Open Payments is designed to do what laws are supposed to do: address widespread public concerns, and in this case, create
a window into an area of healthcare previously unavailable to the public. In 2009, the Institute of Medicine published a report,
"Conflicts of Interest in Medical Research, Education and Practice" that described such concerns. The influential report also
recommended implementing a national disclosure program for payments to healthcare providers and prescribers. The Open Payments
program was created to address this and other calls for transparency of these financial relationships between the industry
and physicians and teaching hospitals.
Like industry, CMS fully appreciates the benefits that accrue from ongoing collaborations among pharmaceutical manufacturers,
physicians, and teaching hospitals. Those joint efforts have long contributed to the discovery, design, and development of
life-saving drugs, and delivered better health to patients worldwide.
However, certain financial relationships may not be beneficial, and may in fact create conflicts of interest that negatively
affect patients. Under Open Payments, the industry will disclose the nature and extent of such financial relationships. The
data will help patients make decisions about the delivery of their healthcare. In the process, disclosure may also help to
discourage improper influences exerted over research activities, education, and clinical decision-making that can potentially
compromise clinical integrity and the quality of patient care—or potentially lead to higher healthcare costs.
Open Payments will serve as a valuable national resource, addressing a long-standing information void and providing more transparency
about the healthcare market. It is in the spirit of transparency that CMS is striving to implement this law, with open engagement
and input from the stakeholders.. We have worked closely with stakeholders to better understand the current scope of the interactions
between manufacturers and physicians and teaching hospitals. Last December, for example, when finalizing the policy and rule
for this program, CMS weighed feedback from nearly 400 interested parties, including pharmaceutical manufacturers. The final
regulation was preceded by no fewer than 251 pages of commentary and explanations, an example of the deliberate approach to
consider and integrate the comments received and make the rationale for final decisions clear and transparent.
Still, CMS understands these disclosure requirements will be a major undertaking for many companies. CMS is taking great care
to simplify the procedures involved and provide support as industry undertakes this effort. Starting with the regulation,
CMS has provided accommodations, such as a longer period of time than was required in the law—six months—for industry to prepare
for the start of data collection.
Already, the CMS website offers considerable information, often in the form of fact sheets, in straightforward language to
help make this program understandable. It has provided manufacturers with three customized file specifications to help implement
their data collection. An electronic system is being developed to facilitate the registration and reporting process via a
portal on a secure website. All participants will then have a voluntary opportunity—45 days—to review, dispute, and correct
any information believed to be inaccurate prior to its publication. This review is very important to help ensure that the
information made public is accurate and complete.
CMS has developed new free mobile apps, one for industry and the other for physicians, that can assist in Open Payments implementation.
You can download the mobile apps directly from your app store (iOS Apple or GooglePlay) and search for Open Payments. It should
be noted that the apps are used for tracking purposes only and do not directly transmit information to CMS
The benefits of compliance are extremely worthwhile. Several advantages are anticipated. Disclosure will enable patients to
make informed decisions when choosing healthcare professionals and treatments. Payers will be better equipped to identify
conflicts of interest and make better decisions regarding ordering or prescribing physicians. And providers will have more
knowledge about those physicians publishing important data and establish guidelines and standards of care.
Compliance with this program is being taken extremely seriously, and the companies involved should understand the consequences
for non-compliance. Violations carry consequences: civil monetary penalties are capped annually at $150,000 for failure to
report and at $1,000,000 for knowing failure to report.
As implemention of this program in collaboration with the industry begins, CMS encourages you to ensure that your organization
is prepared and ready to be in full compliance with the reporting requirements. Start early and integrate the processes into
your business operations, and use the CMS website and its resources to help educate your employees about the program. The
public deserves to be fully informed about financial relationships among healthcare providers, and industry should welcome
the opportunity to be more transparent than previously required. We are all in the healthcare business. Healthcare means taking
care of patients, and the new law will better enable all of us to keep putting patients first.
Shantanu Agrawal, MD, is Medical Director for CMS's Center for Program Integrity and the Director of Data Sharing and Partnership. He can
be reached at Shantanu.Agrawal@cms.hhs.gov