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SNL2006 CHAPTER P-12.01

PHARMACEUTICAL SERVICES ACT

Amended:

2012 c2; 2012 cO-7.02 s64; 2012 cP-12.2 s66; 2013 c12; 2014 cC-10.1 s63

CHAPTER P-12.01

AN ACT RESPECTING PHARMACEUTICAL SERVICES

(Assented to December 12, 2006 )

Analysis


       
1.   Short title

       
2.   Definitions

              PART I
CONFIDENTIALITY, AGREEMENTS AND GENERAL ADMINISTRATION

       
3.   Appointments by minister

       
4.   Confidentiality

       
5.   Information required

       
6.   Duties under Act

       
7.   Agreements, contracts

       
8.   Programs and pilot projects

       
9.   Protection for actions in good faith

     
10.   Review

     
11.   Delivery principles

              PART II
NEWFOUNDLAND AND LABRADOR PRESCRIPTION DRUG PROGRAM

     
12.   Program established

     
13.   Terms of program

     
14.   Program components

     
15.   Benefits lists

     
16.   Participation in program

     
17.   Fees and payments

     
18.   Special authorization review

              PART III
INTERCHANGEABLE DRUG PRODUCTS FORMULARY

     
19.   Formulary

     
20.   Advisory committee

     
21.   Substitute drugs

     
22.   Price

     
23.   Pricing requirements

     
24.   Non-lowest price

     
25.   Non-formulary

              PART IV
TAMPER RESISTANT PRESCRIPTION DRUG PAD PROGRAM

     
26.   Tamper resistant prescription drug pads

              PART V
UTILIZATION AND PRESCRIBING REVIEWS

     
27.   Utilization review

     
28.   Prescribing patterns

              PART VI
AUDITING

     
29.   Audit

     
30.   Generally accepted auditing standards

     
31.   Documentation and other information

     
32.   Deadlines

     
33.   Further information

     
34.   Review committee

     
35.   Annual report

              PART VII
RECOVERY

     
36.   Recovery from beneficiaries

     
37.   Notice

     
38.   Recovery from pharmacies and dispensing physicians

     
39.   Notice

              PART VIII
INTERNAL REVIEW AND APPEAL

     
40.   Internal review

     
41.   Appeal from section 40

     
42.   Audit appeal board

     
43.   Appeal of audit under section 38

     
44.   Powers of board

     
45.   Further appeal

     
46.   Alternate dispute resolution

              PART IX
OFFENCE AND PENALTY

     
47.   Offence

     
48.   Penalty

     
49.   Limitation period

              PART X
GENERAL

     
50.   Fees and forms

     
51.   Regulations

     
52.   Ministerial regulations

     
53.   SNL2002 cI-0.1 Amdt.

     
54.   SNL2005 cM-4.01 Amdt.

     
66.   Use of tamper resistant prescription drug pads

     
55.   SNL1994 cP-12.1 Amdt.

     
65.   Contravention

     
66.   Actions

     
56.   NLR 80/98 Amdt.

     
57.   Transitional

     
58.   Commencement


Be it enacted by the Lieutenant-Governor and House of Assembly in Legislative Session convened, as follows:

Short title

        1. This Act may be cited as the Pharmaceutical Services Act .

2006 cP-12.01 s1

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Definitions

        2. In this Act

             (a)  "appellant" means a person who appeals to an appeal board under Part VIII;

             (b)  "beneficiary" means a person who receives a benefit under the Newfoundland and Labrador Prescription Drug Program;

             (c)  "benefit" means a benefit conferred on a person who is eligible under this Act or the regulations;

             (d)  "benefits list" means the list of drugs and drug related items for which a beneficiary may be considered eligible;

             (e)  "department" means the department presided over by the minister;

             (f)  "dispense" means to provide a substance or item ordered by prescription but does not include the administration of that substance or item to a person or animal;

             (g)  "drug" means drug as defined in the Pharmacy Act, 2012;

             (h)  "drug formulary" means the Interchangeable Drug Formulary established under Part III;

              (i)  "interchangeable drug products" means pharmaceutical equivalents or pharmaceutical alternatives that are the therapeutic equivalents of and that have the same route of administration as a reference product;

              (j)  "minister" means the minister appointed under the Executive Council Act to administer this Act;

             (k)  "payment" means

                      (i)  a payment to a participating pharmacy or dispensing physician to reimburse the cost of dispensing a drug or related item from the benefits lists, and may include a fee for professional services, or

                     (ii)  a payment directly to a beneficiary under subsection 17(4);

              (l)  [Rep. by 2012 c2 s1]

           (m)  "pharmaceutical alternatives" means drug products that contain the same or similar amount of the same or similar medicinal ingredients, in comparable dosage forms but do not necessarily contain the same non-medicinal ingredients;

             (n)  "pharmaceutical equivalents" means drug products that contain the identical amounts of the identical medicinal ingredients, but do not necessarily contain the same non-medicinal ingredients;

             (o)  "pharmacist" means a person registered under the Pharmacy Act, 2012, and includes a pharmacy as the context requires;

             (p)  "prescriber" means a person who is entitled to prescribe drugs under the laws of the province and includes

                      (i)  a medical practitioner licensed under the Medical Act, 2005 ,

                     (ii)  a dentist or dental surgeon licensed under the Dental Act ,

                    (iii)  an optometrist licensed under the Optometry Act, 2012,

                    (iv)  a veterinarian licensed under the Veterinary Medical Act, 2004 , and

                     (v)  a nurse practitioner licensed under the Registered Nurses Act ; and

             (q)  "therapeutic equivalents" means pharmaceutical equivalents or pharmaceutical alternatives that have been shown to be bioequivalent to a reference product as demonstrated by bioavailability, pharmacodynamic or clinical studies.

2006 cP-12.01 s2; 2012 c2 s1; 2012 cO-7.02 s64; 2012 cP-12.2 s66

PART I
CONFIDENTIALITY, AGREEMENTS AND GENERAL ADMINISTRATION

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Appointments by minister

        3. (1) The minister may appoint those officers, auditors or other persons considered necessary for the operation of this Act who shall be responsible for the duties and functions that the minister may determine.

             (2)  The minister may, in writing, delegate a power or duty under this Act to a person referred to in subsection (1), except the power to report to the police under subsection 27(7).

2006 cP-12.01 s3

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Confidentiality

        4. (1) A person employed in the administration of this Act shall preserve secrecy with respect to all matters that come to his or her knowledge in the course of that person's employment and shall not communicate the matters to another person, including a person employed by the government, except

             (a)  to a prescriber for a purpose relating to drugs or drug products that have been prescribed or dispensed to a beneficiary;

             (b)  to a pharmacy for a purpose relating to drugs or drug products which have been prescribed or dispensed to a beneficiary;

             (c)  for the purpose of the administration of this Act;

             (d)  for the purpose of consultation between the minister and a board or governing body of the professions referred to in paragraphs 2(o) and (p);

             (e)  at the discretion of the minister, to a regional health authority established under the Regional Health Authorities Act ;

             (f)  to a person where the disclosure of that information is required by law;

             (g)  at the discretion of the minister, to a person engaged in health or medical research;

             (h)  to a professional body, for the purpose of reporting possible conduct deserving of sanction;

              (i)  to the police for the purpose of reporting a matter under subsection 27(7); and

              (j)  in other circumstances that may be prescribed by order of the Lieutenant-Governor in Council,

and the information released under this section shall only be used for the purpose for which it was released.

             (2)  The Crown is not liable for damages caused to a person as a result of the release of information under subsection (1).

2006 cP-12.01 s4

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Information required

        5. Records or other information required to be submitted under this Act shall be submitted in a form required by the minister, and may be submitted in electronic form.

2006 cP-12.01 s5

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Duties under Act

        6. (1) Pharmacies, pharmacists, dispensing physicians, prescribers and beneficiaries participating in the programs established under this Act shall comply with this Act and the regulations made under it, including any policies and terms and conditions set by the minister in the administration of this Act and the regulations.

             (2)  Pharmacists, dispensing physicians and prescribers participating in the programs under this Act shall at all times abide by all applicable federal and provincial legislation relating to their professional practice, as well as the by-laws and codes of practice set by their relevant governing bodies.

2006 cP-12.01 s6

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Agreements, contracts

        7. The minister may make and enter into

             (a)  agreements on behalf of the department with other departments, on behalf of the province with the Government of Canada or the government of a province or territory of Canada or an agency of either of them or with a private entity or agency with respect to a matter under this Act, including

                      (i)  information sharing agreements,

                     (ii)  memoranda of understanding,

                    (iii)  agreements to verify income for the purposes of eligibility, including ongoing eligibility, and

                    (iv)  agreements with the Pharmacists’ Association of Newfoundland and Labrador ; and

             (b)  contracts with third parties with respect to the provision of programs and services.

2006 cP-12.01 s7

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Programs and pilot projects

        8. (1) The minister shall provide services under programs established by this Act from funds appropriated by the legislature for the purpose.

             (2)  In providing services under subsection (1), the minister may provide for pilot projects, demonstration projects and innovations in drug programs and services in all or part of the province.

2006 cP-12.01 s8

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Protection for actions in good faith

        9. (1) An action for damages does not lie against

             (a)  the minister, or an officer, employee or committee appointed by the minister; or

             (b)  a pharmacy, pharmacist, dispensing physician or prescriber

for any proceeding initiated or taken in good faith under this Act, for an act done or omitted to be done in good faith in carrying out his or her duties or obligations under this Act, the regulations, terms and conditions or policies of the minister under the authority of this Act, or a decision or order made or enforced in good faith under this Act.

             (2)  An action does not lie against a person for the disclosure of information or a document or anything in it under this Act if that disclosure was made in good faith.

             (3)  An action for damages does not lie against a pharmacy, pharmacist, dispensing physician or prescriber or any other person for disclosing information, books, records, papers and other documents in their possession or control when disclosed in good faith as required by this Act.

2006 cP-12.01 s9

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Review

      10. The minister shall, every 5 years, perform a review of this Act and the regulations made under it, the principles upon which it is based and consider the areas in which it may be improved and report his or her findings to the Lieutenant-Governor in Council.

2006 cP-12.01 s10

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Delivery principles

      11. The following principles apply to the delivery of programs and services under this Act:

             (a)  access to the program and services shall be provided in a timely manner with appropriate consideration of a person’s unique circumstances and needs, as departmental resources, including budgetary appropriations, permit;

             (b)  funding decisions for drugs and related products shall be made on the best clinical and economic evidence available and shall be openly communicated in as timely a manner as possible;

             (c)  there shall be transparency and accountability through review of this Act and the regulations made under it; and

             (d)  this Act, the regulations made under it, and the policies and procedures of the department, shall, to the extent possible, be available to the public upon reasonable request in the manner determined by the minister.

2006 cP-12.01 s11

PART II
NEWFOUNDLAND AND LABRADOR PRESCRIPTION DRUG PROGRAM

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Program established

      12. (1) There is established a program entitled the Newfoundland and Labrador Prescription Drug Program.

             (2)  The program is administered and operated by the minister.

             (3)  The objects of the program are to provide appropriate prescription drugs and other related benefits in a cost effective manner to those eligible for them.

             (4)  The minister may require that a beneficiary contribute to the cost of a benefit at a rate of co-pay prescribed by the regulations, and that rate may vary according to the component of the program under which the benefit is received.

2006 cP-12.01 s12

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Terms of program

      13. The program shall be the payor of last resort and shall pay prescription drug costs and other related benefits in the manner prescribed by this Act for which a person is eligible only where those services are not, or are no longer, reimbursable by a third party.

2006 cP-12.01 s13

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Program components

      14. (1) The components of the Newfoundland and Labrador Prescription Drug Program are:

             (a)  the Foundation Plan;

             (b)  the 65Plus Plan;

             (c)  the Access Plan;

             (d)  the Assurance Plan; and

             (e)  the Select Needs Plan.

             (2)  The Lieutenant-Governor in Council may, by regulation, prescribe eligibility criteria for the components referred to in subsection (1), and those criteria may vary according to the component of the program to which they apply.

             (3)  Eligibility referred to in this section shall include initial and ongoing eligibility.

             (4)  The eligibility of a person under the program components referred to in subsection (1) or the consideration of a person for coverage under subsection (8) shall be determined by the minister based on the information provided by that person and any other information available to the minister for that purpose.

             (5)  The minister may request and a person shall provide in a timely manner information required to determine eligibility under the program and the minister may seek verification of that information as he or she considers necessary.

             (6)  Participation by a beneficiary in a component of the program, including use of a drug card for the purpose of obtaining benefits under the program, shall be considered to be consent by the beneficiary for the release to the minister of the information required

             (a)  to determine that person's eligibility for the component of the program;

             (b)  for audits under the program, including the release of copies of prescriptions as part of that process;

             (c)  to determine special authorization requests, if made; and

             (d)  for review of utilization under section 27.

             (7)  A person shall be a resident of the province for the purposes of eligibility, including continued eligibility under the program.

             (8)  Where a person is not eligible under a component of the program the minister may, in his or her discretion,

             (a)  based on a financial assessment performed in the manner prescribed by regulation; or

             (b)  in exceptional circumstances as prescribed by regulation

provide coverage under the program and the minister may prescribe the limits of that coverage.

2006 cP-12.01 s14; 2012 c2 s2

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Benefits lists

      15. (1) The minister shall, by regulation, establish benefits lists which shall

             (a)  set out the drugs and related products which shall be covered under each component of the program, and the limitations of that coverage; and

             (b)  prescribe the amount to be paid for the drugs and related products referred to in paragraph (a) calculated in the manner determined by the minister.

             (2)  The benefits list shall be on file with the minister and may be available electronically on the Internet.

2006 cP-12.01 s15

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Participation in program

      16. (1) A pharmacy may apply for participation in the program, and shall, in order to participate in the program, obtain a provider number under subsection (2).

             (2)  The minister may issue a provider number to a pharmacy that applies to participate in the program and the minister may cancel or suspend a provider number in the circumstances prescribed by the regulations.

             (3)  The minister may prescribe the terms and conditions of participation in the program and, where a pharmacy has applied under subsection (1) and has been approved, the pharmacy and all pharmacists working in it shall, by participation in the program, be considered to have accepted those terms and conditions and shall comply with them.

             (4)  Notwithstanding subsections (1) and (2), a dispensing physician may apply and the minister may issue a provider number to a dispensing physician who applies for participation in the program where that dispensing physician practices in a geographically remote or isolated area of the province.

             (5)  The minister may prescribe terms and conditions of participation in the program by a dispensing physician and, where that dispensing physician has applied and been approved for participation in the program, the dispensing physician shall, by his or her participation, be considered to have accepted those terms and conditions and shall comply with them.

2006 cP-12.01 s16

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Fees and payments

      17. (1) Payments to pharmacies and dispensing physicians under the program shall be processed in the manner determined by the minister. 

             (2)  Claims submitted for processing shall include the information that the minister may require, and may be submitted electronically.

             (3)  The minister may set professional fees to be paid under this Act, and the minister may consult with the Pharmacists' Association of Newfoundland and Labrador in setting those fees.

             (4)  Where drugs or related products

             (a)  have been obtained from a participating pharmacy by a person who is later determined to be a beneficiary eligible for those benefits; or

             (b)  have been obtained from a pharmacy that is not a participating pharmacy under this Act but that are benefits for which a beneficiary is eligible,

the department may reimburse a beneficiary for the costs of his or her benefits directly.

2006 cP-12.01 s17

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Special authorization review

      18. (1) A prescriber may, on behalf of a beneficiary, request a drug for which special authorization is required under the program.

             (2)  A request shall be considered in accordance with criteria developed by

             (a)  the National Common Drug Review or the Joint Atlantic Common Drug Review or their successor organizations;

         (a.1)  the pan-Canadian Oncology Drug Review; or

             (b)  other committees or processes as determined by the minister

and adopted by the minister.

             (3)  If a request for special authorization has been declined based on the criteria referred to in subsection (2), a prescriber may request an internal review of the matter.

             (4)  If, after consideration in an internal review the request for special authorization is again denied, a prescriber may apply to the medical practitioner designated by the minister for a review of the decision and the decision of that medical practitioner with respect to the special authorization is final.

2006 cP-12.01 s18; 2012 c2 s3

PART III
INTERCHANGEABLE DRUG PRODUCTS FORMULARY

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Formulary

      19. (1) The minister shall, by regulation, establish an Interchangeable Drug Products Formulary setting out

             (a)  drugs that may be used interchangeably with other drugs upon approval for entry into the formulary;

             (b)  maximum prices to be charged for drugs listed in the formulary;

             (c)  submission requirements for interchangeable drugs; and

             (d)  the review process for determining interchangeable drug products.

             (2)  Drugs that may be used interchangeably with other drugs in the formulary shall be the pharmaceutical equivalents or the pharmaceutical alternatives that are the therapeutic equivalents of and have the same route of administration as the reference drug.

             (3)  The formulary shall be on file with the minister and may be available electronically on the Internet.

             (4)  The minister may remove a drug from the formulary where

             (a)  the manufacturer is not adhering to the price quoted for the drug upon approval for entry into the formulary;

         (a.1)  the manufacturer does not comply with pricing requirements set out in the regulations;

             (b)  removal from the formulary is advisable in the public interest; or

             (c)  the minister considers it necessary to do so.

2006 cP-12.01 s19; 2013 c12 s1

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Advisory committee

      20. (1) The minister shall appoint an advisory committee consisting of 2 pharmacists, 2 physicians, the deputy minister of the department or his or her designate, and those other persons that he or she may wish to appoint, to advise on the contents of the formulary and other matters relating to drugs.

             (2)  The minister shall consult with the Pharmacists’ Association of Newfoundland and Labrador and the Newfoundland and Labrador Medical Association on the appointments to be made under subsection (1) from their respective professions.

             (3)  The minister shall designate one of the members to be chairperson of the advisory committee.

2006 cP-12.01 s20

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Substitute drugs

      21. (1) Where a pharmacist or dispensing physician is given a prescription directing the dispensing of a drug by its brand, chemical or generic name, that pharmacist or dispensing physician shall dispense a substitute drug other than the drug specifically prescribed where

             (a)  the drug to be substituted is listed in the formulary as a drug that may be used interchangeably with the drug prescribed; and

             (b)  the drug to be substituted is less expensive than the drug prescribed.

             (2)  Subsection (1) does not apply where the prescription contains a specific written direction in the handwriting of the person prescribing the drug that the drug shall not be substituted.

             (3)  Where a drug is prescribed that must be dispensed in accordance with subsection (1) has a number of substitutes listed in the formulary, the person dispensing the drug

             (a)  shall dispense the lowest priced substitute drug listed in the formulary at the price listed in the formulary plus a professional fee; or

             (b)  shall, if the lowest priced drug is not available, dispense another drug listed in the formulary as a substitute for the prescribed drug,

                      (i)  at the price of the lowest priced substitute drug listed in the formulary plus a professional fee where the lowest priced substitute drug is generally available within the province, or

                     (ii)  where the lowest priced substitute drug is not generally available within the province, at the price of the lowest priced substitute drug that is so available plus a professional fee.

2006 cP-12.01 s21

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Price

      22. Where a prescription contains a written direction that the prescribed drug is not to be substituted, the person dispensing that specific prescribed drug shall not charge more for the drug than the price listed in the formulary, where the drug is so listed, plus a professional fee.

2006 cP-12.01 s22

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Pricing requirements

      23. (1) The price for a generic drug listed on the formulary shall be no more than the maximum price calculated in accordance with subsection (2).

             (2)  The maximum price shall be calculated as a percentage of brand price in the manner prescribed in the regulations.

             (3)  Where a submission includes a price for a generic drug which is less than the maximum price of that drug calculated in accordance with this section, the price for that drug shall be guaranteed for the period of time determined by the minister.

             (4)  The price for a drug determined under this section, whether it is 

             (a)  the maximum price calculated in accordance with this section; or

             (b)  less than the maximum price,

shall be the price offered for that drug to all pharmacies and dispensing physicians in the province.

2012 c2 s4

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Non-lowest price

      24. (1) Notwithstanding sections 21 and 22, a person may request that the prescribed drug dispensed be an equivalent drug listed in the formulary, other than the lowest priced drug listed in the formulary.

             (2)  Where a prescribed drug is dispensed by a person under subsection (1), that person shall inform the person requesting a specific equivalent drug of the difference in cost between the requested formulary drug and the lowest priced equivalent formulary drug.

             (3)  A person who makes a request under subsection (1) shall pay the difference in cost between the requested formulary drug and the lowest price equivalent formulary drug.

2006 cP-12.01 s24; 2012 c2 s5

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Non-formulary

      25. Where a prescribed drug not listed in the formulary is dispensed by a person authorized by law to dispense prescriptions and

             (a)  a drug with the same active ingredients and strength; and

             (b)  in the same or similar dosage form

is listed in the formulary, that person shall charge for that dispensed drug the price of the lowest priced drug as referred to in paragraphs (a) and (b) that is listed in the formulary.

2006 cP-12.01 s25

PART IV
TAMPER RESISTANT PRESCRIPTION DRUG PAD PROGRAM

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Tamper resistant prescription drug pads

      26. (1) There is established a program entitled the Tamper Resistant Prescription Drug Pad Program which shall require the use by a prescriber of tamper resistant prescription drug pads as provided by the minister.

             (2)  The minister shall, by regulation, establish a list of drugs the prescription of which requires the use of tamper resistant prescription drug pads.

             (3)  The list of drugs referred to in subsection (2) shall be on file with the minister and may be available electronically on the Internet.

             (4)  Tamper resistant prescription drug pads shall be used in a manner determined by the minister.

             (5)  Drugs listed under subsection (2), the prescription of which requires the use of tamper resistant prescription drug pads, shall not be dispensed where the prescription is presented by telephone communication.

             (6)  A pharmacist or dispensing physician shall not dispense a drug included in the list established under subsection (2) unless the prescriber prescribing the drug has written or typed the prescription on a tamper resistant prescription drug pad approved by and provided to the person by the minister, or a person or body on behalf of the minister, and the written or typed prescription is presented to the pharmacist or dispensing physician or faxed in accordance with standards of practice for facsimile transmission set by the Newfoundland and Labrador Pharmacy Board continued under the Pharmacy Act .

             (7)  The minister may prescribe, by regulation, the information required to be included when using tamper resistant prescription drug pads and where the required information has not been provided, or the prescription has not been completed in the manner required by the minister under subsection (4), a pharmacist may refuse to dispense that drug.

             (8)  Where a prescriber has had his or her licence suspended or cancelled by his or her supervising professional body, or stops practicing in the province, the prescriber shall return all tamper resistant prescription drug pads to the minister within 3 days of that suspension, cancellation or change of practice.

             (9)  A prescriber who fails to comply with subsection (8) is guilty of an offence under this Act.

          (10)  Where a pharmacist receives a prescription for a drug which is required to be prescribed according to this Part, and that pharmacist reasonably believes that the prescription is suspect, the pharmacist may

             (a)  refuse to fill the prescription; or

             (b)  report his or her reasonable suspicion to the police for investigation.

2006 cP-12.01 s26

PART V
UTILIZATION AND PRESCRIBING REVIEWS

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Utilization review

      27. (1) The minister may review the payment and utilization history of a beneficiary to determine whether there may be inappropriate utilization by that beneficiary of his or her benefits under the Newfoundland and Labrador Prescription Drug Program.

             (2)  Where the minister

             (a)  suspects that there are overlapping claims for the same or similar medication from 2 or more prescribers filled at 2 or more pharmacies; or

             (b)  finds from a review of utilization under subsection (1) that a beneficiary's pattern of use is inappropriate, in the minister's opinion,

the minister may restrict the use of a person’s drug card to one pharmacy of the person's choice and advise the person, his or her prescribers and the pharmacy of choice of that action and the reasons for that action.

             (3)  Where a beneficiary fails to choose a pharmacy under subsection (2) in the time allotted by the minister, the minister may suspend that person’s benefits under the Newfoundland and Labrador Prescription Drug Program until a pharmacy is chosen.

             (4)  Where measures taken under subsection (2) satisfy the minister that utilization has been inappropriate, or the minister reasonably believes that a beneficiary has violated the Controlled Drug and Substances Act (Canada ), a review of utilization may be conducted by the Medication Review Committee of the department.

             (5)  The Medication Review Committee shall be composed of

             (a)  persons with medical and pharmaceutical expertise who shall have voting authority; and

             (b)  persons with auditing expertise.

             (6)  The Medication Review Committee shall perform the review referred to under subsection (4) and shall report to the minister and make recommendations regarding action, including reporting to the police.

             (7)  The minister shall consider the report of the committee under subsection (6) and, in his or her discretion, report the matter to the police for investigation.

2006 cP-12.01 s27

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Prescribing patterns

      28. (1) The minister may review the prescribing patterns of a prescriber utilizing the program database and may inform that prescriber of the results of the review.

             (2)  A review of a prescriber’s prescribing patterns under this section shall be carried out using statistical analysis and comparative data, and the minister may request a review of prescribing patterns by the Medication Review Committee of the department.

             (3)  The Medication Review Committee is composed of the members referred to in subsection 27(5).

             (4)  The Medication Review Committee shall review the request of the minister under subsection (2) and shall report to the minister and make recommendations regarding action including

             (a)  notification of the prescriber of the concerns of the committee; and

             (b)  requiring an explanation of the prescriber's prescribing patterns which are of concern within 10 days of the prescriber receiving that request.

             (5)  Where

             (a)  the required information under subsection (4) has not been provided by the prescriber in the time period required by that subsection; or

             (b)  the minister considers it necessary, based on the analysis performed under this section,

the minister may report those prescribing patterns to the prescriber's disciplinary body for investigation.

2006 cP-12.01 s28

PART VI
AUDITING

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Audit

      29. In order to determine compliance with the Newfoundland and Labrador Prescription Drug Program, an audit may be performed under this Part to determine compliance with this Act, the regulations, policies and the terms and conditions of participation in the program.

2006 cP-12.01 s29

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Generally accepted auditing standards

      30. Audits performed under this Act shall be performed according to generally accepted auditing standards and audits may be performed using those techniques which may be prescribed by regulation that are considered necessary to complete audits according to the required standard.

2006 cP-12.01 s30

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Documentation and other information

      31. (1) An auditor performing an audit may examine and copy those prescriptions, documents, papers, and records that the auditor considers necessary to complete the audit in the manner required by this Act.

             (2)  An examination of records referred to in subsection (1) includes electronic records, and an auditor may make a copy of those records, including electronic records, in a manner that the auditor considers necessary, including photocopying, scanning and electronic copying of data.

             (3)  Where reasonably necessary to determine compliance under this Act, an auditor or other person appointed or designated by the minister under this Act may, at reasonable times, without a warrant, enter a pharmacy or pharmacy related business premises to inspect the documents referred to in subsection (1).

             (4)  A pharmacy shall provide the information required by an auditor under this Act in order to determine compliance with this Act and that information may be provided by mail, facsimile or by electronic transmission.

             (5)  An examination of records required under this section may also include an examination of information, documentation or other records held by a pharmacy regarding a beneficiary’s insurer and any records of payment to that insurer or other method of obtaining coverage for the drugs or related products.

2006 cP-12.01 s31

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Deadlines

      32. (1) The minister may set deadlines for providing information to auditors acting under this Part.

             (2)  The time period set by the minister under subsection (1) may be varied with the agreement of the parties.

2006 cP-12.01 s32

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Further information

      33. The minister may require that a pharmacy, prescriber, dispensing physician or beneficiary supply further information where the minister requires the information to substantiate a claim.

2006 cP-12.01 s33

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Review committee

      34. (1) The minister may, in accordance with the regulations, appoint a committee to review and advise upon matters referred to it by the minister under this Part.

             (2)  The minister shall, by regulation, prescribe

             (a)  the terms of reference for the committee;

             (b)  the composition of the committee; and

             (c)  the duties of the committee.

             (3)  The minister may consult with the Pharmacists' Association of Newfoundland and Labrador and the Newfoundland and Labrador Pharmacy Board on the appointments to be made under subsection (1).

             (4)  The committee shall review the matters referred to it and advise the minister on its findings.

             (5)  The committee may make recommendations to the minister regarding its findings, including recommendations that

             (a)  recovery of funds; or

             (b)  investigative action

be commenced.

2006 cP-12.01 s34

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Annual report

      35. An annual report of audits performed under this Act, including decisions made and the outcomes of the audits, shall be prepared by auditors appointed under this Act and submitted to the minister.

2006 cP-12.01 s35

PART VII
RECOVERY

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Recovery from beneficiaries

      36. (1) If the minister is satisfied that a beneficiary

             (a)  has provided false or misleading information to obtain benefits under this Act;

             (b)  is entitled to reimbursement by a third party for the costs of benefits which were provided under this Act; or

             (c)  has otherwise incorrectly obtained benefits under this Act,

the minister may assess the beneficiary for those benefits and may recover those benefits as a debt due to the Crown in right of the province.

             (2)  Benefits which have been paid to a beneficiary under subsection (1) shall be recovered in the manner prescribed by the regulations.

             (3)  Notwithstanding subsection (2), the minister may recover benefits paid under subsection (1) in a different manner where there is an agreement with the beneficiary to do so.

             (4)  A beneficiary dissatisfied with the assessment made by the minister may request an internal review of the matter under section 40.

2006 cP-12.01 s36

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Notice

      37. Where it has been determined under section 36 that a beneficiary has received benefits to which he or she is not entitled, the minister shall, in writing, notify the beneficiary

             (a)  that the assessment under section 36 is a debt due to the Crown;

             (b)  of the amount of money paid in error and the manner of calculating the amount;

             (c)  that the amount of money may be recovered according to this Part; and

             (d)  of the beneficiary’s right to internal review or appeal under Part VIII.

2006 cP-12.01 s37

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Recovery from pharmacies and dispensing physicians

      38. (1) Where, following an audit performed under this Act, it has been determined that a payment has been made to a pharmacy or dispensing physician in excess of the amount which was required to be paid under the Newfoundland and Labrador Prescription Drug Program, that money is a debt due to the Crown in right of the province.

             (2)  Payments which are determined to have been paid in excess under subsection (1) shall be recovered in the manner prescribed by the regulations.

             (3)  Notwithstanding subsection (2), the minister may recover the amount of a payment made in excess in a different manner where there is an agreement with the pharmacist or dispensing physician to do so.

             (4)  The minister may charge interest on payments made in excess referred to in subsection (2) in the circumstances and at a rate prescribed by the regulations.

2006 cP-12.01 s38

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Notice

      39. Where it has been determined under section 38 that excess payments have been made to a pharmacy or dispensing physician, the minister shall, in writing, notify the pharmacy or dispensing physician

             (a)  that the money is a debt due to the Crown;

             (b)  of the amount of the money paid in excess and the manner of calculating the amount;

             (c)  that the amount may be recovered according to this Part; and

             (d)  of the pharmacy's or dispensing physician's right to alternate dispute resolution or appeal under Part VIII.

2006 cP-12.01 s39

PART VIII
INTERNAL REVIEW AND APPEAL

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Internal review

      40. (1) The minister shall, according to the regulations, appoint an officer or officers to perform an internal review of the matters referred to in subsection (2).

             (2)  A person

             (a)  denied participation in any component of the Newfoundland and Labrador Prescription Drug Program as set out in subsection 14(1) may request an internal review of a decision respecting eligibility for or cancellation of benefits made under the authority of this Act and the regulations;

             (b)  denied coverage under the program as set out in subsection 14(8) may request an internal review of that denial of coverage under that section; or

             (c)  who has been assessed as owing a debt to the Crown under section 36, may request an internal review of that assessment.

             (3)  A request under subsection (2) shall be made in writing by the person no later than 60 days after being notified of the matters referred to in subsection (2).

             (4)  An officer or officers appointed under subsection (1) shall perform an internal review in the manner prescribed by the regulations.

             (5)  An internal review shall be performed within 20 business days of the receipt of the written request for it, and the results of an internal review shall be provided to the person who requested the review, in writing, within 5 business days of being decided, and the person is considered to have received the outcome of the internal review 7 business days after it has been decided.

2006 cP-12.01 s40; 2012 c2 s6

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Appeal from section 40

      41. (1) A person may appeal, either personally or through another person acting on his or her behalf with his or her written consent, the outcome of an internal review under section 40 to the appeal board appointed under section 42 of the Income and Employment Support Act and the powers of that board are those prescribed in that Act.

             (2)  An appeal under this section shall be made in writing no more than 60 days from the receipt of the outcome of an internal review under section 40.

             (3)  The appeal board shall

             (a)  acknowledge the appeal;

             (b)  arrange a date for hearing the appeal;

             (c)  give at least 7 days notice of the date, time and place fixed for hearing the appeal to the appellant and to the officers of the department who are concerned;

             (d)  notify an appellant of his or her right to appear and to be represented under subsection (4); and

             (e)  within 30 days of receiving the appeal, hear the appeal.

             (4)  For the purpose of presenting his or her case and producing evidence, an appellant may appear before the appeal board on his or her own behalf or be represented by counsel or an agent of his or her choice and may accompany and appear with his or her counsel or agent before the appeal board, and this provision shall also apply where appeals are heard by teleconference, video conference or other method approved by the minister.

             (5)  An appellant or the minister may request, in writing, with reasons, a postponement of the hearing of an appeal for a reasonable period as determined by the appeal board and the appeal board may, in its discretion, grant the postponement.

             (6)  The minister may appear and be heard in a proceeding under this section.

             (7)  Where

             (a)  an appellant has not been granted a postponement under subsection (5); or

             (b)  the appellant, either in person or by his or her counsel or agent, does not attend the hearing of the appeal after being notified under this section,

the appeal board may proceed in his or her absence to examine into the matter of the appeal and to hear the witnesses and adjudicate on the matter.

             (8)  The appeal board may, where the appropriate documents for consideration of the appeal have not been received, postpone the hearing until the earliest possible date after those documents have been received.

             (9)  For the purpose of this Act, the appeal board has the powers that are or may be conferred on a commissioner under the Public Inquiries Act.

2006 cP-12.01 s41

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Audit appeal board

      42. (1) The Lieutenant-Governor in Council shall appoint 3 persons to act as an independent external audit appeal board

             (a)  one of whom shall be a pharmacist recommended by the minister, and the minister may solicit the advice of the Pharmacists’ Association of Newfoundland and Labrador in the formulation of that recommendation;

             (b)  one of whom shall be a chartered professional accountant;

             (c)  one of whom shall be a lawyer in good standing with the Law Society of Newfoundland and Labrador who shall be the chairperson of the board; and

             (d)  none of whom shall be officers of the department or employees of the government of the province or of a board, commission, corporation or other body that is an agency of the Crown.

             (2)  Members appointed under subsection (1) or alternates appointed under subsection (3) shall be appointed for 3 years, shall be eligible for reappointment and shall hold office until re-appointed or until a successor is appointed.

             (3)  The Lieutenant-Governor in Council may appoint 3 persons who are not employees of the government of the province or of a board, commission, corporation or other body that is an agency of the Crown, as alternate members of the appeal board to act as members of the appeal board as a result of the absence, resignation, illness or death of a regular member appointed under subsection (1) at a hearing to be held under this section.

             (4)  The persons appointed as alternates under subsection (3) shall be

             (a)  a pharmacist;

             (b)  a chartered professional accountant; and

             (c)  a lawyer,

and those persons shall act as alternates for the persons appointed under subsection (1) in their respective professions and a lawyer who is an alternate under paragraph (c) shall act as chairperson of the board where the chairperson is absent or unable to act.

             (5)  An alternate member appointed under subsection (3) is considered for the purpose of this section to be a member of the appeal board.

             (6)  The minister shall appoint an officer to be the secretary of the appeal board.

             (7)  The secretary appointed under subsection (6)

             (a)  shall not have voting privileges; and

             (b)  shall keep full records of the proceedings of the appeal board.

             (8)  All the members of the board, or their duly appointed alternates, shall be present for the purpose of a quorum of the board.

             (9)  Appeals heard by the board may be conducted in person or by teleconference or video conference or other means as approved by the minister provided that, in a meeting, all participants may participate simultaneously and instantaneously.

          (10)  A board member participating in a meeting by teleconference, videoconference or other method approved by the minister shall be counted as a member present at the meeting for the purpose of establishing a quorum under subsection (8).

          (11)  Where there is a tie vote on a motion or resolution of the board, that motion or resolution shall be considered to be defeated.

2006 cP-12.01 s42; 2014 cC-10.1 s63

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Appeal of audit under section 38

      43. (1) A person may appeal, either personally or through another person acting on his or her behalf with his or her written consent, the outcome of an audit performed under Part VI to the appeal board.

             (2)  An appeal under this section shall be made in writing no more than 30 days from the receipt of the outcome of the audit.

             (3)  The appeal board shall

             (a)  acknowledge the appeal;

             (b)  arrange a date for hearing the appeal;

             (c)  give at least 14 days notice of the date, time and place fixed for hearing the appeal to the appellant and to the officers of the department who are concerned;

             (d)  notify an appellant of his or her right to appear and to be represented under subsection (4); and

             (e)  within 60 days of receiving the appeal, hear the appeal.

             (4)  For the purpose of presenting his or her case and producing evidence, an appellant may appear before the appeal board on his or her own behalf or be represented by counsel or an agent of his or her choice and may accompany and appear with his or her counsel or agent before the appeal board, and this provision shall also apply where appeals are heard by teleconference, video conference or other method approved by the minister.

             (5)  An appellant or the minister may request, in writing, with reasons, a postponement of the hearing of an appeal for a reasonable period as determined by the board and the board may, in its discretion, grant the postponement.

             (6)  The minister may appear and be heard in a proceeding under this section.

             (7)  Where

             (a)  an appellant or the minister has not been granted a postponement under subsection (5); or

             (b)  the appellant or minister, either in person or by counsel or agent, does not attend the hearing of the appeal after being notified under this section,

the appeal board may proceed in the absence of either party to examine into the matter of the appeal and to hear the witnesses and adjudicate on the matter.

             (8)  The board may, where the appropriate documents for consideration of the appeal have not been received, postpone the hearing until the earliest possible date after those documents have been received.

             (9)  For the purpose of this Act, the appeal board has the powers that are or may be conferred on a commissioner under the Public Inquiries Act .

2006 cP-12.01 s43

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Powers of board

      44. (1) The board may, within 30 days of hearing the appeal, confirm, vary or set aside the finding or decision appealed from with power to give directions, consistent with this Act and the regulations made under it, respecting the amount of money owing by a pharmacy or dispensing physician under this Act and shall notify the parties of that decision.

             (2)  Notwithstanding subsection (1), the board shall not make an order inconsistent with the benefits lists established in the regulations.

             (3)  A decision of the board shall, within 5 business days of its being decided, be communicated in writing to the appellant and to the officers of the department who are concerned.

2006 cP-12.01 s44

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Further appeal

      45. (1) The minister, a pharmacy or dispensing physician aggrieved by a decision of the board under section 44 may, within 60 days from the date of the order of the board, appeal the decision to the Trial Division.

             (2)  The court may

             (a)  uphold, amend or revoke the decision of the appeal board; or

             (b)  make another decision considered appropriate in the circumstances,

and the court may make an order as to costs for or against the appellant or the Crown and fix the amount of those costs.

             (3)  An appeal may be taken from an order or decision of the Trial Division upon a point of law.

2006 cP-12.01 s45

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Alternate dispute resolution

      46. Notwithstanding another provision of this Part, the minister may employ alternate dispute resolution mechanisms in resolving the matters related to audit reviews and appeals in the manner prescribed by regulation.

2006 cP-12.01 s46

PART IX
OFFENCE AND PENALTY

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Offence

      47. (1) A person shall not, on behalf of himself or herself or on behalf of another person, knowingly obtain or receive benefits to which that person or the other person is not entitled to obtain or receive under this Act.

             (2)  A person shall not provide a false or misleading statement in an application made under this Act or provide any false or misleading information to the minister or a pharmacist, pharmacy, dispensing physician or prescriber.

             (3)  A person shall not knowingly aid or abet another person in applying for, obtaining or receiving any benefits under this Act that the person is not eligible for under this Act.

             (4)  A person who violates this section is guilty of an offence.

2006 cP-12.01 s47

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Penalty

      48. A person guilty of an offence under this Act or the regulations is liable on summary conviction to a fine of not more than $1,000.

2006 cP-12.01 s48

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Limitation period

      49. A prosecution under this Act or the regulations shall be started within 3 years from the date the offence is alleged to have been committed.

2006 cP-12.01 s49

PART X
GENERAL

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Fees and forms

      50. The minister may set fees and prescribe forms for the purpose and administration of this Act.

2006 cP-12.01 s50

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Regulations

      51. The Lieutenant-Governor in Council may prescribe regulations

             (a)  respecting the rate of co-pay for the components of the Newfoundland and Labrador Prescription Drug Program, and that rate may vary according to the component to which it relates;

             (b)  respecting the eligibility criteria for components of the Newfoundland and Labrador Prescription Drug Program under subsection 14(2) and the criteria may vary according to the component of the program to which they apply;

             (c)  respecting the manner of conducting a financial assessment to determine limited coverage under paragraph 14(8)(a);

             (d)  respecting the exceptional circumstances under which limited coverage may be provided under subsection 14(8)(b);

             (e)  respecting the circumstances in which provider numbers may be suspended or cancelled under subsection 16(2);

             (f)  respecting the auditing techniques considered necessary to conduct audits under section 30;

             (g)  respecting the manner of recovering benefits under section 36;

             (h)  respecting the manner of recovering benefits under section 38;

              (i)  respecting the circumstances under which interest may be charged under subsection 38(4), and the rate at which that interest may be charged;

              (j)  respecting alternative dispute resolution for the purpose of Part VIII and the procedure for that resolution; and

             (k)  necessary for the administration of this Act.

2006 cP-12.01 s51

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Ministerial regulations

      52. The minister may prescribe regulations

             (a)  establishing benefits lists setting out the drugs and related products covered under the Newfoundland and Labrador Prescription Drug Program and the limitations of that coverage;

             (b)  respecting the manner of calculating costs to be paid for drugs and related products under paragraph (a);

             (c)  establishing the drug formulary under paragraph 19(1);

             (d)  respecting the list of drugs which are required to be prescribed using a tamper resistant prescription drug pad under section 26;

             (e)  respecting the information which may be required to be included on tamper resistant prescription drug pads and the manner of their use;

             (f)  respecting the appointment of officers under section 40; and

             (g)  respecting the appointment of the committee under section 34, and prescribing

                      (i)  the terms of reference,

                     (ii)  the composition, and

                    (iii)  the duties

of that committee.

2006 cP-12.01 s52

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SNL2002 cI-0.1 Amdt.

      53. (1) Paragraph 2(c) of the Income and Employment Support Act is repealed and the following substituted:

             (c)  "appellant" means an applicant or recipient who appeals the outcome of an internal review to the appeal board and includes a person

                      (i)  who appeals the outcome of an internal review performed under section 4.2 of the Health and Community Services Act, or

                     (ii)  who appeals the outcome of an internal review performed under section 40 of the Pharmaceutical Services Act;

             (2)  Subsection 43(1) of the Act is amended by adding immediately after the reference "Health and Community Services Act " a comma and the phrase "or under section 40 of the Pharmaceutical Services Act ".

             (3)  Subsection 43(2) of the Act is amended by adding immediately after the reference "Health and Community Services Act " a comma and the phrase "or under section 40 of the Pharmaceutical Services Act ".

             (4)  Subsection 44(1) of the Act is amended by adding immediately after the reference "Health and Community Services Act " where it first occurs the phrase "or the Pharmaceutical Services Act " and by deleting the word "or" at the end of paragraph (c) and the period at the end of paragraph (d) and substituting a semi-colon and the word "and" and by adding immediately after that paragraph the following:

             (e)  respecting a matter referred to in section 40 of the Pharmaceutical Services Act.

             (5)  Section 44 of the Act is amended by adding immediately after subsection (2) the following:

         (2.1)  Notwithstanding subsection (1), the board shall not make an order inconsistent with the benefits lists established by the minister under the Pharmaceutical Services Act.

             (6)  Paragraph 44(3)(b) of the Act is amended by adding immediately after the reference and comma "Health and Community Services Act , " the phrase and comma "or the Pharmaceutical Services Act ,".

2006 cP-12.01 s53

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SNL2005 cM-4.01 Amdt.

      54. Section 66 of the Medical Act, 2005 is repealed and the following substituted:

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Use of tamper resistant prescription drug pads

      66. A medical practitioner who prescribes a drug included in the list of drugs and drug products under paragraph 53(1)(d) of the Pharmaceutical Services Act shall write or type the prescription on a tamper resistant prescription drug pad approved by and provided to the medical practitioner by the minister.

2006 cP-12.01 s54

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SNL1994 cP-12.1 Amdt.

      55. (1) The Pharmacy Act is amended by repealing sections 58 to 64.

             (2)  The Act is amended by repealing sections 65 and 66 and substituting the following:

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Contravention

      65. A pharmacist who contravenes Part III of the Pharmaceutical Services Act is considered to have committed professional misconduct for the purposes of Part IV of this Act.

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Actions

      66. An action does not lie against a person by reason only of the prescribing or dispensing of a substitute drug in accordance with Part III of the Pharmaceutical Services Act.

2006 cP-12.01 s55

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NLR 80/98 Amdt.

      56. Section 44.1 of the Pharmacy Regulations is repealed.

2006 cP-12.01 s56

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Transitional

      57. (1) Where a policy of the minister is replaced in whole or in part by the coming into force of this Act and the regulations and the provisions of this Act and the regulations are substituted, in an audit to determine compliance begun before the Act and the regulations came into force, the procedure established by the substituted provisions shall be followed so far as it can be adapted.

             (2)  A benefit or a payment improperly conferred or improperly paid before the coming into force of this Act, whether discovered before or after the coming into force of this Act shall be recovered on the same basis and in the same manner as provided for in this Act and the regulations.

             (3)  An audit conducted under a policy of the minister prior to the coming into force of this Act and the regulations is considered to have been validly undertaken as if it had been conducted under this Act and the regulations.

2006 cP-12.01 s57

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Commencement

      58. This Act shall come into force on a day to be proclaimed by the Lieutenant-Governor in Council. (In force - Jan. 31/07)

2006 cP-12.01 s58