Balancing the Increased Demand for External Funding
Patient Assistance and Access Programs - 2017
16 March 2017
Presented by Rob Shropshire, Polaris
Increased demand for external funding
The life sciences industry is increasing its funding to patient related organizations for various initiatives, such as patient assistance and aid, patient education grants, as well as patient advocacy grants and charitable contributions to patient related organizations.This support, along with traditional funding for independent medical education and other commercial supports, routinely comes in the form of external requests for funding, or planned giving in support of the manufacturer’s therapeutic area strategy.As products focused on specialty and rare disease segments continue to dominate R&D pipelines, patient-related funding activities will become more prevalent and more strategic to corporate missions.There is an acute need to support patient care and access through financial aid to advocacy and other grass-roots organizations. Rendering this support presents the challenge of balancing the need to support the corporate mission with the need to ensure compliant and fair-funding practices.
Independent Medical Education
Patient Assistance Programs
Patient Education
Charitable Contributions
Sponsorships
Balancing support needs and fair-funding practices
Funding decisions and practices for patient programs and other charitable causes are not immune to prosecutorial risks and reputational damage that have long been present in other grant programsFederal Anti-kickback statutes (AKS)Exerting influence over the therapeutic areas covered or products supported by a charityProviding support to charities which offer assistance to only one drugGathering information which can draw connections between donated amounts and number of supported prescriptions for manufacturers productsFederal Food, Drug, and Cosmetic Act (FDCA) and False Claims Act (FCA)Directly influencing content, speakers or attendees of CME or patient education programs to promote off-label usageInfluencing reimbursement underMedicare / Medicaid for unapproved use or based upon prohibited financial inducementsPublic and government pressure on pricingContinuedperception that advocacy programs are used to have direct influence over rising drug pricingTransparency into funding practicesMounting pressure to disclose beneficiaries of grants beyond traditional Health Care organizations / Teaching hospitals
Consistent controls to manage funding requests
The role manufacturers play in providing education and aid to patients and organizations providing patient assistance is significant.Removing industry contributions would create a significant gap in funding for underprivileged patients which would not be easily replaced.Donor support from industry can continue if it is properly balanced with concerns of OIG investigations and increased public scrutiny.Areas of focus for managing external requests for funding
Consistent controls to manage funding requests
Definition of corporate mission & funding plans
Independent planning and budgeting of a company’s giving activities assist with the assertion of independence with PAPs and patient driven charitiesEstablishing budget for types of support (CME, PAP, Sponsorships), therapeutic areas and associated budgetsTrack and monitor allocation of funding throughout budget yearAudit and monitor requests and approved funding awarded outside of established plan
Process to submit, review and approve requests
Consistent controls to manage funding requests
The organizational structure and process for reviewing external requests are important levers to reinforce internal controls and mitigate risk of OIG investigationsConsistent validation and screening of external requestors and organizations (ex. tax status, OIG exclusions, SAM validation)Organizational “firewalls” to eliminate any commercial influence on non-commercial supportsEstablish guidelines and procedures for any direct interactions with external requestorsAssess company’s support in comparison to total support including diversity of products offered
Consistent controls to manage funding requests
Tracking of spend and outcomes of programs are important to fully evaluate the effectiveness of support and determine plans for future grant funding.Define appropriate level of reporting and data collection based upon program typeMeasuring outcomes for a CME program vs. patient specific updates for assistance programsFinancial reconciliation of support provided versus funds usedOn-going reporting of organizations receiving funding and their adherence to guidelines and policies for supportAppropriate use of fundsReporting on program effectiveness & detailed outcomes
Global tracking of historic support provided
Consistent controls to manage funding requests
Data collection and monitoring are important steps to continually evaluate a company’s external funding process. Additionally, as global transparency requirements expand, reporting of contributions to traditionally non-covered recipients may become required.Periodic monitoring and reporting of company and 3rdparty interactions with PAPs and other charitable organizationsData collection to ensure compliance with future transparency requirements
Internal and external reporting & compliance requirements
End-to-end process addressing the funding lifecycle
Organization and user information is providedRegistrations are systematically screened for:Tax statusExclusion listsUpload of required documents
Applicants select a type of request based on company definitionsProgram data is provided and supplemented with supporting documents
Review of materials for completeness and complianceReview criteria including factors mandated by law and specified by grantorAbility to send request back for editing and additional clarifications
Review committees view request information and make funding decisionsStrategic allocation of funds based on pre-defined categories
After event completion, grantee to reconcile financialsDetailed Outcomes evaluation of the program can be part of this processMonitoring and audit of programs and recipientsDetailed reporting and analysis
An integrated process with program based controls is a key element to ensure continued support for education, patient assistance and other commercial supports while offsetting associated risks.Technology solutions assist in automating these processes, providing efficiencies and improving strategic decision making through analytics and performance dashboards.
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