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Ensuring Access to Prescription Medications in the Post-ACA Healthcare Access Landscape: The Essential Role of FQHCs in the Safety Net for the Underinsured
Lizheng Shi, PhD, MSPharm, MA; M. Kristina Wharton, MPA, MPH; and Alisha Monnette, MPH
A Descriptive Study of Patients Receiving Foundational Financial Assistance Through Local Specialty Pharmacies
Julia Zhu, MPH, MS; Randall Odebralski, MBA; Safia Boghani, MPH; Clorinda Walley; Frank Koen, RPh; Chad Conley; and Heather S. Kirkham, PhD, MPH

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

Lizheng Shi, PhD, MSPharm, MA; M. Kristina Wharton, MPA, MPH; and Alisha Monnette, MPH
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.
ABSTRACT

Objectives:
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.

Study Design: 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.

Methods: 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.

Results: 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.

Conclusions: Despite 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
Takeaway Points
  • 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.1 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.2-4 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.5,6 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 2010,7 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.8,9 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.7 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.7 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.10 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.

BACKGROUND

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,10 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.11

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.12 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.13 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,14 improving access to asthma medication and treatment plan adherence among uninsured Spanish-speaking Hispanic patients,15 and improving cancer medication access in conjunction with partner Disproportionate Share Hospital systems.16,17

PAPs in Community Health Centers

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,18 and their utilization has been proven to decrease patient prescription expenditures for the uninsured,19 in particular for high-cost medications, such as cancer treatments.20

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.18 More than 53% of the top 200 prescriptions were offered via PAPs to qualifying indigent patients through manufacturers.19 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.18,19

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.21 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,22 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.

METHODS

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).

 
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