Life Science Topics - Dispute Resolution

As engagements between life sciences companies and healthcare professionals (HCPs) become more frequent and complex, the financial ties associated with those engagements continue to create significant compliance risk for many life sciences organizations. While there are many benefits to increased HCP engagements, such as helping to design clinical trials, conducting continuing medical education, developing clinical [...]

Building a transparency reporting program is easy. Building an effective transparency reporting program, however, is much more challenging. Partnering with over a hundred medical device and pharmaceutical companies, I have had a first-hand opportunity to build from scratch, enhance and overhaul numerous transparency programs focused on U.S. and global reporting requirements. Through my experience, I [...]

The Centers for Medicare & Medicaid Services recently published their 2019 Open Payments data. In the 2019 report, which includes transactions that took place between Jan. 1 and Dec. 31, 2019, applicable manufacturers reported $10.03 billion in publishable payments, ownership, and investment interests to healthcare professionals (HCPs) and healthcare organizations (HCOs), which is approximately 680 [...]

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 [...]