Life Science Topics - Dispute Resolution

Many life sciences companies are using manual processes or inefficient software to manage their end-to-end workflow process associated with educational, sponsorship, charitable and/or research (IIS/IIT) grant requests. When a manual process or inefficient software are no longer meeting your business needs, developing a business case is essential to advance forward. Building a business case for [...]

On July 23, 2021, the Centers for Medicare and Medicaid Services (CMS) published a draft of the calendar year 2022 payment policies under the Medicare Physician Fee Schedule (PFS) in the Federal Register. The PFS includes a number of proposed changes to the Open Payments Program which would become effective for data gathered in 2023 [...]

The Centers for Medicare and Medicaid Services (CMS) recently published their 2020 Open Payments data as well as newly submitted and updated payment records for previous program years. The 2020 report includes transactions that took place between January 1st and December 31st. Applicable manufacturers reported $9.12 billion in reportable payments, ownership and investment interests to [...]

On May 19, 2021, the Department of Justice (DOJ) announced a civil settlement in the Eastern District of Pennsylvania with Medicrea International, a French medical device manufacturer, along with its U.S. affiliate, Medicrea USA, Inc., to resolve alleged violations of the Anti-Kickback Statute as well as Open Payments Program violations. The federal settlement resolves allegations [...]

Intuitive grants processes benefit both external applicants and the life sciences companies who support them. For life sciences companies, one of the most critical aspects of managing any grants and research program is the ability to provide a self-explanatory application process. Applicants will only have an organization’s website and application form to understand the grants [...]

The Centers for Medicare & Medicaid Services (CMS) recently held two webinars regarding the 2021 Open Payments program expansion as well as the review and dispute resolution process. CMS began by reviewing the data submitted by pharmaceutical and medical device manufacturers for the 2019 calendar year. In 2019, there were 10.98 million records published for [...]

The Centers for Medicare and Medicaid Services (CMS) recently published their 2021 Open Payments data as well as newly submitted and updated payment records for previous program years. The 2021 report includes transactions that took place between January 1st and December 31st. Applicable manufacturers reported a total of $10.9 billion payments or transfers of value [...]

Since January 1, 2021, MedTech Europe and the European Federation of Pharmaceutical Industries and Associations (EFPIA) have a common platform assessing medical conferences. The two trade associations have a long-standing experience and commitment to strong ethical principles for the support provided in the context of medical congresses. Recently, both associations have decided to combine the [...]

On January 1, 2021, the Medicines New Zealand and New Zealand Medical Association (NZMA) Joint Transparency Initiative went into effect. “This initiative aims to promote public confidence in the biopharmaceutical industry through increasing transparency around the interactions between Healthcare Professionals (HCPs) and companies from the innovative medicines sector,” said NZMA. “The cornerstone of the Transparency [...]

In Lithuania, the Pharmacy Law was amended to add a disclosure obligation for marketing authorization holders (MAHs) regarding transfers of value (ToVs) to healthcare professionals (HCPs) or healthcare organizations (HCOs). The rules were approved by the Minister of Health on June 23, 2020. Although many pharmaceutical companies were already reporting in line with the principles [...]