Compliance officers today strive to balance improving patient care and providing legitimate product support, while also staying within the guardrails of the law, industry codes and best practices.

In particular, the increase in specialty pharmaceutical products has driven more complex product access and delivery models. This increased complexity has also led manufacturers to devote significant human capital resources and investment in patient services, including Hub-provided prior authorization support, coverage investigations, and copay support, among others.

What are Hubs? Hubs are commonly defined by a set of goals and services that include connecting patients with other healthcare stakeholders to improve patient access and outcomes. However, in the absence of explicit guidance from the DOJ or OIG, manufacturers must be vigilant of investigation and enforcement activity, as well as apply the Anti-Kickback Statute, False Claims Act, and HIPAA patient privacy rules to evolving Hub activities.

Hub-provided activities that have come under specific scrutiny from the DOJ or OIG include some of the most important mechanisms for patient support: benefit coverage and access support, health coaching and nursing support, co-pay assistance programs, billing and coding assistance, and reimbursement support. A good example of this is the growing number of governmental investigations and settlements over the past year that seem to call into question the practice of pharmaceutical companies donating to independent charities that provide financial assistance with out-of-pocket drug costs to patients. With Jazz Pharmaceuticals PLC’s securities disclosure in May 2018 of its pending settlement with the U.S. Department of Justice¹, and a similar multimillion-dollar settlement by United Therapeutics Corporation², over patient assistance allegations; Patient Assistance Programs (“PAPs”) should now be considered a high-risk activity for any pharmaceutical company — especially those companies with high-cost drugs.

From the government’s point of view, prohibited remuneration can take on many different forms, some of which overlap with valid and necessary activities undertaken to improve patient care and outcomes. While HUBs do indeed provide much needed services to help patients gain access to life-critical products, Hub-directed or -managed reimbursement support can be perceived by regulators as steering patients to a certain manufacturer’s product, providing support that overlaps with what physicians’ practices already provide, or providing improper copay support through PAPs, coupons or other methods — just to name a few.

As the activities surrounding patient access become more complex, so have the compliance challenges faced by manufacturers. It is essential to work closely with your market access team to identify the market access challenges and related patient/customer support activities specific to the therapeutic area, patient community and the product. Additionally, working hand-in-glove with your HUB partner to develop trainings, call scripts, and carefully choreograph the transition of a patient/caregiver to other vendors (e.g., specialty pharmacy, medical information call center, etc.).

Moreover, it is essential to partner with a Hub that has robust data gathering and analytical skills in order to leverage that knowledge base in support of an ongoing commitment to compliance. This data can help a manufacturer identify existing or potential legal risks, and is an essential method to ensure a Hub will create synergies that lead to improved care and commercial outcomes without risking the continuity of compliance.

Finding the right partner that demonstrates a dynamic and effective commitment to ethical and regulatory guidelines is essential. However, finding the right Hub partner and creating robust processes can be challenging, which is where partnering with compliance professionals that have robust Hub and PSP subject matter expertise and reporting systems can help form the building blocks for a toolkit to mitigate these PSP-related risks.

Pharmaceutical companies must ensure that compliance, marketing, and commercial teams manage compliance risk by following a multi-step protocol, beginning by documenting the need— which is by far the most critical task. The following tenets should be conducted to develop the activities that a Hub should provide, conducting due diligence on the Hub:

• Identify the need/market access challenges and related patient/customer support activities specific to the therapeutic area, patient community and the product
• Controlling Hub interactions with physician office personnel, payers, specialty pharmacies, and other stakeholders
• Implement restrictions around data sharing (due diligence to de-identify and protect PHI as defined by HIPAA)
• Conduct transparent, detail-oriented due diligence
• Create and execute contracts with precision
• Develop and communicate clear processes for cross-silo guidance
• Develop job aids, business rules, program guidance and training tools
• Provide robust training to maximize human capital investment

With this foundation, a manufacturer can mitigate and quickly remediate risks. In addition to the above, downstream controls, including vigilantly monitoring and auditing, are essential. Outcomes and findings of monitoring and auditing activities provide the basis for further assessments, adjustments to practices and protocols, and ongoing training and guidance programs – all of which are then in turn monitored and audited, beginning the cycle anew.

In this environment of evolving regulations/enforcement activity and new patient access-related needs, it is challenging to navigate executing patient access support in a compliant manner, and broad-based patient support services require a compliance-centric approach to risk mitigation.

For more information about IQVIA Commercial Compliance, please email commercialcompliance@iqvia.com or visit our webpage. Our experts leverage the industry’s leading technologies to deliver streamlined processes and improved efficiencies that solve your toughest engagement and transparency challenges. From automating and managing the entire HCP/O contracting lifecycle, to capturing, collecting, and reporting global spend; to planning efficient and compliant HCP meetings and engagements—discover how our solutions can make compliance easier for you.