Porzio Life Sciences offers a range of solutions to its clients, including the Porzio Compliance Digest, Porzio AggregateSpendID and Porzio GST^®. What has been your key area of focus over the past year?

Porzio Life Sciences has continued to specialize across several avenues, but one area of particular interest has been transparency and transparency reporting – which is the reporting of financial interactions and transfers of value between life science companies, healthcare practitioners and healthcare organizations. Transparency reporting is multi-layered, affecting individuals and companies at the city, state and federal level. Under the Affordable Care Act, there is a law – the Physician Payment Sunshine Act (PPSA) – that requires companies to report their financial relationships with physicians and teaching hospitals. Moreover, there are states that require reporting on a broader group of healthcare practitioners, including nurse practitioners, physician assistants, certified midwives and registered nurses and pharmacies. Specified regulations have also trickled down to cities; for example, Chicago requires sales representatives to be licensed by the Department of Health and to maintain records in connection with interactions with physicians. Most transactions of value within the healthcare industry have to be tracked, analyzed and reported, and thus the states have introduced regulations that consider transactions between the industry and mid-level practitioners. This is a way to regulate the sales and marketing operations of life sciences companies, and Porzio Life Sciences is increasingly assisting companies in this process. 

Given the current attention on drug pricing, has there been an increase in demand for Porzio Life Sciences’ services?

Porzio Life Sciences has definitely experienced an increase in demand, especially with respect to transparency. Transparency reporting has evolved to include price transparency, particularly following regulations requiring drug companies to report price increases over a certain amount. We track all the laws, regulations and pending legislation, not only federally, but in all 50 states in the United States. Each state is a little different, as there are varying factors that trigger the reporting requirements. We have also expanded our capabilities to track and comply with worldwide regulations and laws.

Could you elaborate on Porzio Life Sciences’ client base?

Our client base is mainly small to mid-sized companies that are looking to outsource reporting as they do not have the internal resources to do so themselves. Larger companies historically did the reporting in house, but also made use of our Porzio Compliance Digest and consulting services in order to stay abreast of regulatory changes and complexities. Now that vendors, most notably Porzio Life Sciences, have demonstrated the ability to handle large quantities of data and to report timely and accurately, large companies are looking to us to handle transparency reporting under our traditional model or new outsourced model. Our focus remains to assist our clients – small or large – to master the evolving regulatory environment for reporting purposes globally.

Could you introduce us to the Porzio Compliance Digest (PCD) and how the platform has evolved in recent years?  

Porzio Compliance Digest (PCD) is the first interactive, internet-based compliance database on state and federal laws, regulations and pending legislation governing the distribution of trade and sample products, sampling to mid-level practitioners and marketing disclosures, restrictions and limitations. The PCD originally started with only three databases, and today has 15. We are currently tracking the regulatory environment in all 50 U.S. states, the District of Columbia and globally. We have increased the number of areas that we track as a result of client demand. Clients are also demanding the distribution and regulatory requirements of products in certain geographic areas. We now also work with clients to compliantly sell, market and distribute their products. Our clients are spread across the entire United States, and we also service foreign companies establishing operations within the United States. We develop systems and processes and then wrap professional and regulatory consulting services around them.

Could you elaborate on Porzio GST^®, Porzio Life Sciences’ second expansion of services related to global transparency requirements?

Porzio GST^® – a global spend transparency solution – provides an easy-to-use, configurable interface that enables companies to capture and manage data elements necessary for meeting their reporting obligations in 40 ex-U.S. jurisdictions. Almost 40 jurisdictions outside the United States have some type of transparency reporting requirement, each with significant and unique challenges. A successful solution must contemplate these challenges and provide practical and effective operational and compliance answers. Our clients rely on us to help them with not only the reports that need to be filed, but also the actual interactions with healthcare organizations and practitioners around the globe so that they can be mindful whether or not they should have concerns regarding compliance. Some of our clients also appoint overseas healthcare practitioners and will then use our advice and services to make sure they comply with all necessary regulations. We have a global risk management system, which allows us to service and offer solutions to our customers internationally.   

What are Porzio Life Sciences’ key objectives for 2019?

We will continue to build out our global transparency and global auditing and monitoring capabilities. The market is now looking for an effective global healthcare professional (HCP) Engagement center, so we will continue building out our capabilities and the ongoing evolution of our Global Spend Transparency (GST) ecosystem.