14. Patient Support Programs and Medical Practice Activities

Patient Support Programs are programs offered by Member companies for the benefit of patients. The programs aim at increasing or facilitating patient understanding of a disease and / or treatment, better patient outcomes as well as possibly improving patient adherence to treatment. Such programs may also serve to ensure or assist with access and/or reimbursement of a product. The programs must have a primary objective of bettering patient health outcomes. Any benefit experienced by the prescribing or dispensing Health Care Professional must be incidental to the primary objective.1

[[1]]Patient Support Programs do not include Health Canada Special Access Programs or any other similar programs which are mandated by Health Canada (e.g. a program which is a condition of the notice of compliance (NOC)).

Examples of Patient Support Programs are diagnostic testing, education of patients on disease state, training by a Health Care Professional of patients on the use of a device or administration of a product, adherence programs and support provided to patients in the form of counselling by a non-prescribing Health Care Professional or a related health service provider.

Programs related to the access and/or reimbursement of a product can include, but are not limited to, financial co-pay programs, provision of product when formulary reimbursement is not available via bridging / payment assistance programs, provision of product via vouchers or via compassionate use programs, financial assistance based on the patient’s inability to pay for a prescribed Member product or assistance with the reimbursement process associated to said product and the patient’s insurance provider.[[1]]

Medical Practice Activities are programs / services offered by Members to contribute to the Medical Practice’s ultimate goal of bettering patient health outcomes via a comprehensive/holistic approach to medicine. The objective of these activities may be related to patient management practices and clinical outcomes management practices but must not be solely intended to improve or manage day-to-day administrative or operational responsibilities. Any benefit experienced by the prescribing or dispensing Health Care Professional must be also be incidental to the primary objective.2
[[2]]For example, activities or services offered by the Member related to how a group medical practice manages a certain patient type with a specific disease therefore allowing the practice to close patient care gaps would be considered Medical Practice Activities.

The provision of resources for the sole purpose of improving the practice’s efficiencies and therefore resulting in greater billing opportunities, for example, would not be considered an appropriate Medical Practice Activity.
[[2]]

The Code recognizes that industry plays a vital role in supporting patients and medical practices for the purpose of enhanced patient outcomes and to benefit health care obtained by patients. However, these programs / services must not serve solely to cover day to day activities or resources considered part of the practice’s operational expenses nor should they replace or compete with services or resources provided and funded by the existing healthcare system. Effort should be made for the healthcare system to absorb the cost of long term initiatives.

When providing Patient Support Programs or support for Medical Practice Activities, the overarching principle is that the activity, whether provided by the Member directly or through a third party acting on the Member’s behalf, should not bring the industry into disrepute. Member company staff / third party vendors must have the requisite training and expertise so as to proceed in an ethical and professional manner. In addition, all elements of these programs / services should be appropriate, reasonable, and in accordance with treatment protocol / guidelines, clinical standards and relevant Code sections.

These programs / services / activities should never be offered nor provided to Health Care Professionals, Medical Practices, patients, their agents or healthcare facilities:

• As an incentive to gain access to a medical practice or hospital formulary listing;
• As an obligation or undue inducement to prescribe particular Prescription Medicines;
• In exchange for recommending for use; or
• In a manner that could be construed as a gift.

Any payment made to a Health Care Professional must be for appropriate services as described in a written agreement. Such payments must not be intended to cover acts or tasks that are part of the Health Care Professional’s standard of care or which are covered as part of the healthcare system’s reimbursement process.

Under no circumstances can the Health Care Professional acting as intermediary between Member company and patient be paid solely for offering the Patient Support Program to their patients.

All clinical decisions, which may include the selection of appropriate Prescription Medicines or the development of management plans, are the responsibility of the relevant Health Care Professional. Product specific activities can be initiated only after the prescribing Health Care Professional has made the treatment decision and/or prescribed the product.

Such services / programs must never be sold, distributed or included on a claim for reimbursement or other submission for payment.3

[[3]]For example, it would be inappropriate to have a set amount provided to the Health Care Professional on a per-patient-enrolled basis. Health Care Professionals are not to be remunerated for simply offering the patient the Member program.

If a Member provides a Patient Support Program to the Health Care Professional free of charge, the Health Care Professional must not subsequently sell it to patients.
[[3]]

These programs / services / activities must be designed and approved by the Canadian Member’s head office so as to ensure proper design according to this and any other related section of this Code as well as the appropriate oversight. 4
[[4]]For example, a Patient Support Program or Medical Practice Activity designed and executed by a sales representative for his/her specific territory would not be an acceptable program or activity.[[4]]

Patient Support Programs or Medical Practice Activities must have clear objectives, timelines and scope:

• The objective should be to achieve better patient health outcomes and/or facilitate access to a Member product.
• The timelines should be predetermined and justified by the clinical purpose.
• Consideration must be given to the appropriate use of the prescribed product (should the program involve a specific product) and the scope of the availability of the programs / services / activities. Members are to design and offer programs/services to be intended for all eligible patients. If the program/services are to be limited in distribution, Members are to consider the criteria for eligibility to ensure a fair and appropriate dissemination.

Members must be clear regarding information and communication with patients or medical practices whether it be done directly by the Member or through a third party acting on behalf of the Member:

• Patient confidentiality must be maintained at all times. In addition, proper privacy practices must be exercised in all such programs /services related to any potential data collected and the purpose of the collected data.
• Transparency regarding the Member Company or any third party acting on behalf of a Member is to be maintained in all programs / services / activities provided to patients or medical practices.
• In the case of the Patient Support Programs, the patient must subscribe or consent to a program and have the ability to opt out of the program at any given time and is to be provided clear instructions on how to do so.

Member companies should make all reasonable efforts to encourage the transparency by Health Care Professionals towards their patients regarding any financial or other material relationships with Members.

Data collected, analysed, disseminated and/or published must be done according to current scientific standards and must be unbiased and accurate.

Key learnings or best practices collected from these programs / services can be used to illustrate the impact on health outcomes, in scientific exchanges and promotional activities. Such findings may also be the subject of reports or other communications provided that appropriate permissions and approvals are obtained.5
[[5]]Members must make a distinction between Section 14 and Section 18 of the Code. Programs / services described in Section 14 are not intended to demonstrate the clinical use of a Prescription Medicine.[[5]]