August Newsletter 2023
Our August edition of the LegalEZ Compliance Digest provides useful information on: US State license registration/certification overview, US CMS Updates, US OIG/DOJ Updates, EU and global disclosure requirements for; France, Colombia, Indonesia & Portugal, EU and Global Updates and ends with a valuable Compliance Commentary. Transparency reporting can be a daunting task for everyone as there is a lot of information to digest and deadlines to adhere to. In addition to the requirements of transparency reporting, manufacturers must ensure they are up to date with the State license registrations.
There are registrations that both manufacturers and sales representatives need to ensure they have either applied for or renewed and if applicable, made the payment for the fees. We have provided an annual overview of the State license/certifications which manufacturers and or sales representatives are required to adhere to.
Some will be pleased to hear that CMS has recently made changes and provided clarifications on the Stark Law. The agency has created new forms under the and streamlined the voluntary self-disclosure process for certain parties. Providers are able to self-disclose noncompliance with the Stark Law and receive reduced penalties for the noncompliance.
There are a few OIG updates, including the department publishing a new frequently asked question (FAQ) document and advisory opinion. Both documents focus on how to analyse arrangements that may involve providing cash, cash equivalents, and/or gift cards to Medicare and/or Medicaid beneficiaries under the beneficiary inducements prohibition provision of the Civil Monetary Penalty Law (CMP) and Anti-Kickback Statute (AKS).
In addition to the above, the OIG has expanded its Frequently Asked Questions (FAQ) program to cover new topics, including Anti-Kickback Statute enforcement, civil monetary penalties, and general compliance considerations. In the new FAQ process, HHS OIG “will issue information, non-binding feedback in response to selected inquiries in the form of an FAQ response.” To submit an FAQ for non-binding feedback, you can email the email address included on the FAQ page here.
Moving outside of US, France and Colombia have a transparency reporting requirement for 1st September and 30th September, respectively. Portugal and Indonesia disclosures are also due on a monthly basis. Detailed transparency reporting requirements are contained within the August newsletter.
Luxembourg’s IML Code of Ethics is now available in English. However, the association has issued a disclaimer stating that the only version that is authoritative is the French Text.
The EU Council has now approved the Batteries Regulation and was adopted on 10 July 2023. The regulation provides that by 2027 portable batteries incorporated into appliances should be removable and replaceable by the end-user, leaving sufficient time for operators to adapt the design of their products to this requirement. The regulation repeals and replaces the existing Batteries Directive 2006/66/EC.
However, MedTech Europe had expressed concerns regarding the proposed transitional period for compliance of portable batteries with the new electrochemical performance and durability requirements as portable batteries would have to be tested in combination with medical devices in order to ensure that patient safety and performance criteria are satisfied.
According to MedTech Europe, the time required for such testing, validation, and subsequent regulatory approval as well as for potential changes to the design of a device resulting from the amended batteries’ specifications would merit an additional 2-year period to transition to the new requirements.
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