Customer Relations Code of Conduct

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					GE Healthcare

GE Healthcare Medical
Diagnostics, US

Customer Relations
Code of Conduct

        imagination at work
                           Statement of Integrity

GE has a worldwide reputation for integrity and high standards of business conduct.
Guiding us in upholding our ethical commitment is a set of GE policies on key
integrity issues.

Because our Medical Diagnostics business is also a pharmaceutical company, there
are a number of additional policies governing our advertising and promotional
activities. These policies are outlined in this booklet and I expect each and every
person involved in the sales and marketing of our products to understand and fully
comply with them.

A reputation for ethical promotion of prescription drugs takes years to develop but
only seconds to lose. Our reputation rests in your hands. I trust that each of you
will be personally accountable to comply not only to the letter of these policies, but
also with their spirit.

Thomas Giordano
Executive Vice President General Manager

             GE Healthcare Medical Diagnostics, US
              Customer Relations Code of Conduct

                          Table of Contents

       Statement of Integrity                                          2

       Introduction                                                    5

I.     Overview of Applicable Laws and Codes

       A. Advertising and Promotional Regulation                       7

II.    Summary of Requirements under the FD&C Act

       A. Approved Use                                                 8
       B. Fair Balance                                                 8
       C. Brief Summary                                                9
       D. Comparative and Superiority Claims                           9
       E. Dissemination of Scientific Information,                     10
          Unapproved Drug Claims
       F. Drug Sampling                                                10
       G. Public Communications                                        11
       H. Adverse Event Reporting                                      11

III.   Summary of Requirements Under Fraud Laws Relating to
       Advertising and Promotion of Prescription Drugs and Industry
       Guidelines on Interactions with Healthcare Professionals

       A. Fraud Laws                                                   12
       B. PhRMA Code                                                   12

IV.    Summary of GEHC Medical Diagnostics Standard
       Operating Procedures Relating to Advertising and Promotion of
       GEHC Medical Diagnostic Products

       A. Promotional Review Team                                      13
       B. Risk Areas                                                   14

                1. Sales Presentations                                14
                2. Business Courtesies                                16
                        a. Gifts                                      16
                        b. Meals                                      17
                        c. Travel, Lodging, and Personal Expenses     17

                3. Education of Healthcare Professionals              21
                       a. Independent Educational Events              22
                       b. Financial Assistance for Training           22
                          Healthcare Professionals
                       c. Company Controlled Educational Programs     26
                       d. Trade Shows and Conventions                 27
                       e. Dissemination of Scientific Information     30
                          Pursuant to an Unsolicited Request

                4. Charitable Contributions                           30
                5. Research Grants                                    34
                6. Consultant Agreements                              34
                7. Interactions with Government Personnel             37
                8. Pricing Policy Introduction                        39
                9. Pricing Strategy Committee                         39

       C.   Adverse Drug Events and Public Safety                     42
       D.   When You Have an Integrity Concern                        44
       E.   How to raise an Integrity Concern                         44
       F.   What Happens When an Integrity Concern Is Raised?         45
       G.   Penalties for Violations                                  45

V.     Additional Internet Links for Guidelines on Marketing and Sales
       Activities                                                      46

VI.    Attachments                                                    47

VII.   Forms                                                          47


 No matter how high the stakes, no matter how great the “stretch,” GE will do
 business only by lawful and ethical means. When working with Customers and
 suppliers in every aspect of our business, we will not compromise our commitment
 to integrity.

 Integrity is a core GE Healthcare (GEHC) value and the foundation of the way we do
 business. Compliance with the US healthcare laws and rules governing our
 interactions with customers, and communications about our products,
 demonstrates our commitment to integrity. Compliance also builds trust with
 patients, healthcare professionals, institutional purchasers, and the government.

 Using the Guide

 The guide offers an overview of the laws, rules, and company policies related to
 healthcare law compliance. The guide also provides a common reference to each
 policy, procedure, and guideline for understanding:

   •   How our work environment is regulated
   •   How healthcare compliance laws apply to our activities
   •   Which activities may raise potential concerns
   •   What we must do to comply with healthcare laws

This guide provides an overview of various healthcare laws, rules, and GE Healthcare
policies, procedures, and guidelines that are specifically designed to:

       • Protect patients and improve the quality of healthcare services
       • Protect medical decision-making from undue influence (eg, improper
         financial incentives)
       • Protect federal healthcare programs, non-government healthcare programs
         supported with public monies, and private healthcare programs from the
         potential for fraud and abuse (the misuse of healthcare funds)

All GE Healthcare employees, particularly those who interact and communicate with
patients, providers, government officials, advocacy groups and the media, are
expected to have a basic understanding of the healthcare laws and rules that apply
to our business, including:

   •   The Federal Anti-Kickback law
   •   The Federal False Claims Act

   •   FDA Laws and Regulations
   •   State Anti-Kickback, Privacy, and Consumer Protection Laws
   •   The PhRMA Code on Interactions with healthcare professionals
   •   Health Insurance Portability and Accountability Act of 1996 (HIPPA)

Compliance not only protects you and GE Healthcare, it also protects our customers,
who are subject to many of the same laws and rules that apply to us.

If you have a question about how a policy applies to you, refer to the relevant
chapter in this guide or consult with your manager or your team’s legal counsel.

                  Overview of Applicable Laws and Codes

Advertising and Promotional Regulation

The advertising and promotion of pharmaceuticals provides an essential function in
the healthcare delivery system, allowing physicians to have the most current
information about the drugs that they prescribe. There are many laws and
regulations that govern this function, however, the Federal Food, Drug and
Cosmetic Act (FD&C Act) is the primary statutory authority on the regulation of
prescription drugs. Other laws, particularly in the area of fraud, are also important.
In addition to these laws and regulations, there are a number of industry and
professional organizations that have issued industry standards on the marketing of
pharmaceuticals that are important to consider in developing appropriate
compliance in this field ; e.g., PhRMA’s Code on Interactions with Healthcare

 Summary of Requirements Under the Food, Drug, and Cosmetic Act

               Found at:\uscode\title21\chapter9.html

 Approved Use

      Prescription Drugs cannot be advertised as safe or effective until the FDA has
      approved the drug product. Advertising and promotional material must not
      contain any claims for a product other than claims specifically approved by
      the FDA and included in the product’s labeling. Promoting a product for
      purposes other than the use for which it is specifically approved by the FDA
      (“off-label use”) is illegal. Examples of promoting an Off-Label Use include
      efficacy claims for an unapproved indication or safety claims that are not
      supported by the labeling. As will be discussed later, however, the scientific
      exchange of off-label information is permitted under certain circumstances.

Fair Balance

      Advertising and promotion must be “fairly balanced” so that healthcare
      professionals and consumers will get a complete picture of the product. “Fair
      balance” is a fair and balanced presentation of both the benefits and the risks
      of a product. Fair balance of an advertisement or promotion is evaluated by
      its affirmative representations and the extent to which the advertising and
      promotion fails to reveal material “facts” about potential consequences from
      product use. A presentation of all side effects and contra-indication
      information must have prominence and readability reasonably comparable to
      the presentation of effectiveness-related information.

Brief Summary

      Any advertisement or promotion that includes both the name of the drug and
      its uses must also contain a full package insert or a brief summary of risks
      (side effects, warnings, precautions and contradictions) from the package
      insert (or make adequate provision for obtaining them). This requirement
      applies to package advertising directed at consumers as well as that which is
      directed to healthcare professionals; although in direct-to-consumer
      advertising the, brief summary information may be presented in consumer-
      friendly format and language.

      Reminder advertisements are exempt from the brief summary and fair
      balance requirements. A reminder advertisement is intended to call attention
      to the name of the products without information on the indications or

      recommended dosage. A reminder ad may only contain the following

                    •      proprietary or established name of the drug
                    •      the established name of each active ingredient of the
                           drug product; and, optionally,
                    •      the amount of each ingredient, the dosage form, the
                           quantity in a package, the price and the name and
                           address of the manufacturer, packer, or distributor, or
                           other written, printed, or graphic material that does not
                           represent or suggest any relation to the advertised drug

 Comparative and Superiority Claims

      A company seeking to make a claim of superiority or compare its product to
      another must have “substantial evidence” or “substantial clinical experience”
      supporting the claim. Comparative safety claims generally require direct
      comparisons between two agents, unless the differences between the two
      agents are “unequivocally established as properties of the drugs”.
      Comparative promotional claims must be consistent with the approved
      labeling of the products being compared.

Dissemination of Scientific Information
Relating to Unapproved Drug Claims

      Historically, the FDA has been very aggressive in enforcing the laws and
      regulations concerning the promotion of unapproved claims. The FDA has
      argued that the public health is at its greatest risk when claims the agency
      has not approved as having objective scientific evidence of safety and
      efficacy are promoted by drug manufacturers. Nevertheless, the FDA does
      recognize that there is a legitimate place for the dissemination of truthful
      information about a drug product. Moreover, the FDA recognizes that it is in
      the public interest to allow learned healthcare professionals to prescribe
      drugs for off-label uses. The practice of medicine is outside the scope of the
      FDA’s jurisdiction. The FDA does not consider individual, non-promotional
      responses by pharmaceutical companies to specific “unsolicited requests” for
      information from healthcare professionals and consumers to be promotional.

 Drug Sampling

       General Rules on Sampling

       GEHC employees must comply with federal and state laws that regulate
       sampling and prohibit the sale, purchase, or trade of samples. GE Healthcare
       policy requires that:

           •   Samples must be distributed only to licensed physicians who request
               samples and who are identified as eligible to receive samples from the
               GE Healthcare sample program
           •   The signature of the physician who requests and receives the samples
               must be obtained on the order-to-ship form. Representatives must
               personally witness the signature of the eligible physician
           •   All samples are shipped to the physician from the GEHC Distribution
           •   Samples must never be sold, purchased, or traded
           •   Physicians must be advised that these samples are free of charge and
               it is unlawful to seek reimbursement under federal or state programs.

       Sales representatives may not provide samples of GEHC products to a
       specialty group of healthcare professionals that would not be reasonably
       expected to prescribe the GEHC product for an approved use.

       The Prescription Drug Marketing Act of 1987 regulates drug sampling
       ( This law sets forth
       guidelines and procedures pertaining to the storage, record keeping and
       sampling of prescription drugs. Please refer to the complete guide on
       Sampling Process and Procedures.

       Click here for complete processes, guidelines, and procedure link to "Product Sampling"

Frequently Asked Questions

Question: Do I have to personally witness the physician sign the sample form, or can I
let the nurse take it to the doctor for signature?

Answer: It is GEHC policy for its representatives to personally witness the signing of the
sample form by the eligible requesting healthcare professional.

Public Communications

      The FDA regulates materials that pharmaceutical companies provide to media
      outlets in the form of press releases, media kits, and video news releases, as
      well as materials provided to the financial community in accordance with the
      disclosure laws of the Securities and Exchange Commission. Materials in a
      press kit that are product-specific require that they be fairly balanced, with
      fair representation of contra-indications, warnings, precautions, and side
      effects. Materials directed at investors include annual reports, prospectuses,
      and letters to shareholders. These materials must be accurate and in context.
      The SEC and FDA work closely together to ensure compliance. The following
      guidance applies to materials intended for the investment community.

      When a product is in the pre-approval stage, or when a product is being
      tested for a new indication, materials for investors should describe the exact
      status of the product or new indication:

                           •    there should be no indication that a product is safe and
                                effective before the FDA has approved it
                           •    there should be no statements that would suggest that a
                                product or new indication is further along in the approval
                                process than it really is; and /or new safety or efficacy
                                concerns raised by the FDA or some other legitimate
                                source, such as a journal article or adverse reaction
                                about a marketed product or product expected to be
                                approved report should not be minimized or dismissed
                                prematurely by the company.

Adverse Event Reporting

      Federal regulations require that all employees of a drug manufacturer report
      any adverse event that they become aware of, whether the reporting source
      is a healthcare professional, a consumer, medical literature, or any other
      source. Generally, the drug manufacturer has 15 days to report these
      adverse events to the health authorities. An adverse event is defined as any
      untoward medical occurrence in a patient to whom a pharmaceutical product
      is administered, whether or not considered drug related.

      Click here for complete processes, guidelines, and procedures link to "Pharmacovigilance"

Summary of Requirements Under Fraud Laws Relating to Advertising
and Promotion of Prescription Drugs and Industry Guidelines on
Interactions With Healthcare Professionals

Fraud Laws

The Federal Anti-Kickback and False Claims Acts have provisions that can affect the
advertising and promotion of prescription drugs. Generally, the Anti-Kickback laws
prohibit a person from giving remuneration, broadly defined to include any good or
service, to induce the purchase of a good, such as a prescription drug, to a provider
of medical services reimbursed under federal or state healthcare programs. The
False Claims Act establishes liability of persons who commit fraud by submitting false
claims for, among other things, reimbursement of goods such as prescription drugs
to the federal government. These laws clearly affect business courtesies that would
be permissible sales promotions in other industries, but in this industry could give the
appearance of a kickback or could give rise to a FCA claim.

        Click here for complete procedures, guidelines, and processes link to “Anti-kickback and False

PhRMA Code

The pharmaceutical industry recognizes that as a unique industry charged with
advancing the public health and welfare, its advertising and sales promotions should
be based, and should be perceived as based, solely on each patient’s medical needs
and the healthcare professional’s medical knowledge and experience. In July 2002,
the leaders in this industry, through the Pharmaceutical Research Manufacturers of
America, adopted a voluntary Code on Interactions with Healthcare Professionals.
The Code ( is based
on the fundamental premise that relationships with healthcare professionals are
intended to benefit patients and to enhance the practice of medicine, and that
industry interactions should be focused on informing healthcare professionals about
our products, providing scientific and educational information, and supporting
medical research and education. The code covers industry interactions with
healthcare professionals in the following areas:

               •        Informational presentations by or on behalf of a
                        pharmaceutical company
               •        Third-Party educational or professional meetings
               •        Use of consultants
               •        Speaker training meetings
               •        Scholarship and educational funds

              •        Educational and Practice-Related Promotional Items

A healthcare professional’s decision to prescribe a product must be independent. No
gifts, grants, scholarships, subsidies, support, consulting contracts, or educational or
practice related items should be provided or offered to a healthcare professional in
exchange for prescribing products or for a commitment to continue prescribing
products. Nothing should be offered or provided in a manner or on conditions that
would interfere with the independence of a healthcare professional’s prescribing

Summary of GEHC Medical Diagnostic Standard Operating Procedures
Relating to Advertising and Promotion of GEHC Medical Diagnostic

Promotional Review Team

 All product advertising and promotional materials shall be reviewed and approved
 by a multidisciplinary team from cradle to grave of the product. The multi
 disciplinary team shall consist of members of the marketing, sales, marketing
 services, medical, regulatory and legal functions. The multidisciplinary team shall
 ensure that all materials comply with the laws and regulations that govern
 prescription drugs.

          Click here for complete procedures, guidelines, and processes link to “Traffic Procedures”

          Click here for complete procedures, guidelines, and processes link to “Regulatory Affairs”

The following materials shall be subject to the multidisciplinary review:

              •        core visual aids
              •        all external correspondence that includes product claims;
              •        all internal correspondence directed to the sales force that
                       discusses product features or competitive products
              •        sales and formulary kits to group purchasing organizations,
                       prescription benefit groups and other large institutional
              •        press kits discussing products
              •        plan of action or similar marketing materials for sales meetings
              •        medical bulletins discussing the product
              •        reprints discussing the product

              •       any product-specific information placed on the GEHC Web
              •       all promotional giveaways to customers or prospective


Sales Presentations

GEHC employees shall only disseminate information to customers that has been
approved through the promotional review process discussed above and shall only
discuss FDA-approved indications and uses of the product. Pharmacoeconomic
information that directly relates to an approved indication for the drug is permitted to
be disseminated, provided it is based on competent and reliable scientific evidence.
GEHC employees are prohibited from creating homemade or cut-and-paste sales
aids or promotional pieces. Promotion to group purchasing organizations and other
organizations that maintain a drug formulary for its members is regulated by the FDA.
Formulary kits that are prepared to support the inclusion of GEHC products in a
formulary or contract must comply with FDA regulations.

Frequently Asked Questions

Question: What written materials may a sales representative use in discussions with
healthcare professionals and how can these materials be used?

Answer: GEHC Headquarters will provide sales representatives with all written materials
that may be used in product discussions. You should use these materials in the same
form in which they are provided to you. You should not highlight, write upon, or sticker
materials to be left behind unless otherwise instructed to do so. Anytime you detail or
leave behind written material or a promotional item, you must leave behind complete
prescribing information for the products discussed with the healthcare professional.

Question: Can a sales representative create letters or e-mails to customers
promoting GEHC products?

Answer: No. You may only use information and materials provided to you by
Headquarters for your product discussions with customers

Question: Can a sales representative give healthcare professionals peer-reviewed
reprints that are in the public domain, but have not been approved for use by GEHC

Answer: No. Reprints that you can give to healthcare professionals will be provided to
you by GEHC Headquarters. You will receive instructions as to how each reprint may be
used. Some reprints may be discussed and left with healthcare professionals. Others will
have a colored sticker indicating how the article may be used. For example, a blue color
over-stamp means that the reprint is not approved for promotion; but may be
distributed if solicited by a customer with the following disclaimer; “This article may
contain information or discussion on use(s) that is (are) not approved by the FDA for GEHC

Question: Are sales representatives allowed to discuss with customers information
they personally gather from journal articles and the Web regarding additional
benefits of GEHC products?

Answer: No. You may only use information and materials provided to you by
Headquarters in your product discussions with customers. If you find journal articles you
think may be useful, forward them to the appropriate marketing team for consideration
and submission for approval.

Question: What is an unsolicited question about an unapproved use?

Answer: An unsolicited question is one that you have not encouraged. Soliciting
questions regarding unapproved uses or encouraging a healthcare professional to ask
questions about unapproved uses is a violation of GEHC policy.

Question: What should sales representatives do if asked an unsolicited question
concerning a use not approved by the FDA?

Answer: Sales representatives should indicate that the question concerns an
unapproved use and refer the healthcare professional to Medical Professional Services
for the information requested at 18006540118, option 1, then 2.

Question: What are the potential penalties and consequences for violating the
FDA promotion and advertising regulations?

Answer: Penalties for violation of FDA Promotion and Advertising Regulations include
legal action against the individual and GEHC, potentially including imprisonment,
fines, civil penalties, and disgorgement of profits. Violating the US Customer Relations
Code of Conduct is considered to be an integrity issue that may result in disciplinary
measures, up to and including termination of employment

Business Courtesies

GEHC relationships with healthcare professionals are intended to benefit patients and
to enhance the practice of medicine. Interactions should be focused on informing
healthcare professionals about products, providing scientific and educational
information, and supporting medical research and education. A business courtesy,
such as a gift or contribution should never be offered under circumstances that
might create the appearance of impropriety. For example, GEHC employees shall not
provide to healthcare professionals gifts, meals, or entertainment in exchange for, or
as an inducement for, prescribing, purchasing, recommending influencing or
providing favorable formulary status for GEHC or GEHC products.

              GEHC may offer healthcare professionals items primarily for the
              benefit of patients if they are not of substantial value ($100 or less). For
              example, an anatomical model for use in examination rooms primarily
              involves patient benefits, whereas a VCR or CD player does not. Items
              should not be offered on more than an occasional basis, even if each
              individual item is appropriate. Providing product samples for patient
              use in accordance with the Prescription Drug Marketing Act and GEHC
              Sample Policy is acceptable.

              Items of minimal value (no more than $25) may be offered if they are
              primarily associated with a healthcare professional’s practice (eg pens,
              notebooks, and similar “reminder” items with company or product
              logos). Items intended for the personal benefit of healthcare
              professionals (such as floral arrangements, artwork, music CDs, tickets
              to a sporting event, or anything that would reduce a cost that the
              professional would otherwise be expected to pay) should not be

              Payments in cash or cash equivalents (such as gift certificates) should
              not be offered to healthcare professionals, either directly or indirectly,
              except as compensation for bona fide services under a consultant,
              speaker, or related agreement. Cash or equivalent payments of any
              kind create a potential appearance of impropriety or conflict of interest.

              Specific state laws may apply to providing gifts to healthcare
              professionals. For example, pursuant to California SB 1765, GEHC has
              set a specific annual aggregate limit on promotional expenditures that
              it will give or otherwise provide for healthcare professionals in the state
              of California. The limit may be revised by GEHC from time to time. The
              GEHC Medical Diagnostics limit is currently set at $1000 per healthcare
              professional. Managers should contact the legal department for

             specific state and local policies concerning gifts, meals, and other
             monetary items.

             All gifts shall be approved in advance by the Marketing and Legal

             Informational presentations and discussions by industry
             representatives and others speaking on behalf of a company provide
             valuable scientific and educational benefits. In connection with such
             presentations or discussions, occasional meals (but no entertainment
             or recreational events) may be offered as long as they are (a) modest,
             as judged by local standards such as AAA ratings and under no
             circumstances exceed $130 per person per day; and (b) occur in a
             place and manner conducive to informational communication and
             provide scientific or educational value. Interactions with healthcare
             professionals should not include entertainment.

             It is not appropriate to offer to pay for meals of a healthcare
             professional’s spouse or other guest. Offering take-out meals or meals
             to be eaten without a company representative being present (such as
             “dine and dash” programs) is also not appropriate.

             GEHC may provide financial support for meals or receptions of third-
             party educational and professional meetings (see discussion on grants
             and contributions).

             Payments for meals of healthcare professionals must be approved by
             an appropriate GEHC manager pursuant to an expense report that
             includes the healthcare professional’s name and the reason for the
             activity or pursuant to an approved formal educational program such
             as a Lunch & Learn Program.

Travel, Lodging, and Personal Expenses

             The action of GEHC paying for travel, lodging, and personal expenses
             of healthcare professionals to attend meetings whether company-
             sponsored or not raises an appearance of impropriety. Except where
             there is an arms length consultant contract that complies with the
             provisions of the policy on consultant contracts or where the meeting
             is part of an approved Preceptorship program, attendees may not be
             reimbursed for their travel, lodging or personal expenses, nor

              compensated for their time. Expenses for Preceptorship programs
              must be approved by the Marketing and Legal Departments.

Frequently Asked Questions

Question: Could a GEHC sales team invite a group of independent physicians to
dinner and an educational presentation at a popular hotel to be followed by
entrance to a no-fee, limited-access bar?

Answer: No. Consider the spirit of the PhRMA Code. We provide education to doctors;
we do not induce them to hear our promotional talks with visits to bars. Hospitality
should be limited to modest food in a venue suitable for an educational talk.

Question: What is an appropriate venue for an educational presentation that will
include a “modest” meal?

Answer: Promotional programs that include meals should be scheduled in
restaurants or establishments that are moderately priced and that are quiet and
private enough to facilitate a scientific or educational discussion. Colleagues are
expected to exercise their good judgment in choosing venues for promotional
programs that will include meals.

Question: A sales representative invites physicians to the café of a nearby
bookstore to hear a scientific presentation about a new drug. Coffee and cake are
served, and, after the presentation, each physician receives a $30 certificate for
books. Does this conform to the PhRMA Code?

Answer: No. The presentation and food may be provided, and the venue and value of
the gift are appropriate. However, an open-ended gift certificate is a cash equivalent
and therefore not appropriate under the PhRMA Code or GEHC Policy.

Question: May we pay physicians for the cost of parking to attend a GEHC
promotional meeting?

Answer: No, we cannot reimburse attendees for parking or other travel expenses. At
promotional meetings, you should not pay or reimburse physicians in cash for any
out-of-pocket expenses. If the restaurant or hotel offers a modest, unit-priced
package that includes parking with the cost of a modest meal, it may be acceptable
to provide parking as part of the program.

Question: Could a group of physician customers be invited to the company suite
at a sporting event for a 45-minute educational presentation followed by a buffet
and the game?

Answer: No. Providing entertainment, including sporting events or recreational
activities, is not consistent with the PhRMA Code. A modest buffet meal
accompanying an educational presentation would be acceptable but having it at a
venue that is not particularly modest and that includes significant entertainment is
not allowed under GEHC policies.

Question: Are spouses of healthcare providers allowed to attend speaker and dinner

Answer: No. The purpose of speaker and dinner meetings is to provide valuable scientific
and educational information to healthcare professionals. These are business meetings,
not social occasions. Inclusion of a healthcare professional’s spouse or other guests is
not appropriate.

Question: What if the healthcare provider pays for the spouse’s meal?

Answer: Regardless of who pays for the meal, it is not appropriate for the spouse to

Question: What do I do if a healthcare provider brings a spouse, or other guest(s), to

Answer: You must ensure that the invitation is clear when the healthcare provider is
invited. Include the following language on a written invitation:

 GE Healthcares has adopted the PhRMA Code on Interactions with Healthcare Professionals. For
this reason, we cannot pay for the expenses of a healthcare professional’s spouse or guest, nor
can they attend meals. We appreciate your understanding and support of our commitment to
these ethical standards.

Question: Can I drop off doughnuts or candy at a healthcare professional’s office for
the staff just as a “thank you?”

Answer: No. Dropping off food or candy for the office staff is not permitted. Food may
only be provided in the context of giving an informational presentation.

Question: What does “modest” mean in connection with meals and travel?

Answer: “Modest” means near the middle of the range for similar expenses in the
relevant geographic area, neither the top nor the bottom. For example, a modest
meal need not be from a quick service restaurant, but cannot be a meal from a high-
end restaurant. For travel, “modest” does not include corporate jets, first- or business-
class air travel or luxury hotels, but would include coach class on a national carrier
and standard business-class hotels. Per Diem cost of meals should never exceed
$130.00 per person.

Question: Can I send holiday gift baskets to practices in my territory? What about
flowers to a doctor or medical receptionist to celebrate a birthday or other special

Answer: No. Personal gifts are not permitted.

Question: May I take a customer to a recreational or entertainment event if I don’t
expense it back to the company or if the customer and I each pay our own expenses?

Answer: No. GEHC policy and the PhRMA Code require that our interactions with
healthcare professionals be limited to professional discussions. Although it is permissible
to have these discussions over an occasional modest meal, recreation and
entertainment events are never permitted. This is true regardless of whether or not the
company is paying.

Question: What if a healthcare professional is my personal friend? Does that mean I
can’t interact with that person on my own time and with my own money?

Answer: No. GEHC policy is meant to clarify how our employees interact with customers.
It is not designed to limit activities in our employees’ personal lives involving friends and

Question: Is it ever appropriate to provide entertainment to customers?

Answer: No. Because entertainment and entertainment environments are not
conducive to the exchange of business, scientific, research, educational, or similar
information, it is never appropriate to provide entertainment for a healthcare
provider. Entertainment includes theater events, concerts, sporting events, golf, and
any other non-business activity. However, on occasion it may be permissible to
participate in entertainment when a customer is present. For example, if a third-party
conference includes entertainment as part of the agenda, you may generally
participate. However, you may not pay for any healthcare provider’s expenses in
participating, or the expenses of a healthcare provider’s guest or spouse.

Question: What gifts are appropriate for customers?

Answer: The Code permits infrequent gifts of only two types: (1) gifts that benefit patients
or provide an educational function and have a value of less than $100 and (2) gifts of
GEHC-branded items having a value of less than $25 that are useful in the recipient’s job.
The gift of GE branded items must be approved by headquarters and may be given to
any customer. Any exceptions must be approved by the applicable manager and by
Legal. Examples of acceptable items include pens, pencils, notepads, calendars, and
coffee mugs. Shirts, caps, sports bags, golf balls, and similar items are not approved.
Questions concerning either type of gift should be sent to your manager or to legal.

Education of Healthcare Professionals

Dissemination of educational information through formal programs or informal
presentations is an important part of the way we inform healthcare professionals
about our products and about the most current science in the markets where our
products are used. GEHC provides several types of funding to support education of
healthcare professionals. The following guidelines shall apply to all GEHC financial
support of education:

      •      Educational grants must be approved by the GEHC Educational Grant
      •      Educational grants shall be awarded only to organizations with a
             genuine educational purpose or function, and shall be used only to
             reimburse the legitimate expenses of a bona fide educational activity
      •      Educational grants shall not be conditioned upon any explicit or
             implicit agreement or understanding to use, purchase, order,
             recommend, arrange or provide formulary status for, prescribe, or
             dispense any GEHC product
      •      No consideration may be given to the past purchases or past
             recommendations to use GEHC products or to the potential for future
             purchases or future recommendations to use GE Healthcare products
      •      Entities seeking grants must provide a written request with a
             description of the objective of the program and a proposed budget
      •      Conferences, speaker events (including training programs) and other
             professional meetings sponsored or otherwise funded by GEHC must
             be held at appropriate locations where the gathering primarily is
             dedicated to promoting objective, scientific and educational activities
             with an opportunity for discussion
      •      Educational grants may not be used to reimburse travel, lodging, other
             personal expenses, or time of the attendees at GEHC grant-supported
      •      Educational grants may not be used to support entertainment or
             recreational activities, or to support the purchase of equipment or
             salaries of grantee employees
      •      Grantees must make appropriate disclosure of GEHC support for an
             educational program
      •      GEHC shall not disseminate or support any program that disseminates
             any information to healthcare professionals that discusses
             unapproved products or off-label uses of approved GEHC products
             except where an educational program is completely independent of
             our control, eg ACCME accredited CME program or when there is an
             unsolicited request for such information and there is compliance with
             the guidelines set forth below.

Independent Educational Events

GE Healthcare will consider grant requests to support events that are independent
and that have an educational focus. These events may be CME and non-CME events.
Grants must never be given in exchange for business or as a reward or incentive for
using GEHC products and must never be used as a selling tool.

           Click here for complete procedures, guidelines, and processes link to “Grants Guidelines”

        Click here for complete procedures, guidelines, and processes link to “Combined Grants criteria

Financial Assistance for Training of Healthcare Professionals

Financial assistance for scholarships or other educational funds to permit students,
residents, fellows and other healthcare professionals in training to attend carefully
selected educational conferences may be offered as so long as the selection of
individuals who will receive the funds is made by the academic or training institution.
“Carefully selected educational conferences” are generally defined as the major
educational, scientific, or policy-making meetings of national, regional, or specialty
medical associations. These grants shall be administered by the Educational and
Charitable Grant Committee. All requests for grants shall be made using the form
approved by the Legal Department.

Frequently Asked Questions

Question: How can I tell the difference between an educational grant and a
charitable contribution?

Answer: If the money is earmarked for a defined educational activity, it is a grant. A
grant, under the GEHC procedures, provides funds to an institution to support a
specific educational, scientific or health-related event or project, such as a seminar
on a disease state.

In contrast, a charitable contribution is a donation of dollars or goods to an IRC
section 501(c)(3) organization for a bona fide and broad charitable purpose. It
increases funds available for the charitable work of the organization.

All Headquarters-initiated requests for charitable contributions must be submitted to
the Charitable Donations Committee.

The most important thing to keep in mind is that neither a charitable contribution nor
an educational grant may ever be given on a quid pro quo basis. There cannot be
any expectation of return, or any implication of reward for past prescribing behavior.

Question: Can GEHC fund an accredited medical education program that has not
been solicited under the GEHC grant program?

Answer: Yes. GEHC supports medical education particularly in the areas that relate
to our products. Where there is a medical need for a CME program, GEHC may seek
a CME provider to sponsor a program that addresses that need.

               Click here for complete procedures, guidelines, and processes link to “ACCME”
               Click here for complete procedures, guidelines, and processes link to “REECM”

Question: If GEHC provides grant funding for a seminar, what kind of input can the
Company provide?

Answer: The content and conduct of the seminar must be independent of GEHC
control. GEHC cannot provide a grant for a seminar if the promoters promise or imply
that GEHC products will be recommended or promise to include specific speakers
suggested by GEHC. However, GEHC can respond to an unsolicited request from the
grant recipient for suggestions regarding speakers or content. Such requests need to
be in writing and may not be solicited by GEHC employees. If you receive an
unsolicited oral request, ask the CME sponsor to put his or her request in a letter to
you and make sure your written response makes mention of the fact that you are
providing suggestions for consideration as requested, but that the final decision rests
with the CME Sponsor.

Question: What is an “unrestricted” educational grant?

Answer: Educational grants are “unrestricted” if GEHC does not control the content of the
sponsored activity or how it is conducted. This means, for example, that GEHC
employees may not write the curriculum or choose the speakers for a program. Note
that educational grants may be used only for the specific activities for which they were

Question: May GEHC provide both promotional and grant funding for large
educational programs?

Answer: Yes. As an example, GEHC could pay to have a promotional table or booth in the
industry display section of the educational venue, and also provide a grant for a portion
of the educational presentation. It is imperative that the grant funds be earmarked for
the educational presentation only.

Question: May a grant be made for a scholarship to attend a major medical

Answer: GEHC may give a grant to an institution to fund a scholarship to attend a major
medical meeting, as long as GEHC does not select the individual recipient(s).
GEHC may not provide grants or other funds to institutions to facilitate attendance at
GEHC meetings or industry sponsored events (e.g., satellite symposia) even if they are
held in conjunction with major medical meetings.

Question: Are there any different requirements for using a grant to fund a military
or VA event?

Answer: The definition of an “open event” in the context of the Department of Veterans’
Affairs (VA) or other government agency means all of a VA facility’s doctors, including
those who work part-time. These events still must meet general GEHC educational grant
guidelines. Specific legal requirements of the VA must also be considered when
providing a grant.

Question: If a hospital asks for a Grand Rounds grant, can a representative
specify that it cover a disease state related to a GEHC product?

Answer: Grand Rounds (e.g. a lecture at a teaching institution) can be funded through an
educational grant (in which case the institution chooses the speaker and topic). If we are
asked to support a Grand Rounds through a grant, it is appropriate, as with support
for any educational program, to ascertain the topic to be discussed and to consider
whether GEHC wants to support education on that topic. Note that Grand Rounds
also can be funded as a promotional event (in which case GEHC chooses a
recognized expert whose talk meets promotional guidelines to the extent it is

Question: Would a grant to support CPR training for nurses and doctors be

Answer: It depends on the circumstances. Yes, if it was a broadly advertised community
initiative; eg “Come to X Hospital on Monday night for a CPR course provided by Y and
funded by an educational grant from GEHC.” It would not be appropriate, however, to
fund CPR training for the staff of a particular practice.

Question: May GEHC provide a grant to an organization with which GEHC
employees are affiliated?

Answer: Yes. GEHC can and does give grants to organizations that include GEHC
employees among their members. GEHC employees may be on the planning and/or
steering committees for programs that may be funded by GEHC grants. However, the
steering and/or planning committees should not consist solely of GEHC employees, but
should be broadly representative of the organization’s membership. A GEHC research
colleague may speak at a grant-funded program if he/she is a renowned “expert” in the

Question: Could GEHC give a grant to fund a meeting designed to bring regional
GEHC medical managers together with the officers of a medical society’s state
chapter for the purpose of getting to know each other better?

Answer: No. A meeting funded by a grant must be educational and health-related.

Question: Can a CME or educational activity sponsor acknowledge that the
program was supported by GEHC? Can the event be described as a GEHC

Answer: All CME and educational activities that we support must acknowledge that the
program was supported by GEHC. However, these events are independent activities
and should never be described as “GEHC programs”.

Company Controlled Educational Programs

As opposed to independent educational programs, GEHC may sponsor and
participate in educational programs in which GEHC has some control of the content
of these programs. These programs include:

Speaker Programs

GEHC supports the use of speaker programs to provide scientific and educational
information focusing on patient care issues involving GEHC products or relevant
disease topics. The following guidelines shall apply to these programs:

             •      Invitations to attend speaker programs shall not be conditioned
                    upon explicit or implicit agreement or understanding to use,
                    purchase, order, recommend, arrange, or provide formulary
                    status of GEHC products
             •      Product-specific information must comply with FDA
                    requirements and presentations shall be on FDA- approved
                    uses when discussing GEHC products
             •      Location and duration of the event shall be appropriate for
                    educational training
             •      Attendees shall not be reimbursed for travel, lodging, or
                    personal expense, or for their time (modest meals may be
             •      No entertainment or recreational events shall be permitted in
                    connection with these programs
             •      Speaker Selection and Training. Speakers are a type of
                    consultant who must be retained through a speaker agreement
                    with GEHC. All speakers must be trained in GEHC compliance
                    policy (See Consultant Policies)

Lunch and Learn Programs

GEHC supports the use of informal presentations by its sales force in settings
such as the grand rounds of a hospital to educate healthcare professionals about
GEHC products. The content of these presentations shall be approved in advance
by the Promotional Review Team and all discussions of GEHC products shall be on
FDA approved uses. Modest meals are allowed to be provided during this


GEHC and its employees may sponsor a booth at a show, meeting or other event or
attend and participate in health-related conventions. GEHC representatives may
meet with Healthcare professionals (HCPs) to discuss product features and benefits.

   •   Only assigned Marketing and Sales personnel or company physicians should
       staff the booth. Although other employees or persons acting on behalf of the
       company may visit the booth, they should not engage in any discussions with
       healthcare professionals
   •   All discussions by Marketing and Sales personnel must be consistent with
       current labeling
   •   Unapproved drugs and unapproved uses of approved drugs must not be
       discussed by Marketing and Sales personnel staffing the booth. Direct the
       inquiring healthcare professional to Medical & Professional Services at GEHC
       headquarters, or the MPS Professional at the booth
   •   Appropriate fair balance information must be offered in all product
   •   On-label reprints approved by the Review Committee may be displayed in the
       booth and provided on request to healthcare professionals
   •   No off-label reprints may be displayed

In conjunction with such meetings, GEHC professionals may occasionally:

       •   Pay for modest meals and receptions for attendees that are conducive to
           the exchange of information
       •   Pay for reasonable travel costs of attendees when necessary (eg for
           demonstrations of non-portable equipment)

       GEHC representatives may NOT:

       •   Invite HCPs to entertainment, recreational activities, or sporting events (eg
           hunting, fishing, boating, ski trips, golf outings), or to cultural events (eg
           theater, concerts), even if these events or activities are used to facilitate
           informational interchanges

       •   Give gifts to or pay for meals, hospitality, T&L of guests/spouses of HCPs or
           any other person who does not have a bona fide professional interest in
           the information being shared at a meeting

       •   These rules also apply to promotional scientific presentations by medical

GEHC representatives and HCPs may jointly participate in off-agenda activities at
sales and promotional meetings, but the GEHC representative may NOT pay for the
HCP or HCP’s spouse or guest.

Frequently Asked Questions

Question: Could GEHC fund a grant to a hospital to support a speaker on a health-
related topic?

Answer: Under some circumstances, yes … but not if the lecture is for the house staff
alone, which would not be a “broad audience.” A provider organization has a continuing
responsibility to educate its own staff. Giving a grant in this instance could be viewed
as providing the hospital with business support. However, GEHC may fund a lecture
that is open to all physicians affiliated in any way with an institution. And, although it
is not appropriate to use a grant to support a routine in-house program for a
customer staff meeting, GEHC could provide an approved speaker as a promotional
event for this audience.

Question: What if an attendee asks the presenter an off-label question during the
speaker program?

Answer: The presenter must state that the question seeks information that is not
within the product labeling, and if the speaker has relevant personal experience,
he/she may answer it briefly to the best of his or her medical knowledge. The speaker
should then return to the approved presentation of data. If the attendee follows up or
requests additional information, the speaker should offer the phone number for the
GEHC Medical & Professional Services Department.

Question: The conference organizer has included six (6) tickets to a reception
dinner and six (6) exhibit entry badges as part of GEHC sponsorship benefits. We
only need three (3) for GEHC employees. Can we give these to customers to use?

Answer: No. Customers cannot be given these tickets or badges. However, GEHC
employees or someone who is not a health care provider, or affiliated with a health
care provider, can use them.

Question: Does the dollar limit on give-away items permissible under the US
Customer Relations Code of Conduct apply only to merchandise given directly to
individuals who visit the GEHC booth, or does this dollar limit also apply to a
larger, raffle item give away?

Answer: The same dollar value limit applies to all giveaways by GEHC, whether they
are being given away to all individuals who visit the booth, or to one winner of a raffle.

The giveaway must be de minimis (under $25.00) and relate to the Healthcare
provider’s everyday practice or benefiting patients. Golf-related items of any sort are
not permitted.

Question: If the conference or trade show organizers approach us and ask if we
will donate an item such as an i-Pod or personal DVD player for a raffle the
sponsor is organizing, can GEHC participate?

Answer: No, GEHC cannot purchase such items directly for the organizer but may
give a cash donation to the organizers for use as they see fit. GEHC can be listed as a
general sponsor of the conference/show, but cannot directly be attributed to the

Question: As an exhibitor at a conference/third party meeting, can GEHC host a
customer event, including food and beverages, during the meeting?

Answer: Yes, however all attendees must be invited to the event (but no spouses or
guests!). The food and beverage provided must modest, consistent with the
conference sponsor’s guidelines, and subordinate in time and focus to the
conference purpose. The question of whether to include alcoholic beverages needs
to be answered in light of whether the function would still be considered “modest”.

Dissemination of Scientific Information Pursuant to an Unsolicited Request

It is permissible to disseminate scientific literature that discusses unapproved uses
upon legitimate unsolicited request from a customer. Unsolicited Requests means
that no one in the company, including a sales representative, has urged a healthcare
professional to request the data. Should a sales representative receive such a
request, he or she is required to contact Medical and Professional Services (MPS) to
respond to this request. Requests should be forwarded, either by telephone, fax or e-
mail, to MPS, including customer contact information product, and specific topic of
interest. MPS will confirm with the customer his or her request and provide the
information directly to the customer. A copy of the letter and first page of the
literature will be sent to the sales representative, stamped “Not for Promotional Use”
for his or her information. Responses may deal with off-label uses for the product, but
the information must be both specific to the request and balanced in discussing the
benefits and the side effects of a particular product. It should also include a package

               Click here for complete procedures, guidelines, and processes link to “MPSSOP”

Charitable Contributions

GEHC may make donations for charitable purposes to healthcare professionals, such
as supporting genuine independent medical research for the advancement of
medical science or education, indigent care, patient education, public education or
the sponsorship of events in which the proceeds are intended for charitable purposes.
It is not appropriate for GEHC to make such donations for the purposes of inducing
healthcare professionals to purchase, lease, recommend, use or arrange for the
purchase or lease of GEHC products. It is not appropriate for donations to be used to
subsidize participation by a healthcare professional in the charitable event. All
requests for donations shall be made in accordance with the charitable contributions
guidelines and procedures.

        Click here for complete procedures, guidelines, and processes link to “Charitable Contributions

          Click here for complete procedures, guidelines, and processes link to “Charitable Donation
                                             Request Application”

           Click here for complete procedures, guidelines, and processes link to “Charitable Criteria

Frequently Asked Questions

 Question: Why do we have a new charitable giving process?

 Answer: In recent years, the relationships between vendors and healthcare providers
 have come under increased scrutiny. To ensure ethical conduct for the benefit of
 both GEHC and its customers, GEHC is establishing a process to require a compliance
 review prior to making any charitable contributions suggested by or that may benefit
 healthcare providers. In addition, as a partner to the healthcare delivery industry,
 GEHC believes it can increase consistency in giving as well as charitable results by
 coordinating giving centrally.

 Question: What does the review process consist of?

 Answer: Posted in the “Issue Escalation Processes” column on this Support Central
 site is a copy of the review process for charitable requests. Briefly stated, to ensure
 that no apparently improper link may be inferred between GEHC charitable activities
 and any commercial transaction, the new process requires that all requests for
 charitable support from GEHC be reviewed for approval by the Charitable Donations
 Committee (CDC). The CDC is a cross-functional committee responsible for reviewing
 donation requests independent of commercial considerations.

 Question: A customer has approached me with a request for donation. How do I
 get this request into the review process?

 Answer: Customers and other organizations requesting donations from GEHC should
 place their requests directly with the CDC. The committee can be reached by the
 following means:

        Phone:        262-548-2355
        FAX:          262-544-3018

 Question: May I enter the information on behalf of a customer?

 Answer: The customer must enter the information directly. In most cases, only the
 customer will have access to all of the required information. Direct customer entry
 will speed the process and help promote independent CDC review. You should not
 evaluate or review the request in any way.

 Question: What about non-monetary requests such as requests for equipment or

Answer: All requests, monetary or not, must be sent to the CDC.

Question: Who provides the funds for approved contributions?

Answer: The CDC will receive an annual budget from GEHC for general charitable
giving and other purposes. Some approved requests will be funded directly from
these funds. In other cases, a request may be approved as compliant by the CDC but
the CDC may decline to fund it. In these cases, the CDC will coordinate with one or
more GEHC businesses to determine whether other funds may be available for the

Question: The amount of the request is only $100. Does it really have to be
officially reviewed?

Answer: Yes. The CDC must review all requests, regardless of size, to determine
whether the donation would be complaint with the GEHC US Customer Relations
Code of Conduct (the “Code”), the text of which is posted on this support central site in
the “Customer Relations Code of Conduct” column.

Question: What criteria will the Charitable Donations Committee use when
reviewing requests for charitable support?

Answer: The minimum criteria for approval are (1) that the requestor and recipient be
a 501(c)(3) organization, (2) that the funds or other support to be provided be used for
acceptable charitable purposes, and (3) that granting the request cannot be
construed as a “thank you” for past commercial purchases or an inducement for
future purchases. A 501(c)(3) organization is a charitable organization as defined in
the US Tax Code. Acceptable charitable purposes include student, patient, and
practitioner education; research; community outreach and awareness initiatives; and
healthcare for underserved populations. Unacceptable purposes include funds for
general administrative expenses of a healthcare provider, equipment purchases,
building expenses, and contributions to Political Action Committees, or PACs. Persons
and organizations requesting support should clearly identify the intended use(s) of
such support.

Question: If the CDC decides that the request should not be funded, can I
personally fund the request as a private citizen (not as a GEHC employee)?

Answer: No. If the CDC has determined that granting a request would violate the
Code, or that no resources are available for the request, individual GEHC employee(s)
may not later decide for themselves to provide the support. Personal support by
GEHC employees for otherwise denied requests might result in liability for GEHC
under applicable regulations, since the actions of employees can be legally attributed
in many cases to the employer.

Question: What can a requestor expect after submitting a request for charitable

Answer: A requester will receive a letter or email acknowledgement upon receipt of
each request. This acknowledgement will include a timeframe in which the requester
can expect a response. The CDC will meet regularly to review new requests. In most
cases, the CDC will approve or decline a request within six weeks to eight weeks. In
some cases, the CDC may need more information, in which case the review process
will be extended accordingly.

Research Grants

GE Healthcare may provide healthcare professionals financial and other support to
fund objective scientific studies of GEHC products. Investigators shall be selected on
their qualifications, training, research and clinical experience in relevant fields, the
potential to recruit research participants and ability to conduct clinical trials in
accordance with good clinical practices and applicable requirements. At no time
shall the support offered under this section be provided to a healthcare professional
in exchange for prescribing GEHC products or for a commitment to continue to
prescribe GEHC products or to grant GEHC products formulary status. Payment to
clinical investigators or their institutions should be reasonable and based on work
performed by the investigator and the investigator’s staff, not on any other
considerations. Requests for research grants in a field of interest to the Medical
Diagnostic business shall be submitted to Medical Professional Services and be
reviewed by the Investigation Initiated Trial Committee.

      Click here for complete procedures, guidelines, and processes link to “IITC Process & Procedure”

Consultant Agreements

GEHC may enter into service contracts with healthcare professionals that are
negotiated at arms length and provide reasonable compensation for those services.
Reimbursement for reasonable travel, lodging, and meal expenses incurred as part of
providing those services is permitted. Token consulting or advisory arrangements
are not to be used to justify compensating healthcare professionals for time or travel,
lodging, and other out-of-pocket expenses. The following factors support the
existence of a bona fide consulting arrangement:

                   •    A written contract in the form approved by the Legal
                        Department that specifies the nature of the services to be
                        provided and the basis for payment of those services
                   •    A legitimate need for the services that has been identified in
                        advance of requesting the services and entering into
                        arrangements with the consultant
                   •    Criteria for selecting the consultants are directly related to the
                        identified purpose of project and the people charged to make
                        the selection of the consultant will insure that the consultant
                        have the appropriate expertise. Selections are not dependent
                        on prescribing or utilization habits
                   •    The number of healthcare professionals retained is not greater
                        than the number reasonably necessary to achieve the identified

                   •    The place and circumstances of any meeting with consultants
                        is conducive to the consulting services and activities related to
                        the services are the primary focus of the meeting, and any
                        social or entertainment events are clearly subordinate in terms
                        of time and emphasis
                   •    Meals provided at any meeting must comply with the guidelines
                        for “meals” set out in the “Business Courtesies” section of this
                        Code of Conduct document

         Click here for complete procedures, guidelines, and processes link to “PhysEngagements”

       Click here for complete procedures, guidelines, and processes link to “Myoview Preceptorship”

Frequently Asked Questions

Question: Can GEHC offer honorariums to speakers (physicians/industry experts)?

Answer: Yes, provided the speaker is acting on behalf of GEHC under a consulting
agreement. GEHC may not reimburse health care providers directly for any
expenses incurred in attending the conference, including lost wages or time spent.
Otherwise, GEHC may make a direct contribution to the conference organizers for
use as they see fit (they may off-set the expenses of their faculty). GEHC cannot
dictate how that contribution is to be used, or for whom.

Question: When selecting a presenter or advisory board member, may I take into
account recommendations from the sales team based upon last year’s purchase

Answer: No. Sales of products or services may NEVER be a basis for selection.
Individuals should be chosen using specified guidelines and based upon a legitimate
business need for the service to be provided.

Question: May compensation be paid in something other than cash, for example,
golf or dinner tickets?

Answer: No. Compensation should be paid in cash using a corporate check or wire
transfer (personal checks or cash may NOT be used) at fair market value Out-of-
pocket reimbursement and meals must be modest and follow current T&L policy.

Question: As a part of a product development committee or scientific advisory
board meeting, may we provide attendees with hospitality or recreational
activities? What about spouses?

Answer: Yes, it is generally permitted to offer modest hospitality and entertainment
or recreational activities as long as they are subordinate in time and focus to the
purpose of the meeting. However, GEHC may NEVER pay for or subsidize such
expenses for spouses or guests of the health care provider attending. Also confirm in
advance that the attendees’ institution does not have any restrictions on accepting
entertainment or recreational activities from vendors.

Interaction with Government Personnel

GEHC Medical Diagnostics employees may be required to attend forums or sessions
hosted by or that include government officials. GEHC Medical Diagnostics employees
will follow GE Integrity policies on Government Business (Policy 20.10), Improper
Payments Policy (Policy 20.4), and the “GE Doing Business with the United States”

For more information see Internet link:

Federal regulation prohibits any form of gifts or gratuities to any government
employee. Violations may result in criminal, civil and/or financial penalties. For
general information regarding standards for appropriate conduct and practices,
please see the policies referenced above.

            Click here for complete procedures, guidelines, and processes link to “Gov Conduct”

Frequently Asked Questions

Question: What constitutes a “government” account?

Answer: A “government” account means any division or agency of the US federal
government (i.e., The Veterans Administration, The Department of Defense, the
National Institutes of Health, the Bureau of Prisons, and Indian Health Services) or
state government. If you are in doubt, contact your Manager or Government
Accounts Focal Point. A list of Government Accounts Focal Points is on this Support
Central site in the “Issue Escalation Processes” Section under “Government Accounts.”

Question: I’ve become friends with an employee at NIH, although she is not
involved in any purchasing decisions. After my sales calls we’ve gone to lunch or
for coffee to “catch up” and I’ve treated. Is this OK?

Answer: No. You may not provide any government employees with any gifts,
entertainment or hospitality or provide them with anything of value (see list in “Do’s
and Don’ts) without the prior approval of the GEHC Legal Department.

Question: I’ve been calling on a government account for almost two years and
know their processes very well. I’ve received a Request for Proposal (“RFP”) and
know what they want to purchase. Can I prepare the quotation and respond to
the RFP myself?

Answer: No. GEHC Representatives must involve the GEHC Government Accounts Focal
Points when submitting Requests for Proposals, quotations, or any other documentation
to a government entity.

Pricing Policy


GEHC Medical Diagnostics pricing policy is based on a philosophy of sound business
practices and compliance with applicable laws and GEHC Best Practices. It is
formulated to achieve specific product objectives. As a result it reflects:

          •     A need to be competitive
          •     A need to be flexible, when necessary, to keep abreast of change
          •     A need to return a fair and equitable profit to GEHC Medical


Pricing strategy shall be set by the Director of Pricing and Business Operations and
approved by the Executive heads of the Medical Diagnostics P&L. The Director of
Pricing and Business Operations shall chair the Pricing Strategy Committee (PSC),
which shall be a standing committee that includes members of the Sales, Marketing,
Finance and National Accounts Departments. A legal representative shall provide
advice when necessary. The PSC shall meet on a regular monthly schedule. Its
primary duties shall be as follows:

          •     Create pricing guidelines for GEHC Medical Diagnostics products and
                distribute to field sales force
          •     Rule on requests for exception to guidelines
          •     Ensure compliance with law and GEHC best practices

              Click here for complete procedures, guidelines, and processes link to “Pricing Policy”

Frequently Asked Questions

Question: What is a “discount” for purposes of the GEHC Customer Relations Code
of Conduct?

Answer: A “discount” means a reduction in the amount a buyer (who buys directly,
through a wholesaler, or a dealer, or through a Group Purchasing Organization) is
charged for GEHC product or service based on an arms-length transaction.
Discounts include credits, rebates or complimentary items, including samples or
products offered for demonstration, loan or trial.

Question: What is a “rebate”?

Answer: A rebate is a reduction in the purchase price of GEHC product or services
applied after the initial purchase. A rebate may be in the form of a credit or a check
and operates to lower the initial purchase price by the amount of the rebate.

Question: What is an “administrative fee”?

Answer: An administrative fee is a payment made to a qualified Group Purchasing
Organization (“GPO”) as part of a written contract for purchases made by eligible
members of that GPO from a supplier of product or services, such as GEHC.

Question: What are GEHC’s obligations as a supplier relating to discount/price
disclosure under the Federal Healthcare Program Anti-kickback law?

Answer: As a supplier of products and services that may be partly or wholly
reimbursed or charged for under federal healthcare programs, GEHC has a legal
obligation to fully and accurately disclose in writing the final price of its products and
services, net of any discounts (including rebates).

Question: What are the customer’s obligations as a buyer of products or services
relating to cost reporting under the Federal Healthcare Program Anti-kickback

Answer: If the customer participates in any federal or state healthcare program
under which it submits charges or seeks reimbursement based on the cost of the
products or services it has acquired from suppliers (such as GEHC), the customer is
legally obligated to submit full and accurate cost reports (using the discount/pricing
information provided by the supplier (i.e. GEHC)).

Question: When does Legal need to approve a special pricing/discounting

Answer: Prior Legal approval must be obtained for below-cost discounts, conditional
discounts requiring bundled products, and discounts that can only be used to
purchase additional GEHC products.

Question:     Is it allowable in a multiple product (or products plus services)
strategic customer agreement to “mark-up” the price of one item to help pay for
the cost of another item in the same agreement?

Answer: No. A fair and accurate price must be stated for each item. Increasing the
price of one item and using the price increase to subsidize the price of a second item
results in an inaccurate statement of the prices for both items. However, offering

different discounts on two items consistent with GEHC pricing guidelines is
acceptable. The sales prices in GEHC internal records must match the sales prices
disclosed to the customer.

Adverse Drug Events and Public Safety

An adverse event is defined as “any untoward medical occurrence in a patient
administered a pharmaceutical product and which does not necessarily have a
causal relationship with the treatment.”

Every employee must report any adverse event of which they become aware as
soon as practical, but no later than 24 hours, to the Pharmacovigilance/Drug Safety
department. Employees should, at minimum, get the source’s name and contact
details, and a description of the adverse event and report this information to:

                        Pharmacovigilance/Drug Safety in Princeton
                        Telephone: 1 800 654 0118, option #2, then option #1
                        Fax: 1 609 514 6575

          Click here for complete procedures, guidelines, and processes link to “Pharmaocviligence”

Frequently Asked Questions

Question: What is an adverse drug experience?

Answer: An adverse drug experience is any undesirable event occurring in a patient
using (or exposed to) the drug whether or not the event is considered to be related to the
use of the drug. Adverse events can include the following: lack of effect (the indication for
which the drug was used does not improve), abnormal lab values (for instance, increased
blood creatinine levels), accidents, or any other undesirable events (whether or not the
events are in the package insert).

Question: What if I am not sure if the reported incident was an adverse event?

Answer: If in doubt, report it to Pharmacovigilance/Drug Safety (PDS) in Princeton at 1-
800-654-0118 then option #1.

Question: What if I am not sure if the adverse event was actually caused by the drug?

Answer: If the adverse event is reported to have occurred while the patient was using or
exposed to a GE Healthcare product, the event must be reported, even if it is not known if
the drug caused the adverse event.

Question: How long do I have to report an adverse event?

Answer: You should report any adverse event as soon as you become aware of it,
generally within 24 hours. It is critical that you report it as soon as possible in order to
meet regulatory requirements.

Question: Do I need to report the adverse drug experience if someone other than a
healthcare professional reports it to me?

Answer: Yes. Adverse drug experiences may be reported to you not only by healthcare
providers, but also by other contacts, including friends, relatives, or lawyers.

Question: Do I need to report the adverse drug experience to Pharmacovigilance if
the reporter tells me he or she will report it (or has reported it)?

Answer: Yes. You are responsible to notify PDS using the procedure outlined above. In
addition, you should indicate that the reporter intends to contact (or has contacted) PDS.

When You Have an Integrity Concern

One of the most important responsibilities each of us has as a GE employee is the
obligation to raise a concern about a possible violation of GE policy or the law.
Sometimes it may seem difficult to raise such a concern. Some of us may even feel
it is a breach of personal ethical standards to do so. If you experience that sense of
conflict, it is important to remember the tremendous harm that not raising a concern
can cause, including:

    •   Serious damage to the health, safety and well being of yourself, your fellow
        employees, the company as a whole, our customers and the communities in
        which we operate
    •   The loss of confidence in GE– by customers, share holders, governments and
    •   Huge fines, damage awards and other financial penalties against the
        company; fines and/or prison sentences for individual employees

Those are the reasons the company requires that employees not sit silently when
they have a policy concern. The point of raising a concern is not to get a friend in
trouble, but to protect a colleague or neighbor from potential harm.

How to Raise an Integrity Concern

The company offers you may ways to get answers to your questions about integrity
issues and to raise any concern about what might be a violation of GE policy:

Locally Within Your Business
   • Your supervisor or manager
   • Your compliance/auditing resource
   • Company Legal Counsel
   • Next level of management
   • Your business integrity helpline – a list of business, country and language
       integrity helpline can be found at:

GE Corporate Ombudsperson
   • Toll Free: 800-227-5003 (USA only)
   • DialCom: 8*229-2603
   • (1) 203-373-2603
   • P.O. Box 911, Fairfield, CT 06430, USA
   • Generally, your supervisor or manager will be in the best position to resolve
      the issue quickly.

   •   If after raising an integrity concern the issue is not resolved, raise it with one
       of the contacts listed above
   •   You can raise your concern orally or in writing, and if you prefer, you can do it

The whole idea is to speak up. Ask Questions. Get answers. Bring the concern
into the open so that any problems can be resolved quickly and more serious
harm prevented.

What Happens when an Integrity Concern is Raised

   •   Assign Review team
   •   Conduct Investigation
   •   Determine Actions
   •   Improve processes
   •   Provide feedback

Early identification & Resolution are Critical!

Penalties for Violations

Employees who violate these policies and procedures are subject to disciplinary
action up to and including termination of employment. The following are examples
of conduct that may result in discipline:

                           •   Actions that violate these policies and procedures;
                           •   Requesting others to violate these policies and
                           •   Failure to promptly raise a known or suspected violation
                               of these policies and procedures
                           •   Failure to cooperate in GE investigations of possible
                               violations of these policies and procedures
                           •   Retaliation against another employee for reporting a
                               violation of these policies and procedures

Violation of these policies and procedures can also mean breaking the law, subjecting
you and the company to criminal penalties (fines and jail sentences) or civil sanctions
(damage awards or fines).

Additional Internet Links for Guidelines on Marketing and Sales

FDA Product Marketing, King and Spalding
SupportCentral - GE Healthcare Legal - Global Regulatory Community

FDA Marketing Regulations – myLearning

Integrity Home Page

Global Legal & Compliance
Support Central
SupportCentral - GE Healthcare Legal - Global Regulatory Community

Healthcare Legal Portal
SupportCentral - GE Healthcare Legal Portal Super Community


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