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B.C. Reg. 222/2014
O.C. 661/2014
Deposited November 27, 2014
effective December 1, 2014
This consolidation is current to July 16, 2019.
Link to Point in Time

Pharmaceutical Services Act

Provider Regulation

[includes amendments up to B.C. Reg. 266/2016, November 28, 2016]

Contents
Part 1 — Definitions
1Definitions
Part 2 — Enrollment
2When not eligible for enrollment
3Enrollment of pharmacy providers
4Enrollment of device providers
5Exception
6Extrajurisdictional applicants
7Information required with application
Part 3 — Duties of Providers
8Notice of changes generally
9Notice of service termination
10Notice of disposition or closure
11Notice of certain actions or events
12Requirement to keep records generally
13Additional records to be kept by pharmacy providers
14Keeping records
Part 4 — Benefits and Claims
15Misuse of identity numbers
16Pre-approvals for certain devices
17Amount of claims and charges
18Alternate payees
19Claims for witnessing methadone ingestion
Part 5 — Administration and Enforcement
20Changes to requirements, limits or conditions
21Giving information to the minister
22Suspension of payments
23Giving notice of ministerial action
24Responding to notice of ministerial action
25Deemed receipt of notices

Part 1 — Definitions

Definitions

1   In this regulation:

"Act" means the Pharmaceutical Services Act;

"applicant" means an applicant for enrollment as a provider;

"billing privileges" means the privilege of seeking payment for the provision to another person of drugs, devices, substances or related services directly from

(a) the minister, whether the privilege is granted under the Act or further to a policy made in relation to the Continuing Care Act, the Pharmacy Operations and Drug Scheduling Act or the Pharmacists, Pharmacy Operations and Drug Scheduling Act, or

(b) in the case of a public drug insurance program, the public insurer through which the program is delivered;

"class" means a class of provider established by the minister under section 11 (4) (b) [enrollment of providers] of the Act, those classes being the following:

(a) pharmacy provider, which includes the sub-classes of Plan B provider and methadone maintenance provider;

(b) device provider, which includes the sub-classes of compression garment provider, limb prosthesis provider, breast prosthesis provider, ocular prosthesis provider and orthosis provider;

"College of Pharmacists bylaws" means those bylaws of the College of Pharmacists of British Columbia made under the authority of the Health Professions Act;

"extrajurisdictional applicant" or "extrajurisdictional provider" means an applicant or a provider, as applicable, having as the subject of his or her application or enrollment a site outside British Columbia but inside Canada;

"First Nations Health Authority" means the First Nations Health Authority, a society under the Societies Act;

"FNHB program" means the First Nations Health Benefits Program delivered through the First Nations Health Authority for the purpose of providing, to First Nations individuals who are residents of British Columbia, financial assistance for health-related goods and services;

"governing body" means the following, as applicable:

(a) the College of Pharmacists of British Columbia;

(b) a body, in another province or territory or in a foreign jurisdiction, that regulates the practice of pharmacy in that other province, territory or foreign jurisdiction;

"identity number" means the identity number referred to in section 15 [identity numbers] of the Act;

"information or billing contravention" means a contravention of any of the following:

(a) a provision of a pharmacy enactment or a requirement of a public drug insurance program in relation to

(i) the provision of false, incomplete or misleading information,

(ii) a failure to provide required information,

(iii) the interference with or obstruction of a person who is exercising a power or performing a duty, or a person acting under the order or direction of that person, or

(iv) a matter that resulted in the suspension or cancellation of billing privileges;

(b) a provision of an enactment of another jurisdiction of Canada that is equivalent to a pharmacy enactment, in relation to any of the matters set out in paragraph (a);

(c) a provision of a pharmacy enactment, the E-Health (Personal Health Information Access and Protection of Privacy) Act, the Freedom of Information and Protection of Privacy Act, the Health Professions Act, the Personal Information Protection Act or a regulation made under any of them, in relation to the collection, use or disclosure of personal information;

"methadone maintenance services" means services provided by a pharmacist described in section 3 (4) [enrollment of pharmacy providers] in relation to the dispensing of methadone for opioid-addiction treatment;

"NIHB program" means the Non-Insured Health Benefits Program delivered through Health Canada for the purpose of providing, to First Nations and Inuit individuals, financial assistance for health-related goods and services;

"owner", in respect of

(a) a corporation and if applicable in the context, includes

(i) in the case of a corporation that is traded publicly, the officers and directors of the corporation, and

(ii) in the case of a corporation that is not traded publicly,

(A) the officers, directors and shareholders of the corporation, and

(B) if a subsidiary corporation, the officers, directors and shareholders of the parent corporation, and

(b) a partnership and if applicable in the context, includes the partners of the partnership;

"partner" and "partnership" have the same meaning as in the Partnership Act;

"Pharmacists, Pharmacy Operations and Drug Scheduling Act" means the Pharmacists, Pharmacy Operations and Drug Scheduling Act before it was amended by the Pharmacy Operations and Drug Scheduling Act, S.B.C. 2003, c. 77;

"pharmacy enactment" means the Act, the Continuing Care Act, the Medicare Protection Act, the Pharmacy Operations and Drug Scheduling Act, the Pharmacists, Pharmacy Operations and Drug Scheduling Act or a regulation made under any of them;

"pharmacy licence" means a community pharmacy licence or a hospital pharmacy licence issued in respect of a pharmacy under the Pharmacy Operations and Drug Scheduling Act;

"Plan B" means the drug plan known as Plan B, as established under section 35 of the Drug Plans Regulation;

"public drug insurance program" means any of the following:

(a) the FNHB program;

(b) the NIHB program;

(c) a public health insurance scheme delivered through a provincial or territorial government of Canada, other than the government of British Columbia, that provides to individuals financial assistance in respect of drugs, devices, substances or related services;

"public insurer" means any of the following:

(a) the First Nations Health Authority;

(b) the government of Canada;

(c) a provincial or territorial government of Canada;

"site" means

(a) a pharmacy,

(b) a site at which a person is authorized under an enactment of a province or territory, other than British Columbia, to store drugs or substances, or to dispense or sell drugs or substances to the public, or

(c) a site through which devices are provided;

"site identification code" means a unique code issued by the minister in respect of a specific site.

[am. B.C. Regs. 73/2015, App. 6; 211/2015; s. 29.]

Part 2 — Enrollment

When not eligible for enrollment

2   (1) This section applies to persons applying for enrollment in any provider class with respect to a particular site.

(2) An applicant is not eligible for enrollment if an owner or a manager of the site

(a) is required to pay an amount

(i) to the government as a result of an audit conducted under a pharmacy enactment, or

(ii) to a public insurer as a result of an audit conducted in relation to the insurer's public drug insurance program,

(b) has been, or is, the subject of an order or a conviction for an information or billing contravention,

(c) has his or her billing privileges suspended,

(d) has had his or her billing privileges cancelled,

(e) has been, or is, an owner or a manager of a site in respect of which

(i) an amount must be paid to the government as a result of an audit conducted under a pharmacy enactment,

(ii) an amount must be paid to a public insurer as a result of an audit conducted in relation to the insurer's public drug insurance program,

(iii) an order or a conviction for an information or billing contravention has been issued, or

(iv) a person's billing privileges have been cancelled,

if the owner or manager was the owner or manager during the period for which the audit was conducted, at the time of the information or billing contravention, or at the time of the incident giving rise to the cancellation of billing privileges,

(f) has, within the previous 6 years, had a judgment entered against him or her in a court proceeding related to commercial or business activities that occurred in relation to the provision of drugs, devices, substances or related services,

(g) has, within the previous 6 years, been convicted of an offence prescribed under section 22 (1) [suspension of payments],

(h) holds a pharmacy licence that is suspended, or has held a pharmacy licence that was suspended or cancelled,

(i) is an owner or a manager of a site in respect of which a person's billing privileges are suspended, or

(j) has had his or her enrollment in any class of provider cancelled.

(3) An applicant is not eligible for enrollment if the applicant provides false or misleading information under section 7 [information required with application].

(4) An applicant is not eligible for enrollment in a sub-class if

(a) the applicant has been enrolled previously in the sub-class that is the subject of the application, and

(b) the applicant's billing privileges in relation to that sub-class were cancelled by the minister.

[am. B.C. Reg. 266/2016, Sch. 1, s. 1.]

Enrollment of pharmacy providers

3   (1) Without limiting section 2 [when not eligible for enrollment], this section applies to a person applying for enrollment within the pharmacy provider class with respect to a particular pharmacy.

(2) An applicant is not eligible for enrollment unless a pharmacy licence has been issued in respect of the pharmacy.

(3) An applicant is not eligible for enrollment if an owner or a manager of the pharmacy has had his or her registration with a governing body suspended or cancelled.

(4) An applicant is not eligible for enrollment in the methadone maintenance provider sub-class unless each pharmacist who will be providing drugs, devices, substances or related services through the pharmacy has successfully completed all relevant training, as required by the College of Pharmacists of British Columbia, with respect to methadone maintenance services.

Enrollment of device providers

4   (1) Without limiting section 2 [when not eligible for enrollment], this section applies to a person applying for enrollment in the device provider class with respect to a particular site through which devices are provided.

(2) An applicant is not eligible for enrollment unless the applicant holds a business licence, issued by a local government, in respect of the site.

(3) An applicant is not eligible for enrollment unless the applicant confirms that each person who will be providing benefits through the site is appropriately qualified to provide the type of benefit he or she will be providing, including confirming the following, as applicable:

(a) in the case of an application for enrollment in the compression garment provider sub-class, that compression garment benefits will be provided through the site only by a person who has completed training, by a compression garment manufacturer, in fitting the type of compression garments to be provided;

(b) in the case of an application for enrollment in the limb prosthesis provider sub-class, that limb prosthesis benefits will be provided through the site only by a person recognized by the Canadian Board for Certification of Prosthetists and Orthotists as a person qualified to fit limb prostheses;

(c) in the case of an application for enrollment in the breast prosthesis provider sub-class, that breast prosthesis benefits will be provided through the site only by a person who has completed training, by a breast prosthesis manufacturer, in fitting breast prostheses;

(d) in the case of an application for enrollment in the ocular prosthesis provider sub-class, that ocular prosthesis benefits will be provided through the site only by a person recognized by the National Examining Board of Ocularists, Inc. as a person qualified to fit ocular prostheses;

(e) in the case of an application for enrollment in the orthosis provider sub-class, that orthosis benefits will be provided through the site only by a person recognized by the Canadian Board for Certification of Prosthetists and Orthotists as a person qualified to fit orthoses.

(4) A person is deemed to be a device provider without applying for enrollment, and subsection (2) does not apply, if the person

(a) is enrolled in the pharmacy provider class, and

(b) provides through the person's pharmacy devices other than those described in subsection (3).

Exception

5   Despite sections 2 to 4 [when ineligible for enrollment], the minister may enroll as a provider an applicant who is not eligible for enrollment under one or more of those sections if the minister is of the opinion that doing so

(a) would not present a risk to the integrity of the provincial drug program, or

(b) would be in the public interest for any reason, including for the purpose of ensuring an adequate supply of benefits to beneficiaries.

Extrajurisdictional applicants

6   (1) Without limiting sections 2 to 4 [when ineligible for enrollment], an applicant is not eligible for enrollment in respect of a site located outside British Columbia unless

(a) the site that is the subject of the applicant's application is located in another province or territory in Canada,

(b) the applicant provides a signed statement confirming that the applicant provides, or intends to provide, drugs, devices, substances or related services to residents of British Columbia, and

(c) the applicant provides a signed statement confirming that the applicant

(i) recognizes and is bound by the laws of the Province of British Columbia in respect of all matters related to the applicant's enrollment and conduct under the Act in respect of the site, and

(ii) agrees that court proceedings in a matter related to the applicant's enrollment and conduct under the Act in respect of the site will be conducted in a court of the Province of British Columbia.

(2) Signed statements under this section must be in the form and manner required by the minister.

[am. B.C. Reg. 50/2016, s. 11.]

Information required with application

7   (1) An applicant's application must include all of the following:

(a) the applicant's contact information;

(b) the operating name and address of, and contact information for, the site that is the subject of the application;

(c) the names of the owner and manager of the site that is the subject of the application, and the owner's contact information;

(d) in the case of a corporate applicant,

(i) a copy of the applicant's power of attorney showing the names and contact information of all persons who may exercise a power of attorney in respect of the corporation,

(ii) a BC company summary showing the names and contact information of all officers and directors of the applicant,

(iii) if the applicant is incorporated under a federal enactment, the names and contact information of all officers and directors of the applicant, and

(iv) if the applicant is not traded publicly, a copy of the shareholder's register and of all shareholder agreements, if any, with respect to the operation of the site that is the subject of the application;

(e) a copy of the pharmacy licence or business licence, as applicable, that has been issued in respect of the site that is the subject of the application;

(f) in the case of an applicant for enrollment in the methadone maintenance provider sub-class, confirmation that each pharmacist who will be providing drugs, devices, substances or related services through the pharmacy that is the subject of the application has completed training as required under section 3 (4) [enrollment of pharmacy providers];

(g) in the case of an applicant for enrollment in the device provider class, confirmation that each person providing benefits through the site that is the subject of the application is recognized or has completed training as required under section 4 (3) [enrollment of device providers];

(h) the operating names of all other sites in respect of which the applicant, or an owner of the applicant, is an owner or a manager, and, for each site, the site identification code.

(2) An applicant's application must give details of all of the following that apply to the applicant:

(a) all audits, orders, suspensions or cancellations of billing privileges, judgments and convictions referred to in section 2 [when not eligible for enrollment];

(b) all registration suspensions and cancellations referred to in section 3 (3);

(c) all disciplinary actions taken by a governing body that resulted in

(i) the imposition of limits or conditions on the practice of pharmacy against an owner or a manager of the site that is the subject of the application, or

(ii) the suspension or cancellation of the registration of an owner or a manager of the site that is the subject of the application;

(d) all actions or proceedings taken by the Canadian Board for Certification of Prosthetists and Orthotists that resulted in the imposition of limits, conditions or prohibitions on the provision of prostheses or orthoses by an owner or a manager of the site that is the subject of the application;

(e) all instances within the previous 6 years in which an owner of the site that is the subject of the application has been the director of a corporation that has declared or been petitioned into bankruptcy.

Part 3 — Duties of Providers

Notice of changes generally

8   (1) A provider must give to the minister notice of the following changes at least 7 days before the change is to occur:

(a) if there is a change to the provider's contact information,

(i) both the current and new contact information,

(ii) the provider's site identification code or codes, and

(iii) the date the change is effective;

(b) if there is a change to the provider's business or corporate name,

(i) both the current and new business or corporate names,

(ii) the provider's site identification code or codes, and

(iii) the date the change is effective;

(c) if there is a change to an owner of a site, other than a change resulting from a disposition of ownership,

(i) the name and address of the site,

(ii) the name of the current owner,

(iii) the name and contact information of the new owner,

(iv) the provider's site identification code or codes, and

(v) the date the change is effective;

(d) if there is a change to the manager of a site,

(i) the site's name, address and site identification code,

(ii) the names of both the current and new managers, and

(iii) the date the change is effective.

(2) A provider must give the following to the minister at least 7 days before a change to the location of the site that is the subject of the provider's enrollment is to occur:

(a) notice of

(i) the site's name and site identification code,

(ii) the addresses of both the current and new sites, and

(iii) the date the change is effective;

(b) a copy of the pharmacy licence or business licence for the new site.

(3) In the case of a corporate owner, a provider must give notice of the following changes at least 7 days before the change is to occur:

(a) a change to the provider's power of attorney;

(b) a change to the provider's officers or directors;

(c) if the provider is not traded publicly, a change to the corporate shareholders.

(4) If notice is given under subsection (3), the provider must also give a copy of the following, as applicable, no more than 30 days after the change occurred:

(a) the power of attorney, showing the names and contact information of all persons who may exercise a power of attorney in respect of the corporation;

(b) either

(i) a BC company summary showing the names and contact information of all officers and directors of the provider, or

(ii) if the provider is incorporated under a federal enactment, the names and contact information of all officers and directors of the provider;

(c) the shareholder's register and all shareholder agreements, if any, with respect to the operation of the site that is the subject of the provider's enrollment.

Notice of service termination

9   (1) A pharmacy provider enrolled in the Plan B provider sub-class must give to the minister notice of the provider's intention to stop providing benefits to beneficiaries enrolled in Plan B no later than the last day of the month that falls before the final full month in which service will be provided.

(2) A pharmacy provider enrolled in the methadone maintenance provider sub-class must give to the minister notice of the provider's intention to stop providing methadone maintenance services at least 30 days before services will end.

(3) A device provider enrolled in any sub-class referred to in section 4 (3) [enrollment of device providers] must notify the minister as soon as reasonably practicable if the device provider's site ceases to be served by a person who is appropriately qualified as described by that subsection to provide the type of benefits relevant to the sub-class.

Notice of disposition or closure

10   (1) A provider who intends to dispose of or close the site that is the subject of the provider's enrollment, rather than changing the location of the site only, must give to the minister notice of the following at least 30 days before the date the disposition or closure is effective:

(a) the site's name, address and site identification code;

(b) the date the disposition or closure is effective;

(c) in the case of a disposition only, the names and contact information of both the current and new owners.

(2) Despite section 20 [changes to requirements, limits or conditions], the minister may not waive or modify the 30 day notice requirement referred to in subsection (1) of this section.

Notice of certain actions or events

11   A provider must give notice to the minister immediately if the provider, or, in the case of a provider that is a corporation, an officer or a director of the provider, becomes subject to, or the subject of, any of the following:

(a) any of the matters, other than an audit, described in section 7 (2) [information required with application];

(b) a requirement to pay an amount to a public insurer as a result of an audit conducted in relation to

(i) the insurer's public drug insurance program, and

(ii) the site that is the subject of the provider's enrollment.

Requirement to keep records generally

12   Providers must keep all of the following records:

(a) original prescriptions and refill authorizations received in respect of beneficiaries, showing the information required under section 6 (2), (4), (7), (9) and (10) of Part 1 of Schedule F to the College of Pharmacists bylaws;

(b) records respecting the provision of benefits to beneficiaries, showing, for each transaction,

(i) the date,

(ii) the benefit provided,

(iii) the beneficiary's name and identity number, and

(iv) the total amount charged and received;

(c) copies of records made or submitted in relation to a claim, including copies of any relevant authorizations given by the minister under the Act before the claim is made;

(d) records of purchase orders and invoices for drugs, devices and substances that may be provided as benefits, with each purchase order and invoice having a unique identifying number and showing, for each purchase,

(i) the names and contact information of both the vendor and purchaser,

(ii) the date the drugs, devices or substances were received,

(iii) the name, strength, unit price, quantity and, if applicable, Drug Identification Number, of the drugs, devices and substances, and

(iv) the total amount charged and paid;

(e) records of shipping orders for drugs, devices and substances for which there is no purchase order or invoice but in relation to which a related service was or is to be provided, with each shipping order having a unique identifying number and showing, for each shipment,

(i) the names and contact information of both the shipper and receiver, and

(ii) the information required under paragraph (d);

(f) records of transfers of drugs, devices and substances that may be provided as benefits between sites or other locations for which a provider is an owner or a manager, showing, for each transfer,

(i) the name and address of both the site from which the drugs, devices and substances were transferred and the site at which the drugs, devices and substances were received,

(ii) the name and signature of the person taking receipt of the transferred drugs, devices and substances,

(iii) the date the transferred drugs, devices or substances were received,

(iv) the name, strength, unit price, quantity and, if applicable, Drug Identification Number or Product Identification Number, of the transferred drugs, devices and substances, and

(v) the total amount charged and paid, if any;

(g) records made in relation to the provision of incentives by the provider as described in section 51 (2) [offences] of the Act;

(h) copies of records issued by a manufacturer or body respecting recognition or training for the purposes of section 4 (3) [enrollment of device providers];

(i) records made in relation to the provision of related services by the provider, regardless of whether the drug, device or substance to which the service is related is a benefit.

Additional records to be kept by pharmacy providers

13   (1) In addition to the records required under section 12 [requirements to keep records generally], a pharmacy provider enrolled in the Plan B provider sub-class must keep a record, in respect of each beneficiary served by the provider who is enrolled in Plan B, that includes all of the following:

(a) the information required under section 13 (2) and (3) of Part 3 of Schedule F to the College of Pharmacists bylaws;

(b) a record of the review required under section 15 of Part 3 of Schedule F to the College of Pharmacists bylaws.

(2) In addition to the records required under section 12, a pharmacy provider enrolled in the methadone maintenance provider sub-class must keep both of the following records in respect of each prescription received by the provider in respect of methadone maintenance services for a beneficiary:

(a) the original prescription form as approved by the College of Physicians and Surgeons of British Columbia and entitled "Methadone Maintenance Controlled Prescription", showing

(i) the beneficiary's personal health number, name, address and date of birth,

(ii) the name, contact information and identification number, as issued by the College of Physicians and Surgeons of British Columbia, of the prescriber,

(iii) the prescription folio number and the date of the prescription,

(iv) the name of the drug, the strength and quantity prescribed, the prescribed daily dose and the dates on which dosing is to begin and end,

(v) whether ingestion must always be witnessed, and, if ingestion need not always be witnessed, a statement in both numeric and alphabetical form of the number of days each week that ingestion must be witnessed,

(vi) whether the drug may be delivered to the beneficiary, and

(vii) the signatures of the prescriber, the dispensing pharmacist and the beneficiary;

(b) a log showing the beneficiary's name and, for each dispensation,

(i) the date the drug was dispensed,

(ii) the prescription or transaction number,

(iii) the quantity of the drug witnessed as having been ingested, the quantity provided for ingestion other than at the pharmacy, if any, and the total quantity dispensed,

(iv) if the drug was provided for delivery to the beneficiary, the address to which and the date on which the delivery was made, and

(v) the signature or initials of the dispensing pharmacist, and the signature of the beneficiary, confirming that the drug was dispensed on the date indicated under subparagraph (i).

Keeping records

14   (1) Records under sections 12 [requirement to keep records generally] and 13 [additional records to be kept by pharmacy providers] must be kept

(a) for at least 4 years, or

(b) if an inspection or audit is in process in respect of the provider or the site that is the subject of the provider's enrollment at the end of the 4 year period, until the inspection or audit is complete.

(2) Without limiting section 11 (4) (c) [enrollment of providers] of the Act, the minister may require a provider to keep records as follows:

(a) in addition to those listed in sections 12 and 13;

(b) for a longer period of time than as set out in subsection (1) of this section.

Part 4 — Benefits and Claims

Misuse of identity numbers

15   Providers are prescribed as persons who must make a report respecting suspected misuse of identity numbers for the purposes of section 15 [identity numbers] of the Act.

Pre-approvals for certain devices

16   (1) A device provider must have written approval from the minister before providing to a beneficiary a prosthetic or orthotic device that will be the subject of a claim for payment under the Act.

(2) Despite subsection (1), the minister may waive approval in respect of the following devices:

(a) lymphedema arm sleeves, gloves or gauntlets;

(b) breast prostheses;

(c) post-mastectomy brassieres;

(d) plagiocephaly helmets;

(e) prosthetic and orthotic supplies, and repairs and adjustments to prostheses and orthoses, if the claim is for an amount of less than $400.

(3) A waiver under subsection (2) may be in respect of a beneficiary or class of beneficiaries, or a device or class of devices.

(4) Claims in respect of a prosthetic or an orthotic device for which approval is required under this section may be submitted to the minister for payment under the Act

(a) only after the device is provided to the patient and all related services are complete, and

(b) no later than 6 months after approval is received, if submitted by a provider having access to PharmaNet, as that term is defined in the Information Management Regulation.

(5) If a device for which approval was received is not provided, and all related services are not complete, within 6 months of receiving approval, the approval expires and a new approval must be sought.

[am. B.C. Reg. 74/2015, Sch. 3.]

Amount of claims and charges

17   (1) A provider must not claim from the minister payment for a benefit in an amount greater than the provider would charge to any other person for the drug, device, substance or related service that is the subject of the claim.

(2) Subsection (1) does not apply in respect of a discount given to

(a) an employee of the provider, or

(b) a private insurer within the meaning of section 43 [sharing information for compliance purposes] of the Act.

(3) A provider must not charge a beneficiary any amount in respect of a benefit that is a drug, substance or related service for which the beneficiary is eligible under a drug plan to have full payment made by the minister, except for the following:

(a) insulin;

(b) nutritional vitamins or supplements for persons suffering from cystic fibrosis.

Alternate payees

18   (1) A medical practitioner is prescribed under section 17 (2) [payments] of the Act for the purposes of receiving payments for claims if

(a) the College of Physicians and Surgeons of British Columbia identifies the medical practitioner to the minister as a person who should be receiving payments for claims, and

(b) the minister is satisfied that it would be in the public interest for the medical practitioner to receive payments for claims, because

(i) the medical practitioner practises medicine in a remote location that is under-served by providers, or

(ii) for any other reason.

(2) Repealed. [B.C. Reg. 266/2016, Sch. 1, s. 2.]

[am. B.C. Reg. 266/2016, Sch. 1, s. 2.]

Claims for witnessing methadone ingestion

19   A pharmacy provider enrolled in the methadone maintenance provider sub-class may submit to the minister for payment under the Act a claim in relation to witnessing the ingestion of methadone only if a pharmacist described in section 3 (4) [enrollment of pharmacy providers] personally witnesses the ingestion.

Part 5 — Administration and Enforcement

Changes to requirements, limits or conditions

20   (1) Subject to this section, the minister may waive or modify one or more requirements, limits or conditions set under any of sections 2 to 4, 7 to 9, 12 (a) and 13 (1).

(2) A waiver or modification must be for one or more of the following reasons:

(a) in the case of an extrajurisdictional applicant or provider, to apply equivalent requirements, limits or conditions, or to substitute different requirements, limits or conditions, from the province or territory in which the site that is the subject of the applicant's application is located;

(b) in any case,

(i) if complying with the requirement, limit or condition would not be reasonably practical in the circumstances, or

(ii) if the minister is of the opinion that the waiver or modification would be in the public interest for any reason.

(3) A waiver or modification

(a) may be in respect of a person or class of persons, and

(b) must be in writing.

Giving information to the minister

21   (1) Nothing in this regulation limits the power of the minister to request additional information under section 30 (4) [applications, notices, hearings, information or reports] of the Act.

(2) On request of the minister, a person who makes an application or gives to the minister a notice, record, report or other information under this regulation must give further details or proof of the matters referred to in the application, notice, record, report or other information.

(3) A request under subsection (2)

(a) may be in respect of a person or class of persons, and

(b) must be in writing.

Suspension of payments

22   (1) For the purposes of section 45 (1) (a) (ii) [suspension of payments] of the Act, the prescribed offences are as follows:

(a) sections 362, 366, 380, 388, 389, 392, 397, 402, 402.2, 403 and 408 [fraud] of the Criminal Code;

(b) section 5 [trafficking] of the Controlled Drugs and Substances Act (Canada);

(c) section 46 of the Controlled Drugs and Substances Act (Canada), as it relates to a contravention of any provision of

(i) Part 2 [permitted activities and general obligations of pharmacists] of the Benzodiazepines and Other Targeted Substances Regulations (Canada), SOR/2000-217, or

(ii) sections 30 to 45 of the Narcotic Control Regulations (Canada), C.R.C., c. 1041.

(2) For the purposes of section 45 (1) (b) of the Act, the prescribed circumstances are as follows:

(a) if the provider is a corporation and an officer or a director of the provider has been convicted of an offence referred to in subsection (1) of this section;

(b) if a provider becomes ineligible to be enrolled as a provider, except in the circumstances described in section 2 (2) (a) or (e) (i) or (ii) [when not eligible for enrollment];

(c) in the case of a pharmacy provider enrolled in the methadone maintenance provider sub-class, if the pharmacy provider's site is no longer served by pharmacists who are appropriately qualified as described in section 3 (4) [enrollment of pharmacy providers];

(d) in the case of a device provider enrolled in a sub-class referred to in section 4 (3) [enrollment of device providers], if the device provider's site is no longer served by a person who is appropriately qualified as described by that section to provide the type of benefits relevant to the sub-class.

(3) If a provider is enrolled in more than one sub-class, suspension of payments in the circumstances described in

(a) subsection (2) (c) may only be in respect of claims related to the provision of methadone maintenance services, and

(b) subsection (2) (d) may only be in respect of claims related to the provision of benefits relevant to the sub-class for which the device provider's site is no longer served by an appropriately qualified person.

Giving notice of ministerial action

23   (1) The minister must give to an applicant for enrollment as a provider notice of an intention to deny the application.

(2) The minister must give to a provider notice of the following:

(a) an intention to change or cancel the provider's designation or enrollment under section 13 (2) [changing or cancelling provider enrollment] of the Act;

(b) an intention to change or add limits and conditions on a provider's enrollment under section 13 (3) of the Act.

(3) A notice described in subsection (1) or (2) of this section, or as required under section 45 (2) of the Act in respect of a suspension of payments, may be given

(a) personally, or

(b) by registered mail or electronically at the last known business address of the applicant or provider.

(4) Despite subsection (3), the minister may waive a requirement for notice or provide notice in an alternate fashion if it is not reasonably practical to give notice in accordance with that subsection.

(5) A notice must include

(a) the reasons for the denial, change, cancellation, addition or suspension, and

(b) in the case of a notice issued under subsection (1), (2) (a) or (3), a statement that

(i) the applicant or provider has 21 days to make a response, in writing, to the denial, change, cancellation or suspension, and

(ii) if the applicant or provider does not make a response, in writing and within the 21 day period, the applicant or provider will be given no further opportunity to be heard.

Responding to notice of ministerial action

24   (1) An applicant or a provider who receives a notice issued under section 23 (1), (2) (a) or (3) [giving notice of ministerial action] may respond to the notice by delivering to the minister, within the period set out in the notice,

(a) a written submission respecting why the minister

(i) should accept the applicant's application for enrollment,

(ii) should not change or cancel the provider's enrollment, or

(iii) should resume payments to the provider,

as applicable, and

(b) any relevant records or other evidence to support the position of the applicant or provider.

(2) On receipt of a response in accordance with subsection (1), the minister

(a) must consider the submission, records and evidence provided,

(b) may vary, confirm or reverse the decision to deny the applicant's enrollment, change or cancel the provider's enrollment, or take any action the minister must or may take under section 45 of the Act, as applicable, and

(c) must give notice to the applicant or provider of the decision or action taken under paragraph (b) of this subsection.

Deemed receipt of notices

25   A notice given by the minister under the Act is deemed to have been received as follows:

(a) if sent by registered mail or any other form of delivery, other than personally or electronically, 3 days after the date the notice was sent;

(b) if sent electronically, 24 hours after the time the notice was sent.

[Provisions relevant to the enactment of this regulation: Pharmaceutical Services Act, S.B.C. 2012, c. 22, sections 61 (1), (4) and (5), 62 (1) (a), 64 (a), (b) and (f) and 65 (3), (4) (b) and (5)]