As part of Codman &
Shurtleff, Inc.'s ongoing efforts in the area of compliance, we have developed
a Comprehensive Compliance Program that is designed to comply with applicable
federal and state laws and industry standards relating to the marketing and
promotion of our products. To our
knowledge as of the date of this declaration, Codman is in compliance with our
Comprehensive Compliance Program, as described here, and with California Health
& Safety Code sections 119400-119402.
Dated: July 1, 2007
Program Description
NOTICE: this information is provided pursuant to the
requirements of Cal. Health & Safety
Code § 119402 (S.B. 1765), which requires certain
pharmaceutical and medical device companies doing business in California to
make available their program for compliance with applicable federal and state
laws and industry standards regulating the marketing and promotion of their
products.
Codman & Shurtleff, Inc. has established a program
designed to materially comply with applicable federal and state laws and
industry standards relating to the marketing and promotion of its products.
Additionally, Codman recognizes that adherence to these standards can be
furthered through a compliance program that is informed by the Compliance Program Guidance for Pharmaceutical
Manufacturers, published by the Office of Inspector General of the
U.S. Department of Health and Human Services (the "OIG Guide"). The OIG Guide
advises that effective compliance programs are comprised of seven
elements. As described below, these
elements form the basis of Codman's program for compliance with the standards
regulating the marketing and promotion of its products.
1. Written Policies and Procedures
Codman has written policies to assure substantial compliance with the
applicable laws and regulations and standards governing the marketing and
promotion of our products. Among these
standards are recognized industry codes of conduct including the Code of Ethics on Interactions with Health Care
Professionals, published by the Advanced Medical Technology Association ("AdvaMed").
Codman has established written policies that govern activities involving communicating with customers about
the appropriate use of our products including appropriate instruction, education, training,
service and technical support required for the safe and effective use of our
products. Codman also has policies governing activities involving the advancement of scientific and
educational activities supporting medical research and education. These policies include:
Codman may provide grants for specific educational
purposes that benefit patients and customers. These may include, but are not limited to, continuing medical and
paraprofessional education programs, fellowships provided to teaching
institutions and similar organizations with a demonstrated commitment to
scientific and technical education, and programs operated by organizations that
provide high-quality, nationally recognized patient education. Funding of
educational programs will generally be provided only to organizations and
institutions and not to individual practitioners.
Research grants to support customer-initiated research
may be provided for programs involving research in areas of legitimate interest
to the company. All requests are subject to scientific review prior to funding approval.
Codman will consider charitable contributions and
requests for patient assistance in the areas of children's health, health care
education, access to health care and community responsibility, consistent with
Codman policies.
Codman will, with very limited exceptions that are in
accordance with nationally recognized standards, not reimburse for travel and
lodging expenses of attendees at promotional and educational programs.
Codman may reimburse attendees for their reasonable
travel and lodging expenses associated with attendance at product training
meetings. Product training meetings
will be conducted in locations conducive to the exchange of information such as
educational or conference settings. Where face-to-face or hands-on
customer training is reasonably necessary for the safe and effective
use of Codman's medical device products is required,
Codman may provide training at company facilities, at independent teaching
centers such as medical institutions, or in other appropriate clinical
settings.
Codman may occasionally offer a modest meal as part of
an educational presentation or a business discussion. The appropriate focus
of these activities is directed to an informational presentation or
discussion; therefore, venues that feature entertainment or recreation,
and attendance by spouses or guests, are not permitted. Modesty is to be judged by
local standards, but in general cost of meals with customers should not exceed $25 for breakfast, $50 for lunch or $125 for dinner.
On occasion, Codman representatives may provide
patient or practice-related items to customers. These items must be of
reasonable value (other than medical texts and anatomical models,
less than $100; medical texts and anatomical models must be less than $350) and infrequent.
Promotional items of nominal value (less than $25)
such as coffee cups, pens, and notepads are permitted under Codman policy.
These items usually feature a company or product logo.
Total Annual Dollar Limit for Meals, Educational or
Practice-related Items and Expense Reimbursement for Product Training Meetings
Codman has established
an annual limit of $1,500 for meals and educational or practice-related item as
the aggregate value of the items or activities that may be provided to
California health care professionals pursuant to the requirements of
Cal. Health & Safety Code § 119402 (S.B. 1765).
In general entertainment (e.g. sporting events, golf
outings, concerts, hunting, etc.) is not permitted as part of Codman's sales
activities. In circumstances when
customers are retained in a consulting relationship, recreational or social
events in conjunction with the consulting services may occur provided they are
clearly subordinate to the consulting services in terms of time and emphasis.
2. Assigned Compliance Officer
Codman has appointed a Health Care Compliance
Officer. Our Health Care Compliance
Officer has been empowered with appropriate authority to exercise independent
judgment and has free and unencumbered access to senior management.
Codman has appointed a Health Care Compliance
Committee. The committee is comprised of the company's Health Care
Compliance Officer and members of the company's management team. The Health Care
Compliance Committee is the Health Care Compliance leadership team.
3. Training
Codman has an annual Health Care Compliance training
process that includes testing and annual certification of appropriate
employees. The training covers
applicable guidelines governing our compliance program.
Employees are also trained on the consequences of failure to comply
with the requirements of the company's compliance program.
4. Communication
Codman encourages open and candid discussion between
management and employees regarding any compliance concerns. Codman employees
are encouraged to report their concerns to their manager, to the Human
Resources Department, to the Law Department or to the company's Health Care
Compliance Officer.
5. Auditing and Monitoring
Codman self-assesses and periodically audits its
compliance with its policies and procedures.
6. Enforcement and Disciplinary Guidelines
Codman will take disciplinary actions in response to
violation of the company's compliance policies or procedures. Codman will conduct a fair and diligent
investigation of matters that are brought to the company's attention in order
to ensure the consistent application of the company's standards.
7. Responses To Detected Problems and Actions To Correct Issues
Codman requires a prompt and
diligent response to potential violations of the company's compliance program, including
its standards regulating the marketing and promotion of our products. Actions in response to
detected problems may include improving policies, procedures, training,
communication and monitoring or may require disciplinary action to prevent
future violations.
For a copy of the above Codman California Compliance Program,
please call our toll free number, (800) 852-4382. Leave a voicemail
clearly stating your name, mailing address, and a copy of the program will be
sent as you requested.