Author: Rebecca Scott, Product Specialist at HealthStream
Rebecca Scott has more than 23 years of experience in the field of Higher Education Administration, the last 13 of which were spent managing clinical trial billing compliance, clinical research risk, and conflict of interest (COI) management for a large academic medical center. Scott joined HealthStream in 2020 and is a COI thought leader who assists clients with COI best practices, efficient product utilization, and managing COI risk.
Most compliance officers and health systems are familiar with CMS’s Open Payments database. Since its inception in 2010 and its initial publication in 2014 through today, CMS has collected data on financial transfers of value from applicable manufacturers and group purchasing organizations (GPOs) to more than one million providers in the US. That number is about to grow, but what does this mean?
If we look back to the Physician Payment Sunshine Act, which was part of the Affordable Care Act of 2010, we recall that applicable manufacturers and group purchasing organizations, simply stated as drug and device companies, have to collect financial information detailing how much money and gifts they give each year to physicians, surgeons, dentists, certain osteopaths, and teaching hospitals. These payments are collectively known as “transfers of value,” and these providers are called “covered recipients.” These transfers of value are reported separately in the Open Payments database under the categories General Payments, Research Payments, Associated Research Funding, as well as Ownership and Investment Interest. Some of these categories encompass sub-categories. The burden of data accuracy and reporting rests on the drug and device manufacturers and GPOs.
The reporting cycle on which these transfers of value are tracked has changed very little from the first full year of financial data reporting and are not likely to change in the future. Applicable manufacturers begin tracking transfers of value in January every year through the end of December. The following year they report these transfers of value to CMS, which then makes the data privately available to providers and teaching hospitals during the Review and Dispute phase. CMS allows 45 days for teaching hospitals and providers to file disputes with the applicable manufactures and GPOs if they determine the data is not accurate. These conversations are between the covered recipients and the drug and device companies and GPOs, not CMS. After the Review and Dispute period closes, CMS makes the data publicly available on the Open Payments website on or before June 30 each year. The financial data, therefore, is always a retroactive look at the previous calendar year.
A thorough understanding of the Open Payments reporting cycle is critical in the context of the SUPPORT Act of 2018. The SUPPORT Act is a large collection of Acts that are all intended to fight the Opioid Crisis in America. Section 6111 of the SUPPORT Act, Fighting the Opioid Epidemic with Sunshine (FOES), statutorily caused the types of covered recipients to expand beyond physicians, surgeons, dentists, and osteopaths. In response to the SUPPORT Act, CMS issued a Final Rule on November 1, 2019 to expand the definition of covered recipients to include physician assistants, nurse practitioners, clinical nurse specialist, certified nurse midwives, and registered nurse anesthetists. The Final Rule also updated the General Payments category to add debt forgiveness, long term medical supply or device loan, and acquisitions as sub-categories. Furthermore, the Final Rule combined the two payment sub-categories for continuing education teaching and non-continuing education teaching into one single category and added reporting requirements for manufacturers and GPOs to include device identification numbers for devices and medical supplies in the Open Payments dataset.
Beginning January 1, 2021, applicable manufacturers and GPOs will begin collecting financial transfer of value information for both the original provider categories and the new. They will collect that information and send it to CMS in the spring of 2022. CMS will publicly publish the expanded data, including the new transfer of value sub-categories, no later than June 30, 2022.
Health systems, teaching hospitals, and all provider types should be ready for this transition. Physicians assistants and nursing staff should receive Conflict of Interest training along with other providers. Institutions should review internal policies and communicate any updates to providers as soon as possible. Continuing Medical Education providers should ensure their speakers are aware of the change in CE-related sub-categories and voice internal expectations to their speakers. Compliance Offices should review their internal conflict of interest disclosure policies and practices and ask themselves if they’re asking the right questions of the right people across all demographics of their organizations in order to identify, mitigate, and manage financial, legal, and reputational risk.
Learn more at https://www.cms.gov/OpenPayments/About/Law-and-Policy
HealthStream provides online healthcare compliance solutions to help health systems, facilities, and organizations across the care continuum comply with government regulations and accrediting body requirements. COI-SMART™ provides comprehensive tools for tracking and managing Conflicts of Interest (COI) disclosures. Learn more.
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