I. Preamble: Goal and Scope of AdvaMed Code and II. Code of Ethics Compliance
- Medical Technologies: medical products, technologies, and related services and therapies used to diagnose, treat, monitor, manage and alleviate health conditions and disabilities
- Health Care Professionals (HCPs): individuals or entities involved in the provision of health care services and/or items to patients, which purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Companies’ Medical Technologies in the United States.
Consolidates former sections I and II into a new Section I – Introduction section.
New “Cornerstone Values”: Innovation, Education, Integrity, Respect, Responsibility & Transparency
New Definitions: Commercial Sponsorship, Educational Grant, Satellite Symposium, Third-Party Program, Third-Party Program Organizer
- Medical Technologies: medical devices and products, technologies, digital and software platforms, and related services, solutions and therapies used to diagnose, treat, monitor, manage and alleviate health conditions and disabilities (e.g., implantable medical devices; surgical devices; digital technology and software platforms; and non-invasive reagents, instrumentation or software).
- HCPs: any person or entity (a) authorized or licensed in the United States to provide health care services or items to patients or (b) who is involved in the decision to purchase, prescribe, order or recommend a Medical Technology in the United States. This term includes individual clinicians (for example, physicians, nurses and pharmacists, among others), provider entities (for example, hospitals and ambulatory surgical centers) and administrative personnel at provider entities (for example, hospital purchasing agents). Does not include Health Care Professionals who are bona fide employees of a Company, while acting in that capacity.
New “Data-Driven Devices & Solutions” information:
acknowledges the role that technology and data-driven solutions play in industry, as well as the potential for improved outcomes and quality of care.
Revises the recommendation to submit an annual certification to AdvaMed declaring compliance with the Code; “a certification” is now sufficient.
New FAQ (FAQ #3 in 2022 Code): underscores that proposed interactions that do not fit within the AKS safe harbors may be permissible under a facts and circumstances analysis.
New FAQ (FAQ #4 in 2022 Code): reiterates that the 2022 Code applies to communications with HCPs under arrangements that involve value- or outcomes-based care.
Adds & revises definitions:
- Medical Technology (revised): “Medical Technology is a broad term that means medical devices and products, technologies, digital and software platforms, and related services, solutions, and therapies used to diagnose, treat, monitor, manage, and alleviate health conditions and disabilities. Some examples include:
. . . Digital technology and software platforms that assist in monitoring, diagnosing, and treating patients or in coordinating patient care . . .”
- Virtual (added): “An interaction that involves attendees participating in a virtual environment that is generally enabled by digital technology rather than meeting in a physical location.”
- Value-Based Care (added): “A health care delivery model in which contributors to care are paid based on individual patient health outcomes, population health outcomes, increasing access to healthcare for underserved populations, managing costs, and/or improving efficiency.”
Arrangements to advance value-based care (also referred to as results-based, outcomes-based, or performance-based payment arrangements) are designed to increase shared accountability among stakeholders for quality of, access to, and/or the total cost of care. These arrangements often condition payment or modify pricing for health care items or services based upon clinical, economic, and/or patient-experience outcomes, and may include payor-driven reimbursement arrangements for providers, arrangements between providers, and arrangements between providers and manufacturers or other participants in the health care system.”
VI. Consulting Arrangements with Health Care Professionals
“Consulting arrangements should be entered into only where a legitimate need for the services is identified in advance and documented.”
“Compensation paid to a consultant should be consistent with fair market value in an arm’s length transaction for the services provided and should not be based on the volume or value of the consultant’s past, present or anticipated business . . . There are different valuation methods that may be used to establish fair market value. In all instances, a Company should use objective, verifiable criteria. The method or methods used by
a Company should be documented.”
Moves to Section II – Consulting Arrangements with Health Care Professionals.
Clarifies that a “legitimate need arises when a company requires the services of a HCP to achieve a specific objective, such as the need to train HCPs on the technical components of safely and effectively using a product; the need for clinical expertise in conducting product research and development; or the need for a physician’s expert judgment on clinical issues associated with a product.”
Explains how to develop fair market value (FMV) methodology: many third-party vendors or other experts can assist a company in developing an approach to assessing FMV compensation. In all instances, a company should use a method that incorporates objective criteria (e.g., an HCP’s specialty, years and type of experience, geographic location, practice setting, the type of services performed).
States that sales personnel must not control or unduly influence the decision to engage an HCP as a consultant, because separation is necessary to avoid the perception that a company has entered into a contract with an HCP to secure or reward the HCP for purchasing, using or recommending the company’s medical technology or other sales considerations.
Also notes that HCPs’ interactions with companies may create potential conflicts of interests (COIs) (e.g., through leadership roles in medical societies, conference planning, medical journal editorial staff). Companies should be aware of these potential COIs and mindful of steps that may be necessary to address conflicts, such as recusal from decisions that implicate conflict.
In addition to entering into consulting arrangements for an HCP’s services in advance, companies should confirm that services are performed in accordance with the agreement.
Revisions clarify that:
- Companies have a responsibility to train HCPs on how medical technologies may improve value-based care arrangements.
- Arrangements to “advance value-based care” may include product trainings and education activities presented by a company. Such training and education may be related to medical device(s) and equipment designed to measure outcomes, as applicable (e.g., services, software, and other equipment or similar offerings).
- Companies may meet with HCPs to discuss value-based solutions, services or arrangements.
- Virtual meetings serve as an appropriate setting.
New FAQ (FAQ #9 in 2022 Code): to provide additional clarity on the provision of alcohol at company meetings and programs; revisions present options to limit availability to attendees.
New FAQ (FAQ #10 in 2022 Code): factors set forth in Section VI should be considered when determining an appropriate venue for holding a company-conducted meeting at a restaurant.
IV. Supporting Third-Party Educational Conferences; XI. Research and Educational Grants and Charitable Donations
Research Grants: “Company may provide research grants to support independent medical research with scientific merit. Such activities should have well-defined objectives and milestones and may not be linked directly or indirectly to the purchase of Medical Technologies.”
Charitable Donations: Donations should be motivated by bona fide charitable purposes and should be made only to bona fide charitable organizations or, in rare instances, to individuals engaged in genuine charitable activities for the support of a bonafide charitable mission.
Consolidates former sections IV and XI into a new Section IV – Educational & Research Grants, Charitable Donations, and Commercial Sponsorships.
Educational Grants: Focuses definition on payment or in-kind support to a third-party entity (e.g., Third-Party Program Organizer or training institution) and clarifies that these programs may or may not be accredited to provide continuing education credits. Also clarifies that third parties may only use grant funds to provide items permissible under the Code. Adds a checklist for grant “Review Processes” for use in evaluating grant requests.
Commercial Sponsorship: Clarifies that company sponsors may not pass along any benefits they receive from the third-party organizer (e.g., complimentary conference registrations) to an HCP.
Satellite Symposia: Companies may cover expenses for an HCP to serve as a bona fide faculty member, including at a Satellite Symposium (limited, as appropriate, to the time necessary to speak at the Satellite Symposium). Companies may not cover expenses if the HCP is merely attending the Symposium.
Research Grants: Clarifies requirements for supporting independent research grant requests:
- Objectives & Milestones: defined goals, objectives and milestones; accompanied by clinical protocols; document the nature and scope of the research activity, the budget, the approximate duration of research, and requirements for independent authorizations or approvals (e.g., FDA approval).
- Limitation: in-kind or monetary support for legitimate, study-related, documented expenses or services, or reasonable quantities of no-charge product for limited duration of research.
- Company Involvement: recipient should retain independent control over research.
- Company Review Process: company should establish controls for reviewing requests for research grants.
- Sales Involvement: sales personnel should not control or unduly influence the decision of who will receive support or the amount of support.
Charitable Donations: Clarifies requirements for providing charitable donations:
- Charitable or Philanthropic Mission: for bona fide charitable purposes and only to charitable organizations and non-profits with bona fide charitable or philanthropic purposes. Companies should consider the entity’s tax status, corporate status under state law, and whether the organization has a charitable mission or purpose, among other factors.
- Use of Funds: company must require donations be used only toward charitable or philanthropic purposes.
- Indigent Care Donations: company may make donations of product for indigent patients, but these donations must serve exclusively to the benefit of patients and be otherwise permitted under applicable laws (e.g., state law). Companies should consider including a provision that no third parties will be billed for the donated product in a formal agreement with a hospital.
- Charitable Events: companies may not pay for HCPs to attend charitable events.
- Sales Involvement: sales personnel should not control or unduly influence the decision whether a particular entity will receive support or the amount of support.
New Section V – Jointly Conducted Education and Marketing Programs
Companies may partner with HCPs to conduct joint education and marketing programs designed to highlight Medical Technology and an HCP’s ability to diagnose or treat medical conditions if:
- There is a bona fide, legitimate need to engage in the activity for its own educational or marketing benefit.
- The company establishes controls to help ensure decisions to engage in these arrangements are not made as an unlawful inducement.
- Content is balanced between the company and the HCP.
- The company and the HCP make equitable contributions toward the activity and cost.
- The arrangement is documented in a written agreement that describes the purpose, roles, responsibilities and contributions of each party.
Consolidates existing travel and venue guidance into new Section VI – Travel & Lodging; Venue.
- To provide consulting services to a company, if the HCP is subject to an executed consulting agreement and there is an objective, legitimate reason to support in-person participation
- To attend company-conducted training or education program concerning Medical Technologies and there is an objective, legitimate reason to support in-person attendance
- To speak on the company’s behalf at Third-Party Program
- Other programs or meetings if there is an objective, legitimate reason that supports in-person attendance
Not permitted for general education programs.
Venue: Provides additional guidance on evaluating appropriate venues for meetings, including:
- Central location and ease of accessibility (such as proximity to airports or highways)
- Not selected because of entertainment or recreational facilities (e.g., season or time of year)
- Avoid top category or luxury hotels or resort facilities without appropriate justification
Revisions clarify that:
- While companies may pay for modest and reasonable travel and lodging, there are limitations and guiderails. There must be a “legitimate need” for travel, and the revised 2022 Code encourages companies to consider whether a legitimate need may be met via a virtual program or meeting.
- Certain principles apply to the chosen setting (e.g., must be conducive to information exchange); however, the principles set out in the 2022 Code apply when the meeting is in person (as they relate to physical settings).
Consolidates guidance on meals and replaces section VIII with new Section VII – Providing Modest Meals and Refreshments to Health Care Professionals.
Strongly encourages companies to develop policies on providing modest and occasional meals to HCPs, including establishing a per-meal spending limit and with consideration for geographic variances.
New Section X – Communicating for the Safe & Effective Use of Medical Technology.
Contains principles for communicating unapproved or uncleared (off-label) uses:
- Only by authorized personnel (e.g., in response to unsolicited requests and by medical affairs)
- Truthful and non-misleading
- Identified as off-label
Companies are encouraged to develop policies and controls that incorporate FDA guidance, judicial decisions, and other relevant applicable authorities.
Moved to Section XI – Provision of Health Economics & Reimbursement Information.
No significant revisions.
New Section XIII – Company Representatives Providing Technical Support in the Clinical Setting.
Provides principles for company representatives providing technical support in the clinical setting, for example:
- Direction/supervision of HCP to explain how a Medical Technology’s settings and technical controls function
- Assisting in clinical/operating room to ensure the appropriate range of necessary devices and accessories are available during a procedure, especially when the Medical Technology involves multiple devices or accessories
- Should only enter and be present in clinical setting at request and supervision of HCP
- Should be transparent that they are acting on behalf of the company in a technical support capacity
- Should not interfere with an HCP’s independent clinical decision-making
- Should comply with applicable hospital or facility policies and requirements (e.g., patient privacy, credentialing requirements).
- A company’s technical support should not eliminate an overhead or other expense that the HCP should otherwise incur while providing patient care.