Currently, 56.2% of Americans under the age of 65 obtain health insurance coverage through an employer. Those who cannot afford to purchase private insurance or do not qualify for state Medicaid programs go without any insurance coverage at all. As a result, there now are an estimated 49.1 million uninsured Americans¹, a number equal to the entire populations of California, Oregon, Washington, and Alaska combined. Furthermore, as of 2007, there were an estimated 25 million underinsured adults in the United States, an increase of 60% since 2003. Lack of adequate insurance coverage is not limited to low-income patients either, as much of this growth comes from the middle class.² Having comprehensive health insurance makes a significant difference as to when, where, and how quickly people are able to access health care. Uninsured and underinsured patients wait much longer to seek health care, resulting in poorer outcomes, decreased adherence to medication regimens, and increased hospitalizations, all of which create greater financial burdens for health care providers.^2-3

As a result of the growing population of un- and underinsured patients, hospitals, infusion centers, and other health care facilities with an increasing percentage of high dollar charity write-offs may benefit from working with the various patient assistance programs (PAPs) offered by pharmaceutical companies as a method to curb these losses. Pharmaceutical manufacturer-sponsored PAPs offer reduced-cost or free medications to patients who meet specific criteria, providing an opportunity for health care facilities to meet the therapeutic needs of their patients while alleviating some of the financial burden. 

PAP Application Process 
Most PAPs are unique and have different guidelines and applications for inclusion. PAPs use the Federal Poverty Guideline to determine a patient’s need for the donation of medication and, although PAP applications are designed for individual patient use, they do require information supplied by a health care provider. Each pharmaceutical manufacturer’s PAP has varying qualifying criteria such as income limits, qualifying disease indications, and/or qualifying residency status, which further add to the complexity of utilizing the programs on a large scale. For example, one PAP may only accept a 1040 Federal Tax Return, whereas another requires three consecutive months of pay stubs to establish a patient’s eligibility. Certain PAPs require an ICD-9 or diagnosis code, while others only provide financial assistance for medications prescribed for FDA-approved indications; some require disease specific information while others do not. All applications do require a patient signature and prescriber signature for completion. For a sample list of biologic manufacturer PAP requirements, see Figure 1. 



While working with PAPs can seem overwhelming to patients and health care providers alike, they do provide a significant opportunity for organizations to advocate for their patients, while at the same time positively impacting their bottom line.

Getting Started
PAP programs are available for many high cost agents used today, including the newer biologics products. Biologics are increasingly being utilized to treat such diseases as cancer, hematologic disease, rheumatoid arthritis, psoriasis, irritable bowel syndrome, hepatitis, and Crohn’s disease. Furthermore, biologic agents tend to be costly, so heavy use can be a fiscal strain on centers that routinely administer high-cost drugs to underinsured and uninsured patients (see Figure 2).



With this in mind, the first step toward working with PAPs is to identify the medication agents used in your facility that present opportunities for your uninsured and underinsured patient populations. The next step is to determine if the manufacturers of those medications have assistance programs and what the terms of those programs are. For example, Rituxan and Abraxane are routinely used, high cost medications, and both have PAPs that provide medication at no cost to the patient. There are also programs that assist underinsured patients by providing funds that can be used toward copayments or medical expenses in the form of a copay grant. Many of these programs are facilitated by non-profit organizations such as the Patient Access Network (panfoundation.org ) or the HealthWell Foundation (healthwellfoundation.org). The availability of these PAPs or copay grants often can be determined through a basic Internet search, and sites such as needymeds.com or rxoutreach.org provide details on available programs and what steps are needed to complete the applications. 

Patient Identification and Service Marketing
Finding qualifying patients in your facility is just as important as knowing which medications can be acquired for those patients. One method is to work with your IT services department to create a report that will identify uninsured patients that are scheduled to receive treatment. Using this type of report gives providers an opportunity to review the patient’s future orders and scheduled course of treatment to determine if there are medications eligible for assistance down the line. Underinsured patients tend to be more difficult to identify because of the variable range of insurance coverage. This illustrates why it is important for all health care providers to be educated about the availability and accessibility of PAPs.

In order for the collective use of PAPs to be successful, all health care providers (ie, nurses, physicians, pharmacists, etc) and support personnel (social workers, schedulers, financial counselors, etc) must be aware that the organization has made a commitment to offer this type of service to their patients. Promoting the service during staff meetings and grand rounds, placing notices in various organizational publications and departmental newsletters, and developing a specific brochure to be sent directly to physician offices are all potential ways to market the service. 

Information Retrieval
As mentioned, many PAPs require both financial and clinical information in order to qualify a patient. Having open access to financial information such as past patient charges, and demographics such as income and Medicaid pending status, is critical. As much as collaborating with IT is valuable for identifying uninsured and underinsured patients, coordinating with your financial department helps to ensure the integrity and accuracy of patients’ financial information. 

Many applications do require clinical information such as ICD-9 codes, previous therapies, and disease specifics (eg, tumor type), so engaging a team of care providers including pharmacists, physicians, and nurses is necessary to ensure the accuracy of patients’ clinical information. Readily available access to electronic medical records and pharmacy IT data also can facilitate the retrieval of information. As a facility develops PAP processes, it may prove beneficial to designate a specific clinical practitioner, such as a pharmacist or nurse practitioner, to work with whomever is charged with accessing clinical information for the assistance programs. 

Receipt of Product
Pharmaceutical manufacturers that operate PAPs often stipulate how products will be provided to the health care facility. Some PAPs require the facility to use a commercial product and then provide free product to replace what has been administered to the patient. Infusion records, physician orders, and nursing administration documentation records are routinely required to receive replacement medications.

Other PAPs require any free medications delivered to the facility to be specifically designated for each unique patient. Still others will issue a credit to the facility’s wholesaler for the quantity of medication administered to the eligible patient. Due to the segregation required for PAP-supplied medications, facilities must establish a central, secure storage location and define processes to receive and account for PAP medications. All invoices should be kept and stored in accordance with state and federal regulations. 

Adjustment of Account 
Once a medication is received from the PAP, a process needs to be put in place to ensure the patient is never charged for that medication. Verification that the patient’s account has been adjusted for the cost of the medication and that the patient has not been charged is an essential part of working with PAPs. Again, working with your finance and IT departments is highly recommended when defining this tracking process and when developing a method for auditing the process. PAPs have the authority to audit facilities that utilize their programs to ensure all steps are completed in accordance with their specific requirements, as well as with a facility’s own policies for PAP administration. See Figure 3 for a sample PAP flowchart.



Creation of a Patient Advocate Position
Due to the complexity of establishing and managing the activities and processes necessary to utilize the various PAPs and copay assistance foundations, it is unrealistic to expect that this work can be accomplished using existing resources. Depending on the size of the facility and the patient population type, organizations will need to dedicate 0.5-1.0 FTE to managing assistance programs. Large health care organizations already taking advantage of these programs often have several employees assigned to these tasks. Ideally, an individual assigned to coordinate the tasks necessary for accessing PAPs would have experience in financial counseling, social work, and medication use (eg, an experienced pharmacy technician). Social workers with experience in a health care setting may be a good fit due to their exposure to both the financial and clinical aspects of patient care.

Regardless of training and background, essential traits for someone in this role include above average organizational, time-management, and communication skills. Attention to detail and ability to multi-task are a must. Although the primary focus of a medication assistance coordinator (MAC) would be accessing PAPs, once someone is dedicated to these activities, they can begin to explore other patient assistance opportunities, such as disease-based grants and copay reduction programs for underinsured patients, and the availability of community resources that can be accessed for both uninsured and underinsured patients. It is recommended that dedicated space be created for this individual that includes necessary office equipment (computer, filing cabinets, etc) and secure medication storage space, including secure refrigeration.

PAP Policy and Procedure 
When utilizing PAPs, it is important to set forth clear expectations and processes for all MAC personnel, patients, and prescribers in the form of a written policy and procedure. Such a policy should address patient eligibility, expected application turnaround time, staff responsibility, the proper receipt and storage of PAP medications, quality assurance of materials and information, applicable account adjustments, and any follow-up for the PAP and/or for the patient. In order to avoid delays in therapy, it is recommended that a defined number of days be set (such as three business days) to allow for the completion and submission of needed paperwork to the PAP. The responsibilities of the patient include providing proof of income, evidence of attending prescriber appointments, and compliance with organizational requests such as applying for state assistance. 

Program Metrics and Audits
As with all cost saving initiatives, tracking value metrics in order to establish and report on the success of a new program to leaders in your organization is critical to ongoing support of the program. Reportable metrics should include the number of applications used by the facility, the value of the medications received, the number of participating prescribers, the number of applications completed and submitted, and an estimate of avoided hospital admissions or readmissions (if able to track this information). Purchasing a customized tracking database is one option for tracking patient, application, and program metrics. There are various programs that can be purchased to assist with this activity from companies such as MedData Services, DataNet Solutions, the Partnership for Prescription Assistance, and RxAssist Plus. Remember, internal audit procedures for accuracy of both clinical and financial information are critical to ensure compliance with all PAP requirements; it is always best to self-identify internal discrepancies prior to being audited by an outside agency. 

Overcoming Barriers
Even the most seasoned facilities that work with PAPs will encounter barriers, but internal barriers can be minimized. Given that a MAC position may be novel at many organizations, classification and integration of such a position may be a challenge. Due to the level of responsibility and combination of skills required, this position does not readily fit into an established category and likely will require a unique classification. Accordingly, the classification and associated salary of the MAC should be periodically reassessed as the program grows and activities are expanded. A strong relationship between your facility’s finance department and the MAC should be established early on to ensure the reliability and timeliness of financial information acquired from the patient access and financial counseling departments. 

While the US has seen recent economic improvement, unemployment remains above 8% and the economy remains volatile. Given this uncertainty, PAPs have proven effective in increasing physician and patient satisfaction by providing accessibility to expensive medications, including biologic agents, without facilities having to bear the cost burden. Uninsured and underinsured patients involved in PAPs tend to see increased continuity of care, decreased emergency room visits, and increased quality of life. The current economic climate continues to exacerbate financial challenges for organizations caring for these patients, but introducing a structured process to take advantage of PAPs can be valuable in reducing the associated burdens of caring for this growing patient population.

References

1. The Uninsured: A Primer. Key Facts About Americans Without Health Insurance. October 2011. The Kaiser Commission on Medicaid and the Uninsured. Publication #74511-07.
2. Schoen C, Collins S, Kriss J, Doty M. How Many Are Underinsured? Trends Among U.S. Adults, 2003 and 2007. Health Affairs, Web exclusive. June 10, 2008; w298-w309
3. Davidoff A, Kenney G. Uninsured Americans with Chronic Health Conditions: Key Findings from the National Health Interview Survey. The Urban Institute and the University of Maryland. May 2005. Available at http://www.urban.org/publications/411161.html

Sarah Hudson-DiSalle, PharmD, RPh, is director of the medication assistance program at The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at The Wexner Medical Center at The Ohio State University in Columbus, Ohio. She received her BS in pharmacy from the University of Toledo and her PharmD from The Ohio State University College of Pharmacy.

Niesha Griffith, MS, RPh, FASHP, is director of pharmacy and infusion services at The Arthur G. James Cancer Hospital at The Ohio State University. After receiving a BS in pharmacy from West Virginia University, Niesha received an MS in hospital pharmacy administration and completed her pharmacy residency at The Ohio State University College of Pharmacy.