AGREEMENT AMONG PRINCIPAL INVESTIGATOR,
INSTITUTION AND STUDY SITE
THIS AGREEMENT (the “Agreement”) is entered into and effective this _____ day of ________________,
2007, by and among THE CHATTANOOGA-HAMILTON COUNTY HOSPITAL AUTHORITY, a Tennessee
governmental entity, which owns, operates, and does business as Erlanger Health System (the "Study Site"),
___________________, having a business address at __________________Chattanooga, TN
37403 (the
"Institution"), and Dr. ______________. (the "Principal Investigator").
W I T N E S S E T H:
WHEREAS, the Institution and Principal Investigator entered into a Clinical Study Agreement (the "Clinical
Study Agreement") with _________ (the "Sponsor"), to conduct a study titled “________________________” (the “Study”);
WHEREAS, Study Site entered into a study site agreement with the Sponsor in connection with the Study (the
"Study Site Agreement");
WHEREAS, the Study Site, Principal Investigator, and Institution hereby enter into this Agreement for the
purposes of delineating and memorializing responsibilities of the respective parties regarding human subject research at
the Study Site in connection with the Study.
NOW, THEREFORE, the parties hereby agree as follows:
1.
Term. This Agreement shall be effective as of
the date set forth above and shall terminate upon the
earliest occurrence of the: (i) termination of the Study at
the Study Site; (ii) termination of the Clinical Study
Agreement; (iii) termination of the Study Site
Agreement; or (iv) termination of this Agreement as set
forth herein.
2.
Termination.
terminated as follows:
This
Agreement
may
be
(a)
Either party may terminate this Agreement
upon thirty (30) days advance written notice to the
other party;
(b)
The Study Site may terminate this Agreement
immediately, upon notice, in the event it determines, in
its sole reasonable discretion, that termination is
necessary to protect the interest, safety or welfare of
the Study Site, its patients or its medical staff.
(c)
The Study Site may terminate this Agreement
immediately, upon notice, in the event Institution or
Principal Investigator violates any term or condition of
this Agreement or the Clinical Study Agreement.
3.
Responsibilities of Institution and Principal
Investigator. The Institution and Principal Investigator
shall:
(a)
Be responsible for all activities undertaken by
Institution and the Principal Investigator pursuant to this
Agreement and the Clinical Study Agreement and shall
supervise the work of all persons who assist in
performing the Study.
(b)
Immediately notify the Sponsor and Study Site
in writing at such time as they become aware that the
Principal Investigator plans to leave the employ of
Institution or shall be otherwise unable to complete the
Study.
(c)
Conduct the Study in strict accordance with
the Protocol and other Study documents, which may be
amended and/or revised from time to time by Sponsor.
(d)
Not permit any Subjects to participate in the
Study unless and until (a) the IRB has reviewed and
approved the Protocol and the information to be
provided to potential Subjects of the Study to secure
their informed consent (the "Informed Consent Form"),
and (b) Institution and Principal Investigator have
provided Sponsor and Study Site with documents
verifying such review and approval.
(e)
Obtain the informed consent of each of the
persons participating in the Study (each a "Subject") in
accordance with 21 C.F.R. parts 50 and 56, including,
without limitation, the completion of an Informed
Consent Form (such activities to be referred to
collectively as "Informed Consent"). Institution and
Principal Investigator shall maintain adequate
documentation of the Informed Consent of each
Subject.
(f)
Monitor the Subjects in accordance with the
Protocol and shall notify Sponsor, Study Site and the
IRB of any information concerning any serious or
unexpected event, injury, toxicity or sensitivity reaction
or any unexpected incidents, and the severity thereof,
associated with the Study within twenty-four (24) hours
of its first becoming aware of such information.
5.
Financial Arrangement. Institution and/or
Principal Investigator shall pay Study Site for services
rendered by Study Site in connection with the Study the
amounts set forth on Exhibit A attached hereto. Study
Site shall submit an invoice to Institution and/or
Principal Investigator identifying the services rendered
by Study Site and the amount owed for such services.
Institution and/or Principal Investigator shall pay the
amount of the invoice within thirty (30) days from the
date of the invoice. Any amount of the invoice not paid
by Institution or Principal Investigator when due shall
bear interest at the rate of one and one-half percent
(1.5%) per month until paid in full. Institution, Principal
Investigator and Study Site each agrees not to seek
reimbursement from any state or federal health care
program or other third party payor for costs reimbursed
by Sponsor pursuant to the Study.
(g)
Conduct the Study in compliance with all rules
and regulations of the Study Site, the medical staff and
appropriate state and other government authorities.
Furthermore, any and all equipment or materials used
by Principal Investigator or Institution in activities,
operations or other matters performed in connection
with the conduct of the Study shall have specifications
that conform to the rules and regulations of the Study
Site, its medical staff and appropriate state and other
government authorities.
Principal Investigator and
Institution shall cause its employees, agents, and other
personnel to comply with and observe such rules,
regulations and the requirements of this paragraph.
(h)
Comply with and shall cause its officers,
agents, employees and contractors to comply with any
and all applicable federal, state and local laws,
statutes, rules, regulations, and guidelines including,
but not limited to, the Federal Food, Drug, and
Cosmetic Act, as amended, and regulations
promulgated thereunder, the United States Food and
Drug Administration ("FDA") regulations governing the
protection of human subjects and regulations governing
clinical investigators, and the Health Insurance
Portability and Accountability Act of 1996 (“HIPAA) and
the regulations published thereunder. In furtherance of
the foregoing, the parties agree that no individual shall,
on the grounds of race, sex, color, creed, national
origin, age or handicap status be excluded from
participation in, be denied the benefits of, or be
otherwise subjected to discrimination by the parties.
6.
Representations and Warranties. Institution
and Principal Investigator hereby jointly and severally
represent and warrant that:
(a)
Any amounts paid to Study Site by Institution
and/or Principal Investigator for services rendered by
Study Site in connection with the Study shall be
consistent with fair market value and shall not be
determined in a manner that takes into account the
volume or value of any referrals or business otherwise
generated between the parties for which payment may
be made in whole or in part under Medicare, Medicaid,
TennCare or other federal or state health care program.
(i)
Provide advice and assistance to the Study
Site and the Study Site's Institutional Review
Committee (herein referred to as "IRC" or "IRB"), and
keep Study Site and the IRB fully informed regarding all
aspects of the Study being conducted by the Principal
Investigator and Institution.
(b)
Institution and Principal Investigator, including,
but not limited to their officers, directors, employees
and other personnel, are currently in good standing
under and have never been suspended, excluded,
barred or sanctioned by Medicare, Medicaid or any
other state or federal health care program, nor have
they ever been convicted of a criminal offense related
to health care. Institution and Principal Investigator
shall notify Study Site immediately if any such action is
proposed or taken against Institution and/or Principal
Investigator or if they become the subject of an
investigation that could lead to such action. Study Site
shall be entitled to terminate this Agreement
immediately, without notice and without penalty or
further obligation to Institution or Principal Investigator,
upon notification by Institution and/or Principal
Investigator, or discovery by Study Site, of any such
action or investigation or at any time Study Site
discovers that the foregoing certification is or may be
untrue.
(j)
Comply with all decisions of the IRB and shall
maintain proper records and file all reports required by
the IRB.
(k)
Comply with and fulfill all of their
responsibilities as set forth in the Clinical Study
Agreement and the Protocol.
(l)
Comply with Study Site’s Code of Conduct and
Ethics and Stark and Anti-Kickback policy, both
attached hereto as Exhibit B, and Study Site’s
Compliance Program.
4.
Responsibilities of Study Site. The Study
Site shall make its facilities reasonably available to
Principal Investigator and the Institution for the purpose
of conducting the Study, after the Study has been
presented to and approved by the IRB.
(c)
Institution and Principal Investigator, including,
but not limited to their officers, directors, employees
and other personnel, have never been and are not
currently Debarred or Disqualified Persons, nor will
they employ any Debarred or Disqualified Person.
Institution and Principal Investigator further represent
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and warrant that neither they nor their officers,
directors, employees and other personnel, have
engaged in any conduct or activity that could render
any of them a Debarred or Disqualified Person and that
they have no notice that the FDA or other regulatory
authority intends to seek disqualification or debarment.
If during the term of this Agreement or the Clinical
Study Agreement, Institution, Principal Investigator or
any of their personnel (i) comes under investigation by
the FDA for debarment action or disqualification, (ii) is
debarred or disqualified, or (iii) engages in any conduct
or activity which could lead to any of them being
rendered a Debarred or Disqualified Person, Institution
and Principal Investigator shall immediately notify
Study Site. For purposes of this paragraph, “Debarred
or Disqualified Person” means any person subject to
limitations or any form of enforcement imposed upon
clinical investigators by the United States Food and
Drug Administration (FDA), the European Medicines
Evaluation Agency (EMEA), or any Regulatory
Authority or other recognized national, multi-national, or
industry body, including but not limited to sections
306(a) and (b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. Section 335a and 335b).
Principal Investigator, Institution, and all of their
employed personnel, if any, in the minimum amounts of
One Million Dollars ($1,000,000) per occurrence and
Three Million Dollars ($3,000,000.00) in the annual
aggregate. Principal Investigator and Institution shall
also maintain commercial general liability insurance,
including blanket contractual liability, with minimum
limits of One Million Dollars ($1,000,000) per
occurrence and Three Million Dollars ($3,000,000) in
the annual aggregate. The foregoing coverage shall
provide protection for any act or omission, which may
result in a claim, because of an act or omission, that
occurred during a time period that this Agreement or
the Clinical Study Agreement was in force.
All
insurance shall be placed with a company or
companies and under contracts acceptable to the
Study Site. Upon request, Principal Investigator and
Institution shall furnish Study Site with copies of each
insurance policy and shall furnish copies of all
amendments and renewals to each policy so long as
this Agreement or the Clinical Study Agreement is in
effect. Principal Investigator and Institution shall cause
to be issued by such insurer(s) a certificate thereof
reflecting such coverage and shall instruct and obtain
the consent of such insurer(s) to provide prior written
notice to the Study Site (equal to notice given to
Principal Investigator and Institution) of the cancellation
or proposed cancellation thereof for any cause or
material reduction in coverage. Principal Investigator
and Institution shall cause the Study Site to be added
as an additional insured under any insurance policies
acquired or maintained pursuant to this paragraph.
(d)
Institution and Principal Investigator shall at all
times during the term of this Agreement and the Clinical
Study Agreement be properly licensed, competent and
qualified to conduct the Study.
(e)
Institution and Principal Investigator shall
retain at their sole cost and expense a sufficient
number of properly licensed, competent personnel to
discharge the duties of Institution and Principal
Investigator under this Agreement and the Clinical
Study Agreement.
9.
Confidentiality.
(a)
In furtherance of this Agreement, it may be
necessary or desirable for the Study Site to disclose
business, financial, proprietary, trade secret, patient
and/or other confidential information (hereinafter
"Confidential Information") to Institution and/or Principal
Investigator. All such Confidential Information shall
remain the property of Study Site. Institution and
Principal Investigator agree that any such Confidential
Information disclosed to him or her, or to it or its
employees, agents and/or contractors, shall be used
only in connection with the legitimate purposes of this
Agreement, shall be disclosed only to those who have
a need to know it and are obligated to keep same in
confidence, and shall be safeguarded with reasonable
care.
7.
Indemnity.
Principal Investigator and
Institution shall jointly and severally indemnify, defend
and hold harmless the Study Site, including, without
limitation, Study Site's agents, Members of the Board of
Trustees, Officers, and employees, against all claims,
losses, costs, damages and expenses (including,
without limitation, reasonable attorneys' fees) relating
to or arising out of (i) any negligent or intentional act or
omission or any other wrongful act or conduct of
Principal Investigator or Institution, its officers, agents,
servants, employees or contractors, in the conduct of
the Study or (ii) Principal Investigator's or Institution's
breach of or default under the provisions of this
Agreement or the Clinical Study Agreement.
(b)
The foregoing confidentiality obligation shall
not apply when, after and to the extent the Confidential
Information disclosed:
8.
Insurance.
Principal Investigator and
Institution shall, at their sole cost and expense, obtain
and maintain appropriate workers' compensation
coverage for their personnel employed to fulfill their
obligations under this Agreement or under the Clinical
Study Agreement, if any, and shall carry professional
liability or errors and omissions insurance covering
(i)
is now, or hereafter becomes,
generally available to the public through no fault of
Institution or Principal Investigator or their employees,
agents or contractors;
3
employee, principal and agent or a partnership or a
joint venture between the Institution and/or Principal
Investigator and Study Site, it being understood and
agreed that no provision contained herein nor any acts
of the parties hereto shall be deemed to create any
relationship between the Institution and/or Principal
Investigator and Study Site other than that of
independent contractors.
Institution and Principal
Investigator understand and agree that (i) Institution’s
and Principal Investigator’s personnel shall be deemed
by the parties and shall be treated by Institution and
Principal Investigator as employees of Institution and/or
Principal Investigator for federal and state tax
purposes, and, consistent with such treatment,
Institution and Principal Investigator shall be
responsible for and shall withhold on behalf of such
personnel, any sums for income tax, unemployment
insurance, Social Security, or any other withholding
pursuant to any law or requirement of any
governmental body relating to Institution and/or
Principal Investigator or their personnel (the "Tax
Obligations"); (ii) Study Site will not withhold on behalf
of Institution and/or Principal Investigator or their
personnel any sums for Tax Obligations or make
available to such personnel any of the benefits afforded
to employees of Study Site; (iii) all Tax Obligations are
the sole responsibility of Institution and Principal
Investigator; (iv) Institution and Principal Investigator
shall provide to Study Site within three (3) days of
Study Site’s request proof acceptable to Study Site in
its sole discretion of payment of Tax Obligations; and
(v) Institution and Principal Investigator shall jointly and
severally indemnify and hold Study Site harmless from
and against any and all loss or liability arising out of or
with respect to the Tax Obligations.
(ii)
was already in the possession of
Institution and/or Principal Investigator without
restriction as to confidentiality at the time of disclosure
as evidenced by competent written records; or
(iii)
is subsequently received by Institution
and/or Principal Investigator from a third party without
restriction and without breaching any confidential
obligation between the third party and the Study Site.
(c)
Confidential Information may also be disclosed
to the extent required by law. To the extent Institution
or Principal Investigator discloses Confidential
Information as required by law, he, she or it agrees to
give maximum practical advance notice of same and
request such confidential treatment of such disclosure
from the recipient thereof as may be afforded by law.
Neither Institution nor Principal Investigator shall
disclose the terms of this Agreement to any third party,
except as required by law or with the permission of
Study Site.
(d)
Institution and Principal Investigator know and
understand that use and disclosure of Protected Health
Information is governed by the Health Insurance
Portability and Accountability Act of 1996, and the rules
and regulations published thereto, all as may be from
time to time modified or amended (hereinafter referred
to as “HIPAA”). Institution and Principal Investigator
hereby agree not to access, use or disclose Protected
Health Information except in strict accordance with
valid HIPAA Authorizations and Informed Consents,
and then only to the extent necessary to carry out the
limited purpose of the access to, use or disclosure of
such Protected Health Information and in accordance
with the provisions of HIPAA and all applicable federal,
state and local laws, rules and regulations. Institution
and Principal Investigator shall indemnify and hold
harmless Study Site including, without limitation, Study
Site’s agents, members of the Board of Trustees,
officers, employees and independent contractors,
against all claims, losses, costs, damages and
expenses (including, without limitation, attorneys’ fees),
and all fines, penalties and interest, arising out of or
relating to Institution’s and/or Principal Investigator’s
breach of the provisions of this paragraph. As used
herein, the term “Protected Health Information” shall
have the meaning as set forth in HIPAA.
12.
Governing Law. This Agreement shall be
governed by an interpreted in accordance with the laws
of the State of Tennessee.
Hamilton County,
Tennessee shall be the sole and exclusive venue for
any litigation, special proceeding, or other proceeding
between the parties that may be brought, arise out of,
or in connection with or by reason of this Agreement or
the Clinical Study Agreement; provided, however, any
judgment or settlement rendered in or agreed upon in
any such litigation or proceeding may be enforced in
any other jurisdiction.
13.
Entire Agreement. This Agreement and all
documents referenced herein supercede all previous
contracts regarding the subject matter herein and
constitute the entire agreement between the parties.
No oral statements or prior written material not
specifically incorporated herein shall be of any force
and effect, and no changes in or additions to this
Agreement shall be recognized unless incorporated
herein by amendment as provided herein, such
amendment or amendments to become effective on the
date stipulated in such amendment or amendments.
10.
Ownership of Medical Records.
Any
hospital medical records generated pursuant to this
Agreement or the Clinical Study Agreement by
Principal Investigator, Institution or otherwise, shall be
the property of Study Site.
11.
Relationship of the Parties.
Nothing
contained in this Agreement shall be deemed nor
construed as creating a relationship of employer and
4
Attn: _______________________
Phone No:___________________
Fax No.: _____________________
14.
Notice.
Any
notice,
demand,
or
communication required, permitted, or desired to be
given hereunder shall be deemed effectively given
when mailed by prepaid certified mail, return receipt
requested; delivered by hand or personal delivery or
overnight courier service; or by facsimile or other
electronic transmission, which date and time stamps
such notices, addressed as follows:
or to such other address, and to the attention of such
other person(s) or officer(s) as either party may
designate by written notice.
15.
Amendments. This Agreement may not be
changed, amended or modified except in writing,
signed by all parties.
STUDY SITE:
16.
Successors and Binding Effect.
This
Agreement shall be binding upon and shall inure to the
benefit of the parties and their respective legal
representatives, successors and assigns.
The Chattanooga-Hamilton County Hospital Authority
975 E. Third Street
Chattanooga, Tennessee 37403
Attn: Stacey Hendricks and President
Fax No.: (423) 778-4170
17.
Assignment.
No assignment of this
Agreement or the rights and obligations hereunder shall
be valid without the specific written consent of all
parties hereto. Any attempted assignment in violation
of this provision shall be void and shall have no binding
effect.
INSTITUTION and PRINCIPAL INVESTIGATOR:
Name:
Address:
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date above first written.
INSTITUTION:
PRINCIPAL INVESTIGATOR:
_______________________________________
By:
.
By:
Name:
Title:
STUDY SITE:
Chattanooga-Hamilton County Hospital Authority
By:
Name:
Title:
F:\LIBRARY\USERS\CLIENTS\016802\2210\Investigator Agmt reh.doc
5
EXHIBIT A
(Price list for medical services rendered by Study Site in connection with the Study)
Reimbursement for study Related Changes
Guarantor will be:
Reimbursement to Study Site: A check will be issued by: ______________ upon an invoice from the Study
Site for the following procedure(s). Research related procedures will be reimbursed at 70%.
(List procedure, service code, patient charge and research charge)
Erlanger Inpatient
Procedure
Service code
Pt. Charge
Research
charge
Outpatient (Plaza)
Service
code
Pt. Charge
Research
charge
The above procedures will only be paid by ________________when they are preformed in compliance with
the study protocol and are not considered standard of care.
_______________________will notify Gigi Crocker in Accounting at 4727; e-mail:
gigi.crocker@erlanger.org for Inpatient related charges. Charity Walton will be notified in Patient
Registration at 6556; e-mail: charity.walton@erlanger.org when a patient needs to be registered in for
outpatient related procedures.
6
EXHIBIT B
Code of Conduct and Ethics
Revised and Effective November 18, 2004.
I. PURPOSE
This Code of Conduct and Ethics (the “Code of Ethics”) has been adopted by the ChattanoogaHamilton County Hospital Authority d/b/a Erlanger Health System (“Erlanger”) to provide
standards by which Erlanger employees, officers, trustees, medical staff and agents will conduct
themselves to protect and promote organization-wide integrity and to enhance Erlanger’s ability to
achieve its organizational mission. The Code of Ethics is intended to serve as a guide to assist
Erlanger’s employees, officers, trustees, medical staff and agents to make sound decisions in
carrying out their day to day responsibilities.
II. RESPONSIBILITIES UNDER THE CODE OF ETHICS
Who must comply with Erlanger’s Code of Ethics?
This Code of Ethics applies to all employees, officers, trustees, medical staff and agents affiliated
with Erlanger throughout Erlanger’s diverse operations, including the following locations: The
Erlanger Baroness Campus, Erlanger East, Erlanger North, Erlanger Soddy Daisy, Erlanger
Bledsoe Hospital, T.C. Thompson Children’s Hospital, the Southside and Dodson Avenue
Community Health Centers, ContinuCare Health Services, Inc., Erlanger Pharmacies, Inc., E-Kids
Learning Centers and any other facilities or services which shall become a part of Erlanger Health
System (the “Affiliates”). Erlanger recognizes the different missions and services that each Affiliate
provides and that the Code of Ethics is designed to allow flexibility for each Affiliate in developing
policies and procedures to achieve the standards and goals set forth in the Code of Conduct while
maintaining each Affiliate’s unique mission and services.
What are the responsibilities of each employee with regard to the Code of Ethics?
• Read the standards of conduct and ethics and think about their application to your work. You
should have a basic understanding of issues covered by each standard and the supplemental
compliance policies that apply to your job function.
• Seek assistance from your supervisor, the Chief Compliance Officer, the Chief Legal Officer or
other Erlanger resources when you have questions about the application of the standards and
other Erlanger policies to your work.
• Understand the numerous options that Erlanger makes available to you for raising conduct or
ethical concerns and promptly raise such concerns. You should raise such concerns with your
immediate supervisor, Erlanger’s Chief Compliance Officer or its Chief Legal Officer. If you prefer
to raise your concerns anonymously, the Erlanger Integrity Line 1-877-849-8338 is another
resource upon which you can rely.
• Cooperate in Erlanger investigations concerning potential violations of law, the Code of Ethics,
the Erlanger Compliance Program and Erlanger policies and procedures.
What are the responsibilities of Erlanger officers, managers and other supervisors?
Build and maintain a culture of compliance by:
• Personally leading compliance efforts through frequent meetings that require compliance reports
and regular monitoring of compliance matters and programs.
7
• Leading by example, using your own behavior as a model for all employees.
• Encouraging employees to raise conduct and ethical questions and concerns.
• Using employee actions and judgments in promoting and complying with Erlanger’s Code of
Ethics and other policies as considerations when evaluating and rewarding employees.
• Equipping the Office of Compliance with the resources it needs to be successful.
Prevent compliance problems by:
• Identifying compliance risks and proposing appropriate policies and procedures to address such
risks.
• Identifying employees whose activities involve issues covered by Erlanger policies.
• Providing education and counseling to assist employees to understand the Code of Ethics,
Erlanger policies and applicable law.
Detect compliance problems by:
• Implementing and maintaining appropriate controls to monitor compliance and mechanisms that
foster the effective reporting of potential compliance issues.
• Promoting an environment that permits employees to raise concerns without fear of retaliation.
• Arranging periodic compliance reviews that are conducted with the assistance of the Chief
Compliance Officer to assess the effectiveness of Erlanger’s compliance measures and to identify
methods of improving them.
Respond to compliance problems by:
• Pursuing prompt corrective action to address weaknesses in compliance measures.
• Applying appropriate disciplinary action when necessary.
• Consulting with Erlanger’s Chief Compliance Officer so that compliance issues are promptly and
effectively addressed.
What are the responsibilities of Erlanger trustees?
• Read the Standards of Conduct and Ethics and think about their application to you.
• Lead by example, using your own behavior as a model for others.
• Make decisions that are in the best interest of Erlanger and which are not affected by conflicts of
interest.
• Trustees are required to be knowledgeable about the Erlanger Compliance Program and
exercise oversight over it.
• Trustees receive appropriate reports from management concerning the status of the Compliance
Program, the resources required to maintain its vitality and Erlanger’s response to identified
compliance deficiencies.
• Trustees receive and act upon advice from management, including the Chief Executive Officer,
the Chief Legal Officer, and the Chief Compliance Officer.
• Trustees assure themselves that the Compliance Program is free from undue restraints and
influences through direct reporting by the Chief Compliance Officer to the Board of Trustees of
compliance matters that promote the integrity of the Compliance Program and raising any
concerns with the Chief Compliance Officer or the Chief Legal Officer.
• Trustees maintain the confidentiality of all compliance-related information provided to them,
subject to the requirements of applicable law.
What are the responsibilities of medical staff?
8
• Read the standards of conduct and ethics and think about their application to your work. You
should have a basic understanding of issues covered by each standard and the supplemental
compliance policies that apply to the services you furnish to Erlanger and our patients.
• Actively participate in compliance activities as requested by Erlanger administration.
• Assist Erlanger in identifying possible compliance issues and in developing possible solutions to
address those issues.
• Understand the various options that Erlanger makes available for raising conduct or ethical
concerns and promptly raise such concerns. You should raise such concerns with Erlanger’s Chief
Compliance Officer or its Chief Legal Officer. If you prefer to raise your concerns anonymously,
the Erlanger Integrity Line 1-877-849-8338 is another resource upon which you can rely.
• Cooperate in Erlanger investigations concerning potential violations of law, the Code of Ethics,
the Erlanger Compliance Program and Erlanger policies and procedures.
What are the responsibilities of agents?
• Read the standards of conduct and ethics and think about their application to the services you
furnish to Erlanger. You should have a basic understanding of issues covered by each standard
and the supplemental compliance policies that apply to the services you furnish to Erlanger.
• Actively participate in compliance activities, such as education and training, as requested by
Erlanger.
• Understand the various options that Erlanger makes available for raising conduct or ethical
concerns and promptly raise such concerns. You should raise such concerns with Erlanger’s Chief
Compliance Officer or its Chief Legal Officer. If you prefer to raise your concerns anonymously,
the Erlanger Integrity Line 1-877-849-8338 is another resource upon which you can rely.
• Cooperate in Erlanger investigations concerning potential violations of law, the Code of Ethics,
the Erlanger Compliance Program and Erlanger policies and procedures.
How May the Code of Ethics Be Revised?
This Code of Ethics may be amended, modified or waived only with the approval of the Chief
Executive Officer and the Board of Trustees.
How Frequently will the Compliance Program Be Reviewed?
The Compliance Program (including the code of Ethics) will be reviewed annually by the Executive
Compliance Committee to foster its effectiveness and at such times when changes to it are
necessitated by changes in laws and regulations applicable to Erlanger. Suggested changes to
the Compliance Program will be presented to the Board of Trustees.
III. STANDARDS OF CONDUCT AND ETHICS
1. Patient Relationships: We are committed to providing a high quality of healthcare and
services to our patients, their families, visitors and the community. We treat all patients
with respect and dignity and provide care that is necessary and appropriate.
Principles:
* We will recognize the right of our patients to receive quality services provided by competent
individuals in an efficient, cost effective and safe manner.
* We will continually monitor the clinical quality of the services we provide and will endeavor to
improve the quality of the services provided.
* We will support every patient’s right to be free from all types of abuse, and will not tolerate
patient abuse in any form.
9
* We will apply our admission, treatment, transfer and discharge policies to all patients based
upon identified patient needs and such policies will be consistent with all legal requirements
applicable to Erlanger.
* We will listen to our patients, families and visitors to understand any concerns or complaints and
will involve patients in the decision-making process about their care.
* We will provide treatment and medical services without discrimination based on race, age,
religion, national origin, sex, sexual orientation or disability.
* We will remain sensitive to our position as a regional leader in tertiary and specialty care and
research, and to our consequent obligation as a health care leader to all segments of our
community.
* We will implement policies and procedures to complete emergency assessments as required for
all who request our emergency services.
* We will fully and fairly evaluate requests to transfer patients to our care from our colleagues and
providers in outlying areas, and will accept such transfers as clinically appropriate.
* We will maintain licensure and credentialing standards to further the provision of clinical services
by properly trained and experienced practitioners.
* We will perform background checks of potential employees and consultants to verify credentials
and to assess whether such individuals and entities have ever been excluded from participation in
any of the federal health care programs, including the Medicare and Medicaid programs.
* We will respect the privacy of our patients, and we will treat all patient information with
confidentiality, in accordance with all applicable laws, regulations and professional standards.
2. General Legal and Regulatory Compliance: Erlanger will continuously and vigorously
promote full compliance with applicable law.
Principles
* We will continuously study our legal obligations and create policies and procedures that facilitate
compliance by our employees, officers, trustees, medical staff and agents with such legal
obligations.
* We will recognize the critical role of research in improving the health status of our community,
and we are committed to conducting all research activities in compliance with the highest ethical,
moral, and legal standards.
* We will engage in open and fair competition and marketing practices, based on the needs of our
community and consistent with the furtherance of our mission.
* We will treat our employees with respect, and will engage in human relations practices that
promote the personal and professional advancement of each employee.
* We will recognize that our employees work in a variety of situations and with a variety of
materials, some of which may pose a risk of injury. We are committed to providing a safe work
environment, and will implement and monitor policies and procedures for workplace safety that are
designed to comply with federal and state safety laws, regulations, and workplace safety
directives.
* We will recognize that the provision of health care may in some instances produce hazardous
waste products or other risks involving environmental impact. We are committed to compliance
with applicable environmental laws and regulations, and will follow proper procedures with respect
to handling and disposing of hazardous and bio-hazardous waste.
* We will expect our employees, officers, trustees, medical staff and agents to understand the
basic legal obligations that pertain to their individual job functions or services they furnish to
Erlanger and our patients, and will require that they strive to make certain that their decisions and
actions are conducted in conformity with such laws, regulations, policies and procedures.
* We will support educational and other training sessions to teach Erlanger employees, officers,
trustees, and as warranted medical staff and agents, about the impact of the law on their duties
and to promote compliance with our collective legal obligations.
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* We will support and maintain multiple resources for employees, officers, trustees, medical staff
and agents to voice any questions about the proper interpretation of a particular law, regulation,
policy or procedure.
3. Avoidance of Conflicts of Interest: Employees, Officers, Trustees, Medical Staff and
Agents maintain a duty of loyalty to Erlanger and, as a result, must avoid any activities
which may involve (or may appear to involve) a conflict of interest or that may influence or
appear to influence the employee, officer, trustee, medical staff member or agent’s ability
to render objective decisions in the course of his or her job responsibilities, or other
services he or she furnishes to Erlanger.
Principles.
* We will maintain policies and procedures that make clear scenarios in which an individual’s
private interests may inappropriately interfere with Erlanger’s interests and will provide support
through which employees, officers, trustees, medical staff and agents may pose questions about
whether a particular outside activity or relationship could be construed as a conflict of interest.
* We will articulate expectations of the conduct that must be demonstrated by employees, officers,
trustees, medical staff and agents in the performance of services for Erlanger, and will require that
such individuals remain free of conflicts of interest in the performance of their responsibilities and
services to Erlanger.
* We will require employees, officers, trustees, medical staff and agents to inform Erlanger of
personal business ventures and other scenarios that could be perceived as conflicts of interest
and will provide for policies and procedures for doing so.
* We will not permit employees, officers, trustees, medical staff or agents to use any proprietary or
non-public information acquired as a result of a relationship with Erlanger for personal gain or for
the benefit of another business opportunity.
* We will render decisions about the purchase of outside services and goods based on the
supplier’s ability to best satisfy Erlanger’s needs and not based on personal relationships.
4. Relationship with Payers: Erlanger will consistently strive to satisfy the conditions of
payment required by the payers with which Erlanger transacts business.
* We will promote compliance with laws governing the submission and review of bills for our
services and will deal with billing inquiries in an honest and forthright manner.
* We will implement reasonable measures to prevent the submission or filing of inaccurate, false
or fraudulent claim to payers.
* We will utilize systematic methods for analyzing the payments we receive and will reconcile
inaccurate payments in a timely manner after discovery and review.
* When warranted, we will investigate inaccurate billings and payments to determine whether
changes to current protocol or other remedial steps are necessary.
* We will implement documentation systems sufficient to create and maintain complete and
accurate documentation of services provided.
* We will review cost reports to be filed with the federal health care programs to determine
whether such reports accurately and completely reflect the operations and services provided to
beneficiaries and to confirm that such reports are completed in accordance with applicable federal
and state regulations and Erlanger policies and procedures.
* We will as necessary rely on internal and external sources to help improve Erlanger’s billing and
coding protocol and to identify potential areas of noncompliance.
* We will compensate billing and coding staff and consultants for services rendered, and will not
compensate such persons in any way related to collections or maximization of revenues.
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5. Relationship with Physicians and Other Providers: Erlanger will monitor its business
dealings to structure relationships in ways that satisfy the needs of the community.
* We will maintain relationships with physicians and other referral sourcesbased only on the needs
of our community and consistent with the furtherance of our mission.
* We will treat referral sources fairly and consistently, and will not provide remuneration that could
be considered payment for referrals, including:
+ free or below-market rents;
+ administrative or staff services at no- or below-cost;
+ grants in excess of amounts for bona fide research or other services rendered;
+ interest-free loans; or
+ gifts, “perks” or other payments intended to induce referrals.
* We will implement policies, procedures and other protocol which require fair market value
determinations for services rendered by referral sources and for services rendered by Erlanger.
* We will implement procedures to require all agreements with referral sources to be reduced to
writing and reviewed and approved as appropriate under law and Erlanger policy.
* We will train the appropriate personnel on the primary laws and regulations governing the
referral of patients and other legal restrictions on the manner in which Erlanger transacts
business, including the penalties that may result for violations of such laws.
6. Respect for Our Culture: We recognize that a diverse workforce enriches the life
experience of all employees and our community, and will promote diversity consistent with
the Erlanger Diversity Plan.
* We will provide equal employment opportunities to employees and applicants for employment
without regard to race, color, religion, sex, national origin, age, veteran status, or disability, in
accordance with applicable law.
* We will implement policies and procedures that promote compliance with laws governing
nondiscrimination in personnel actions, including recruiting, hiring, evaluation, transfer, workforce
reduction, termination, compensation, counseling, discipline, and promotion of employees.
* We will promote diversity with respect to individuals with disabilities, and will make reasonable
accommodations to any individual as required by law.
* We will recognize the right of our employees to a workplace free of violence and harassment,
and will not tolerate any form of harassment or violence toward our employees.
* We will implement policies and procedures that promote appropriate conduct in the workplace
and prohibit unwanted or hostile interaction, including degrading or humiliating jokes, physical or
verbal intimidation, slurs, or other harassing conduct.
* We will not tolerate any form of sexual harassment, either overt, such as request for sexual
favors in return for promotions, or less obvious forms of harassment, such as sexual comments.
* We will maintain policies and procedures prohibiting workplace violence, including robbery,
stalking, assault, terrorism, hate crimes, or violence directed at supervisors.
7. Information and Information Systems. We recognize that the provision of health care
services generates business, financial, and patient-related information that requires special
protection. We will establish systems that ensure such information is used appropriately
and safeguarded zealously.
* We are committed to the security and accuracy of documents and records in our possession,
and will develop systems, policies and procedures sufficient to safeguard the integrity of our
documents and records, including systems, policies and procedures to:
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+Establish retention periods and protocols for business, financial and patient records in the
Erlanger system.
+Prevent the altering, removal, or destruction of records or documents except according to
our records retention policy and applicable ethical and legal standards.
+Promote the accurate, thorough, detailed, and complete documentation of all business,
financial, and patient transactions.
+Control and monitor access to Erlanger communications systems, electronic mail, Internet
access, and voicemail to ensure that such systems are accessed appropriately and used in
accordance with Erlanger’s policies and procedures.
+Protect the privacy and security of patient medical, billing, and claims information by
implementing sufficient physical, systemic, and administrative measures to prevent
unauthorized access to or use of patient information, and to track disclosures of such
information as required by law.
+Provide access to their medical, billing, and claims information for our patients and their
legal representatives as required by law.
+Safeguard the personal and human resources information of our employees, including
salary, benefits, medical, and other information retained within the human resources
system.
IV. VIOLATIONS OF THE CODE OF ETHICS
Erlanger is committed to providing all employees, officers, trustees, medical staff and agents with
a means of raising questions and concerns, and reporting any conduct that the employee, officer,
trustee, medical staff member or agent suspects is in violation of this Code of Ethics. Employees,
officers, trustees, medical staff and agents are expected and required to communicate any
suspected violations of the Code of Ethics to, as applicable, a direct supervisor, the Chief
Compliance Officer or the Chief Legal Officer. If you prefer, you can anonymously call the Erlanger
Integrity Line which is available 24 hours a day, 7 days a week: 1-877-849-8338. The Chief
Compliance Officer will maintain primary responsibility for investigating reports received on this
hotline. The following list, while not exhaustive, describes the type of concerns and questions that
you should raise with your supervisor, the Chief Compliance Officer, the Chief Legal Officer or
through the Erlanger Integrity Line:
(i) the possible submission of false, inaccurate, or questionable claims to Medicare, TennCare or
any other payer;
(ii) the provision or acceptance of payments, discounts or gifts in exchange for referrals of
patients;
(iii) the utilization of improper physician recruitment techniques under applicable law;
(iv) allegations of discrimination;
(v) potential breaches of confidentiality or privacy; and
(vi) situations that could raise conflicts of interest concerns.
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Personal Commitment and Certification
I acknowledge and certify that I have received and read the Erlanger Code of Conduct and Ethics
and I understand my obligations to comply with the Code. I agree to comply with the Erlanger
Code of Conduct and Ethics.
Employees and Officers:
I understand that compliance with this Code is a condition of my continued employment. I further
understand that violation of the Code of Conduct and Ethics may result in disciplinary action up to
and including termination.
Initials: ____
Trustees: I understand that compliance with this Code is essential to my service on the Board of
Trustees of the Chattanooga-Hamilton County Hospital Authority.
Initials: ____
Medical Staff: I understand that compliance with this Code is a condition to my ability to practice
my profession at Erlanger. I further understand that violation of the Code of Conduct and Ethics
may result in disciplinary action as provided in the Bylaws of the Medical Staff.
Initials: ____
Agents: I understand that compliance with this Code is a condition of my continued ability to
furnish services to Erlanger. I further understand that violation of the Code of Conduct and Ethics
may result in a termination by Erlanger of any relationship with Erlanger.
Initials: ____
Please sign here: _____________________________ Date: _________________
Please print your name: _______________________ Dept. _________________
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Erlanger Health System
Origination Date: Feb. 20, 2006
Approval:
Policy and Procedure
Reviewed
Date
Revised
Date
Approval:
Index Title: Compliance with the Anti-Kickback Statute and Stark Law
Originating Department: Office of Compliance
Number: 8316.980
Description for EHS Intranet: To ensure compliance with the Anti-Kickback
Statute and Stark Law
Policy statement:
In order to provide quality health care to members of the community, Erlanger
employs and conducts business with a number of different physicians.
Erlanger’s interactions with physicians can affect a variety of issues including
the Anti-Kickback Statute and the Stark Law. Erlanger is committed to
complying with all applicable laws in its relationships with physicians,
maintaining the highest ethical standards, and ensuring that the physicians
practicing at Erlanger’s facilities also adhere to the highest ethical standards.
Scope:
All Erlanger Health System employees, members of the Board of Trustees
(“Board”), members of the medical staff, and agents.
Definitions:
Agents. Those individuals or entities that have contracted with or volunteer at
Erlanger to provide health care related services, equipment or other items or
services, including, but not limited to, residents, medical students,
independent contractors, consultants, volunteers and vendors.
Procedure:
Stark Law. The Stark Law prohibits physicians from referring patients to Erlanger
for certain health services if the physician or the physician’s family member has a
financial relationship with Erlanger.
A financial relationship can include an
ownership or investment interest or a compensation arrangement. Any
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relationship involving the
Compliance with the Anti-Kickback Statute and Stark Law 8316.980 Page 2 of 3
transfer of payments or benefits, including income guarantees, certain types of
loans, free or discounted services equipment or office space, constitutes a
compensation arrangement.
Anti-Kickback Statute. Physicians and employees are strictly prohibited from
accepting gifts, favors payments, services, or anything else of value which might
appear to influence the actions of the physicians or of Erlanger. Physicians and
employees may retain gifts of nominal value and should report any inappropriate
offers to the Chief Compliance Officer (”CCO”), a member of the Compliance
Committee, or any supervisor. Physicians and employees are strictly prohibited
from soliciting or accepting anything of value in exchange for patient referrals or in
exchange for purchasing or leasing any item or service which may be reimbursed
by Medicare, Medicaid, or any federal or state health care program.
Erlanger will maintain relationships with physicians and other referral sources
based only on the needs of the community and consistent with the furtherance of
Erlanger’s mission.
Erlanger will treat referral sources fairly and consistently, and will not provide
remuneration that could be considered payment for referrals, including:
Free or below market value rents;
Administrative or staff services at no- or below cost;
Grants in excess of amounts for bona fide research or other services
rendered;
Interest-free loans; or
Gifts, “perks” or other payments intended to induce referrals
Compliance with these policies is a required condition of employment or continued
engagement with Erlanger. Violations of these policies should be reported in
accordance with the Compliance Program’s Reporting Policy. All arrangements
shall be reviewed by the CCO and legal counsel competent in the area of
compliance with the Anti-Kickback Statute, Stark Law, and the regulations and
other guidance documents related to the statutes, and business or financial
arrangements or contracts that generate unlawful federal health care program
business in violation of the statutes. All agreements with physicians are also
subject to the Arrangements Database and Monitoring Policy.
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Compliance with the Anti-Kickback Statute and Stark Law 8316.980 Page 3 of 3
Committee
Approval/Date
Compliance Department________________________________________Feb. 20, 2006___________
Compliance Committee_______________________________________________________________
Policies and Procedures Committee_____________________________________________________
References:
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