Quarter 1 Newsletter 2024
As we usher in the new year, let’s unite in our commitment to excellence. The first quarter brings a flurry of deadlines, and we’re here to guide you through each one, ensuring your journey towards transparency is not only smooth but also impactful. Here’s to a year filled with insights, collaboration, and the continued pursuit of transparency excellence.
In the forthcoming January edition, marking the onset of the first quarter, our newsletter will encompass the following engaging topics:
- US federal Reporting Calendar: January-March
- US State Reporting Calendar: January-March
- US Updates EU & Global Reporting Calendar: January-March
- EU & Global Updates
- Compliance Commentary
For 2023 data, adherence to Open Payment regulations mandates companies to report individual transfers of value exceeding $12.69. In cases where the aggregate amount for a single HCP or HCO equals or surpasses $126.89, all transfers of value, irrespective of amount, are deemed reportable.
The Penalties under The Patients Protection and Affordability Care Act and Section 403.912 of the Code of Federal Regulation, for non-compliance are very strict. They range from $1,000, to a maximum $10,000 for each payment or other transfer of value or ownership or investment interest not reported. The fines increase to a higher figure for manufacturers who knew they had to make disclosure but failed to do so.
We have included a helpful chart outlining the penalties in the newsletter, so be sure to review it!
There are a few State reporting requirements for the first quarter of 2024. Oregon has a Sales Representative License Renewal. Additionally, there is also a Disclosure Deadline for Oregon on 1st April 2024 which is required to be made by Pharmaceutical Company Representatives.
In Nevada, Pharmaceutical Manufacturers’ Sales Representatives must make a transparency disclosure under Nevada Board of Pharmacy – Senate Bill 539 by 1st March 2024.
Pharmaceutical Company Representatives in Oregon and Pharmaceutical Manufacturers Medical Device Manufacturers in Vermont are required to make transparency disclosures by 1st April 2024.
Several US Updates are notable this quarter, starting with CMS. The Open Payments data has been updated to reflect changes that took place since the last publication in June 2023. The Open Payments data is refreshed annually to include updates from disputes and other data corrections made since the initial data publication. The refreshed Open Payments data includes: Record Updates, Disputed Records and Record Deletions.
Nevada’s reporting template has been updated and now includes compensation types. These included Consulting, Drug Samples, Education/Education materials, Food, Honorarium, Promotional Materials, Travel/Lodging, Other. For those who are required to report are reminded to ensure the required information is disclosed correctly.
In other State updates Vermont has updated its Gift Ban Guide so if you are interacting with HCP’s in Vermont you should familiarise yourself with the changes.
Several global reporting deadlines are due this quarter of 2024, spanning countries like the Philippines, Denmark, Slovakia, Brazil, Indonesia, Portugal, Estonia, Australia, Czech Republic, Israel, Saudi Arabia, France, Colombia, Romania, and the UK.
Transitioning to global updates; The Danish reporting template has been updated. The template now requests for the covered recipient’s full name in one column (first then last name). The email address and profession have been added and the address has been removed.
Detailed reporting requirements for both US and Global are provided in the Quarter 1 MedPharma Transparency Newsletter, along with briefings on ABPI, South Korea, and Mexico.
If you express interest in arranging a meeting with our esteemed LegalEZ™ team to dive deep into our newsletter, then we invite you to contact us at your earliest convenience. Your inquiry is highly valued, and we look forward to the opportunity to assist you further.