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Compliance Manual
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courage to make decisions following our inner compass.
Answers for life.
Siemens Healthcare USA
Compliance Manual
(For Use in the United States Only)
Effective 2014
Tell Us Help Desk
1-855-303-9798 Toll Free in the U.S.
or www.siemens.com/tell-us
Siemens Medical Solutions USA, Inc.
Malvern, PA
Siemens Healthcare USA Corporate Policies
SIEMENS
Siemens Healthcare USA Corporate Policies
https://intranet.healthcare.siemens.com/cms/MedUSA/en/Processes_and_Tools/Policies/Pages/MedUSA_Corporate_Policies.aspx
Siemens Healthcare Compliance Manual—
U.S. Policy; Directive
Document ID:
0.0 Compliance Policy
Owner:
RC-US H CO
Status:
Released
Effective Date:
September 4, 2014
Prepared by:
Mark Petrille, H CO USA
Reviewed by:
Regina Puls, H DX CO
Released by:
Gregory Warner, H L-USA-SPEC LC
Kevin Royer, H DX GC
Anthony D’Adamio, H CX L-USA
Michael Wendt, RC-US H IM
Anthonie Goudemond, H HR DX
Ann Custin, RC-US H CSC
Note: This document is maintained in electronic form. Printed copies are not updated.
Copyright (c) Siemens Medical Solutions USA, Inc. All rights reserved.
This document is confidential and proprietary to Siemens. It is protected by copyright laws in the US and
abroad, and should not be disclosed to anyone outside of Siemens without the owner’s specific consent.
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Siemens Healthcare Compliance Manual—U.S. Policy
Page 1 of 55
Effective Date: 09-04-2014
Author: Mark Petrille, H CO USA
Siemens Medical Solutions USA, Inc.
Malvern, PA
Siemens Healthcare USA Corporate Policies
Siemens Healthcare
Compliance Manual—U.S. Policy
In consideration of the fact that the policies and procedures contained in the Compliance
Manual may change from time to time, the official copy of this compliance manual is
located on the intranet at the below URL address.
Although updates to the Compliance Manual may be directly communicated to Siemens
employees, it is imperative that employees’ behavior and actions are consistent with the
policies and procedures set forth in the official copy of the Compliance Manual.
https://intranet.healthcare.siemens.com/cms/MedUSA/en/About_Us/Compliance/Pages/
Compliance.aspx
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Effective Date: 09-04-2014
Author: Mark Petrille, H CO USA
Siemens Medical Solutions USA, Inc.
Malvern, PA
Siemens Healthcare USA Corporate Policies
Table of Contents
Page
1.
Scope and Purpose ............................................................................................. 4
2.
Promotion of Healthcare Products in accordance with Federal Regulations......... 7
3.
Charitable Contributions .................................................................................... 10
4.
Drawings, Contests, Sweepstakes, and Surveys ............................................... 13
5.
Free-of-Charge Products and Services .............................................................. 14
6.
Loaner Equipment and Trade-In Sales .............................................................. 16
7.
Providing Discounts and Rebates ...................................................................... 18
8.
Federal and State Disclosure/Aggregate Spend Laws ....................................... 19
9.
Interactions with Federal, State, and Local Government Employees.................. 22
10.
Prohibition on Entertainment and Recreation ..................................................... 25
11.
Compliance Scorecards ..................................................................................... 26
12.
Business Courtesies when Conducting Sales and Promotional Events.............. 27
13.
Business Meals with Healthcare Professionals .................................................. 29
14.
Business Gifts.................................................................................................... 31
15.
Sales Agents and Distributor Relationships ....................................................... 34
16.
Advisory Boards ................................................................................................ 35
17.
Siemens-Sponsored Product Training and Education Events ............................ 37
18.
Payments for Services, Speakers, Advisory Boards, and
Other Fee-for-Service Arrangements ................................................................. 40
19.
Siemens-sponsored Promotional Site Visits, Plant Tours, and Road Shows ...... 41
20.
Grants for CME, CEU, and Third Party Educational Conferences ...................... 44
21.
Professionals Week ........................................................................................... 48
22.
Clinical Research and Collaborations ................................................................ 49
23.
Compliance Training .......................................................................................... 51
24.
Compliance Helpline and Tell Us Hotline ........................................................... 52
25.
Disciplinary Standards ....................................................................................... 53
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Effective Date: 09-04-2014
Author: Mark Petrille, H CO USA
Siemens Medical Solutions USA, Inc.
Malvern, PA
1.
Siemens Healthcare USA Corporate Policies
Scope and Purpose
The Siemens Healthcare Compliance Manual (Compliance Manual) is for use in
the United States (U.S.) only and applies to all Siemens Healthcare (Siemens)
contractors and employees (inclusive of Siemens Healthcare Diagnostics
employees), and their interactions with U.S. Healthcare Providers (HCPs), and
Healthcare Organizations (HCOs) and their employees. All healthcare delegates,
contractors, and employees conducting business inside or outside the U.S. must
also observe these guidelines when interacting with U.S. HCPs and HCOs.
All Siemens employees are also expected to be familiar with and perform their
operations and business functions in accordance with Siemens Business
Conduct Guidelines.
Many interactions with HCPs/HCOs require prior approval from the Compliance
Department. Such requests, depending on the scope and purpose of the
proposed interaction, should be entered into one of the following tools
(accessible from the Compliance Department Intranet):
Online Grant Systems Portal by HCPs/HCOs directly
Compliance Approval Process (CAP) Tool by Siemens employees
Sponsorships, Donations, and Memberships (SpoDoM) Tool by Siemens
employees
Note that the review and approval process for interactions with HCPs/HCOs
outside the U.S. may differ from general guidance provided in this Compliance
Manual.
It is important that Siemens employees interacting with HCPs/HCOs outside the
U.S. not only contact the Compliance Department in the U.S., but also the local
Compliance Departments where the HCPs/HCOs are located and/or where the
events are taking place for further guidance.
In addition, it is necessary to have proper documentation/verification from the
Export Control & Customs Department in advance if visiting customers are
foreign nationals coming to the U.S. for events (e.g., speaker engagement, site
visit, advisory board, etc.).
Because the healthcare industry is highly regulated, Siemens believes it is
important and necessary to provide employees with detailed guidance on how to
interact with HCPs/HCOs, vendors, and government agencies in a manner that is
compliant with applicable law.
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Effective Date: 09-04-2014
Author: Mark Petrille, H CO USA
Siemens Medical Solutions USA, Inc.
Malvern, PA
Siemens Healthcare USA Corporate Policies
The Compliance Manual governs many aspects of Siemens’ relationships with
HCPs/HCOs, including customer education and training, sponsoring customers’
attendance at professional conferences and CME programs, contracting for site
visits, providing grants to doctors and hospitals, establishing personal service
agreements, providing speaking engagements, entertainment, etc.
It is Siemens’ policy to fully comply with all federal and state requirements in
every business aspect, especially those involving Siemens products that are
reimbursed by the government. Siemens employees are expected to fully comply
with all federal and state healthcare program requirements, as well as
requirements within the Compliance Manual. Some requirements that impact
Siemens’ relationships with HCPs/HCOs are based on:
Federal Anti-Kickback Statute
The Federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)) establishes
severe civil and criminal penalties for anyone who knowingly and willfully
offers, pays, solicits, or receives any remuneration in cash or in-kind, directly
or indirectly, to induce someone (e.g., physician or hospital) to purchase,
lease, order, arrange for, or recommend purchasing, leasing, or ordering any
item for which payment may be made under any federal or state healthcare
program. Recent amendments to the law specify that a person need not have
actual knowledge of the Anti-Kickback Statute or specific intent to commit a
violation.
To ensure remuneration to HCPs/HCOs is in accordance with the law and
accepted industry practices, Siemens has adopted fair market value (FMV)
guidelines for interactions with HCPs/HCOs. More information on FMV,
including Siemens’ Fair Market Value Policy on Interactions with Healthcare
Professionals, is accessible from the Compliance Department Intranet.
Office of Inspector General Guidelines
The Office of Inspector General (OIG) Guidelines state that a violation may be
found even if only one purpose of the remuneration is to induce the purchase
of products regardless of legitimate purposes for the payment (One Purpose
Rule). In addition, there does not have to be an agreement to purchase in
exchange for the remuneration, and there is no requirement the remuneration
result in an increase in state or federal healthcare expenditures.
Industry Organization Codes of Conduct
The Compliance Manual is consistent with the AdvaMed Code of Ethics and
the MITA Code of Ethics, but is tailored to address Siemens’ business models
and to provide additional U.S.-specific guidance. Therefore, while Siemens
Medical Solutions USA, Inc. and its subsidiaries (including Siemens
Healthcare Diagnostics Inc.) may certify adherence to such U.S. industry
codes, the Compliance Manual directly governs the U.S. activities of Siemens
employees’ interactions with U.S. HCPs/HCOs.
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Effective Date: 09-04-2014
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Siemens Medical Solutions USA, Inc.
Malvern, PA
Siemens Healthcare USA Corporate Policies
In addition, federal and state governments have enacted laws to prevent,
detect, and punish fraud and abuse of healthcare plans and programs. At the
federal level, these laws include but are not limited to the Federal Civil False
Claims Act (31 U.S.C. §3729-33). A person or company that violates the
False Claims Act is liable for damages up to three times the amount the
government is defrauded plus mandatory penalties of $5,500 to $11,000 for
each false claim submitted. Many states have enacted similar laws.
As stated previously, the Compliance Manual applies to Siemens employees’
interactions with U.S. HCPs/HCOs. This includes interactions with
HCPs/HCOs who work in the U.S., but where the interaction occurs outside
the country, such as a conference or other event. Siemens employees having
questions relating to interactions, inside or outside the U.S., with international
HCPs/HCOs, should contact their organization’s compliance officer for further
guidance or consult MOR 3.3/01e—Compliance in the Healthcare Sector.
MOR 3.3/01e—Compliance in the Healthcare Sector
MOR 3.3/01e—Compliance in the Healthcare Sector provides Siemens
employees with an overview of the most important compliance topics and
respective corporate regulations. The MOR also specifies additional
Compliance Organization regulations specific to the business.
Although Siemens employees are not required to be fully versed in the laws
affecting his/her responsibilities, it is the expectation of Siemens that every
employee with significant responsibilities have a working knowledge of the
permissible activities involved in his/her work and to seek guidance from the
Compliance Department, the Legal Department, or a superior concerning matters
where there is a question.
Note that in the event of any discrepancies or conflicts between the Compliance
Manual and any other Siemens policies, quality regulations (QRs), and/or MORs
referred to herein, the Compliance Manual’s guidance takes precedence.
The Compliance Manual is accessible to the public on the Siemens Internet.
However, the internal policies and tools referenced in the Compliance Manual
are restricted to Siemens employees and internal use only, and are not provided
to external persons or parties unless deemed necessary.
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Effective Date: 09-04-2014
Author: Mark Petrille, H CO USA
Siemens Medical Solutions USA, Inc.
Malvern, PA
2.
Siemens Healthcare USA Corporate Policies
Promotion of Healthcare Products in accordance with
Federal Regulations
Promotional materials and other information provided in writing or verbally to
HCPs/HCOs about Siemens products must be accurate and consistent with all
U.S. Food and Drug Administration (FDA) and regulatory requirements governing
such communications. The FDA strictly regulates advertising or promoting
products for uses not cleared or approved by the FDA. To ensure Siemens
complies with all applicable requirements, product materials and information
provided to HCPs/HCOs must have prior Regulatory Department approval and,
when necessary, Legal Department approval. Quality Regulation (QR) 7 and its
attachments define the basic requirements for the control of external
communications, ensuring compliance with laws and regulations as well as
Siemens’ business strategy.
Three risks in particular must be avoided in the promotion of Siemens products:
1. Inquiries about Off-Label Use of Siemens Products
Off-label promotion is promotion of a clinical application or use for which a
device has not received FDA clearance or approval. If a doctor, laboratory
director, or other HCP asks an unsolicited question about uses other than the
approved/cleared intended use for Siemens products, employees must advise
the inquirer that Siemens policy prohibits discussion of off-label uses, and
may direct the inquirer to the Director of Regulatory Affairs. Employees may
not solicit this type of inquiry, nor may employees provide articles or other
forms of written communication discussing approved or unapproved uses to
prompt questions about unapproved uses of Siemens products. Employees
may also contact the Regulatory Help Desk for further assistance at: 1-610219-6100. Note that this number is intended for employees and internal use
only.
2. Premature Promotion, Marketing, or Sale of a Product
U.S. law prohibits the sale, promotion, and/or marketing of medical devices
before such devices are 510(k) cleared or achieve pre-market approval, as
applicable. For Siemens products not yet cleared or approved in the U.S.,
employees may not in writing or verbally make safety or effectiveness claims,
set expectations, or make commitments about whether products will be
cleared or approved by the FDA, when they will be cleared, or what may be
their cost. Employees may not make preliminary or binding quotes for such
products, or discuss such non-commercially available product features in
writing or verbally even though such products may be legally sold in other
countries.
Employees with questions should refer to QR 7, or contact the Regulatory or
Legal Departments for assistance.
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Effective Date: 09-04-2014
Author: Mark Petrille, H CO USA
Siemens Medical Solutions USA, Inc.
Malvern, PA
Siemens Healthcare USA Corporate Policies
3. Guidance for Providing Reimbursement Information
In general, employees may not provide advice, recommendations, consulting
services, or other assistance to HCPs/HCOs regarding their submission of
healthcare claims for reimbursement based in whole or in part on the use of
Siemens products. The Siemens’ Policy and Strategy Office is responsible
for, among other things, identifying appropriate procedural, product coding,
and reimbursement information for Siemens products. This information is
obtained from authoritative sources, such as the American Medical
Association, the Centers for Medicare & Medicaid Services (CMS), regional
and local public contractors (i.e., carriers, fiscal intermediaries, and durable
medical equipment regional carriers), and private insurance contractors.
It is Siemens’ policy that reimbursement information comes directly from
these authoritative sources, and is provided to HCPs/HCOs to assist them in
understanding and complying with CMS and other insurers’ requirements.
Employees must adhere to the following guidelines when discussing
reimbursement issues with customers:
Siemens sales associates, distributors, and agents may only provide
insurance coding, coverage, or payment information for Siemens products
if the following requirements are met:
o The coding, coverage, or payment information comes directly from an
entity authorized to make such determinations, such as CMS or third
party payers.
o Siemens offers the same information, in the same format, to all
purchasers or potential purchasers of Siemens products.
o Siemens does not in any way add to, delete, or modify third party
information, and must include a disclaimer on third party information
indicating the information comes from a third party and is not advice
from Siemens.
Consistent with the requirements previously mentioned, Siemens may
provide customers with billing codes (e.g., CPT and HCPCS) to use when
submitting claims to third party payers for Siemens products. It is
Siemens’ policy to promote products based solely on their effectiveness,
safety, and cost. Employees may not offer unsolicited comments
regarding the amount customers might receive in reimbursement from
Medicare or Medicaid for Siemens products or competitors’ products.
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Siemens Medical Solutions USA, Inc.
Malvern, PA
Siemens Healthcare USA Corporate Policies
Employees may not provide personal opinions or interpretations of
coding, coverage, or reimbursement information, nor should employees
offer unsolicited comments about such topics. If asked about
reimbursement issues not related to specific coding, coverage, or payment
by customers or other individuals, employees should inform the parties
that it is against Siemens policy to provide reimbursement advice and that
the parties should consult an appropriate third party, such as a Medicare
carrier or private insurer.
To ensure the above requirements are met, all information related to
insurance coding must be obtained through or be approved by Siemens’
Policy and Strategy Office at: 1-610-448-3410.
Employees with questions regarding promotion of products reimbursed by
Medicare or Medicaid should contact their supervisor or the Legal
Department for assistance.
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Effective Date: 09-04-2014
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Siemens Medical Solutions USA, Inc.
Malvern, PA
Siemens Healthcare USA Corporate Policies
3. Charitable Contributions
Siemens may make donations as outlined in this section where the proceeds are
intended solely for charitable purposes. From a compliance perspective, a
charitable contribution is not permitted if any of the following traits are present:
It is intended as a price term or offered in place of a price concession.
It is contingent on the purchase of any Siemens products.
It is intended to encourage the recipient to use, purchase, or recommend
Siemens products.
It is intended to reward or compensate the recipient for purchasing, using, or
recommending Siemens products.
It is made at the request of an HCP in his/her individual capacity (e.g.,
request by a physician to fund his/her preferred charity).
It is intended for an event that is strictly celebratory in scope.
Siemens Healthcare Giving (SHG) supports Siemens in the processing of
donation requests to qualified 501(c) 3 organizations. Through SHG, Siemens
supports selected initiatives that focus on community and patient health
education programs.
SHG receives all requests directly from requesting organizations via the Online
Giving Request Portal and performs the initial assessment by reviewing requests
against the below criteria. Requests that meet initial criteria are reviewed by the
Compliance Department and the cross-functional Healthcare Executive Advisory
Committee (HEAC), comprised of Siemens executives, which select those
initiatives to be supported. Certain sponsorship opportunities may also require
review by Siemens’ Business Units, subsequent to requests determined to be
approvable by the HEAC.
Approved requests are ultimately entered by the Online Giving Request Portal
Administrator into the SpoDoM Tool for organizational approvals per Siemens
guidelines—CC Circular No. 2/2012 / CL CO Circular No. 2/2012—SpoDoM and
MOR 3.2/08e—SpoDoM Supplementary Regulation. Due to limited annual
funding, not all requests that meet criteria can be supported. SHG handles the
processing of selected requests, notifications to the requesting organizations
(awarded or declined), and tracking/reporting.
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Effective Date: 09-04-2014
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Siemens Medical Solutions USA, Inc.
Malvern, PA
Siemens Healthcare USA Corporate Policies
Siemens’ key areas for monetary donations include:
1. Initiatives that focus on community and patient health education programs,
specifically in the areas of:
Cardiology
Oncology/cancer
Breast cancer awareness
Neurology/stroke
Pediatrics
Accessibility to medical care
Diagnostics
2. Educational and philanthropic programs in the areas previously mentioned,
whereby an organization is requesting donations from the healthcare
community to assist in funding.
3. Initiatives involving multiple Siemens entities/organizations, and those that
engage employees.
4. Funding that is direct-to-beneficiary (Siemens does not sponsor third party
activities to support donation efforts; rather, Siemens sponsors beneficiary
organizations directly, when appropriate).
5. The request does not fund the following:
Construction or capital improvements
Endowments, general operation costs, employee salaries, etc.
International programs (even if the charity is a U.S. organization)
Education programs for HCO employees
Individuals
Religious or political purposes
6. The fundraising is not accomplished via a golf outing, or other sporting event
or recreational activity.
7. Any charitable fundraiser (e.g., gala) being sponsored provides, at minimum,
65% of the funds to the intended cause as opposed to administrative/event
expenses.
Employees may not make charitable donations on behalf of Siemens. If
employees want to support charities in an individual capacity and such charities
are customers or affiliated with customers, then donations must meet the
following criteria:
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Siemens Medical Solutions USA, Inc.
Malvern, PA
Siemens Healthcare USA Corporate Policies
The donation is made directly to the charity.
The donation is made anonymously.
The customer is never informed directly or indirectly about the donation.
Attendance by designated employees at charitable events may be permitted in
order for Siemens to demonstrate support for such charities. However, inviting
customers or HCPs to these charity events is not appropriate under any
circumstance.
Contributions for Health Fairs/Medical Screenings
Charitable contributions may be requested to support community health fairs or
medical screenings intended to promote disease awareness and provide testing
for early diagnosis. Examples include medical test or screening events offered
free-of-charge to the community (e.g., prostate cancer screening).
Siemens may contribute funds or products to third parties that qualify as taxexempt charitable organizations to support health fairs or screenings if the
following requirements are met:
Siemens cannot provide funds or product to a private HCP, practice group, or
any charity controlled or operated by a private HCP/practice group.
More than one medical group or more than one HCP, each from different
medical groups, must participate in the health fair or medical screening.
The health fair or medical screening must be free-of-charge to the community
and open to all community members.
All charitable contributions are subject to audit to ensure compliance with
Siemens policies and the Compliance Manual. The government (e.g., IRS) may
also request to audit/review charitable contributions.
Employees with questions regarding charitable contributions should contact the
Compliance Department for assistance.
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Effective Date: 09-04-2014
Author: Mark Petrille, H CO USA
Siemens Medical Solutions USA, Inc.
Malvern, PA
Siemens Healthcare USA Corporate Policies
4. Drawings, Contests, Sweepstakes, and Surveys
Drawings, contests, and sweepstakes, that offer the opportunity for customers,
patients, HCPs, or anyone else to receive something of value, are to be generally
avoided.
Requests by conference organizers for Siemens to supply funds for drawings,
sweepstakes, or similar situations must be approved by the Compliance and
Legal Departments. Furthermore, items to be used for drawings, contests, or
sweepstakes must comply with the requirements of the Compliance Manual as
set forth in the “Business Gifts” section (i.e., direct patient and/or educational
benefit). All requests to support third party drawings, contests, sweepstakes, or
similar situations must be approved in advance by the Compliance Department
by submitting a request in the Compliance Approval Process (CAP) Tool.
Employee requests to conduct surveys for promotional and marketing purposes
that include remuneration must be approved by the Compliance and Legal
Departments. All requests to support surveys must be approved in advance by
the Compliance Department by submitting a request in the CAP Tool.
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Effective Date: 09-04-2014
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Siemens Medical Solutions USA, Inc.
Malvern, PA
Siemens Healthcare USA Corporate Policies
5. Free-of-Charge Products and Services
Free-of-charge products and services are those items provided to customers or
other third parties at no charge. Depending on the Siemens Business Unit, items
may be consumable material, software and related licenses, imaging devices, or
product-related services. This may also include use of free-of-charge products for
research collaborations and development where devices are placed with
customers to generate data (through testing of residual samples) in order to
prepare FDA clearance/approval materials.
Unless properly documented as a discount or promotion, or in-kind payment for
personal services, Siemens may never provide free-of-charge items to
customers, such as HCPs/HCOs, even if only one purpose of such action is to
encourage them to use or purchase other Siemens products (One Purpose
Rule).
In general, free-of-charge items may only be provided for
warranty/repair/replacement, dispute settlement, limited-time pre-purchase
evaluation, payment for personal services, research purposes, validation,
correlation or waste, etc., after evaluation by the Legal and Finance
Departments. For Siemens Healthcare Diagnostics, free reagents or assays
provided for the purpose of pre-purchase evaluation should only be delivered in
reasonable quantities. Any such transaction must be approved and documented
by qualified employees as described below in the CAP Tool.
The value of these materials must be disclosed to customers in writing with a
reminder that the value must be considered by HCPs/HCOs in their cost
reporting activities when the materials are provided to resolve bona fide disputes.
Free-of-charge items provided to qualified charities should follow the guidance
provided in the Compliance Manual section “Charitable Contributions.” Free-ofcharge items provided in connection with product sales (e.g., buy one, get one
free) must comply with the Compliance Manual section “Providing Discounts and
Rebates.” Providing free-of-charge items may be reportable to the federal
government under the Physician Payments Sunshine Act (Sunshine Law) and/or
to states according to state law.
Siemens may agree to provide customers with free-of-charge items for purposes
of conducting quality or other validation studies pursuant to written agreements
when necessary. The value of such materials must be disclosed to customers in
writing.
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Siemens Medical Solutions USA, Inc.
Malvern, PA
Siemens Healthcare USA Corporate Policies
Products and/or services may be marketed as free-of-charge items. However,
they must be reflected as a discount on the invoice (e.g., It is permissible to
state “buy four, get one free,” however, the invoice should reflect this as a 20%
discount). For additional information, employees should consult the Compliance
Manual section “Providing Discounts and Rebates” and the Legal Department, as
necessary.
Goods or services provided as an apology for customer satisfaction or because
of customer status are free-of-charge items and subject to this policy, and are
not permitted. When there are bona fide warranty/service/performance issues,
replacement product, service, or a credit may be offered, provided the
transaction is documented with the warranty safe harbor language which must be
evaluated and documented by the Legal Department.
Employees with questions regarding free-of-charge items should contact the
Compliance or Legal Departments for assistance.
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Siemens Medical Solutions USA, Inc.
Malvern, PA
Siemens Healthcare USA Corporate Policies
6. Loaner Equipment and Trade-In Sales
Loaner Equipment
Loaner equipment in the context of the Compliance Manual refers to equipment
that may or may not have commercial value and is provided at no charge.
Any loaner equipment provided (hardware and/or software) must comply with
MOR 2.3/03E (Sales-related loans) and be provided pursuant to a written
agreement that has been approved by the Product Loan Group or any other
responsible group within the Siemens Business Unit (e.g., equipment evaluation
agreement). Sales-related equipment loans are permissible if:
1. It is to bridge delivery difficulties in the case of binding order promises (e.g.,
product on backorder);
2. It is a pre-purchase evaluation for testing purposes in the interest of a
potential customer, in order to check whether the product meets the
customer’s requirements; or
3. It is a temporary replacement of a defective customer device as part of a
maintenance contract.
Sales-related equipment loans are limited to the durations of existing reasons
and subject to a maximum of three months (90 days). In exceptional cases where
longer loan periods are deemed necessary, approval for extensions must be
obtained from the Compliance Department prior to the expiration of the initial
equipment loans.
Equipment may not be loaned free-of-charge to customers hosting
demonstration site visits.
Equipment loaned for charitable events must be submitted in the CAP Tool and
approved by the Compliance Department. A daily loan rate, including
transportation of equipment, must be captured and documented for Aggregate
Spend Tracking and Reporting (ASTAR) purposes. For additional information on
ASTAR reporting, employees should reference the Compliance Manual section
“Federal and State Disclosure/Aggregate Spend Laws.”
Loaned equipment for educational events (for either continuing medical
education or non-continuing medical education purposes) does not need to be
reported in ASTAR.
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Siemens Medical Solutions USA, Inc.
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Trade-In Sales
Because trade-in equipment represents an exchange of value designed to
facilitate standardization of products by customers’ employees in clinical practice,
customers must relinquish their existing inventory to Siemens. Except in certain
circumstances, customers cannot receive free Siemens products and retain the
ability to use their existing equipment.
Trade-in equipment becomes assets owned by Siemens upon turnover of the
new products to customers. Should customers have legitimate needs to delay
completion of trade-ins after passing titles to Siemens (i.e., old equipment now
belongs to Siemens), loan extensions must be completed.
Trade-in allowances must be consistent with the fair market value of the
equipment received. Any exceptions to this process must be approved by the
Compliance or Legal Departments.
Employees with questions regarding trade-in and loaner equipment should
contact the Compliance or Legal Departments for assistance.
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7. Providing Discounts and Rebates
Siemens may generally provide discounts, rebates, and other price concessions
to customers provided the conditions of this section are met. In order to ensure
Siemens complies with the Discount Safe Harbor provision to the Anti-Kickback
Statute, the true net cost to customers of Siemens products must be
transparently documented—fair market value or customer realized price (CRP)—
in written contracts that notify recipients of their obligations to report the
arrangements to government payors, such as Medicare and Medicaid.
Side letters or price concessions offered outside of written contracts are strictly
prohibited. Any unanticipated credits or price changes in contract amendments or
other change orders must be approved under the Delegation of Authority Policy
and properly documented in contract amendments or other change orders, and
included in the contract history files.
When customers trade in units toward new equipment, the value of the trade-ins
is a form of discount against purchase of the new equipment and must be
properly documented.
Rebates are price concessions based on purchase volume or fulfillment of other
established criteria where the final amount of the price concession may not be
known at the time of product invoice or contract signing. If the value of a rebate is
not known at the time of invoice or contract signing, the invoice or contract
should reflect that additional discounts may become available at a later time.
Siemens should also provide the formula for subsequent calculation of discounts,
and must provide a form of written statement describing any rebates awarded to
customers, notifying them they may be required to report discounts and other
price concessions to the government in its annual Medicare cost reports.
Employees with questions regarding discounts or other price concessions should
contact the Compliance or Legal Departments for assistance.
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8. Federal and State Disclosure/Aggregate Spend Laws
Federal and state laws require the annual reporting of payments and other
transfers of value made by Siemens to physicians, certain HCPs and HCOs (and
in some cases their employees) related to the compensation for services,
payment of expenses, and other transactions other than the sale or license of
goods.
Such information is captured in the appropriate Aggregate Spend Tracking and
Reporting (ASTAR) system (i.e., EZ Suite, ATDT, ASTAR Webform, etc.). These
systems are accessible under the ASTAR Intranet. It is highly important all
such transactions be timely, accurately, and completely reported to the
Compliance Department to avoid the risk of government sanctions. Any ASTARrelevant transactions made by Siemens entities/employees working outside the
U.S. and engaging U.S. HCPs are to be properly documented using the ASTAR
Webform available under the ASTAR Intranet.
Federal Physician Payments Sunshine Act
Federal law requires medical device manufacturers operating in the U.S., such
as Siemens, to comply with specific reporting requirements for transaction data
captured in accordance with this policy and MOR 3.3/01 IN 06e—ASTAR
Submission Guidance.
Management must ensure appropriate training to employees on proper
ASTAR processes and tools;
Employees must timely (entered no more than two weeks after being
incurred), completely (listing, for example, all internal and external attendees
at a meal), and accurately record all ASTAR-relevant transactions in the
appropriate tool (accounts payable, T&E, etc.);
All payments and other transfers of value to HCPs/HCOs must be reported
internally, including but not limited to:
Consulting fees
Educational items
Expenses such as travel, lodging, and meals
Grants and charitable donations
Honoraria
Licensing and royalty fees
Payment made to another entity at the request of or on behalf of a
physician or teaching hospital
o Research-related expenses
o Training and education expenses
o
o
o
o
o
o
o
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Note that all transfers of value to HCPs and HCOs must be internally reported
via the ASTAR process.
State Reporting Requirements—Massachusetts
Massachusetts has a Marketing Code of Conduct for medical device companies
that interact with Massachusetts HCPs/HCOs. It is important to note that unlike
Vermont’s state reporting requirements, Massachusetts’ Code of Conduct applies
to all interactions with covered recipients (defined below) who are licensed in
Massachusetts but practicing anywhere, regardless of whether those
interactions occur in or outside Massachusetts. Covered recipients include (but
are not limited to):
Massachusetts HCPs
Hospitals
Nursing homes
Pharmacists
Health benefits plan administrators
Employees of covered recipients
With certain exceptions, Massachusetts requires Siemens to track and annually
disclose the value, nature, purpose, and recipient of any fees, payments,
subsidies, items of value, or other economic benefits valued at $50 or more and
provided to covered recipients. Such information is captured in the appropriate
ASTAR system (i.e., EZ Suite, ATDT, ASTAR Webform, etc.).
Business Meals
Employees may pay for occasional, modest meals and refreshments when
meeting with Massachusetts HCPs. Meals must be provided with a Siemens
representative present or in connection with an educational presentation by a
Siemens representative to educate and inform HCPs about the benefits, risks,
and appropriate uses of medical devices, disease states, or other scientific
information.
Product Training and Education Events
Payments will only be made for travel, lodging, and other expenses
associated with Siemens-sponsored product training programs for
Massachusetts HCPs/HCOs.
Payments for Services, Speakers, Advisory Boards, and Other Fee-forService Arrangements
Siemens may reimburse individuals or entities for out-of-pocket expenses
associated with providing services, which could include the cost of meals,
however, written agreements are required. Accordingly, if Massachusetts
HCPs are providing services, employees may take the HCPs to dinner,
provided that it is covered under the agreement for services.
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State Reporting Requirements—Vermont
Vermont defines healthcare providers as hospitals, nursing homes, pharmacists,
health benefit plan administrators, or any other persons authorized to dispense or
purchase for distribution prescribed products in the State of Vermont. Hospital
foundations organized as nonprofit entities separate from the hospitals are not
considered healthcare providers.
Vermont defines healthcare professionals as persons who regularly practice in
the State of Vermont and are authorized to prescribe or recommend prescribed
products (e.g., licensed clinical social worker, licensed psychologist, etc.), as well
as licensed by the State of Vermont to provide or is otherwise lawfully providing
healthcare in the State of Vermont.
With some exceptions, Vermont bans:
Anything of value provided to a healthcare provider for free.
Any payment, food, entertainment, travel, subscription, advance, service, or
anything else of value provided to a healthcare provider.
Certification of spend data for federal and state disclosure requirements
submitted for aggregate spend purposes much be certified each quarter by
appropriate Siemens management. Certifiers must state that the potentiallyreportable aggregate spend data for their portion of the business is timely,
accurate, and complete to the best of their knowledge and belief.
For additional information, employees should consult MOR 3.3/01E IN 06e—
ASTAR Submission Guidance.
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9.
Siemens Healthcare USA Corporate Policies
Interactions with Federal, State, and Local Government
Employees
Federal, state, and local laws and regulations governing gifts, business meals,
speaker grants, educational grants, and travel compensation provided to federal,
state, and local government employees, including part-time government
employees, are much stricter and more specific than laws and regulations for
private customers.
Siemens employees should read this section to avoid any conduct that may
present even the appearance of impropriety with any federal, state, or local
government employee (government employee). Employees who are unsure
whether individuals are government employees should consult the individuals or
their facility/employer. For additional information, employees should consult the
Siemens Government Contracting Policy.
Government employees include anyone (military or civilian) employed by facilities
associated with the Department of Defense (military or DoD), Department of
Veterans Affairs (VA), Federal Public Health Service (PHS) entities, Indian
Health Services, National Institutes of Health (NIH), or other federal, state, or
local government entities. According to federal law, government employees
include part-time employees of the government and part-time workers at
government facilities.
The following are considered examples of government employees:
A resident while he/she is doing a rotation at the VA.
A physician who works part-time at the VA and part-time at a civilian
institution (the amount of time spent at the VA hospital is irrelevant).
The following, for example, are not considered government employees:
An individual who works at a civilian facility that has a contract with the
government to treat government beneficiaries (e.g., a civilian physician at a
TRICARE facility).
In general, providing government employees with meals, gifts, compensation,
expense reimbursement, etc., is prohibited unless Siemens employees receive
prior approval from both the Compliance Department via the CAP Tool and the
ethics officers with the appropriate government agencies.
Various government agencies regulate commercial sales interactions with
government employees. Violations of these rules can result in criminal or civil
sanctions against Siemens and the individuals involved. Siemens employees
engaging in government business must understand and comply with such rules.
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General Prohibition
Siemens employees may not offer or provide gifts, business meals,
entertainment, travel reimbursement, or anything else of value—regardless of
amount—to government employees. Siemens employees may not offer or
provide gifts or entertainment to government employees regardless of the
amount or whether the gifts may benefit patients or provide genuine educational
value. Siemens employees may not provide gifts, meals, entertainment, travel
reimbursement, or anything else of value to spouses or guests of state or local
government employees. For example, it is clearly not permissible for a Siemens
employee to buy a government employee lunch when he/she visits with a
government employee.
It is permissible, however, for Siemens employees to supply modest meals to
government employees if such meals are provided in conjunction with a
contractually agreed upon purpose (e.g., food provided at a contractually
arranged training). Such cases are very limited exceptions and must receive prior
approval from the Compliance Department via the CAP Tool. Examples of limited
exceptions include:
Widely Attended Gatherings
Government officials (and various state employees where their state policy is
restrictive regarding meals, etc.) may attend certain group events of a medical
or educational nature, referred to as widely attended gatherings, sponsored
by Siemens. Widely attended gatherings include events sponsored by
industry associations open to both government and civilian officials (e.g., third
party conferences). In order to be considered as such, the events must be
open to all attendees of the conference or convention, (e.g., a Siemenssponsored keynote address at the annual AACC convention). However,
Siemens may not invite government employees (or state employees where
their state policy is restrictive regarding meals, etc.) to attend a Siemenssponsored limited target audience event (e.g., dinner at a Siemens table at a
HIMSS, RSNA, or AACC Conference).
Simple Business Courtesies
Government officials (and various state employees where their state policy is
restrictive regarding meals, etc.) may be provided simple business courtesies
such as coffee, soft drinks, pastries, cookies, or light refreshments (no
sandwiches or meals).
Federal, State, and Local Employee Attendance at Site Visits
In general, site visits are permissible for government officials, however, prior
approvals from the Compliance Department via the CAP Tool and relevant
government agencies are required.
Speaker and Educational Grants
Grants to support government speakers may only be provided to bona fide
third party organizations (e.g., Henry M. Jackson Foundation, True
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Foundation, Geneva Foundation, etc.) established for the purpose of
accepting and disseminating grant funds on behalf of federal entities
(including the DoD and VA). Siemens may provide funds to these
organizations for educational purposes, including sponsoring government
officials to speak at or attend medical conferences, only if the third party
organizations, not Siemens, determine how the funds are used. Grants must
be consistent with the third party organizations’ character or authority.
In addition, all grant requests for funding government speakers and
government attendance at medical education and training events must follow
the process described in the Compliance Manual section “Grants for CME,
CEU, and Third Party Educational Conferences” and require approval by the
Compliance Department via the CAP Tool. The government has strict rules
(e.g., potential conflicts of interest) around the hiring of their employees for
personal services (e.g., speaking events, advisory engagements, etc.);
therefore, the Legal Department must be involved.
Siemens employees should contact the Legal Department should any planned or
spontaneous interactions with U.S., state, or local government employees take
place outside the U.S., or if it is believed exceptions to this general policy are
warranted.
Record Retention
The Accounting Department must maintain payment request packages for
periods of six years or longer, as required by law or the Corporate Record
Retention Policy.
Audits
Spending for gifts and business meals or other business expenses associated
with state and local government employees is subject to audit to ensure
compliance with this section. Educational grants are subject to audit by the
Operational Review Department to ensure compliance with these policies. The
federal government (e.g., IRS) may also request to audit/review educational
grant payments to state government employees at any time.
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10.
Siemens Healthcare USA Corporate Policies
Prohibition on Entertainment and Recreation
Siemens employees’ interactions with HCPs should be professional in nature and
facilitate the exchange of medical or scientific information to benefit patient care.
Siemens employees are prohibited from offering entertainment and/or
recreational events to HCPs or HCO employees.
To ensure the appropriate focus on an educational and/or informational
exchange and to avoid the appearance of impropriety, Siemens will not provide
or pay for any entertainment or recreational events or activities (e.g., theater
performances, sporting events and equipment, golf outings, hunting excursions,
trips/vacations, etc.) for HCPs who are not employees of Siemens. Such
entertainment and recreation events/items should not be provided, regardless of:
1. Their value;
2. Whether the HCP provides services to Siemens under an agreement; or
3. Whether the entertainment or recreation is secondary to an educational
purpose.
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11.
Siemens Healthcare USA Corporate Policies
Compliance Scorecards
The CAP and SpoDoM Tools are used by Siemens to evaluate the
appropriateness of all interactions with U.S. HCPs, except for business meals
and exhibits (for these activities, employees should refer to the sections
“Business Meals” and “Business Courtesies when Conducting Sales and
Promotional Events” for further guidance).
For employees who are working outside the U.S. and engaging U.S. HCPs
(public or private sector), the U.S. Scorecard may be used as a first point of
reference (the U.S. Scorecard is weighted in such a way that employees using
the tool are directed to contact the Compliance Department for further guidance).
Siemens mandates that employees use Scorecards for gifts and business meals
for the countries in which the benefits are granted and/or where the HCPs are
located. Other interactions, such as non-local travel, site visits, and/or speaker
engagements require approval by the Compliance Department (U.S.) via the
SpoDoM Tool or from the respective local Compliance Department prior to
offering or granting benefits.
When the thresholds of Scorecards are exceeded, employees must consult their
regional Compliance Officer before offering or granting benefits. Completed
Scorecards should be signed and included with expense reports. Scorecards are
accessible from the Compliance Department Intranet.
Note that all economic benefits, including gifts and business meals, paid by
Siemens entities/employees working outside the U.S. and engaging U.S. HCPs
are to be properly documented using ASTAR. Employees should refer to the
Compliance Manual section “Federal and State Disclosure/Aggregate Spend
Laws” for further guidance on ASTAR reporting.
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12.
Siemens Healthcare USA Corporate Policies
Business Courtesies when Conducting Sales and
Promotional Events
This section provides guidance for Siemens employees on the appropriate
standards of conduct relating to Siemens’ sales and promotional activities and
services in accordance with applicable national, state, and local laws and
regulations, as well as applicable industry guidelines.
In addition, this section establishes a framework of standards of conduct for
employees relating to compliance and legal aspects of all Siemens-sponsored
sales meetings, promotional activities, and convention services (whether directly
or indirectly through distributors, agents, and sales associates, in whole or in
part).
Approval prior to events by the Compliance Department via the CAP Tool is
required depending on the event type (routine business meals do not require
submission in the CAP Tool provided the activities meet the requirements set
forth in the section “Business Meals with Healthcare Professionals”).
Attendee Selection
Only HCPs who have a legitimate business need to attend Siemens sales
meetings and promotional activities (e.g., tradeshows) should be invited.
Siemens employees may not invite HCPs to sales and promotional meetings
based on their purchasing habits or to reward large purchasers of Siemens
products. In addition, employees may not invite guests or spouses of HCPs. If
uninvited guests or spouses of HCPs attend, their meals must be at their own
expense.
In regard to permissible travel with HCPs, Siemens should generally purchase
airline tickets and make arrangements to pay hotels so business guests do not
incur these costs, and so Siemens can ensure arrangements are consistent with
applicable company policies on reimbursement for business travel.
Federal, State, and Local Government Employees
It is generally not appropriate for Siemens to pay for meals, refreshments, or
travel for government employees (e.g., military and Department of Defense). For
additional information on business interactions with federal government
employees, employees should refer to the Compliance Manual section
“Interactions with Federal, State, and Local Government Employees.”
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Private Institution Rules (Non-Government)
Non-government HCOs may have rules governing their employees' interactions
with vendors such as Siemens (e.g., customers may place a dollar limit on
provided business courtesies, such as meals, or they may prohibit acceptance
altogether). Violation of customer policies can harm both the business contacts
and Siemens. When in doubt, employees should ask individuals with whom they
are conducting business whether they can engage in activities such as business
meals.
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13.
Siemens Healthcare USA Corporate Policies
Business Meals with Healthcare Professionals
Siemens may pay for occasional, modest meals when employees meet with
customers to discuss business. Siemens policy prohibits employees from offering
anything of value to HCPs to encourage individuals to purchase, order, or
recommend Siemens products, as this could violate the Anti-Kickback Statute
and relevant state statutes.
This section covers interactions with all HCPs who may purchase, lease,
recommend, use, prescribe, or arrange for the purchase or lease of Siemens
products. Note that the definition of an HCP is very broad and includes
individuals other than physicians and nurses, such as laboratory directors,
distributors, technicians, and medical office assistants.
It is not necessary for business meals to be submitted in the CAP Tool, provided
the following criteria are met:
1. Siemens business will be discussed.
2. The venue is appropriate, conducive to business discussions, and enables
the employee to meet the criterion of modest as defined below.
3. The cost of the meal is modest and meets compliance guidelines, and
includes tips, beverages, and taxes. Maximum amount per meal, per person
is:
Breakfast—$35.00
Lunch—$60.00
Dinner—$100.00
4. The individual(s) in attendance have a bona fide business need to be present
at the discussion.
5. Business meals with the same individual(s) are infrequent.
6. The policies of the affiliated organization, including local and state facilities
governing the individual’s interaction with Siemens, allow for the meal to be
provided and at such cost levels (employees should refer to the Compliance
Manual section “Federal and State Disclosure/Aggregate Spend Laws” for
Massachusetts- and Vermont-specific guidance).
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7. No employees of federal government facilities are in attendance (e.g., VA,
NIH, etc.). Company policy prohibits Siemens from providing business meals
to federal government employees. State and local government facility rules
dictate whether employees of such facilities may be in attendance. Siemens
employees should obtain written confirmation from state or local facilities that
confirm the benefits acceptable. Siemens employees intending to provide
such benefits to state and local employees must receive prior approval from
the Compliance Department via the CAP Tool.
Employees should refer to the Compliance Manual section “Federal and State
Disclosure/Aggregate Spend Laws” for information governing attendees, and
collecting and submitting proper and accurate data.
Note that any deviations from the guidance previously mentioned require prior
approval by the Compliance Department via the CAP Tool.
Siemens employees are always responsible for ensuring that business meals are
submitted timely and accurately as customer expenses per the Travel and
Entertainment (T&E) Policy (also accessible from the Compliance Department
Intranet), and that all relevant ASTAR information is accurately captured.
Audits
Spending for business meals is subject to audits to ensure compliance with this
section, including proper documentation, spending limits, and company spending
policy. The government (e.g., IRS) may also request to audit/review expense
reports.
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14.
Siemens Healthcare USA Corporate Policies
Business Gifts
With the exception of business meals (previous section), Siemens policy and the
Compliance Manual prohibit employees from offering anything of value, including
business gifts, to HCPs to encourage HCPs to prescribe, purchase, or order
Siemens products, or to recommend the prescription, purchase, or ordering of
Siemens products. Offering or providing gifts or items of value to encourage
HCPs to prescribe, order, or recommend Siemens products may violate the
Federal Anti-Kickback Statute and other relevant state statutes.
In most circumstances, Siemens employees cannot accept gifts from
HCPs/HCOs. Employees should contact the Compliance Department before
accepting gifts from HCPs/HCOs.
This section covers interactions with HCPs/HCOs who may purchase, lease,
recommend, use, or prescribe Siemens products. Note that the definition of HCP
is very broad and includes individuals other than doctors and nurses, such as
laboratory directors, technicians, and medical office assistants. This section also
applies to Siemens Sales Agents who assist Siemens in selling products to
customers.
Acceptable Business Gifts as a General Rule
All business gifts must benefit patients or serve genuine educational functions.
The monetary limit is $100 per gift (other than medical textbooks; employees
should refer to the sub-section “Medical Textbooks” below). There is no specified
limit on the maximum amount Siemens may spend on any HCP in a 12-month
period. However, employees are responsible for using good judgment to ensure
the aggregate value and quantity of gifts and/or business meals to any recipient
is reasonable, modest, and occasional.
It is important to remember the government may view business gifts and/or
meals that are provided too frequently or that are too expensive as an improper
inducement to purchase Siemens products. In addition, business gifts may
never include payments in cash or cash equivalents (e.g., gift cards, gift
certificates, loans, savings bonds, lottery tickets, airline upgrade coupons, etc.).
Prohibited Business Gifts
Branded promotional items that are not educational cannot be given to HCPs,
regardless of whether the items have minimal value, and are related to HCPs’
work. Examples of non-educational, branded promotional items include pens,
notepads, mugs, calendars, and other items that have Siemens’ name, logo, or
product name/logo. Gifts may not be received from, offered, or given to Siemens
suppliers of goods or services.
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Pre-Approval Requirement of Acceptable Business Gifts
All business gift requests must receive prior approval from the Compliance
Department via the CAP Tool (or Compliance Scorecard if outside the U.S).
The following are examples of appropriate business gifts:
Resident handbooks
Anatomical models
Educational DVDs on medical conditions and treatment
Commemorative plaques provided to institutions
Branded notepads and pens offered during customer training/education that
are covered in tuitions or sales orders
Memory sticks only for purposes of Siemens product marketing, educational,
and/or training materials (memory stick size must be comparable to materials
used)
The following are examples of inappropriate business gifts:
Personal items that do not benefit patients and do not serve genuine
educational functions (e.g., tickets to a sporting event)
Gifts, regardless of cost, that reward HCPs for purchasing Siemens products
Multi-media devices, golf balls, sports bags, cuff links or clothes, even if they
contain a Siemens logo or product logo
Any dual-purpose gifts, such as televisions, Blue Ray/DVD players, computer
equipment, iPads, or MP3 players, even if the cost is less than $100 and the
HCP indicates it will be used for medical purposes
Branded or non-branded pens, notepads, or mugs
Business Gifts/Meals Provided By Healthcare Vendors/Suppliers
Business gifts/meals from vendors/suppliers cannot be monetary or in the form of
gift certificates. Only promotional items (e.g., pens, notepads, etc.) with a
nominal value that do not exceed $25 may be accepted by Siemens employees
from vendors/suppliers of healthcare goods or services. In addition, nonpromotional gifts (e.g., candy, fruit baskets, etc.) are acceptable but must be
modest (under $50), infrequent, and shared with Siemens co-workers.
Business Gifts Provided By Customers
Business gifts that convey a personal benefit may not be received from
customers. Siemens employees may not accept any gifts from customers that
Siemens would not be able to provide to them.
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Medical Textbooks
Medical textbooks may be offered only through the Marketing Department.
Textbooks valued at more than $100 may be provided only to hospitals, practice
groups, or other entities where the number of physicians in the group ensures the
value of the textbook does not exceed $100 per physician. Textbooks valued at
more than $100 should never be given to only one individual. Note that offering
gifts without prior CAP approval by the Compliance Department is not allowed,
even if it is provided to a group for use by multiple individuals.
Medical textbooks provided to HCPs/HCOs are considered gifts and must be
reported via the ASTAR process. Note that any deviations from the guidance
provided in the Compliance Manual require prior approval by the Compliance
Department.
Siemens employees are always responsible for ensuring that business meals are
submitted timely and accurately as customer expenses per the Travel and
Entertainment (T&E) Policy (also accessible from the Compliance Department
Intranet), and that all relevant ASTAR information is accurately captured.
Audits
Spending for gifts are subject to audit to ensure compliance with this section,
including proper documentation, spending limits, and company spending policy.
The government (e.g., IRS) may also request to audit/review related spending.
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Siemens Healthcare USA Corporate Policies
Sales Agents and Distributor Relationships
Sales Agents are an extension of Siemens’ sales force and provide sales
quotes on Siemens company paper. Therefore, Sales Agents must adhere to
the Compliance Manual when selling Siemens products. In addition, all Sales
Agents must be properly vetted through the due diligence process as outlined in
CL CO Circular No. 2/2011—Compliance Guidelines for Cooperation with
Business Partners.
Distributors (Dealers) are independent business partners that purchase Siemens
products, take title, and resell these products on dealer paper in the market.
Dealers are also subject to the due diligence process as outlined in the circular
mentioned above.
Unless explicitly outlined in the contract, incentives (cash or in-kind) may not be
provided directly to Sales Agents and/or Dealers.
Most forms of value provided to Sales Agents or Dealers must be pursuant to a
contract. For ASTAR purposes, any remuneration provided by Sales Agents to
HCPs is potentially reportable and must be appropriately captured as part of
Siemens aggregate spend process in a form and manner directed by Siemens.
Because they are independent of Siemens, Dealers’ spend does not need to be
captured in ASTAR.
For additional information, employees should refer to the Compliance Manual
section “Federal and State Disclosure/Aggregate Spend Laws.” Employees with
questions regarding Sales Agent or Dealer relationships should contact the
Compliance or Legal Departments.
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Siemens Healthcare USA Corporate Policies
Advisory Boards
Advisory boards provide Siemens with significant and valuable feedback on its
products and product plans. Payments for advisory boards must be made in
accordance with the following Compliance requirements, and also require review
by the Legal Department:
If, at the request of Siemens, an HCP visits a Siemens facility in the U.S. or
another country, or some other location specifically to review and comment
on a product, to discuss a research product, or explore collaborative
research, a fair market value payment for time spent may be paid, provided
that the HCP services are genuine and not token.
If an HCP attends and actively participates in an advisory board, he/she may
be paid a fair market value fee for time spent participating in the advisory
board and reimbursed for reasonable, out-of-pocket expenses, provided the
HCP services are genuine. When reimbursing travel, Siemens should
generally purchase airline tickets and make arrangements to pay hotels so
business guests do not incur these costs and Siemens can ensure
arrangements are consistent with applicable Siemens policies on
reimbursement for business travel.
Siemens may not provide a gift of appreciation.
For advisory boards, the following applies:
o The purpose of the meeting must not be to promote a product.
o The number of HCPs on the advisory board must be reasonable.
o The Siemens employee hosting the advisory board is advised to take
minutes of the meeting that are sufficient to document the time and
effort contributed by participants.
o The total dollar amount involved for a particular advisory board must
be reasonable.
Any payment to an HCP in connection with an advisory board must be made
pursuant to a written agreement as described in the Compliance Manual
section “Payments for Services, Speakers, Advisory Boards, and Other Feefor-Service Arrangements.”
To the extent required by contract or terms of employment, participants must
obtain permission from their companies prior to participating in an advisory
board.
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Any meals or refreshments must be provided in accordance with the
Compliance Manual section “Business Meals with Healthcare Professionals.”
For information regarding interactions with foreign HCPs, employees should refer
to the Compliance Manual section “Scope and Purpose” and the Compliance
Department Intranet.
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Siemens Healthcare USA Corporate Policies
Siemens-Sponsored Product Training and Education
Events
Siemens recognizes the importance of providing training on its products and
education on topics directly relating to its products to HCPs. Within the context of
the Compliance Manual, training means training on the safe and effective use of
Siemens products. Similarly, education means communicating information
directly regarding or associated with the use of Siemens products, such as
information about disease states and product benefits to certain patient
populations.
In general, it is appropriate for Siemens to financially sponsor or furnish such
product training and education to HCPs. Siemens-sponsored education events
are typically promotional or scientific events at which presenters are speaking on
behalf of Siemens. This may include Siemens-sponsored events ancillary to third
party events, but that must be scheduled and organized consistent with third
party rules. Siemens employees may only control and influence speakers or
program content in cases when the only topics of discussion are approved uses
of Siemens products. A Siemens representative must attend each program.
For information regarding employee interactions with foreign/international HCPs,
employees should refer to the Compliance Manual section “Scope and Purpose”
and the Compliance Department Intranet.
Payments to Speakers and Attendees
Speakers may receive fair market value payments for their services, however, all
payments must be made pursuant to written contracts and require review by the
Compliance and Legal Departments. In addition, speaker contracts and
payments must comply with the Compliance Manual section “Payments for
Services, Speakers, Advisory Boards, and other Fee-for-Service Arrangements.”
Attendees may not receive anything of value (e.g., cash, cash equivalent, gifts,
etc.) in connection with events other than meals and refreshments. Any such
meals and refreshments should be modest in value and subordinate in time and
focus to the educational or training purpose of the meetings. Attendees may
include Siemens suppliers and others that financially or otherwise support
Siemens events.
Siemens may only pay for reasonable travel and modest lodging costs incurred
by attending customers if travel is necessary in order for Siemens to efficiently
deliver training on its products not otherwise covered under agreements. If
customers travel more than four hours door-to-door and/or Siemens covers any
hotel or transportation other than modest ground transportation, it must receive
prior approval from the Compliance Department via the CAP Tool.
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In general, Siemens should purchase airline tickets and make arrangements to
pay hotels so that business guests do not incur these costs, and Siemens can
ensure arrangements are consistent with applicable Siemens policies on
reimbursement for business travel.
Payments may only be made for travel, lodging, and other expenses associated
with Siemens-sponsored product training programs for Massachusetts HCPs if
such payments are paid pursuant to and described under written purchase
agreements for products.
It is not appropriate for Siemens to pay for meals, refreshment, travel, or other
expenses for guests of customers or for any other persons who do not have a
bona fide professional interest in the information being shared at the training
programs or education meetings.
Program Topics and Location
Topics must address approved uses of Siemens products and be of a scientific
or medical nature. For example, training and education programs can include
hands-on training, cadaver workshops, educational lectures, and grand rounds.
Topics such as “Retirement Planning” or “Billing and Coding” do not meet these
criteria. In addition, program agendas should not include marketing presentations
or any other activities promoting Siemens products.
The location of programs must be conducive to the exchange of information and
the presentation format planned for the program. Training and education
programs should be conducted in clinical, educational, conference, or other
settings, including hotels or other commercially available meeting facilities,
conducive to training. Programs providing hands-on training should be held at
training facilities, medical institutions, laboratories, or other appropriate facilities.
Locations that are, by their very venue, entertainment-based (e.g., dinner
riverboat cruises) are not appropriate.
Training staff, including Siemens employees, should have the necessary
qualifications and expertise to conduct training programs. Employees who
participate in training are prohibited from soliciting or providing information on
unapproved uses of Siemens products. If asked to assist in specific prescribing
or billing decisions, employees should not do so. HCPs who request information
on an unapproved use should be directed to the Regulatory Affairs Department.
CME/CEU Accreditation
As a manufacturer, Siemens cannot provide ACCME accreditation. Under the
ACCME Standards for Commercial Support, ACCME credits may not be issued
for Siemens product training programs since these events are financially
sponsored by Siemens and the program content is primarily controlled by
Siemens.
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To the extent product training is undertaken for education credit (e.g., CEUs)
through accreditation organizations other than ACCME, Siemens employees
must adhere to guidelines set forth by those organizations.
At the discretion of the Siemens Business Unit, they may charge fair market
value for Siemens-sponsored business credits. However, where credits are
provided free-of-charge, they must be awarded consistently and without HCP
preference. For additional information on educational grants, employees should
refer to the Compliance Manual section “Grants for CME, CEU, and Third Party
Educational Conferences.”
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Siemens Healthcare USA Corporate Policies
Payments for Services, Speakers, Advisory Boards, and
Other Fee-for-Service Arrangements
In order to avoid violation of the Anti-Kickback Statute, Siemens’ Fair Market
Value (FMV) Policy provides strict guidelines that focus on its financial
relationship with HCPs and provides a methodology to assess the maximum
compensation level that must not be exceeded for rendered services. Such
services include, but are not limited to, speaking engagements, training,
contracting for site visits, services agreements, advisory boards, R&D
arrangements, etc.
As a result of continual updates in the industry’s fair market value rates, the
policy and corresponding rates are published and made available on the
Compliance Department Intranet.
Pursuant to written agreements, Siemens may reimburse individuals or entities
for out-of-pocket expenses associated with providing services, which may include
the cost of meals. According to Massachusetts law, if Massachusetts HCPs are
providing services, employees may take the HCPs to dinner. However, the HCPs
should pay on separate checks and submit the expenses for reimbursement.
Prior approval by the Compliance Department via the CAP Tool is required for
such arrangements. For additional guidance, employees should consult MOR
3.3/01e—Compliance in the Healthcare Sector or MOR 3.3/03e—Collaboration
Management.
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Siemens Healthcare USA Corporate Policies
Siemens-Sponsored Promotional Site Visits, Plant Tours,
and Road Shows
Site visits and attendance at road shows provide a significant means for
customers to learn about and evaluate Siemens products that otherwise may not
be practically provided in another forum. In addition, customers may visit
Siemens facilities, designated customer sites, and off-site locations to learn
about Siemens product capabilities and observe them in operation, including
their safe and effective use.
Siemens will not pay for travel and lodging expenses associated with promotional
events. Payment is acceptable only if these events are necessary for evaluating
products for purchase. If the customer is a U.S.-licensed HCP invited by a
Siemens employee, and travel and lodging is paid by Siemens, prior approval by
the Compliance Department via the CAP Tool is required.
If visiting customers are foreign nationals invited by Siemens to the U.S. to attend
such activities, and travel and lodging is paid by Siemens, prior approval must be
obtained from the Compliance Officer for the country in which the foreign national
resides or is registered. In addition, the request must be approved prior to the
event by the Compliance Department via the CAP Tool.
Purpose of Site Visits
Current and prospective customers may visit sites to become familiar with
Siemens products and observe product demonstrations in environments similar
to their work environments. Such visits generally include sales presentations,
product demonstrations, scientific discussions, and/or tours of manufacturing and
operational facilities.
For visits involving government employees, employees should refer to the
Compliance Manual section “Interactions with Federal, State, and Local
Government Employees.”
Siemens shall not arrange for site visits and/or demonstrations where there is no
legitimate business need.
Reimbursement of Expenses
Siemens may pay reasonable and necessary travel expenses of customers
visiting sites for legitimate business purposes in cases where such a purpose
cannot be achieved without a visit (e.g., demonstration of a large imaging unit).
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In addition, Siemens may reimburse reasonable and necessary travel expenses
of customers visiting Siemens sites for purposes of providing product information,
education, or demonstrations. Siemens may also reimburse reasonable and
necessary travel expenses of customers for product information, education, or
demonstrations that occur at off-site locations, such as hotels or conference
centers (e.g., regional sites). However, Siemens may not reimburse customers or
pay customers a fee for taking time off from their business to attend site visits.
In general, Siemens should purchase airline tickets and make arrangements to
pay hotels so business guests do not incur these costs, and Siemens can ensure
arrangements are consistent with applicable Siemens policies on reimbursement
for business travel.
In general, travel should be booked in coach class, unless flight time of any leg is
five hours or more, in which case business class may be permitted if approved by
the Compliance Department. Note that final approval for flights other than coach
also require management approval. Siemens is not permitted to reimburse travel
or other expenses for spouses or guests in connection with site visits.
Siemens may never use site visits or demonstrations as pretext for reimbursing
customers for trips not intended for customers’ evaluations of Siemens products
for potential purchase. Specifically, Siemens may not reimburse or pay travel
expenses of customers to attend or participate in third party conferences or trips
of a personal nature (e.g., HIMSS, RSNA, AACC, etc.).
Venue
It is appropriate for Siemens employees to meet with HCPs to discuss product
features, contract negotiations, and sales terms. Sales and promotional meetings
should occur at locations near places of business of HCPs, at Siemens facilities,
or locations selected because of their convenience to a large number of targeted
HCPs (e.g., sites of well-attended conventions or educational programs), where
Siemens can minimize reimbursement costs for travel, lodging, and meals.
For example, it is permissible to invite an HCP from New York City to meet in
Nashville for a demonstration if it was the closest location where a product could
be effectively demonstrated. However, it would be inappropriate to invite the
same HCP to meet in Puerto Rico for a demonstration if the product was
available at a location closer to New York City. In general, it is not appropriate to
conduct such meetings at resort-like locations.
Promotional Site Visit, Road Show, and Plant Tour Approvals
Promotional site visits, road shows, and plant tours generally require prior
approval by the Compliance Department via the CAP Tool. Submissions in the
tool must have appropriate documentation that provides details regarding event
locations, attendee numbers, etc., for review by the Compliance Department.
Additional specifications include:
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If travel time for a visit is less than four hours one way, then it is not required
to be submitted via the CAP Tool, provided that travel does not include
airfare.
Any travel time for a visit that is over four hours (whether land or air) must be
submitted via the CAP Tool, along with appropriate documentation.
All air travel must be submitted via the CAP Tool.
The standard booking arrangements for customer travel is coach class. If
business class travel is desired, written approval from the Compliance
Department is required before booking the travel and/or committing to the
customer. Also, from a compliance perspective, business travel is typically
only allowed if the travel is five hours or more one way by plane.
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Siemens Healthcare USA Corporate Policies
Grants for CME, CEU, and Third Party Educational
Conferences
Siemens provides educational grants to third party conference sponsors solely to
support independent, educational conferences and meetings that promote
scientific knowledge, medical advancement, and/or efficient healthcare delivery
(educational conferences).
Educational grants may be paid only to support independent educational
conferences sponsored by the following types of conference sponsors:
National, regional, or specialty medical associations
Charitable foundations or medical schools affiliated with teaching institutions
Continuing medical education (CME) or continuing educational unit (CEU)
providers accredited by an organization such as the Accreditation Council for
Continuing Medical Education (ACCME) or other relevant accreditation
organization (Siemens employees must ensure compliance with ACCME
guidelines where applicable).
Educational conferences supported by Siemens educational grants must be for
scientific or educational purposes, and not for the purpose of promoting any
Siemens products. Any discussion of Siemens products at educational
conferences must be objective, balanced, and scientifically focused. Any exhibit
booths at such events for Siemens products must meet all sponsor and/or
accreditation organization rules, and exhibitor fees must be based on reasonable
rental space values.
Educational grants may not be conditioned, in whole or in part, on the purchase
of Siemens products or directed toward specific HCPs who are in a position to
use or order Siemens products. Siemens may not contribute to programs
sponsored by customers unless programs are accredited for education credits
(e.g., CME, CEU, or other applicable credit), or are sponsored by charitable
foundations or medial school affiliates.
Terms, conditions, and purposes of educational grants must be specified in
written agreements between Siemens and conference sponsors as outlined
below.
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Siemens Medical Solutions USA, Inc.
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Educational Grant Recipients
Siemens may provide educational grants:
1. Directly to conference sponsors to reduce educational conference costs.
Educational grant funds cannot be used to offset expenses not directly related
to educational conferences, such as office rent for conference sponsors or
other overhead costs incurred by conference sponsors. A portion of Siemens
educational grants may be used by conference sponsors to defray costs of
modest meals and refreshments for attendees at educational conferences.
Siemens may only support CME events or other third party educational
conferences or professional meetings to the extent they are held in venues
appropriate and conducive to the communication and training of medical
information.
2. Directly to conference sponsors to help cover reasonable travel and modest
lodging expenses of HCPs in training (e.g., residents, fellows, and medical
students) attending educational conferences, if conference sponsors select
the attendees.
Control of Conference/ Faculty Expenses
Conference sponsors, not Siemens, must have independent control of and be
responsible for the content, faculty, educational methods, materials, and
selection of attendees for educational conferences. Conference sponsors must
make all decisions regarding use of financial support from Siemens.
All or a portion of Siemens educational grants may be applied by conference
sponsors to pay for reasonable honoraria, travel, lodging, and modest meal
expenses for educational conference faculty members selected by conference
sponsors.
If faculty members have financial relationships with Siemens, Siemens should
ensure the financial relationships are disclosed to conference sponsors since
programs presented by such faculty members may be ineligible for CME credits
under ACCME Standards for Commercial Support.
Siemens may not direct conference sponsors to use grant funds for specific
faculty members. Siemens may also not pay individual faculty members directly.
Should conference sponsors permit vendors to conduct marketing activities,
Siemens may retain the services of HCPs to perform such services pursuant to
written speaker or service agreements that comply with the Compliance Manual
section “Payments for Services, Speakers, Advisory Board Members, and Other
Fee-for-Service Arrangements.”
Modest Meals and Hospitality
Siemens may directly provide meals and refreshments for educational
conference attendees if such meals and refreshments are:
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Provided to all attendees
Provided in a manner consistent with applicable standards established by
conference sponsors and, if applicable, entities accrediting the educational
activities
Modest in value
Subordinate in time and focus to the purpose of the educational conferences
Clearly separate from the educational portion of the conferences
In accordance with the policies of participants’ employers.
Siemens employees may conduct sales or promotional meetings with one or
more attendees at educational conferences, and provide meals or refreshments,
provided that meetings are conducted, and meals and refreshments supplied, in
accordance with conference sponsors’ guidelines. For additional information,
employees should refer to the Compliance Manual sections “Business Meals with
Healthcare Professionals” and “Siemens-Sponsored Promotional Site Visits,
Plant Tours, and Road Shows.”
Siemens Involvement in Educational Grants
Siemens employees may not be involved in the following activities associated
with educational grants to third parties:
Selecting content, faculty, educational methods, materials, or venues for
educational conferences. Siemens may respond to unsolicited written
requests from conference sponsors for suggestions of names for possible
speakers only. Siemens must provide (where reasonable) names of more
than one speaker, descriptions of suggested presenters’ qualifications, and
disclosure of any significant financial or other relationships between Siemens
and suggested presenters.
Promoting Siemens or Siemens products during educational conferences
funded, even partially, by educational grants. Siemens employees may
participate in educational conferences supported by Siemens grant funds as
attendees. If they are attendees, however, employees may not engage in
formal or informal promotional activities inside or outside meeting rooms. It is
acceptable for Siemens employees who are not attending educational
conferences to conduct appropriate promotional activities outside program
meeting rooms, such as adjacent exhibits.
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Unacceptable Educational Grants
Educational grants are not permitted if they are:
Intended as price terms, or offered in lieu of price concessions
Intended to encourage off-label use
Contingent on the purchase of Siemens products
Intended to encourage recipients to use, purchase, or recommend Siemens
products
Intended to reward or compensate recipients for having purchased, used, or
recommended Siemens products
Made at the request of HCPs for their individual events (e.g., request to fund
pet projects).
Made in return for anything of value provided to Siemens by recipients, with
the exception of disclosure in program materials that the program is funded
by Siemens.
All educational grant requests must receive prior approval by the Compliance
Department via the SpoDoM Tool.
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Siemens Healthcare USA Corporate Policies
Professionals Week
Each year national, state, and local professional organizations sponsor
Professionals Week to increase public understanding and appreciation of the
work various non-physician professionals contribute to the patient care and
healthcare industries.
Customers may ask Siemens to sponsor a Professionals Week, for example, by
providing breakfast or lunch for their staff. While Siemens supports the
educational purpose and goals of Professionals Week, any financial support
must be conducted in accordance with guidance provided in respect to such
events either as noted in the Compliance Manual or provided in any
communications released prior to the events.
To ensure Siemens’ participation is structured appropriately, requests must meet
the following requirements:
Requesting organizations must provide written documentation that their
internal policies permit Siemens to cover meal costs.
Meals should take place at organizations’ facilities.
Cost per person for meals may be no more than $10 all inclusive.
A list of all event attendees must be maintained.
There must be an educational/training component to the events.
A Siemens employee must be present at the events (no “drop-and-go”
scenarios).
Activities must be submitted in the CAP Tool under the event type “Nationally
Recognized Event” with all relevant supporting documentation.
No additional support, such as gifts or donated items for customer-driven
raffles, is allowed.
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Siemens Healthcare USA Corporate Policies
Clinical Research and Collaborations
All collaborations (i.e., projects with research institutes, customers, or potential
customers of Siemens in which Siemens receives non-monetary values against
non-monetary or in-kind contributions) supported by Siemens should promote
legitimate goals.
Research support may come in the form of equipment, services and supplies,
and/or monetary support. Siemens may enter into arrangements to sponsor or
authorize collaborations for purposes of developing clinical information
concerning Siemens products, both pre- and post-market, provided that the
clinical information sought is necessary to achieve a commercially reasonable
business purpose.
Support for collaborations cannot be provided with the intent to induce or
encourage the order or purchase of Siemens products. All Siemens employees
must adhere to MOR 3.3/03e—Collaboration Management.
In addition, there may be requirements unique to collaborations that involve
international HCPs or that take place outside the U.S. Employees who have
questions and are involved in such collaborations should contact their local
Compliance Officer.
In all collaborations worldwide, the following four basic compliance principles
must be followed:
1. Transparency Principle—Collaboration relationships should be clearly
defined in comprehensive, formal, written contracts, and approved by the
Legal Department.
2. Separation Principle—Collaboration agreements may not be used to
influence procurement decisions. Proposed collaborations must be evaluated
and any resulting agreements negotiated and managed by Siemens
employees who have no role in selling products or services to the
collaboration partners.
Siemens may not sponsor or authorize collaborations not intended to or that
do not develop clinical information concerning Siemens products. Siemens
may not compensate principal investigators/HCOs based on volume or value
of business generated, or reward past purchases.
3. Equivalence (Fair Market Value) Principle—Financial or in-kind
compensation must be equivalent to the deliverables and services rendered
by the collaboration partners. Such equivalence should be based on predefined approved standards, such as the Siemens Fair Market Value Policy.
In addition, equipment used for collaborations may not be used for
reimbursable procedures.
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4. Documentation Principle—Deliverables and services received from
collaboration partners must be documented. All goods and services provided
must be invoiced by both parties. Financial compensation may only be made
to accounts of collaboration partners’ organizations as specified in
collaboration agreements and on invoices.
All collaborations in the U.S., with limited exceptions, must receive prior approval
from the Compliance Department via the CAP Tool.
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Siemens Healthcare USA Corporate Policies
Compliance Training
Once new hire compliance training is assigned, new employees must complete
all training in a timely manner as specified. Such training may be in-person or
web-based depending on employees’ job titles and levels.
Employees receive compliance training each year that may cover:
Siemens Compliance System
State regulations and reporting requirements related to aggregate spend with
U.S.-based HCPs
Proper methods for marketing and selling products reimbursed by
government programs
Employee’s personal obligation to ensure government-reimbursed products
are marketed and sold in accordance with all applicable requirements of
government programs
Legal rules and sanctions for violations related to products reimbursed by
federal programs such as the Anti-Kickback Statute
In addition, all Siemens employees receive a copy of Siemens Business Conduct
Guidelines upon joining Siemens.
Compliance educational campaigns (in-person or web-based training) are 100%
mandatory for employees selected to be part of compliance education
campaigns.
Siemens’ focus, as a company, is on conducting business with the highest
integrity, and complying with applicable laws and company policies. As a part of
this commitment, all Siemens employees are accountable for completing and
remaining current with Siemens policies through training.
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Siemens Healthcare USA Corporate Policies
Compliance Helpline and Tell Us Hotline
Compliance Helpline
The Compliance Helpline is a resource that Siemens employees can use to pose
compliance questions that arise in a day-to-day business context.
Employees may either submit their compliance-related questions directly to a
compliance representative (a list of representatives can be found on the Siemens
Compliance Department Intranet) or call the Compliance Helpline telephone
number at: 1-610-448-4234.
Tell Us Hotline
Tell Us is an easy way for Siemens employees to confidentially and anonymously
report actual or potential violations of law, Siemens Business Conduct
Guidelines, or other Siemens policies in a secure manner, 24 hours-a-day, 7
days-a-week. The Tell Us Hotline is managed by a third party, and can be used
not only by employees but by customers, suppliers, and other stakeholders as
well. All reported content is handled exclusively by Siemens.
The Tell Us Hotline is: 1-800-303-9798.
Tell Us allows employees to disclose, confidentially and without retaliation, any
identified issues, questions, or suspected violations of laws and Siemens
policies, practices, or procedures. Callers are safeguarded by special regulations
that protect individuals who make good faith reports to the best of their
knowledge. Employees should be aware that intentional reporting of false
information is prohibited by law in many countries.
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Effective Date: 09-04-2014
Author: Mark Petrille, H CO USA
Siemens Medical Solutions USA, Inc.
Malvern, PA
25.
Siemens Healthcare USA Corporate Policies
Disciplinary Standards
Siemens’ focus as a company is conducting business with the highest level of
integrity. Integrity requires taking responsibility and having the courage to make
decisions following what Siemens terms as “our inner compass.” Each and every
employee is an important element in the Siemens Compliance System, and is
expected by their conduct and support, to make a contribution to its success.
When violations of the Compliance Manual occur, the Compliance Department’s
monitoring process ensures they are followed by disciplinary measures, up to
and including termination of employment.
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Effective Date: 09-04-2014
Author: Mark Petrille, H CO USA
Siemens Medical Solutions USA, Inc.
Malvern, PA
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Siemens Healthcare USA Corporate Policies
Page 54 of 55
Effective Date: 09-04-2014
Author: Mark Petrille, H CO USA
Siemens Medical Solutions USA, Inc.
Malvern, PA
Siemens Healthcare USA Corporate Policies
Change History
The Change History table below describes the changes made to each revision level of the
document.
Revision
Level
Effective Date
Pages
Description of Change
Initial publication.
Document formatting changes only.
Full content revision. Subsequent
mandatory employee web-based
training with required assessment was
released to H USA employees.
Full content revision. Subsequent
mandatory employee web-based
training with required assessment will
be released to H USA employees.
1
2
July 6, 2005
November 1, 2007
All
N/A
3
July 1, 2009
All
4
September 4, 2014
All
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Effective Date: 09-04-2014
Author: Mark Petrille, H CO USA
Order No. A912HQ-CCEC-142512-P1-4A00
Printed in USA 09-2014 | All rights reserved
© 2014 Siemens Medical Solutions USA, Inc.
Global Siemens Headquarters
Siemens AG
Wittelsbacherplatz 2
80333 Muenchen
Germany
www.siemens.com/healthcare
Local Contact Information
Siemens Medical Solutions USA, Inc.
51 Valley Stream Parkway
Malvern, PA 19355-1406
USA
Telephone: +1-888-826-9702
www.usa.siemens.com/healthcare
Global Siemens Healthcare ­
Headquarters
Siemens AG
Healthcare Sector
Henkestrasse 127
91052 Erlangen
Germany
Telephone: +49 9131 84-0
www.siemens.com/healthcare