340B Drug Discount Program: Here’s What Patient Advocates Need to Know

The 340B Drug Discount Program for years has had little attention, aside from a few Congressional Hearings. As we cited last month in a blog, 340B program purchases has more than quadrupled in the last decade, now exceeding Medicaid’s outpatient drug sales. This growth has disturbed the bargain made between manufacturers, providers, and lawmakers in 1992, often leaving patients out of the benefit meant to be gained by the program.

Because 340B is an exceedingly nuanced payment system design, lawmakers have been reluctant to touch the issue – fearing a need to “crack” into the legislation, lacking agreement on how to proceed, and having to balance interests that are often in conflict – preferring to leave the management of issues arising around 340B to the Health Services Resources Administration (HRSA), which then has the unfortunate duty to remind lawmakers, the agency’s statutory authority is limited, and their budget is not large enough for more meaningful oversight. As administrations change, so do the perspectives on how to ensure the intent of 340B, making sure poorer patients can afford and access outpatient medications and the care required to acquire those medications, is captured in how the programs actually operates. Leaving us with the current situation of competing interpretations and interests heading to the court system to find answers and settle disputes.

Part of this program growth is driven by hospitals as a type of “covered entity”; a 2015 analysis showed the program having grown from about 600 participating in 2005 to more than 2,100 hospitals in 2014. In fact, a 2018 Government Accountability Office report found “charity care” and uncompensated care provided by hospitals receiving 340B revenue had steadily been decreasing over the years. The Affordable Care Act has something to do with that – in extending Medicaid eligibility, the Medicaid qualified population grew and as enrollment grew, so did the amount if “disproportionate share” of Medicaid patients certain hospitals served. Ultimately, this meant more hospitals qualified for the 340B Drug Pricing Program than had prior to the ACA.

Another reason for program growth is an expansion of definition of “covered entities” to include contract pharmacies – which have grown as an industry – used by federal grantees like federally qualified health centers (FQHCs) and hemophiliac clinics. Tim Horn, director of the Health Care Access team at the National Alliance of State and Territorial AIDS Directors, described why it was necessary for this expansion, in particular to Ryan White clinics, serving communities affected by and vulnerable to HIV as opposed to limiting program qualification to those pharmacies run and owned by clinics themselves, “340B contract pharmacies are vital to Ryan White and other safety net providers for a couple of important reasons: they help ensure equitable access to affordable medications by uninsured clients, including patients who might live too far from a program's in-house pharmacy, and they help programs maximize their ability to generate essential revenue on prescription fills for insured clients.”

Regardless of entity type, most patients access care through a “payer” (health care insurance provider, be they public – like Medicaid managed care organizations – or private), who play a central role in the 340B payment system design. In turn, this means “pharmacy benefit managers” (PBMs - who sometimes also own the contract pharmacies in question) also play a central role, by designating schemes for how providers are reimbursed for care they’ve provided or medications that have already been dispensed. Jeffrey Lewis, a board member of Community Access National Network and President & CEO of Legacy Health Endowment, described how some PBMs engage in discriminatory practices by paying for 340B drugs at lower rates than non-340B drugs, reducing the benefit Congress intended to give 340B hospitals and clinics:

“340B providers receive less revenue than if 340B drugs are reimbursed at normal non-340B rates. That loss of revenue results in 340B providers having less money to underwrite the cost of providing uncompensated care, including serving uninsured or underinsured patients or providing services that insurers do not reimburse. PBMs, on the other hand, retain the difference between the 340B and non-340B payment rates for themselves. This program "benefit", which was intended to go to non-profit safety net providers, ends up going to for-profit PBMs instead. In this manner, PBMs' payment policies prioritize PBMs’ for-profit interests over 340B providers' non-profit missions to support public health.”

The center of one of the most pressing actions to date is “who’s job is it to make sure the rules are being followed?” with manufacturers being the first to move – by way of seeking the ability to require entities wishing to participate in 340B to provide additional claims data. Lewis points out that in a unanimous Supreme Court decision in 2011, courts had previously interpreted covered entities as lacking authority to seek enforcement against manufacturers, so the same must be true in reverse, requiring all parties to use a dispute resolution process dictated by HRSA. Indeed, the ruling even goes so far to cite the ACA’s directive for HRSA to issue a formal “alternative dispute resolution” process. However, HRSA failed to formalize this process in a final rule until December 2020. That rule is now part of a patch work of suits from manufacturers looking to the courts for clarity, with manufacturers arguing that statutory enforcement can’t be one-sided – if manufacturers must provide these discounts, someone should be ensuring the entities receiving these discounts are actually using them for patients and HRSA, by their own admission, doesn’t have the capacity to do so. Of note, Justice Ginsburg, who pinned the 2011 ruling in Astra USA, Inc., noted HRSA’s failure to bilaterally enforce the rules did not necessarily provide for a right of action by 340B actors.

Nonetheless, 340B remains a critical source of revenue for Ryan White clinics and other federal grantees already meeting the legislative intent of the program, at least generally better than other payer and provider actors in this scheme. As a result of sustainable federal funding and legislators prioritizing public health funding, federal grantees are scrambling – and manufacturers should consider how best to not harm the “good guys” in what ever actions taken next. Indeed, NASTAD’s Tim Horn stated:

“340B program revenue will always be an important – and dynamic – supplemental funding source for our HIV care programs, particularly where Medicaid has not been expanded and where federal and state funding is both limited and inflexible. A number of factors that have real or potential impacts on 340B…are now requiring serious discussions regarding the sustainability of program revenue generation. Simply put, we're not going to end HIV as an epidemic without significant and nimble funding required to support the myriad medical and support services associated with the best possible health outcomes. 340B revenue is a substantial part of this and, absent alternative funding streams to ensure that these programs remain whole, will remain the lifeblood of HIV service delivery in the United States.” 

Legacy Health Endowment’s Jeffrey Lewis agreed:

“The value and importance of the 340B program are well known. However, where there is ambiguity, it impacts both covered entities and patients. With the positive growth of covered entities to serve more people in need, Congress must take a thorough look at why 340B was created, its absolute value and tackle the tough questions where ambiguity may exist. Clarity is needed now more than ever to stop pharmaceutical companies from indiscriminately deciding whether and how to participate and prevent jeopardizing patients' lives. Similarly, Congress has an obligation to evaluate the role of PBMs and Third-Party Administrators (TPAs) operating in the 340B space and set a specific rule regarding revenue sharing. The 340B program was created to aid covered entities in serving more people in need. Unfortunately, every dollar taken by PBMs or TPAs reduces the ability of covered entities to care for more and more patients.

Clear legislative intent and rules are critical to ensuring program stability and, ultimately, safety net provider stability. Ryan White Centers, Hemophilia Centers, FQHCs, and rural hospitals as particularly vulnerable to Congressional, HRSA, and OPA ambiguity. The current and future failure to clarify the uncertainty of the 340B program jeopardizes patients and the financial stability of covered entities.”

While the finger-pointing on “who’s at fault” for an unsustainable program growth rages on and works its way through both the courts and the minds of lawmakers or who is responsible for drawing the lines in which manufacturers, providers, and payers can color inside of, the only thing clear is the population this program is meant to serve is not receiving as much benefit from the program as it should. We could say “patients” here, but that word apparently needs to be defined with regard to 340B. In the end, all stakeholders, outside of lawyered language, know exactly who has been harmed by bad actors in the 340B landscape. Everyone with power in this minefield would do well to remember that.

We invite you to download the 340B Final Report, issued by the Community Access National Network’s 340B Commission.

Community Roundtable Emphasizes Impacts of Covid-19

In late June, Community Access National Network hosted a virtual Community Roundtable on Covid-19’s Impacts on HIV, Viral Hepatitis, Sexually Transmitted Infections, and Substance Use Disorder. CANN’s policy consultant (yours truly) was joined by A. Toni Young, founder and executive director at Community Education Group, and Kenneth Westberry, senior manager of policy and government relations at the National Coalition of STD Directors, in discussing the wide-reaching impacts of the Covid-19 pandemic and subsequent public health emergency on the nation’s longest and most well-funded public health service providers…so far. Attendees included representatives from patient advocacy organizations, state and local health departments, clinical laboratories, hospitals, pharmseutical companies, and federally or state funded service providers from 20 states and the District of Columbia. The event was sponsored by ADAP Advocacy Association, ViiV Healthcare, Abbvie, Merck, and Janssen Pharmaceutical Companies of Johnson & Johnson.

Toni started off a whirl wind of information with making direct comparisons between the previous year’s overdose death rates and this year’s and emphasizing the plight of West Virginia by comparing the nation’s increases to the state’s. This opened the roundtable with a clear message that would ring through with every new data point: the pandemic’s impacts are not equal. Building upon the point made in a blog post earlier this year, Toni pointed to a stark decrease in HCV screening and, more pointedly, reviewed available data on HCV medication access – showing a decrease of 37-48% during the first few months of the public health emergency. She warned listeners not view initial lower incidence rates as optimistic, rather these findings should be viewed under a lens of a lack of access to screening and services. She further stressed the lack of SUD services accessed at the beginning of the pandemic resulting in alarming increases in injection drug use-related HIV diagnoses as a year over year trend with 2021 looking even more worrisome. Rounding out this segment of the roundtable, Toni cautioned attendees: we have good reason to believe screenings will not necessarily return to their pre-pandemic levels in a speedy fashion or without additional effort and funding.

I followed Toni’s dynamic presentation, picking up with the Centers for Disease Control and Prevention surveillance reports for 2015-2019 – reminding the audience federal level data often lags by two years and the CDC has already presented data for 2020 on fewer HIV tests being performed. This portion of the presentation highlighted disparities in HIV along geography, racial and ethnic lines, as well as sex assigned at birth. I needed to note: gender identity is not uniformly collected data in HIV surveillance. The CDC’s pre-exposure prophylaxis data was similarly…unfortunate. With right around 10% for Hispanic/Latino people identified as living at risk for HIV receiving PrEP services and medication in 2018 and just over 6% of African American/Black people living at risk for HIV receiving PrEP services and medication in the same year. Similarly, people assigned male at birth were more likely than people assigned female at birth to have access to PrEP. Looking to the pandemic, I cited two Kaiser Family Foundation reports one on the similar disparate impacts between HIV and Covid-19 among racial and ethnic communities compared to their white peers and the other on Covid-19’s impact on Ryan White service providers. The KFF reports showed service providers reporting an increase in patients without insurance or receiving Medicaid, some clinics reporting a decrease in patient retention and other reporting increases in patient retention, and clinics reporting a decrease in patient demand for HIV screenings and accessing PrEP services.

The final presenter, Kenneth Westberry, began by giving a brief overview of the state of STI’s as public programming: a steady increase year over year in reported STI incidence, a lack of significant funding increases in the last 15 years, and nearly 40% of clinics reporting a decrease in hours or closing entirely during the height of Covid-related restrictions. Of the particular burdens, Covid-19 brought state and local health departments, nearly 80% redeployed their staff from STI programming to Covid-19 programming, reducing capacity to manage STI caseloads, and facing an unprecedented lack of testing supplies as manufacturers also refocused on making Covid-19 tests. Kenneth then reviewed the findings of NCSD’s surveys seeking to evaluate the state of STI programs (phase I, phase II, and phase III) showing many health departments are still behind in terms of having enough staff to meet the needs of both Covid-19 as a public health emergency and regular STI programs.

Moving onto the nuts and bolts of the federal response to Covid-19, Kenneth highlighted the role of disease intervention specialists historically and in response to Covid-19, answering the “why” the Biden Administration’s change in stature toward the pandemic was critically necessary. Particularly, the American rescue Plan Act added $1.13 billion to expand and sustain current DIS and the President’s budget request includes an increase in funding for STI programs in addition to current spending levels.

The three panelists then spent a brief amount of time discussing the funding weaknesses exposed by Covid-19 diverting resources. In a particular “shot across the bow”, Toni stated “Health departments and appropriators have learned Ryan White dollars aren’t sacrosanct anymore. If the emergency is big enough, they can grab those monies,” urging advocates to keep on their toes and watch actions at the state and local as much as they do at the federal level. Each panelist also mentioned a need for greater collaboration between “silos” in order to reach the nation’s lofty public health goals with regard to HIV, HCV, STI’s, and SUD.

Panelists wrapped up by highlighting upcoming events for each organization, sharing resources, and once again thanking each other, attendees, and sponsors. The slide deck can be downloaded here.

Future events will be hosted to ensure we’re “tracking what’s on the ground” and connecting community partners with pertinent resources and information.

Emergency Alert: Substance Use Safety Net in Trouble

In April, the Biden Administration released a Statement of Drug Policy Priorities, outlining areas of improvement and policy priorities necessary to address the nation’s opioid epidemic. The statement was followed up in May by the Substance Abuse and Mental Health Services Administration (SAMHSA) announcing $3 billion in block grants to be distributed to states as emergency funding related to the American Rescue Plan Act, passed in March. The press release from SAMHSA highlighted preliminary data from the Centers of Disease Control and prevention (CDC) showing an estimated 90,000 overdose deaths in 2020, a 20,000 overdose death increase from 2019. Belying the nature of “emergency”, the SAMHSA announcement came 2 months after President Biden signed the American Rescue Plan Act, the release did not include a timeline for these block grants to be received by states or any indication from SAMHSA that guidance attached to use of these funds would be forth coming. That’s a problem for substance use treatment service providers who have been struggling to keep their doors open and services flowing throughout the COVID-19 public health emergency.

According to Michael Pickering, executive director for Regional Addiction Prevention, Inc. (a residential treatment program in Washington, D.C.), residential programs had to cut the available number of patients who could be housed at any given time, in order to help slow the spread of COVID-19 and reduce risks of clients and staff contracting the virus while restrictions were in place. That meant revenue necessary to operate shrunk dramatically. However, in order to maintain a minimum number of services, not many staff were reduced. Ultimately, these combined factors underscored a long-term issue as the agency faces potential closure: private and public payer rates for are so low that even the slightest emergency could be catastrophic for many substance use service providers.

Indeed, the Centers for Medicare and Medicaid Services (CMS) last adjusted addiction treatment services reimbursement rates for inflation in 2016 – meaning the “basement” for reimbursement hasn’t increased in 6 years while the rest of costs associated with providing care have grown. According to one entity, CODAC Behavioral Healthcare, reported reimbursement losses of nearly 40% from Medicaid on a 45-minute treatment session. The same report cited the American Society of Addiction Medicine (ASAM) as stating Medicaid as the largest payer of medication assisted treatment (MAT) for opioid use disorder, accounting for anywhere between 35 and 50% of services provided in the hardest hit states.

Tucked among Biden administration priorities in drug policy is a familiar statement regarding racial equity in health care. At the intersection of disparities in access to care and lack of health equity along racial lines is Medicaid’s low reimbursement rate. A study, included in the Statement, specifically highlighted how few private providers accept Medicaid for substance use treatment, opting instead for “cash-pay only” policies, resulting in a concentration of services provided to white people and leaving an unmet need among people of color, who have also been disproportionately impacted by the COVID-19 pandemic.

While the Biden administration also cited a need to recruit and retain medical providers and staffing talent to stigma, low reimbursement rates also translate to low compensation relative to other areas of health care and substance use services require more time to functionally provide for the needs of a client than other areas of health care. This leaves clinics and providers serving the public with an exceedingly high turn-over rate; CODAC cited a near 50% turnover rate for 2019. Just as with federally qualified health centers, compensation rates tied to clinic revenue (reimbursement rates) and grant awards that aren’t meaningfully increased, can’t compete in terms of compensation – the private sector, focused on profit margins and serving well-to-do clients, can readily recruit skilled talent from public service entities with more attractive compensation packages.

The administration’s priorities in drug policy are lofty and admirable, with a comprehensive map on moving forward. However, getting these resources – especially emergency funding - to entities providing critically necessary services seems to be a major barrier the administration doesn’t seem to have a good plan to deal with. Just as with the emergency rental assistance monies allocated under the American Rescue Plan, emergency monies are slow to reach substance use service providers in dire need, risking destabilizing an already weak safety net. Regional Addiction Prevention, Inc. provides just one example of an entire industry at risk, where funds are bottlenecked at the local agency distribution level. Earlier this month, advocacy organizations from around the country and service providers in D.C. wrote to the Mayor and City Council urging an expedited process to ensure emergency funds for these services were distributed in a more timely fashion.

The Biden administration can set all the goals in the world and even secure funds from Congress, but these goals won’t be met on a one-time funding or periodic “emergency” funding basis. The administration needs to provide funding distribution guidance commiserate with the urgency of keeping public addiction service providers afloat, ensure the country’s annual budget reflects these priorities, and increase Medicaid reimbursement rates to reflect these policy priorities.

Deceptive Masks: COVID’s Threat to STI Surveillance

In April, the Centers for Disease Control and Prevention (CDC) released its annual sexually transmitted infections (STIs) surveillance report, reflecting an increase in overall rates for the sixth year in a row, with a nearly 30% increase in STIs from 2015 to 2019. While sharpest increases in incidences were of syphilis among newborns, the infection burden is not equal with young (ages 15-24) people, gay and bisexual men, and people of color facing exceedingly disproportionate diagnoses. What’s important to note is traditional CDC surveillance reports lag by about two years – these data do not account for COVID-19 impacts among screening and treatment of STIs.

In the report’s press release, the CDC acknowledged COVID-19 posed extreme threats to screening, treatment, and prevention, as public health programs and staff typically used to address STIs had largely been repurposed in response to COVID-19, citing a survey from January showing about one third of local and state health department STI staff were still deployed to COVID-19 activities. Shortages also include screening supplies, according to a September 2020 “Dear Colleague Letter” with regular updates posted on the agency’s drug and diagnostic test notices page showing marginal improvement as reported by testing kit and supplies manufacturers.

The aforementioned survey of local and state health departments was conducted by the National Coalition of STD Directors (NCSDDC), “a national public health membership organization representing health department STD directors, their support staff, and community-based partners”. While NCSDDC usually throws most of its resources into advocating for public health policy changes, funding, and offering technical assistance, throughout the COVID-19 public health emergency, NCSDDC has found itself in the unique position of reporting on the situational needs of health departments and their staff, tasked with meeting a multitude of needs in any given community. The organization summarized its Phase III survey results as follows:

“This continued diversion of staff and other resources has caused delays in providing disease intervention services, leaving some STDs completely unchecked. STD programs continue to report clinic closures, reduced clinic hours and services, STD testing kit shortages, and diminished laboratory capacity. Additionally, STD programs report severe burnout as disease intervention specialists (DIS) pivot from COVID-19 investigations and contact tracing back to STD disease intervention and partner services work.”

For context, NCSDDC, in March of 2020, initially phrased the state of local and state health departments responding to COVID-19 as a “starved public health system in distress”. An indication that despite pledges from the White House and billions in funding allocated by law makers, “on the ground” not much has yet changed for the first responders of public health.

Complicating matters, some health officials are debating the implications of initial surveillance reports for 2020 seemingly showing certain decreases in STI diagnoses, according to one news report, as either a reduction in sexual activity among at risk persons during stay at home orders or a lack of screening. Given the context of reduced capacity, staffing, and supplies, entertaining the possibility of decreased sexual activity rather than decreased access to services shifts the responsibility (and pressure) on state lawmakers and executive offices to appropriately fund and support public health programs to that of undersupported health departments, contracted service providers, their staff, and the vulnerable communities they serve.

As discussed in HEAL blog posts from earlier this year, COVID-19’s impact on public health activities is still being discovered, largely through emerging surveillance gaps (lack of screening) and, as the CDC’s STI report shows, at a lag of data rather than a decrease of incidence, leaving communities vulnerable to outbreaks.

Later this month, on June 30th, NCSDDC will be joining Community Access National Network and Community Education Group for a virtual Community Roundtable on COVID-19’s impacts on HIV, HCV, STIs, and substance use disorder, providing stakeholders and advocates a space to further explore where public health efforts have been strained and can be strengthened in light of COVID-19.

Mr. Becerra, Bring Back the Mega-Guidance. With Love, 340B

Last month, President Biden released details of his proposed budget, including a much needed 23% increase in discretionary spending for the Department of Health and Human Services. Among numerous proposals for these funds, including refilling supplies in the National Strategic Stockpile, expanding mental and behavioral health services, and advancing Ending the HIV Epidemic initiative, is a giant but quiet drug rebate program: 340B. Outside of health policy “wonk” circles, 340B doesn’t often get very much attention. However, inside of those circles an obsessive chant can be heard, “bring back the mega-guidance”.

Let us back up some.

In the early 90’s, another time when drug prices were nearing the height of health care conversations on the national level, Congress and pharmseutical manufacturers struck a balance: in order to ensure a manufacturer’s products were available to a ready purchaser (Medicaid, Ryan White, and other safety net programs), manufacturers would offer their products at exceptional discount based on use – or a rebate. The dollars received as rebates were expected to be used “to the benefit of patients”. The idea being a system-oriented effort to ensure poorer patient populations could get both the medicines and the care they need. Later, the definition of eligible entities for these discounts were expanded to include entities who were not necessarily federal grantees or subrecipients.

The problem, nearly 28 years later is regardless of Congressional intent, no one has definitions for what any of this means. Manufacturers argue non-federal grantee entities (including for-profit hospitals, contract pharmacies, and pharmacy benefit managers) are abusing the program and not just to the detriment of their own interests but to the detriment of patients by way of narrowed provider networks, skewing formularies, and buying up competing practices as examples. Indeed, these are the very examples Senators cited in 2018, the last time 340B was meaningfully discussed on the Hill. Senators then listened as representatives from the Government Accountability Office (GAO) and Health Resources Services Administration (HRSA) see-sawed between saying they either lacked the statutory authority or merely lacked the proper funding support to shore up to program, eliminate abuse, and more adequately perform audits.

The issue at hand was the result of the then-new Trump administration torpedoing the Obama administration’s “mega-guidance”, which would have defined “patient”, provided for a federal portal of products captured under 340B to extend transparency, and more. For context the Obama administration had given notice in 2010 of proposed rulemaking. Which ultimately didn’t manifest an actual proposed rule until August 2016, by which time it was too late to finalize as is the tradition for incoming administrations to pause or cancel late-made rules of the previous administration.

In that 2018 Senate committee hearing, Senators argued HRSA already had the authority necessary – pointing toward the abandoned mega-guidance – and ultimately came to no conclusions other than “things need to change”. That’s an understandable sentiment given the growth of the program. Even if the general public is to question the data of the Pharmaceutical Research Manufacturers of America (PhRMA) stating provider and pharmacy profit margins from 340B grew more than 900% from 2013 to 2018, instead of sharing those savings with patients. However, even HRSA’s own data now puts 340B at nearly the size of Medicaid’s outpatient drug program, up by 23% from 2018-2019 alone. If consumers considered the idea their medications might have been 23% lower in cost if those savings were shared with them instead of pocketed by other entities in the health care pipeline in one year alone, the rising anger shifts the blame quite readily.

There’s plenty to go around, though. The 340B can has gotten kicked down the road for far too long. In the absence of rulemaking, various players in industry have tried to fill the gaps. Last year, several manufacturers began implementing their own practices, primarily by imposing new, internal requirements on contract pharmacies to prove a patient actually qualified or merely refused to allow contract pharmacies to play middle men at all. HRSA responded by sending letters to 6 of the largest manufacturers implementing these programs and demanding they resume offering the discount program to the contract pharmacies – including a threat to penalize manufacturers who refused to cease these limiting activities. A particular manufacturer, Eli Lilly, sued to stop HRSA from enforcing this threat.

Ultimately, though, HRSA hasn’t been able to meaningfully explore its regulatory powers with regard to 340B. President Biden’s effort to fund oversight of 340B is necessary as market-based solutions are at best messy and slow and apparently needing judicial intervention. With sufficient funding for oversight and enforcement under the President’s proposed budget, all that’s left is the same, repeated call of patient advocates and “wonks” alike from the last 4 years: bring back the mega-guidance.

For a more detailed review of the variety of issues 340B faces, please review Community Access National Network’s 2019 report here.

Rising Morbidity: Viral Hepatitis Co-Infection with HIV and Age All Associated with Increased Rates of Liver Cancer

In February, researchers associated with numerous universities across Canada and the United States published one of the most comprehensive data reviews thus far conducted on the incidence rates of the most common type of liver cancer among people living with HIV/AIDS (PLWHA) and PLWHA co-infected with viral hepatitis. The study reviewed data collected as part of the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD), conducted between 1996 and 2015, with clinical data from 109,283 participants. Conclusions from the study were fairly straight-forward: the combination of HIV status (mono-infection), co-infection with viral hepatitis (HBV and/or HCV) and age all correlated with an increased chance of developing liver cancer (hepatocellular carcinoma [HCC]). The hope of researchers, as evidenced in the study’s introduction was to “inform expectations for other regions with a substantial burden of HIV and HBV-HCV coinfection but with delayed cART [combination antiretroviral therapy] scale-up and limited access to viral hepatitis treatment”.

While most research papers wait to include study limitations at the end, I prefer to open with them as prefacing allows for contextualizing data. The first and primary limitation on the review is clinical information reviewed was necessarily from those people linked to care and correlations provided by the data in the study cannot be applied to the diagnosed-but-not-in-care or undiagnosed population. Second, researchers note, information on relevant, individual health factors were missing from significant portions of participants data (example: smoking and drinking habits, natural clearance of HCV, fibrosis score, and HIV exposure risk). Additionally, data collection was not uniform across all participating entities at the time of linkage to care, though a quality analysis was used to help even things out and ensure the integrity of data comparisons. This lack of uniform protocol also included certain sites not administering or participants not receiving HCV or HBV screening. The last, though likely most significant limitation of the study is the data were collected prior to the advent of curative direct acting agents (DAAs) for HCV, and conclusions cannot be made on the potential positive impacts of readily available DAAs.

A limitation not mentioned and data unassessed is any reference between older ART regimens and newer ones, in which toxicity and tolerability is commonly known to be considerably improved with newer regimens. Liver health monitoring is fairly standard, among other relevant patient labs, for PLWHA because of a relationship between ART and liver health. While it’s understandable researchers who generally enjoy significant funding from manufacturers may wish to avoid broaching this topic, not mentioning the issue, even to say “we can’t make any conclusions on cART tolerability and toxicity as an indicator for adherence or risk of developing HCC” misses an incredibly important elephant in the room for researchers, providers, and patients alike.

Instead, researchers chose to focus on cART “eras” (1996-2000 [A], 2001-2005[B], and 2006-2015[C]), in which there’s a positive correlation between age and era; or those aging with HIV were more likely to be diagnosed with HCC. Highest rates of HCC diagnosis by cART area are as follows: A – between 50 and 60 years-old (HBV co-infection with HIV), B – lower end 70-80 (HCV co-infection with HIV), and C – upper end 70-80 (HCV and HBV co-infection with HIV). This data is particularly valuable on its own, however, as the associated risk cohort shift appears to be very closely related to age (ie. those in the upper end of the C “era” are also those to first receive effective cART and the 20-year age gap between the C and A cART eras).

Ultimately, PLWHA were more than 3 times as likely as the general population to develop HCC and more than 20 times more likely to develop HCC if co-infected with viral hepatitis. HCC incidence among study participants fell along rather predictable lines in terms of HIV related clinical monitoring metrics; those with higher viral loads and lower CD4 counts were more likely to develop HCC.

The study’s finding highlight the need for ensuring access to DAAs and HBV vaccines, ready ART uptake upon linkage to care, and strengthening the integrity of AIDS Drug Assistance Programs, Medicaid Programs, and care provided to incarcerated persons – specifically, ensuring the inclusion of coverage of DAAs in these.

Advocates, providers, and patients can review DAA coverage inclusion in ADAPs and Medicaid and harm reduction policies impacting HIV and HCV with Community Access National Network’s quarterly HIV-HCV Co-Infection Watch report.

CMS Sides with the Devil: Insurers’ Co-Pay Accumulators Remain…for Now

The Affordable Care Act (ACA) was revolutionary in how prescriptive statutory language was in ensuring health insurers (payers) covered costs associated with pre-existing conditions, if they accepted even a penny of federal funding. The trade off was a simple theory: “cover more people and their entire health and we’ll make sure you’re still profitable”. There were hundreds of pages of caveats, definitions, incentives for public programs, pharmaceutical research, and regulatory authority passed to state and federal agencies. Everyone got a piece of the pie to the end benefit of Americans for whom health care had been out of reach for the majority of their lives. We would be healthier together by simply providing people the care we need and reducing overall costs. However, as these things go, payers are creative and pay their lawyers handsomely to find ways around that basic agreement. As payers fight to “contain costs”, co-pay accumulator programs are one of the most disingenuous methods to limit consumer access to quality care and pad payers profit margins.

From issues of discriminatory plan design, or making consumers pay the highest cost-sharing for medications which are only used to treat certain conditions like HIV, to limiting provider networks in such a way that a patient requiring a surgery or emergency care results in surprise bills to toxic practices known as “utilization management” (including, but not limited to, abusive prior authorizations and step therapy, also known as “fail first”), payers have paid their lawyers quite well to find loopholes or design new problems in order to maintain their profits. The ACA’s medical loss ratio (MLR) rule, also known as 80-20/85-15 rule (in general requiring 80% or 85% of a plans premiums to actually be used on costs of care or pay back to balance to consumers) has resulted in a startling 2 billion dollars to be paid back to consumers in 2019 alone. But the rule doesn’t necessarily count other income payers can produce by way of cost-sharing or deductible payments, co-pays (a fixed price typically paid after deductibles are met for care and medications), and – now, more commonly – “co-insurance” (a percentage price typically paid after deductibles are met for care and medications) as part of that rule. The result is consumers and those who would like to see us get the quality, individualized care we need are being put on the hook for payers’ greed.

Patient advocacy often has interesting bedfellows. And at the intersection of our care interests and that of industry, pharmaceutical manufacturers have found what can arguably described as a somewhat socialist model by way of patient assistance programs, often enacted as co-pay card or discount programs aimed at directly benefiting patients by taking care of the patients’ share of a medication’s cost. These programs are quite frequently limited by income or if a person is insured. The idea being to make sure the most costly medications make their way into the hands of the people who need them most and can least afford them. In this, our interests as patients absolutely converge with that of manufacturers. We want quality therapies made available to us. However, when a medication “goes generic”, often these programs are no longer available as a less costly, generic medication is preferred by the payer unless a patient fails that particular medication (see: step therapy, “fail-first”). The problem is generic medications are not held to extraordinarily strict requirements for Food and Drug Administration (FDA) approval that brand name medications are held to. Indeed, earlier this year, Vice offered a fantastic explanation of the problem with preferencing generic medications by payers (both public and private) is harmful to patients and why our generics “approval” process is a threat to the health and safety of patients. It’s no wonder, with the lax oversight of generic medications and the offer of payment assistance from manufacturers that patients would want access brand name and newer medications on the market.

One of the most amazing benefits of patient assistance programs is, in theory, because they’re meant to cover the patient’s cost-sharing obligations, these out-of-pocket (OOP) costs should apply to the patient’s deductible and OOP maximums and reduce the cost burden to patients for future care throughout the plan year. Right?

Wrong.

Payers have near uniformly adopted a practice known as “accumulator adjustment programs”, or co-pay accumulators, in which a payer basically says to a patient and a manufacturer “all for me, none for thee”, taking the entirety of the benefit offered by a patient assistance program and not crediting the patient with those funds received against the patient’s deductible, co-pay or co-insurance, or out-of-pocket maximums. To boot, manufacturers have zero control over this practice and often don’t know when it’s happening until a patient complains about the experience. Payers justify this move as “cost-containment” and disincentivizing patients from seeking more costly medications – which translates to newer, more effective, safer medications (go back to the problem with generic approvals above).

So far, the Centers for Medicare and Medicaid Services (CMS), the primary authority in which payment rules are issued from the federal government to payers, have generally made extraordinary effort to ensure protect the interests of patients and those who align with our interest. In the instance of CMS’s newest rebate rule, CMS chose to side with payers for some inexplicable reason. The rule states pharmaceutical manufacturers, not payers, would have to count these direct-to-consumer assistance programs among “best price” calculations, which govern Medicaid rebate price setting or what the government pays for a medication, if a patient didn’t receive 100% of the benefit of the assistance program. Previous rules on what to consider in calculating “best price” were generally limited to prices negotiated within industry movers inside the supply chain, not that of end users. The theory goes like this: “if ultimately this assistance program is paying an insurer’s bottom line and not helping patients, then it should be considered a price you (manufacturers’) negotiated. You were planning for that in setting your prices anyways, right?” Pop quiz answer: wonky negotiations with payers is not what manufacturers were planning on in designing income limited, only-accessible-by-consumers-asking for-it assistance programs. The solution CMS offered was for manufacturers to ensure patients received the intended benefit by requiring patients to pay for a medication up front and then ask for reimbursement – a process that only makes medication access and affordability infinitely more complicated and burdensome for patients.

In the end, CMS decided that in response to an excessively abusive payer practice that disadvantages patients, the answer was to create further barriers to accessing care for patients rather than to reduce them.

Let’s make this real and “back of the envelope” this practice in terms of realized patient experiences:

Monthly Income: $2,583 (based on average US income in 2019 provided by the Census Bureau)
Monthly premium: $304 (lowest cost local silver deductible is $3,400, OOP maximum is $8550, co-insurance is 20-40%)

Absent a public payer intervention, co-pay accumulators might allow a patient assistance program to cover the estimated $600 per month co-insurance would demand for a certain medication, however, I’m not likely to meet my deductible or maximum OOP for the year at all. With local rent costing about $1000 per month, a car payment and car insurance in order to work (there’s no meaningful public transit in the vast majority of the country), food costs, utilities, etc. Even with federal subsidies provided via the health care market place, every month, I’m in the negative. Which means I can’t afford to see my doctor or get my quarterly labs, which means I can’t get my medication in the first place.

However, without the application of a co-pay accumulator, accessing just 3 month’s worth of a patient assistance program would meet my deductible and maximum OOP costs for the year. I don’t have to worry about at least $200 per month in medical costs. And one less financial strain is off my shoulders.

For the vast majority of us, our medications are not a luxury item. They’re not something we can afford to pay for up front and mail-in a rebate request and wait months for. In doing so, CMS not only suggests an increase to the paperwork burden on patients and manufacturers alike, CMS also seeks to increase barriers to accessing life saving medications to begin with.

All to the benefit (read: profit) of payers. So it’s no wonder the trade organizations, Pharmaceutical Research & Manufacturers of America (PhRMA) chose to initiate a lawsuit to halt the implementation of CMS’s backwards and punitive rule.

While patient advocates may spar readily about the role of industry among advocates, we should also recognize actions that align with our own interests on their face. Yes, PhRMA may be leading up this suit - and CMS should listen to the needs of patients, reverse course, and voluntarily pull this rule.

Medicaid Access: HCV Medication Stalls

In November 2015, the Centers for Medicare and Medicaid Services (CMS) issued a stark warning to state managers of Medicaid programs regarding restrictive limits on accessing newly developed and emerging direct acting agents (DAAs) for the therapeutic and curative treatment of Hepatitis C. Since then, Harvard’s Center for Health Law and Policy Innovation (CHLPI) has steadily tracked the three most impactful methods of restricting access to DAAs in Medicaid programs: fibrosis restrictions, sobriety requirements, and prescribing provider requirements.

Briefly, fibrosis restrictions require a patient to have advanced in the amount of liver damage to a specific degree in order to qualify for care, sobriety requirements restrict access to DAAs based on a person’s self-attested stated or clinically documented sobriety, and prescribing provider requirements restrict recognition of “medical necessity” to that of a specialist or with consultation of specialist in order to receive coverage of a particular DAA. CHLPI’s most recent survey of Medicaid programs outlines progress of the policies of restriction by state. As of the date of the survey, 4 states maintain fibrosis restrictions, 13 states require some period of abstinence/sobriety with an additional 15 states requiring a patient to participate in some level of alcohol and/or drug screening and counseling, and 18 sates have some level of specialist prescriber requirements. Additionally, Community Access National Network’s quarterly HIV-HCV Coinfection Watch Report details which states cover which Hepatitis C therapies and DAAs under their Medicaid preferred drug lists (PDLs).

Of particular note, the 2015 CMS notice specifically highlight the practices of fibrosis stage and sobriety requirements as running counter to various provisions under Section 1927 of the Social Security Act. A 2020 legal review by CHLPI’s Phil Waters describes various case law and potential enforcement mechanisms in which to combat these restrictions, which may prove prescient for federal enforcement agencies and advocates alike. Of particular note, Waters argues the Americans with Disability Act (ADA) presents a “novel” approach in addressing the most caustic and immediate barrier to accessing DAAs by Medicaid recipients: sobriety restrictions/abstinence requirements. Waters notes opposition to this method of seeking enforcement may argue such policies “benefit” the class of persons affected by same. While 2018 guidance from the Department for Health and Human Services (HHS) recognizes substance use disorder as a disability, the same guidance specifically exempts people currently using illicit and illegal drugs from the protections afforded by the ADA.

As we referenced in a blog earlier this year, the Centers for Disease Control and Prevention (CDC) Hepatitis C surveillance data indicates an extraordinary increase in new HCV diagnoses relative to the opioid epidemic. Arguably, requiring an otherwise qualified Medicaid client to undergo additional, non-emergency treatment or engage in non-medical activities in order to gain coverage of a live saving therapy is necessarily discriminatory. After all, a particular Medicaid pharmacy and therapeutics committee cannot evaluate the degree of limitations a person’s experience with substance use disorder causes and imposing additional requirements that specifically target this particular is counter to best practices. Indeed, requiring a person to “get clean” before receiving life-saving medical care is the exact opposite of managing substance use recovery. Relieving pressures of medical need, housing, and other negative pressures related to determinants of health are what set people up for success in combating substance use.

In order for the Biden administration to fulfill its promises with regard to combating the opioid epidemic, for states to fulfill their responsibilities under the National Viral Hepatitis Strategy, and to meaningfully address the intersection of these syndemics, federal agencies tasked with enforcement of these rules and Medicaid directors should consult and act in alignment with advocates with lived experience and best practices in combating both the opioid epidemic and resulting infectious disease outbreaks and diagnosis, including HIV and Hepatitis C. Just as with strategic, culturally competent approaches to combatting HIV and STIs focus on sex-positive education and access to resources, including prevention and treatment interventions, barrier reduction is critically necessary in order to succeed in this fight. As it stands, Medicaid programs present one of the best opportunities to ensure and enact meaningful access to care in an effort to eliminate Hepatitis C. These access limiting policies also present the biggest barriers to achieving that goal.

Jen’s Half Cents: Fixing the Broken Patient Advocacy Pipeline

One of my first conversations with Bill Arnold was particularly memorable. I had just started hormone replacement therapy, my beard wasn’t nearly as strong as it is now, and I’m certain I looked like a 16-year-old. In a moment of career transition, I had also recently joined the board of directors for ADAP Advocacy Association (aaa+). The Washington, DC air was warm, indicating a cool evening ahead, and we were taking a break outside during the ADAP Annual Conference. Following a detailed but brief chat about the state of political play around the Affordable Care Act, we went back inside for the next session and ran into Brandon M. Macsata, aaa+ CEO. What ensued was a discussion of strategy to recruit and engage younger advocates in patient advocacy and in particular the space of HIV. I think, in no small part, because I was the youngest board member at the time and because I was one of the newest board members, this “getting to know you” opportunity was also an excellent opportunity to discuss various priorities in advocacy and the current state of the advocacy ecosystem.

It should come as no surprise we independently concluded the health of the patient advocacy ecosystem was weak, having surpassed the moment of crisis, interests in our needs were waning, especially with certain competing priorities, advancements in therapeutics to treat HIV, and chronic nature of the illness that brought us all together. To be honest, the time between then and now, much like the nature of any chronic illness, has not much changed and it certainly hasn’t advanced. Even with the heavy reliance on a variety of expertise from the field of HIV to address, mitigate, manage, and – with any hope – defeat COVID-19, HIV patient advocacy has suffered greatly in the last decade. Arguably longer.

I’ve often mulled this conversation and the complex realities impacting the health of our aging advocate community. The truth is, many of the survivors of the AIDS Crisis never expected to live this long. All that work, all that fight, transformed into one of three paths; death, patient, or industry. Many people who took up the mantle of HIV patient advocacy or care delivery with extraordinary efficacy. To date, given the enormous obstacles of funding, access, stigma, and systemic biases, debatably, few public health campaigns have been as effective as those associated with the prevention, testing, and treatment of HIV. However, despite all of our successes and advocacy, according to the Centers for Disease Control and Prevention, progress in combatting the domestic HIV epidemic has stagnated over the last decade.

Central to this issue, few states have expanded their HIV funding in the last decade (kudos to Georgia’s HIV advocates for the recent influx of state funding to their State AIDS Drug Assistance Program), onerous rules on how to funds may be spent have left federal funds on the table, unused until usurped by political ideologues to put kids in cages, service providers are experiencing an extraordinary rate of burnout, competition in advocacy space has discouraged younger talent from staying in the field, or problematic policies or personalities in legacy institutions have pushed these young advocates to start their own agencies with little in the way of support – further compounding the field of competition.

Our ideas have aged as much as our leadership has. At the 30-thousand-foot view, this is one of many of the core reasons we’ve failed to advance in our fight against HIV.

In order to meaningfully advance HIV patient advocacy and thus work toward a more equitable regulatory and funding landscape, private funders and foundation partners need to re-examine “leadership development” initiatives and projects. Currently, these so-called “leadership development” programs are often short-lived, focus on recruiting a specific demographic audience, may share some story-telling skills, and maybe offer some networking among audience members. The idea being to further engage highly affected populations which may not otherwise fit traditional requirements in hiring and promotion screening. Often, these funds go to large entities which may lack specific expertise or experience with the intended demographic audience. Deliverables for these programs do not require hiring or connecting to employment opportunities for attendees, nor do they include requirements to advance leadership opportunities with existing staff or external recruitment from target demographics or affected community. These “leadership” programs lack any substantial applied benefit for affected communities, target demographics, or the patient advocacy landscape at large.

Internally, funders and providers required to engage community advisory boards often suffer the same stagnation. Community advisory boards maintain the same membership for years and years, with limited power of influence over industry activities, and zero incentive to seek new voices or experiences, including lack of compensation for time spent. To be clear, for our pharmaceutical manufacturing partners and government agency partners: community advisory boards should be disease state or demographic identity specific and not generalized for chronic illnesses or general populations in order to meaningfully affect the health and wellness of these communities, ensure equitable clinical trial and programmatic designs, and prioritize the needs of the impacted communities as those communities define them.

The argument goes “We need the institutional knowledge or connections. We can’t afford to lose the investment already made into these members.” And whole host of other reasons that amount to “that’s too hard.”

In order to move forward or even maintain effective advocacy, funders, both public and private, commercial industry and non-profit industry, need to re-work the deliverables associated with advancing leadership and recruiting and fostering advocacy expertise.

In short, it’s time to fund the retirement of aging leadership that never thought they’d live this long.

This is not a flippant suggestion, nor is it intended to provoke overnight changes that ultimately weaken the human infrastructure of advocacy. Rather, in order to meaningfully invest in the patient advocacy pipeline – and ultimately ensure shared interests of communities and industry and public health are met – “leadership” and “development” programs should aim to require, at least, the following, as appropriate:

• Recruit candidates on the basis of advancing their personal careers and career goals, in alignment with the entity’s mission, as opposed to existing skill sets (job skills can be taught and indeed most are taught on the job)

• Develop and implement a leadership change plan (ex. Year 1: identify candidates, Year 2: Mentor candidates in role, function, and networking. Year 3: Shadow candidate in performance of duties, critique and advise)

• Review and update human resources policies including but not limited to education requirements for positions (ie. lived experience in lieu of formal education requirements), compensation relative to private industry competitors and best practices, and staff demographics relative to client demographics (these should be relatively on par to each other)

• For conference style programs: require job placement or work search assistance until placement is found for the candidate

• For community advisory boards: term limits, industry standard consultant compensation for board members, demographics reflecting that of affected communities, and member transition and mentoring programs aimed at recruiting

Part of how we’ve lost our way in advocacy is focusing on “cause” to drive interest and, frankly, cause does not keep the lights on. As non-profit industry moves to better understand that “cause over compensation” is robbing us of our best and brightest minds, so must our funders. We cannot recruit and retain the most creative generation of talent by racing to the cheapest contract.

President Biden is oft cited as saying “Don't tell me what you value, show me your budget, and I'll tell you what you value.” Though the sentiment has long existed and touted by others. And it misses the point of implementation.

Your integrity is spending your money in a way that actualizes your values.

Beyond Medication: Tech Advances in Care Delivery

Broad telehealth acceptance is just the tip of the iceberg when it comes to technology advancements and innovations in the general health care space. From mobile Apps designed to encourage patient-provider communication and medication reminders to drone being the next home delivery pharmacy tool, much hope and concern rests on the horizon of health-in-your-hand-and-on-demand.

In this, as with many developments in care delivery and equitable access, the space of chronic care, specifically HIV, has long helped lead the way for the rest of the industry. A 2018 post on HIV.gov and 2020 post on webMD cite several mobile Apps with focuses on prevention services, linkage to care, care support, and social support. Some study has been done about effective strategies of user engagement with mobile Apps, with a particular focus on younger demographics. One such study, from University of North Carolina at Chapel Hill and Duke University, with participants ranging from 16-24 years of age, found extraordinary efficacy with a “gamifying” approach, including “badges” and “tokens” among users as rewards for adherence and completing tasks or engaging with the App. At 13 weeks, frequent users of the App were more than 56% more likely to achieve viral suppression and regular App users were more than twice as likely to self-report near perfect ART adherence at benchmark periods of the study. Another study, offering social support, with participants at or above 60 years of age across a period of 6 months showed the 30 participants accessed the App more than 2400 times for an average nearing 9 minutes per session.

Many of the studies working to understand best practices in client engagement, messaging, and positive outcomes are exceptionally limited. Beyond the cohort size, technology barriers appear to the biggest hurdles; including ensuring clients have appropriate devices for any particular App design, updated software, ensuring App accessibility across hardware platforms (phones, tablets, computers), appropriate data plans, and access to mobile data signal or Wi-Fi services.

Another avenue under exploration includes modernizing the time-tested aid delivery method of airdrops with drones to reach hard-to-reach rural area health care providers. However, as Uganda Medical Association’s secretary general, Mukuzi Muhereza, cited, drones only address medication transportation to health centers, not issues of medication shortages or transportation barriers from client homes to those same health care providers.

When given this topic for this week, my contract manager questioned “if this can be done in Uganda, why can’t it be done in rural Alabama?” Which is a good question…with lots of discussion worthy of following.

The business that cannot be escaped when discussing consumer data and tech also cannot be avoided in discussing health care delivery systems innovation: Amazon. In 2018, Amazon acquired PillPak, including all their state-based pharmacy licensing agreements, now billed toward Prime customers as Amazon Pharmacy. While posing as a potential exploration into the health care landscape, Amazon Pharmacy’s effort builds upon a concurrent effort to make the company’s voice assistants HIPAA compliant. However, much of Amazon’s effort don’t necessarily fall inside the entity scope requiring patient privacy compliance as HIPPA and explicitly cites compliance with law enforcement activities, recalling community fears associated with molecular surveillance and the criminalization of HIV status. Particularly, Amazon has been known to exploit its collection of user data for the sake of profit, skirt regulatory requirements on technicalities and mutilation of language, and frankly, lacks ethical grounds worthy of potentially courting government funding in light of its anti-labor practices.  Additionally, Amazon has faced numerous data breaches in the last few years and European Union former executives for Amazon have warned the company does not do enough to ensure security of users’ information. Garfield Benjamin gives a deeper dive into the history and context of these concerns, many already experienced in the United Kingdom, here.

That doesn’t mean Amazon, or any company making similar inroads into direct-to-consumer care models, is “always” a bad actor. Indeed, with the Federal Aviation Administration’s recent approval to study Amazon’s drone delivery system, known as Amazon Air, the possibility of delivery to your door within the hour of an appointment is deeply appealing to many consumers seeking easier access to medication. It just means the risks of the moment, of unanswered questions and unregulated technicalities needs to be addressed – and with expediency. Because just as with injectable ARVs being the next wave of innovation in ARVs, streamlining the consumer experience with greater privatization and expanded home delivery options is also on the horizon.

We have this brief moment, now. Where the mega-movers, like Amazon, and regulators, can reach outside of the provider and payer communities and discus with patient and consumer communities to ask us what we’re worried about. If public payers are not prepared to integrate appropriate reimbursements, leverage those reimbursements to ensure our privacy and access to care, to further Health Justice, then we run the risk of only furthering existing disparities, even more than COVID has. Between the rural hospital crisis only deepening and the Biden administration already running into push back on including expanding broadband access in its infrastructure package, as easy examples of the necessary “what-abouts” if we’re to meet this moment for its actual potential – for either good or ill.

Stakeholders across the spectrum should look beyond any development of their own proprietary App functions and into the broadest approach to this space to ensure consumer trust is maintained as one of the highest priorities, collaborative rather than competitive efforts so as not to duplicate efforts or get lost in the sea of App developments, and ensure our technology reflects our values as communities, not just that of those who may find new avenues of profit on our backs.

Global & National Perspectives on HIV & HCV Co-Infection

On April 26, UNAIDS issued a report briefly detailing the state of HIV and Hepatitis deaths, globally, taking particular note of the issue of coinfection among people who inject drugs. Here in the United States, multiple jurisdictions have declared new HIV and ongoing Hepatitis C outbreaks, all combined with a surge in overdose deaths.

Domestically, federal public health initiatives have long sought to understand and address intersections of these issues, offer guidance, and shifted – albeit slowly – to understand HIV, HCV, and SUD exist as syndemics. And I want to talk about this language.

Syndemic, in general, means two or more linked health problems, interacting synergistically, and contributing to the disease burden of a given population; operating in a fashion that feed one another. To prevent or treat a syndemic, entities must not only treat each health problem but also the social ills that bridge these health problems.

This distinction is important – if we are to meet any of our public health goals on any of these, we need expertise, advocates, and structural support that both address the singular nature of each and the intersections, un-siloed from one another. Unique expertise in designing solutions is as valuable and necessary as expertise with the vision to see the whole system.

As we move through the COVID-19 pandemic, well-publicized discussion on the conflicts between national strategies and local actions mirrors fights patient and policy advocates have been fighting for four decades and continue to fight today. Even as we’ve made progress in ensuring direct acting agents (DAAs) are included in AIDS Drug Assistance Program (ADAP) formularies, at least one state has set an unchallenged precedent of denying this basic care to incarcerated people based on budgets and the Democratic mayor of the city with the “most concerning” HIV outbreak in the nation has back tracked on commitments to work with local public health experts.

This quarter’s HIV-HCV Coinfection Watch Report highlights some progress in syndemic-oriented policy changes and some more…unfortunate changes. While the American Rescue Plan, passed earlier this year, provides for more funding to address state budgets harmed by COVID-19 related revenue decreases, a few states have instituted – and currently maintain – restricted services. For example, while Georgia’s ADAP maintains DAAs on the formulary, payment for same is halted due to funding and Texas’s ADAP has removed all HCV medications, except one DAA from the formulary. Positive notes from earlier this year include Kentucky’s Medicaid program moving to a universal preferred drug list (PDL).

Of the space that has the greatest amount of room to progress and needing nuanced advocacy changes is harm reduction policies. Well-established federal policy and laws only reach so far if state and local laws act in direct opposition to those model positions or even merely lack the funding to establish comprehensive programs. One such space is the near universal adoption of “Good Samaritan Laws”, wherein, generally speaking, if a person, regardless of capacity, does their level best to help another, they cannot be held liable. However, several states have amended their “Good Samaritan Laws” or criminal codes to remove that liability protection from people who distribute illicit substances – disincentivizing reporting of overdose incidents and calling for medical help as they happen. Along the same lines, doctor shopping laws are aimed at preventing patients from seeking multiple prescriptions or seeking multiple providers if one is unsatisfied with their care. However, many states rely upon “lock-out” programs administered by insurance providers or managed care plans to implement under the guise of preventing “drug seeking behavior”. As Alison Gaye stated in a recent presentation to Louisiana’s Commission on HIV, AIDS, and Hepatitis C Education, Prevention, and Treatment, “drug seeking behavior often looks like care seeking behavior, subject to the personal biases of the examining provider”.

Harm reduction policies are in dire need to evolve and delve into the difficult nuanced spaces currently unaddressed if we’re to meaningfully work to end the syndemics of HIV and HCV. Far, far too often the solution found by policy makers in addressing public health needs has been to incarcerate those among us who need help. Driven by stigma, whether the issue is HIV criminalization or lack of access to standard HCV care or refusing adequate insurance coverage for recovery programs, shoving people into prisons has not served this country well on any front.

As we step into the next phase of our advocacy, evaluating existing programs, practices, and priorities cannot include a carceral mindset if we are to effectively reduce the harm caused by these syndemics and our past policies.

SCOTUS Sets Dangerous Precedent for Incarcerated People Needing Care

The 8th Amendment to the United States Constitution reads as follows:

“Excessive bail shall not be required, nor excessive fines imposed, nor cruel and unusual punishments inflicted.”

Long standing precedent, Estelle v. Gamble, sets one standard of “cruel and unusual punishment” as “deliberate indifference” to the medical needs of incarcerated people. Additional precedents include an affirmative need to evaluate these medical needs on an individual basis, cannot be excused as mere neglect when an incarcerated person is at “substantial risk of harm” if that need is not met, and that providing care that is “grossly inadequate as well as by a decision to take an easier but less efficacious course of treatment” are also considered measures of “deliberate indifference”.

In August 2020, the US Court of Appeals for the 6th Circuit added an asterisk: “…if the state decides it can afford to…” provide the care required under the 8th amendment [paraphrasing].

Last month, the Supreme Court of the United States refused to hear the appeal of Atkins v. Parker, where a group of incarcerated people alleged their 8th amendment rights were violated because the state was rationing their HCV related care. In the 6th Circuit appeal, the state argued, successfully, that rationing care was “reasonable” due to budgetary constraints supposedly outside the control of the prison system.

Coverage of both appeals referred to a 2018 settlement in Michigan, wherein the state’s Medicaid program, after suit, expanded coverage to include direct acting agents. However, in a lone descent, Judge Gilman drew more direct parallels in other SCOTUS and 11th Circuit rulings regarding prison overcrowding and access to AZT (case was in 1991) for incarcerated people, ruling in part “The fast moving status of research and medical advances in AIDS treatment is continually redefining what constitutes reasonable treatment.”, respectively. Indeed, in Atkins, the state’s position boils down to “new drugs are too expensive” to be “reasonable” for incarcerated people to have access to. The majority argued because Tennessee’s Department of Corrections Medical Director, Dr. Williams, had only recently restructured the state’s rationing of DAAs and individual assessments, the state had fulfilled its obligations, within budgetary constraints. Judge Gilman correctly argued the state’s medical administrator for the prisons was obligated to request appropriate funding to meet these needs in order to fulfill the state’s 8th amendment requirements – of which, no evidence was presented to prove Dr. Williams did make such a request. Judge Gilman closes the descent with well-established citation that treating HCV early reduces overall costs of care compared to delayed or denied care.

That said, with SCOTUS refusing to hear the appeal, affected people in prisons are facing a dangerous precedent of state officials shirking their Constitutional responsibilities to provide a basic standard of care to the people in their custody. Legislatures merely need to neglect increasing a budget, as we’ve seen in other state-run health care programs, in order to avoid meeting their Constitutional duties.

Interestingly, also in April, the Department of Justice filed a statement of interest in a case in the Georgia, where an incarcerated transgender woman has been subject to violent attacks and refusal of care. The Biden administration’s position here is denying incarcerated people gender affirming medical care is a violation of the 8th amendment’s protections and is thus “deliberate indifference” to the person’s medical needs.

There’s an intersection between Diamond and Atkins that cannot be missed. While the timing of Atkins didn’t favor intervention by the current administration, this administration must also recognize the precedent set forth by Atkins, fight for appropriate funding measures to meet the medical needs of incarcerated people, and update Federal Bureau of Prisons HCV guidance to with regard to prioritization not justifying rationing of care. As with nearly every infectious disease, prisons are both a “canary in the coal mine” of the local community and the ideal environment for manifesting new diagnoses.

The most startling statistic in Atkins is even after DAAs were available, at least 109 incarcerated people had died due to HCV complications. Death by neglect, by rationing is still a death sentence.

Even as I write this, President Biden argued “health care should be a right, not a privilege.”

As it turns out, according to the 6th Circuit, it’s a right, with a large asterisk.

To ensure this injustice is answered for, advocates must remember the courts do not always find justice and our advocacy must reach every level of government. If we don’t, the asterisks will continue to add up.

Checking-In: 100 Days of the Biden Administration

Advocates in public health and addressing HIV, viral hepatitis, and substance use disorder will affirmatively tell anyone the race to win these fights is a marathon, not a sprint. Globally, despite the devastation, COVID-19 is likely to be much the same with most experts anticipating COVID-19 to become endemic for a variety of reasons. And while every administration takes extraordinary efforts to brand their term with lofty promises of what “starts” in the first 100 days of a presidency, the Biden administration is making some tentative progress in some of those named goals.

Maintaining the brand that arguably helped him win the 2020 general election, Biden’s press team has focused on the sympathetic messaging while delivering policy appeals. One remarkable example likely to please disability and care giver advocates is Biden’s commitment to include an expansion of community and home-based services and better pay, benefits, and the right to unionize in the American Jobs Plan. Indeed, Biden’s infrastructure plan goes far outside of more traditional notions of “infrastructure” and seeks to initiate or expand several initiatives directly addressing to the gaps COVID-19 has highlighted with idea that infrastructure is the economic ecosystem supporting the country, regardless of industry. All of this is on the back of Biden’s American Rescue Plan, which expanded subsidies established by the Affordable Care Act and moves like recently announced renewed funding for Marketplace Navigators for 2022, extension of a universal school lunch program, and expansion of syringe services funding, among others.

The administration detailed further in the President’s Discretionary Budget Request for Fiscal Year 2022, priorities in further spending, namely requesting additional funding for the Ending the HIV Epidemic, reforms to the criminal justice system related to racial inequities and substance use treatment for incarcerated persons, addressing the opioid epidemic with – as some advocates have called – a “reformist” mindset rather than a penalty mindset. While these efforts are a solid move in the right direction and arguably a good down payment on Biden’s campaign promises, they do fall short of some of the funding goals advocates have long sought. And that’s just the beginning of the problems in finding the money to meet those lofty goals. For example, the United States is facing a new height to the overdose crisis and advocates have long argued to meaningfully tackle this epidemic funding needs to answer to the tune of $125 billion. Even if the president were to get his wish list funding of $10.7 billion in addition to the $4 billion provided for in the ARP, this still falls incredibly short of that advocate driven funding goal.

Much of the Biden administration’s priorities are likely to find similar fates and advocates should be prepared to both take their wins and lick their wounds. COVID-19’s havoc isn’t the only thing standing in the way of progress. With the exceptionally narrow divide in the House and Senate, the man seemingly wielding the power of majority leader, Senator Joe Manchin’s dedication to maintaining the filibuster, Democrats have an uphill battle in helping their party deliver on the promises sold to the country. Whether the issue is Nancy Pelosi’s (D-CA) desire to maintain ACA subsidy expansion or an entirely opaque drug pricing policy overhaul or expanding the age eligibility of Medicare, Democrats have promised to go big and if they don’t, they can very likely look forward to “going home”, either in the midterms or 2024.

Meanwhile, COVID-19 has very likely pared back minimal gains made in the South with regard to fighting the HIV epidemic in the United States, HIV and STI health care workers are burning out at extraordinary rates due to having to pull double duty for the last year, studies are finally digging into the hepatitis and HIV related health disparities among transgender people, and every other issue of health equity prior to pandemic has lost ground. Biden’s Health Equity Taskforce should absolutely take into consideration the nuances of emerging data on these existing disparities and advocates should seize this moment and pathway provided by engaging the taskforce on addressing these issues. After all, we’ve argued all along COVID-19 is merely thriving in these long neglected communities and it’s not unique for COVID-19 manifest disparate impacts among marginalized peoples, every other epidemic has.

It’s a marathon, not a sprint.

All Together Now: West Virginia’s HIV Outbreak

On April 5th, 2021, Washington’s “Most Important Man”, Senator Joe Manchin, submitted a Congressional Inquiry to the Centers for Disease Control regarding the well-publicized HIV outbreak in Kanawha County, West Virginia. The CDC has called the West Virginia HIV outbreak “the most concerning” in the United States, with an unprecedented growth in new diagnoses related to intravenous drug use (IDU). For context, in 2018, the county reported just two new HIV diagnoses related to IDU compared to at least thirty-five new diagnoses related to IDU reported in 2020 – New York City, with a population almost forty-five times that of Kanawha County, reported thirty-six new HIV diagnoses related to IDU in 2019.

A. Toni Young, founder and executive director of Community Education Group and Rural Health Services Provider Network, said, “We kinda saw this coming, unfortunately. The state has been facing a Hepatitis C outbreak for years now [related to substance use] and the lack of coordinated response between stakeholders, specifically providers, with different areas of expertise has kept us siloed and limited in our response – we’re approaching this as multiple epidemics rather than a syndemic.”

Dr. Demetre Daskalakis, the CDC’s Director of HIV Prevention, told a news outlet, “It is possible the current case count represents the tip of the iceberg.” Young echoes this sentiment, “I think we have a state-wide outbreak.” They’re not wrong to believe this outbreak extends across the state, given a 2020 presentation on the Cabell County outbreak, also citing the state’s long fight against opioid use. Though, improvement in the outbreak in Cabell County has already begun, thanks, in large part, to a syringe exchange program – a situation near the mirror opposite of Kanawha County, where a similar county-run program closed its doors in 2018 after city officials and first responders complained about used syringes being improperly disposed of.

Local officials, however, seem steeped in their “moral panic” and rebuffed the CDC’s assessment of the outbreak and requested a federal inquiry into the data provided by the CDC.

While local, volunteer-lead program, Solutions Oriented Addiction Response (SOAR) has stepped in to fill the syringe exchange need, problems have plagued the organization. In January, while under police investigation – which found no wrong-doing on the part of the organization – the program paused operations. During that time, co-founder Sarah Stone, said clients requested bleach in order to clean syringes, even while volunteers advised those same clients such a practice would not guarantee safety.

All while this is transpiring, the state legislature is considering a bill that will significantly impact how syringe services programs operate. SB 334 would give county health departments more freedom to shut down SSPs, require clients provide identification in order to receive services, and require SSPs to obtain a special permit to operate. Opponents of the bill call it a move that may drastically harm community trust and willingness to engage the programs, give leeway to local political pressure as opposed to proven public health interventions, and potentially prevent these community-based programs from operating all together.

Young has a different perspective. “Ok. If this is the way we have to go, show me the data. Let’s use this chance to see exactly how much this move will cost or save the state in terms of all resources – I’m talking money and lives. We cannot forget people’s lives are stake here.” Young goes further and credits the state’s health department operations in their response to COVID-19 as successful – proof the state is able to response appropriately to a public health emergency, when provided enough resources. Young specifically cites resources to include financial of rural hospitals, community-based programming and services, and, rightly, the people-power to enact these services.

In order to meaningfully address the syndemic nature of the state’s situation, Young calls on public health officials and both federal and state legislators to prioritize a holistic, coordinated response to addressing HIV, HCV, SUD, and COVID-19. “Listen, we can do this. It’s just a matter on if we want to do this. We need MAT [medication assisted treatment] providers, addiction services providers, HCV screeners, Ryan White providers, county health departments – all of us need to be at the same table and seeing our clients, our community, as the same people. We cannot split a single person into multiple ‘problems’, we shouldn’t be treating our residents’ needs as if they can be split apart.” Indeed, the National HIV Strategy calls for this type of coordination. “We need an integrated plan – an integrated workgroup,” Young added.

Mirroring a sentiment other advocates have voiced, Young also thinks public health metrics should shift to be more reflective of the client experience, rather than the service provider’s experience, “A referral is not care and it shouldn’t count as care.”

“I’m not gonna sugar-coat this,” Young concluded, “we need money and people and the investment into meaningful, collaborative infrastructure to meet the needs of this community.”

The Most Meaningful Public Health Intervention: Housing

A note on the language used in this article: Some housing advocates reference a difference between “homelessness” and “houselessness” with exceptional, nuanced conversations on individual experiences with housing instability, connection to community, and personal autonomy. While some advocates may opt to consider a frame of “home is where the heart is” as an issue of empowerment, I, as an author and advocate, use these distinctions because of well-established links between housing instability and uncertainty in situations of domestic violence. A roof does not necessarily a “home” make. For the stakeholder targets of this blog, the link between intimate partner violence/domestic violence and HIV is so notable, the Department of Housing and Urban Development has recently announced funding opportunities for joint demonstration projects between HOPWA and VAWA (Housing Opportunities for People with AIDS and the Violence Against Women Act, respectively).

For 30 years, people living with HIV have advocated “housing is health (care)” religiously. A drumbeat of nearly every action, the inevitable topic of any roundtable or meeting, even if housing isn’t an agenda item – or especially if housing isn’t an agenda item. Arguably, when it comes to issues of “social” Justice and policies impacting the notion of equity, outpacing even health care is housing. Housing is the lone sustainable investment any person or family in the United States can make and, generally, expect to last well beyond their own time. Housing is the basis of both defeating and maintaining systems of inequity and oppression. Housing is such a significant factor in individual and collective outcomes it had its own carve out, separate and apart from the Ryan White Care Act, via the program known as Housing Opportunities for People with AIDS.

Indeed, the housing’s impact on health care is so exceptional, in 2019, the American Medical Association built upon limited calls to improve identification access for people experiencing houselessness and expanded their policy position for more comprehensive and collaborative resources aimed to bring care to this population and called for decriminalizing houselessness. In the same year, the Department of Housing and Urban Development’s annual “point in time” data estimated about 568,000 people were experiencing houselessness on any given night in the United States, a near 10% increase of “unsheltered persons” from the prior year.

Late last month, the University of Bristol published in The Lancet a systemic review and meta-analysis of housing instability and houselessness finding among people who inject drugs (PWID), recent houselessness and housing instability were associated with a 55% and 65% increase in HIV and HCV acquisition, respectively. Additional findings include of the global 15.6 million PWID, over 1 in 6 have acquired HIV and over half have acquired HCV at some point and an astounding estimation that half of PWID in North America actively experiencing houselessness or housing instability.

None of the studies included data collect prior to the start of the COVID-19 pandemic. While several states near immediately began introducing short-term eviction moratoriums and the CARES Act provided for federally backed mortgage holders to seek forbearance or deferment, these protections were short-lived, with many states looking toward the federal government for guidance. As with many issues, the summer of 2020 brought the country little comfort due to a lack of cohesive and coordinated public health response to the emergency. A paper published by housing heavy-weight, Emily Benfer, and HIV champion, Gregg Gonsalves, among others, found this failure to uphold and maintain meaningful and enforceable state-based eviction moratoriums contributed to racial health inequity and cited research finding that lifting moratoriums prematurely, triggering displacement, is associated with an additional 10,700 preventable COVID-19 deaths and 433,700 excess cases. In fact, an organization Benfer serves with, Eviction Lab, rates nearly every state in the country as “one star” in terms of housing protections for renters.

Under this frame, tens of millions of people in the United States are at extraordinary risk of contracting COVID-19. Which is part of why the Centers of Disease Control attempted to flex some public health muscle by issuing an eviction moratorium for public health purposes in October, 2020. Like with other investments made in the fight against COVID, the move was bittersweet for public health advocates at the intersection of housing and HIV, HCV, and SUD syndemics – where was this before now?

“Among the Biden administration’s first priorities is the advancement of racial equity and support for underserved communities,” Benfer said. “This requires redress of the structural and systemic discrimination in housing. As an immediate measure, the federal government should bolster the nationwide moratorium on evictions to apply to all stages of eviction, all forms of eviction, and all renters who face housing instability. At the same time, to prevent an avalanche of evictions and protect small property owners from harm once moratoria lapse, policy makers must provide the rental assistance necessary to address the accumulating back rent and sustain renters, state and local governments, and the housing market—and direct it to the communities at the greatest risk of housing instability.”

“Preventing COVID-19 eviction alone could save the U.S. upwards of $129 billion in social and health care costs associated with homelessness,” Benfer added.

However, the CDC’s moratorium is on shaky ground and implementation/access is not automatic – those seeking to use this protection most pro-actively notify their landlords and express intent to seek cover of the moratorium in eviction court. Several states and localities have not evenly implemented the moratorium or setting up “eviction kiosks” to expedite the process, because so many cases were in que, and some going so far as to list children as defendants in eviction actions. Which, according to Benfer, is not an uncommon occurrence. And due to the lack of protections for tenants and outdated credit reporting associated with eviction judgements, these legal actions can and often do follow people for at least a decade, compounding barriers to housing and drastically increasing the risk of houselessness. Because state-based protections have ended, Texas is allowing evictions to resume and the 6th Circuit Court of Appeals has recently allowed a challenge to the authority expressed by the CDC for the moratorium to move forward, even as some landlords are openly exploiting loopholes in the moratorium.

Landlords aren’t the only abusive persons seeking to take advantage of weaknesses in our housing protections. An unfortunate side-effect of the moratorium actions and our lack of investment in ensuring adequate resources for people experiencing intimate partner violence is perpetrators exploited stay-at-home orders and survivors, who are already at exceptional risk of housing instability, with an estimated 26% increase in domestic violence abuse calls made in some cities across the US during the strictest of those orders.

Additionally, with more people facing a lack of houselessness, even more are now at risk for “mobile homelessness” – or a lack of car to sleep in – an issue which may be masking just how many people are experiencing houselessness and housing instability, due to the design of some point in time surveys are conducted. And with an estimated 49% increase in chronic homelessness expected as a result of COVID-19 over the next 4 years, the potential exacerbation of the existing housing crisis in the US may well likely become an even larger, permanent feature without extraordinary action from all levels of government and, or even especially, private stakeholders. To put this figure into context, this would twice as much homelessness as was caused by the 2008 housing recession.

In The American Eviction Crisis, Explained, Benfer suggests there’s some basic policy moves to be made for longer-term successes:

“In the long term, federal, state, and local policymakers must reform the housing market in a way that provides equal access to housing, thriving communities, and areas of opportunity. Rental subsidies, new construction or rehabilitation, home ownership, and investment in long ignored communities would increase long-term affordable housing. Government-Sponsored Enterprises (GSEs) must remedy the current market conditions that can be traced to racially discriminatory lending policies. This means GSEs must address disparities in asset accumulation and the persistence of discrimination in mortgage lending and the siting of homes.

Where eviction is absolutely necessary, the eviction system itself must be reformed. Evidence-based interventions, such as providing a right to counsel, diversion programs, ‘just cause’ and ‘clean hands’ policies, as well as altering the eviction process, and sealing or redacting identifying information from eviction records, can prevent or mitigate the harm of eviction.”

That long-term investment is well past-due in addressing the needs of people living with and affected by HIV, HCV, and substance use disorder.

Benfer added, “Eviction prevention and the right to safe and decent housing must be the priority. As President Biden said while signing executive orders directed at ending housing discrimination: ‘Housing is a right in America, and homeownership is an essential tool to wealth creation and to be passed down to generations.’ It’s time the U.S. fulfilled the promises of the 1944 Economic Bill of Rights, which includes a right to a decent home, and the 1949 Housing Act that set the national housing goal: ‘the realization as soon as feasible of the goal of a decent home and a suitable living environment for every American family.’ Ultimately, our policies and budgets reflect our humanity and morality as a nation, and nothing could justify the continued denial of basic human needs and access to opportunity. If we are ever to call our society humane or just, we must finally redress housing disparities and discrimination and secure every American’s right to a safe and decent home.”

For far too long, housing as been placed on a shelf as an “unreachable” necessity in actionable advocacy. We cannot afford to “kick this can down the road” any longer. We’ve long known housing is one of the most effective interventions in prevention and in patient care. The oft-touted “it’s too expensive” excuse has manifested a broken dam with lives sifting through the cracks. We already pay for housing for PWID, it’s just most often manifested in the form of imprisonment. A far more meaningful investment in a person’s recovery and success, regardless of recovery, and in community health and in Ending the HIV Epidemic and in ending violence against women and interrupting cycles of generational poverty and answering our most sacred, moral promise and…and…and… would be to address the issue squarely: it’s time to invest in housing.

One Shot or Two? Necessity of COVID-19 Vaccination Among People Living with HIV and/or Chronic Liver Disease

At the time of this writing, the United States’ Food and Drug Administration (FDA) has provided Emergency Use Authorizations (EUAs) to 3 COVID-19 vaccines, with Novavax’s product potentially leading the race to become the fourth. While some have fretted over “which vaccine” is “the best”, governors and clinicians have resoundingly adopted a simple answer: “which ever vaccine you can get”. While President Biden has pushed to expand eligibility to all adults in the US by May 1st, as we’re all too familiar with in patient advocacy, eligibility does not necessarily equate to access and, in this respect, demand still vastly outstrips vaccine supply domestically.

The debate on who should get a vaccine and when began well before the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations in December 2020. ACIP’s recommendations focused primarily on constructing an ethical model based on hospitalizations and mortality, with an eye toward those performing duties most necessary to meet the health care demands of the moment. Ultimately, outside of this job-based prioritization, ACIP gave top priority via age-based allocation and then ascertaining those at-risk for these outcomes based on pre-existing conditions. Most states adopted some version of these prioritized populations. The debate on the efficacy of this model continues to rage on – what about those in marginalized communities more impacted by COVID-19 than more affluent communities? What about younger people with comorbidities? Which health conditions should be prioritized?

Regardless of where one’s local government falls on this debate, evidence catalogued by the CDC indicates a very real need for people living with HIV and those with chronic liver diseases to seek a vaccine as readily as possible as these cohorts are at increased risk for complications related to a COVID-19 infection. Studies have found PLWH experiencing an acute COVID-19 infection may see as much as 50% drop in CD4 T-cells compared to their historical levels, a condition known as lymphopenia – of which, is also an indicator for severe COVID-19 and protracted recovery or death. Additionally, the same study found key clinical metrics used to measure inflammation were similarly increased among PLWH. Another study out of Wuhan, examining people with chronic, yet controlled Hepatitis B infections may see a reactivation of viral activity and/or potentially face significant progression of liver cirrhosis during and after a COVID-19 diagnosis. Another study found SARS-CoV-2 may target certain cells in the bile tract and cause focused damage to the systems serving a person’s liver, with another study suggesting the need for health care providers to emphasize liver repair post COVID diagnosis.

While Janssen ensured PLWH were enrolled in phase 3 clinical trials for their product, none of the currently authorized products included solid organ transplant recipients in their trials. While the American Society of Transplantation notes COVID-19 vaccine administration recommendations for solid organ transplant recipients remains the same as other vaccines (either completed at least 2 weeks prior to transplant or initiated at least 1 month after transplant). Which may pose a problem according to a study published in March showing transplant recipients having received the first shot in the series mounted an antibody response just 17% of the time. While antibody responses are not necessary to confer immunity, they are the leading indication of an immune response. The authors of this study will be seeking to answer that question later this year.

Furthermore, additional research is needed in assessing post-acute COVID-19 infections and the implications of “long COVID”. Most research at this moment on long-COVID is tied to assessing symptom presentation and frequency of health care needs. However, there is a minor bit of information regarding organ function post-hospitalization with COVID-19 – none of it is “good news”. In particular, people experiencing chronic liver diseases were almost 2 times as likely to experience “major adverse events” after being released from the hospital due to COVID-19.

All of this information culminates with a sense of urgency some states are heeding in expanding vaccine access “ahead of schedule” to include people living with HIV or specific programming targeted to provide vaccines to these communities.

Brandon Macsata, CEO of ADAP Advocacy Association, recently penned a blog addressing any hesitancy among people living with HIV around getting their vaccines: “Vaccines are an important element of the journey, along with proven public health strategies (i.e., wearing masks, remaining social distant, washing hands). For the HIV-positive community, it is even more important for us to do our collective part to protect ourselves, as well as the people around us. Get your Covid-19 vaccine!”

With the CDC’s guidance on prioritizing our communities in vaccination schemes, I couldn’t agree more.

Novel Developments: Merck & Gilead Partner on New ARVs

On March 15th, 2021, Merck and Gilead Sciences announced a partnership in development of their novel products, Islatravir and Lenacapavir – both currently in clinical trial phases. The partnership isn’t limited to these investigative products – both, if successful, would establish new classes of antiretrovirals each. The agreement allows an option by either manufacturer to investigate potential combination therapies with the other’s already established products. Additionally, while current trials for these medications are focused on oral administration and injectable application, Merck is investigating the potential for Islatravir as PrEP via an annual implant.

Let’s take a moment to acknowledge the remarkable nature of these proposed products. Gilead’s Lenacapavir is aimed at addressing those with multidrug resistance and – here’s the kicker – with a potential to be effective for as long as 6 months via subcutaneous injections. While Merck’s Islatravir has been described as “potent”, it’s so strong that in order for it to be taken once daily, it must be “lightly sprayed” onto a doravirine tablet (the partner medication for Islatrvir in current studies). Which is great for that aim at being a once weekly therapy.

With these two potential first-in-class medications inching closer to the finish line of approval, this partnership also stands to benefit advocates in a another direct way. Merck has been an exceptionally strong advocacy partner, edging into nuanced regulatory territories and working hard to ensure patients lead those discussions and the company’s positions. Gilead is savvy in their marketing, contracting, and programming; from flashy commercials on targeted tv platforms and innovative radio campaigns to the ease in which their products become “preferred” on some formularies to providing 10-day “sample” bottles – which some providers have used to initiate same day treatment for newly diagnosed people living with HIV without ever having to leave the provider’s office.

Merck and Gilead’s partnership here is…interesting to say the least. Prior to January 19, 2021, when the Supreme Court of the United States refused to hear Merck’s appeal, these two pharmaceutical behemoths were engaged in a legal fight over patent rights to hepatitis C medications, Harvoni and Sovaldi, since 2016.

When you work in HIV and Hepatitis patient advocacy, these kinds of things are our soap operas in their own way. We love our contacts within these companies and often share a great deal of our personal lives with them. That type of relationship is tinged, like most familial relationships, when we have conflicts of interest with our friends – where our priorities diverge from those of the corporation’s. The issue of patents and anti-competitive contracting are some of these hot button issues. All of that said, despite the faux-shock theatrics some advocates have used to enjoy the spotlight, our friends in pharmaceutical manufacturing are also some of the strongest supporters of our work (read: the largest share of corporate funding supporting advocacy).

Thankfully, the vast majority of these relationships are dynamic. Advocates enjoy space to call-out practices we find detrimental, direct funding to programs and priorities in alignment with our values, and provide feedback on nuanced areas like clinical designs and regulatory structures. One might say our greatest allies pay us to argue with them. And there’s good logic to such a scheme; a team grows stronger when the weaknesses are evaluated, addressed, and turned into strengths.

Indeed, this partnership, with its expansive nature to include development, manufacturing, and marketing, holds both great promise and great concern for our communities. Gilead is already learning from its failure with Descovy trials to include people assigned female at birth (AFAB) – including cisgender women in clinical trials for Lenacapavir as a long acting injectable (for both treatment and prevention) to begin later this year; though Gilead should note: “people of trans experience” won’t all fit neatly into the clinical trial including cisgender men. To be fair, Merck’s Gardasil commercials still refer to “males and females” rather than the simpler “everyone”.

Sincerely, the trans guy writing this blog.

Taken as a whole, this team poses the potential to be “The Dream Team” in both treatment and prevention and as partners to advocates. We’ll need to see the best of them, not the worst and we’ll need to keep a close eye on how those relationships we’ve come to rely upon may change in light of this new partnership.

In the meantime, (I’m going to say this for the first time a year with a humorous intent rather than a morbid one) pass the popcorn. This season is going to be fantastic!

Covid-19: How Far We’ve Come & How Far We Have to Go

Unraveling a tangle of yarn can be maddening. Pull here, threads get tighter. Pull there, you’ve created another knot. Now, imagine having to weave with the same tangle – “undo” a well-organized mess and make it something functional, beautiful even. The fragile public health system in United States during the Covid-19 pandemic is much like that tangled yarn.

This dual task is very much an oversimplified explanation of where the American health care landscape exists in this moment. Like most collective traumas, this stage isn’t the “undoing” stage, it’s the stop the damage stage. In writing the first blog of the year, tracking site Worldometers reported 20 million confirmed COVID-19 cases in the United states and about 345,000 COVID-19 deaths. As of the time of this writing, the same site is reporting more than 30 million confirmed COVID-19 cases in the US and about 550,000 COVID-19 deaths. Daily case counts continue to remain high at around 50 thousand confirmed cases a day and around 1,100 deaths per day on average. While the introduction of 3 vaccine products has brought hope and another tool to our COVID toolkit, and daily new cases and deaths are far below their height, the pandemic still rages on.

Which is…concerning for the entirety of the health care spectrum and especially so for those spaces that have been historically underserved or needing additional protection or funding. From the Centers for Disease Control report at the Conference on Retroviruses and Opportunistic Infections (CROI) the United States performed at least 700,000 fewer HIV screenings and 5,000 fewer new diagnoses in the first 6 months of the pandemic (compared to the same time in 2019) to the extraordinary implications of COVID among vulnerable populations to Senators Grassley and Klobuchar introducing legislation to allow drug importation (despite very clear warnings about why this is not a great idea) to the Biden Administration issuing a formal disapproval of Medicaid work requirements, to say information is coming at “break neck speed” may well be as much of an understatement as a tangled ball of yarn.

With an emerging “surveillance gap” for both HIV and HCV, a startling HIV outbreak in West Virginia, overdoses increasing as a result of COVID, some of greatest tools gained in combating this pandemic, even those advocated for by the CDC, have already started to go away as states begin to “open up”. Indeed, Congress has already begun taking up old questions regarding telehealth restrictions and payment systems designs, this time with an eye for permanency.

While President Joseph R. Biden’s American Rescue Plan, recently passed by Congress and signed into law, offers a great deal of funding to address the needs of certain entities and programs to tackle COVID and even offers the most meaningful adjustments to the Affordable Care Act by expanding subsidies, the existing needs of the health care ecosystem have largely been neglected for the last year. Well…far longer…but I digress. Like any trauma, our need to strengthen patient protections and access, incentivize quality of care over quantity of services, and meaningfully reduce health disparities have been the ends of thread tightening around the knot of COVID. This pandemic did not create these disparities and the needs outlined above – but not having a plan for a pandemic, not addressing structural inequities and these burning policy needs with the urgency they so deserve absolutely made us more vulnerable to the most devastating impacts of any pandemic.

This isn’t “the end”, certainly. For advocates, this has always been our “normal”. We need those who have hung on our every word and insight through this emergency to stay at the table – we’re not done yet. Everything you were outraged by (and may still be enraged by thanks to vaccine access scarcity) remains and will continue to loom just over our shoulders, waiting to be exploited by an opportunistic disaster.

Indeed, the ghost of Scott County may well continue to haunt us for some time to come. This is, after all, a very big ball of very tangled yarn.

What About Us? Reflections on What the Global Covid-19 Vaccine Means to HIV

A year ago, the world turned its eyes to a justifiably disparate race to find any possible treatment, cure, or prophylactic for COVID-19. The collective experience was familiar to veterans of the fight against HIV – though, for some, the feeling was tinged with dulling hope and cynicism. Afterall, the first HIV vaccine trial began in 1987. A near 35 years later and we’ve yet to find an effective and safe protective vaccine.

The COVID-19 effort spurred extraordinary and sometimes bizarre theories, with journalists soaking up non-peer-reviewed pre-prints with the abandon of a starving person. From theories on hormone replacement therapies to reduce blood clotting risks to the now-infamous hydroxychloroquine episodes to convalescent plasma to repurposing our own antiretroviral therapies, many, if not most, of these failed the test of time. Something HIV advocates and researchers are all too familiar with. As a result of the pressure and need, the Trump Administration initiated one of the largest scale federal research funding initiatives in history: Operation Warp Speed, promising to deliver a vaccine for the novel coronavirus in record time.

The resulting skepticism was understandable. Previously, the fastest any modern vaccine had been developed was about 5 years, with the current mumps vaccine. The difference this time, though, was vaccine tools that had failed elsewhere, in the fights against cancer, Ebola, and other diseases, had provided us the opportunity to “practice” for such an incident – expanding the unused tools in the toolbox as it were. Included among these was a near 50 year old theoretical approach, using messenger RNA to teach our bodies how to fight this new pathogen. Moderna and Pfizer did indeed produce such a product in December 2020.

While the world praised these developments, HIV also took an exception to the announcements. We’ve been waiting nearly 40 years for the same technological miracle. With more than 75 million known transmissions, approximately 32 million having died from AIDS related complications, and 38 million people currently living with HIV, since the start of our pandemic, it’s understandable to ask “what about us?” Where was this “warp speed” effort in 1995 when AIDS was the leading cause of death among 25-44 year-olds in the United States?

It’s important to note: coronaviruses and HIV are two very different types of viruses. Coronaviruses maintain a greater integrity in their reproduction processes and HIV’s “copy writers” are known for making “mistakes”, developing mutations and resistance to medications. As such, coronaviruses “mutate” at a much slower rate than HIV. Despite the very warranted concerns on SARS-CoV-2 variants, most vaccine products coming to market are showing promise in beating back these emerging threats. Whereas HIV is also known to “hide” viral reservoirs within a person’s body – merely waiting to be activated, thwarting certain progress.

Still, technology moves forward and hope springs eternal. Moderna has already announced intentions to use mRNA vaccine technology to produce more accurate vaccines for influenza, personalized vaccines for certain cancers, and HIV. Scribbs Research has also recently announced a phase I trial utilizing “germline targeting” technology to stimulate the exact B-cell responses for a body to develop HIV neutralizing anti-bodies.
Additionally, in a remarkable find, Abbott has recently identified an extraordinary occurrence of elite controllers, those with HIV antibodies but no or undetectable viral load without the use of antiretroviral therapies, in the Democratic Republic of Congo (DRC). With a prevalence of 2.7-4.3%, as opposed to 0.1-0.2% elsewhere in the world, researchers believe this population provides us an opportunity to investigate what is essentially a natural occurring immunity to HIV, something medicine doesn’t currently understand well enough to replicate. Abbott was able to identify this population through surveillance activities, as its screening tools are used in about 60% of the world’s blood supply donations, where information gathered is also used to identify emerging diseases – in particular “new” strains of HIV and viral hepatitis. Abbott’s findings state this occurrence of elite controllers is extends as far back as 1987, prior to the advent of antiretroviral therapies, at “similarly elevated levels”.

Regardless of the promise (read: hope) of a protective or therapeutic vaccine for HIV, any effective product is bound to face the same persistent issues of equity COVID vaccines are currently facing. From trial design by and inclusion of the most affected communities to equitable distribution outside of western countries, we absolutely run the risk of perpetuating existing global health disparities. Manufacturers, governments, and researchers will need to better align their actions with our moral and ethical obligations in order to truly end HIV for all, instead of just some.

Painting Roses in the Desert: Despite Medicaid Expansion, Gaps Remain in Arizona

[Editor’s Note: This blog is, in part, a replication of a blog hosted by the ADAP Advocacy Association. Supplementary policy analysis on hepatitis treatments continues in this blog]

It shouldn’t be a surprise to anyone that many AIDS Drug Assistance Program advocates are in favor of Medicaid expansion. Indeed, as noted here, those same advocates view Medicaid expansion as an opportunity to strengthen health care access for the most vulnerable people living with HIV, meet needs unaddressed by a state’s ADAP coverage, and help ADAPs remain financially stable. For ambitious advocates (I’m talking about myself), when sufficient support exists to support those at or below the expanded Medicaid eligibility threshold of 138% of the federal poverty level, state ADAPs could consider expanding income eligibility above 400% of the federal poverty level. Indeed, Louisiana is one such state.

However, like all health care policy, the details matter.

In Arizona, the state’s Medicaid formulary is restrictive and slow to adapt to the needs of qualified people living with HIV, shifting financial pressure to the state’s ADAP and requiring the most impoverished clients to manage interacting programs in order to achieve coverage of certain medications. As the payer of last resort, when ADAP clients have other coverage (ie. Medicaid), conflicting payment processes are most often felt at the point of medication delivery or when a client gets told, inadvertently, their medication is not paid for. The process of correcting this mistake can take a matter of days or weeks, depending on a pharmacy’s experience with co-occurring payers.

In that time, patients can fall out of care, drastically reducing their likelihood of achieving an undetectable viral load.

For ADAP formulary advisory committees, for states that have them, the process of adding and adjusting formularies is sometimes relatively expedient. Relatively, in part, because those medical experts and community experts understand the need and nature for ensuring access to an expansive list of antiretroviral medications and modern advancements. Arizona’s Medicaid formulary lacks several single tablet regimens and, in the opinion of Glen Spencer, executive director of Aunt Rita’s Foundation, favor outdated “cocktails” (or multi-tablet regimens), complicating daily care for people living with HIV and accessing Medicaid, often subjecting clients to greater experiences of toxicity, and ultimately interjects an unnecessary interruption in both patient choice and provider care.

In aiming to impress the need of Arizona’s Medicaid formulary to expand in both supporting the sustainability of the state’s ADAP and meeting national initiatives Mr. Spencer stated, “It is critically important that Arizona’s Medicaid program include all single-tablet regimens on its formulary to offer patients the right medication for them, and to provide medical providers with the flexibility they need to prescribe the right medication for each patient.”

To this end, Aunt Rita’s advocacy efforts are also expanding with proposed legislation addressing the failure of Arizona’s Health Care Cost Containment System (AHCCCS) to take up the issue. According to Mr. Spencer, the bill is not likely to make it out of committee this year and lacks any great deal of interest for legislators battling over other budgetary and policy concerns and does not currently have a companion bill in the state Senate. On the other hand, the bill is sponsored in the Arizona House by a bipartisan coalition of 9 legislators.

“In order to end the HIV epidemic, both the patient and provider community will need all therapies available to them to support persons living with HIV, save lives, and get patients to an undetectable viral load.” Mr. Spencer added, “This policy not only promotes patients’ ability to lead a robust life, but also prevents new infections given the science behind U=U.”

The state’s ADAP and Medicaid formularies also present a similar situation for medications used to treat Hepatitis C, leaving a critical gap in available health care services and treatment for those at risk of contracting Hepatitis C. While the state’s ADAP coverage includes most direct acting agents, Arizona’s Medicaid formulary only covers Epclusa, Mavyret, Ribovirin, and Peginterferon.

Arizona’s situation offers a critical reminder that even with the value of Medicaid expansion, in order to achieve the greatest reach of ADAPs, tackle the absolutely critical inclusion of treatment and retention in prevention efforts, and to eliminate viral hepatitis, the details matter and advocates will need to adapt old fights to new environments.