Q&A: Edwards Lifesciences VP Discusses Physician Payments Sunshine Act
By Christopher White, general counsel, AdvaMed, and Diane Biagianti,VP and chief responsibility officer, Edwards Lifesciences
Christopher White, general counsel for AdvaMed, recently sat down with Diane Biagianti,VP and chief responsibility officer for Edwards Lifesciences, to talk about the importance of collaboration between physicians and medical technology companies, and implementing the Physician Payments Sunshine Act.
White: How do patients benefit from interactions between physicians and medical device industry companies?
Biagianti: From the inception of Edwards Lifesciences, we have recognized the necessity of working relationships between physicians and medical device companies. Edwards was founded as a result of the collaboration between an engineer, Miles “Lowell” Edwards, and a cardiothoracic surgeon, Dr. Albert Starr. They worked together to develop the world’s first commercially available artificial heart valve to help address an unmet patient need.
These relationships continue to transform patient care, and we are proud of our long-standing relationships with clinicians. Like AdvaMed, we share a common commitment to transparency, the highest ethical standards, and patient access to lifesaving technologies.
White: Why does Edwards support transparency?
Biagianti: Strong collaboration between scientists, engineers, entrepreneurs, and the clinical community is critical to innovation and the safe and effective use of medical devices. We believe that bringing transparency to our relationships with physicians helps the public better understand the critical role physicians play in the advancement of medical technology and patient care. Patients and the public deserve comprehensive context to help them understand industry-physician transfers of value. Such context helps prevent confusion and potential misrepresentation of what may be lifesaving collaborations between companies and clinicians.
While Edwards understands that the behavior of certain individuals and a select few companies in the past has caused some to question the nature of these relationships, we adhere to the highest ethical standards, and our commitment to the best patient care is enhanced by our physician relationships.
White: What have you learned about the challenges of implementing physician payment disclosures?
Biagianti: Since Jan. 1, 2009, Edwards Lifesciences has voluntarily tracked and reported financial relationships with U.S. physicians. Despite this significant reporting experience, we spent more than six months revamping our systems and procedures to meet the requirements under the Sunshine law. As the first medical device company to implement such a program on a voluntary basis, we know first-hand the challenges of reporting the many types of relationships between device companies and healthcare professionals. Regardless, we remain committed to compliance with the Sunshine law.
White: What is reportable under the law?
Biagianti: Reportable items under the Sunshine law include payments for consulting, education, serving as faculty or as a speaker for continuing education, honoraria, research, and grants — as well as other transfers of value such as gifts, meals, travel, and entertainment — if they are worth $10 or more (or even items worth less than $10 if the total for a doctor adds up to $100 in a given year). The law also requires the reporting of ownership/investment interests by covered providers.
White: How often is this data reported?
Biagianti: The data will be provided to the Centers for Medicare and Medicaid Services (CMS) in reports that cover the previous calendar year. The initial reporting will cover payments made between Aug. 1, 2013, and Dec. 31, 2013, and will occur in two phases. The first phase requires aggregate payment data submitted by March 31, 2014. The second phase requires detailed data on payments, transfers of value, and ownership interests specific to individual physicians and teaching hospitals, and will begin in May 2014 and last for at least 30 days. This two-phased approach to data submission only applies to the 2013 program year (i.e., data collected from Aug. 1, 2013, to Dec. 31, 2013). Subsequent reporting will cover an entire calendar year and will be due on the 90th day of the following year.
White: Will I know if a manufacturer reports a gift/payment to me?
Biagianti: Providers will be able to access their own data, once it is made available by CMS, on a secure online portal sometime in mid-2014. However, they will need to register with CMS to view the payments. The details have not yet been finalized, but many AdvaMed members will be providing this information to healthcare providers when it is available. Once annual payments are posted on CMS’s website, providers will have 45 days to review the data submitted under the Sunshine law to ensure that it is correct or to initiate disputes before it is made public.
White: Who else can see the payments?
Biagianti: Starting in September 2014, patients and other important stakeholders will be able to see these reported payments and transfers of value on a searchable public CMS website.
Because this is a new reporting program, there may be glitches as it is rolled out. However, it is important that healthcare providers who receive these sorts of payments or transfers of value be aware of the program, since these payments will be a matter of public record.