Industry’s Changes to 340B Drug Discount Program

****The following is a joint statement by Jen Laws, President & CEO of the Community Access National Network, and Brandon M. Macsata, CEO of the ADAP Advocacy Association****

The Community Access National Network (CANN) and ADAP Advocacy Association, back in October 2020, issued a Dear Colleague letter to our industry partners in the pharmaceutical manufacturing space surrounding HIV therapies. We detailed our concerns regarding the 340B Discount Drug Program and the necessity to ensure safety-net public health programs do not “get caught in the crossfire between pharmaceutical companies and contract pharmacies.” Our efforts led to constructive conversation, as well as a commitment to protect patients access to timely, appropriate care and treatment. Essentially, we sought a “carve out” for certain Covered Entities, namely the Ryan White Grantees (“Grantees”) serving clients living with HIV/AIDS.

In the time since, considering our collective concerns for the sustainability, stability, and honest efforts to provide necessary services to PLWAHA, many of our industry partners have ensured additional efforts at transparency and accountability do not add to already existing reporting burdens of the Grantees. We still contend that the carve-out is essential to avoiding possible damaging effects on the safety-net programs crucial to the HIV-positive community.

Unfortunately, a few of our industry partners have express concerns about “bad actors” trying to encroach on the federal grantee carve-outs industry partners have thus far offered in requesting additional reporting of 340B Covered Entities. It has been our earnest position that solving the problems facing the 340B Drug Discount Program are achieved in a way that preserves benefit to patients and intent of the program while protecting against bad actors. However, any effort requires a scalpel, not a hatchet. The carve-out of these additional reporting requirements, in light of the oversight already offered by being federal grantees, has helped our industry partners align their values with their actions in working to ensure program integrity and minimize risks to patient benefit.

It is important to recognize the historical and current reality many Grantees face. Yet, should pharmaceutical manufacturers insist on blanket reporting requirements for all Covered Entities void of any carve-outs, it should be done by supporting these Grantees, and thus the services and medications their patients rely upon. We urge our industry partners to pair any new reporting requirements with funding for the following activities:

·        necessary expertise to navigate the establishment of third-party administrator and contract pharmacy agreements.

·        extend program initiation funding for the 3 years after qualification to meet the labor needs of fulfilling this reporting requirement.

·        develop other programming clinics specifically identify to work collaboratively.

Whereas our two organizations have long-supported reforms to the 340B Drug Pricing Program, because they are overdue and opportunities exist to ensure every single penny squeezed out of the program directly benefits patients, let’s not throw the baby out with the bathwater. Provided our industry partners are genuine in their expression and desire to preserve 340B’s intent to benefit patients, the aforementioned steps are modest and support appropriate transparency and accountability.

Respectfully, we believe any genuine effort to introduce added reporting burden on Grantees, of which are already most closely monitored in the 340B space, must also include support to meet these burdens. Any adjustments to Grantees’ reporting supported by funding and programming designed for Grantees to be “set up for success” on all accounts. We believe our industry partners are up to the task at hand and maintain the integrity to align actions and values.

Provider Survey: Prior Authorizations Harm Patients

The issue of prior authorizations (PAs) comes across my plate quite frequently. Really, it’s bigger than PAs. PAs are but one of several types of practices known as “utilization management” and it’s also one of the fastest ways to get me hot under the collar in a way reminiscent of the fury and frustration of a poison oak rash. But PAs are particularly notorious because they’re one of the methods of utilization management health care providers have to directly engage with, rather than something saddled in the lap of a pharmacist or patient at the point of sale. If you haven’t run into the issue of prior authorizations, let me back up some and give you a brief explanation.

The health insurance you get when it’s branded with a major corporation’s name (rather than a government program) is either a commercial plan or that of the same entity working as a “managed care organization” on behalf of a government funded program. But that package is generally two different types of benefits packaged as one, medical coverage over the cost of seeing your doctors and getting labs and pharmacy coverage over your prescription medications. Just like when your medical coverage limits the type of provider you can see or the facility “in-network” they’ll pay for you to go to, your pharmacy benefit may include a limit or design to steer you toward a limited network of pharmacies and that benefit decides what types of medications they’ll cover, what they’ll make you pay in cost sharing (co-pays), and what hoops you have to jump through when they don’t want to cover a particular medication because it’s costly. One of the ways both of these types of benefits seek to discourage patients from seeking out expensive care or medications is by making your provider ask them pretty please if you can have a particular treatment. This is a prior authorization.

But who calls the shots when your doctor and the pharmacy benefit manager (PBM) disagree about you needing that specific treatment? That’s a complicated answer and what happens to patients navigating that space of waiting for your doctor and PBM to communicate and figure things out is not well studied in clinical terms. PBMs generally ask a third-party with expertise to make a medical decision on if you really need that particular treatment or if something else might be…ok based on the reasons your provider says you need that specific treatment. The thing is, the PBMs both pick and pay that third-party. There is no truly independent arbiter to navigate a coverage decision. That third-party has a vested interest in maintaining their business model and keeping the folks who write their checks happy. And those folks aren’t you or your doctor. They tend to view the PA under the lens of a singular condition, lacking the whole context of your health needs and history, and while “medical necessity” is the most common claim needed to get around a PA, proving that can often be a onerous and sometimes lengthy process.

None of that addresses that your doctor is your doctor for a reason. They’re intimate with your personal medical situation, co-occurring conditions, things like how big a pill you can swallow without choking, what vitamins you take, and more. There is never a better decision-making process than the one made between patient and provider.

The best way to explain the PA process is calling it “deny and delay”. Deny the claim, delay a patient getting the care they need. There’s a quiet and underlying assumption that patients and providers are picking their care based on what costs the most, which neglects the fact that plan designs already make it ridiculously challenging for the average person to afford even basic care, much less care required to manage chronic conditions. Sky-high premiums and deductibles to tune of thousands of dollars mean most patients simply can’t afford to pursue costly care, even if you need it.

The American Medical Association has sought to measure these experiences and outcomes with a physician survey, asking doctors and their administrative staff to quantify what’s going on for doctors offices and patients when running up against PAs. The survey findings are shocking but not surprising if you, dear reader, can recall any time you’ve already had to navigate a PA. Let’s run down the top line numbers:

- 93% of participants said PAs delay care for patients (up from 92% in 2017)
- 82% of physicians said PAs lead to medication abandonment at least sometimes (24% said “often” and 2% said “always”)
- 91% said PAs have a “somewhat or significant” negative clinical impact on patients
- 51% said their patients had to take time off work in order to navigate a PA
- physicians said they had to manage about 41 prior authorizations a week and have to dedicate about 2 full days a week to navigating PAs with about 40% of their staff solely working to manage the paperwork associated with PAs

Patient outcomes were seriously impacted by PAs with 34% of physicians reporting they had patients experience adverse events as a result of delayed care due to PAs, 24% of physicians said they’ve had patients hospitalized waiting on an approval from their insurer, 18% reported that a PA lead to a life threatening event for a patient, and 8 % of participating physicians said PAs have lead to patients becoming disabled, experiencing cognitive anomaly, permanent bodily damage, birth defects, or even death.

Here’s the kicker, while 98% of providers have found claims by insurers their PA policies are evidenced based, only 30% of physicians agreed those policies in practice were actually evidenced-based.

All of this is to say, providers see payer abuses of utilization management harming patients quite regularly all in the name of profit making for insurers and PBMs. An insurance policy isn’t worth the paper it’s written on much less the money spent if, in the end, patients can’t actually get the care they’re paying for. If a provider’s contentious process of educating a patient about their health, why they need a particular treatment, and monitoring of that health condition to a patient’s benefit is how a consumer would generally define “practicing medicine”, then the denial of that specific care must also be considered “practicing medicine”. We don’t pay insurers to practice medicine, we pay them to cover the costs of our care.

For their part, the AMA has also previously suggested 21 principles in the reform of utilization management in order to stop the practice of payers practicing medicine by utilization review. Clearly, more needs to be done on the legislative and regulatory fronts in order to protect patients from these predatory and abusive practices. Insurers and PBMs are excellent at planning ways to punish legislative action and patients if constraints are placed on them. It’s time our law makers and government begin responding to existing abuses of our health care ecosystem and affirmatively anticipate market adjustments favoring profit over patients. It’s beyond time government funded programs require payers to actively engage patients in feedback processes and meet minimum metrics of patient success and satisfaction as the government does with all other stakeholders receiving those dollars. Payers can no longer be exempt from the basic decency required to be a full-fledged player in health care rather than the grifter status they enjoy right now. Patients simply can’t afford it.

Treatment Restrictions Hampering Hep C Harm Reduction Efforts

In January, Harvard’s Center for Health Law and Policy Innovation (CHLPI) and the National Viral Hepatitis Roundtable (NVHR) issued their 7th update to the Hepatitis C: State of Medicaid Access report. Originally published in 2017, the report seeks to evaluate and document the nuances of Hepatitis C treatment access in state Medicaid programs and was borne out of the payer originated barriers instituted after curative direct acting agents (DAAs) came to market as concerns over cost rose, especially in light of the fact that a patient being cured does not mean they cannot be re-infected and the most at-risk population for contracting HCV are drug users. The combination of moralized policy making and fiscal fears set the stage for Medicaid to offer curative HCV treatments as a “yes, but…” situation.

Medicaid coverage of treatment came with layers of restrictions on patients and providers alike. From more common utilization management practices, like prior authorizations, to restrictions in who can access treatments (sobriety and fibrosis requirements) and requiring patients to visit a specialist in order to receive coverage (when a primary care physician should be able to manage the necessary care), barriers abound. Harm reduction advocates rightly pointed out refusing treatment coverage worked against best practices in interrupting HCV chains of transmission. Indeed, the American Association for the Study of Liver Diseases has strongly discouraged sobriety requirements because doing so artificially inserts barriers to care and harms public health efforts to eliminate HCV, stating:

… there are no data to support the utility of pretreatment screening for illicit drug or alcohol use in identifying a population more likely to successfully complete HCV therapy. These requirements should be abandoned because they create barriers to treatment, add unnecessary cost and effort, miss an opportunity to decrease HCV transmission, and potentially exclude populations that are likely to obtain substantial benefit from therapy. Instead, scaling up HCV treatment in PWID is necessary to positively impact the HCV epidemic in the US and globally.

The pushback against the moralized argument, which frames drug users as “unworthy” of receiving potentially life-saving care, is that people who use drugs are still patients and we don’t get to tell patients how to prioritize their care based on a payer or provider’s biases. Just as providing gender affirming care results in improved health outcomes in transgender people living with HIV, providing people who use drugs with the medical care they need to cure HCV improve the behavioral health factors that contributed to drug use in the first place.

CHLPI and NVHR’s work has contributed to awareness of these policy issues, with the updated report being used as an effective tool in advocacy for removing these unethical restrictions on accessing HCV treatments. Since the 2017 report, 33 states have eliminated or reduced their fibrosis requirements, 29 states have eliminated or significantly relaxed their sobriety requirements, and 28 states have reduced their qualifying prescriber requirements.

Similar qualitative evaluation of other “harm reduction” policies, should be done to consider how these policies may potentially work against the goals of why they were instituted in the first place; including but not limited to Good Samaritan laws (where carve outs for those reporting over doses may result in the reporter being charged with a crime, rather than protected for seeking help) and “lock-in” laws and policies (where a patient may not be allowed to seek a different pharmacy or provider). In each of the two examples, people who use drugs are discouraged from engaging with public service personnel by disempowerment and threat of criminalization, risking either losing a patient in care or losing a life.

The mark of quality policy making, much like the mark of good science, is being willing and able to consider changing things when the facts of a given situation change or the available information changes. If we are to meaningfully invest in harm reduction policies at the intersection of drug use and HCV, we have to get a handle on what’s working and what’s not. And we have to learn not to repeat our mistakes in the coverage restrictions finally falling out of favor.

A Call to Action: HIV Advocacy Must Affirm the Human Rights of Transgender People

The Community Access National Network (CANN) recently announced a campaign designed to promote transgender leadership in HIV advocacy. The campaign’s foundation is centered on a Values Statement on Affirming the Human Rights of Transgender People. Why?

Last year, after Terrence Higgins Trust of the United Kingdom united HIV advocacy and service organizations in providing a statement of support of the human rights of transgender people, William Arnold asked me, “Has anything like this been done here?” My answer was frank, “not precisely.” I explained what typically happens is HIV advocacy and service organizations issue statements of support independently of one another but often tend to lack defined actions, policy goals, or a commitment to more than words. Perhaps there’s programming our partners have but they’re often managed by cisgender peers or don’t speak to the actual needs of transgender people. Similarly, if they are grant-making entities, funding awards are often given to large umbrella organizations rather than smaller by/for organizations. This comes at the detriment of a diversified brain trust, unique employment offerings tailored to trans communities, and consolidates services and power outside of the reach of transgender communities…or at least, outside of our trust. Our power is often undercut because it is just easier to give funding to larger umbrella organizations.

“We should do something about that,” Bill told me. He always had the vision to understand that we cannot solve the health disparities in HIV without addressing the holistic needs of communities living with these disparities.

As 2022 politics offer this country a horrific but robust “trans panic 2.0” by way of more than 280 proposed pieces of state legislation and policy attacks, which often garner much less attention and have fewer remedies than campaigning against legislation or law suits, now is the time for HIV advocacy organizations, service providers, and funders to commit themselves to defending and advancing the human rights of transgender people.

A cornerstone of Bill’s personal mission was ensuring access to life saving medications for everyone who needed them. Such a mission is centered in a sense of justice and, frankly, love. It’s a mission, ultimately that all HIV advocacy, service organizations, and funders share. To that end, I need to be clear and to state that under no uncertain circumstances, gender affirming care is lifesaving care. Indeed, gender affirming care improves the HIV-related health outcomes of transgender people. In order to End the HIV Epidemic, in order to fulfill the promises many of us have made to our predecessors, our families, our loved ones lost in the fight against HIV… in order to fulfill our sacred promises, we must affirm and defend the human rights of transgender people in all aspects of life. We must do so in concert, in a fashion coordinated to support existing services and advocacy dedicated to transgender people and communities. We must do so with a unified and collaborative voice that uplifts, empowers, and invests in transgender people, communities, leadership, and rights.

On the issue of the human rights of transgender people, we can no longer act independently of one another or divorced from the transgender advocates already dedicated to this space. In order to act with the integrity this moment and movement needs, our partners must also commit to living the principles reflective of these human rights. Our houses must be in order as it were. In order to End the HIV Epidemic.

We are calling on all our partners to join us in support of affirming the human rights of transgender and gender diverse communities, to commit to the development of transgender leadership within our organizations and empower the self-determination necessary to End the HIV Epidemic.

Nonprofit organizations, community partners, and industry partners interested in lending their support to CANN’s campaign to promote transgender leadership in HIV advocacy, go to https://www.surveymonkey.com/r/XT8LCN7.

Biden’s State of the Union: Bold Promises on Public Health

On March 1st, President Biden delivered his first State of the Union Address to both chambers of Congress and the American people at large. Amid a slew of foreign and domestic policy proclamations, particular attention should be afforded to the statements and commitments made about addressing the COVID-19 pandemic and public health, more broadly. Championing the landmark legislation that was the American Rescue Plan, the President laid out how the legislation’s programming reduced food pantry lines, increased employment, and how expansion of the Affordable Care Act’s subsidies resulted in lower insurance premiums for many Americans. In addressing the COVID-19 pandemic, Biden also recognized a sobering outcome that will shake the nation: within the next few weeks, the United States’ official COVID death toll will surpass one million people. Though the President misstated the moment in that those empty seats at dinner tables will be more than a million; on average each COVID death has impacted 9 other people, including orphaning children across the country. Biden then shifted the address, citing the Centers for Disease Control and Prevention’s recent announcement of adjust masking guidelines and metrics of risk, trying to signal a much-needed political win in the fight against COVID. However, immediately following these statements, the President also focused on providing the country with another round of free at-home COVID-19 tests and implementing a tactic already well-known in the HIV space: test-to-treat, with added bonus of the program following the COVID vaccine model and having no out-of-pocket expense for patients.

The program ideals outlined in the days that followed found some confusion, need for clarity, and even some professional association bickering. Public health professionals who have long advocated for more robust responses to the pandemic took to news outlets to vent their frustrations and the American Medical Association drew derision on social media for their statement discouraging pharmacists prescription and provision of COVID antivirals. Pharmacists have long been a target for HIV advocates, especially in terms of increasing pre-exposure prophylaxis (PrEP) access and decreasing test to treat initiation delays. Wouldn’t it be nice if this COVID program provided a model outside of vaccination in which pharmacists could also serve a more robust role in facilitating seamless treatment and prevention? The meaningful hiccups the administration and advocates should keep a close eye on in this regard is the labor shortage of pharmacists, closing of more rural locations for chain pharmacies, and any developments around anti-competitive practices of pharmacy benefit managers (PBMs) associated with pharmacies. Consequences of these will extend beyond immediate COVID programming and ideal HIV programming.

The President also made statements referring to medication costs and price controls and needing to make sure more Americans could afford their care. However, details were lacking and if any recent effort is indicative, singularly focusing on manufacturer list prices won’t address patient costs or get much anywhere. Buyer beware, some proposals in the apparently sunk Build Back better legislation would also cut provider compensation in public payer programs, a dire consequence as the nation struggles with health care staffing shortages. Those shortages should be noted in detail because the American Rescue Plan provided funding meant to supplement the financial demands of staffing a pandemic and there’s good reason to suspect administrators, rather than providers, enjoyed the fruits of that labor. Further, most Americans experience their out-of-pocket costs of care due to the benefit design of their insurer (and PBM), not the manufacturer list price. Indeed, the Biden Administration appears to eb as insurer friendly as the Obama admin. To impact the costs facing patients more meaningfully at the pharmacy counter and other burdens in accessing medication, the Biden administration should focus more on developing patient protections via the regulatory process, limiting the aggressive utilization management (or deny-first coverage) policies, increasing formulary restrictions, and discriminatory plan design. Some of the tools for doing so already exist, but the federal government has yet to curb the tactics of payers in avoiding their responsibilities under the ACA’s medical-loss-ratio rules or ensure payers are not inappropriately applying cost-sharing for qualifying preventative medications and services.

The President also became the first to mention “harm reduction” in a State of the Union Address. Urging Congress to pass the Mainstreaming Addiction Treatment Act (MAT Act), President Biden is seeking to fulfill his commitments to address the opioid epidemic and move toward modernizing domestic drug policy. In a sign of acknowledgment of the scope and size of substance use epidemic in the country, Biden endorsed recovery programs and recognized the more than 23 million people struggling with addiction in the country. Immediately following the MAT Act mention, the President moved on to address of a lesser defined but equally important need in encouraging commitment to a robust set of policy ideals aimed at meeting the mental health needs of the country.

All these good things can easily be outweighed by what wasn’t mentioned. President Biden did not mention any interest in extending another round of stimulus payments, despite the program resulting in one of the largest reductions in poverty in US history. And while there was focus on rebuilding the nation’s health care staffing, no mention was afforded to rebuilding the nation’s public health infrastructure. Meanwhile, we’ve known for quite some time poverty as a notable association with HIV and decreasing poverty also decreases HIV risks and prevalence, data remains in the decline with regard to HIV and STI screenings, Hepatitis C rates are still on the rise, and inconsistencies in PrEP usage during the height of initial COVID waves likely foretells a more diverse at-risk community. Even the government’s own HIV.gov webpage dedicated to the State of the Union fails to mention any HIV or HCV specific programming efforts associated with the address.

While there’s much to celebrate about the President’s COVID goals, advocates should be cautious about projecting those goals onto other public health efforts. Afterall, COVID proved we could provide more up to date reporting than the 2 year delays we typically see in HIV and HCV surveillance, but we haven’t. COVID-related telemedicine expansion was welcomed by patients across the nation but Congress is poised to claw back those gains. For many of us, while the state of the union is improving coming out of the Omicron wave of the COVID-19 pandemic, much work remains. Including reminding this administration that it is empowered to protect patients, access to and affordability of care, an obligation to invest in public health programs beyond COVID and has committed to advancing efforts to End the HIV Epidemic.

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