Community Health Center 340B Program: A Qualitative Study of the Experiences of Patients with Diabetes

Abstract

Background: The 340B Drug Pricing Program provides discounted drug prices to safety-net entities which help stretch scarce resources to expand comprehensive services and treat more vulnerable patients. The program has received criticism questioning whether the original intentions are being accomplished.

Objective: This qualitative study aimed to understand lived experiences of patients accessing high-cost injectable diabetes medication(s) through a 340B Prescription Cash Discount Program (PCDP) provided at a community health center.

Methods: This qualitative study utilized semi-structured individual interviews. We invited patients ≥18 years old with diabetes for >1 year who utilized the 340B PCDP to fill an injectable diabetes medication at least twice between 3/1/2020-3/1/2021 to participate. Trained personnel interviewed ten participants in 11/2021-2/2022 and completed thematic analysis of the transcribed interviews.

Results: Themes included 340B feedback, benefits of 340B, consequences of being without 340B, community pharmacy experience, and use of other services. Participants deemed the 340B program as a “lifesaver.” Perceived benefits of the program included improved diabetes control and savings that made their prescriptions more affordable. Consequences of being without the program include that medication was too expensive to take as prescribed and rationing/skipping doses. Participants were pleased with the accessibility of the network of contract pharmacies and described benefiting from services supported by 340B savings.

Conclusions: Recent criticisms question whether the 340B program accomplishes its original intentions of stretching scarce federal resources to help safety-net entities expand services and treat more patients. This study provides insight into the personal impact of the 340B program on underserved patients with chronic disease accessing high-cost medication(s). Findings highlight crucial strengths of the program from the patient perspective, which policymakers and other stakeholders should consider to provide support for the continuation of these services.

Objectives/Introduction

The federal 340B Drug Pricing Program (340B Program) provides discounted drug prices to safety-net entities which help them stretch scarce resources to expand comprehensive services and treat more vulnerable patients. The trend of rising drug prices continues to shake the healthcare space. It is estimated that the national spending on glucose-lowering medications increased by 240% ($16.9 to $57.6 billion/year) in 2015-2017 compared with 2005-2007. Over the same period, there was a 38% increase (15.3 to 21.1 million) in the number of people using glucose-lowering drugs and a 147% increase ($1,106 to $2,727) in the average annual cost/user.¹ Some of the highest costs are associated with insulin for which prices have increased >200% between 2008-2017.² Cost-related underuse affects almost 25% of patients prescribed insulin for diabetes.³ The increasingly high cost of diabetes medications can be a barrier for patients in achieving glycemic control and preventing complications. The ability to afford medications is directly related to economic stability, which is one of the social determinants of health⁴ (SDoH). SDoH affect an individual’s risk of developing diabetes and their ability to achieve glycemic control.⁵ Those with lower income and lower education are 2-4 times more likely to develop diabetes and those facing economic instability are less likely to have control of their diabetes.⁵ Community health center (CHC) patients are disproportionally affected by SDoH. In 2020, greater than 90% of CHC patients nationwide had incomes ≤200% of the Federal Poverty Level (FPL).⁶ Without CHCs, many of these patients would not be able to access healthcare.

CHCs were established to address barriers to optimal healthcare for the nation’s most vulnerable populations.⁷ A CHC is considered a safety-net entity because it is a “non-profit that provide(s) access to services without charge or using a sliding scale to low income and vulnerable patient populations”.⁸ To address economic barriers, eligible safety-net entities, can enroll in the federal 340B Program as a covered entity (CE) and receive discounted drug pricing which helps stretch scarce federal resources to reach more patients and provide more comprehensive services. The 340B Program requires pharmaceutical manufacturers who wish to participate in Medicaid and Medicare Part B to provide covered outpatient drugs at a discounted price to CEs. The program has a two-pronged approach: (1) a CE may provide uninsured / underinsured patients with a significant discount on their medications and (2) for insured patients, a CE can replenish the drug at a discount and the savings generated will be reinvested into patient care.^8,9 A recent meta-analysis demonstrated that 340B-affiliated organizations have expanded resources and offered more services in more locations, which provides indirect benefits to patients by increasing access to comprehensive healthcare services.¹⁰ Additionally, a national review of dispensing records at 340B contract pharmacies showed that the medications dispensed address the general chronic disease burden of the U.S. population,¹¹ illustrating that the program meets the needs of the vulnerable population it was intended to serve.

While several benefits of the 340B Program have been demonstrated, there are also criticisms and conflicting studies. Some studies claim that the 340B Program favors hospitals that disproportionately serve low-income patients and does not require them to repurpose financial gains to improve care for the underserved in ways that would expand care or lower mortality.¹² The debate over the validity and prevalence of this claim is ongoing. Although most criticisms are related to hospital (non-grantee) entities, grantees (e.g., CHCs) and their patients are caught in the crossfire and significantly affected by the attacks on 340B which have led to threats to the program. For CHCs, it is by law, statute, and mission that they use all savings resulting from their participation in 340B to expand their patients’ access to care.⁶ For example, CHCs may reinvest 340B savings to support medication access. The standard 340B discount is 23% off the list price for brand-name drugs and 13% off for generics.¹³ Any larger discounts occur only when the manufacturers raise a drug’s list price (retail, non-340B price) faster than inflation.⁸ Often, a drug’s 340B price is still too high for a low-income patient to afford. In these instances, a CHC may absorb much of the cost to ensure that the patient can access the medication – demonstrating additional assistance in a patient’s healthcare journey.

With the recent criticism around this federal policy and the criticism’s consequential impact on patients within CHCs, it is important to holistically understand patient perspectives as they provide valuable insight that should be used to guide healthcare decision making and can further inform stakeholders on this debate.¹⁴ To our knowledge no studies have been done to gather patient perspectives of the personal impact of the 340B Program and whether it is meeting its intended goals in the CHC setting. This study aims to understand the lived experiences of underserved patients prescribed high-cost injectable diabetes medication(s) who received those drugs through a 340B prescription assistance program provided at a CHC.

Methods

Study Setting

We performed this study at PrimaryOne Health (P1H) in collaboration with The Ohio State University (OSU) College of Pharmacy and OSU’s institutional review board provided approval. P1H is a CHC and level 3 patient-centered medical home (PCMH) serving >44,000 individuals in culturally and socioeconomically diverse areas. P1H offers comprehensive, interprofessional primary care services, including physicians, nurse practitioners, nurses, pharmacists, dietitians, behavioral health, vision, dental, women’s health, substance use disorder, psychiatry, physical therapy, and more.

One of the ways P1H serves vulnerable patients is through its 340B Prescription Cash Discount Program (PCDP). This assistance program is an opportunity to pass 340B discounts directly onto patients who are uninsured/underinsured. P1H uses contract pharmacies to provide 340B discounts as it does not own any pharmacies and serves patients spread across over 200 zip codes. For prescriptions where the 340B discount is still too costly for low-income patients to afford, P1H absorbs some of the cost beyond the standard 340B discount to ensure that the patient can access the drug. This is done by subsidizing the cost for patients that meet certain income requirements (≤200% FPL, enrolled as a person experiencing homelessness, and/or enduring circumstantial financial hardships).

This qualitative study explored the lived experiences of patients enrolled in the 340B PCDP for injectable diabetes medication(s) via one-on-one semi-structured interviews. We identified potential participants using P1H’s 340B PCDP database which was cross-referenced with the electronic health record to obtain demographics including age, gender, race, ethnicity, diabetes type, preferred language, and contact information. Patients qualified to participate in an interview if they were ≥18 years old, utilized the 340B PCDP to fill a prescription for an injectable diabetes medication at least twice from 3/1/2020-3/1/2021, and had a diabetes diagnosis for >1 year since the first qualifying prescription. Our study excluded patients if they were not comfortable completing the interview in English as this was necessary to obtain consent and fully understand/answer the questions appropriately.

We extended invitations to participate in the study in a systematic order with purposive sampling. Purposive sampling allowed investigators to identify participants that had experience using the 340B PCDP and were able to communicate their lived experiences. We extended invitations in-person at clinic, via telephone, and via e-mail. The study team enrolled participants on a first-come basis and obtained both written and verbal consent for participation.

A trained member of the research team interviewed ten participants individually. The interviews occurred at P1H in a private clinic room and lasted up to 60 minutes. Personnel utilized an interview guide to gain further insight regarding patients’ financial experiences, access to healthcare, engagement in care, and disease state control. We audio recorded and transcribed the interviews through Zoom¹⁵ and the interviewer reviewed and corrected transcripts before analysis. Participants received a thirty-dollar grocery store gift card and five-dollar gas card.

For further insight, we reviewed participant fill history for injectable diabetes medication(s). The study team recorded fill date, day-supply, wholesale acquisition cost (WAC), and patient cost for each fill during the study period and six months after the second fill of the qualifying medication(s). We collected quantitative data for triangulation to understand the extent of savings passed on to participants.

Data Analysis

To identify common themes across participant responses, we completed thematic analysis of the ten transcribed interviews using an inductive coding approach. Three investigators independently analyzed transcripts from the first three interviews line-by-line to develop draft open codes. Then, the three remaining investigators reviewed the responses from each of the three interviews to reach an agreement on a single set of open codes before independently applying them to subsequent responses. A codebook of the single set of open codes, and their definitions, was created in Microsoft® Excel¹⁶ and we compared coding decisions for the remaining interviews to ensure a collective agreement was reached for interpretation of open codes. For any new themes, we developed a new open code and discussed with all members of the research team. Saturation was determined when no new themes were identified and study team was agreeable to extend enrollment until saturation was met, if applicable. Once all interviews were coded using the initial open codes, similar themes were grouped into higher level category codes. We also analyzed prescription fill history data using descriptive statistics.

Results

The study team conducted ten individual interviews included in data analysis. Most participants had type 2 diabetes (90%) and half of participants were at 200% or below the FPL. Participant demographics can be found in Table 1. Prescription fill history data showed that participants saved an average of $1,011.14/prescription over a six-month period when using the 340B PCDP based on the difference between patient out-of-pocket cost (average $13.58/prescription) and WAC ($1,024.72/prescription).

Table 1:

Participant Demographics Source/Notes: Authors’ analysis of study data.

Participant Demographics		n = 10
Age, years – mean ± SD		56 ± 10.2
Gender – n (%)	Female	9 (90)
	Male	1 (10)
Race/Ethnicity – n (%)	White	2 (20)
	Black or African American	4 (40)
	Hispanic or Latino/a/x	4 (40)
Diabetes Type – n (%)	Type 2	9 (90)
	Type 1	1 (10)
200% or Below the Federal Poverty Line – n (%)	Yes	5 (50)
	No	5 (50)

During the interviews, the most common reasons mentioned in conversation for utilizing the 340B PCDP included being uninsured (n = 2), underinsured (n = 2), losing a job (n = 2), and losing insurance coverage (n = 2). Three participants mentioned more than one reason for utilizing the 340B PCDP.

Participants reported a variety of experiences utilizing the 340B PCDP for their injectable diabetes medication(s). Five themes emerged from the study data: 340B feedback, the benefits of 340B, consequences of being without 340B, community pharmacy experience, and use of other services. A full list of illustrative quotes for each theme, and corresponding open codes can be found in Table 2.

Table 2:

Themes and Illustrative Quotations from Participant Interviews Source/Notes: Participant interview responses.

Themes (Category Codes)	Open Codes	Example Illustrative Quotations
340B Feedback	340B Positive Remarks: Participant emphasizes positive remarks and impressions of 340B participation.	“If anything could be said about assistance, the 340B is greatly needed. And until you need something, you don’t realize the importance of it and this program needs to never go away.”
		“I would say that my experience with the card has been… life changing… All I can say is that it made such a difference. So many prescriptions… Well as far as I’m concerned there’s no downside for me. It’s a Godsend. You know I appreciate it.”
		“It has been a blessing.”
		“For me it is a really good help.”
		“It’s a program that will help with medications designed to fit your budget.”
		“It’s just that I feel that it’s a big help for me and to use it is a big discount off the medicine. Other way I don’t know what other help I would go through.”
		“Life saving. Life changing.”
		“… It’s good for people like me. Make me feel good because I can be healthy.”
		“[340B provides] access to your means of medication that you need to maintain the quality of life.”
		“I think it’s a blessing to be able to use. To not have to use the excuse to withdraw from being able to get your goals done for your health.”
	Referring: Participant has referred other vulnerable patients or was referred themself to CHC for 340B program assistance.	“Certain medications that copays were out of reach for them [family members] so I told them about this [340B].”
		“This clinic because you know they have a program and you don’t have to pay all this much. So, I give them their address. I don’t know if they came or not…And the pharmacist was trying to talk to them to see if they were going to get it or not. Like woah that’s a lot of money. And then they asked me if I speak English, and I tried to help. So, I was like I mean not a lot but I can understand. And then I was like there is a clinic that I go to. And then you know went through their phones and give them their phone numbers. I was like… they will take care of you. They will send you your medicine. I mean they will do it and then you just have to pick it up…Yeah, I was like I mean if you don’t need it right now like really bad then you just go to the clinic and you will get a big discount. I mean you are gonna not even pay half of it.”
		“Yeah, so my daughter’s friend works for a different PrimaryOne [Health location] and she told me to come here and try to get some kind of help.”
		“Someone that I was working with started and our insurance was not that great. And because she had children it just wasn’t affordable through the employer, and I gave her the number and they were able to get on the [340B] program. So, three children and an adult were able to benefit.”
		“One of them I know has blood pressure issues. And she would always say ‘oh I know my blood pressure is high but I don’t have any money.’ So, I tell them go to the one on Agler primary care. And there was someone that came here for OBGYN. But yeah, it’s helped.”
	340B Formulary Change: Participant’s diabetes medication(s) affected by fluctuating changes in what affordable 340B drug products are available on 340B formulary.	“Um no yeah just because of that the 340B I had to use… [name of insulin brand].”
		“But with the injections I don’t know last year I was using [name of insulin brand] and that wasn’t covered [by 340B].”
		“Under [insulin #1] it was anywhere from 6.5 to 7 [referring to hemoglobin A1c %]. Three times in a row it’s been at 10 since I’ve gotten off [insulin #1] and all they can probably do for me is to increase my nighttime insulin with [insulin #2 (the replacement)]. But then what happens is it tends to run low because I don’t know when it peaks and it’s just very sad.”
Benefits of 340B	Affordable: Participant discusses savings received through 340B on injectable diabetes medication(s) making prescriptions more affordable.	“I thought I had won the lottery actually [referring to when found 340B program to use on medication].”
		“And then after coming here everything seemed to slim down as far as I am able to afford my medications now.”
		“No, your insurance is charging you $55 let me see…let’s run through 340B. Then they give through 340B and they give to me for $12.”
		“Yeah, yes so total life changes yeah you know, the fact that I have a [340B] card which makes it [medication] financially feasible for me to use.”
		“And then it was suggested that I use the prescription card [340B card] which I did, which brought the savings down tremendously. So yeah, it’s been a really big factor in me being able to keep that medication.”
		“But I mean, even if I have to pay a little bit out-of-pocket [with 340B], I mean it’s better than $1600 a month.”
		“The discount helped because I know I don’t have an excuse not to get treated. Because before the excuse was like ‘oh, you can’t afford it’.”
	Improved Diabetes Control: Participant notes 340B participation has contributed to improved diabetes/glycemic control.	“When I first started coming to PrimaryOne my A1c was up around 11[%]. And now it’s down close to lower eights almost to seven. It has went down to 7 one time. It went back up but I’m hanging on and trying my hardest to keep it down.”
		“I haven’t needed to go to the emergency room. Just my regular checkups at the doctor. So, I think it’s really helped. Having the medication, that [340B] card really helps to be able to afford the medications. So, it cuts down on having to do extra things like go to the doctor because it’s out of range.”
		“I think it’s [340B] probably made all the difference for me managing my diabetes. Plus, without the insulin I’m not sure what the outcome would be.”
		“There’s no way that, even if I tried to eat a right diet, and it wouldn’t be enough to allow me to be able to get my blood sugars down to a manageable level to be able to function on a daily basis [in regards to control with vs. without access to injectable medication].”
	Health Improvements: Participant mentions improvement in health outside of diabetes.	“Yeah, that’s it. In fact, my blood pressure has went down also [since having access to 340B].”
		“Health wise, I think it has changed. I mean I feel better. Um since losing weight and taking medications as prescribed, I do feel better overall [since having access to 340B].”
		“Without insulin I would definitely have more yeast infections…so yeah because the [340B] card being able to afford my insulin everything’s I’m just yeah my overall health is a lot better.”
		“And I think that the 340B has allowed me to get access to those, you know, medications that give me a better quality of life.”
	340B Provides Stress Relief: Participant mentions less stress due to participation in 340B program.	“Sometimes despite best efforts, a type 1 diabetic will have to have an amputation, will go blind, will have a stroke, will have a heart attack. And that’s with insulin. So, I can only imagine without the access to the insulin and the stress that goes with that…what a horrendous life I would have.”
		“So, I’m overwhelmed you know about how I’m going to do this [afford medication]. PrimaryOne has helped.”
		“Less stress. Oh yes, that made me feel a little bit more… like ‘okay if I don’t have insurance, I can get it 340B. And it’s there for me’.”
		“There are no issues. I’m not stressed about trying to come up with money to get it [since using 340B].”
		“Yeah, so not having to worry about cost [with 340B].”
		“I mean its [340B] helped me. And I think its took off a lot less worry or stress on being able to get the medications.”
Being Without 340B	Medication Expenses: Participant mentions expensive injectable diabetes medication costs prior to or without 340B.	“So, when I went to the pharmacy, and it was like $500 … or $600. That’s too expensive. But then I come here [the CHC]. Yeah, it’s too expensive to get it from another place…In that moment it was like my paycheck.”
		“So, yeah everything’s not that cut and dry and then people don’t care. You know that’s my issue. You’re diabetic, you got $6,000 worth of medication you need. Um the pharmacist isn’t just going to dole out insulin.”
		“Um, very expensive. I didn’t think I was going to be able to do it because, being on social security and just not having enough money. So, I couldn’t afford it.”
		“One year I pay $800 for one. I think it was [name of GLP-1 agonist brand injectable] in that year…for one month. In that year for some reason, maybe insurance or maybe something happened, I stopped using.”
		“Because you know if you buy it at the regular price it’s expensive.”
		“… like $100. I think I paid the most I paid was two, almost $300 and I think that was for like three pens if I remember correctly. But I was working yeah like I said in sales [at the time]. So, anyway, I could afford it but it’s like who wants to pay every month.”
		“And I’m like right there in the middle, but then I don’t really have the funds to say that I could pay, you know that kind of money. Or, you know, I couldn’t even pay the entire half of the month for that prescription.”
		“Before that [340B] I was buying my prescriptions and they were really expensive.”
	Financial Responsibilities: Participant mentions having to postpone or choose between other financial responsibilities prior to or without 340B.	“I mean, you don’t have any money. You have bills and your bills don’t go away and your creditors don’t care that you’re diabetic. Or the electric company doesn’t care if you’re diabetic or nobody cares and it’s getting worse,”
		“I had to pay out-of-pocket probably around $50 for each flexpen or whatever and then the other one was like $36 or something on top of that so like $136. You know I have about $250 to live on.”
		“Oh yes, impact me a lot because we wasn’t having the money. And um, we had problems with money in that month. And I don’t remember but my husband he tried to get some money from the credit card or something. I think it as cash but was asking somebody to borrow and pay later.”
		“It was juggling of the bills [without 340B]. It was like well I gotta get this medicine, you know. Do I put off the car, no, no, it was you know you have to juggle. You gotta have your medication now. And it’s like my body is insulin dependent. Like I believe that it’s not as if I can go without it.”
		“So, it [medication prices without 340B] takes a toll out of being able to buy like the groceries, the healthier stuff.”
	Rationing or Skipping: Participant discusses skipping doses, rationing, or being without their medication(s)/supplies in an effort to extend day supply without/prior to 340B.	“Like I said one was like $1600 a month and I couldn’t afford it. So, I was to the point that I wasn’t going to take any insulin.”
		“[without 340B] I probably wouldn’t be using the [name of insulin brand] because I wouldn’t be able to afford it.”
		“When I first became a diabetic, I was using the vials of insulin and the syringes and I was informed that there are [people] that have to reuse their syringes…and I almost got to that point.”
		“Before coming here [going without injectable diabetes medication] happened every three or four months yeah. It was often yeah.”
		“Sometimes [I skipped doses because I couldn’t afford it]. I tried not to do it.”
		“Like you know skipping dosages and that kind of thing that would definitely would have to happen if I didn’t have the discount.”
		“And not taking the medication at one point. Because it was you know so high in cost.”
	Health Issue: Participant mentions negative impact on their health without/prior to 340B.	“I would have what I call a panic attack [when unsure of how going to obtain the injectable diabetes medication]. What am I going to do (gasp). What am I going to do (gasp). Ya know, I had to call the emergency squad once. I didn’t really know what a panic attack was at first. Thought I was having a heart attack.”
		“And we get a little bit of stress [without 340B], the sugar go up.”
		“[Referencing going without medication] So, I got lethargic. You know, just doing the best you can. Trying to still check my blood sugars. Making sure they didn’t get really high.”
		“[Referencing times going without medication] Miss work. I don’t feel good. I’m sleepy most of the time, or just tired. I don’t sleep well at night. I mean, I think that when my blood sugar is high I think my neuropathy is worse in my feet.”
Community Pharmacy Experience	Community Pharmacy Accessibility: Participant mentions being pleased with 340B-contracted pharmacy accessibility and/or having the choice to choose among that network.	“Where I pick it up is like right next door to where I work. So, it’s really convenient. Sometimes I may go to work early just to pick it up first and then go to work. As opposed to being anywhere else in the city to pick it up so it’s really convenient where I do pick it up.”
		“There is a [340B pharmacy] that’s by my house which is literally 2 minutes away. So, I’m going to go check them out today and see [about changing to them]. Because that’s just easier… and it just doesn’t work out when you have to go out of your way and you can just go right in your neighborhood.”
		“I am fortunate that the [pharmacy] near me honors it.”
		“You can call the pharmacist [at 340B pharmacy] and they can deliver my medication.”
		“Because I live very close to the pharmacy where I go to. It’s very convenient.”
		“They [PrimaryOne Health] always like give us a [340B] card I know for sure. They have a discount with the store or something like that. They always give us a choice of where to pick up the medicine.”
		“Actually, it’s close [the 340B pharmacy]. Five to seven minutes [from home].”
	Ease of Use: Participant describes using 340B as very easy, simple, patient-friendly, and/or having no issues.	“They have been a big help talking me through it. This would be cheaper if you went that way… going over the things with me… do you know you could take a generic brand, do you know it’d be cheaper if you took three months in advance… that kind of thing. So, you know my pharmacy has really been helpful.”
		“It’s not hard at all [to use 340B at a community contract pharmacy], because the pharmacy I go to are very helpful, very understanding, and they talk to me. and that’s what I like. They’re not just like come and get your order and leave.”
		“It’s easy [to use 340B].”
		“Very easy. No problems [using 340B].”
		“It was really easy to use the [340B] card.”
		“It’s been easy [using 340B] … I don’t have any issues when I go.”
		“It’s simple. You go and actually I feel it’s good. Never have any problems [using 340B].”
		“I’ve had a good experience [using 340B].”
	Contract Pharmacy Issue: Participant mentions a challenge using 340B Prescription Assistance Card at contract pharmacy.	“When I first started, I didn’t know that that [340B pharmacy] honored it and I went to another [non-340B pharmacy] and they weren’t really well-versed on how [340B] worked.”
		“At first, I did [have trouble using 340B] because we weren’t familiar enough with it to know whether I should be using it or not. So, it took a little bit longer to pick up my prescriptions. And you know I don’t know if they got upset…they didn’t get upset but I don’t know if they got, you know tired of me coming around. But we worked it out. They know everything goes through 340B if it can. And if not, whichever is the lowest cost [referring to the pharmacy’s available retail price].”
		“The one pharmacy call me and let me know like ‘… you have a prescription to pick up’ or ‘… it’s ready’. Which the other one doesn’t so I’m kinda like ‘… I don’t know what I have to pick up or when do I have to pick up’.”
		“[I got a call from 340B pharmacy] that said to come pick [medication] up. And then she [pharmacy staff] looks at it, and like ‘oh that was from last month.’ It’s like ‘okay I just got the call today’.”
		“I mean I have some issues; just like between they call over my prescription
		somehow in the translation to get over to the pharmacist and the pharmacist filling it. That I might have you know, a delay, but I mean it’s been pretty good.”
		“[The 340B pharmacy] will say ‘okay we will have it ready.’ And then you go back that day and they go ‘okay we don’t have it ready. I don’t know who told you that’.”
Use of Other Services	Nutrition Care: Participant has been seen at P1H for dietitian services or offered the opportunity.	“I was seen by the dietitians and at that time they had cooking classes and other classes I could take. So, I did and I learned a lot…”
		“[Dietitians] helped me at the beginning and I actually think I did good. I really liked it. With the dietitian I remember [the instructions for healthy lifestyle changes]. She give me this class and it was really nice. I [go] home and actually measure stuff and try to make healthy choices…”
		“Well, it went well [meeting with dietitian]. She [dietitian] gave me information over the phone. I learned a lot you know.”
		“I did try a little weight thing…and I went to [dietitian-run] classes.”
		“I guess the information that was given to me here by the dietitian. I work with the dietitian from here.”

340B Feedback

Participant feedback on the 340B PCDP was one theme and responses fell into three areas: positivity, referrals, and 340B formulary changes due to availability. When speaking generally about 340B, all participants emphasized positive remarks and impressions. When asked to describe the 340B PCDP in one sentence, many participants mentioned the program being a “lifesaver.” One participant said, “I would say that my experience with the card has been… life changing… All I can say is that it made such a difference.” and went on to say “Well as far as I’m concerned there’s no downside for me. It’s a Godsend. You know, I appreciate it.”

Many participants (90%) also acknowledged having referred other vulnerable patients or being referred themselves to the CHC for 340B program medication assistance due to its perceived benefit. One participant described a scenario where she encountered two individuals picking up prescriptions at the pharmacy that were going to cost around five or six-hundred dollars. When describing the situation, the participant said, “I was like ‘there is a clinic that I go to. And then you know went through their phones and give them their phone numbers. I was like, … they will take care of you. They will send you your medicine. I mean they will do it and then you just have to pick it up… you just go to the clinic, and you will get a big discount. I mean you are gonna not even pay half of it.’”

A few participants mentioned having to switch their injectable medication as certain agents were no longer available through the 340B PCDP. In some cases, participants even mentioned this leading to worsening control of their diabetes. As one participant states, “under [insulin #1] it was anywhere from 6.5 to 7 [referring to hemoglobin A1c %]. Three times in a row it’s been at 10 since I’ve gotten off [insulin #1] and all they can probably do for me is to increase my nighttime insulin with [insulin #2 (the replacement)]. But then what happens is it tends to run low because I don’t know when it peaks and it’s just very sad.”

Benefits of 340B

Another theme was the benefits of using the 340B PCDP for injectable diabetes medication(s). Participants discussed benefits of financial savings, decreased stress with having to worry less about how to get their medication(s), improved health (including diabetes control) and well-being, increased engagement in healthcare, and more stability when having access to the 340B PCDP.

Many of these benefits are interconnected. One participant mentioned the following: “And then it was suggested that I use the prescription card which I did, which brought the savings down tremendously. So, yeah it’s been a really big factor in me being able to keep that medication… I haven’t needed to go to the emergency room. Just my regular checkups at the doctor. So, I think it’s really helped. Having the medication, that card really helps to be able to afford the medications. So, it cuts down on having to do extra things like go to the doctor because it’s out of range.” This participant alludes to the financial savings having helped improve their health by cutting back on emergency room visits, therefore providing more stability.

Another participant said “When I first started coming to PrimaryOne, my A1c was up around 11[%]. And now it’s down close to lower eights almost to seven. It has went down to 7[%] one time. It went back up but I’m hanging on and trying my hardest to keep it down,” discussing improved diabetes control and engaging in their health care to maintain control.

Being without 340B

All participants reflected on their experiences being without the 340B PCDP. Many noted that consequences of being without 340B was expensive injectable diabetes medication (100%), having to postpone or choose between other financial responsibilities (50%), and skipping doses, rationing, or being without their medication(s) (50%). Referencing medication expenses without 340B, one said “So, when I went to the pharmacy, and it was like $500… or $600. That’s too expensive. But then I come here [the CHC]. Yeah, it’s too expensive to get it from another place… In that moment it was like my paycheck.”

Due to medication expenses without 340B, participants also discussed difficulty balancing financial responsibilities. “I mean you don’t have any money. You have bills and your bills don’t go away, and your creditors don’t care that you’re diabetic. Or the electric company doesn’t care if you’re diabetic or nobody cares and it’s getting worse,” reports one participant. Another stated, “I had to pay out-of-pocket probably around $50 for each flexpen or whatever and then the other one was like $36 or something on top of that so like $136. You know I have about $250 to live on.” In another instance, a participant mentioned the price of their medication prior to 340B being unattainable by stating, “Like I said one was like $1600 a month and I couldn’t afford it. So I was to the point that I wasn’t going to take any insulin.”

Other participants mentioned having to use alternative treatment regimens, negative impacts on their health, and feeling stressed without 340B.

Community Pharmacy Experience

The interviewer also asked participants about their experience at the pharmacy when utilizing the 340B PCDP. All participants stated that they were pleased with pharmacy accessibility and/or having the option to choose from the CHC’s network of contracted pharmacies. Nine of the ten participants described using the 340B PCDP at contract pharmacies with ease. Despite reports of the occasional issue at the pharmacy (90%), participants shared that most of the issues were easily resolved (78%). Some participants described experiences that reflect the busyness of community pharmacies, and how it can be challenging to get their prescriptions without delay.

One participant had this to share regarding the staff at their 340B community pharmacy: “They have been a big help talking me through it. This would be cheaper if you went that way… going over the things with me… do you know you could take a generic brand, do you know it’d be cheaper if you took three months in advance… that kind of thing. So, you know my pharmacy has really been helpful.” Another said, “It’s not hard at all [to use 340B at a community pharmacy], because the pharmacy I go to are very helpful, very understanding, and they talk to me. And that’s what I like. They’re not just like come and get your order and leave.”

Additional feedback about using 340B at community pharmacies was the geographical accessibility of the pharmacies, with participants noting that convenience and access within their neighborhood were important to them. One noted, “Where I pick it up is like right next door to where I work. So, it’s really convenient. Sometimes I may go to work early just to pick it up first and then go to work. As opposed to being anywhere else in the city to pick it up so it’s really convenient where I do pick it up.” Another patient shared, “There is a [340B pharmacy] that’s by my house which is literally 2 minutes away. So, I’m going to go check them out today and see [about changing to them]. Because that’s just easier… and it just doesn’t work out when you have to go out of your way and you can just go right in your neighborhood.”

Use of Other Services

Several participants mentioned benefiting from services at P1H that are supported by 340B savings. They mentioned utilizing dietitian services most frequently (100%), followed by clinical pharmacist diabetes management (60%), and vision services (60%). Other services mentioned on occasion included dental care (30%), women’s health (20%), and COVID-19 services (10%).

One participant noted, “I was seen by the dietitians and at that time they had cooking classes and other classes I could take. So, I did and I learned a lot…” Another shared “[Dietitians] helped me at the beginning and I actually think I did good… I really liked it… With the dietitian I remember [the instructions for healthy lifestyle changes]. She give me this class and it was really nice. I [go] home and actually measure stuff and try to make healthy choices,” describing their experience with the dietitian services.

Discussion

In this qualitative study of ten individuals who use the 340B PCDP for their injectable diabetes medication(s), thematic analysis showed five themes: 340B feedback, the benefits of 340B, consequences of being without 340B, community pharmacy experience, and use of other services.

The theme of 340B feedback had overwhelmingly positive remarks for the program when we open-endedly asked patients to describe the 340B PCDP. Some participants discussed formulary changes and 340B availability describing the effect of changes in what injectable diabetes medication(s) were covered by 340B. As a result, these participants had to switch to another injectable diabetes medication. At times, the participants even attributed this to worsening glycemic control. Unfortunately, the study team confirmed that these changes in 340B availability stemmed from certain drug manufacturers placing restrictions on providing 340B pricing for CHCs who use contracted pharmacies. Drug manufacturers state that the need for restrictions is due to the rapid increase in contract pharmacies which creates the risk of diversion (when 340B drugs are provided to ineligible patients) and duplicate discounting (where the drug manufacturer ends up providing a discount in both Medicaid and 340B for the same claim).¹⁷ However, patients and CHCs have been seeing severe, negative effects from the restrictions including having to alter treatment regimens that patients were stable on which leads to suboptimal health outcomes. Additionally, not all patients live as close to the CHC as they do to a contract pharmacy, and many CHCs do not have their own pharmacy.¹⁷ In fact, a recent national report showed that almost half of CHC survey respondents lack an in-house pharmacy, and 86% of CHCs use contract pharmacies to serve hundreds of zip codes.⁶ Contract pharmacies play a crucial role in providing 340B pricing to vulnerable patients and without them there would be a significant reduction in affordable medication access.

Participants also acknowledged several benefits of 340B, including overcoming barriers to medication access, increased adherence, saving money on prescriptions, decreased stress, improved diabetes control and overall health, increased engagement in healthcare, and increased stability. On the other hand, when participants were without 340B they mentioned unaffordable medication costs, having to choose between competing financial responsibilities such as electricity bills and car payments, and having to skip/ration/go without their medication(s). A recent national survey of CHCs had similar findings demonstrating the importance of the 340B Program to CHCs and their patients. It found that 32% of respondents estimated that more than half of their patients would go without needed medications if they did not have access to 340B discounts, 88% believe that at least 10% of their patients would go without needed medications if they did not have access to 340B discounts, 92% utilize 340B savings to increase access for low-income and/or rural patients by maintaining or expanding services in underserved communities, and 90% reported that their 340B program has positively affected quality outcomes such as medication adherence, clinical outcomes, and access to care.⁶ This survey demonstrates that CHCs around the nation acknowledged similar values of 340B as the patients at P1H.

In our study, participants saved an average of $1,011.14/prescription. Based on the 2022 federal poverty guidelines, the monthly income for a one-person household at 200% FPL is $2,147. For those living at or below this threshold, an average patient savings of $1,011.14 is 47% of the monthly income. Bakkila and colleagues² used nationally representative data to review out-of-pocket spending on insulin and found that 14.1% (almost 1.2 million) of Americans who use insulin reached catastrophic spending, defined as spending more than 40% of household income on daily insulin, within a one-year period. These results further demonstrate the need to lower out-of-pocket spending for patients. Both our study and others prove that the 340B Program significantly reduces the out-of-pocket cost of medications for patients with diabetes.¹⁸

In addition to cost, participants also noted the importance of accessibility of the pharmacy for obtaining their medications. Participants were pleased with the flexibility to choose their pharmacy and the accessibility of the network of contracted 340B pharmacies. The increasing number of drug manufacturer restrictions on the ability to deliver CHC-purchased 340B drugs to contract pharmacies significantly decreases safety-net providers’ ability to ensure a network of community pharmacies where patients live, work, worship, and play. As a result, this restricts the accessibility of 340B medications for vulnerable populations.¹⁷ Participants also mentioned some challenges with experiencing delays at community pharmacies. It is important to note that this is not unique to 340B-contracted pharmacies and reflects larger national issues surrounding resource and staffing support for community pharmacies.¹⁹

Several participants mentioned using beneficial services at P1H, including dietitian, clinical pharmacist diabetes management, vision, COVID-19, dental, and women’s health services, which are all supported by 340B savings. It has been proven that access to dietitians and clinical pharmacist services improved diabetes outcomes for the vulnerable patients that CHCs serve^20,21, which further highlights the importance of the 340B Program in providing support for these services. The federal 340B Program plays a vital role in the ability of the CHC to expand service offerings and fund uncompensated care to increase access.

Limitations

This study has limitations to consider when interpreting the findings. First, interviewee responses may have been influenced by recall error, selective perceptions, or a desire to please the interviewer which could have resulted in experiences being left out or misremembered. Second, patients not comfortable completing an interview in English were excluded from the study which is ~38% of the patient population at P1H. Although we conducted the study at the largest CHC in central Ohio, another limitation is that we recruited participants from one CHC and patient perspectives from other CHCs or other geographic areas across the U.S. may differ. Future research should include perspectives from diverse geographic areas, those who speak languages other than English, and various CHCs. Another potential limitation could have been small sample size; however, saturation was met for this study so it is unlikely that additional interviews would have yielded new themes.

Conclusions

All participants had positive remarks toward the 340B Program and many described it as a “lifesaver”. They stated that the 340B Program makes their injectable diabetes medication(s) affordable when they would otherwise be too expensive and contributes to improving their diabetes control. Results provide further insight into the personal impact the 340B Program has on underserved patients receiving high-cost injectable diabetes medication(s), including the benefits of 340B pricing, benefits of community pharmacy (340B contract pharmacy) accessibility, consequences of not being able to access 340B, and the patient use of comprehensive services made possible by 340B savings. Responses are evidence of the importance of the 340B Program from the patient perspective and should be shared with policymakers and other key stakeholders. Further studies are needed to bring more patient stories to life and further explore how the 340B Program addresses multi-faceted SDoH to provide medication access.

Disclaimer: The statements, opinions, and data contained in all publications are those of the author(s).