Vector Health has been delivering event updates via its social media channels and this practice will persist in the forthcoming editions of the LegalEZ newsletters.
CMS representatives were present at the Transparency, Aggregate Spend & HCP Engagement event in Washington, DC, US whereby they provided some very useful information. The representatives highlighted the key Final Rule Changes which were introduced earlier this year and touched upon the up-coming CMS Audits.
The CMS audits have certainly caught the attention of compliance officers. The audits are thought to be imminent and companies will be selected both on a risk and random based criteria. Some of the risk factors may include: companies with non-compliant data, regular late reporting, high dispute rates or other compliance issues identified by the OIG or other government agencies.
It is important for companies to start preparing for the audits now. We have outlined some of the best practices and suggested ways to prepare for an audit in the newsletter. Some of these include: having good contracts with vendors, carrying out internal audits, reviewing submitted data on CMS to check if it is in line with the evidence you hold on your internal system.
Preparing for the audits now will save time and resources if your company does get selected. Companies should be taking a proactive rather than a reactive approach. CMS will write to the companies who have been selected after which the auditors will get in contact with the company to start the audits. For those companies who are high risk may wish to consult counsel, especially during the audit conclusion negotiations.
The US continues to make new and stricter transparency laws. Connecticut have now issued a new law which requires Licensure and Reporting for Pharmaceutical Sales Representatives Starting October 1, 2023. The law requires, all pharmaceutical manufacturers that employ individuals to perform the duties of pharmaceutical sales representatives to register on an annual basis with the Connecticut Department of Consumer Protection as a pharmaceutical marketing firm.
No pharmaceutical manufacturer is permitted to have individuals acting as pharmaceutical sales representatives on their behalf unless they have obtained the required registration from the Department.
It is no exaggeration when someone says that transparency reporting is a complex matter. Venturing in to the global transparency landscape can be an intimidating experience. Given the multitude of laws, regulations, and national codes of conduct in existence worldwide, navigating global transparency can prove challenging for both new startups and established companies venturing into this arena. We have outlined a guide to global reporting for new start-ups or those existing companies who are looking into venturing into global transparency.
Moving across the pond and to EU, the most awaited Italian Sunshine Act seems to now be making progress. Recent developments have shed a little light on the situation. The Ministry of Health has stated that a structure has been identified for the technical characteristics of the electronic public register and the requirements and methods for how the data will be uploaded on to the platform.
Industry experts have predicted that the process should now move relatively quickly with the initial disclosure requirements coming into effect as early as July 2024. Vector Health will continue to monitor the situation closely and provide regular updates on its social media pages and future newsletter editions.