AdvaMed Updates Code to Provide Guidance on Innovative Arrangements, Medical Technology, Interactions with HCPs – JD Supra

Code Section AvaMed Code 2009 AvaMed Code 2020 AvaMed Code 2022 Section I Introduction I. Preamble: Goal and Scope of AdvaMed Code and II. Code of Ethics Compliance

Definitions:

New Cornerstone Values: Innovation, Education, Integrity, Respect, Responsibility & Transparency

New Definitions: Commercial Sponsorship, Educational Grant, Satellite Symposium, Third-Party Program, Third-Party Program Organizer

Revised Definitions:

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:

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.

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 arms length transaction for the services provided and should not be based on the volume or value of the consultants 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.

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 physicians 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 HCPs 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 companys 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 HCPs services in advance, companies should confirm that services are performed in accordance with the agreement.

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.

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.

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:

Charitable Donations: Clarifies requirements for providing charitable donations:

Companies may partner with HCPs to conduct joint education and marketing programs designed to highlight Medical Technology and an HCPs ability to diagnose or treat medical conditions if:

Travel:

Permitted:

Not permitted for general education programs.

Venue: Provides additional guidance on evaluating appropriate venues for meetings, including:

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.

Contains principles for communicating unapproved or uncleared (off-label) uses:

Companies are encouraged to develop policies and controls that incorporate FDA guidance, judicial decisions, and other relevant applicable authorities.

No significant revisions.

Provides principles for company representatives providing technical support in the clinical setting, for example:

Company personnel:

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AdvaMed Updates Code to Provide Guidance on Innovative Arrangements, Medical Technology, Interactions with HCPs - JD Supra