 Patients with cancer often face financial hardships, including loss of productivity, high out-of-pocket (OOP) costs, depletion of savings, and bankruptcy. By providing financial guidance and assistance through specially trained navigators, hospitals and cancer care clinics may be able mitigate the financial burdens to patients and also minimize financial losses for the treating institutions.

 Financial navigators at 4 hospitals were trained through The NaVectis Group, an organization that provides training to healthcare staff to increase patient access to care and assist with OOP expenses. Data regarding financial assistance and hospital revenue were collected after instituting these programs.

 Amount and type of assistance (free medication, new insurance enrollment, premium/co-pay assistance) were determined annually for all qualifying patients at the participating hospitals.

 Of 11,186 new patients with cancer seen across the 4 participating hospitals between 2012 and 2016, 3572 (32%) qualified for financial assistance. They obtained $39 million in total financial assistance, averaging $3.5 million per year in the 11 years under observation. Patients saved an average of $33,265 annually on medication, $12,256 through enrollment in insurance plans, $35,294 with premium assistance, and $3076 with co-pay assistance. The 4 hospitals were able to avoid write-offs and save on charity care by an average of $2.1 million per year.

 Providing financial navigation training to staff at hospitals and cancer centers can significantly benefit patients through decreased OOP expenditures and also mitigate financial losses for healthcare institutions.

Am J Manag Care. 2018;24(5 Suppl):S74-S79

The use of trained oncology financial navigators can increase access to care and save money for both patients and hospitals.

In the 4 hospitals studied, patients saved a total of $39 million over 11 years.

Patients, on average, received $33,265 in free medications per year and saved $12,256 through enrollment in insurance plans, $35,294 with premium assistance, and $3076 with co-pay assistance each year.

Hospitals saved $2.1 million annually on care that would have previously been provided as charity care or gone to bad debt.

After a cancer diagnosis, patients and families face many stressors, including the possibility of significant short-term and long-term financial consequences. Rising premiums, deductibles, coinsurance, and co-payments for oral oncology drugs, many of which cost over $10,000 per month, expose patients and families to significant out-of-pocket (OOP) healthcare spending. These direct medical costs, in combination with the indirect costs related to patients’ and families’ decreased work hours or loss of employment, create a perfect storm for financial devastation. Indeed, up to 75% of patients with cancer report experiencing high levels of anxiety or distress related to the financial aspects of treatment. Many patients, particularly younger, nonwhite, and lower-income individuals, experience significant financial setbacks, including accrual of debt and loans, loss of savings and assets, and personal bankruptcy, as a result of healthcare costs.

 Recent studies have shown that patients with cancer who experience financial hardship have a higher risk of treatment nonadherence, poorer quality of life, and higher mortality than those who do not experience such hardship.

 Efforts to mitigate the financial burden of cancer treatment are therefore desperately needed.

Many have argued that a critical step in addressing the financial side effects of cancer care is improving communication about costs between patients and oncologists.

 However, most oncologists fall short in providing adequate guidance to patients and families about financial issues. In fact, although a majority of oncologists feel that it is important to discuss how treatment may affect financial well-being, nearly one-third feel uncomfortable doing so and one-fifth do not think that cost should ever be considered when making treatment decisions.

 Improving cost communication between patients and oncologists is therefore not sufficient in order to truly address patients’ and families’ financial issues; clinics must either collaborate with outside organizations that have expertise in financial counseling and medical costs or invest in internal financial navigation resources to provide consistent and proactive financial support to all patients beginning at diagnosis.

 The latter model is appealing in that in-house navigators can work with other members of the team and access clinical information easily and quickly. Few such models for providing financial navigation within the clinical setting have been described. In practice, the work of financial navigation frequently falls on poorly trained staff who do not have the required education or credentials to be able to offer true expertise in dealing with the complexities of the insurance marketplace and treatment-related costs.

 Therefore, a high need exists to establish and evaluate the benefits associated with different types of oncology financial navigation models.

The NaVectis Group is a company that provides education and training to healthcare staff on how to improve patient access to financial assistance. Key components of the program include training staff who have higher levels of education, implementing systematic processes for identifying patients in need, obtaining or improving insurance coverage for patients, and using tracking software to quantify benefits. Here, we show that by instituting a financial navigation program using trained counselors, hospitals can save money that would typically have gone to bad debt, and patients can gain access to care that would otherwise have been unaffordable.

Four hospitals in the United States participated in this study and received training by The NaVectis Group to implement a financial navigation program. Three hospitals trained current employees, and the fourth hospital hired a new employee for the position. All patients with cancer seen at the hospitals were eligible to be seen by these NaVectis-trained financial navigators.

After training of staff by The NaVectis Group and implementation of the financial navigator program, de-identified information regarding the number of patients seen, number receiving assistance, types of assistance, and amounts of assistance were tracked annually. Each hospital instituted the program at different times, with Hospital #1 having 1 year of operation (2016), Hospital #2 having 3 years (2014-2016), Hospital #3 having 2 years (2015-2016), and Hospital #4 having 5 years (2012-2016). Only new patients seen in a given year were included in that year’s data.

Calculation of Cost Savings to Patients and/or Hospitals: Categories of Cost Savings and Assumptions 

 In cases where free medication was provided directly to patients or to hospitals on patients’ behalf, we calculated patient cost savings as the amount that would have been charged to the patient by the hospital or pharmacy. Hospitals were either supplied with free medication on behalf of individual patients or were reimbursed for the cost of previously dispensed medication. In both cases, the benefit to the hospital was considered to be the acquisition cost of the medication.

 Cost savings from co-pay assistance were calculated as the total amount paid to hospitals to offset co-pays for medications and other services by patient assistance foundations or pharmaceutical industry programs.

 When hospitals paid insurance premiums for a patient, the benefit to the hospital was calculated as the amount of insurance reimbursement for the patient’s care minus the amount the hospital paid for the premium. As hospitals’ insurance payments for patient care are typically less than the initial charge, patient savings were calculated as the cost of the premium payments in addition to 150% of the insurance payments to the hospital, with a likely range between 100% and 200%.

Financial navigators educated patients on insurance options and referred them to insurance brokers to help them enroll in insurance plans, including Medicaid, Medicare Part D, Medicare Supplement, Medicare Advantage, and Affordable Care Act (ACA) Marketplace plans. Based on prior data collected by The NaVectis Group, the patient benefit of enrollment in Medicare Supplement or Medicare Advantage was estimated to be $5000 annually, with hospitals receiving increased payments of $4000 and $2500, respectively. When hospitals helped a patient to enroll in a Medicaid or Marketplace plan, the benefit to the hospital was recorded as the value of the insurance payments to the hospital. The benefit to patients was estimated at 150% of the hospitals’ payments, assuming that direct-to-patient bills would be higher than the insurance negotiated rate, with a likely range between 100% and 200%. For Medicare Part D, the benefit to patients was recorded as the value of initial coverage under the Part D plan.

 Financial navigators helped patients in ACA Marketplace plans to obtain the highest level of coverage with the lowest OOP costs. Hospital #3 reported the actual cost savings to the patient and hospital, but for Hospitals #1 and #2, it was estimated that patients saved $2500 in OOP expenses from restructuring of their health plans and hospitals then received that same amount in insurance payments. Hospital #4 did not assist patients with Marketplace maximization. 

 Patients frequently received assistance for other costs, such as transportation and medical equipment. This was reported as the actual amount that the patient received, with no benefit to the hospital.

A total of 11,186 new patients with cancer were seen across the 4 hospitals after financial navigation programs were instituted (

). Hospital #1 was able to obtain financial assistance for 87% of new patients seen in the first year of the program, whereas other hospitals helped between 15% and 39% of new patients each year. There were differences in the number of patients helped in each assistance category (eg, free medication, premium assistance) among hospitals. For instance, Hospital #1 provided free medication to 15% of new patients in 2016, whereas fewer than 1% of patients at Hospital #4 received this benefit. All hospitals helped patients to enroll in insurance plans, with hospital #4 seeing a large increase, from 27 patients enrolled in 2013 to 174 in 2017, after they began helping patients to enroll in health insurance exchanges mandated by the ACA. Hospital #4 did not report data on community assistance or Marketplace maximization, in which financial navigators helped patients change to more appropriate coverage using healthcare exchanges.

Financial navigators saved patients a total of $39 million (range, $31-$47 million varying on the estimated cost savings) in the 11 total years of follow-up in the 4 hospitals. These savings consisted of help covering OOP costs, such as medications, co-pays, and insurance premiums, as well as helping patients obtain insurance and receive medical care that they otherwise would not have been able to afford (

Medication costs were often covered by foundational support or drug companies, which allowed patients to save an average of $33,265 per year. Similarly, financial navigators helped patients access co-pay assistance programs, which primarily helped with co-pays for medications but also other types of care, totaling $2.5 million in assistance. All hospitals instituted programs in which they paid insurance premiums for patients who were unable to do so; this allowed patients to maintain insurance coverage that paid for their cancer care. This service provided $35,294 (estimated range, $23,529-$47,058) per year in care to patients. Financial navigators assisted patients in enrolling in insurance plans, such as Medicare Supplement, Medicare Advantage, Medicaid, and ACA Marketplace plans. As shown in Table 2, patients received medical care with an estimated total cost of $11,214,225 (range, $7,948,370-$14,480,079) or $12,256 (estimated range, $8687-$15,825) per patient annually as a result of gaining insurance coverage. Another service offered was helping patients to change medical plans and coverage through the ACA Marketplace plans in order to maximize coverage and minimize costs. Aside from direct costs of medical care, patients were frequently provided with community assistance to help with expenses like transportation, accounting for nearly $900 in aid per patient. As patient savings were only reported within the first calendar year after establishing care, it is probable that the total benefit to patients was much greater than these amounts, as many patients were likely seen for several years.

Hospitals also benefited significantly from the financial navigation services provided to patients. This increase in revenue largely consisted of payments from insurance companies or patient assistance programs to cover costs that otherwise would have been provided as charity care or written off as bad debt. With medications, hospitals benefited either by having free medications provided specifically for the patients or by having medication replaced after its use, worth a total of $3 million across all hospitals (

). Although the hospitals had to pay several thousand dollars to help each patient with insurance premium payments, the resultant insurance payments more than made up for the initial spending, averaging $1 million per year per hospital in increased revenue. Hospitals also received payments for medications and services through patient co-pay assistance programs, which were reported as the actual amount paid to the hospital. As with the benefit to patients, the benefit to hospitals from enrolling patients in insurance plans was the actual amount of insurance payments for some plans but an estimate for others, such as Medicare Supplement and Medicare Advantage. This amount varied greatly among hospitals, largely due to the types of insurance and number of patients helped, with hospitals claiming increased revenue between $43,500 and $2,823,704 per year. For instance, once Hospital #4 began enrolling patients in ACA Marketplace plans in 2014, the amount that it received in insurance payments for patient care increased dramatically from $88,000 in 2012 to $2.8 million in 2016. Hospital #2 was able to increase revenue after enrolling patients in Part D as it had a hospital-owned retail pharmacy where oral oncolytic prescriptions were filled, whereas patients at all other hospitals used independent mail-order pharmacies. In total, the hospitals were able to increase revenue or avoid bad debt by an estimated total of $23 million during the 11 years of follow-up.

By instituting financial navigation programs for patients, hospitals were able to provide cancer care that previously would have been unaffordable to many patients. OOP expenses for medications can be a large financial burden for patients, and financial counselors were able to assist patients by procuring free medication and helping to cover the high co-pays that insurance companies often charge for expensive cancer medications. Although all Americans were at the time mandated by the ACA to have health insurance coverage, many remained uninsured or underinsured. Financial navigators were successful in enrolling patients in many types of insurance plans, including Medicare Supplement, Medicare Advantage, Medicaid, and ACA Marketplace plans. Although this study did not specifically look at the financial toxicity that these patients faced, we expect that the financial navigation services helped to decrease some of the economic stresses associated with their care. As financial toxicity is associated with noncompliance and poorer outcomes, these patient navigation services would have the ultimate effect of improving outcomes for patients with cancer.

Hospitals that treat patients with cancer, particularly those with large underserved populations, can face millions of dollars in losses by providing care for which they will not be reimbursed. The services provided by trained financial navigators can help to mitigate these losses through the same programs that help the patients by increasing the number of insured patients, paying insurance premiums to help keep patients insured, finding programs to help patients with OOP costs that would not be otherwise be paid, and obtaining free medications from patient assistance programs.

Although the benefits to patients and hospitals are obvious, this study did have several limitations. First, the only hospitals included in this analysis were those that had already begun utilizing trained financial navigators. We did not have data on the number of patients who received financial assistance, types of assistance, or amount of assistance at the same 4 hospitals before instituting the structured programs. If a hospital already had a systemic, structured method to identify patients who would benefit from financial counseling and could provide those patients with similar types of assistance, the addition of trained navigators may not result in a significant increase in benefit to patients and hospitals. Additionally, there was no comparison with similar hospitals that did not use trained financial navigators over the same time period.

Our ability to accurately quantify the savings and benefits to patients and hospitals was limited by several factors. First, only “new” patients were included in the data for each year; therefore, even if a patient received care, and financial assistance, over multiple years, the only benefits recorded were those obtained by December 31 of the year in which they were first seen. This, however, would probably serve to underestimate the amount of assistance given to patients. Second, not all benefits were exact dollar amounts, particularly the benefit for enrolling patients in various insurance plans. Enrollment in Medicare Supplement and Advantage plans were estimated to provide $5000 in care to patients, but in actuality, the number was probably much higher given the high cost of cancer care in the United States. Again, this likely underestimated the total benefit to patients and hospitals. Lastly, many of the estimates of benefit to patients were also based on an assumption that the OOP costs to uninsured patients would be much greater than the actual amount reimbursed to hospitals by insurance providers, but this estimate was required because only the reimbursement received by the hospital was recorded.

Hospitals that used trained financial navigators were able to provide significant financial assistance for their patients with cancer and hopefully alleviate some of the financial distress felt by many patients that can lead to adverse outcomes.

 Clinical Research Division (TY, JS, KW, VS), and Division of Public Health Sciences (VS), Fred Hutchinson Cancer Research Center, Seattle, WA; Division of Medical Oncology, University of Washington School of Medicine (TY, VS), Seattle, WA; The NaVectis Group (DS), Caledonia, MI.

 Mr Sherman is owner and president of The NaVectis Group. The remaining authors report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

 Concept and design (JS, KW, DS, VS); acquisition of data (TY, JS, DS, VS); analysis and interpretation of data (TY, JS, VS); drafting of the manuscript (TY, JS, VS); critical revision of the manuscript for important intellectual content (TY, VS); statistical analysis (TY); administrative, technical, or logistic support (JS, KW); and supervision (KW, DS).

 Todd Yezefski, MD, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, D5-100, Seattle, WA 98109-1024. Email: tyezefsk@fredhutch.org.

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Articles

POLICY

Hospitals that used trained financial navigators were able to provide financial assistance for their patients with cancer, providing access to care that would otherwise be unaffordable.

Impact of Trained Oncology Financial Navigators on Patient Out-of-Pocket Spending

Federally qualified health centers (FQHCs) are essential to underinsured populations in the safety net by offering them several means of access to reduced cost medications. This study employed a 2-pronged approach to evaluate FQHCs’ role, estimating both the need for patient assistance and the impact of the safety net.

A multiyear panel data study for post—Affordable Care Act (ACA) years 2012 to 2016 and a 2016 cross-sectional analysis design were utilized to analyze FQHCs, their patient populations, and prescription assistance programs.

Publicly available Health Resources and Services Administration (HRSA) Uniform Data System data were merged with HRSA Office of Pharmacy Affairs Information System data on 340B programs. Descriptive statistics were produced to evaluate the need for patient assistance, costs, and conditions treated at FQHCs.

There were 1337 FQHCs serving more than 2.5 million patients, nearly 29% of whom were uninsured. FQHCs utilized 2 programs to provide affordable, reduced-cost prescriptions for patients without insurance: 1) the HRSA 340B Drug Pricing Program and 2) prescription assistance programs, which rely on pharmaceutical manufacturer donations of reduced-cost medications or coupons. Although these programs were effective at providing affordable prescriptions, program accessibility varied widely by state and FQHC resources.

changes in the healthcare access landscape due to the ACA, underinsured populations remain prevalent and the need for financial assistance with medications persists. FQHCs are uniquely situated to provide access to these essential services. Further policy and funding efforts, such as expansion of 340B programs, could assist FQHCs in fulfilling the role of prescription safety-net providers.

Am J Manag Care. 2018;24(5 Suppl):S67-S63

Federally qualified health centers (FQHCs) serve an important role in providing need-based, reduced-cost prescription medications to the uninsured in the post—Affordable Care Act (ACA) landscape.

FQHCs utilize 2 programs to provide affordable prescriptions for underinsured patients: 1) the Health Resources and Services Administration 340B Drug Pricing Program and 2) prescription assistance programs, which rely on pharmaceutical manufacturer donations of reduced-cost medications or coupons.

Despite changes in access to health insurance and care in the post-ACA era, FQHCs continue to serve uninsured patients everywhere, but particularly in states that did not expand Medicaid.

Further policy and funding efforts, such as expansion of 340B programs, could assist FQHCs in fulfilling the role of prescription safety-net providers.

Access to affordable prescription medications is an essential component of healthcare services utilization, which has been demonstrated to improve health outcomes.

 With the costs of prescriptions rising, underinsured and uninsured populations are especially at risk for not being able to access needed medications and, consequently, at risk for noncompliance with treatment plans.

 Federally qualified health centers (FQHCs), which are primary care safety-net providers established to serve patients regardless of their ability to pay and insurance status, play a key role in closing the prescription access gap by offering several ways uninsured and underinsured populations can receive reduced-cost medications.

 Specifically, FQHCs utilize 2 programs to meet prescription needs: 1) the Health Resources and Services Administration (HRSA) 340B Drug Pricing Program and 2) prescription assistance programs (PAPs), which rely on pharmaceutical manufacturer donations of reduced-cost medications or coupons.

Throughout the dynamic post—Affordable Care Act (ACA) healthcare environment, the role of FQHCs in the primary care and prescription medication safety net remains essential. Although rates of underinsured and uninsured citizens in the United States have been declining and disparities in access decreasing since the passing of the ACA in 2010,

 FQHCs persist as critical access points for the underserved and those who are still ineligible for insurance subsidies on the Marketplace or who reside in a state that did not expand Medicaid.

 Since the inception of the ACA Marketplaces and Medicaid expansion, rates of uninsurance have decreased across racial/ethnic groups and across levels of poverty status.

 Despite these improvements, racial/ethnic and income disparities in access persist: African American and ethnically Hispanic individuals are more likely to be uninsured than nonminorities, and individuals and families with relatively lower incomes are more likely to be uninsured compared with counterparts with higher-income status.

 Access to reduced-cost medicines is under further threat due a recent cut to the 340B program by CMS, effective on January 1, 2018.

To this end, FQHCs are uniquely situated in the post-ACA landscape to serve these underserved communities per their mission to provide access; they are physically located in designated medically underserved areas and they have grant stipulation to provide care regardless of patients' ability to pay. In states that did elect to expand their Medicaid program eligibility to residents with incomes up to 138% of the federal poverty level (FPL), FQHCs are more likely to accept new Medicaid patients than are other primary care providers because of their health center grant requirements and enhanced prospective payment plan from CMS.

 In the 18 states that did not expand Medicaid eligibility as of 2018, FQHCs serve as the primary care and prescription medication safety net for residents who do not qualify for traditional or categorical Medicaid nor for the subsidies provided on the ACA Marketplace, for which eligibility begins at 100% of the FPL.

HRSA 340B Programs in Community Health Centers

The utilization of the HRSA 340B Drug Pricing Program, in which covered entities are able to purchase and redistribute prescription and nonprescription medications for outpatients at reduced costs,

 is a crucial tool with which FQHCs provide access to affordable prescription medications for under- and uninsured health center patients. The Pharmacy Services Support Center (PSSC) is a unique collaboration between HRSA and the American Pharmacists Association in which HRSA grantees, such as FQHCs, are provided with technical assistance on HRSA demonstration projects and programs aimed at addressing the prescription medication access gap for the under- and uninsured, namely the 340B program.

Clinic-level case studies related to 340B program utilization have demonstrated that health center patients without insurance and/or prescription drug coverage, a sample including nearly 90% of patients at or below 200% of the FPL, were able to gain access to affordable $4 generic prescriptions through the 340B program.

 FQHCs are adept at stretching limited resources and collaborating with community partners. In one case, a health center expanded medication formularies leveraging their 340B program and partner organizations.

 Furthermore, FQHCs have demonstrated their ability to optimize their 340B programs and wield their expertise in serving the communities in which they are located. FQHCs have proven their 340B programs useful for providing contraception medications to uninsured adolescent and young adult populations,

 improving access to asthma medication and treatment plan adherence among uninsured Spanish-speaking Hispanic patients,

 and improving cancer medication access in conjunction with partner Disproportionate Share Hospital systems.

PAPs (also known as drug assistance programs) are another essential tool with which FQHCs provide access to prescription medications to under- and uninsured patients. PAPs are health center—organized programs that distribute medications to qualifying indigent patients at little or no out-of-pocket cost,

and their utilization has been proven to decrease patient prescription expenditures for the uninsured,

in particular for high-cost medications, such as cancer treatments.

The medications are provided by pharmaceutical manufacturer donations, and recipient qualifications and application processes differ among manufacturers, with some requiring as many as 4 applications per year per prescription per patient.

 More than 53% of the top 200 prescriptions were offered via PAPs to qualifying indigent patients through manufacturers.

Another study found that the average drug procured through a PAP for a sample of 32 pharmaceutical manufacturers cost $25.18 per prescription and required approximately 6 minutes of health center staff time per submission per prescription, indicating that the effectiveness of these programs is heavily dependent on which prescriptions and how many medications health center patients require, as well as staff availability to manage applications.

The literature notes that the success of prescription access programming, both the 340B program and PAPs, for the under- and uninsured in health centers is reliant on resources such as staffing, access to patient data, and coordination with community partners, such as retail pharmacies, for 340B programs.

 Findings from another study show that an interdisciplinary team approach involving physicians with midlevel providers, clinical pharmacists, nurses, social workers, and eligibility specialists is most effective in assisting patients without insurance or prescription coverage to gain access to their prescription medications,

 again situating FQHCs to play an important role in bridging the prescription access gap, as they often employ a wide range of staff to provide comprehensive primary care, mental health and substance use assistance, and eligibility services in accessible and coordinated locations.

ACA initiatives, such as the Community Health Center Fund, an $11-billion operations and infrastructure building grant to FQHCs; the Centers for Medicare and Medicaid Innovation Advanced Primary Care Practice Demonstration, which funded and assisted FQHCs to obtain National Commission for Quality Assurance Patient-Centered Medical Home designation in a 3-year demonstration ending in 2014; and funding for Marketplace Outreach and Enrollment assistance at health centers, poise FQHCs to maintain an essential role in providing primary care and access to medications for the under- and uninsured in the post-ACA era across the country. Although evidence substantiates this vital role, there remains a gap in the literature reflecting a formal evaluation of FQHCs’ performance in providing access to prescription medications to the under- and uninsured. This study aimed to evaluate FQHCs’ role, estimating both the need for patient assistance and the impact of the safety net. Findings of this study are intended to be of interest to patient advocacy groups concerned with prescription medication costs, such as the Patient Access Network Foundation; legislators involved with HRSA funding and programming to meet these needs; and FQHC advocates and leaders responsible for implementing these PAPs.

A 2-pronged approach was used to evaluate FQHCs as a safety net for access to prescription medications: 1) assessing the need for patient assistance and 2) evaluating the FQHC safety-net system for prescription medications. HRSA Uniform Data System (UDS) complete report data were obtained via a Freedom of Information Act request from the HRSA Bureau of Primary Health Care for all health center programs for 2013 and 2014, with the FQHC grantee as the unit of analysis. Additionally, publicly available partial report data were collected and utilized for 2012 to 2016 for panel data analysis. UDS data were merged by HRSA grant recipient identifier with HRSA Office of Pharmacy Affairs Information System data related to 340B Drug Pricing Program covered entities, which are also publicly available.

The first research question, regarding the need for patient assistance, yielded a descriptive analysis of the underinsured FQHC patient populations benefiting from programs offering financial assistance for prescriptions, including their income, insurance status, and disease diagnoses. Additionally, the study estimated the impact of Medicaid expansion on the uninsured patients served by FQHCs using a difference-in-differences (DID) method, as it pertains to the question of where the need for prescription medication assistance is most concentrated, theorizing there would be greater rates of uninsurance in states that did not expand Medicaid. Panel data were constructed using UDS data for years 2012 to 2016. The 50 states and the District of Columbia (DC) were evaluated, excluding the Commonwealth of Puerto Rico and other US territories from the panel. A vector of time-variant control variables were included in the estimating equation: insurance changes (private/other third-party payer, Medicare), population age (children younger than 18 years, adults younger than 65 years), racial and/or ethnic minority, and total costs per patient. Standard errors (SEs) were clustered at the state level, and linear time trending was identified and used in the model specification process. State and year fixed effects were included in the model. Several robustness checks were also employed and presented to ensure the validity of the findings. The treatment reflected state-based Medicaid expansion decisions and included the Section 1115 waiver states (8 states that implemented Medicaid expansion with slightly different provisions than outlined in the ACA) as well as states that expanded Medicaid after January 1, 2014 (for which expansion date by year was reflected in the model for the treatment time). STATA 13.0 was utilized for this analysis (StataCorp LP; College Station, Texas).

The second approach aimed to evaluate the FQHC safety net itself. This analysis produced estimations of the size of the FQHC safety net, types of medication access programs offered, approximated costs of these programs, and accessibility of reduced-cost prescription programs in FQHC settings. A cross-sectional study design was utilized to provide the analysis of underinsured FQHC patients and the FQHC PAPs for all FQHCs for 2016, the most recent UDS data available. Descriptive statistics were utilized to estimate the need for patient assistance at FQHCs and costs and accessibility of the programs. Analyses were conducted using STATA 13.0.

The need for patient assistance in an FQHC setting is well established. In 2016, the most recent reporting year, 25.4 million patients were served by 1337 FQHCs across all 50 states and DC. The number of FQHCs per state in 2016 ranged from 4 (North Dakota) to 176 (California). Of these patients, 28.7% were uninsured, 90.6% had incomes at or below 200% of the FPL, and 66.7% had incomes at or below 100% of the FPL, as shown in 

. Uninsured patient rates varied greatly by state, ranging from 9% in Vermont to 59% in Wyoming. From 2012 to 2016, the rate of uninsured FQHC patients decreased from 40.4% in 2012 to 28.7% in 2016. Indicators of patient income remained relatively constant, as in 2012, FQHC patients at or below 200% of the FPL accounted for 92.0% of FQHC patients and those at or below 100% of the FPL, 68.9%; these figures were very close to their above-mentioned 2016 counterparts.

FQHC services utilization remained consistent across the 5 years of UDS data reports, as 85.2% and 83.7% of FQHC patients utilized medical services in 2012 and 2016, respectively; 21.4% and 21.8% utilized dental services; 5.5% and 7.7% utilized mental health services; and 12.4% and 11.7% utilized enabling services, which include PAP services. Notably, FQHC Public Health Service Section 330 grants increased during the period as a result of the ACA Community Health Center Fund, increasing by $1,214,902 in annual grant funding from $1,949,332 in 2012 to $3,164,234 in 2016. Furthermore, the FQHC cost per patient also increased by $273 per patient per year, from $688 per patient per year in 2012 to $960 in 2016.

, the most prevalent chronic conditions included hypertension, overweight and obesity, asthma, and heart disease. Mental health and substance use disorders were also common, with the most prevalent being depression, anxiety disorders, other mental health disorders, and tobacco use disorders (Table 2). Additionally, communicable diseases, including HIV, hepatitis C, sexually transmitted diseases (excluding HIV), and hepatitis B, were often primary diagnoses and causes for visits.

Results from the DID analysis aiming to assess the impact of Medicaid expansion on uninsured patient rates for FQHC patient panels yielded anticipated results, as shown in 

. January 1, 2014, was the first day that states were able to expand Medicaid eligibility requirements per ACA provisions, and 24 states expanded immediately. Seven states expanded later: Michigan (April 1, 2014), New Hampshire (August 15, 2014), Pennsylvania (January 1, 2015), Indiana (February 1, 2015), Alaska (September 1, 2015), Montana (January 1, 2016), and Louisiana (July 1, 2016). Maine is slated to expand Medicaid at a date to be determined.

The impact of Medicaid expansion on the uninsured rate of FQHC patients was a decrease of 7.9% (SE = 0.01; 

<.001) in 2014, controlling for changes to time-invariant differences among the states in the DID model and controlling for time-variant differences by controlling for changing patient demographics and costs to health centers. The Medicaid expansion DID model results did not demonstrate significant impact on FQHC uninsured rates after the policy implementation year of 2014, despite the impact of the 7 states that elected to expand their Medicaid eligibility at a later date. Additionally, no significant results demonstrating changes in services utilization were produced from the estimations. Medical services utilizations were not affected and ancillary services (vision, dental, mental health/substance abuse, and enabling services) utilizations were not changed at statistically significant levels, as referenced in Table 3.

Results demonstrated that substantial FQHC resources are allocated to pharmacy and medication access services, as presented in 

). Roughly 2% of all FQHC personnel by full-time equivalent employees  (FTEEs) were allocated for pharmacy services in 2016, averaging 84 FTEEs per state. Totaled direct (accrued) costs and indirect costs, including facility and nonclinical support services (excluding pharmaceuticals), allocated in FQHC cost reports for pharmacy services, averaged $17,156,369.48 per state, ranging from a minimum of $302,730 ($6.07 in spending per FQHC patient) in Delaware to a maximum of $147,063,607 ($33.42 in spending per FQHC patient) in California. FQHC costs allocated to pharmaceuticals in cost reports averaged $28,661,283.59 by state, ranging from $1,118,380 ($63.61 per patient) in Wyoming to $250,485,263 ($56.93 in spending per patient) in California. Enabling services costs allocations, which include PAP services, averaged $4,566,594.92 per state.

 presents HRSA 340B Drug Pricing Programs implemented through FQHCs. Numbers of 340B programs by FQHC varied greatly by state, with a minimum of 3 (Nevada) to a maximum of 129 (California). Percentages of FQHCs operating 340B programs ranged from 60% to 100%; in several instances, there were more 340B programs affiliated with FQHCs than number of FQHCs themselves because a partner agency managed the 340B program (such as a health department, Disproportionate Share Hospital, or community clinic) and collaborated with local health centers. Additionally, because an individual FQHC can implement multiple 340B programs (eg, if the FQHC operates multiple sites, outreach locations, or pharmacies, or contracts with different locations of retail pharmacies for their 340B program), the number of 340B programs ranged greatly by state. The maximum frequency was in California, where there were 8709, and the minimum frequency was in Wyoming at 25. The average number of 340B programs per FQHC ranged from 2.6 (Alaska) to 72.6 (Illinois). The ratio of 340B programs to FQHC patients (programs:patients) ranged from 1:263 (South Dakota) to 1:2098 (DC).

FQHCs play a vital role in the prescription safety net. Despite the ACA provision broadening healthcare access by providing funding to states for voluntary Medicaid eligibility expansion, just 32 states elected to expand their Medicaid programs. Results of our analyses demonstrated that FQHCs still serve a vital role in providing healthcare access to patients without health insurance in a post—Medicaid expansion and post–ACA Marketplace landscape. The 2 programs that serve FQHC patients’ prescription medication needs, HRSA 340B and PAPs, have been studied and evidenced to be affordable in several case studies in FQHC settings, at roughly $4 per prescription for generic medications in FQHC 340B programs and $25.18 per prescription cost to FQHC in PAPs.

 However, affordability to uninsured patients may not indicate accessibility. The wide range of variations in proportions of FQHC patients and uninsured patients served by health centers and 340B programs may indicate that access to affordable prescription medications for uninsured patients relies heavily upon the patient’s state of residence.

Areas of opportunity were identified for increasing access to affordable medications and include expanding these programs to states that are comparatively underserved. Specifically, although the ACA Community Health Center Fund has increased FQHC funding significantly (a 62.3% increase from 2012 to 2016), it may be advantageous to: 1) focus funding on FQHCs located in states that did not expand Medicaid in order to ensure access to affordable medications and 2) focus on resources, including technical assistance as outlined in the HRSA PSSC program, or funding to FQHCs in states that have not initiated 340B programs. Fewer than 80% of FQHCs in Nevada, DC, Vermont, California, Louisiana, Indiana, and Idaho (ranked in order from least to greatest percentage of FQHC 340B programs) operated 340B programs. Further, it may be beneficial to focus resources on FQHCs in states that have low 340B program-to-FQHC patient ratios. The lowest ratios were in states where there is only one 340B program per 1000 or more FQHC patients, ranked in order of lowest ratios: DC, Alaska, Montana, Missouri, New Mexico, Nevada, Hawaii, Wisconsin, Colorado, and Alabama.

One study limitation of the DID analysis was that there were only 2 years available for the pre—Medicaid expansion UDS data, 2012 and 2013, to be included in the pre-policy period for the evaluation. Although UDS data are available for years prior to 2012, the format of the publicly available UDS data does not include the health center–level data that were used for this study. Additionally, the study assumed that the data relating to the price of prescriptions in 340B programs and PAPs found in the literature review apply to all health centers with 340B programs and PAPs currently and across the country.

Despite changes in the healthcare access landscape due to the ACA, underinsured populations being served by FQHCs remain significant, and the need for financial assistance with medications persists. FQHCs are uniquely situated to provide access to these essential services. Both the HRSA 340B program and PAPs are important tools with which FQHCs continue to serve their uninsured patients: The 340B program requires drug manufacturers to provide outpatient drugs to eligible healthcare organizations and covered entities at significantly reduced prices, and the drugs are then provided to indigent patients through contracts with retail pharmacies or direct provision, and PAPs rely on pharmaceutical manufacturer donations of reduced-cost medications or coupons, which are then distributed to patients through a need-based system. This study substantiates that further policy and funding efforts to assist FQHCs in fulfilling the role of prescription safety-net provider should be encouraged.

 Department of Global Health Management and Policy, Tulane University School of Public Health and Tropical Medicine (LS, MKW, AM), New Orleans, LA.

 The authors report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

 Concept and design (LS, MKW); acquisition of data (MKW); analysis and interpretation of data (LS, MKW, AM); drafting of the manuscript (MKW, AM); critical revision of the manuscript for important intellectual content (LS, MKW, AM); statistical analysis (MKW); provision of patients or study materials (MKW); administrative, technical, or logistic support (MKW); and supervision (LS, MKW).

 Lizheng Shi, PhD, MSPharm, MA, Tulane University School of Public Health and Tropical Medicine, 1440 Canal St, Ste 1900, New Orleans, LA 70112. Email: lshi1@tulane.edu.

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Primary Care: America’s Health in a New Era

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8. Katz AB, Felland LE, Hill I, Stark LB. A long and winding road: federally qualified health centers, community variation and prospects under reform. 

The role of federally qualified health centers is evaluated in serving uninsured patients and providing need-based, reduced-cost prescription medications in the post–Affordable Care Act landscape.

Ensuring Access to Prescription Medications in the Post-ACA Healthcare Access Landscape: The Essential Role of FQHCs in the Safety Net for the Underinsured

For most of us, it would be hard to imagine skipping meals, defaulting on our mortgages, or taking only half of the required dose of our critical medication because the deductibles, co-pays, and coinsurance for our prescriptions are unaffordable.

Unfortunately, this is a reality for thousands of middle-class Americans living with life-threatening, chronic, and rare diseases who have health insurance, but whose incomes fall between 150% and 400% of the federal poverty level. These individuals often are forced to make impossible financial choices in order to survive. Many of them are Medicare beneficiaries. A recent Kaiser Family Foundation report showed that, in 2015, 3.6 million Medicare beneficiaries with Part D coverage had out-of-pocket (OOP) drug costs above the catastrophic threshold of $6680. Of these, more than 1 million did not qualify for a federal low-income subsidy to protect them from high OOP drug costs, and the number of these individuals has more than doubled since 2007.

Access to medically necessary healthcare is critical for successful patient outcomes, yet it is often impeded or blocked entirely by cost sharing—healthcare expenses that insurers don’t cover and that must be paid out of pocket by the patient. Despite its value as a tool to limit discretionary healthcare spending, cost sharing can create overwhelming barriers between patients and medications, diagnostic tests, office visits, surgeries, and other needed services. There are significant concerns that cost sharing limits access to critical treatment for economically vulnerable patients and families. And because of benefit designs that penalize the use of expensive medications, even when there are no less-costly alternatives, and place no limits on unreasonably high OOP costs, the problem of skyrocketing deductibles and coinsurance falls disproportionately on the most seriously ill patients.

Independent charitable patient assistance foundations like the Patient Access Network (PAN) Foundation are among the only places to which Medicare beneficiaries can turn for financial assistance for their prescription medications. However, these charities are just a finger in the dike. The problem will continue to grow until policy makers address the underlying factors that contribute to high OOP costs, including excessive cost sharing, unnecessary administrative costs, and, of course, the high price of specialty medications and treatment. Until then, independent charitable patient assistance programs will continue to play an essential role in ensuring that hundreds of thousands of patients get the care that they need.

With the issue of rising OOP costs setting the stage, the PAN Foundation is pleased to have continued our partnership with 

) for the third year to have together sponsored the 2017 PAN Challenge. The PAN Challenge comprised a call for papers, issued in summer 2017, titled “The Patient Assistance Safety Net: How Many Need Help? How Many Are Helped?” This national competition solicited papers that addressed the need for patient assistance, the size of the safety net, or both; described the research conducted to analyze and quantify the need for patient assistance and/or the size and characteristics of the safety net; identified the population and specific medical conditions researched, if appropriate; and proposed recommendations to address the need for patient assistance and gaps in the safety net.

The 2017 PAN Challenge winning paper, “Ensuring Access to Prescription Medications in the Post-ACA Healthcare Access Landscape: The Essential Role of FQHCs in the Safety Net for the Underinsured”; the runner-up, “Impact of Trained Oncology Financial Navigators on Patient Out-of-Pocket Spending”; and the honorable mention, “A Descriptive Study of Patients Receiving Foundational Financial Assistance Through Local Specialty Pharmacies,” are featured in this supplement. We hope that these papers will foster conversations about how to rein in OOP costs to eliminate barriers between patients and their critical medical treatments.

1. One million Medicare Part D enrollees had out-of-pocket drug costs above the catastrophic threshold in 2015 [news release]. Washington, DC: Kaiser Family Foundation; November 7, 2017. kff.org/medicare/press-release/one-million-medicare-part-d-enrollees-had-out-of-pocket-drug-costs-above-the-catastrophic-threshold-in-2015. Accessed November 7, 2017.

INTRODUCTION

This supplement showcases the winning papers from the PAN Challenge, which aimed to foster conversations about how to rein in out-of-pocket costs to eliminate barriers between patients and their critical medical treatments.

Rising Out-of-Pocket Costs Threaten an Already Vulnerable Population: An Introduction to the PAN Foundation and AJMC® Collaborative Supplement

 To describe the population of patients who received financial assistance from the Good Days Foundation (GDF) as facilitated by Walgreens local specialty pharmacies (LSPs).

 This was a retrospective descriptive study.

 This study used a joint foundational and pharmacy claim database between January 1, 2014, and December 31, 2016.

Among 1572 eligible patients who received GDF financial assistance as facilitated by Walgreens LSPs, 1524 had disease state information and 14 of these patients receveived financial assistance for 2 disease states (patient count denominator, 1538). The top 3 disease states by patient count were oncology (1403; 91.2%), multiple sclerosis (49; 3.2%), and hepatitis C (39; 2.5%). Of the 777 patients who had complete data and disease state information, 2 received finanical assistance for 2 disease states (denominator, 779); oncology remained the disease with the highest patient count (724; 92.9%). The mean annual financial assistance per patient was highest for hepatitis C ($4156), followed by oncology ($3603) and miscellaneous/rare disease ($1829), which covered 98.8%, 99.3%, and 99.6% of these patients' total co-pay requirements, respectively. In addition to prescription co-pay assistance, 21 patients received travel assistance of $554 per year per patient from GDF. The mean persistence of oncology patients was 170.7 days without a 30-day gap over 1 year of observation time.

The facilitation of treatment by GDF and Walgreens LSPs may be the key to many patients receiving their treatment and maintaining medication persistence. GDF co-pay assistance helped cover most out-of-pocket costs associated with medications and aided with travel expenses for patients, especially in the area of oncology. For many patients, this meant reducing the significant financial barriers to accessing care and facilitating the necessary treatment for their chronic or life-altering disease. Without this assistance, many patients would simply not have been able to meet the expected medication persistence and thus would have received suboptimal treatment.

Am J Manag Care. 2018;24(5 Suppl):S80-S84

A collaboration between the Good Days Foundation and Walgreens local specialty pharmacies may have been crucial in saving lives, preventing financial ruin, and supporting patient medication persistence. For patients dealing with chronic or life-altering diseases, the assistance and support provided through this collaboration included:

Providing hope when it was needed the most.

Extending life and allowing more time with loved ones.

A viable option for dealing with the reality that insurance, including Medicare, does not always cover everything related to treatment needs.

An alternative to reduce rising out-of-pocket costs and improve the ability to afford both treatments and the necessities of everyday living.

Numerous studies have demonstrated that higher co-pay, coinsurance, and out-of-pocket (OOP) costs can lead to medication underuse and lower adherence.

 This lack of adherence is associated with poor clinical outcomes and greater cost of care.

 The rates of cost-related medication underuse tend to be greater among patients with lower incomes, higher OOP prescription drug costs, and less generous prescription benefits.

Specialty medications are typically more expensive than other medications, potentially making cost a barrier to patient adherence.

 In 2015, specialty drugs accounted for 36% of the $428.8 billion total spending on medicine and 75% of new drug spending growth.

 The high costs of these medicines are known to be related to medication nonadherence among patients,

 which could eventually lead to more significant burden to the healthcare system.

Given that medication underuse or nonadherence could lead to serious health consequences, some researchers and policy makers have suggested that selectively lowering patients’ prescription costs might improve adherence and decrease the overall cost of their care.

 For example, first-dollar coverage of angiotensin-converting enzyme inhibitors appeared to reduce costs for Medicare beneficiaries with diabetes and extend their lives.

 Lowering OOP drug costs for people with chronic diseases could save money for patients and third-party payers directly and reduce medication costs indirectly by achieving better clinical outcomes for patients. A prospective cohort study by Schoen et al

 examined the impact of a financial assistance program on clinical outcomes and drug adherence among uninsured or underinsured indigent patients with cardiovascular disease. After receiving 6 months of financial assistance, the study found an increased mean international normalized ratio among patients receiving warfarin, a lower mean diastolic blood pressure among patients with hypertension, and decreased mean low-density lipoprotein level among patients receiving free lipid-lowering drugs. The program was also shown to reduce hospitalization events and improve drug adherence.

The high cost burden of drugs could be reduced if patients are able to take advantage of financial assistance programs offered by nonprofit organizations, foundations, and pharmaceutical companies.

 Unfortunately, study findings have shown that only a small percentage of patients reporting cost-related adherence problems were given information from their clinicians about such programs.

Walgreens local specialty pharmacies (LSPs) have collaborated with multiple assistance providers, such as the Good Days Foundation (GDF), to help overcome financial barriers to medication use for patients.

 Key steps taken by Walgreens LSPs included identifying those patients who were at risk of not filling their prescriptions due to financial barriers, evaluating patient eligibility, coordinating with assistance providers like GDF, and matching patients to the appropriate sources of financial assistance.

Since 2003, GDF has provided financial assistance to eligible patients who cannot afford their medications and established individual funds for more than 30 disease states. In addition to co-pay assistance, GDF also offers programs to provide premium and travel assistance for patients in need. Based on donations received, the premium assistance program provides assistance to cover the monthly insurance premium of eligible patients with any of the following conditions: chronic granulomatous disease, nephropathic cystinosis, severe malignant osteopetrosis, and urea cycle disorder. Premium assistance is also offered to the patient’s dependents when applicable (eg, if the patient is a minor, it is offered to the patient’s guardian as part of a family plan). The travel assistance program provides assistance to eligible patients who need help with their travel-related expenses for diagnosis-related treatments. These expenses include public transportation (eg, bus, taxi, or train), parking, gas, tolls, rental cars, hotels, airfare, and meals, when applicable. GDF also makes all travel arrangements and stays in contact with the patient, physician, and/or hub case manager (ie, an individual who helps patients navigate payer access and patient assistance services) throughout the course of the patient’s therapy

Based on the previous discussion and aforementioned gaps in the literature, we identified 3 key study objectives: characterizing the study population overall and by disease category, estimating OOP cost savings of the study population overall and by disease category, and describing medication persistence.

This was a retrospective cohort study using joint administrative data from both Walgreens and GDF from January 1, 2014, to December 31, 2016. Our study sample included patients who were 18 years or older, had filled at least 1 medication, and had received financial assistance from GDF as facilitated by Walgreens LSPs. The GDF approval process is shown in the 

). To qualify for financial assistance from GDF, the following criteria must be met: patient must be diagnosed with a covered disease and program must be accepting enrollments; patient must have a valid Social Security number to apply for assistance and receive treatment in the United States; patient must have valid medical insurance with at least 50% coverage of the costs of treatment, excluding deductibles; patient must be seeking assistance for a prescribed medication that is approved by the FDA to treat the covered diagnosis; and patient income level must be at or below 500% of the federal poverty level (FPL) based on household size.

 Several types of financial benefits were measured for the 3-year period by disease state: mean annual original OOP costs, mean assistance amount received per patient, mean annual OOP costs after foundational co-pay assistance, mean annual co-pay assistance received as a percentage of mean annual original co-pay cost (OOP cost plus insurer cost was calculated), and mean annual amount of other types of assistance (ie, travel or premium assistance) during the study period.

 Persistence was defined as “the duration of time from initiation to the discontinuation of therapy”

 and was measured by time in days. Patients were considered to have discontinued the adequate regimens if a gap in therapy of 30 days or more occurred. Patients were included in the persistence analysis if they were in possession of adequate regimens for 30 days or more or if they had at least 30 observation days. 

All statistical analyses were performed using SAS Enterprise Guide 7.1 (SAS Institute Inc; Cary, North Carolina).

 summarizes the demographic characteristics of 1572 eligible LSP patients who received GDF assistance. Per eligibility requirements, all patients had an income at or below 500% of the FPL based on household size. The mean annual per capita income was $19,159 (SD = $17,156). The majority of patients were 65 years or older (85%), and half of them were female (51%). Among the 1559 patients with insurance information available, most (92%) had Medicare Part B or D. Most patients (91%) were receiving assistance for oncology medications. Across patients, the average initial co-pay of $728 per patient per year was reduced by an average of $722 in financial assistance to yield an average final co-pay of $6. Due to the complexity of the data captured in 2 systems (Walgreens and GDF), approximately half of these patients (777) had consistent cost data between data systems (see the second column of Table 1). Characteristics of this subset of patients were similar to the larger sample.

 provides the average co-pay before and after financial assistance, as well as the proportion of costs covered by financial assistance for the subset of patients with consistent cost data between data systems. The top 3 disease categories by patient count were oncology (93%), hepatitis C (4%), and miscellaneous/rare diseases (2%). Among the oncology patients, the top 3 cancers were multiple myeloma (43.2%), liver cancer (19.3%), and non—small cell lung cancer (12.6%). The mean financial assistance per patient was highest for hepatitis C ($4156), followed by oncology ($3603), miscellaneous/rare disease ($1829), and multiple sclerosis ($1439), which covered between 99% and 100% of total co-pay requirements. After receiving financial assistance from GDF, the mean patient co-pay ranged from $0 to $51 per patient per year.

In addition to this prescription assistance, some patients received other types of financial aid from GDF, such as premium or travel assistance. Within the study population, 21 received travel assistance, averaging $554 per patient per year. None of the patients in this study population received premium assistance. Furthermore, oncology patients persisted, on average, 170.7 days without a 30-day gap over 1 year of observation time.

Our study results indicate that, without assistance programs, the financial burden of medications for complex diseases like oncology and hepatitis C was very high among individuals who were underinsured, especially the Medicare population. Our findings show that a high proportion of this financial burden in our study population was covered by co-pay assistance, leading to lower OOP costs for patients.

Of note, the majority of our study population in this analysis had cancer and were Medicare beneficiaries with low family incomes. According to findings of a study conducted by Narang and Nicholas from 2002 to 2012,

the mean annual OOP costs of cancer therapies ranged from $2116 to $8115 among Medicare beneficiaries

; other reports indicated that the median income of the Medicare population was less than $24,150.

 As such, the burden of OOP spending relative to patient income was very high, which is consistent with the findings of this study.

This financial burden can lead to patient noncompliance with therapy.

 According to the findings of a study by Starner et al,

 an OOP expense of $250 was considered the point at which patients were much more likely to abandon costly therapies, including biologic anti-inflammatory drugs and drugs for multiple sclerosis (

 = .09 compared with the reference group, $0-$50), in the majority of cases. A significantly higher abandonment rate was detected when monthly OOP expenses were $500 or more (

<.001). Co-pay assistance programs have been developed to address this and help patients overcome financial burdens. In our study, co-pay assistance covered most OOP patient costs; the mean annual patient OOP cost decreased to $0 to $51 with the foundational co-pay as facilitated by Walgreens LSPs, which might have helped decrease the medication abandonment rate.

As is the case with other observational studies using administrative data, this study had some limitations. First, data were limited to 1 pharmacy chain. If a patient visited another pharmacy, it would not be reflected in Walgreens’ pharmacy claims; thus, persistence rates in this study may be underestimated. Second, the results of this study were descriptive because we could not compare eligible patients who received financial assistance with those who did not. Third, physician discontinuation of a drug regimen might have been misclassified as nonpersistence. Finally, the administrative data were not collected for research purposes, resulting in data inconsistencies that hampered a complete analysis dataset.

Financial assistance through the collaboration between Walgreens LSPs and GDF contributed to dramatic reductions in patients’ co-pay burden. As of late 2016, the total underinsured population in the United States had doubled since 2003 to 41 million individuals.

Local specialty pharmacies collaborated with a charitable assistance organization to provide a safety net and to facilitate care for patients with chronic illnesses, allowing them to focus on receiving and adhering to medication, rather than on financial toxicity.