The Centers for Medicare and Medicaid Services (CMS) has proposed changes to the Open Payments program that would significantly expand transparency reporting requirements. Developed in response to the SUPPORT Act, these updates aim to curb the opioid epidemic, by increasing the transparency and accountability around the prescribing practices of any healthcare professional who can prescribe opioids, not only physicians.

The updates, if enacted, will be the most significant changes to US transparency reporting requirements since their inception. In its current form, the regulatory change will go into effect for data collection as of January 1, 2021 and be incorporated for the first time in 2022 reports. Manufacturers have a narrow window of time to implement the technology and processes to capture this additional data.

Proposed Changes

• CMS proposes expanding the scope of HCPs for whom TOVs must be reported to cover several categories of non-physician healthcare professionals, including nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse-midwives, along with physician assistants.
• New payment categories include debt forgiveness, acquisitions and long-term medical supply or device loans. CMS intends these distinctions to help manufacturers provide greater specificity about the nature of the ToVs, a key goal of the Sunshine Act’s Open Payments program.
• The reporting categories for accredited and non-accredited educational programming are being combined, as CMS determined that the distinction is no longer necessary.
• Device manufacturers would be required to report unique device identifiers (DIs) in the same manner as drugs and biologics are currently reported via the national drug code (NDC).
• CMS also clarified that NDC reporting is required for both research and non-research payments.

How to Prepare

Organizations will need to modify their reporting categories to conform with the changes and adopt more comprehensive collection practices to include the new inclusion of non-physicians into the classification of covered professionals. Device manufacturers will need to collect the new device identifier and align their systems accordingly.

None of this is insurmountable, but time for implementation is short. In reality, organizations will need to take 2020 as a sort of dry run for these new requirements. Any lapses or gaps can be addressed and rectified before the threat of penalties looms. Companies already working with a solutions platform for compliance and transparency reporting will have the easiest transition process.

Expectations for Future Regulation

Since the passage of the US Sunshine Act, the number of countries that have adopted transparency regulations has grown to 47. For organizations that have not yet implemented global compliance platforms, the proposed CMS changes are a reminder that scalable solutions need to be a top priority for 2020 and beyond.

For more information about IQVIA Commercial Compliance, please email commercialcompliance@iqvia.com or visit our webpage. Our experts leverage the industry’s leading technologies to deliver streamlined processes and improved efficiencies that solve your toughest engagement and transparency challenges. From automating and managing the entire HCP/O contracting lifecycle, to capturing, collecting, and reporting global spend; to planning efficient and compliant HCP meetings and engagements—discover how our solutions can make compliance easier for you.