Ontario Public Drug Programs, Ministry of Health and Long-Term Care. For the Influenza Immunization Season

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Ontario Public Drug Programs, Ministry of Health and Long-Term Care Notice from the Executive Officer: Pharmacist Administration of Publicly Funded Influenza Vaccines and Claims Submission using the Health Network System For the 2016-2017 Influenza Immunization Season Pharmacists who have successfully completed the required injection training and are registered as such with the Ontario College of Pharmacists (OCP) may administer the publicly funded influenza vaccine (i.e., injectable and nasal spray format) to eligible Ontarians at participating pharmacies. Required training includes current certification in cardiopulmonary resuscitation (CPR) and First Aid 1. Please note that administration of the nasal spray does not require the same training/certification as that the injectable because it is not a controlled act. Pharmacies that have been approved to provide publicly funded influenza vaccine under the Universal Influenza Immunization Program (UIIP) for the 2016/2017 season and have completed a User Agreement for Pharmacies Requesting Publicly Funded Influenza Vaccine 2 may submit claims for payment using the Ministry s Health Network System (HNS) for eligible Ontario residents. Patient Eligibility Ontarians who are five years of age or older and have a valid Ontario Health Card are eligible to receive a publicly funded influenza immunization under the UIIP. There are certain restrictions that may apply (see Restrictions section below). Description Eligible Ontario residents may receive a publicly funded influenza vaccine from the pharmacy at no cost. Completion of a consent form for the administration of the vaccine is required. The influenza vaccine cost is covered by the Ontario government through the UIIP. 1 Pharmacists, who provide patient care, are required to maintain certification in CPR and First Aid to ensure patient safety. 2 The User Agreement outlines requirements for pharmacies in meeting the Universal Influenza Immunization Program (UIIP) including vaccine ordering, storage and handling; cold chain requirements and incident management; vaccine refrigerators and inspections; and other requirements of the program. A minimum of one trained pharmacist who is registered as such with the OCP must be listed on the respective approved pharmacy s User Agreement with the Public Health Division, Ministry of Health and Long-Term Care.

Refer to Table 1 for the 2016/2017 season for a list of publicly funded influenza vaccines that are available to pharmacies to order, including patient age requirements for each vaccine 3. Pharmacies will be reimbursed $7.50 per eligible claim for the administrative costs associated with administering each of the six injectable publicly funded vaccine using its assigned Drug Identification Number (DIN), through the HNS. Pharmacies will be reimbursed $5.00 per eligible claim for the administration of FluMist (nasal spray vaccine) using its assigned DIN through the HNS. Procedures The pharmacist who administers the publicly funded influenza vaccine must be identified in the prescriber field on the claim submitted for payment through the HNS. Please use the DIN specific to the publicly funded influenza vaccine administered. Pharmacists must not administer publicly funded influenza vaccine to children less than five years of age. Pharmacists must ensure that the patient s date of birth, health card number and name (as it appears on the health card) are part of the HNS claims submission. Failure to do so - especially for non-odb patients - may impact the ability to submit future claims for these patients. Per User Agreement, the service also includes providing patients with a written record of their influenza immunization injection. Pharmacy Documentation Requirements Name of Patient Name and Lot # of the publicly funded vaccine that was administered Time and date the vaccine was administered Name and signature of the trained pharmacist who administered the vaccine Signed and dated patient consent form Written record of influenza immunization provided to the patient Pharmacies must keep a record of every dose of publicly funded influenza vaccine administered. Pharmacy documentation must be maintained in a readily retrievable format for the appropriate record retention period of at least 10 years from the last recorded professional pharmacy service provided to the patient, or until 10 years after the day on which the patient reached, or would have reached, the age of 18 years, whichever is longer. 3 Inclusion of a product in the list of publicly-funded vaccines available for pharmacies to order does not guarantee supply of the product is available through the Ontario Government Pharmaceutical and Medical Supply Service (OGMPSS) or participating pharmaceutical wholesaler, whichever may apply. 2

Payment $7.50 per injectable influenza vaccine administered by a trained pharmacist $5.00 per influenza nasal spray vaccine administered by a pharmacist operating under the UIIP Table 1: Vaccines DIN Influenza Product Availability Eligibility for 2016/2017 02428881 02420686 02269562 02362384 02420783 02432730 02420643 02426544 Agriflu Novartis Vaccines & Diagnostics, Inc (Trivalent influenza vaccine) Fluviral GlaxoSmithKline Inc. (Trivalent influenza vaccine) Influvac BGP Pharma (Trivalent influenza vaccine) Fluad Novartis Vaccines & Diagnostics, Inc (Trivalent influenza vaccine) FluLaval Tetra GlaxoSmithKline Inc. (Quadrivalent influenza vaccine) Fluzone Quadrivalent Sanofi Pasteur Limited (Quadrivalent influenza vaccine) Fluzone Quadrivalent Sanofi Pasteur Limited (Quadrivalent influenza vaccine) FLUMIST Quadrivalent AstraZeneca Canada (Quadrivalent influenza vaccine) 15 mcg/ 0.5mL; 5 ml (multi-dose) vial 15 mcg/ 0.5mL; 5 ml (multi-dose) vial 15 mcg/ 0.5mL; single dose, pre-filled syringe Intramuscular injection.15 mcg/ 0.5mL; single dose, pre-filled syringe Intramuscular injection.15 mcg/ 0.5mL; 5 ml (multi-dose) vial 15 mcg/ 0.5mL; 5 ml (multi-dose) vial 15 mcg/ 0.5mL; single dose, pre-filled syringe Intranasal Spray, 10 6.5-7.5 FFU/0.2 ml; 0.2 ml pre-filled, single-use glass sprayer 5 years and older* 5 years and older* 18 years and older 65 years and older 5 to 17 years (inclusive) 5 to 17 years (inclusive) 5 to 17 years (inclusive) Age 5 to 17 years * Unless specifically requested the trivalent influenza vaccines (TIVs) are primarily targeted to adults 18 years of age and older. 3

Pharmacy billing procedure for publicly funded influenza vaccines Claims for the vaccine administration fee may only be submitted for publicly funded influenza vaccines delivered by trained pharmacists to eligible Ontarians five years of age and older. Claims for the administration fee through the HNS may not be submitted for vaccinations provided by other health-care professionals, such as nurses hired for pharmacy clinics. Claims for the administration fee must be submitted using the appropriate DIN. Do not enter a drug cost, mark-up or a dispensing fee. Record the lot # and the time and date of the administration in your pharmacy records. Recording vaccine lot numbers and other information is required as per the User Agreement and important in the event of a vaccine recall or an adverse event following the immunization. For ODB-eligible recipients The claim submission follows the normal process for submitting claims on the HNS with the following additional information: Intervention code PS : (Professional Care Services) Drug Identification Number (DIN): as per the publicly funded influenza vaccine administered Valid Pharmacist ID For Non-ODB recipients When submitting a claim for a person who does not have ODB coverage, pharmacists must submit the following information: Patient Gender: F = female; M = male Patient Date of Birth: Valid YYYYMMDD Patient s Ontario Health Card number Intervention codes: PS: Professional Care Services ML: Established eligibility coverage (i.e., 1 day of the Plan S coverage) Carrier ID: S Drug Identification Number (DIN): as per the publicly funded influenza vaccine administered Valid Pharmacist ID 4

Restrictions to the UIIP Restrictions include: The publicly funded influenza immunization service fee may not be claimed for residents of long-term care homes, patients in hospital or other institutions licensed by the ministry. Patients are expected to provide their health card for the service, and submission of their health card information is a requirement to process a pharmacy claim for payment. Should a patient not have a valid Ontario Health Card, a pharmacist can still administer the influenza vaccine so long as the patient possesses valid documentation that they live, work or study in Ontario. It should be noted, however, that the pharmacist will not be paid any administration fee for these doses and cannot pass the fee onto that patient. Alternatively, pharmacists may refer him/her to the local Public Health Unit for influenza immunization. If the pharmacist does administer the vaccine to a patient without an Ontario health card, the pharmacist must complete the required form, and submit it to their local public health unit. For more information, please contact UIIP.MOH@ontario.ca. The form is available at: www.forms.ssb.gov.on.ca/mbs/ssb/forms/ssbforms.nsf/getfileattach/014-4455-64e~3/$file/4455-64e.pdf Administration of non-publicly funded influenza vaccine products that are privately purchased by the pharmacy do not qualify for reimbursement under the UIIP for influenza vaccine or through the ODB HNS for the vaccine administration fee. Pharmacists may not transfer publicly funded influenza vaccine inventory to another pharmacy. The ministry does not accept paper claims for pharmacist administered influenza vaccines. A pharmacist s recommendation to a prescriber that a patient ought to get his/her influenza vaccine whether it is eligible for public funding or not, does not meet the criteria of the Pharmaceutical Opinion Program and is therefore not a billable service under that program. Reimbursement of Epinephrine Auto-Injection using the Health Network System for Emergency Treatment In the event of an adverse drug reaction resulting immediately after a pharmacist s administration of the publicly funded influenza vaccine to an eligible Ontarian five years of age and over, the ministry will reimburse pharmacies the acquisition cost of the epinephrine autoinjection up to the Total Amount Reimbursed (see Table 2 below) when used for emergency treatment in the pharmacy or at the immunization location. 5

Under the Regulated Health Professions Act, 1991, any pharmacist may render emergency first aid or temporary assistance in an emergency situation 4. The pharmacist who administered the epinephrine must use their valid pharmacist identification on the claim submitted for payment through the HNS using the proper product identification number (PIN) specific to the epinephrine auto-injection product that was administered for emergency use as a result of the pharmacist s administration of the influenza immunization. Pharmacy Documentation Requirements Name and signature of the pharmacist who administered the epinephrine auto-injection Name of the epinephrine auto-injection administered Name of patient Time and date the epinephrine auto-injection was administered Cross-reference to the Influenza Immunization Administration claim for the patient receiving epinephrine Pharmacies must keep a record when the epinephrine auto-injection was administered for emergency use due to a pharmacist-administered influenza vaccine. Pharmacy documentation must be maintained in a readily retrievable format for the appropriate record retention period of at least 10 years from the last recorded professional pharmacy service provided to the patient, or until 10 years after the day on which the patient reached, or would have reached, the age of 18 years, whichever is longer. Pharmacy billing procedure The total amount reimbursed of the epinephrine auto-injection will be reimbursed by the Ontario government. Table 2: Epinephrine Products PIN Epinephrine Product Total Amount Reimbursed 09857423 Epipen 1/1000 (1mg/1mL) DIN 00509558 $94.35 09857424 Epipen Jr. 0.5 mg/ml DIN 00578657 $94.35 4 Under the Regulated Health Professions Act, 1991 (RHPA), the administration of a substance by injection is a controlled act which unauthorized persons are prohibited from performing. Under the Pharmacy Act, 1991 (PA), certain pharmacists are authorized to inject individuals with epinephrine in the course of providing health care services to an individual (subject to the conditions laid out in regulation under the PA which include the condition that a pharmacist only perform the act for the purpose of patient education and demonstration). Where the administration of a substance by injection is done for the purposes of rendering first aid or temporary assistance in an emergency, the RHPA exempts such injections from the controlled act prohibition regardless of who performs it. 6

If administering for emergency use, the epinephrine PIN will be billed as a second claim following the influenza vaccine claim on the same day of service. Please note the cost of the epinephrine auto-injection for this transaction will appear in the dispensing fee field of the claim. Claims must be submitted using the PIN associated with the epinephrine product. Only the acquisition cost of the drug is eligible for reimbursement. Do not enter the DIN or a mark-up or a dispensing fee. For ODB-eligible recipients The claim submission follows the normal process for submitting claims on the HNS with the following additional information: Intervention code PS : Professional Care Services Product Identification Number (PIN): as per the epinephrine auto-injection administered (see above) Valid Pharmacist ID For Non-ODB recipients When submitting a claim for a person who does not have ODB coverage, pharmacists must submit the following information as the second claim following the vaccine administration claim: Patient s Ontario health card number Intervention codes PS: Professional Care Services Product Identification Number (PIN): as per the epinephrine auto-injection administered (see above) Valid Pharmacist ID code must be included with the claim Restrictions on Epinephrine Auto-Injection Epinephrine auto-injection will not be reimbursed for the following situations (other examples may apply): Providing the epinephrine auto-injection to the patient to self administer or take home (for example: in the event the patient may experience an adverse event after leaving the pharmacy). Pharmacist emergency injection of epinephrine auto-injection not due to an adverse drug reaction resulting from the administration of the publicly funded influenza vaccine. Pharmacist emergency injection of epinephrine auto-injection at a nurse-led pharmacy clinic. Pharmacists / pharmacies that are providing any injection or inhalation for the purpose of demonstration or education. 7

The ministry does not accept paper claims for epinephrine auto-injection claims. 8