Reducing Medication Abandonment; Improving Retention in Care

In early 2021, Riley Johnson, the community co-chair for Florida’s Comprehensive Planning Network, and Kim Molnar, the Director of The AIDS Institute’s Center for Convening and Planning, reached out to me to discuss a more and more pressing issue the state’s pharmacies were noticing: medications patients weren’t picking up. Their primary concern was understanding the scope of the problem and developing interventions appropriate to ensure the state’s Ryan White clients were getting the medications they needed. How does this problem fit into the state’s Integrated Plan and Ending the HIV Epidemic efforts?

The question of scope is one highlighted in a recent report from the trade organization known as PhRMA (Pharmaceutical Research and Manufacturers of America). The report focuses on how medication abandonment is a symptom and measure of health equity (or inequity, as is the case). Comparing the rise in high cost-sharing commercial insurance plans and medication abandonment from between 2016 and 2020, there’s a clear association. Not only did medication cost-sharing increase on new brand name medications, the out-of-pocket costs of many existing brand name medications increased and with those rises in costs came a rise in medication abandonment.

Insurers set the prices end-user patients have to pay at the pharmacy counter and increasing these costs effectively allow for these payers to defer expenses on care. When out-of-pocket costs reached $125 at the pharmacy counter, medication abandonment increased from 40% in 2016 to 58% in 2020. Across all prescriptions, medication abandonment only rose by 4% for the same timeframe, from 10% to 14%. It’s important to note these high cost-sharing medication because they’re often those assigned to chronic conditions, like diabetes, HIV, and hypertension, in which generic options aren’t’ as effective, have difficult to manage side effects, or aren’t even available. Indeed, our providers prescribe particular medications because those medications are appropriate to our individual and personal care.

Digging in further, PhRMA recognized an immediate disparity in who was not picking up their medications. On average, Black patients were 7% more likely to abandon new medications than their white peers. The disparity was particularly high among patients seeking pre-exposure prophylaxis for the prevention of HIV (PrEP) with Black patients 41% more likely to abandon a new fill compared to their white counterparts. Similarly, when a medication’s out-of-pocket cost rose to $125 per fill, PrEP again out paced other medication classes with a 34% disparity between Black and white patients. On the issue of income, between patients who earn less than $50,000 per year (lower-income) and those earning more than $100,000 per year (high-income), lower-income patients were 16% more likely to abandon their medications compared to their high-income peers, in an overall analysis.

PhRMA offers a few policy solutions to help overcome the cost-at-the-counter barrier; 1. Sharing the rebate and discount savings offered to pharmacy benefit managers and health insurers by manufacturers directly with the patients, 2. Covering particular medications from “day one” of benefits, rather than requiring a separate pharmacy benefit deductible to paid first, and 3. Ensuring all value of manufacturer patient assistance programs be credited toward patient deductibles, copays, and out-of-pocket maximums. The report also urges investment in better understanding the root causes of medication abandonment, as one of the limitations of the review includes not being able to account for factors like stigma, the effects of racism, education, or other social determinants of health.

In even this brief, yet national, review of medication abandonment, the necessity of intervention is obvious. That last bit, accurately understanding the “why” and offering an opportunity to intervene is exactly why Louisiana’s Ending the HIV Epidemic plan includes improving data sharing agreements and aims to reach beyond Ryan White funded entities to include the state’s Medicaid program and encourages appropriate coordination for the benefit of patients who need some extra help. When a patient has failed to pick up a medication, it’s the first sign a patient may not yet be ready to start a particular therapy or other barriers to care are pressing enough they’re prime to drop out of care. Improving retention in care by utilizing real-time data or software tools to notify an interventionist, be they case managers or peers, when a patient is struggling to pick up their medications would allow for programs to reach-out, identify the particular barrier a patient may be struggling with and empower or assist them in navigating that barrier. Data collected from these engagements is critical to better understanding and actively quantifying various barriers to care and better targeting individual and community wide interventions.

Medication abandonment is but one issue in which creative solutions, better data sharing while appropriately protecting patient data, and thoughtful considerations from the patient perspective can drive meaningful change.

Making All Copays Count is a Critical Tool in Patient Access to Care

Making sure patients can access and afford the medications that save lives and maintain a dignified quality of life is the singular goal of Patient Access Network Foundation’s programming and advocacy. The primary way patients interact with PAN Foundation is through programming aimed at funding the care needs of patients via grants or linkage to other funds, including covering the costs of transportation and food, if needed. The other work PAN Foundation does is directly aimed address the why the entity is needed in the first place: advocacy around health care policies directly addressing the high out-of-pocket costs of care and medication. To that end, squarely in the target for PAN Foundation’s 2022 agenda is tackling so-called “copay accumulator” programs enacted by private insurers, particularly pharmacy benefit managers, as a means of double dipping into the flow of funds and denying patients the maximal benefit of patient assistance programs.

The Hepatitis B Foundation defines a copay accumulator (or accumulator adjustment program) as "a strategy used by insurance companies and Pharmacy Benefits Managers (PBMs) that stop manufacturer copay assistance coupons from counting towards two things: 1) the deductible and 2) the maximum out-of-pocket spending." In years prior to copay accumulators as a practice, manufacturer copay assistance programs might issue a healthy benefit that would be applied to the out-of-pocket costs or deductibles a patient is required to pay their insurer. This resulted in the patient fanatical responsibility spending down based on the value of the patient assistance program (PAP), rather than the actual dollars spent by patients, extending affordability of accessing care and medications for patients. It was glorious, honestly. Let’s have a “back of the envelope” example:

Deductible: $1500
Out-of-Pocket Cap (In-Network): $3000
Co-pay: $150 per 30-day fill

Patient Assistance Program Benefit: $7500

Previously, a PAP would cover the initial deductible and all of the plan year’s co-pays while counting toward that maximum out-of-pocket cap all counted as something a patient paid into the plan. Now, insurers keep the entirety of the benefit and only count the $150 co-pay toward what a patient has paid into the plan. This process demands patients pay for those costs themselves and the insurer gets to keep all of that $7500 value from the PAP. Ultimately, this tactic increases patient costs.

PAN Foundation executive vice president, Amy Niles, argues “These discriminatory policies reduce access to critical and often life-saving prescription medications.” And she’s right.

Deductibles and co-pays are generally called “cost-sharing”, which is a bit of a misnomer because patients must pay the deductible before an insurer begins paying the benefits the plan offers. This means pre-deductible costs are not “shared” by anyone but patients. With only about 4 in 10 Americans with enough money in the bank to cover an unexpected expense of $1000 or more, one of the tactics insurers are using to minimize patients actually accessing care is by increasing deductibles. PAN Foundation polled adults and seniors on Medicare and found most couldn’t afford even $100 medical emergency. Advocates, myself included, argue insurers are seeking to limit patients even initiating care (or continuing pre-existing care from previous years) by making those initial payments due too expensive to afford in the first. Can’t get your meds if you can’t afford to see the provider prescribing them, right?

This level of insanity is firmly in the realm of the Centers for Medicare and Medicaid Services to regulate and, indeed, the previous administration issued a rule in 2020 that expressly allowed co-pay accumulators and the Biden administration sided with insurers over patients when it came to this same issue in 2021. Despite calls from advocates, the payment rules for 2023 (announced in 2022) do not address this abusive practice. Some states have introduced and even passed legislation that expressly requires some, but not all, insurers to apply the total value of PAPs to patient costs. However, no national law currently exists to prohibit co-pay accumulators.

All of this is why PAN Foundation and numerous other patient advocacy organizations have come together as members of the All Copays Count Coalition and are urging congress to pass H.R. 5801, the HELP Copays Act, which would require all additional payments, discounts, and other financial assistance be applied to the cost-sharing patients are expected to pay into a health care insurance plan.

If we’re to realize the maximum benefit of manufacturer patient assistance programs, family dollars being spent to help patients, and charitable foundation dollars are being appropriately applied in a fashion that maximizes patient access to care, we have to make all copays count.

PAN Foundation has even made it easy to take action today.

[Disclosure: Amy Niles, Executive Vice President of PAN Foundation is a long-standing board member for Community Access National Network]

Jen’s Half Cents: Supporting Patients by Supporting Families and Survivors of Intimate Partner Abuse

I’m a family man. I always have been. I tend to write in the evenings or at night and I like to do so sitting in bed. As I write this, my partner has dozed off next to me and her children are sleeping down the hall after a busy day of school and family time. I’m thinking about one colleague who had a health scare over the last couple of days (he’ll be ok) and the depth of emotion between worry and love is something that I can near physically feel. My sense of family is strong and the relationships I consider familial extend to a very select group of colleagues in the space of patient advocacy. I’ve often cited that sense of family as part of what keeps me happy in this work. That love is one I am fortunate to have and it’s something I like to remind folks of from time to time, in part, because this work is hard and paying witness to struggles comes with its own emotional toll and reminding colleagues we are driven to this work from a sense of justice and love is often…refreshing, reinvigorating.

A few years ago, at one of ADAP Advocacy Association’s first Fireside Chats, one of my most favorite industry partners, and one of the most brilliant people I’ve had the pleasure of knowing, raised the issue of intersections between the dual epidemics of HIV and substance use. Particularly, she focused on needing to raise awareness of long-term risks for those experiencing non-fatal overdoses, those intersections with infectious disease, and how public health programming would be better served with a more holistic approach to patient care, rather than the often-segmented or siloed environment we still have today. While more syringe services programs are adopting HIV and Hepatitis C testing and linkage to care activities and more HIV programs are offering more competent care for substance users, especially around medication assisted treatment, outside of these activities, there’s little being done to ease the high burden on patients to coordinate their own care across multiple providers or entities. National strategies and funding certainly prioritize referrals, but referrals aren’t the same as successful linkage, successful linkage isn’t the same as retention in care, and at the point of patient experience and meeting public health goals, those distinctions are important. I am of the somewhat unpopular opinion among some recipients and subrecipients that program metrics and grant awards should reflect these differences but that’s for another discussion.

My friend would move the discussion forward by talking about how powerful and moving testimony and advocacy from affected mothers and families, targeting these voices for education on the intersection of infectious disease and substance use, building coalitions would serve to advance the interests of both of these patient communities and especially so for patients living at the intersection of these conditions. As I was meeting with her in December of this year, I had to tell her, “I think about this conversation a lot.” And I do. Years later, this conversation pops up in my mind as I think about patient stories and priorities, different data about isolation as a predictor of substance use or how social supports are clear indicators in successful retention in care and viral suppression. We dedicate a massive chunk of behavioral health resources to ensuring patients have social supports precisely because having those supports is such a strong indicator of successful care. I often find myself thinking about the role families play in being a primary source of social support for many people, how ever we define family for ourselves. I think about this role of family when I assess intimate partner abuse data or read about how mothers experience legal abuse as a form of coercive control in custody situations. I think about it anytime we approach the issue of caregiver supports. I certainly thought about it last year when I wrote about how family courts and child welfare agencies are missed opportunities for linkage to care. I thought about the role of family and that conversation when a former co-worker was being stalked by the father of child at work and the employer failed to support or protect her. I thought about that conversation when recently asked to provide input on an academic institution’s midwifery committee and when a couple we’re friends with announced they’re going to start working to have another baby. I think about that conversation at every headline involving COVID and kids and how the financial supports extended in 2020 and 2021 reduced child poverty. I thought about that conversation while listening to a constituent impact panel on HIV criminalization in the state of Louisiana, how much patients rely on their families to advocate, navigate, support, and love them through what ever health challenges they may be facing. I think about that conversation when considering my own end of life planning and what I want for my family.

I found myself thinking again about that conversation and the need to better support families through public policy as one of many vehicles necessary for addressing the needs of people living with HIV, eliminating Hepatitis C, and tackling the substance use epidemic. I thought about that conversation last week as a bipartisan group of Senators introduced the Violence Against Women Reauthorization Act of 2022, after 3 years of failing to advance a reauthorization. As I read through the bill, I was happy to see funding for marginalized populations, including at-risk populations in Alaska and LGBTQI+ communities. I was happy to see Senators invest funding in directing a federal study on how parents alleging intimate partner violence are likely to lose primary custody over their children, already knowing how abusers leverage family court processes as a means of post-separation abuse is well-documented. I was happy to find a similar study on the association between intimate partner violence and substance use, specifically, how intimate partner violence increases the risk of substance use. I was disappointed to see a failure to more directly require family courts to be educated as to these issues because regardless of those study outcomes, families are weakened when abusers are able to leverage divorce proceedings as a means of further abusing their victims.

I think about all of these things when I think about what our advocate partners and funders are willing to take up as an issue worthy of their labor and dollars. While “mission creep” and maximizing our limited resources are certainly issues patient advocates and our funders must balance, we also have a moral and ethical calling to consider how those whose interests we seek to represent must also be represented holistically in the actions we take. More directly, those providers, patient advocates, and our funders should work to support public policies aimed at strengthening families and ending intimate partner violence on national and state levels. Today, we can do so by vocally supporting the long-overdue reauthorization of VAWA.

Cabenuva Approved for 2 Month Injections; Insurers Remain a Barrier to Access

In late January of 2021, ViiV Healthcare and Janssen Pharmseutical Companies announced the Food and Drug Administration’s (FDA) approval of the first extended-release injectable medication regimen for the treatment of HIV as a once-monthly administration, branded as Cabenuva. Eleven (11) months later, the FDA approved cabotegravir as an extended-release injectable suspension for the prevention of HIV as a once-every-two-month administration, branded as Apretude. Again, on February 1, 2022, the FDA expanded Cabenuva’s administration to be a once-every-two-month administration. Near overnight, people living with HIV-related medication therapy and prevention efforts went from a burdensome three-hundred sixty-five (365) pills to six (6) injections.

This kind of innovation has been long anticipated and while advocates and patients recognize not every patient will desire to switch to injectable medications and resistance profiles may require some people living with HIV to maintain their tablet regimens, injectables offer yet another tool in the tool box. The extended-release nature of injectables offer an opportunity to overcome “treatment fatigue”, reduce opportunities for missed doses and subsequent treatment resistance, and even address safety in storing medications at-home – especially for those people living with and at risk for acquiring HIV that may also be experiencing houselessness. This becomes even more of an astounding tool, in addressing disruptions in care when patients live in areas prone to natural disasters, as seen in Florida during Hurricane Michael when the state’s central pharmacy operations came to a halt, forcing the state to rely on a private-public partnership with CVS, and in Puerto Rico after Hurricane Maria, in which patients lost access to life-saving medications. The issue of natural disasters interrupting care is not new and will likely be something providers and patients need to have plans for as every indication exists climate change will produce more and more powerful hurricanes. Indeed, despite the lessons learned from Hurricane Katrina, I personally witnessed multiple calls across social media channels among people living with HIV seeking additional medication in order to manage loss of their anti-retrovirals in 2021, during Hurricane Ida. Despite the state of Louisiana and the department of Health and Human Services declaring a public health emergency and activating the Emergency Prescription Assistance Program for uninsured and underinsured patients, anecdotal reports found the program hard to manage for those who needed daily administration of medications.

Yet and still, despite these incredible advancements at our finger tips, both public and private insurance programs remain reticent to allow patient and provider choice to guide what therapies patients actually have access to. Indeed, one of the largest payers in both the public and private spaces is CVS Health, who, on December 16, 2021, published priorities in “weighing cost” versus clinical benefit while specifically naming cabotegravir as an active agent in Cabenuva and Apretude. The payer outlines tactics known as “utilization management” to include initially blocking coverage of new drugs, “strongly favor[ing] generic use”, and “select[ing a] preferred agent generating lowest net cost option in category”. Even some AIDS Drug Assistance Programs (ADAPs) are delaying adding the innovative therapy to their coverage formularies. All of which creates a system of care where people living with HIV are experiencing limitations on their access to effective therapies based on their income, rather than their need as determined by them, as patients, and their provider. Deny-first utilization management practices risk losing people to care by creating unnecessary and burdensome administrative process and delays.

When Cabenuva was first approved, advocates in the community and among public services stressed concern about getting patients to return for monthly shots and the logistics of administering the shots. The concern on costs to public programs also raised its head and has done so even more recently as a limited study concluded Apretude wasn’t “cost-effective”. However, in the time since these initial discussions, tens of millions of people have received their COVID-19 vaccines, which are situated a mere 3 weeks apart and variant development has left many experts expecting the need for annual boosters of the same. The logistics of administering shots have clearly been addressed. As for the “cost-effectiveness” study, the limitation the authors cite is one that’s patently…ridiculous: “Uncertain clinical and economic benefits of averting future transmissions.” We well know the clinical benefits of preventing transmissions means fewer HIV diagnoses, a goal outlined by the United States’ federal government in the Ending the HIV Epidemic initiative, and the economic realities of preventing new transmissions is as apparent in reducing the costs of care associated with stagnant or even rising transmission rates.

The truth is, long-acting anti-retroviral therapies are the next step in innovation at extending effective care to people at risk of acquiring and living with HIV. These advancements will come with a cost that is significantly outweighed by improvements in patient quality of life, retention in care, and reduction in new transmissions. If we aren’t careful in ensuring equitable access to these innovations, existing health disparities will only grow. Barriers to care originating from payer processes, from formulary inclusion to co-pay accumulator programs, should be well-documented by providers and advocates need to be forceful in seeking access to these innovations for all patients, regardless of income or economic status. Policymakers, lawmakers, and regulators need to move quickly to address these barriers. Innovation waits for no one and that which exists in the balance between these interests are people’s quality of life and their very lives.

Congress Eyes Equipping Providers to Combat the Opioid Crisis; The MAT Act

A year ago this month, Representative Paul Tonko introduced H.R. 1348 to the House of Representatives and Senator Maggie Hassan (NH) introduced its companion bill, S. 445, to the Senate. Both of these bills hold the short title “Mainstreaming Addiction Treatment Act of 2021”. The House version boasts 239 cosponsors with the Senate version enjoying 3 cosponsors. Both are supported on a bipartisan basis. The most recent action on the MAT Act is Senate “HELP” (Health, education, Labor, and Pensions) Committee hearing on February 1st, 2022, wherein the committee discussed and heard testimony on issues of mental health amid the COVID-19 pandemic.

End Substance Use Disorder, an issue education campaign endorsing the MAT Act, describes the more than a century old policy of outlawing medication assisted treatment as “outdated” and a moralization of a medical condition. Founded by Erin Shanning after her younger brother, Ethan, experienced a fatal overdose, the organization seeks to educate legislative stakeholders and urge action to adopt a more modern and medicalized approach to substance use disorder. The MAT Act removes the prohibition on providers on prescribing certain medications for the treatment of opioid use disorder maintained in the Controlled Substances Act and entirely removes the necessity for the DEA waiver of this prohibition, known as the “X” waiver. According to ESUD is joined by 418 organizations have either directly supported the MAT Act or have voiced support for eliminating the X waiver, including criminal justice and law enforcement entities. For immediate transparency, Community Access National Network is one of those 418 organizations.

This relatively straight-forward bill would help to expand access to care – especially in rural communities, move public policy into better alignment with research-proven best practices, combat racialized public health disparities, better support families, reduce overdose deaths, and more. Directly, the most immediate and significant impact of the MAT Act is an expansion of providers eligible to prescribe medication assisted treatment, specifically including certain community health practitioners. The only apparent opposition to the MAT Act is a group representing the interests of commercial addiction treatment centers.

With overdose deaths having skyrocketed by at least 20% in 2020, relative to 2019, emphasizing the need to press forward with the MAT Act is the least the Biden administration can do to begin to meet its promises around drug reform and health care access. Mental health and substance use service providers still need more support from the federal government in order to meet the need of the moment. Equipping providers with tools like medication assisted treatment, improving (read: increasing) Medicaid reimbursement rates for the treatment of substance use disorder, working to destigmatize the issue of substance use disorder, and more explicitly issuing Department of Justice guidance to family courts, social service organizations, and employers on protections afforded under the Americans with Disabilities Act for people recovering from substance use disorder are the least in a long list of actions this administration can take today.

If you would like to urge your elected representatives to remove barriers to care for clinically-proven, best practices in harm reduction, follow this link and to add your organization’s name to ESUD’s letter of support for the MAT Act, click here.

How One FQHC is Advancing Health Communication

Earlier this month, new outlets got a hold of a local (to me) treasure: NoiseFilter. Local health heroes, Dr. MarkAlain Dery and Dr. Eric Griggs, have been hosting Noise Filter since the beginning of the COVID-19 pandemic as an innovative way to educate the public about pressing health issues. The show started as a podcast, moved to live streams on Facebook, and has recently found a niche in animated shorts designed to engage and entertain patients. One of the latest episodes, titled Test, Treat, Cure, focuses on explaining Hepatitis C and curative treatments.

Before we go further, you can check out other Noise Filter animated videos here and you really should. They’re fun! At a recent virtual event aimed at educating stakeholders on the issue of HIV criminalization, after reviewing the science behind Undetectable Equals Untransmittable (U=U) and other access to care issues, Dr. MarkAlain played this episode for the audience. The audience happened to include Centers for Disease Control and Prevention Division of HIV Prevention Director, Dr. Demetre Daskalakis, who may or may not have chair danced with the end of the video. They really are that exciting!

This isn’t Dr. MarkAlain’s first foray into utilizing broadcasting platforms to reach patients as audience members. In 2014, the good doctor helped found local radio station WHIV (102.3FM). Staffed by volunteer hosts and DJs and focused on issues of social justice, human rights, and community health, WHIV titles itself as “…not a radio station with a mission…a mission with a radio station.” The station’s programming digs into issues of policy, politics, faith, entertainment, and more.

Both Doc Griggs and Dr. MarkAlain and both programs are tied to one of Louisiana’s largest Federally Qualified Health Center networks, Access Health Louisiana. AHL is actively involved in the state’s health planning activities and has been one of the mobile testing providers even before the COVID-19 pandemic and was one of the state’s first at-home testing providers (for HIV screenings), positioning the entity well in terms of already having infrastructure in place to mobilize and having Doc Griggs’ astounding communications talent for breaking down complex health issues, setting patients at ease, and empowering communities to activation makes the entity accessible and flexible in meeting the needs of served communities.

In many ways, both Noise Filter and WHIV seek to speak to patients as whole people, with whole lives, living in whole communities.

We need more of that. We need more of this.

Biden Drug Policy Agenda: NIH Invests in Harm Reduction

On December 29th, 2021, the National Institute of Health (NIH) issued two new requests for application (RFA), one for the establishment of a “Harm Reduction Network” and another for a data coordination center in support of the network. The idea the NIH proposes is to develop and test new harm reduction strategies, examining the efficacy of existing harm reduction models, effective implementation of harm reduction strategies, and examining new models targeting diversified settings and delivery models of harm reduction services. The data coordination center will focus on meeting with relevant stakeholders, defining common metrics, developing research and clinical practice models, and otherwise analyzing the landscape of harm reduction across the nation. This move represents the “investigative” phase of the Biden Drug Policy Agenda.

Of note, the NIH very specifically cites interest in exploring the impacts of decriminalization and safe consumption sites as harm reduction policies and syringe service programs (including vending machines and mail programs), community based infectious disease services and prevention programs (specifically mentioning HIV and HCV), naloxone programs, and fentanyl testing strip programs.

In discussing decriminalization as a policy, much existing work is focused on marijuana decriminalization (either for medical or recreational use) in which several states have progressed in passing legislation in recent years. However, few of these pieces of legislation address people who are incarcerated currently or previous criminal records or restitution to these people for imprisonment related to possession, use, or distribution of marijuana. This has left an extraordinarily inequitable landscape with regard to marijuana as an industry – white guys are getting rich for what Black men and women are being imprisoned for. But none of this speaks to the motivation of NIH in these RFAs: reducing fatal and non-fatal overdose deaths and marijuana isn’t typically associated with these types of outcomes. Rather, state drug paraphernalia laws may be more apt at addressing these issues. For example, Louisiana’s statute outlines anything used to test a substance’s “purity” as prohibited and criminal. Decriminalization efforts should be broadly construed for applications and not just focus on particular illicit substances but also the items substance users may access to consume products safely. Indeed, being able to “test” a substance is a well-established mechanism for users to reduce potential harms.

Similarly, safe consumption sites have long faced an uphill battle in the United States due to the “crack house” provision of the Controlled Substances Act (CSA), exemplified by the legal fight Safehouse of Pennsylvania is currently facing. Safehouse argues the relevant provision of the CSA doesn’t apply to them; the language makes it a crime to own or operate a property meant for the consumption of illegal or illicit substances, Safehouse argues they operate for the purposes of saving (a religious calling protected by the Religious Freedom Restoration Act), not drug consumption. The most effective way to save lives is by offering services where they’re needed most, including overdose reversal, housing and recovery linkage to care, syringe exchange, and HIV screenings. The Office of National Control Policy has expressed support for safe consumption sites, generally speaking, but refuses to address the legal issues Safehouse is facing. The clear lack of alignment between OFNCP and the Department of Justice has left advocates more than a tad frustrated. What’s important to note about the CSA’s “crack house” provision is the reason users gather is often related both to enjoyment of experience but also safety; they’re “unsanctioned” consumption sites, as users have until recently had to rely upon their own networks for safety. Like with any issue of access to care, sanctioned safe consumption sites pose the potential to further existing health disparities. As states warm up to the idea of supervised consumption as a service to the community, policy makers and program planners need to consider those areas which exist as medical deserts may very well be the same areas in which safe consumption sites need to exist.

Biden’s drug police agenda has numerous other items of note, including strengthening protections for people with substance use histories in the labor market under the Americans with Disabilities Act, addressing the illicit and illegal drugs supply in the country, and preventing youth from engaging in drug use. Arguably, a key component missing in much of these discussions is how to protect the interests of drug users and strengthen families struggling with substance use disorder. Under the existing punitive approach, drug users are isolated from their families by way of criminal and family courts, isolating them from a core source of social support. A common refrain in recovery, “addiction is a disease of isolation”, also has decent behavioral science research support. Separating people from their families, when those families are generally well-situated to provide necessary support, operates in direct contrast to addressing the needs of a drug user and only sets them up for failure. The Biden administration needs to evaluate family strengthening policies and incentives, including education directives and best policy practices to family courts and child protection agencies as part of this effort and the NIH initiatives should consider qualifying and quantifying how policies in these areas intersect with other harm reduction efforts.

While these initiatives and this funding opportunity is a good start. The Biden administration has a long way to go to fulfilling campaign promises and we’re already twenty-five percent of the way through his first term.

Return of the Flu: Flurona, a Co-occurring Infection that is NOT

The beginning of 2022 brought about an ominous rise in COVID-19 cases as the Omicron variant began to ravage the United States in earnest, with the Centers of Disease Control and Prevention reporting about 1.3 million new cases on January 10th. While this report is inclusive of a weekend backlog, representing the majority of states’ reporting for 2 days, rather than 1, this kind of report for any respiratory transmission is truly startling. In the background, another virus with a respiratory transmission mode, influenza, had been crushed to near non-existence during the 2020-2021 season, according to the CDC’s FluView surveillance report. Indeed, on the surface, what appears to stop COVID transmission, stops flu transmission even better. But with the relaxing of mitigation measures, “pandemic fatigue”, and society eagerly looking to move on, the flu has begun to mount its seasonal return.

In comes the frightening shadow of “flurona”! Social media sites buzzed with the dire warning experts had given in 2020: a ghastly winter with two very dangerous, highly communicable diseases ripping through the nation. The difference in late 2021 and early 2022, compared to the year before, is obvious: wide access to COVID-19 vaccinations (in the United States, at least) and a continuation of annual influenza vaccination availability. This co-occurring infection, however, isn’t new. Indeed, the United States likely experienced some combined infections during the early days of the COVID pandemic in 2020, prior to the wide availability of diagnostic COVID tests, and again in the 2020-2021 flu season. While the instances may have been relatively rare due to the decrease in influenza transmission, the situation was not entirely unknown. It was, after all, the CDC’s FluView surveillance that shaped our initial tracking of community transmission of SARS-CoV-2 (the virus that causes COVID-19); the surveillance program tracks weekly reports from health care providers and local and state health departments of influenza like illness (ILI) incidence and the results of flu screenings in order to ascertain key metrics of public health response.

Let’s pause for a moment to acknowledge just how remarkable the 2020-2021 flu season was. A key measure in tracking influenza is pediatric mortality. In both the 2018-2019 and 2019-2020 flu seasons, the CDC reported 144 and 199, respectively, pediatric deaths attributed to the flu. In the 2020-2021 season, the CDC reported only 1 pediatric flu death (CDC data application). The total national percent positivity (or number of reactive tests relative to total tests administered) for influenza during the 2020-2021 flu season never crested the national baseline for the season of 2.6% positivity compared to only being about half way through the season this year and already having crested the national baseline (2.5%) for the last 5 weeks. In the 2019-2020 flu season, percent positivity for the flu crested the national baseline (2.4%) for 22 weeks.

We shouldn’t be dismissive of influenza. It is still a serious illness that hospitalizes many, especially vulnerable populations. National vaccination programs have done a great deal to help curb the potentially deadly impacts of influenza, though, schools have been known to be shut down due to flu outbreaks, including in early 2019. The idea of selective mitigation efforts coming and going in order to address outbreaks, isn’t new.

So here we are with Flurona – an incidence which may well have been happening this whole time, but because we don’t specifically track this particular co-occurring infection, we can’t say for sure. While there’s limited data on what to expect with a co-occurring flu and COVID infection, that data is a tad concerning; mortality did not necessarily increase but the symptomology of this type of situation did require frequent use of mechanical ventilation.

The catchy combined name of these viruses went…well…viral, even if only for a short period of time. As the project director for CANN’s HIV-HCV Coinfection Watch, the idea of a co-occurring viral infection didn’t surprise me. And it probably doesn’t surprise many of our readers here. The fact that it did surprise many members of the public, even after Dr. Anthony Fauci and other officials had previously mentioned the possibility, is indicative, inditing even, of how information is delivered and disseminated in today’s world. Numerous studies have been done on the amount of stress and anxiety people are experiencing in light of the COVID-19 pandemic. The CDC has also dedicated a page to “Coping with [pandemic-related] Stress” and many states have adopted mental health helplines for residents to dial into. The relationship between the public, experts, and news media is deeply damaged by practices of all parties – a busy public less interested in reading longer, more detail articles, a news media competing for clicks and attention in order to fund their outlets, and experts competing for space and importance because of outlet bias and lack of vetting have all harmed our ability to cohesively respond to the COVID-19 pandemic.

I’m not usually one to say “can’t we all just get along”, my job, in fact, is often about digging deep into spaces of disagreement or interest conflict and hammering out mutually beneficial concessions. This place we’ve found ourselves in as a society, where we’re all operating out of scarcity and competition at all costs is ultimately how we all “lose”; be it this pandemic, the next, or even in combatting long standing ills already needing address. Patient advocates and public health officials having to divert time and resources to educate patients and the public when a panic-inducing headline aimed at derailing the reader’s tasks is, in fact, derailing to multitudes of efforts to better the world around us if by sheer inability to focus on our tasks at hand.

If you’re struggling with coping with stress of the pandemic, flurona headlines, COVID variant headlines, any headlines, please, take a moment to review the National Alliance on Mental Illness (NAMI) COVID Resource and Information guide, or give them a shout on their hotline to be directed to area specific resources by calling 800-950-6264 or by clicking “chat with us” at the bottom of this page.

There’s little in this world that can’t be made a tiny bit more manageable with a snack, a nap, or a hug. Check those boxes, take a deep breath, and know you’re not alone.

Improvements to Public Health Guidelines, Despite Covid-19

2022 is off to a roaring Covid-19 start with both mainstream news and scientific outlets focusing on variant development, diversifying vaccines, and the impacts of the pandemic on various aspects of our lives. Last year, Community Access National Network opened our blog with discussing Covid-19’s Impact on HIV, HCV, and Substance Use Disorder and the theme crawled through our public policy discussions of the last year. While the topic is likely to set the frame for all variety of public health and policy throughout 2022, there is a necessity to discuss the developments in our space in spite of the distractions COVID has to offer.

Early 2021 found the Biden administration rescinding the “axe” the previous administration gave to the so-called “X” waiver, a requirement for providers to seek specified training in order to administer buprenorphine based medication assisted treatment for patients experiencing opioid use disorder. While providers and advocates hailed eliminating the X-waiver as a move toward advancing care, reports stated administration officials found problems with the rule as written, calling it “premature”. The Department of Health and Human Services (HHS) would later update treatment guidelines by way of formal notice posted to the federal register on April 28th, expanding eligibility of providers to administer the treatment when they “intend” to treat fewer than 30 patients a year. What enforcement looks like around the word “intent will be an area to watch as this area of public policy develops.

Later in the year, the Centers for Disease Control and Prevention (CDC) updated their Sexually Transmitted Infections Treatment Guidelines, the first overhaul since 2015. While the most significant updates to the guidelines are focused on the treatment of gonorrhea, an area of focus given the bacteria’s penchant for developing resistance to treatment, other highlights include aligning the guidelines with the CDCs 2020 recommendation for universal Hepatitis C screenings and adoption of the Advisory Committee on Immunization Practices (ACIP) recommendation for Human Papilloma Virus (HPV) “catch-up” vaccination schedules for people assigned male at birth. These and other additional updates were made, in part, because the CDC’s 2021 annual report found the United States facing the 6th consecutive year of STI increases.

Among ACIP’s many accomplishments in a year that found the panel meeting nearly twice as often as usual, a November meeting overshadowed by the endorsement of recommending Covid-19 vaccines for 5-11 year olds provided also found ACIP recommending universal adult Hepatitis B vaccination.

In a similar vein to the aforementioned updates (and with much rejoicing from advocates), the White House Office of National AIDS Policy “turned the lights back on” with the appointment of Harold Phillips as Director. Mr. Phillips provided an update to the National HIV/AIDS Strategy, announced in December with a focus on acknowledging structural barriers to achieving goals, including racism, stigma, and violence against transgender women. The plan, however, does not specifically outline ways to address these particularly challenging, systemic issues. President Biden also recognized World AIDS Day with a characteristically frank review of the history this country has with HIV and AIDS and the obstacles we still face in working to Ending the HIV Epidemic.

One of the last developments of 2021 included the CDC updating its clinical practice guidelines for pre-exposure prophylaxis for the prevention of HIV (PrEP). The update shifts language in such a way to encourage providers to more openly bring up the issue of PrEP with all patients rather than solely seeking to target “high-risk” populations. This move falls in-line with the efforts to reduce PrEP stigma among the broader public and, specifically, among providers. This was a particularly exciting development in light of the Food and Drug Administration’s (FDA) approval of cabotegravir (branded as Apretude) for PrEP. The long-acting injectable was first approved for the treatment of HIV in early 2021 and poses an extraordinary advancement in the potential for medication delivery mechanisms, improving adherence, and, ultimately, advancing efforts to End the Epidemic. Of note, pharmacy benefit managers, specifically CVS, anticipated this move as much as advocates and patients have. Despite a supposed commitment to investing in health equity with regard to HIV, CVS’ own “payor solutions” site boasts of the methods the entity will use seeking to delay or deny access to this and other innovative care under the need to “balance cost” with effective or curative treatments.

Looking into the new year, HHS’ annual policy report indicates the agency will seek to strengthen protections afforded to LGBTQ patients and more appropriately define discrimination in plan design, affecting patients living with HIV and HCV.

While these changes in direction and advancements in treatment are quite thrilling, advocates should be prepared to compete for space to be heard and anticipate familiar “foes” continuing to refuse to engage or finding ways to blockade access to care. Be they based in political ideal or industry priority or even from providers, patients and advocates would be better served when those who have traditionally disfavored advancing equity and access engaged in discussions on how to find the win-win for all parties. Community Access National Network remains committed to engaging stakeholders across interests in this space and looks forward to the good-faith efforts of those who seek to move these adversarial relationships to partnerships and even friendships.

2022: New Beginnings, New Changes

The Community Access National Network (CANN) ushers in a new beginning with the 2022 New Year, evidenced not only by the changing of the guard with our new President & CEO, but also with some important programmatic changes with our organization. We felt it important to share these changes with you.

Our weekly blog, previously branded as the HEAL Blog (Hepatitis Education, Advocacy & Leadership), is being repurposed to serve our broader mission “to define, promote, and improve access to healthcare services and supports for people living with HIV/AIDS and/or viral hepatitis through advocacy, education, and networking.” As such it is now the CANN Blog, and its areas of interest will focus on HIV/AIDS, viral hepatitis, substance use disorder, harm reduction, patient assistance programs (PAPs), Medicare, Medicaid, and the ongoing Covid-19 pandemic and its impact on public health. In keeping with the desire to monitor broader public health-related issues and appropriately engage stakeholders, our CANN Blog will be disseminated to a larger audience. Therefore, some of you may notice one more email in your inbox each Monday morning since we’re employing our general listserv to share the blog posts. It is our hope that you’ll deem the added email of value and thus maintain yourself on our listserv.

Additionally, our acclaimed HIV/HCV Co-Infection Watch will also be shared with our general listserv. But don’t worry, it only means one additional email each quarter! The HIV/HCV Co-Infection Watch offers a patient-centric informational portal serving three primary groups - patients, healthcare providers, and AIDS Service Organizations. The quarterly Watches are published in January, April, July, and October.

In 2022, our Groups will also be more active. Since 1996, our National ADAP Working Group (NAWG) has served as the cornerstone of CANN’s advocacy work on public policy. Whereas NAWG will continue to engage our HIV/AIDS stakeholders with monthly news updates, we will also convene periodic stakeholder meetings to discuss important issues facing the HIV community. Likewise, our Hepatitis Education, Advocacy & Leadership (HEAL) Group has served as an interactive national platform for the last decade on relevant issues facing people living with viral hepatitis. Periodic stakeholder meetings to discuss important issues facing the Hepatitis community will now complement the HEAL monthly newsletter. If you would like to join either the NAWG or HEAL listserv, then please do so using this link.

CANN will also launch its 340B Action Center this year. It is designed to provide patients with content-drive educational resources about the 340B Drug Discount Program and why the program matters to you. The importance of the 340B Program cannot be under-stated, and CANN remains committed to taking a balanced “money follows the patient” approach on the issues facing the program and advocating for needed reforms.

Finally, like most advocacy organizations, CANN is constantly evaluating whether it is safe (or not) to host in-person stakeholder meetings. Covid-19 has changed the advocacy landscape. Over the last two years our two signature meetings (Community Roundtable and Annual National Monitoring Report on HIV/HCV Co-Infection) have been hosted virtually, rather than in-person. CANN is taking a “wait and see” approach on how best to proceed in 2022 with these events. We will keep you apprised of our decision.

As we close the door on 2021 and open it for 2022, CANN looks forward to working with all of its community partners, industry partners, and you!

2021: A Year in Reflection

The end of 2021 is upon us and that makes this a timely opportunity to reflect on the work by the Community Access National Network (CANN). During an exceedingly busy news cycle, we have published fifty blogs (including this one) on a variety of topics ranging from the latest on policy and regulatory issues, as well as some personal perspectives. Our HIV-HCV Coinfection Watch and our Annual Monitoring Report tracked Hepatitis C (HCV) therapies covered under the State AIDS Drug Assistance Programs, Medicaid, Veterans Administration, as well as patient access via patient assistance programs, and other relevant news items affecting our patient community. We also conducted a community roundtable seeking to highlight the impacts of Covid-19 on public health programs aimed at addressing HIV, HCV, and substance use disorder (SUD).

Notably, CANN published the following six-part series designed to educate patients on various aspects of the 340B Drug Discount Program:

·        A Patient’s Guide to 340B: Why the Program Matters to You

·        A Patient’s Guide to 340B: Why Transparency Matters to You

·        A Patient’s Guide to 340B: Why Accountability Matters to You

·        A Patient’s Guide to 340B: Why the Decline in Charity Care Matters to You

·        A Patient’s Guide to 340B: Why the Middlemen Matters to You

·        A Patient’s Guide to 340B: Why Program Reform Matters to You

With Congress engaged in high-conflict communication, to abuse a euphemism, navigating public policy developments and pertinent issues to patients can be challenging. CANN remains committed to being an essential source of two-way communication, information, and education wherein patients write the narrative driving policy reforms and priorities. In this, we are ever grateful to the patients and caretakers who have engaged with us at every turn. Your stories matter and you are not alone in your experiences.

The diverse partnerships behind this work are critical to our success and as we end the year, we want to offer our gratitude to these essential partnerships, ranging from other patient advocacy organizations, public health associations, and industry partners.

The issues affecting our public health space of patient advocacy have not relented this year. Covid-19 has only emphasized the need to ensure these programs are effective and efficient while also highlighting the existing weaknesses and strengths of these programs. To be clear, the structural and pervasive drivers of health disparities have been named; racism, sexism, classism, ableism, and all other biases which reflect a moral justification for out ethical failings must be addressed in tandem with policy changes and adequate public health program funding in order for us to succeed in these fights for patient lives. Health equity cannot be meaningfully segregated from the policy mechanisms in which these disparities have survived in the face of another pandemic – when our collective awareness of these inequities and leverage to progress on these issues should have been their strongest and yet were not.

It’s with these things in mind, we want to leave you with the enduring sentiment that next year offers us yet another opportunity to approaches these challenges with fresh eyes and fresh ideas. We are indeed stronger together and we sincerely look forward to working with you all to move closer in realizing a world of greater access to care, fewer and smaller health disparities, and, ultimately, a more fair and loving environment in which to live our lives and raise our families.

Author’s note: I often end certain professional meetings with telling my colleagues “Love ya’ll”. It’s a sentiment I mean to depths of my soul. I am fortunate to work with some of the most amazing people in the world – folks who share an unbridled commitment to improving the lives of those around them. It’s from this same space I wish to offer each of you reading this a moment to breathe and the same open heartedness. I want to leave you all with a short story that has shaped me in more ways than I can count, The Perfect Heart, and an encouragement to tell someone you love them as soon as you can. May this next year be gentler with us all and find us giving away more pieces of our hearts.  

FDA Move Aims to Diversify HCV Test Maker Market, Reduce Regulatory Burden

On November 19th, the Food and Drug Administration (FDA) released a pair of orders affecting Hepatitis C (HCV) antibody screening and diagnostic tools. The move was announced as a proposed order in April 2020 with a total of 13 comments on the proposed orders, including the National Association of State and Territorial AIDS Directors (NASTAD), Hawaii and Washington state Departments of Health, the National Hepatitis Roundtable, and one of the current leading device manufacturers, Abbott.

The final orders reclassify already existing screening and confirmatory blood and plasma testing while also changing the name of acknowledged name of the technology in use from “assay devices” to “tests”. The move is anticipated to reduce the burden in applying for regulatory approval of new tests but also require “special controls” to ensure the quality of testing technologies on the market continue to meet the high safety and accuracy standards they currently meet.

Of note, the FDA considered the impact the new final orders would have on public health initiatives, specifically the National Viral Hepatitis Strategic Plan.  Additionally, Abbott’s support comment was relatively brief and contained only the concern for possible product code labeling limitations for potential technologies; suggesting the FDA take a similar approach as taken to combination antibody and antigen testing with regard to HCV as with HIV testing. Abbott’s recommendation in the comment was to merely name the technologies “serological” tests rather than limiting application based on the mechanism of action in the test as both the proposed and final orders did.

NASTAD’s comment highlighted the difficulty in current surveillance efforts as confirming an acute or active HCV infection is a two-step process, of which, the organization claims few providers or patients follow through. NASTAD drew direct and natural and logical conclusions from the Centers for Disease Control and Prevention’s (CDC’s) Viral Hepatitis Surveillance Report, highlighting the public health risk HCV poses and the barriers to more effective surveillance efforts, including the cost and regulatory hurdles for new screening technologies to enter the market. The public health interests commenting requested the FDA consider expanding the final rule to include potential future technologies like over the counter (OTC) antibody tests or screening technologies based on body fluids other than blood and plasma or combination testing technologies targeting multiple types of viral hepatitis or HCV-HIV combination tests. The FDA’s response to comments in the final orders stated the new final order could not go beyond the scope of existing technologies and, as such, would not be able to change the approval pathway for new or emerging technologies.

While the orders represent an encouragement for manufacturers to enter the existing technologies market with regard to HCV screenings, diversifying the field, the announcement does not affect developing or new technologies and the pathways to approval those potential products will need to navigate.

Jen’s Half Cents: Stepping into the Shadow of a Giant

I’ve often tried to distinguish between the sense of grief and shock that follows the death of a hero. Emotions are complex…layered especially when it comes to grief and the amount of work that’s involved in mourning and appropriate appreciation for a person’s life. When a young person dies unexpectedly, the sense of shock layered onto grief is exorbitant. That shock is expected to be less so when a person of advanced age moves on from this plane. This sentiment is not to disregard the tragedy of loss but to distinguish between “heavy” and “sharp” pains.

When William “Bill” Arnold passed on September 29th, I didn’t expect to feel the deep sense of shock that struck my heart. Tragedy, yes, because losing the presence of this titan is indeed a tragic loss for the community of advocates his work and passion shaped. But the shock was unexpected. There’s this thing that happens when admiration is a core part of one’s perception of a person – regardless of age, the relationship seems to defy necessary acknowledgments of nature even if, as was the case with Bill, the subject of said admiration challenged the admirer to not forget. In writing my second “Half Cents” this year, Bill appreciated the emphasis on needing to shore up the advocacy pipeline. After all, the blog was based in part on the very first discussion he and I shared. He cautioned, however, “there’s an obvious target here”, referring to himself. A stark reminder of his age. I think…I should have taken more note of the comment and in retrospect I regret not seeking more of an opportunity to discuss how he felt about the piece and what it meant for him, personally.

Writing this blog is a particular challenge in that few words can express the deeply complex set of feelings I’ve had to navigate since Bill’s death. The last in-person conversation Bill and I had was outside of a restaurant, after a fireside chat hosted by CANN’s sister organization, ADAP Advocacy Association in early December of 2019. As Bill and I were among the few smokers in the crowd, I enjoyed spending time with him outside, even in the bitter cold New Jersey had to offer that evening. We didn’t talk about recent politics or the upcoming election or even particular policy issues the event focused on earlier in the day, as was more common of our “smoker’s chats”. Instead, we talked about his childhood and the quite remarkable, yet humble life Bill lead. I like to remind advocates we should “bleed a little” in our work because the lives we seek to impact and the stories that drive this work are the emotional blood bonds of effective advocacy. It is unjust to expect patients to share the intimate aspects of their lives and health and to not return the favor. And in those moments, what Bill chose to share with me felt less like bleeding a bit of himself and more like welcoming me into his home. I don’t know how to reconcile that quite yet.

The greatest tragedy of death, however, is the world does not stop for grief. Things still need to be done in order for the world to function, work does not stop piling up, decisions must be made in order to not compound the difficulty of an already difficult time. In that respect, CANN’s general consultant, Brandon M. Macsata was tasked with making a recommendation of succession of Bill’s duties to CANN as President and Chief Executive Officer to the organization. This was not an easy thing. Bill had been a mentor and friend to Brandon for more than 20 years and the enormity of the moment weighed on him. He wanted to fulfill his responsibility to the organization and do justice to the Bill’s legacy, as did CANN’s Board of Directors. In this space, while we may not all always be friends, we are all comrades in a fight for improving access to care and thus the lives of those around us, in particular, the most vulnerable of our shared communities. This decision was both professional and personal, as it should be, in such intimate work.

So, when the Board of Directors, through Brandon, approached me to ask if I would be interested in assuming the role of President and Chief Executive Officer, stepping into Bill’s shadow, I had to take a moment. “These are mighty big shoes to fill”, I’d say before expressing some trepidation, not at my skill or ability, but because of an earnest desire to ensure Bill’s legacy would be appropriately honored - the Board, our patient community, and our partners would be proud of the work that follows. In expressing confidence and navigating the decision-making process, CANN’s board members placed an emphasis on both skill and temperament, a need to focus on policy changes from the patient perspective, and for the next chapter of leadership for the organization to balance these qualities and ideals.

“You and Bill are cast from the same mold”, will forever be one of the greatest compliments I will ever receive. It’s one I hold dear to my heart and the sentiment provides me a laser focus the mission at hand.

The outpouring of support CANN has received, both in offering condolences and in appointing me to the role of President and Chief Executive officer, has been incredible. While changes are certain for CANN’s future, the organization will continue with the same goals it was founded upon and has served for the 25 years; “defining, promoting, and improving access to healthcare services and supports for people living with HIV/AIDS and/or viral hepatitis through advocacy, education, and networking.”

A Patient’s Guide to 340B: Why Program Reform Matters to You

***This is the final report in a six-part series to educate patients about the 340B Drug Pricing Program***

The 340B Drug Pricing Program has no doubt added benefit for patients and providers, alike. The measure of this benefit, however, is shrouded by uncertainty over the lack of transparency and accountability, decline in hospital charity care, as well as the explosive middleman growth in contract pharmacies and pharmacy benefit managers. Twenty-nine years after the program’s inception, it is now unclear to both regulators and patients, both qualitatively and quantitatively, if the Congressional intent is being met.

With all the noise around whether rebate programs might encourage pharmaceutical manufacturers to raise the cost of their products, there is no conversation on how those rebate dollars are used. The lack of the requisite transparency reporting among non-federal grantee covered entities participating in the 340B program makes it impossible to distinguish between anecdotal claims of abuses versus legitimate use of these rebate dollars to the benefit of patients.

These combined situations place the future of the 340B program at exceptional risk, if only by politicization of the national conversation on medication affordability alone. That national conversation churns now, as Congress debates drug pricing legislation. Aside from notorious stump speeches about the prices other countries pay for their medications, nowhere in these discussions do we talk about payers (insurers) and the middleman dictating the at-the-counter prices of medications realized by patients. The ongoing political debate is absent of the larger impacts on safety-net programs benefitting from 340B revenue and the impact on the poorest patients among us. Without clear guidance, all patients can come to expect is more squabbling among covered entities, drug manufacturers, hospitals, and regulators. It is this type of environment in which an idealistic program finds itself at risk.

Lawmakers have reasonably argued federal regulators have not demonstrated a particular need for additional regulatory powers because the Health Services and Resources Administration (HRSA) has not adequately flexed their current oversight muscle (…much less that such would be exercised efficiently). Therefore, regulatory interpretation should be updated, specifically regarding the patient definition, and possibly with further defining “low-income” for more clarity on who the program should benefit most. To the extent of “cracking open the legislation”, there is a singular area in which lawmakers from both sides and the Biden Administration agree: the issue of transparency in reporting. Earlier this year, the Biden Administration’s discretionary budget included an ask of Congress to specifically fund greater oversight and administration of 340B, explicitly including requirements on reporting of how non-grantee entities use these dollars. In this space, where few agreements can be made found, this is one area where legislators can and should move swiftly. The data generated by transparent reporting on use of these dollars is invaluable in evaluating the efficacy of 340B in benefitting patients or otherwise meeting the intent of the program.

To the extent HRSA may need more room for rulemaking, legislators desperately need extend rulemaking authority to include allowable uses for 340B dollars and clarity on the intent of the program. Federal grantees already have to report use of these dollars while other covered entities aren’t. With executives reaping in millions of dollars, reasonable people can grow concerned these dollars are being used to prop up the profiteering and personal enrichment administrators may be enjoying at the expense of employees providing care and patients themselves. Employees of federal grantees don’t generally get to enjoy much in the way of raises and their pay is not on par with the private sector. Hardware and software systems lag in terms of keeping up with modern technology. Sustaining non-revenue generating or underfunded patient benefit programs is absolutely something many entities enjoy as a use of their 340B dollars. There is no doubt these dollars can be used to patient benefit beyond directly sharing the savings with patients, though sharing the savings is the most direct means patients benefit from 340B. Putting guardrails on allowable uses of these dollars would serve well everyone touched by the program. Frankly, anyone fighting this transparency as a suggested method of shoring up 340B in meeting its intended purpose has something to hide and deserves closer scrutiny.

As an additional area of critical need to consider, for non-grantee covered entity hospitals, records of charity care and minimum realized values in served communities should be determinative for qualification to participate as a covered entity. The current calculation of disproportionate share hospitals as 340B participants or non-340B participants by the Government Accountability Office has shown a steadier and steeper decline of charity care among 340B hospitals than among non-340B hospitals. Additionally, hospitals carry the highest issuance of medical debt in the United States, disproportionately affecting low-income patients. Part of ensuring low-income patients get the most benefit from the discount drug program was and remains the ability to extend no- and low-cost care, writing off costs of providing that care, without punishing patients for having a need. If hospitals are to receive the benefit of this program, that same benefit should be extended to patients.

Lastly, in addressing the sheer size of the 340B discount drug program, the most significant areas of growth with questionable benefit to patients are among contract pharmacies. HRSA’s recognized this potential in commentary with its 2010 final rule only to realize those cautionary concerns and integrate guidance curbing the use and growth of contract pharmacies in the no-shelved 2015 “mega-guidance”. While the mega-guidance has been shelved, the abuse of the program by contract pharmacies has not abated. Among reducing the number of contract pharmacies a covered entity may make agreements with, and other geographic requirements, lawmakers and regulators should consider establishing market appropriate flat fees associated with services and a database of fees charged by pharmacy benefits managers, contract pharmacies, and third-party administrators, similar to the 340B ceiling price database established under the Office of Pharmacy Affairs Information System. A similarly situated claims hub would also allow for greater clarity in audits, assessment of potential duplicate discounts, and (if appropriately structured and compliant with patient privacy laws) detect potential diversion.

340B is a massive program which, arguably, has not yet been realized by much of the patient population. Not doing anything in this case doesn’t mean “keeping things status quo”, rather it means leaving the program open to attack, inefficiency, ineffectiveness, and abuse.  We can and should do more to ensure patients are aware of the program, how the program is used by covered entities nearest to them, and how this critical support to federally funded health care programs might be impacted by additional health care policy reform efforts. If ensuring the health and well-being of the country is the priority of all players in this system, then its time patients know it.

For more information on the issues facing the 340B Program, you can access the Community Access National Network’s 340B Commission final report and reform recommendations here.

Sources:

• Community Access National Network (February 2019). 340B DRUG DISCOUNT PROGRAM: The Issues Spurring Discussion, Stakeholder Stances and Possible Resolutions. 340B Commission Final Report. Retrieved online at https://docs.google.com/gview?url=http://www.tiicann.org/pdf-docs/2019_CANN_340B_Commission_Final-Report-v5_03-07-19.pdf&embedded=true

A Patient’s Guide to 340B: Why the Middlemen Matters to You

***This is the fifth report in a six-part series to educate patients about the 340B Drug Pricing Program***

When the 340B Drug Pricing Program was enacted in 1992, there were a few “gaps” between the law’s statutory language and the program’s practical application. Among them was the realization that some covered entities that couldn’t afford to operate their own pharmacy. The Health Resources and Services Administration (HRSA) issued guidance to address the gap. After all, what’s the use of a discount drug program if providers can’t realize those discounts simply because they don’t have a pharmacy?

In 1996, after the urging of some covered entities, HRSA issued guidance telling covered entities and manufacturers that covered entities could contract with a single, independent pharmacy to provide pharmacy services necessary to engage the discount program. The idea was simple: create an access pipeline to the program, so it could be accessed by small providers, but not abused. In 2001, HRSA began to allow a few pilot projects, for lack of a better term, wherein covered entities would have more than one contract pharmacy. In theory, it isn’t a bad idea. Different pharmacies have different distributors, and as such supply can sometimes be an issue (i.e., natural disasters).

Additionally, it allows industrious covered entities to open the door for competition on “value added” services from contract pharmacies – such as programmatic record keeping for the purposes of 340B and/or financial reporting for federal grantees. And since the pharmacy was the one handling the purchasing and distribution of the medications to patients, that’s one less labor task for smaller covered entities to fund. In 2010, HRSA would later expand these pilot project allowance for multiple contract pharmacies per covered entity.

Sounds great, right? More patients have access to discounted outpatient medications, right?

Right? Not exactly!

Under the 340B program, patients don’t always get their share of the savings from the rebates and discounts. Arguably, it would appear everyone is directly benefiting one way or another from the program and its lucrative revenue stream, except for patients.

Contract pharmacies all want their piece of this pie, too. For example, take the dispensing fees that a pharmacy charges to fill a prescription medication. Indeed, dispensing fees for 340B contact pharmacies are so wildly non-standard a Government Accountability Office (GAO) report from 2018 found dispensing fees ranging from $0 to almost $2000 per fill on 340B eligible drugs. Those fees come out of 340B revenue, which could be supporting a patient’s ability to pay copays or the cost of a drug and instead.

Can you imagine, if you will, you’re a person living with HIV or Hepatitis C, living at about 200% of the Federal Poverty Level (FPL; 200% in 2021 is approximately $25,760 per year for a single person), but thankfully receiving insurance coverage for your medical care. Yet, co-pays and deductibles drain your finances when you could be getting your medications at no cost if the pharmacy or covered entity was applying 340B dollars to your bill? How many Rx fills would that be?

If the payer wasn’t applying a co-pay accumulator or co-pay maximizer program, the dispensing fee of two fills could mean extending your ability to access care for an entire coverage year – not just for medications, but for all health care. If the intent behind the 340B program is to extend limited federal resources, ensuring those exorbitant dispensing fees weren’t so exorbitant would certainly be one way to do it. Ultimately, 340B is a pie – when there’s more taken out, hacked at along the payment pipeline of getting medications to patients, there’s fewer resources left for patients to benefit from.

What’s more concerning about the explosive growth in the number of contract pharmacies with their hands in the 340B cookie jar, is HRSA knew when the 2010 guidance was issued that diversion and duplicate discount increases, abuses of the program, would most certainly follow. In part, because the program would grow and at such a pace that HRSA couldn’t keep up. In fact, GAO included that warning in a 2011 report, stating “…increased use of the 340B Program by contract pharmacies and hospitals may result in a greater risk of drug diversion, further heightening concerns about HRSA’s reliance on participants’ self-policing to oversee the program.”

The best part? By the “best”, I mean the worst: contract pharmacies, like non-grantee hospital entities, don’t have to show any benefit to patients for any of the dollars. Clearly, it raises questions over the legislative intent of the program and whether it is being met?

Now, contract pharmacies, like hospitals, like to massage and carefully select data to pitch answers to these concerns (there are a great number of “concerns”) by saying “we served X many 340B eligible patients”. They get around having to say if those patients realized any of those savings and benefitted from the program, without defining what they mean by “eligible”, and without defining “patient”. Contract pharmacies and hospitals get away with not having to provide meaningful information because statutory language doesn’t define “low-income” or “eligible” and regulatory guidance has an outdated definition of “patient”. Regardless of the existing language in regulation, a bona fide relationship should exist in order to call a consumer a “patient”, otherwise this is all just pocketing dollars meant for extending medication access to needy people.

All this lack of transparency fees assessed against the program could easily be solved with merely requiring contract pharmacies to establish a “flat”, reasonable dispensing fee and to describe what those fees actually cover. If the contract pharmacy is providing an additional navigation benefit to patients or an in-house location for a federally qualified health center, reasonable people can see fees being slightly elevated to cover additional costs. However, those costs should be outlined like any other contractor would be expected to do in any other contract for service. Most hospitals already have their own in-house pharmacy, they shouldn’t be contracting that service out and thus giving room for inappropriate 340B related rebate claims. And if HRSA just does not have the capacity to meaningfully audit 340B claims and the use of these dollars, they could at the very least make more room for the other mechanism in the statute for audit: manufacturer-originated audits. That’s right. The statutory language of 340B anticipated HRSA wouldn’t be able to keep up if the program was successful or even particularly abused. So, legislators reasoned if manufacturers were taking a cut of their potential profits through discounts and rebates, manufacturers should be able to audit the claims seeking those discounts and rebates to make sure everything was in line. When a retailer offers a discount to veterans, they typically require proof of veteran status. Why would medication discounts be any different?

In the end, if contract pharmacies don’t have anything to hide, then they need to stop hiding so very much. There are enough hands in the 340B cookie jar that patients are being squeezed out and left with crumbs. When legislators ask “is the intent of the program being met?”, these are the questions on their minds. Patients should have them on their minds as well.

For more information on the issues facing the 340B Program, you can access the Community Access National Network’s 340B Commission final report and reform recommendations here.

Sources:

• Community Access National Network (February 2019). 340B DRUG DISCOUNT PROGRAM: The Issues Spurring Discussion, Stakeholder Stances and Possible Resolutions. 340B Commission Final Report. Retrieved online at https://docs.google.com/gview?url=http://www.tiicann.org/pdf-docs/2019_CANN_340B_Commission_Final-Report-v5_03-07-19.pdf&embedded=true

• Fein, J. Adam (2020, May 19). Copay Maximizers Are Displacing Accumulators—But CMS Ignores How Payers Leverage Patient Support. Drug Channels. Retrieved online at https://www.drugchannels.net/2020/05/copay-maximizers-are-displacing.html

• U.S Government Accountability Office (September 2011). DRUG PRICING: Manufacturer Discounts in the 340B Program Offer Benefits, but Federal Oversight Needs Improvement. GAO-11-836. Retrieved online at https://www.gao.gov/assets/gao-11-836.pdf

• U.S. Government Accountability Office (June 2018). DRUG DISCOUNT PROGRAM: Federal Oversight of Compliance at 340B Contract Pharmacies Needs Improvement. GAO-18-480. Retrieved online at https://www.gao.gov/assets/gao-18-480.pdf

• Office of the Federal Register (1996, August 23). 61 FR 43549 - Notice Regarding Section 602 of the Veterans Health Care Act of 1992; Contract Pharmacy Services. GovInfo.gov. Retrieved online at https://www.govinfo.gov/app/details/FR-1996-08-23/96-21485 

• Office of the Federal Register (2010, April 5). 75 FR 10272 - Notice Regarding 340B Drug Pricing Program-Contract Pharmacy Services. GovInfo.gov. Retrieved online at https://www.govinfo.gov/app/details/FR-2010-03-05/2010-4755

A Patient’s Guide to 340B: Why the Decline in Charity Care Matters to You

***This is the fourth report in a six-part series to educate patients about the 340B Drug Pricing Program***

A cornerstone argument in favor of the 340B Drug Pricing Program centers on so-called charity care rates of the participating Disproportionate Share Hospitals (DSH). Those covered entities, specifically DSHs, should be able to leverage their 340B dollars to extend care and out-patient medications to offset losses from uncompensated care. In the ideal, offsetting the costs associated with charity care to provide more care to low-income patients is noble and moral and just, and one society should support. The problem occurs when charity care is wrapped up or conflated with all “uncompensated, unreimbursed care” because a significant portion of uncompensated care is written off as bad debt, and that debt all too often gets reported to patients’ credit reports. Whereas charity care is care provided at no cost or debt to the patient. Moving forward, we must not confuse, conflate, or combine generalized uncompensated care with charity care.

The argument from the American Hospital Association is narrowly focused to present the rosiest picture, touting the totality of charity care provided by 340B DSH covered entities ($64 billion in of 2017, the latest available data as of the AHA’s statement). It ignores 340B participating hospitals have seen a steady decline in both charity care and uncompensated care, according to the Government Accountability Office’s 2018 report. The AHA’s own data reveals the same thing, despite exponential growth of the 340B program, largely attributed to hospitals and contract pharmacies. Unlike Federally Qualified Health Centers (FQHCs, a type of federal grantee entity in the 340B program), which are required provide care “regardless of ability to pay”, hospital systems, in large part, have a much more extensive debt collection program; they are not necessarily beholden to rules regarding debt collection practices. FQHCs, as an example, may be required to seek debt payments from internal billing specialists, but don’t generally have contracts to sell the bad debt to collections companies or report to credit bureaus. Furthermore, they are prohibited from doing so in certain circumstances.

While the Affordable Care Act (ACA) prohibited certain types of hospital-originated debt from being reported to credit bureaus, it doesn’t stop the hospital from selling the debt and then the collection company reporting the debt. Indeed, hospitals are notorious for reporting medical debt and sending bills to collections. If 340B dollars are meant to offset some of these expenses, with program growing about 23% per year, why does the Census Bureau report that about 20% of Americans are under some form of medical debt? Why has that medical debt grown from $81 billion in 2016 to $140 billion in 2019?

The ACA required non-profit hospitals to offer charity care programs, and the vast majority of hospitals across the country are non-profit hospitals. Adding insult to injury, that tax designation and the requirement to offer charity care hasn’t stopped these “non-profit” hospitals from chasing after low-income patients and further impoverishing them. A recent Kaiser Health News “An Arm and a Leg” podcast dove into just one state’s effort to tackle an epidemic of “non-profit” hospitals suing patients as a result of medical debt. The effort found a massive coalition of 60 entities, including a nurses’ union, and startling data supporting the need for Maryland’s now-passed “Medical debt Protection Act.”

Data included notation of almost 150,000 lawsuits against patients over the last 10 years, making almost $60 million from patients who would otherwise automatically qualify for charity care, and hospitals negotiating with for state funds to support charity care taking in $119 million than they actually gave out in charity care. And that’s just in one state. Indeed, according to information behind this report, Johns Hopkins – a 340B hospital – alone raked in $36 million more from this state-funded charity care support than they spent. While Maryland already had certain patient protections from these predatory practices on the books, too few patients knew about those protections and the state awarded these dollars without ever investigating the existing status of bad debt to charity care ratios. All the paper in the world written into the law is meaningless if affected people and corporations are not made to be transparent and held accountable.

Access to care, and freedom to access care, are two different things. Access to care being an open door, and freedom to access care is the freedom to walk through that door without fearing a dire financial consequence. While some special interests may argue the program is critical to hospitals extending access to care, their rhetoric lacks practical application when patients don’t have the freedom to access that care without fear of acquiring life-altering debt. The fear of medical debt keeps people away from seeking care. In fact, one of the most immediate and meaningful ways to tackle the country’s medical debt crisis would be for 340B covered entities to share the savings with patients. A patient’s medical debt reported to their personal credit file can, and does, perpetuate cycles of poverty; it is harming patients’ wealth, health, and overall well-being. If 340B dollars are supposed to be aimed at ensuring access to care, then concerns over medical financial toxicity shouldn’t be discounted.

Hospitals, in large part, though not universally, have seen a significant decrease in uncompensated care due to the ACA’s expansion of Medicaid. With more patients qualifying for Medicaid, meaning an ability for providers to be reimbursed where none previously existed, hospitals should be able to shift their uncompensated care burden from bad debt to patient financial assistance and charity care programs.

On the other end of decreases in charity care provided by 340B hospitals, are truly magnificent non-profit hospital chief executive officer compensation.  In a 2019 hearing, CEOs admitted to having salaries in the millions of dollars per year range – that’s before bonuses. They also admitted to holding more money in reserves than they generally need in order to operate safely or not run the risk of running out of funding. Other instances of concern from this hearing include a hospital group using their 340B dollars to acquire a stand-alone oncology center. Typically, when these types of purchases are made, patients experience an increase in costs of care and sometimes experience a reduction in ability to access care due to an increase in patient load without subsequent staffing support or their provider’s office is physically moved as part of the consolidation effort, reducing a patient’s ability to physically get to and from office visits.

In addressing potential reforms that would benefit patient experiences, increase the sense of freedom patients feel to access care, and improve program efficacy, policy and law makers should both distinguish between generalized uncompensated care and charity care in annual financial reporting and 340B related audits and require a threshold of charity care for hospitals seeking to qualify for the 340B program. If hospitals are dissatisfied with their Medicare or Medicaid reimbursement rates and what that means for boosting their bottom line, they would do well to send their lobbyists after reimbursement dollars rather than disingenuously justifying their pilfer effort to rob 340B of its noble cause. Either way, it’s time these entities see requirements tied to their dollars, including rules around charging off debt against low-income patients.

For more information on the issues facing the 340B Program, you can access the Community Access National Network’s 340B Commission final report and reform recommendations here.

Sources:

• American Hospital Association (September 2020). 340B Hospital Community Benefit Analysis. Retrieved online at https://www.aha.org/guidesreports/2020-09-10-340b-hospital-community-benefit-analysis.

• American Hospital Association (December 2017). UNCOMPENSATED HOSPITAL CARE COST FACT SHEET. Retrieved online at https://www.aha.org/system/files/2018-01/2017-uncompensated-care-factsheet.pdf.

• Bennett, N., Eggleston, J., Mykyta, L., & Sullivan, B. (2021, April 7). 19% of U.S. Households Could Not Afford to Pay for Medical Care Right Away. U.S. Census Bureau. Retrieved online at https://www.census.gov/library/stories/2021/04/who-had-medical-debt-in-united-states.html.

• Community Access National Network (February 2019). 340B DRUG DISCOUNT PROGRAM: The Issues Spurring Discussion, Stakeholder Stances and Possible Resolutions. 340B Commission Final Report. Retrieved online at https://docs.google.com/gview?url=http://www.tiicann.org/pdf-docs/2019_CANN_340B_Commission_Final-Report-v5_03-07-19.pdf&embedded=true

• Committee on Energy and Commerce, Subcommittee on Oversight & Investigations (2017, October 11). EXAMINING HOW COVERED ENTITIES UTILIZE THE 340B DRUG PRICING PROGRAM. U.S. House of Representatives. Retrieved online at https://www.govinfo.gov/content/pkg/CHRG-115hhrg27577/html/CHRG-115hhrg27577.htm.

• Kliff, S. & Sanger-Katz, M. (2021, July 20). Americans’ Medical Debts Are Bigger Than Was Known, Totaling $140 Billion. The New York Times. Retrieved online at https://www.nytimes.com/2021/07/20/upshot/medical-debt-americans-medicaid.html.

• U.S. Government Accountability Office (2018, June 18). Drug Discount Program: Characteristics of Hospitals Participating and Not Participating in the 340B Program. GAO-18-521R. Retrieved online at https://www.gao.gov/assets/gao-18-521r.pdf.

• Weissmann, Dan (2021, October 7). PODCASTS – ‘An Arm and a Leg’: How One State Protects Patients From Hospital Lawsuits. Kaiser Health News. Retrieved online at https://khn.org/news/article/podcast-an-arm-and-a-leg-how-one-state-protects-patients-from-hospital-lawsuits/?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsmi=168013149&_hsenc=p2ANqtz-_sXa4onkYlNPYAtzOv-Hn4b_y9OgQhBcwhnxYvtugSLuAXK1sYZ1_OWiArpRr29-YxGGpHZCZ9t4IhZVASXKpQZ-lS5A&utm_content=168013149&utm_source=hs_email.

A Patient’s Guide to 340B: Why Accountability Matters to You

***This is the third report in a six-part series to educate patients about the 340B Drug Pricing Program***

The word accountable is defined as “being required or expect to justify actions or decisions.” Accountability is often broadly discussed on a variety of levels about governmental and social issues, and the 340B Drug Pricing Program is certainly no exception. The 340B program exists to address the health care needs of a segment of society – social needs. As such, program accountability is of paramount importance since patient health depends on it.

Accountability in use of 340B dollars follows the benchmarks of transparency in reporting: federal grantees are required by contract to demonstrate patient benefit in use of program dollars and non-grantee covered entities are held to no such standard. Without fiscal transparency, non-grantee entities cannot be held accountable for their use of these revenues. The Health Resources Services Administration (HRSA) largely selects covered entities for audit based on a selection of “risk” characteristics. While some criticism of manufacturers is warranted in terms of accountability, manufacturers have only one statutory requirement. That requirement is to provide discounts or rebates on qualifying medications to covered entities. HRSA selects manufacturers for audit based on complaints from covered entities. Areas of complaint about manufacturers typically consist of overcharging a covered entity, not making a particular medication available, or not being transparent about the “ceiling price” of a drug.

To be fair, the statutory accountability requirements of 340B program are…limited and…vague. However, according to a 2020 report by the Government Accountability Office (GAO-20-108), the Health Resources and Services Administration (HRSA) severely lacks meaningful oversight, uniform assessment and request standards, and, as with many other reports, finds HRSA’s administration of the program to be largely inadequate.

As an example, GAO identified HRSA audits from 2017 and 2018 reviewed less than 10% of all non-governmental hospitals enrolled in the program. HRSA primarily relies upon hospitals to self-attest their eligibility. Of the selected hospitals participating in the GAO review, 18 submitted documents that would constitute a government contract – any description of a community program – and when HRSA found these instances, allowed the hospitals to avoid getting in trouble by acquiring contracts with retroactive applicability. All of that meaning, these hospitals in question did not experience any reprimand for failing to provide programming to low-income people but they got to enjoy the perks of unaccountable 340B dollars until they got caught. At the rate HRSA reviews these entities, it’s possible for a non-compliant or otherwise non-qualifying entity could go an entire decade soaking up dollars meant for patients in needs.

While HRSA’s annual 340B audits are primarily targeted toward covered entities, drug manufacturers are also audited to ensure they’re not charging covered entities more than they should be for 340B medications, to ensure drug manufacturers are not discriminating against covered entities, and make sure drug manufacturers are making sure their products are made available in compliance with the 340B program. Manufacturers represent about ten percent of annual audits, while covered entities represent about 90 percent and there are about 900 drug manufacturers participating in the program (dramatically less than covered entities). To be fair, GAO concluded HRSA also needed to provide clearer guidance to drug manufacturers regarding what qualifies as an acceptable distribution restriction due to anticipated or actual supply shortages and to provide specific guidance as to what constitutes “discrimination” of covered entity participants.

This issue of defining discrimination is developing and playing out in “real-time”. In May of 2021, HRSA announced notification letters sent to 6 manufacturers regarding their new policies requiring additional reporting from covered entities with contract pharmacies (as opposed to in-house pharmacies). HRSA’s interpretation of statutory language (“…shall…each covered entity…”) as non-discretionary on the part of manufacturers. In essence, if an entity is registered with HRSA for the program, a manufacturer is required by law to offer medications at ceiling price or below to that entity, regardless of any potential for a covered entity to use program dollars outside of the intent of the program. While skepticism of non-grantee use of these dollars may be warranted due to lack of transparency in use of these dollars, diversion, or duplicate discount concerns, given that federal grantees are already required to report use of these dollars to their federal funders, a more narrowly tailored policy directed exclusively at non-grantee covered entities would be more appropriate to address the interest needs of manufacturers, the public, and program stability. However, given HRSA’s interpretation of the statutory language, even such a proposal might run the risk of rubbing regulators wrong. At the time of this writing, at least one of the manufacturers has sued the Department of Health and Human Services to prevent any monetary penalties related to these letters from being imposed. A judge has dismissed the government’s opposition to the suit in June of 2021. And on September 22, 2021 HRSA issued letters to the manufacturers in question, stating the issue had been referred to the Office of the Inspector General.

Lack of transparency means less accountability. Patients are better served when 340B-related dollars remain within the same geographic area they were generated by the covered entities. After all, if serving low-income patients means serving community and getting usable revenue required to be used on low-income patients, those dollars should be put back into the same community in which they were generated, right? But covered entities with large networks and multiple covered entity sites aren’t required to show those revenues are reinvested in the same area they were generated. For instance, monies made off the health and illness of an Atlanta community should not be spent to buy up profit generating imaging machines in a well-to-do suburban area outside of Los Angeles. But, without both transparency and accountability, 340B dollars can easily become a slush fund of revenues for any industrious non-grantee covered entity.

Indeed, many large contract pharmacies offer software programs to covered entities as a measure of their own “transparency” with internal reporting but the real goal is to show the covered entities “here’s how you can make more 340B dollars” – but at a cost of providing the service and without uniform assessment metrics. That means the contract pharmacy can tilt the experience of a patient by applying pressure to the covered entities very subtly through software programs telling the provider, “You can make more money off this patient by prescribing…”. Advocates have very good reason to be suspicious of contract pharmacies associated with (or even owning) pharmacy benefit managers who, then, can very easily provide programming that targets their profits over ensuring rebate dollars make it back to a patient.

Statutory clarification could greatly benefit the intended purpose of the 340B program – ensuring low-income patients get the care they need by taking a few, simple steps, specifying reporting requirements that mirror existing transparency and accountability found among grantees. Additional oversight is needed in numerous areas, all designed to further benefit patient access to care and medications. Among them, non-grantee entities should be required to report how 340B dollars are being used, by which payer source a claim is generated, how much charity care a non-grantee entity provides, and how much revenue is generated from pharmacy sales (and how much is generated from 340B sales). Patients might not understand the nuances behind the program complexities, but they do understand when they cannot access the care they need and deserve. If the purpose of the 340B program is to expand access to care and medications, then why not go that extra mile?

Congress could go a great deal further to ensure these billions of dollars serve patients, rather than the interests of shareholders in private hospital systems or propping-up senior management compensation packages, or other non-medically-related expenses. Congress could also opt to provide for additional minimum requirements in order to qualify as a covered entity – especially with regard to private hospitals providing a certain percentage of charity care.  

For more information on the issues facing the 340B Program, you can access the Community Access National Network’s 340B Commission final report and reform recommendations here.

Sources:

• Community Access National Network (February 2019). 340B DRUG DISCOUNT PROGRAM: The Issues Spurring Discussion, Stakeholder Stances and Possible Resolutions. 340B Commission Final Report. Retrieved online at https://docs.google.com/gview?url=http://www.tiicann.org/pdf-docs/2019_CANN_340B_Commission_Final-Report-v5_03-07-19.pdf&embedded=true

• Health Resources Services Administration (September 2021). 340B Drug Pricing Program – Program Integrity. HRSA Correspondence to Stakeholders 2021. U.S. Department of Health & Human Resources. Retrieved online at https://www.hrsa.gov/opa/program-integrity/index.html

• Lagasse, Jeff (June 2021). Judge dismisses HHS Challenge of AstraZeneca's 340B Contract Pharmacies Lawsuit. HealthCare Finance. Retrieved online at https://www.healthcarefinancenews.com/news/judge-dismisses-hhs-challenge-astrazenecas-340b-contract-pharmacies-lawsuit

• U.S. Government Accountability Office (December 2019). 340B DRUG DISCOUNT PROGRAM: Increased Oversight Needed to Ensure Nongovernmental Hospitals Meet Eligibility Requirements. GAO-20-108. Retrieved online at https://www.gao.gov/assets/gao-20-108.pdf

A Patient’s Guide to 340B: Why Transparency Matters to You

***This is the second report in a six-part series to educate patients about the 340B Drug Pricing Program***

All public-private partnerships require transparency to instill confidence in program function, private business operations, and government accountability. Transparency is an essential part of the equation; it brings us more accountability and more effective programs. It helps to identify areas of improvement in operations or enforcement, as well as limiting waste, fraud, and abuse. The 340B Drug Discount Program is no exception because transparency ensures investments into patient access to medications for critically vulnerable populations are reaching patients. Transparency – in every programmatic aspect – serves the public interest and is, frankly, just good government. It builds confidence in the efficacy of the program and good will of the participating entities.

In general, under the 340B program, those entities receiving federal grant funding – known as “federal grantees” – under other programs (i.e., federally qualified health centers, Ryan White HIV/AIDS clinics, hemophilia centers, and others) receive a great deal over oversight on how they use their discounts and rebates from 340B, though that oversight comes as part of their fiscal reporting under those other programs. For non-grantee covered entities, oversight is primarily dependent on audits and self-attestation of compliance and corrections to issues. With non-grantee covered entities lacking dedicated oversight like federal grantees, there’s a lack of transparency in how those entities qualify under the program and how those entities are using 340B-generated revenues to benefit low-income patients.

Regardless of program, dollars meant to serve low-income patients are often scarce. As such, patients lose when the investments needed to support and expand services for vulnerable populations are directed elsewhere (outside of the community those dollars originated from or for-profit building purposes). Patients lose out on funding support that keeps programs stable, ensures access to critical health programs nearest to them, and ultimately threatens to destabilize a program relied upon by the federal government and community stakeholders to keep clinic and hospital doors open.

At the inception of the 340B program, legislation such as the Patient Protection and Affordable Care Act did not exist, and only 29 million people nationwide were enrolled in Medicaid. Fast forward to 2018, Medicaid rolls had grown to 72 million people – meaning in all but the hold-out “non-expansion states” nearly any hospital in the country might qualify as a “disproportionate share hospital” – a situation 340B never considered at inception. The development and growth of the program was analyzed in a 2018 report issued by the U.S. House of Representatives’ Committee on Energy & Commerce.

According to a Government Accountability Office report (GAO-21-107) about 80% of current covered entities are federal grantees and 20% of covered entities are hospitals. However, many of these entities, especially hospitals operate multiple sites – not all entities are created equal in terms of generating program revenue. Of the approximate 37,500 covered entity sites participating in the program, about 75% of those sites are hospital affiliated with hospitals, not federal grantees. Hospitals are able to qualify specifically because of the low threshold of “disproportionate share” of low-income patients who can now afford to seek care thanks to Medicaid expansion – even if the hospital entity is generally well off enough to not actually need those dollars in order to provide care. In order to better understand how these changes have impacted growth and qualification of the program, “disproportionate share” may not be the best formula to ensure 340B dollars are helping those who need it most. Particularly, given the decreasing share of charity care certain hospital entities have offered over the years, evaluating charity care percentages and qualifying patients by income and payer type (self-pay, Medicaid, private insurance, etc.) may be more accurate in ensuring entities are actually serving low-income communities.

To be clear, “charity care” is a specific type of “uncompensated care” – or when patients receive care but can’t pay their bills. Unlike other types of uncompensated care, whereby providers may send a patient’s bill to a collections company, charity care releases the patient from a portion or all of their financial responsibility. Typically, charity care is limited to those who have to choose between putting food on their table and seeking preventative care like mammograms or having to decide in what life-saving neonatal care a family might need. Given the intersection of race and poverty in this country, charity care is a critical, even if anecdotal measure of how much a hospital is invested in their local community and combating community health disparities like pregnancy-related mortality.

The 340B program’s statutory language is largely silent on how these revenues dollars may be spent and because of that, there’s little to ensure these dollars are actually going to benefit patients instead of hospital networks or pad executive pay. Patient advocates have long crowed about the need for non-grantee covered entities to meet the same transparency requirements federal grantees are required to meet. Indeed, one of the biggest challenges facing the 340B program is better understanding how these dollars are spent. Now, typically, where statute is vague, government agencies tasked with managing programs have the regulatory power to make rules and the man power to enforce them. That’s just not the case with 340B and the Health Resources and Services Administration (HRSA) has repeatedly stated a lack of surety in its ability to regulate beyond guidance and frequently cited an inability to expand auditing capacity due to lack of funding. So much so that President Biden included $17 million in his budget request to strengthen and expand oversight of the program specifically in terms of auditing how 340B revenues are generated and spent among on-grantee covered entities.

Given the program’s growth, there’s reason and need to further clarify the intent of the program, cemented into unambiguous statutory language to reflect the country’s health care landscape of today and ensure the revenues generated are actually helping patients and not padding executive pockets. In our next blog, we’ll discuss the accountability processes currently in play for covered entities and manufacturers and the glaring holes in that part of the oversight “net”.

For more information on the issues facing the 340B Program, you can access the Community Access National Network’s 340B Commission final report and reform recommendations here 2018 report.

Sources:

• Centers for Disease Control & Prevention (2020, February 4). Infographic: Racial/Ethnic Disparities in Pregnancy-Related Deaths — United States, 2007–2016. U.S. Department of Health & Human Services. Retrieved online at https://www.cdc.gov/reproductivehealth/maternal-mortality/disparities-pregnancy-related-deaths/infographic.html

• Community Access National Network (February 2019). 340B DRUG DISCOUNT PROGRAM: The Issues Spurring Discussion, Stakeholder Stances and Possible Resolutions. 340B Commission Final Report. Retrieved online at https://docs.google.com/gview?url=http://www.tiicann.org/pdf-docs/2019_CANN_340B_Commission_Final-Report-v5_03-07-19.pdf&embedded=true

• House Committee on Energy & Commerce (2018). Review of the 340B Drug Pricing Program. U.S. House of Representatives. Retrieved online at https://republicans-energycommerce.house.gov/wp-content/uploads/2018/01/20180110Review_of_the_340B_Drug_Pricing_Program.pdf

• King, Robert (2021, June 1). From 340B to a public option: 4 healthcare items you may have missed in Biden's budget. Fierce Healthcare. Retrieved online at https://www.fiercehealthcare.com/hospitals/from-340b-to-a-public-option-4-healthcare-items-you-may-have-missed-biden-s-budget

• U.S. Government Accountability Office (December 2020). DRUG PRICING PROGRAM: HHS Uses Multiple Mechanisms to Help Ensure Compliance with 340B Requirements. GAO-21-107. Retrieved online at https://www.gao.gov/assets/gao-21-107.pdf

A Patient’s Guide to 340B: Why the Program Matters to You

***This is the first report in a six-part series to educate patients about the 340B Drug Pricing Program***

In 1992, Congress struck a deal with pharmaceutical manufacturers to expand access to care and medication for more patients: If pharmaceutical manufacturers wanted to be included in Medicaid’s coverage, they’d have to offer their products to outpatient entities serving low-income patients at a discount. The idea was brilliantly simple; drug manufacturers could have a guaranteed income from participation in the Medicaid program, and “covered entities” could have guaranteed access to discounted medications. Congress set-up a payment system by way of rebates, affording healthcare providers a way to fund much-needed care to patients who could not otherwise afford it.

This payment program is little known but, now it is significantly large. It is the 340B Drug Pricing Program.

“At the inception [of the 340B program], these entities [Hemophilia Treatment Centers (caring for all patients with both bleeding and clotting disorders), Ryan White Clinics and FQHCs were specifically identified] were the prime targets to benefit from the  three major goals of the initial PHS pricing program: first, that pharmaceutical products would be purchased at markedly reduced 340B pricing; secondly, the discounts would be passed on to the payors and finally that a small, reasonable, percentage would go to the entity itself, to sustain Covered Entities to care and expand diagnostic and clinical services.”
– Dr. Diane Nugent, National Commission on 340B (2018)

Initially, covered entities were exceptionally restricted, including but not limited to federally qualified heath centers (FQHCs), Ryan White HIV/AIDS clinics, hemophilia treatment centers, and only one category of hospitals, so-called “disproportionate share hospitals” (DSH). DSH is a hospital entity that provides a “disproportionate” number of low-income patients, evaluated quarterly and calculated through a formula dictated by statute. Of these entities, those receiving federal grant dollars under any number of federally funded programs are called “federal grantees”.

Federal grantees are required by statutory language to certain transparency in how they spend their 340B-related revenue. In trade, participating drug manufacturers are also required to be transparent in their contributions to the program.

In addition, federal grantees are required to be transparent and accountable regarding their 340B-generated dollars by their federal grants, not by the statutory language of the 340B program. That means every dollar a federal grantee generates is held accountable to serving the needs of low-income patients. How these dollars may be used from grantee to grantee may look a little different but they’re still required to fit within the guardrails of the grant and, for many federal grantees, the most direct way of achieving this goal is sharing the savings with patients at the pharmacy counter. By its very nature, 340B’s purpose is to reduce the amount of tax dollars spent on these grants by providing an avenue of program revenue, and thus support existing efforts to provide care for the most vulnerable.

Over the years, covered entities have expanded to include contract pharmacies, family planning centers, children’s hospitals, critical access hospitals, rural referral centers, freestanding cancer centers, and sole community hospitals. From 1992 until about 2001, participation in the program by covered entities was fairly static – it didn’t grow or change in any massive quantity. After 2001, covered entities able to access the 340B program began to grow at an exceedingly fast pace, with even more growth among “covered entity sites” and the greatest amount of growth among contracted pharmacies. This was reflected in 340B sales, as well. According to the Drug Channels Institute, 340B purchases grew from about $2.4 billion in 2005 to more than $38 billion in 2020.

In general, 340B-related income looks like an insurer reimbursing the cost of a medication for a patient to a covered entity, a pharmacy filling the medication at the rebated cost with addition of a minor dispensing fee, and the covered entity keeping the excess as savings. Covered entities are allowed spend those excess funds in particular ways which qualify as “expanding access” to medication or care. For entities applying those funds directly to outpatient medications, this is known as “following the patient” or “sharing the savings”. Other uses may include anything that directly impacts access to or quality of care for low-income patients. Notable examples may include technology upgrades to be in-line with patient security and best practices in extending scarce human resources (i.e. how efficient care can be delivered to patients), acquiring new care technology to provide care not previously available (i.e. imaging and x-ray machines), and infrastructure like mobile medical units in order to bring care to patients rather than bringing patients to care or opening new locations in order to be more accessible to their served communities. 340B prohibits covered entities on double dipping on discounts or applying rebate dollars to inpatient medications or to a particular patient that does not qualify as low-income (“diversion”).

That patient getting their share of the savings makes a great deal of sense. Indeed, a Government Accountability Office report (GAO-18-480) of selected covered entities stated of 55 interviewees, 30 reported providing low-income, uninsured patients on 340B dispensed medications and all “30 covered entities providing patients with discounts reported providing discounts on the drug price for some or all 340B drugs dispensed at contract pharmacies. Federal grantees were more likely than hospitals to provide such discounts and to provide them at all contract pharmacies.” Patients realize the savings of the rebate program immediately. Benefits of the program which may be less recognizable to patients for a similar report from 2011 (GAO-11-836) included funding a non-revenue-generating case management program, patient and family education programs similar to guidance pharmacists provide on medication interactions, and transportation to and from care appointments. All of which are critically necessary in terms of creating a safety net of accessible care for vulnerable communities and patients.

For more information on the issues facing the 340B Drug Pricing Program, you can access the Community Access National Network’s 340B Commission final report and reform recommendations here 340B Drug Pricing Program.

Sources:

• Community Access National Network (February 2019). 340B DRUG DISCOUNT PROGRAM: The Issues Spurring Discussion, Stakeholder Stances and Possible Resolutions. 340B Commission Final Report. Retrieved online at https://docs.google.com/gview?url=http://www.tiicann.org/pdf-docs/2019_CANN_340B_Commission_Final-Report-v5_03-07-19.pdf&embedded=true

• Hasan, Shiraz, and Sofi Peterson (2021, April 16). 340B Drug Discount Program Growth Drivers. IQVIA. Retrieved online at https://www.iqvia.com/locations/united-states/blogs/2021/04/340b-drug-discount-program-growth-drivers

• Health Resources & Services Administration (2021). Sec. 340B PUBLIC HEALTH SERVICE ACT. U.S. Department of Health & Human Services. Retrieved online at https://www.hrsa.gov/sites/default/files/opa/programrequirements/phsactsection340b.pdf

• U.S. Government Accountability Office (2011, September). DRUG PRICING: Manufacturer Discounts in the 340B Program Offer Benefits, but Federal Oversight Needs Improvement. GAO-11-836. Retrieved online at https://www.gao.gov/assets/gao-11-836.pdf

• U.S. Government Accountability Office (2018, June). DRUG DISCOUNT PROGRAM: Federal Oversight of Compliance at 340B Contract Pharmacies Needs Improvement. GAO-18-480. Retrieved online at https://www.gao.gov/assets/gao-18-480.pdf

Where Public and Private Payers Fail, Patient Assistance Programs Step In

During Community Access National Network’s Co-Infection Annual Monitoring Report, hosted during this year’s SYNC Conference, in reviewing Hepatitis C (HCV) treatment coverages offered by state Medicaid and State AIDS Drug Assistance Programs (ADAPs), I stated “ADAPs play a critical role even in Medicaid expansion states. With the cost of medications for both HIV and HCV, even making just about the Medicaid threshold can create a catastrophic gap in patient financial stability. Given the distinct exposure risks shared for both disease states, ADAP advocates should consider the advantages of their programs to fill this need.” And…

Earlier this year, I wrote a guest blog for ADAP Advocacy Association regarding the funding situation for Georgia’s AIDS Drug Assistance Program in light of shortfalls due to COVID-19. While Georgia has since enjoyed the benefit of astounding state advocates’ work, a hole in the program remains. At the bottom of Georgia’s most recent ADAP formulary a notice reads as follows: “Georgia ADAP Hepatitis C Program is currently on HOLD until future funding is available. Please utilize Patient Assistance Programs (PAP’s) for Hepatitis C medications.” Georgia wasn’t the only state to consider ceasing coverage of HCV medications, Texas did as well, though Texas has since added a single direct acting agent back into their ADAP formulary. In discussing the state’s funding shortfalls earlier this year, state representatives mentioned to providers referral to patient assistance programs in order to meet patients’ needs.

The summation here is publicly funded programs are not always aptly designed to meet the needs of vulnerable populations. Indeed, Harvard’s Center for Health Law and Policy outlines barriers to care instituted by public payers, like ADAPs and Medicaid programs, in an annual report. These barriers largely mirror the barriers to care instituted by private payers, wherein private payers argue these are necessary “cost containment” measures (otherwise referred to as “utilization management”). However, for patients, these “cost containment” measures largely amount to “care containment” measures and, frankly, do little more than push patients out of care through administrative burdens, commonly manifested as lengthy appeals processes or requirements for sobriety.

When public and private payers fail patients by refusing coverage of HCV treatments, they also fail our public health goals, perpetuating preventable illness and death. In the space where payers deny coverage and where people cannot afford coverage due to premiums or deductibles or being too high or where patients simply can’t afford insurance coverage and can’t access public programs, patient assistance programs step in. Patient assistance programs may be run and funded by medication manufacturers or by community-based funding programs and navigation information tools.

CANN’s quarterly Co-Infection Watch monitors HCV specific patient assistance programs for status and limits, in order to make identifying resources easy for patients and advocates reviewing the report.

While these tools are excellent tools of last-resort, they are limited and cannot be used as a substitute to sufficient public funding, regulation or legislation ensuring non-discriminatory plan designs, and adequate patient protections. Public payers have come a long way in abandoning caustic programmatic barriers for patients to jump through in order to access care and medication and private players have much farther to go. Regardless of circumstance, neglecting this critical medical intersection by way of foregoing HCV medication coverage is a public health and public payer program failure. All it does is kick a snowball down a hill. We’re already set to fail meeting our 2030 goals toward HCV elimination. We must do better to ensure this problem, at the very least, doesn’t grow.