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ontario regulation 264/08

made under the

Ontario Drug Benefit Act

Made: July 23, 2008
Filed: July 28, 2008
Published on e-Laws: July 30, 2008
Printed in The Ontario Gazette: August 16, 2008

Amending O. Reg. 201/96

(General)

1. (1) Section 18 of Ontario Regulation 201/96 is amended by adding the following subsections:

(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.

(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 nursing home under the Nursing Homes Act, a home under the Homes for the Aged and Rest Homes Act, or an approved charitable home for the aged under the Charitable Institutions Act, 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).

(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.

(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.

(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).

(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.

(2) Subclause 18 (8) (b) (i) of the Regulation is revoked and the following substituted:

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

2. Section 27 of the Regulation is revoked and the following substituted:

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 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.

3. The Table to subsection 29 (1) of the Regulation is amended by adding the following rows at the end:

 

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.

4. (1) Subject to subsection (2), this Regulation comes into force on the day it is filed.

(2) Subsection 1 (2) comes into force on the day section 194 of the Long-Term Care Homes Act, 2007 comes into force.