FSHD Society Compliance Program
and Code of Conduct
The Society believes, at its core, in Doing Good the Right Way, and our Compliance Program (“the Program”) is an expression of that. This Program, led by our Compliance Officer, Amanda Hill, and the Compliance Committee which includes at least one board member, is an organized system, comprised of written standards, training, monitoring, and auditing, to ensure that we operate in an ethical, lawful, and compliant manner.
Compliance Program (“the Program”) is an expression of that. This Program, led by our Compliance Officer, Amanda Hill, and the Compliance Committee which includes at least one board member, is an organized system, comprised of written standards, training, monitoring, and auditing, to ensure that we operate in an ethical, lawful, and compliant manner.
The Compliance Program applies to the Society, its Board of Directors, its officers, its employees, its vendors, its donors, its contractors, its advisers, and its volunteers. We can only live up to our commitment to Doing Good the Right Way if we all are working together. Accordingly, the Compliance Program and its requirements apply broadly, and its provisions should be interpreted in the broadest manner possible to effectuate its important purposes.
Consistent with guidance issued by the Office of the Inspector General for the Department of Health and Human Services “OIG”), this Compliance Program consists of the following core elements, which we refer to as our “7 pillars”:
The foundation of everything that we do–is our written standards, including our Code of Conduct and our policies and procedures. Together, these written standards set out what we expect of ourselves and our partners. Doing Good the Right Way begins with articulating our compliance expectations so that everyone understands what is required.
Our standards reflect our values: putting the patient first, integrity, accountability, a commitment to fostering innovation, and transparency. Read our Code of Conduct to learn more about who we are and what we require of ourselves and those who work with us.
Our Compliance Program is led by the Compliance Officer, Amanda Hill, and the Compliance Committee. The Compliance Officer has direct access to the full board and will, in coordination with the Compliance Committee, regularly apprise the Board regarding the Program, its status, and its operation. The Compliance Officer and the Compliance Committee will update the Code of Conduct and the Compliance Program on a periodic basis, as the need arises.
Because we cannot live up to our mission of Doing Good the Right Way without ensuring that our people understand what is expected of them, an important pillar of our program is training. The Board of Directors, all officers, and all employees will receive at least one compliance training session each year, and new members of the Board, new officers, and new employees will be trained on the Compliance Program within 60 days of when they join the organization. Volunteers and key contractors, vendors, and advisers will be trained on a schedule determined by the Compliance Officer and Committee.
We do not just set expectations and hope for the best. Doing Good the Right Way means that we use monitoring and auditing to test our performance.
Monitoring involves on-going mechanisms designed, as part of our regular operations, to make sure that we are living up to our Compliance Program, our Code of Conduct, and our compliance policies and procedures.
Audits, which are more involved reviews than day-to-day monitoring, will occur on a periodic basis, as determined by the Compliance Officer and Compliance Committee.
Acting through its Compliance Officer, as supported by the Compliance Committee, the Society will respond promptly and appropriately to any potential compliance issue that is identified. Depending on the nature of the issue and the information presented, the Compliance Officer, acting in coordination with the Compliance Committee, may respond to the issue directly, including by conducting any appropriate internal review. In appropriate circumstances, an external resource may be engaged to help address the issue.
Because it is critical that any potential compliance issue is provided to the Compliance Officer, so that it can be appropriately addressed, every person subject to the Program is required to report any and all potential compliance issues promptly.
Potential issues can be reported to an immediate supervisor, who will then be responsible for sharing the information with the Compliance Officer, or they may be communicated directly to the Compliance Officer, either by telephone at 781-301-6060 x2200 or by email at Amanda.Hill@fshdsociety.org. In addition, issues can be reported to any member of the Compliance Committee, whose initial members are Jess Carter and Bob Humphreys. Finally, issues can be reported anonymously by using the dedicated
compliance mail box at compliance@fshdsociety.org.
We will maintain the anonymity of reports to the extent consistent with the need to investigate and respond to all issues appropriately. Anyone raising a potential issue in good faith cannot, under the terms of our Compliance Program, be the subject of retaliation. Where issues are raised in good faith, the Compliance Program prohibits any act of retaliation.
Everyone subject to the Compliance Program is subject to discipline if we fail to meet the expectations of the Program. We can’t be sure that we are Doing Good the Right Way unless we reinforce the expectations of the Program through appropriate discipline in those cases where discipline is warranted. The OIG expects that any effective compliance program will include disciplinary standards. Integrity requires program enforcement and individual accountability. Discipline will be appropriate to the circumstances and may range from oral counseling, to written warnings, to termination, as well as other potential action, in appropriate cases.
For more information, or if you have any questions about how to proceed in any situation, please contact the Compliance Officer or any member of the Compliance Committee:
This Code of Conduct reflects core standards that the Society itself and its Board of Directors, its officers, its employees, its vendors, its donors, its contractors, its advisers, and its volunteers are all expected to honor fully and in the spirit of our shared commitment to Doing Good the Right Way. This Code of Conduct springs from and is informed by our values of putting the patient first, integrity in everything that we do, accountability, and transparency. It should be interpreted broadly and consistent with those values.
Some variation in the applicable standards are made to reflect distinctions in the missions, operations, and activities of the Society and the hub, which is a separate legal entity. Unless the hub is referred to separately in this Code of Conduct, references to “the Society” include the hub.
This Code of Conduct reflects expectations that exceed the requirements of applicable law. Our Code of Conduct requires us to act ethically, beyond what is required by law.
We act with integrity and honesty at all times.
The mission of the Society must guide, inform, and control everything we do.
We comply with all applicable federal, state, and local laws and regulations.
We perform all duties assigned to us diligently, with purpose, and in an ethicalnmanner, acting in the best interests of the Society and/or in accordance with our contractual obligations.
We only act for the Society as authorized, and we never mislead anyone that we are speaking for the Society when that is not the case.
We interact with our Society colleagues in a manner that reflects mutual respect, honesty, and collaboration.
Except when acting as a vendor to the Society, we operate independently of any outside entity or interest at all times.
Conflicts or potential conflicts of interest must be promptly and fully disclosed and appropriately addressed and managed, as provided under Society policy and procedure and/or under the applicable contract.
We protect the Society’s resources and assets, using them only in a manner consistent with the Society’s mission.
Personal interests are not permitted to interfere with or to impede the operations or mission of the Society or to subvert the Society’s interest in maintaining its assets and resources. Vendors may act in a manner consistent with their contract with the Society.
Assets and resources of the Society will only be used to further the mission of the Society.
The Society’s assets and resources are prudently managed and safeguarded.
We manage all expenses of the Society efficiently.
We only submit costs for reimbursement to the Society that are valid, accurate, and in accordance with the Society’s policies, procedures, and/or the applicable contract.
We act, at all times, as good stewards of the Society’s resources, assets, and reputation.
We do not offer or accept any remuneration of any kind, directly or indirectly, related to any decision of the Society or any order, referral, purchase, recommendation, or other act involving the use of any health care item or service in any manner that does not fully comply with all applicable law.
We enter into contractual and other relationships based on arm’s length negotiations, where the Society pays and receives only reasonable compensation and fair market value for the items or services it provides or receives, without regard to the volume or value of any health care referrals, orders, purchases, or recommendations, or other business that might be generated between the parties in any manner not permitted by all applicable law.
The Society does not recommend any provider, institution, manufacturer, or other provider of any particular health care item or service to any patient in any manner that does not comply with all applicable law.
Notwithstanding any other provision of this Code, we may present multiple options for items or services to patients, emphasizing that the patient should, with his or her family and caregivers, choose the option that is in the patient’s best interest.
We do not select options presented to patients or others based on the presence or potential for any financial relationships that exist or may be developed in any manner that does not comply with all applicable law.
All interactions with industry, including, but not limited to, all pharmaceutical and device manufacturers, shall be conducted in a manner that reflects the Society’s commitment to ethical conduct and compliance with all applicable laws and regulations.
We respect and adhere to all organizational and corporate non-disclosure and confidentiality agreements.
We comply with all Securities and Exchange Act requirements, including those prohibiting insider trading.
In awarding grants, we ensure that we provide truthful and accurate information, ensure that the process is fair and competitive, and that the process and resulting grants are in accordance with the Society’s mission and all applicable law.
In applying for and receiving grants, we provide truthful and accurate information, act in accordance with all applicable processes, and abide by all conditions associated with any resulting grants as consistent with all applicable law.
We maintain the confidences of the Society at all times, and we do not engage in any unauthorized disclosures of Society data, plans, or other information.
We do not use or disclose any information about any person, including patients and their family members, except as permitted by applicable law or applicable consents, authorizations, or terms of condition.
We comply with all applicable federal and state laws and regulations regarding the privacy and security of information and data.
We do not discriminate against any person on the basis of race, color, age, national origin, religious creed, disability, sexual orientation, veteran status, or any other basis that is protected by federal, state, or local law.
We do not permit any unlawful harassment of any kind, including bullying.
We do not affiliate, in any way, with an individual or entity that has been excluded from any federally funded or state health care programs by OIG or any other agency.
We are truthful in all fundraising activities, including in all solicitations.
We ensure that fundraising costs are reasonable and in proportion to what they can reasonably be expected to generate in lawful donations to the Society.
The Society’s officers and employees are compensated reasonably and appropriately and in accordance with compensation provided to like personnel in like organizations.
We take no compensation and accept no employment or other affiliation which is inconsistent with our obligations to the Society, including our obligations to inform the Society of other employment or other activities.
We do not offer or accept gifts beyond what is modest in nature, such as small, inexpensive items or events that are offered or received in a manner consistent with our policies and procedures, are disclosed as required under those policies and procedures, and that create neither the actuality nor a perception of undue or unlawful influence.
The Society’s financial records and reporting are true, accurate, and complete to the best of the information and belief of the individuals responsible for those records and that reporting.
We maintain all records, documents, and data as required by our document retention policies and procedures.
Records, documents, and data are not destroyed if it is reasonably anticipated that they are likely responsive to any pending or anticipated litigation or other legal proceeding.
We do not engage in discussions that might be understood as attempting to fix any price or dividing any market or otherwise unlawfully restraining trade.
Doing Good the Right Way: Our promise to FSHD patients (and to the wider FSHD community) is that they will never face this disease alone. Our mission is to find treatments and a cure for FSHD and to empower FSHD patients and their families in the fight against this disease. Our core values that animate both our promise and our mission, every day, include an unwavering commitment to do good the right way—to always maintain the highest ethical, legal, and compliance standards in undertaking our work. The Compliance Program is a product of that commitment.
A: Lots of reasons, really.
First and foremost, because, consistent with the way that we have always conducted our important work, we are committed to Doing Good the Right Way, and a compliance plan is an organized means to both express that commitment and to live it.
Because health care is such a highly regulated area, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) has long encouraged health care stakeholders, including patient advocacy groups, to show their commitment to ethical and compliant conduct by voluntarily adopting effective compliance programs. Our partners, whether they be health care providers, institutions, other patient advocacy groups, and companies devoted to bringing new treatments to market, have almost invariably adopted their own compliance programs.
Given our patient-driven promise and mission and our commitment to being a good partner dedicated to Doing Good the Right Way, the adoption of the Compliance Program was an easy decision. It largely reflects what we have long done and long believed anyway.
A: It’s an integrated program of standards, training, monitoring, and auditing, led by a Compliance Officer and a Compliance Committee, designed to make sure that we are always living up to our commitment to Doing Good the Right Way.
A: At a big picture level, it’s our bedrock commitment to Doing Good the Right Way. But, in addition, those standards are reflected in the attached Code of Conduct and the policies and procedures that the Society has implemented and will implement consistent with this Compliance Program. The best way to understand more about the standards that animate our Compliance Program is to review our Code of Conduct.
A: That leadership comes from the Compliance Officer, Amanda Hill, who on a day-to-day basis, is the person charged with making sure that our Compliance Program is operating as intended and helping us live up to our compliance motto of Doing Good the Right Way. But the Compliance Officer is supported and guided by the Compliance Committee, a sub-committee of Governance Committee of the Board of Directors. The Compliance Officer also has direct access, at any time, to the full Board of Directors.
A: The Compliance Program applies to the Society, its Board of Directors, its officers, its employees, its vendors, its donors, its contractors, its advisers, and its volunteers. We can only live up to our commitment to Doing Good the Right Way if we all are working together. So, yes, the Compliance Program and its requirements apply broadly.
A: Absolutely. Training is a core element of the Compliance Program. The Board of Directors, all officers, and all employees will receive at least one training session each year, and new members of the Board, new officers, and new employees will be trained on the Compliance Program within 60 days of when they join the organization. Volunteers and key contractors, vendors, and advisers will be trained on a schedule determined by the Compliance Officer and Committee.
A: Monitoring are on-going mechanisms designed, as part of our regular operations, to make sure that we are living up to our Compliance Program, our Code of Conduct, and our compliance policies and procedures. We have always completed multiple monitoring activities in our day-to-day operations as part of our commitment to our mission and our patients and families.
Consistent with our obligations as a tax exempt organization and under the Federal Antikickback Statute, we, for instance, evaluate whether the amounts that we pay and receive under our contracts reflect fair market value.
Audits, which are more involved reviews than day-to-day monitoring, will occur on a periodic basis, as determined by the Compliance Officer and Compliance Committee. They will focus on areas that would potentially benefit from more detailed review. Doing Good the Right Way includes a commitment to making sure that we are, in fact, doing things the right way.
A: Absolutely. You can contact your immediate supervisor to share any concern or our Compliance Officer by telephone or by email. In addition, you can contact any member of the Compliance Committee. Their contact information is included in the Compliance Program description that is attached. Finally, you can raise an issue anonymously by submitting a written report to compliance@fshdsociety.org. We will maintain the anonymity of reports to the extent consistent with the need to investigate and respond to issues appropriately, but we may identify a reporter of an issue if reasonably necessary to effectuate the Program.
A: Yes, we all have an obligation under the Compliance Program to report any potential compliance issues. We can only ensure that we are Doing Good the Right Way when we all bring any potential issue forward so that it can be addressed appropriately. If you see a potential issue, you should report it promptly; it’s an important way that you can help to make sure that we are Doing Good the Right Way.
A: No, absolutely not. Anyone raising a potential issue in good faith cannot, under the terms of our Compliance Program, be the subject of retaliation. Where issues are raised in good faith, the Compliance Program prohibits any act of retaliation.
A: Yes, all of us, members of the Board, officers, employees, and everyone else subject to the Compliance Program are subject to discipline if we fail to meet the expectations of the Program. We can’t be sure that we are Doing Good the Right Way unless we reinforce the expectations of the Compliance Program through appropriate discipline in those cases where discipline is warranted. Integrity requires accountability. Discipline will be appropriate to the circumstances and may range from oral counseling, to written warnings, to termination, as well as other potential action, in appropriate cases.
