October Newsletter 2023

There have been many recent updates in the field of transparency reporting both in the US and across the globe. Keeping well-informed of these updates may pose a challenge, yet it remains imperative for manufacturers to ensure that their company is up-to-date about these changes and is in complete compliance with transparency reporting obligations.

This is why our LegalEZ Newsletter is a hit with our subscribers as we not only provide you with up-to date information around transparency reporting but also provide suggested best practices on how to prepare for changes.

The following topics will be covered in the October edition of the newsletter:

• US CMS Data Collection Templates for General, Research & Ownership Payments
• US CMS Updates: 2024 Reporting Threshold & Teaching Hospital List.
• US CMS Reminder: Post Deadline Submissions & Record Resubmission
• US State laws: Florida Stark Law & Connecticut Licensure Application
• EU & global disclosure requirements for; Indonesia & Portugal.
• EU & Global Updates: Proposed UK Sunshine Act & South Korea Disclosure update
• EU Update on the Italian Sunshine Act.
• Compliance Commentary.

Starting with the CMS Updates; CMS has published the 2024 Reporting Thresholds. The Open Payments Thresholds for reporting TOV’s have been adjusted based on the Consumer Price Index. This again is usually updated every year taking into account the inflation rate.

Small payments or other transfers of value of less than $13.07 do not need to be reported, except when the total annual value of payments or other transfers of value to a covered recipient exceeds $130.66 for Program Year 2024.

The Teaching Hospitals List has also been updated so make sure you check to see if the Teaching Hospital you provide a TOV to in 2024 is on the list. If it is then you will be required to disclose the payment on the Open Payments Portal as part of the 2024 disclosure.

CMS has issued a General Reminders on Post Deadline Submissions & Record Resubmission. If your organisation has reportable payments or other transfers of value that have not yet been reported to CMS, then those records must be submitted immediately upon confirmation of the error or omission.

CMS Audits are looming, late or non-submissions are a factor in their selection process. It is advisable to utilize the assumptions document to communicate the reasons for late submissions; these comments will be confidentially reviewed by CMS and will not be disclosed publicly.

The Connecticut Department of Consumer Protection website now has the application for eLicensure available. pharmaceutical manufacturers that employ pharmaceutical sales representatives are required to register with the Department of Consumer Protection, under section 3-7 of the Public Act 23-171.

The website is not very user-friendly so make sure you pay attention to detail when completing the application. The state will issue additional guidance on the annual disclosure report in due course.

The State of Minnesota has updated its disclosure template. Many of the changes were mostly rewording and formatting and a copy of the template can be accessed via the state’s website.

Moving across to the Global updates; the only transparency reporting disclosure for the month of November is Indonesia and Portugal; which are due on a monthly basis. We have outlined the requirements for these countries in the newsletter.

This may not come as a surprise to some, but The Department of Health & Social Care (UK) recently issued an open consultation on the possible introduction of a UK Sunshine Act. This has come as a result of the review carried out by the Independent Medicines and Medical Devices Safety (IMMDS). The Consultation has now ended and we are excited to see how this proposed law progresses.

For those who have a reporting requirement in South Korea should note that members of the Ministry of Health (MOH) are requesting companies to submit the 2022 disclosure reports to the MOH. The MOH is now being pro-active in this approach so companies are advised to be vigilant of this.

The public consultation of the Italian Sunshine Act has now ended and the MOH has issued a report on the consultation. The report merely offers an overview of the different quantitative and qualitative contributions arrived through the questionnaire and does not provide any material updates in relation to the telematic register.

It is however still anticipated that the register should be ready by the end of 2023. Companies should prepare themselves to be ready to collect TOV data starting from 1st January 2024, in readiness to make the first set of disclosure on 1st July 2024.

Our LegalEZ team has organized a compelling webinar around the Italian Sunshine Act on Wednesday, October 25th, from 3:30 pm to 4:30 pm CET / 9:30 am to 10:30 am EST. Don’t miss this chance to engage in a profound discussion with industry leaders and have your questions addressed. You can register for the webinar here