State-Level Monkeypox Surveillance Highlights State-Level Disparities

The Community Access National Network (CANN) launched an ambitious patient awareness campaign focused on the ongoing Monkeypox (MPV) outbreak. Its ‘MPV Response Project for People Living with HIV’ seeks to gather data and issue reports covering MPV in the United States. The reports will focus on epidemiological trends, vaccine access and equity, state-level access to vaccine and antiviral supplies, HIV and MPV co-infection risk and reporting, and the latest news related to the outbreak. The project is broad in scope, and it will tackle the MPV outbreak in a way that is both data-focused and patient-centric. This month’s blog will focus on the demographic disparities of the MPV outbreak, in general, and how those disparities vary at the state level. 

The Centers for Disease Control and Prevention (CDC) has been providing considerably detailed data about MPV since the beginning of the outbreak in the U.S. in May 2022. From its MPV data portal, users can get a surprisingly robust amount of national-level data, one of the most striking of which is that Black Americans account for roughly 44% of all new MPV diagnoses across the U.S. (CDC, 2022). 

As part of this MPV Response Project, CANN has decided to dig deeper by attempting to gather and analyze state-level epidemiological reporting where it exists. Our experience with state-level surveillance has shown that, while every state has some sort of surveillance system in place, no two systems are created equally. That is to say, while some states provide robust surveillance and reporting, other states—particularly those located in the American South and rural West—do not. More to the point, they likely cannot, as a result of underfunded and understaffed departments.

With this established, here is what we found:

As of October 28th, 2022:

• 28 states (AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MS, NJ, NM, NY, NC, RI, SC, TX, VA, WA, & WI) and the District of Columbia provide detailed demographic reporting on Monkeypox virus incidence on state-run websites. Both DE and FL omit race demographics from their reporting.

• 13 states (HI, ID, IA, KS, ME, MT, ND, OH, OR, SD, TN, UT, & WY) provide case counts, but no demographic breakdowns on state-run websites.

• 9 states (AK, AZ, MO, NE, NH, OK, PA, VT, & WV) and Puerto Rico report data directly to the CDC with no reporting on state-run websites.

• 1 state (NV) currently has a reporting dashboard under construction

It was heartening to see that roughly half of the jurisdictions in the U.S. (when including the U.S. territories) provided relatively thorough demographic reporting. This is likely because the data dashboard systems for reporting real-time disease surveillance were already purchased and in place as a result of tracking implemented to report COVID-19 data. 28 states provide some level of demographic reporting, and almost all of those states provide reporting on race.

There are still, however, significant gaps in these data. For example, Florida—one of the most racially diverse states in the U.S.—provides no demographics broken down by race; only by age. This lack of reporting presents a significant barrier to advocates, providers, and legislators because it homogenizes the results. If we are unable to see which populations are disproportionately impacted by MPV—or any disease, for that matter—then how are we to deliver data-driven public health interventions?

An additional issue exists with states’ decisions on how and where they account for Hispanic populations. While some states include “Hispanic” as a separate race category, others treat it as an “Ethnicity” that overlaps multiple race categories. While the latter classification is technically correct—there are Black and White persons who are also Hispanic—this creates a data issue that makes comparing data across states difficult.

In the states with state-level demographic reporting, Black Americans account for a majority of new MPV diagnoses in eleven states (AL, AR, GA, LA, MD, MI, MS, NC, SC, TN, & VA). Of those states, nine are located in the American South, all of which rank in the top ten states with the highest number of Black residents as a percentage of their states’ populations. As an example, in Alabama, Black Americans constitute 26.5% of the state’s population but account for 71% of MPV diagnoses (Alabama NEDSS Base System, 2022). Similarly, in Georgia, Black Americans constitute 32% of the state’s population but account for 77% of MPV diagnoses (Georgia Department of Public Health, 2022).

This is not the case, however, in every jurisdiction. In California, New Jersey, and New York state, Hispanic Americans represent the majority of new MPV diagnoses, as well as in New York City, which is counted as a separate jurisdiction from New York state. Additionally, in Colorado and Massachusetts, while Hispanic Americans do not account for the majority of new diagnoses, they do account for a significantly greater percentage of diagnoses than Black Americans living in those states. In Colorado, Hispanic Americans constitute for 22% of the state’s population but account for 34.8% of MPV diagnoses (Colorado Department of Public Health, 2022). Similarly, in Massachusetts, Hispanic Americans constitute 12.8% of the state’s population but account for 31% of MPV diagnoses (Massachusetts Department of Public Health, 2022).

Unfortunately, in the United States, case surveillance is set at the state level, with each state determining what diseases they track, how they track them, and how they report them. This system, while protected under the 10th Amendment, is more of a liability than an asset. By leaving these decisions in the hands of states, they are infinitely more subject to political machinations by anti-science legislators than were these decisions to be placed under the purview of the Department of Health and Human Services.

Further complicating the inefficiency of our nation’s myriad surveillance systems is that state departments of epidemiology and surveillance must be adequately funded to perform these duties—a feat that, at least at the state level, is becoming less likely given the political makeup of their legislatures. One of the unfortunate impacts of the COVID-19 pandemic’s stellar state-level reporting was that certain political factions have determined that disease surveillance is political, rather than factual; that the science is not to be trusted, because the science is “biased.”

An example of this occurred in West Virginia, in 2021, when state and local legislators, in a public hearing, informed Dr. Demetre Daskalakis, then Director of the Division of HIV/AIDS Prevention at the CDC, that they did not believe him when told that West Virginia’s outbreak of HIV among Persons Who Inject Drugs was worse than in New York City (Peace, 2021). In response to his assertion, the Kanawha County Commission demanded that Senator Joe Manchin submit a congressional inquiry with the CDC to question the validity of his statements (Raby, 2021). This was not an isolated incident; state legislators in Conservative-run states have consistently disregarded and even demonized basic scientific data reporting as if it were a conspiracy against them.

As a result of this increased, and yet paradoxically incurious, scrutiny of disease surveillance, some states are choosing to decrease or drastically cut funding to those departments. And the stark reality is that this trend is likely to get worse before competent heads prevail. In response to what members of one political party have consistently referred to as “government overreach,” at least 20 Conservative-run states used their 2021 legislative sessions to enact new laws that “…preclude the use of proven public health measures or more broadly constrain the authority of state and local health officials, and governors, in a public health crisis” (Vestal, 2021). This means that, even with targeted federal funds, state departments of health and local health officials may be constrained in what they can legally do at the state level. Worse still, many of those state legislators have created committees designed to identify “misspending”—a thinly veiled code for “work we find objectionable”—and to slash budgets to ensure that the “overreach” cannot be implemented, again.

What patients, providers, and advocates can do is reach out to their state and federal legislators to advocate for greater funding specifically for surveillance, and to request that those funds come with stipulations for how they can and cannot be used and when they must be disbursed, so that states do not allow those funds to languish in interest-bearing accounts rather than spending those funds. Additionally, readers can reach out to their states’ departments of health to request that they improve the availability or make available demographic data that are broken down into useful categories that can be turned into direct action to address any disparities these data may identify.

The quest to improve the quality of our data is going to require both federal standard setting and the funds to implement them. Let’s make it happen.

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 References

Alabama NEDSS Base System. (2022, November 01). What You Need to Know About Monkeypox in Alabama. Alabama Department of Public Health. https://tableau.adph.state.al.us/views/MPXFINALusingextractallsheets/MPXPublic?%3Adisplay_count=n&%3Aembed=y&%3AisGuestRedirectFromVizportal=y&%3Aorigin=viz_share_link&%3AshowAppBanner=false&%3AshowVizHome=n

Centers for Disease Control and Prevention. (2022, October 26). Monkeypox Cases by Age and Gender, Race/Ethnicity, and Symptom. Atlanta, GA: United States Department of Health and Human Services: Centers for Disease Control and Prevention: Poxvirus: Monkeypox. https://www.cdc.gov/poxvirus/monkeypox/response/2022/demographics.html

Colorado Department of Public Health. (2022, October 26). Colorado Monkeypox Data. Colorado Department of Public Health: Diseases A to Z: Monkeypox. https://cdphe.colorado.gov/diseases-a-to-z/monkeypox

Georgia Department of Public Health. (2022, October 26). Georgia Monkeypox Situational Report – October 26, 2022. Georgia Department of Public Health: GA Monkeypox Outbreak Cases and Vaccination. https://dph.georgia.gov/document/document/mpx-situational-report-october-26-2022/download

Massachusetts Department of Public Health. (2022, October 27). Monkeypox Cases and People Vaccinated by Age, Sex and Race/Ethnicity. Massachusetts Department of Public Health: Bureau of Infectious Disease and Laboratory Sciences: Monkeypox. https://www.mass.gov/doc/weekly-report-monkeypox-cases-and-people-vaccinated-october-27-2022/download

Peace, L. (2021, February 11). The CDC says Kanawha County’s HIV outbreak is the most concerning in the United States. Mountain State Spotlight. https://mountainstatespotlight.org/2021/02/11/the-cdc-says-kanawha-countys-hiv-outbreak-is-the-most-concerning-in-the-united-states/

Raby, J. (2021, April 06). CDC inquiry sought on HIV outbreak in Kanawha County. The Parkersburg News & Sentinel. https://www.newsandsentinel.com/news/local-news/2021/04/cdc-inquiry-sought-on-hiv-outbreak-in-kanawha-county/

Vestal, C. (2021, July 29). New State Laws Hamstring Public Health Officials. The Pew Charitable Trusts. https://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2021/07/29/new-state-laws-hamstring-public-health-officials

Winter is Coming and so are Waves of Respiratory Illnesses

When the COVID-19 pandemic hit its first fall, many worried about the potential for a “twindemic” wherein influenza and COVID-19 would experience concurrent seasonal waves that brought untold death upon the country and the world at large. However, because all of the activities of non-pharmaceutical intervention used to mitigate COVID-19 are the same as what’s needed to prevent influenza, the 2020-2021 Flu season was remarkably quiet.

Likely the least active Flu season on record, the United States experienced only one pediatric death during the 2020-2019 fall and winter months. Comparatively, the 2009-2010 Flu season was one that was considered “pandemic” with the H1N1 strain (sometimes called “swine flu”) with 288 pediatric deaths and the 2019-2020 season saw 199 pediatric deaths, according to the U.S. Centers for Disease Control and Prevention’s (CDC’s) “FluView” data, which tracks influenza, influenza-like-illnesses (“ILI”), and, since testing became widely available, COVID-19. The data includes diagnoses, hospitalization, and deaths, among other factors and the important thing to remember when viewing the 2019-2020 Flu season is it accounts for the initial period of time when COVID-19 as wholly novel and such a threat whole governments and countries shut down, and the year still outpaces the immediate previous two seasons. The 2021-2022 Flu season saw a slight, though only remarkable in how low the number was, return to regular flu season – still only 48 children died from Flu in the 2021-2022 season.

Typically, “Flu” seasons, which we should really start calling “respiratory illness season” begins in “week 40” of the year (which also typically falls as the first full week of October). As of this year’s respiratory illness seasons, we’re already above the national baseline for outpatient ILI diagnoses and far outpacing all previous seasons at week 40 through 2017-2018. Dr. Mark Kline, of Children’s Hospital New Orleans and the leading pediatrician in the state, is regularly posting the hospital’s respiratory census and urging parents, families, and individuals to get their updated booster shots and return to precautions we’ve now deemed “COVID precautions” but generally work to halt the transmission of most respiratory illnesses. While COVID-19 isn’t the largest share of pediatric hospitalizations for respiratory illnesses, it does rank. Influenza A and Rhino and Enterovirus (generally illnesses that cause the common cold and most “stomach bugs”). Co-infections are common. Another virus they’re watching closely is respiratory syncytial virus (RSV) because it’s typically the leading cause of pediatric hospitalization. There is no vaccine for RSV, currently, but several manufacturers are pursuing candidates at the moment.

In short, this respiratory illness season is likely to be… “bad” is an understatement. But there’s things you can do to help ease these risks and protect the people around you. You can ensure you’ve had your annual flu shot and updated COVID-19 booster, you can opt to return to masking or even selective masking, and the washing of hands and limiting our interactions when ill is just plain courteous.

HCV ‘Netflix’ Model Reveals Price Isn’t the Biggest Problem

A recent article published to STAT News offers a detailed view on how in 2019, Louisiana and Washington State invested in the headline making, flashy deal of the century. It involved an unlimited supply of direct acting agents (DAAs) known to cure Hepatitis C (HCV) for the price of a standard “subscription” fee. Now, it wasn’t a $9.99 per month, endless video watching gig, but rather thousands of prescription fills per month meant to address the needs of each state’s Medicaid program and correctional facilities. However, such penned deals are estimated to have already saved the two states hundreds of millions of dollars. The subscription model is exciting, STAT reports the Biden Administration wants to build a similar program on the federal level. So that should solve the problem, right?

Not so fast! The data, and the experts, offer a more cautious tone.

A heady launch led to incarcerated people, who had previously sued for access to these curative treatments, finally received them. The states moved to reduce the “utilization” restrictions, like prior authorizations or requirements to have a specialist supervise the care. But that steady progress slowed to a trickle, and signs exist that the progress is already being lost.

2020 brought well-known disruptions in care, including reductions in screenings in hospital settings, and strained prison and jail staffing. And while the COVID-19 pandemic’s crisis phase may provide somewhat of a pass, it doesn’t explain all of the losses and slow return to focus on each state’s plan to eliminate HCV.

What’s at the core of the elimination efforts missing their mark? The planning and implementation of the program hinged on the idea that drug cost was the primary issue as to why people weren’t accessing this curative treatment. Turns out, even if the drug is free to patients and affordable for states, there’s more to care than cost, especially in public health. Despite hundreds of millions in saved dollars, neither state set aside enough (or any) of those projected savings to bolster provider education, invest in the human capital necessary in health care entities serving the most affected public (like federally qualified health centers), or reimbursement for “street medicine”, or innovative program designs, or – as especially is the case in Louisiana – ensuring state health departments have the staff dedicated toward HCV elimination.

Let us take a second to consider that last point. Louisiana’s STI, HIV, and Hepatitis Program is in pretty desperate shape. A long list of job openings reflects the fact that much of the program’s staff are subcontractors with those contracts spread across three different entities, a result supposedly of former Governor Bobby Jindal’s efforts to gut the program entirely, the program can’t attract or retain talent because wages remain ridiculously uncompetitive and, in instances where staff is offered promotions, they have to consider the trade off of losing their health benefits and accrued vacation days for a short period of time if that position is being held under one of the other three contracts. With that kind of tangled web to navigate, no wonder the state is falling behind. On social media, some state legislators have openly mocked the Louisiana Department of Health asking for budget increases. None of that touches the lack of physical access points of care patients need in more rural parts of the state – sometimes driving hours to find a provider to treat their HCV – or the failure of jails and hospitals to universally implement the screening elements of a successful elimination plan.

With the Biden Administration already struggling to get Congress to fund similar subscription plans for COVID-19 testing and treatment and flat out refusal from certain Senators to fund the Centers for Disease Control and Prevention’s sexually transmitted infections work despite data showing that under no uncertain terms the need exists, is there any real hope an appetite exists for similar funding to eliminate HCV in the United States?

One thing is clear, the cost of medication a payer sees (public or private) is not the biggest barrier to care for patients. Indeed, few patients care very much at all about what a payer’s costs are – patients care what their costs are and that includes costs not readily recognized by payers (like costs associated with time off work due to narrowed provider networks), or the time it takes providers to build trust in highly affected, highly marginalized communities. In fact, if policymakers wish to make the great investments necessary to eliminating HCV, they can start with sensible steps like requiring and enforcing hospitals to implement opt-out screening activities by way of rule making or legislation directing HCV screening to be a standard of care and integrated into the state’s essential health benefits benchmarks. Similarly, those same policymakers could require and enforce implementation of universal screening in all carceral settings or introduce legislation which requires departments of corrections to provide DAA to all incarcerated people diagnosed with HCV, regardless of cirrhosis status. States could require commercial health plans to cover DAAs at no cost sharing or require that all covered entities in that state charge a flat dispensing fee for DAAs (recognizing abusive dispensing fees for DAAs necessarily reduce the dollars available to support public health programming). States could dig into consolidation of access points to care to the exclusion of entire geographies hard hit by disparities.

There’s so much more to “access” to care than what a payer negotiates with a drug manufacturer and focusing exclusively on the issue of drug pricing. Without robust planning, reinvestment of “savings” into the logistical supports – including competitive wages and benefits packages for labor needs – necessary to feed the roots of this tree, all we’ll be left with is the low hanging fruit and rotten wood. And if we’re not careful, efforts at Ending the HIV Epidemic might end up looking much the same.

National Monitoring Report Highlights Disruptions and Opportunities

In September, Community Access National network (CANN) and Health HIV, Health HCV, and the National Coalition for LGBT Health partnered for the 7th Annual National Monitoring report on HIV/HCV Co-Infection as a “pre-Sync” session, warming up public health advocates and professionals for SYNChronicity 2022, which will be held virtually December 6-8. Presented by Marissa Tonelli, Director of Health Systems Capacity Building for Health HIV, and yours truly. Attendees represented a variety of stakeholders including funders, patients, advocates, providers, and public health professionals. The National Monitoring Report was generously supported by ADAP Advocacy Association, Gilead Sciences, Janssen Pharmaceutical Companies of Johnson & Johnsons, Merck & Co, and ViiV Healthcare.

The annual report presented information highlighting coverage of hepatitis C (HCV) curative direct acting agents (DAAs) in public health programs, including AIDS Drug Assistance Programs (ADAP), Medicaid, and Veterans Affairs as public payers. Additional information was presented on areas of intersectional focus, including harm reduction policy and programs across different states and at the national level.

Particular note was made on disparities of HCV diagnoses along racial identity, age, and geography, emphasizing where public health programs and advocates have room to improve in outreach, education, screening, linkage to care, and coverage. Highlighting data from the Centers for Disease Control and Prevention (CDC) on HCV diagnoses in 2020 and data presented earlier this year from the CDC on HCV screening and linkage to care based on payer type, both presenters discussed a failure of providers to screen for HCV. The failure of providers, particularly hospitals, to effectively enact opt-out screening has impact of furthering health outcome disparities and not taking opportunities to stop chains of transmission. While some of these missed opportunities may be attributed to disruptions to care due to the crisis phase of the COVID-19 pandemic, many of these failures are related to a lack of incentive to screen. Both presenters insinuated an expectation of HCV diagnoses to increase in the coming years as a result of these disruptions and failures.

Barriers to care from providers include failure to adopt the 2019 recommendations for universal screening, utilization management practices from payers which may limit the ability for providers to ensure patients are receiving DAAs (including extraordinary prior authorization requirements), lack of infrastructure to implement HCV programming, and a lack of consensus in the care guidelines. Patient barriers to care include lack of knowledge, social barriers (like homelessness), cost of insurance and restrictions from payers, and substance use-associated comorbid conditions. The commonality of payer roles as barriers to care is worthy of particular attention as advocates engage public health program administrators and seek to leverage public programs for better practices. Advocating for integrating HCV screening as a standard of care and ensuring states adopt HCV screening and linkage to care as part of state level “Essential Health Benefit” benchmarks is one approach which would tie provider reimbursements with screening and linkage to care activities.

While no debate occurred, discussion was had around the issue of “co-located” and telehealth models as a means of extending care and support for affected communities. The model of providing comprehensive care in a single site proves an opportunity for patients to access providers and support services is effective for certain communities. But if this model consolidates access sites, it may also prove to be a barrier for patients not closely located to these “one stop shops”.

Despite these tools and a generally supportive statutory environment, the nature of health care access is not necessarily getting easier for service providers or patients but more complicated. Advocates should be mindful of unintended consequences and how to leverage broader health care reform as they approach solution finding.

An archive of the event is available here.

Navigating Monkeypox: Challenges Patients Face

The Community Access National Network (CANN) has launched an ambitious patient awareness campaign focused on the ongoing Monkeypox (MPV) outbreak. Its ‘MPV Response Project for People Living with HIV’ seeks to gather data and issue reports covering MPV in the United States. The reports will focus on epidemiological trends, vaccine access and equity, state-level access to vaccine and antiviral supplies, HIV and MPV co-infection risk and reporting, and the latest news related to the outbreak. The project is broad in scope, and it will tackle the MPV outbreak in a way that is both data-focused and patient-centric.

One of the first things CANN discovered while seeking this data is that, as is the case with many relatively new outbreaks, what data are available are both disjointed and confusing for any patients and affected communities to try to navigate. While the U.S. Centers for Disease Control & Prevention (CDC) has done an admirable job in creating a data reporting center that is relatively timely in terms of updates and data availability, their data are only as good as the data they receive from states.

This has been a problem across numerous disease states for decades: state epidemiology departments and state and local departments of health across the United States are almost universally chronically underfunded, understaffed, poorly regulated, and frequently disorganized and disconnected from even state-level, much less federal-level, networks and reporting standards.

The issues include:

1.) A lack of federal reporting standards and duplicative reporting across funding opportunities makes gathering, interpreting, and reporting data about disease states, such as MPV, an arduous and frustrating task.

An example, out of 55 reporting jurisdictions in the United States, MPV vaccine administration data presented by the CDC only accounts for 48 of them. The jurisdictions that are not included—Arizona, the District of Columbia, Indiana, Mississippi, Montana, Nebraska, and Puerto Rico—represent some of the poorest, most underserved patient populations in the U.S. Another example is that, of the 527,818 first-dose vaccine administrations reported in the U.S., an astounding 44,192 (8.4%) had no accompanying racial demographic information included.

This issue extends beyond vaccine reporting. Because MPV diagnoses and testing information reporting requirements are not standardized, each state can (and does) provide vastly different reporting based upon local standards. An example of this is that the state of Alabama breaks reporting of race categories into “White,” “Black,” and “Other.” This is despite the fact that 18.7% of Alabama’s population is Hispanic and 6% is Asian. Apparently, other races need not apply? Other states, such as Alaska, report their data directly to the CDC and provide no epidemiological information specific to the state on their state websites.

It can be incredibly frustrating, particularly as community service organizations and healthcare providers seek and use data as a tool for advocacy and patient engagement. It is certainly not a lofty expectation that each state’s governmental agencies be required to comport with some sort of standard. It is not a Herculean task for states to report data in a similar manner and format, but for this to become the standard, those at the federal law and policy needs to define and implement reporting requirements across disease states. As it stands, except in limited circumstances, states are not required to report these data, rather the CDC and other federal entities are left to negotiate data collection and sharing agreements as part of federal funding opportunities.

2.) States are still ill-prepared to deal with disease outbreaks.

One would think that, after nearly three years of dealing with a global pandemic outbreak, state departments of health might have figured out ways to deal with getting out information quickly, effectively, and in an organized manner. One would be wrong.

A big hurdle that CANN encountered while seeking state-level data was that state websites are, by and large, disorganized, confusing messes, even for the most experienced patient. For the average patient, trying to find information about MPV in most states requires several steps through difficult-to-find links to try to get where they need to go. Additionally, these pages are not uniformly located on state websites as opposed to state health department websites, when those websites are different, rather than integrated into the same website.

It is not too much to ask for state websites to have a featured link on the homepage of their websites for disease outbreaks that are of national and state-level importance? Indeed, many states and state health departments are quite familiar with using banner bulletins as seen during the initial crisis phase of the COVID-19 pandemic, as an example.

More galling is the fact that, despite nearly two years of administering mass vaccination drives, several states still don’t have this down to a science. An essential tool, only realized broadly on the federal level and through private partnerships, is a centralized vaccine scheduling system. Again, not to belabor the point, we did this with COVID-19 vaccines. We should be able to provide similar supports and patient access tools across all disease states and especially in infectious disease outbreaks in which a vaccine product is available.

Instead, what we have is a sort of secret club lottery that leaves patients with the onus of calling multiple healthcare providers and health departments just to check to see if the vaccine is available, and to try to schedule an appointment.

3.) Event-based testing and vaccination drives are effective, but underutilized and overly depended upon tools for addressing MPV.

There are two men for whom CANN has the absolute highest respect: Dr. Demetre Daskalakis and Dr. David Holland. Both of these men have taken amazing steps to go out into communities that are at high risk of transmission of diseases like HIV and MPV and deliver care where people are. From drag brunches to bathhouses to leather bars and circuit parties, they have consistently led the charge in a very public way. We have been doing this with HIV testing for decades but delivering point-of-care services at these locations has always been something of a taboo that needs to be overcome for reasons including addressing these outbreaks and overcoming social stigma which harms members of marginalized sexual and gender identity communities beyond these health disparities.

That said, it is a drop in the bucket. An important drop, but a drop, still. These events still run into issues of being accessible to people who work non-traditional hours, in service industries, do not have reliable transportation, or face any host of barriers, including social stigma which may make associating receiving care at these events unsafe or feel less welcoming for people outside of the immediately targeted community. Gay, bisexual, transgender, and other men who have sex with men, the population most affected by the current MPV outbreak, are not uniformly attracted to attending drag brunches or circuit parties but may lead full and active sex lives outside of those spaces. Considering the disparities already manifesting in the current MPV data, those people making up more and more of the share of new MPV diagnoses may well be best approached outside of these types of events. This is not to suggest we should cease having vaccination and testing events in sex positive spaces. This is to say our approach should be an “and” approach.

Beyond just COVID and MPV vaccines, we need to start delivering additional vaccine services in these locations, including influenza, Hepatitis A/B, Shingles, and the like.

4.) This nation needs round-the-clock medical services.

It’s time to leave behind the 8:00 – 4:00 and 9:00 – 5:00 physician and clinic hours of operation. We have known for decades that limited office hours force patients to choose between earning enough money to survive and receiving medical care. While some federally qualified health centers and STI clinics have offered services outside of traditional healthcare hours, many have not, insisting either their communities don’t need these extended hours or stating plainly, the funding does not exist to maintain the necessary staff to operate outside of traditional business hours. Even fewer private providers and health department clinics offer non-traditional hours.

It has never made sense that physicians' offices are only open during working hours…when people are expected to be working. Maybe it has to do with the idea that, at one point in American history, at least one parent was a stay-at-home parent who had the time and wherewithal to take kids and partners to the doctor’s office. Now that virtually every family member is required to work to make ends meet, we need a different solution.

The arguments against it consistently have to do with money—it’s expensive, and you can’t turn a profit. Healthcare provision should never be about making a profit at the expense of helping people. If that means that you find physicians, physician assistants, nurses, and administrative staff to work later shifts, that’s what it means. More likely, however, it means we need to address public and private payer efforts to constantly reduce provider reimbursement, given full credentialling to nurse practitioners in all states, and more readily hire non-clinical support staff from the communities immediately served by these entities.

Beyond the fact that this move would make basic healthcare services, such as testing and vaccination, more easily accessible to people who work during the day, it might also open up additional opportunities for more people to schedule appointments that don’t require sitting in a waiting room for a half-hour beyond their appointment time.

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Editor’s Note: These issues may sound minor—like the sour grapes of an exhausted and annoyed patient advocate—but the truth is that patients get frustrated with the lack of user-friendliness of every aspect of our public health infrastructure.

Patients need to be able to find what they’re looking for without having to jump through seven different hoops to find out where to schedule a vaccine appointment. Patients should be able to find what they’re looking for without having to jump through seven different hoops and spend hours trying to find out where to schedule a vaccine appointment.

We should expect to be able to see if various locations actually have vaccine stock on hand without having to call an office and annoy an administrative employee to find out if they have it in stock and if any appointments are available.

It’s 2022, basic technology has existed since the mid-2000s and these better practices in public health and healthcare engagement have been known since the late 1980’s. It’s time to get it together.

Advocates Gather to Discuss Pressing Healthcare Issues

The ADAP Advocacy Association held its second Fireside Chat retreat this year, assembling in Chicago to discuss a broad range of issues. The Fireside Chats are somewhat coveted for the nature of the space they provide, with representation of a variety of industry partners, advocacy and service organizations, and patient advocates who don’t necessarily hold any particular affiliations. CEO, Brandon M. Macsata, refers to the gathering as “a group therapy session” whereby the richness of the advocacy work is most frequently the result of conversations at the Fireside Chat, but not necessarily rooted in seeking specific solutions confined to the four walls of the meeting room. The meeting format frees attendees from needing to be the “problem solvers” and allows for a free flow of ideas and perspectives collaboratively that might not otherwise arise. Topics for this event included combatting counterfeit medications, reforming the 340B Discount Drug Program, and dissecting COVID-19’s impact on public health programs.

While many of the participants were familiar with the notion of counterfeit medications, few were necessarily familiar with the details of safeguards taken to ensure patients are indeed receiving the medications they expect to receive or how large recent instances of counterfeit HIV medications were possible. Shabbir Imber Safdar from the Partnership for Safe Medicines started the conversation by sharing the status of implementation of the Drug Quality and Security Act, and how packaging was sold and resold with fake product in containers as part of one of the counterfeit schemes in Florida. Participants asked about various aspects of enforcement and implementation, drivers of fake medicines and medication supplies, to learn that enforcement largely falls outside of criminal codes and to civil litigation on fraud, pushed by medication manufacturers – a cost not well appreciated when put under the lens of medication costs. Advocates also considered more overt impacts of counterfeit medications in the opioid crisis and how they might need to approach community education on the issue of counterfeits in order to further medical mistrust.

The 340B discussion proved to be particularly lively. While having to segregate the pointed and necessary reminder that much of public health program funding is largely dependent on 340B revenues because Congress refuses to adequately fund public health programs, within minutes, participants began asking where patients fell in the funding scheme. Issues of charity care as a measure of success of the program (and the fact that hospital charity care has fallen dramatically since the passage of the Affordable Care Act), the ever-expanding role of contract pharmacies, and how federal grantees are being “caught in the middle” were frequently mentioned. As advocates asked questions, one participant rightly and repeatedly reminded the audience “there are no requirements as to how those dollars are spent.” One participant asked pointedly, as the usual “sides” of the 340B debate began to settle in, “will you come to the table with those perspectives you disagree with to find solutions?”

The final discussion of the Fireside Chat returned to COVID-19’s impact on public health programs. Once again, yours truly facilitated the discussion, though this time it was less on policy issues and more on the state of patient advocacy and provider services as a response. With concentration on sustainability and succession planning, participants reflected how the crisis phase of the COVID-19 pandemic highlighted not just the weaknesses in public health programs, but also re-emphasized the need for HIV advocacy to consider appropriate succession planning and mentorship, as much as our service organization partners need to find room in their budgets to hire enough staff to not burn out their existing staff. Reminding the audience, I reflected, “Because eventually Bill Arnold dies.” The statement hit home for the room’s audience, referring to the empty seat draped in the fishing vest with the AIDS red ribbon on the lapel once worn by the Lion of HIV/AIDS advocacy. We have to plan better and we have to be willing to make these investments now, not later. I implored funders in the room to consider how they might incentivize funded organizations to begin succession planning and mentor investments.

After two years of most, if not all, in-person patient advocacy events being suspended, it was refreshing to convene with such a diverse group of public health stakeholders in Chicago. The ADAP Advocacy Association’s Fireside Chat retreats have filled a void in the patient advocacy space by the very nature of their uniqueness, and CANN remains committed to seeing them succeed. Chicago, like the one earlier this year in Wilmington, did just that.

Special Interests Favor S.4395, but Patients Oppose It...Here's Why

This blog post is a collaborative piece, co-written by Brandon M. Macsata, CEO of ADAP Advocacy Association, and Jen Laws, CEO of Community Access National Network.

The very first words of the Ryan White HIV/AIDS Treatment Extension Act of 2009 read, “An Act to amend title XXVI of the Public Health Service Act to revise and extend the program for providing life-saving care for those with HIV/AIDS.” These words reflect the true legislative intent of the Act, which is to provide life-saving care and treatment for people with HIV/AIDS (PLWHA). For over thirty years, these words have represented a contract between our government and PLWHA, reflecting a commitment to patients. The Ryan White HIV/AIDS Program (RWHAP), as the payor of last resort, has literally served as the only lifeline for hundreds of thousands of patients in some of the most marginalized communities. That is why the ADAP Advocacy Association and the Community Access National Network (CANN) have led a national advocacy campaign to thwart any effort to undermine the legislative intent.

A proposed bill, S.4395 (otherwise known as the "Ryan White PrEP Availability Act"), would, for the first time in the 32-year history of this life-saving contract, open the Act to divert programmatic funding from PLWHA to people who are not living with HIV. The legislation is not only ill-conceived, it is potentially very dangerous. The special interests behind this legislation, as well as their inside-the-beltway lobbying tactics, do not reflect the general sense of the much broader HIV patient advocacy community. 

In fact, nearly 100 national, state, and local organizations joined the ADAP Advocacy Association and Community Access National Network in submitting a sign-on letter to Congress expressing the HIV patient advocacy community's collective concerns over the legislation. The sign-on letter was sent to Chair and Ranking Member of the Senate Committee on Health, Education, Labor & Pensions (HELP), Chair and Ranking Member of the House Committee on Energy & Commerce (E&C), and the Co-Chairs of the Congressional HIV/AIDS Caucus. Several of these offices applauded our efforts upon acknowledging receipt of the letter.

David Pable, who has been deeply embedded in South Carolina's patient advocacy community, expressed strong sentiments against the legislation. Pable said, "For almost 20 years, Ryan White has been a lifeline for me, and it was truly the safety net that saved my life. Ryan White-funded medical care, case management, and mental healthcare services have transform my life and the lives of countless others to survive and thrive." Pable's views are shared by nearly all PLWHA who learn about the potential danger lurking behind S.4395.

Over the years, Pable had the opportunity to be involved in many planning meetings for prevention services, including the need for an adequate PrEP program with dedicated funding. According to Pable, never in any of those meetings was it discussed as a good idea to funnel funding from the Ryan White Program to pay for PrEP. "Treatment, care and prevention make up three sides of the triangle," he said. "Together they each hold up the other, but take one piece away to support the other and eventually it will all fall apart." 

S.4395 would authorize the Health Resources & Services Administration (HRSA) to divert already limited resources away from providing care and treatment for PLWHA. The legislation reads, in part, "Any eligible area, State, or public or private nonprofit entity that receives a grant under part A, B, C, or D may use program income received from such a grant to provide to individuals who are at risk of acquiring HIV... drugs and biological products for pre-exposure prophylaxis (PrEP)... medical, laboratory, and counseling services related to such drugs and biological products...and referrals and linkages to appropriate services for the prevention of HIV."

The legislation is extremely ill-advised for numerous reasons. Amending the Ryan White Program (Pub.L. 101-381) would:

• Open-up the law, (which is currently unauthorized) and thus subject it to potentially harmful changes in a hyper-partisan political environment.

• Change the purpose of the law, in that the purpose of the Ryan White Program is serving people living with HIV/AIDS.

• Create yet another access barrier for the approximately 400,000 PLWHA who are not in care.

• Further isolate PLWHA who are already disproportionally impacted by homelessness, hunger, substance use disorder, and undiagnosed and/or untreated mental health conditions.

• Impede Ending the HIV Epidemic's efforts to both increase enrollment and expand services for low-income PLWHA, especially since discretionary funding is already limited.

Unfortunately, special interests continue to push false narratives in their efforts to shove the harmful legislation through the Congress. Probably one of the most egregious claims, “The bill’s intent and text doesn’t take money from people living with HIV.” This is false! 

Indeed, legislative language reads, “To allow grantees under the HIV Health Care Services Program to allocate a portion of such funding for services to individuals at risk of acquiring HIV.” While subsection “B” of the legislation entitles the program as “voluntary” and to not allow federal grant dollars for the use of funding PrEP or PrEP services, it would allow federal grant dollars to be used for referrals – explicitly providing funding for people not living with HIV.

Photo Source: oncnursingnews.com

More concerning, special interests supporting the legislation conflate programmatic revenue as not grant dollars, as a somehow meaningful distinction. There is no difference in this distinction because each funded RWHAP recipient and subrecipient is required under current law to use their programmatic revenue to support providing services included in the grant – for people living with HIV. The design of these programs are significantly dependent on revenues generated from the 340B Drug Discount Program (340B) in order to meet the goals outlined in each of the grants. 

And that gets to the heart of the issue here. 340B's intent was “to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” The program, amid much criticism, allows federal grants funding public health programs count on 340B revenues in order to show they can operate a sustainable program.

Let's be clear: S.4395 would divert RWHAP programmatic revenues – including 340B dollars – away from providing services and supports to PLWHA who are living at or below 400% of the federal poverty level (the income threshold for qualifying as eligible for receiving RWHAP funded services). It is important to remember that more than 50% of the patients receiving care from the State AIDS Drug Assistance Program are living at or below 100% of the federal poverty level. More than 250,000 patients, or approximately one quarter of all the estimated people living with HIV in the United States are earning less than $13,000 per year. 

Kathie Hiers, President & CEO of AIDS Alabama argued, "The HIV community needs to get its act together around funding for PrEP.  We have been told by the Director of the Office of National AIDS Policy that our messaging is not cohesive. At AIDS Alabama, we understand that stable PrEP programs are absolutely necessary if we ever hope to end HIV as an epidemic. However, raiding the Ryan White Program to fund prevention is not the answer, particularly as the needs of an aging HIV-positive population continue to grow."

As it stands, gaps in care still remain for too many marginalized communities. It isn't uncommon for patients to fall out of care because they have to prioritize work, or child care, or buying food, or finding affordable housing, or finding transportation. Funding to meet the needs for these patients is already stretched way too thin and the current inflationary pressures have only made things harder for far too many PLWHA. There are tens of thousands of people living with HIV who have no roof over their heads when they try to find a safe spot to sleep tonight.

Photo Source: debralmorrison.com

Robbing Peter to pay Paul is not the solution to funding HIV prevention efforts in the United States. A better option to meet the needs of people who would benefit from PrEP, and that is additional HIV prevention funding. This approach would allow patient choice in medicines and support for ancillary services, provider education and outreach. Additionally, HIV prevention funding could be directed to communities that are most in need of prevention medicines and services, thereby providing more equitable access. This approach would also use and could strengthen the existing HIV prevention infrastructure.

One local health department official (who asked to remain anonymous) in Florida said the people behind the legislation did not understand the nuances between funding for HIV prevention and HIV treatment. We couldn't agree more!

The HIV+Hepatitis Policy Institute's Carl Schmid summarized, "It's not an issue of not wanting clinics that receive Ryan White Program funding to be engaged in PrEP, we think they are the perfect places for PrEP to be delivered. It is an issue of taking funding generated from caring and treating for people living with HIV away from the intended purpose of the Ryan White Program – to provide for people living with HIV. With so many people with HIV living longer, who are not in care or have fallen out of care, you would think that these Ryan White grantees would devote that money to people who are living with HIV, as it was intended."

With more than a decade of science to back the position that effectively treating PLWHA, ensuring viral suppression both empowers positive health outcomes for PLWHA and prevents new transmissions. One of the most startling and, frankly, concerning shifts in the public policy conversation regarding Ending the [domestic] HIV Epidemic is a move away from focusing on the needs of PLWHA in favor of PrEP. The policy issues at hand, including the necessary funding, should not be proposed as an “either/or” situation, but an “and” situation. The same things that make a person vulnerable to contracting HIV are the same things that are killing people already living with HIV. 

While the U.S. Centers for Disease Control and Prevention (CDC) 2020 Surveillance data found 70% of white PLWHA were virally suppressed, only 60% of their Black/African American peers were virally suppressed. Additionally, while the U.S. Department of Housing and Urban Development (HUD) reported a general homelessness rate across the country as about 0.2% of the population, the CDC’s 2019 data found that PLWHA among communities of color were experiencing homelessness at a rate of 11%. It cannot be understated how the power RWHAP dollars hold to address these disparities specifically affecting patients. Failing to do so not only betrays the contract at the center of the legislative intent, it perpetuates injustices levied against our peers, our family, and our community. Raiding precious dollars from this program is nothing short of consenting to the unjust neglect of our communities.

Said Murray Penner, U.S. Executive Director for Prevention Access Campaign: "The Ryan White Program is crucial for people living with HIV, providing treatment and supportive services to keep people healthy and undetectable so they will not sexually transmit HIV. With over 400,000 people living with HIV in the U.S. who are not virally suppressed, there is significant unmet need for additional services. S.4395 would move money out of the Ryan White Program, potentially leaving people without the crucial treatment and services that keep them healthy and prevent new transmissions. Ensuring that the Ryan White Program is fully funded is critical for us to improve the quality of life for people living with HIV and thus improve our country's viral suppression rate and help us end the HIV epidemic."

A cornerstone of the HIV patient advocacy community's success over the last 40 years has been its desire to come together for a common purpose, which has centered around the notion of do no harm! S.4395 and the special interests and inside-the-beltway lobbyists pushing it have failed to meet that test. Raiding Ryan White programmatic funding for PrEP would negatively impact patients. Trying to authorize or amend an already underfunded program, when there is still so much unmet need in its originally intended population, undermines the goals of the program. If we try to be everything to everyone, we will end up failing on all fronts. The powers that be in Congress have assured us that this legislation "ain't going anywhere" this year!

Assessing Cultural Competency

In the ideal, the patient-provider relationship is smooth, easy, and full of trust. The imagery providers and hospitals often use is reflective of this ideal – smiling patients, providers with the warm but professional demeanor of a teacher speaking to a student, and well-lit surroundings. This is not the experience many of us can ever recall having, even when we do have a positive relationship with our providers. In the best of circumstances, our providers don’t always have as much time as we’d like to help explain something and, in the worst, we’re left feeling angry, talked down to, concerns dismissed, and so thoroughly frustrated, we don’t want to ever see a doctor again. These experiences shape the patient experience in similar ways to consumers approaching any other retail situation. The problem is the relationship between patient trust and engagement in care is far more consequential, often doesn’t allow for much choice, and even the smallest fracture in that trust can affect an individual patient for their entire lives – for communities, it can affect the health of generations.

Kaiser Health News recently covered the issue of assessing patient experiences and satisfaction and how issues of cultural competency are not being adequately measured to identify opportunities for improving patient experiences and even potentially tackling pervasive problems like implicit bias. Of particular note, author Rae Ellen Bichell pointed toward a Health Affairs study that evaluated clinician notes for coded language. The results of the study were remarkable with provider language using a negative frame toward Black patients at 2.5 times the rate white patients were described in a negative light. Digging into the nuances of how providers train to manipulate patient responses, how survey results published by the Centers for Medicare and Medicaid Services (CMS) only publish aggregate information rather delineated information which might identify an issue of disparate experiences, and how these surveys do not ask patients questions which would assess cultural competency, Bichell puts a fine point on the need to integrate cultural competency as a measure and tool of health equity. As Dr. Oni Blackstock pointed out earlier this year (and routinely does so in a fashion that providers everywhere should take note of), language matters and reflects how providers view their patients – necessarily reflecting how providers approach their patients’ needs.

These buzz words, “health disparities” and “cultural competency”, have been around for some time, picking up steam and attention as the Biden Administration set goals to address disparities further highlighted by the COVID-19 pandemic. Clinics and hospitals tend to offer “cultural competency” trainings, reviewing the needs of particular marginalized demographics. But these trainings tend to also be cursory, quick, and do not have a functional and effective tool to measure patient experiences. Lacking a complementary assessment tool, these trainings do little more than teach providers what slurs they cannot use when describing a patient, rather than ensuring patients are receiving the quality of care they deserve – the quality of care patients need in order to remain engaged in their own care.

Indeed, a common sentiment in assessing HIV and Hepatitis C programs, especially under the frame of stagnating metrics of success, is the notion that “these patients” are just harder to reach, keep in care. So much so that when reviewing various Ending the HIV Epidemic plans, there’s a very clear focus on testing and PrEP, with retention in care as a priority falling far behind despite scientific knowledge that undetectable equals untransmittable – successful engagement in care for people living with HIV is effective prevention. This frame necessarily puts the burden on patients to be engaged without acknowledging barriers to care and the very responsibility of providers (and their government funders) to assess what providers could do differently to earn the trust of patients.

As much noise been made of providers working to be more culturally competent in care, little has been done to measure that competency from the patient perspective. Lacking that data also leaves us blind as to identifying potential problems in provider approaches. Advocates and providers would do well to consider that “patient-centered” care means the patient perspective and experiences is the most key indicator as to if a patient is actually centered in care. Successful provider-patient relationships are the key to tackling medical mistrust and a critical tool in dismantling the systems that further health disparities.

Overdose Awareness Day Requires Holistic Interventions

August 31st was recognized as International Overdose Awareness Day, with governments and entities around the world observing the annual campaign to “end overdose, remember without stigma those who have died, and acknowledge the grief of the family and friends left behind.” The campaign, starting in 2001 by sally Fin in St. Kilda, Melbourne, is used to highlight the health consequences of overdoses, provide an avenue for those who may be grieving a loved one to do so without external stigma, advocate for policy changes, and educate local communities about the issue. This year, the Biden Administration issued a proclamation, designating August 28 through September 3 as “Overdose Awareness Week” with special recognition of the day and a call to action for the country to “raise awareness of substance use disorder to combat stigmatization, to promote treatment and celebrate recovery, and to strengthen our collective efforts to prevent overdose deaths.”

The Biden Administration’s focus on the overdose crisis is largely centered on shifting the national stature of drug policy from punitive as an issue of moral character to treating substance use disorder as a health issue which mist addressed through social, structural, and medical intervention and not necessarily carceral intervention. This plan has recently been met with some push back, in large part due to the issue of stigma. Remarkably, that push back also comes amid a staggering report from the National Vital Statistics System (NVSS) that United States average life expectancy has dropped to its lowest in almost three decades – in large part due to the COVID-19 pandemic but also because of fatal drug overdoses. The report notes overdoses typically take three to six months to be appropriately assessed at the local level and those data may be delayed, underestimating the life expectancy implications of the crisis. Indeed, the cause of death which caused the second most substantial influence on average life expectancy was “unintentional injuries”, of which overdoes represent a largely significant segment.

The U.S. Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) announced awarding $79.1 million in grants to various programs aimed at addressing certain aspects of the overdose crisis, including projects targeting supporting first-responders and rural emergency medical services as a point of overdose treatment, capacity building and technical assistance to providers, residential programs, and an effort to strengthen support for medication assisted treatment. SAMHSA’s page recognizes the 30% rise in overdose deaths since 2019, racial disparities affecting Black communities and American Indian and Alaskan Native communities, and the fact of socioeconomic disparities dramatically impact overdose rates.

While not mentioned in the White House, HHS, and SAMSHA pages relative to recognizing International Overdose Awareness Day, the day is meant to also recognize the impacts of non-fatal overdoes. In particular to the issue of long-term physical health, non-fatal overdoes have deep implications as to viral Hepatitis and HIV transmission and our efforts to end those epidemics. In order to adequately address overdoses, we must recognize the syndemic nature of these issues and the systemic drivers of disparities affecting these communities. Mental health is often reflective of the socioeconomic experience of a person (and community); racism, for example, significantly but not singularly defines both the social experience and economic experience of racially marginalized people.

In recognition of International Overdose Day and the holistic needs of highly affected communities, we must consider society-wide, comprehensive interventions that treat these social ills as the causative factors they are.

Feds Launch National HIV/AIDS Strategy Implementation Plan

On August 26th, the White House Office of National AIDS Policy (ONAP) director, Harold Phillips, announced publication of the Federal Implementation Plan for the National HIV/AIDS Strategy. A “dear Colleague” letter was circulated among advocates shortly before the announcement and Mr. Phillips discussed the release of the implementation plan via recorded video, published to the federal government’s HIV.gov blog.

Significantly, the implementation plan details more than 380 action items from 10 different federal agencies and specifically adds focus issues of quality of living among people living with HIV/AIDS (PLWHA) which will be added to the Medical Monitoring Project’s data tables in 2023. Many of the action items detailed include education and outreach and coordination of efforts between affected federal agencies and state partners. Much of this work intersects with the Biden Administration’s efforts to address health equity and disparities, given the disproportionate representation of marginalized communities affected by HIV.

For most advocates, the announcement was a “mixed-bag” of good news and frustration at planning that primarily highlights assessments and monitoring where data may already exist or where advocates have already outlined more concrete steps they wish the federal government to take. For example, advocates and the federal government is well-aware that thanks to the advancements in quality of medications to treat HIV and being able to keep more patients engaged in care, the population of PLWHA is generally much older than they were in say…2000. However, our planning and supports for this aging population is not sufficiently strong. Medicare integration and coverage of support services specific to PLWHA is lacking and the federal government has had to engage in repeated enforcement actions against skilled nursing facilities and assisted living facilities, both regarding the refusal to provide services to PLWHA and the failure to have adequate services for PLWHA in the facility’s care.

The new quality of life metrics focus on issues of mental health, behavioral health support, food insecurity, unemployment, and unstable housing for PLWHA, with the last 3 items being considered “structural/subsistence” issues for patients. These items are arguably significantly intertwined and success or failure in any may implicate success or failure in all of these items.

In order for the federal government’s efforts to meaningfully move forward, these plans should be treated as a roadmap, rather than actions themselves. One of the things we are very good at in HIV is planning and processing. Where efforts tend to fall short is in implementation and in order to improve implementation, we need to identify if those failures to implement are due to lack of appropriate resources, expertise, or conflicting federal and state policies and priorities. Advocates should seek to hold our friends at ONAP and other agencies accountable to proactive action in defending the rights of PLWHA as patients and acting on appropriate integration of care for our aging colleagues and friends – both in terms of ensuring existing entities serving an aging population are aware of how to care for PLWHA and in ensuring entities serving PLWHA are adequately supported to care for an aging population.

In assessing effective uses of limited resources and the plan’s goals toward meeting these quality of life metrics, advocates and the federal government should consider how to leverage the Ryan White program as a workforce development and employment opportunity in order to help lift patients and highly affected communities out of poverty and, in so doing, addressing the other listed quality of life metrics. The 2021 (fiscal year) budget for the Ryan White program is $2.4 billion (not including AIDS Drug Assistance Programs). Those dollars, when focused on employing people living with and at risk for HIV, those who would otherwise be or are already Ryan White clients, would provide a significant opportunity to address these quality of life concerns and meaningfully put these dollars to use in the community the funds are meant to serve.

European Commission Approves Once Every 6 Month Supplemental HIV-Treatment

Last week, the European Commission (EC) approved use of Gilead Sciences’ investigational medication, lenacapavir (branded as Sunlenca), for use in treatment for people whose HIV is highly treatment resistant. Lenacapvir has been closely watched by advocates because of great anticipation regarding injectable and otherwise long-acting agents (LAAs) and because of its exceptionally long half-life in the body, providing efficacy for about 6 months from just one subcutaneous injection, providing a potential for the longest acting agent to hit the market thus far.

Lenacapavir also stands out as a first-in-class product because it works in a way that no other antiretroviral medication works. Offering a novel mechanism of action, binding the shell (capsid) surrounding viral genetic material that highjacks our own cells in HIV reproduction, capsid inhibitors will work against HIV in multiple areas of the virus’ life cycle. And because this is a tool we’ve never used before, it’s ideal for meeting the treatment needs of people living with highly resistance HIV – the virus doesn’t recognize the medication and has not yet found a way around it. Because HIV is highly adaptable, that lack of resistance may be short-lived once broad reach of the product is made available but excitement remains for a novel product, especially for people who have developed such resistance that options of effective care have diminished to near zero.

Gilead Sciences is awaiting a decision from the United States’ Food and Drug Administration (FDA) on its recently resubmitted “New Drug Application” (NDA), after the agency declined to accept the NDA due to issues with the glass vials used for the injectable form of the medication. The vial issue has since been fixed and research resumed for use of lenacapavir as a supplement to “background” treatment, first-line treatment, and as pre-exposure prophylaxis (PrEP). At the end of July, the FDA provided Gilead with a December 27, 2022 prescription drug user fee date. This is one of the final steps in an initial new drug approval. (Briefly, the Prescription Drug User Fee Act funds a massive portion of the FDA and those medications which pose potential benefit to public health may receive an expedited fee date; HIV advocates historically championed the act as a massive “win” in the early 90’s when introducing this funding scheme sped up their processes to make oncology and HIV medications more readily accessible.)

Patients who may hear about “once every 6-month treatment) should be kindly reminded lenacapavir will serve only as a supplement to other therapies – administering the medication is required to be done by a provider and patients will still need to remain adherent to their existing treatment regimen. HIV medications for treatment need between 2 and 3 different combinations of medications and PrEP only needs 1. As such, there may be a disparity in lenacapavir as PrEP and Sunlenca as treatment in terms of uptake because, while lenacapavir won’t require maintenance of other medications, Sunlenca as treatment will require patients to continue to take the oral medications that are “optimized” with Sunlenca acting almost like a “soft reset” for patients.

Operationalizing will remain an issue, especially for state ADAP Program’s that have not fully implemented access to cabotegravir, in terms of injectable medication management and for arguments that frame investing in successful patient care as something that requires a “cost consideration”. Patient advocates should be well-prepared to defend a desire to see this product come to their patients as those patients so desire it.

Despite All Evidence in Support of Harm Reduction, Stigma Drives Public Attitudes

Earlier this year, a false claim spurred outrage from commentators and politicians regarding federal grant dollars for harm reduction programs across the country. Shortly after, in April 2022, the U.S. Department of Justice (DOJ) issued guidance on how the Americans with Disability Act (ADA) provides protections for people with opioid use disorder (OUD), which may also apply broadly to people with substance use disorder (SUD). From local and national advocates to actions from the Biden Administration, as a nation, the United States is facing the greatest change in drug policy since the Nixon Administration introduced a national policy officer (“drug czar”) on the issue. Forty years after Nancy Reagan’s “Just say no” campaign and the abject failure of the D.A.R.E. (drug abuse resistance education) program, the United States’ “War on Drugs” has only succeeded in criminalizing a health status with, up until relatively recent history, with broad bipartisan support. The effort to combat the stigma sewn into the fabric of our social attitudes towards drug use and misuse is coming to a fever pitch.

Scrolling through my own social media, I can across Representative Malinda Brumfield White’s post regarding a methadone clinic opening in Bogalusa – expressing “concern” for the location. The comments were rife with assumptions as to what the clinic might “mean” for the area and opposition to its location. The animus voiced is the exact type of animus an industrious litigator might cite to prove the attitudes DOJ cited as discriminatory and might spur actions which could violate the ADA. This clinic didn’t pop up out of nowhere, Louisiana’s legislature ordered a needs assessment on the impacts of the opioid crisis in 2018 after the Governor Bobby Jindal ushered in closing of most of the clinics in the state. Subsequently, the state’s health department identified a need to establish at least 10 new harm reduction service providers, focusing on addiction treatment centers (specifically, medication assisted treatment). A request for proposals (RFP) was issued in late 2021 and signed with Behavioral Health Group (BHG) shortly thereafter. But it’s just now that the local electeds are making noise about the clinic – as the operation is getting set to open.

Meanwhile, in California, Governor Gavin Newsom is rumored to be thinking about vetoing SB57, a piece of well-supported state legislation that would allow for pilot project locations for safe consumption sites. The project would be the largest yet seen, after New York allowed for a similar project last year, and is facing tough opposition even after the bill passed out of the state’s legislature, with a concerted campaign urging Governor Newsome to veto the bill. New York expanded their project this year thanks in large part due to the success of reversing hundreds of overdoses already.

Vermont’s Governor has already vetoed a similar bill. Though, that veto also axed additional funding for multiple modalities of harm reduction, including ones already existing in Vermont, Governor Phil Scott specifically cited the safe consumption sites projects as “counterintuitive” – a statement rooted in stigma (his assertation that data did not exist to support the project is false – see previous links on New York’s success). A bill in Kentucky to initiate a pilot project didn’t even get a committee hearing this year. And Rhode Island is finally finding a way to fund safe consumption sites – by using the state’s opioid settlement dollars. Rhode Island had already passed a law allowing study of safe consumptions sites, the legislation just did not include any funding to do so and those entities interested in opening sites were hard strapped to find enough private funding to open.

In other states, advocates are playing slower “games”, taking time to further educate their legislatures and communities. In North Carolina, experts took time to both debunk the claim the Biden Administration was pushing on smoking pipes but also how those same tools would be an improvement in harm reduction offerings already existing in the state. In Massachusetts, elected representatives are supportive of safe consumption sites but elected law enforcement isn’t. Those same elected law enforcement officials are peddling stigmatizing ideas with ominous sound bites like “let’s ask people in neighborhoods where they already exist and see if they feel it’s safer.” When there’s no one there to challenge these ideas, or journalists’ follow up questions aren’t answered, the dark clouds gather around pious suburbanites as if their own families aren’t one or two degrees of separation from experiencing the damaging impacts of an unabated overdose crisis.

Decades old attitudes which moralize a health condition as a personal failing and threat to our families hasn’t worked. Indeed, overdose deaths and non-fatal morbidities are on the rise…again. Despite having the tools, decades of behavioral intervention study, and a desperate need to address this issue, we keep seeing the same approached used over and over again – stigmatize, criminalize, and isolate. Our elected officials have an obligation to both educate themselves and advocate for more effective policy. The families affected by the opioid crisis, substance use disorder, Hepatitis C, and HIV are the voters and constituents these representatives are tasked to…represent. As advocates trudge on in sharing stories, we must leverage what we know to be true. This is indeed a moral fight – it is immoral and unethical to allow people to die with a callousness of disinterest, even triumph as if those deaths are somehow “deserved”. While our lawmakers are returning home as the federal legislative session comes to a brief break, they must also take this moment to lead their constituents in making the moral choice and support comprehensive harm reduction policies and programs.

Blame Payers for Only 1:3 Patients Receiving HCV Cure

On August 9th, the Centers for Disease Control and Prevention (CDC) provided an early release of a Morbidity and Mortality Weekly Report (MMWR), detailing the massive inequity between insured patients in need of curative Hepatitis C (HCV) treatment. By evaluating the HealthVerity claims and encounters database, researchers were able to identify particular patient characteristics, including payer type (private, Medicaid, and Medicare), sex, race, and age. Of particular note, assessment included recognition of various restrictions some state Medicaid programs impose on patients.

Importantly, the CDC notes that about 2.2 million people in the United States are living with an HCV diagnosis and 14,000 people die of HCV-related conditions annually. These deaths are largely preventable thanks to the development of curative treatments through direct acting agents (DAA)s. The analysis also cites previous research finding that providing timely, curative HCV care reduces costs to payers (and their sponsors) compared to costs of denying care. This remains true even when patients experience reinfection or treatment interruptions. Essentially, a cornerstone of public health is affirmed in curing patients of HCV, patient quality of life and health, engagement in society, and the economic benefits thereof are well-served when patients have ready access to life-saving treatment. This all emphasizes why the disparities displayed in the findings of this report are unacceptable and must be addressed with urgency.

Generally, for inclusion in the analysis, patients needed to be enrolled in health insurance coverage consistently just before and during the time period used in the paper. Of the unique patient files evaluated, just under 48,000 qualified for inclusion in this analysis. Medicaid and patients with private insurance saw about the same number of HCV screenings performed, however, Medicaid patients were more than twice as likely to receive an HCV RNA test whereas Medicare patients were most likely to receive an HCV RNA test than the other two payer types with rate of HCV positivity was highest among Medicaid patients. Of Medicaid patients qualified, more patients lived in states with treatment restrictions (47%) than in states without restrictions (38.8%). Overall, patients enrolled in private care were most likely to initiate DAA treatment inside of the following year (35%) and Medicaid patients were the least likely (23%). Treatment initiation was most likely to occur within 6 months of diagnosis. Critically, there did not seem to be a massive racial disparity within a particular payer type, except those patients who selected “other” or were missing racial information in their claim. For Medicaid patients, the drop was significant (19% and 20% respectively). Patients enrolled in Medicaid in states with program restrictions were 23% less likely to initiate treatment than Medicaid patients in states without restrictions.

The authors urge some caution because the qualification for inclusion required a long period of continuous insurance enrollment and did not include uninsured, incarcerated people, or people who receive coverage through other public payers (Veterans Administration or AIDS Drug Assistance Programs). The CDC expects treatment initiation for people who experience disruption in insurance coverage are less likely to initiate curative HCV treatment, in general. And the data provided has no ability to inform the “why” behind delays in initiation or failure to initiate curative treatment.

The data did not mention how the COVID-19 pandemic may have affected claims, treatment initiation, screening and testing, or even insurance enrollment during the period of time included in the assessment.

The Center for Health Law and Policy Innovation at Harvard and the National Viral Hepatitis Roundtable issued a lengthy statement urging policymakers to take note of the report. The groups highlighted their annual report on barriers to care in state Medicaid programs, Hepatitis C: State of Medicaid Access, pointing toward to work as a guidepost for reducing barriers to care and increasing patient access. The report has recently undergone an update in metrics assessed as progress has been made on fronts regarding issues raised in previous reports. Notably, the updated metrics include an “other restrictions” category to include restrictions on treating reinfections, requirements in on medication adherence (including adherence to medications not used to treat HCV), and refusal to cover lost o stolen medications. That last piece needs note because the state of Florida is one of those (9 in total) programs which limit coverage for lost and stolen medications and these barriers, under issues of natural disasters, institute yet one more barrier to care and burden when patients can afford disruption the least – such disruptions also impact adherence, creating what can amount to an unwinnable situation for many Medicaid patients.

Significantly, the CDC’s report opens with noting that all of this is preventable. Advocates should consider pressing this report with their federal and state electeds and policymakers, emphasizing these findings represent the “best” of circumstances, in terms of coverage, and many of their constituents (and ours) do not enjoy the best circumstances.

Assessing Responses to the US Monkeypox Outbreak

On August 4th, the Biden Administration declared a Public Health Emergency (PHE) regarding the ongoing Monkeypox outbreak in the United States and other countries where the virus is not endemic. Two days prior, the White House announced a National response Team, lead by the Federal Emergency Management Agency’s (FEMA) Robert Fenton and the U.S. Centers for Disease Control and Prevention (CDC) Dr. Demetre Daskalakis.

Bob Fenton holds some notoriety at FEMA, in part, because in 2005, while helping to coordinate on-the-ground responses to Hurricane Katrina’s devastation, he warned officials in Washington, D.C. that more needed to be done to meet the needs of the moment. Dr. Demetre Daskalakis has been credited with helping to curb and end a measles outbreak in 2018 and 2019 in New York City, prior to joining the CDC, but more aptly, his extraordinary efforts in 2014 to end the meningitis outbreak by bringing vaccines to bath houses, dressing in drag, and otherwise successfully bringing care to communities and people who needed it. With these histories, there’s no wondering why the White House selected these two professionals to lead this response. And having well-qualified leaders with excellent analytical skills and histories of putting success strategies into action aren’t necessarily going to be enough.

In a protracted opinion published to The New York Times, a former U.S. Food and Drug Administration (FDA) lead, Scott Gottlieb, accurately assessed a lack of political appetite to allocate more power and funding into public health. Specifically, Gottlieb argued the CDC has failed to compel a more coordinated response from state level partners, despite a very evident need to make these kinds of investments to shore up the country’s preparedness and ability to respond to health threats. The Biden Administration has instead suggested a need to make more agencies, which may be a way of trying to get around that lack of appetite and still achieve some measure of these investments. This type of move is, as Gottlieb described, a “very Washington response”, from both the short-sightedness of the legislator-politicians tasked with serving the best interests of the country’s populous and the Biden Administration’s fumbling response. He is correct in saying monkeypox, like other viruses foreign to the United States, may well become yet another public health failure. However, Gottlieb also argued the delayed or at least slow federal response to this monkeypox outbreak showed a need for the CDC to get out of the business of preventing illnesses other than infectious diseases and leave that work to other agencies. A gentle reminder, “Prevention” is in the name of the agency and adding layers of bureaucracy will not fix the fact that existing bureaucracy just…isn’t working as fast or efficiently as we need it to in order to respond to public health emergencies.

Those politically powerful voices, like Mr. Gottlieb’s, with influence must push the conversation with their audiences, especially political leadership, to draw a line in the sand in the interests of the nation. The more any party leadership is willing or even happy to promote inflammatory, conspiracy minded, and objectively false claims, especially those around issues of public health, just to win elections, the less power our federal government will have to respond to emergencies and the less states will be willing to cooperate when cooperation is needed.

Of the notable assessments Gottlieb offers, the most meaningful are drawing a potential definition of “public health failure” as monkeypox becoming an endemic virus to the United States in which persistent but low-level of the virus continues to circulate. Another is the potential of an “ascertainment” bias, but not the one most folks discussing this issue might jump to first – regarding communication around at-risk populations – but that this outbreak may seem like it “appeared out of nowhere”. Instead, it has likely been circulating undetected for some time and misdiagnosed or assumed as some other illness among health care professionals. Given the genomic distinctions discovered shortly after the initial detection of cases in Europe and North America, there’s good evidence to support that conclusion; a conclusion that lends great concern for that definition of “public health failure” to be accurate.

On the more technical analyses regarding this outbreak, a lack of precise, effective communication and a willingness for the public to accept complex realities has plagued federal, state, and local health agencies. Arguments between well-intentioned advocates, journalists, and public health professionals on effective messaging have enveloped the discussion around Monkeypox, flooding and fueling social media speculation and concerns of misinformation. Indeed, maliciously intended politicians, like Representative (GA-R) Marjorie Taylor Greene’s repeated statements (which will not be linked here as readers can Google search these things) equating the rare Monkeypox cases being reported among children are some evidence of sexual assault being perpetuated by men who have sex with men, were among the fears voiced on these platforms in June.

Public health agencies are looking to perform a balancing act in ensuring the resources, including vaccines and treatments, are reaching the most highly affected communities, while also educating and informing the public at large when addressing a unique outbreak where clinical information on transmission risks is limited, even as data is becoming more readily available. To be clear, the current global outbreak of monkeypox is concentrated among the social-sexual networks of men who have sex with men (including transgender men). Messaging and resource allocation are two very different things and should not be treated as one in the same. And educational messaging must be carefully tailored to its intended audience in order to not perpetuate stigma and the violence that can result from stigma. Indeed, issues of stigma, violence, and even public policy already suppressed investigation around a previous monkeypox outbreak in Nigeria, which may have better prepared the world for preventing this one. As Dr. MK Titanji pointed out, part of this previous disinvestment and lack of investigation is a direct result of the fact that half of the world’s countries criminalizing homosexuality are within the African continent, some of which are the only countries in the world where monkeypox is already endemic.

Critically important, stigma and other factors which perpetuate health disparities are already finding familiar lines in the United States. The CDC’s Morbidity and Mortality Report Weekly (MMWR), published on August 5th, found that even in the limited data available, "The percentage of cases among Black persons increased from 12% (29 of 248) during May 17–July 2 to 31%." Additionally, for those cases with full profiles, 41% of cases were among MSM living with HIV. The confounding factor to consider with that high rate of HIV prevalence among monkeypox cases is thanks to robust, though certainly not perfect, public health infrastructure specifically in response to HIV, people living with HIV/AIDS (PLWHA) may be more able to readily access health care professionals who are aware and educated about this monkeypox outbreak than other populations. The press conference immediately following the declaration of public health emergency had federal officials discussing a “vaccine sparing” strategy in order to facilitate reaching more people in need. However, given this concentration of case identification among PLWHA and that the available vaccines may not be as effective for this population, there’s good reason for patients and advocates to be concerned what dose sparring may mean for the most impacted population.

As this situation develops, we’re lucky to have the expertise the White House has engaged, who have readily sought out community feedback and engagement. As an example, Harold Philips, the Director of the Office of National AIDS Policy (ONAP), has had subsequent conversations with stakeholders in HIV to discuss leveraging the HIV infrastructure in order to help address this outbreak. And there’s much left unknown, including what exactly the risk is to children who may be in close, consistent, physical contact with people who have been diagnosed with monkeypox. Advocates are already coming together from across jurisdictions in an effort to appropriately influence public policy and program designs. Our efficacy in that work and in coordinating a response based in best practices of meaningful engagement means our private industry stakeholders must also support us in this work.

Additional reading which may be beneficial: From our friends over at the Center for Disaster Philanthropy; Monkeypox Briefing, including suggestions to funders in supporting advocacy and services to address the outbreak.

Institutional Barriers Still Stand in the Way to Equity

On July 28, 2022, the World Health Organization (WHO) released new guidelines on the use of long-acting, injectable cabotegravir (branded as Apretude) as pre-exposure prophylaxis (PrEP), just ahead of the 24th International AIDS Conference (AIDS2022) in Montreal. On the same day, ViiV Healthcare announced a voluntary licensing agreement with Medicines Patent Pool in an effort to extend access to the medication to middle- and low-income countries, particularly sub-Saharan African countries.

These are very exciting developments as the innovative products (Cabenuva for the treatment of HIV and Apretude for the prevention of HIV) represented the most recent of biomedical interventions around HIV with the potential for dramatic changes for the better. Expanding options, allowing for patients to choose between a daily tablet or once-every-two-months provider administered injection, gives patients the choice to pick between highly effective regimens to suit their comfort and lifestyles. While that may sound like a sales pitch for a phone, it’s not – it’s the effort to make life-saving medications appealing and easy. Frankly, they should be.

But in the long fight to make these medications available, we should be reminded that “available” and “accessible” are two, very different things. The difference is big – so big – that it can be measured in the 4,000 new diagnoses a day and 650,000 AIDS-related illness deaths in 2021.

That gulf, the pit in your stomach reading that data, the silence at the end of the hope and joy you had reading those first two paragraphs – that’s the space between “available” and “accessible”.

In order to fully appreciate the extraordinary efforts to improve living with and life for people living with HIV, we must also fully appreciate the barriers to care patients face every day. From housing to transportation to stigma to food – clean water and food – patients have consistently been blamed by policymakers, both foreign and domestic, for failing a moment in which patients aren’t the ones with institutional power to change the circumstances of their journey to care.

A large portion of AIDS2022 is dedicated to highlighting these disparities, the specific policy mechanisms countries should consider implement* in order to create a more equitable world for all and to ultimately End the HIV Pandemic. From discussing discordances in criminal laws and public health best practices (sex work, harm reduction) to practical investments in education and health care systems to very direct conversations on how political opportunism finds readiness in villainizing people and communities highly affected by HIV, the International AIDS Conference is a dedication in love, spanning thousands of years of lived experiences and expertise. The lessons learned from the collaborative and sometimes confrontational efforts highlighted at this event are lessons we ultimately should also appreciate here, in the United States.

At home, though, the disconnect between federal authorization of innovative medical products and state-based policies to ensure access is the representation of that engulfing silence from earlier. Patients, especially low-income patients, are still struggling to realize the benefits and flexibilities of the biomedical innovations. Medicaid programs were slow to appreciate the need to cover Cabenuva and Apretude (some still don’t). A national coverage determination has not yet been made to ensure Medicare patients have access. And even if every last corner of these public payers covered these medications, private payers still maintain the power over a patient’s choice by simply refusing to pay for them – instead forcing patients to suck up whatever the payer determines is acceptable.

Of all the systemic and institutional barriers to care patients face domestically, payers remain some of the least regulated, least accountable, and most profitable – of the top 12 most profitable companies in the US, 3 are or own pharmacy benefit managers. Food, housing, transportation all take many, many layers of work to dig into. But changing what patients pay at the pharmacy counter, relieving that stress and making patients less fearful of having to choose between those necessities and their medications? That takes one layer, one set of actors, to be held accountable to everyone who pays them to stay in business – including and especially the United States government. Advocates would do well, as federal legislators prepare to go elbow deep in “drug pricing” legislation, to readily ask “lower prices for whom?” The difference in the answers can be measured as the difference between “available” and “accessible.”

*The strikethrough and italics is the author’s commentary on language used by politicized entities to urge necessary policy changes.

Jen’s Half Cents: Industry Investment in Advocacy Must Look Beyond the Next Quarter

A reoccurring theme over my career in patient advocacy has been concern over the future. The discussion takes shape in different ways, mostly with looking thoughtfully into the different aspects of what we mean by “investment” and “resources” and how we define “success” in advocacy. These words tend to float around with some ambiguousness but for the purposes of this blog (and honestly the conversation at large), we do need to define them and contextualize this language before we dig into the meat of what it means to have a robust, well-supported patient advocacy ecosystem.

I’ll get straight to the point by defining the ways we use these terms:

“Investment”
Most commonly referred to mean financial commitments but these commitments, when used strategically, are built on the backs of dynamic relationships between the people involved and the representation of our various stakeholders. To this end, while investment” is tied to dollars and checks, we must be explicit about “investing” time and energy into one another, buying into avenues of trust and plutonic connection. I mean this honestly – lots of folks don’t want to talk about their personal lives and wish to keep work and home separate. While that may have been perfectly functional in the past, it’s not any longer. We must invest in one another, in our missions and purpose, our visions and analyses, and this investment must look beyond what bills are being passed into law or tallying up dollars spent.

”Resources”
As with investment, “resources” tends to refer just this side of explicitly to money. And money does indeed make advocacy a career as opposed to a hobby. I’ll frequently remind advocates and funders that we don’t get to have the luxury of being in these rooms talking with one another without being able to have the necessity of our lights on and bellies full being assuredly met. Money buys the resource of time and child care and transportation. Money also buys the resource of talent and training; it allows us to invest in the potential of community members who wish to participate beyond their scarce off-work hours. Resources are bodies and minds seeking solutions to complex problems and exploring the topography of politics and policy.

“Success”
This one requires nuance. For many funders and even board members of advocacy organizations, “success” is also financial but the word has other, programmatic and sometimes situational definitions. “Success” can be growing the interest of a community member to become an advocate. Success can be passing a bill into law or preventing one from becoming law. Success can be the number of patients linked to care or educated as to certain aspects of care. Success can be activating a patient base on particular political or policy issues. Success can be being able to trust that new relationship and giving them a call to discuss ideas. Success, however, is always tangible.

We must acknowledge that in all the ways we have previously succeeded and are currently lacking in success are directly tied to the investment of resources in patient advocacy.

Funders Concerned About AIDS has tracked a steady decrease in HIV-related funding and decrease in diversity of funders, over the last several years. Much like the social atmosphere in the South, funders are shifting their attention to other issues of Justice or health, and away from HIV as a singular, defining issue. The idea of HIV being “exceptional” is diminishing at one of the worst possible times for this phenomenon to happen. On the cusp of success or at a time when gains are being disrupted by yet another pandemic and the politics of the day, is not the time to pull away from the exceptional nature of HIV and patient advocacy as a whole.

The late-Bill Arnold used to tell me “We can’t look away. The Crisis is always right around the corner.” This was as much a pragmatic sentiment as it was an emotional one. The nature of infectious diseases, especially HIV, is they can run quietly in the background of our lives and society for an exceptional amount of time. And if we allow that to happen, as evidenced by lacking investments and flagging resources, only to come back at the moment of crisis or emergency, then we won’t ever succeed.

Much like public health, advocacy cannot succeed without continuous investment – yes, both dollars and relationships.

Our funders must maintain a commitment to funding patient advocacy now, more than ever, because the stagnation of domestic politics won’t last forever. We will face a moment in the future where we either move forward or we slide back and there won’t be enough resources to push us forward or guard against the slide back unless those investments are something advocates can rely upon.

Improving Liver Health for People Who Inject Drugs

A recently published study in the Annals of Internal Medicine found that providing Hepatitis C treatment to people who inject drugs (PWID) showed significant improvement in liver health outcomes when provided with community-based access to care and treatment. The study, which drew its cohort from Baltimore and collected data from 2006 to 2019, found a particular value to participants in low-barrier access to care – a mainstay of harm reduction advocates.

The qualifying condition for participants was a chronic HCV diagnosis, with the majority of participants being Black, assigned male at birth, and not having an HIV diagnosis. Within the last 6 months of the participants’ lives prior to study enrollment, 54% had injected drugs and 27% were on methadone. 56% of participants also scored as having had severe, harmful, or hazardous alcohol use. The initial rate of cirrhosis was 15%, rising to 19% in 2015 and dropping dramatically in 2019 to 8%, with the rate of detectable HCV RNA reducing from 100% in 2006 to 48% in 2019. Self-reported treatment also increased from 3% to 39% across the study period. Some of the most significant findings of the study were specific to broader outcomes – those with undetectable HCV RNA were 72% less likely to develop cirrhosis and were at 46% lower risk of all-cause mortality. While 430 of the participants died across the span of the study, 394 had chronic HCV and 36 had no detectable HCV RNA. 29% of those deaths were categorized as from drugs or trauma, 41% from chronic illness, and 6% from liver disease/cirrhosis.

The study itself did not depend on distribution of treatment to patients but rather, it sought to assess how patients engaged in care in community-based settings and what accessing services through these settings means for patient health outcomes. The study’s findings aren’t particularly surprising for anyone familiar with providing services to communities which are often marginalized. Indeed, for communities and patients experiencing poverty or living in health care deserts, also coinciding with red-lined neighborhoods and thus associated with Black communities, access to “traditional” health care settings is limited or not meaningfully existent. Trust of traditional health care and even public health services is equally limited due to historical traumas, including forced sterilization, concerns for law enforcement engagement, and – perhaps most directly – due to provider bias. Community-based, low-barrier care in light of these realities and lived-experiences are simply…more welcoming.

In recognizing a sense of welcoming, observers should also recognize the sense of safety patients to these settings feel – that trust in tangible for patients. It’s also important to recognize a particular failure in federal funding focuses in entities that may claim being based in a particular community but are not necessarily required to hire providers or staff from the service area or served populations. Indeed, during a recent O’Neill Institute call, this distinction was of particular complaint. Funding is typically awarded to larger entities rather than smaller ones and holds no particular requirement for staff to be reflective of the patient population. For those larger entities, they tend to also be stuck in programming with limited creativity, are explicitly tied to specific clinical outcomes, and extraordinarily strict and onerous reporting requirements. Those requirements can and do translate into administrative barriers for patients and limit the creativity that may also translate less directly or immediately to measurable health outcomes. The complaints were broad, generally stating a need to take a more diverse approach that looked at longer-term investments into patient health through relationship building.

Those relationships are critical to the success of patients and introducing the ideas behind “harm reduction”. Another barrier to successful harm reduction can be found in particular state and federal policies which may run contrary to the best practices identified by academics and advocates. In this, the details matter. For example, most “good Samaritan” laws maintain a carve out of exception for drug dealers in reporting overdoses – even if they wanted to help, they could be prosecuted for homicide if a person dies, discouraging intervention from the course. For states with syringe exchanges (now facing conservative backlash by way of moralizing substance use rather than viewing substance use as a health condition), many still maintain paraphernalia laws which means patients engaging with syringe exchange programs can be arrested and charged either going to or coming from accessing services at syringe exchange sites.

Community Access National Network’s HIV-HCV Co-Infection Watch monitors certain state-level harm reduction measures in an effort to provide a resource to advocates and our Annual Monitoring Report discusses these nuances. Advocates know well the positive health outcomes for patient and communities when public health programs are designed with long-term investments are made and comprehensive approaches are taken. State and federal law and policy makers would do well to reconcile the conflicts between these and strive to achieve a policy environment which fosters the development of creative, safe, low-barrier care and reduces risks to people who inject drugs.

Criminal Counterfeits Threaten Patient Safety

In February 2021, a patient in New York City opened a sealed bottle of the HIV drug Biktarvy, took his pill, and found that he couldn’t walk or speak. The medicine in the bottle was actually Seroquel, an antipsychotic that can cause dangerous sedation and poses additional risks for patients with high blood pressure, diabetes, or low white blood counts. This patient’s experience reflects a worrying uptick in financial fraud, counterfeiting and drug diversion in the HIV medicine world since 2019. Read on to learn about recent court cases that shed light on the problem, and it threatens HIV patients.

Forged documents helped sell tens of thousands of bottles of questionable HIV meds 

Between February and April 2021, at least eight different patients found Seroquel, the wrong HIV treatment or, in one case, over-the-counter painkillers, in what appeared to be factory-sealed bottles of Biktarvy or Descovy. The Janssen Pharmaceutical Companies had warned about a similar issue in December 2020, when bottles labeled Symtuza turned out to contain Seroquel or Prezcobix, a different Janssen HIV treatment which contains half of Symtuza’s active ingredients, and won’t, by itself, control a patient’s viral load.

After investigating, Gilead Sciences and Janssen filed lawsuits against more than 70 defendants, including licensed distributors and pharmacies, who allegedly sold unsafe versions of HIV drugs acquired in nefarious ways. They used a variety of methods to get perfect looking bottles, including buying them at the street level from HIV patients who needed money. According to court papers and investigative journalists, the medicine the alleged criminals sold was unsafe: some bottles contained the wrong pills altogether, some were no longer factory-sterile because they had been opened and resealed, and all of them came with forged documentation.  According to Gilead, the ring made hundreds of millions of dollars by putting more than 85,000 fake bottles of its products on pharmacy shelves over a two-year period.

Florida HIV prevention medicine assistance program bilked of $68MM

In May, Gilead Sciences settled a lawsuit it filed in November 2020 to stop a scam run by 58 Florida-based clinics, pharmacies, labs and affiliated individuals. According to Gilead’s complaint, the defendants hired van drivers who visited sites like soup kitchens, public libraries, bus terminals, and churches to offer homeless and low-income people money to sign up to receive PrEP, which helps prevent HIV infection, through the program, regardless of whether PrEP was an appropriate treatment for them. Sometimes, after patients received the medicine they had never wanted, the drivers bought it back so that it could be resold into the black market. More than $68M of assistance was diverted from patients who actually needed help paying for their medicine and the scheme provided an avenue for more mishandled, secondhand and potentially expired medicines to reach patients.

Another $230MM in black market HIV drugs slipped into U.S. pharmacies

In June, the Justice Department (DOJ) indicted a Miami man for his alleged role in distributing $230 million in HIV drugs he had acquired illegally. According to the DOJ, he and his co-conspirators established licensed wholesale drug distributors in four states and used them, with false documentation, to sell the medicines at a discount to other co-conspirators running distribution companies in Mississippi, Maryland, and New York. Ultimately, those treatments reached pharmacies, and patients across the country.     

We’re likely to hear more about rings like this; according to the Wall Street Journal, the Department of Justice launched a criminal investigation that involves products from at least 12 drugmakers.

Resold and diverted drugs threaten patients

Patients in the early years of the HIV/AIDS epidemic pooled resources to share medicines with those who could not access new treatments. No one could ensure that those drugs were safe and effective, but community action was critical, and it saved many lives. These days, regulated, safely manufactured HIV medicines are available through public and private insurance and through assistance programs. By steadily controlling viral loads, these drugs help people live long, healthy lives.

These medications only work, however, if patients take the right pills with the right ingredients all the time—and there’s no way to ensure that that’s happening if black market drug rings are breaking into the drug supply. In these cases, vast networks of drug diverters and counterfeiters are enriching themselves while endangering the lives of people living with HIV/AIDS, and they must be stopped.

The scale of these crimes—committed in the last three years— is staggering. The last major drug counterfeiting charge was pegged at around US$80mm, and just this year we’ve had three cases, each one of them around that size or larger. While law enforcement and brand protection attorneys are actively using every last civil and criminal option to protect patients, patients can also take steps to protect themselves using the tips in HIV survivor Brandon Macsata’s recent PSA about counterfeits. PSM urges all HIV patients to take two minutes to learn how to stay safer.

The Time Has Come to Centralize HIV Services in West Virginia

My name is Marcus J. Hopkins, and I have been living with HIV since 2005. While I’m not considered a “long-term survivor” of HIV—a term deservedly ascribed to People Living with HIV/AIDS (PLWHA) since the 1980s or 1990s—my experiences receiving treatment for HIV through the Ryan White HIV/AIDS Program (RWHAP) and AIDS Drug Assistance Program (ADAP) have run an interesting gamut across five states: Georgia, Florida, Tennessee, California, and West Virginia. Across those five states, I have experienced a wide variety of HIV services provision over the course of being in HIV treatment since 2007, and can truly attest to the adage, “When you’ve seen one ADAP, you’ve seen one ADAP.”

Over the course of sixteen years of receiving services through the RWHAP and ADAP programs, several things have changed:

• Providers no longer wait until a patient receives an AIDS diagnosis to initiate HIV Antiretroviral Therapy (ART)

• Treatment regimens have largely transformed from multi-pill regimens to single-pill regimens and even long-term injections requiring once monthly or every other month injections

• The emergence of Pre-Exposure Prophylaxis (PrEP)—a once-daily pill or once-monthly or every other month injection to prevent the transmission of HIV between serodiscordant sex partners—means that the possibility of no new diagnoses is a distinct possibility within our lifetimes

• The threat of waiting lists to receive treatment and services is largely a thing of the past

• The passage of the Affordable Care Act (ACA, or “Obamacare”) allowed state ADAP programs to pay the premiums and co-pays for private insurance for eligible clients

• The passage of the ACA also allowed states to expand Medicaid in such a way that PLWHA are now automatically covered by state Medicaid programs, rather than ADAP. To date, 39 states have expanded their Medicaid programs (Kaiser Family Foundation, 2022)

And yet, despite all of these advancements, issues remain, particularly in rural parts of the country where even basic medical services are limited, much less HIV-specific services. Such is the case for my home state of West Virginia.

Since returning to West Virginia from Los Angeles in 2013, my experience with this state’s HIV services has been…fraught, at best. I can’t complain about the quality of care I’ve received, here; I can say that qualifying and recertifying for the various RWHAP parts is made extremely cumbersome.

You see, in the state of West Virginia, there is one organization that handles Ryan White Part B (basically, the ADAP program) for the entirety of the state. This entity is separate from the clinics that provide Part C and Part D services (outpatient care and the provision of medical care and support services for low-income women, children, and youths with HIV and their families, respectively). And THOSE entities are entirely separate from the Part F services, which cover education, HIV treatment projects, dental programs, and the Minority AIDS Initiative. And even THOSE entities are entirely separate from the ones that provide services for the Housing Opportunities for People with AIDS (HOPWA) program that provides various housing and utility assistance services for PLWHA.

So, let’s do a quick recap: in order to receive the full breadth of services to which most PLWHA are eligible in the state of West Virginia, one must engage with at least four separate entities. This doesn’t even address nutrition assistance, non-emergency medical transportation for visits, and other supportive services.

This is a problem.

It is a problem for patients; it a problem for providers; it is a problem for the HIV Care Continuum (United States Department of Health and Human Services, 2021); it is a problem for HIV surveillance and prevention.

As far as I can tell, this problem seems kind of unique to West Virginia. West Virginia never saw the proliferation of AIDS Service Organizations (ASOs) that most of the rest of the country saw during the 1990s and early-2000s. While the rest of the country and especially surrounding states saw an influx of new 501(c)(3) non-profit organizations and clinics step in to provide the wide swath of HIV case management, clinical, behavioral health, and supportive services, West Virginia’s services developed in inefficient siloes that left patients scrambling to figure out the veritable pantheon of providers necessary to get the services for which they are eligible.

By comparison, in the northeastern region of the state of Tennessee (still deep in Appalachia), Ryan White caseworkers went out of their way to assist with every aspect of HIV care, from enrollment in the program to clinical services to mental health services to dental services to HOPWA services to enrolling in nutrition assistance programs—they did it all. The same was true of my experiences in California and Florida.

In West Virginia, however, every aspect of seeking and qualifying for HIV services requires patients to perform an intricate and ever-changing ballet, the steps for which they are never taught. Because there are so few providers of these services, when patients experience issues, there aren’t really any other avenues to turn to for assistance.

This has become the case with one of West Virginia’s terribly mismanaged HOPWA grantees.

Again, unlike virtually every other state in the U.S., HOPWA services in West Virginia are not seated within the HIV treatment and services infrastructure, insufficient as it is, but within various organizations dealing with homelessness, such as Covenant House and the West Virginia Coalition to End Homelessness. Comparatively, in other states, referral to and enrollment in the HOPWA program is handled by ASOs, who work in concert with state housing agencies to assist with housing issues.

Over the course of the past few years, when one of West Virginia’s HOPWA service providers stopped paying housing and utility payments in a timely manner, patients had nowhere to turn without having to go through multiple channels to resolve their issues…but not even really resolve them; just lodge a complaint. Those HOPWA clients would have had to complain, first, to the very agency that failed to return their panicked calls, as they lost their housing or their electricity was cut off; instead, they had to jump through several different hoops just to find out where to go to complain—the regional office in Pittsburgh, PA, which initiated an investigation which, frankly, doesn’t do anything for those who are trying to get their rent paid or their electricity reconnected.

The time has come for the formation of not one, but several ASOs in the state of West Virginia to centralize these services. It is unconscionable that a state with a burgeoning HIV infection rate should have such a disorganized and disjointed service provision landscape. The time has come to centralize services at these ASOs, lest we continue to beat numerous dead horses and fail to serve those living with HIV.

Sources:

• Kaiser Family Foundation. (2022, April 26). Status of State Medicaid Expansion Decisions: Interactive Map. Washington, DC: Kaiser Family Foundation: Medicaid. https://www.kff.org/medicaid/issue-brief/status-of-state-medicaid-expansion-decisions-interactive-map/

• United States Department of Health and Human Services. (2021, June 21). What Is the HIV Care Continuum? Washington, DC: United States Department of Health and Human Services: HIV [dot] gov: Federal Response: Policies & Issues. https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum

Of Pride and Prejudice: Biden Administration Combats State Discriminatory Actions

Fairly regularly, our CANN Blog tends to highlight impacts of various public health actions as they relate to LGBTQIA+ populations because these communities are disproportionately impacted by a variety of social determinants of health as found in the 2015 United States Transgender Survey, conducted and published by the National Center for Transgender Equality (NCTE). It’s important to note, NCTE will be launching data gathering efforts later this year to provide updated data. Public health programs have long been leveraged to either help or harm (often via neglect of data pointing toward broader protections and specific programming) trans and non-binary people, depending on the ideological lean of the administration issuing regulations and rules, both on the federal and state levels.

2022 has been particularly challenging for transgender youth. We’ve witnessed state legislatures and governors through administrative agencies have sought to limit access to gender-affirming care. There remains deep community concern, despite some governors vetoing sports and health care related bills, judges regularly ruling against these actions, a lack of clear political support, and commitments from the Biden Administration to defend the rights of transgender people. These actions, however, aren’t just limited to transgender youth. Florida, for example, is currently proposing a rule that would prohibit the state’s Medicaid program from covering gender-affirming care for anyone, again, despite similar rules and laws having been struck down as recently as November 2021. (Editor’s Note: Florida’s rule, by the way, is open to public comment through July 8th.) Advocates for equitable access to care in public health programs and concerned on issues of health equity should readily take the time to comment. Public comment on state and federal rulemaking is a key element for policy engagement and can sometimes be used to reflect bad faith efforts on the part of these regulatory agencies, as was seen when Kentucky’s Medicaid work requirement waiver was initially squashed for failing to adequately address concerns raised in public comments.

In response to these moves, the Biden Administration has issued new executive orders including directing various agencies to assess more appropriate data gathering of sexual orientation and gender identity (SOGI) data of people participating in federally funded programs. Additionally, Biden has directed federal agencies to review existing data for information on when LGBTQIA+ youth and parents are separated from their families in child welfare matters, and issue rules to both define discrimination and protect LGBTQIA+ people from discrimination in federally funded programs. Indeed, on June 23rd, the U.S. Department of Education released a proposed rule that would extend certain protections for transgender students and seeks to further protect sexual assault and harassment victims in educational settings. An additional rule is expected later this year which would provide guidance on integrating transgender youth into school sports. We’re also still awaiting – any day now – the U.S. Department of Health and Human Services issue a new proposed rule regarding the Affordable Care Act’s non-discrimination provision known as Section 1557. The Trump Administration sought to narrowly define these protections in 2020, but it was blocked shortly after the U.S. Supreme Court issued its decision in Bostock v. Clayton County when a federal judge ruled against the Trump Administration after noted health clinic Whitman Walker sued to stop the discriminatory rule from going into effect.

These state efforts are aimed at finding “carve outs” to the precedents and rules protecting transgender people from stigma, violence, and discrimination merely as a political tactic. But just because this population is being used as a political football, doesn’t mean there aren’t severe public health consequences, some which may reach beyond the issue of gender identity. “Trans health is the canary in the coal mine,” a long-time advocate, Riley Johnson, said to me when discussing Florida’s effort to limit access to gender affirming care in its Medicaid program. “Once they can redefine ‘medically necessary’ to mean whatever they want it to mean, despite standards of care, every legitimate medical association, and decades of data, who’s to say they don’t decide to re-define ‘medical necessity’ for people living with HIV or STIs or hepatitis C, and return us to the days of moralistic ‘you did this to yourself’ or ‘it’s a choice’.” Johnson continued, “It’s real easy to look at substance users and decide their care doesn’t matter when we’re looking for reasons to justify the cruelty of denying people life-saving care.”

Johnson is correct in highlighting how bias-driven rulemaking affecting public health programs turns into a slippery slope. Experienced advocates should be mindful of intersecting issues of public health and encourage those budding advocates to take advantage of these…interesting times to build their knowledge, engage in policy development and evaluation processes, and invest in strengthening the public health advocate pipeline.