Life Science Topics - State Legislation

On June 17, 2020, an important decree related to “anti-benefits” was published in France, including the ministerial orders implementing this decree. The new rules contain changes in the regulatory framework for interactions between the industry and healthcare professionals (HCPs). A summary of the decree can be found below and a link to the full decree [...]

The Maine Board of Pharmacy finalized its gift ban rule last month, providing guidance for manufacturers and wholesalers over a year after initial regulations were proposed. The final rule, effective June 6, provides guidance on minimal value in relation to modest meals and refreshments, reasonable honoraria and research. The Board clarified that the gift ban [...]

As mentioned in a blog published last year, EPFIA consolidated their three EFPIA Codes (PO – HCP – Disclosure) into one simplified Code. EFPIA stated their reasons to consolidate the Codes were “the simplification of concepts, the removal of repetitive provisions and the clarification of the content”. Member Associations were asked to transpose the revised Code provisions [...]

1. Implementation Time Investment A migration to a SaaS solution may seem intimidating and you might have concerns about the bandwidth of your IT department for such a project. Typically, the actual implementation and rollout of a SaaS solution is a relatively quick and easy process. In fact, most pharmaceutical and medical device companies will [...]

On June 1, 2020, the Department of Justice (DOJ) updated its guidance document on the “Evaluation of Corporate Compliance Programs.” As outlined below, the DOJ identifies the adequacy of resources and the access to data and analytics as key components to establishing an effective compliance program. The original version of the guidance document was published [...]

While the healthcare industry has always been highly regulated, recent developments mandate that transparency and compliance monitoring are not afterthoughts for manufacturers, healthcare organizations and healthcare professionals (HCPs). The number of regulations continue to grow, and the penalties for violations become significantly larger given the availability of large volumes of spend and prescription data in [...]

The Massachusetts Department of Public Health requires pharmaceutical and medical device manufacturers to disclose certain transactions with anyone who prescribes, dispenses, or purchases prescription drugs or medical devices in the Commonwealth. This includes any fee, payment, subsidy, or other economic benefit with a value of at least $50. Massachusetts revised its reporting template and updated [...]

The fundamentals of good compliance require the ability for compliance professionals to intercede, either prospectively or retrospectively, at key control points. Whether these are activity, contract, payment or document controls, an inability to apply these controls reflects an inability for the compliance professional to manage enterprise risk. Historically, many business processes have evolved from manual, [...]

Whether you’ve just completed your first submission to Centers for Medicare & Medicaid Services (CMS), or you’ve had a transparency reporting program in place for years, it pays to take a look at your process to identify opportunities to increase efficiency and reduce risk. Think back to the most recent reporting period and ask your [...]

Meeting US federal, US state and international transparency reporting requirements requires a substantial amount of time and resources from you and your team. Regulations have grown increasingly more complicated and will continue to expand as more jurisdictions introduce new laws and expansions to current rules. Creating an efficient, time-saving process for transparency reporting is a [...]