Beyond the Test: Ensuring Linkage to Care After HIV Self-Testing
HIV self-test kits have emerged as a pivotal tool in the fight against HIV/AIDS, offering a private and convenient method to determine one's status. The World Health Organization endorsed these kits in 2016, marking a significant step in global HIV/AIDS prevention. The COVID-19 pandemic further highlighted their importance as traditional testing declined, with the Centers for Disease Control & Prevention (CDC) emphasizing their role in ensuring continued access to HIV testing.
In the U.S., 14% of the estimated 1.1 million people living with HIV are unaware of their status. Men who have sex with men (MSM) have a particularly high prevalence of undiagnosed men with sero-positive status. Yet, a study in JAMA Network found that only 25.7% of MSM in urban areas had used an HIV self-test. This limited adoption and data indicating that many don't pursue necessary treatment or prevention post-testing, highlights the challenges ahead.
HIV Self-Testing: Nuances and Linkage to Care
HIV self-test kits, endorsed for their easy access to HIV testing, come with detailed instructions for self-administration and result interpretation. However, users are strongly advised to verify their results at a healthcare facility, particularly if they end up with a reactive (“positive”) result.
While the potential of HIV self-testing is evident in its ability to increase the number of people aware of their HIV status, the real challenge lies in ensuring that those who test positive are seamlessly linked to appropriate medical care and support. A study in The Lancet highlighted a significant gap in connecting these individuals to post-testing HIV care. This gap is alarming, considering the importance of early intervention in HIV management, which not only benefits a person’s health but also reduces the risk of transmission.
A systematic review by The Conversation further emphasized this challenge:
There's an 8% increase in users finding an HIV clinic post-testing.
A significant number of users did not initiate HIV treatment or PrEP after self-testing.
Women sex workers were 47% more likely to seek medical care post-testing, yet testing rates among clients of sex workers remained unchanged.
MSM users might engage more in condomless anal sex post self-testing.
One major obstacle in this linkage to care is the lack of localized resources accompanying the test kits. For example, kits from OraSure, a leading manufacturer, provide general post-test advice but often lack specific resources or directions for localized care, leaving people, especially those testing positive, uncertain about their next steps.
To address these challenges, it's crucial to not only link people to care but also ensure they access the necessary treatment and preventive measures. Strategies that have proven effective in bridging care gaps for chronic conditions, like hepatitis B, can be adopted. Leveraging community-based participatory approaches, partnering with community organizations, and implementing robust referral systems can ensure that people receive the essential care and support post-testing.
Benefits, Hurdles, and Real-World Implications of Self-Testing
HIV self-testing offers a private and convenient alternative to traditional methods, addressing barriers such as transportation, stigma, confidentiality concerns, and outdated HIV criminalization laws. A Vital Signs report from 2016 revealed that 38% of new HIV transmissions were from people who were unaware of their status, emphasizing the need for increased testing. The CDC's eSTAMP study found that self-tests doubled the likelihood of MSM identifying new HIV transmissions.
However, challenges persist. Many users, despite recognizing their status, don't or can’t take subsequent necessary steps, such as pursuing HIV treatment or initiating PrEP, as highlighted in The Conversation. Additionally, functional considerations like storage conditions play a role in the effectiveness of self-tests. For instance, the OraQuick test should be stored between 36°F and 80°F, a factor that becomes increasingly relevant in the face of climate change, hot summers, and extended transit times. Similarly, self-testing kits produce physical evidence of screening that needs to be discarded by the person using the test. If that person is in a safe, welcoming situation, storing the test or disposing of the materials from the test might result in risks of experiencing stigma, discrimination, or even harm.
Accuracy in self-testing is paramount. The OraQuick In-Home HIV Test claims over 99% accuracy for negative results and 91.7% for positive ones, though the testing window period can influence accuracy. Users appreciate the autonomy self-testing offers, but it should be part of a broader strategy, complemented by counseling and care linkage and stigma reduction, as emphasized by The Lancet study.
Financial Incentives and Real-Life Implications:
In many studies evaluating the effectiveness and adoption of HIV self-tests, participants were often provided financial incentives to report their test results. This approach ensured a higher rate of result reporting and offered insights into user behavior post-testing. However, in real-life scenarios, such financial incentives are absent. This discrepancy raises concerns about the actual rate of result reporting and subsequent linkage to care when people purchase and use these kits outside of a study environment. Without the motivation of financial incentives, there's a potential risk that some people might not seek further care or counseling after a reactive test, especially if they lack access to localized resources or support systems.
Economic Factors, Barriers, and the Way Forward
Self-testing presents a promising avenue to increase HIV status awareness, but economic and psychological barriers hinder its adoption. The CDC found that 61% of Americans had never been tested for HIV, and less than 30% of those most at risk had been tested in the preceding year.
The CDC's eSTAMP study highlighted the effectiveness of mailing free self-tests, with recipients being more likely to discover their HIV status. Such initiatives are cost-effective, with potential savings of nearly $1.6 million in lifetime HIV treatment costs, as estimated from the eSTAMP trial.
Despite these advantages, challenges like misconceptions about HIV risk, unawareness of self-tests, and cost considerations persist. Additionally, the emotional toll of a reactive result, especially when received alone, is a significant concern. The CDC's efforts to make HIV self-testing more accessible are commendable and addressing these barriers is essential for the initiative's success.
Conclusion
HIV self-testing is a crucial and beneficial tool in our ongoing fight against the HIV/AIDS epidemic. Yet, as with any innovative solution, it's not without its challenges. The true measure of our commitment to Ending the HIV Epidemic lies not just in the tools we develop but in the systems we put in place to ensure their effective use. As we embrace the promise of self-testing, we must also confront the gaps in linkage to care, address the barriers to widespread adoption, and ensure that every person and community, regardless of background, has the support they need post-testing.
We must ask ourselves: Are we doing enough? Are we truly leveraging the potential of these tools to make a lasting impact? The answers to these questions will shape the trajectory of our fight against HIV/AIDS.
Healthcare advancements are made every day, and it's our collective responsibility to ensure these innovations reach and benefit all, especially the most vulnerable among us. As we move forward, let's commit to not only advocating for the tools but also for the comprehensive systems of support that make them truly transformative. Because in the end, it's not just about testing; it's about reducing stigma, saving lives, building healthier communities, and creating a future free from the shadow of HIV/AIDS and that’s worth investing in.
Mid-Year Public Health Policy Update
Ya’ll…the last 4 months have been wild.
Let’s start with the “win”, shall we?
Last week, the Supreme Court of the United States (SOCTUS) issued its ruling in Talevski, authored by Justice Jackson and siding 7-2 in favor of patients’ private right of action to initiate lawsuits when their rights issued by law or regulation relative to a federally funded program are violated by an entity paid under that program. Now, the Taleski family still has to go back to district court to fight the Health and Hospital Corporation of Marion County (HHC) – SCOTUS just denied the effort by HHC to claim patients didn’t have a right to seek remedy when the payor was the government. As we described in January, this idea that patients couldn’t initiate lawsuits when federally funded programs weren’t administered fairly or didn’t comport with the statutory language or regulatory definitions is pretty bonkers. Indeed, for most actions regarding any kind of federally funded programming, the government typically comes in after the fact and those injured have to initiate the court processes themselves. Some advocates, particularly disability and Medicaid advocates, called the potential of the court to rule restrictively in Talevski “the Dobbs of Medicaid”, and urged the parties to consider settling ahead of a ruling. However, the potential crisis was averted because, as Justice Jackson put it, “Hewing to [the relevant statute]’s text and history (not to mention our precedent and constitutional role), we reject HHC’s request, and reaffirm that ‘laws’ in [the statute’s text] means what it says.”
Fancy that, laws meaning what they say.
Speaking of laws and problematic folks tryna skirt them, the 5th Circuit Court of Appeals heard oral arguments as to the stay – not the whole merits of the case – of Judge Reed O’Connor’s effort to strip the Affordable Care Act’s (ACA) preventative coverage mandate by way of extraordinary bigotry – targeting HIV prevention medication because “ewww, the gays”. As our friend, Chris Geidner, over at Law Dork covered those arguments and boy howdy! I wouldn’t wanna be Jonathan Mitchell – well for a lot of reasons but this one is pretty good, too. Mitchell’s name should look familiar as he’s arguing for book bans, helped author Texas’ head-hunting abortion law known as SB8, and is, in general, a deeply rotten human being. During thee oral arguments Mitchell fell more than a little flat, in no small part because the Department of Justice’s attorney, Alisa Klein, was gracious in asking “what’s the harm in putting in a stay?” In essence, she argued the physicians that Mitchell represented – who have themselves claimed to have never personally administered to an abortion or anyone needing HIV-related services but might, maybe, one day have to help a patient who experienced adverse events as a result of these extremely safe medications on the off chance they respond poorly to them – don’t actually have a tangible harm in putting off implementing O’Connor’s “universal remedies”, while some 2 million health plans as an industry and millions of patients across the country certainly will experience an impact if the ruling were to go into effect while being appealed. Mitchell kinda fell flat footed and basically asked the court to speculate what would happen if the stay wasn’t implemented. Hint: Courts aren’t actually supposed to pull conclusions out of thin air, “facts” must be presented inside of defined rules. So Mitchell then hedges cuz everybody suddenly seems real skeptical in how this might relate to standing and he asks of he can maybe meet with the DOJ to come up with some settlement agreement between the parties on the stay.
Now for the not so good news and there’s two bits to this one we’re gonna need to watch for quite some time; 1. Medicaid unwinding and 2. public health funding claw backs in the debt ceiling deal.
Last week, CANN hosted it’s third and final Community Roundtable in a series on COVID-19 impacts on public health and all the bad news is related to that intersection.
Because the House and the Senate voted to end the COVID-19 public health emergency a month early, Medicaid’s continuous coverage unwinding began pretty chaotically. To literally no one’s surprise, millions of folks are already losing their Medicaid coverage and not necessarily because they don’t qualify. The administrative or procedural disenrollments happen not because of a person or family no longer being qualified for Medicaid, but because a program administrator has not received necessary document responses. But the thing about that is, not a whole lot of folks who gained coverage for the first time during COVId-19 actually know a whole lot about the process, according to a Kaiser Family Foundation survey. And not every state is making it easy. Indeed, Arkansas and Florida are in a massive rush to get folks off Medicaid rolls – so fast that advocates are begging those states’ governors to slow down the process in order to reduce the risks of losing people to care who might otherwise qualify. Those states’ governors aren’t likely to respond to these pleas, despite guidance from the Centers for Medicare and Medicaid (CMS) to “not rush” the process. Those disproportionately at risk for being thrown off Medicaid are also those who are most at risk for acquiring HIV or already living with HIV and being covered by Medicaid. Again, about 40% of people living with HIV are covered by Medicaid, it stands to reason our patient population is at risk of potentially falling out of care if these processes are rushed.
Back in April, CANN reviewed annual sexually transmitted infection (STI) surveillance data released by the Centers for Disease Control and Prevention (CDC). In doing so, we pointed out the potential hazards of the Biden Administration failing to uphold its promise to reinvest in public health programming, specifically million dedicated to replenishing the workforce via disease intervention specialists (DIS). Those dollars were promised under the American Rescue Plan (ARP) but, as with all federal programs, take time to disburse. In the case of workforce development in state health departments, that means identifying an appropriate vendor to contract with to provide training, then contracting them to develop a curriculum, then giving guidance as to qualifying certification, then disbursing dollars to contract provider entities, then actually hiring people (in which there’s serious churn), training them, and so on. It takes time. But states weren’t quick to use those dollars and many of them remained unspent as the debt ceiling approached. A late-minute deal was struck between the White House and House Republicans in which certain public health funding allocated under the ARP are being clawed back. How this impacts our nation’s ability to provide meaningful public health services and address rising crises like STIs, we’ll find out in the worst possible way. For what it’s worth, our friends over at the National Coalition of STD Directors has called on the Administration to protect the public health workforce in light of the country’s first STI National Strategic Plan and how cutting those dollars risks any tangible ability to respond.
Advocates have tons more to pay attention to as the Biden Administration begins responding to this state legislative session’s “Hate Slate”, targeting LGBTQ people and our care. And because Congress is working to address things like reforming pharmacy benefit managers and 340B.
In all, advocates should work to focus on their strengths, strengthening relationships with service providers and legislators – sharing the human costs of these moves – and taking care themselves. With so much going on all of the time, we have to celebrate our wins while fighting for a fairer system serving patients. In order to do that, we have to also take care of ourselves.
Assessing Responses to the US Monkeypox Outbreak
On August 4th, the Biden Administration declared a Public Health Emergency (PHE) regarding the ongoing Monkeypox outbreak in the United States and other countries where the virus is not endemic. Two days prior, the White House announced a National response Team, lead by the Federal Emergency Management Agency’s (FEMA) Robert Fenton and the U.S. Centers for Disease Control and Prevention (CDC) Dr. Demetre Daskalakis.
Bob Fenton holds some notoriety at FEMA, in part, because in 2005, while helping to coordinate on-the-ground responses to Hurricane Katrina’s devastation, he warned officials in Washington, D.C. that more needed to be done to meet the needs of the moment. Dr. Demetre Daskalakis has been credited with helping to curb and end a measles outbreak in 2018 and 2019 in New York City, prior to joining the CDC, but more aptly, his extraordinary efforts in 2014 to end the meningitis outbreak by bringing vaccines to bath houses, dressing in drag, and otherwise successfully bringing care to communities and people who needed it. With these histories, there’s no wondering why the White House selected these two professionals to lead this response. And having well-qualified leaders with excellent analytical skills and histories of putting success strategies into action aren’t necessarily going to be enough.
In a protracted opinion published to The New York Times, a former U.S. Food and Drug Administration (FDA) lead, Scott Gottlieb, accurately assessed a lack of political appetite to allocate more power and funding into public health. Specifically, Gottlieb argued the CDC has failed to compel a more coordinated response from state level partners, despite a very evident need to make these kinds of investments to shore up the country’s preparedness and ability to respond to health threats. The Biden Administration has instead suggested a need to make more agencies, which may be a way of trying to get around that lack of appetite and still achieve some measure of these investments. This type of move is, as Gottlieb described, a “very Washington response”, from both the short-sightedness of the legislator-politicians tasked with serving the best interests of the country’s populous and the Biden Administration’s fumbling response. He is correct in saying monkeypox, like other viruses foreign to the United States, may well become yet another public health failure. However, Gottlieb also argued the delayed or at least slow federal response to this monkeypox outbreak showed a need for the CDC to get out of the business of preventing illnesses other than infectious diseases and leave that work to other agencies. A gentle reminder, “Prevention” is in the name of the agency and adding layers of bureaucracy will not fix the fact that existing bureaucracy just…isn’t working as fast or efficiently as we need it to in order to respond to public health emergencies.
Those politically powerful voices, like Mr. Gottlieb’s, with influence must push the conversation with their audiences, especially political leadership, to draw a line in the sand in the interests of the nation. The more any party leadership is willing or even happy to promote inflammatory, conspiracy minded, and objectively false claims, especially those around issues of public health, just to win elections, the less power our federal government will have to respond to emergencies and the less states will be willing to cooperate when cooperation is needed.
Of the notable assessments Gottlieb offers, the most meaningful are drawing a potential definition of “public health failure” as monkeypox becoming an endemic virus to the United States in which persistent but low-level of the virus continues to circulate. Another is the potential of an “ascertainment” bias, but not the one most folks discussing this issue might jump to first – regarding communication around at-risk populations – but that this outbreak may seem like it “appeared out of nowhere”. Instead, it has likely been circulating undetected for some time and misdiagnosed or assumed as some other illness among health care professionals. Given the genomic distinctions discovered shortly after the initial detection of cases in Europe and North America, there’s good evidence to support that conclusion; a conclusion that lends great concern for that definition of “public health failure” to be accurate.
On the more technical analyses regarding this outbreak, a lack of precise, effective communication and a willingness for the public to accept complex realities has plagued federal, state, and local health agencies. Arguments between well-intentioned advocates, journalists, and public health professionals on effective messaging have enveloped the discussion around Monkeypox, flooding and fueling social media speculation and concerns of misinformation. Indeed, maliciously intended politicians, like Representative (GA-R) Marjorie Taylor Greene’s repeated statements (which will not be linked here as readers can Google search these things) equating the rare Monkeypox cases being reported among children are some evidence of sexual assault being perpetuated by men who have sex with men, were among the fears voiced on these platforms in June.
Public health agencies are looking to perform a balancing act in ensuring the resources, including vaccines and treatments, are reaching the most highly affected communities, while also educating and informing the public at large when addressing a unique outbreak where clinical information on transmission risks is limited, even as data is becoming more readily available. To be clear, the current global outbreak of monkeypox is concentrated among the social-sexual networks of men who have sex with men (including transgender men). Messaging and resource allocation are two very different things and should not be treated as one in the same. And educational messaging must be carefully tailored to its intended audience in order to not perpetuate stigma and the violence that can result from stigma. Indeed, issues of stigma, violence, and even public policy already suppressed investigation around a previous monkeypox outbreak in Nigeria, which may have better prepared the world for preventing this one. As Dr. MK Titanji pointed out, part of this previous disinvestment and lack of investigation is a direct result of the fact that half of the world’s countries criminalizing homosexuality are within the African continent, some of which are the only countries in the world where monkeypox is already endemic.
Critically important, stigma and other factors which perpetuate health disparities are already finding familiar lines in the United States. The CDC’s Morbidity and Mortality Report Weekly (MMWR), published on August 5th, found that even in the limited data available, "The percentage of cases among Black persons increased from 12% (29 of 248) during May 17–July 2 to 31%." Additionally, for those cases with full profiles, 41% of cases were among MSM living with HIV. The confounding factor to consider with that high rate of HIV prevalence among monkeypox cases is thanks to robust, though certainly not perfect, public health infrastructure specifically in response to HIV, people living with HIV/AIDS (PLWHA) may be more able to readily access health care professionals who are aware and educated about this monkeypox outbreak than other populations. The press conference immediately following the declaration of public health emergency had federal officials discussing a “vaccine sparing” strategy in order to facilitate reaching more people in need. However, given this concentration of case identification among PLWHA and that the available vaccines may not be as effective for this population, there’s good reason for patients and advocates to be concerned what dose sparring may mean for the most impacted population.
As this situation develops, we’re lucky to have the expertise the White House has engaged, who have readily sought out community feedback and engagement. As an example, Harold Philips, the Director of the Office of National AIDS Policy (ONAP), has had subsequent conversations with stakeholders in HIV to discuss leveraging the HIV infrastructure in order to help address this outbreak. And there’s much left unknown, including what exactly the risk is to children who may be in close, consistent, physical contact with people who have been diagnosed with monkeypox. Advocates are already coming together from across jurisdictions in an effort to appropriately influence public policy and program designs. Our efficacy in that work and in coordinating a response based in best practices of meaningful engagement means our private industry stakeholders must also support us in this work.
Additional reading which may be beneficial: From our friends over at the Center for Disaster Philanthropy; Monkeypox Briefing, including suggestions to funders in supporting advocacy and services to address the outbreak.
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.
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.
Deceptive Masks: COVID’s Threat to STI Surveillance
In April, the Centers for Disease Control and Prevention (CDC) released its annual sexually transmitted infections (STIs) surveillance report, reflecting an increase in overall rates for the sixth year in a row, with a nearly 30% increase in STIs from 2015 to 2019. While sharpest increases in incidences were of syphilis among newborns, the infection burden is not equal with young (ages 15-24) people, gay and bisexual men, and people of color facing exceedingly disproportionate diagnoses. What’s important to note is traditional CDC surveillance reports lag by about two years – these data do not account for COVID-19 impacts among screening and treatment of STIs.
In the report’s press release, the CDC acknowledged COVID-19 posed extreme threats to screening, treatment, and prevention, as public health programs and staff typically used to address STIs had largely been repurposed in response to COVID-19, citing a survey from January showing about one third of local and state health department STI staff were still deployed to COVID-19 activities. Shortages also include screening supplies, according to a September 2020 “Dear Colleague Letter” with regular updates posted on the agency’s drug and diagnostic test notices page showing marginal improvement as reported by testing kit and supplies manufacturers.
The aforementioned survey of local and state health departments was conducted by the National Coalition of STD Directors (NCSDDC), “a national public health membership organization representing health department STD directors, their support staff, and community-based partners”. While NCSDDC usually throws most of its resources into advocating for public health policy changes, funding, and offering technical assistance, throughout the COVID-19 public health emergency, NCSDDC has found itself in the unique position of reporting on the situational needs of health departments and their staff, tasked with meeting a multitude of needs in any given community. The organization summarized its Phase III survey results as follows:
“This continued diversion of staff and other resources has caused delays in providing disease intervention services, leaving some STDs completely unchecked. STD programs continue to report clinic closures, reduced clinic hours and services, STD testing kit shortages, and diminished laboratory capacity. Additionally, STD programs report severe burnout as disease intervention specialists (DIS) pivot from COVID-19 investigations and contact tracing back to STD disease intervention and partner services work.”
For context, NCSDDC, in March of 2020, initially phrased the state of local and state health departments responding to COVID-19 as a “starved public health system in distress”. An indication that despite pledges from the White House and billions in funding allocated by law makers, “on the ground” not much has yet changed for the first responders of public health.
Complicating matters, some health officials are debating the implications of initial surveillance reports for 2020 seemingly showing certain decreases in STI diagnoses, according to one news report, as either a reduction in sexual activity among at risk persons during stay at home orders or a lack of screening. Given the context of reduced capacity, staffing, and supplies, entertaining the possibility of decreased sexual activity rather than decreased access to services shifts the responsibility (and pressure) on state lawmakers and executive offices to appropriately fund and support public health programs to that of undersupported health departments, contracted service providers, their staff, and the vulnerable communities they serve.
As discussed in HEAL blog posts from earlier this year, COVID-19’s impact on public health activities is still being discovered, largely through emerging surveillance gaps (lack of screening) and, as the CDC’s STI report shows, at a lag of data rather than a decrease of incidence, leaving communities vulnerable to outbreaks.
Later this month, on June 30th, NCSDDC will be joining Community Access National Network and Community Education Group for a virtual Community Roundtable on COVID-19’s impacts on HIV, HCV, STIs, and substance use disorder, providing stakeholders and advocates a space to further explore where public health efforts have been strained and can be strengthened in light of COVID-19.