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.
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.