Regulation - LGIC

Streamlining Recordkeeping Requirements for Pharmacies and Dispensing Physicians under the Ontario Drug Benefit Program

Regulation Number(s):
O.Reg. 201/96
Bill or Act:
Ontario Drug Benefit Act
Summary of Proposal:
Currently, section 29 of Ontario Regulation 201/96 (Regulation) under the Ontario Drug Benefit Act (ODBA) sets out various records that pharmacies and dispensing physicians must retain and the retention time periods for each type of record.

Through the Ontario Drug Programs Reference Manual (Manual), which pharmacies and dispensing physicians are required to follow, the Ministry of Health (ministry) has described supporting documentation that is required for various types of drug funding claims submitted to the Ontario Drug Benefit program. In addition, the Manual requires that the supporting documentation be kept on file at the pharmacy in a readily retrievable format for a minimum of two years from the date of the last claim for validation purposes under the ODB program.

To ensure alignment between record retention requirements in the Regulation and ministry policies, the ministry is proposing to amend section 29 of the Regulation to reduce the specific records described in that section, and add a general requirement that pharmacies and dispensing physicians retain the records required to support or validate a claim for payment or a claim reversal submitted under the ODBA as described in the Manual for the period of time specified in the Manual. The ministry would then review and update the Manual, if necessary, to ensure that all record retention requirements for pharmacies and dispensing physicians are in that document with clear retention periods. The proposed regulatory amendments would enable most recordkeeping requirements for pharmacies and dispensing physicians to be set out in the Manual to streamline recordkeeping requirements into one document for ease of implementation.

Recent amendments to the ODBA and Regulation allow the government to incorporate the Manual by reference into the Regulation, and to publish updates to the Manual without having to amend the Regulation to reflect each new publication of the Manual. As a result, this proposal to amend s. 29 of the Regulation would provide ongoing flexibility to include record retention requirements in the Manual that can be updated by the ministry from time to time to reflect new policy and program changes.

These proposed amendments to the Regulation would provide clarity to pharmacies and dispensing physicians on documentation requirements for the post-payment verification of drug and pharmacy service claims by making them available in one accessible document (the Manual), and therefore, reduce regulatory burden for dispensers.

Analysis of Regulatory Impact:
Costs: The proposed regulatory changes would have no costs involved, as these requirements, for the most part, are already in place. The proposed regulation would not create any new administrative costs for business.

Benefits: The proposed regulation would align record retention requirements in the Regulation with ministry policies, by referring pharmacies and dispensing physicians to the Manual for the specified records and retention periods. This would ensure that all record retention requirements for pharmacies and dispensing physicians are in one document with clear retention periods, and there is alignment between the policy and the regulation.
Further Information:
Proposal Number:
20-HLTC038
Posting Date:
October 21, 2020
Comments Due Date:
December 5, 2020
Contact Address:
5700 Yonge St., 3rd Floor
Toronto, ON
M2M 4K5
Comment on this proposal via email