HLA Pharmacy Adherence Pilot Terms and Conditions
These Terms and Conditions cover the Health Literacy Australia Pty Ltd (“HLA”) Pilot program to run a mail based medication adherence program via information provided by a number of retail pharmacies.
The agreement to be part of the Pilot Program and the subsequent supply to HLA of the required information also acts as an indication of acceptance of the following Terms and Conditions.
Any notice or communication given pursuant to this Agreement will be in writing and will be sufficiently given if personally delivered, sent by registered or certified mail, return receipt requested, postage prepaid, sent by facsimile or other means of electronic transmission with a confirmatory copy by first class mail, postage prepaid, or sent by overnight courier service which maintains delivery records, to the parties at their addresses set forth below, or to such other address as a party may designate by a notice given pursuant hereto.
Health Literacy Australia
Level 8, 217 Clarence St
Sydney NSW 2000
WHEREAS, The Pharmacy wishes to become part of a Pilot Program to provide direct mail communications that qualify as “refill reminders” communications (“Refill Reminders”) to some of its customers, as well as other Health Information communications and services as may be agreed to in writing by the parties in the future; and
WHEREAS, The Pharmacy wishes to appoint HLA as its agent to obtain sponsorship for Refill Reminders from pharmaceutical, biotech, device, or other appropriate companies, charities, foundations, governmental entities, or any other appropriate and willing sponsor (“Sponsors”)
WHEREAS, the Parties wish to enter into this Agreement to ensure compliance with the Privacy, Security, and Breach Notification Rules implemented pursuant to the Australian Privacy Act 1988 (“Privacy Act”) and the Privacy Regulation 2013 (“Privacy Regulation”), as the same may be amended from time to time, and other applicable Australian laws; and
WHEREAS, pursuant to the performance of this Agreement, it will be necessary for The Pharmacy to disclose certain information (“Information”) to HLA pursuant to the terms of this Agreement, some of which may constitute Private Health Information (“PHI”) under the Privacy Act and Privacy Regulation; and
WHEREAS, The Pharmacy understands and agrees that it will be necessary for HLA to disclose certain The Pharmacy Information and The Pharmacy PHI to agents or subcontractors of HLA; and
WHEREAS, The Pharmacy desires to provide Pharmacy Data and for HLA to utilize Pharmacy Data for healthcare operations research purposes and to fully de-identify Pharmacy Data such that it is not considered Protected Health Information under the Privacy Act and Privacy Regulation (“de-identified Pharmacy Data”), to provide Analytics Reporting Services (as defined in Exhibit B attached hereto and incorporated herein), and
WHEREAS, The Pharmacy believes providing the Analytics Reporting Services will also improve the effectiveness of Refill Reminders, and
NOW THEREFORE, in consideration of the mutual promises contained herein and the exchange of information pursuant to this Agreement, the parties agree as follows:
The Pharmacy hereby appoints HLA as its non-exclusive provider of Refill Reminders programs (see additional description on Exhibit A attached hereto), and as a non-exclusive provider of such other services as The Pharmacy and HLA may from time to time agree in writing.
“Protected Health Information” (“PHI”) means individually identifiable health information including, without limitation, all information, data, documentation, and materials, including without limitation, demographic, medical and financial information, that relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual; and that identifies the individual or with respect to which there is reasonable basis to believe the information can be used to identify the individual. “Protected Health Information” includes, without limitation, “Electronic Protected Health Information,” as defined below.
“Pilot Program” or “Pilot” means the two phase Pilot Program being run to test the effectiveness of the adherence protocol. The Pilot Program will be run within a single 12 month period that begins from the date of acceptance of these Term and Conditions and will include two – three month Pilot periods during which communications may sent out on behalf of the Pharmacy to consented patients.
4. Obligations and Activities of HLA.
- Identification of Sponsors. Sponsors for Refill Reminder Programs. Where a Sponsor is identified for a Refill Reminder or other, HLA will be responsible to contract with the Sponsor on behalf of the The Pharmacy. In such cases, the parties understand and agree that HLA enters into such agreements with the Sponsors (“Sponsorship Agreements”) on behalf of The Pharmacy.
- Collection and Distribution of Sponsorship Funds. Except as may be specifically set forth otherwise in an applicable Sponsorship Agreement, all payments made by Sponsors under the Sponsorship Agreements are payments collected by HLA as agent for The Pharmacy.
- Implementation. HLA will provide programming, set-up, content development, intervention protocol design, control group randomization, program analysis, patient opt-out processes, and other services as are necessary for the proper administration and implementation of the Refill Reminders.
- Reporting. HLA will provide The Pharmacy with a report, at the end of the Pilot, which includes operational statistics including number of Refill Reminders generated by letter type and/or by drug.
- Opt-Out Procedure. HLA, either directly or through a subcontractor, will provide a nonexclusive automated patient opt-out telephone number as well as an Internet based interface.
- Permitted Uses and Disclosures. HLA may use and/or disclose PHI received by HLA pursuant to this Agreement (“The Pharmacy’s PHI”) solely in accordance with the specifications set forth in this Agreement, or as Required By Law.
g. Safeguards. HLA agrees to use appropriate safeguards to prevent use or disclosure of The Pharmacy’s PHI other than as provided for by this Agreement.
h. Documentation. HLA agrees to document such disclosures of PHI and information. 5. Permitted Uses and Disclosures of PHI by HLA.
a. Refill Reminders. Except as otherwise limited in this Agreement, HLA may use or disclose PHI on behalf of, or to provide services to, The Pharmacy for the following purposes, if such use or disclosure of PHI would not violate any Privacy Laws or Regulations if done directly by The Pharmacy:
- Seek funding from pharmaceutical manufacturers for Refill Reminders Programs; and,
- Conduct the Refill Reminders as described in Exhibits A; and,
- Provide Aggregated Reporting / Information Services to pharmaceutical manufacturers related to refill reminder programs to which such manufacturer participates. Notwithstanding the foregoing, in no circumstance whatsoever shall HLA provide a pharmaceutical manufacturer, as part of its Aggregated Reporting / Information Services, any PHI of The Pharmacy.
ii. Additional services as may be mutually agreed by the parties in writing pursuant to an addendum to this Agreement.
b. Management and Administration of HLA.
i. Except as otherwise limited in this Agreement, HLA may use PHI for the proper management and administration of HLA, or to carry out the legal responsibilities of HLA.
ii. Except as otherwise limited in this Agreement, HLA may disclose PHI for the proper management and administration of HLA, provided that disclosures are Required By Law, or HLA obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential and used or further disclosed only as Required By Law or for the purpose for which it was disclosed to the person, and the person notifies HLA of any instances of which it is aware in which the confidentiality of the information has been breached.
c. Subcontractors. To accomplish the Refill Reminders described herein, HLA may disclose The Pharmacy’s PHI to its agents or subcontractors. Before disclosing any Pharmacy Data to its agents or subcontractors, HLA will execute contracts with its agents and subcontractors. The contracts will require HLA’s agents and subcontractors to abide by the restrictions and conditions regarding the use and disclosure of PHI and Pharmacy Data that apply to HLA under this Agreement. HLA agrees to ensure that any agent, including a subcontractor, to whom it provides PHI received from, or created or received by HLA on behalf of The Pharmacy agrees to the same restrictions and conditions that apply through this Agreement to HLA with respect to such information.
6. Obligations of The Pharmacy.
a. Provision of Data. The Pharmacy agrees to provide to HLA and its nominated sub-contractors or agents timely access to its dispensary systems for the purpose of the extraction of the PHI data. The parties understand and agree that such Patient Records will contain PHI. The delivery of the Pharmacy Data will be accomplished through an interface provided by HLA (or its nominated sub-contractor or agent).
- Profile Information. The Pharmacy agrees to provide HLA with an Electronic Version of Pharmacy Profile Information, as more fully described in Exhibit C, and update such information promptly as changes occur.
- Payment. The Pharmacy agrees to pay HLA fees for Treatment Communication programs provided at the request of The Pharmacy and as agreed between The Pharmacy and HLA.
- Notification of Opt Out. The Pharmacy shall notify HLA, through a nonexclusive automated patient opt- out telephone number or an Internet based interface, of the identity of any patient wishing to opt-out of receiving future Refill Reminders. The Pharmacy shall notify HLA within two (2) business days of The Pharmacy receiving such opt out notice by the patient. In the event that The Pharmacy fails to comply with the proper Opt Out Notifications contained herein, HLA may, at HLA’s option, terminate this Agreement. In the event the Agreement is terminated pursuant to this paragraph, HLA may, in addition to other damages, withhold or recover from The Pharmacy any amounts previously paid, or due, The Pharmacy.
- Notice of Changes. The Pharmacy shall notify HLA of any changes in, or revocation of, permission by Individual to use or disclose PHI, to the extent that such changes may affect HLA’s use or disclosure of PHI.
7. Permissible Requests by The Pharmacy.
The Pharmacy shall not request HLA use or disclose PHI in any manner that would not be permissible under the Privacy Act and Privacy Regulations if done directly by The Pharmacy.
8. Terms, Termination, and Duties Upon Termination.
a. Term. The term of this Agreement shall be effective as of the date these Terms and Conditions are agreed and shall continue for 12 months.
b. Termination for Cause. Upon either party’s knowledge of a material breach by the other party, the non- breaching party shall either:
- provide an opportunity for the breaching party to cure the breach or end the violation and terminate this Agreement if the other party does not cure the breach or end the violation within the time specified by the non breaching party;
- immediately terminate this Agreement if the breaching party has breached a material term of this Agreement and cure is not possible; or
- if neither termination nor cure are feasible, the non breaching party shall report the violation to the Privacy Commissioner. and shall terminate when all of the PHI provided by The Pharmacy to HLA, or created or received by HLA on behalf of The Pharmacy, is destroyed or returned to The Pharmacy, or, if it is infeasible to return or destroy PHI, protections are extended to such information, in accordance with the termination provisions in this Section.
c. Termination without Cause. This Agreement may be terminated at any time by HLA.
d. Effect of Termination.
- Except as provided in paragraph (ii.) of this Section, upon termination of this Agreement for any reason, HLA shall return or destroy all PHI received from The Pharmacy, or created or received by HLA on behalf of The Pharmacy. This provision shall apply to PHI that is in the possession of subcontractors or agents of HLA. HLA shall retain no copies of the PHI.
- In the event that HLA determines that returning or destroying the PHI is infeasible, HLA shall provide to The Pharmacy notification of the conditions that make return or destruction infeasible. Upon such notification that return or destruction of PHI is infeasible, HLA shall extend the protections of this Agreement to such PHI and limit further uses and disclosures of such PHI to those purposes that make the return or destruction infeasible, for so long as HLA maintains such PHI.
9. Exchange of Data.
THE PARTIES AGREE THAT ANY AND ALL PHARMACY DATA PROVIDED BY The Pharmacy REMAINS THE EXCLUSIVE PROPERTY OF The Pharmacy AND THAT THIS AGREEMENT DOES NOT CREATE A LICENSE, OR ANY OWNERSHIP INTEREST WHATSOEVER IN SAID PHARMACY DATA BY HLA. Notwithstanding the foregoing, The Pharmacy shall be under no obligation to disclose to HLA any information the disclosure of which The Pharmacy determines is prohibited by law, The Pharmacy’s own policies and/or procedures, or third party contractual proscriptions.
Each of the parties (an “indemnifying party”) agrees to indemnify and hold harmless the other party (an “indemnified party”) and the indemnified party’s officers, directors, employees and agents from and against any and all claims, demands, costs and liabilities (including reasonable fees and disbursements of counsel) of any kind whatsoever (collectively “Damages”) arising directly or indirectly out of any breach of any representation or covenant of the indemnifying party contained herein or the bad faith, negligence or willful misconduct of the indemnifying party. Notwithstanding the foregoing, HLA and The Pharmacy understand that each are assuming their own risks as to whether or not the provision of Refill Reminders programs or the engagement in programs of the type contemplated by this Agreement violate any Applicable Laws.
Neither party will be liable for special, consequential, incidental or punitive Damages.
11. Intellectual Property.
The Pharmacy and HLA acknowledge the other party’s exclusive right, title and interest in and to all trademarks, trade names, service marks, logos, identifications and other proprietary interests (“Intellectual Property”) of such other party and agree not to represent that it has any ownership interest in any of the Intellectual Property of the other party. Subject to the foregoing, The Pharmacy consents to HLA’s use of The Pharmacy’s Data and Intellectual Property for the provision of the Refill Reminders hereunder.
12. Confidential Information.
Except to the extent legally required, HLA and The Pharmacy agree to hold in confidence the confidential information of the other and to use such information solely for the purposes of performing its respective obligations contemplated by this Agreement. In the event either party becomes legally compelled to disclose confidential information of the other, the party required to make such disclosure will promptly notify the other
party thereof and will use reasonable efforts to afford such other party an opportunity to seek a protective order or otherwise limit such disclosure.
13. Warranty of Authority and Performance.
Each of the parties, and their respective representative, represents and warrants that they have the authority to enter into and perform this Agreement and that the execution, delivery and performance of this Agreement does not and will not violate any order, judgment or decree applicable to or binding upon such party or conflict with any contract or commitment which is binding upon such party.
14. Compliance With All Laws.
Each of the parties covenants and agrees to comply with any and all federal, state, local, and foreign laws, regulations, rules, and orders applicable to its participation in the provision of the Refill Reminders described herein.
15. Entire Agreement.
This Agreement, together with its addendums and schedules attached hereto: (a) sets forth the entire understanding between the parties with respect to the subject matter hereof; (b) can be modified only by a writing signed by the parties to this Agreement; (c) will inure to the benefit of and be binding upon the parties and their respective successors and assigns; (d) may be executed in one or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same agreement.
- Amendment. The Parties agree to take such action as is necessary to amend this Agreement from time to time as is necessary for The Pharmacy to comply with the requirements of the Privacy Act and Privacy Regulations
- Survival. The respective rights and obligations of Business Associate under Section 8 of this Agreement shall survive the termination of this Agreement.
- Interpretation. Any ambiguity in this Agreement shall be resolved to permit The Pharmacy to comply with the Privacy Act and Privacy Regulations.
- Additional Services. HLA may, from time-to-time, provide services for The Pharmacy that are not covered by this Agreement. The Pharmacy will pay HLA for such services on a project-by-project basis as mutually agreed upon by both parties. Services may include, but are not limited to, Database Processing, Program Development and Tracking, and/or Prescription Activity Reporting.
You acceptance of these Terms and Conditions is given by your electronic acceptance of this Agreement and also indicated by your ongoing active part in the Pilot Program.
“Refill Reminders” shall be defined as: “Communications instituted with the specific objective of educating The Pharmacy’s patient population regarding medications being taken and to maintain therapy as prescribed by their physician, or as otherwise agreed upon in writing by the Parties. At its core the Refill Reminders are a series of patient specific customized communications sent by first class mail to the patients in their homes.”
Patients will receive Refill Reminders based upon the Product Identification Number of their prescription and their prescription status. Refill Reminders may include the following;
- Enrollment letter – the initial communication received by a patient that explains the program, creates expectations, and may offer drug specific information and an opportunity to opt out with information on how to do so.
- Reminder letter – usually arrives about three-to-five (3-5) days prior to the refill due date and may discuss, refill information, drug information, disease and lifestyle information.
- Urgent reminder – timing is variable but will arrive after a refill is missed by x number of days and attempts to get the patient back on track with refills.
- Last reminder – in addition to the usual reminder information, the status of the prescription refills is described indicating no refills remain and reinforces the need for talking with their physician or pharmacist about the need to continue therapy.
- Patient Education mailing – a letter sent to a patient regarding an educational aspect of a medication he/she has received or regarding a disease state typically associated with a medication he / she has received.
- Drug recalls – when a product recall occurs, notify all current patients on the medication
The Pharmacy understands and agrees that HLA may enter into agreements with agents or subcontractors toassist HLA in the implementation and administration of the Refill Reminders. NoteUpon prior agreement with The Pharmacy, HLA may from time to time provide services for The Pharmacy which are not covered by this agreement. The Pharmacy will pay HLA for such services on a project by project basis as mutually agreed upon by both parties.Services may include, but are not limited to, ad hoc mailings that are not covered by specific HLA programs, Database Processing, Program Development and Tracking, Prescription Activity Reporting, etc.
Analytics Reporting Services
1. In addition to the uses of Pharmacy Data described in the Services Agreement, The Pharmacy grants HLA permission to utilize Pharmacy Data owned by The Pharmacy, for healthcare operations research purposes to provide the following data analysis and reporting services (“Analytics and Reporting Services”) to HLA’s and/or its affiliate’s customers. The Analytics and Reporting Services being provided include, but are not limited to:
- Observational Analysis and Predictive Modelling of Drug Compliance and Persistence
- Observational Analysis and Predictive Modelling of Drug Switching and Titration
- Observational Analysis and Predictive Modelling of Drug Abandonments
- Analysis of Effectiveness of Marketing Interventions
- PBS Coverage Gap Analysis
- Prescriber Modelling & Postcode Trending Analysis
- Drug Therapeutic Class Trending Analysis
- Drug Rx Tracking Analysis
2. In the provision of Analytics and Reporting Services:
- Except as expressly permitted by the Services Agreement, HLA will not, under any circumstances use, disclose or transfer any Pharmacy Data unless it has been de-identified. HLA agrees to de- identify The Pharmacy Data in accordance with the provisions of the Privacy Act and Privacy Regulations.
- HLA will from time to time disclose or transfer summary level data as described in Section 1 of this Exhibit defined as a result of Analytic Services provided from Pharmacy Prescription Data to HLA. HLA will not identify The Pharmacy and/or any its affiliates as the pharmacy whose data has been included in these Analytics and Reporting Services.
- Subject to the provisions of the Services Agreement, HLA may from time to time disclose or transfer individual Rx level data on a fully de-identified basis (not considered PHI under Privacy Act or Privacy Regulations) as part of an Analytics Project to HLA clients, its affiliate(s) and its affiliates’ clients. Any identification of participating pharmacy will be limited to “HLA Pharmacy Network”
3. Except as provided in Section 2 above, HLA will not sell or transfer any Pharmacy Data, even in de- identified form, in bulk for use or resale by any other party whatsoever.
Exhibit C Pharmacy Profile Information
- Name of Person Authorised to Complete the Form
- Title of Person Authorised to Complete the Form
- Email Address of Person Authorised to Complete the Form
- Pharmacy Name
- Pharmacy Address (street, city, state, postcode)
- Pharamcy Business Phone Number
- Name of Pharamcist
- Electronic copy of Pharmacists Signature
- Pharmacists Qualifications
- Electronic copy of Pharmacy Logo
- QCCP Accreditation Status
- Guild Membership Status
- Copy of executed Nostradata Consent Form