$9B ‘Remedy’ to SCOTUS Ruling Still Leaves Patients Behind

In July 2023, the Centers for Medicare and Medicaid Services (CMS) issued a proposed ‘remedy’ to the United States Supreme Court’s 2022 ruling in American Hospital Association v. Becerra. In the case, AHA argued that the U.S. Department of Health and Human Services (HHS) misapplied statutory rulemaking powers when reducing certain payments to 340B hospitals from 2018 to 2022 because the federal agency had not completed a survey of those hospitals drug acquisition costs, as outlined in statute. HHS argued the interpretation of the statutory language should yield to their interpretation due to the precedent set by Chevron, which held that, generally speaking, courts and private actors should allow executive agencies to define the meaning in statutory language when it’s reasonably interpreted in multiple ways outside of those issues defined by legislators.

The idea behind Chevron Deference is that these agencies are generally responsible for making rules and enforcing them and courts don’t necessarily want to be bogged down by bad-faith claims on what certain statutory language actually means. In this instance, despite fears SCOTUS might overturn Chevron, the high court did not touch the precedent but did reject HHS’ claim regarding interpretation of the statutory language – a survey must be performed or based on the average sales price by drug manufacturers (with certain adjustments). The Court ordered HHS to review the ruling and issue a ‘remedy’ to fill the gap created by what the affected hospitals would have made from 2018 to 2022 rather than a setting a specific dollar amount like one might see in a civil judgment. CMS’ estimated dollar amount is just about $9 billion across affected hospitals and CMS is proposing to make those payments in one lump sum to the approximate 1,600 affected hospitals.

In an addendum to the proposed rule, the amount of money going to each hospital is listed out. The addendum has to be downloaded from the CMS website under the filename NPRM OPPS Remedy for 340B-Acquired Drug Payment Addendum AAA. A curious reader should note, the entities listed are by hospital, not by hospital system. There’s some really interesting tid bits in the spreadsheet worth pointing out.

To illustrate how lucrative hospitals view the 340B gravy train, let’s look at Cleveland Clinic. Cleveland Clinic will receive about $35 million in remedy payments, but in 2018 only had $74 or so in drug claims. If that makes your eyes pop, it should. The clinic went from about $10 million in drug claims in 2020 to almost $1.4 billion 2022. According to Cleveland Clinic’s 2021 tax return, the provider’s financial assistance ‘at cost’ (or ‘charity care’) as was about $177 million or about 1.5% of its total expenses.

Various Bon Secours hospitals will receive almost $50 million.

Ascension hospitals will receive about $45 million.

If those two hospital chains sound familiar, they should. Bon Secours was the subject of The New York Times article highlighting how the hospitals system abused 340B, specifically, by investing program revenues from poorer neighborhoods into richer communities. Dr. Lucas English, in the article, described the practice as “…laundering money through this poor hospital to its wealthy outposts.”

Ascension was the subject of another explosive NYT investigation for chronic understaffing in the name of decreasing expenses, even at the cost of patient safety. The whole design left the facilities in the system unprepared for the COVID-19 pandemic, which eventually lead to the system hiring contract and traveling medical staff in order to keep up – tossing the labor and wage ecosystem in healthcare into an upward spiral of costs which would be later passed onto patients by way of increased insurance premiums.

These aren’t the only two systems in the dataset that deserve scrutiny but they certainly represent a tiny sample of why the discount drug program needs reform.

Ultimately, the issue with these payments isn’t necessarily “hospitals shouldn’t get them” but “Why should bad-actors be further rewarded when they’ve already been shown to be abusing the program?”

Earlier this year, Kaiser Family Foundation analyzed charity care vs. realized tax breaks hospitals enjoy. Hospitals received about $28.1 billion in tax breaks while only dolling out about $16 billion in charity care – and that’s before the entirely non-transparent revenues generated from 340B. All of these entities are registered as “non-profit” but that $12 billion gap and stories like Bon Secours and Ascension and even the Cleveland Clinic’s leave even a casual viewer asking “But are they really?”

Earlier this month, Lown Institute’s Vikas Saini stated, “The distinction between not-for-profit and for-profit – certainly in health care and certain in relationship to hospitals – is negligible or nonexistent.”

SCOTUS wasn’t tasked with considering if hospitals that might receive a differential payment might not necessarily be operating within the intent of the 340B program but this kind of highlights why Congress can’t leave this issue to the courts to hammer out between the parties. Congress has a chance and, arguably the obligation, to make sure sufficient statutory provisions exist to actually meet achieve the intent of the program. Indeed, not acting to reform the program, in light of these “remedy” payments, will only encourage more bad actors to abuse 340B.

DEA Appears Open to Tele-Script for Certain Controlled Substances

On August 7th, the Drug Enforcement Agency (DEA) issued a notice of meeting regarding telemedicine prescription of certain controlled substances (Schedule II only). The meeting(s) will be conducted as “listening sessions”, conducted Tuesday, September 12th, and Wednesday, September 13th from 9 a.m. to 5:30 p.m. at the DEA Headquarters (located at 700 Army Navy Drive, Arlington, VA). Participants must pre-register using this link, before or on August 21st. In-person requests will be granted via lottery and the sessions will be live-streamed. Similarly, those wishing to provide limited oral presentation, either in-person or via live-stream must also fill out the form. Again, these will be selected by DEA personnel based upon quality of summary of presentation. Presentations may be made by anyone with an interest in and expertise in the subject matter. The DEA has asked for feedback on the following questions:

• If telemedicine prescribing of schedule III–V medications were permitted in the absence of an in-person medical evaluation, what framework, including safeguards and data, with respect to telemedicine prescribing of schedule III–V medications do you recommend to help DEA ensure patient safety and prevent diversion of controlled substances?

• Should telemedicine prescribing of schedule II medications never be permitted in the absence of an in-person medical evaluation? Are there any circumstances in which telemedicine prescribing of schedule II medications should be permitted in the absence of an in-person medical evaluation? If it were permitted, what safeguards with respect to telemedicine prescribing of schedule II medications specifically would you recommend to help DEA ensure patient safety and prevent diversion of controlled substances?

• If practitioners are required to collect, maintain, and/or report telemedicine prescription data to DEA, what pieces of data should be included or excluded? What data is already reported to federal and state authorities, insurance companies, and other third parties?

• If pharmacies are required to collect, maintain, and/or report telemedicine prescription data to DEA, what pieces of data should be included or excluded? What data is already reported to federal and state authorities, insurance companies, and other third parties?

The listening sessions come as a direct result of the DEA receiving truly unprecedented responses to proposed rules published in March, in anticipation of the end of the COVID-19 public health emergency, and, thus, the DEA’s telemedicine waiver issued at the beginning of the COVID-19 pandemic. In all, the DEA received almost 40,000 comments across the proposed rules with much focus on the General Telemedicine proposed rule. We covered the content of those rules (and why they were a step backward as written) in March. In particular, we expressed concern over returning to pre-pandemic limitations on telemedicine when the pandemic-related waiver did not prove any spike in diversion and did, indeed, improve access to medication assisted substance use treatment for many patients. Along similar lines, because testosterone is considered a controlled substance, such a return at the height of bias-driven, state-based legislation limiting access to certain gender affirming care would have a disproportionately harmful impact among transgender men and undermine President Biden’s commitment to combat these hateful efforts.

The relationship between the DEA and harm reduction advocates has been long and fraught. Many harm reduction advocates criticize the role of law enforcement’s actions, particularly that law enforcement agency, working against best practices in public health, even those best practices recognized by federal public health agencies. For example, a couple of weeks ago, we highlighted the Substance Abuse Mental Health Administration’s document (currently open to public comment) aimed at formalizing certain policy positions, entitled Harm Reduction Framework. Nowhere in the “framework” is the conflict with law enforcement positions addressed.

Putting more pressure still on the DEA’s absolute refusal to meet its commitment from 2009 to introduce meaningful telemedicine rules (in response to passage of the Ryan Haight Online Pharmacy Consumer Protection Act) is the fact that the stimulant medication shortage is at its worst. Things are so bad the U.S Food and Drug Administration (FDA) and DEA issued a joint letter on August 1st to further detail actions being taken to address the shortage and consumer struggles. The problem with the letter is it is largely bypasses the responsibility the DEA has in the current situation. Leaning into a claim that manufacturers haven’t filled their annual quota limits in production and pointing fingers at an increase in legitimate prescription of stimulants to manage conditions like attention deficit hyperactivity disorder (ADHD), the letter fails to recognize that the DEA also places extraordinary limits and scrutiny on pharmacies dispensing stimulant medications. Known as “drug diversion”, the idea behind monitoring pharmacies has some merit when viewed under the lens that pharmacies have a responsibility to limit index events like those “pill mills” associated with the opioid epidemic. However, the DEA doesn’t take responsibility for pharmacy raids or strict enforcement against prescribing providers working to keep patients from turning to street supplies by providing legitimate prescriptions.

For the DEA to be a meaningful partner in combatting both illicit and harmful drug use and overdoses and help to address drug shortages, limiting harmful diversion, the agency needs to consider a dramatic shift from an “all drugs are bad, and the people who use them are bad” mindset. There needs to be a thoughtful “medium, wherein stakeholders other than law enforcement can engage in distinguishing best practices in supply chain security and harm reduction and readily identifying criminals taking advantage of patients seeking care by any means they can achieve it – including illegal and illicit channels.

Patient advocates outside of harm reduction and substance use disorder focuses and the industry stakeholders who serve these patients would do well to consider engagement in these and other opportunities to help re-shape and re-imagine the DEA’s role, ideas, and programs to better serve the public at large, better secure the supply chain and limit disruptions, and ensure patients can have ready, reliable, and modernized access to the care we need.

Payers Finally Facing Scrutiny for Denying Coverage

In February of this year, we covered the issues of inequity and administrative barriers patients face when seeking medically necessary care, especially when that care is for chronic or complex conditions. The blog followed ProPublica’s review of Christopher McNaughton’s trials (quite literally – there was a lawsuit) and tribulations with United Healthcare’s refusal of coverage. The situation highlighted how the payer had never intended to cover McNaughton’s care, regardless of necessity, and shopped “appeals” doctors in order to avoid finding his care was “medically necessary” and therefore required to be covered.

The ProPublica article was published some two years after United Healthcare (UHC) had floated instituting a policy of retroactive review and denial of emergency room care – the scheme went something along the lines of “if we think you didn’t really need to go to the ER, we’ll make you pay the whole bill yourself.” The tactic was roundly shouted down by advocates and providers as dangerous. Afterall, a payor reviewing documents rather than actually serving in an emergency room is never going to grasp the details of certain situations – like the unique symptoms women face when having a heart attack. Eventually UHC pressed the pause button and after some jockeying back and forth between the payer and the American Hospital Association, UHC said the entity wouldn’t enact the policy. Turns out, that might not have been an honest assertation according to a lawsuit issued by the U.S. Department of Labor (DOL). To be clear, the payer entity that’s targeted in the suit is a third-party administrator within UHC’s subsidiary – called UMR – but arguing that nuance isn’t going to matter to a patient who had their care claim unjustly denied.

The lawsuit asserts that UMR denied “thousands” of urine drug screenings and emergency room visits and violated the Affordable Care Act’s “prudent layperson” standard. That standard requires that payers reviewing claims consider how the average patient might approach concerns or symptoms they’re experiencing, not a medical professional. Now, there’s a thing about when these denials took place, 2015 to 2018, means UHC’s proposed policy of retroactive denial might have been an improvement over their previous policy of denying every urinalysis claim. Which is just…wild. Further, the suit alleges that UHC wouldn’t clearly tell doctors what additional information they needed during appeals processes – which sounds strikingly related to McNaught’s troubles with the payer.

DOL wants UHC to review all denied claims and adopt new policies which wouldn’t result in what amounts to an automatic denial process. And it’s not unheard of. In 2020, a judge in California found another UHC subsidiary automatically denied coverage of care to patients seeking to use their mental health and substance use treatment benefits and ordered some 67,000 claims to be re-reviewed and new processing policies to be adopted.

Similarly, Cigna is coming under scrutiny. A class action lawsuit filed in California is alleging Cigna denied some 300,000 claims in just two months last year. The absolutely bonkers part about that is Cigna used an algorithm that spent just 1.2 seconds on each claims review before sending them off to doctors to sign them – meaning those claims might not have ever actually been seen by human eyes in what amounts to an automatic denial process. Cigna, for its part, decided its public facing comment would be to call ProPublica’s coverage of their denial process “poorly written”. All that despite the House found ProPublica’s investigation worthwhile enough to drag Cigna in front of the Energy and Commerce Committee for a hearing on the legality of these denials. Mike Kreidler, the insurance commissioner for Washington characterized Cigna’s operation as an “abhorrent” practice “to routinely deny just to enhance the bottom line.”

All of this coming just weeks after the Office of Inspector General released a report on how Medicaid managed care organizations (MCOs) are utilizing prior authorizations processes and denial of care in an abusive fashion, harming the poorest patients in the country and with little oversight by the states contracting these MCOs. Among those listed with a prior authorization denial rate higher than 25% was United Healthcare. And none of that touching that more and more providers are contracted by UHC, meaning those denials were denials of care in which their own providers had decided what was medically necessary.

The scrutiny of payors coming by way of lawsuits is welcomed but advocates and policymakers shouldn’t wait for judges to determine the scope of harm patients are experiencing. We need to seek a statutory and regulatory reigning-in of these run-away practices bilking our healthcare systems at the expense of patient health. And we need to do it now.

Feds: “Harm Reduction Framework”

On May 15th, Substance Abuse Mental Health Services Administration (SAMHSA) published a document which seeks to “…inform SAMHSA’s harm reduction activities moving forward, as well as related policies, programs, and practices,” and “to inform SAMHSA of opportunities to work with other federal, state, tribal, and local partners toward advancing harm reduction approaches, services, and programs.” The document, called the Harm Reduction Framework, specifically acts as a “level setting” document in addressing substance use as a public health issue.

While the document includes reach within the Office of National Drug Control Policy (ONDCP) and other agencies, like the Centers for Disease Control and Prevention (CDC), it does not have any “mission control” or enforceable policy influence with the Drug Enforcement Agency (DEA) or other law enforcement, which has been a central tool in federal, state, and local government responses to drug use and the opioid epidemic. Indeed, “law enforcement” only shows up once in the document’s contents and once more in the document’s references list. Arguably, whereas the document serves well as a “level setting” opportunity between various stakeholders, which claims to include “law enforcement” personnel, this effort is admirable but will lack “teeth” due to harm reduction as a programmatic idea from a public health lens when law enforcement remains a contraindicated method of response.

SAMHSA has also asked for specific feedback on the framework by way of a public comment form, indicating an effort more to formalize the framework's ideas as a policy stance.

The form follows the flow of the document with the first question seeking general and overall feedback. The second question asks for feedback on the document’s introduction and review of the working group, why the document exists, and historical recognition of how harm reduction has operated in response to substance use. This should be relatively uncontroversial for most respondents. The majority of feedback may seek to clarify or otherwise add details which lengthen the document, if adopted, but will not necessarily impact the substance of this section. The only area which might become “sticky” is the inclusion of “sex work” among “behaviors” associated with substance use and among those who might benefit from harm reduction programming.

The next four questions seek feedback on the core chaptered content pf the document as follows:

• “Pillars” of harm reduction

• “Supporting Principles”

• “Core Practices”

• “Community-Based Harm Reduction Programs” (CBHRP)

The document’s Pillars are outlined to include:

1. Guided by people who use drugs (PWUD) and with lived experience of drug use (this might also include family members, intimate partners, friends, and so forth of PWUD)

2. The inherent value of people

3. Commits to deep community building and engagement

4. Promotes equity, rights, and reparative social justice

5. Offers low-barrier access and non-coercive support

6. Focuses on any positive change as defined by the person

Supporting Principles include:

• Respecting autonomy

• Practicing acceptance and hospitality

• Providing support

• Connecting family (biological and chosen)

• Provides many pathways to wellbeing across the continuum of health and social care

• Values practice based evidence and on-the-ground experiences

• Cultivates relationships

• Assists and not directs

• Promotes safety

• Engages first

• Prioritizes listening

• Works toward systems change

Core Practice Areas” include:

• Safer practices

• Safer settings

• Safer access to healthcare

• Safer transitions to care

• Sustainable workforce and field

• Sustainable infrastructure

The final segment focuses on a brief description of CBHRPs, up to and including research projects used to explore innovation and efficacy of particular programs.

This section is noted with an asterisk “as permitted by law” – a nod toward the issue of law enforcement as a primary response tool to substance use and the limitations of SAMHSA as a result.

Advocates should anticipate some funding and program initiatives to reflect the general ideas around this framework or any final product around this framework. However, those barriers as a result of law enforcement and politicized attitudes will remain a barrier and perhaps present challenges for implementing novel programs. Strategically, much like SAMHSA’s drug court grants, the agency should consider how to leverage supportive funding incentives for states and municipalities to involve themselves in any resulting programming.

The public comment period is open until August 14th.

House Appropriations Mark-Up Alarms HIV Advocates

On July 14th, the U.S House of Representatives Committee on Labor, Health and Human Services, Education, and Related Agencies (LHHS) issued its fiscal year (FY) 2024 appropriations mark-up (Editor’s Note: the mark-up hearing can be viewed here). The bill passed out of committee on a party line vote, with Republicans voting in favor and Democrats voting against. The party split reflects what Democrats have framed as bad faith undermining of agreements on spending levels made in May’s debt limit ceiling deal and include policy provisions geared toward stoking a “culture” war. While the leading issue is incredibly steep cuts to public health programs, including entirely eliminating funding for the previous administration’s Ending the HIV Epidemic initiative (which the Biden Administration wished to continue), the policy riders at issue would also undermine best practices for achieving our public health goals by limiting the types of care, education, and support services communities accessing HIV services might be able to access.

Brass tax, Committee proposed:

• Ending the HIV Epidemic eliminated (-$524M)

• Ryan White HIV/AIDS Program reduced (-$74M, eliminates dental coverage and AIDS Education Training Centers [AETCs], as included in Part F)

• Minority AIDS Initiative reduced (-$32M)

• Substance Abuse Mental Services Administration – MAI eliminated (-$117M)

• Flat funding for the Centers for Disease Control and Prevention’s HIV and HCV prevention programs

• Flat funding for other parts of the Ryan White HIV/AIDS Program, particularly for AIDS Drug Assistance Programs (ADAPs)

Non-HIV related cuts seek to further defund public education and the National Institutes of Health and eliminate Title X and Teen Pregnancy Prevention Programs, the federal work-study program, among other things.

HIV advocates across the country decried the bill, including but not limited to The AIDS Institute, HIV + Hepatitis Institute, AIDS United, the National Association of State and Territorial AIDS Directors (NASTAD), and the National Minority AIDS Council. Southern AIDS Coalition (SAC) has organized a letter for individual advocates and organizations to sign-on. The letter is addressed to Senators Tammy Baldwin and Shelly Moore Capito. Astute observers already recognize this appropriation will not survive the Senate as drafted by the House.

Earlier this year, HIV media outlet The Body called these efforts out for what they are and by title “HIV is Being Swept Up in the Anti-Woke Agenda”. Mandisa Moore-ONeal, Executive Director of the Center for HIV Law and Policy (CHLP), drew a direct link between behavior seen earlier this year in Tennessee as a forebearer of federal moves, “Can’t help but think back to all those…who dismissed us when we said to notice these state funding cuts and to start moving against them but told us again and again ‘It’s just the South’.” The Centers for Disease Control & Prevention’s landing page for regional analysis on HIV identifies that 51% of new HIV diagnoses are among Southerners.

Politically, Southern states are often dismissed by politicians (and advocates) not from here because some of the country’s most conservative strategies are developed in the South. However, the racial diversity of the South is also the reason progressive advocates need to focus on the region. That same diversity is precisely why the nation’s civil rights battles started here and why the forefront of combatting the domestic HIV epidemic, be it advocacy, services, or policy, must be focused here.

The Community Access National Network has already joined our colleagues in signing-on and condemning these cuts which, if enacted would not only bring a halt toward our progress in combatting HIV and other public health concerns, but would signal a dramatic step back and make our goals impossible to achieve. The House’s appropriation amounts and the policy riders included are not only mean-spirited, political jockeying of resources the most vulnerable communities in the country rely upon, they are staggeringly dangerous.

New CDC Report; More than a Decade After a Cure, HepC Persists

Last year, the Centers for Disease Control and Prevention (CDC) published a Vital Signs report detailing how “too few people” are  being “treated for Hepatitis C” (subtitled: “Reducing Barriers Can Increase Treatment and Save Lives”). Today, the CDC’s landing page reflects a finding from April 2020 that reads “dramatic increases in Hepatitis C” (subtitled: “CDC now recommends hepatitis C testing for all adults”). And in late June, the CDC published a new Morbidity and Mortality Weekly Report (MMWR) on a worryingly low rate of HCV clearance in the United States.

Our previous blog reviewed last year’s report under the lens of health disparities highlighted by researchers’ review of 48,000 patient charts that met the inclusion criteria for the analysis. Then, much like in this new report, identified that lack of curative treatment access was not uniform and was largely informed by the type of insurance patients qualified for. Those payer types (Medicaid, Medicare, and Commercial plans) also represent patients from different backgrounds – meaning different socio-economic statuses, different genders and racial backgrounds – with different outcomes. Overall, Medicaid recipients were only ever prescribed curative treatment about 23% of the time, whereas Commercial payer patients were able to see that rate increase to 35%. The CDC also recognized these payers, and the politicians who set the public policy of Medicaid, represent incredibly tangible barriers via administrative processes, like prior authorization, and policy barriers, like requiring sobriety, a high level of liver damage, or other restrictions to gaining access to curative treatments.

For this year’s report, researchers partnered with Quest Diagnostics to review the viral clearance (or cure) of approximately 1 million patients with an initial infection (Quest provided data for 1.7 million patients with evidence of a history of HCV during the direct acting agents era, or from January 1, 2013 – December 31, 2022). Based on an estimated 2.4 million people in the United States with HCV, this sample represents about 43% of those believed to have experienced an HCV infection in this time frame. This is noted as a limitation in the data, in part, because it only represents data from one commercial laboratory. Though, reasonable observers can make certain conclusions from this data.

Now, we should also note, only about 88% of the 1.7 million patients identified as having evidence of HCV infection ever had received testing and, of those, 69% were identified as having an initial infection. This means the majority of patients identified were newly diagnosed and not facing a chronic HCV infection. Of those, about 7% of patients showed evidence of viral persistence.

Authors note “These findings reveal substantial missed opportunities to diagnose, treat, and prevent Hepatitis C in the United States.”

Coverage was highest among those enrolled in commercial insurance (50%) and lowest in Medicare and Medicaid (8% and 9%, respectively). Particularly startling in the differences between payer types was the prevalence of viral testing; those with an unspecified payor type were screened at about 79% and those with commercial insurance or Medicare had a testing prevalence of about 91%.

Patients with “other”, “unspecified”, or Medicaid as their insurance or payer had showed a lower viral clearance rate (23%, 33% and 31% respectively) than their counterparts enrolled in Medicare or commercial plans (40% and 45%, respectively). Overall, the cure rate was about 34%.

The age range with the highest rate of HCV diagnoses was 40-59 years, representing about 43% of the patient records reviewed. 60% were identified in their charts as male. However, the highest rate of viral clearance was among those aged over 60 and the lowest was for those aged between 20-29 years.

Other limitations to the data include a lack of uniformity in the follow-up period between testing, which might lead to some difference in rates. Similarly, patients might use or be referred to a different lab for follow-ups. Though, the data also does not follow patients and would not capture any representation of subsequent reinfection and cannot make any assumptions as to clearance or viral persistence among those who did not have RNA testing (and referral for treatment) – meaning the data likely underestimates the patients in each of these categories.

Advocates can look toward these data and findings to inform necessary policy changes, particularly by payer type and in seeking appropriate provider activation on screening and treatment. The sheer reality is HCV is both preventable and curable and policymakers and payers need to work more efficiently in order to prevent the approximate 14,000 HCV related deaths this country faces annually.

Prescription Drug Advisory Boards: What They Are and Why They Matter to Patients

It’s no secret that the high cost of healthcare is a significant concern for most Americans. The total national health expenditure in 2021 increased by 2.7% from the previous year to 4.3 trillion dollars which was 18.3% of the gross domestic product. The federal government held the majority of the spending burden at 34%, with individual households a close second at 27%. A cornerstone component of medical treatment is the access to prescription drugs. In 2019 in the U.S., the government and private insurers spent twice as much on prescription drugs as in other comparatively wealthy countries. Despite catchy phrases that poll well, and “simple” solutions by politicians that promise to fix the problem—such as Prescription Drug Advisory Boards (also known as Drug Pricing Advisory Boards)—it is mindful to remember one thing: if it sounds good to be true, then it probably isn’t true.

CANN PDAB infographic: What are they and why do they matter? (https://tiicann.org/dpab-project.html)

While list prices of prescription drugs continue to increase, medication costs do not represent the largest share of healthcare costs or the largest growth in healthcare costs in the United States. The cost burden on patients is so untenable for many that some have to decide between paying for medications, food, or mortgages. However, due to a number of incentives and the role of loosely regulated pharmacy benefit managers (PBMs), there is little direct relationship between drug list prices and patient cost burdens. This fact is only just now being appreciated by lawmakers but is not currently reflected in our healthcare funding schemes. As such, the discourse surrounding lowering cost is a consistently turbulent sea navigated by diverse public and private parties, with the language around drug pricing assuming efforts to curb costs relate to patient costs and access – but not explicitly saying so (and for good reason). Some proposals are government related, such as federal drug pricing proposals. Recent developments are state-level focused closer to home. One such development is the Prescription Drug Advisory Boards, or PDABs.  

PDABs are part of state divisions of insurance. Drug pricing efforts, in the general sense, could be a good thing. PDABs are being marketed to the public as a better means to make drugs more affordable for patients. However, the details of the implementation of developing PDABs are wherein lies significant challenges. Overall, the boards focus specifically on the prices of the drugs. However, the focus on pricing is mainly related to what governments, insurance companies, hospitals, and pharmacies are paying for the medications. This purview and the monitored metrics associated with PDABs do not necessarily translate into the actual costs patients pay at the pharmacy counter.

Because these designs are singularly focused on the “cost” to payors, current proposals and initiatives benefit both public and private payors at the expense of the patient access and the provider-patient relationship. It is unacceptable for any planned PDAB activity to disrupt the patient-provider relationship. Community Access National Network (CANN) has consistently opposed any policy initiative that might increase administrative barriers and patient burdens. Two examples are step-therapy and prior authorization. Activities such as these are considered what is known as utilization management. Utilization management helps lower prescription drug spending for public and private payors but creates additional costs for patients financially and logistically, affecting their continuity of care, amounting to a cost burden shift, not a meaningful increase of access to affordable, high-quality care and treatment for patients.

Additionally, the narrow specific focus on the list prices of drugs overlooks essential issues. Lowering the list price for medications can, for example, harm organizations that depend on revenues from the 340B Drug Pricing Program. The 340B program allows safety net clinics and organizations to purchase prescription drugs from manufacturers at a discounted price while being reimbursed by insurance carriers at a non-discounted cost. The surplus enables these entities to provide many services that the low-income populations they serve depend on. This is especially vital to low-income people living with HIV that do not have the means to afford all of their healthcare needs.

It is imperative that PDABs receive input directly from patients and caregivers as well. PDABs are aggregating a large amount of data. However, more of that data needs to include considerations of the patient experience. For example, drug rebate reductions can impact care and support services, such as transportation assistance or mental health services at federally qualified health centers (FQHCs). Moreover, there needs to be an examination of the actual pass-through savings to patients. Most importantly, PDABs need to explore how pricing decisions affect patient access. A lower drug list price is not beneficial to patients if it creates or increases administrative burdens or increases costs for patients in other ways outside of paying for the cost of medication.

Most policymakers do not always have robust experience in understanding the nuances of dealing with public health programs, clinics, and populations. This is especially true regarding the marginalized community of people living with or at risk for acquiring HIV, those affected by Hepatitis C, or people who use drugs. PDABS must be held accountable for acquiring anecdotal qualitative and quantitative data regarding patient experience, accessibility, and affordability while developing recommendations related to drug pricing. As it stands, of the states that have implemented a PDAB, none have statutorily mandated metrics monitoring patient experience and access.

Patients, caregivers, and advocates with direct experience and greater understanding of the policy landscape around healthcare access play a vital role in helping to shape legislation and informing proper implementation of programs to meet the goals those programs were “sold” on. If monitored metrics do not consider or reflect patient experiences, then the program is simply not about increasing access for patients.

PDABs, fortunately, do have numerous opportunities for patients, caregivers, advocates, and providers to become involved and to elevate patient priorities over that of other stakeholders. Getting involved and staying involved with a state’s PDAB work is critically necessary to ensure any final work or regulation is patient-focused.

CANN will be present and offering feedback at various PDAB meetings in affected states. The next meeting CANN will be attending is virtual for the state of Colorado, on July 13th at 10am Mountain time. You can register here and participate in ensuring any action taken reflects patient needs.

Opioid Settlements in America

In 2021, a group of state State Attorneys General announced a $26-billion national opioid settlement with three of the largest drug distributors—McKesson Corp., Cardinal Health, Inc., and AmerisourceBergen Corp.—and drugmaker Johnson & Johnson that would see $21b and $5b from those groups, respectively. This settlement deal was approved by all but four states—Alabama, Oklahoma, West Virginia, and Washington—and distribution of those funds began in 2022.

As with every such settlement, funds are distributed to states and municipalities, but how those funds are used is largely up to the recipients. One of the primary critiques of the 1998 Tobacco Master Settlement Agreement was that states and municipalities could use the settlement funds for any purpose. Many states, including West Virginia, used (and abused) those funds to plug holes in their budgets, fund infrastructure improvements, and, in the case of West Virginia, fund teacher pension funds. This lack of direction and oversight meant that relatively few funds actually went to provide healthcare, cessation, or prevention services. Despite this, adult smoking rates have largely plummeted since 1998 but remain relatively high in Appalachian and Midwestern states (Figure 1).

Figure 1 – Current Cigarette Use Among Adults (Behavior Risk Factor Surveillance System) 2019

Source: Centers for Disease Control and Prevention. (2021, October 22). Map of Current Cigarette Use Among Adults. https://www.cdc.gov/statesystem/cigaretteuseadult.html

Negotiators appear to have learned from that mistake, and the National Opioid Settlement is different. However, while the settlement agreement requires that 85% of the funds going directly to states and municipalities must be used for “…abatement of the opioid epidemic,” the settlement doesn’t go so far as to enumerate what qualifies as “abatement.”

According to Kaiser Family Foundation reporting, funds from the settlement are split between states and are then divided in varying percentages across state agencies, local governments, and councils that oversee opioid abatement trusts. But, there has been little transparency around the settlements, including how much each state is received, how those funds are then divided, and how those funds will be used. To date, just 15 states (Arizona, Colorado, Connecticut, Delaware, Florida, Idaho, Massachusetts, Minnesota, Missouri, New Hampshire, New Jersey, North Carolina, Oregon, South Carolina, and Utah) have explicitly promised to report 100% of their Distributor and Johnson & Johnson settlement expenditures. These promises are not, however, legally binding, and recent moves by certain state administrative and legislative bodies to make private information that is statutorily mandated to be public under state Sunshine Laws bode poorly for those hoping to hold states accountable for their use of the funds.

There have been some successful efforts to track the distribution of national settlement funding out of the National Academy for State Health Policy (NASHP). Their map, however, is limited in that it only covers funds from that National Opioid Settlement, meaning that states that chose to continue pursuing additional damages (i.e., West Virginia, Alabama, Oklahoma, and Washington) are not tracked on the map. In addition to the interact map, NASHP provides a pretty comprehensive breakdown of how each state is using opioid settlement funds, including those states that did not participate in the national settlement.

Because we’re still in the early days of the settlement disbursements, there’s not really a great way to measure whether or not the funds will be successfully utilized, nor whether or not the abatement programs will actually have an impact. What we have seen outside of the settlement is that there is little consensus between states on how best to approach the continuing opioid epidemic. While some states increased access to harm reduction services, others have reduced access to, heavily regulated, or eliminated those services altogether.

In states where the opioid epidemic has become part of the fabric of life, such as Indiana, Kentucky, Ohio, and West Virginia, anecdotal reports and some limited research have found that, while additional and public health professionals are actively attempting to implement policies, plans, and interventions to openly and positively confront the opioid crisis, state residents are simply exhausted after dealing with over twenty years of devastation, loss, and both perceived and real destruction to their ways of life.

On the anecdotal front, I recently returned to Eleanor, WV, where I briefly lived and attended school and where my father taught music. What I found made my heart ache: the town’s lone shopping center essentially abandoned and left in disrepair; a middle school whose track and football field (which are still actively used by students) so destroyed that the track was little more than broken concrete loosely interspersed between fields of overgrown grass and bleachers literally tilting from rust and overuse; a set of buildings that once served as some of the town’s few apartment buildings literally burned out and boarded up with graffiti-covered plyboard; school bus stops that looked like they’d been hit by a tornado, and nobody repaired them.

We’re not talking about a major metropolitan area—we’re talking about a town of just over 1,500 residents that carries the moniker, “The Cleanest Town in West Virginia.” And the devastation didn’t stop there. I spent the next hour or so driving along the routes I used to travel as a kid and teenager, and every place that once held a great memory for me was absolutely destroyed or so badly damaged as to be wholly unrecognizable.

When I go through Facebook to check on friends from my time in Eleanor, a significant percentage of them are either recovering, in active use, or have lost their lives to the opioid epidemic. Even after working in the public health and advocacy space for more than fifteen years, the realities sometimes feel remote, and this drive allowed me to see what the opioid epidemic has done to West Virginia: it has deprived us of hope that things can or will get better. What’s more, our state legislature seems determined to make things worse.

These are the states and towns where opioid settlement funds are desperately needed, but it’s unclear whether or not they will receive or utilize them well. I know that I will be actively following how these funds are used in Appalachia, particularly in my capacity as Founder and Executive Director of the Appalachian Learning Initiative (APPLI, pronounced like “apply”).

When Anti-Equality Means Anti-HIV

As a teenager in Western Illinois, the educational content I received on sexual health consisted of what can best be described as “MadLibs Sex Ed” - sheet after sheet of entire sections of a book, meticulously handwritten by my teacher with various words replaced by blanks. It stands to reason then that my functional knowledge of this content also had some gaps. In the years since, my world has drastically shifted as has the world around me. I came out, transitioned, and found my footing as a queer and trans health advocate, all the while access to comprehensive sex ed has remained polarized despite gains made in HIV prevention and treatment such as PrEP and U=U (Undetectable=Untransmittable). It is amongst this backdrop that I learned that the great State of Iowa had recently put a sweeping bill into law - SF 496 - that, under the guise of parental rights, eliminates the requirement of age-appropriate information about HIV/AIDS and HPV.

To say this is concerning is an understatement. By eliminating the mandate of HIV education, the state of Iowa is essentially choosing the path of willful ignorance on behalf of its young people. The State of Iowa would have one believe that young people are either too young to safely know about sexuality or are certain to have a parental figure able to competently have “the talk” with them in such a way that the necessary content will be covered. The reality is that the Centers For Disease Control and Prevention’s (CDC’s) Youth Risk Behavior Survey from 2021 found that 1 in 5 high school students is currently sexually active, and among those, only 52% used a condom the last time they had sex and less than 7% had been tested for HIV or STIs.  Additionally, In the United States, 20% of new HIV diagnoses in 2020 were among young people aged 13-24. Earlier this month, Iowa Public Radio noted that despite national new HIV infection rates falling overall, Iowa’s new infection rates have remained steadfast. It would seem that now is not the time to stand down on HIV education efforts.   

Truly comprehensive sex education empowers individuals with accurate and evidence-based information about HIV transmission, prevention, and treatment. By teaching individuals about how HIV is transmitted, the importance of condom use, regular HIV testing, and the use of PrEP and nPEP, comprehensive sex education equips folks with practical skills to protect themselves and their partners from HIV transmission and unintended pregnancy. Additionally and equally importantly, comprehensive sex ed, when done well, stresses the importance of communication, negotiation, and consent, which are essential elements in fostering healthy relationships throughout the lifespan and even outside of sexuality-based contexts.

It is also important to note that the same law that eliminates the requirement of HIV education also eliminates any mention of sexual orientation or gender identity through the sixth grade. As a queer and trans person raised in a similar environment, I spent my childhood and adolescence staring out across the corn and soybean fields, intensely aware that I was different yet with no feasible outlet (or Internet) to understand why. This bill (and the onslaught of others like it elsewhere in the U.S.) targets the exploration of sexual orientation and gender identity and hopes to harken back to the bad ol’ times when access to information was limited and supportive resources were scarce. Interestingly, this bill also includes mechanisms to make it easier to ban books in schools and explicitly prohibits students from serving on committees that determine or provide recommendations concerning banning books and other materials from school libraries. Because not only do we want young people under-informed about their bodies and their options, we also want to make sure they don’t dare have agency about what happens in their school - yet we hope for them to be good and engaged citizens. How interesting and perfectly sensible!  

What happens next is both predictable (in that some of us have lived it before) and preventable. In the Mad Lib, SF 496 of it all, young people will not get access to the information they need to make sound decisions or to feel less isolated. There will still be gay young people or trans young people - just less understood by their peers and less likely to see themselves in the literature at their schools. There will be more young people who become HIV positive and unknowingly transmit it to others, and because removal of HIV education means removal of HIV testing information, there will be more people who have no idea about what testing means, how frequently to do it, and where one can do it. Therein lies the work for HIV advocates. The State of Iowa has created a “tough row to hoe” as they say in my hometown, but I take solace in the fact that whether overlooking the cornfields, the beaches of my adopted home, or the haze of a city elsewhere in the world, HIV advocates don’t give in and they don’t give up.

The Necessity of Patient-Centered 340B Reform

On the issue of any health policy discussion, many, powerful stakeholders are inserting their priorities and interests, working to be the “most favored” entity group in any final outcome. For the Affordable Care Act (ACA), some fights were seen between providers that asserted some feigned “moral” objection to any given type of care, others included insurance companies fighting to get a bigger piece of the subsidy pie or establishing themselves as “managed care organizations” to take over management of Medicaid programs. To this day, Judge Reed O’Connor has ruled on the ACA more than any other federal judge outside of the Supreme Court. But repeatedly, despite the political stump speeches and the claims of high ethical priorities from other stakeholders, actual patients do not tend to dominate in terms of who benefits most when health policies are enacted or when reforms are needed. The 340B Drug Discount Program is no different. In fact, serving the intent of the program is at the center of the patient-centered reform movement.

Often these fights happen without sufficient focus on how they impact patients. Providers, particularly provider administrators, and payers (public and private) are well-funded enough to out-shout patients and then claim some paternalistic insight as to what will “really” benefit patients. Having someone speak for us is not where we end up being the “winning” stakeholder. It’s part of why patient self-determination is at the core of The Denver Principles. And, again, 340B is no different in this regard.

Bad actors in this space continue to tout prioritizing patients while doing…not that.

For a recent example in a long line of examples, Allina Health System was routinely denying care to patients, despite being designated a “non-profit” health organization. Indeed, in that specific health system, not only were patients denied care for having a balance or struggling with paying medical bills, as evidenced by the system’s less than half of one percent charity care rate indicates patients weren’t being made aware of the system’s own financial assistance policy even when facing collections.

Collections…

Hospital-related collections are the driving factor for health-related GoFundMe and other, similar crowd sourcing, mutual aid sites. A pregnancy complication. A non-life-threatening injury, like a broken arm or a potentially terminal one, like a cancer diagnosis. Regardless of the particular causes, patients needing care and not being able to afford it is the throne in the side of millions of Americans. Medical debt touches more families than even student debt, with one estimate showing at least 11 million owing more than $2,000 in medical debt and at least 3 million owing more than $10,000. And unlike student loans, medical care is an absolute necessity of life.

We need to be clear, some 75% of adults with medical debt owe that debt to hospitals. It isn’t “mom and pop” providers (though hospitals are buying them out at an alarming rate) or your local community clinic. The vast majority of “medical debt” is really just hospital debt. And that medical debt – it’s not evenly distributed. An Urban Institute analysis from 2022 found Black Americans experienced medical debt at a higher rate and higher amount than their white peers. But looking at Bon Secours, an entity that took these vital dollars from Black communities and reinvested them in wealthier, whiter communities, we can’t be terribly surprised to see this data on debt and predatory practices are tinged with racist impact.

We’ll gently remind our readers that equity-minded persons and entities prioritize “impact over intent” is a very real thing.

These things are so sufficiently related that the Los Angeles County Department of Public Health issued a report suggesting the most efficient way to handle the medical debt crisis was for hospitals and mega-providers to pony up and actually meet their charitable service obligations. Meeting those charitable missions thereby reduces medical debt, addresses at least one aspect driving health disparities (financial toxicity), and ensures those program revenues are being geographically oriented to serve the most medically marginalized populations in this country. That includes incentives to address hospital and pharmacy deserts, whereby the experience of patient communities has been pilfering followed by abandonment.

Here’s a simple fact: reforming 340B to better meet the intent of the program does not pose a threat to those entities already meaningfully serving the intent of the program – serving patient needs.

Mid-Year Public Health Policy Update

Ya’ll…the last 4 months have been wild.

Let’s start with the “win”, shall we?

Last week, the Supreme Court of the United States (SOCTUS) issued its ruling in Talevski, authored by Justice Jackson and siding 7-2 in favor of patients’ private right of action to initiate lawsuits when their rights issued by law or regulation relative to a federally funded program are violated by an entity paid under that program. Now, the Taleski family still has to go back to district court to fight the Health and Hospital Corporation of Marion County (HHC) – SCOTUS just denied the effort by HHC to claim patients didn’t have a right to seek remedy when the payor was the government. As we described in January, this idea that patients couldn’t initiate lawsuits when federally funded programs weren’t administered fairly or didn’t comport with the statutory language or regulatory definitions is pretty bonkers. Indeed, for most actions regarding any kind of federally funded programming, the government typically comes in after the fact and those injured have to initiate the court processes themselves. Some advocates, particularly disability and Medicaid advocates, called the potential of the court to rule restrictively in Talevski “the Dobbs of Medicaid”, and urged the parties to consider settling ahead of a ruling. However, the potential crisis was averted because, as Justice Jackson put it, “Hewing to [the relevant statute]’s text and history (not to mention our precedent and constitutional role), we reject HHC’s request, and reaffirm that ‘laws’ in [the statute’s text] means what it says.”

Fancy that, laws meaning what they say.

Speaking of laws and problematic folks tryna skirt them, the 5th Circuit Court of Appeals heard oral arguments as to the stay – not the whole merits of the case – of Judge Reed O’Connor’s effort to strip the Affordable Care Act’s (ACA) preventative coverage mandate by way of extraordinary bigotry – targeting HIV prevention medication because “ewww, the gays”. As our friend, Chris Geidner, over at Law Dork covered those arguments and boy howdy! I wouldn’t wanna be Jonathan Mitchell – well for a lot of reasons but this one is pretty good, too. Mitchell’s name should look familiar as he’s arguing for book bans, helped author Texas’ head-hunting abortion law known as SB8, and is, in general, a deeply rotten human being. During thee oral arguments Mitchell fell more than a little flat, in no small part because the Department of Justice’s attorney, Alisa Klein, was gracious in asking “what’s the harm in putting in a stay?” In essence, she argued the physicians that Mitchell represented – who have themselves claimed to have never personally administered to an abortion or anyone needing HIV-related services but might, maybe, one day have to help a patient who experienced adverse events as a result of these extremely safe medications on the off chance they respond poorly to them – don’t actually have a tangible harm in putting off implementing O’Connor’s “universal remedies”, while some 2 million health plans as an industry and millions of patients across the country certainly will experience an impact if the ruling were to go into effect while being appealed. Mitchell kinda fell flat footed and basically asked the court to speculate what would happen if the stay wasn’t implemented. Hint: Courts aren’t actually supposed to pull conclusions out of thin air, “facts” must be presented inside of defined rules. So Mitchell then hedges cuz everybody suddenly seems real skeptical in how this might relate to standing and he asks of he can maybe meet with the DOJ to come up with some settlement agreement between the parties on the stay.

Now for the not so good news and there’s two bits to this one we’re gonna need to watch for quite some time; 1. Medicaid unwinding and 2. public health funding claw backs in the debt ceiling deal.

Last week, CANN hosted it’s third and final Community Roundtable in a series on COVID-19 impacts on public health and all the bad news is related to that intersection.

Because the House and the Senate voted to end the COVID-19 public health emergency a month early, Medicaid’s continuous coverage unwinding began pretty chaotically. To literally no one’s surprise, millions of folks are already losing their Medicaid coverage and not necessarily because they don’t qualify. The administrative or procedural disenrollments happen not because of a person or family no longer being qualified for Medicaid, but because a program administrator has not received necessary document responses. But the thing about that is, not a whole lot of folks who gained coverage for the first time during COVId-19 actually know a whole lot about the process, according to a Kaiser Family Foundation survey. And not every state is making it easy. Indeed, Arkansas and Florida are in a massive rush to get folks off Medicaid rolls – so fast that advocates are begging those states’ governors to slow down the process in order to reduce the risks of losing people to care who might otherwise qualify. Those states’ governors aren’t likely to respond to these pleas, despite guidance from the Centers for Medicare and Medicaid (CMS) to “not rush” the process. Those disproportionately at risk for being thrown off Medicaid are also those who are most at risk for acquiring HIV or already living with HIV and being covered by Medicaid. Again, about 40% of people living with HIV are covered by Medicaid, it stands to reason our patient population is at risk of potentially falling out of care if these processes are rushed.

Back in April, CANN reviewed annual sexually transmitted infection (STI) surveillance data released by the Centers for Disease Control and Prevention (CDC). In doing so, we pointed out the potential hazards of the Biden Administration failing to uphold its promise to reinvest in public health programming, specifically million dedicated to replenishing the workforce via disease intervention specialists (DIS). Those dollars were promised under the American Rescue Plan (ARP) but, as with all federal programs, take time to disburse. In the case of workforce development in state health departments, that means identifying an appropriate vendor to contract with to provide training, then contracting them to develop a curriculum, then giving guidance as to qualifying certification, then disbursing dollars to contract provider entities, then actually hiring people (in which there’s serious churn), training them, and so on. It takes time. But states weren’t quick to use those dollars and many of them remained unspent as the debt ceiling approached. A late-minute deal was struck between the White House and House Republicans in which certain public health funding allocated under the ARP are being clawed back. How this impacts our nation’s ability to provide meaningful public health services and address rising crises like STIs, we’ll find out in the worst possible way. For what it’s worth, our friends over at the National Coalition of STD Directors has called on the Administration to protect the public health workforce in light of the country’s first STI National Strategic Plan and how cutting those dollars risks any tangible ability to respond.

Advocates have tons more to pay attention to as the Biden Administration begins responding to this state legislative session’s “Hate Slate”, targeting LGBTQ people and our care. And because Congress is working to address things like reforming pharmacy benefit managers and 340B.

In all, advocates should work to focus on their strengths, strengthening relationships with service providers and legislators – sharing the human costs of these moves – and taking care themselves. With so much going on all of the time, we have to celebrate our wins while fighting for a fairer system serving patients. In order to do that, we have to also take care of ourselves.

Jen’s Half Cents: Digging Deep on Leadership Equity in HIV

Much focus is given to the “noise” leadership from advocacy organizations have to offer. Public statements are signed by folks with titles like Chief Communications Officer or Executive Director. Media interviews focus on selecting personalities based on their organizational role. This isn’t necessarily a bad thing. It’s a chance to set public narratives and share personal backgrounds in a storytelling fashion…it’s how we humanize what often feels like a faceless discussion. That humanization is critically necessary for effective advocacy. Patients, people living with HIV, are not blots of ink on paper or some series of numbers assigned in a budget. We’re more than the “black and white” of a grant application. We are certainly more than our titles or our jobs. We are whole persons with a plethora of experiences and aspirations and families and communities that depend on us in all variety of ways.

There’s a quality of those ongoing discussions of public health that’s enriched and made more effective, more tangible when those speaking to the issues also live those issues. The discussion itself, at least with regard to HIV, centers on issues of equity across the lives of those most affected – economic equity, health, education, and so on. The quality of that discussion is so sufficiently elevated that we built community principles which are meant to guide our engagement; Meaningful Involvement of People with AIDS (MIPA), the Denver Principles, and so on. Hell, the statutory requirements of the Ryan White CARE Act includes these ideas in requiring recipient jurisdictions to have planning and advisory councils.

So must our organizational leadership reflect these ethical directives in exactly who sits in those seats and their experiences in getting there.

As we begin to see some, though not enough, generational shift in HIV leadership, how we get there is going to matter as to our sustainability.

For those not “in the know”, an unsurprising fact of this generational shift is the “new” leaders talk to one another about how we’re navigating those changes. For me, it was the absence of a mentor in Bill Arnold’s death. For others, it might look like fighting an institution’s inclination to rely upon previous leadership to undermine decisions of the current or incoming leadership, for others still, it might look like founders prioritizing legacy contacts over that of newer blood. We need places to vent but also to share strategic alignment, which might look different than things have in the past.

We are, after all, each other’s peers in every professional respect.

In discussing with a colleague their experiences with how these shifts feel very reminiscent of the very problems we’re being tasked to address by our mere presence, they shared the following, “The intersections of founder’s syndrome and white supremacy are profound and real and exhausting. For all the emphasis we put on new Black queer leadership, let’s also hold the old leaders accountable for not letting go.”

My colleague… my friend asked of anonymity if I were to include this quote anywhere. I’m endlessly grateful I have earned their trust and will work to continue to earn their trust.

And we really do need to do more than sit with this idea if we’re to not beat down the fabulous innovation and talent that awaits us. The time for “sitting” and reflecting on how our leadership might be more reflective of the epidemic, how we might address “subtle” (it’s not subtle, ya’ll) slights and “cultural competency trainings” aren’t going to do it.

HIV diagnoses have not meaningfully declined in the last decade in the United States, except for white, gay, bisexual, and same-gender loving men. Our overall leadership, the slow pace of generational change, and the barriers to meaningful leadership change are all part of the reasons for that.

We will not make meaningful progress by doing the same things, with the same people, over and over and over again. We will not break chains of racism or misogyny or stigma or ableism or any other bigotry by requiring a new generation to perform in the environment in which those…less than palatable ideas flourished to begin with.

HIV not only needs to consider the necessity to expedite leadership changes but how we get there.

How do we ensure we’re not burning out bright stars before they even start? How are we actively planning for success in succession? How is old leadership, including board members, releasing its idea of how thing “should” be, going beyond “allowing” new leadership to guide, and moving forward with enthusiastic support for a different vision of how to get to the same goal?

“How” matters as much as “who” or “when”.

We need to dig deep to ensure the equity we seek in the world around us is also reflected in the leadership guiding us and the experiences of those coming into leadership.

An Expression of Support for Basic Human Decency

Earlier this week, ADAP Advocacy Association and Community Access National Network (CANN) issued a joint statement announcing an embargo of each respective organization’s patient advocacy and education activities within the state of Florida. Both organizations also cited a need to protect advocates and patients from outside of the state from the very real dangers associated with traveling to the state, while also emphasizing that both organizations will continue to support local advocates in the state as they work to create positive public policy changes for Floridians living with HIV. The decision to adjoin both the ADAP Advocacy Association and the Community Access National Network to the previously issued formal travel advisory by the NAACP wasn’t taken lightly because maintaining strong ties to the community is important in generating effective advocacy. The move wasn’t a political statement either, but rather an expression of support for basic human decency.

The announcement comes after the state’s governor, Ron DeSantis, signed into law a series of bills targeted toward harming Black, Brown, LGBTQ+, and immigrant people. The transgender community was probably singled out more viciously than any of the marginalized communities throughout this hate-inspired Florida Legislative Session. Make no mistake about it why this effort to enflame a “culture war” is an issue of organizational values and something quite personal to both of us. The non-trans guy here taking issue with the fact that the trans guy here now cannot take “a leak” without fear of being charged with a felony has nothing to do with politics and everything to do with basic human rights.

The fact is we both previously lived in the state for many years – it’s where we started our HIV policy work, even before we knew one another. It is where we met over a decade ago. Upon reflection, we still can regularly be found discussing mutual friends from Florida, those still living and those who have passed on, in different phases of their lives. 

From recalling Bishop S.F. Makalani-MaHee's testimony to the Florida Legislature in 2016, against a bathroom bill (which failed that year), to his death on Transgender Day of Remembrance in 2017, part of this internal discussion was a reflection on the deep history he had with advocates serving both the Transgender and HIV communities of the state. What we’re witnessing right now in Florida is challenging for us, personally and professionally, but state-sponsored discrimination, hate, and stigma drew a line that cannot be ignored.

In 2017, Human Rights Watch published an important report, Living At Risk: Transgender Women, HIV, and Human Rights in South Florida and the very same year ADAP Advocacy Association published it’s issue paper, Transgender Health: Improving Access to Care Among Transgender Men & Women Living with HIV/AIDS Under the AIDS Drug Assistance Program. Both of us worked on the ADAP project, and it was important for a transgender advocate (Jen) with lived experience to lead in writing model policies meant to serve Transgender People Living with HIV. The decision to issue a travel advisory in Florida for people living with HIV is rooted in disparities and areas of improvement emphasized in those two reports.

Much of our hearts belong to Florida for the dedication and innovation the people of this state can and do offer, despite every unnecessary public policy challenge they face. People like Mick Sullivan and Donna Sabatino (formerly with Tibotec Therapeutics), Connie Reese and her amazing work with Simply Amazing You Are (SAYA) in Miami-Dade County, Riley Johnson promoting trans equality in accessing medical care via RAD Remedy, Michael Ruppal’s leadership with The AIDS Institute, and the late Tiffany Marrero, who served to voice the experiences of vertical transmission patients and Black Women and only recently left us. Heck, Trelvis Randolph and Maria Mejia both reside in South Florida, and they serve on CANN’s board of directors. These folks not only are colleagues, but they are friends and expressing concern over traveling to a place once call “home” saddens us.

But some things are larger than us. Recognizing the inherent roots of racism, which has prompted the NAACP to issue a travel advisory, our joint statement read, in part:

The state of Florida's moves to harm Transgender people, Black and Brown communities, and immigrant families undermines the exceptional work the state's Health Department has done in the last several years and only serves to further existing health disparities affecting these communities, particularly as it relates to HIV. For example, according to Florida's own data, while Black and Hispanic/Latino communities make up about 15.6% and 26.7% of the state's population, respectively, these same communities represent 37.7% and 39.6% of HIV diagnoses. Put another way, in Florida, while white people experience a rate of HIV diagnoses of 8.5 per 100,000 people, that rate among Black communities is 51.8 and for Hispanic/Latino communities it's 31.7.

Similarly, Florida has, in years past, made extraordinary strides in ensuring transgender people can access HIV related care, specifically by integrating best practices and guidance from the Health Resources and Services Administration (HRSA) on integrating gender affirming care into HIV care provision. Indeed, as a result of these moves, transgender women represent some of the greatest successes in linkage to care, retention in care, and viral load suppression of any demographic in the state. Recently signed bills prohibiting state contracted clinics from providing gender affirming care will have a dramatic affect in reversing these long sought after wins. 

Make no mistake, we are frustrated with an apparent lack of involvement from the federal agency charged with implementing the Ryan White HIV/AIDS Program. Because Ryan White program dollars are passed through the state and then contracted with counties, local areas, or directly with a provider, and because other health initiatives of the state are also part of how providers in Florida acquire funding to provide public health services, they may be prohibited from providing gender affirming care at all - regardless of where those dollars originate (state or Federal).

It is incumbent upon HRSA to provide guidance beyond ‘allowable’ uses and inform that state it has contractual, fiduciary responsibilities associated with its grant and subrecipient contracts to ensure these dollars serve these communities. HRSA must move beyond the language of ‘allowable’ uses to ‘expected integration of best practices.’

In many situations, we have been willing and able to confront harsh environments. Indeed, we recognize the need to be present in the spaces where political forces wish to silence us. However, Florida has crossed a line in becoming hostile to the very existence of Black and Brown and Immigrant and Transgender people, those same communities most affected by HIV. The people who enacted these hateful laws were motivated by hateful politics; our response is motivated by concern for the people we’re charged with representing in our community…many of whom feel silenced. This is a line which we cannot cross and still consider ourselves as living the values we espouse.

We came to the difficult decision that neither the ADAP Advocacy Association or Community Access National Network will host any advocacy or educational event in the state of Florida. We will continue to support local advocates and people living with HIV residing in the state, including scholarship support for intrastate travel by local advocates. We will continue to offer analysis on the state's activities. But we will not ask advocates from outside of the state to risk their mental health or physical safety to travel to the state.

Lived Values: Trans Employment Survey of National HIV Advocacy Organizations

In the summer of 2020, the U.S. Supreme Court ruled the wording of Title VII of the Civil Rights Act specifically around “sex” and previous precedent regarding “sex stereotyping” protects workers from discrimination based on their gender identity or sexual orientation. Bostock was a landmark decision that many social justice advocates across the nation hoped would open the door for extending similar gender and sexual orientation protections in other titles of the Civil Rights Act.

While some circuits are considering cases which might reflect broader protections, we have yet to definitively see how this ruling might impact the ways in which the higher courts may determine whether or not they feel LGBTQIA+ people deserve protection when accessing things like housing, education, and healthcare (spoiler alert: we do). In the meantime, even with active federal workplace protections, many LGBTQIA+ folk are still struggling to find and maintain the employment and employment benefits they need to survive, let alone thrive.

We know that previously existing workplace protections under the Civil Rights Act related to race, color, religion, sex, or national origin have far from eradicated experiences of racism, misogyny, ethnocentrism and any other discriminatory experience that these kinds of rulings are intended to ameliorate.

While these protections do offer some hope that a person with the right access to resources might be able to fight back if their rights are violated, many more average LGBTQIA+ workers, especially those with oppressed intersecting identities, are left wondering the same thing: “Will these rulings actually make any difference in my life?”

It feels entirely relevant to wonder about the durability of the few federal protections the LGBTQIA+ community is offered considering the current maelstrom of state-level legislative attacks on our community. As of May 2023, over 500 bills that aim to limit the rights of LGBTQIA+ people have been filed nationally, and organizers in nearly every state have been exhaustively strategizing in response.

In the midst of these attacks, many advocates have continued to champion the fight to update their own state employment anti-discrimination laws to mirror the protections for gender and sexual identity that Title VII offers. In many states, this is no new battle. For example, advocates in Louisiana came to their legislature for the 30th consecutive year, demanding protections for sexual orientation and gender identity this legislative session…but to no avail.

Last week, many passionate activists (myself included) held the Labor Committee chamber floor for 3 hours of moving testimony in which community members relayed the ways that homophobia and transphobia had negatively impacted their ability to find and maintain work in Louisiana. Advocates have been laboring just as fiercely in the sixteen other states that also have yet to expand these protections for their citizens. I cannot speak for how organizers are feeling in other states, but I can confirm that in Louisiana, many of us are deeply tired.

People who have dedicated their lives to HIV advocacy are no strangers to the kinds of personal and collective tolls that result from having to constantly fight for our community’s access to basic needs like healthcare, housing, and employment. A silver lining of this truth is that our community also has a rich legacy of developing community-level supports when governmental accommodations fall short. HIV focused organizations have been well ahead of the curve in promoting the benefits of hiring staff that reflect the communities they serve. This has resulted in generations of LGBTQIA+ identified public health workers starting their careers at organizations that focus on providing HIV care and prevention services… but is merely hiring people from our community enough to make an organization a safer space for LGBQ and transgender and gender diverse workers?

It can be challenging to shift the broader culture of a LGBQ-friendly work environment to adequately accommodate transgender and gender diverse employees. While there are noteworthy steps that can be taken to create safer work spaces for staff based on their sexual identity, creating work spaces and benefit designs that are reflexive to the unique needs of gender diverse people is a far more nuanced endeavor.  Precious few HIV focused organizations have had access to the kind of technical support or assistance they would need to more holistically consider how their hiring and promotion systems – that were likely designed to meet the needs of cisgender staff – might be insufficient when accommodating gender diverse employees. Hiring us with good intention is not enough.

“We cannot be tokens to garner funding at the expense of funding ‘by-for’ advocacy and service organizations in trans and gender diverse-centered HIV advocacy,” Jen Laws, President and CEO of Community Access National Network (CANN) shared with me. “We won’t achieve equity in access to treatment or quality of care, we won’t end this epidemic by waving a handful of trans staff in front of funders like a flag. We have to meaningfully invest in accessible benefit designs, leadership, and programming that reaches deep into gender queer spaces,” Laws continued. “The Denver Principles and decades of advocacy have shown us this. It’s time we hold ourselves accountable to these ideals.”

For these reasons, CANN is launching a nation-wide assessment for HIV advocacy organizations to help better gauge their strengths and support needs about hiring, promotion, and good benefit designs serving the needs of transgender and gender diverse staff. The survey will be accompanied by an anonymous employee experience survey to better inform CANN’s future goals of providing capacity building and training opportunities related to hiring and maintaining gender diverse workers. Most importantly, while the results of the survey will be de-identified, the goal of this assessment will be to create a sense of accountability within the culture of national HIV advocacy.

We absolutely have the power within our own organizations to advocate for evolving internal practices that would make it easier for gender diverse people to flourish. Now, more than ever, we need to be in communication with each other to ensure our values related to workplace equity are in alignment with our practices to create work environments that are supportive for people of all genders. “Integrity is integrating our values into our actions,” as Jen likes to remind his audiences. We hope you’ll join us in filling out the survey – we need your voice in our efforts to build an HIV advocacy movement that makes space for all of us to join and endure in this fight, together.

To learn more, please contact me at dietzconsultingllc@gmail.com or Jen at Jen@tiicann.org.

Several national HIV advocacy organizations received an introduction to this initiative in the last week. If your organization did not receive an introduction and you would like to see your organization participate, please, reach out to the emails above.

MPOX Resurgence Points to Potential Trouble Ahead

Earlier this year, as part of Community Access National Network’s (CANN’s) Monkeypox (now MPOX, previously MPV) Response and Monitoring Project, this blog cautioned against premature declarations of “victory”, urged a recognition of the likelihood MPOX would become endemic to the United States, and relayed anecdotal reports of new MPOX infections, both breakthrough and naive. CANN’s concerns were and remain centered on insufficient vaccine coverage and screening among highly marginalized, highly affected communities. Very specifically, due to anecdotal reports relayed to CANN in January 2023, heightened concern exists regarding provider knowledge, willingness to screen when presented with symptoms, and willingness of public health agencies to take community reports at face-value, rather than paternalistically denying the potential or possibility of new outbreaks or breakthrough cases.

Since then, a study out of France has identified a new cluster of MPOX cases, of which most had some level of previous vaccination, with more than half having had a “complete” vaccination cycle (several potential situation are qualified as “complete”, including a combination of childhood smallpox vaccination and “3rd generation” vaccination in 2022 as part of the 2022 MPOX outbreak). Of these, none were associated with a specific event – which indicates independent exposure among a social-sexual network and not an “index” event.

Similarly, a recent report from Howard Brown Health indicates there is a resurgence of MPOX virus cases in the Chicago area since April 17, 2023. Since April 17th, seven new cases have been identified in the area, representing a departure from the three months prior, when just one case of MPOX was identified in the area, and the highest case rate since November 2022. Patient data related to these cases have not been made available.

This increase in cases in the Chicago area is concerning, particularly as the city is about to see an influx of tourists for this year’s International Mr. Leather (IML) contest from May 25-29, 2023. The event brings in thousands of LGBTQ+ people from across the world for a variety of contest events, parties, and social gatherings where the populations most at risk of contracting MPOX—Black, Indigenous, and other People of Color (BIPOC) Same Gender Loving, Gay, and Men who have Sex with other Men (SGMSM) and Persons Living with HIV/AIDS (PLWHA)—will be in close contact with one another in crowded spaces often wearing little clothing, actively engaging in social-sexual environments, or otherwise increasing their sexual partners, often time anonymously, which will increase their possibility of being exposed to MPOX. To be clear, sexual activity in these spaces should be celebrated and effective interventions should be designed around how to empower fulfilling sexual activity while reducing risk of exposure.

After IML, Chicago will begin its 2023 Pride month, with the festivities to continue through the month of June—another prime opportunity for MPOX to spread from person to person.

In addition to the pressing concerns related to potential infections, this serves as an excellent example of why we should not be quick to call an end to public health emergencies. From almost the beginning of the 2022 MPOX outbreak, it was a disease that disproportionately impacted minority and underserved patient populations—those who were least likely to have access to or feel comfortable and safe seeking healthcare services that would lead to the identification, diagnosis, and treatment of MPOX, much less receive prophylactic vaccinations to reduce the risk of transmission.

Any time we call an end to a public health emergency where the disease primarily impacts underserved populations, we run the risk of de-prioritizing physician awareness of the disease. This is particularly true with MPOX, with which physicians outside of the infectious disease space were largely unfamiliar. Additionally, although vaccine supplies were increased by dividing the single subcutaneous dose into a two-dose intradermal delivery system, vaccine supplies were initially highly limited. Moreover, Black patients were the least likely to receive vaccination against MPOX, meaning that a priority population is still unprotected again a potential resurgence of the disease.

Another concern related to the spread of MPOX relates to the efficacy afforded by the vaccine over time. Few data are available about the continued protection of the MPOX vaccine, largely because this was one of the first use cases of the vaccine in a real-time setting with an adjusted dosing mechanism. If there are concerns about the efficacy waning, local health officials and event coordinators should make efforts to secure and provide vaccination services on-site at these very public, sex-positive events, and at a full single dose, rather than a two-dose series. While those vaccines may not provide immediate protection, they could serve as a prophylaxis against infection and transmission.

Ending public health emergencies almost always poses the risk of shifting attention away from populations where a disease may continue to flourish largely unchecked. We must remain vigilant and keep easily transmissible diseases at the front of our minds when providing services to those most at risk.

Advocates should remain engaged with their local communities, encourage ready responses from public health entities, and those same entities (contracted providers and state and community health departments) should be held accountable for being responsive, creative, and careful as community members and advocates identify potential cases and outbreaks.

HIV Advocates Gather in Nashville for Health Fireside Chat

From April 27th through 29th, ADAP Advocacy Association (aaa+) hosted its first Health Fireside Chat of the year. The series was rebranded to encompass a broader focus on public health, changing from the HIV/AIDS Fireside Chat to the Health Fireside Chat. Unlike previous Fireside Chats, Nashville’s event added an “ice breaker” activity, themed in light of the hosting city – a line dancing lesson, as well as a town hall meeting convened in partnership with Positively Aware. The additional half day of activities - including the ice breaker, townhall meeting, and meet and greet - allowed attendees to settle into conversation expediently after having a solid hour of good laughs, encouragement, and bonding. Once down to business, policy discussions focused on Tennessee’s politically-motivated decision to decline HIV prevention funding, reforming the 340B Drug Discount Program to better meet patient needs, and the intersection between U=U (undetectable equals untransmittable) and reforming HIV criminalization laws.

The townhall meeting, which was facilitated by Rick Guasco, Acting Editor-in-Chief of Positively Aware, started with recognition that Nashville was explicitly chosen as a hosting city due to the state of Tennessee’s rejection of federal HIV prevention dollars. While a later discussion was specific to that issue, the town hall dug into underlying (and broader) concerns around systemic discrimination as a driver of today’s HIV epidemic. Digging into how racism, as an example, manifests can be a touchy subject in any group, even among those who generally align. Such a charged set of topics, especially among HIV’s thought-leadership, can and does lead to transformational moments, particularly because creating a space of “internal” advocacy provides a chance for us to experience, and navigate, conflict amongst ourselves. That conflict and navigation also provides us a chance to grow together and to break down silos of interest, work, and thought. And this townhall did exactly that.

The first policy session, “Tension in Tennessee: Is an HIV Access to Care & Treatment Crisis Looming?”, lead by the O’Neill Institute’s Jeff Crowley, invited local advocates to discuss their internal view of Tennessee’s “troubles” with some national advocacy representation. While much of the discussion focused on the details of local communication and national assumptions, some discussion on how the state may implement its newly allocated funding (will the state’s budget continue to fund prevention efforts next year?), much of the conversation that followed was explicitly about how local advocates can communicate and collaborate with national advocacy efforts. What became clear from that conversation is much of the national and state level advocacy we tend to reflect fondly of when speaking on decades past is relatively fragile and not well-coordinated. Planning bodies have diminished to largely being provider groups and some don’t even meet – despite a statutory requirement to do exist. An attendee with capacity building expertise pointed out the need for investment in this space. Many planning bodies have been weakened by atrophy, others have faced a demographic shift (and as a result a change in the barriers and assistance needed in order to appropriately activate affected community). The discussion as a whole highlighted the extreme silos working against a cohesive and collaborative advocacy network necessary to support ending the HIV epidemic.

340B remains an important issue for HIV advocates. As such, “340B Drug Discount Program: The Issues Spurring Discussion, Stakeholder Stances, and Possible Resolutions?“ was the focus of the second policy session. Some of the advocates in attendance knew little about the program, so the discussion provided an excellent educational opportunity on how the discount drug program works. Laser focused on issues of health equity, Kassy Perry of Perry Communications Group lead the group to dig in – and quickly. Advocates less familiar with 340B were readily able to identify the need for reform when assessing reductions in charity care and increases in medical debt. The group readily recognized 340B as a powerful tool toward addressing health disparities, especially economic consequences for patients, and where those consequences can and do negatively impact entire areas of patients’ lives. Attendees from industry partners listened intently as advocates described their concerns and the need for the program to better reflect the intent in which it was established.

Day two concluded with attendees enjoying a meal with one another, and a round of singing “happy birthday” to Brandon M. Macsata, the ADAP Advocacy Association’s CEO, who turned 50. This was truly a moment (many of them really) in which attendees got to buy into my desire to ensure our colleague felt loved and celebrated, since we were all together. All told, it is very likely Brandon heard the song “happy birthday” some two dozen times or more throughout the event (and I sincerely encourage ya’ll to do so again, if you find yourself in a meeting with him during the month of May).

The final policy session, “U=U: Is 'Undetectable Equals Untransmittable' Changing the Landscape for HIV Criminalization Laws?“, focused on the intersection of issues between U=U and reforming HIV Criminalization Laws with the conversation hosted by Mandisa Moore-O’Neal, executive director of the Center for HIV Law and Policy, and Murray Penner, executive director of U=U Plus. Mandisa shared with the group the exceptional nature of HIV criminalization laws, but also how general criminal codes are out of date, furthering the HIV epidemic, and nearly exclusively used against Black and Brown people living with HIV. Mandisa also discussed how these laws can and are leveraged to further domestic violence (and coercive control). Murray then discussed how laws which allow for “affirmative defenses” only help those people living with HIV which can readily access and maintain care. All of which emphasized that the design of these laws assume that because someone is living with HIV, they are necessarily presumed “guilty”. Advocates discussed how to break silos, including the potential to partner in prosecutor and public defender education efforts. Advocates focused on health or with strong relationships with their local health departments, for example, might wish to participate in education efforts alongside legal advocacy organizations or a state Bar.

The Health Fireside Chat series remain an exceptional retreat to advance thought-leadership, deep-dive policy conversations, as well as often-under appreciated advocacy collaboration. The ADAP Advocacy Association plans to host additional Health Fireside Chats later this year in Philadelphia, PA, and New Orleans, LA.

Underrepresented: HIV Prevalence Among Transgender Men

At the United States Conference on HIV and AIDS in September of 2022, Sybastian Smith from the National Center on Transgender Equality and I talked with one another after a session focusing on trans masculine representation, data collection, and policy leadership development. We reflected on years of what we understood to be significant under-representation of transgender men and masculine persons in HIV – in research, in data collection and surveillance activities, in advocacy…everywhere.

There are complex intersections of experience that lead to this under-representation, in no small part because an unspoken assumption of transgender men is we transition from being cis-gender women who have sex with cis-gender women to being transgender men who have sex with cis-gender women. Therefore, our “risk” of acquiring HIV by way of sexual activity is astronomically low. However, that’s not always true. At the intersection of survival, the fluidity in sexuality that might occur was we transition (some people are same-sex attracted, therefore changing gender identity might also mean a change in who someone chooses to have sex with). Gay transgender men exist. Indeed, there’s a whole segment of the porn industry which is exploding in popularity that’s dedicated to transgender men who have sex with cis-gender men. And, anecdotally, gay transgender men tend to have the kinds of sex their cis-gender counterparts have and for the same reasons, rather than the kinds of sex cis-gender women have or for those reasons.

An added layer is the discrimination transgender men face in accessing health care. This includes public health activities which do not capture our data. Many “risk” assessment forms focus exclusively on identity and make assumptions as to what behaviors someone might engage in based on their identity. For example, when a cis-gender woman fills a form or discusses with an outreach worker, they’re generally asked about the identity of who they have sex with and if they engage in injection drug use. But discussion of what kinds of sex they have or what body parts their sexual partners have aren’t necessarily accounted for. And that lens is applied to transgender men. In fact, the Take Me Home screener questions ask what a requestor’s gender identity and assigned sex at birth are but only ask the identity of sex partners. For someone who is a transgender man who has receptive penetrative sex with a transgender woman, the “risk” assessment will miss essential behavioral data because of this.

This is just one of many ways in which transgender men are disregarded as men.

This isn’t significantly different from how transgender women have historically been “grouped” with men who have sex with men based on assumptions of behavior. However, transgender men have almost no representation in HIV data, despite this close mirror of considerations. Indeed, the Center for Disease Control and Prevention’s (CDC) webpages under “HIV by group” for “transgender people” only mention information about transgender women (prevalence and prevention challenges).

So it comes as no surprise for transgender men working and living in HIV spaces when two studies, one from New York and one from Germany, found that transgender men who have sex with men had a higher rate of HIV prevalence than the general population (at 2.5%). For good reason, some might suggest this could be an undercount. The data also found that only 24% of transgender men who have sex with men have ever had an HIV test and only 45% have ever had a STI screening, both significantly lower than their cis-gender counterparts.

If we are to address HIV in the transgender community, we need to include all of the transgender community. Resources should be allocated appropriately but not in a fashion which excludes highly affected, marginalized populations.

We need to include both identity and sufficient assessment of detailed behavior to design effective education and interventions.

Australia is on Track to End HIV…by Focusing on Treatment

Last week, researchers funded by the National Health and Medical Research Council of Australia published an assessment of Australia’s success in combatting HIV and how the country might meet its goals to end their domestic HIV epidemic. The study is remarkable in many ways and readers should be cautioned to appreciate the various differences in dynamics between the epidemic in their country of residence and Australia. For example, Australia has been willing to get creative with its policy and program environment and infrastructure to address barriers to care – something many other countries, including the United States, might face steeper challenges in doing.

The study, which focused itself in New South Wales and Victoria – the country’s most populous states. While these areas hold large urban populations, Melbourne and Sidney for example, they also have large rural geographies as they get closer to the interior of the country. This isn’t dissimilar to much of the United States, where the coasts and land boarders, to a lesser degree, are well populated and as you get closer to the interior of the country, that population becomes more rural. Rural and urban geographies present very unique dynamics in and of themselves. And those differences should be well-appreciated when considering the findings of the study.

Specifically, the study sought to assess “whether treatment-as-prevention could achieve population-level reductions in HIV incidence among gay, bisexual, and other men who have sex with men (GBM)”.

What’s most interesting about the study – though not necessarily surprising given historical evidence – is it found a positive correlation between increasing viral load suppression and reduction of new HIV diagnoses. But it’s not a 1-to-1 ration. The study found a 1% increase in viral load suppression was associated with a WHOPPING 6% decrease in new diagnoses. That’s not all folks – that decrease was AFTER an adjustment to account for pre-exposure prophylaxis (PrEP), meaning the 1-to-6 correlation between increased viral load suppression and reduction of new diagnoses was INDEPENDENT of PrEP uptake and use.

Now, that’s not bash PrEP. Rather, the authors argue that to achieve maximum benefit, PrEP should continue to be partnered with our understanding of treatment-as-prevention, or, as messaging goes, Undetectable Equals Untransmittable (U=U). Indeed, the data from the study spans 10 years, which means the authors were able to positively demonstrate how PrEP increases the successes related to treatment-as-prevention.

Authors conclude their work with a direct interpretation: “Our results suggest that further investment in HIV treatment, especially alongside PrEP, can improve public health by reducing HIV incidence among BGM.”

This work is especially important as the United States begins considering a nationalized PrEP program and making exceptional investments in doing so. This study very specifically reminds us that we will NOT reach our goal of ending the HIV Epidemic with PrEP alone…but we might with treatment-as-prevention. And if we were forced to do so with treatment alone, we might still get there if we could overcome barriers to care like stigma, unnecessary barriers to care like utilization management practices, employers leveraging their power in the private market, meeting people where they physically are, closing gaps between “available” and “accessible”, overcoming discriminatory actions aimed at harming those already most affected by HIV, and more.

There’s another advantage in not moving onto PrEP with a near exclusive fervor, HIV treatment is directly life-saving. It is the humanitarian and right thing to do to ensure people already living with HIV are receiving the care and treatment and resources and support we need to thrive.

Directly, this data shows us that we will not defeat HIV by only focusing on people not already living with HIV. Rather we must ensure the lion’s share of our work focuses on people already living with HIV.

There’s much work to do and much promise on the horizon.

I’ll leave advocates with this and a request to search internally.

In December, HBO will be releasing a documentary on the Honorable Nancy Pelosi. The trailer for it is out already. In one clip, one quote, Representative Pelosi, one of our dearest champions, summarizes where our work should guide us, “I came here to do a job, not keep one.”

New STI Surveillance Report – It’s Not Good

In late 2021, ProPublica profiled the efforts of a local public health worker, Mai Yang, Mai Yang, as she sought to track down a pregnant client recently screened for syphilis Yang was urgent in the need to find this client and get her curative treatment, three uncomfortable injections of penicillin, completed at least 30 days before giving birth. Congenital syphilis is a killer with a near 40% chance of a newborn dying or being stillborn. Beyond death, congenital syphilis risks a range of difficulties, from disabling deformities to cognitive dysfunction. COVID-19 impacts were readily felt throughout the story as Yang’s client, Angelica, struggled with housing, a language barrier required an interpreter, and, eventually, the clinic Yang sought to link Angelica to was not able to accommodate a walk-in appointment, despite Yang having gotten assurances they could.

Last week, the Centers for Disease Control and Prevention (CDC) released its annual sexually transmitted infection (STI) surveillance report for the year 2021, and the news, while not surprising in retrospect, is not good. Both syphilis and congenital syphilis cases rose about 32%, compared to 2020. 2020, on its own saw a moderate rise in both syphilis and congenital syphilis. However, the CDC notes 2020 as the most affected year in STI surveillance with a marked decreases in screening activities in much of 2020 and higher than previous baseline diagnoses throughout much 2021 (mostly around the 150% level but a massive spike well above 200% around November 2021 – or about the time of ProPublica’s report being published).

Gonorrhea and chlamydia cases rose, though not as dramatically. Herpes, despite being a prevalent STI, is not a reportable illness and thus not tracked in the annual report.

This marks the eight consecutive year of increasing STI diagnosis, as noted by the National Coalition of STD Directors and Association of State and Territorial Health Officials. The situation is dire, going forward. Public health offices across the country are expecting to see an exodus of staff in the next 5 years. Between low pay and poor benefits relative to the private sector and displeasure with supervisors (which may be attributed to a lack of flexibility befitting the modern world or political pressures exerted at the appointment level), young and even well-established professionals are planning on leaving this space. And none of that necessarily reflects struggles with private partners or contracted clinics, which are equally struggling with securing funding and meeting ever increasing demands to do more with less.

In the ProPublica article, former CDC Director Dr. Tom Frieden reflected on how the United States has a terrible tendency to go through “a deadly cycle of panic and neglect”. And the same might be considered here. When President Biden announced in May of 2021 that his administration would be working to secure funding for “tens of thousands” of jobs to respond to COVID-19 and support local public health officials, there was an implication those dollars (secured in the American rescue Plan) would also fund positions that had been left to atrophy or were usurped by COVID-19 activities – most notably, disease intervention specialists. But COVID-19 is winding down, in so far as the Biden Administration seems prepared to invest much in the way of workforce dollars, and that promise made in 2021, was supposed to extend through 2026. If comments from federal legislators last year were any indication, there’s not much hope yet in this Congress choosing to ensure funding is secured to help these programs meet their goals.

In a recent interview, U.S Food and Drug Administration (FDA) Commissioner Dr. Robert Califf said “misinformation” was a leading cause of a decline United States life expectancy. And while that may one element of the issue, an abject failure to appropriately fund, stay competitive with the private market, and retain the talent needed to execute public health programs is core and central to this issue. The latest STI surveillance report shows us this plainly. Technology can only do so much in terms of outreach and extending capacity – in order to meet the demands of public health, the human element must be sufficiently supported.

Advocates would do well to take the long-view of their work. It is critically necessary to support existing public health programming and to address disparities being laid bare by annual surveillance data in order to reach an equitable health dynamic in this country – health justice. We cannot get there without supporting public health entities, shielding them from the politicalization of their mission work, and ensuring they’re appropriately appreciated for the life-saving work they do. We cannot represent patients when we don’t know who they are. We must participate with our partners in elevating the STI crisis for what it is – a public health emergency.

Stigma: ‘The PrEP Penalty’

Since the beginning of the HIV Epidemic in the United States, advocates have worked to combat HIV-related stigma, and the populations most affected by it. That stigma, in no small part, originates from the messaging and official positions from the country’s foremost public health institutions and the government itself. Starting with the Reagan Administration’s labeling of affected communities under four specific categories, now referred to as the “4-H Club” (homosexuals, hemophiliacs, Haitians, and heroin users), some of those perpetuated by the Clinton and W. Bush Administrations, eased under the Obama Administration, and weaponized by the Trump Administration. Despite each of these past leadership regimes coordinating programing and funding to address the domestic HIV epidemic, they have all participated in certain furthering in stigma by policy, position, or language.

In response, advocates have largely targeted efforts to address social attitudes, with some effort to address policy issues which might define that stigma. One of the challenges of addressing stigma is appropriately defining the real-life experiences of people living with HIV and where, having been diagnosed with HIV, that stigma influences institutional assumptions and wherein power is exercised to affect a person’s life. Much advocacy combating stigma has been focused on modernizing state HIV criminalization laws. Advocates can and should be thinking more broadly, and specifically, around other areas in which people living with and at risk of acquiring HIV might be affected.

In February 2021, this blog published a piece defining that stigma in terms of family courts and child welfare systems and where advocates might find themselves involved in policy work to better protect families affected by HIV from adverse rulings or actions involved in custody and child welfare matters. This is but one example of where specific advocacy, leveraging existing protections, can and does dramatically affect the lives of people living with HIV for the better. Additional advocacy is necessary, including pressure on professional standards, continuing education, and licensing organizations to eliminate stigma and protect people living with HIV interacting with these systems. For example, what might it look like for the American Bar Association to promulgate ethics rules or specifically define that mentioning someone’s HIV status (or gender identity) in a child custody hearing is a breach of professional ethics worth sanctioning? In 1992, the Association of Family and Conciliation Courts warned of high-conflict parents trying to incite biases and assumptions of family court judges with making claims around their ex’s HIV status. These professional associations and those like them have incredible sway and should be realized as an opportunity for advocates to identify new allies.

One tool analyzing these concepts of stigma, and as a result identifying areas of opportunity for advocates to combat same, comes from Doron Dorfman, a law professor at Seton Hall University. In Dorfman’s paper, published in March 2021, The PrEP Penalty, the professor examines how stigma is institutionalized by various agents and agencies of the government as well as the attitudes (and stereotypes) behind the qualifiers of stigma. I got the chance to speak to Professor Dorfman on Thursday, March 30. It just so happened that morning, Judge Reed O’Connor issued a judgment in Braidwood v. Becerra which would gut the Affordable Care Act’s mandate for coverage of pre-exposure prophylaxis (PrEP) with no cost-sharing.

“If you look at the ruling itself, you can see clearly this isn’t about PrEP, per se, but about how O’Connor and the plaintiffs view PrEP as something that ‘encourages homosexuality’,” Professor Dorfman said, speaking to core of what drives stigmatization of PrEP. Recounting initial insurer refusal to cover PrEP and continued problems in ensuring payers are covering both the medication and related, required laboratory screenings for PrEP maintenance, Professor Dorfman argued these positions really center on a ”de-medicalization” of HIV prevention. This concept removes the nature of preventative tools as a medical necessity and conflates engaging protective measures with “enabling” “risk taking” or that patients are engaged in “risk compensation” – compensating behavior to mitigate negative health outcomes while still engaging in activities which are moralized as “undesirable”. Indeed, in his ruling, O’Connor ruled the Religious Freedom Restoration Act claims had standing and were legitimate because the plaintiffs argued providing insurance with PrEP coverage “facilitates and encourages homosexual behavior, intravenous drug use, and sexual activity outside of marriage between one man and one woman.” This argument failed to recognize that HIV can and does pose a risk between married, heterosexual, sero-discordant couples. O’Connor also flatly rejected that the government has a “substantial interest” in preventing new HIV transmissions – or the public health argument. The fact that the government has an interest in preventing new transmissions of an infectious disease of any kind is indisputable and this end of O’Connor’s judgment is likely the weakest of an already weak ruling.

Instead, Professor Dorfman says that patients utilizing PrEP should be appreciate for assessing a risk and working to mitigate the potential negative outcomes. Penalizing PrEP engagement due to these rather naked biases creates a “chilling effect”, discouraging people and whole communities from seeking out necessary medical care. Dorfman compared this to the anti-gay stigma around prostate and colon screenings, wherein heterosexual, cis gender men might avoid seeking out recommended screenings because “getting something put up my butt makes me gay”.

These stigmatizing attitudes and stereotyping are universal around “sexually charged preventative measures”; we see it when people are charged for solicitation as a prostitute because they carried condoms on them, around access to the morning after pill and abortion, and certainly we’ve seen these attitudes around the human papilloma virus vaccine. These attitudes are so pervasive that providers sometimes refuse to prescribe PrEP and, when they are, they may find themselves avoiding doing so for patients in their teens for fear of a parent acting out as a result.

While the Americans with Disability Act 9ADA) and related guidance and rulings have offered some protection for people living with HIV, those protections are not offered to people utilizing PrEP – but they could be, with some creative thinking, in part, because the ADA protects people from stereotypes related to an “assumed” disability. If a situation arose where PrEP use was specifically assumed to mean someone is likely to develop or already has an HIV diagnosis, the ADA protects patients from harmful stereotyping. But that would be extraordinarily specific. Instead of trying to make that stretch, Professor Dorfman thinks seeking out state or federal legislation which prohibits medical discrimination more broadly than disability status could be useful. Similarly, guidance and policies which apply a personalized assessment of risk, tied with scientifically accurate information may also be useful. For example, a personalized assessment in evaluating people for blood donation, rather than a categorical (though, now more limited) ban might create a sense of equity between potential donors and address some of the stigmatizing assumptions that come from the policy.

Professor Dorman has another, forthcoming paper, Penalizing Prevention, which includes case studies – one wherein a parent’s engagement with PrEP was one factor used against them in a child custody matter – that assesses how preventative care is adversely treated by various institutions.

Advocates should consider what it means to define “stigma” and evaluate what comes next. Such as, what are potential policy answers as well as identifying private, professional organizations with power to influence the persons exercising those biases as potential partners in addressing HIV stigma. Invested policymakers should consider a variety of ways, including legislation, regulatory guidance or rulemaking, and requirements attached to grants as a means of combating stigma and promoting a more robust public health landscape. Lastly, funders should consider what it means to have an active and effective strategy for addressing stigma beyond “education” - which of your grantees and partners are getting creative in changing our environment for good? More specifically defining stigma allows us to identify ways in which to address that stigma and make tangible improvements in people’s lives and we should not shy away from exploring these potentials.