Committed to Transparency
At Sanofi US, we are focused on making a difference in patients’ lives. To ensure the availability of new medicines, we often seek to work and innovate with other individuals and organizations including physicians and teaching hospitals with a common aim to improve patient health. We are fully committed to the financial transparency of these relationships; it is important to us to foster an understanding of these interactions and to prevent any real or perceived conflict of interest.
Under federal law and implementing regulations (now referred to as “Open Payments”), issued by the Centers for Medicare and Medicaid Services (CMS) any payment or other transfer of value we make to a physician or teaching hospital is subject to collection and potential public reporting. Certain states have also enacted laws and regulations relating to transparency of interactions with healthcare professionals which often cover additional categories of healthcare professionals and are separate and in addition to the federal transparency reporting requirements. We are committed to complying with federal and applicable state laws and regulations today and in the future.
Value of Collaboration
Partnering with physicians and teaching hospitals is an integral part of Sanofi’s efforts to develop new medicines and treatments. Working with physicians leads to valuable feedback, improvements in patient care, developments in medical treatment, scientific advancements, and development of new medicines. We collaborate with physicians in a variety of ways, including: input on the design and running of clinical trials, interpretation of new scientific data, identification of unmet medical needs, publication of clinical trial results in medical journals, and presentation at medical conferences. We believe that when people understand the nature of these relationships, they are better able to understand the value and benefits of such collaboration.
Research & Development of New Medicines
Discovering and development of new medicines and treatments is a lengthy process that spans years and includes multiple clinical trials often involving hundreds or thousands of patients. These studies are required to show that a medicine is safe and effective to treat a particular disease or condition, and to meet the strict approval requirements of the US Food and Drug Administration (FDA) and other regulatory authorities. Conducting clinical studies would not be possible without the involvement of physicians, clinics and hospitals. We work with these healthcare practitioners to design trial programs, recruit patients, monitor safety and report study findings. Such collaboration is critical to make new and effective medicines that advance patient care.
Education of Healthcare Professionals about Health Conditions and Medicines
Physicians value the opportunity to learn from their peers who have real-life experience with our medicines. To help facilitate this learning, we work with physicians and other healthcare professionals to serve as educators and speakers. Patients and caregivers may also participate in educational sessions with healthcare professionals on the proper use of Sanofi US medicines. We also interact with physicians and healthcare professionals and their staff with presentations that may be given by Sanofi representatives. Through these interactions, physicians may provide us with insights about patient care and we share information about our medicines including the benefits and risks, the diseases they treat, and the appropriate patients.
Sanofi US is committed to funding high quality, independent educational activities in therapeutic areas of interest to the company that have the potential to improve patient care and health outcomes. The purpose of an educational grant is to support an independent activity that encourages an educational interchange with respect to available scientific and medical information.
Corporate Giving and Support
Sanofi US supports patient organizations and professional associations in their efforts to advance medical care and improve patient outcomes. Sanofi US is committed to working together with national and community-based organizations to make a difference in patients’ lives. We support programs and initiatives of external, independent, not-for-profit organizations that align with the Sanofi US corporate vision and values. These organizations are generally healthcare-oriented and focus on one or more therapeutic areas in which Sanofi US is actively involved. We view our support through financial contributions as opportunities to establish meaningful partnerships with those whose values we share and whose actions truly drive change.
How Sanofi US Works with Physicians
Sanofi US values its relationships with the physicians we work with and welcomes the opportunity to make a positive impact on patient health without jeopardizing physician independence or integrity. These healthcare professionals invest their time and energy in the valuable work they perform for patients. When consulting on patient treatments or conducting research for Sanofi, their efforts involve time commitments and draw on their professional expertise. Sanofi compensates physicians consistent with fair market value and reimburses reasonable expenses incurred in connection with the services provided (e.g. travel and expense reimbursement where applicable).
For example, Sanofi US may enter into a collaboration with a physician for a variety of reasons, including but not limited to: study protocol development and conducting clinical trials, interpretation of new scientific data, identification of unmet medical needs, identification of a need for additional drug development in a particular disease state/condition, and sharing information on diseases and products with other physicians. When physicians are required to travel in conjunction with work on behalf of the company, Sanofi US covers reasonable travel expenses, including travel and lodging. When Sanofi engages with physicians and other healthcare professionals at in-office meetings, during a meal break time food and beverages may be provided. Services other than consulting include physician presentations at disease awareness programs and meetings where an expert speaks to a physician or patient audience about a disease.
Sanofi US has policies and procedures in place to guide the appropriate engagement of physicians in alignment with industry standards and government regulations.
How Patients Benefit
We believe the scientific exchange between healthcare manufacturers and healthcare providers is essential to the advancement of medicine and the quality of patient care. Science sometimes advances quickly, consultant meetings with physician experts can help identify and address potential treatment gaps as it allows providers and manufacturers to objectively discuss medical information. We also collaborate with thought-leading physicians on the development of new medicines and treatments. These activities may lead to important medical advances that improve patients’ lives.
Open Payments Reporting
The Patient Protection and Affordable Care Act (ACA) is a US federal statute that requires drug, biologic, device, and medical supply manufacturers to track payments and transfers of value to US licensed physicians and teaching hospitals and report them to the federal government for public disclosure. The intention of these regulations is to provide more transparency in the relationships between the healthcare industry and healthcare professionals.
In addition to US federal laws, there are also several states with laws that impose additional restrictions or requirements on pharmaceutical manufacturers and may cover additional categories of healthcare professionals.
As part of our commitment to transparency and Open Payments regulations, Sanofi US implemented additional control processes for timely, accurate and complete data collection and developed training programs to further educate employees on Open Payments requirements and policies and procedures.
Sanofi US is committed to reporting data to CMS “Open Payments” that is accurate, complete and timely. We will continue to work with covered recipients on questions they have pertaining to their data.
Additional information on Open Payments is available on the CMS website.
Reportable Payments and Transfers of Value
Direct (to the physician or covered recipient) and indirect payments (made to a third party at the request of the physician or teaching hospital) and other transfers of value provided by manufacturers to physicians and teaching hospitals must be reported to CMS under Open Payments.
Applicable manufacturers are required to identify a nature of payment category for each transfer of value that they report. Similar to other pharmaceutical manufacturers, Sanofi US therefore has associated payments or transfers of value with what we believe to be an appropriate CMS nature of payment. In some instances, Sanofi US has used certain nature of payment categories, such as gift or grant, to include capture of transactions that do not meet the criteria for any of the other categories provided. Please visit CMS.gov for FAQs on definitions and natures of payment categories.
Frequently Asked Questions
- How does Sanofi ensure the data reported by CMS is accurate? Sanofi is committed to providing accurate, complete and timely data to CMS as part of the Open Payments requirements. We have implemented control processes for data quality prior to submission to CMS. We followed the reporting requirements and procedures established by CMS for submitting data to their site at the time of submission. We will continue to work with covered recipients should there be cause to question any aspects of the accuracy of the data.
- Why does Sanofi invest so heavily in research? Before medicines and medical technologies are approved by the US Food and Drug Administration (FDA) for use by patients, they must be tested extensively through clinical trials. This research examines how well potential drugs and treatments may work for patients. Physician participation is integral to the success of these trials. Physician investigators conduct the research, track patient progress, and may participate in reporting the research in peer-reviewed journals. Sanofi US companies compensate physician investigators according to fair market value for the research being performed and reimburse expenses necessary to the research (e.g., investigator meeting travel).
- Do Sanofi payments to physicians influence their prescribing habits? Sanofi does not work with or pay physicians or other healthcare professionals to induce or reward prescribing, recommending or referring our product.
- Does hiring physicians to consult or speak about Sanofi products increase the cost of medicines and ultimately healthcare? Sanofi believes that patients ultimately benefit and costs are reduced when physicians are well informed and knowledgeable about our medicines and treatment options. Physicians play a key role in selecting the appropriate treatment option for their patients. These interactions take many forms, including clinical trials to investigate the safety and efficacy of potential new medicines and providing the Company with advice that allows us to better understand treatment challenges and unmet medical needs.
- Why is there spend associated with product indicator ‘none’ (no product was discussed)? Sanofi US may have discussions with physicians about general topics, such as a disease states, patient care or other healthcare issues. In situations like these, there is no product discussed so the product indicator is none.
- I am attending a conference/event at which a meal will be provided. Can I forego the meal or pay my own way? You can forego partaking in the meal but, due to the complexities of financial tracking, we cannot accept reimbursement for the meal. When you attend, place your name on the sign-in sheet and check the appropriate box in the column, “I will/will not consume the provided meal.”
- I have a question regarding a transaction on my report. How do I get it resolved? The CMS designated review and dispute period will open in early April and close in late May in the year following the year being reported. CMS has indicated that any notation of dispute status or change in data will not post in June when the data is published. We are committed to accurate reporting and have developed a process to support questions and concerns. Please contact our Customer Service teams with any questions or concerns.
- I do not recognize a payment listed under my name. How did this happen and what can I do about it?
CMS requires reporting of a wide range of value exchanges including some you may not immediately recognize. Examples include:
- You may have received food and beverage items at a meeting that our company sponsored. This would be an indirect “in kind” transfer of value under the CMS regulations.
- Compensation for services other than consulting (e.g. speaker fees).
- You may not recognize the legal name of the entity that received the payment, which could be a doctor’s office, hospital or LLC. The CMS-required reporting method may include a company name that is different from the one you know.
- You may have received the payment or value exchange indirectly. CMS requires companies to report value exchanges that are received directly or indirectly through a third party.
- My report as shown on the CMS website doesn’t match the tax documents I received from the company. Why? CMS Open Payments reporting requirements are entirely separate from IRS tax reporting requirements. Consult your tax advisor with any questions you have.
- I received a transfer of value at an industry event, but the date that is reflected for the reported value transfer does not match the date I received the value. The dates reported for the value transfer may not align with the date that the activity took place. In-kind value transfers like meals, hotel, and educational items are generally reported using the date that the expense/activity occurred or when the expense was processed. However, direct payments for fee for service, grants, and reimbursements for items such as meals or travel are reported on the date they are actually paid or reimbursed to the covered recipient, which is likely a different date than the activity.
- Once data is published, can I dispute with CMS and changes be made to CMS reporting? Please visit the CMS Open Payments website for more details related to submission process and timing.
- I have additional questions. Who can I contact? Sanofi US is committed to accurate reporting and has developed a process to support your questions and concerns. Please contact our Customer Service teams with any question or concerns you may have. Sanofi US (includes R&D and Sanofi Pasteur, VaxServe, SP Biologics & SP R&D) US.Transparency@sanofi.com - All email inquiries will receive a response within two business days. Sanofi Genzyme 877-GENZYME (877-436-9963), option 7 Operation Hours: Mon-Fri, 9:00am – 4:30pm EST
- How might I find additional information about Open Payments? The best place to get the most up-to-date information about Open Payments is the Open Payments page of the Centers for Medicare and Medicaid Services website. There are specific sections offering guidance for physicians and teaching hospitals, as well as “Frequently Asked Questions.” There is also a feature available where you can sign up for e-mail updates from CMS about Open Payments.