Life Science Topics - Patient Protection and Affordable Care Act

For life science companies, paid engagements with healthcare professionals and organizations (HCP/O) are crucial to growing your business. However, with enforcers turning a closer eye to monitoring engagements, ensuring and maintaining compliance can slow down your process. How does your organization supercharge its business growth, but do so compliantly? These paid engagements remain a key [...]

Many life sciences companies could be missing a key opportunity by not proactively leveraging their aggregated spend data and the publicly available CMS Open Payments data. Examining all available data is essential to help gain competitive intelligence and further inform strategic business decisions. The organizations currently mining this valuable data are usually large companies that [...]

As one of the most regulated industries in the world, life science organizations need a well-developed compliance plan to stay ahead of the game. Creating or enhancing a compliance program can be overwhelming, and if you choose the wrong partners, implementing new policies, procedures and technology can cause confusion, waste valuable time and drain your [...]

In July 2021, Oregon’s governor signed into law Senate Bill 763 requiring pharmaceutical representatives to obtain a license prior to marketing or promoting products to healthcare providers (HCPs). The law also included a provision granting the Department of Consumer and Business Services (DCBS) the authority to require licensees to submit disclosures related to their interactions [...]

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 [...]