Patient Support Programs can be invaluable tools for Life Sciences companies but monitoring compliance of these programs takes no small investment of resources. Various laws and regulations come into consideration, including the False Claims Act, Anti-Kickback statutes, HIPAA, and other data privacy laws. To successfully manage this complexity, vendor partners must be chosen with the utmost care.
Patient Support Programs (PSPs), though rife with compliance considerations, offer patients with complex disease states meaningful, and frequently essential, services. Through PSPs, manufacturers can act as valuable advisors for both providers and patients to ensure appropriate therapeutic delivery, monitoring and communication as a function of best-in-class disease management. In turn, manufactures can benefit from increased product adherence and utilization.
While polling conducted at the 2019 Canadian Pharmaceutical Compliance Congress indicated that the responsibility for managing PSPs falls across different lines of a manufacturer’s business such as medical affairs or patient advocacy teams, 37% have their operational “home base” in a commercially-focused department. Given risks associated with commercial and promotional activities with both patients and healthcare providers, manufacturers must be sure to recognize and effectively manage potential risk associated with key services offered through a PSP.
With the cross-functional activities found within a PSP, centralized oversight and management of compliance risk is a necessity. There is too much at stake for patients, as well as manufacturers, should any part of the protocol “slip through the cracks.” As the scope of program services becomes broader and more complex, manufacturers often look to partner with specialized providers to manage the operations and associated risks. When building, implementing or assessing a PSP provider, ensure a compliance-centric approach by considering the following three issues:
- Patient support often includes a financial component to make sure that a patient has access to important treatment. Financial assistance, if offered, must be compliant with the False Claims Act and Anti-Kickback statutes, as well as industry codes and enforcement activities (including Corporate Integrity Agreements). To that end, having a robust and transparent platform to connect the dots from various different data sources – both internal and external (if a vendor is executing PSP services) – is key.
- With a goal to optimally support patients, implementing a PSP represents a significant investment. A good provider should be able to help protect that investment by balancing efficient program operations management with the appropriate oversight and governance necessary to minimize risk to both patients and manufacturers. For example, a robust training plan of a program’s standards and policies should be introduced for patient-facing nurses, therapeutic consultants, and other PSP-associated healthcare professionals. Appropriate testing and monitoring plans should also be in place to ensure adherence to the PSP’s compliance framework.
- When implementing Patient Support Programs, manufacturers and their providers should always be looking ahead and beyond current regulatory requirements. Data collection, as well as development, implementation and operation of a PSP, should take into consideration all aspects under the compliance-centric umbrella and be designed to be adaptive and accommodate a changing healthcare landscape or future legislative and regulatory requirements.
By promoting therapeutic continuity and adherence, healthcare providers, insurers and patients can all benefit. To drive your organization’s healthcare outcomes forward, be sure to ask questions around these three key areas before signing on with any compliance technology vendor. They will need an intuitive technology paired with a deep, industry-wide knowledge base that can meet or exceed your oversight and reporting requirements, both now and in the future.
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