Open Payments and Transparency
COMMITTED TO TRANSPARENCY
At Merit, we strive to be the most customer-focused company in healthcare—seeking each day to make a difference by understanding our customers’ needs and innovating and delivering a diverse range of products that improve the lives of people and communities throughout the world. To ensure the availability of innovative medical devices and technologies in the ever-changing world of healthcare, 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 (aka “Open Payments” or “Sunshine Reporting” laws), 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 transparency and disclosure laws and regulations that often cover additional categories of healthcare providers, 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
Collaborating with physicians and teaching hospitals is an integral part of Merit’s efforts to develop new medical devices. Working with physicians leads to valuable feedback, improvements in patient care, developments in medical treatment, scientific advancements, and development of new technologies. We collaborate with physicians in a variety of ways, including: product and procedural development; scientific and clinical research; physician and employee training and education; strategic planning and market research, healthcare policy, and reimbursement; publication and faculty presentations at medical conferences; and therapy awareness training and public education. 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 AND DEVELOPMENT OF NEW DEVICES
Discovering and developing new devices and technologies is a lengthy process that spans years and may include multiple clinical trials involving hundreds or thousands of patients. These studies are required to show that a device 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 providers to design trial programs, recruit patients, monitor safety, and report study findings. Such collaboration is critical to developing effective medical devices that advance patient care.
EDUCATION OF HEALTHCARE PROFESSIONALS ABOUT MEDICAL DEVICES AND THERAPIES
Physicians value the opportunity to learn from their peers who have real-life experience with our products. To help facilitate this education, 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 Merit’s products. We also interact with physicians and healthcare professionals and their staff with presentations that may be given by Merit representatives. Through these interactions, physicians may provide us with insights about patient care, and we share information about our devices, including the benefits and risks, the diseases they treat, and the appropriate patients.
Merit is committed to funding high-quality, independent educational activities in therapeutic areas of interest to Merit 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. When Merit elects to provide an educational grant, we provide it directly to the conference organizer to reduce the overall cost of attendance of participants or to cover reasonable speaker compensation, travel, meals and accommodation expenses to healthcare professionals who are good faith conference faculty members. https://www.merit.com/about/grant-request/
HOW MERIT WORKS WITH PHYSICIANS
Merit values its relationships with the physicians with whom we work 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 educational projects or conducting research for Merit, their efforts involve time commitments and draw on their professional expertise. We compensate physicians consistent with fair market value and reimburse reasonable expenses incurred in connection with the services provided, e.g., reasonable travel and expense reimbursement where applicable.
Merit has policies and procedures in place to guide the appropriate engagement of physicians in alignment with industry standards and government laws and regulations.
OPEN PAYMENTS REPORTING
The Patient Protection and Affordable Care Act 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 transparency in the relationships between the healthcare industry and healthcare professionals.
As part of our commitment to transparency and Open Payments regulations, Merit 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. Merit is committed to reporting data to CMS “Open Payments” that are 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
Applicable manufacturers are required to identify a nature of payment category for each transfer of value that they report. Similar to other medical device manufacturers, Merit has associated payments or transfers of value with what we believe to be an appropriate CMS nature of payment. Please visit CMS.gov for FAQs on definitions and nature of payment categories.
To view Merit’s past disclosures of payments and transfers of value to US physicians and teaching hospitals related to speaking, advising, consulting, and other transfers of value:
- Go to the CMS Open Payments Data Search Tool website at
- Click the tab “Company Making Payments”
- Enter the company name “Merit Medical” and click “Search”
- Select “Merit Medical Systems Inc.” by clicking on the company name in the search results
The CMS search tool will then display a summary of Merit’s overall payment information. You will also have the ability to search and view more detailed payment information for individual physicians and teaching hospitals.
Merit believes that disclosing its payments related to interactions with physicians and related entities helps foster trust and supports our commitment to maintaining the highest ethical standards in the work we do. We are committed to transparency and to meeting all state and federal reporting requirements, including Open Payments, as well as the Corporate Integrity Agreement (CIA) which Merit entered into with the Office of the Inspector General for the Department of Health and Human Services in October, 2020.
Questions? Contact Merit’s Chief Compliance Officer at 801-316-3835 or [email protected].