Regions
MAIN/REGIONS
regions/
Regions
  1. Americas
  2. Asia & Oceania
  3. Europe
  4. Middle East & Africa
  1. Who We Help
  2. Insights
  3. Events
  4. Contact Us
MAIN/search
MAIN/Who We Help
Who We Help/
WHO WE HELP
  • Pharmaceutical Manufacturers
  • Emerging Biopharma
  • MedTech
  • Financial Institutions
  • Government and Public Health
  • Health Plans
  • Hospital and Health Systems
  • Insurers and Risk
  • Medical Specialty and Patient Advocacy
Pharmaceutical Manufacturers

Harness unparalleled healthcare data, advanced analytics, and cutting-edge technologies with our expertise to accelerate the development and commercialization of innovative medicines, enhancing patient lives.

Discover More
Pharmaceutical Manufacturers
Emerging Biopharma (Global page)

Boost your innovation with IQVIA's expert team. Our comprehensive solutions integrate top-tier insights, technology, and expertise to maximize your asset's success in a competitive landscape.

Discover Innovations
MedTech

Navigating MedTech's unique landscape: U.S. decision-making now rests with GPOs, IDNs, and payers, who demand solid value proof through rigorous outcomes analyses and pricing scrutiny.

Explore MedTech
MedTech
Financial Institutions

Invest in healthcare with confidence. Stay ahead of pharma and medical device trends using real-time, high-quality data. Access market insights, historical sales, prescription trends, and emerging product information for informed, risk-reduced decisions.

Access Insights
Government and Public Health

Unlock deeper health insights with unmatched data and innovative technology to enhance decision-making for your essential government programs.

Unlock Innovations
Government and Public Health
Health Plans

Accelerate digital innovation with our data-driven expertise in data science and healthcare, optimizing business processes for smarter decisions.

Navigate Health Plans
Hospital and Health Systems

Leverage digital innovation to cut costs, boost efficiency, and elevate patient engagement, all while enhancing quality and health outcomes.

Streamline Decisions
Hospital and Health Systems
Insurers and Risk

Enhance your ability to evaluate and forecast population risk swiftly and accurately by integrating unmatched data, expertise, and technology.

Uncover More
Medical Specialty and Patient Advocacy

Transform into a data-driven organization that enhances your specialty and showcases value to your members through digital transformation.

Explore Now
MAIN/Insights
Insights/
U.S. PROGRESS POINT

A curation of IQVIA's best thinking on topics and trends driving change, disruption, and progress in the United States healthcare market.

LEARN MORE
BLOGS, WHITE PAPERS & CASE STUDIES

Explore our library of insights, thought leadership, and the latest topics & trends in healthcare.

DISCOVER INSIGHTS

PODCASTS

"Discover the future through our enlightening podcasts available in the United States.

EXPLORE PODCASTS

FACT SHEET

"IQVIA AI Medical Record Review

LEARN MORE

BLOG

"Decoding DSCSA: Ensuring Compliance in the Pharmaceutical Supply Chain

READ MORE
MAIN/Events
Events/
ON-DEMAND WEBINARS

Visit our library of on-demand webinars.

WATCH ON-DEMAND WEBINARS
UPCOMING EVENTS & WEBINARS

View our upcoming events and webinars.

DISCOVER EVENTS & WEBINARS

EVENT

"26th Controlled Substances and State Regulatory Conference

REGISTER NOW
MAIN/Contact Us
Contact Us/
Blog
Ensuring Compliance in Pharma: Mastering Bona Fide Service Fees with CPNavigator
John Moose, MBA, ABV - Principal at IQVIA
Frank Spender, Managing Principal, Global Compliance Advisory Services, IQVIA
Feb 27, 2024

In the rapidly evolving pharmaceutical industry, the assessment and management of bona fide service fees (BFSF), as well as related assessments, are essential for maintaining compliance with various reporting requirements for Medicare and Medicaid programs and those under the Public Health Service Act and the Veterans Affairs Act. This blog reviews certain managerial issues surrounding BFSF, including the complexities of BFSF assessments and the critical consequences of mismanaging BFSFs, and introduces CPNavigator—a tool designed to streamline the process and ensure robust documentation and compliance.


Navigating BFSF issues and challenges in the pharmaceutical industry

For purposes of price reporting, funds exchanged between pharmaceutical manufacturers and entities in the distribution channel are classified into three broad categories: prices paid for the product, discounts and rebates on the product, and BFSF. Accurate reporting on each of these categories is essential to avoid overpayment by Medicare or underpayment of rebates under the Medicaid program. Inaccurate reporting can lead to millions of dollars in legal fees and corrective actions. 

Due to unclear and complex guidance, manufacturers often make significant assumptions when calculating the Average Manufacturer Price (AMP) or Best Price, with 91% of surveyed manufacturers admitting to such practices. Moreover, 10 out of 20 manufacturers indicated a lack of clear guidance, leading to disparate treatments of services among competitors, which can have further implications for pricing and reporting. The documentation of these assumptions and the safeguarding of data contemporaneous with the transactions is paramount, yet small and mid-tier pharmaceutical companies tend to take a ‘shotgun’ approach to documentation. Much supporting documentation is gathered by external parties (e.g., counsel and valuation experts) and not placed in one central location, it is not well organized, and it is easily accessible to all parties (i.e., price reporting, market access, contracting, and compliance).

The challenges faced by manufacturers in this regard underscore the importance of having a robust, centralized system for documenting and managing BFSFs and their associated documentation. Such a system can ensure compliance and mitigate the risks of government inquiries, potential investigations, and associated penalties.


Introducing CPNavigator: A robust compliance tool for pharma

CPNavigator was developed to centralize and streamline the documentation and approval of BFSF and fair market value (FMV) assessments, ensuring that all relevant information is centrally stored and easily accessed. CPNavigator provides the following features and functions:

Document repository - Centralizes information and makes it easily accessible by multiple parties. This is particularly valuable for companies operating within the pharmaceutical sector, where adherence to regulations and maintaining accurate records of approvals is paramount. Additionally, the CPNavigator tool includes a feature that enables reference to past FMVs, thus empowering informed decision making. By having historical data at the ready, companies can ensure consistency and accuracy when determining FMVs for new contracts. 

Audit features - Embedded within the tool is the ability to trace actions and decisions through a transparent record-keeping system.

Email notifications - The inclusion of email notifications ensures that users are kept abreast of necessary actions and updates, facilitating a seamless workflow.

Cloning capabilities - The tool's cloning capabilities for contract data significantly reduce manual effort, allowing for efficient reuse of previously documented information.


Conclusion
The documentation and approval of BFSF is recognized as crucial for compliance with government programs, but many companies struggle with collecting and maintaining this necessary documentation over years. CPNavigator is designed to streamline the documentation and approval processes and provide easy access to the information by all interested parties.

Webinar: Fast and Easy BFSF Assessments

Learn how IQVIA’s CPNavigator, an innovative new BFSF optimization tool, can help boost your team’s efficiency by supporting the documentation, review, and approval of bona fide service fees.
view on demand

Related solutions

Contact Us