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 a […]
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 assessments […]
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 Initiative […]
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 […]
A special fraud alert was issued by the Office of the Inspector General (OIG) on November 16, 2020 highlighting the potential fraud and abuse related to the offer or payment of remuneration for speaker programs by pharmaceutical and medical device companies. Speaker programs were defined by the OIG for purposes of the special fraud alert […]
Earlier this year, we published a blog highlighting the French Decree on ‘anti-gifts’ that was published on June 17, 2020.[1] Additional ‘orders’ related to the French ‘anti-gift’ provisions were issued on August 7, 2020.
The French “anti-gift” provisions strictly frame the conditions under which companies in the health […]
The landscape of meeting compliance needs within life sciences is changing. Today, life sciences organizations are rapidly shifting to a digital centric world. This is especially true for solutions aimed at the highly complex task of managing healthcare professional (HCP) engagements as well as meeting global transparency reporting obligations. These solutions are a […]
If your organization is like most these days, resources are tight and teams are lean. Efficiency becomes a key ingredient to an effective compliance program. Running lean doesn’t mean corners must be cut or best practices need to be sacrificed. Below are five ways to keep your healthcare professional (HCP) engagement process in […]
One of the key areas of focus for compliance teams is pre-empting and managing risk across the organization before it becomes a compliance issue. Given that there could be many different sources of risk, especially in large global organizations, compliance teams need access to tools that can […]
