable, includes a compounding fee determined by the executive officer under subsection 17 (2) of the Act. O. Reg. 459/06, s. 12.

(3)  The executive officer shall publish the price agreed to under subsection (1) on the Ministry’s website. O. Reg. 459/06, s. 12.

16.  Revoked: O. Reg. 459/06, s. 12.

17.  (1)  The amount the executive officer shall pay a physician under subsection 5 (3) of the Act is the amount calculated by adding the amounts determined under paragraphs 1, 2 and 3 and subtracting from that total the maximum co-payment that may be charged in respect of the supplying of a listed drug product for an eligible person:

1. The dispensing fee determined under subsection (2).

2. The drug benefit price set out opposite the listed drug product in the Formulary but, if there are other listed drug products that are interchangeable with the drug product, the drug benefit price shall be deemed to be the lowest of the drug benefit prices for the drug product and the listed drug products that are interchangeable with it.

3. A mark up equal to 8 per cent of the drug benefit price. O. Reg. 459/06, s. 13.

(2)  The dispensing fee referred to in paragraph 1 of subsection (1) shall be,

(a) in the case of a physician whose office is within 20 kilometres of an accredited pharmacy, $4.28; and

(b) in any other case, $5.10. O. Reg. 459/06, s. 13 (1).

(3)  Subsections 6 (3), (4) and (5) of the Act and sections 14 and 15 of this Regulation apply with necessary modifications with respect to amounts payable by the executive officer to physicians under subsection 5 (3) of the Act. O. Reg. 459/06, s. 13 (1).

Limits on Amounts Paid by Executive Officer

18.  (1)  If an eligible person is entitled to receive drug benefits under the Ontario Works Act 1997, the executive officer is only required to pay under the Act for the quantity of a listed drug product supplied for the person at one time that is sufficient for a 35-day course of treatment. O. Reg. 301/02, s. 1; O. Reg. 459/06, s. 14 (1).

(2)  If an eligible person will be leaving Ontario for a period of at least 100 consecutive days within six months after the day a listed drug product is supplied for the person, the executive officer is only required to pay under the Act for the quantity of the product supplied for the person at one time that is sufficient for a 100-day course of treatment. O. Reg. 301/02, s. 1; O. Reg. 459/06, s. 14 (2).

(3)  The executive officer is only required to pay under the Act for the quantity of a listed drug product supplied for an eligible person, other than a person mentioned in subsection (1) or (2), at one time that is sufficient for a 30-day course of treatment if the product supplied is a product other than insulin and if the product supplied has not been supplied for the person within the previous 12-month period. O. Reg. 301/02, s. 1; O. Reg. 459/06, s. 14 (3).

(4)  Despite subsection (3), the executive officer is required to pay for the quantity of a listed drug product described in that subsection that is sufficient for a 100-day course of treatment if, in the opinion of the person dispensing the product, the person will not be able to obtain a further supply of the product at the end of a 30-day course of treatment. O. Reg. 301/02, s. 1; O. Reg. 459/06, s. 14 (4).

(5)  The executive officer is only required to pay under the Act for the quantity of a listed drug product supplied for an eligible person, other than a person mentioned in subsection (1) or (2), at one time that is sufficient for a 100-day course of treatment if the listed drug product supplied is a product other than one mentioned in subsection (3). O. Reg. 301/02, s. 1; O. Reg. 459/06, s. 14 (5).

(6)  The following rule applies for the purposes of subsections (2), (4) and (5):

1. If a listed drug product is supplied for a person who is part of the eligible class of persons designated under section 3 and if, by supplying a 100-day course of treatment of the product, the last day of the course of treatment would be more than 30 days after the end of the period for which the person is eligible, the executive officer is only required under the Act to pay for the quantity of the listed drug product sufficient for a course of treatment that ends 30 days after the end of the period for which the person is eligible. O. Reg. 301/02, s. 1; O. Reg. 459/06, s. 14 (6).

(7)  It is a condition for payment of a dispensing fee that the dispenser supply at one time to an eligible person the lesser of,

(a) the maximum quantity of a listed drug product for which the executive officer is required to pay under subsections (1) to (6); or

(b) the entire quantity of the listed drug product specified in the prescription to be dispensed at one time. O. Reg. 264/08, s. 1 (1).

(8)  The condition for payment of a dispensing fee set out in subsection (7) does not apply if,

(a) the listed drug product is a product or belongs to a class of drug product that is specified by the executive officer and published on the Ministry website;

(b) the eligible person is a resident of,

(i) a long-term care home under the Long-Term Care Homes Act, 2007, or

(ii) any other residential facility funded by the Government of Ontario that is designated by the executive officer and published on the Ministry website; or

(c) the dispenser has determined that the quantity supplied should be less than the amount required under subsection (7) because,

(i) in the dispenser’s professional opinion, the eligible person is incapable of managing his or her medication as a result of physical, cognitive or sensory impairment, and

(ii) the eligible person or the person presenting the prescription agrees that the quantity supplied should be less than the amount required under subsection (7). O. Reg. 264/08, s. 1 (1, 2).

(9)  Where the dispenser has made a determination under clause (8) (c),

(a) the dispenser shall make a written record of the reasons for his or her opinion under subclause (8) (c) (i) and shall provide a copy of the record to the executive officer on request; and

(b) the dispenser shall obtain in writing the agreement required under subclause (8) (c) (ii) of the eligible person or of the person presenting the prescription. O. Reg. 264/08, s. 1 (1).

(10)  Except in the case of a listed drug product dispensed under clause (8) (a) or (b), the executive officer shall not pay more than two dispensing fees for the supply of a listed drug product in a calendar month even if the prescription specifies intervals such that the listed drug product is to be dispensed in more than two intervals in the calendar month. O. Reg. 264/08, s. 1 (1).

(11)  Pursuant to subsection 1.1 (9) of the Act, it is provided that the executive officer has the power,

(a) to specify a listed drug product or class of listed drug product for the purposes of clause (8) (a); and

(b) to designate a residential facility for the purposes of subclause (8) (b) (ii). O. Reg. 264/08, s. 1 (1).

(12)  If the executive officer specifies a listed drug product or class of listed drug product under clause (11) (a) or designates a residential facility under clause (11) (b), he or she shall publish the specification or designation on the Ministry website. O. Reg. 264/08, s. 1 (1).

19.  (1)  For the purposes of subsections 4 (6) and 6 (5) of the Act, the executive officer shall not pay the amount determined under subsection 4 (5) of the Act in respect of a prescription that contains a direction that there be no substitutions unless,

(a) in the case of a written prescription,

(i) the prescription is accompanied by a form completed and signed by the prescriber in which the interchangeable product that caused the adverse reaction is identified, and

(ii) the direction is made by the prescriber writing “no sub” or “no substitutions” on the prescription; and

(b) in the case of an oral prescription, the prescriber satisfies the operator of the pharmacy or the dispensing physician that a form in which the interchangeable product that caused the adverse reaction is identified has been completed and signed by the prescriber and will be delivered to the operator of the pharmacy or the dispensing physician forthwith. O. Reg. 201/96, s. 19 (1); O. Reg. 459/06, s. 15.

(2)  The form referred to in clauses (1) (a) and (b) is the Health Canada adverse drug reaction form and is available from Health Canada or from the Ministry. O. Reg. 201/96, s. 19 (2).

20.  The amount payable by the executive officer to the operator of a pharmacy in respect of methadone provided to an eligible person is an amount determined by an agreement between the operator and the executive officer. O. Reg. 459/06, s. 16.

Co-payment

20.1  For the purposes of subsection 6 (1) of the Act and subject to section 20.2, the maximum co-payment that the operator of a pharmacy may charge a person other than the executive officer in respect of supplying a listed drug product for an eligible person is $2 or the operator’s usual and customary dispensing fee, whichever is less. O. Reg. 324/96, s. 2; O. Reg. 459/06, s. 17.

20.2  (1)  If a listed drug product is supplied for an eligible person described in subsection (3), the maximum co-payment that the operator of a pharmacy may charge in respect of the supply of the drug product for that eligible person shall be determined in accordance with this section. O. Reg. 83/98, s. 3 (1).

(2)  In this section,

“allowable drug costs” means the sum of,

(a) any amount spent on co-payments in respect of listed drug products supplied for an eligible person in the current fiscal period, and

(b) any amount spent in respect of nutritional products or diabetic testing agents supplied for the eligible person in the current fiscal period that, in the absence of the co-payment scheme applied in respect of those products and agents, would have been paid by the Ministry as specified in the Formulary;

“annual net income” means the amount indicated on line 236 of the Notice of Assessment issued under the Income Tax Act (Canada) for the relevant taxation year or, if no Notice of Assessment has been issued, the amount that would appear on that line had the Notice of Assessment been issued, in either case minus both,

(a) the amount of income from the Universal Child Care Benefit program of the Government of Canada that was reported or that should have been reported on line 117 of the relevant Canadian income tax return, and

(b) the amount withdrawn from Canadian Registered Disability Saving Plans that was reported or that should have been reported on line 125 of the relevant Canadian income tax return;

“deductible amount” means an amount determined in accordance with subsections (6), (7), (8), (9) and (10);

“fiscal period” means the period of July 15, 1996 to March 31, 1997, the period of April 1, 1997 to July 31, 1998 and each succeeding 12-month period that commences on August 1 of each year and ends on July 31 of the following year;

“relevant taxation year” means, with respect to a person, the person’s most recent taxation year, or such other taxation year, as may be determined in accordance with section 20.3. O. Reg. 83/98, s. 3 (1); O. Reg. 459/06, s. 18 (1); O. Reg. 556/06, s. 3; O. Reg. 94/09, s. 3.

(3)  This section applies with respect to eligible persons referred to in paragraph 4 of subsection 2 (1) who are not part of any other class of eligible persons under the Act. However, the section does not apply if,

(a) the eligible person,

(i) has an annual net income of less than $16,018 and is single, or is no longer cohabiting with his or her spouse because the spouse is a person mentioned in paragraph 2, 5, 6 or 7 of subsection 2 (1), or

(ii) cohabits with a spouse and, together with his or her spouse, has an annual net income of less than $24,175; and

(b) the Ministry has been informed of the facts referred to in clause (a). O. Reg. 324/96, s. 2; O. Reg. 83/98, s. 3 (2, 3); O. Reg. 69/00, s. 8 (1); O. Reg. 90/03, s. 1; O. Reg. 334/05, s. 3.

(4)  Revoked: O. Reg. 69/00, s. 8 (2).

(5)  The maximum co-payment that may be charged in respect of the supply of a listed drug product for an eligible person under this section during a fiscal period shall be determined in accordance with the following rules:

1. Until the eligible person’s allowable drug costs for the fiscal period reach the deductible amount, the maximum co-payment that may be charged shall be the amount equal to the full amount otherwise payable by the executive officer under section 6 of the Act in respect of the supply of the drug product less,

i. if the drug product is supplied in a pharmacy operated in a hospital approved as a public hospital under the Public Hospitals Act, $4.17,

ii. if the drug product is supplied by a physician whose office is within 20 kilometres of an accredited pharmacy, 23 cents,

iii. if the drug product is supplied by a physician whose office is more than 20 kilometres from an accredited pharmacy, 27 cents, and

iv. in all other cases, the amount, if any, by which the dispensing fee exceeds $6.11.

2. Despite paragraph 1, if charging the maximum co-payment permitted under that paragraph would result in the eligible person’s allowable drug costs for the current fiscal period exceeding the deductible amount, the maximum co-payment that may be charged shall be the difference between the deductible amount and the amount of the eligible person’s allowable drug costs paid so far in the current fiscal period.

3. On or after the day the eligible person’s allowable drug costs for the fiscal period reach or exceed the deductible amount, the maximum co-payment that may be charged for the remainder of the fiscal period shall be,

i. if the drug product is supplied in a pharmacy operated in a hospital under the Public Hospital Act, $2.83,

ii. Revoked: O. Reg. 459/06, s. 18 (3).

iii. if the drug product is supplied by a physician whose office is within 20 kilometres of an accredited pharmacy, $4.05,

iv. if the drug product is supplied by a physician whose office is more than 20 kilometres from an accredited pharmacy, $4.83,

v. in all other cases, the lesser of $6.11 or the amount the operator of the pharmacy that supplied the drug product sets as its dispensing fee under subsection 6 (1) of the Drug Interchangeability and Dispensing Fee Act. O. Reg. 83/98, s. 3 (4); O. Reg. 74/99, s. 3; O. Reg. 459/06, s. 18 (2, 3).

(6)  For the purposes of subsection (5), the deductible amount used to determine the maximum co-payment that may be charged for the supply of a listed drug product for an eligible person during any fiscal period shall be as follows:

1. For any fiscal period other than the fiscal period referred to in paragraph 2, $100.

2. For the fiscal period in which the person to whom this section applies becomes eligible under the Act, the amount determined in accordance with subsections (8), (9) and (10). O. Reg. 83/98, s. 3 (4).

(7)  If a person becomes eligible under the Act during a fiscal period other than the fiscal period referred to in subsection (8), the deductible amount used under subsection (5) to determine the maximum co-payment that may be charged during the fiscal period for the supply of a listed drug product for that eligible person shall be the percentage of $100 that is equal to the result obtained by dividing the number of months in the fiscal period by the number of months during the fiscal period that the person is eligible. O. Reg. 83/98, s. 3 (4).

(8)  If a person becomes eligible under the Act during the period of April 1, 1996 to March 31, 1997, the deductible amount used under subsection (5) to determine the maximum co-payment that may be charged during the fiscal period of July 15, 1996 to March 31, 1997 shall be the percentage of $100 that is equal to the result obtained by dividing the number of months in the period of April 1, 1996 to March 31, 1997 by the number of months during that period that the person is eligible. O. Reg. 83/98, s. 3 (4).

(9)  Tables 1, 2 and 3 to this subsection set out the deductible amount determined in accordance with subsections (7) and (8) applicable to the following fiscal periods:

1. The deductible amount applicable for the fiscal period that begins on July 15, 1996 and ends on March 31, 1997 with respect to a person who becomes eligible under the Act between April 1, 1996 and March 31, 1997 is set out in Column 2 to Table 1 opposite the period during which the person becomes eligible set out in Column 1 to the Table.

2. The deductible amount applicable for the fiscal period that begins on April 1, 1997 and ends on July 31, 1998 with respect to a person who becomes eligible under the Act during that fiscal period is set out in Column 2 to Table 2 opposite the period during which the person becomes eligible set out in Column 1 to the Table.

3. The deductible amount applicable for any fiscal period that begins after the fiscal period referred to in paragraph 2 with respect to a person who becomes eligible under the Act during the fiscal period is set out in Column 2 to Table 3 opposite the period during which the person becomes eligible set out in Column 1 to the Table.

TABLE 1

Column 1

Column 2

Period in which person becomes eligible

Deductible Amount

On or before April 1, 1996

$100.00

On or after April 2, 1996 but before May 2, 1996

91.67

On or after May 2, 1996 but before June 2, 1996

83.33

On or after June 2, 1996 but before July 2, 1996

75.00

On or after July 2, 1996 but before August 2, 1996

66.67

On or after August 2, 1996 but before September 2, 1996

58.33

On or after September 2, 1996 but before October 2, 1996

50.00

On or after October 2, 1996 but before November 2, 1996

41.67

On or after November 2, 1996 but before December 2, 1996

33.33

On or after December 2, 1996 but before January 2, 1997

25.00

On or after January 2, 1997 but before February 2, 1997

16.67

On or after February 2, 1997 but before April 1, 1997

8.33

TABLE 2

Column 1

Column 2

Period in which person becomes eligible

Deductible Amount

On or before April 1, 1997

$100.00

On or after April 2, 1997 but before May 2, 1997

93.75

On or after May 2, 1997 but before June 2, 1997

87.50

On or after June 2, 1997 but before July 2, 1997

81.25

On or after July 2, 1997 but before August 2, 1997

75.00

On or after August 2, 1997 but before September 2, 1997

68.75

On or after September 2, 1997 but before October 2, 1997

62.50

On or after October 2, 1997 but before November 2, 1997

56.25

On or after November 2, 1997 but before December 2, 1997

50.00

On or after December 2, 1997 but before January 2, 1998

43.75

On or after January 2, 1998 but before February 2, 1998

37.50

On or after February 2, 1998 but before March 2, 1998

31.25

On or after March 2, 1998 but before April 2, 1998

25.00

On or after April 2, 1998 but before May 2, 1998

18.75

On or after May 2, 1998 but before June 2, 1998

12.50

On or after June 2, 1998 but before August 1, 1998

6.25

TABLE 3

Column 1

Column 2

Month in which person becomes eligible

Deductible Amount

On or before August 1

$100.00

On or after August 2 but before September 2

91.67

On or after September 2 but before October 2

83.33

On or after October 2 but before November 2

75.00

On or after November 2 but before December 2

66.67

On or after December 2 but before January 2

58.33

On or after January 2 but before February 2

50.00

On or after February 2 but before March 2

41.67

On or after March 2 but before April 2

33.33

On or after April 2 but before May 2

25.00

On or after May 2 but before June 2

16.67

On or after June 2 but before August 1

8.33

O. Reg. 83/98, s. 3 (4).

20.3  (1)  The annual net income for an eligible person referred to in subclause 20.2 (3) (a) (i) shall be the annual net income for his or her most recent taxation year. O. Reg. 83/98, s. 4.

(2)  The annual net income for a couple under subclause 20.2 (3) (a) (ii) shall be determined based on each person’s annual net income for his or her most recent taxation year. O. Reg. 83/98, s. 4.

(3)  A person’s most recent taxation year is the person’s taxation year that ended before the beginning of the fiscal period during which the listed drug product is supplied. O. Reg. 83/98, s. 4.

(4)  Despite subsections (1) and (2), an eligible person may elect, for the fiscal period that begins on April 1, 1997 and ends on July 31, 1998,

(a) if he or she is single, to have his or her annual net income be the annual net income for his or her taxation year immediately preceding his or her most recent taxation year; and

(b) if he or she has a spouse, to have the couple’s annual net income be the sum of both person’s annual net income for their taxation year immediately preceding their most recent taxation year. O. Reg. 83/98, s. 4; O. Reg. 69/00, s. 9 (1); O. Reg. 334/05, s. 4 (1).

(5)  Despite subsection (1), an eligible person who is single may elect to have his or her annual net income determined based on his or her annual net income for the taxation year immediately following his or her most recent taxation year if the election would result in a difference of 10 per cent or more in the person’s annual net income. O. Reg. 83/98, s. 4.

(6)  Despite subsection (2), an eligible person who has a spouse may elect to have their annual net income determined based on each person’s annual net income for the taxation year immediately following his or her most recent taxation year if the election would result in a difference of 10 per cent or more in the couple’s annual net income. O. Reg. 83/98, s. 4; O. Reg. 69/00, s. 9 (2); O. Reg. 334/05, s. 4 (2).

(7)  Subsections 4 (6) and (7) apply to the determination of the annual net income of a person or couple who makes an election under subsection (5) or (6). O. Reg. 83/98, s. 4.

Amount Charged to Person Other Than Executive Officer

21.  (1)  In addition to any amounts authorized in the Act, the operator of a pharmacy who supplies a listed drug product for an eligible person may charge, or accept payment from, a person other than the executive officer in accordance with this section. O. Reg. 201/96, s. 21 (1); O. Reg. 459/06, s. 19 (1).

(2)  If the quantity of a listed drug product supplied at one time for an eligible person exceeds the maximum quantity for which the executive officer may pay under section 18, the operator of the pharmacy that supplied the product may charge a person other than the executive officer an amount in respect of the additional quantity supplied. O. Reg. 201/96, s. 21 (2); O. Reg. 459/06, s. 19 (2).

(3)  The operator of a pharmacy shall not charge an amount under subsection (2) unless,

(a) the operator explains to the person who purchases the listed drug product the reason for the charge; and

(b) the operator gives the person the choice of receiving the additional quantity of the product and paying for it or of receiving only the quantity of the product for which the executive officer is required to pay under section 18. O. Reg. 201/96, s. 21 (3); O. Reg. 459/06, s. 19 (3).

(4)  An operator of a pharmacy who supplies a listed drug product for an eligible person may charge a person other than the executive officer an amount equal to the amount otherwise payable by the executive officer under subsection 5 (1) or (3) of the Act if the person elects to pay the amount and, before the product is supplied, the person is advised that, subject to any co-payment, the product is available free of charge. O. Reg. 201/96, s. 21 (4); O. Reg. 459/06, s. 19 (4).

(5)  If the premises from which the operator of a pharmacy dispenses drugs are not electronically connected to the Health Network and, as a result, the operator does not submit claims by direct electronic transmission in accordance with section 24, the operator may charge, or accept payment from, a person other than the executive officer in respect of supplying a listed drug product for an eligible person in an amount equal to the amount that would have been payable by the executive officer were the operator entitled to be paid under subsection 5 (4) of the Act. O. Reg. 324/96, s. 3; O. Reg. 459/06, s. 19 (5).

(6)  In subsection (5),

“Health Network” has the same meaning as in subsection 23 (1). O. Reg. 324/96, s. 3.

22.  For the purposes of subsection 4 (2) of the Act, a physician may charge, or accept payment from, a person other than the executive officer in such amounts as may be charged by the operator of a pharmacy under subsection 4 (3), (4) or (5) of the Act or under section 21 of this Regulation. O. Reg. 201/96, s. 22; O. Reg. 459/06, s. 20.

Miscellaneous

23.  (1)  In sections 24 to 30,

“claim reversal” means a claim submitted to the executive officer to cancel a claim for payment that was previously submitted to the executive officer under the Act;

“Health Network” means the electronic information retrieval system used by the Ministry to receive and process claims for payment under the Act;

“Manual” means the Ontario Drug Programs Reference Manual dated September 1, 2005, available from the Ministry of Health and Long-Term Care. O. Reg. 201/96, s. 23 (1); O. Reg. 484/05, s. 3; O. Reg. 55/06, s. 2; O. Reg. 459/06, s. 21 (1).

(2)  For the purposes of sections 24 to 30, a claim for payment made under the Act does not include a claim reversal. O. Reg. 201/96, s. 23 (2).

(3)  For the purposes of sections 24 to 30, anything submitted to or done by the Minister before October 1, 2006 shall be deemed to have been submitted to or done by the executive officer. O. Reg. 459/06, s. 21 (2).

24.  (1)  An operator of a pharmacy or a physician who submits a claim for payment from the executive officer under the Act or a claim reversal shall submit the claim to the executive officer by direct electronic transmission via the Health Network. O. Reg. 201/96, s. 24 (1); O. Reg. 459/06, s. 22 (1).

(2)  Despite subsection (1), the following claims may be submitted on paper:

1. A claim for payment that is submitted to the executive officer more than seven days after the drug is supplied because proof that the drug is for an eligible person is not provided to the operator of the pharmacy or physician who supplied the drug until that time.

2. A claim reversal that is made more than seven days after the day the original claim to which the claim reversal relates was submitted.

3. A claim for payment requiring more than two codes, as set out in the Manual.

4. A claim for payment by the executive officer in respect of supplying a listed drug product where the amount claimed is $10,000 or more.

5. A claim for payment for the supply of an extemporaneous preparation where the claim indicates that time spent on the compounding of the preparation was 100 minutes or more.

6. A claim for payment that is determined by the Ministry to be eligible for submission following a review by the Ministry or an inspection carried out under section 14 of the Act.

7. A claim for payment that is submitted in accordance with subsection 26 (3). O. Reg. 201/96, s. 24 (2); O. Reg. 324/96, s. 4; O. Reg. 574/99, s. 1; O. Reg. 55/06, s. 3 (1); O. Reg. 459/06, s. 22 (2, 3).

(3)  Except for claims submitted under paragraph 6 of subsection (2), claims for payment that are submitted on paper shall be submitted no more than six months from the day on which the service giving rise to the claim was provided. O. Reg. 55/06, s. 3 (2).

25.  (1)  A claim for payment from the executive officer under the Act shall contain the following information:

1. The bank identification number of the Ontario Drug Benefit Program, as assigned by the Canadian Payments Association.

2. The pharmacy claim standard version number used to transmit the claim.

3. The code for identifying the transaction as a claim for payment, as set out in the Manual.

4. The code for identifying the pharmacy’s or physician’s computer system, as set out in the Manual.

5. The code assigned by the software vendor to identify the version of the pharmacy’s or physician’s software.

6. The pharmacy identification code, as assigned by the executive officer to the pharmacy or the physician.

7. A number assigned to the transaction by the operator of a pharmacy or the physician.

8. The prescription number recorded on the prescription for the listed product supplied by the person dispensing the product.

9. The drug identification number of the listed drug product supplied or, in the case of a product other than a listed drug product, the product identification number assigned by the executive officer to the product supplied.

10. The Ontario drug benefit eligibility number together with any version code that may appear on the health card of the eligible person for whom the listed drug product was supplied.

11. The first and last names of the eligible person for whom the listed drug product was supplied.

12. The year, month and day on which the listed drug product was supplied.

13. The quantity of the listed drug product supplied.

14. The number of days of treatment contained in the prescription, as estimated by the operator of the pharmacy or the physician.

15. The drug cost amount or, if the acquisition cost of the drug is payable under the Act, the acquisition cost of the drug supplied.

16. The dispensing fee for supplying the drug and the mark up on the drug, if any.

17. The total amount claimed by the operator of the pharmacy or physician for the supplying of the drug.

18. Any other information that is necessary to process the amount payable on the claim. O. Reg. 201/96, s. 25 (1); O. Reg. 459/06, s. 23 (1-3); O. Reg. 320/07, s. 4 (1).

(2)  A claim for payment by the executive officer under the Act with respect to the supplying of an extemporaneous preparation for an eligible person shall include, in addition to the information required under subsection (1), the following information:

1. The drug benefit price or, if the acquisition cost of the ingredient is payable under the Act, the acquisition cost of each ingredient and the total costs of all the ingredients.

2. The length of time in minutes that was spent compounding the ingredients, not including the time required to dispense the preparation and the amount claimed for the time spent compounding the preparation.

3. The product identification number assigned by the executive officer to the extemporaneous preparation or, if there is no product identification number,

i. the drug identification number of the ingredient used in the preparation that has the highest cost, and

ii. the unlisted compound code assigned by the executive officer to the preparation, as set out in the Manual. O. Reg. 201/96, s. 25 (2); O. Reg. 459/06, s. 23 (4-6).

(3)  If an operator of a pharmacy or a physician makes a claim for payment of the acquisition cost of a listed drug product under subsection 6 (3) of the Act, the claim for payment with respect to the supplying of the listed drug product shall include, in addition to the information required under subsection (1), the following information:

1. The acquisition cost of the listed drug product in accordance with section 14.

2. The code for identifying the claim as being one to which subsection 6 (3) of the Act applies, as set out in the Manual.

3. Any other information that is necessary to calculate the cost to the operator of the pharmacy or the physician of the listed drug product. O. Reg. 201/96, s. 25 (3); O. Reg. 320/07, s. 4 (2).

(4)  If an operator of a pharmacy or a physician makes a claim for payment under the Act with respect to the supplying of a drug to which the executive officer has made the Act apply under section 16 of the Act, the claim shall include, in addition to the information required under subsection (1), the following information:

1. The drug cost amount of the drug as determined under section 15 of this Regulation.

2. Revoked: O. Reg. 320/07, s. 4 (4).

3. Any other information that is necessary to calculate the cost to the operator of the pharmacy or the physician of the drug. O. Reg. 201/96, s. 25 (4); O. Reg. 459/06, s. 23 (7-9); O. Reg. 320/07, s. 4 (3, 4).

(5)  If the operator of a pharmacy or a physician makes a claim for payment under the Act with respect to the supplying of a listed drug product pursuant to a prescription that contains a direction that there be no substitutions, the claim shall include, in addition to the information required under subsection (1), the following information:

1. The code for identifying the claim as being one to which subsection 6 (5) of the Act applies, as set out in the Manual.

2. Any other information that is necessary to calculate the cost to the operator of the pharmacy or the physician of the listed drug product. O. Reg. 201/96, s. 25 (5).

(6)  If the operator of a pharmacy or a physician makes a claim for payment on paper under subsection 24 (2), the claim shall be submitted on a form that is provided by the Ministry and is completed and signed by the operator of a pharmacy or by the physician, as the case may be, and shall include all the information required under subsection (1) other than the information referred to in paragraphs 1, 2, 4, 5 and 7 of that subsection and shall include the information required under subsections (2), (3), (4) and (5), if applicable. O. Reg. 201/96, s. 25 (6).

26.  (1)  In a claim reversal, the operator of a pharmacy or physician shall include the following information:

1. The code used to identify the claim as a claim reversal, as set out in the Manual.

2. The pharmacy claim standard version number used to transmit the claim, as set out in the Manual.

3. The information referred to in paragraphs 1, 2, 4, 5, 6, 7, 8, 10 and 12 of subsection 25 (1).

4. The intervention and exception code, if applicable, as set out in the Manual. O. Reg. 201/96, s. 26 (1).

(2)  If a claim reversal is made on paper under subsection 24 (2), the operator of the pharmacy or the physician, as the case may be,

(a) shall submit the claim on a form provided by the Ministry, completed and signed by the operator of the pharmacy or the physician; and

(b) despite paragraph 3 of subsection (1), shall not include the information referred to in paragraphs 1, 2, 4, 5 and 7 of subsection 25 (1) in the claim. O. Reg. 201/96, s. 26 (2).

(3)  If, after a claim for payment of the acquisition cost of a listed drug product under subsection 6 (3) of the Act is submitted, the acquisition cost of the listed drug product is varied as a result of a price reduction given to the operator of the pharmacy or the physician in respect of the listed drug product, the operator of the pharmacy or the physician, as the case may be, shall submit to the executive officer forthwith,

(a) a claim reversal that includes the information required under subsection (1); and

(b) a new claim for payment that includes a revised calculation of the cost of the listed drug product. O. Reg. 55/06, s. 4; O. Reg. 459/06, s. 24.

27.  For the purposes of sections 11.1 and 11.2 of the Act, the following are prescribed conditions:

1. The operator of the pharmacy or the physician, as the case may be, must be a party to a subscription agreement with the Ministry whereby the operator or physician agrees to have the premises from which he or she dispenses drugs connected electronically to the Health Network and to submit all claims for payment under the Act via the Health Network.

2. The operator of the pharmacy or the physician must comply with the terms and conditions of the subscription agreement referred to in paragraph 1.

3. The operator of a pharmacy or the physician must comply with,

i. the Act and its regulations, and

ii. any other statute and its regulations related to the operation of a pharmacy or the practice of a physician including, without limitation and as applicable, the Drug Interchangeability and Dispensing Fee Act, the Drug and Pharmacies Regulation Act, the Narcotics Safety and Awareness Act, 2010, the Regulated Health Professions Act, 1991, the Pharmacy Act, 1991, the Medicine Act, 1991, the Personal Health Information Protection Act, 2004, the Food and Drugs Act (Canada), the Criminal Code (Canada), and the Controlled Drugs and Substances Act (Canada).

4. Without limiting the condition set out in paragraph 3, the operator of the pharmacy or the physician must not have committed an offence under the laws of Canada or Ontario related to fraud in the operation of the pharmacy or, in the case of a physician, in the practice of medicine.

5. The operator of the pharmacy or the physician must comply with the Manual.

6. The operator of the pharmacy or the physician must not submit any claims that the operator or physician knows or reasonably ought to know are false, inaccurate or misleading. O. Reg. 264/08, s. 2; O. Reg. 20/13, s. 3.

28.  (1)  An eligible person who is entitled to be paid by the executive officer under section 11.3 of the Act shall submit a claim for payment by the executive officer on paper. O. Reg. 201/96, s. 28 (1); O. Reg. 459/06, s. 26.

(2)  An eligible person who submits a claim under section 11.3 of the Act shall include the following information in the claim:

1. The name and full address of the person.

2. The receipt provided upon payment for the listed drug product.

3. The Ontario drug benefit eligibility number of the person.

4. The drug identification number of the listed drug product supplied.

5. The quantity of the listed drug product supplied. O. Reg. 201/96, s. 28 (2); O. Reg. 320/07, s. 5.

28.1  (1)  If the operator of a pharmacy charges a person other than the executive officer an amount under subsection 21 (5) in respect of supplying a listed drug product, the eligible person for whom the product was supplied is entitled to be paid by the executive officer the amount that would have been paid to the operator of a pharmacy had the operator been entitled to payment under subsection 5 (4) of the Act. O. Reg. 324/96, s. 5; O. Reg. 459/06, s. 27.

(2)  An eligible person who is entitled to be paid under subsection (1) may submit a claim for payment on paper and the claim shall include the information set out in subsection 28 (2). O. Reg. 324/96, s. 5.

(3)  This section applies to an eligible person who submits a claim in respect of supplying a listed drug product for which a person was charged by a physician under section 22 in accordance with subsection 21 (5). O. Reg. 324/96, s. 5.

29.  (1)  Every operator of a pharmacy and physician shall retain the records set out in Column 1 of the Table to this subsection for a minimum of the period of time indicated opposite the record in Column 2 of the Table.

TABLE

Column 1

Column 2

A copy of a statement of daily transaction totals prepared each day.

A period of two years from the day on which the daily statement is prepared.

A copy of each summary remittance statement or reject statement received from the executive officer.

A period of two years from the day on which the statement is received.

A copy of each claim for payment or claim reversal submitted to the Ministry, together with a record of the date on which the claim was submitted.

A period of two years from the day on which each claim is submitted.

The monthly Ontario drug benefit eligibility card or a copy of the card with respect to each eligible person for whom a drug is dispensed.

A period of two years from the day on which the first drug is dispensed for the eligible person.

Each prescription received that contains a direction that there be no substitution, as well as a copy of the Health Canada adverse drug reaction form received with the prescription.

A period of two years from the date on which the form was received.

Each prescription received that contains a Reason For Use Code, as set out in the Formulary, which shall be deemed to be confirmation by the prescriber that the applicable clinical criteria for limited use set out in the Formulary have been met.

A period of two years from the date on which the prescription was received.

For each extemporaneous preparation supplied for an eligible person, the formula of the preparation, set out in a manner that clearly indicates all the ingredients and the quantities of those ingredients, the cost of each ingredient and the compounding time.

A period of two years from the date on which the preparation was supplied.

In all cases where the acquisition cost of a drug is claimed, a copy of the supplier’s invoice and a detailed calculation in accordance with section 14 of the cost of purchasing the drug product.

A period of two years from the date on which the invoice is received.

The record required under clause 18 (9) (a).

A period of two years from the date on which the record is made.

The written agreement required under clause 18 (9) (b).

A period of two years from the date on which the written agreement is received.

O. Reg. 201/96, s. 29 (1); O. Reg. 484/05, s. 4; O. Reg. 459/06, s. 28; O. Reg. 264/08, s. 3.

(2)  The records referred to in the Table to subsection (1) shall be kept in, or be readily available to,

(a) in the case of the operator of a pharmacy, the pharmacy or the dispensary of the pharmacy; or

(b) in the case of a physician, the dispensary of the physician. O. Reg. 201/96, s. 29 (2).

29.1  Revoked: O. Reg. 320/07, s. 6.

30.  Omitted (provides for coming into force of provisions of this Regulation). O. Reg. 201/96, s. 30.

TABLE
ANNUAL OUT-OF-POCKET EXPENSE TO BE EXCEEDED TO BECOME ELIGIBLE FOR TRILLIUM DRUG PROGRAM (IN $500 INCREMENTS)

Annual Net Income ($ Dollars)

Single

Family of Two

Family of Three

Family over Three

up to

 

6,500

350

250

200

150

6,501

-

7,000

353

253

203

153

7,001

-

7,500

359

259

209

159

7,501

-

8,000

364

264

214

164

8,001

-

8,500

370

270

220

170

8,501

-

9,000

376

276

226

176

9,001

-

9,500

381

281

231

181

9,501

-

10,000

387

287

237

187

10,001

-

10,500

393

293

243

193

10,501

-

11,000

398

298

248

198

11,001

-

11,500

404

304

254

204

11,501

-

12,000

410

310

260

210

12,001

-

12,500

415

315

265

215

12,501

-

13,000

421

321

271

221

13,001

-

13,500

427

327

277

227

13,501

-

14,000

432

332

282

232

14,001

-

14,500

438

338

288

238

14,501

-

15,000

444

344

294

244

15,001

-

15,500

449

349

299

249

15,501

-

16,000

455

355

305

255

16,001

-

16,500

461

361

311

261

16,501

-

17,000

466

366

316

266

17,001

-

17,500

472

372

322

272

17,501

-

18,000

478

378

328

278

18,001

-

18,500

483

383

333

283

18,501

-

19,000

489

389

339

289

19,001

-

19,500

495

395

345

295

19,501

-

20,000

500

400

350

300

20,001

-

20,500

511

411

361

311

20,501

-

21,000

534

434

384

334

21,001

-

21,500

556

456

406

356

21,501

-

22,000

579

479

429

379

22,001

-

22,500

601

501

451

401

22,501

-

23,000

624

524

474

424

23,001

-

23,500

646

546

496

446

23,501

-

24,000

669

569

519

469

24,001

-

24,500

691

591

541

491

24,501

-

25,000

714

614

564

514

25,001

-

25,500

736

636

586

536

25,501

-

26,000

759

659

609

559

26,001

-

26,500

781

681

631

581

26,501

-

27,000

804

704

654

604

27,001

-

27,500

826

726

676

626

27,501

-

28,000

849

749

699

649

28,001

-

28,500

871

771

721

671

28,501

-

29,000

894

794

744

694

29,001

-

29,500

916

816

766

716

29,501

-

30,000

939

839

789

739

30,001

-

30,500

961

861

811

761

30,501

-

31,000

984

884

834

784

31,001

-

31,500

1,006

906

856

806

31,501

-

32,000

1,029

929

879

829

32,001

-

32,500

1,051

951

901

851

32,501

-

33,000

1,074

974

924

874

33,001

-

33,500

1,096

996

946

896

33,501

-

34,000

1,119

1,019

969

919

34,001

-

34,500

1,141

1,041

991

941

34,501

-

35,000

1,164

1,064

1,014

964

35,001

-

35,500

1,186

1,086

1,036

986

35,501

-

36,000

1,209

1,109

1,059

1,009

36,001

-

36,500

1,231

1,131

1,081

1,031

36,501

-

37,000

1,254

1,154

1,104

1,054

37,001

-

37,500

1,276

1,176

1,126

1,076

37,501

-

38,000

1,299

1,199

1,149

1,099

38,001

-

38,500

1,321

1,221

1,171

1,121

38,501

-

39,000

1,344

1,244

1,194

1,144

39,001

-

39,500

1,366

1,266

1,216

1,166

39,501

-

40,000

1,389

1,289

1,239

1,189

40,001

-

40,500

1,411

1,311

1,261

1,211

40,501

-

41,000

1,434

1,334

1,284

1,234

41,001

-

41,500

1,456

1,356

1,306

1,256

41,501

-

42,000

1,479

1,379

1,329

1,279

42,001

-

42,500

1,501

1,401

1,351

1,301

42,501

-

43,000

1,524

1,424

1,374

1,324

43,001

-

43,500

1,546

1,446

1,396

1,346

43,501

-

44,000

1,569

1,469

1,419

1,369

44,001

-

44,500

1,591

1,491

1,441

1,391

44,501

-

45,000

1,614

1,514

1,464

1,414

45,001

-

45,500

1,636

1,536

1,486

1,436

45,501

-

46,000

1,659

1,559

1,509

1,459

46,001

-

46,500

1,681

1,581

1,531

1,481

46,501

-

47,000

1,704

1,604

1,554

1,504

47,001

-

47,500

1,726

1,626

1,576

1,526

47,501

-

48,000

1,749

1,649

1,599

1,549

48,001

-

48,500

1,771

1,671

1,621

1,571

48,501

-

49,000

1,794

1,694

1,644

1,594

49,001

-

49,500

1,816

1,716

1,666

1,616

49,501

-

50,000

1,839

1,739

1,689

1,639

50,001

-

50,500

1,861

1,761

1,711

1,661

50,501

-

51,000

1,884

1,784

1,734

1,684

51,001

-

51,500

1,906

1,806

1,756

1,706

51,501

-

52,000

1,929

1,829

1,779

1,729

52,001

-

52,500

1,951

1,851

1,801

1,751

52,501

-

53,000

1,974

1,874

1,824

1,774

53,001

-

53,500

1,996

1,896

1,846

1,796

53,501

-

54,000

2,019

1,919

1,869

1,819

54,001

-

54,500

2,041

1,941

1,891

1,841

54,501

-

55,000

2,064

1,964

1,914

1,864

55,001

-

55,500

2,086

1,986

1,936

1,886

55,501

-

56,000

2,109

2,009

1,959

1,909

56,001

-

56,500

2,131

2,031

1,981

1,931

56,501

-

57,000

2,154

2,054

2,004

1,954

57,001

-

57,500

2,176

2,076

2,026

1,976

57,501

-

58,000

2,199

2,099

2,049

1,999

58,001

-

58,500

2,221

2,121

2,071

2,021

58,501

-

59,000

2,244

2,144

2,094

2,044

59,001

-

59,500

2,266

2,166

2,116

2,066

59,501

-

60,000

2,289

2,189

2,139

2,089

60,001

-

60,500

2,311

2,211

2,161

2,111

60,501

-

61,000

2,334

2,234

2,184

2,134

61,001

-

61,500

2,356

2,256

2,206

2,156

61,501

-

62,000

2,379

2,279

2,229

2,179

62,001

-

62,500

2,401

2,301

2,251

2,201

62,501

-

63,000

2,424

2,324

2,274

2,224

63,001

-

63,500

2,446

2,346

2,296

2,246

63,501

-

64,000

2,469

2,369

2,319

2,269

64,001

-

64,500

2,491

2,391

2,341

2,291

64,501

-

65,000

2,514

2,414

2,364

2,314

65,001

-

65,500

2,536

2,436

2,386

2,336

65,501

-

66,000

2,559

2,459

2,409

2,359

66,001

-

66,500

2,581

2,481

2,431

2,381

66,501

-

67,000

2,604

2,504

2,454

2,404

67,001

-

67,500

2,626

2,526

2,476

2,426

67,501

-

68,000

2,649

2,549

2,499

2,449

68,001

-

68,500

2,671

2,571

2,521

2,471

68,501

-

69,000

2,694

2,594

2,544

2,494

69,001

-

69,500

2,716

2,616

2,566

2,516

69,501

-

70,000

2,739

2,639

2,589

2,539

70,001

-

70,500

2,761

2,661

2,611

2,561

70,501

-

71,000

2,784

2,684

2,634

2,584

71,001

-

71,500

2,806

2,706

2,656

2,606

71,501

-

72,000

2,829

2,729

2,679

2,629

72,001

-

72,500

2,851

2,751

2,701

2,651

72,501

-

73,000

2,874

2,774

2,724

2,674

73,001

-

73,500

2,896

2,796

2,746

2,696

73,501

-

74,000

2,919

2,819

2,769

2,719

74,001

-

74,500

2,941

2,841

2,791

2,741

74,501

-

75,000

2,964

2,864

2,814

2,764

75,001

-

75,500

2,986

2,886

2,836

2,786

75,501

-

76,000

3,009

2,909

2,859

2,809

76,001

-

76,500

3,031

2,931

2,881

2,831

76,501

-

77,000

3,054

2,954

2,904

2,854

77,001

-

77,500

3,076

2,976

2,926

2,876

77,501

-

78,000

3,099

2,999

2,949

2,899

78,001

-

78,500

3,121

3,021

2,971

2,921

78,501

-

79,000

3,144

3,044

2,994

2,944

79,001

-

79,500

3,166

3,066

3,016

2,966

79,501

-

80,000

3,189

3,089

3,039

2,989

80,001

-

80,500

3,211

3,111

3,061

3,011

80,501

-

81,000

3,234

3,134

3,084

3,034

81,001

-

81,500

3,256

3,156

3,106

3,056

81,501

-

82,000

3,279

3,179

3,129

3,079

82,001

-

82,500

3,301

3,201

3,151

3,101

82,501

-

83,000

3,324

3,224

3,174

3,124

83,001

-

83,500

3,346

3,246

3,196

3,146

83,501

-

84,000

3,369

3,269

3,219

3,169

84,001

-

84,500

3,391

3,291

3,241

3,191

84,501

-

85,000

3,414

3,314

3,264

3,214

85,001

-

85,500

3,436

3,336

3,286

3,236

85,501

-

86,000

3,459

3,359

3,309

3,259

86,001

-

86,500

3,481

3,381

3,331

3,281

86,501

-

87,000

3,504

3,404

3,354

3,304

87,001

-

87,500

3,526

3,426

3,376

3,326

87,501

-

88,000

3,549

3,449

3,399

3,349

88,001

-

88,500

3,571

3,471

3,421

3,371

88,501

-

89,000

3,594

3,494

3,444

3,394

89,001

-

89,500

3,616

3,516

3,466

3,416

89,501

-

90,000

3,639

3,539

3,489

3,439

90,001

-

90,500

3,661

3,561

3,511

3,461

90,501

-

91,000

3,684

3,584

3,534

3,484

91,001

-

91,500

3,706

3,606

3,556

3,506

91,501

-

92,000

3,729

3,629

3,579

3,529

92,001

-

92,500

3,751

3,651

3,601

3,551

92,501

-

93,000

3,774

3,674

3,624

3,574

93,001

-

93,500

3,796

3,696

3,646

3,596

93,501

-

94,000

3,819

3,719

3,669

3,619

94,001

-

94,500

3,841

3,741

3,691

3,641

94,501

-

95,000

3,864

3,764

3,714

3,664

95,001

-

95,500

3,886

3,786

3,736

3,686

95,501

-

96,000

3,909

3,809

3,759

3,709

96,001

-

96,500

3,931

3,831

3,781

3,731

96,501

-

97,000

3,954

3,854

3,804

3,754

97,001

-

97,500

3,976

3,876

3,826

3,776

97,501

-

98,000

3,999

3,899

3,849

3,799

98,001

-

98,500

4,021

3,921

3,871

3,821

98,501

-

99,000

4,044

3,944

3,894

3,844

99,001

-

99,500

4,066

3,966

3,916

3,866

99,501

-

100,000

4,089

3,989

3,939

3,889

O. Reg. 201/96, Table; O. Reg. 83/98, s. 5.

SCHEDULE 1 Revoked: O. Reg. 508/96, s. 3.

SCHEDULE 2

1. Insulin

2. Adrenocorticotrophic hormones

3. Nitrate vasodilators

O. Reg. 201/96, Sched. 2.

SCHEDULE 3 Revoked: O. Reg. 220/10, s. 6.

SCHEDULE 4 Revoked: O. Reg. 459/06, s. 29.

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