The combined company offers a comprehensive suite of enterprise software and services for global regulatory and commercial compliance, medical affairs, field enablement and revenue management solutions designed to empower life sciences companies to grow their business compliantly.

While the company will continue under the MediSpend name, the merger marks a significant evolution of the brand. Medispend is introducing a refreshed visual identity, including a new logo, color palette, and emblem, to reflect its expanded capabilities, forward-looking vision, and commitment to innovation.

The unified MediSpend is positioned to become a single, trusted vendor providing the most comprehensive suite of life sciences compliance, stakeholder engagement, medical affairs, field enablement, and revenue management solutions in the industry. By combining the strengths of both organizations, MediSpend now offers an expanded product portfolio supported by advanced technology, enhanced analytics, and scalable managed services designed to meet the evolving needs of global life sciences organizations.

“This merger represents a pivotal moment for our customers and the industry,” said Leigh Powell, executive chairman of Medispend. “By bringing together RLDatix Life Sciences and MediSpend under one brand, we are accelerating our ability to deliver innovative, purpose-built solutions that help customers reduce risk, streamline operations, and confidently grow their business in an increasingly complex regulatory environment.”

Christopher Gingras, president of Medispend, said, “The new Medispend brand reflects a clear future vision, which includes our continued investment in innovative technology, expanded managed services, and a relentless focus on customer success.”

Existing customers will continue to receive uninterrupted service and support, while benefiting from the expanded capabilities and resources of the combined organization.

About Medispend:

Medispend is a global leading provider of SaaS solutions that deliver secure, scalable and intuitive cloud-based software enabling life sciences organizations to grow their business compliantly. More than 400 pharmaceutical, biotech and medical technology companies from around the world rely on Medispend to reduce compliance risk, improve customer engagements, optimize operations and make data driven decisions. Our mission is to help customers scale confidently and compliantly in an increasingly complex healthcare environment. For more information, visit www-stg.medispend.com.

Media Contact:
Seth Houston

Chief Commercial Officer
shouston@medispend.com
(215) 779-2415

The post Medispend and RLDatix Life Sciences Complete Merger, Uniting Under the Medispend Brand to Create The Leading Life Sciences Compliance Software-as-a-Service Provider appeared first on MediSpend.

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Fair Market Value (FMV) remains a central focus within the life sciences industry, as underscored at the recent Pharmaceutical and Medical Device Ethics and Compliance Congress. As the regulatory environment continues to evolve, companies are under increasing scrutiny regarding the appropriateness of compensation paid to healthcare professionals (HCPs). Corporate integrity agreements repeatedly highlight deficiencies in FMV methodologies, reinforcing the importance of strong governance, defensible processes, and ongoing monitoring. Because FMV determinations directly intersect with anti-kickback statute risk, compliance professionals must regularly evaluate whether their policies, procedures, and operational practices are both current and effective.

A foundational component of FMV governance is the framework used to assess an HCP’s skills, experience and qualifications. When developing tiering questions or criteria, organizations should ensure that all measures are objective, evidence-based, defensible and applied consistently. FMV determinations must never be influenced by prescribing volume or referral potential. Instead, tiering tools should reflect the HCP’s expertise and professional accomplishments. Common criteria include academic appointments, publication and presentation history, clinical research involvement, leadership roles and depth of specialty experience. Additional considerations include the HCP’s clinical specialty, the country of licensure and whether the HCP possesses rare disease or highly specialized expertise. Rate cards—centralized lists of approved compensation rates—should be benchmarked against credible market data and reevaluated periodically. Organizations must also determine which internal stakeholders are best suited to perform HCP tiering, balancing subject-matter expertise with independence from commercial influence.

Travel time

Compensating HCPs for travel time presents unique challenges, and companies should adopt methodologies that are fair, transparent and aligned with FMV principles. Travel time represents compensated professional activity, as HCPs are unavailable to treat patients while traveling for company-sponsored services. Approaches vary widely. Some organizations compensate door-to-door travel at 100 percent of the HCP’s FMV hourly rate, others adopt a 50 percent reduced rate, and still others apply hybrid models depending on distance or duration. One practice discussed at the congress involved the use of a flat, FMV-supported travel flat rate calculated based on round‑trip mileage, offering consistency and administrative simplicity.

Preparation time

Preparation time remains a consistently challenging area within FMV frameworks. Companies should develop a detailed standard operating procedure that outlines permissible preparation activities, reasonable time expectations and the documentation required to support claimed hours. Preparation time should reflect what is necessary for the HCP to meet the defined expectations of their engagement—no more, no less.

Where possible, organizations may “hard‑code” preparation time ranges by event type, requiring elevated approval for requests that exceed those thresholds. Special consideration should be given to chairs or moderators of major scientific events, whose responsibilities often require substantially more preparation than standard participants. Establishing clear, defensible assumptions reduces variability, enhances consistency and strengthens audit readiness.

Social media influencers

FMV considerations for social media influencers continue to evolve, and industry standards are far less mature than those governing traditional HCP engagements. Unlike conventional FMV frameworks, rate cards generally do not exist in this space, and factors such as content development and platform reach may be relevant depending on the nature of the services provided. The most effective approach is to establish defensible principles tailored to influencer‑based engagement, focusing on the content created, the expertise of the influencer (e.g., HCP, patient, caregiver) and the complexity and time required for the requested activity.

Companies should distinguish between original content development, which typically warrants higher compensation, and simple reposting, which may require significantly less time and expertise. Any original content should undergo review and approval by the appropriate medical, legal and regulatory stakeholders to ensure accuracy and compliance.

Conclusion

As the FMV landscape continues to mature, life sciences companies must proactively refine their compensation methodologies to ensure compliance, fairness and operational consistency. Strong governance, objective and defensible tiering tools, thoughtful approaches to travel and preparation time, and emerging best practices for social media influencers all contribute to a comprehensive FMV framework. By continuously assessing and strengthening these elements, organizations can reduce risk, enhance transparency, and maintain the trust of regulators, HCP partners and the broader healthcare community.

For more information on fair market value governance or to discuss how we can support your compliance initiatives, contact us today.

November 18, 2025

Jay Ward
Life Sciences Solutions Director

The post Making Sense of FMV: Strategies for the Life Sciences Industry appeared first on MediSpend.

September 02, 2025 – MediSpend and RLDatix Life Sciences, a subsidiary of RLDatix, today announced a definitive agreement to merge, creating a new unified company at the forefront of life sciences innovation and compliance. The new company offers the most comprehensive suite of software, data and workflow tools to support the entire lifecycle for global compliance, transparency, and sales enablement for the life sciences industry. The combined company currently serves over 300 pharmaceutical, biotech, and medical device companies worldwide.

Backed by Five Arrows (the alternative assets arm of Rothschild & Co), Susquehanna Growth Equity, TA Associates, and Nordic Capital, the new company brings together RLD Life Sciences’ expertise in providing services for pharmaceutical product development, commercialization, and distribution with robust compliance, and sales enablement alongside MediSpend’s best-in-class transparency, stakeholder engagement, and data solutions supporting both commercial and clinical stakeholders.

MediSpend brings innovative technology that enables life sciences companies to grow their businesses compliantly through SaaS-based Stakeholder Engagement, Event Management, Spend Transparency, and advanced Clinical Data Document Anonymization and Redaction capabilities.

RLDatix Life Sciences contributes unmatched subject matter expertise and market-leading skills by empowering life sciences companies to master complexity, mitigate risk, and continually exceed the standards of compliance – from Government Pricing to Learning and Development.

This strategic integration empowers pharmaceutical and life sciences companies to accelerate innovation, ensure regulatory integrity, and bring high-quality healthcare solutions to market more efficiently and ethically, while adhering to the highest compliance standards.

“This combination builds on our commitment to delivering innovative software, services, and support to life sciences companies across the globe,” said Michael Allelunas, CEO of the new company. “Together, we combine our purpose-built platform of solutions to streamline global compliance, drive operational efficiency, and unlock new opportunities for our customers.”

Leigh Powell, Chairman of the new company, added: “This merger represents a powerful alignment of mission and capability. We are excited to bring together our technologies, teams, and customers to provide the go-forward partner of choice for the life sciences industry. Our shared focus on innovation and client success will continue to guide us.”

Clients and partners can expect uninterrupted service, increased investment in product development, and a clear commitment to a seamless integration experience. The company will continue to operate under both brand names in the near term, with a long-term vision to unify under a new common name which will be announced in the coming months.

About MediSpend

MediSpend’s leading solutions empower life sciences companies to grow their business compliantly through top-rated solutions and client services. MediSpend provides commercial compliance solutions for the largest pharmaceutical, medical device and dental companies as well as emerging biotech companies across the world. MediSpend is headquartered in Portsmouth, N.H., with offices in Minnesota, New York, Pennsylvania and the Netherlands. Visit MediSpend online at www-stg.medispend.com.

About RLDatix Life Sciences

RLDatix Life Sciences, a subsidiary of RLDatix, is a leading provider of comprehensive solutions in the life sciences industry. Formed through the integration of Porzio Life Sciences, iContracts, and iCoachFirst, RLDatix Life Sciences offers cutting-edge compliance solutions, and strategic coaching and training services. The company is committed to driving excellence and innovation within the life sciences industry. Visit www.rldatixlifesciences.com to learn more.

About Five Arrows

Five Arrows is the alternative assets arm of Rothschild & Co and has over €29 billion in assets under management, with offices in Paris, London, New York, Los Angeles, San Francisco, and Luxembourg.

With more than €10 billion of assets under management, the corporate private equity business of Five Arrows is focused on investing in companies with strong management teams; business models with high visibility of organic unit volume growth and strong unit economics; and multiple operational levers that can be used to unlock latent value. Sectors are limited to data and software, technology–enabled business services, and healthcare.

For more information, visit: www.rothschildandco.com/en/five-arrows/corporate-private-equity

About SGE

Susquehanna Growth Equity (“SGE”) is an entrepreneur-centric growth equity fund with flexible capital and time horizons. SGE is exclusively focused on growth-stage software, services, internet, and information services companies. The firm has invested in over $5 billion in 100+ market-leading technology and services companies over the last 19 years and has portfolio companies across the US, Canada, Europe, and Israel. SGE is backed by a unique and patient source of capital, enabling the firm to give entrepreneurs and management teams freedom and flexibility to manage growth. To learn more, please visit www.sgep.com.

About TA

TA is a leading global private equity firm focused on scaling growth in profitable companies. Since 1968, TA has invested in more than 560 companies across its five core sectors – technology, business services, financial services, healthcare and consumer. Leveraging its deep industry expertise and strategic resources, TA collaborates with management teams worldwide to help high-quality companies deliver lasting value. The firm has raised $65 billion in capital to date and has more than 160 investment professionals across offices in Boston, Menlo Park, Austin, London, Mumbai and Hong Kong. More information about TA can be found at www.ta.com.

About Nordic Capital

Nordic Capital is a leading sector-specialist private equity investor with a resolute commitment to creating stronger, sustainable businesses through operational improvement and transformative growth. Nordic Capital focuses on selected regions and sectors where it has deep experience and a long history. Focus sectors are Healthcare, Technology & Payments, Financial Services, and Services & Industrial Tech. Key regions are Europe and globally for Healthcare and Technology & Payments investments. Since inception in 1989, Nordic Capital has invested c. EUR 30 billion in over 150 investments. The committed capital is principally provided by global institutional investors such as pension funds. Nordic Capital Advisors have local offices in Sweden, the UK, the US, Germany, Denmark, Finland, Norway, and South Korea. For more information see www.nordiccapital.com.

“Nordic Capital” refers to, depending on the context, any, or all, Nordic Capital branded entities, vehicles, structures, and associated entities. The general partners and/or delegated portfolio managers of Nordic Capital’s entities and vehicles are advised by several non-discretionary sub-advisory entities, any or all of which are referred to as “Nordic Capital Advisors”.

Media Contact

Seth Houston
shouston@medispend.com

The post MediSpend and Life Sciences Subsidiary of RLDatix Merge to Form Leading Global Provider of Regulatory and Compliance SaaS Solutions for Life Sciences appeared first on MediSpend.

The post From Hot Mess to High-Performing: Building a Scalable Third-Party Due Diligence Program appeared first on MediSpend.

Alucio’s BEACON platform enables seamless and compliant content engagement across medical affairs, clinical affairs, and market access, empowering field teams to deliver dynamic, personalized scientific interactions with healthcare professionals (HCPs) and organizations.  This strategic move supports MediSpend’s ongoing mission to empower life sciences companies to grow their business compliantly while delivering more meaningful stakeholder interactions and insights.

Driving Innovation with AI-Powered Scientific Engagement
Alucio brings advanced AI-powered capabilities that transform how medical affairs teams manage and share scientific information. By integrating artificial intelligence into content management and HCP engagement workflows, the MediSpend platform offers expanded functionality to personalize interactions, streamline content distribution and generate real-time insights. These enhancements support high-impact, compliant scientific exchange on a global scale.

“This acquisition brings valuable innovation into the MediSpend platform,” said Leigh Powell, Executive Chairman of MediSpend. “With these added capabilities, we’re strengthening our ability to support medical affairs teams with smarter tools for managing content and delivering compliant, high-quality scientific communications.”

Delivering Value Across the Life Sciences Industry
By combining MediSpend’s trusted compliance infrastructure with Alucio’s AI-driven communication capabilities, clients gain a cohesive solution that supports compliant, efficient and insight-driven engagement across both commercial and medical teams. Clients will benefit from:

• Smarter Scientific Exchange: AI-assisted delivery enables tailored, compliant interactions between MSLs and HCPs.
• Seamless Content Management: Efficient tools for organizing, presenting and sharing scientific information that are designed to meet both internal needs and regulatory standards.
• Actionable Analytics: Built-in intelligence provides visibility into engagement metrics and content performance, enabling teams to make data-driven decisions.

“We’re excited to join MediSpend and expand the reach of our technology,” said Dave Gulezian, CEO of Alucio. “Together, we’ll deliver next-generation solutions that elevate how medical affairs teams communicate and engage with HCPs in a compliant manner.”

Strengthening MediSpend’s Leadership in Life Sciences Technology
The integration of BEACON into the MediSpend platform will create a seamless solution for life sciences companies seeking to unify compliance, transparency, and engagement functions—an increasingly critical need in today’s complex regulatory environment.

About MediSpend
MediSpend’s best-in-class solutions empower life sciences companies to grow their business compliantly through top-rated solutions and client services. MediSpend provides commercial compliance solutions for the largest pharmaceutical, medical device and dental companies as well as emerging biotech companies across the world. MediSpend is headquartered in Portsmouth, N.H., with offices in Minnesota, New York, Pennsylvania and the Netherlands. Visit MediSpend online at www-stg.medispend.com.

About Alucio
Alucio is dedicated to the development of innovative software applications specifically for the life sciences industry. Alucio’s flagship product, Beacon, is a modern, AI-enabled scientific exchange platform that enhances scientific dialogue and engagement between life science companies and healthcare professionals. For more information, please visit the company’s website at http://www.alucio.io.

Media Contact
Seth Houston
Chief Commercial Officer
MediSpend
Email: shouston@medispend.com
Phone: +1 (215) 779-2415

The post MediSpend Acquires Alucio to Expand AI-Enabled Stakeholder Engagement Capabilities appeared first on MediSpend.

A modern SaaS-based third-party due diligence platform is no longer a luxury — it’s a regulatory and operational imperative. 

Why Third-Party Risk Management Is Critical in Life Sciences

Financial, data privacy, and cybersecurity risks to the business posed by vendors, subcontractors, distributors and service providers span multiple domains:

• Compliance and Regulatory Risk: Engagements with debarred or sanctioned entities can trigger FDA, OIG/DOJ, SEC, and even OFAC enforcement actions or ABAC/FCPA violations.
• Operational Risk: A Contract Resource Organization (CRO) with quality system deficiencies can jeopardize an entire clinical program.
• Reputational Risk: Third-party misconduct (e.g., bribery, data mishandling) can harm brand credibility and trigger shareholder scrutiny.

Given the complexity of global operations and the scrutiny from regulators, a fragmented approach to due diligence simply won’t cut it.

Essential Capabilities of a SaaS-Based Third-Party Due Diligence Platform

1.) Sanctions, Debarment and Watchlist Screening

Screening third parties, their principals, and other key stakeholder relationships against government and international lists is mandatory. This includes:

• OFAC and EU Sanctions Lists
• United Nations Security Council (UNSC)
• FDA Debarment List
• OIG LEIE (List of Excluded Individuals/Entities)
• SAM.gov exclusions
• Interpol Red Notices
• World Bank Debarment
• Politically Exposed Persons (PEP) Lists
• US Federal and State Exclusion Databases

Although the above may be mandatory, conducting a more thorough check against state-owned entities (SOEs) and state-invested entities (SIEs) has been overlooked. Given the geopolitical environment, this is a must.

Advanced platforms such as the solution we offer at MediSpend, also monitor politically exposed persons (PEPs) and perform adverse media screening, identifying potential risk signals beyond formal databases.

2.) Customizable Risk Assessments & Due Diligence Questionnaires

Different third-parties present different levels of risk. Look for platforms that support:

• Tiered, dynamic questionnaires
• Triggers for enhanced due diligence based on geography, business activity or spend level
• Configurable workflows for internal approvals and escalations

3.) Third Party Portal for Engagement & Certification

A self-service vendor portal significantly reduces administrative burden and improves audit readiness. Key portal functions should include:

• Questionnaire and document submission
• Annual recertification
• Policy acknowledgment tracking
• Real-time status updates and two-way communication

Ensure that your current solution enables the ability to create custom questionnaires and has the capability of selecting from a library of assessments.

4.) Document Management and Audit Trails

Maintaining a central, searchable record of vendor certifications, agreements and due diligence artifacts is crucial. Features should include:

• Secure upload and storage of contracts, licenses, NDAs, QMS certifications
• Expiration date tracking and renewal alerts
• Full audit logs and exportable histories for regulatory audits

5.) Risk Scoring & Dashboards

Compliance and procurement teams require clear visibility to effectively identify and address all risks. A modern platform should:

• Score vendors based on questionnaire responses, screening results and risk logic
• Display real-time dashboards with heat maps, KPIs and risk summaries
• Integrate with BI tools or export for reporting, or better yet, offer an out-of-box BI tool

Any provider of a third-party due diligence platform should already offer business intelligence capabilities that enable your organization to proactively monitor risk through dashboard and ad-hoc reporting capabilities that are configured based on your company policies and procedures.

6.) Continuous Monitoring

Risk doesn’t stop after onboarding. Leading platforms provide:

• Automated ongoing screening for sanctions, legal issues or media hits
• Alerts on corporate ownership changes or executive turnover
• Reassessment triggers based on predefined thresholds

7.) Optional: Contract Lifecycle Management (CLM)

While not required, having contracting tools enhances governance, especially for high-risk vendors. Some platforms allow:

• Pre-approved templates for NDAs, MSAs and quality agreements
• E-signature integrations (e.g., DocuSign)
• Clause-level version tracking and legal review workflows

Best-in-class third-party due diligence solutions come with an end-to-end contracting capability because you shouldn’t have to leverage multiple different systems to unify your company’s third-party due diligence program.

Conclusion: Don’t Let Risk Hide in Plain Sight

The cost of failing to manage third-party risk is high — not just in fines and disruptions, but in trust, market share and patient impact.

Life sciences companies need a platform that goes beyond basic checklists to deliver real-time insight, regulatory alignment and operational efficiency. A well-designed SaaS platform helps compliance, legal, procurement and risk teams work together to prevent problems before they start via a cost-effective approach.

Don’t put your business at risk! MediSpend’s third-party due diligence solution will provide your organization with peace of mind while protecting your bottom line and your reputation.

Ready to modernize your third-party due diligence process? Request a demo today.

The post What Life Sciences Companies Need in a Third-Party Due Diligence Platform appeared first on MediSpend.

Key Milestones and Implementation Timeline

• June 26, 2022 – Law 62/2022 entered into force.
• August 17–September 24, 2023 – Ministry of Health conducted public consultation on technical specs and draft decree.
• October 8, 2023 – Consultation feedback report published.
• December 4, 2023 – Stakeholders formally met with the Ministry to present concerns.
• March 20, 2025 – Ministry showcased the Sanità Trasparente (Transparent Health) register and reporting process.
• March 24, 2025 – Stakeholders submitted written feedback highlighting outstanding concerns.

Based on a recent presentation provided by Confindustria Dispositivi Medici, the Italian trade association representing medical device companies, if the register goes live in December 2025, then the following represents the applicable reporting timeline:

• Agreements, disbursements, and ToVs from:
  • Jan–Jun 2026 must be reported by Dec 31, 2026 (published Jan 1–7, 2027)
  • Jul–Dec 2026 must be reported by Jun 30, 2027 (published Jul 1–7, 2027)
• Financial interests for the full year 2026 must be reported by Jan 31, 2027 (published in March 2028)

What Must Be Disclosed

• Transfers to HCPs > €100/item or > €1,000 annually
• Transfers to HCOs > €1,000/item or > €2,500 annually
• Service agreements, consultancies, and participation in events, committees, or advisory boards
• Shareholdings, bond ownership, and intellectual property royalties

Public Registry and Penalties

• Data will be published on the Ministry of Health’s Sanità Trasparente portal for 5 years
• Consent is implied upon acceptance of the benefit or agreement
• Penalties include:
  • €1,000 + 20x the undeclared amount
  • €5,000–€100,000 for missing, false, or uncorrected disclosures
  • Publication of violating companies’ names for at least 90 days

Next Steps for Companies

With enforcement now within reach, companies should:

• Align SOPs, contracts, and CRM systems with the law
• Prepare for XML-based data submissions
• Evaluate how overlapping international transparency requirements (EFPIA, MedTech Europe) interact with Italy’s regulations

As one of the most comprehensive transparency laws in the EU, compliance with Italy’s Sunshine Act will require companies to review all processes and systems involved with the capture of transfers of value to Italian HCPs and HCOs.

May 29, 2025

Tim Robinson
General Counsel & Privacy Officer

The post Italy’s Sunshine Act: Implementation Advances After Three-Year Wait appeared first on MediSpend.

Recently, the Department of Justice (DOJ) reached a settlement with a global pharmaceutical company, resolving allegations that one of its subsidiaries paid kickbacks to healthcare providers (HCPs) to boost prescriptions of their drug. In addition to the allegations regarding speaker programs discussed in Part 1, the DOJ found that the subsidiary deliberately underreported speaker payments to conceal its quid pro quo arrangements. According to the settlement, the subsidiary reported only about 10% of the payments made to each speaker to prolong its scheme.

For example, in the 2020 reporting year, the subsidiary reported just three payments totaling $4,700 for one HCP. However, internal company records later revealed that the provider actually received 61 payments totaling over $91,000.

Ensuring Compliant Transparency Programs

This settlement is a clear reminder that the government is continuously monitoring Open Payments data, and they are using that data as part of their investigations to identify potential fraud. Life science companies must proactively evaluate and strengthen their transparency practices in several key areas:

• Compliance Leadership and Oversight: Leadership buy-in and the tone at the top are crucial for transparency reporting success. Senior leaders must understand the importance of transparency reporting, advocate for its value and allocate appropriate resources–including staffing–for accurately preparing, reporting and auditing data.
• Written Policies and Procedures: Comprehensive, documented policies are essential to support consistent and compliant reporting. These policies should clearly outline responsibilities, timeline and standards across all relevant transparency standards, including U.S. federal, state and international requirements.
• Data Management: Many organizations fall into the trap of compiling, preparing and submitting data at the last minute. Open Payments data management should be a continuous process to provide ample time to review and correct any data issues as well as perform proper auditing and monitoring activities. Consider implementing annual attestations from individuals engaged in HCP-related spend to facilitate a complete and accurate data submission.
• Data Inventory: It’s critical to identify all sources of transparency data, including third-party vendors. Map out your data sources and trace how an auditor might uncover missing transactions. Document all transparency data flows in a matrix to create visibility and support defensible processes.
• Auditing and Monitoring: Regular audits and assessments are essential for transparency compliance. Reviewing your transparency program thoroughly now allows you to understand the effectiveness of all systems, processes and controls. A robust audit plan should test your ability to detect missing transactions and provide supporting documentation. Share audit findings with executive leadership using dashboards and KPIs to highlight gaps and improvements.
• Data Analytics: Data analytics can supercharge your auditing and monitoring efforts. Use analytics to answer key questions such as:
  • Who are the top HCPs and organizations (HCP/Os) that we are spending most of our money on? Are we spending too much money with certain HCP/Os?
  • What is the total number of payments generated by type and purpose for each drug or device?
  • What is the distribution of payments by type for each sales rep, district, region and company? And which HCP/Os are they spending the money on?
  • When it comes to meal costs and venue locations, are payments in line with company policies and industry codes of ethics?

How to Strengthen Your Transparency Program Compliance

The DOJ’s latest enforcement action highlights the urgency for life science companies to proactively assess and enhance their transparency program policies. Staying ahead of enforcement trends starts with a proactive, well-documented compliance strategy.

Ready to revolutionize your transparency reporting process? Discover why MediSpend’s global transparency reporting solution is top-rated by compliance professionals. To learn more about how MediSpend can support your organizations growth while mitigating risk, contact us today.

April 23, 2025

Jay Ward
Director, Life Science Solutions

The post Strengthening Compliance in Transparency Programs: Key Lessons from Recent DOJ Settlement (Pt. 2) appeared first on MediSpend.

According to the settlement, the subsidiary allegedly paid improper remuneration in the form of excessive speaker honoraria and high-end meals to influence prescribing behavior, violating the Anti-Kickback Statute. Some HCPs were paid tens of thousands of dollars, with a few receiving over $100,000. These individuals were selected for the speakers’ bureau with the expectation that their honoraria and lavish meals would encourage them to prescribe the company’s drug.

Beyond concerns about speaker selection and compensation, the settlement also highlighted issues with program attendees and the lack of legitimate educational content at these events. The DOJ found that some HCPs in attendance, including speakers’ spouses, family members, friends and colleagues, had no legitimate need to attend the programs. Additionally, HCPs were allowed to repeatedly attend programs on the same product without receiving new educational benefits, and many events were held at luxury venues with extravagant meals.

Ensuring Compliant Speaker Programs

This settlement serves as a stark reminder for life sciences companies that the government is continuously monitoring these programs, and that they must ensure these programs are structured for genuine education, not as a vehicle for sales and marketing. To mitigate risk, life sciences companies should evaluate and enhance their event management practices in these key areas:

• Speakers
  • Select speakers based on their qualifications, expertise and ability to deliver meaningful, well-documented education, and not based on past or potential prescribing behavior.
  • Ensure speaker compensation aligns with Fair Market Value (FMV).
  • Limit the number of speaker programs per speaker and monitor the overall program volume.
  • Conduct regular reviews of the number of speakers, their fees and the total program spending.
• Attendees
  • Restrict attendance to HCPs with a legitimate educational need.
  • Prevent spouses, family members, office staff and other non-essential attendees from registering or participating.
  • Implement tracking and analytics systems to monitor and identify excessive and repeat participation in programs on the same topic.
• Spending
  • Select venues that are modest and appropriate for an educational setting, adhering to company policy and industry codes of ethics such as AdvaMed and PhRMA.
  • Ensure food and beverage costs are reasonable and compliant with company policy and industry guidelines.
  • Avoid luxury venues and high-end restaurants.
• Auditing & Monitoring
  • Conduct regular audits and risk assessments to ensure compliance.
  • Maintain detailed documentation of program objectives, speaker selection, attendee lists and expense reports to demonstrate compliance.
  • Continuously review the number of speakers, their fees and the total speaker program spend.
  • Identify repeat attendees attending multiple events on the same topic.

How to Strengthen Your Speaker Program Compliance

The DOJ’s latest enforcement action underscores the need for life sciences companies to proactively assess and enhance their speaker program policies.

MediSpend’s events management solution helps companies structure compliant, data-driven speaker programs by offering visibility into HCP engagements, tracking program spend and ensuring adherence to industry regulations.

Interested in learning more? Contact us today to see how our platform can help your organization stay ahead of compliance risks.

March 28, 2025

Jay Ward
Director, Life Science Solutions

The post Strengthening Compliance in Speaker Programs: Key Lessons from Recent DOJ Settlement (Pt. 1) appeared first on MediSpend.