Maryland and North Dakota Take Steps to Kick Their HIV Criminalizations Back to the 1980s

By: Ranier Simons, ADAP Blog Guest Contributor

HIV criminalization laws represent the worst of society’s response to the AIDS epidemic, rooted in fear, homophobia, and hysteria…and a lot of misinformation. The United States was the first nation to enact HIV-specific criminal laws, dating back to 1986-87. HIV criminalization laws still exist, but the wheels of progress are slowly chipping away at them as medical advances have changed HIV/AIDS from a death sentence to a manageable chronic disease. Equally important is the growing acceptance of the science behind “Undetectable Equals Untransmittable” (U=U), which has weakened the argument for these outdated, inhuman laws. Recently, two states, Maryland and North Dakota, passed bills to remove HIV criminalization laws from their statutes.

Photo Source: CHLP | The Marshall Project

Yet, many states still have active HIV criminalization laws in place. From 2008 to 2013, at least 180 people living with HIV/AIDS (PLWHA) were arrested or charged under HIV criminalization laws (Tang, 2024). These HIV statutes have not been updated to reflect evidence-based science and are predatory towards PLWHA. As of February 2025, 32 states have offenses that criminalize exposure to and/or transmission of HIV (CHLP, 2025). In 1994, Texas was the first state to repeal its HIV criminalization law (CHLP, 2020). The reality is that much work remains to kick HIV criminalization laws back to the 1980s, and some states are doing it!

In February of this year, Senate Bill 356 and House Bill 39 passed in both Maryland chambers. Both bills are repeals of a section of the Maryland code that specifically criminalized the intentional transfer of HIV from one person to another. The statute declared the knowing transmission of or attempted transmission of HIV a misdemeanor subject to a fine of up to $2,500 or a jail term with a maximum of three years, or both. Legislators passed the bills with the understanding that the law was not an effective means of protecting public health. Delegate Kris Fair stated (seen below), “The law was, for right or wrong, thought to help curb the transmission of HIV…What public health experts and criminal justice organizations have taught us … is that we’ve actually seen the exact opposite.” (Brown, 2025).

Photo Source: Maryland Matters | Photo by Danielle J. Brown

Also, on February 20, 2025, North Dakota passed House Bill 1217. This repeals a section of the code regarding the willful transfer of bodily fluid containing HIV. ‘Transfer’ here is defined as “engage in sexual activity by genital-genital contact, oral-genital contact, or anal-genital contact, or to permit the reuse of a hypodermic syringe, needle, or similar device without sterilization.” The law being repealed states that a person who knowingly transfers HIV to another person without their knowledge can be charged with a Class A felony with a maximum penalty of 20 years in prison and a maximum fine of $20,000. The bill changes the crime from a felony to a misdemeanor (Gall, 2025). In North Dakota, HIV is the only disease attributed to a felony charge, whereas other STI transmission crimes are misdemeanors. The bill now needs to be considered in the House.

Both states acknowledge that HIV criminalization is discriminatory. Singularly carving out HIV as a disease requiring enhanced criminal penalties increases stigma, is a disincentive for the public to normalize testing, and disproportionately affects specific populations. Fear of potential criminal prosecution means that people will be more hesitant to seek testing and subsequently must disclose their status to their partners (Yang, 2018). Additionally, it can adversely affect the trust within the doctor-patient relationship, resulting in delayed antiretroviral treatment initiation, poorer treatment outcomes, and adversely affecting public health. 

Medical science has made the possibility of HIV transmission effectively non-existent by PLWHA, who are undetectable on treatment. “U=U” is not a catchy slogan – it is an evidence-based scientific reality. Requiring an individual to indisputably prove their disclosure of their status if accused of exposure without consent is virtually impossible (Lazzarini, 2013). When HIV criminalization laws are in place, people can nefariously use them against people, such as a spurned partner retaliating against a former partner when a relationship does not end on good terms. Predatory laws harm PLWHA because being convicted does not even require actual HIV transmission to occur or proof of intent to deliberately pass the virus on to someone. 

Photo Source: Red Bubble

HIV criminalization laws also disproportionately affect marginalized groups, such as communities of color, specifically black men. Racial inequities and social determinants of health have already been shown to increase the likelihood of black male exposure to the criminal legal system (AIDS Vu, 2021). When HIV criminalization laws add enhanced sentencing or create violations that otherwise would not exist, they exacerbate targeted adverse outcomes. In Maryland, for example, Black people are 30% of the population, 71% of those who are PLWHA, and 82% of HIV-related criminal cases. Black men, specifically, are 68% of those accused in HIV-related cases despite comprising only 14% of the state population and 44% of Maryland PLWHA (UCLA, 2024).

Maryland and North Dakota’s recent bills to eliminate HIV criminalization are positive steps, but much more needs to be done. The number of states that currently have laws specifically targeting HIV for violations outside of standard communicable disease statutes or heightened sentencing is unacceptable. The stigma and hindrance to widespread testing of HIV criminalization add to the numerous barriers to ending the HIV epidemic in the United States. It would be easily conquerable if laws would catch up to science.

[1]  AIDSVu. (2021, May 10). HIV Criminalization. Retrieved from https://aidsvu.org/news-updates/hivcriminalization/#:~:text=HIV%20criminalization%20laws%20have%20also,transgender%20women%2C%20and%20sex%20workers.

[2] Brown, J. (2025, February 22). Bills to repeal ‘antiquated’ law criminalizing transfer of HIV sail through House, Senate. Retrieved from https://marylandmatters.org/2025/02/22/bills-to-repeal-antiquated-law-criminalizing-transfer-of-hiv-sail-through-house-senate

[3] The Center for HIV Law and Policy (CHLP). (2020). HIV CRIMINAL LAW REFORM: BEFORE & AFTER: Texas. Retrieved from https://www.hivlawandpolicy.org/sites/default/files/HIV%20Criminal%20Law%20Reform%20Before%20and%20After%20Texas%2C%20CHLP%202020.pdf

[4] The Center for HIV Law and Policy (CHLP). (February, 2025). Mapping HIV Criminalization Laws in the U.S. Retrieved from https://www.hivlawandpolicy.org/sites/default/files/2025-02/Mapping%20HIV%20Criminalization%20Laws%20in%20the%20US%2C%20CHLP%202025.pdf

[5] Gall, P. (2025, February 20). House Bill to reduce HIV transmission penalty advances in North Dakota. Retrieved from https://www.ksjbam.com/2025/02/20/intentional-hiv-transmission-charge-may-be-lowered-from-felony-to-misdemeanor/#:~:text=House%20Bill%201217%20passed%20on,to%20the%20Senate%20for%20consideration.

[6] Lazzarini, Z., Galletly, C. L., Mykhalovskiy, E., Harsono, D., O'Keefe, E., Singer, M., & Levine, R. J. (2013). Criminalization of HIV transmission and exposure: research and policy agenda. American Journal of Public Health, 103(8), 1350–1353. https://doi.org/10.2105/AJPH.2013.301267

[7] UCLA School of Law Williams Institute. (2024, January). Enforcement of HIV Criminalization in Maryland. Retrieved from https://williamsinstitute.law.ucla.edu/wp-content/uploads/HIV-Criminalization-MD-Jan-2024.pdf

[8] Tang, Catherine (2024). Our country's dark history of persecuting people with HIV. HIV Plus Magazine. Retrieved from https://www.hivplusmag.com/stigma/us-history-hiv-criminalization.

[9] Yang, Y. T., & Underhill, K. (2018). Rethinking Criminalization of HIV Exposure — Lessons from California’s New Legislation. New England Journal of Medicine, 378(13), 1174–1175. https://doi.org/10.1056/nejmp1716981

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates. 

IRA Spelling Trouble for Community Pharmacies, and Patient Access Could be Next

By: Ranier Simons, ADAP Blog Guest Contributor

The Inflation Reduction Act of 2022 (IRA) contains multifaceted goals to improve healthcare access and lower healthcare costs, including prescription drug costs (CMS, 2025). The Medicare Drug Price Negotiation program is one such initiative, according to the Centers for Medicare and Medicaid Services (CMS). This initiative authorizes Medicare to directly negotiate the price of prescription drugs with manufacturers for outpatient drugs under Medicare Part D and later for physician-administered drugs under Part B. The initial ten drugs identified for “negotiation” have already been selected, and their new pricing will go into effect in 2026 under what has been termed the Maximum Fair Price (MFP). Whether the IRA’s lofty goals – such as lowering patient drug costs and lowering insurance premiums – are successful remains questionable. However, community pharmacies are already being adversely impacted by the new, untested pricing scheme, which could spill over and cause harm to patients. The National Community Pharmacists Association (NCPA) recently released an analysis of the MFP’s potential unintended effects on pharmacies' financial stability and cash flow (NCPA, 2025). The picture is bleak. 

Photo Source: NCPA

Implementing the MFP is a departure from the current status quo of pharmacy reimbursement. Presently, pharmacies purchase drugs, pay their acquisition cost, and are subsequently reimbursed by PBMs after filing their claim. The drugs on the MFP list require a different payment mechanism. The MFP program requires payment from PBMs and refunds from manufacturers. In general, PBMs will reimburse pharmacies an amount equal to the MFP, and then manufacturers will be required to reimburse pharmacies for the difference between the acquisition price and the MFP (NCPA, 2025). The mechanisms for implementation and the amounts paid are the sources of cash flow concern for pharmacies.

The MFP payments will be made utilizing a system in development called the Medicare Transition Facilitator (MTF) (NCPA, 2025). It will have two parts, the MTF Data Module (MTF DM) and the MTF Payment Module (MTF PM). All parties must enroll in the MTF DM to ensure compliance with open data exchange for expedient application of negotiated prices. The MTF PM is optional for manufacturers who can make refund payments via it or by another means of their choosing. The time delay in reimbursement payments for both the PBM payment and the manufacturer refund is an issue.

NCPA’s analysis of historical payment data indicates that PBMs currently reimburse pharmacies around 14 days after a claim is filed (NCPA, 2025). They constructed a payment model of cash flow, indicating the new MTF PM approach would add a delay to completed reimbursement. NCPA anticipates that, on average, manufacturers would refund pharmacies around one week after PBMs submitted reimbursement. This would mean pharmacies would have less cash for operating expenses while waiting for full reimbursement. The PBM payment would theoretically be equal to the MFP, which is a significant discount on the acquisition cost, on average 60 percent (NCPA, 2025). Thus, a pharmacy would have to function with a cash flow deficit until the manufacturer’s refund was paid, potentially making them whole regarding what they paid to acquire the drug. Moreover, this leads to potential issues of reimbursement amounts.

Photo Source: Lagniappe Pharmacy

Under the status quo, pharmacies already deal with issues of under-reimbursement. There is potential for additional harm under an MFP scenario. Presently the NCPA found that pharmacies are operating with small margins of profit. Under the MFP framework, pharmacies could bring even less revenue (NCPA, 2025). Currently, pharmacies operate profitably with payments higher than their acquisition costs. Under the MFP PM system, profit due to pricing differential is lowered or eliminated. Additionally, the MFP is the maximum possible PBM reimbursement. There is a possibility that PBM reimbursement may be lower than the MFP (NCPA, 2025). Thus, pharmacies could end up at a loss when net reimbursement is the difference between the acquisition cost and the sum of the PBM reimbursement and manufacturer refund.

Patients’ access to medications could be harmed if pharmacies close due to their inability to operate under financial losses. Additionally, NCPA posits that pharmacies associated with 340B Covered Entities could be adversely affected. Their model, which assumes an operational average of 15 fills of MFP medications per week, would equal a typical annual loss of revenue in the range of $240,060.60 to $ 433,633.20 (NCPA, 2025). Losses on this level would mean termination or significant scaling back of services for vulnerable populations that 340 B Covered Entities serve. NCPA also emphasizes in their reporting that the MFP does not mandate a dispensing fee, nor does any IRA document indicate any dispensing fee guidance (NCPA, 2025).

The NCPA based its analysis and modeling on available data of historical Medicare prescription drug data. However, the inferences made could be drastically different once the MFP PM approach is put into effect. Delays in payments from PBMs and manufacturers could be longer than expected, leading to even greater financial instability due to a poorer influx of cash flow. Terms between wholesalers and pharmacies could change further, negatively affecting pharmacy reimbursement levels. There is the theoretical possibility of improvements in revenues for pharmacies where the MFP manufacture refund would be more than they usually receive for reimbursement. However, this is not what NCPAs analysis indicates as a widespread possibility (NCPA, 2025). The end result is patients unable to access the medications they need.

Photo Source: ConsumerMedSafety.org

The bottom line is that while well-intentioned, the MFP could have a host of unexpected negative potential outcomes. Many details of the MTF have not been completely fleshed out. Moreover, NCPA analysis indicates that the amount of potential financial loss increases as the volume of a pharmacy’s MFP-associated drug prescription fills increases (NCPA, 2025). Being engaged with the continued development of the MTF-DM and MTF-PM is crucial to ensure that policymakers do not end up codifying effectuating harm.

[1] CMS. (2025, January 20). Inflation Reduction Act and Medicare. Retrieved from https://www.cms.gov/inflation-reduction-act-and-medicare#:~:text=People%20with%20Medicare%20will%20benefit,Changes%20to%20Medicare%20Part%20B

[2] National Community Pharmacists Association (NCPA). (2025, January). Analysis on Pharmacy Cash Flows. Retrieved from https://ncpa.org/sites/default/files/2025-01/January2025-ThreeAxisAdvisors-Unpacking-the-Financial-Impacts-of-Medicare-Drug-Price-Negotiation.pdf

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates. 

340B Paradigm Shift: New Rebate Model Puts Patients First, Not Providers

By: Ranier Simons, ADAP Blog Guest Contributor

Since its inception in 1992 up until 2010, patients were generally thought to have benefited from the 340B Drug Pricing Program. That perception began to change with the passage of the Affordable Care Act (ACA), however. Although the expansion of the 340B program was supposed to have worked hand in glove with the ACA to expand the provision of affordable health care to the underinsured and uninsured, the 340B program, post-ACA, was accompanied by new challenges that have remained largely unchecked over the subsequent 15 years. The result is a program that has veered from its intended purpose. This is evidenced by explosive growth in the number of healthcare providers, or covered entities, participating in the program, while 340B hospitals have actually reduced the charity care they offer to needy patients. The total value, at list price, of the purchases made under the program now exceeds $124 billion (Fein, May 2024), even as medical debt in the United States has soared to $220 billion (Rakshit, February 2024). An IQVIA study demonstrated that only 1.4% of 340B patients receiving 340B drugs through contract pharmacies had any assistance with their out-of-pocket costs at the pharmacy counter. But the growing chorus calling for reform of the 340B Program now includes a new idea: 340B pricing made available through rebates instead of upfront payments. Patients are beginning to ask if it is an idea that could benefit them?

Photo Source: Healthcare Dive

In August 2024, Johnson & Johnson Health Care Systems, Inc (JJHCS) announced its 340B rebate model (J&J, Aug 2024). The new model was an attempt to correct some of the improper utilization of the 340B program and ensure that patients received direct benefits from the savings. Instead of the most prevalent chargeback model, JJHCS decided to offer Stelara and Xarelto to disproportionate share hospital (DSH) covered entities via rebate (J&J, Aug 2024). All other 340B eligible entities would remain on the standard chargeback model. DSH-covered entities would be required to purchase the two drugs from wholesalers at the commercial non-discounted price and then submit a rebate claim for the 340B discount. After the claims are validated, the rebates would be deposited into the bank accounts of the DSH-covered entity. This arrangement applied regardless of whether the medication was dispensed through an in-house pharmacy or contract pharmacy.

Stelara and Xarelto are high-volume, expensive medications. Offering the 340B rebate on these two medications would provide significant savings for a large patient base and their providers, and it would also affect JJHCS’s financial bottom line. The rebate would be calculated as a Wholesale Acquisition Cost (WAC) 340B ceiling price even if a 340B DSH hospital has an agreement with a wholesaler for a lower price (J&J Innovative Medicine, 2024). The rebate concept is not novel. Kalderos, a data infrastructure and analytics company, presented a similar ideology in 2020 based on a discount drug payment platform of their own creation. Their research showed that converted entities benefited from higher revenues when rebates were based on WAC as opposed to contract pharmacy reimbursement tied to discounted Average Wholesale Price (AWP) (Fein, 2022).

HRSA responded to JJHCS unfavorably, even though the 340B statute requires HRSA to “provide for ‘any rebate or discount’ in accounting for the “amount required to be paid” under the program. HRSA nevertheless claimed that JJHCS’ proposed 340B rebate model violates the 340B statute. The agency’s interpretation of the law is that the rebate model’s requirement that a covered entity pay a commercial price upfront and then receive a rebate thereafter (even though payment is promised in “no more than seven to ten days”) violates the statute because the initial price is higher than the statutory ceiling price. Additionally, HRSA claims that it has the authority to approve any proposed rebate or other models before they are allowed to go into effect, even though it has never done so for any model employed over the 33 years that the program has been in effect. 

In contrast, JJHCS contends that the 340B rebate plan is like the rebate processes that AIDS Drug Assistance Programs (ADAPs) use and the replenishment model that most 340B covered entities use. 

In October 2024, Bristol-Myers Squibb (BMS) informed HRSA that it would also start using a 340B rebate model, and it was met with the same resistance by the agency. Despite some patient advocates arguing the BMS model is explicitly pro-patient, in that it offers “even faster” rebate payments if the covered entity “agrees to share” 340B pricing with the patient. The BMS model provides a real opportunity to encourage covered entities to live up to the original intent of the program by providing a direct benefit to patients at the pharmacy counter. 

HRSA has informed both JJHCS, BMS, and other manufacturers proposing rebate models that it will take significant enforcement action if they proceed. The threats of enforcement action were particularly sharp concerning Johnson & Johnson Health Care Systems. In that case, HRSA stated that implementation of the rebate would result in civil monetary penalties as well as termination of the company’s Pharmaceutical Pricing Agreement (PPA). A termination would mean that any affected manufacturer would not be able to participate in not just the 340B program but would also lose Medicare Part D and Medicaid coverage for all its products, cutting off potentially millions of patients from the drugs on which they are dependent for their health and safety. 

JJHCS, BMS, and multiple other manufacturers filed suit against HRSA arguing that the rebate model is explicitly permitted by statute. ADAP Advocacy and CF United jointly filed an amicus brief in support of the JJHCS lawsuit and BMS lawsuit (ADAP & CF, 2025). They were the first two patient advocacy groups to do so.

Photo Source: ADAP Advocacy

Amanda Boone, co-founder of CF United, a patient advocacy group representing people living with cystic fibrosis and other rare diseases, said, “Our patient organization, CF United, decided to file an amicus brief in support of this issue because the experiences of cystic fibrosis patients and other rare disease communities illustrate the urgent need for reform. The current system leaves many of us—who are already battling life-threatening conditions—burdened with insurmountable medical debt, often without being informed of available financial assistance.” Boone is a member of ADAP Advocacy’s patient working group focused on 340B reform.

The amicus brief supports the JJHCA and BMS lawsuits by adding needed color to the complaint from a patient perspective and highlighting additional issues for the court’s consideration. First, the amicus brief explains that manufacturers have a right to utilize the 340B rebate model under the statute (ADAP & CF, 2025). The statute does not specify a mode of 340B reimbursement. Nor does the statute give HRSA any “pre-approval” authority to solely and exclusively decide whether a particular rebate model is valid. The brief explains that assuming such authority is wholly inconsistent with the plain language of the statute and HRSA’s implementation of the program to date.

Second, the brief explores how some covered entities, particularly the large, highly resourced hospitals that receive up to 80% of the billions in profits from the program, serve their economic interests at the expense of patients at the pharmacy counter. According to the factual background provided in the brief, 340B program purchases increased by 1,000% from 2011 to 2022, but charity care decreased from 2.60% to 2.15% (ADAP & CF, 2025). Most egregiously, many 340B hospitals, even as they are making millions from the program, pursue aggressive collections against poor patients without offering any charity care to those in need (ADAP & CF, 2025). The 340B rebate model, particularly as BMS has proposed it, enables transparency that can and should benefit patients. BMS’ model ensures that 340B purchases are legitimate, directs the rebate to the proper entities, and helps encourage low-cost pricing to be shared directly with patients.

Third, the amicus briefs express serious concerns about HRSA’s threat to remove JJHCS’s PPA because of the far-reaching adverse effects it would have on patients. William Sarraille, ADAP Advocacy’s Special Counsel on issues related to the 340B Drug Pricing Program, explains, “HRSA’s threat to remove manufacturers from the 340B program—and thereby cut off Medicare and Medicaid patient access to their drug therapies—was a recklessly anti-patient act. Sadly, it showed that HRSA cares more about protecting covered entities that engage in diversion, duplicate discounts, and that fail to share 340B pricing with patients than it does about patient access to desperately needed medications.” Sarraille adds, “HRSA could have insisted on certain safeguards in helping to adapt the rebate model for such covered entities as clinics serving HIV and AIDS patients, but it was willing, under lobbyist pressure, to put patients at risk in a blanket refusal to entertain any additional transparency.”

Community Access National Network’s President & CEO, Jen Laws, added, “HRSA has had 30 years to figure itself out in terms of correcting some of the misaligned incentives of the 340B program. Indeed, as recently as the passing of the Inflation Reduction Act, HRSA got the nudge from federal legislators to figure it out. The agency has simply refused to do so.” CANN was the first patient advocacy organization in the HIV space to express support for the new rebate model so long as protections existed for Grantees.

Laws’ reference to the Inflation Reduction Act’s (IRA) drug price negotiation program is, in fact, part of the impetus for the litigation. Under rules established to implement the IRA, drug manufacturers are responsible for ensuring duplicate IRA and 340B discounts are not applied.  Without a rebate model, manufacturers will inevitably pay those duplicates, contrary to the IRA. 

“You can’t just say, ‘Well, good luck figuring it out’ and then disempower any ability to audit claims”, Laws commented. “HRSA doesn’t have the capacity and covered entities, PBMs, and third-party administrators have refused to do so”, he added.  “If you’ve got nothing to hide, this shouldn’t be such a big deal.” Laws argued that it is always CANN’s preference for policy issues to be hammered out by policymakers as opposed to judges with what amounts to ‘downloaded expertise’, either by litigation or legislation. “We support 340B reform. Adjusting payment models to empower manufacturers to ensure their dollars meant to benefit patients actually are benefiting patients is simply good stewardship of the program. It’s a damned shame HRSA can’t get on board with that,” he added.

Photo Source: CANN

In general, hospitals oppose the 340B rebate model. They purport that the rebate model would cause financially damaging delays in recouping rebates, would place manufacturers in charge of 340B pricing, instead of HRSA, and would overburden hospitals with bureaucratic red tape (Freedman et al., 2024). Conversely, manufacturers point out that their rebate system increases transparency, provides for prompt payment, upon validation of a claim, within 7-10 days (faster than covered entities are required to pay wholesalers), and involves only the submission of data that covered entities already are required to collect and maintain. Additionally, the platform for execution is free (J&J, Aug 2024). Ryan White clinics oppose the model out of concern for the upfront financial expenditure, but are, at least at this point, carved out of several of the proposed models, including the JJHCS model, which is limited to disproportionate share hospitals.

In filing its amicus brief in support of the manufacturers' new rebate model, ADAP Advocacy noted because of the difference between 340B hospitals and some covered entities, like clinics serving clients living with HIV, it appreciates that, in deploying rebate mechanisms, steps have been taken to carve out some 340B clinic types. 

The 340B rebate program has evolved far from its narrowly focused beginnings. Instead of being patient-focused, directly benefiting the vulnerable populations it was meant for, it has become a runaway cash cow for those knowledgeable enough to game the system and willing to put their interests above their patients. Various 340B rebate policy proposals aim to make sure rebate revenues flow in the manner they were originally meant. Patients deserve better, and the country continues to suffer excessive medical and fiscal expenditures due to 340B abuse. All eyes will be watching the outcomes of these and future 340B lawsuits.

[1] ADAP Advocacy, CF United. (2025, February 10). Motion for Leave by Amici Curiae, CF United, and ADAP Advocacy. Retrieved from https://www.adapadvocacy.org/urls/DC_Dist_Court_Johnson-Johnson_v_Dorthy-Fink_DHHS_Diana-Espinosa_HRSA_02-10-25.pdf

[2] Fein, A. J., PhD. (2022, January 14). The 340B rebate model: a solution to the contract pharmacy controversy. https://www.drugchannels.net/2022/01/the-340b-rebate-model-solution-to.html

[3] Freedman, L., Hardy, X., Santiago, A. (2024, November 12). Unpacking Johnson & Johnson’s Lawsuit Over 340B Rebate Model. Retrieved fromhttps://www.mintz.com/insights-center/viewpoints/2146/2024-11-19-unpacking-johnson-johnsons-lawsuit-over-340b-rebate#:~:text=The%20announcement%20of%20the%20rebate,protect%E2%80%9D%20the%20DSH%20covered%20entities.

[4] Johnson, Carole. (2024, September 17). Letter to JJHCS. Retrieved from https://340breport.com/wp-content/uploads/2024/09/HHS-letter-to-JJ-09.17.2024.pd

[5] Johnson & Johnson. (2024, August 23). Notice to 340B End Customers Regarding Purchases of STELARA and XARELTO. Retrieved from https://sponsors.aha.org/rs/710-ZLL-651/images/Johnson%20%20Johnson%20Innovative%20Medicine%20340B%20Rebate%20Model%20Policy%20Update%2008-23-2024_FINAL.pdf?version=0

[6] Johnson & Johnson Innovative Medicine. (2024).12 things to know about J&J’s 340B Rebate Model Policy. Retrieved from https://transparencyreport.janssen.com/12-things-to-know-about-j-js-340b-rebate-model-policy#:~:text=340B%20rebates%20will%20be%20paid,”%20until%20January%201%2C%202026.&text=J&J's%20rebate%20model%20requires%20industry,purchase%20and%20the%20product%20dispense.

[7] Rajan, G., Coates, S. (2024, November 15). Lilly sues US agency over blocking of drug-rebate program. Retrieved fromhttps://www.reuters.com/legal/lilly-sues-us-agency-over-blocking-drug-rebate-program-2024-11-15/#:~:text=Eli%20Lilly%20said%20its%20program,Sign%20up%20here. 

[8] White, S. (2024, September 30). Letter to HRSA. Retrieved from /https://transparencyreport.janssen.com/letter-in-response-to-hrs

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates. 

Infusion Clinics Could Expand Utilization of Long-Acting Injectables, but Barriers Hinder Access

By: Ranier Simons, ADAP Blog Guest Contributor

The advent of long-acting injectables (LAI) for HIV prevention and treatment is a noteworthy breakthrough in medical science. Despite the growing number of options and continuing clinical studies showcasing their efficacy, they are under-utilized. While there are various drug-level and patient-level barriers to LAI uptake, one of the most significant barriers is access at the system level (Cooper et al., 2022). Many people who would greatly benefit from LAIs for prevention and people living with HIV/AIDS (PLWHA) in need of better options for treatment can’t access them. Logistics and coverage issues stand as obstacles to life-saving treatment and public health prevention.

Photo Source: HIV.gov

Discrepancies in insurance coverage constitute a significant barrier. In the U.S., 40 percent of PLWHA are insured by Medicaid, and 27 percent get medication from state AIDS Drug Assistance Programs (ADAP) (Zalla et al., 2025). A recent study examined prescription drug formulary coverage of long-acting cabotegravir/rilpivirine (CAB/RPV-LA) for HIV treatment for those who achieved viral suppression and lenacapivir (LEN) for adults with multi-drug-resistant strains. CAB/RPV-LA was not covered without prior authorization (PA) by 26 state Medicaid programs and had no coverage by 15 state ADAPs. LEN was not covered without prior authorization by 32 Medicaid programs and had no coverage by 18 ADAPs (Zalla et al., 2025). Eighteen state Medicaid plans had unencumbered uniform coverage of CAB/RPV-LA with no PA, and 11 had unencumbered uniform coverage of LEN with no PA (Zalla et al., 2025). A distinction is made between coverage with and without PA because prior authorizations for LAIs are particularly cumbersome. Additionally, many health insurers require reapproval processes for continued treatment.

Another recent study surveyed providers inquiring about identified barriers to LAI utilization for treatment and prevention regarding long-acting cabotegravir/rilpivirine (CAB/RPV-LA) for treatment and long-acting cabotegravir (CAB-LA) for HIV prevention (Marcus et al., 2025). These providers highlighted PA approval and appeals, re-verification of eligibility for continuous coverage, and coverage of LAIs as a medical benefit instead of a pharmacy benefit (Marcus et al., 2025).

Both studies highlight the central barrier of insurance bureaucracy as a hindrance to LAI access. Cumbersome PAs delay the initiation of treatment. Requiring re-verification of eligibility for treatment not only causes treatment delays but also adds to the administrative burden of providers (Marcus et al., 2025; Zalla et al., 2025). Providers cannot afford to be saddled with the extra administrative burden of soliciting and managing PAs or the financial expenditure of hiring staff for that purpose. Additionally, when LAIs are covered under insurance as a medical benefit instead of a pharmacy benefit, that can require a provider to purchase medications on the front end and bill the insurance on the back end in a “buy and bill” situation (Marcus et al., 2025). Not only is a financial investment for the medications required, but special storage and refrigeration is required. This may be logistically challenging and cost-prohibitive to a provider.

Photo Source: Pharmacy Practice News

When vulnerable patients rely on Medicaid or ADAPs to obtain LAIs, poor formulary coverage means a lack of access. Even if there is coverage, patients fall in and out of eligibility for Medicaid and ADAPs regularly due to income restrictions. When there is non-alignment of coverage between Medicaid and ADAP in a state, patients risk lengthy treatment interruptions. This is dangerous because LAIs remain in the body for long periods of time at low levels. As such, treatment interruptions can result in developing drug resistance (Zalla et al., 2025).

One solution to assist providers in avoiding some of the challenges of administering LAIs is referral to infusion clinics. Increasing the utilization of infusion clinics to administer LAIs would be an innovation of care delivery and implementation science from a process improvement perspective. As founder and CEO of Agile Infusion Services LLC, Yossi Faber states, “Freestanding ambulatory infusion clinics play a crucial role in expanding access to long-acting injectables for HIV prevention and treatment. However, without addressing systemic barriers such as restrictive insurance policies, provider education gaps, and operational constraints, these therapies won’t reach those who need them the most. Ensuring sustainable policies and adequate provider support is key to equitable access.”

Infusion centers that are not inside hospitals or other medical practices solely focus on infusion and injection therapies. Freestanding centers are in communities; thus, they are often more convenient for patients in terms of physical access. Additionally, the centers’ staff are highly trained with respect to injections and infusions. The advanced training increases patient safety and is a standard operational characteristic of their care model. They have lower overhead and can negotiate with payers at a lower price (Cheney, 2022).

Photo Source: Rx Toolkit

Primary care doctor offices and other medical clinics do not typically have the built-in workflow, refrigeration, and storage capacity, nor administrative capacity to effectively handle the utilization of LAIs. Infusion centers are experienced with the administrative navigation of prior approvals, medication handling, medication dispensing, and the logistics of obtaining drugs from specialty pharmacies. Moreover, primary care doctors are not well-versed on preventative LAIs. PLWHA utilize providers experienced with LAIs for their care. Those desiring LAIs for PrEP are typically unfamiliar with the HIV treatment landscape and have an unclear path to access. Faber explains, “This lack of awareness on the part of providers can result in significant underutilization of these therapies, as providers are often hesitant to recommend treatments with unfamiliar medications or modalities, particularly if they are unaware of where such therapies can be obtained.” Referring patients to infusion centers to administer LAIs for treatment and prevention is part of a comprehensive solution.

There is a dire need to improve access to long-acting injectable medications. Patients need to access many other beneficial therapies, such as Trogarzo, an LAI for treatment-resistant HIV, and Abilify Maintena for antipsychosis. Solutions to access issues require a multi-faceted approach. Policy intervention is necessary for insurers to streamline the PA process and remove the need for LAI reapproval. Congress should pass PrEP legislation to bolster assistance to people who are uninsured or underinsured. States should fund PrEP assistance programs. Congress should also increase funding for the Ryan White HIV/AIDS Program to help with the evolving demand for LAIs for treatment and prevention to make sure those vulnerable populations who can benefit the most are empowered with access. Medical science is evolving quickly. Thus, policy and funding innovation must also evolve to ensure equitable access to effective treatment for all.

[1] Cheney, C. (2022, August 3).Standalone Infusion Center CEO: 'The Patient Experience Is Superior.' Retrieved fromhttps://www.healthleadersmedia.com/clinical-care/standalone-infusion-center-ceo-patient-experience-superior#:~:text=Standalone%20infusion%20centers%20can%20offer,with%20lower%20overhead%20and%20expenses.

[2] Cooper, S. E., Rosenblatt, J., & Gulick, R. M. (2022). Barriers to Uptake of Long-Acting Antiretroviral Products for Treatment and Prevention of Human Immunodeficiency Virus (HIV) in High-Income Countries. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 75(Suppl 4), S541–S548. https://doi.org/10.1093/cid/ciac716

[3] Lauren C Zalla, Tim Horn, Sita Lujintanon, Catherine R Lesko, State-Level Variation in Access to Long-Acting Injectable Antiretroviral Therapy for HIV in the United States, Health Affairs Scholar, 2025;, qxaf016, https://doi.org/10.1093/haschl/qxaf016

[4] Marcus, J. L., Weddle, A., Kelley, C. F., Agwu, A., Montalvo, S., Sherman, E., Vijayan, T., Gutierrez, J., Hickey, M. D., Dilworth, S. E., Krakower, D., Davis, T. L., Collins, L. F., McNulty, M. C., Colasanti, J. A., & Christopoulos, K. A. (2025). Policy recommendations to support Equitable access to Long-Acting Injectables for Human Immunodeficiency virus prevention and Treatment: A policy paper of the Infectious Diseases Society of America and the HIV Medicine Association. Clinical Infectious Diseases. https://doi.org/10.1093/cid/ciae648

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates. 

Despite Ongoing Chaos, Ryan White Program 2030 Plan Remains Relevant

By: Ranier Simons, ADAP Blog Guest Contributor

In December 2024, Ryan White HIV/AIDS Program (RWHAP) partners received a guidance letter about the Ryan White Program 2030 plan (RWP 2030) from the Health Resources Services Administration (HRSA). The guidance, in the form of a Dear Colleague Letter (DCL) did not include specific policy explanations or detailed implementation instructions, but rathe highlights of directives and unifying paradigms of action. Given the current political climate and the state of flux regarding public health programs and access to public health data on federal agency websites this letter might now be undermined. That said, it is also an acknowledgment of past successes and how they relate to future targets.

(Editor's Note: Some of the links included in the Dear Colleague Letter have already been scrubbed from their websites)

RWP 2030 maintains a focus on an efficacious, high standard of care for those presently benefiting from programs and services through the Ryan White HIV/AIDS Program (RWHAP). The DCL emphasizes the importance of increased efforts to find people living with HIV/AIDS (PLWHA) who are undiagnosed or who have fallen out of the care continuum and bring them into proper care. Data from August of 2024 indicates that 13 percent of the 1.2 million PLWHA in the U.S. are undiagnosed and unaware (HIV.GOV, 2024). That is roughly 156,000 individuals in danger of serious adverse health outcomes due to lack of treatment as well as the potential to unknowingly spread HIV. A combined 40 percent of PLWHA in the U.S. are undiagnosed or diagnosed and not receiving care. 

Great strides have been made regarding viral suppression, and a renewed focus on reaching untreated individuals is the RWP 2030’s aim to increase those numbers. From 2010 to 2023, viral suppression amongst those receiving care under the RWHAP increased from 69.5% to 90.6% (HRSA, 2024). Viral suppression does not happen overnight and is not a permanent self-maintaining endpoint. Reaching viral suppression requires consistent care, and maintaining it requires permanent care.

Source: HIV.gov

The DCL stresses the need for community-driven collaboration and planning. PLWHA live in populations and communities of significant heterogeneity. The RWP 2030 aims to equip people and entities with the resources, capacity-building tools, and training to create the infrastructures needed to meet the specific needs of identified communities. The letter states that success will require “collaboration across sectors, innovation in care delivery, and a commitment to addressing barriers to care” (HRSA, 2024). 

The RWP 2030 framework of leveraging partnerships, focusing interventions, and community engagement is the most effective mindset to have going forward (HRSA, 2024). Presently, there is much uncertainty concerning funding, policy, and potentially adverse effects of political expediency. The DCL reminds RWHAP recipients of the importance of being vigilant with the reevaluation of programs and services to maximize the allocation of efforts to meet locally identified needs. Monitoring is imperative to balance furthering the appropriate care of those already receiving RWHAP services and engaging people new and returning to care.

HRSA plans to release specific guidance and development of tools to support RWHAP recipients in realizing RWP 2030 goals. Some of the education on best practices for outreach, linkage to, and engagement in care is not available as many HIV resources, such as TargetHIV.org, are not available, having been removed from online access by the current administration as of the time of this blog. This fortifies the need for innovative measures of collaboration and the inclusion of non-traditional partnerships to strengthen infrastructures of care. In addition to training and resources, HRSA plans to hold a series of listening sessions in 2025 (HRSA, 2024). The goal is to facilitate exposure to a diverse range of perspectives and experiences associated with navigating the hurdles and pitfalls on the journey of ending the HIV epidemic.

Photo Source: HRSA HIV/AIDS Bureau

Program letters are not only a press statement or documentation for the purposes of public record. HRSA DCLs are a source of information, motivation, hope, and reassurance that RWHAP recipients are supported and are not isolated islands. Reminding entities of their mission and identifying the means to find the help they need is vital for programmatic success. How this plan plays out under the ongoing attacks on public health programs still remains to be seen.

[1] HRSA. (2024, December 20). Dear Colleague Letter. Retrieved from https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/rw-program-letter-2030.pdf

[2] HIV.GOV. (2024, August 15). U, S. Statistics. Retrieved from https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics#:~:text=Approximately%201.2%20million%20people%20in,sex%20with%20men%20(MSM)

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates. 

Injurious Tactics Associated with Alternative Funding Programs are Growing

By: Ranier Simons, ADAP Blog Guest Contributor

Barriers to accessing prescription medications, especially specialty drugs, is a constant challenge for many patients in the healthcare expenditure ecosystem. It is made more complicated by the constant tug-a-war between public payors, insurance companies, pharmacy benefits managers (PBMs) and drug manufacturers over cost. Unfortunately, patient harm is often the collateral damage of the insurers attempting to cut costs while maximizing profits. To save money, alternative funding program (AFP) utilization by insurers and PBMs is a gimmick increasing in popularity. The injurious tactics associated with AFPs are growing, and more data is being collected regarding the problems they are causing patients.

Photo Source: MMIT

A recent study indicated that 75% of employers utilizing AFPs plan to continue their use, with one in three large employers considering using them in the future (Doxey & Balicki, 2024). AFPs operate by partnering with employers to fraudulently, for their profit, utilize programs offered by drug manufacturers and private charitable entities that are in place to help needy patients. It also targets certain public safety net programs, such as State AIDS Drug Assistance Programs (ADAPs).

They do this by manipulating employer plans to take advantage of copay assistance programs, patient assistance programs (PAP), and even international mail orders. In return for employers saving money, patients are suffering. A patient experience study involving a survey of 227 patients utilizing AFPs showed that 88% reported stress and anxiety due to medication uncertainty due to coverage denial, the average wait time to receive medication was 68.2 days, and 24% explained the delay caused them adverse side effects including worsening of their condition (Wong et al., 2024).

One of the most dangerous AFP practices is drug importation. In this case, AFPs force patients to take non-FDA-approved drugs from overseas. They, in essence, broker personal drug importation between patients and unlicensed illegal foreign pharmacies (Partnership for Safe Medicines, 2024). First and foremost, in most circumstances, personal importation of drugs and devices into the U.S. is illegal (FDA, 2024). In the narrow instances where the FDA allows some permissible discretion with importation, the expectation was for specific individual needs. It was not for large-scale utilization by employers and AFPs. As explained by Shabbir Imber Safdar, Executive Director of the Partnership for Safe Medicines (PSM), “Employers participating in these plans are opening themselves up to enormous legal liability when they encourage their employees to take a risk with their medical care in order to save the employer a few dollars.”

Photo Source: Partnership for Safe Medicines

Under the drug importation scheme, AFPs convince employers to carve out expensive and specialty medications from coverage to source them from outside of the United States for lower prices (Partnership for Safe Medicines, 2024). Patients using these self-funded employer plans are told they must agree to foreign-sourced medication to receive their needed therapies. To avoid violating essential health benefit (EHB) coverage laws, some employers simply encourage patients to use foreign-based medications instead of carving out medications from coverage. Employers explain to patients that they will pay less money if they buy the foreign drugs in comparison to what they’d be charged by the plan otherwise. 

The foreign sources used to obtain these medications are outside of the U.S. Drug Supply Chain Security Act tracking system known as “track and trace” (Partnership for Safe Medicines, 2024). As such, patients are in danger of receiving dangerous counterfeit drugs or drugs that have not been appropriately handled. Safdar says, "These medicines are not inspected or approved by the U.S. Food and Drug Administration. Their packaging and safety instructions are not the same as the U.S. product, if they're even real at all, and they're dispensed by unlicensed foreign businesses." Patients have no protection or recourse if they are harmed by counterfeit or poorly handled foreign-sourced medication. Additionally, the medications most commonly targeted for AFP drug importation schemes are used to treat asthma, cancer, epilepsy, hepatitis, HIV, pulmonary hypertension, and organ rejection (Partnership for Safe Medicines, 2024). These vulnerable populations could suffer fatal harm from counterfeit or ineffective medications.

Using the Freedom of Information Act (FOIA), PSM analyzed 16 towns and school districts, identifying over $4 million of imported medication invoices. Employers are enticed by the cost savings presented by AFPs. In one city, PSM found that the base cost of one Trulicity prescription was $1,100.00 without foreign drug importation and only $438.00 with the drug being imported. Several widely used HIV antiretrovirals were also found on these invoices: Biktarvy, Dovato, Genvoya, and Descovy. Employers that utilize the AFP drug importation programs pay fees to the AFPs. Safdar further explains that employers usually pay a percentage of the perceived “savings” difference between the regular market costs of the drugs compared to the foreign import costs. Thus, employers are spending money for the program in addition to what they are paying to purchase the imported drugs. AFPs are purely profit-driven and are not in service of helping patients.

All AFP schemes are predatory, whether they are exploiting PAPs, utilizing copay accumulators, or foreign drug importation schemes. However, AFPs are also discriminatory. Specifically, they are discriminatory against low-income patients. The PAPs that AFPs exploit, whether they be a manufacturer or charitable organization, usually have income threshold requirements. Thus, the patients likely to be approved for the programs are those with lower incomes (Prescription, 2023). Employees with higher incomes will not qualify, and subsequently, the employer plan will end up covering their medication under standard cost-sharing. However, the lower-income employees are forced to remain on the AFP-obtained PAP.

Photo Source: Optum for Business

In this manner, lower-income employees face higher barriers to medication access. However, they are paying the same premiums as other employees whose income disqualifies them from utilizing fraudulent PAP enrollment (Prescription, 2023). Low-income employees are subject to delays due to mail-order pharmacy requirements and the stress of navigating the bureaucracy of application and approval of the PAP access via the AFP. Employees on standard covered medications can start their treatment immediately upon receiving a prescription from their doctor. Patients prescribed “carved-out” medications are subject to suboptimal care.

Patients expect the insurance plans they pay for to provide the coverage they need. By utilizing deceptive AFPs, employers with self-insured health plans, both large and small, do not fulfill their fiduciary duties nor the promise of patient care. For the sake of profit, AFPs endanger patients' health and well-being, impede patient assistance entities' ability to provide help to those genuinely in need and violate the law. Outlawing them will protect the vulnerable workers they exploit and add some stability to the presently fragile healthcare ecosystem.

[1] Doxey, P., Balicki, C. (2024). The Present and Future of Alternative Funding Programs for Specialty Drugs. Retrieved from https://leavittpartners.com/the-present-and-future-of-alternative-funding-programs-for-specialty-drugs/

[2] The Partnership for Safe Medicines. (2024). Alternative Funding Programs: Offshoring patients, importing risks. Retrieved from https://www.safemedicines.org/2024/04/afps-offshoring-patients-importing-risks.html

[3] Prescription for Better Access. (2023, November 17). 12: How Alternative Funding Programs Exploit Patient Assistance Programs (Podcast). Retrieved from https://prescriptionforbetteraccess.com/12-how-alternative-funding-programs-exploit-patient-assistance-programs/

[4] United States Food and Drug Administration. (2024, October 8). Personal Importation. Retrieved from https://www.fda.gov/industry/import-basics/personal-importation

[5] Wong, W. B., Yermilov, I., Dalglish, H., Bienvenu, L., James, J., & Gibbs, S. N. (2024). A descriptive survey of patient experiences and access to specialty medicines with alternative funding programs. Journal of managed care & specialty pharmacy, 30(11), 1308–1316. https://doi.org/10.18553/jmcp.2024.30.11.1308

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates. 

Harvard Pilgrim Health Care Offered Discriminatory Plans to People Living with HIV

By: Ranier Simons, ADAP Blog Guest Contributor

Discrimination is nothing new for people living with HIV/AIDS (PLWHAs), as it impacts multiple facets of their daily lives. Aside from HIV-related discrimination in employment, housing, healthcare, and criminal justice, an often-overlooked area is insurance. Discriminatory plan design refers to the barriers health insurance companies impose on PLWHAs thereby limiting access to care and treatment for years, advocacy groups have battled insurers with public scrutiny and, in some cases, litigation (Andrews, 2016.) Despite some coverage improvements, complaints and lawsuits continue as insurers maintain practices in non-compliance with federal law. 

Photo Source: AIDS Foundation of Chicago

One recent large plan instance of discriminatory coverage involved Harvard Pilgrim Health Care (HPHC). In November of 2024, the HIV+Hepatitis Policy Institute filed discrimination complaints against HPHC because their Core 4-Tier and Core 5-Tier plans in Maine, New Hampshire, and Rhode Island contained inadequate coverage of HIV antiretrovirals in violation of the ACA. In solidarity of the cause, several other groups sent a letter to the insurer. A few of the groups included were the Federal AIDS Policy Partnership (FAPP), HealthHIV, NASTAD, and AIDS Alabama (HIV+HEP, 2024).

The U.S. Department of Health and Human Services (HHS) guidelines recommend four preferred treatment regimens as initial HIV antiretroviral therapy: Biktarvy, Dovato, Symtuza, or a combination of Tivicay with either Truvada or Descovy (“Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV,” n.d.). The plans only covered Dovato or Tivicay + Truvada. Biktarvy is a single-pill regiment prescribed to over 49% of PLWH and should be covered (HIV+HEP, 2024). Dovato was covered but is not appropriate for PLWH with high viral loads or HIV that is resistant to lamivudine or dolutegravir. The plans excluded Symtuza, even though it is the only recommended treatment for PLWH who have taken long-acting injectable PrEP (cabotegravir) and have possible HIV resistance to Integrase strand transfer inhibitors (INSTI) (HIV+HEP, 2024). There are other clinical situations where HHS guidelines recommend Delstrigo, Odefsey, Triumeq, and a combination of Prezcobix and Epzicom as initial regimen alternative therapies. The plans covered only Odefsy and Triumeq (HIV+HEP, 2024).

When patients lose access to covered medications, they not only experience lapses in treatment but sometimes must change to treatments that are not the best for them. Sometimes, even alternative therapies still result in a financial burden or non-adherence due to treatment. If a patient is moved from a single-pill regimen to a multi-pill treatment, they are likely to have issues staying consistent with their treatment plan (HIV+HEP, 2024). Lack of coverage on one plan may also force a patient to choose a different one that may cover their needed medication but has adverse financial effects.

Photo Source: HIV + HEP Policy Institute

As a result of advocacy bringing public awareness directed at state policy leadership and insurance carriers, HPHC reversed its problematic coverage decisions and updated the Maine, New Hampshire, and Rhode Island formularies at the end of December. For 2025, they now cover eight complete initial HIV treatment regimens: Biktarvy, Dovato, Symtuza, Tivicay (in combination with Truvada or Descovy), Delstrigo, Odefsey, Triumeq, and Prezcobix (in combination with abacavir and lamivudine) (HPHC, 2025). While this is progress, the medications are located on the highest drug tiers of the formularies. This may render the formularies clinically effective, but they are still cost-prohibitive. Drugs on the highest formularies have the highest cost-sharing for patients, requiring them to pay significant percentages of the drug's prices as co-insurance. A high financial burden is still a barrier to access and effective care. 

As Tim Horn, Director of Medication Access with NASTAD, points out, “Relegating virtually all branded antiretrovirals to the highest cost-sharing tiers has been associated with co-insurance that typically exceeds 25% of the retail cost of the prescribed antiretroviral drug product(s), which can be considerable costs, certainly for plan beneficiaries but also for safety net programs like state ADAPs.” Director Horn also adds, “ADAP-funded insurance programs providing premium and cost-sharing support for people living with HIV are likely important factors in these carriers' decisions to ultimately engage in discriminatory formulary design practices. Of course, it is vitally important that ADAPs are able to provide premium and cost-sharing support for their clients and, likely, a significant proportion of otherwise uninsured people living with HIV in these states.”

Insurance companies do not want ADAPs to utilize their plans because they are a built-in permanent population of covered lives requiring expensive medication. Director Horn further explains, “Carriers, particularly those operating in states where few other carriers or Marketplace plans, likely consider ADAPs making their plans affordable for people living with HIV as a risk to their bottom lines. The result, as we saw with the initial Harvard Pilgrim Health decision to remove a huge swath of important antiretroviral drugs from its core formularies in three states, can be profoundly cynical and discriminatory practices that can have serious repercussions for both people living with HIV and the vitally important, yet fiscally constrained, HIV programs, such as state ADAPs.”

According to Carl Schmid, Executive Director of the HIV+Hepatitis Policy Institute, more vigorous enforcement would be a solution to discriminatory plan design. For example, in Texas, the Affordable Care Act guidelines are not enforced by the state insurance regulator but are enforced by the federal government. Moreover, the federal government constructs templates delineating ACA appropriate coverage guidelines for insurance plans to follow. Schmid explains that the templates in use are outdated, thus not reflecting current best practices. Hence, the federal government is not effectively engaging in enforcement. 

Unfortunately, advocacy groups and public outcry are how most insurance companies’ discriminatory plan malfeasance comes to light. Currently, many other grievances are being elevated and watched. Two, in particular, involve Medica and Community Health Choice Texas. HIV + HEP Policy Institute filed complaints against Medica in Minnesota and Iowa for inadequate recommended coverage in addition to placing all HIV antiretrovirals on their highest tiers. Their filing in Texas against Community Health Choice was also regarding inadequate HIV drug coverage regarding treatment guidelines (Burke, 2024).

The vigilance of advocacy groups, patients, and other entities is the only robust tool against discriminatory plan design. Until more effective federal and state enforcement occurs, there will not be any consistent ethical and legal behavior in the industry. The law, regulations, guidance, and implementation all must be aligned. As Schmid states, “Insurers will try to get away with as much as they can until they are caught.”

Patients living with HIV experiencing similar health plan discriminatory design are encouraged to alert the HIV + HEP Policy Institute at https://hivhep.org/contact/.

[1] Andrews, M. (2016, October 18). 7 Insurers Alleged To Use Skimpy Drug Coverage To Discourage HIV Patients. Retrieved from https://kffhealthnews.org/news/7-insurers-alleged-to-use-skimpy-drug-coverage-to-discourage-hiv-patients/

[2] Burke, J. (2024, December 17). Press Release. Retrieved fromhttps://hivhep.org/wp-content/uploads/2024/12/hiv-discrimination-complaints-maine-harvard-pilgrim-12.17.24.pdf

[3] Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. (n.d.). In Centers for Disease Control and Prevention, U.S. Food and Drug Administration, Health Resource and Services Administration, & National Institutes of Health, Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/tables-adult-adolescent-arv.pdf

[4] Harvard Pilgrim Health Care. (2025, January 2). Press Release. Retrieved from https://www.harvardpilgrim.org/public/news-detail?nt=HPH_News_C&nid=1471978029629

[5] HIV + HEP Policy Institute. (2024, November 8). Substandard & Discriminatory HIV Medication Coverage & Plan Design by Harvard Pilgrim Health Care. Retrieved from https://hivhep.org/wp-content/uploads/2024/11/maine-harvard-pilgrim-HIV-complaint-11.8.24.pdf

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.