The MediSpend Legislative Watch provides users with news and content related to global transparency reporting and compliance in the life sciences. Recently, we hosted a webinar to inform participants about updates to the Legislative Watch and changes in law that could influence their compliance strategy.
“The goal of the Legislative Watch is to keep track of different transparency and legislative changes in the life sciences industry locally, federally, and around the world,” said Howe. “We're really trying to give you the opportunity to stay on top of some of the latest regulations, which as we all know, are expanding rapidly.”
U.S. Open Payments
By March 31, life sciences organizations conducting business in the United States must complete their annual reports and submit them to the Centers for Medicare and Medicaid Services (CMS). Howe reminded participants of the following:
- Ensure the Enterprise Identity Management (EIDM), which is used to identify organizations, is active.
- Reporting entities that are due for recertification are given a status of “pending recertification.”
- Recertification confirms all details in the Open Payments system are accurate.
- Organizations must identify someone with the position of officer to perform recertification.
- Contact the Open Payments Help Desk if no one holds the officer role.
MediSpend always suggests clients submit as early as possible. “There have been issues in the past with the open payment system moving slowly due to so many people trying to report at the same time,” said Howe. “There's occasionally some downtime in the portal or maintenance issues that have occurred.”
Nevada Pharmaceutical Disclosure
This reporting requirement is for pharmaceutical companies only and the deadline was March 1. Manufacturers are required to provide Nevada Department of Health and Human Services (NDHHS) with an annual list of sales representatives who market the manufacturer’s prescription drugs to Nevada licensed, certified, or registered HCPs, pharmacies, and medical facilities. The events that are eligible for reporting include any type of compensation greater than $10 or total compensation with a value that exceeds $100 in aggregate.
International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
Since Jan. 1, 2019, the IFPMA Code has been in force. There are no transparency provisions, however we discussed two of the changes in this code that are particularly significant.
- The organization updated several provisions, including a ban on gifts and promotional aids.
- IFPMA created the value-based Ethos to replace its rules-based philosophy. This one serves as a guiding light based on four principles – care, fairness, honesty, and respect.
In 2018, members of MedTech, the European trade association for the medical technology industry, had to report on educational grants for the first time. At the end of August, the organization published the information.
Linked to this, member companies were not permitted anymore to pay expenses directly to individual Healthcare Professionals to participate in conferences. Support is only allowed through educational grants.
A number of European industry associations already followed suit by aligning their codes with the MedTech Europe Code of Ethical Business Practice. Member associations must transpose the Code at the national level by Jan. 1, 2020.
The Ministry of Health and Social Protection in Colombia (the ‘Ministry’) issued a resolution in 2018 that obliges life science companies to report on payments to actors in the health sector. Companies need to start collecting the data in the second half of 2019.
The group of covered recipients indicated in the Resolution is quite broad. It concerns people who perform certain activities in “the national territory” in the health sector, including persons that prescribe services, pharmaceutical products, and health technologies, but also people who provide services covering health issues in any communication media. Likewise, it covers organizations in the health sector including associations that are scientific, medical or trade-union in nature, but also benefit plan administrating entities.
The threshold for reporting transfers of value (ToVs) is “one (1) month of the current minimum legal salary (MMLS).” However, if the transfer of value relates to delivery and/or payment for food and beverages or delivery of documents or objects that contain printed promotional advertising information, the threshold is “three (3) days of the current minimum legal salary (DMLS)”. The MMLS for 2019 is 828,116 Colombian pesos.
The Ministry informed stakeholders that for the first reporting period, between January and March 2020 (ToVs made in favor of a Receptor from July - Dec 2019), the ToV will not be published. The Ministry mentioned that they will make an official announcement in this respect by the end of March. We will post additional information on our Legislative Watch as we learn more.
Ultimately, the MediSpend team is here to ensure clients stay up-to-date on global transparency reporting requirements. Life sciences organizations must track the quickly evolving regulatory landscape in all the regions where they conduct business to devise a comprehensive compliance strategy. The MediSpend Legislative Watch is a helpful tool for getting informed about evolving regulations.