What the Sunshine Act means for GI & AGA reform efforts: Q&A with Dr. Michael Kochman

Dr. KochmanThe information gathered under the Sunshine Act will be made public by CMS on Sept. 30; the review and dispute process remains open until August 27. Michael L. Kochman, MD, AGAF, chair of the American Gastroenterological Association Center for GI Innovation and Technology, explains what the Open Payments program means for physicians and what changes the AGA would like to see in the legislation.

Question: How does the Sunshine Act affect gastroenterologists?

Dr. Michael L. Kochman: I don't believe that it affects gastroenterologists any differently than any other group of physicians. Clearly the SSA has raised awareness of the potential for conflict.

Q: Are there positive effects of the Open Payments program?

MK: It has served as a reminder to all physicians to be mindful of the potential for conflict and to be aware of the potential for the perception of conflict.

Q: What is the biggest challenge posed by the Sunshine Act?

MK: From the physician perspective, one of the largest challenges is to make sure that the actual reporting that occurs is accurate and properly amended if an inaccuracy is detected. Another significant challenge is understanding how the reporting is perceived and interpreted by the public, as the aggregate totals may be misleading as to the actual attribution and indication for the report. To this point, CMS has yet to provide reliable guidance on the contextual information that will accompany the data, which will be critical to determining the usefulness of the information.

In cases of misleading or inaccurate information, physicians face a challenging mechanism for disputing data. Disputes and resolutions occur at the user level without significant involvement from CMS, making the process dependent on the ability of physicians and industry representatives to reach consensus. If information is disputed by a physician and no agreement can be reached with the industry representatives, the information will still be posted online with a disclaimer, which will be challenging for physicians to explain or correct.

Q: What changes would the AGA like to see made to the Sunshine Act?

MK: The AGA would like there to be more advance notice of the program's changes, deadlines and requirements, as well as better guidance materials from CMS that provide sufficient clarity for physicians to better navigate a difficult registration process. The program's success and utility will depend on achieving critical participation levels from physicians to ensure data integrity and review.

The AGA would also like to see changes made to the review and dispute process that better protect physicians against misinformation, which could result in unfair damage to reputations and cause patients to make healthcare decisions without a full understanding of the information being provided to them.

We are hopeful that CMS will take steps to ensure that evolving requirements for the Open Payments program do not threaten the ability of physicians to participate in ongoing, educational activities, such as continuing medical education, that are of great value to patients and ensure high-quality care based on the most recent evidence and clinical information available.

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New GI technology on the scene: 5 devices receive FDA 510(k) Clearance in July

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