AdvaMed-Code-of-Ethics-2021.pdf

On Interactions with U.S. Health Care Professionals

ADVAMED CODE OF ETHICS

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

TABLE OF CONTENTS

Section I – Introduction 2

The Value of Interactions with Health Care Professionals 2

The Purpose of the AdvaMed Code & Its Cornerstone Values 3

Scope & Applicability of the Code 4

Complying with the AdvaMed Code 4

Glossary 6

Section II – Consulting Arrangements with Health Care Professionals 8

Engaging a Health Care Professional to Provide Consulting Services to a Company 8

Royalties 10

Clinical Studies & Research Arrangements 10

Section III – Company-Conducted Programs & Meetings with Health Care Professionals 11

Company-Conducted Training & Education 11

Company Business Meetings 12

Section IV – Educational & Research Grants, Charitable Donations, and Commercial Sponsorships 14

Supporting Third-Party Programs Through Educational Grants and Commercial Sponsorship 14

Supporting Other Third-Party Programs Through Educational Grants 18

Supporting Independent Third-Party Research 19

Supporting Charitable Programs 20

Section V – Jointly Conducted Education and Marketing Programs 21

Section VI – Travel & Lodging; Venue 23

Section VII – Providing Modest Meals and Refreshments to Health Care Professionals 25

Section VIII – Educational & Patient Beneﬁt Items; Prohibition on Gifts 26

Section IX – Prohibition on Entertainment & Recreation 27

Section X – Communicating for the Safe & Eective Use of Medical Technology 28

Section XI – Provision of Health Economics & Reimbursement Information 29

Section XII – Demonstration, Evaluation, and Consigned Products 31

Section XIII – Company Representatives Providing Technical Support in the Clinical Setting 33

Section XIV – Explore Additional Code of Ethics Resources Online 34

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

SECTION I Introduction

The Advanced Medical Technology Association (AdvaMed) is a global trade association of Companies that develop,

produce, manufacture, and market Medical Technologies. We are dedicated to advancing medical science;

developing high quality, innovative Medical Technology; and improving patient care.

The Value of Interactions with Health Care Professionals

Health Care Professionals’ ﬁrst and highest duty is to act in the best interests of their patients. Medical Technology

Companies help Health Care Professionals meet this duty through necessary, collaborative interactions.

Why does AdvaMed have a Code of Ethics that diers from codes that govern pharmaceutical

or biologics companies?

Drugs and biologics act on the human body by chemical means and can often be administered by the patient alone

without the direct supervision of a Health Care Professional or the involvement of a Company representative to instruct

on their safe and eective use. Medical Technology, on the other hand, often consists of complex tools, devices, and

echnology requiring highly dependent “hands on” interactions with Health Care Professionals from beginning to end.

Health Care Professionals require training on and an understanding of how to use these products in a safe and eective

way. We have developed the AdvaMed Code to address interactions with Health Care Professionals that are speciﬁc

to the Medical Technology industry.

[Posted Dec. 7, 2018]

Companies and Health Care Professionals advance medical care and

clinical science through research, product development, and product

testing that results in new or improved, innovative Medical Technology

Companies promote charitable giving and public awareness of medical

and health conditions through grants and donations in support of

indigent care and patient education

Companies support Health Care Professionals’ scientiﬁc and medical

research, as well as the enhancement of clinical skills and educational

opportunities to improve patient care

Companies provide product service and technical support for

Health Care Professionals to help ensure the safe and eective use

of Medical Technology

Companies instruct, educate, and train Health Care Professionals

on the safe and eective use of complex Medical Technology

FREQUENTLY ASKED QUESTIONS

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

The Purpose of the AdvaMed Code & Its Cornerstone Values

The AdvaMed Code provides Medical Technology Companies with guidance on ethical interactions and relationships

with Health Care Professionals, based on the following cornerstone values:

Companies should review all interactions with Health Care Professionals in light of these values and should

always avoid interactions designed to circumvent the Code. The Code may be silent on a speciﬁc interaction

or may not address all aspects of an interaction with a Health Care Professional. The Code is intended to help

Companies make reasonable and appropriate decisions that align with the Code’s values.

Companies and their employees and agents should be mindful of their interactions and the perception of their

interactions with Health Care Professionals.

SECTION I Introduction

Advance the development and availability of safe and eective Medical

Technology that Health Care Professionals use to improve & save lives

INNOVATION

EDUCATION

INTEGRITY

RESPECT

RESPONSIBILITY

TRANSPARENCY

Deliver high-quality training and education to help ensure that Health

Care Professionals safely and eectively use Medical Technology

Conduct business with integrity at all times and avoid real or perceived

conﬂicts of interest with Health Care Professionals

Respect the independent clinical judgment of Health Care Professionals

to decide the best manner and method for treating patients

Promote socially and ethically responsible business practices that

protect patients, their rights, and their safety

Conduct interactions with Health Care Professionals fairly, openly,

and transparently

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

Scope & Applicability of the Code

Complying with the AdvaMed Code

The AdvaMed Code does not replace any laws, regulations,

or codes that may contain stricter requirements (for example,

government ethics rules or state marketing laws). The AdvaMed

Code requires Companies to comply with all applicable laws,

regulations, and codes. Companies are strongly encouraged

to adopt an eective ethics and compliance program aimed at

(1) promoting an organizational culture that encourages ethical

practices and a commitment to comply with the law and

(2) preventing and detecting inappropriate conduct. Programs

should be appropriately tailored for each Company.

Legal Principles

The Code does not provide legal advice or

create legal rights or obligations.

Geographic

Reach

The Code applies to all Company interactions

with U.S. Health Care Professionals, whether

occurring inside or outside the United States

(such as at a conference or other event).

Interactions

with Health Care

Professionals

The Code applies to a Company’s interactions

and a Company’s employees’ and agents’

interactions with U.S. Health Care Professionals,

even if an employee or agent pays for the

interaction himself/herself.

Representatives

A Company adopting the Code is required

to communicate the Code’s provisions to its

employees, agents, dealers, and distributors,

with the expectation that they will adhere

to the Code.

Multiple Business

Lines

Companies with dierent business lines

(for example, medical devices, pharmaceuticals,

biologics, consumer items, and/or research-

only products) may have other industry codes

that apply to their businesses.

The AdvaMed Code applies to Companies’

interactions linked to Medical Technology.

Combination

Products

The Code applies to all interactions with

U.S. Health Care Professionals related to

combination products that include a Medical

Technology component (for example, those

that are both biologics and devices or drugs

and devices), which may also be subject to

other trade association codes.

SECTION I Introduction

To which Company employees,

agents, dealers, or distributors

does the AdvaMed Code apply?

The AdvaMed Code is intended to apply

to all bona ﬁde employees and agents

of a Company when acting on the

ompany’s behalf, regardless of the

individual’s job function or position.

The AdvaMed Code is also intended to

apply t

o all dealers, distributors, and

resellers – including sub-dealers and

sub-distributors – that provide sales and

marketing support for the Company

and that interact with U.S. Health Care

rofessionals (as deﬁned in the Glossary)

on the Company’s behalf.

[Posted June 14, 2019]

FREQUENTLY ASKED QUESTIONS

ADDITIONAL INSIGHTS

No Unlawful Inducements

Throughout, the Code refers to the

concept of an “unlawful inducement”

to reﬂect the prohibitions found in

the U.S. Federal Anti-Kickback Statute.

The Anti-Kickback Statute prohibits the

kno

wing and willful payment (or oer to

pay) or receipt (or solicitation to receive)

of anything of value to induce or reward

referrals or the generation of business

that is payable under a Federal health

care program, such as Medicare.

“Appropriately tailored” means that

each Company’s implementation of an

e

ective compliance program diers

depending on a variety of factors

(such as size, resources, work force,

and business line, among others).

Given the wide diversity within the

Medical T

echnology industry, there is

no single best compliance program.

ompanies should develop and

implement compliance controls that

addr

ess the speciﬁc types of risks that

apply to their operations.

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

For assistance in evaluating a compliance program’s eectiveness, Companies may consider referring to government-

issued or other industry guidance on what constitutes an eective compliance program (for example, the U.S. Federal

Sentencing Guidelines and materials from the U.S. Department of Justice and the U.S. Department of Health and

Human Services Oce of Inspector General). Elements of an eective compliance program can include:

A Company that adopts the Code is strongly encouraged to submit to AdvaMed an annual certiﬁcation stating that

the Company has adopted the Code and has implemented an eective compliance program.

AdvaMed member Companies must, and non-member Companies may, supply contact information for the Company’s

compliance program or an anonymous hotline to facilitate reporting of possible violations of the Code. AdvaMed will

publish on its website the contact information supplied by each Company.

SECTION I Introduction

Board & senior

management are

knowledgeable

about and

oversees the

compliance

program

Individuals in

leadership

with overall

esponsibility for

the compliance

program

Compliance

personnel with

day-to-day

program

responsibility,

including

appropriate

Board access

and reporting

Ret

ention of

personnel who

have not engaged

in conduct

inconsistent

with an eective

ompliance

program

Eective lines of

communication

(including an

anonymous

reporting

hotline)

Written policies

& procedures

that incorporate

and foster

compliance with

the Code

Int

ernal risk

assessments,

monitoring,

and

auditing

ompt

response to

detected

problems

and corrective

action undertaken

tandards

enforced through

disciplinary

action

E

ective

training and

education

Appr

opriate

oversight and

management of

the compliance

program

COMMITMENT

TO ETHICAL

CULTURE

ELEMENTS OF AN EFFECTIVE COMPLIANCE PROGRAM

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

Glossary

Commercial

Sponsorship

A payment or in-kind support provided to a third party in exchange for advertising or

promotional opportunities for the Company (for example, a Company exhibit at a

Third-Party Program).

Company

A company that develops, produces, manufactures, and markets Medical Technology.

Educational Grant

A payment or in-kind support to a third-party entity (for example, a Third-Party Program

Organizer or a training institution) to reduce the costs of providing education. An Educa-

tional Grant is not oered for Commercial Sponsorship opportunities.

Health Care

Professionals or HCPs

A Health Care Professional is 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). This term does not include Health Care Professionals who are bona

ﬁde employees of a Company, while acting in that capacity.

Medical Technology

Medical Technology is a broad term that means medical devices and products, technolo-

gies, 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:

• Implantable medical devices that are placed in or on the human body to replace, repair,

or strengthen a body part;

• Surgical devices used to perform procedures;

• Digital technology and software platforms that assist in monitoring,

diagnosing, and treating patients; and

• Non-invasive reagents, instrumentation, and/or software to aid in

the diagnosis and treatment of patients; among other technology.

Modest

Moderate value, but may dier depending on regional dierences

Occasional

An interaction is considered occasional if it occurs infrequently and not on a routine basis

SECTION I Introduction

For purposes of the AdvaMed Code, a “Health Care Professional” is not necessarily limited to a licensed clinician. Whether

an individual qualiﬁes as a Health Care Professional may vary based on the facts and circumstances.

ADDITIONAL INSIGHTS

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

SECTION I Introduction

Satellite Symposium

A Satellite Symposium is a Company-organized and funded program that is appended to

a Third-Party Program agenda but that the Third-Party Organizer does not control.

These programs often take place during meal breaks at the Third-Party Program and may

address education and training topics that coincide with the Third-Party Program’s focus.

A Satellite Symposium does not include a Company-organized meeting, training, or

educational session (such as an advisory board, consultant meeting, or product education

session) that (a) may be held in close physical and temporal proximity to a Third-Party

Program and (b) is not appended to or included in the Third-Party Program’s ocial agenda.

Third-Party Program

A bona ﬁde, independent health care-related educational, scientiﬁc, business, and/or

policymaking conference, meeting, or event put on by a third party other than a Company.

This term includes programs that are accredited to provide continuing education credits

and programs that are not accredited.

Third-Party Program

Organizer

A third-party entity that organizes and/or oversees the development of the Third-Party

Program, including the selection of presenters, attendees, topics, materials, and methods.

A Third-Party Program Organizer could include, for example, a health care professional

society, institution, and association, medical trust fund, continuing medical education

provider, or hospital or other health care entity.

The AdvaMed Code’s history spans several decades. The Code originally appeared as the Health Industry

Manufacturers Association Code in 1993. It was later updated and relaunched as the AdvaMed Code in 2003.

The last revision and restatement of the Code became eective in 2009.

This version of the AdvaMed Code of Ethics on Interactions with Health Care Professionals in the United States,

upon its eective date, supersedes and replaces all previous versions of the AdvaMed Code.

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

SECTION II Consulting Arrangements with Health Care Professionals

Companies rely on Health Care Professionals’

expertise in a variety of important ways, such as

training on the safe and eective use of Medical

Technology, conducting research, and developing

product advancements that lead to safer and

more eective treatments for patients.

Based on legitimate need, Companies engage

Health Care Professionals through written

contracts that document the Health Care

Professional’s services and any fair market value

compensation for those services.

KEY CONCEPTS

A. Engaging a Health Care Professional to Provide Consulting Services

Companies engage Health Care Professionals to provide a wide-range of valuable, bona ﬁde consulting services.

Some examples include arrangements for a Health Care Professional to provide education and training, speaking

services, proctoring and preceptorships, reference center or center of excellence services, participation on advisory

boards or focus groups, medical technology development and research services arrangements (such as research

and development, clinical studies, clinical investigator services, collaborative research, and post-market research),

and arrangements for the development or transfer of intellectual property.

A legitimate need arises when a

Company requires the services of

a Health Care Professional to achieve a

speciﬁc objectiv

e, such as the need to

train Health Care Professionals on the

technical components of safely and

eectively 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.

Designing or creating an arrangement to

gener

ate business or to reward referrals

from the contracted Health Care

Professional (or anyone aliated with

the Health Care Professional) are not

legitimate needs for a consulting

arrangement.

Companies should apply the following principles to all consulting

arrangements with Health Care Professionals:

• Legitimate Need. A Company should enter a consulting

arrangement with a Health Care Professional only if it has

identiﬁed a legitimate need for the Health Care Professional’s

services in advance.

• Consultant Selection. A Company should select only duly

vetted Health Care Professionals to serve as consultants, based

on the Health Care Professional’s qualiﬁcations to meet the

identiﬁed need. Some examples of these qualiﬁcations include

the Health Care Professional’s specialty, years of experience,

location, practice setting, clinical research experience, podium

presence, speaking and publication experience, or experience

with, usage of, or familiarity with a speciﬁc Medical Technology,

among other qualiﬁcations.

A Company may not select or compensate consultants as a

reward for past usage or as an unlawful inducement for future

purchases. A Company should implement safeguards so that

consultants are not selected based in whole or in part on

sales considerations.

ADDITIONAL INSIGHTS

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

• Number of Consultants. A Company should engage

only as many consultants as are necessary to fulﬁll the

Company’s requirements for the bona ﬁde services.

• Fair Market Value Compensation. A Company should

compensate a consultant consistent with the fair market

value in an arm’s length transaction of the services

provided. A Company should not base compensation

on the volume or value of the consultant’s past,

present or anticipated business. A Company should

conﬁrm the services performed by the Health Care

Professional in accordance with the agreement.

• Expenses. A Company may pay for documented,

reasonable, and actual expenses incurred by a

consultant that are necessary to carry out the

consulting arrangement, such as costs for travel,

lodging, and modest meals. See Sections VI and VII

of the Code for information on providing travel,

lodging, and meals to Health Care Professionals.

• Written Agreement. A Company should enter into

written agreements that describe all consulting

services to be provided and the compensation to be

paid in exchange for the services. When a Company

contracts with a consultant to conduct clinical

research services, there should also be a written

research protocol.

• Sales Involvement. Sales personnel cannot control or

unduly inﬂuence the decision to engage a particular

Health Care Professional as a consultant. A Company’s

sales personnel may provide input about the

qualiﬁcations of a proposed consultant. A Company

should consider implementing appropriate controls

to promote compliance with this section.

When determining whether a Health

Care Professional is qualiﬁed to serve as

a consultant, is it appropriate to consider the

Health Car

e Professional’s subjective abilities,

for example his or her recognition as an expert

or thought leader on the speciﬁc topic?

Yes. There is no single appropriate method of

evaluating a Health Care Professional’s qualiﬁcations

to serve as a consultant. A Company may take into

account objective factors, such as number of years

of practice, familiarity with the Company’s products,

educa

tional and training background, or geographic

location, among others. A Company may also take

into account subjective factors, such as recognition

as a thought leader or the ability to eectively deliver

training content.

A Company may weigh these factors dierently in

making consultant selections, depending upon the

type of consultant the Company needs and the type

of services to be delivered. For example, a Company

may consider educational background and clinical

experience to be important factors when engaging

an HCP to perform clinical research. Or, a Company

may consider recognition as a thought leader as a

critical factor for some types of HCP consulting

services.

[Posted June 14, 2019]

How can a Company establish “fair market

value” for goods or services?

There are dierent valuation methods that may be

used to establish fair market value. For example,

many third-party vendors or other experts can assist

a Company in developing an approach to assessing

fair market value compensation. In all instances, a

Company should use a method that incorporates

objective criteria – for example, a Health Care

Professional’s specialty, years and type of experience,

geogr

aphic location, practice setting, the type of

services performed, etc. A Company is encouraged

to document its method(s) for evaluating whether

compensation reﬂects the fair market value of the

services provided.

[Posted Dec. 7, 2018]

SECTION II Consulting Arrangements with Health Care Professionals

Why does the AdvaMed Code restrict the

involvement of sales in selecting consultants?

The Code requires this separation to avoid the perception

that a Company has entered a contract with a Health

Care Professional to secure or reward the Health Care

Professional for purchasing, using, or recommending

the Company’s Medical Technology or other sales

onsiderations.

[Posted Dec. 7, 2018]

FREQUENTLY ASKED QUESTIONS

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

SECTION II Consulting Arrangements with Health Care Professionals

A Company should base the calculation of royalties payable to a Health Care Professional in exchange for

Intellectual Property on factors that preserve the objectivity of medical decision-making and avoid the potential

for improper inﬂuence. For example, a Company should not condition royalties paid in exchange for Intellectual

Property on: (1) a requirement that the Health Care Professional purchase, order or recommend any product or

Medical Technology of the Company or any product or technology produced as a result of the development

project; or (2) a requirement to market the product or technology upon commercialization.

Companies are strongly encouraged to consider whether it is appropriate and practicable to exclude from the

calculation of royalties the number of units purchased, used, or ordered by the Health Care Professional and/or

members of the Health Care Professional’s practice.

C. Clinical Studies & Research Arrangements

Arrangements that involve clinical research services by a Health Care Professional in return for compensation are

also a type of consulting arrangement, subject to the principles in this section of the Code. The clinical program

for which the services are being provided should fulﬁll a legitimate research purpose. A written services agreement

should govern these arrangements, and Companies should base compensation on the fair market value of the

services provided.

A clinical study agreement typically is entered between a Company and a Health Care Professional that is a facility,

institution, or practice group, and compensation for the clinical research services is paid to that entity. An individual

Health Care Professional may act as a study investigator but also provide related services in his or her individual

capacity that is outside the scope of the services covered in the clinical study agreement (e.g., protocol development,

delivering education and presentations on the Company’s behalf, etc.). In that case, it may be appropriate to enter

a separate consulting arrangement with that individual Health Care Professional.

To which Company employees,

agents, dealers, or distributors

does the AdvaMed Code apply?

The AdvaMed Code is intended to apply

to all bona ﬁde employees and agents of

a Company when acting on the Compa-

ny’s behalf, regardless of the individual’s

ob function or position. The AdvaMed

Code is also intended to apply to all

dealers, distributors, and resellers – in-

cluding sub-dealers and sub-distributors –

hat provide sales and marketing support

for the Company and that interact with

U.S. Health Care Professionals (as deﬁned

in the Glossary) on the Company’s behalf.

[Posted June 14, 2019]

FREQUENTLY ASKED QUESTIONS

B. Royalties

Arrangements involving the payment of royalties to a Health

Care Professional should meet the standards listed in this section

of the Code.

Health Care Professionals often make valuable contributions

that improve products or Medical Technologies. They may

develop intellectual property (for example, patents, trade secrets,

or know-how), under a product or technology development or

intellectual property licensing agreement.

A Company should enter a royalty arrangement with a Health

Care Professional only if the Health Care Professional (individually

or as part of a group) makes a novel, signiﬁcant, or innovative

contribution to the development of a product, technology,

process, or method, subject to intellectual property protections.

A signiﬁcant contribution by an individual or group, if it is the basis

for compensation, should be appropriately documented.

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

SECTION III Company-Conducted Programs & Meetings with Health

Care Professionals

Companies have a legitimate

need to provide important

training and education to

Health Care Professionals

about the safe, eective, and

ecient use of Medical

Technologies.

Companies may also have a

legitimate need to conduct

other business meetings with

Health Care Professionals (for

example, a manufacturing

facility tour, a product devel-

opment meeting, or meetings

to discuss service oerings or

sales terms).

All Company-conducted

programs and meetings with

Health Care Professionals

should be conducted in a

manner conducive to the

exchange of information,

and all attendees must have

a legitimate need to attend

the program or meeting.

KEY CONCEPTS

Companies have a legitimate need to conduct training and education for Health Care Professionals and to hold

other important business meetings with Health Care Professionals. This section of the Code provides Companies

with guidelines for organizing and conducting these meetings and programs.

A. Company-Conducted Training & Education

Companies have a responsibility to train and educate Health Care Professionals on their Medical Technologies,

the procedures in which these Medical Technologies are used, and related information:

• Medical Technology may involve complex equipment, devices, and/or sophisticated software platforms

that require technical instruction.

• Procedures in which Medical Technologies are used may be complex and require skilled clinical instruction.

• Health Care Professionals need training and education on disease states and treatment options, patient

selection criteria, clinical treatment standards and outcomes, care pathways, and how Medical Technologies

beneﬁt certain patient populations, among other important topics.

All of this information contributes to the safe and eective use of Medical Technology. In fact, the U.S. Food

and Drug Administration (FDA) often mandates this training and education.

This section of the Code applies to Company-conducted

training, education, or other business meetings.

For a discussion of programs or meetings conducted by

a thir

d party (for example, third-party educational

conferences), see Section IV of the Code.

ADDITIONAL INSIGHTS

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

Companies should apply the following principles when conducting training and education programs concerning

Medical Technologies for Health Care Professionals:

• Setting. Companies should conduct live or virtual training and education programs in settings that are

conducive to the eective transmission of information. These may include clinical, educational, conference,

or other settings, such as hotels or other commercially available meeting facilities. It could also include

the Health Care Professional’s location.

Programs providing hands-on technical training and instruction on Medical Technologies (for example, a cadaver

lab) should be held at training facilities, medical institutions, laboratories, or other appropriate facilities.

• Faculty. Companies should only engage faculty that have the proper

qualiﬁcations and expertise to conduct the training or education.

This may include Health Care Professionals or qualiﬁed Company

employees (including ﬁeld sales sta) who have the technical expertise

and experience necessary to perform the training.

• Attendees. Health Care Professionals must have a legitimate need

to attend a Company-conducted training or education program

(for example, the need to obtain technical instruction on how to use

a new Medical Technology).

• Travel & Lodging. See Section VI of the Code for more information on

providing travel and lodging to Health Care Professionals to attend a

Company-conducted training or education program.

• Meals & Refreshments. See Section VII of the Code for information on providing meals and refreshments

to Health Care Professionals attending a Company-conducted training or education program.

SECTION III Company-Conducted Programs & Meetings with Health

Care Professionals

See Section II of the AdvaMed

Code for guidelines on engaging

Health Care Professionals to

provide consulting services on

behalf of a Company, such as

serving as faculty at a Company-

conducted training and education

ogram.

ADDITIONAL INSIGHTS

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

B. Company Business Meetings

Companies may identify a legitimate need to conduct other types of business meetings with Health Care

Professionals to discuss, for example, Medical Technology features, sales terms, Company service oerings and

their impact on health care delivery, product line oerings, health economics information, or purchase contract

arrangements. Other examples could include plant or facility tours, meetings to demonstrate equipment, or

meetings to explore product development or clinical testing needs.

SECTION III Company-Conducted Programs & Meetings with Health

Care Professionals

Companies should apply the following principles when organizing and conducting business meetings:

• Legitimate Need. Companies must have a legitimate need to conduct the meeting. For example, a company

may identify a need to show Health Care Professionals how they make Medical Technologies, their quality control

systems, or other aspects of their manufacturing processes through a plant tour.

• Setting. Companies may hold meetings at or close to a Health Care Professional’s place of business or facility;

another centralized location; or at a Company’s own facility that may be a more appropriate setting for the

meeting, depending upon the topics discussed. In all instances, the setting for a Company-conducted program

or meeting must be conducive to the discussion of relevant information.

• Attendees. Each Health Care Professional in attendance must have an objective, legitimate need

to attend a Company’s business meeting.

• Travel & Lodging. See Section VI of the

Code for information on providing travel

and lodging to Health Care Professionals

attending a Company’s business meeting.

• Meals & Refreshments. See Section VII

of the Code for information on providing

meals and refreshments to Health Care

Professionals attending a Company’s

business meeting.

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

SECTION IV Educational & Research Grants, Charitable Donations, and

Commercial Sponsorships

Medical Technology

Companies – together with

other organizations – play an

important role in educating

Health Care Professionals and

patients, providing charitable

support to the community,

and supporting life-changing

research.

Medical Technology

Companies may support

third-party educational,

charitable, and research

programs through

monetary, in-kind, and

other contributions.

Medical Technology

Companies should establish

processes and guidelines so

that decisions to support

Third-Party Programs are

made objectively and not

used as unlawful inducements

to Health Care Professionals.

KEY CONCEPTS

Companies provide monetary, in-kind, and other contributions to third

parties in support of their educational, charitable, and research programs.

Companies can support these programs for many valid reasons, such as

advancing medical education and training for Health Care Professionals,

raising patient and public awareness on important health care topics,

helping underserved or indigent populations through bona ﬁde charitable

programs, or funding independent scientiﬁc or clinical research.

A. Supporting Third-Party Programs Through

Educational Grants and Commercial Sponsorship

Third-Party Programs allow Companies to support Health Care

Professional- and patient-related training and education; to participate

in clinical, research and scientiﬁc exchanges related to their Medical

Technologies; and to advertise and promote their products and services.

Companies should apply the following principles when supporting

Third-Party Programs through Educational Grants and/or

Commercial Sponsorship:

Documentation.

A Company should document

ants, donations, and sponsor-

ships in writing as appropriate

based on the pr

ogram and type

of support provided. This could

include

, for example, a written

agreement.

Funding Requests.

Companies may receive requests

o support Third-Party Programs

that include requests for both

Educational Grants and Commercial

Sponsorship. Sometimes these

requests can be co-mingled.

ADDITIONAL INSIGHTS

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

Supporting Third-Party Programs Through

EDUCATIONAL GRANTS

A Company may provide an Educational Grant in support of a

Third-Party Program directly to the Third-Party Program Organizer

or, in some instances, to a training institution or other entity

designated by the Third-Party Program Organizer.

A Third-Party Program Organizer (or training institution or

designee) may use an Educational Grant:

• To defray or reduce the costs of conducting the educational

components of a Third-Party Program

• To allow Health Care Professionals-in-training (for example,

medical and nursing students, residents, and fellows) to attend

the Third-Party Program, provided that the Company does

not select or control the selection of the speciﬁc Health Care

ofessionals-in-training who will beneﬁt

• To cover the reasonable compensation, travel, lodging, and

modest meals of Health Care Professionals who serve as bona

ﬁde faculty at the Third-Party Program

• To provide Health Care Professionals attending the Third-Party

Program with items of value permissible under the Code, such

as modest meals, refreshments, and educational items.

Sales personnel should not control or unduly inﬂuence the decision

of whether a particular entity will receive an Educational Grant or

the amount of the grant. A Company’s sales personnel may provide

input about the proposed Educational Grant recipient or program.

Review Processes

Companies are encouraged to

adopt controls for reviewing requests

to support Third-Party Programs.

Companies should consider the

ollowing questions when reviewing

such requests:

Is the request for funding

reasonable and reﬂective of

the educational purpose of

the program?

Do the topics, faculty, attendees,

and educational materials

reﬂect an objective, legitimate,

educa

tional purpose?

Are the venue and setting

conducive to the exchange of

educa

tional information?

Does the agenda reﬂect the

legitimate educational, medical,

scientiﬁc, or policymaking

purpose of the meeting?

Do any of the meals or

refreshments, recreational

activities, or free time provided

detr

act from the primary purpose

of the Third-Party Program?

Does the Third-Party Program

appear to primarily promote

the medical services of a speciﬁc

ovider (for example, a program

focused on highlighting a

particular physician practice

oup’s medical services vs.

appropriate educational topics)?

[Posted Dec. 7, 2018]

Supporting Third-Party Programs Through

COMMERCIAL SPONSORSHIPS

When Companies provide Commercial Sponsorship in support of

a Third-Party Program, the level of Commercial Sponsorship

should reﬂect a commercially reasonable fee in exchange for the

mark

eting and promotional beneﬁts received by the Company,

such as advertising, signage, display/exhibit space, or other

promotional opportunities.

A Company may provide Commercial Sponsorship, even if the

Company determines not to provide the Third-Party Program

Organizer with an Educational Grant.

SECTION IV Educational & Research Grants, Charitable Donations, and

Commercial Sponsorships

FREQUENTLY ASKED QUESTIONS

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

• No Support to Individuals. A Company may not provide

any contribution (whether monetary or in-kind) directly

to an individual Health Care Professional or pay directly

for an individual Health Care Professional’s registration,

fees, or travel or lodging expenses to attend a

Third-Party Program.

• Adherence to Program Standards. Companies should

adhere to all standards established by the Third-Party

Program Organizer or the body accrediting the

Third-Party Program, as applicable.

If permitted by applicable standards, a Company can

(a) recommend a knowledgeable faculty or appropriate

categories of attendees; or (b) select and send faculty

to the Third-Party Program to speak on the Company’s

behalf, provided that the Company contracts with the

faculty subject to the provisions of Section II of the Code

and an appropriate disclosure is made to the Program

attendees that the faculty is presenting on behalf of

and paid by the Company.

Each Third-Party Program may vary in terms of the accreditation

standards that apply (for example, ACCME standards) and the

Third-Party Program Organizer’s own internal rules and requirements.

As part of my Company’s ﬁnancial

support of a third party’s program, the

organizer has oered several sponsorship

beneﬁts, including a golf foursome and

several additional badges to secure entry into

the conference. Can my Company invite a

Health Care Professional to join the golf

foursome? Can we give one of the badges to

a Health Care Professional?

No. A Company should not pass along to a Health

Care Professional any beneﬁts that the Company

receives in exchange for its ﬁnancial support,

including for educational and charitable programs.

[Posted Dec. 7, 2018]

Does the Code permit my Company to

host a Satellite Symposium?

Yes. The opportunity to host a Satellite Symposium

may be oered to Companies who provide a

Commercial Sponsorship in support of a

Third-Party Program. Although the Company

is responsible for the content of the Satellite

ymposium, these programs may be subject to

the Third-Party Organizer’s application and

approval process. While Satellite Symposia are

generally included on the Third-Party Program’s

agenda and promotional materials, these are

Company-conducted events. Companies should

be transparent in promoting these as such.

[Posted Dec. 7, 2018]

Can a Company oer meals and

refreshments at a Satellite Symposium?

Yes, a Company may oer meals and refreshments

at a Satellite Symposium, provided that they

comply with (a) the Third-Party Program

Organizer’s or the relevant accrediting body’s

tandards; and (b) Section VII of the Code

(Providing Modest Meals and Refreshments to

Health Care Professionals).

[Posted June 14, 2019]

SECTION IV Educational & Research Grants, Charitable Donations, and

Commercial Sponsorships

FREQUENTLY ASKED QUESTIONS

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

Can my Company pay for the travel,

lodging, or registration expenses of a

Health Care Professional who serves as faculty

or attends a Satellite Symposium?

• If a Health Care Professional serves as faculty

at the Satellite Symposium: Yes. A Company may

engage a Health Car

e Professional to serve as a

bona ﬁde faculty member on its behalf, including

at a Satellite Symposium, subject to the

requirements in Section II of the Code. This

includes c

overing the Health Care Professional’s

relevant registration fees (limited, as appropriate,

to the time necessary to speak at the Satellite

Symposium) as well as modest and reasonable

travel and lodging expenses, subject to Section

VI of the Code.

• If a Health Care Professional is only attending the

Satellite Symposium: No. A Company generally

draws its audience for Satellite Symposium from

the attendees of the related Third-Party Program.

The Code prohibits Companies from directly

paying for the travel, lodging, or registration

fees for Health Care Professionals to attend a

hird-Party Program, including Satellite Symposia

held at Third-Party Programs.

This prohibition does not preclude a Company from

paying for a Health Care Professional’s modest and

reasonable travel and lodging expenses to attend

a separate, unrelated Company-organized training

or educational session or Company-conducted

onsultant meeting (for example, an advisory board),

as described in Sections II and III of the Code.

[Posted Dec. 7, 2018]

In evaluating Educational Grant requests

or requests for Commercial Sponsorship in

support of a T

hird-Party Program, how should

Companies assess the venue of the Third-Party

Program?

A Company may give varying weight to dierent

factors when assessing whether to support a

Third-Party Program through an Educational Grant

and/or Commercial Sponsorship. For those programs

with venues that may be considered luxury, resort,

or “getaway” locations, a Company may want to

onsider other factors about the program to determine

if, on the whole, the program is appropriate, such as

a robust agenda; whether there are signiﬁcant gaps

in the agenda; whether ther

e are entertainment or

recreational activities associated with the program;

whether the Third-Party Organizer promotes the

luxury or resort nature of the venue in its promotional

materials; whether the venue maintains appropriate

and adequate conference facilities; whether the

audience is composed of mostly local physicians;

among many other factors. Reviewing Educational

Grant requests and Commercial Sponsorship requests

requires the Company to look at all of the facts and

circumstances surrounding the program to determine

whether to fund, partially fund, or deny the request.

[Posted June 14, 2019]

What are examples of giveaways or

other beneﬁts that a Third-Party Program

ganizer cannot use Educational Grant funds

to support under the Code?

Section IV of the AdvaMed Code lists the appropriate

uses of a Company’s Educational Grant. This includes

providing HCPs with items of value “permissible

under the Code, such as modest meals, refreshments,

and educational items.” The AdvaMed Code permits

a Third-Party Program Organizer to use Educational

ant funds to provide items to HCPs attending the

Third-Party Program that are permissible under the

Code. Some examples of prohibited items include gift

baskets, entertainment or recreational activities,

and branded, non-educational promotional items,

among others.

(Posted August 21, 2019)

SECTION IV Educational & Research Grants, Charitable Donations, and

Commercial Sponsorships

FREQUENTLY ASKED QUESTIONS

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

Can a Company sponsor a luncheon during a

Third-Party Program through the Third-Party

Program Organizer?

A Company can provide a meal to an HCP directly

under the AdvaMed Code (see Section VII). The

AdvaMed Code also permits a Company to provide an

Educational Grant to a Third-Party Program Organizer,

which can in turn provide a meal to the HCP attendees

of a Third-Party Program. In both instances, a meal

must be modest; subordinate in time and focus to a

bona ﬁde discussion of scientiﬁc, educational, or

business information; and oered in a setting that is

conducive to such discussion.

(Posted August 14, 2019)

SECTION IV Educational & Research Grants, Charitable Donations, and

Commercial Sponsorships

FREQUENTLY ASKED QUESTIONS

B. Supporting Other Third-Party Programs through Educational Grants

A Company may provide Educational Grants to training institutions (such as medical schools and teaching hospitals)

and to other third-party entities in support of their legitimate educational and training programs and activities.

This includes, but is not limited to, Educational Grants to support the education and training of health care and

medical personnel (for example, physicians, medical students, residents, fellows, or other Health Care Professionals-

in-training), patients, and the public about important health care topics.

A Company may not make an Educational Grant to individual Health Care Professionals or individual Health Care

Professionals-in-training, and Companies may not select or inﬂuence the selection of the individual Health Care

Professionals who might beneﬁt from the Company’s support.

Sales personnel should not control or unduly inﬂuence the decision of whether a particular institution will receive support

or the amount of the support. A Company’s sales personnel may provide input about a proposed Third-Party Program.

Is a “journal club” considered a “Third-Party

Program” under the AdvaMed Code?

Yes. A “journal club” is a group of HCPs who meet

regularly to review and evaluate academic literature

on a core medical or clinical topic. Companies should

evaluate requests for journal club support based on

all of the facts and circumstances of the proposed

arrangements. The AdvaMed Code permits Companies

to support journal clubs as Third-Party Programs,

and Companies can provide such support as outlined

under Section IV of the Code

First, a Company can provide an Educational Grant to

the journal club organizer, subject to the requirements

of Section IV. The journal club organizer can use a

Company’s Educational Grant funding to defray the

costs of putting on the program (ex: AV needs and

space rental) and to provide Code-permissible items

to participants (ex: a modest meal).

Second, a Company could provide Commercial

Sponsorship to the journal club organizer in exchange

for marketing and promotional beneﬁts, such as

advertising, signage, or display space.

(Posted August 14, 2019)

Can a Company sponsor a meal

with entertainment during a Third-Party

Program (for example,

live music)?

No. Section IX of the AdvaMed Code prohibits

providing or paying for any entertainment or

recreational events. Further, Section VII of the Code

requires all Company meals to be subordinate in time

and focus to a bona fide discussion of scientific,

educational, or business information and “should not

be part of an entertainment or recreational event.”

Accordingly, a Company cannot sponsor a meal with

entertainment, even if held in connection with a

Third-Party Program.

(Posted August 21, 2019)

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

C. Supporting Independent Third-Party Research

Supporting third-party research programs and partnering with Health Care Professionals to advance independent

research can provide valuable scientiﬁc and clinical information, improve clinical care, lead to promising new

treatments, promote improved delivery of health care, and otherwise beneﬁt patients. To help meet these objectives,

a Company may provide in-kind or monetary research grants in support of independent research with scientiﬁc merit.

• Objectives & Milestones. A Company may provide support for research that has deﬁned goals, objectives,

and milestones. Requests for research grants should be accompanied by clinical protocols that outline these

objectives and milestones. Requests for research grants should also document the nature and scope of the

research activity, the budget, the approximate duration of the research, and where applicable, the requirements

for independent authorizations or approvals.

• Limitations. Research grants may include in-kind or monetary support for legitimate, study-related, documented

expenses or services and/or reasonable quantities of no-charge product for the limited duration of the research.

• Company Involvement. The recipient of a Company’s monetary or in-kind research support should retain

independent control over the research.

• Company Review Processes. A 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 the support. A Company’s sales personnel may provide input about the proposed

research program or recipient.

Company-initiated or directed research involving a Company’s Medical Technologies (such as clinical study

agreements) is addressed separately in Section II of the Code.

SECTION IV Educational & Research Grants, Charitable Donations, and

Commercial Sponsorships

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

D. Supporting Charitable Programs through Charitable Donations

and Commercial Sponsorship

A Company may make monetary or in-kind charitable donations of product or equipment for charitable purposes,

such as indigent care, patient or public education. A Company may also provide Commercial Sponsorships in

support of events where the proceeds are intended for charitable purposes.

My Company has been asked to

sponsor a local hospital’s heart

walk to raise money for heart disease

research. In exchange for a fee, my

Company will receive exhibit space

at a health care expo the hospital is

holding in c

onnection with the

charitable walk. My Company will also

eceive prominent placement in the

relevant advertising. Is this OK?

Yes. A Company may provide a

Commercial Sponsorship in support of

a charitable fundraiser, separate from a

charitable dona

tion. As with Commercial

Sponsorship of a Third-Party Program:

The level of Commercial Sponsorship

should reﬂect a commercially

reasonable fee in exchange for the

marketing and promotional beneﬁts

received by the Company, such as

advertising, signage, display/exhibit

space, or other promotional

opportunities; and

The Commercial Sponsorship

must comply with applicable laws

verning the marketing and

promotion of its products.

[Posted Dec. 7, 2018]

SECTION IV Educational & Research Grants, Charitable Donations, and

Commercial Sponsorships

FREQUENTLY ASKED QUESTIONS

• Charitable or Philanthropic Mission. Donations should be

made for bona ﬁde charitable purposes and should be made

only to charitable organizations or other non-proﬁt entities

with bona ﬁde charitable and/or philanthropic purposes.

A Company should exercise diligence to ensure the charitable

organization or charitable purpose is bona ﬁde. Relevant

factors to consider may include (1) the entity’s tax status,

(2) the entity’s corporate status under state law, and

(3) whether the organization has a charitable mission or

purpose, among other factors.

• Use of Funds. A Company must require that any donation

is used only towards charitable or philanthropic purposes.

• Indigent Care Donations. A Company may make charitable

donations of product for indigent patients, provided that

these donations serve exclusively to beneﬁt patients and are

permitted under applicable laws. Companies should consider

making product donations for indigent cases contingent upon

a hospital’s agreement that no third parties will be billed for

the donated product.

• Charitable Events. A Company may not pay for or provide

tickets to Health Care Professionals or their spouses or guests

to attend charitable events, such as galas and golf outings.

• Sales Involvement. Sales personnel should not control or

unduly inﬂuence the decision of whether a particular entity

will receive support or the amount of the support. A Company’s

sales personnel may provide input about a proposed charitable

program or recipient.

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

SECTION V Jointly Conducted Education and Marketing Programs

Companies may partner with Health Care

Professionals to conduct joint education and

marketing programs designed to highlight

both Medical Technology and a Health Care

Professional’s ability to diagnose or treat

medical conditions.

A Company and a Health Care Professional

should serve as bona ﬁde partners, and

contributions and costs should be shared fairly

and equitably between the parties.

KEY CONCEPTS

Medical Technology Companies may partner with

Health Care Professionals to jointly conduct education

and marketing programs. These programs serve an

important purpose by allowing Companies and Health

Care Professionals to educate patients and other

Health Care Professionals on medical conditions and

the range of testing or treatment options available,

including the availability of Medical Technology and

the Health Care Professional’s ability to diagnose or

treat related medical conditions.

Companies should apply the following principles:

• There must be a bona ﬁde, legitimate need for

the Company to engage in the activity for its own

educational or marketing beneﬁt.

• Companies should establish controls to help ensure

that decisions to engage in these arrangements

are not made as an unlawful inducement.

Companies should also require Health Care

Professionals participating in these arrangements

to comply with Company guidelines on providing

information related to a product’s labeling and

guidelines for furnishing appropriate health

economics information, among other controls.

• Jointly conducted education and marketing

programs should be balanced and promote both

the Company and its Medical Technologies, and

the Health Care Professional and the range of

services oered for the diagnosis and treatment

of related medical conditions.

What are examples of the types of

programs that fall under Section V?

The following are examples of jointly conducted

education and marketing programs:

• A promotional advertisement that appears in

a magazine or periodical, on a billboard, a

elevision or radio spot, an online advertisement

or social media, featuring he beneﬁts of the

Company’s Medical Technology and highlighting

the skills and expertise of the HCP to perform

procedures that use the Medical Technology.

• An educational program for patients or referring

physicians during which a Company and an

HCP provide clinical information about speciﬁc

Medical T

echnology; and an HCP describes

what patients should expect when undergoing

a procedure, relevant treatment options, and

his/her own ability to perform the procedure

tha

t uses the Medical Technology.

This list is not meant to be exhaustive. There are

other types of programs on which Companies

and HCPs can collaborate to deliver high-quality,

e

ective educational content to patients, other

physicians, or the public.

[Posted June 14, 2019]

These programs could include, for example, an event

in which a Company shares information about its

Medical Technologies to an audience of Health Care

Professionals or patients, and a physician speaks

about the medical conditions that the Medical

Technology is intended to treat, the procedures that

use the Medical Technology, and the physician’s

ability to perform these procedures.

FREQUENTLY ASKED QUESTIONS

ADDITIONAL INSIGHTS

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

SECTION V Jointly Conducted Education and Marketing Programs

• The Company and the Health Care Professional

should serve as bona ﬁde partners in the program

and should make equitable contributions towards

the activity and costs (for example, developing

content, invitations, space rental, AV needs, and

other production costs).

• The arrangement should be documented in a

written agreement that describes the purpose of

the arrangement and the roles, responsibilities,

and contributions of each party, including

payment of costs.

What types of controls should companies

implement in connection with jointly

conducted programs?

Companies and HCPs engaged in a jointly conducted

educational and marketing program may adopt many

types of controls. Some examples include appropriate

governing policies; periodic assessment of the

appropriate business need for the program; focused

training; a process for evaluating the fair market

value of jointly conducted education and marketing

ograms; and ﬁeld-based monitoring, among others.

A documented, jointly conducted program between

a Company and an HCP should also entail both parties

making

equitable contributions towards the costs of

the program. While costs do not need to be split

evenly between the parties (for example, monetary

or in-kind contributions of both parties), each party

should c

ontribute to the program in a way that is

commensurate with the beneﬁts it receives.

[Posted June 14, 2019]

FREQUENTLY ASKED QUESTIONS

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

SECTION VI Travel & Lodging; Venue

Companies may pay for Health Care Professionals’

modest and reasonable travel and lodging costs

to attend a Company-conducted program or

meeting under certain circumstances.

In all instances, there must be objective,

legitimate reasons that support the need for

travel and lodging for Health Care Professionals.

KEY CONCEPTS

There may be programs or meetings for which a Company determines it is appropriate to pay for Health Care

Professionals’ travel and lodging costs. This section of the Code provides Companies with guidance on paying for

a Health Care Professional’s travel and lodging costs. Companies should apply the following principles:

• Legitimate Need. There must be objective, legitimate reasons that support the need for out-of-town travel,

such as the need to deliver training and education concerning Medical Technologies, the inability to eectively

deliver the content of the program through means other than an in-person meeting, or the need to demonstrate

equipment. Companies are encouraged to document the legitimate need for travel.

Does the Code permit Companies

to pay for travel to attend Company-

conducted training or education program?

Yes. The Code contemplates that a Company

may bring Health Care Professionals together

at a central location to deliver training and

education concerning Medical Technologies,

which may make out-of-town travel necessary.

[Posted Dec. 7, 2018]

Does the Code permit a Company

to pay for travel to a Company-

conducted general educational program

not c

oncerning a Medical Technology?

No. It may be appropriate for a Company to

conduct a general educational session not

concerning a Medical Technology, but it is

not the type of program for which Company-

supported travel would be appropriate

under the Code.

[Posted Dec. 7, 2018]

When does the Code PERMIT a Company

to pay for a Health Care Professional’s

travel & lodging?

To provide consulting services to a Company,

if the Health Care Professional is subject to an

xecuted consulting agreement and there is

an objective, legitimate reason that supports

the Health Care Professional’s in-person

participation (see Section II)

To attend a Company-conducted training or

education program concerning Medical Technologies,

if ther

e is an objective, legitimate reason that

supports the Health Care Professional’s in-person

attendance (see Section III)

To speak on a Company’s behalf at a Third-Party

Program, subject to the conditions described

in Section IV

Companies may determine that there are other

types of programs or meetings that qualify to

cover a Health Care Professional’s modest travel

and lodging costs to attend. Some examples

could include plant tours and demonstrations

of equipment, among others. In all instances,

ther

e must be an objective, legitimate reason that

supports the Health Care Professional’s in-person

attendance at the program.

FREQUENTLY ASKED QUESTIONS

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

• Modest and Reasonable Travel and Lodging. Travel and

lodging accommodations and costs must be modest and

reasonable under the circumstances. Companies are encouraged

to establish controls on the appropriate class of travel service

and the appropriate level of lodging accommodations.

• Travel Time & Destination. Companies are also encouraged

to establish controls on the timing and location of travel

arrangements for Health Care Professionals.

• Guests. Companies may not pay for or otherwise subsidize

the travel or lodging of spouses or guests of Health Care

Professionals or for any other person who does not have a

bona ﬁde professional interest in the information being shared

at the Company’s meeting.

• Personal Travel & Lodging. Companies may not pay for

a Health Care Professional’s personal travel or lodging.

• Setting. The setting for a Company-conducted program or

meeting of Health Care Professionals should always be

conducive to the exchange of information and should not be

the main attraction of the event. Companies should consider

the following principles when choosing a setting:

- The setting should be centrally located and easily accessible

(for example, considering proximity to airports and highways)

in relation to the place of origin of the invited participants.

- Companies should not select a setting because of its

entertainment or recreational facilities (considering, for

example, the season or time of year of the event).

- Companies should avoid top category or luxury hotels

or resort facilities without an appropriate justiﬁcation.

• Other Laws. Companies should be aware that other laws or

regulations may apply to paying for Health Care Professionals’

travel and lodging, including potentially more restrictive state laws.

What types of controls should

Companies consider with respect

to limiting Health Care Professionals’

travel and lodging costs associated

with a Company-conducted meeting?

Companies may consider many types of

controls with respect to HCP travel and

lodging. Some examples include, among

others: limiting the duration of Company-

funded travel and lodging to arrangements

tha

t are the closest in time and in location

to the Company program or meeting

for which the Health Care Professional is

aveling; applying limits to class of travel

and lodging; placing restrictions on how

travel and lodging arrangements can be

changed, by whom, and whether the

Company or the HCP must pay for any

related change fees or additional costs.

[Posted June 14, 2019]

Ski resorts, island or beach resorts, and

other resorts in geographic locations

renowned primarily as seasonal vacation

destinations may not be appropriate

during the season in question.

Companies may assess the appropriateness

of these venues dierently, for example:

• If the Company is headquartered or

has a signiﬁcant facility in one of

these geographic areas;

• If the Company is hosting a strictly

local Company-conducted program

attended by local Health Care

Professionals (for example, a technical

aining program held in Hawaii for

local Hawaiian physicians); or

• If the Company is hosting a meeting

held in conjunction with a Third-Party

Program.

[Posted Dec. 7, 2018]

When does the Code PROHIBIT a Company

from paying for a Health Care Professional’s

travel & lodging?

To attend any Company meeting without an objective,

legitimate reason that supports the need for travel

To attend a Third-Party Program (see Section IV)

SECTION VI Travel & Lodging; Venue

FREQUENTLY ASKED QUESTIONS

ADDITIONAL INSIGHTS

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

SECTION VII Providing Modest Meals and Refreshments to Health

Care Professionals

Meals and refreshments provided to Health Care

Professionals must be provided in a manner and

place that are conducive to the presentation of

scientiﬁc, educational, or business information.

Meals and refreshments should be subordinate

in time and in focus to the discussion and

presentation of scientiﬁc, educational, or

business information.

KEY CONCEPTS

A Company occasionally may provide Health

Care Professionals with modest meals and

refreshments, subject to the following principles:

• Purpose. The meal or refreshments should be

subordinate in time and in focus to the bona

ﬁde discussion and presentation of scientiﬁc,

educational, or business information.

Companies should provide meals and

refreshments in a manner conducive to the

presentation or discussion of such information.

The meal or refreshments should not be part

of an entertainment or recreational event.

• Setting and Location. Meals and refreshments

should be provided in a setting that is

conducive to bona ﬁde scientiﬁc, educational,

or business discussions. This may include,

for example, the Health Care Professional’s

place of business or an o-site space that

is conducive to the discussion, such as

a restaurant.

• Participants. A Company may provide a

meal or refreshments only to Health Care

Professionals who actually attend and have a

bona ﬁde purpose for attending the meeting.

A Company may not provide a meal or

refreshments:

- For an entire oce sta where everyone

does not attend the meeting;

- If a Company representative is not present

(such as a “dine & dash” program); or

- For guests of Health Care Professionals or

for any other person who does not have a

bona ﬁde professional interest in the

information being shared at the meeting.

For Companies that have chosen to place per-meal

spending limits on meals with Health Care Professionals,

does AdvaMed recommend a speciﬁc dollar value?

No. AdvaMed does not recommend a speciﬁc dollar amount

for a per-person spending limit on meals with Health Care

Professionals. AdvaMed maintains benchmarking and best

practices information on its website, and Companies take

diering factors into account in establishing their spending

limits. The fact that a meal costs less than a Company’s

spending limit does not mean the meal complies with the Code;

ather, all meals and refreshments provided to HCPs must meet

all of the requirements of Section VII of the Code.

[Posted June 14, 2019]

Is a general discussion to build good business

relationships an appropriate purpose for providing

a meal to a Health Care Professional?

No. A meal should only be provided to a Health Care Professional

as part of a bona ﬁde business discussion. This includes, for

example, discussions on Medical Technology development and

improvement, pricing, or contract negotiations, among other

legitimate topics. The discussion should account for most of

the time spent during the meal. A casual get-together or the

development of general goodwill should not be the primary

purpose of a meal with a Health Care Professional.

[Posted Dec. 7, 2018]

ESTABLISHING MEAL POLICIES

Companies are strongly encouraged to develop policies

on providing modest and occasional meals to Health

Care Professionals.

his may include establishing a per meal spending limit for meals

and refreshments with a Health Care Professional and whether

the amount should vary to account for geographic areas

(for example, New York City) that are generally more expensive.

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

FREQUENTLY ASKED QUESTIONS

ADDITIONAL INSIGHTS

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

SECTION VIII Educational & Patient Beneﬁt Items; Prohibition on Gifts

Companies may not provide branded, promotional

items or “gifts” to Health Care Professionals.

Companies may provide modest, appropriate

educational items or patient beneﬁt items to

Health Care Professionals.

KEY CONCEPTS

A Company may occasionally provide modest,

appropriate educational items to Health Care

Professionals that beneﬁt patients or serve

a genuine educational function for Health

Care Professionals.

Companies may not provide gifts to Health

Care Professionals. This means that a Company

may not provide Health Care Professionals with

the following:

• Items that the Health Care Professional

(or his or her family members, oce sta,

or friends) can use for non-educational or

non-patient-related purposes (for example,

oce supplies, scrubs, a tablet, Smart Phone,

laptop, or other mobile device capable of

personal use)

• Branded, non-educational promotional items,

even if the item is of minimal value, related

to the Health Care Professional’s work, or

for the beneﬁt of patients (for example, pens,

notepads, mugs, and other items with a

Company or product name or logo)

• Gifts such as cookies, wine, ﬂowers, chocolates,

gift baskets, holiday gifts or cash or cash

equivalents (for example, gift cards)

Other important principles include:

• Any item given to a Health Care Professional’s

sta should be treated as though it is given

to the Health Care Professional and is subject

to all applicable provisions of the Code.

• A Company may not rae or give away an

item that it could not otherwise give a Health

Care Professional under the Code.

What are “modest” educational items?

Other than medical textbooks or anatomical models

used for educational purposes, any educational item provided

to a Health Care Professional should have a fair market value

of less than US $100.

[Posted Dec. 7, 2018]

Does the AdvaMed Code include any restrictions on

a Company employee or

representative accepting

a gift from a Health Care Professional?

No. The AdvaMed Code does not address whether a

Company employee or representative can accept a gift from

a Health Care Professional. Companies are encouraged to

develop their own internal policies on this concept,

recognizing that the giving and acceptance of gifts could

create a real or perceived conflict of interest.

[Posted June 14, 2019]

FREQUENTLY ASKED QUESTIONS

What is an item for the beneﬁt of patients?

Items considered to be intended for the beneﬁt of

patients could include starter kits, and educational brochures,

for example. With respect to starter kits, a Company should

adopt appropriate safeguards regarding the provision of such

kits to ensure they are not oered as an unlawful inducement.

[Posted Dec. 7, 2018]

May a Company or its representative provide a

gift to recognize a life event for a Health Care

Prof

essional, such as a wedding, birth, anniversary, or

death of a family member?

No. A Company or its representative acting on the Company’s

behalf may only provide items to Health Care Professionals

that are intended for the beneﬁt of patients or serve a genuine

educational function for the Health Care Professional. Gifts

such as ﬂowers, fruit baskets, etc. do not meet this requirement,

even if provided to recognize a signiﬁcant life event.

[Posted Dec. 7, 2018]

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

SECTION IX Prohibition on Entertainment & Recreation

Companies may not provide entertainment or recreation to Health Care Professionals in any form.

KEY CONCEPTS

A Company may not provide or pay for any entertainment or recreational event for a Health Care Professional.

Some examples of entertainment and recreational activities include, among others, theater, sporting events,

golf, skiing, hunting, or vacation trips.

This prohibition applies regardless of (1) the value of the activity; (2) whether the Company engages

the Health Care Professional as a consultant; or (3) whether the entertainment or recreation is secondary

to an educational purpose.

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

SECTION X Communicating for the Safe & Eective Use of Medical Technology

Access to truthful and non-misleading information

relating to Medical Technologies is critical to a

Health Care Professional’s ability to exercise his

or her medical judgment, to provide high-quality

care, and to safely use available Medical

Technology.

Companies are encouraged to apply the

principles outlined in this section and develop

related controls.

KEY CONCEPTS

Health Care Professionals may use a product for any use that they determine is in the best medical interests of

their patients. This includes uses that are contained in the Medical Technology’s labeling or otherwise consistent

with such labeling, but it could also include uses that are not approved or cleared (i.e. “o-label” uses). As recognized

under U.S. law and by the FDA, o-label use of these Medical Technologies can be an important part of medical

practice and may even constitute a medically recognized standard of care.

Access to truthful and non-misleading information relating to Medical Technologies, including information on both

on- and o-label uses, is critical to a Health Care Professional’s ability to exercise his or her medical judgment in

the best interest of patients, to provide high-quality care, and to safely use available Medical Technology. Industry

appropriate communications of such information can include, among other activities:

• Proper dissemination of peer-reviewed scientiﬁc and medical journal articles, reference texts, and clinical

practice guidelines;

• Presentations at educational and medical meetings regarding clinical trial results or research and development

data for an investigational use (taking care that no claims are made regarding safety and eectiveness); and

• Discussions with consultants and Health Care Professionals to obtain advice or feedback relating to topics

such as unmet patient needs, product research and development, and the like.

The following principles recognize industry’s responsibility to communicate about medical and scientiﬁc

information to assist in achieving positive patient outcomes and support of the public health:

1. Company responses that contain information regarding unapproved or uncleared uses

should be provided by authorized personnel.

2. Company communications must be truthful and non-misleading.

3. Information related to unapproved or uncleared uses should be identiﬁed as such.

Companies are encouraged to develop policies and controls that apply the principles above and that incorporate

the requirements of applicable guidance (for example, judicial decisions related to appropriate product

communications, guidance from the FDA, and the like).

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

SECTION XI Provision of Health Economics & Reimbursement Information

Medical Technology Companies may support

patients in obtaining access to a Company’s

Medical Technology by providing Health Care

Professionals with timely and complete coverage,

reimbursement, and health economics information.

Medical Technology Companies may not, however,

interfere with a Health Care Professional’s

independent clinical decision making or provide

coverage, reimbursement and health economics

support as an unlawful inducement.

KEY CONCEPTS

As Medical Technologies have become increasingly complex, so have payor coverage and reimbursement policies.

Patient access to necessary Medical Technology depends on Health Care Professionals and/or patients having

timely and complete coverage, reimbursement, and health economic information. To promote patient access to

Medical Technologies:

• A Company may provide this information regarding its Medical Technologies if it is accurate and objective.

• A Company may also collaborate with Health Care Professionals, patients, and organizations representing their

interests to achieve government and commercial payor coverage decisions, guidelines, policies, and adequate

reimbursement levels that allow patients to access its Medical Technologies.

Permissible activities involving the provision of coverage, reimbursement, and health economic information

may include, but are not limited to:

• Identifying the clinical value of the Company’s Medical Technologies and the services and procedures in

which they are used

• Collaborating with Health Care Professionals, their professional organizations, and patient groups to conduct

joint advocacy on coverage, reimbursement, and health economics issues

• Supporting Health Care Professionals and their professional organizations in developing materials and otherwise

providing direct or indirect input into payor coverage and reimbursement policies

• Promoting accurate Medicare and other payor claims by providing accurate and objective information and

materials to Health Care Professionals regarding the Company’s Medical Technologies, including identifying

coverage, codes, and billing options that may apply to those Medical Technologies or the services and

procedures in which they are used

• Providing accurate and objective information about the economically ecient use of the Company’s Medical

Technologies, including where and how they can be used within the continuum of care

• Providing information related to the Company’s Medical Technologies regarding available reimbursement

and associated costs

• Providing information relating to changes in coverage or reimbursement amounts, methodologies and policies

and the eects of such changes to help a Health Care Professional in the decision to buy or use the Company’s

Medical Technologies

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

SECTION XI Provision of Health Economics & Reimbursement Information

• Providing accurate and objective information designed to oer technical or other support intended to aid in

the appropriate and ecient use or installation of the Company’s Medical Technologies

• Facilitating patient access to the Company’s Medical Technologies by providing Health Care Professionals

with assistance in obtaining patient coverage decisions from payors, including providing information on payor

policies and training on procedures for obtaining prior authorization, providing sample letters and information

on medical necessity and appeals of denied claims

In addition, at the request of a Health Care Professional to facilitate patient access to the Company’s Medical

Technology, and subject to appropriate privacy safeguards, the Company may assist the patient by facilitating

the preparation and submission of requests for coverage determinations, prior authorizations, pre-certiﬁcations

and appeals of denied claims, relating to a Company’s own Medical Technology; however, such assistance

should not be provided as an unlawful inducement.

A Company may not interfere with a Health Care Professional’s independent clinical decision making or provide

coverage, reimbursement, and health economics support as an unlawful inducement. For example, a Company

should not provide free services that eliminate an overhead or other expense that a Health Care Professional would

otherwise have incurred as part of its business operations. Further, a Company should not suggest mechanisms

for billing for services that are not medically necessary, or for engaging in fraudulent practices to achieve

inappropriate payment.

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

SECTION XII Demonstration, Evaluation, and Consigned Products

Companies may provide reasonable quantities

of products to Health Care Professionals at no

charge to permit Health Care Professionals

to evaluate and assess whether to purchase

the product.

Companies may also provide Health Care

Professionals with non-sterile demonstration

units to use in educating patients about

the product and its use.

KEY CONCEPTS

A. Demonstration & Evaluation Products

Providing products to Health Care Professionals at no charge for evaluation or demonstration purposes can improve

patient care, facilitate the safe and eective use of products, enhance patient awareness, and educate Health Care

Professionals regarding the use of products. Under certain circumstances, a Company may provide reasonable

quantities of products to Health Care Professionals at no charge to allow Health Care Professionals to assess

the appropriate use and functionality of the product and determine whether and when to use, order, purchase,

or recommend the product in the future.

What are examples of

appropriate reasons for providing

single-use or multiple-u

se evaluation

products to a Health Care Professional?

Examples may include the Health Care

Professional may have not recently

purchased or used the products (i.e. the

Health Care Professional is not familiar

with the product); or the product may

be marketed for a new indication or new

sur

gical technique; among other reasons.

[Posted Dec. 7, 2018]

Company products that may be provided to Health Care

Professionals for evaluation include single use (for example,

samples of consumable or disposable products) and multiple

use products (sometimes referred to as capital equipment).

Company products provided for evaluation are typically expected

to be used in patient care. Companies should provide Health

Care Professionals with appropriate documentation to allow

the Health Care Professional to address any reimbursement

reporting obligations, including providing information on

the no-charge status of these products.

• Single Use/Consumables/Disposables. The number of single

use products provided at no charge should not exceed the

amount reasonably necessary for the adequate evaluation

of the products under the circumstances.

• Multiple Use/Capital. Multiple use products provided without

transfer of title for evaluation purposes should be furnished

only for a period of time that is reasonable under the

circumstances to allow an adequate evaluation and consistent

with any applicable transparency reporting requirements.

Transparency.

A Company should consider whether

ederal or state law (for example, the

U.S. Physician Payments Sunshine Act)

equires reporting the value of evaluation

products provided to Health Care

Professionals.

FREQUENTLY ASKED QUESTIONS

ADDITIONAL INSIGHTS

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

What additional asset management

principles should companies

consider adopting?

In addition to the principles outlined

in Section XII of the AdvaMed Code,

ompanies may also want to consider

other controls regarding asset

management, including product provided

t no charge (for example, demonstration

and evaluation units, loaned products,

in-kind grants/donations) or for charge

(for example, rental products, placed

capital, consignment product). Possible

examples of these controls may include

the following:

• Written policies, procedures and work

instructions that govern when assets

can be supplied to an HCP, including

related auditing and monitoring;

• Specialized training and education

for Company representatives; and

• Clear documentation, recordkeeping,

and asset tracking requirements,

including any obligations to

compensate or return Medical

Technology to the Company,

as appropriate.

[Posted June 14, 2019]

- The length of time necessary for a Health Care Professional

to evaluate a multiple use product can vary among products

and may depend on the frequency of anticipated use, the

duration of required training, the number of Health Care

Professionals who need to evaluate the product, the length

of time needed to evaluate dierent product features, and

similar considerations.

- The terms of an evaluation of such multiple use products

should be set in advance in writing, specifying the length

of the evaluation period and addressing products that have

not been returned within the evaluation period.

- Companies should retain title to multiple use products

during the evaluation period and should have a process in

place for promptly removing multiple use products from

the Health Care Professional’s location at the conclusion of

the evaluation period unless the Health Care Professional

purchases or leases the products.

• Demonstration. Company demonstration products are

typically unsterilized single use products or mock-ups that

are used for Health Care Professional and patient awareness

and education. For example, a Health Care Professional

may use a demonstration product to show a patient the type

of device that will be implanted in the patient.

• Demonstration products typically are not intended to be

used in patient care.

SECTION XII Demonstration, Evaluation, and Consigned Products

B. Consigned Products

Consigned products are Medical Technologies (a) that a Company provides to a Health Care Professional for use

in and storage at the Health Care Professional’s patient care setting and (b) to which the Company retains title until

the product is used.

• Consignment arrangements should generally be subject to an agreement that addresses the terms

of consignment, for example, the number of products, any requirements to segregate consigned products

from other products, and storage space rental terms (if applicable).

• Companies are encouraged to consider implementing appropriate controls. This could include (among other

measures) taking periodic inventory of consigned devices for purposes such as billing and restocking;

reconciling discrepancies between the Company’s records and the number of products used or veriﬁed during

inventory; and return or removal of expired product.

FREQUENTLY ASKED QUESTIONS

• Demonstration products typically are identiﬁed as not intended for patient use through designations

like “Sample” or “Not for Human Use” on the product, the packaging, or documentation that accompanies

the product.

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

Company representatives may play an important role in the clinical setting by providing technical support on

the safe and eective use of Medical Technology. Some examples include:

• Company representatives may need to explain how a Medical Technology’s unique settings and technical

controls function and may make recommendations.

• Company representatives may assist the clinical/operating room team to ensure that the appropriate range of

necessary devices and accessories are available during a procedure, especially when dealing with Medical

Technology that involves multiple devices and/or accessories.

Companies should apply the following principles:

1. Company representatives should enter and be present in the clinical setting only at the request of and under

the supervision of a Health Care Professional.

2. Company representatives should be transparent that they are acting on behalf of the Company in a technical

support capacity.

3. Company representatives should not interfere with a Health Care Professional’s independent

clinical decision-making.

4. Company representatives should comply with

applicable hospital or facility policies and re-

quirements, including patient privacy and cre-

dentialing requirements.

5. A Company’s technical support should

not eliminate an overhead or other expense that

the Health Care Professional should otherwise

incur while providing patient care.

SECTION XIII Company Representatives Providing Technical Support in

the Clinical Setting

Access to truthful and non-misleading information

relating to Medical Technologies is critical to

a Health Care Professional’s ability to exercise

his or her medical judgment, to provide

high-quality care, and to safely use available

Medical Technology.

Companies are encouraged to apply

the principles outlined in this section and

develop related controls.

KEY CONCEPTS

Revised and Restated AdvaMed U.S. Code of Ethics | Eective January 1, 2020

SECTION XIV Explore Additional Code of Ethics Resources Online

AdvaMed oers MedTech companies guidance, training and certiﬁcation to assist compliance with the AdvaMed

Code, encourage ethical business practices and facilitate socially responsible industry conduct.

Visit www.advamed.org/ethics to explore our extensive collection of resources and tools.

Code Certiﬁcation Center

The AdvaMed Code Certiﬁcation Center is open to

both AdvaMed member and non-member MedTech

ompanies. Sign on to the Code, obtain a certiﬁcation

logo you can proudly display, and reap the beneﬁts

of Code certiﬁcation.

Accel Center for Ethics

At the Accel Center for Ethics (ACE), smaller companies

are provided with the tools and resources needed to

adopt the AdvaMed Code of Ethics and implement its

provisions to help ensure eective compliance.

Online Code Training

For company representatives who need more in-depth

training, AdvaMed worked with HealthStream, a provider

of workforce and provider solutions for the healthcare

industry, to provide Code of Ethics training via the

RepDirect™ platform, where for a reasonable fee learners

can access training and receive a credential accepted

by healthcare providers nationwide.

Code Resources Center

The AdvaMed Code Resources Center hosts new

and updated tools, resources and other materials to

sist both member and non-member companies in

AdvaMed Code adoption, training, communication

and implementation.

• 2020 Code Training Deck for an introductory course

on the Revised AdvaMed Code of Ethics.

• Crosswalk - AdvaMed Code of Ethics (Revised For

2020) for understanding the dierences between

the old Code and revised Code.

• Illustrative Best Practices Tools for The AdvaMed

Code for thirteen decision trees intended to both

provide a summary of the AdvaMed Code and guide

employees in ethical and compliant decision-making.

• Pocket Card - Code 2020 for a more concise summary

of AdvaMed and the Code, what’s new, and a series of

questions to help you understand if your company is

prepared to certify.

• Overview - AdvaMed Code of Ethics (Revised For

2020) for background information on AdvaMed and

the Code, what is new in the revised Code, reasons

to certify and the thirteen sections of the revised

Code to reﬂect which aspects of HCP interactions

the Code addresses.

• AdvaMed Code Flashcards for learning the answers

to many of the essential questions the Code addresses.

• AdvaMed Meal Survey Results for benchmarking

data on company meals with HCPs.

• AdvaMed Brochure On Educational Conference

Support for extensive guidance on company support

of educational conferences.

• Distributor Training Slides 2020 for training

distributors with joint guidance from MedTech

associations across the globe.

• AdvaMed MedTech Europe SMI Brochure 2020

for joint guidance on ethical sales and marketing

intermediary (SMI) interactions with HCPs and

government ocials.

• Comparison Chart: AdvaMed Code, AdvaMed China

Code, MedTech Europe Code, And APACMed Code

for identifying the dierences between the AdvaMed

ode and other major global Codes of Ethics.