ADAP Advocacy Association Resumes Fireside Chat Retreats

The Community Access National Network (CANN) celebrated the return of ADAP Advocacy Association’s (aaa+) “Fireside Chat” retreats after a two and a half years pause, due to the COVID-19 pandemic. CANN has regularly participated in the Fireside Chats since their inception and enjoys a robust partnership with our sister organization aaa+. The event, held in Wilmington, NC, featured 23 stakeholders, including patients, advocates, and manufacturer representatives and discussed the issues of “utilization management”, the status of Ending the HIV Epidemic (EHE) plans and activities in the South, and the overall impact of the COVID-19 pandemic on public health.

Recognizing current COVID-19 transmission and community level trends, aaa+ developed a robust self-administered testing protocol, wherein participants tested prior to travel, upon arrival, and after returning to their home areas. aaa+ provided rapid self-test kits to each of the attendees. The idea here is important to note, in part, because a chain of transmission was indeed interrupted when one planned attendee reported a reactive test result from their test upon arrival, despite having had a nonreactive test result from their pre-travel test the day before. As a result, the person affected did not actually attend any sessions and appropriately self-isolated. Other attendees expressed gratitude for the reduction of risk, respect of their health and the health of attendee household members, and wished the person affected a speedy recovery. Truly, gathering safely can be done and done well, as demonstrated by aaa+’s efforts here.

Prevention Access Campaign’s United States Executive Director, Murray Penner, presented the issue of payer “utilization management” affecting people living with HIV and AIDS (PLWHA), with respect to broad issues of health care and specific to AIDS Drug Assistance Programs (ADAPs). Opening commentary reminded the audience that utilization management practices affecting health other than HIV also affects access to care for PLWHA and, in some cases, where care or coverage is denied may also result in a patient disengaging from their HIV-specific care. Conversation also discussed utilization management affecting access to pre-exposure prophylaxis for the prevention of HIV (PrEP), in the context of generic antiretroviral (ARV) products, barriers to accessing new products, as a benefit of reducing unnecessary medical tests and preventing contraindicated care. Patients and advocates readily shared how utilization management being a barrier to care is not an “outlier” situation in which patients being denied medically necessary care only occurs in “rare” occasions, rather this is a frequent occurrence with these payer practices routinely and regularly require additional administrative burdens to be met and sometimes requiring circumstances contraindicated by the Food and Drug Administration’s (FDA) approved indications for products or services. Advocates pushed back against the idea “you just want the latest drug like you want the latest iPhone” by emphasizing how the fight against HIV will not be won by having disparities in access maintained along lines of who can afford the most “elite” health care plans. Discussing how advocates can leverage state planning bodies and the role public payers could play in directing managed care organizations to reduce barriers to care as presented under utilization management practices, attendees envisioned robust yet protective access to care aimed at addressing issues of health equity and the critical role of payers in Ending the HIV Epidemic. Attendees also suggested evaluating utilization management practices under a lens of the Affordable Care Act’s rules against “discriminatory plan design”.

A lovely networking lunch followed the first discussion and attendees got the chance to bond with others they had yet to meet or reconnect with those they haven’t seen in a while. Honestly, the amount of respect and joy had during the lunch filled the room, with discussion of other areas of interest and even raucous laughter could be heard from the hallway. The energy generated from the first discussion was readily palpable.

The second discussion, lead by Community Education Group’s Director of Regional and National Policy, Lee Storrow, lead the second discussion on the status of Ending the HIV Epidemic in the South. In providing context for the update, advocates discussed their hopes and expectations when EHE had been announced under the Trump administration. While much energy had been generated, and that in and of itself is exceptionally valuable in the context of the 40-year fight against HIV, the “significant resources” advocates expected have not materialized and the addition of yet another plan has further complicated already layered reporting burdens for service providers funded under Ryan White and other HIV related initiatives and governmental funding streams. One attendee remarked “we’ve been doing the same thing for 30 years and the last 10 haven’t progressed, it’s time to do something different.” As a response, discussion moved to develop planning and programming to include the lens of “economic empowerment” of PLWHA by way of employment opportunities generated from these programs being targeted to recruiting staff from affected patient populations and served zip codes. Another attendee discussed how such an opportunity elevated her own professional experience and helped ensure her program better reflected the demographics of affected communities – ensuring better engagement and more effective outreach in her area. Attendees discussed the idea behind EHE as a “moon shot” but really seems to be hindered by the lack of cohesive systems communication across public health programs, in particular with data sharing between Medicaid and Ryan White funded programs in various states. This highlighted opportunities and barriers, manifesting in strategic planning on what cohesive data sharing might look like in an ideal.  The session ended with conversation regarding “gatekeeping” among certain advocate circles when it comes to accessing institutional and governmental power and a certain lack of transparency as to exact “who” decision makers are due to bureaucratic processes, with the final note being “where is the red tape and who has scissors?”

The first day of planned discussion was capped with a dinner in which attendees continued to share with one another personal and professional details and ideas, making plans to socialize, discussing advocacy development opportunities, upcoming concerns regarding court ruling, legislation, and regulation, and programmatic planning within each other’s specific entities. The theme being “how can we help each other succeed?”

The second day of discussion held the final topic, COVID-19 impacts on public health, facilitated by CANN’s chief executive officer, Jen Laws (me). I opened the conversation by sharing the goal of the conversation being to “define” the impacts of COVID-19 on public health infrastructure and programs. Attendees were asked to share one “good” thing to come out of our collective response to the cOVID-19 pandemic and one “bad” thing (or “something we would like to go away”). Many attendees celebrated the innovation of flexibilities offered by various temporary governmental regulation and the “forced modernization” of health care in many situations – namely, telehealth. These flexibilities, including the continuous coverage requirement for Medicaid programs under the public health emergency declaration, are threatened to end as the public health emergency winds down and advocates attend the Fireside Chat expressed a certain foreboding of returning to “normal”. Specific highlights were given to the downside of relying on telehealth, especially for rural communities lacking the necessary infrastructure to make health care accessible – particularly in hospital deserts. Attendees reflected on the data “blindness” of the current moment, noting the Centers for Disease Control and Prevention’s (CDC) 2020 HIV surveillance report lack of completeness compared to previous years. “Bill Arnold reminded me frequently that the AIDS crisis is still just around the corner. We can’t blink,” I shared with the group to many nods as concerns for patients who dropped out of care weighed on the moment. Moving the discussion forward, attendees identified methods of advocate development and influencing state and federal power by more readily engaging manufacturers in their efforts to prioritize patient voices and experiences. The necessity to recognize the state of advocacy as needing re-development and investment was apparent and the note the event ended on, as attendees reflected the impacts of the COVID-19 pandemic on the public health and advocacy workforce.

While much discussion was had throughout the Fireside Chat, much more was committed to following the event. As with many in-person events, as opposed to virtual events, the quality of the experience was not absent on anyone there. It felt good to be in the physical presence of one another. We sought and gained inspiration and enthusiasm and we do so with clear cognizance of COVID-19 as a risk. If advocates and our partners can continue to similar efforts that both keep us safe and connected, the future (not without its challenges) is bright, equity-focused, empathic, and patient-driven.

Addressing the Intersection of HIV and Methamphetamine Use

A recent convening, hosted by the O’Neill Institute, found government representatives, service providers, and community advocates discussing methamphetamine use among gay/bisexual men, transgender women, and transgender men under the lens of exploring stigma, sexual health, and HIV. The intersectionality between HIV and Methamphetamine, commonly known as “meth”, is significantly associated with greater risk for HIV transmission and numerous co-morbidities for people living with HIV.

Attendees received updates on existing data and policy relevant to methamphetamine use. Often overshadowed by the opioid epidemic, wherein the “gaps” in epidemiological data explicitly on meth use were glaringly obvious and largely dependent on supplemental data gathered during HIV outreach activities or related to broader assessments of substance use. Similarly obvious were the reasons why these data would be challenging to gather: law enforcement. According to the Substance Abuse and Mental Health Data Archive (SAMHDA), in 2019, more than 400,000 people who use methamphetamine were arrested and booked into jail for at least one time during the previous twelve (12) months. While the convening focused on gay, bisexual, and other men who have sex with men (MSM), transgender women, and transgender men, federal data found similar rates of methamphetamine use among heterosexual men and MSM. Additionally, there was no statistical difference in methamphetamine use between heterosexual women and lesbian-identified women. There was however an increase in self-reported methamphetamine use among bisexual women. Data provided did not distinguish between cisgender and transgender people, an issue explained as participants in data gathering were not asked necessarily asked questions regarding their sexual or gender identity, rather this information was largely assumed unless a participant disclosed otherwise.

Following the data sharing, patient advocates and service providers discussed their perspectives on what to consider in assessing policy and federally funded programs. Presenters highlighted their own lived-experiences as influencing their ideas on where policies and programs have succeeded and failed – largely coming to an unspoken consensus that we must do at least something differently than we are today. One presenter stated existing funding structures tend to reward large entities which is perceived to be at the expense of small service entities, which may or may not be trusted by people who use substances. Another focused on the contrary policy priorities being voiced by the Biden Administration between supporting harm reduction and supporting law enforcement – giving an explicit voice from community advocates that law enforcement often poses a threat of harm to drug users. Presenters also pointed out the need to distinguish between recreational use, misuse, and addiction, as the stigma associated with substance use often conflates these experiences with one another, when the reality is very, very different. For my part, I shared the idea that existing funding designs associated with HIV, where substance use harm reduction is largely aligned both on issues advocacy and service provision, may perpetuate social stigma by prioritizing the experiences and work of health care providers over that of patients – especially with regard to metrics of “success”. A reworking of funding and program designs and incentives that look at addressing health disparities from a human rights lens is necessary. Envisioning Ryan White programs as workforce development and community investment programs in addition to being public health programs, recognizing the potential detriment of a consolidating provider market and the need to incentivize provider diversification, and shifting funding and goals to better reflect efforts to meet the needs of communities as those communities define them.

Lastly, presenters shared honest assessments of “on the ground” perspectives and what programs are working. With meaningful geographic and demographic diversity represented on the final panel, confirming sentiments of the previous one, presenters discussed novel (and often underfunded) approaches to ensuring affected communities are receiving high quality sexual health education, linkage to care, and low-barrier interventions for those people are seeking them. Panelists discussed the need for policy makers and funding to reinforce those novel programs which do work and to consider novel metrics to better capture these successes. From reinvestments in the Ballroom scene as a safe and empowering space of expression to the successful effort from affected Latino communities in Texas to engage with their state health department, educating health care administrators and providers on the necessity of harm reduction, these programs which originate from the priorities of communities, rather than from the dictates of statehouses are already doing more and going farther than traditional programming.

So…why don’t we have more of this?

To learn more about the initiatives of the O’Neill Institute at Georgetown University, click here.

2020 HIV Surveillance Proves Earlier COVID-19 Concerns

On May 24th, the U.S. Centers for Disease Control and Prevention (CDC) issued its much anticipated annual HIV surveillance report. The anticipation is akin to waiting for a bill in the mail, “how bad is it gonna be?” In the same vein as this sentiment is the understanding that we, as a country, made the policy decisions to underinvest in public health programs, the political calculus in response to a public health emergency, and the diversion of already too scarce personnel and infrastructure resources in HIV in the effort to address COVID-19. We’re reminded of this shifting of costs, “robbing Peter to pay Paul”, throughout the annual report, in every infographic, and in the press releases associated with the report’s announcement: “Data for 2020 should be interpreted with caution due to the impact of the COVID-19 pandemic.”

Source: CDC. Diagnoses of HIV infection in the United States and dependent areas, 2020. HIV Surveillance Report 2021;33; retrieved online at: https://www.cdc.gov/hiv/library/reports/hiv-surveillance/vol-33/index.html

The top line of the report is a marked decrease in new HIV diagnoses; where since 2016, we’ve typically seem about a 3% annual decrease in new diagnoses, 2020 gave us a 17% decrease. The aforementioned press release states the decline in new diagnoses should be “attributed to declines in testing caused by less frequent visits to health centers, reduced outreach services, and shifting of public health staff to COVID-19 response activities.” The press release went further, remarking that because COVID-19 is “still ongoing, more time and data are needed to accurately assess COVID-19’s impact on HIV” and urged those relying on these data to not provide assessment s on trends in HIV diagnoses to include 2020 data are a result. A noted difference from traditional reports, this year’s supplemental Estimated HIV Incidence and Prevalence in the U.S. will not be published.

Another finding in the report is the rate of death for people with an HIV diagnosis. While the report appropriately notes the data is “all cause” deaths among people living with HIV and those deaths should not necessarily be attributed to an HIV-related complication, the incidence of death among people living with HIV did increase in 2020 significantly. This particular data category is one the CDC notes should not be “assessed” as misinterpretation is distinctly possible, if not likely. With more than one million dead from COVID-19 in the United States, HIV will not be an outlier in seeing increased all cause mortality. However, this data should be closely watched given our aging patient population and the high correlation between COVID-19 mortality risks and age.

The report encourages viewers to access the CDC’s data tool, Atlas Plus, to review “Stage 3” (AIDS) classification and prevalence. The data table for this shows a similar marked decrease in providers classifying patients living with HIV with advanced conditions and AIDS-defining diagnoses, compared to similar years. However, that decrease should be viewed extreme caution as data on linkage to and retention in care is not yet available. As NBC’s, Benjamin Ryan reported, some providers who saw patients drop out of care during the height of COVID-19-related restrictions and are now seeing patients return to care “devastatingly ill with multiple AIDS-defining diagnoses”.

A final note on the data provided, Black gay and bisexual and other men who have sex with men, Black women, and Black transgender people remain a patient demographic hard hit by new HIV diagnoses. The South accounts for nearly half of all new diagnoses. These things are not coincidental. While expanding Medicaid in southern states would provide additional opportunities for communities to find health care coverage, a lack of Medicaid expansion does not explain these geographic and demographic disparities. It is important to always recall the vast majority of the Black people living in the United States also happen to live in southern states – ultimately, racism, while hard to “measure” in a public health context, cannot be dismissed or overcome by the limited imagination of expanding Medicaid. Medicaid expansion would well-serve southern states and provide an excellent tool but should not be considered the only tool or surest answer to the social ills inflicting harm on southern Black communities.

Supplemental reports are published throughout the year, helping to further define the contours of the domestic epidemic. We’ll be monitoring and evaluating the data from these as they’re published and encourage stakeholders to review these data, weighing how best to support public health programs aimed at addressing HIV and the health and social disparities that drive the epidemic. As always, pertinent data monitoring public health programs serving at the intersection of HIV and Hepatitis C can be found in Community Access National Network’s quarterly HIV-HCV Coinfection Watch.

In multiple previous blogs throughout 2021 and during both the 2021 and 2022 Community Roundtable events, I’ve stressed the issue of “flying blind” as a result of losing hard earned ground with regard to regular testing, linkage to care, and engagement in care. The 2020 surveillance unfortunately proves this point and, as the CDC has noted, the COVID-19 pandemic is still ongoing. I’d go further and state the disruptions caused by the COVID-19 pandemic are also still ongoing. While many public health programs are working to recover personnel shifts, some state legislatures are cutting funding for health departments. Yes, activities associated with HIV programs are generally federally funded and administrative supports necessary to hire and train sufficient personnel are tied to broader public health programming and if these jobs aren’t filled, then the jobs associated with HIV programming may well go unfilled as well. Stakeholders will need to keep an eye on the evolution of data as we begin to uncover just how much COVID-19 has cost us in HIV progress.

Misinformation: An Ever-Growing Public Health Threat

Author’s note: For good reasons, the terms “misinformation” (those ideas which are slightly distorted) and “disinformation” (ideas which are contrary or contradictory to actual fact) are distinct. However, for the purposes of public messaging, these terms are often interchangeable so as to not collide with natural defense mechanisms of an audience. Similarly, for this blog, the terms will be used interchangeably.

There’s no two ways about the issue of health misinformation – politely, a term to describe conspiracy theories which range from moderately frustrating and lacking factual evidence to downright deadly. On the issue of public health measures and mutual community investment into one another’s health outcomes, the issue grows exorbitantly.

Before we move forward – the issue of gun violence is both a public health issue and a humanitarian one. Like abortion and gender affirming care, the issue of gun violence is not an area of expertise I possess and the analyses provided in these blogs are specific to policies and programs affecting HIV, HCV, and substance misuse. However, we cannot move on without directly addressing the role misinformation is playing right now as families grieve the loss of their children as a result of another school shooting. Within mere hours after the shooting made national news and before even the full count of children murdered had yet become clear, misinformation, driven by conspiracy and bias regarding the shooter’s identity was already proliferating across social media. Indeed, the idea which falsely linked multiple transgender women to the shooting was touted by Representative Paul Gosar. These actions have already resulted in a trans woman being assaulted in Texas.

This isn’t new. The problem of misinformation around COVID-19 had already grown so significant by the time President Biden named a Surgeon General, one of Dr. Vivek Murthy’s first acts as Surgeon general for this administration was to issue an advisory warning of the personal and public health dangers of misinformation. In addition to the issue brief accompanying the advisory, the Surgeon General’s office now maintains an information page for various stakeholders, including individuals. Yet and still, even two years into this pandemic, where incredible feats of science – like producing a viable vaccine within twelve months of an initial outbreak – have occurred, people so well-regarded as to be elected to federal and state offices are either outright shouting flagrant falsehoods or calmly suggesting COVID-19 vaccines cause AIDS, like Senator Ron Johnson did earlier this month. The seed of doubt and big bad scary things are the things of nightmares and in the absence of easy to access, easy to understand, and static answers, there are people willing to consider these nonsensical leaps as valid possibilities.

None of this is new for folks navigating HIV misinformation or stigma. The problem of misinformation around HIV isn’t some far off issue that we don’t need to concern ourselves with domestically, indeed it thrives today in the backyards of “every day Americans”. The most pernicious idea being “HIV is over” seconded only by the moralizing ideas around “who” gets HIV – that such a diagnosis is somehow a justified punishment from “God” rather than the end result of a negligent society so infected with layered biases as to not acknowledge that racism (not race), misogyny, homophobia, ablism, and every other moral and ethical rot has driven those most in need to also be those most at risk. Hate and misinformation so often leaves “disproportionately impacted communities” so “vulnerable” the Centers for Disease Control and Prevention (CDC) has a whole segment of their website and millions of dollars in programming aimed at reducing HIV stigma.

Part of the issue lies with a lack of digital literacy, an undying effort for fragile egos to leverage fear and their own ignorance for pitiful power grabs, and a near tangible disgust lobbed in response to casual conversation going just a bit sideways – tribalism at its best, as it were. Misinformation and conspiracy theories thrive when people are afraid and looking for answers that are easy to grasp and never change and the idea that things would never change once investigated is, at its roots, anti-science. The nature of science is to explore and challenge assumptions, test theories, and change our ideas based on the results. Regardless of what one thinks of themselves, reading an article about a study or even ten articles about a dozen studies isn’t “research” – it’s not even a literature review – and the fact that we as a society cannot come to agree on what defines a “fact” or “research” or release a desire to exclaim “expertise” in an effort to save an ego is deadly.

I’m a giant fan of librarians, the last great defenders of knowledge at every turn in history, and the attacks on their profession are as dangerous, in general, as they are to public health, in specific. Ultimately, librarians are the ones who end up teaching us how to navigate conflicting information and maintain the humility that is necessary to fight this moment – no question is dumb, asking for help is a super power, and being able to admit when you’re wrong is next to Godliness.

As state capitols across the country grapple with the likes of Robert Kennedy Jr. showing up exploit people’s fears, it is the duty of advocates across all issues to urge our political leaders to not indulge in conspiracy and misinformation, to show some kindness to our audiences who are coming from a very reasonable sense of being afraid of what it might mean if COVID-19 really is with us forever, and work to find that common ground we all proclaim to fight for:

We all want the same things for ourselves and our families; a safe place to call home, a good job that pays the bills, and a sense of happiness and peace. In the meantime, those with the power to influence policy also need to be advocating for meaningful funding in both public health and public education.

Community Roundtable Defines the Shape of Public Health Advocacy Amid COVID-19

Last week, Community Access National Network (CANN) hosted its annual Community Roundtable event, like last year, focused on the impacts of COVID-19 on public health programs and patient advocacy around HIV, viral hepatitis, and substance use disorder. CANN’s President & CEO (your’s truly) was joined by Kaiser Family Foundation’s (KFF) Director of LGBTQ Policy, Lindsey Dawson, and Georgetown University’s Katie Keith. Attendees included representatives from patient advocacy organizations, state and local health departments, clinical laboratories, hospitals, pharmaceutical companies, and federally or state funded service providers. The virtual event was sponsored by ADAP Advocacy Association, Janssen Pharmaceutical Companies of Johnson & Johnson, Merck, and ViiV Healthcare.

I welcomed attendees, noting my own professional admiration for both Lindsey and Katie, as experts leading in education on policy issues and data analysis around issues affecting communities highly impacted by HIV, viral hepatitis, and substance use disorder. Prior to co-presenters introducing themselves, audience members were reminded both KFF and Georgetown University are both non-partisan, education entities. The impetus and aims of this year’s event in including these astounding co-presenters was to help define the ecosystem of public health affecting programs particularly serving patient communities CANN serves.

Lindsey’s presentation offered a “potpourri” of relevant data regarding AIDS Drug Assistance Programs and Ryan White Funding stagnating, tele-PrEP, the federal Ending the HIV Epidemic (EHE) initiative, Medicaid programs, and LGBTQ people’s health outcomes (especially mental health) throughout the pandemic thus far. Reviewing previously published KFF data and briefs, Lindsey reminded attendees that federal appropriations for HIV programs have largely stagnated for more than a decade and, when adjusted for inflation, have fallen. Despite the federal EHE initiative, seeking to jump start the country’s stagnating HIV progress, does not meet the funding requests of advocates. Large doubt remains as to exactly how much can be done with how little has yet to be given. For good reason, the audience was asked to consider if the existing roadmap is the “right” roadmap and what EHE might need to look like in the coming years in order to meet the goals of the initiative. Lindsey reminded attendees that 36% of PLWH live in Medicaid non-expansion states, including Georgia (which just last week shut down a proposal to expand the state’s Medicaid program to PLWH under a waiver). Moving onto a particular point with regard to access to care, tele-PrEP program successes (and weaknesses) could be attributed to flexibilities which have been the direct result of early policy answers to COVID-19. These flexibilities are among policies patient and provider communities stand to lose when the public health emergency comes to an end, unless legislators take action. Wrapping up her presentation, Lindsey drew attention to the health outcomes affecting a highly impacted patient population, LGBTQ people. Data from KFF showed LGBTQ people were more likely have received a COVID-19 vaccination series, more likely to consider COVID-19 vaccination a duty to community and others in an effort to help keep healthy, and more likely to have experienced negative mental health outcomes as a result of the pandemic.

I followed Lindsey’s presentation discussing the landscape of patient advocacy in the age of COVID. Recognizing COVID-19, despite any sentiment of the public at large, is not “over”. Considerations regarding in-person attendance to events, meetings, and travel are still in flex. Also recognizing the political landscape has significantly soured relative to “public health” in general, even if not to HIV, viral hepatitis, and substance use programs specifically, and that dramatically impacts both court rulings and legislators’ willingness to consider the crucial role “legacy” public health programs play in maintaining the health of the nation. Cautioning against potential neglect, rather than support (so much for the “heroes” of the early epidemic), I reminded audiences of the power of in-person events and the need to weigh precautions and monitoring of COVID transmission metrics when planning in-person events, regardless of how big or small they may be. Further on, the presentation focused on the structure of effective advocacy via storytelling, personalizing experiences, providing supporting data to make those personal experiences tangible among a constituency, defining an “ask” by knowing the mechanisms of action (re: actionable policy), and readily recognizing the powers, humanity, and limits of an advocate’s audience.

The final presentations, provided by, Katie Keith, reviewed historical and anticipated policy changes, including those relative to the Affordable Care Act (ACA) – specifically, the family glitch and section 1557 – and those as a result of early COVID-19 legislation, much of which is quickly coming to the end of their legislatively defined program periods, either by specified date or by way of ending the federally declared public health emergency. Katie reviewed how the Biden administration approached some of these issues upon transition to power, having already met 8 of the policy requests of advocates, have yet to meet 4 of those requests, and at least 1 request was “in progress” with potential for administrative resolution any day now (section 1557 final rule re-write, specifically defining the edges of the ACA’s non-discrimination protections. Katie also briefly discussed how the Dobbs (abortion) ruling may impact domestic public health programs, urged attendees to watch Kelley v. Becerra, and urged advocates to closely watch the 2022 midterm elections as legislators have an unbridled ability to impact public health programs.

Panelists wrapped up by reminding attendees they and their organizations remain a readily available resource. The slide deck can be downloaded here.

Pediatric Hepatitis of Unknown Origin: Are Viruses to Blame?

Navigating new and especially concerning developments can be challenging in the day and age of the Internet being the foremost platform for receiving up to date information…and misinformation. Navigating emerging evidence and opinions, prioritizing what “voices” hold prominence in your own formation of ideas can be difficult. I need to emphasize, the most reliable sources of information are official sources, those associated with government and institutions of positive reputation. Even if you have personal distaste for the approach or conclusions of these entities or personalities, their base facts are indeed facts, not conflation or cherry picking. Internet literacy is a critical skill set in navigating the most expedient tool of information. These details are particularly important as medical personnel and public health professionals turn their eyes to the developing issue of pediatric patients presenting with acute hepatitis “of unknown origin”.

At the time of this writing, more than 300 cases had been identified across more than 20 countries and at least 5 children have died. None of the cases being investigated have uncovered typical hepatitis viruses. According to a Centers for Disease Control and Prevention (CDC) brief, many of the cases in the United States have found active adenovirus infections. The CDC’s brief also “ruled out” COVID-19 as a cause. In the United Kingdom however, about 20% have uncovered active SARS-CoV-2 (the virus that causes COVID-19) infections. Other potential causes are being investigated as public health officials at the WHO and across are requesting providers share case data with local health departments in order to aggregate sufficient information.

Using the official CDC Director’s Twitter account, Dr. Rachel Walensky shared recently issued guidance to providers. The responses from users claiming a variety of expertise expressed concern at the CDC’s declaration that COVID-19 is not a potential cause for these cases. For these users, and likely parents watching the issue hit various news outlets, the omission of a potential for post-COVID responses seems odd and without an explanation and clarity as to investigative processes taken, doesn’t do a whole lot for repairing already deeply damaged public trust. Indeed, all of the readily available links on the issue from the CDC’s website exclusively point toward adenovirus, undermining the nature of investigative efforts to explore multiple potential causes. In contrast, the UK’s governmental updates outline why the COVID vaccine has been ruled out: most children affected are too young to have received the shots (the CDC’s briefing does not include this statement). The United Kingdom Health Security Agency’s latest update on this issue can be found here.

Part of why COVID is suspected is because of some of the unique features of the virus. A growing body of evidence is finding “pieces” of SARS-CoV-2 in a variety of body tissue, not just the lungs or brain as has been readily covered in other reports. One of the most persistent theories being tossed around includes hepatitis (generally, inflammation of the liver) as an issue of “long COVID” or a type of “post-viral” syndrome as a result of COVID infection. Part of the reason for that leap is SARS-CoV-2 has a special propensity for causing cell-to-cell fusion, resulting in “giant” cells with multiple nuclei and allowing the virus to spread in a body in an unusual fashion, evading the immune system. An additional concern is the issue of SARS-CoV-2 “superantigens” or a pathogen that “hyper-stimulates” immune responses. In one theory, currently being investigated, the super-antigenic effects of a COVID infection are being looked at as to the potential causation of multisystem inflammatory syndrome in children (MIS-C). Indeed, the issue is of such concern researchers have submitted to the Lancet (a leading scientific journal regarding infectious disease) an article urging providers to appropriately test tissue samples beyond blood in order to rule out potential long-lasting but harder to detect impacts of a SARS-CoV-2 infection.

Regardless of particular cause, at this stage, parents concerned about their children’s health should be aware that acute hepatitis tends to present similarly to most gastrointestinal bugs; abdominal pain, fever, vomiting, and nausea are common. Jaundice of the skin and eyes and darkening of urine are very key indicators something severe is occurring and needs immediate medical attention. Parents should contact their child’s provider if their children are expressing concerning symptoms.

Access Issues Remain: Protecting and Providing PrEP

Last week, I got to tackle the intersections of medication access and the issues of abortion and transgender health care. In doing so, I brought up one of the court cases I’m watching closely (and you should be too) as the next great attack on the Affordable Care Act (ACA). Kelly v. Beccera asks courts to strike down a portion of the ACA that outlines a requirement of services, care, and medications recommended by the United States Preventative Services Task Force (USPSTF) are required to be covered, with no “cost-sharing” to beneficiaries of a health insurance policy (or at no out-of-pocket cost to patients enrolled in a covered plan). Specifically, petitioners in the case object to the requirement because USPSTF gave a “Grade A” recommendation for preexposure prophylaxis for the prevention of HIV infections (PrEP).

The recommendation, originating with the USPSTF recommendation issued in 2019, and culminating in federal guidance offered in 2021, most insurers were put on notice to begin offering coverage for PrEP and support services at no cost to patients. However, according to an analysis by HIV + Hep Policy Institute, more work needs to be done to ensure payers were complying with the requirements of the law. State and federal regulators are tasked with evaluating benefit design, ensuring compliance, and enforcement when compliance fails. However, those regulators are deeply dependent upon patients and providers to initiate complaints about their experiences in payers who refuse to cover PrEP and the associated services necessary to maintain proper program adherence at no cost to patients. Successfully getting a complaint heard is time consuming and often difficult. Some payers have taken to a tactic of blaming providers for improper coding and billing as to why claims and coverage are being denied to patients. And while the law requires coverage of PrEP, it doesn’t stop insurers from implementing utilization management tactics, like prior authorizations (PAs), in which the insurer prefers a lower-cost generic medication over a higher-cost brand name medication. PAs are a deny and delay effort from payers that generally frustrate the process of a patient accessing the medication and care the patient and their provider has already determined to be of best interest to a patient’s health.

Sometimes, PAs can be an abusive. For example, one state’s public payer program required a PA in order for a patient to receive coverage for Cabenuva (Cabenuva is the treatment sister medication to Apretude, ViiV Healthcare and Janssen Pharmaceutical’s long-acting PrEP product). In this situation, the payer required patients to both be virally suppressed and have trouble swallowing their current oral medication – a complete contradiction to the medical science of HIV treatment. In terms of preventative medications, requiring a patient to fail their current treatment would necessarily mean requiring a patient to risk acquiring HIV unnecessarily – or worse yet to actually acquire HIV, negating the value of PrEP in the first place. Despite all of the value advancing pharmaceutical products and medication modalities may offer us, payers prioritizing costs over benefits realized by patients threatens to undermine the modern gains in the fight against HIV.

This point moves from acute to near painful when considering one pillar of the Ending the HIV Epidemic effort is prevention, the Department of Health and Human Service’s Ready, Set, PrEP program, and President Biden’s push to invest nearly $10 billion into PrEP and other HIV-related programing. But between payers limiting provider networks, provider bias leaving PrEP prescription largely to specialists rather than general practitioners, and the patient costs of navigating a complex payer effort to deny coverage at every turn, our highest ideals of accessible care come to a screeching halt.

Federal and state regulators must go beyond “calling” on payers to cover PrEP and the associated provider and lab services at no cost-sharing. They must refuse to certify payers without comprehensive PrEP coverage policies and practices as managed care organizations (MCOs) for Medicaid, marketplace plans, and qualified employer sponsored plans. If the practices of a payer substantially challenges a patient or provider from accessing PrEP, they are necessarily behaving in a discriminatory fashion. Regulators could require more proactive action on the part of payers to assume eligibility for particular PrEP medications, they could also require payers to “lock-in” medications and services meeting the USPSTF recommendation requirement without ability for mid-year adjustment, particularly with regard to formulary design, they could require payers receiving federal subsidy engage in patient satisfaction surveys as a meaningful engagement of patients and reflection of patient-realized access, they could simply make the penalties for failing to adhere to the law so painful as to not engage in these tactics. Much could be done to curb payer avoidance of covering necessary preventative care and we, as advocates, should readily challenge why these changes haven’t yet been made. And we’ll still have to tackle issues of access for our uninsured peers, often living at the intersections of greatest risk, we’ll still have more work to do to overcome provider bias and social stigma.

Making sure our regulatory structures meaningfully empower and enforce our legal protections as patients is an excellent first step in that process.

Jen’s Half Cents: Attacks on Abortion and Trans Care are Attacks on Medication Access

Coming into HIV advocacy, I was quickly introduced to this idea that access to life saving and life improving medications is a human right, best public health practice, and a public policy goal, something all stakeholders, public and private, held “on high” and were working toward. Everywhere I turned, “we must ensure access to life saving and quality of life improving medications”. I mean everywhere. This mantra was hammered home to me because antiretrovirals are medications that both save lives and improve the quality of life for people living with HIV and, thanks to the advent of pre-exposure prophylaxis (PrEP), people at risk for acquiring HIV. It is often the firm position of HIV advocates that restricting access to these medications is threat to life and quality of life and any such restrictions are an assault upon our lives. We fight day in and day out for programs and policies that safeguard access to care (medication and services). Every advancement is a fight and we have to muster up the same, very old arguments about the value of a patient’s life always being greater than the dollar sign attached to a medication.

That core piece is access to medication.

As the previous presidential administration issued rules that restricted international funding for those entities providing abortion services or referrals, I got antsy. Increasingly nervous and frustrated. In 2019, quite predictably, advocates confirmed those rules found impact primarily by reducing international aid to HIV services. Those rules also included one that required international partners to pledge to “denounce” sex work, a rule the Supreme Court upheld. Similarly, a whole slate of domestic policy moves sought to limit access to non-discrimination protections provided to people who sought or had an abortion and those who provided or referred a patient to abortion services. Those same rules sought to exempt transgender people and our care from non-discrimination protections. Of an important note: most abortions in the United States are medication abortions, not surgical.

If you’re new to these issues, let me help some. One of the first and most prominent methods of gender affirming medical care is by accessing medications falling under an umbrella of “hormone replacement therapy”, almost all of those medications are approved by the Food and Drug Administration and none of them have a specific indication to include gender affirmation (even cisgender folks – here’s looking at every old, cis guy who uses testosterone to feel young again). However, because medical experts generally agree these medications meet the needs of patients experiencing a wide variety of conditions, these medications are typically able to be written “off-label” or outside of their FDA approved indication. After years of advocacy and some last-minute push from the Obama administration regarding the Affordable Care Act’s Section 1557 (the non-discrimination provision of the law) , most private payers began covering some very basic transition-related hormone therapies (they were covering cisgender men seeking testosterone and other medications related to sexual performance for decades prior). The same rule prohibited covered entities from discriminating against people who had abortions, wanted abortions, or performed abortions. But Reed O’Connor, a long-time villain in the fight to defend the ACA, said “no” on the last day of 2016 and the guys who left the White House in 2021 agreed with him.

So here we are with this groundwork, this public health understanding that when people need care, they need as comprehensive care as they can get – as close to “one-stop-shop” as possible. And that’s true especially for people and communities experiencing the greatest disparities in health outcomes. Well-known among HIV advocates are the disproportionate number of women of color and transgender people living with and being diagnosed with HIV. The one thing all of these people, these patients need is medication access.

I need to not mince words, access to abortion is absolutely an issue of life improving care for someone who isn’t ready or doesn’t want a child. Adoption is not an option for a person who does not wish to complete a pregnancy and forcing them to do so by criminalization or by way of policy is state-sponsored seizure of that person’s body. Forcing a trans person (youth or adult) by criminalization or by way of policy is state-sanctioned violence. Denying people access to the medications that help them maintain their lives and the lives they wish to live is, at its core, an egregious attack on medication access.

Indeed, the next process-driven attack on the ACA is being pursued by plaintiffs that claim “moral injury”, if they should have to cover PrEP or contraception – issues of medication access. Kelly v. Beccera is, once again, in front of our previously mentioned judge, Reed O’Connor. We already know how this is gonna go. Meanwhile, we’re waiting on SCOTUS to decide the fate of Roe v. Wade (and possibly Casey), states are in the middle of a fight to beat everyone else to the punch. From proposing legislation that would criminalize access to abortion pills, to passing laws that criminalize providing gender affirming care to people under the age of 18, to passing laws that protect a person’s right to abortion and several states proposing bills that would protect families seeking safe-haven in order to provide children with gender affirming care, the landscape of US health care is becoming very fractured and much like some horror story of a wild west shoot out. Take a moment to ask if a state passes a law designed similar to Texas’ S.B. 8, wherein a private actor may sue a person for seeking or performing an abortion, that person runs to a state protecting those rights – or a parent ensuring their child is getting gender affirming care – exactly where does that fall? That’s not conjecture – how many families do you personally know who can afford the legal fight over jurisdiction?

Sure, we know where the executive branch of the federal government is gonna fall on this, at least until early 2025. But what then? Hope for the best?

HIV service providers need to get good with identifying quality lawyers and establishing relationships with their local or state queer and abortion advocacy organizations. And HIV advocacy needs to leverage our power to assist and uplift, not usurp, this issue. At the core of our work, we’ve maintained access to life saving and life improving medication is a must. We must not fail that mission now.

Sadly Predictable: STIs & HCV Rates Rising Again

The U.S. Centers for Disease Control and Prevention (CDC) recently shared data showing a rise in most sexually transmitted infections (STIs) in 2020, despite a reduction in screening due to the COVID-19 pandemic disrupting public health programs aimed at STIs screening and treatment. While the statement focused on syphilis, chlamydia, and gonorrhea, Hepatitis C and HIV can also be transmitted via sexual contact. Dr. Juno Mermin, the CDC’s Director of the National Center for HIV, Viral Hepatitis, STD, and TB Prevention, blames some of the issue on a historical lack of investment in public health and stigma.

While Dr. Mermin’s sentiments are well appreciated, the potential for a developing “blind spot” as a result of COVID-19 diverting already scarce resources serving these programs in order to address COVID-19, including human resources (disease investigation specialists – DIS – to be specific), was well-noted and should not be considered to be well-understood as of 2022. Public health surveillance and other aspects of infectious disease monitoring have been direly harmed by the diversion of these brain and labor trusts as opposed to a national effort to strengthen these amid a compounded public health emergency. Indeed, we’re just now beginning to assess the potential damage caused by COVID-related disruptions in pre-existing public health programs, specifically those designed to address STIs. And while we’re doing all of this effort to better understand what’s happened, we’re at risk of state legislators underappreciating the necessity of the moment as politically driven distaste for public health programming is resulting in states considering massive cuts to their health departments (ie. Louisiana’s House just passed a budget gutting the health department by $62 million, despite the agency struggling to recruit and retain talent due to years of disinvestment – and Louisiana isn’t alone).

The disease burden of these rising infections falls most heavily among Black communities and young people, with a special note to be given to the incredible rise of congenital syphilis infections, especially among impoverished pregnant people struggling with access to care. Dr. Mermin has emphasized a need to invest in both public health programs and prophylactic vaccines to prevent the bacterial infections. To be clear, when we talk about public health investments, we mean:

• funding increases so that public programs can compete with private industry for labor and talent recruitment and retention;

• infrastructure increase so that health departments and their funded service contractors and grant subrecipients can afford things like modernized software, functioning computers, and integrated data systems that aren’t reliant on fax machines;

• flexibilities and appropriate funding for support services, especially those designed to address housing needs of served communities;

• federal funding leveraged to increase linkage and retention in care services (including transportation to medication retrieval as well as medical service visits); and

• federal funding incentivizing stigma and bias reduction in medical and service providers who are also grant recipients and subrecipients.

In addition to public investments, private investments are long overdue in terms of antibiotic treatment developments, especially with regard to multidrug resistant STI-causing bacterium. The last time a truly novel antibiotic was developed was 35 years ago in 1987 and the [pipeline isn’t looking particularly promising. The lack of investment in developing more effective and new antibiotics is so stark, Pew just kinda gave up on tracking it in December 2021.

Beyond access to care and treatment, education regarding STIs has been under attack for…well…as long as any of us can remember and 2022 has found politicians claiming this kind of education, when presented comprehensively, might be considered “grooming” children (referring to psychological training of vulnerable people to make them more compliant with being sexually exploited and assaulted). Despite thirty years of research showing comprehensive sex education reduces the incidence of STIs among youth and well into adulthood politicians continue their assault on public by making particularly disingenuous claims regarding the nature of sex education n publicly funded schools. Let me back that up, these folks are outright lying in order to leverage fear, ignorance, and already existing social tensions to exploit and marginalize already vulnerable populations.

The unfortunate nature of public health, especially for those who had zero knowledge of public health prior to COVID-19 screaming onto the scene, is the more we disinvest, the more harm we see come to those communities and people who can least afford the ability to cope with said harms. The further we lower the bar on medically focused sex education, the more likely young people will have to face higher rates of youth pregnancy, HIV, and STIs. The more we see attacks on and defunding of health departments, the fewer people are going to want to work there.

We need the political will, the private support, and collaborative spirit of advocates across issue areas to face this moment. Syphilis untreated or untreatable is deadly, gonorrhea and chlamydia untreated or untreatable can and will render people infertile among other permanent injuries to internal organs, and untreated HIV and HCV is also deadly. The communities most affected by these illnesses are also least likely to be able to afford health care, housing, and have adequate health insurance. The people most affected by these illnesses are often Black, Brown, young, queer, or assigned female at birth. We need to care more about achieving health Justice and we need to do it together.

DOJ: ADA Protections Offered to People Living with Opioid Use Disorder

Every time something big comes up in the way of protections interpretations, I take a moment to recognize the incredible work done by the disability community. I also do my best to remind anyone who will listen the folks at the center of disability rights and protections have been laying the ground work for many of the policy issues for…well…ever. If we’re to build successful coalitions, it is our obligation to stand with one another both in our specified areas of interest and in alignment with those organizations that share the best interests of the communities we seek to represent. I was reminded again of how much we owe to disability advocates on April 5th, as the Department of Justice (DOJ) issued new guidance on protections for people living with opioid use disorder under the Americans with Disability Act (ADA).

Take a moment to read through the breadth of this guidance. It’s eight pages of gloriousness that builds on previously issued factsheets and settlements. What’s of particular note is the strength of language the guidance uses with regard to describing Title II discrimination, hinting the Department of Health and Human Services (HHS) and DOJ are gearing up to target state and local governments and their agency and court instruments for enforcement action, including family courts.

To be clear, the explicit language of the ADA prohibits the protections being applied to actual or perceived “active use of illegal” substances. However, people who use drugs seeking treatment or “rehabilitation”, regardless of modality (including medication assisted treatment), or those who have previously used drugs are protected under the ADA from having that history used against them by:

• any government entity;

• any private entity administering public services (like privatized jail systems); and

• any entity providing public accommodations (generally, any business open to the public and most employers)

The guidance specifically cites an example: “A town refuses to allow a treatment center for people with OUD to open after residents complained that they did not want ‘those kind of people’ in their area. The town may violate the ADA if its refusal is because of the residents’ hostility towards people with OUD.” This speaks to the long-held issue many programs have faced for decades, including zoning law adjustments and refusal of permits, for treatment facilities and half- and three-quarter-way houses to be established in neighborhoods. As the DOJ is still in talks with SafeHouse to establish a safe consumption site, a harm reduction facility in which people who inject drugs may receive sterile supplies or medical supervision with the explicit purpose to intervene in overdoses, reduce transmission of infectious diseases, and offer linkage to care, including recovery services. If treatment facilities are protected under the ADA, would treatment referral entities also be protected? Indeed, in paragraph 5 (five) of the document, the DOJ explicitly states “…an individual cannot be denied health services, or services provided in connection with drug rehabilitation, on the basis of that individual’s current illegal use of drugs…”.

This is a clear sign the Biden administration has decided that part of combating the country’s “Opioid Crisis” means combating social stigma by providing protections to people with substance use disorder. This is the rather blunt and litigious means of moving the needle on stigma associated with substance use, but when empathy fails, policy priorities must speak through litigation.

DOJ and other enforcement entities generally do not initiate investigations or enforcement actions on their own and are highly dependent on the public to file complaints. If you suspect you have been discriminated against on the basis of a perceived or actual disability and/or perceived or actual impacts to your daily living, you may file a complaint by clicking here.

Industry’s Changes to 340B Drug Discount Program

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

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

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

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

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

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

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

·        develop other programming clinics specifically identify to work collaboratively.

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

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

Provider Survey: Prior Authorizations Harm Patients

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

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

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

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

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

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

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

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

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

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

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

Treatment Restrictions Hampering Hep C Harm Reduction Efforts

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Reducing Medication Abandonment; Improving Retention in Care

In early 2021, Riley Johnson, the community co-chair for Florida’s Comprehensive Planning Network, and Kim Molnar, the Director of The AIDS Institute’s Center for Convening and Planning, reached out to me to discuss a more and more pressing issue the state’s pharmacies were noticing: medications patients weren’t picking up. Their primary concern was understanding the scope of the problem and developing interventions appropriate to ensure the state’s Ryan White clients were getting the medications they needed. How does this problem fit into the state’s Integrated Plan and Ending the HIV Epidemic efforts?

The question of scope is one highlighted in a recent report from the trade organization known as PhRMA (Pharmaceutical Research and Manufacturers of America). The report focuses on how medication abandonment is a symptom and measure of health equity (or inequity, as is the case). Comparing the rise in high cost-sharing commercial insurance plans and medication abandonment from between 2016 and 2020, there’s a clear association. Not only did medication cost-sharing increase on new brand name medications, the out-of-pocket costs of many existing brand name medications increased and with those rises in costs came a rise in medication abandonment.

Insurers set the prices end-user patients have to pay at the pharmacy counter and increasing these costs effectively allow for these payers to defer expenses on care. When out-of-pocket costs reached $125 at the pharmacy counter, medication abandonment increased from 40% in 2016 to 58% in 2020. Across all prescriptions, medication abandonment only rose by 4% for the same timeframe, from 10% to 14%. It’s important to note these high cost-sharing medication because they’re often those assigned to chronic conditions, like diabetes, HIV, and hypertension, in which generic options aren’t’ as effective, have difficult to manage side effects, or aren’t even available. Indeed, our providers prescribe particular medications because those medications are appropriate to our individual and personal care.

Digging in further, PhRMA recognized an immediate disparity in who was not picking up their medications. On average, Black patients were 7% more likely to abandon new medications than their white peers. The disparity was particularly high among patients seeking pre-exposure prophylaxis for the prevention of HIV (PrEP) with Black patients 41% more likely to abandon a new fill compared to their white counterparts. Similarly, when a medication’s out-of-pocket cost rose to $125 per fill, PrEP again out paced other medication classes with a 34% disparity between Black and white patients. On the issue of income, between patients who earn less than $50,000 per year (lower-income) and those earning more than $100,000 per year (high-income), lower-income patients were 16% more likely to abandon their medications compared to their high-income peers, in an overall analysis.

PhRMA offers a few policy solutions to help overcome the cost-at-the-counter barrier; 1. Sharing the rebate and discount savings offered to pharmacy benefit managers and health insurers by manufacturers directly with the patients, 2. Covering particular medications from “day one” of benefits, rather than requiring a separate pharmacy benefit deductible to paid first, and 3. Ensuring all value of manufacturer patient assistance programs be credited toward patient deductibles, copays, and out-of-pocket maximums. The report also urges investment in better understanding the root causes of medication abandonment, as one of the limitations of the review includes not being able to account for factors like stigma, the effects of racism, education, or other social determinants of health.

In even this brief, yet national, review of medication abandonment, the necessity of intervention is obvious. That last bit, accurately understanding the “why” and offering an opportunity to intervene is exactly why Louisiana’s Ending the HIV Epidemic plan includes improving data sharing agreements and aims to reach beyond Ryan White funded entities to include the state’s Medicaid program and encourages appropriate coordination for the benefit of patients who need some extra help. When a patient has failed to pick up a medication, it’s the first sign a patient may not yet be ready to start a particular therapy or other barriers to care are pressing enough they’re prime to drop out of care. Improving retention in care by utilizing real-time data or software tools to notify an interventionist, be they case managers or peers, when a patient is struggling to pick up their medications would allow for programs to reach-out, identify the particular barrier a patient may be struggling with and empower or assist them in navigating that barrier. Data collected from these engagements is critical to better understanding and actively quantifying various barriers to care and better targeting individual and community wide interventions.

Medication abandonment is but one issue in which creative solutions, better data sharing while appropriately protecting patient data, and thoughtful considerations from the patient perspective can drive meaningful change.

Making All Copays Count is a Critical Tool in Patient Access to Care

Making sure patients can access and afford the medications that save lives and maintain a dignified quality of life is the singular goal of Patient Access Network Foundation’s programming and advocacy. The primary way patients interact with PAN Foundation is through programming aimed at funding the care needs of patients via grants or linkage to other funds, including covering the costs of transportation and food, if needed. The other work PAN Foundation does is directly aimed address the why the entity is needed in the first place: advocacy around health care policies directly addressing the high out-of-pocket costs of care and medication. To that end, squarely in the target for PAN Foundation’s 2022 agenda is tackling so-called “copay accumulator” programs enacted by private insurers, particularly pharmacy benefit managers, as a means of double dipping into the flow of funds and denying patients the maximal benefit of patient assistance programs.

The Hepatitis B Foundation defines a copay accumulator (or accumulator adjustment program) as "a strategy used by insurance companies and Pharmacy Benefits Managers (PBMs) that stop manufacturer copay assistance coupons from counting towards two things: 1) the deductible and 2) the maximum out-of-pocket spending." In years prior to copay accumulators as a practice, manufacturer copay assistance programs might issue a healthy benefit that would be applied to the out-of-pocket costs or deductibles a patient is required to pay their insurer. This resulted in the patient fanatical responsibility spending down based on the value of the patient assistance program (PAP), rather than the actual dollars spent by patients, extending affordability of accessing care and medications for patients. It was glorious, honestly. Let’s have a “back of the envelope” example:

Deductible: $1500
Out-of-Pocket Cap (In-Network): $3000
Co-pay: $150 per 30-day fill

Patient Assistance Program Benefit: $7500

Previously, a PAP would cover the initial deductible and all of the plan year’s co-pays while counting toward that maximum out-of-pocket cap all counted as something a patient paid into the plan. Now, insurers keep the entirety of the benefit and only count the $150 co-pay toward what a patient has paid into the plan. This process demands patients pay for those costs themselves and the insurer gets to keep all of that $7500 value from the PAP. Ultimately, this tactic increases patient costs.

PAN Foundation executive vice president, Amy Niles, argues “These discriminatory policies reduce access to critical and often life-saving prescription medications.” And she’s right.

Deductibles and co-pays are generally called “cost-sharing”, which is a bit of a misnomer because patients must pay the deductible before an insurer begins paying the benefits the plan offers. This means pre-deductible costs are not “shared” by anyone but patients. With only about 4 in 10 Americans with enough money in the bank to cover an unexpected expense of $1000 or more, one of the tactics insurers are using to minimize patients actually accessing care is by increasing deductibles. PAN Foundation polled adults and seniors on Medicare and found most couldn’t afford even $100 medical emergency. Advocates, myself included, argue insurers are seeking to limit patients even initiating care (or continuing pre-existing care from previous years) by making those initial payments due too expensive to afford in the first. Can’t get your meds if you can’t afford to see the provider prescribing them, right?

This level of insanity is firmly in the realm of the Centers for Medicare and Medicaid Services to regulate and, indeed, the previous administration issued a rule in 2020 that expressly allowed co-pay accumulators and the Biden administration sided with insurers over patients when it came to this same issue in 2021. Despite calls from advocates, the payment rules for 2023 (announced in 2022) do not address this abusive practice. Some states have introduced and even passed legislation that expressly requires some, but not all, insurers to apply the total value of PAPs to patient costs. However, no national law currently exists to prohibit co-pay accumulators.

All of this is why PAN Foundation and numerous other patient advocacy organizations have come together as members of the All Copays Count Coalition and are urging congress to pass H.R. 5801, the HELP Copays Act, which would require all additional payments, discounts, and other financial assistance be applied to the cost-sharing patients are expected to pay into a health care insurance plan.

If we’re to realize the maximum benefit of manufacturer patient assistance programs, family dollars being spent to help patients, and charitable foundation dollars are being appropriately applied in a fashion that maximizes patient access to care, we have to make all copays count.

PAN Foundation has even made it easy to take action today.

[Disclosure: Amy Niles, Executive Vice President of PAN Foundation is a long-standing board member for Community Access National Network]

Jen’s Half Cents: Supporting Patients by Supporting Families and Survivors of Intimate Partner Abuse

I’m a family man. I always have been. I tend to write in the evenings or at night and I like to do so sitting in bed. As I write this, my partner has dozed off next to me and her children are sleeping down the hall after a busy day of school and family time. I’m thinking about one colleague who had a health scare over the last couple of days (he’ll be ok) and the depth of emotion between worry and love is something that I can near physically feel. My sense of family is strong and the relationships I consider familial extend to a very select group of colleagues in the space of patient advocacy. I’ve often cited that sense of family as part of what keeps me happy in this work. That love is one I am fortunate to have and it’s something I like to remind folks of from time to time, in part, because this work is hard and paying witness to struggles comes with its own emotional toll and reminding colleagues we are driven to this work from a sense of justice and love is often…refreshing, reinvigorating.

A few years ago, at one of ADAP Advocacy Association’s first Fireside Chats, one of my most favorite industry partners, and one of the most brilliant people I’ve had the pleasure of knowing, raised the issue of intersections between the dual epidemics of HIV and substance use. Particularly, she focused on needing to raise awareness of long-term risks for those experiencing non-fatal overdoses, those intersections with infectious disease, and how public health programming would be better served with a more holistic approach to patient care, rather than the often-segmented or siloed environment we still have today. While more syringe services programs are adopting HIV and Hepatitis C testing and linkage to care activities and more HIV programs are offering more competent care for substance users, especially around medication assisted treatment, outside of these activities, there’s little being done to ease the high burden on patients to coordinate their own care across multiple providers or entities. National strategies and funding certainly prioritize referrals, but referrals aren’t the same as successful linkage, successful linkage isn’t the same as retention in care, and at the point of patient experience and meeting public health goals, those distinctions are important. I am of the somewhat unpopular opinion among some recipients and subrecipients that program metrics and grant awards should reflect these differences but that’s for another discussion.

My friend would move the discussion forward by talking about how powerful and moving testimony and advocacy from affected mothers and families, targeting these voices for education on the intersection of infectious disease and substance use, building coalitions would serve to advance the interests of both of these patient communities and especially so for patients living at the intersection of these conditions. As I was meeting with her in December of this year, I had to tell her, “I think about this conversation a lot.” And I do. Years later, this conversation pops up in my mind as I think about patient stories and priorities, different data about isolation as a predictor of substance use or how social supports are clear indicators in successful retention in care and viral suppression. We dedicate a massive chunk of behavioral health resources to ensuring patients have social supports precisely because having those supports is such a strong indicator of successful care. I often find myself thinking about the role families play in being a primary source of social support for many people, how ever we define family for ourselves. I think about this role of family when I assess intimate partner abuse data or read about how mothers experience legal abuse as a form of coercive control in custody situations. I think about it anytime we approach the issue of caregiver supports. I certainly thought about it last year when I wrote about how family courts and child welfare agencies are missed opportunities for linkage to care. I thought about the role of family and that conversation when a former co-worker was being stalked by the father of child at work and the employer failed to support or protect her. I thought about that conversation when recently asked to provide input on an academic institution’s midwifery committee and when a couple we’re friends with announced they’re going to start working to have another baby. I think about that conversation at every headline involving COVID and kids and how the financial supports extended in 2020 and 2021 reduced child poverty. I thought about that conversation while listening to a constituent impact panel on HIV criminalization in the state of Louisiana, how much patients rely on their families to advocate, navigate, support, and love them through what ever health challenges they may be facing. I think about that conversation when considering my own end of life planning and what I want for my family.

I found myself thinking again about that conversation and the need to better support families through public policy as one of many vehicles necessary for addressing the needs of people living with HIV, eliminating Hepatitis C, and tackling the substance use epidemic. I thought about that conversation last week as a bipartisan group of Senators introduced the Violence Against Women Reauthorization Act of 2022, after 3 years of failing to advance a reauthorization. As I read through the bill, I was happy to see funding for marginalized populations, including at-risk populations in Alaska and LGBTQI+ communities. I was happy to see Senators invest funding in directing a federal study on how parents alleging intimate partner violence are likely to lose primary custody over their children, already knowing how abusers leverage family court processes as a means of post-separation abuse is well-documented. I was happy to find a similar study on the association between intimate partner violence and substance use, specifically, how intimate partner violence increases the risk of substance use. I was disappointed to see a failure to more directly require family courts to be educated as to these issues because regardless of those study outcomes, families are weakened when abusers are able to leverage divorce proceedings as a means of further abusing their victims.

I think about all of these things when I think about what our advocate partners and funders are willing to take up as an issue worthy of their labor and dollars. While “mission creep” and maximizing our limited resources are certainly issues patient advocates and our funders must balance, we also have a moral and ethical calling to consider how those whose interests we seek to represent must also be represented holistically in the actions we take. More directly, those providers, patient advocates, and our funders should work to support public policies aimed at strengthening families and ending intimate partner violence on national and state levels. Today, we can do so by vocally supporting the long-overdue reauthorization of VAWA.

Cabenuva Approved for 2 Month Injections; Insurers Remain a Barrier to Access

In late January of 2021, ViiV Healthcare and Janssen Pharmseutical Companies announced the Food and Drug Administration’s (FDA) approval of the first extended-release injectable medication regimen for the treatment of HIV as a once-monthly administration, branded as Cabenuva. Eleven (11) months later, the FDA approved cabotegravir as an extended-release injectable suspension for the prevention of HIV as a once-every-two-month administration, branded as Apretude. Again, on February 1, 2022, the FDA expanded Cabenuva’s administration to be a once-every-two-month administration. Near overnight, people living with HIV-related medication therapy and prevention efforts went from a burdensome three-hundred sixty-five (365) pills to six (6) injections.

This kind of innovation has been long anticipated and while advocates and patients recognize not every patient will desire to switch to injectable medications and resistance profiles may require some people living with HIV to maintain their tablet regimens, injectables offer yet another tool in the tool box. The extended-release nature of injectables offer an opportunity to overcome “treatment fatigue”, reduce opportunities for missed doses and subsequent treatment resistance, and even address safety in storing medications at-home – especially for those people living with and at risk for acquiring HIV that may also be experiencing houselessness. This becomes even more of an astounding tool, in addressing disruptions in care when patients live in areas prone to natural disasters, as seen in Florida during Hurricane Michael when the state’s central pharmacy operations came to a halt, forcing the state to rely on a private-public partnership with CVS, and in Puerto Rico after Hurricane Maria, in which patients lost access to life-saving medications. The issue of natural disasters interrupting care is not new and will likely be something providers and patients need to have plans for as every indication exists climate change will produce more and more powerful hurricanes. Indeed, despite the lessons learned from Hurricane Katrina, I personally witnessed multiple calls across social media channels among people living with HIV seeking additional medication in order to manage loss of their anti-retrovirals in 2021, during Hurricane Ida. Despite the state of Louisiana and the department of Health and Human Services declaring a public health emergency and activating the Emergency Prescription Assistance Program for uninsured and underinsured patients, anecdotal reports found the program hard to manage for those who needed daily administration of medications.

Yet and still, despite these incredible advancements at our finger tips, both public and private insurance programs remain reticent to allow patient and provider choice to guide what therapies patients actually have access to. Indeed, one of the largest payers in both the public and private spaces is CVS Health, who, on December 16, 2021, published priorities in “weighing cost” versus clinical benefit while specifically naming cabotegravir as an active agent in Cabenuva and Apretude. The payer outlines tactics known as “utilization management” to include initially blocking coverage of new drugs, “strongly favor[ing] generic use”, and “select[ing a] preferred agent generating lowest net cost option in category”. Even some AIDS Drug Assistance Programs (ADAPs) are delaying adding the innovative therapy to their coverage formularies. All of which creates a system of care where people living with HIV are experiencing limitations on their access to effective therapies based on their income, rather than their need as determined by them, as patients, and their provider. Deny-first utilization management practices risk losing people to care by creating unnecessary and burdensome administrative process and delays.

When Cabenuva was first approved, advocates in the community and among public services stressed concern about getting patients to return for monthly shots and the logistics of administering the shots. The concern on costs to public programs also raised its head and has done so even more recently as a limited study concluded Apretude wasn’t “cost-effective”. However, in the time since these initial discussions, tens of millions of people have received their COVID-19 vaccines, which are situated a mere 3 weeks apart and variant development has left many experts expecting the need for annual boosters of the same. The logistics of administering shots have clearly been addressed. As for the “cost-effectiveness” study, the limitation the authors cite is one that’s patently…ridiculous: “Uncertain clinical and economic benefits of averting future transmissions.” We well know the clinical benefits of preventing transmissions means fewer HIV diagnoses, a goal outlined by the United States’ federal government in the Ending the HIV Epidemic initiative, and the economic realities of preventing new transmissions is as apparent in reducing the costs of care associated with stagnant or even rising transmission rates.

The truth is, long-acting anti-retroviral therapies are the next step in innovation at extending effective care to people at risk of acquiring and living with HIV. These advancements will come with a cost that is significantly outweighed by improvements in patient quality of life, retention in care, and reduction in new transmissions. If we aren’t careful in ensuring equitable access to these innovations, existing health disparities will only grow. Barriers to care originating from payer processes, from formulary inclusion to co-pay accumulator programs, should be well-documented by providers and advocates need to be forceful in seeking access to these innovations for all patients, regardless of income or economic status. Policymakers, lawmakers, and regulators need to move quickly to address these barriers. Innovation waits for no one and that which exists in the balance between these interests are people’s quality of life and their very lives.

Congress Eyes Equipping Providers to Combat the Opioid Crisis; The MAT Act

A year ago this month, Representative Paul Tonko introduced H.R. 1348 to the House of Representatives and Senator Maggie Hassan (NH) introduced its companion bill, S. 445, to the Senate. Both of these bills hold the short title “Mainstreaming Addiction Treatment Act of 2021”. The House version boasts 239 cosponsors with the Senate version enjoying 3 cosponsors. Both are supported on a bipartisan basis. The most recent action on the MAT Act is Senate “HELP” (Health, education, Labor, and Pensions) Committee hearing on February 1st, 2022, wherein the committee discussed and heard testimony on issues of mental health amid the COVID-19 pandemic.

End Substance Use Disorder, an issue education campaign endorsing the MAT Act, describes the more than a century old policy of outlawing medication assisted treatment as “outdated” and a moralization of a medical condition. Founded by Erin Shanning after her younger brother, Ethan, experienced a fatal overdose, the organization seeks to educate legislative stakeholders and urge action to adopt a more modern and medicalized approach to substance use disorder. The MAT Act removes the prohibition on providers on prescribing certain medications for the treatment of opioid use disorder maintained in the Controlled Substances Act and entirely removes the necessity for the DEA waiver of this prohibition, known as the “X” waiver. According to ESUD is joined by 418 organizations have either directly supported the MAT Act or have voiced support for eliminating the X waiver, including criminal justice and law enforcement entities. For immediate transparency, Community Access National Network is one of those 418 organizations.

This relatively straight-forward bill would help to expand access to care – especially in rural communities, move public policy into better alignment with research-proven best practices, combat racialized public health disparities, better support families, reduce overdose deaths, and more. Directly, the most immediate and significant impact of the MAT Act is an expansion of providers eligible to prescribe medication assisted treatment, specifically including certain community health practitioners. The only apparent opposition to the MAT Act is a group representing the interests of commercial addiction treatment centers.

With overdose deaths having skyrocketed by at least 20% in 2020, relative to 2019, emphasizing the need to press forward with the MAT Act is the least the Biden administration can do to begin to meet its promises around drug reform and health care access. Mental health and substance use service providers still need more support from the federal government in order to meet the need of the moment. Equipping providers with tools like medication assisted treatment, improving (read: increasing) Medicaid reimbursement rates for the treatment of substance use disorder, working to destigmatize the issue of substance use disorder, and more explicitly issuing Department of Justice guidance to family courts, social service organizations, and employers on protections afforded under the Americans with Disabilities Act for people recovering from substance use disorder are the least in a long list of actions this administration can take today.

If you would like to urge your elected representatives to remove barriers to care for clinically-proven, best practices in harm reduction, follow this link and to add your organization’s name to ESUD’s letter of support for the MAT Act, click here.