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Ontario Drug Benefit Act

Provincial Principles
Legislation • Meet needs of patients, consumers and
Ontario Drug Benefit taxpayers in Ontario
• Involve consumer and patients in a
Act meaningful way - Accountability
and • Operate transparently to fullest extent for
Regulations all who have an interest in the system
• Ensure best use of resources, value for
money and cost-effectiveness
Gregory Ujiye, R.Ph., B.Sc., • Utilize best clinical and economic
Professional Practice evidence for funding decisions for drugs
Advisor/Inspector

Ontario Drug Benefit Act


Ontario Drug Benefit Act Powers of the Executive Officer
• ODB depends on DIDFA to achieve cost • Executive Officer (EO) replaces the Minister of
savings Health
– Utilize principles of interchangeability (DIDFA) • Perform any function or duty under both the
• Don’t confuse ODB and DIDFA ODBA and DIDFA
– DIDFA applies to all prescriptions in Ontario • Administer the Ontario public drug programs
– ODB only applies to ODB eligible drugs for ODB • Keep, maintain and publish the Formulary
eligible recipients
• Definitions in both DIDFA and ODB crucial to • Apply the Act for unlisted or restricted criteria
understanding the Acts e.g. executive officer, drugs
interchangeable, listed drug product, listed • Manage the listing or removal of designated
substance, designated… products
Continued…

Ontario Drug Benefit Act Ontario Drug Benefit Act


Powers of the Executive Officer Pharmacy Council
• Designate products as interchangeable with • Creation of the Pharmacy Council to
other products under DIDFA or their removal
• Negotiate agreements with manufacturers,
advise EO and MoH on health and
agree to pricing with manufacturers pharmaceutical policies
• Define template requirements for information – Ensures involvement of pharmacists
provided to EO
• Make payments under the programs • Define and implement professional
• Establish clinical criteria for drugs under s.23 services
• Pay for professional services and determine • Co-chaired by representatives of the
amounts based on prescribed conditions.
Ministry and the Ontario Pharmacists
Association

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Ontario Drug Benefit Act Ontario Drug Benefit Act
The Formulary The Formulary
• ODB Formulary/Comparative Drug Index 12 “Parts” or sections
commonly referred to as the Formulary serves
a dual purpose and identifies: • Part I – Introduction
– all “listed drug products” and “listed substances” – Background, How to Use, Dispensary
eligible for reimbursement by the ODB program
– all products that are interchangeable for the purposes Reimbursement/Procedures,
of DIDFA Information/Contacts
– drug benefit prices
• Part II – Preamble
• Products and prices effective the date
published in the Formulary (or ceases when • Part III – Formulary/Comparative
removed) Drug Index (CDI)
• Any other information necessary for
administering the ODB program Continued…

Ontario Drug Benefit Act Ontario Drug Benefit Act


The Formulary The Formulary
• Part IV – Alphabetical Index for Part • Part VIII – Individual Clincal Review
III Program (ICR) formerly “s. 8 drugs”
• Part V – Pharmaco-Therapeutic • Part IX – Additional Benefits;
Classification Index nutritional/diabetic testing agents
• Part VI – Facilitated Access • Part X – Abbreviations, Tables,
Program and eligible drugs e.g. Sample forms
HIV/AIDS and Palliative care drugs, • Part XI – currently not used
• Part VII – Trillium Program • Part XII – Limited Use Products,
Cont’d… (consolidation of LU from Part III)

Ontario Drug Benefit Act Ontario Drug Benefit Act


Eligible Persons Application of the Act
• member of a “prescribed class” • Only applies to
– insured under the Health Insurance Act – supplying of “listed drug products”
(OHIP)
– 65 years of age or older – persons eligible to receive benefits
– eligible for pension under Part I of the Old • Does not apply to the cash or private
Age Security Act or
sector*
– Receiving services or residing in a home
identifed in the Regulations (O.R. 201/96)
• persons entitled to receive drug * Health care sector divided into groups – 1) public sector,
benefits under publicly funded by government or 2) private sector, cash
– Family Benefits Act, Ontario Works Act, paying or people covered by private insurance
Ontario Disability Support Program Act

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Ontario Drug Benefit Act Ontario Drug Benefit Act
Billing Restrictions: Section 4 “No Substitution” by “patient”
• No operator of a pharmacy or a • Patient choice protected in the ODB Program,
physician can charge or accept same principle as DIDFA
payments from anyone except the EO • Brand or more expensive listed interchangeable
for the purposes of this Act drug product is requested by patient, i.e. no
substitution
• Allows for collection of the co-payment • “May charge” or collect the difference between
from the patient the more expensive interchangeable product
• Can collect from the patient only what and what ODB will pay
the Act allows • s. 4(5) provides formula for calculating the
difference
• Collection of co-payment is not
• Document
mandatory – “pharmacist may charge…”

Ontario Drug Benefit Act Ontario Drug Benefit Act


Payment of Claims: s. 5 Amount executive officer to Pay
Section 6
• Executive officer obligated to pay for
those claims where provisions of the Act • Provides the formula for calculating
and Regulations are met i.e. drug benefit what the EO will pay,
cost, markup and fee less the co-pay. (Drug Benefit Price + Markup +
• EO may pay a different amount subject Dispensing Fee – co-payment) =
to prescribed requirements what the Minister pays
• Allows for agreements to pay different • Above components determined by
amounts where agreements are in place Regulations
e.g capitation on Methadone

Ontario Drug Benefit Act Ontario Drug Benefit Act


Dispensing Fees s.6(2) Amount Executive Officer to pay
For Pharmacies:
Drug Benefit Price (DBP) + the Mark-up
– No dispensing fee where a listed drug product
does not require a prescription for sale and to (MU) + the Dispensing Fee (DF) – (the
which this clause applies
Co-payment) = what the Executive
– in all other cases, the lesser of,
(i) The dispensing fee prescribed by the Officer pays
regulations (currently $7.00) or
(ii) the amount the operator sets under
subsection 6(1) of the Drug Interchangeability (DBP + MU + DF) – (co-pay) = payment
and Dispensing Fee Act. (i.e. usual and
customary dispensing fee the operator of the
pharmacy registers with the College) (10.00 + 0.80 + 7.00 – 6.11) = 11.69
(phm’t collects $6.11 copay)
• Pharmacist responsible for collecting co-pay

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Ontario Drug Benefit Act Ontario Drug Benefit Act
Amount Executive Officer to pay
Amount Executive Officer to pay
Where dispensing fee is less than the co-
payment prescribed, the lower High Acquisition Cost
dispensing fee also becomes the co-
payment • Acquisition cost higher than drug
benefit cost
(DBP + MU + DF) – (co-pay) = payment • Mechanism to recover the
(10.00 + 0.80 + 4.99 – 4.99) = 10.80 difference from the EO provided in
(phm’t collects $4.99 copay)
the Act
• Pharmacist responsible for collecting co-
payment (must maintain documentation for
proof, i.e. invoice)

Ontario Drug Benefit Act Ontario Drug Benefit Act


Amount Executive Officer to pay Amount Executive Officer to pay
s6(5) provides for the payment of eligible
Interchangeable Products drugs where the Physician has
• Where interchangeable products are indicated “no substitution”
dispensed, you must charge for the • Must meet conditions prescribed by the
lowest priced interchangeable product Regulations
listed – Physician must indicate in writing “no
• You can dispense a higher priced substitution” for a written Rx
interchangeable product but you will only – Physician must provide an adverse drug
be paid for the lowest priced reaction form for the pharmacist
interchangeable product listed – Oral Rx – pharmacist must ensure that
an adverse drug reaction form is
provided by the physician

Ontario Drug Benefit Act Ontario Drug Benefit Act


Refusal to Dispense Prohibited: s. 10 Administration: s.11-s.11.3
• Cannot refuse to supply a listed • Opting out by pharmacies
drug product to an eligible person • Suspending pharmacy operators
to avoid meeting requirements of right to payments
the Act • Suspending physicians right to
• Exception – the use of payments
professional judgement, e.g. • Claims from eligible persons
harm may come to patient

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Ontario Drug Benefit Act Ontario Drug Benefit Act
Administration: s.11.4 - s.11.6 Administration: s.12 – s.15
• Process for pricing listed drug • Agreements, confidentiality, collection of
personal health information, inspections,
products by manufacturers etc.
• Rebates by manufacturers • Requirement for manufacturers and
• Enforcement and penalties by EO pharmacies to provide information other
than personal health information
• Defines “rebates” (s. 11.5 (18)) • Inspections and powers of inspectors
• EO establishes “Code of Conduct” – broad powers to examine any records
relating to the business practices relating to
(s 11.5 (15)) for provision of the Act
“professional allowances/rebates” • Offences and penalties

Ontario Drug Benefit Act Ontario Drug Benefit Act


Unlisted Drugs, Special Cases s.16 “Limited Use” s. 23
• For unlisted drugs (formerly s. 8 drugs) and special • For some drugs or classes of drugs where
cases specified clinical criteria must be met in order to
• Patient requires drug “not listed” be reimbursed
– Physician can apply to EO
– Specific conditions
– EO may make Act apply to that drug
– Use of drugs by particular patients or group of
– Price determined by EO
patients from a particular physician or class of
• Patient requires a “listed” drug for a condition which physicians
is not an approved condition for payment for that
“listed” drug e.g. Limited Use product – Requirement a specific person or an expert panel
recommend or approve use a particular drug or class
– EO may make Act apply to that drug of drugs
• EO may make application apply retroactively
• Where patient does not meet clinical criteria,
pharmacy may charge patient for the drug
– Amount the same as if the drug were covered

Ontario Drug Benefit Act Ontario Drug Benefit Act


Regulation 201/96 Regulation 201/96
• Introduction of new concepts and Clarifies the difference between a “rebate”
definitions, some examples: and “professional allowance”
– Deductibles and co-pays Professional Allowances in the definition of
– Therapeutic substitution “rebate” means
– Professional allowance – a benefit, in the form of currency, services
– Castatrophic drug coverage or educational materials that are provided by
a manufacturer to a wholesaler, operators of
• Clarifies the role and powers of the pharmacies or companies that own, operate
Executive Officer or franchise pharmacies or their directors
• Concepts and definitions are made for officers, employees or agents, for the
purposes of direct patient care as
purposes of the Act and the Drug Benefit identified in paragraphs 1-8
Program Continued…

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Ontario Drug Benefit Act Ontario Drug Benefit Act
Regulation 201/96 Regulation 201/96
Professional Allowances s. 1(10): Professional Allowances:
1. Continuing education programs that 4. Education days provided by
enhance scientific knowledge or pharmacists for health protection and
professional skills if held in Ontario promotion days, targeted to general
2. Continuing education programs for public
specialized services or specialized 5. Compliance packaging assisting
certifications if held in N. America patients with complicated medication
3. Clinic days provided by pharmacists to regimes
disseminate disease or drug related 6. Disease management and prevention
information to the general public initiatives
Continued… Continued…

Ontario Drug Benefit Act Ontario Drug Benefit Act


Regulation 201/96 Regulation 201/96
Professional Allowances
Professional Allowances: • Benefits not to be confused with
professional services
7. Private counselling areas in
• Formula for calculating professional
pharmacies allowances in regulations
8. Hospital in-patient or long term – any amount in excess of the calculations
care home resident clinical considered a rebate and subject to recovery
pharmacy services • Benefit not a professional allowance if
not in compliance with Code of Conduct

Ontario Drug Benefit Act


ODBA, Regulation 201/96
Eligible Persons: Designated Class
Regulation 201/96
• Receiving home care services under the Health
Insurance Act Trillium Program
• Residing in homes licenced under s.5 of the Homes
for Special Care Act
• Catastrophic Drug Program
• Eligible for a pension under Part I of the Old Age – Program runs from Aug. 1 of one year
Security Act (Canada) to July 31 of next
• Persons who have attained 65 years of age (some
conditions apply) – Must meet annual deductible – paid in
• Residing in an approved charitable home for the 4 installments through the year
aged under the Charitable Institutions Act
• Residing in homes under the Homes for Aged and
– Once deductible met, co-pay is $2.00
Rest Homes Act for each prescription.
• Residents of homes under the Nursing Homes Act

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Ontario Drug Benefit Act Ontario Drug Benefit Act
Regulation 201/96 Regulation 201/96
Trillium Program: Requirements Extemporaneous Preparations/Compounds*
• Insured under the Health Insurance Act, – Cannot be equivalent to a manufactured product
i.e. a valid Ontario Health Insurance – For internal consumption and contains a solid dosage
Card form of a listed product and no other active ingredient
– For topical or dermatological use and contains a listed
• Total household unit have collectively drug product and no other active ingredient other
spent amount determined by the than those listed in the regulations e.g. menthol,
regulations camphor etc.
– For injection and prepared under direct supervision of
• Application to the executive officer a pharmacists registered in Ont. (some restrictions)
• All forms of health insurance expended – For specific ophthalmic preparations
– Maximum of 5 minutes compounding time paid

*detailed conditions for extemp. prep. found in Part I of Formulary

Ontario Drug Benefit Act Ontario Drug Benefit Act


Amounts paid by Executive Officer Regulation 201/96
Total cost of extemporaneous Amounts Paid by Minister: s.13-17
preparations is the sum of • Legislative authority to determine DBP,
(DBP of ingredient + Acquisition cost markup and dispensing fee
of any unlisted ingredient + time*) • The Drug Benefit Price - as listed in the
Total the minister will pay Formulary
• Mark Up currently 8%
((Ext.DBP + MU) + time) + fee –
• Dispensing Fee for pharmacies is
copay) currently $7.00 (or Usual and Customary
* time is included as part of cost Fee if lower than ODB fee)

Ontario Drug Benefit Act Ontario Drug Benefit Act


Regulation 201/96 Regulation 201/96
Limits on Amounts paid by executive officer
Amounts paid by executive officer
• Authority to administer and control costs
Dispensing Physicians • Ontario Works Act, 1997 recipients
• Dispensing fee for physicians limited quantities
– Sufficient for a 35 day supply
whose office is within 20 km. of an
• All other eligible recipients can receive
accredited pharmacy is $4.28 up to a 100 day supply
• All other cases dispensing fee is • Limits amounts paid where eligibility
period ends – will pay to a maximum of
$5.10 30 days beyond end of eligibility e.g.
Trillium

continued…

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Ontario Drug Benefit Act Ontario Drug Benefit Act
Regulation 201/96 Regulation 201/96
Limits on Amounts paid by executive officer
Co payments: s.20.1/20.2
“30 day program”
• Introduces co-payments and new
• On all new prescriptions or prescriptions that
patient has not had in previous 12 months definitions such as:
• Limits the initial Rx to a 30 day quantity – Deductible amount, allowable drug costs,
regardless of quantity authorized Fiscal period (Aug 1 – July 31)
• Allows a person to try medication and allows • Introduces concept of a “deductible”
physician to monitor for efficacy – amount that must be paid initially in order for
• Designed to reduce waste an eligible person to receive benefits from a
• Provides for exceptions if patient cannot come drug plan
back in 30 days (document reasons) – Different from co-pay – cost sharing on each
• Administered through adjudication system prescription

Ontario Drug Benefit Act Ontario Drug Benefit Act


Regulation 201/96 Regulation 201/96
Co-payment: s. 20.2
Co-payment: s. 20.1/20.2 • Separates eligible persons based on
• s.20.1 establishes co-payment as income, by exempting those that have
attained 65 years of age
$2.00 or U&C whichever is less subject
– who earn less than $16,018 as a single
to conditions listed in regulation person or cohabit with a spouse and earn
• s.20.2 provides for different co- less than $24,175 as a couple
payments for the specific group of – Co-payment for this group remains at $2.00
eligible persons that have attained 65 • Establishes a different criteria and higher
years of age and determines criteria for co-payment for those that earn more
these groups than $16,018 as a single or $24,175 as a
couple

Ontario Drug Benefit Act Ontario Drug Benefit Act


Regulation 201/96 Regulation 201/96
Co payment and criteria for higher income Higher income Seniors
eligible seniors: s.20.2
• Benefit period based on fiscal year (Aug.
• $100 deductible (pay the first $100)
1-July 31)
• Establishes higher co-pay once the
deductible is satisfied as: – Must pay the $100 deductible each year
– $2.83 for accredited pharmacies operating in • For new seniors (first year when turning
hospitals
65) deductible based on month of birth
– $4.05 or $4.83 for dispensing physicians
depending on distance to a pharmacy – Amount decreases from August to July
– $6.11 for community pharmacies or lower if ($100 decreases through year to $8.33 in
U&C is less than $6.11 June/July)
Continued…

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Ontario Drug Benefit Act Ontario Drug Benefit Act
Nutritional Products Additional Benefits Part IX Diabetic Testing Agents: Additional Benefit Part IX

• Not a Formulary benefit but an additional • Most testing agents (blood


benefit for ODB eligible persons under
defined circumstances glucose strips covered by ODB)
– Sole source of nutrition • Requires a prescription from
– Must meet functional impairment criteria physician
– Must be supported by a Nutrition Product • ODB only pays a maximum
Form (keep for 2 years)
• ODB does not pay the full amount on all
amount and pharmacist may
products and pharmacist may charge collect from patient where amount
patient for difference on specific products exceeds maximum ODB will pay
only on specified products

Ontario Drug Benefit Act Ontario Drug Benefit Act


Limited Use Part III (ODBA s. 23) Limited Use Part III (ODBA s. 23)
• For specified drug products or classes • Physician responsible for criteria
of drug products
• Criteria not met, EO not responsible
• Reimbursement tied to
criteria/conditions for use of drug
for payment, pharmacist may
charge patient
• Physician indicates LU code
– Written, verbal, faxed – should explain to patient reasons
• Expiration of LU Rx dependent on – charge the patient the same as if it
specified drug were an ODB product
Continued…

Ontario Drug Benefit Act


Regulation 201/96 Ontario Drug Benefit Act
• Nurse Practitioners in the Extended
Amount charged to eligible persons: s.21 Class - RN(EC)
• May charge eligible persons for a listed drug
under certain conditions: • Limited prescribing privileges
– Quantity exceeds maximum quantity defined by the • Only eligible listed drugs in the
Act (e.g. greater than 100 days supply)
– Explain to patient the reason why Formulary will be reimbursed by ODB
– Offer patient the choice to pay or receive only quantity • RN(EC) list of drugs may change from
allowed
• May charge amount payable by EO, if eligible
time to time
person elects to pay and is advised before – new drugs added to RN(EC) schedule
dispensing that drug is available free of charge automatically become eligible if they are
• Document listed in the Formulary

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ODBA, Regulation 201/96 ODBA, Regulation 201/96
Code of Conduct: Schedule 3 Code of Conduct: Schedule 3
• Guidance document governing use of • Prohibition of Professional
professional allowances Allowances:
• Principles – Advertising or promotional flyers
– Payments from manufacturers to pharmacies (exception: clinic days as defined)
in the form of professional allowances must
only be used for defined activities – Entertainment, social or sporting
– All persons involved in the drug distribution events
system must act transparently – Meals and travels not directly
– All suppliers and operators of pharmacies associated with defined programs
must commit to abide by the Code of – Convention displays
Conduct
Continued…

ODBA, Regulation 201/96 ODBA, Regulation 201/96


Code of Conduct: Schedule 3 Code of Conduct: Schedule 3
• Personal gifts to operators • Fees or penalties for inventory
adjustments
• Staff wages or benefits except as
defined • Purchases of sales and prescription
related items
• Packaging costs or delivery • Fees for listing products in inventory
services in respect of prescription • Renovations, leasehold improvements
and dispensing fees and similar matters
• Taxes • Store fixtures
• Inventory costs • Real estate purchases or sales,
continued encumbrances, leases or rents.

ODBA, Regulation 201/96


Code of Conduct: Schedule 3
Ontario Drug Benefit Act
• Pharmacy representatives shall • Remember this is a drug plan and
conduct business ethically and in a rules apply
manner that is in the best interest of
• Will only pay for eligible drugs for
the patient
eligible recipients
• Procurement and purchasing
decisions cannot be solely based • Questions about the program
on the provision of professional should be directed to the ODB help
allowances desk
• Detailed reporting to EO

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Ontario Drug Benefit
Ontario Drug Benefit Act
Phone Numbers
Pharmacist Help Line
1-800-668-6641
Seniors Info Line
1-888-405-0405
Trillium Drug Program
Questions?
1-800-575-5386
(416)-326-1558 (Toronto)

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