The American Medical Association (AMA) is committed to transparency and supports the release of data that can help improve quality of care for patients, including information about physician's financial interactions with the industry which could help promote understanding and trust and strengthen the patient-physician relationship. For that reason, the AMA supported the Sunshine Act when it was passed by Congress. However, because of issues with the implementation of the law, the AMA believes that certain safeguards are needed to ensure the information is depicted correctly and in context to be useful for patients and fair to physicians. Thus, the AMA strongly encourages media to consider the following in their coverage to ensure data is indeed presented in an accurate and informative way to help patients understand and interpret the information correctly.

About the open payments program

Under the Sunshine Act passed by Congress in 2010, industry is required annually to report financial interactions with individual physicians to the Centers for Medicare and Medicaid Services (CMS), and this information is then to be made public. To implement the law, CMS developed the Open Payments program.

Are open payments data accurate?

Patients deserve to have access to accurate information. Publishing inaccurate data can lead to misinterpretations, harm reputations and erode the trust patients have for their physicians. It can also unfairly impact physicians' ability to attain or keep research grants and other employment opportunities that require disclosure.

AMA has strongly urged the federal government to adopt measures to ensure that the information released is accurate. Unfortunately, the CMS' Open Payments program has to date been plagued by significant shortcomings that call into question the accuracy of information published, including an overly complex registration process and inadequate opportunity for physicians to review their individual data .

Inadequate opportunity for physician review

For the 600,000 physicians affected by the Sunshine Act, CMS provided a short, 45 day window to review and correct any inaccurate data. Unfortunately, several factors hindered participation by many of the physicians impacted including:

• Inadequate notification to the physician community about key implementation deadlines for the program, including the beginning of the official 45-day registration and review period. CMS originally intended to open the registration process on January 1 of each year.  It continues to miss this mark by several months and continues to provide inadequate notification to the physician community about key implementation deadlines for the program.

• A time-consuming, non-user friendly and complicated registration process, which physicians are required to complete in order to review information being reported about them.  A 413 page guidance document (a 53 page increase over last year) that CMS developed to help physicians through the process provides too much information while not detailing all the steps involved to register with the system, review personal reports, and seek correction of any inaccurate data. 

What does having financial relationships with industry really mean?

Publicly reporting industry payments to individual physicians can imply, wrongly, that such payments are always inappropriate. In order to make an informed judgment on the data, it is vital that the information is in context. For example, just because a physician has a relationship with industry does not automatically mean that his or her professional judgment has been influenced inappropriately.

The AMA strongly opposes inappropriate, unethical interactions between physicians and industry. However, some relationships with industry can help drive innovation in patient care, contribute to the economic well-being of communities, and provide significant resources for professional medical education, to the ultimate benefit of patients. An urgent challenge for both physicians and industry is to preserve strong, productive collaborations for the benefit of patients and the public and at the same time take clear, effective action to avoid conflicts of interest and relationships that would undermine trust.

Meanwhile, CMS is required by the Sunshine Act to provide context for the data released through the Open Payments program. AMA and other stakeholders have repeatedly offered to help CMS in developing meaningful contextual guidance, yet the Agency has done the bare minimum to comply with the letter of the law. 

The AMA encourages members of the media to provide clear and concise examples of interactions between physician and industry in order to help the public understand the important role that appropriate relationships between physicians and industry can play in advancing the practice of medicine.

Some examples of appropriate interactions include:

• Advancing Medical Knowledge - Research to develop new treatments and improve patient care is costly. It takes time and money to carry out clinical trials and get demonstrated new therapies through the approval process and into clinical use. Physicians in academic medical centers and other organizations receive funding from industry as investigators in clinical research and as consultants who help design and evaluate clinical trials or develop new medical technologies. In some cases, industry support for multiple projects is reported under the name of the academic dean or program director, which can make it seem as if the individual received a large dollar amount from industry when in fact the money financed the cost of the clinical trial and was distributed to several endeavors actually led by other physicians.

• Advancing Physician Knowledge - Industry also supports physician education, and in some instances that will be reported as payments to individual physicians, even if the physicians are not aware. For example, a physician may receive an honorarium from his or her medical society for being on the faculty of an educational program put on by the society. If the society received a grant from industry to help support the program, that honorarium may be reported as indirect payment from industry through the Open Payments system, even though the physician received the honorarium directly from the medical society and wasn't aware of the industry support.

Continuing Medical Education courses funded by the industry as well as visits from pharmaceutical representatives to physician offices or health care organizations to talk about new research and treatment options can also supplement physicians' knowledge about new advances in medicine. Additionally, industry sometimes provides physicians with reprints of peer-reviewed medical journal articles and medical textbooks, which likewise help physicians stay abreast of the latest medical treatments.