As an independent charitable patient assistance foundation, the PAN Foundation is committed to compliance, transparency, and operational excellence so we can connect thousands of people each year with financial assistance. We reinforce this commitment by implementing an independent, standardized process for identifying and launching new disease funds, including key operational safeguards.
I know that the medication that I receive help with is making a big difference between just being alive and actually living a life.
Monika Stanley, PAN grant recipient
Comprehensive new disease fund development
- Identify a prospective disease fund through rigorous ongoing research
- Prepare a comprehensive dossier with the parameters of the disease fund
- Review with medical experts including our Medical Director to confirm the fund is clinically compliant
- Review with our external legal counsel to confirm that fund is OIG compliant
- Approve the fund by our Board of Directors Patient Assistance Committee
- Launch the new disease fund once a donation is received
Identifying prospective disease funds
The PAN Foundation has sole discretion in identifying new disease funds and is not influenced by, nor do we accept, recommendations from donors regarding the design of a disease fund. In addition, we will not create a new disease fund in response to a donor request.
Research
Our Clinical Affairs team, comprised of licensed pharmacists and our Medical Director, maintains a rigorous research process throughout the year, independently researching disease states for their potential to be considered as a PAN Foundation disease fund. Our extensive sources include, but are not limited to, medical databases which list chronic, rare, and life-threatening diseases, reports from peer reviewed medical literature, healthcare news feeds, patient inquiries, and healthcare professional inquiries.
While researching any potential disease states, we adhere to strict criteria based on guidelines from the U.S. Department of Health and Human Services Office of the Inspector General (OIG) and internal standards, including:
- Is the disease widely recognized by the medical community and defined by widely accepted and respected medical sources?
- Who are the affected population groups?
- What are the available treatments for the disease state?
- Does the disease and its treatments impose high out-of-pocket costs on patients?
Finalizing prospective disease funds
Once our Clinical Affairs team and other key stakeholders verify the disease as a viable fund candidate, we publish the prospective disease fund to our website—giving donors an easy way to find all the disease areas we hope to support.
Implementing safeguards
A new disease fund can only be established if PAN Foundation’s Board of Director’s Patient Assistance Committee reviews and approves the fund.
The PAN Foundation does not identify, consider, create, delineate or modify disease funds based on recommendations from lapsed, current, or prospective donors or their affiliates; or donor requests.
Defining disease funds in accordance with widely recognized clinical standards
We define our disease funds in accordance with widely recognized clinical standards, specifically using ICD-10 codes to specify the clinical scope and supplement the definition of a widely recognized disease state.
Metastatic cancer funds
The OIG has specified that disease funds cannot be defined or narrowed based on specific symptoms, severity of symptoms, method of drug administration, type of drug treatment, stages of a particular disease, or any other narrowing criteria. However, the OIG clarified in its 2015 modification to PAN’s Advisory Opinion 07-18 that cancer disease funds may be limited to metastatic forms.
Launching a disease fund
Once we receive funding for a prospective disease fund, we are then ready to launch the disease fund to the public.
When a disease fund is launched, we announce the launch to our network of patients, healthcare professionals, advocacy partners, and donors at the same time. No party is given advance notice of the launch of any disease fund. We also update our website to indicate that the disease fund is open and accepting applications. All grants are provided to patients on a first-come, first-served basis and the disease fund will stay open until the funding runs out. Once a disease fund is closed, we operate a disease fund wait list.
Disease fund formularies
We create standardized formularies for each disease fund that contains all prescription medications. This includes generic or bioequivalent drugs that are FDA-approved, listed in official compendia, or published in evidence-based or clinical guidelines for a diagnosis that qualifies a patient for the assistance program.
