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.