Aggregate spend and transparency relate to the tracking and reporting of interactions with healthcare practitioners (HCPs), healthcare organizations (HCOs) and patient organizations (POs).
These interactions include but are not limited to: marketing activities, clinical trials, sales practices, advertising, meals and consulting.
As new regulations and industry codes continue to develop, companies are adding resources to track, collect and report data. Companies must also train vendors to collect data, implement new policies and procedures and purchase aggregate spend or transparency solutions to comply with the evolving and complex global requirements, such as EFPIA obligations.
Preemption - The Sunshine Act is in full effect, and it preempts any state or local law that requires similar reporting. This means that companies are now only required to report to the states on covered recipients not tracked under the Sunshine Act, such as Advanced Practice Registered Nurses (APRNs).
Dispute Resolution - On an annual basis, CMS will provide the opportunity for physicians and teaching hospitals to review the data reported against them and dispute each transaction. Many companies are now thinking about proactively reaching out to physicians and teaching hospitals to resolve any disputed data before it is published. Organizations should be looking to implement tracking and management solutions to track, manage and resolve any disputes against their data.
Countries throughout the world continue to enact laws and industry codes to facilitate transparency. Due to data privacy laws, the industry codes in many countries require companies to obtain HCP, HCO and PO consent prior to disclosing their spend on an individual basis. Companies must report on an individual recipient level when the disclosure of spend has been consented to and, alternately, on an aggregate level if the disclosure of spend has not been consented to.
As consent can be revoked, companies will need to ensure they are tracking both consent and revocation, and then be able to update their reports in accord with applicable codes and data privacy laws. Also, as many countries require disclosure reports to be completed in more than one language, organizations will need to create multiple reports in a variety of different languages.
How We Can Help
We offer solutions that track global regulations, codes and pending legislation relating to aggregate spend and transparency.
- Porzio Compliance Digest's Transparency & Limitations Database
- Porzio Compliance Digest's International Life Sciences Transparency Database
These databases include a comprehensive summary of each jurisdiction's requirements, as well as quick access to all the necessary guidance documents.
PorzioLS has a team of experienced regulatory professionals ready to assist with your aggregate spend and transparency needs. PorzioLS also receives legal oversight from our parent company, the law firm of Porzio, Bromberg & Newman, which provides added reassurance that the laws and regulations driving compliance are properly understood and followed.