Acceleron is dedicated to the discovery and development of innovative, life-changing medicines for patients with a wide range of serious and rare diseases. Acceleron is committed to achieving this goal while maintaining the highest level of good corporate conduct, integrity, and ethics in all of our activities. Establishing and maintaining an effective Compliance Program is a key component of this commitment. Guidance issued by the Office of Inspector General, U.S. Department of Health and Human Services (”OIG”) outlines seven key elements of an effective compliance program. We have developed and implemented our Compliance Program to address each of these elements.
The purpose of our Compliance Program is to foster a culture of compliance and to prevent, detect, and remediate any violations of law or company policy. Acceleron expects our employees, contractors, and agents to comply with our Code of Business Conduct and Ethics (“Code of Conduct”) and all applicable written standards established in support of it.
The key components of our Compliance Program are described below, addressing each of the seven elements of an effective compliance program as outlined in OIG guidance. As OIG guidance envisions, we have designed our Compliance Program to fit the size, resources, market position, and other unique aspects of our company. At Acceleron, we recognize that an effective compliance program must evolve and respond to the changing circumstances of the company and its environment. To this end, we are committed to continuous quality improvement based on regular review, assessment, and development of the Compliance Program and the changing regulatory and business environment.
Key Components of our Compliance Program:
1. Responsibility and Oversight
Acceleron’s Board of Directors is committed to upholding high standards of corporate governance and has designated the Audit Committee to oversee the effectiveness of the Compliance Program. Acceleron has also appointed a Chief Compliance Officer (“CCO”), who is responsible for developing, overseeing, and monitoring our Compliance Program, and ensuring that it upholds our values and fosters a culture of integrity. Our CCO has the authority to exercise appropriate professional judgment regarding the Compliance Program, and to develop and implement revisions and improvements as needed to maintain it. Our CCO reports to the General Counsel and has independent reporting authority and responsibility to our Board of Directors on compliance-related matters.
Acceleron has also established a Compliance Committee, comprised of key functional leaders across the company, as well as the Chief Executive Officer. The Compliance Committee collaborates with the CCO to advance Acceleron’s Compliance Program and meets to review and develop action plans for compliance-related matters.
2. Written Standards
Acceleron’s Code of Conduct is a testament to our ways of working with integrity and good judgment, that guide our daily operations. The Code of Conduct establishes key ethical principles that we expect our personnel to follow, as well as standards to help ensure compliance with applicable laws, industry standards, and company policies. To emphasize the importance of the principles contained in our Code of Conduct, we require each of our employees to read, attest to, receive training on, and abide by it and all other applicable Acceleron written standards.
Acceleron has also developed and implemented policies, procedures, guidelines, and training to, among other things, address potential risk areas for biotechnology manufacturers, including those identified in OIG guidance. These efforts also ensure adherence to the standards of the PhRMA Code on Interactions with Health Care Professionals, which we voluntarily adopt.
3. Education and Training
Education and training are essential to effectively communicate our standards to Acceleron personnel and enable them to perform in accordance with them. All personnel are provided training on Acceleron’s Code of Conduct and other written standards applicable to their job functions. We maintain and monitor training records to ensure all personnel have received the appropriate training, and periodically update our training program to reflect any changes in our business or externally. Education and training are critical elements of our Compliance Program, specifically with regard to training personnel on their legal and ethical obligations under applicable state and federal health care program requirements.
4. Internal Communication and Reporting
Acceleron is committed to fostering an active and healthy dialogue between management and employees regarding ethics and compliance matters. Acceleron personnel are encouraged to proactively ask questions and are provided with access to compliance resources, including how to report potential compliance concerns. Acceleron understands that our personnel must not just know how to access these resources, but also must feel comfortable doing so without fear of retaliation. Acceleron has adopted policies and procedures that strongly encourage all personnel to report potential compliance concerns, and include measures to ensure that no report is met with retaliation by Acceleron or its personnel. Acceleron has established a secure hotline and website to report potential compliance concerns, and to do so anonymously when permitted by law. The reporting hotline can be accessed by calling 1-833-687-0008 or accessing www.lighthouse-services.com/acceleronpharma. Information about Acceleron’s reporting hotline and website is given to all personnel as a part of new hire orientation, annual compliance training, and is made available on our intranet site.
5. Auditing and Monitoring
Acceleron’s Compliance Program includes the monitoring and auditing of business activities to assess compliance with our Code of Conduct and written standards. Consistent with OIG guidance, we take a number of factors into consideration when determining the nature, extent, and frequency of our compliance monitoring and auditing activities. New legal requirements, developments in business practices, results of our compliance risk assessments, and similar considerations may result in new or revised monitoring and auditing activities to help ensure that compliance risks are appropriately addressed.
6. Enforcement of Standards
Our Compliance Program aims to instill confidence in our employees to make the right decisions and practice good judgment. We recognize those who carry out business activities in accordance to our written standards. We also maintain processes for addressing potential compliance missteps. These help ensure that relevant facts and circumstances are understood and considered in connection with all remediation activities. They are also intended to make sure that appropriate and consistent action is employed to address any missteps and deter future violations.
7. Corrective Action
Acceleron works on an on-going basis to ensure compliance with all applicable health care laws and our internal written standards. We believe that our Compliance Program increases the likelihood of preventing or identifying unlawful and unethical behavior. We recognize, however, that even an effective compliance program will not prevent all violations. Our Compliance Program, therefore, requires the company to respond promptly to potential violations of law or Acceleron written standards, take appropriate disciplinary action, assess whether the violation may be due to gaps in our policies, processes, or internal controls, and take appropriate corrective action to prevent or limit future violations.
Acceleron conducts an annual compliance risk assessment to ensure that our Compliance Program continues to address appropriate risks related to our business activities and informs us of how to continually update the program.
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Acceleron is committed to conducting our activities in compliance with applicable laws and ethical standards. We believe we have developed and implemented an effective Compliance Program, and will work to continually improve and evolve it.
Annual Declaration: February 2021
State of California Compliance Program Declaration
To the best of our knowledge, as of February 3, 2021, Acceleron is in material compliance with our Comprehensive Compliance Program and the requirements of the California Health and Safety Code §§ 119400-119402.
Consistent with our understanding of the California Health and Safety Code, this declaration is limited to those activities undertaken by Acceleron that are directed to California. Acceleron makes this declaration, in good faith, in the absence of clarifying regulations or guidance from the State of California. This declaration reflects our consideration of the OIG Guidance, which gives broad discretion to manufacturers in the development, design and definition of the scope of compliance programs.
Annual Cap under California Health and Safety Code § 119402
As required by the California Health and Safety Code § 119402, Acceleron has established a maximum annual aggregate dollar limit of $1,500 for gifts, meals, educational items, and other business courtesies provided to healthcare professionals licensed in the State of California.
This limit does not include:
- Legitimate professional services provided by healthcare professionals, provided that the payment does not exceed fair market value of the services rendered;
- Drug samples given to healthcare professionals intended for free distribution to patients;
- Financial support for continuing medical education forums; and
- Financial support for health educational scholarships
The $1,500 limit is an annual cap, not a goal or average, and it may be revised by Acceleron in our sole discretion.
A written copy of this declaration may be obtained by contacting our Compliance Department at firstname.lastname@example.org.