GUIDELINES FOR PHYSICIANS IN INTERACTIONS WITH INDUSTRY
The history of health care delivery in Canada has included interaction between physicians and the pharmaceutical and health supply industries; this interaction has extended to research as well as to education. Physicians understand that they have a responsibility to ensure that their participation in such collaborative efforts is in keeping with their primary obligation to their patients and duties to society, and to avoid situations of conflict of interest where possible and appropriately manage these situations when necessary. They understand as well the need for the profession to lead by example by promoting physician-developed guidelines.
The following guidelines have been developed by the CMA to serve as a resource tool for physicians in helping them to determine what type of relationship with industry is appropriate. They are not intended to prohibit or dissuade appropriate interactions of this type, which have the potential to benefit both patients and physicians.
Although directed primarily to individual physicians, including residents, and medical students, the guidelines also apply to relationships between industry and medical organizations.
1. The primary objective of professional interactions between physicians and industry should be the advancement of the health of Canadians.
2. Relationships between physicians and industry are guided by the CMA's
Code of Ethics and by this document.
3. The practising physician's primary obligation is to the patient. Relationships with industry are inappropriate if they negatively affect the fiduciary nature of the patient-physician relationship.
4. Physicians should resolve any conflict of interest between themselves and their patients resulting from interactions with industry in favour of their patients. In particular, they must avoid any self-interest in their prescribing and referral practices.
5. Except for physicians who are employees of industry, in relations with industry the physician should always maintain professional autonomy and independence. All physicians should remain committed to scientific methodology.
6. Those physicians with ties to industry have an obligation to disclose those ties in any situation where they could reasonably be perceived as having the potential to influence their judgment.
7. A prerequisite for physician participation in all research activities is that these activities are ethically defensible, socially responsible and scientifically valid. The physician's primary responsibility is the well-being of the patient.
8. The participation of physicians in industry sponsored research activities must always be preceded by formal approval of the project by an appropriate ethics review body. Such research must be conducted according to the appropriate current standards and procedures.
9. Patient enrolment and participation in research studies must occur only with the full, informed, competent and voluntary consent of the patient or his or her proxy, unless the research ethics board authorizes an exemption to the requirement for consent. In particular, the enrolling physician must inform the potential research subject, or proxy, about the purpose of the study, its source of funding, the nature and relative probability of harms and benefits, and the nature of the physician's participation and must advise prospective subjects that they have the right to decline to participate or to withdraw from the study at any time, without prejudice to their ongoing care.
10. The physician who enrolls a patient in a research study has an obligation to ensure the protection of the patient's privacy, in accordance with the provisions of applicable national or provincial legislation and CMA's Health Information Privacy Code. If this protection cannot be guaranteed, the physician must disclose this as part of the informed consent process.
11. Practising physicians should not participate in clinical trials unless the study will be registered prior to its commencement in a publicly accessible research registry.
12. Because of the potential to influence judgment, remuneration to physicians for participating in research studies should not constitute enticement. It may cover reasonable time and expenses and should be approved by the relevant research ethics board. Research subjects must be informed if their physician will receive a fee for their participation and by whom the fee will be paid.
13. Finder's fees, whereby the sole activity performed by the physician is to submit the names of potential research subjects, should not be paid. Submission of patient information without their consent would be a breach of confidentiality. Physicians who meet with patients, discuss the study and obtain informed consent for submission of patient information may be remunerated for this activity.
14. Incremental costs (additional costs that are directly related to the research study) must not be paid by health care institutions or provincial or other insurance agencies regardless of whether these costs involve diagnostic procedures or patient services. Instead, they must be assumed by the industry sponsor or its agent.
15. When submitting articles to medical journals, physicians must state any relationship they have to companies providing funding for the studies or that make the products that are the subject of the study whether or not the journals require such disclosure. Funding sources for the study should also be disclosed.
16. Physicians should only be included as an author of a published article reporting the results of an industry sponsored trial if they have contributed substantively to the study or the composition of the article.
17. Physicians should not enter into agreements that limit their right to publish or disclose results of the study or report adverse events which occur during the course of the study. Reasonable limitations which do not endanger patient health or safety may be permissible.
Industry-Sponsored Surveillance Studies
18. Physicians should participate only in post-marketing surveillance studies that are scientifically appropriate for drugs or devices relevant to their area of practice and where the study may contribute substantially to knowledge about the drug or device. Studies that are clearly intended for marketing or other purposes should be avoided.
19. Such studies must be reviewed and approved by an appropriate research ethics board. The National Council on Ethics in Human Research is an additional source of advice.
20. The physician still has an obligation to report adverse events to the appropriate body or authority while participating in such a study.
Continuing Medical Education / Continuing Professional Development (CME/CPD)
21. This section of the Guidelines is understood to address primarily medical education initiatives designed for practicing physicians. However, the same principles will also apply for educational events (such as noon-hour rounds and journal clubs) which are held as part of medical or residency training.
22. The primary purpose of CME/CPD activities is to address the educational needs of physicians and other health care providers in order to improve the health care of patients. Activities that are primarily promotional in nature, such as satellite symposia, should be identified as such to faculty and attendees and should not be considered as CME/CPD.
23. The ultimate decision on the organization, content and choice of CME/CPD activities for physicians shall be made by the physician-organizers.
24. CME/CPD organizers and individual physician presenters are responsible for ensuring the scientific validity, objectivity and completeness of CME/CPD activities. Organizers and individual presenters must disclose to the participants at their CME/CPD events any financial affiliations with manufacturers of products mentioned at the event or with manufacturers of competing products. There should be a procedure available to manage conflicts once they are disclosed.
25. The ultimate decision on funding arrangements for CME/CPD activities is the responsibility of the physician-organizers. Although the CME/CPD publicity and written materials may acknowledge the financial or other aid received, they must not identify the products of the company(ies) that fund the activities.
26. All funds from a commercial source should be in the form of an unrestricted educational grant payable to the institution or organization sponsoring the CME/CPD activity.
27. Industry representatives should not be members of CME content planning committees. They may be involved in providing logistical support.
28. Generic names should be used in addition to trade names in the course of CME/CPD activities.
29. Physicians should not engage in peer selling. Peer selling occurs when a pharmaceutical or medical device manufacturer or service provider engages a physician to conduct a seminar or similar event that focuses on its own products and is designed to enhance the sale of those products. This also applies to third party contracting on behalf of industry. This form of participation would reasonably be seen as being in contravention of the CMA's Code of Ethics, which prohibits endorsement of a specific product.
30. If specific products or services are mentioned, there should be a balanced presentation of the prevailing body of scientific information on the product or service and of reasonable, alternative treatment options. If unapproved uses of a product or service are discussed, presenters must inform the audience of this fact.
31. Negotiations for promotional displays at CME/CPD functions should not be influenced by industry sponsorship of the activity. Promotional displays should not be in the same room as the educational activity.
32. Travel and accommodation arrangements, social events and venues for industry sponsored CME/CPD activities should be in keeping with the arrangements that would normally be made without industry sponsorship. For example, the industry sponsor should not pay for travel or lodging costs or for other personal expenses of physicians attending a CME/CPD event. Subsidies for hospitality should not be accepted outside of modest meals or social events that are held as part of a conference or meeting. Hospitality and other arrangements should not be subsidized by sponsors for personal guests of attendees or faculty, including spouses or family members.
33. Faculty at CME/CPD events may accept reasonable honoraria and reimbursement for travel, lodging and meal expenses. All attendees at an event cannot be designated faculty. Faculty indicates a presenter who prepares and presents a substantive educational session in an area where they are a recognized expert or authority.
Electronic Continuing Professional Development (eCPD)
34. The same general principles which apply to "live, in person" CPD events, as outlined above, also apply to eCPD (or any other written curriculum-based CPD) modules. The term "eCPD" generally refers to accredited on-line or internet-based CPD content or modules. However, the following principles can also apply to any type of written curriculum based CPD.
35. Authors of eCPD modules are ultimately responsible for ensuring the content and validity of these modules and should ensure that they are both designed and delivered at arms'-length of any industry sponsors.
36. Authors of eCPD modules should be physicians with a special expertise in the relevant clinical area and must declare any relationships with the sponsors of the module or any competing companies.
37. There should be no direct links to an industry or product website on any web page which contains eCPD material.
38. Information related to any activity carried out by the eCPD participant should only be collected, used, displayed or disseminated with the express informed consent of that participant.
39. The methodologies of studies cited in the eCPD module should be available to participants to allow them to evaluate the quality of the evidence discussed. Simply presenting abstracts that preclude the participant from evaluating the quality of evidence should be avoided. When the methods of cited studies are not available in the abstracts, they should be described in the body of the eCPD module.
40. If the content of eCPD modules is changed, re-accreditation is required.
41. Physicians may be approached by industry representatives and asked to become members of advisory or consultation boards, or to serve as individual advisors or consultants. Physicians should be mindful of the potential for this relationship to influence their clinical decision making. While there is a legitimate role for physicians to play in these capacities, the following principles should be observed:
A. The exact deliverables of the arrangement should be clearly set out and put in writing in the form of a contractual agreement. The purpose of the arrangement should be exclusively for the physician to impart specialized medical knowledge that could not otherwise be acquired by the hiring company, and should not include any promotional or educational activities on the part of the company itself.
B. Remuneration of the physician should be reasonable and take into account the extent and complexity of the physician's involvement.
C. Whenever possible, meetings should be held in the geographic locale of
the physician or as part of a meeting which he/she would normally attend. When these arrangements are not feasible, basic travel and accommodation expenses may be reimbursed to the physician advisor or consultant. Meetings should not be held outside of Canada, with the exception of international boards.
Clinical Evaluation Packages (Samples)
42. The distribution of samples should not involve any form of material gain for the physician or for the practice with which he or she is associated.
43. Physicians who accept samples or other health care products are responsible for recording the type and amount of medication or product dispensed. They are also responsible for ensuring their age-related quality and security and their proper disposal.
44. Practising physicians should not accept personal gifts of any significant monetary or other value from industry. Physicians should be aware that acceptance of gifts of any value has been shown to have the potential to influence clinical decision making.
45. These guidelines apply to relationships between physicians and all commercial organizations, including but not limited to manufacturers of medical devices, nutritional products and health care products as well as service suppliers.
46. Physicians should not dispense pharmaceuticals or other products unless they can demonstrate that these cannot be provided by an appropriate other party, and then only on a cost-recovery basis.
47. Physicians should not invest in industries or related undertakings if this might inappropriately affect the manner of their practice or their prescribing behaviour.
48. Practising physicians affiliated with pharmaceutical companies should not allow their affiliation to influence their medical practice inappropriately.
49. Practising physicians should not accept a fee or equivalent consideration from pharmaceutical manufacturers or distributors in exchange for seeing them in a promotional or similar capacity.
50. Practising physicians may accept patient teaching aids appropriate to their area of practice provided these aids carry at most the logo of the donor company and do not refer to specific therapeutic agents, services or other products.
Medical Students and Residents
51. The principles in these guidelines apply to physicians-in training as well as to practising physicians.
52. Medical curricula should deal explicitly with the guidelines by including educational sessions on conflict of interest and physician-industry interactions.
ACHIEVING PATIENT-CENTRED COLLABORATIVE CARE
The Canadian Medical Association (CMA) recognizes that collaborative care is a desired and necessary part of health care delivery in Canada and an important element of quality, patient-centred care. The CMA considers patient-centred care to be the cornerstone of good medical practice. This is reflected in the first principle of the CMA Code of Ethics, which states that physicians have a fundamental responsibility to "Consider first the well-being of the patient." As patient advocates, physicians strive to ensure that their patients receive the best possible care.
The CMA supports greater collaboration among providers in the interest of better patient care. In the context of clinical practice, the CMA defines collaborative care as follows:
"Collaborative care entails physicians and other providers using complementary skills, knowledge and competencies and working together to provide care to a common group of patients based on trust, respect and an understanding of each others' skills and knowledge. This involves a mutually agreed upon division of roles and responsibilities that may vary according to the nature of the practice personalities and skill sets of the individuals. The relationship must be beneficial to the patient, and acceptable to the physician and other providers.
If designed appropriately, collaborative care models have the potential to:
* improve access to care;
* enhance the quality and safety of care;
* enhance the coordination and efficiency of care; and
* enhance provider morale and reduce burnout within health professions.
To realize this full potential, the profession acknowledges and accepts that it has a central role to play in the evolution of a team-based approach to care.
These policy principles have been prepared by the Canadian Medical Association in order to ensure that the evolution of collaborative care in Canada is built around the needs of individual patients and groups of patients. This policy is founded on the CMA's document, Putting Patients' First: Patient-Centred Collaborative Care - A Discussion Paper.
Principles for Collaborative Care
The medical profession supports collaborative care, both in the hospital and in the community, as one of the essential elements of health care delivery in Canada. In the interests of enhancing the evolution of patient-centred collaborative care, the CMA proposes the following "critical success factors" and principles to address meaningfully the issues and barriers identified by physicians and bring clarity to the discussions.
1. PATIENT-CENTRED CARE
First and foremost, medical care delivered by physicians and health care delivered by others should be aligned around the values and needs of patients.
Collaborative care teams should foster and support patients, and their families, as active participants in their health care decision-making. New models should have the potential to empower patients to enhance their role in prevention and self-care.
Models of collaborative care must be designed to meet the needs of patients.
Collaborative models of practice must reduce fragmentation and enhance the quality and safety of care provided to patients.
It is the patient who ultimately must make informed choices about the care he or she will receive.
2. RECOGNITION OF THE PATIENT-PHYSICIAN RELATIONSHIP
The mutual respect and trust derived from the patient-physician relationship is the cornerstone of medical care. This trust is founded on the ethical principles that guide the medical profession as defined in the CMA Code of Ethics. The impact of collaborative models of practice on this relationship, and hence the patient's satisfaction and experience with their care, is unknown.
Models of collaborative care must support the patient-physician relationship.
Entry into and exit from a formal collaborative care arrangement must be voluntary for both the patient and the physician.
A common Code of Ethics should guide the practice of collaborative care teams.
Every resident of Canada has the right to access a personal family physician. †
3. PHYSICIAN AS THE CLINICAL LEADER
Effective teams require effective leadership. A defined clinical leader is required to ensure proper functioning of the team and to facilitate decision-making, especially in complex or emergent situations. In collaborative care the clinical leader is responsible for maximizing the expertise and input of the entire team in order to provide the patient with comprehensive and definitive care.
It is important to differentiate "clinical leadership" from "team coordination."
The CMA defines a clinical leader as:
"The individual who, based on his or her training, competencies and experience, is best able to synthesize and interpret the evidence and data provided by the patient and the team, make a differential diagnosis and deliver comprehensive care for the patient. The clinical leader is ultimately accountable to the patient for making definitive clinical decisions."
Whereas, the team coordinator is defined as:
"The individual, who, based on his or her training, competencies and experience, is best able to coordinate the services provided by the team so that they are integrated to provide the best care for the patient."
The concept of "most responsible physician" has been and continues to be used to identify the individual who is ultimately responsible for the care of the patient. The "most responsible physician" is responsible for collecting, synthesizing and integrating the expert opinion of physician and non physician team members to determine the clinical management of the patient. Similarly, the presence of a defined clinical leader in a collaborative care setting creates clarity for patients, their families and the health care team by making lines of communication and responsibility clear, ultimately improving the quality and safety of care.
In the CMA's opinion, the physician is best equipped to provide clinical leadership. This does not necessarily imply that a physician must be the team coordinator. Many teams will exist in which the physician will have a supporting role, including those focused on population health and patient education. We believe the most effective teams are ones in which the leadership roles have been clearly defined and earned. Some physicians may be prepared to play both roles; however, other members of the team may be best suited to serve as team coordinator.
Currently, patients rely on, and expect, physicians to be clinical leaders in the assessment and delivery of the medical care they receive. In a collaborative care environment this expectation of physician leadership will not change. Team members will have specific knowledge and expertise in their respective disciplines. Physicians, by virtue of their broad and diverse knowledge, training and experience, have a unique appreciation of the full spectrum of health and health care delivery in their field of practice and are therefore best qualified to evaluate and synthesize diverse professional perspectives to ensure optimal patient care.
The physician, by virtue of training, knowledge, background and patient relationship, is best positioned to assume the role of clinical leader in collaborative care teams. There may be some situations in which the physician may delegate clinical leadership to another health care professional. Other health care professionals may be best suited to act as team coordinator.
4. MUTUAL RESPECT AND TRUST
Trust between individuals and provider groups evolves as knowledge and understanding of competencies, skills and scopes of practice are gained. Trust is also essential to ensuring that the team functions efficiently and maximizes the contributions of all members.
Funders and providers should recognize the importance of team building in contributing to team effectiveness. Collaborative care funding models should support a more formalized and integrated approach to both change management and team building.
As relationships are strengthened within the team, so too are trust and respect. Physicians and all team members have an opportunity to be positive role models to motivate and inspire their colleagues. All team members ought to make a commitment to respect and trust each other with the knowledge that it will lead to enhanced care for patients and a more productive work environment for all.
To serve the health care needs of patients, there must be a collaborative and respectful interaction among health care professionals, with recognition and understanding of the contributions of each provider to the team.
In order to build trust and respect within the team it is essential that members understand and respect the professional responsibility, knowledge and skills that come with their scope of practice within the context of the team.
5. CLEAR COMMUNICATION
In collaborative care environments, it is essential that all members of the team communicate effectively to provide safe and optimal care. Effective communication is essential to ensure safe and coordinated care as the size of the team expands to meet patient needs. It is the responsibility of all team members to ensure that the patient is receiving timely, clear and consistent messaging.
Physicians can take a leadership role in modeling effective communications throughout the team. In particular, there is an opportunity to enhance the consultation and referral process, in order to provide clear and concise instructions to colleagues and optimize care. Sufficient resources, including dedicated time and support, must be available to the team to maximize these communication requirements.
Effective communication within collaborative care teams is critical for the provision of high quality patient care. Planning, funding and training for collaborative care teams must include measures to support communication within these teams.
Mechanisms must be in place within a collaborative team to ensure that both the patients, and their caregiver(s) where appropriate, receive timely information from the most appropriate provider.
Effective and efficient communications within the collaborative care team, both with the patient and among team members, should be supported by clear documentation that identifies the author.
A common, accessible patient record in collaborative care settings is desirable to ensure appropriate communication between physicians and other health care professionals, to prevent duplication, coordinate care, share information and protect the safety of patients.
An integrated electronic health record is highly desirable to facilitate communication and sharing among team members.
6. CLARIFICATION OF ROLES AND SCOPES OF PRACTICE
In order for the team to function safely and efficiently, it is critically important that the scope of practice, roles and responsibilities of each health care professional on the team be clearly defined and understood. In turn, the patient, as a team member, should also have a clear understanding of the roles and scopes of practice of their providers.
Collaborative care must first and foremost serve the needs of patients, with the goal of enhancing patient care; collaborative care is not contingent upon altering the scope of practice of any provider group and must not be used as a means to expand the scope of practice and/or independence of a health professional group.
Changes in the scope of practice of all provider groups must be done with oversight from the appropriate regulatory authority.
Where non-physicians have been provided with an opportunity to undertake activities related to patient care typically unique to the practice of medicine (e.g., ordering tests), they must not do so independently but undertake these activities within the context of the team and in a manner acceptable to the clinical leader.
The role and scope of practice of each member of the collaborative care team should be clearly understood and delineated in job descriptions and employment contracts.
A formal process for conflict resolution should be in place so that issues can be dealt with in a timely and appropriate manner.
7. CLARIFICATION OF ACCOUNTABILITY AND RESPONSIBILITY
In the context of providing optimal care, providers must be accountable and responsible for the outcome of their individual practice, while sharing responsibility for the proper functioning of the collaborative care team. This individual responsibility is required so that regardless of the number and diversity of providers involved in the team, patients can be assured that their well-being is protected and that the team is working toward a common goal.
In collaborative care teams, a physician should be identified as the person most responsible for the clinical care of individual patients, and as such must be accountable for the care rendered to patients. This is consistent with the commitment made by the physician in the doctor-patient relationship, mirrors the clinical training of the physician relative to other providers, is reflective of the current state of tort law as it applies to medical practice, and is compatible with the structure of care delivery in hospitals and in the community. Clearly, this type of arrangement does not eliminate the necessity for all providers to be accountable for the care that they provide.
It is essential that all providers be responsible and accountable for the care that they provide and for the well-being of the patient.
As clinical leader, the physician should be responsible for the clinical oversight of an individual patient's care.
8. LIABILITY PROTECTION FOR ALL MEMBERS OF THE TEAM
As discussed earlier in this paper, the resolution of the multiplicity of liability issues that result from care delivered by teams requires clearly defined roles and responsibilities in the team setting and the absolute requirement for appropriate and sufficient liability coverage for each health professional. The August 2006 statement of the Canadian Medical Protective Association, Collaborative Care: A medical liability perspective, identifies issues of concern to physicians and proposes solutions to reduce those risks.
All members of a collaborative care team must have adequate professional liability protection and/or insurance coverage to accommodate their scope of practice and their respective roles and responsibilities within the collaborative care team.
Physicians, in their role as clinical leaders of collaborative care teams, must be satisfied with the ongoing existence of appropriate liability protection as a condition of employment of, or affiliation with, other members on collaborative care teams.
Formalized procedures should be established to ensure evidence of this liability protection.
9. SUFFICIENT HUMAN RESOURCES AND INFRASTRUCTURE
Collaborative models of health care delivery hold the promise of enhancing access to care for patients at a time of serious health human resource shortages. However, effective patient-centred collaborative care depends on an adequate supply of physicians, nurses and other providers. Governments and decision-makers must continue to enhance their efforts to increase the number of physicians and nurses available to provide health care services.
Collaborative care should not be seen as an opportunity for governments to substitute one care provider for another simply because one is more plentiful or less costly than the other.
In addition, governments must understand that co-location of individuals in a team is not a requirement for all collaborative care. Where team co-location does not exist, appropriate resources must be dedicated to ensure communication can be timely, effective and appropriate between providers.
Governments, at all levels, must address the serious shortage of physicians to ensure quality patient care for Canadians.
The effective functioning of a collaborative care team depends on the contribution of a physician.
Governments must enhance access to medical care by increasing the number of physicians and providers, and not by encouraging or empowering physician substitution.
10. SUFFICIENT FUNDING & PAYMENT ARRANGEMENTS
Funding must be present to support all aspects of the development of collaborative care teams. At the practice level, remuneration methods for physicians, irrespective of their specialty, must be available to facilitate collaborative care arrangements and environments in which physicians practice. All care delivery models, including collaborative care teams, must have access to adequate and appropriate resources. This includes, but should not be limited to, funding for health human resources, administration/management infrastructure, liability protection, clinical and team/administrative training, team building, and information technology.
Remuneration models should be established in a manner that encourages providers to participate effectively in the delivery of care and team effectiveness.
Reimbursement models must be configured to remunerate the communicator, coordinator, manager, and other roles and responsibilities of providers necessary for the success of collaborative care practice.
The ability of a physician to work in a collaborative care team must not be based on the physician's choice of remuneration. Similarly, patients should not be denied access to the benefits of collaborative practice as a result of the physician's choice of payment model.
Collaborative care relationships between physicians and other health care providers should continue to be encouraged and enhanced through appropriate resource allocation at all levels of the health care system.
Physicians should be appropriately compensated for all aspects of their clinical care and leadership activities in collaborative care teams.
Physicians should not be expected to incur the cost of adopting and maintaining health information technology capabilities that facilitate their ability to participate in collaborative practice teams. Governments must fund and support in an ongoing manner, both financially and technically, the development and integration of electronic health records.
11. SUPPORTIVE EDUCATION SYSTEM
Canada is renowned for a quality medical education system and for the early efforts to enhance interprofessional training. The success of collaborative care requires a commitment towards interprofessional education and is contingent upon the positive attitudes and support of educators. To facilitate a sustainable shift toward collaborative practice, these efforts must be continued and enhanced in a meaningful way. However, governments and educators must ensure that the availability and quality of medical education is not compromised for medical trainees.
Interprofessional education, at the undergraduate, postgraduate and continuing education levels, is necessary to facilitate a greater understanding of the potential roles, responsibilities and capabilities of health professions, with the overall goal of building better health care teams founded on mutual respect and trust.
Governments must understand the importance of interprofessional education and fund educational institutions appropriately to meet these new training needs.
Educational opportunities must exist at all levels of training to acquire both clinical knowledge and team effectiveness/leadership training.
Interprofessional education opportunities must not come at the expense of core medical training. High quality medical education must be available to all medical trainees as a first priority.
12. RESEARCH AND EVALUATION
More research and evaluations are necessary to demonstrate the benefits of collaborative care, to foster greater adoption by providers and to attract the necessary investment by governments. Quality management systems must be built into the team to ensure efficiencies can be recorded. Measures of the quality of care, cost effectiveness and patient and provider satisfaction should be evaluated.
Research into the effectiveness of collaborative care models on health outcomes, patient and provider satisfaction and health care cost effectiveness should be ongoing, transparent and supported by governments.
Quality assessment measures must be incorporated into the ongoing work of collaborative care teams.
† Where the term "family physician" is used, it is also meant to include general practitioners.
The Canadian Medical Association (CMA) supports the concept of a strong publicly funded health care system where access to medical care is based on need and not on the ability to pay. Health care services in Canada have historically been funded and delivered by a mix of the public and private sectors. At the present time, approximately 70% of health expenditures are publicly funded from general tax revenues; the remaining 30% are privately funded either through private insurance or out-of-pocket payment. The public-private interface occurs in two key areas: the private delivery of publicly funded services, and the delivery of privately funded services in publicly owned facilities.
Drawing on the key issues raised in the CMA's June 2006 discussion paper, It's About Access, this policy summary sets out guidelines for decision-making and policy development for managing the public-private interface within Canada's health care system in order to optimize timely access to high-quality care.
The following principles provide a framework for guiding future strategies for managing the public-private interface.
1. Timely access: Canadians should have timely access to medically necessary care and individual recourse should wait times be unreasonably long.
2. Equity: Access to medically necessary care must be based on need and not on ability to pay.
3. Choice: Canadians should have choice of physician; and physicians should have choice with respect to their practice environment.
4. Comprehensiveness: Canadians should have access to a full spectrum of medically necessary care.
5. Clinical autonomy: Any care model should respect the autonomous decision-making within the patient-physician relationship. Physicians must be free to advocate on behalf of their patients.
6. Quality: The public and private health care sectors must be held to the same high quality standards and be independently monitored. To ensure professional accountability, any facility providing medical services must be subject to medical supervision.
7. Professional responsibility: The medical profession has a responsibility to promote the strongest possible health care system that best meets patients' needs. Both public and private sectors have a responsibility to train the next generation of health professionals and to advance knowledge through teaching and research.
8. Transparency: Decisions affecting the mix of public-private funding and delivery must be made through an open and transparent process. Providers faced with potential conflicts of interest have a duty to recognize and disclose them and to resolve them in the best interest of patients.
9. Accountability: The public and private health sectors should be held to the same high accountability standards including clinical outcomes, full cost accounting and value-for-money.
10. Efficiency: The public and private sectors should be structured to optimize the use of human and all other resources.
Public-Private Interface Issues
In light of the foregoing principles, the CMA has identified several key issues where improved management of the public-private interface could lead to better access to high-quality health care services for Canadians.
Implementing a wait-time care guarantee
Canadians face increasingly long wait times for necessary medical care, frequently beyond recommended maximum wait times. In the 2004 first ministers' agreement, wait time benchmarks were established for five priority areas in the publicly funded system: cardiac care, cancer care, diagnostic imaging, joint replacement and sight restoration. When care is not delivered within benchmarks, there is no effective "safety valve" to provide recourse. Patients are forced to wait for care in Canada or seek it within the private sector or in other jurisdictions at their own expense.
A safety valve is needed to enable Canadians to obtain required care where wait time guarantees cannot be met. Ideally, Canadians would never have to use the safety valve, but its inclusion in Canadian health policy would help restore confidence in the public health system and focus governments upon meeting commitments to provide timely access to care. The Patient Wait Times Guarantee Trust announced in the 2007 federal budget is a positive first step.
The CMA recommends that:
* Governments work with the CMA and other medical organizations to establish clinically appropriate wait-time benchmarks for all major diagnostic, therapeutic, surgical and emergency services.
* Where wait-time benchmarks can be established, governments implement them nationally.
* If national wait-time benchmarks are not met, Canadians should be entitled to a publicly funded safety valve whereby the government would reimburse payment for treatment, travel and other appropriate costs if the service is provided outside the home jurisdiction or within the private sector.
* When access to timely care cannot be provided in the publicly funded system, Canadians should be able to use private health insurance to reimburse the cost of care obtained in the private sector. Private insurance contracts are now permissible in Quebec for hip replacement and cataract surgery, with the stipulation that the insurer must fund all aspects of the treatment including rehabilitation. At present, it is not clear how this could work in practice in terms of risk rating of either the patient or on the performance of the public system.
* In the interest of providing timely care within the publicly funded system, governments must ensure that Canada has sufficient health professionals and infrastructure to meet need.
Improving performance measurement, quality assurance and accountability in the public-private interface
It is essential that the health care system be accountable to Canadians, in particular with respect to the roles and responsibilities of different levels of government and their delegated agents, such as regional health authorities and specialty boards. Accountability becomes all the more pressing as public-private collaboration expands.
There may be a growing role for the private sector in the delivery of publicly funded health care provided that it delivers services in a cost-effective manner. As with the public sector, any private sector involvement in health care must be patient-centered as well as transparent and accountable. Health care services in both sectors must be delivered to the same high standards of quality. In order to achieve this, solid means of quality assurance must be in place to ensure that value-for-money is being received where public funds are used to contract for service delivery in public and private settings and to monitor the impact of privately funded services on the public system.
There are currently a number of data gaps that need attention. For example, there is a lack of formal comparative studies of the cost-effectiveness and quality of public and private delivery in Canada based on primary data; there is confusion surrounding the monitoring of quality for uninsured services; and there is uncertainty about the extent of voluntary accreditation of health care facilities in the public and private sectors.
The CMA recommends that:
* Governments establish uniform requirements and regulation where appropriate for measuring quality of care in both public and private settings, including:
a) collection of data on process and outcomes of care;
b) reporting of such data on all publicly insured services to regulatory bodies;
c) accreditation standards for both public and private service delivery equivalent to those of the Canadian Council on Health Services Accreditation; and
d) protection of health information privacy.
* Governments and regional health authorities that enter into public-private partnerships do so through an open and transparent tendering process.
* Where governments include public-private delivery mechanisms to expand system capacity, they do so with regulation to evaluate quality and cost-effectiveness.
* Governments conduct ongoing evaluation of the quality and cost-effectiveness of public-private delivery options.
Defining the public health care system and the basket of publicly insured services
The delineation of publicly insured services is a fundamental policy issue for governments, health care providers and patients. The publicly-funded health system cannot be expected to meet all needs for all patients; choices must be made and trade-offs negotiated. However, decisions about the basket of insured services have typically been ad hoc and made behind closed doors. The system has also been slow to respond to emerging technologies and shifts in the delivery of care.
At the present time the national medicare basket includes hospital and medical services. The provinces/territories also fund additional services at their discretion (e.g., seniors' drug coverage, home care). While this widens the scope of public coverage, it creates disparities in access across jurisdictions, and Canada is often referred to as a "patchwork quilt" in this regard.
The CMA recommends that:
* There should be ongoing periodic monitoring and reporting of the comparability of Canadians' access to a full range of medically necessary health services across the country.
* In keeping with the CMA's 1994 document Core and Comprehensive Health Services: A Framework for Decision-making, there is a need to define a set of nationally comparable, publicly funded core services. The nature of these services should be continually assessed in an evidence-based and transparent manner. The mode of delivery for these services should be at the discretion of local jurisdictions and may involve both the public and private sectors.
* Government health insurance plans should give adequate notice when services are to be delisted.
Transparency and accountability in the regulation of physician activity within the public-private interface
The ability of physicians to choose whether or not to participate in the public health insurance plan has been a key feature of Medicare since its inception. Physicians are willing to accept reasonable limits on their ability to opt in or out of the public health plan to ensure that adequate access to medical services is maintained. In order to achieve this, an effective regulatory framework is required to govern the intersection of public and private health care and there must be concerted effort on the part of stakeholders to investigate the implications of and opportunities to minimize conflicts of interest. When considering options for the delivery of publicly insured services by the private sector, it is critical that the integrity of the public system is maintained and that Medicare remain the cornerstone of Canadian health care.
The reality for many physicians is that they must concurrently deal with multiple payers -
patients covered by provincial/territorial health insurance plans, injured workers covered by workers' compensation boards and various groups of individuals covered by third-party insurers. Whatever the funding arrangement, the following fundamental characteristics of the physician-patient relationship cannot be altered:
* Patients should be able to choose their physician.
* Physicians must have freedom to advocate on behalf of their patients.
* Physicians should be allowed to have choice in their practice environments, including the right to opt out of the publicly funded system.
* It is the duty of providers to recognize and disclose potential conflicts of interest and to resolve them in the best interests of patients. The CMA will work with its divisions and affiliates to develop a code of conduct for physicians who provide services in the private sphere and for those who provide services in both sectors.
The CMA recommends that:
* Governments should allow physicians to have choice in their practice environments, including the right to opt out of the public health insurance program provided that patient access to publicly funded care is not compromised. This is presently permitted in all jurisdictions except Ontario.
* Governments should examine practice arrangements where physicians are able to work in both the public and private sectors so as to maximize the availability of medical services, particularly in situations where there are budget constraints resulting in inefficient use of health human resources and physical infrastructure.
* Governments should remove bans preventing physicians from opting out or preventing them from practising in both the public and private sectors where it can be shown that this would improve access to services for the entire population, increase the capacity of the health care system and reduce wait times.
Medical education and training
Physicians collectively have a responsibility to train future generations. Looking ahead, we may expect to see a continued trend toward the delivery of diagnostic, medical and surgical procedures in specialized facilities that are privately owned and operated. From the standpoint of medical education and training, this raises two issues. First, a significant number of the current complement of clinical teachers may perform an increasing proportion of their work in such facilities, which may have implications for public teaching hospitals. Second, to the extent that the delivery of services may migrate from teaching hospitals to specialized facilities, this may potentially limit the education and training exposure of medical residents.
The CMA recommends that:
* Physicians must be appropriately trained for the scope of practice in which they are engaged, whether in the public or private sector.
* Medical trainees need exposure to all types of practice arrangements across the public-private interface.
* Medical trainees need exposure to all areas of clinical medicine, including those areas predominately delivered by either the public or private sectors.
* Governments that choose to contract out services to private delivery must ensure that training opportunities include exposure to both sectors.
* The CMA, in partnership with medical student organizations, will promote education about the public-private interface and health care funding and delivery issues.
Canada's health care system is the product of a long-standing partnership between public and private funding and delivery. The interaction between both sectors will continue to be an important dimension of medicare that must be carefully managed. The framework of decision-making principles and recommendations set out in this policy will hopefully enhance debate among stakeholders and the public about future directions for how to best manage the public-private interface.
CMA Board of Directors May 2007
It's Still About Access
Medicare Plus: CMA Policy Statement July 2007
Toward a Sustainable Publicly Funded Health Care System in Canada
Medicare is now 40 years old in Canada, and by all accounts it continues to be highly valued by Canadians. However, there is evidence suggesting that in its present state, Medicare will not be able to effectively deliver timely access to high quality care that reflects the needs of our changing health care landscape. In order to sustain Canada's health care system for the next generation, changes need to be made to bring about a new vision for Medicare. The CMA identifies this future vision as "Medicare Plus." This policy statement expresses the views of the Canadian Medical Association (CMA) at the present time and reflects, in the CMA's opinion, a future vision of Medicare which respects the current Canadian values, legislative frameworks and commitments from government.
Three key steps must be undertaken to implement this vision:
a) the current Medicare program must be shored up to deliver timely access to care;
b) a guarantee that provides individual recourse to timely treatment must be put in place; and
c) the basket of services must be expanded along the continuum of care through a variety of means.
a) The public system must commit to timely access to care according to relative need for all necessary hospital and medical services. Governments have made a good start by providing for a stable funding base and by making strategic investments in medical equipment and health information technology. They have begun to deliver on their 2004 wait-time commitments by establishing national benchmarks in 2005 and by agreeing to implement a wait-time guarantee in at least one of the five priority areas by 2010. However, the job is far from finished. Governments have yet to set out the timelines for achieving their benchmarks, and there are many other procedural areas beyond the initial five for which benchmarks need to be established. Moreover the benchmark approach now needs to be expanded beyond the specialist-patient decision to treat to include access to primary care and specialist consultation.
Delivering on timely access will not be achievable without an adequate supply of doctors, nurses and other health care professionals. Canada must adopt a pan-Canadian planning approach to health human resources with a goal of national self-sufficiency that engages key stakeholders on an early, meaningful and ongoing basis. Just as the 1966 Health Resources Fund Act was instrumental in expanding the health education and research infrastructure in the 1960s and 70s, further federal and provincial/territorial investments are critical now, in light of the recent expansion of medicine, nursing and other health professional enrolment and the establishment of new health disciplines. Considerable further investment is also required in health information technology. While the establishment of the Canadian Institutes for Health Research has been a positive step, further investment is necessary, particularly in the area of knowledge transfer - from bench to bedside.
b) It is essential to implement a means of guaranteeing that Canadians can obtain timely access to care. As the Supreme Court found in the Chaoulli decision, the Canada Health Act and provincial/territorial health insurance legislation provide for a virtual monopoly for public health insurance, which "on the evidence, results in delays in treatment that adversely affect the citizen's security of the person," hence it does not conform to the principles of fundamental justice. The CMA has called for a Canada Health Access Fund that would provide for a means of individual recourse to patients facing waits that exceed benchmark thresholds. When the wait time is exceeded the patient and their physician would be able to seek timely treatment where it is available, ideally close to home, but potentially in another city, another province/territory, or country. The $612 million Patient Wait Times Guarantee Trust established in the 2007 budget is a step in this direction. To the extent that the current public infrastructure constrains capacity, governments should consider contracting publicly funded services to the private sector.
Failing the enactment of a publicly funded safety valve, the Chaoulli decision has established that patients cannot be denied a private sector insurance and treatment option. The Quebec government has since made provisions in its legislation to comply with the decision, however it has so narrowly circumscribed the terms and conditions under which private insurance contracts might be offered and delivered that it is highly unlikely private coverage will be offered. Nonetheless the Chaoulli decision put governments on notice, as evidenced by their progress on benchmarks and reduced wait times. Governments may be further stimulated by the fact that a case similar to Chaoulli has been filed in Alberta and another is about to be filed in Ontario.
c) Medicare must be modernized to reflect the current reality of the delivery of care. In 1975, just after Medicare was fully adopted, hospital and physician expenditures represented 60% of total health expenditures; as of 2006, this share has dropped by almost one-third to 43%. Over the past two decades, prescription drugs as a proportion of total health spending have doubled from 7% in 1986 to an estimated 14.2% in 2006. While a majority of Canadians have prescription drug coverage from either private or public plans, it is estimated that some 3.5 million are either uninsured or underinsured for prescription drug costs. Looking ahead, we can expect to continue to see a mix of public and private plans and out-of-pocket payments (e.g., co-payments) and greater use of tax policy. This is the experience of most European and other industrialized countries. In Canada and internationally, the prospects for additional health programs funded on a first-dollar basis out of general taxation revenues are slim. However, there is a clear consensus as reflected in the Romanow and Kirby reports on the need for catastrophic prescription drug coverage and a growing concern about how to address the issue of very costly "orphan" drugs for rare diseases, and expensive treatments for common diseases such as breast cancer. In 2003, first ministers committed to having catastrophic drug coverage in place by the end of 2005-06, and while this is one of the elements of the National Pharmaceutical Strategy, little collective action has taken place beyond further study. Similarly a 2003 commitment by first ministers to first-dollar coverage for a basket of short-term acute home care, community mental health and end-of-life care services remains unmet.
The issue of long-term care (LTC) of the elderly looms on the horizon as the first cohort of the baby boom generation turns 65 in 2011. Indeed hospitals are already feeling the pinch of a lack of alternative level of care beds. International experience suggests that LTC cannot nor should not be financed on the same pay-as-you-go basis as medical/hospital insurance. Germany has implemented a social insurance approach to pre-funding LTC. In its 2007 budget, the federal government introduced a Registered Disability Savings Plan (RDSP) to help parents of children with a severe disability to ensure their children's future financial security by investing after-tax income on which the investment income will accumulate tax-free. Consideration should be given to implementing a similar program for LTC.
(NOTE - to see "Medicare Plus" table -- see PDF)
In summary, we must first ensure that the current Medicare system is on sustainable footing for future generations. Second, Canadians must have a measure of certainty that not only will they receive quality care, but that they will receive it in a timely fashion. Third, recognizing the boundaries of our current Medicare program, we must address the terms and conditions under which Canadians will be able to access the broader continuum of care. Finally, it must be recognized that the health policy landscape is not static, a fact of which governments are aware. For example, in its 2007 budget, Quebec announced that former health minister Claude Castonguay will chair a task force to address sustainable health funding. In addition, British Columbia has been holding a "Conversation on Health" with its citizens that will wrap up in the fall of 2007. As the debate on the future of Medicare changes over time, the CMA's policy will continue to be redeveloped and redefined.
CMA Board of Directors May 2007