Letting the sunshine in

Financial relationships between the healthcare industry and the clinical community are a prevalent aspect of the healthcare landscape. A common financial interaction, for example, is when a physician receives a fee for consulting with a pharmaceutical company about a drug in development. Such financial arrangements are widespread, but they are often known only to the parties directly involved.

Now, because of the Patient Protection and Affordable Care Act, there will be increased public transparency about these financial relationships. The Open Payments program—part of the Affordable Care Act, which included the Physician Payments Sunshine Act—requires that manufacturers of drugs, devices, biological and medical supplies annually report to the CMS most payments and “other transfers of value” they make to covered recipient physicians and teaching hospitals.

This also includes reporting about ownership and investment interests that are held by physicians and their immediate family members in manufacturing companies and group purchasing organizations and the payments made to those physicians. Information about these financial relationships will be collected by the CMS and published on a publicly available website in late 2014.

This idea of public transparency is important. Open Payments is designed to create a publicly available resource that achieves a broad goal: creating greater knowledge, accountability and understanding about the financial relationships between manufacturers, GPOs and covered recipient physicians and teaching hospitals. Collaboration among covered recipient physicians or teaching hospitals and industry can—and does—contribute to the development of life-saving drugs and devices. Sometimes, however, payments from manufacturers to physicians and teaching hospitals can introduce conflicts of interest.

Under the law, manufacturers must disclose the nature and extent of these financial relationships. This will help all of us, including patients and families, the clinical community, the CMS and other stakeholders, to be better informed and will reduce undue influence on research, education and clinical decision-making. This in turn will improve clinical integrity and help promote sound, evidence-based decisions about patient care.

Industry data collection and tracking of its financial relationships with physicians and teaching hospitals began Aug. 1. Industry registration in the Open Payments program and submission of 2013 data to the CMS must be completed by March 31, 2014. In the fall of 2014, the CMS will post the 2013 data on its Open Payments website, which will be accessible to the public. The CMS will post program data annually.

This may all raise some big questions. Are you and your organization ready for this new, broad transparency program? How will the new law work? What will the public, and specifically patients, think of this new information?

Through extensive planning and consideration of these issues, the CMS has simplified the reporting process. Last December, the CMS took into account feedback on the draft rules from nearly 400 interested parties, including medical professionals. The CMS website (go.cms.gov/openpayments) now features fact sheets and other information.

One important fact is that physicians and teaching hospitals are under no obligation to register or report anything to the CMS. All of the reporting is done by industry. Still, we encourage physicians as well as teaching hospitals to do the following: become familiar with the information reported about them; register with the CMS and subscribe to the Listserv to receive updates on the program and be notified when information is reported about them; and work with manufacturers to confirm that details submitted about them are correct. Also, physicians especially can ensure that their National Plan and Provider Enumeration System data is accurate, as companies will be refer to this information when reporting.

Because tracking your financial interactions with industry will help to ensure the accuracy of what gets reported, the CMS has created a free, mobile app that you can download and use to track payments. Industry has a similar application, and the two apps can communicate with one another to share contact information or information about the payment if you wish. It should be noted that the apps are used for tracking purposes only and do not directly transmit information to the CMS.

The objective of these apps is to make tracking payment information easier and more convenient, and to improve the accuracy of payment information. This is an optional tool but one that we recommend you check out. You can download the mobile apps directly from an app store by searching for Open Payments Mobile for Physicians or Open Payments Mobile for Industry, depending on which app you are downloading.

As the program unfolds, Open Payments will do what laws are supposed to do: address widespread public concerns. All of us—physicians, teaching hospitals, manufacturers and the CMS—will have to take our share of the responsibility to make sure this new law works. Full compliance will strengthen the American healthcare system—and help you to keep putting your patients first.

Dr. Shantanu Agrawal is medical director for the CMS' Center for Program Integrity and director of its Data Sharing and Partnership Group