Tension in Tennessee: HIV Crisis Looms

Earlier this month, Tennessee announced it would begin refusing federal funding for HIV prevention activities including surveillance activities, which monitor the progress of reducing new HIV transmissions and diagnoses as well as help identify populations and geographies disproportionately affected by HIV. The funding mechanisms targeted by the state for being rejected are known as PS 18-1802 (surveillance and prevention funding) and PS 20-2010 (supporting state health departments in Ending the HIV Epidemic). The U.S. Centers for Disease Control and Prevention (CDC) announcements for recipients of these dollars show Tennessee receives about $6.2 million from PS 18-1802 and just under $2.1 million from PS 20-2010. A letter issued to subrecipients on January 17, 2023 from Dr. Pamela Talley, Medical Director of Tennessee’s HIV, STI, and Viral Hepatitis Programs, the move is supposed to “decrease its [Tennessee’s] reliance on federal funding and assume increased independence,” with an end date for those federal funds to be May 31, 2023. The same letter promises, “Other state initiatives will support all HIV prevention and surveillance staff and activities in funded metro health departments. Our goal is for new service contracts to be in place on” June 1, 2023.

It's not yet entirely clear how Tennessee will make up for the $8.3 million dollars the two funding streams offer but Governor Lee has emphasized a desire to not have “strings attached” that come with federal dollars. It’s also not clear that Tennessee can effectively have those replacement dollars and contracts in place in the less-than-six-months deadline described in the aforementioned letter.

PS 20-2010 specifically funds efforts aimed at addressing needs in Shelby County, where Memphis is situated, as a priority jurisdiction for Ending the HIV Epidemic (EHE), an initiative started under President Trump and continued by President Biden (displaying the long, historical record of bipartisan support regarding HIV). According to AIDSVu, as of 2020, 6,283 people are living with HIV/AIDS (PLWHA) in Shelby County, with 81.7% of those PLWHA whose race is identified are Black. The county’s rate of PLWHA is more than twice that of the state overall (819 vs 314 per 100,000) and the rate of new HIV diagnoses is nearly three times the rate of the rest of the state and the country at large (31 vs 11 per 100,000). The CDC’s dashboard to track EHE progress, known as America’s HIV Epidemic Analysis Dashboard (AHEAD), shows provisional data which indicates a decrease in new diagnoses (this does not mean fewer transmissions), a light increase in linkage to care rates (which could be explained by the decrease in new diagnoses), and a decrease in pre-exposure prophylaxis (PrEP) coverage in years 2020-2022. According to the U.S. Census Bureau, Shelby County’s racial demographics are 54.6% Black and 40.4% white, including Hispanic white persons. Furthermore, the CDC’s 2020 analysis of counties vulnerable to HIV outbreaks included an astounding forty-two counties in Tennessee were among the two hundred twenty top counties at risk, with Hancock County, a rural area which boarders closely to Kentucky, Virginia, and North Carolina, ranks as thirteenth most likely to experience an HIV outbreak. Separately, but certainly related, local news reported a “spike” in new HIV diagnoses in Chattanooga in November 2022.

While the state says it can best manage these dollars, there’s good reason to doubt that and to doubt that this move is not ideologically driven.

For example, the state, through reports to news outlets, has said it will emphasize prevention programming on non-profits to best serve human trafficking victims, first responders, and to prevent perinatal HIV transmission from mothers to children. However, According to Tennessee’s own epidemiological report there were zero perinatal HIV transmissions in 2019. The CDC tracks certain occupational transmissions of HIV and describes the risk associated with certain situations of exposure, which few first responders even experience. To that end, even the CDC admits “occupational HIV transmission is extremely rare” on a page that tracks occupational transmissions among health care personnel, where first responders of ilk are most likely to be at risk. According to the CDC’s page dedicated to occupational transmission, only 58 cases of confirmed occupational transmission have ever been reported in the US, with an additional 150 possible transmissions reported to the agency. Yet and still, since 1999, only one confirmed occupational transmission has occurred among health care personnel. As for human trafficking victims, there’s a bit more opacity there. Likely, those victims are already well-served by those entities already contracted by the current funding mechanisms tied to federal dollars. Limiting or shifting those resources away from well-established service providers risks harming the communities served, reducing access to care, and might run up a pre-existing injunction.

Planned Parenthood just so happens to be one of the contracted service providers for the state and has already run up against the state attempting to strip funding from the entity. In 2012, Judge William Haynes issued an injunction against the state of Tennessee from attempting to stop HIV prevention dollars going to the provider. At the core of the issue, the state through then-Governor Haslam, who committed to defunding Planned Parenthood and public statements to that effect were submitted as evidence of animus against the entity’s First Amendment protected speech and advocacy, sought to refuse grant renewal with Planned Parenthood. Planned Parenthood had responded to a request for proposals (RFP) for these dollars and had previously scored well in the grant application to independent grant reviewers at United Way, the state’s assigned administrative agent for distributing the federal awards. Planned Parenthood also had a successful track record of meeting the grant deliverables associated with the funding, which was mostly centered around condom distribution. Judge Haynes found the state did not have just cause for refusing to continue contracting with Planned Parenthood, given their score, past success with the same funding, and because Planned Parenthood’s “clientele and communities will lose important public health services on matters of grave public health concern.” The injunction still exists today, though it was issued in federal courts, not state courts, because the dollars used are federal dollars.

That said, it’s entirely clear, given the state’s suggestion these dollars will also flow through non-profit providers, if the injunction would not still apply. However, the state has since removed Planned Parenthood from its website listing contracted condom distributors.

Other changes to the state’s website include removing all mention of priority populations identified by the federal government, according to an internet archive, including the MSM (men who have sex with men) taskforce and the transgender taskforce.

The state’s transgender taskforce specifically came to Governor Lee’s attention because of right-wing attacks on Vanderbilt University medical Center’s gender affirming care clinic in later 2022. Vanderbilt receives some state dollars to provide a wide variety of care, not just HIV-related services or gender affirming care for transgender and non-binary people. Conversations with local advocates found a broad understanding the Governor’s commitment to “investigate” Vanderbilt and the entity’s use of state dollars, which would have readily disclosed the CDC’s designated priority populations to include transgender people and which entities are funded by the CDC’s grants.

Tennessee service providers funded by these federal dollars have voiced their concerns repeatedly through media interviews, some specifically pointing towards how this disruption will also be detrimental to the state’s response to the opioid epidemic.

It is currently unclear how much Tennessee’s new health commissioner, former state-Senator from Kentucky Dr. Ralph Alvarado, had a hand to play in these developments. While Alvarado officially began his duties just a couple of weeks ago, he was appointed by Governor Lee in November. Alvarado’s voting record and public statements show animus toward transgender people and abortion access, with him voting to bar transgender girls from playing on sports teams and to increase various abortions restrictions in Kentucky’s 2022 legislative session. When Alvarado was introduced to the Tennessee Senate’s Health and Welfare Committee on Wednesday, January 25, 2023, rather than the typical meet and greet type hearing, Senator Jeff Yarbro, who has a personal connection to HIV, asked Alvarado about the changes and was met with a regurgitation of the state’s letter to health departments. Alvarado is expected to return to the Committee in March, even as time ticks down.

Senator Yarbro and Representative John Clemmons have introduced state legislation which would require Tennessee to pursue and accept federal dollars “to implement programs for the prevention, testing, and treatment of” HIV. These bills largely mirror state statutes which require states pursue all federal dollars made available to state unemployment insurance funds. They make sense on the surface, if federal dollars are available for programming important to the residents of a state, the state should be pursuing those dollars first. The bills, in an already packed legislative session and a hyper-partisan atmosphere, are not likely to pass.

Additionally, Tennessee Representative Steve Cohen (TN9-D) publicized a formal request to Health and Human Services Secretary, Xavier Becerra, about redirecting funding through county health departments to circumvent the state’s moves. The request also copied the CDC’s Director, Dr. Rochelle Walensky.

As of yet, news reports seeking to touch base with the CDC on the status of these changes have found the CDC has not yet been notified of Tennessee’s withdrawal from these funding mechanisms. Without formal notification, those dollars will renew automatically at the end of the grant year.

Part of the struggle in nailing down exactly the extent of the impact refusing these federal dollars will create is the complicated structure behind providing services and funding those employees who provide those services. For many entities funded by multiple streams of federal dollars, employees, measured in grant language as “full-time equivalent” (FTE), may have related duties in which each duty under their job description is funded by separate grants. For example, in a federally qualified health center (FQHC) providing counseling, testing, education, linkage to care, and HIV treatment services, a single employee might be funded by one grant to provide counseling and testing while also being funded by another grant to link patients to care when a test comes back reactive or doing what’s known as partner notification (an activity performed with the participation of a newly diagnosed patient but designed to maintain the patient’s anonymity, if they so desire). Similarly, state disease surveillance infrastructure might employ one or two data analysts to compile data on a number of conditions, each of those conditions funded by separate grants, even though the employee doing the work is the same. So, if said analyst is examining reports on HIV diagnoses one day, another day they might be examining particular sexually transmitted infections – both activities funded by different federal grants. Surveillance activities also include things like monitoring PrEP uptake, a distinctly prevention activity.

Directly speaking to the duties which might be dually funded by multiple grants, the treatment, linkage-to-care, and re-engagement in care activities a FQHC employee might be engaging in will impact people living with HIV, not just those seeking prevention services. This does nothing to speak of health care providers or their support staff who also see their salaries dually funded. So while Tennessee’s refusal of federal prevention dollars does not directly hit funding streams tied to the Ryan White CARE Act grantees, subrecipients, and contracted service providers, PLWHA may well still an impact in the quality of treatment services provided to them due to staffing changes, including those support services which are dually funded for prevention and treatment.

Adding one last layer of complication onto matters, it is also not known how much of Tennessee’s prevention programming generates 340B revenues and savings, which would typically be directed back into prevention programming. Those dollars, if any (there are certainly significant sums involved as each grant requires the recipient, subrecipient, and contractors to propose revenue generating activities and 340B is considered a significant source of those revenue dollars), will be gone from the state’s health ecosystem. With Tennessee also pointing at redirecting dollars from other state initiatives, there’s good reason to believe some, if not all, of those suggested dollars might be from state programs generating 340B revenues. All of that means other programming benefitting from 340B rebates would then see a reduction of programmatic dollars for those programs – whichever they might be. And there’s reason to believe that might be what’s happening, if we look at what New York is proposing in terms of the state usurping 340B revenues to prop up its budget at the expense of grantee service providers who have come to rely upon those monies to meet the needs of patients. Certainly, redirecting 340B revenues to fill budgetary shortfalls from any state away from service providers who are expected to produce accounting as part of their federal grantee status does not serve the intent of the 340B program, “stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive care.” In order to stretch federal resources, those federal resources must be there to begin with.

With questions remaining on exactly how Tennessee, which up until now, has not directly funded those programs which have been federally funded, advocates and service providers remain nervous about how this whole thing shakes out. Even if there were private interests ready to “save the day” by providing stop-gap funding, those same private interests cannot fund state surveillance activities. There will be a gap, regardless of efforts to fill the gaps that manifest as a result of these types of reckless moves. And those gaps, created on ideological lines and conspiracy theories, might well be something other states pick up on – a fear many advocates, local and national, have looking forward. What is clear, regardless of why one finds themselves as stakeholders in this space, active efforts to fortify both prevention and treatment funding and services are direly needed.

Without prevention properly funded, fewer people will be testing or linked to PrEP. Without testing and PrEP, fewer people will be linked to care upon diagnosis. Without diagnosis, fewer people will receive the treatment and support services necessary to achieve viral suppression. Without treatment and support services, more diagnoses will occur.

Our ecosystem is fragile and very carefully built. Removing one key component risks destroying all of our progress and returning us to a very localized version of the AIDS crisis.

Xylazine: Advocates, Service Providers on High Alert

As friends to organizations whose missions are primarily centered on harm reduction and as an organization that recognizes and often seeks to break down the silos associated with HIV, Hepatitis C, and Substance Use Disorder as distinctive but intersecting health states, Community Access National Network (CANN) is sometimes skeptical as to “alerts” the United States law enforcement community might offer through various news media. The “rainbow fentanyl” hype from the fall of 2022 speaks to why advocates may find themselves questioning the veracity of these kinds of warnings. However, the issue of xylazine is unfortunately based in very tangible realities for the United States, which have been documented as far back as the 2000’s in Puerto Rico. The prevalence of xylazine is increasing across the country’s street-based drug supply, often times in combination with fentanyl – most significantly complicating efforts to reverse overdoses and causing wounds which are atypical to more common fentanyl or heroin use.

Last week I spent time discussing a friend’s personal (and social) sexual health and as conversation developed they expressed concern over the development of xylazine, sometimes known as “tranq dope” or “down”, becoming more prevalent in the illicit drug trade of their community. Planning for events and even social outtings are requiring them to consider carrying more doses of Narcan on them and they’re noticing a higher demand for fentanyl testing strips. They conveyed a familiarity with the strips being used to ensure the illicit substances being used were indeed fentanyl and not the animal tranquilizer that seems to be driving up fatal overdoses in the surrounding community. Our conversation wrapped up with my friend sharing with me a sentiment another friend had shared, “Crack sucked, opioids suck…but they were a progression. People knew what they were doing. This is innocent. People aren’t making these choices.”

And while some might moralize what making “those” choices might mean, ultimately the best approach to helping folks navigate substance use doesn’t come with judgment but an acceptance that we all cope with the world around us differently. History tells us readily that prohibition movements seldomly achieve their goals and, economically, criminalization is less beneficial than harm reduction measures in curbing illicit substance use. Harm reduction measures, when adequately situated and supported, link people who use drugs to care where wounds may be treated, safe supplies might be obtained, chains of transmission of infectious diseases are identified and interrupted, and, when someone is ready, linkage to substance use counseling is available. It is this intersection of interest where harm reduction and patient advocacy intersect.

Hard-won victories which have helped advocates create safer environments for people who use drugs may not be sufficient for handling this corruption of street supply, as the wounds being associated with xylazine are resulting in amputations, in part because of providers being less familiar with how these wounds are presenting, which may still be present even when someone is not injecting their substance of choice, but swallowing, smoking, or snorting it. Trust in hospital providers is slim because emergency rooms are received as hostile environments which do not typically offer substance use treatment referrals and where people who use drugs often experience provider biases, sometimes resulting in substandard care. Fear of withdrawal is also a compelling factor for avoiding necessary care, as community-based programs are trying to meet the needs of their clients, their communities, mostly on their own.

While Philadelphia’s struggle with xylazine infiltrating the street supply is well documented, other jurisdictions are seeing signs of the tranquilizer. Delaware firmly expects to see 2022’s fatal overdose tally surpass 2021’s, even as provisional data is still being cleaned. Similarly, Connecticut, New Hampshire, and Rhode Island among several other east coast states have identified xylazine in the local supply as well as fatal overdoses increasing.

In the face of these challenges, House Republicans have asked the Drug Enforcement Agency and (DEA) to “schedule” xylazine and if the agency doesn’t, they might seek legislation to schedule it anyways – a move advocates warn might only make the problem worse. “Scheduling” refers to introducing a specific substance to the “schedule” of illegal and illicit substances maintained under the Controlled Substances Act – thereby adding certain criminal enhancements to the possession, use, and distribution of the tranquilizer. The concern from advocates in such a move is it would encourage further addition of other synthetic adulterators into street supplies, just as we’re learning (and researching) how to handle xylazine. Dr. Ryan Marino, medical director of toxicology and addiction medicine at University Hospitals in Cleveland scolded, “This is more of the same short-sighted and reactionary political grandstanding that may help politicians but won’t help any American citizens and doesn’t solve any of our drug problems.”

The U.S. Food and Drug Administration (FDA) issued an alert to health care professionals in November 2022, and the Biden Administration’s other agencies are already beginning to tackle the subject. But, what will it amount to?

Federal and state funding is already largely prohibited from backing safe consumption sites and Canada’s advocate proposal of a “safe supply” would be an ever further stretch for politicians wishing to appear “tough on drugs” (but apparently lacking the empathy and expertise to be helpful to communities struggling with deaths). A congressional Research Service report, also shared in November 2022, offered some answers, ranging from treating safe consumption sites similarly to medical marijuana dispensaries, wherein the U.S. Department of Justice (DOJ) is prohibited from using resources to seek prosecution of those businesses so long as they comply with state law, lawmakers could opt to fund these sites, giving explicit endorsement of a well-proven intervention that has already saved hundreds of lives in New York, or Congressional leaders or the President might choose to actively pursue criminal litigation and legislation which explicitly outlaw safe consumption sites. The Biden Administration appears to be leaning toward non-enforcement, if the recent updates about the DOJ and Safehouse, an organization in Philadelphia, meeting an “amicable settlement” prove to be fruitful.

Because overdoses of the tranquilizer are also presenting atypically from more traditional fentanyl overdoses, community health workers are noticing Narcan is less effective in reversing these overdoses and even when they are effective, the person experiencing the overdose may not rouse as easily because of the contamination with xylazine. Some have reported oxygen supplements might help in stabilizing someone in need of emergency care in response to an overdose. This would prove an exceptional challenge for street-based workers but certainly something a safe consumption site would be able to have on hand. As states continue to develop their harm reduction policies and empower community-based organizations to respond to these crises, policymakers should evaluate things like ensuring adequate oxygen supplies for these entities and even their community partners (which might include businesses like bars) and increasing allowable and covered purchases of Narcan, as administering the overdose reversal medication is still highly recommended when encountering an overdose.

We urge our partners to keep a close eye on this issue at it continues to develop.

Patient Care Suffers at the Intersection of Nursing Shortages and Hospital Consolidation

Last week, New York City nurses at Mount Sinai and Montefiore hospitals went on strike for about three days before the hospitals reached a tentative agreement, bringing nursing staff back to work immediately. The New York State Nurses Association, which organized the strike, lead an incredible media campaign around the strike effort, warning communities (and hospitals) well ahead of the strike about the need for good faith negotiation and changes weren’t just about ensuring nursing staff compensation kept up with inflation, but primarily based on working environments and patient safety, with key demands around improving staff to patient ratios. The campaign was so successful, four other hospitals which would have been subject to the strike reached agreements ahead of the Monday deadline. While the American Nurses Association did not have a direct hand in the strike, they supported the move by the New York State Nurses Association, stating the need indicates a “systemic breakdown” regarding safe staffing levels, protecting nurses from workplace violence, and supporting nurses’ mental health and well-being, among other challenges.

That idea offered by the American Nurses Association isn’t wrong – this issue is systemic. Lats month, the New York Times outlined how Ascension, one of the nation’s largest hospital systems, had neglected staffing needs for years, leading to hospital locations across the country being ill-prepared for the demands and challenges COVID-19 brought. The piece, entitled How a Sprawling Hospital Chain Ignited Its Own Staffing Crisis, details how Ascension bragged about reducing its labor costs and reducing its number of employees per occupied bed. But this, in combination with other factors like health care workers becoming sick, left Ascension hospitals in a near unimaginably bad position to handle waves of COVID-19 patients. Indeed, the New York Time also ran a piece in August of 2021, highlighting the plight of nurses struggling to keep up with demand of the “Delta variant wave”. The beds were there, the staff to ensure those beds could be safely occupied were not. On top of already having poor staffing to patient ratios and many staff falling ill with COVID-19, thousands of health care workers died in these “crisis” waves. Several times throughout various COVID-19 “waves”, hospitals advertised their need for nursing talent and offered to pay exceptionally well for those traveling nurses who could help meet the immediate demands of the moment. Already retained nurses were not necessarily offered similar compensation as their traveling counterparts, even if some hospitals did end up offering supplemental pay. Largely, those supplemental payments have dropped off as CARES Act dollars have dried up.

Put yourself in the nurse’s position, for a moment. If you could get paid say… three months’ worth of salary working two weeks away from home by traveling, would you do it? Consider now, there is no end in sight for the demand in traveling nurses. You can find work whenever you want and it’s well-paid enough that you don’t have to worry things like negotiating to compensate for inflation. And if the area you’re working is experiencing workplace safety issues or violence from patients who have bought into conspiracy theories that you and your colleagues are somehow making up a respiratory pandemic, you can just leave. More and more nurses weighed this position and more and more nurses opted to travel. This has had likely one of the most significant drivers of hospital labor costs increasing by at least 37% since 2019. And hospitals, for their part, aren’t necessarily cutting out activities like buying up other entities or executive compensation in order to reinvest in their staff, rather, they’re billing insurance companies more. That increase in cost of care also translates to an increase in insurance premiums for consumers and other plan changes that might adversely affect patients and patients’ ability to afford care. For example, Health System Tracker, a project of Peterson Center on Healthcare and Kaiser Family Foundation, detail how the Affordable Care Act’s maximum out of pocket limit is growing faster than wages and how emergency department visits are now exceeding affordability thresholds for many consumers with private insurance.

These systemic changes need to be addressed immediately by state and federal policymakers. Unions alone cannot stop hospital consolidation and can only leverage so much to ensure appropriate staffing levels without risking the quality of care patients receive in any given community.

Because of the greed that drives hospital consolidation, the “rural hospital crisis” is coming to an urban area near you. An example of the emergency nature of this situation can be found in Atlanta Medical Center’s sudden closure, an issue Louisiana Children’s Medical Center’s purchase of Tulane hospitals from HCA Health could replicate in another majority Black city.

Given the billions of dollars hospitals have received in CARES Act dollars and continue to receive in 340B dollars, regulators need to slam on the breaks of approving hospital consolidation purchases. Communities and their elected officials should also critically ask hospital executives (and investigate a factual answer, not a public affairs answer), “Are you really operating as a health care provider or are you operating as a real estate entity and buying out all of your competition at the expense of our communities?” Indeed, the real question that’s going to drive some much, much needed oversight on hospitals would be, “Are you using these dollars meant for public benefit to buy out your competition?”

It's high time hospitals be held accountable.

2023: Regulatory Items to Watch

Last week, the politically interested got to watch a preview of how the United States federal government will approach legislating for the next two years – it’s not pretty. With the narrowly divided U.S. House of Representatives barely eking out enough votes to select a Speaker, nearly coming to the time old tradition of fist fights in the process, passing meaningful legislation will be fraught, regardless of the issue at hand. None of that takes into account that Democrats still control the U.S. Senate (even if also by a narrow margin) and the priorities of both chambers are now split by party. There may be some surprising room for agreement though. As of the time of this writing, this may well be the first Republican-controlled Congress that is not riding on a platform of repealing or replacing the Affordable Care Act (ACA). That doesn’t mean potentially meaningful changes couldn’t come, it’s just highly unlikely.

That leaves the courts, which we discussed in our last blog, and the Biden Administration’s own executive authority through regulatory agencies to carry the burden of change through the 2024 election cycle. A few things to remember include the previous administration’s actions to pack the federal judiciary, including Supreme Court seats, the dynamic controls of implementation priorities between states and the federal government, and the Biden Administration’s support for insurers over the last two years will shape what we might see in terms of regulatory action.

A prime example of all of these factors playing out can be seen in Judge Reed O’Connor’s September 2022 ruling on Braidwood, wherein O’Connor ruled the ACA “preventative services mandate” was unconstitutional particularly because of the plaintiff’s objections to covering pre-exposure prophylaxis (PrEP) as violation of their religious beliefs and because of some wonky interpretation of delegation of powers or what defines an agent of the government and the process by which those agents are appointed. Notably, O’Connor has been previously overruled on highest profile rulings, mostly those with extreme anti-gay and anti-ACA positions…repeatedly. As this case makes its way through higher courts, the 5th Circuit is next, states may have the chance to implement their own versions of minimum benefits and services insurers and covered entities must provide. Much like the issue of Medicaid Expansion, this type of action would further disparities across states in terms of access to care, but would provide some protection for minimum coverages for residents of those states. Here we have the Biden Administration’s interpretation of both the law and the entity responsible for implementing the law, a federal court’s disagreement on process, and the state dynamic of “what do we do now?”

Let’s take a look at the annual Notice of Benefit and Payment Parameters (NBPP), issued to describe how insurers and providers must handle certain nuanced rules and regulations for a given benefit year. NBPPs are generally issued in the year prior to when the rule should go into effect, sometimes a little earlier but in enough time for insurers to make sure their plan offerings comply with the rule. The 2023 NBPP included provisions on the ACA’s non-discrimination rule and an effort to strengthen coverage and services to LGBTQ patients. This operated as a nod toward the Biden Administration’s aim at addressing rule-making for the ACA’s actual non-discrimination rule, known as Section 1557 (which has been subject to numerous lawsuits, including those in front of O’Connor). The 2024 NBPP, proposed rule (not final), looks to address some definitions of “network adequacy”, or making sure the benefit networks offered by insurers are meaningfully useful for patients and, with some theorized framework, hopes to make selection of a qualified health plan off the federal marketplace a little bit easier by introducing standardization. Watching NBPP final rules and processes will remain a prime opportunity to advocate with regulators, both state and federal, and read tea leaves of other regulatory actions down the road (in the 2023 NBPP final rule, which includes answers to some comments made about the proposed rule, the Biden Administration directly answered that it would be addressing Section 1557 in response to questions as to why the non-discrimination provisions did not go further to more explicitly protect transgender patients).

The Biden Administration will also get the chance to start to implement and define the rules around its prize jewel, Inflation Reduction Act (IRA), which, among other things, introduces the idea of drug price negotiation in public payer programs like Medicare.

Before we jump on some details to watch there, it’s important to note, the provisions of the IRA affecting drug pricings do not necessarily have a direct impact on what patients pay at the pharmacy counter and have zero impact on those patients not enrolled in affected public payer programs. Furthermore, when politicians of all stripes tout “saving money” in public payer programs, they’re not necessarily talking about patients saving money. Indeed, most of the time they’re not. They’re talking about reducing the costs to the federal government for operating those programs – sorta. The way it works is the federal government can’t really handle all of the medical and medication claims associated with these public payer programs, so they contract with private insurers or encourage patients to enroll in supplemented private plans to handle these claims and reduce the labor and expertise burden on the federal government. States do this too with Medicaid. However, those companies, particularly pharmacy benefit managers (PBMs) handle the costs of medications and formularies, engage in all the same dirty tricks with their public payer programs as they do with their private plan offerings, including abusive prior authorizations, step therapy, network limits, and steering patients to mail-order pharmacies which those entities then own. There’s little oversight given and limited regulatory action to prevent these private entities handle the administrative processes of these programs from abusing their role for the sake of their own profits.

Indeed, pharmacy benefit managers came about in our ecosystem promising to negotiate prices on medications already. And they have, in large part, successfully done so, either consuming dollars through rebate programs or negotiating lower prices by buying in bulk. However, PBMs haven’t shared those savings with patients, despite that being the selling promise. In fact, PBMs have been one of the fastest profit-growth businesses in the country because they’re not passing on those savings to patients.

That’s right, drug prices are already negotiated. So why haven’t we, as patients, really seen the benefit of that? Why are patients having to argue with their insurers constantly to get the medication coverage they need or watching their medication formularies shrink? Cuz PBMs are in desperate need of regulatory control. Hopefully, the Federal trade Commission’s most recent inquiry into their business practices will shed some light on these issues and well-motivated constituents can remind their Senators and Representatives we need more action. We’ll also need pressure on the Biden Administration on these issues. They’ve dodged it so far.

Back to the IRA, there’s some pretty cool stuff in the health care pieces. Particularly, the cap on insulin copays for Medicare patients is a big deal. The limit on out-of-pocket costs Medicare patients will pay on the medications is also a massively big deal. These are the provisions that will benefit affordability the most for most Medicare patients. But we’ll need to watch for our veggies on this plate, as it were. The trade-off might look like PBMs further limiting formularies and advocates need to keep an eye out for that. Cautious advocates have much to celebrate in these pieces, as they directly affect affordability of and access to care, and should remain watchful for how implementation and enforcement rolls out but also as to any unintended consequences which may need additional answers later.

Now, the drug pricing and negotiation pieces on the other hand, might dicey as time goes on. Nothing in the IRA requires any “savings” private administrators might receive or the federal government might view to be passed onto patients. Nothing. Furthermore, certain pieces of the IRA prevent judicial review, which means if patients find themselves adversely affected by a regulatory move or certain implementation of the IRA, they can’t sue to government to fix the issue. That’s never a good thing. It’s also a particularly bad thing to include in any legislation, especially as we look down the barrel of patients losing their right to private action to seek enforcement of non-discrimination and disability protection laws (again, see our previous blog). We should always retain the right to seek redress under our judiciary, even if only to give light to how “bad” legislation (or short-sighted provisions) might be hurting patients. One of the pieces affected by the non-review bit includes the “what-if a manufacturer refuses to play ball on negotiation of a particular medication?” The answer is the feds have the right then to remove ALL of that manufacturer’s medications from covered public payer programs. Now, that might seem like the manufacturer is the bad guy there. But the drugs targeted by the IRA are the highest cost medications on the market and the highest cost medications on the market are those typically designed to treat or manage rare, chronic, or life-threatening illnesses and in which there are limited or no alternatives. These areas also happen to be where manufacturers have been leading medications for quite some time, to the benefit of patients. More personalized medications mean more specific care for a patient’s needs. The “negotiation”, which is really not a negotiation when an ethical manufacturer seeking to recoup costs and generate enough revenue to reinvest in discovering and developing new medications, investing in underserved disease states, is essentially forced to take a hit or have their entire portfolio yanked out from patients. “Take the hit or we’ll hurt the people that it’s your mission to serve.”

Now, I have plenty of criticism for our industry friends. This shouldn’t be taken as “oh you’re a shill” moment. Rather, my biggest disagreement is the inability of patients who might lose access to medications to seek redress and the lie which premises the need for the federal government to “negotiate” prices. As described above, negotiation already happens and they dynamic of this law isn’t “negotiation” but hostage taking. And patient access to care is what’s being held hostage. None of that addresses what some suspect will be manufacturer responses by consolidation in the industry and increases in launch prices. Essentially, these provisions only put a bandaid on a gaping wound and it’s not even on the wound the public cares most about. It’s kinda hanging off to the side.

Ultimately, my view is the federal government should gladly invest in our care. “Cutting cost” has always and will continue to sound an awful lot like “that’s not something we really wanna spend money on or invest in”, regardless if it’s a private insurer or a politician. Our care, our health, our families matter and they should be an investment priority for political leaders.

We’ll spend plenty of time later this year discussing the other “alligators” “closer” to patients than manufacturers and why we need to address those actors first.

Future legislation that seeks to make care more affordable and accessible needs to work from the perspective of patients, not insurers.

The last thing we’re gonna touch is something that pretty much every patient advocate can celebrate, so long as it’s done right. In the later end of 2022, the Biden Administration proposed a rule to improve patient and provider experiences with the administrative burden insurers love to impose on us. Particularly aimed at addressing electronic health data exchanges and streamlining prior authorizations (PAs), a process which has been wildly abused by payers, the rule hopes to improve patient experiences in care. Often times, PAs result in denials of coverage in which a patient (or provider on a patient’s behalf) must appeal to the exact same payer that denied coverage in the first place. Those letters are often vague or confusing, or in my own situation for hormone replacement therapy, tell patients to try something they’ve already tried or was already included in the provider’s rationale for a specific medication or treatment course. The rule requires more specificity in reasons for denials, which would allow a provider to more directly address those reasons as inappropriate for the patient or, as is the case sometimes, not even based in medical science. The rule also seeks to speed up the process. Currently, many patients have to wait weeks if not months to get responses on PAs or appeals. The rule would require most PAs to be answered inside of 7 days or inside of 72 hours, if it’s urgent. The rule also forces payers to begin using more modern technology to review PAs. Rather than outdated forms, faxes, and even mail, payers would have to provide either a web portal or direct email address in which patients and providers might more securely ensure their request has been received. Lastly, the rule would require payers to post specified PA metrics. Be it care or medication, patients and providers would be able to view on a payer’s website just how often they deny care and how much burden that payer is going to place on them to receive the care they’re entitled to.

Now, the PA rule is, as many, limited in scope but not by much. It would apply to Medicaid managed care plans, ACA plans, the Children’s Health Insurance Program, and Medicare Advantage plans – nearly everybody.

Regulatory actions won’t be limited to these so keep an eye out!

2023 Poses Threats and Promises for Public Policy and Patient Advocates

Annually, Bill Arnold had a traditional “open” for the Hepatitis Education, Advocacy, and Leadership (HEAL) blog, now the Community Access National Network (CANN) blog. Those blogs were a mile marker in the landscape of advocacy. “Here’s where we are and here’s what CANN will be looking at in the coming year”. Largely, they were on point, and often set the tone for the upcoming year’s work while also reflecting on the previous year’s movement. Last year, we took a slightly different tact, needing to ensure our community, members, and stakeholders were “in the loop” on the changes the organization was going through. Bill’s death caused a change in leadership and the Omicron wave of the COVID-19 pandemic meant we were not yet sure of how things might look “operationally”, especially with regard to our national meetings and presentations, which had, prior to 2020, been in-person events.

In 2022, as we had in 2021, CANN held its Community Roundtable and National Monitoring Report, in partnership with HealthHIV, virtually, in no small part because the access virtual programing provides patients, advocates, and other stakeholders is critical to maintain. A challenge many advocacy organizations and even government agencies have faced, and will continue to face, is striking a balance between “Zoom fatigue” and ensuring participants have ready access to engaging, informative, educational programming and timely updates. 2023 will likely include more in-person events for a number of our partners and as we rejoice in seeing one another over meals and hugs and sometimes a…spirited discussion or two, we should also keep a mind toward ensuring access to the quality of these conversations with our community members who are less financially secure, who experience physical and emotional challenges which limit travel, and for our patient community which must be more mindful about respiratory illness outbreaks or waves which could threaten their health. As a culture and industry, we must ensure we do not lose the potential of the last few years in expanding access to advocacy, much less access to influence.

Parts of 2023 will include some…hangover from 2022. Indeed, much of the nature of effective advocacy means recognizing our work is perpetually reflective of the path laid in previous years and even decades. To that end, CANN encourages our audience to watch the continuation of the zombie court case known as Doe v CVS. This is a continuation of a case which was previously scheduled to be heard by the Supreme Court of the United States (SCOTUS) in December of 2021 but, by mutual consent of the parties, was pulled back from the high court. The 9th Circuit case now moving forward reflects many of the same claims of disability discrimination under the Affordable Care Act (ACA) the previous case held. Particularly, the case focuses on how CVS, as a pharmacy benefit manager, forces or heavily influences (read financial coercion) patients to use their mail-order pharmacy rather than a physical pharmacy location, necessarily denying patients the benefit of in-person medication counseling and risks the quality of certain medications because of being exposed to the elements through mail services. While the case is being brought by patients living with HIV, the application of the case and its outcome could affect any patient with a chronic condition which requires medication for management.

Similarly, we’ll be watching the outcome of Talevski, already heard by SCOTUS, yet without a decision as of this writing. The case focuses on Medicaid and the enforcement of rules states are subject to but, depending the ultimate outcome, may have impact well beyond Medicaid and into a whole swath of other federally regulated programs. The case centers on exactly who is allowed to initiate lawsuits to enforce regulations and the law as a whole. Do patients have a “fight of action” or is that exclusively held as a responsibility of the federal government? This might seem like an odd question to ask SOCTUS to decide but, by and large, the federal government relies very heavily on private citizens to bring lawsuits to courts to argue for enforcement actions. In those situations, the federal government steps in as “intervenors”, or third parties which may have a heavy interest or even standing in which to bring the suit in the first place. In this fashion, the feds can and do carefully select cases in which clarifying precedent or novel approaches might be “tested”. However, in this case, the Health and Hospital Corp of Marion County, Indiana, has asked SOCTUS to upend that entire history and declare that only the federal government may initiate a lawsuit seeking to enforce federal regulations against the entity…or any entity subject to federal regulations for that matter. This is akin to many cases heard by SCOTUS in an era from 1890 to 1937 known as the Lochner era. While the Lochner era generally focused on issues of labor rights and regulations, the attitude and rulings from SCOTUS at that time were generally very anti-government and anti-regulation. A majority conservative SOCTUS might seek to revive that sentiment through cases like Talevski. Just as was the case in the Lochner era, this type of shit would largely be detrimental to the “every man”, especially in areas of human and patient rights.

Speaking of…the Biden Administration is going to have its hands full in 2023 as states which have previously failed to pass anti-transgender legislation appear to be geared up to try again. Despite a ridiculously poor showing during the 2022 mid-term elections, which rode on “anti-woke” sentiments (read: anti-human rights and dignity) and “culture wars”, right-wing politicians are set to revive the very effort that turned a “red wave” into little more than trickle. Partners more focused on civil liberties will write plenty and work hard around the civil rights aspects of libraries being threatened. Another aspect of this very rise-of-the-Anita-Bryant-zombie is how hospitals and health care providers have been targets of both political attacks and criminal efforts to shutter access to care. And it’s not just trans kids they’re after. Several state efforts, including Florida’s Board of Medicine and Texas’ child welfare programs, have included administrative rule-making to target families and patients seeking care, regardless of age.

We also want to highlight the astounding work done by STAT’s Nicholas Florko on how the United States’ penal system has failed to reach its Constitutional and ethical obligations to provide care for incarcerated people living with Hepatitis C. In a series entitled Death Sentence, Florko follows the path of US prisons and their officials in denying live-saving, curative treatment to the people in their custody, effectively sentencing these patients to significant morbidity or, in some cases, death. US Courts have previously ruled things like budget constraints might be an allowable excuse for not providing care which would otherwise be required under the 8th Amendment. Allowing state lawmakers to abdicate their Constitutional obligations by not requiring coverage of curative direct acting agents is still a death sentence by neglect. The 8-part series is an absolute must read on how far behind the US court system is in meeting the demands of our Constitution and our conscience.

Lastly, China has abandoned its efforts to reach “zero-COVID” (joining much of the rest of the world on this policy issue). That doesn’t mean things are going to “return to normal”, either in terms of consumer goods logistics or global health. The Chinese government has not been as transparent as many of its partners desire in terms of its current outbreak or the potential for yet another debilitating variant being introduced into the global ecosystem. Keep an eye on developments there, including the tone of politicians who hold the greatest amount of influence and responsibility to ensuring we all enjoy a more diplomatic future with regard to infectious diseases. A lack of trust and transparency is at the core and center of every pandemic.

Troubling Issues with HIV and Monkeypox Co-Infection

In the process of gathering state-level data on the incidence and demographics of Monkeypox (MPV) in the United States, we have come across several reports of people who have been diagnosed with MPV being co-infected with HIV. This worrisome trend indicates the need for targeted interventions, increased testing, and better communication about MPV in both patient and provider settings. 

The Community Access National Network (CANN) has launched an ambitious patient awareness campaign focused on the ongoing Monkeypox 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 disparities faced by people living with HIV/AIDS (PLWHA) and MPV. 

Data from the European Union, United Kingdom, and the United States suggest that between 28% and 51% of persons diagnosed with MPV are also living with HIV (Kuehn, 2022). According to estimates from the U.S. Department of Health and Human Services (HHS), an estimated 40% of people who have been diagnosed with MPV in the U.S. are also living with HIV (HIV [dot] gov, 2022). 

These data are considerably troublesome, particularly as research is beginning to show that PLWHA are likelier to have worse manifestations of MPV, require hospitalization more frequently than persons who are not living with HIV, and are likelier to die as a result of MPV co-infection. 

The underlying issue? 

We simply don’t have enough localized data (or really, financial resources) to create strategic responses. 

Currently, there are only three major jurisdictions in the U.S. that publicly report on HIV co-infection in MPV diagnoses—Michigan, North Carolina, and Rhode Island. This includes looking at the municipal jurisdictions that were specifically targeted for JYNNEOS vaccine supplies—Los Angeles, Chicago, New York City, and Houston—of which only Los Angeles’ reporting mentions HIV, and even then, only in relation to tecovirimat (TPOXX) prescribing data. 

So, what does this mean? 

Primarily, it means that we need to look at other sources in order to extrapolate co-infection data and use modeling to make educated guesses about where risks of co-infection are highest and how best to respond. 

There are currently only a handful of recent studies and surveys that focus on the United States outbreak of MPV from which we can glean these data: 

1. Curran, et al., published in September 2022, focused on a sample of 1,969 from eight jurisdictions:

• California

• Los Angeles

• San Francisco

• District of Columbia

• Georgia

• Illinois

• Chicago

• New York (excluding New York City) 

These jurisdictions were selected because they were independently funded for HIV surveillance and because they represented areas with the highest rates of MPV infections in the United States.

Curran, et al., found that 755 patients (38%) of that sample were co-infected with HIV. Of those patients, 94% had received HIV care in the past year, and 82% were virally suppressed (Curran, et al., 2022). 

2. Miller, et al., released in October 2022, looked at a significantly smaller sample size of just 57 patients who had been admitted to hospitals for severe manifestations of MPV.

Of this sample, 47 (82%) were co-infected with HIV, just four of whom (9%) were receiving antiretroviral therapy (ART) to treat their HIV prior to being diagnosed with MPV.

In terms of demographics, 68% of this sample were non-Hispanic Black Americans, which highlights disparities in HIV treatment in Black communities.

Prior to the release of this report, 12 of those patients died. MPV was listed either as the cause of death or a contributing factor in five of those deaths, six deaths remain under investigation to determine if MPV was the cause or a factor, and 1 death was deemed neither the cause nor a contributing factor (Miller, et al., 2022)

So, what can we learn from these relatively limited findings: 

1. We can determine that PLWHA, particularly Men who have Sex with Men (MSM), are at higher risk of contracting MPV than their heterosexual or women peers.

From the data we have reported in previous blog posts and the reports we’ve released, MPV infection rates are highest in three primary populations:

a. MSM
b. Black Americans
c. Hispanic Americans 

This should lead us to build strategies that focus on education of providers about properly identifying MPV lesions, testing, vaccination, and treatment of MPV in these communities.

An additional consideration is a lack of uniformity in gender identity reporting and data collections. As of current, while some jurisdictions are collecting gender identity data for MPV metrics (with many more getting a much better handle on the same data for HIV-related metrics), most are not. Similar to data collection and reporting in HIV prior to about 2016, MPV data does not typically distinguish between a person’s sex assigned at birth and gender identity, thus not adequately capturing data that would appropriately represent transgender communities.

In our gathering of state-level MPV reporting, we found that 22 of the 32 jurisdictions that provide gender demographic reporting either do not report on transgender patient populations, at all, or lump all non-cisgender patients into an “Other” category that fails to capture the diversity of patient populations and health outcomes between them.

Two examples of how this data delineation proves particularly relevant can be observed in the emergence of information regarding HIV prevalence among transgender women, particularly transgender women of color, and, more recently, transgender men have largely been ignored as a target population, likely because of stereotypes and assumptions as to the types of sexual activity transgender men might engage in and because transgender men are less likely to access care (Demmons, 2019). A recent study conducted by AIDS United highlighted how deeply flawed some of those assumptions are, with 35% of the transgender men responding to the survey with a self-reported HIV-positive status (AIDS United, 2022).

Further consideration should also be given to persons experiencing or at risk of experiencing homelessness. Miller, et al., found that 23% of the admitted patients were experiencing homelessness, which is likely indicative of a growing outbreak among a key population: PLWHA who may be housing insecure.

2. We don’t know what we don’t know.

One of the largest concerns, here, is that a majority of providers in the United States simply aren’t familiar enough with MPV to identify the disease consistently and correctly. Since the beginning of the epidemic, physicians have struggled to do so, with many misdiagnosing MPV as other diseases or infections, such as herpes or syphilis (Doucleff, 2022). This is because both of those sexually transmitted infections may manifest as skin lesions, similar to MPV. Misdiagnosis can lead to both the provision of ineffective treatments and result in the unchecked spread of MPV. This highlights the need for better provider education about MPV, its manifestations, and how to correctly differentiate between various diseases.

Additionally, while both Curran and Miller provide reporting on HIV co-infection in persons diagnosed with MPV, none of the listed jurisdictions from which they selected their sample groups provide public-facing reporting on HIV co-infection.

In the three jurisdictions we found with this reporting—Michigan, North Carolina, and Rhode Island—48.6% of MPV patients were co-infected in Michigan, 51.6% in North Carolina, and 27.7% in Rhode Island.

These findings fall relatively neatly into the HIV.gov reporting that 28% - 52% of MPV patients are likely to be co-infected with HIV.

However, these numbers could potentially be higher, particularly in major cities, such as Los Angeles, San Francisco, Chicago, New York, DC, Atlanta, and other areas that have higher populations of PLWHA and more areas and venues where PLWHA tend to congregate (e.g., bars, restaurants, sex clubs, steam rooms, et cetera).

3. Although overall diagnoses of MPV have fallen precipitously since August 2022, there is a significant risk of MPV becoming endemic in MSM, LGBTQ, and PLWHA populations.

This will require the development and wider distribution of better MPV-specific vaccines, better MPV-specific treatments, and better education and health communication about MPV and its transmissibility.

There seems to be a prevailing belief that the United States has weathered the worst of MPV. With declining positivity rates, there are some in the public health community who have decided that resources and attention would be better spent elsewhere—specifically, they’re looking at the tridemic of COVID-19, influenza, and respiratory syncytial virus (RSV) that is leaving hospitals once again scrambling for ICU beds. More accurately, it may be said that jurisdictions either cannot or will not expand the existing resources and personnel to allow for the continued surveillance of MPV. This essentially relegates the work of focusing on, addressing, and frankly caring about MPV to those working in HIV and infectious disease spaces.

Already, we are seeing this trend in data reporting: the state of Texas has removed MPV data entirely from its data dashboard, replacing it with Multisystem Inflammatory Syndrome in Children (MIS-C). This is indicative that a lack of financial and human resources, or the lack of political will or interest to increase those resources, will force state departments of health to reduce reporting on MPV in favor of diseases that impact populations they deem “more important” than MSM, Black, and Hispanic populations.

This, again, raises the concern that MPV will become a virus that is all but forgotten by the general public and general practitioners, as those who face the greatest impacts are already marginalized populations. The disparities faced by those bearing the brunt of MPV mirror those in new HIV diagnoses; it is incumbent upon us to respond evaluate and respond to those trends accordingly.

References

AIDS United. (2022, November). CHANGING THE GAME: Visibility of Trans Men in the South. Washington, DC: AIDS United: News and Resources. https://aidsunited.org/wp-content/uploads/2022/11/ChangingTheGame-FinalReport.pdf

Curran, K.G., Eberly, K., Russell, O.O., et al. (2022, September 09). HIV and Sexually Transmitted Infections Among Persons with Monkeypox — Eight U.S. Jurisdictions, May 17–July 22, 2022. MMWR Weekly 71(36), 1141-1147. http://dx.doi.org/10.15585/mmwr.mm7136a1

Demmons, S. (2019, July 10. Why are trans men invisible in HIV prevention & care? San Francisco, CA: San Francisco AIDS Foundation: Our Voices. https://www.sfaf.org/collections/beta/why-are-trans-men-invisible-in-hiv-prevention-care/

Doucleff, M. (2022, June 06). Monkeypox cases are going undetected or misdiagnosed. Washington, DC: National Public Radio: All Things Considered. https://www.npr.org/2022/06/06/1103372564/monkeypox-cases-are-going-undetected-or-misdiagnosed

HIV [dot] gov. (2022, November 30). mpox and People with HIV. Washington, DC: United States Department of Health and Human Services: Office of Infectious Disease and HIV/AIDS Policy: HIV.gov. https://www.hiv.gov/hiv-basics/staying-in-hiv-care/other-related-health-issues/monkeypox

Kuehn, B. M. (2022, September 27). Interim Guidance for Monkeypox Among Patients With HIV. JAMA 328(12), 1173-1174. https://doi.org/10.1001/jama.2022.14727

Miller, M J., Cash-Goldwasser, S., Marx, G.E., Schrodt, C.A., Kimball, A., Padgett, K., Noe, R.S., McCormick, D.W., et. al. (2022, October 26). Severe Monkeypox in Hospitalized Patients — United States, August 10–October 10, 2022. MMWR ePub. http://dx.doi.org/10.15585/mmwr.mm7144e1

Advancing Access Through Place Based Care

Repeatedly over the years, I’ve asked funders to consider investing in (sponsoring) various sexual-social events. Often these events are already tapped into local clinic networks or community service organizations and, historically, these organizations are not “large” by any stretch of the imagination. If we look at one of the most influential (and sometimes notorious) examples, The Sisters of Perpetual Indulgence, the raucous, often raunchy members of the organization’s chapters are deeply, deeply tied into any given community’s needs. From providing street “ministry” by giving food to houseless persons to giving out condoms, education, and, in the case of the Las Vegas chapter, providing a community-based AIDS drug assistance program for people needing more assistance than the state program offers, the Sisters aren’t known for being…conservative. And they’re not alone.

Indeed, in nearly every large city (and often even smaller cities) across the country, there is some kind of sexual fraternity which gathers at leather bars, bathhouses, and large events, like International Mr. Leather or International Ms. Leather. These events are explicitly sexual in nature. But they’re also where these communities we seek to serve gather and often with intentional efforts are welcoming and involving people who live at layered intersections of marginalization; Onyx, for example, aims to meet the social needs of queer men of color. And all of these organizations and events and the clinics that find ways to serve these events could well stand to use additional financial support.

Every time that ask has come up, I’ve been told it might be “too edgy” to place a well-known brand in sponsorship. The Ryan White CARE Act explicitly forbids federal grant dollars from “promoting homosexual behavior” – necessarily prohibiting any financial support of these spaces which operate as centralized gathering of an audience and only allowing service providers to show up. But those sponsor dollars are what makes it possible for service organizations – be they clinics or these fraternal organizations – to show up and engage in the most effective place-based outreach and care. In November, Time published the opinion piece, We Need to Bring Sexual Health Care to Places Where People Have Sex. The piece highlights the effectiveness of place-based, going to the source, outreach, education, and vaccination in response to the mpox outbreak that’s wrapped its fingers around the globe. Across the country, health departments and federally funded clinics have quietly been working in these spaces for decades. Dr. Demetre Daskalakis, the director of the Center for Disease Control and Prevention’s (CDC’s) HIV Prevention Program, is reasonably well credited for ending a meningitis outbreak in New York City by providing vaccines on location at bath houses – where people have sex.

HIV and Hepatitis C do not thrive in “neat” and “clean” and “conservative” environments. Rather these viruses thrive where people are getting their own needs met and that includes where people are getting their sexual needs met and their coping needs met (drug use is, at its core, a coping mechanism). And interventions to curb the transmission and detrimental effects of these viruses thrive when communities come together.

Just as we need to extend funding supports that incentivize churches to host testing and education events in order to address stigma, we also need to fund the entities, communities, formal and informal, and places where communities gather. Leaning into culture, as opposed to avoiding it, ensuring existing communities thrive, meeting people where they’re at, and funding where advocacy goes to celebrate is something we need more of. Advocacy needs our funders, of all stripes, to not be afraid of being labeled “sex-positive” and to show up for us and our communities in the places we already exist.

Nevada Adds New Syringe Exchange Vending Machines, Building on Success

Just before the holiday, the Southern Nevada Health District (SNHD) announced it would be showcasing a newly added harm reduction vending machine to the located at the main SNHD health center on Decatur Boulevard in Las Vegas. In a year where other some jurisdictions are seeing local and state legislators push back against harm reduction programs of all sorts, the Las Vegas health entity has chosen to invest in successes already achieved and expand their vending machine program.

In 2017, Nevada became the first state in the country to offer syringe exchange services via vending machine, after the legislature passed a harm reduction measure allowing the state to fund these efforts, known as HB 410. Nevada’s syringe change program is operated by Trac-B Exchange out of a store front and the entity was one of three in which the program launched as a pilot. Sometimes called “public health” vending machines when numerous types of self-administered care supplies are offered, kits in the machine include syringes, tourniquets, a disposal container, first aid supplies, safe sex supplies, naloxone (the opioid overdose reversal medication), pregnancy tests, and hygiene kits. Health officials also highlighted how these kits might be used for “street” hormone replacement therapy, or when a transgender person is not engaged in traditional care but is still acquiring hormone medications (commentary also addressed bodybuilders for similar activities). The machines do not require cash to operate, rather a person seeking to use the machine is required to fill out a form and will receive a code and card. Identifying information is not required to receive access to the vending machines. Advocates and program operators have cited how the machines save public dollars by reducing the labor burden and keeping more people engaged in care.

In 2017, Las Vegas had at least 5,800 active injection-drug users and program staff have cited the success of the pilot as to part of why the newest vending machine was added. With nearly ten percent of Nevada’s new HIV diagnoses being attributed to illicit syringe use and the well-studied benefits to reducing Hepatitis C transmissions, SNHD’s newest addition seeks to engage a broader range of the public as the kits offered are more expansive in meeting care needs. Since the 2017 pilot launch in Nevada, other jurisdictions have considered beginning their own programs (not without opposition). Ohio, for example, launched a vending project in early 2021 (in part to reduce the risks associated with in-person care during a wave of high COVID-19 transmission), making it the second state to offer this type of access program. Those machines included “smoking” kits and their safe consumption kits also include fentanyl testing strips as options. Since the launch, more than 1300 items have been dispensed and almost 600 overdoses have been reversed in the community the vending machine serves.

Research released in June of 2022 found the anonymous nature of the vending machine programs was critical for many people using them. Researchers established a baseline of foot traffic for the machines by setting up a camera (which would identify consumers), afterwards setting up near the machine to offer services and information. While some consumers engaged with peers they recognized, many chose not to and the researchers had good indication at least a few potential consumers avoided the machine they might otherwise use because of the researchers’ presence. In an interview as part of the study, one person admitted to avoiding getting supplies they needed because of police presence near the vending machine. This presents a difficult-to-balance issue in working to ensure people using the machines are actively linked to care they need. Potential solutions include offering a QR code on the machine, reliance on drug using and former drug using peers to staff tables, information inserts in each kit, and possibly having a table staffed at regularly posted times so that consumers could chose to engage when and how they’d like. However, the issue of police presence as a deterrent to seeking care will remain a barrier and has been problematic for other syringe exchange programs across the country. Because law enforcement activity appears to be a significant barrier to engaging in harm reduction services, specifically syringe exchange programs or in reporting overdoses (the limitations of Good Samaritan laws vary by state, often with carve outs for drug users reporting a need for help for a friend), legislatures could address the conflict by passing laws which carve out certain enforcement, but prosecutors and police department leadership need to “buy-in” as well. Reducing uniformed patrol around these areas or committing to not prosecute people seeking harm reduction services and products via vending machines would go a long way to reducing law enforcement engagement with patient populations, increasing trust with affected communities (with both law enforcement and care provider entities), and increasing engagement with these critically necessary, life-saving programs.

Jen’s Half Cents: Employers’ Role In Ending the HIV Epidemic, Addressing Health Equity, and Retaining Talent

For more than a year, employer voices have complained about an inability to fill open positions and retain talent. Often referred to in news media as “The Great Resignation”, it is a backdrop that also includes labor voices being dissatisfied with certain aspects of their work environment. A Pew Research survey asked those leaving their jobs for insights as to why and the findings centered around shifts as a result of realizing just how the workplace might look in a more modernized world. For two decades, employers of all stripes argued the necessity of being “in office” and the crisis phase of the COVID-19 pandemic proved just how easily modern technology would allow for greater flexibilities in work hours and work place. It also shook open the reality that many workplaces face the same problems experienced in society at large, with Pew’s findings highlighting a general complaint of “feeling disrespected” as a “major” reason for resignations in 35% of respondents. Other areas of employee complaint included a “lack of opportunities for advancement”, “child care”, and “benefits weren’t good” (arguably, child care could be considered a “benefit” offered by an employer, though very few do as United States labor law does not require such an offering). We’re gonna focus on this benefits piece because of a survey published by the Employee Benefit Research Institute earlier this month.

The survey, entitled “Workplace Wellness Programs and the LGBTQ Community”, showed where some of the contours of employee satisfaction can be defined. The survey found LGBTQ employees were generally less satisfied than their non-LGBTQ peers with their jobs across all income brackets, with an overall 44% of LGBTQ employees being satisfied with their jobs and 61% of non-LGBTQ employees being satisfied. Interestingly enough, the difference with satisfaction with benefits offerings (including health, paid leave, and retirement benefits) was less of a gap than overall job dissatisfaction between these cohorts (overall 34% of LGBTQ employees were satisfied with their employee benefits with 45% of non-LGBTQ employees). More dramatically, the survey found LGBTQ employees would prefer higher wages over enhanced benefits. The reason why might be found in the fact that LGBTQ employees were less likely than their non-LGBTQ peers to qualify for benefits, even if they were as likely or more likely to use them when those benefits were offered. Even when getting into the details of what benefits were offered, LGBTQ employees were about as knowledgeable as their non-LGBTQ peers). So what gives?

First, lets acknowledge that, according to this survey, queer folks are more likely to value “work-life balance” over their non-LGBTQ peers to an extraordinary degree (this area being the greatest difference between these cohorts in “What Workers Value”). LGBTQ employees were more likely to have financial struggles and concerns than their non-LGBTQ peers as well. This, combined with the unique health needs of LGBTQ people and the need to identify a queer-friendly provider and the ever-growing threat of violence under a more and more caustic political atmosphere leading to LGBTQ people valuing retirement benefits as high as their non-LGBTQ peers, helps explain why the dollars matter more than the paper of insurance coverage. This is a plight many queer people can personally identify with pin-point precision: “If my life expectancy doesn’t reach the age of retirement, why should I plan for it?” And that’s not too terribly different from “If my insurance isn’t going to cover competent care of my needs, why does it matter if it’s offered?” These things might work for a cisgender, heterosexual couple with 2.4 kids, but they’re not meant for us.

Let’s start with a concrete example. In 2021, the National Women’s Law Center launched a class action lawsuit against Aetna for its fertility benefit design because the design of the benefit offering and language of the policy required those seeking the benefit to document or attest to 12 month or more of “failed” attempts to conceive through penis-in-vagina sexual activity. That type of benefit necessarily excludes single people, same-sex couples, and couples where at least one partner is transgender.

Periodically over the last year (and honestly for years prior but with less of a focus on the role of employers), I’ve spent time discussing with partners how important it is for employers to consider their role in Ending the HIV Epidemic and addressing issues of Health Equity. With employer-sponsored health plans covering nearly 50% of the country’s population, according to Kaiser Family Foundation, these issues don’t come down to the mere fact of offering health benefits but the quality of those benefits as it relates to employee needs. Benefit designs which race to the bottom of a sponsor’s costs are more likely to have narrowed provider and pharmacy networks and restrictive formularies. And despite the fact that Bostock did not necessarily carve out a means for queer employees to argue benefit design might constitute a discriminatory compensation scheme, that is exactly what our community considers when evaluating their job satisfaction and what “competitive” compensation is supposed to look like. And that’s not unique to LGBTQ people, it’s true for employees of all marginalized status. When speaking with a Black, Women colleague recently she stated most directly “If my network doesn’t include a Black doctor for my kids to see, the plan doesn’t matter to me – I can’t count that as part of my compensation, regardless of how my employer looks at this.”

Adding another layer of consideration for employers, as sponsors with some of the greatest amount of leverage to influence the insurance marketplace, ensuring parity in pharmacy benefits with medical benefits is important. The details of those plans matter. To go beyond birth control as an easily relatable example, if an employee living with HIV doesn’t see the provider they’ve gone to for the last decade in-network or an expansive formulary lacking the burdens of prior authorizations for innovative therapies, they’re not gonna find as much value in that benefit. An employee that has to spend hours every six months navigating a prior authorization for their injectable preventative medication is gonna have less personal “bandwidth” to dedicate to work and find less value in that coverage. They might even decide to go out-of-pocket to over those costs and that translates into a meaningful reduction in wages, from the employee perspective. This also speaks directly to the role employers play in Ending the HIV Epidemic – broader coverage of antiretrovirals and infectious disease providers in-network with lower administrative burdens means employees have more meaningful access to care.

At the end of the day, every employee is a patient. We well know in patient advocacy that speaking to these intimate, personal health needs makes people feel cared about and appreciated. It’s why we do what we do in the first place. If employers want to address employee satisfaction, they could invite their employee resource groups for listening sessions on what adequate health benefit offerings look like and then demand those offerings from their contracted payers. It’s a simple series of actions where employers can come out on top in a variety of ways; addressing health disparities, hearing and meeting employee needs, contributing meaningfully to public health goals around HIV, and overall integrating their stated social values into tangible action.

Honestly, it’s all employees and communities really want from their employers - just a little bit of integrity. Evaluating and elevating health benefit offerings is an excellent place to start.

Making Sure We Count: United States Trans Survey is Live

Last week, Americans went to the polls to ensure their voices are heard and the issues most important to them are prioritized in our government. Voting is one of those sacred things that many of us engage in as part of our civic duty but also because we wish to have level of control and influence over those deciding the fate of trillions of our tax dollars. We want our experiences reflected.

While pundits are pouring over data and strategists are autopsying results and turn out and all sorts of data, other data gathered by our government significantly impacts how our government evaluates programs, policy, and spending. The Census, for example, isn’t just active every decade – the Census Bureau engages in all sorts of data gathering, including the National Health Interview Survey and the American Community Survey. These data tell our collective and individual stories in ways the influence government funded programming. These data are critically important to advocacy efforts – if we’re not counted, our issues cannot be considered or weighed in policymaking. Reflecting on this notion, the politicization of transgender identity, manifesting in actions across the country in the vein of Florida’s Board of Medicine issuing rules prohibiting gender affirming care for minors to the Trump Administration omitting information gathering on queer identified residents of the country, has in no small part relied upon gatekeeping these tools – making sure transgender people don’t get counted. If we don’t see any problems, no problems exist which need addressed, right?

While the Centers for Disease Control and Prevention (CDC) and other government agencies have long worked to include data gathering on transgender and non-binary people, those efforts are fractured, often incomplete or not competently delivered, and do not necessarily consider nuances transgender people are all too familiar with. Thus, we rely heavily on privately gathered data, which is sometimes fraught with weaknesses in reach and assessment. For example, the Workplace Wellness Survey evaluated the satisfaction of LGBTQ employees had with their employer benefits compared to their heterosexual and cisgender peers, with top level findings generally showing LGBTQ people are less likely to be eligible for benefit offerings than their non-LGBTQ peers. With employers being the number one source of health insurance coverage in the United States, if employer sponsored health coverage doesn’t meet the needs of queer employees, health disparities will necessarily continue. Economic impacts from this are certain – LGBTQ employees having to spend more dollars out of pocket on getting the health care they need means greater economic insecurity for this demographic.

Despite the weaknesses in private data gathering, it’s what we have. And for transgender people living in the United States, the National Center for Transgender Equality’s (NCTE) United States Trans Survey (USTS) is one of the most essential sources of data on our experiences and interactions with the world around us.

It's been seven years since we’ve gotten new data and, in those seven years, USTS has been cited tens of thousands of times by advocates as to the reasons why more government data needs to be gathered and used to inform programming and policy. The 2015 data has been cited so many times some advocates have memorized significant sections of the 302-page report.

With a goal to reach 32,000 transgender people in the country, NCTE has partnered with several advocacy organizations to recruit participants, host survey parties, and more. The survey takes about 30 minutes to complete on a laptop (I completed mine this last weekend in 20 minutes) but may take longer for some people. As a matter of safety and recognizing the climate we live in today, there are “safe exit” tools incorporated into the survey design so that people who need to exit the survey quickly can.

As we approach Transgender Day of Remembrance and Resilience (TDOR, November 20) and recognizing that HIV disproportionately affects transgender women of color, Community Access National Network would like to encourage our partners and community members to amplify appropriate participation in this year’s US Trans survey.

We cannot count unless we are counted.

You can access NCTE’s US Trans Survey here.

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.