by Chris White and Diane Biagianti
Partners for Healthy Dialogues partner Christopher White (general counsel, AdvaMed) recently sat down with Diane Biagianti, vice president, chief responsibility officer, Edwards Lifesciences, to talk about the importance of collaboration between physicians and medical technology companies, and implementing the Physician Payments Sunshine Act.
How do patients benefit from interactions between physicians and medical device industry companies?
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.
Why does Edwards support transparency?
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.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
While Edwards understands that the behavior of some individuals and a 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.
What have you learned about the challenges of implementing physician payment disclosures?
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 health care professionals. Regardless, we remain committed to compliance with the Sunshine law.
What is reportable under the law?
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 reporting of ownership/investment interests by covered providers.
How often is this data reported?
The data will be provided to the Centers for Medicare and Medicaid Services (CMS) in reports filed every March 31 that cover the previous calendar year. The initial report, due March 31, 2014, will include payments made between Aug. 1, 2013, and Dec. 31, 2013.
Will I know if a manufacturer reports a gift/payment to me?
Providers can 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 health care 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.
Who else can see the payments?
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 health care providers who receive these sorts of payments or transfers of value be aware of the program and that these payments will be a matter of public record.
This was originally posted on healthydialogues.org.
