While much attention has been focused on the policy aspects of the new Open Payments (Physician Payments Sunshine Act) transparency program, there is a technical engine behind the policy which will make or break this initiative. When it comes to the success of the program and the process by which organizations will implement and comply with it, the role of information technology will prove pivotal.
Open Payments requires manufacturers of covered drugs, devices, biologicals, and medical supplies to annually report to the Centers for Medicare & Medicaid Services (CMS) certain payments and other transfers of value (e.g., research grants, consulting fees, gifts, travel, meals, etc.) they make to physicians and teaching hospitals (“covered recipients”). The law also calls for reporting of ownership and investment interests held by physicians or their family members in manufacturing companies and applicable group purchasing organizations (GPOs), as well as payments made to those physicians. This reported data, which will disclose financial relationships among industry, physicians, and teaching hospitals, will then be aggregated and published annually by CMS on a publicly accessible website.
This law, a part of the Affordable Care Act (ACA), serves to increase transparency by putting data about these financial relationships into the public domain. This is important, because while financial ties among manufacturers, physicians, and teaching hospitals can help lead to the development of innovations and life-saving treatments or devices, they can also introduce the opportunity for conflicts of interest. These conflicts of interest could unduly influence prescribing or ordering behavior, and impact patient care and health care costs. Open Payments will establish a comprehensive resource that creates transparency and access to a national dataset of physicians, teaching hospitals, and industry data regarding these financial relationships. The data will help patients and families, as well as the clinical community, know about the nature and extent of the relationships and use it for more informed decision-making.
Are You and Your Organization Ready for this New Law?
CMS takes compliance seriously, and there are financial consequences for industry non-adherence. Violations of the reporting requirements will carry civil monetary penalties which are capped annually at $150,000 for failure to report, and at $1,000,000 for knowingly failing to report. So being prepared, as well as tracking and reporting accurate and complete data to CMS, is critical.
Open Payments is now underway. Industry began to collect data and track their financial relationships with physicians and teaching hospitals on August 1, 2013. They will then be required to register and submit 2013 data to CMS in early 2014. Then, in the fall of 2014, CMS will post the 2013 data on its Open Payments website for the public to view, search, and download. As you can imagine, a national data-collection initiative such as this will require robust IT solutions appropriate for data collection, submission, and reporting. CMS is taking great care to design and develop the secure IT infrastructure necessary for data submission and reporting as well as other functions. Similarly, industry users will require sufficient IT solutions to allow for data collection, storage, and retrieval so that data can be submitted to CMS each year and retained as required by the regulation. All parties must take caution to ensure data accuracy and integrity so that only the appropriate data is reported. This includes encouraging physicians to get involved to review their data prior to public posting.
CMS has looked for every opportunity to engage industry, stimulate awareness, and provide helpful tools, including information technologies. CMS carefully considered feedback on the proposed rule from nearly 400 interested parties, including health information specialists. Throughout the process, CMS has taken care to simplify procedures and support stakeholders as they undertake the effort of program compliance. To that end, CMS is in the process of presenting a series of technology-focused webinars designed to introduce features of the Open Payments system currently in development.
The CMS Open Payments website offers comprehensive information to help industry comply with the law, including targeted fact sheets presented in straightforward language. After the deadline for data submission each year, program participants will have the opportunity to review, dispute, and correct any information believed inaccurate prior to data publication.
CMS is also developing an electronic system to facilitate the reporting process via a portal on a secure website. And in July 2013, we introduced a free mobile application to help health care industry users track payments and other financial transfers that need to be reported under Open Payments. The app, compatible with iOS and Android platforms, offers real-time, 24-hour convenience and is intended primarily to ensure accurate reporting (another app is available for physicians). It should be noted that the apps are used for tracking purposes only, and do not directly transmit information to CMS.
Here’s our advice on how to get ready for Open Payments:
- Refer often to the CMS Open Payments website for informational resources and details on past and upcoming webinars that will help educate your employees about the program and system.
- Learn how to navigate the CMS Open Payments system and understand its user interfaces. CIOs and Compliance Officers with manufacturers, for example, will need to interact with the CMS system—industry will need to collect the data, create extract files of your data, and transmit the information to CMS on an annual basis. Training information on Open Payments system navigation will be available on the Open Payments website.
- Review the Data Submission and Attestation web page on the Open Payments site, in order to align your internal IT systems accordingly. This will dictate how you configure your system to align with the CMS system to be able to produce the necessary file for submission to CMS.
- Register with the Open Payments system if you are required to submit data—the sooner you register, the better. Only then can CMS conduct the vetting process necessary to verify your identity and validate your role representing a given organization. Registration will be open in early 2014.
- Subscribe to the listserv on the Open Payments website to receive updates about the program, learn about available training opportunities, and eventually, view any information reported about your company.
Again, this law, though clearly a shared responsibility among many parties involved, will require strong information technologies and associated solutions. Indeed, CIOs and health IT leaders with the health care manufacturers must understand and adhere to the processes. This is necessary in order for the spirit of transparency embodied in this law to become a reality of standard practice.
Anita Griner is Deputy Director of the Data Sharing and Partnership Group at CMS's Center for Program Integrity.