The False Economy of Rationing Life
Across the country, states are making a choice. Faced with budget shortfalls driven by flat federal funding, the expiration of enhanced ACA premium tax credits, and the downstream wreckage of H.R. 1's nearly $800 billion in Medicaid cuts, they are choosing to solve their fiscal problems by restricting access to the medications that keep people living with HIV alive and stop the virus from spreading. Eighteen states have implemented cost-containment measureson their AIDS Drug Assistance Programs, with five more considering changes. Florida slashed ADAP eligibility from 400% to 130% of the federal poverty level on March 1, cutting off more than 12,000 people and removing Biktarvy, which accounts for 52% of the U.S. ARV market, from its formulary. Louisiana is considering HB927, legislation that would repeal the state's long-standing statutory protections against prior authorization and step therapy for antiretrovirals in Medicaid.
The pressures are real. ADAP enrollment surged 30% from 2022 to 2024 as states shed Medicaid enrollees after the pandemic. NASTAD's February 2026 ADAP Watch reports 19 ADAPs forecast deficits for the upcoming fiscal year. When adjusted for inflation, ADAP appropriations have declined 31% since 2005, with the FY2025 appropriation carrying roughly the same purchasing power as FY1999 levels. Nobody disputes the math. What we dispute, forcefully and on the evidence, is the response.
Utilization Management on ARVs Is Clinically Indefensible
Step therapy requires a patient to "fail" a medication before accessing the one their provider has already determined is best for them. In HIV treatment, failure means the virus has replicated in the presence of inadequate drug levels and potentially developed resistance, rendering the entire associated drug class less effective or ineffective. For someone on PrEP, "failing" a regimen means they have seroconverted and acquired HIV, possibly with resistance that limits their treatment options from day one. Prior authorization creates gaps in access while paperwork is processed. Drug resistance can develop within several weeks of stopping ART, as some components of a combination regimen remain in the body longer than others, leaving HIV exposed to one or two drugs instead of a full suppressive regimen. CD4+ cell counts can decline by up to 100 cells/mm³ within weeks of interruption. The SMART trial demonstrated that episodic ART interruption was associated with increased risk of opportunistic disease and death, findings so conclusive the strategy was abandoned entirely.
The CMS Medicare Part D Manual specifically notes that utilization management tools like PA and step therapy are generally not employed in best-practice formulary models for HIV/AIDS drugs. The American Academy of HIV Medicine issued a white paper with a single recommendation: HIV medications should be exempt from prior authorization requirements. As of 2019, 14 states had enacted laws prohibiting at least some UM techniques for ARVs. The broader health policy world is arriving at the same conclusion about PA generally: a January 2026 KFF Health Tracking Poll found that four in ten people with chronic conditions say prior authorization is their single biggest healthcare burden beyond costs, and KFF President Drew Altman has openly questioned whether its short-term cost control benefits are worth the costs to patients in an already overburdened system. If the mainstream is questioning PA broadly, the case for applying it to ARVs, where the clinical stakes include drug resistance, viral transmission, and death, does not exist.
The Math Doesn't Work, and the Motive Is Worse
Here is where we need to stop treating this conversation as though it is happening in good faith.
The stated rationale for stripping UM protections from ARVs is cost containment. But anyone who has watched private insurance markets operate over the past two decades recognizes what utilization management on high-cost drug classes actually produces: leverage. Private payers have used UM as a negotiating tool for years, threatening to restrict formulary access unless manufacturers offer deeper discounts. The people whose treatment gets disrupted in the process are the collateral damage that makes the threat credible.
CANN has been warning for years that as state Medicaid programs face mounting budget pressure, the temptation to adopt this same playbook would grow. That is exactly what is unfolding. When states impose PA and step therapy on antiretrovirals, the practical effect extends well beyond cost management. It creates a bargaining position where patient access to life-saving medication becomes a concession to be traded for supplemental rebates from manufacturers. This is the private payer model of healthcare as revenue generation imported into public health programs responsible for managing a communicable disease. It transforms the health of people living with HIV into a bargaining chip, and it represents a fundamental betrayal of what public health programs exist to do.
The people whose medications get delayed, whose viral loads rebound, whose resistance profiles narrow while prior authorizations are processed are not an unfortunate side effect of this model. They are the leverage. That is not healthcare. It is government treating public health as a profit center.
The economics don't support it either. Every new infection from someone with a detectable viral load carries an estimated lifetime medical cost of $326,500, with the cost avoided by preventing that infection estimated at $229,800. More recent analyses from HIVMA put average lifetime expenditures between $500,000 and more than $1.2 million. A Precision Health Economics analysis estimated that allowing UM on Part D antiretrovirals alone could result in over 6,750 new HIV infections. Whatever supplemental rebate a state might extract by threatening formulary restrictions will be dwarfed by the downstream costs. And in a U.S. cohort studied between 2021 and 2023, 28% of people with HIV experienced a treatment interruption of 90 days or more, with those affected disproportionately women, Black, dealing with substance use, and less likely to have commercial insurance. These barriers concentrate harm on the people who are already most structurally vulnerable.
We Have Already Watched This Fail
We don't need to theorize. We watched it happen with Hepatitis C. For years, state Medicaid programs and MCOs imposed PA, step therapy, sobriety requirements, and prescriber restrictions on curative direct-acting agents for HCV. People were denied treatment while their disease progressed. By the end of 2025, 34 jurisdictions had removed PA requirements for most Medicaid HCV patients, reflecting the national consensus that those restrictions never served patients or budgets. Louisiana itself now receives an "A" grade for HCV Medicaid access. As CANN's letter to Vice Chair McMahen on HB927 notes, the bill proposes substantially similar risks to HIV medication access as those once imposed on HCV, in a state that passed model PrEP and PEP legislation in 2024 that these same UM tools would undermine.
What Must Happen
Florida's own legislature proved these cuts are not inevitable when it passed HB 697 in mid-March with $31 million to restore ADAP eligibility for over 11,000 people. Bipartisan, responsive, and proof that different choices are available when the political will exists.
States must fight for adequate federal ADAP funding, which has been flat-funded since FY2014 while program costs have grown relentlessly. They must leverage 340B rebates and supplemental funding rather than cutting the people the programs exist to serve. They must design Medicaid formularies to ensure access following federal HIV treatment guidelines, not undermine them. And their federal legislators should realize that if we can fund the Department of Defense at a trillion dollars a year, we can surely pay to keep people from dying from AIDS.
There is no clinical necessity for removing ARV protections. Doing so will not balance budgets. It will create drug resistance, increase transmission, push people into more expensive care settings, and compound the harms of H.R. 1's Medicaid budget cuts and work requirements, which threaten coverage for 42% of Medicaid enrollees with HIV. At every level of analysis, this approach fails. What it succeeds at is transferring the cost of federal policy failures onto the bodies of people living with HIV, and that is not fiscal responsibility. It is abandonment dressed in budget drag.
Third Wave of Medicare Drug Price Negotiation Adds More Potential Peril
The Centers for Medicare & Medicaid Services (CMS) recently announced its selections for the third cycle of drug price negotiations. For this iteration, not only is it the first time Medicare Part B drugs are on the list, but it is also the first time an infectious disease drug is on the list. The infectious disease drug selected is Biktarvy, a widely used HIV antiretroviral. The decision to start including Part B drugs has many stakeholders concerned, given the distinctly different nature of administration and reimbursement in comparison to Part D drugs. The inclusion of an infectious disease drug, specifically, Biktarvy, is significant because the previous focus was on non-infectious chronic conditions. Including HIV-antiviral drugs and other infectious disease treatments is concerning, given the potential for adverse effects on access.
The selection of Part B drugs is significant because those are medications that cannot be self-administered. These drugs are often administered in a clinical setting, such as an infusion center, hospital outpatient department, or physician's office, or, in certain circumstances, in a home setting by authorized personnel. Part B drugs often include cancer chemotherapy, immunosuppressants, and some vaccines. Entyvio, Orencia, Cosentyx, Cimzia, Xolair, and non-cosmetic Botox are the drugs clearly delineated as Part B-qualified on the third cycle list. The aforementioned drugs treat conditions including Crohn’s disease, ulcerative colitis, plaque psoriasis, asthma, and ankylosing spondylitis. These are potentially debilitating conditions that patients depend on for an acceptable quality of life.
Many physician-administered Part B drugs are purchased by practices via a ‘buy-and-bill’ system. This is when physicians buy, store, and administer the medications directly and then bill Medicare. Presently, physicians are reimbursed on the Average Sales Price (ASP) plus an additional 6% fee. The Maximum Fair Price (MFP) drug negotiation structure means that reimbursement would be limited to the negotiated price. Thus, physicians would be at a higher financial risk of having to purchase medications at acquisition prices higher than the MFP reimbursement rate. In theory, the CMS guidance is supposed to require manufacturers to offer physician-administered drugs to practices at the MFP. However, Part B drugs are not privy to the rebates and PBM negotiations that Part D drugs are.
Therefore, the cost differential between acquisition prices and MFP is higher. If the lack of enforcement results in physicians purchasing drugs at acquisition prices well above MFP reimbursement, then they are financially at a loss. If practices then have to wait on the proposed Medicare Transaction Facilitator (MTF) to recoup full reimbursement from manufacturers, they are financially floating a fiscal deficit. In this case, time is literally money, which adversely affects practices’ ability to function and provide care. Moreover, physicians would have to manage the purchasing of inventory of the same drugs at non-MFP commercial prices for their non-Medicare patients. This not only increases the administrative burden but also the up-front financial risk.
The selection of Biktarvy for the drug negotiation list generates a nuanced, different subset of concerns. HIV medications are generally covered under Medicare Part B. A notable exception is provider-administered HIV pre-exposure prophylaxis (PrEP) drugs for prevention that are covered with no cost-sharing, thus zero dollar deductibles or copays, as long as it is for prevention and not treatment. HIV treatment medications, such as Biktarvy, under Part D are subject to deductibles, copays, and coinsurance based on the particular plan, such as Medicare Advantage. Starting in 2025, Part D includes a $2,000 annual cap on out-of-pocket drug spending. Additionally, antiretrovirals are among the six protected classes that Medicare plans are required to cover regardless of the drug formulary.
Medicare Part D patients cannot use patient assistance programs (PAPs), such as ‘copay coupon cards’ for medications like Biktarvy. However, they are eligible for financial assistance through AIDS Drug Assistance Programs (ADAPs), State Pharmaceutical Assistance Programs (SPAPs), charitable organizations, and the Medicare Low-Income Subsidy (LIS/Extra Help). Notably, over 70% of HIV patients on Medicare are enrolled in the LIS program for financial support in obtaining their medications. Thus, setting an MFP for Biktarvy would not lower the out-of-pocket cost for the medication since cost-sharing is a direct product of plan design. The only savings potentially generated would be for the federal government.
HIV is a unique infectious and chronic disease. Successful treatment is very individualized and has specific requirements based on biological factors. HIV treatment involves the consideration of comorbidities, immune system status, contraindications, the likelihood of successful adherence, and more. It is not a chronic disease in which multiple medications are immediately interchangeable or can be readily swapped out for something that appears ‘cheaper’ on the surface. There is also a distinct difference between a treatment and a regimen. Biktarvy is a single-pill treatment consisting of several drugs. It is less cumbersome in terms of adherence than multiple-tablet regimens (MTRs), in which several medications are taken in single-drug-ingredient form.
Biktarvy is the only 1A DHHS-recommended single-tablet regimen (STR) that does not have viral load restrictions, does not require HBV testing, and has no resistance testing requirements. The 1A DHHS recommendation indicates the highest strength of recommendation based on the highest quality of evidence from clinical trials and other research. Studies across Medicare, commercial, and managed Medicare populations show consistently higher persistence on Biktarvy compared to other DHHS 1A-recommended regimens. Higher persistence indicates fewer medication switches, suggesting patient satisfaction and adequate disease control.
Moreover, direct-comparison studies show that Biktarvy has significantly lower total costs than dolutegravir and multi-tablet regimens, despite its higher price, due to better control and patient outcomes. (Note: these studies did not include Dovato as they were done before its widespread usage). Cost is not limited to the initial drug price. Costs include advanced medical care as a result of other ineffective regimens due to drug characteristics, barriers to adherence, or even the development of resistance. Biktarvy is also overwhelmingly recommended for initial rapid-start HIV therapy. Rapid initiation of treatment is the ideal path to successful treatment and ultimately an undetectable viral load. This is especially important given that in the Medicare-aged community, when undiagnosed transmission is discovered, it is at a later stage of disease progression, where more immune system damage has been done. Therefore, evidence-based, consistent, effective, and reliable therapy is essential.
Ongoing data already indicate that the Medicare Drug Price Negotiation program poses significant risks to patient access, pharmacy stability, and adverse disturbances to provider services. HIV and the medical conditions most often represented in Part B coverage are all conditions that are debilitating, without vast amounts of treatment options. Most importantly, HIV is an infectious disease that is forward-promoting, meaning that its control is a matter of public health. Undetectable viral load means untransmittable disease. Adding these drugs to the third wave of negotiations risks the well-being of vulnerable patients, pharmacies, and the healthcare provider ecosystem. Ultimately, the only benefactor of any real savings would be the federal government.