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Third Session, 45th General Assembly 55 Elizabeth II, 2006 |
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AN ACT RESPECTING PHARMACEUTICAL
SERVICES |
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Received and Read the First Time................................................................... |
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Second
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Committee...................................................................................................... |
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Third
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Royal Assent................................................................................................... |
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HONOURABLE Minister of Health and Community Services |
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Ordered to be printed by
the Honourable House of Assembly |
EXPLANATORY NOTES This Bill would establish the Part I of the Bill would set out the general administrative parameters of the programs under the Act, including confidentiality and release of information requirements and the principles upon which the Act is to be administered. In Part II of the Bill, the The Bill would consolidate the law with respect to the Interchangeable Drug Formulary and the Tamper Resistant Prescription Drug Pad Program in Parts III and IV. Part V of the Bill describes a process of review of drug utilization by beneficiaries and prescribing patterns by prescribers. Parts VI and VII of the Bill relate to audits of compliance with the Act under the Newfoundland and Labrador Prescription Drug Program and recovery functions where pharmacies, dispensing physicians or beneficiaries have erroneously received payments or benefits under the program. Part VIII would set out an internal review process for beneficiaries and an appeal to the appeal board established under the Income and Employment Support Act for eligibility and other enumerated matters. With respect to appeals of audit and recovery, the Bill would establish an external audit appeal board with appropriate professional representation to hear appeals. Parts IX and X of the Bill are general provisions relating to offence and penalty under the Act, regulation-making powers, consequential amendments and transitional provisions. |
A AN ACT RESPECTING PHARMACEUTICAL SERVICES Analysis 1. Short title 2. Definitions PART
I 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 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
19. Formulary 20. Advisory committee 21. Substitute drugs 22. Price 23. Requirements of manufacturers 24. Non-lowest price 25. Non-formulary PART
IV 26. Tamper resistant prescription drug pads PART
V 27. Utilization review 28. Prescribing patterns PART
VI 29. Audit 30. Generally accepted auditing standards 31. Documentation and other information 32. Deadlines 33. Further information 34. Review committee 35. Annual report PART
36. Recovery from beneficiaries 37. Notice 38. Recovery from pharmacies and dispensing physicians 39. Notice PART
VIII 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 47. Offence 48. Penalty 49. Limitation period PART
X 50. Fees and forms 51. Regulations 52. Ministerial regulations 53. SNL2002 cI-0.1 Amdt. 54. SNL2005 cM-4.01 Amdt. 55. SNL1994 cP-12.1 Amdt. 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. 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 (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; (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) "personal information" means
personal information as defined in the Access
to Information and Protection of Privacy Act; (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, 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, 2004, (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. PART I 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). 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 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 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). 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. 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. 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 (b) contracts with third parties with respect to
the provision of programs and services. 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. 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. 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. 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. PART II Program established 12. (1) There
is established a program entitled the (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. 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. Program components 14. (1) The
components of the (a) the Income Support component; (b) the Senior Citizens component; (c) the Low Income component; and (d) the Special Needs component. (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. 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. 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. 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 (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. 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; 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 senior medical consultant designated by the minister for a review of the
decision and the decision of that consultant with respect to the special
authorization is final. PART 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; (b) removal from the formulary is advisable in the public interest; or (c) the minister considers it necessary to do so. 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 (3) The minister shall designate one of the
members to be chairperson of the advisory committee. 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. 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. Requirements of manufacturers 23. (1) Where a drug is to be included on the formulary, the manufacturer of that drug shall provide a guaranteed price for that drug for the time period required by the minister. (2) The guaranteed price for a generic drug under
subsection (1) shall be the best price available in any other province or (3) The guaranteed price of a drug referred to in
subsection (1) shall be the price offered by the manufacturer for that drug to
all pharmacies and dispensing physicians in the province. 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. 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. PART IV 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. PART V 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 (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 (4) Where measures taken under subsection (2) satisfied
the minister that utilization has been inappropriate, or the minister reasonably
believes that a beneficiary has violated the Controlled Drug and Substances Act ( (5) The Medication Review Committee shall be comprised 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. 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. PART VI Audit 29. In
order to determine compliance with the 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. 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. 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. 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. 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 (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. 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. PART 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. 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. 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. 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. PART VIII 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 the low income or income support components 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. 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 that 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. 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 (b) one of whom shall be a chartered accountant, certified management accountant or a certified general 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 accountant, certified management accountant or certified general 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. 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. 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. 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. 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. PART IX 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. 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. 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. PART X Fees and forms 50. The minister may set fees and prescribe forms for the purpose and administration of this Act. Regulations 51. The Lieutenant-Governor in Council may prescribe regulations (a) respecting the rate
of co-pay for the components of the (b) respecting the
eligibility criteria for components of the (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. Ministerial regulations 52. The minister may prescribe regulations (a) establishing benefits lists setting out the
drugs and related products covered under the (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. 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,
". SNL2005 cM-4.01 Amdt. 54. Section 66 of the Medical Act, 2005 is repealed and the following substituted: 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. 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: Contravention 65. A
pharmacist who contravenes Part 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 NLR 80/98 Amdt. 56. Section 44.1 of the Pharmacy Regulations is repealed. 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. Commencement 58. This Act shall come into force on a day to be proclaimed by the Lieutenant-Governor in Council. ŠEarl G. Tucker,
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