Transparency Reporting

Porzio attorneys can serve as your company’s single resource for transparency compliance.  We  provide the following services to life sciences companies, whether big or small, pharmaceutical or medical device, to facilitate compliance with federal and state reporting obligations:

  • Readiness and compliance assessments
  • Policies, procedures, work instructions, and business rules development
  • Executive, management, and field force training
  • Requirements interpretation and legal memoranda guidance
  • Assumptions guidance and documentation
  • Data capture set-up and review for internal departments and external vendors
  • Data review, report generation, and filing instructions
  • Governmental inquiry responses
  • Customer/healthcare professional communications
  • Dispute services
Assessments

Porzio helps clients prepare for initial capturing and reporting by uncovering and reviewing interactions and providing guidance on how to collect data, both internally and externally, with advanced and basic systems.  Our attorneys also regularly review practices, identify gaps, and provide recommendations on improvements for companies with established tracking and reporting systems.

Interpretations and Assumptions

As with most laws, the federal Sunshine Act and many state transparency laws provide the basis for the law and general rules for disclosure.  Companies then must make assumptions and define their interpretations about what terminology to use, how to determine value, and whether certain interactions must be reported at all.  Porzio attorneys provide legal guidance, through legal memoranda, weekly interpretations meetings, and benchmarking.  Due to the breadth of the Sunshine Act, we analyze privilege issues, help companies draft assumptions documents and provide guidance on disclosure to CMS.

Transparency Reporting

Often in conjunction with our subsidiary, Porzio Life Sciences, LLC (PorzioLS), our lawyers assist companies by preparing and reviewing their transparency filings.  Our regulatory professionals can review data, identify healthcare professionals and organizations, and format reports and create submissions.  Attorneys often review reports for completeness and compliance with the laws’ legal and operational requirements. 

If your company is looking for an end-to-end aggregate spend solution, PorzioLS, in conjunction with partner MedPro Systems, offers Porzio AggregateSpendID™.  PorzioLS and MedPro have partnered to fuse data matching and aggregation technology with regulatory and compliance expertise.  This robust solution enables life sciences companies to track and integrate expenditures from multiple sources, whether incurred by home office, field personnel or third-party vendors, and to efficiently prepare regulatory compliance and internal management reports.

Up-to-Date Compliance Requirements

Porzio Life Sciences, LLC  offers the Transparency and Limitation (T&L) Database to provide current and concise information on federal and state transparency requirements.  The T&L Database provides in-depth information summarizing current laws and pending legislation on the marketing and sales practices of life sciences companies and their interactions with healthcare professionals. Topics include gifts to physicians, drug price reporting, prescriber data and direct-to-consumer advertising. The database also includes all relevant documents, including disclosure forms, guidance documents, and FAQs and Q&As from the government.  PorzioLS also offers Porzio Compliance Modules which provide "at-a-glance" information regarding federal and state transparency and limitation requirements.