By John H. Fisher II
April 6, 2017
The Affordable Care Act added the Physician Payment Sunshine Act (Sunshine Act) as section 1128G to the Social Security Act. The Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical supplies and certain group purchasing organizations to report annually to the Centers for Medicare & Medicaid Services (CMS) certain payments or items of value that are provided to physicians and teaching hospitals. The Sunshine Act also requires CMS to publish payments reported on a public Web site.
In 2013, CMS issued final regulations interpreting and clarifying the requirements of the Sunshine Act. The final regulations clarify the reporting process, identify exceptions and exclusions from the reporting requirements, and provide further details regarding what constitutes a reportable relationship. The final rule delineates the specific data elements reporting organizations are required to include and the required reporting format. Reporting organizations failing to make required reports are subject to potential civil monetary penalties.
Physicians are often surprised to see the information reporting agencies submit. Early on, errors in reporting were frequent as reporting companies struggled to integrate reporting requirements into their compliance process. Reports tend to be more accurate now, but there are certainly instances where reporting organizations create reports that should be questioned. A process is included to afford physicians and teaching hospitals to review and dispute the information a reporting organization proposes to report. The regulations require physicians to exercise diligence to review information being submitted that describes items of benefit they are alleged to have received. The regulations include a 45-day review and correction period, but report information does not automatically come to a physician unless affirmative action is taken to sign up to receive this information.
If the physician or teaching hospital receive notification, a process can be used to dispute the proposed disclosure with the applicable manufacturer. There is a very short time window to dispute and resolve the issue before publication is made for the applicable year so it is critical a dispute be invoked promptly upon receipt of notice of the proposed report. Signing up for notifications also permits access to the web-based dispute system. The review period lasts for 45 days and reporting organizations have 15 days after the end of this period to correct data to resolve disputes.
Errors in amount, the nature of items reported, and methodology of calculating or allocating expenditures among numerous recipients are frequent areas of error. For example, situations have occurred where expenditures that benefitted numerous physicians were allocated to a single physician. The opportunities for error in reporting are endless; particularly given the multiple parties that can be involved in the reporting chain for the reporting company.
Inaccurate reporting is not without consequence to the subject of the report. Inaccurate reports can be indicative of conflict of interest and can impact publication or reviewer credibility. A report can also be an indication of further potential fraudulent payments and can result in further government investigation regarding the fair market value of services provided in a consulting or other relationship. In extreme cases, payments inflated over fair market value for services that are actually and legitimately provided can indicate potential Anti-Kickback Statute and other compliance violations which can carry significant penalties. If a review is based on an inaccurate or inflated report, a positive resolution can likely be reached with investigators. However, anyone who has ever been involved in a government compliance investigation understands the intangible damage the process can create.
In order to avoid complication that could result from inaccurate reports, physicians and other reporting subjects should be certain to register to receive notification of proposed Physician Sunshine Act reports. Any inaccuracies should be disputed promptly.
The content in the following blog posts is based upon the state of the law at the time of its original publication. As legal developments change quickly, the content in these blog posts may not remain accurate as laws change over time. None of the information contained in these publications is intended as legal advice or opinion relative to specific matters, facts, situations, or issues. You should not act upon the information in these blog posts without discussing your specific situation with legal counsel.
© 2021 Ruder Ware, L.L.S.C. Accurate reproduction with acknowledgment granted. All rights reserved.