Prescription Drug Affordability Boards and the ADA: A Potential Conflict?

Could state efforts to lower prescription drug prices inadvertently violate a federal civil rights law? It’s a question being asked about Prescription Drug Affordability Boards (PDABs) as they gain traction across the United States. PDABs are state-level entities designed to address the soaring cost of prescription medications, a crisis impacting millions of Americans. As policymakers seek solutions to improve affordability, PDABs have emerged as a popular strategy, with a growing number of states enacting legislation to establish these boards. While the intent behind PDABs is laudable, their implementation requires careful consideration to ensure they do not inadvertently create barriers for people with disabilities. The potential conflict between well-intentioned affordability initiatives and the Americans with Disabilities Act (ADA) highlights the need for vigilance to protect the rights of people with disabilities in the pursuit of lower drug prices. Our analysis reveals that PDABs are disproportionately focusing on medications used to treat conditions likely classified as disabilities under the ADA, raising concerns about potential ADA violations.

A Disproportionate Focus on Drugs for Disabilities

A recent analysis conducted by Community Access National Network (CANN) reveals a concerning trend: PDABs are disproportionately targeting medications used to treat conditions highly likely or likely to be classified as disabilities under the ADA. This finding raises serious questions about the potential for PDABs to create disparate impact and limit access to essential medications for people with disabilities.

The table below summarizes the key data points from the CANN Data Analysis Report:

State	Total Drugs Eligible	HIGHLY LIKELY	LIKELY	Total Potentially Disabling	% Potentially Disabling	% HIGHLY LIKELY	% LIKELY
CO-E	343	306	28	334	97.4%	89.2%	8.2%
CO-S	4	2	2	4	100%	50.0%	50.0%
MD	8	3	5	8	100%	37.5%	62.5%
OR	39	24	15	39	100%	61.5%	38.5%
WA	188	94	68	162	86.2%	50.0%	36.2%

Note: Percentages are based on the total number of drugs on each state's "Eligible for Review" list (or "Selected for Review" in Maryland's case), which represents the medications the PDAB could choose for a full affordability review. The Colorado data is presented in two rows: “CO-E” represents the 343 drugs eligible for review, and “CO-S” represents the four drugs ultimately selected for review by the PDAB. It is important to note that a lack of data transparency from some states limited our ability to perform a complete analysis for all PDABs. To determine a drug's relevance to this analysis, we evaluated each condition a drug treats based on its likelihood of being classified as a disability under the ADA, using a four-tiered ranking system: HIGHLY LIKELY, LIKELY, UNLIKELY, and VERY UNLIKELY.

In Colorado, 97.4% of the drugs initially eligible for review by the PDAB treat conditions categorized as “HIGHLY LIKELY” or “LIKELY” disabilities under the ADA. In Maryland and Oregon, every drug eligible for review falls into these categories. Even in Washington, where the percentage is lower, 86.2% of the drugs on the "Eligible for Review" list treat potentially disabling conditions.

This data demonstrates a clear pattern: PDABs are predominantly focusing on medications used by people with disabilities. This trend is particularly concerning given the variability and uncertainty surrounding PDAB processes for setting upper payment limits (UPLs), as highlighted by a recent analysis in Health Affairs.

A closer look at the specific condition categories targeted by PDABs further underscores this concern. In Colorado, the most frequently targeted categories include cancer, genetic disorders, autoimmune disorders, and hematological disorders. Maryland's PDAB focuses on endocrine disorders, autoimmune disorders, and respiratory disorders. Oregon’s list includes autoimmune disorders, addictive disorders, cancer, and endocrine disorders. Washington’s PDAB targets a similarly broad range of conditions, including autoimmune disorders, cancer, neurological disorders, and endocrine disorders. These categories encompass numerous conditions with a high likelihood of being classified as disabilities under the ADA.

The potential for PDABs to negatively impact people with disabilities is not merely hypothetical. In Colorado, the PDAB has already conducted affordability reviews on Enbrel and Stelara, two drugs used to treat conditions highly likely to be considered disabilities under the ADA. The Board determined that both medications are unaffordable, potentially leading to the establishment of UPLs, which would set limits on how much payers can reimburse for these drugs. If UPLs are set on these medications, it could significantly limit access for people who rely on them to manage their conditions.

Navigating the Legal Landscape: The ADA and Health Care

The disproportionate targeting of medications used by people with disabilities raises serious concerns about the potential for PDABs to violate the Americans with Disabilities Act. This landmark civil rights law prohibits discrimination against people with disabilities in all areas of public life, including healthcare.

A key concept in ADA law is disparate impact. This occurs when a policy or practice, even if seemingly neutral on its face, has a disproportionately negative impact on people with disabilities. As legal scholar Sara Rosenbaum explains, "Disparate impact claims arise when a plaintiff can demonstrate that a facially neutral policy disproportionately burdens or harms people with disabilities." In the context of PDABs, disparate impact could occur if, for example, the setting of UPLs on medications for disabling conditions leads to greater utilization management or formulary restrictions, effectively limiting access for people with disabilities while having a less pronounced impact on people without disabilities. The potential for supply chain disruptions and the lack of guaranteed cost savings for patients, as highlighted in the recent Health Affairs article, further underscore the risk of disparate impact.

The ADA also requires covered entities, including healthcare providers and insurers, to provide reasonable accommodations to people with disabilities. Reasonable accommodations are adjustments to policies, practices, or procedures that enable people with disabilities to participate fully and equally in programs and services. However, the ADA does recognize that some accommodations may pose an "undue burden" on covered entities, meaning they would require significant difficulty or expense. The ADA National Network provides relevant examples in the healthcare context, such as modified meeting formats, accessible materials (e.g., large print, Braille), and the provision of sign language interpreters. PDABs must proactively incorporate reasonable accommodations into their processes to ensure meaningful participation for people with disabilities. This includes providing accessible meeting locations and materials, offering alternative formats for public comments, and ensuring that people with disabilities have equal opportunities to engage in the PDAB’s decision-making process.

Any limitations on access to medications resulting from PDAB actions must be justified by legitimate, non-discriminatory reasons. Historically, a common defense used to shield discriminatory coverage designs from legal challenges has been the "fundamental alteration" defense. This defense argues that modifying a benefit plan to accommodate the needs of people with disabilities would fundamentally alter the nature of the plan and is therefore not required under the ADA. However, the Affordable Care Act (ACA)'s emphasis on comprehensive coverage and non-discrimination weakens this defense. As the Supreme Court recognized in Alexander v. Choate, the benefit provided through a healthcare program is not merely the individual services offered, but also the opportunity for meaningful access to those services. The ACA's statutory language in Section 1557 reinforces this principle, prohibiting discrimination in benefit design and requiring coverage of essential health benefits. This shift in healthcare law strengthens the legal basis for challenging discriminatory PDAB practices that limit access to medications for people with disabilities.

The QALY Conundrum: Undervaluing Life with a Disability

Compounding the risk of discrimination in PDAB practices is the potential for these boards to rely on a flawed metric known as the Quality-Adjusted Life Year (QALY) when evaluating drug affordability. The QALY is a measure used to assess the value of medical interventions by considering both the quantity and quality of life gained. While seemingly objective, the QALY inherently devalues life with a disability.

The problem lies in how the QALY calculates "quality" of life. It relies on societal perceptions of health and functioning, often derived from surveys of the general public. As the Disability Rights Education & Defense Fund (DREDF) explains in a recent report, "The QALY equation relies on a baseline of 'perfect health' that is calculated by society’s conception of health and functioning." This means that people with disabilities are automatically assigned a lower quality-of-life score, regardless of their own lived experiences.

The DREDF report provides compelling examples of how the QALY can lead to discriminatory coverage decisions. For instance, the drug Trikafta, a breakthrough treatment for cystic fibrosis, has been shown to significantly extend the lives of people with this condition. However, because cystic fibrosis often involves functional limitations, the QALY undervalues the life extension benefit of Trikafta, potentially leading payers to deem it too expensive to cover. Similarly, medications for opioid use disorder, which can dramatically improve daily functioning and quality of life for people with this condition, are often undervalued by the QALY due to societal stigma and negative perceptions of opioid use disorder.

Some proponents of the QALY have proposed an alternative measure called the Equal Value of Life Years Gained (evLYG). The evLYG avoids discounting life extension based on quality of life. However, as the DREDF report points out, the evLYG fails to account for quality-of-life improvements, making it an incomplete solution.

The potential for PDABs to rely on QALY-based analyses is a serious concern. While some states explicitly prohibit the use of QALYs in setting UPLs, the lack of consistent language across all states and the continued focus on cost-related factors raise concerns about the perpetuation of bias in drug valuation. If PDABs utilize the QALY or similar metrics that fail to account for the true value of medications for people with disabilities, they risk exacerbating existing disparities and undermining the ADA’s guarantee of equal access to healthcare.

Can PDABs Overcome Inherent Bias in Drug Selection?

The establishment of PDABs, despite their purported goal of lowering drug costs, raises serious concerns about potential discrimination against people with disabilities. Our data analysis reveals a deeply troubling pattern: across all states examined, the vast majority of drugs targeted by PDABs are those used to treat conditions highly likely or likely to be classified as disabilities under the ADA. This striking trend, with some states demonstrating an exclusive focus on medications for potentially disabling conditions, calls into question the fundamental fairness and equity of PDAB drug selection processes.

This overwhelming focus on medications for potentially disabling conditions raises a fundamental question: can PDABs, as currently designed, ever truly operate in a manner that is equitable and non-discriminatory? The very nature of these boards, tasked with identifying "unaffordable" drugs and setting limits on their reimbursement, appears inherently biased against medications vital to the health and well-being of people with disabilities. Furthermore, the potential for PDABs to negatively impact the 340B Drug Pricing Program adds another layer of concern. As previous CANN articles have highlighted, UPLs set by PDABs could significantly reduce the revenue generated by 340B discounts, undermining a major source of funding for safety-net providers and jeopardizing access to care for vulnerable communities.

Proposals for mandatory ADA compliance reviews, data transparency, and stakeholder engagement, while necessary, are unlikely to fully address this fundamental flaw. Compliance reviews are reactive and cannot prevent all discriminatory outcomes. Data transparency, while necessary for accountability, does not guarantee equitable decision-making. And even meaningful engagement with disability rights organizations and people with disabilities cannot fully compensate for the inherent biases that may be embedded in PDAB processes.

Given the clear evidence of implicit bias in PDAB drug selection, more investment needs to be made in studying the potential discriminatory nature of these boards.

• Quantify the Disparate Impact: Conduct comprehensive analyses to determine the extent to which PDAB drug selection and UPL-setting processes disproportionately impact people with disabilities.

• Evaluate Alternative Strategies: Explore and compare the potential impact of various drug affordability strategies, including PDABs and alternatives such as direct price negotiations, expanded patient assistance programs, and bulk purchasing agreements, on access to medications for people with disabilities.

• Develop Robust Safeguards: If states choose to move forward with PDABs, they must develop and implement comprehensive safeguards to mitigate the risk of discrimination. These safeguards should include mandatory ADA compliance reviews, comprehensive data transparency requirements, and meaningful engagement with disability rights organizations and people with disabilities throughout all stages of the PDAB process.

Addressing the complex intersection of drug affordability and disability rights requires a nuanced and evidence-based approach. Until we have a deeper understanding of the potential for discrimination and the efficacy of safeguards, the viability of PDABs remains in question.

ADA & HIV Legal Protections

The fight for disability rights has been long and arduous, marked by significant milestones and persistent challenges. For people living with HIV (PLWH), this struggle intersects with ongoing battles against stigma, misinformation, and discrimination. While legislation like the Americans with Disabilities Act (ADA) has provided important protections, achieving true equality and inclusion demands vigilance and robust, consistent enforcement.

Systemic barriers often obstruct PLWH from educational opportunities and professional fulfillment. Take Robin Dugas, a cosmetology student in Arkansas. Despite being fully qualified, she was denied her license by the Arkansas Board of Cosmetology solely because she disclosed her HIV-positive status. This blatant discrimination, challenged by Dugas and the ACLU, exemplifies the ingrained stigma PLWH continue to face.

The ADA guarantees equal opportunity and prohibits discrimination against people with disabilities, including PLWH, recognizing that HIV, even in asymptomatic stages, can limit major life activities. However, as Dugas' case shows, legal protections alone don't ensure lived equality. PLWH still face stigma and discrimination, especially in healthcare, employment, and access to services.

The emergence of HIV in the 1980s led to widespread fear, misinformation, and discrimination, affecting marginalized communities and resulting in societal rejection, job loss, and denial of healthcare.

In response, the ADA was passed in 1990, marking a turning point against HIV discrimination by recognizing people with HIV as having a disability. This ensures their right to equal opportunities in employment, public accommodations, housing, essential services, and as we have seen recently, the justice system. The ADA’s impact was solidified in the Supreme Court case Bragdon v. Abbott (1998), where the Court ruled that even asymptomatic HIV qualifies as a disability. This decision underscored that discrimination based on HIV status is unlawful and affirmed the rights of PLWH.

The ADA as a Tool for Change

The ADA requires ongoing interpretation, enforcement, and adaptation. Recently, the U.S. Department of Health and Human Services (HHS) updated Section 504 of the Rehabilitation Act to strengthen protections against disability discrimination, particularly relevant to PLWH. Research shows that healthcare professionals sometimes harbor biases against PLWH, leading to a lower standard of care and poor health outcomes. The updated rule directly combats this by explicitly prohibiting discrimination in medical treatment decisions based on biases, stereotypes, or judgments about the value of life based on disability. Healthcare providers cannot deny, delay, or provide lower quality care to PLWH simply because of their HIV status.

Additionally, this update mandates accessibility for websites and mobile applications and works to ensure equal access for people with disabilities, including providing sign language interpreters and accessible medical diagnostic equipment, such as exam tables and mammography machines.

These updates enhance the legal framework to hold healthcare providers accountable for discriminatory practices and empower patients to advocate for their rights. As HHS Office of Civil Rights Director Melanie Fontes Rainer stated, “By removing barriers to healthcare and social services, this rule advances justice for people with disabilities who have for too long been subject to discrimination.”

Persistent Challenges: Evidence of Ongoing HIV Discrimination

Despite ADA protections, many PLWH still face discrimination. Recent cases and public health data highlight the need for robust ADA enforcement, education, and state-level policy reforms.

A 2021 UNAIDS fact sheet showed that in 7 out of 11 countries surveyed, 21% of PLWH were denied healthcare in the past year, and over 50% experienced job loss due to HIV-related discrimination. These findings highlight the global scope of the problem.

The ViiV Healthcare Positive Perspectives survey (Wave 1) found that 39% of respondents experienced institutional stigma, including denial of jobs, visas, health services, or education. Nearly a quarter worried that their HIV status would negatively impact their relationship with their primary care provider.

These data emphasize the need for interventions addressing HIV stigma and discrimination, particularly those intersecting with race, gender identity, and socioeconomic status. Legal protections like the ADA are essential but must be supported by enforcement, public education, and efforts to dismantle systemic barriers. Indeed, the necessity of robust enforcement and education becomes apparent when examining real-world incidents where these protections falter.

Case Study: Tractor Supply Company

In 2024, Tractor Supply Company settled a lawsuit filed by the Equal Employment Opportunity Commission (EEOC) for $75,000 on behalf of a Mississippi woman with HIV. The manager disclosed her HIV status to coworkers and then fired her after she complained about the resulting harassment. The woman endured verbal abuse and discriminatory treatment from colleagues fearing HIV transmission. The EEOC argued that Tractor Supply failed to protect her from a hostile work environment and retaliated against her for reporting the discrimination.

Marsha Rucker, a regional attorney for the EEOC, stated, “Tractor Supply Company created and maintained a hostile work environment for this employee by publicizing her private medical information and then failing to address the harassment this generated. Rather than protect this employee from harassment, the company fired her.” This case highlights the vulnerability of PLWH to workplace discrimination, even with clear legal protections.

Case Study: Tennessee’s Aggravated Prostitution Law

The criminal justice system can also be used as a tool of discrimination. The lawsuit OutMemphis v. Lee, brought by OutMemphis, the ACLU, and the Transgender Law Center, challenges Tennessee’s aggravated prostitution statute under the ADA and the U.S. Constitution. This ongoing case highlights how such laws disproportionately target and punish PLWH, effectively barring them from various social, employment, and housing opportunities due to the requirement to register as sex offenders.

Parallel to this, the Center for HIV Law and Policy (CHLP) submitted complaints to the Department of Justice (DOJ) which launched its own investigation, focusing on the discriminatory enforcement of the aggravated prostitution statute in Shelby County. The DOJ’s investigation found that the state and the Shelby County District Attorney’s Office violated Title II of the ADA by subjecting people living with HIV to harsher criminal penalties solely because of their HIV status.

When asked about the strategy to challenge the aggravated prostitution statute, Jada Hicks, staff attorney with CHLP’s Positive Justice Project explained, “if a person is accused of being a sex worker… that's a misdemeanor charge. If they then find out that they're HIV positive, it's a felony. That's it. That's all it takes. That is the most clear violation of the ADA that I can think of. It’s the perfect example of how you can violate the ADA based on someone's health status.”

The impact of this legal challenge has been profound, resulting in a landmark settlement agreement and a major win in the fight against HIV criminalization. This case marked the first time the ADA has been successfully used to challenge and dismantle such a law. Sean McCormick, a staff attorney at CHLP, highlighted the significance of this achievement: "This really reflects a tremendous milestone in this fight to use the ADA to attack HIV criminalization [as it] represents the first tangible, concrete change to laws, policies, practices that promote and enable HIV criminalization." There are currently 10 other states with similar aggravated prostitution laws that could be impacted by the Tennessee case, underscoring the broader potential for reform and the importance of strategic advocacy to address these unjust laws on a national scale.

In apparent backlash to these legal actions, Tennessee passed an amendment that expands the offense of aggravated rape to include cases where the defendant, knowing they are infected with HIV, commits rape and transmits the virus to the victim. This amendment, enacted in May of 2024, reflects ongoing legislative efforts that may further stigmatize and criminalize PLWH, highlighting the need for vigilant advocacy and legal challenges.

McCormick reflects on the role of HIV criminalization laws in oppressing marginalized groups, "the Tennessee experience with aggravated prostitution really speaks to the way that HIV criminalization continues to oppress marginalized folks... these laws are used as a way to target marginalized communities, particularly black trans and cisgender sex workers."

Hicks adds, "People who sit at the intersection of multiple identities are at an increased risk of interacting with the criminal legal system. For instance, if you're black, trans, inject drugs, and you're an immigrant, it's just increasing your chances of having an interaction with the carceral system."

This case serves as a potent example of how the ADA can be utilized to challenge similar laws in other states. As McCormick points out, "The most obvious translation is other states with very similar sentences and sentence enhancements for people who are convicted of aggravated prostitution." CHLP is actively working with advocates in states like Ohio and Pennsylvania to replicate the success achieved in Tennessee.

The Need for State-Level Reform

While federal laws like the ADA provide crucial protections for PLWH, as we have seen, state-level laws remain inconsistent and often inadequate. This patchwork of protections creates confusion and vulnerability, as PLWH may face different consequences depending on their state. Outdated HIV criminalization laws and sentence enhancements are still on the books in 30 states, highlighting the ongoing need for state-level advocacy and reform.

Realities Facing PLWH:

• Indiana: Indiana has HIV-specific criminal statutes that classify nondisclosure of HIV status to sexual partners, needle-sharing partners, or exposure to bodily fluids as felonies or misdemeanors. These laws discourage HIV testing and disclosure, perpetuating stigma and discrimination. Additionally, these statutes do not account for modern medical understanding of HIV transmission, leading to potentially unjust legal consequences.

• Tennessee: Despite removing aggravated prostitution as a "violent sex offense" requiring sex offender registration, Tennessee maintains the aggravated prostitution offense. This law penalizes PLWH harshly for consensual sex work, disproportionately affecting those who are already marginalized by race, gender identity, poverty and other intersectional social determinants.

• Louisiana: Louisiana's HIV-specific laws are particularly concerning. The state's broadly written statute criminalizes "intentional" exposure to HIV through sexual contact, even without transmission risk. The law's failure to define "intent" leaves interpretation to law enforcement and prosecutors, discouraging open communication about HIV status and leading to potential prosecutions without intent to harm. No actual transmission is required for conviction, meaning PLWH can be prosecuted for behaviors like spitting, biting, or consensual sex with a condom. The Center for HIV Law and Policy's analysis highlights how Louisiana courts have interpreted "sexual contact" broadly, allowing subjective enforcement and encompassing acts with no risk of HIV transmission.

The journey toward equality for people living with HIV (PLWH) has seen notable achievements, such as the protections offered by the Americans with Disabilities Act (ADA), yet it remains hindered by ongoing stigma and discrimination. Despite legal safeguards like the ADA, real-world equality requires consistent enforcement and proactive advocacy.

Discrimination in healthcare, employment, and through punitive laws like Tennessee’s aggravated prostitution statute highlights the significant challenges PLWH face. These laws disproportionately affect those at the intersection of multiple marginalized identities, making the vigorous application of the ADA across states crucial. The updated Section 504 of the Rehabilitation Act by the U.S. Department of Health and Human Services (HHS) is a step forward, ensuring that biases in healthcare and other services do not undermine the rights of PLWH.

Looking ahead, it's essential to support litigation efforts, push for legislative reforms, and educate the public to dismantle systemic barriers. Organizations like the ACLU and CHLP play a critical role in this fight, but broader community engagement is vital for sustained change.

By enhancing ADA protections and advocating for their robust enforcement, we can transform societal attitudes and ensure that all individuals with HIV live dignified lives, free from prejudice. For more information, visit the Americans with Disabilities Act homepage and the Center for HIV Law and Policy.

DOJ: ADA Protections Offered to People Living with Opioid Use Disorder

Every time something big comes up in the way of protections interpretations, I take a moment to recognize the incredible work done by the disability community. I also do my best to remind anyone who will listen the folks at the center of disability rights and protections have been laying the ground work for many of the policy issues for…well…ever. If we’re to build successful coalitions, it is our obligation to stand with one another both in our specified areas of interest and in alignment with those organizations that share the best interests of the communities we seek to represent. I was reminded again of how much we owe to disability advocates on April 5th, as the Department of Justice (DOJ) issued new guidance on protections for people living with opioid use disorder under the Americans with Disability Act (ADA).

Take a moment to read through the breadth of this guidance. It’s eight pages of gloriousness that builds on previously issued factsheets and settlements. What’s of particular note is the strength of language the guidance uses with regard to describing Title II discrimination, hinting the Department of Health and Human Services (HHS) and DOJ are gearing up to target state and local governments and their agency and court instruments for enforcement action, including family courts.

To be clear, the explicit language of the ADA prohibits the protections being applied to actual or perceived “active use of illegal” substances. However, people who use drugs seeking treatment or “rehabilitation”, regardless of modality (including medication assisted treatment), or those who have previously used drugs are protected under the ADA from having that history used against them by:

• any government entity;

• any private entity administering public services (like privatized jail systems); and

• any entity providing public accommodations (generally, any business open to the public and most employers)

The guidance specifically cites an example: “A town refuses to allow a treatment center for people with OUD to open after residents complained that they did not want ‘those kind of people’ in their area. The town may violate the ADA if its refusal is because of the residents’ hostility towards people with OUD.” This speaks to the long-held issue many programs have faced for decades, including zoning law adjustments and refusal of permits, for treatment facilities and half- and three-quarter-way houses to be established in neighborhoods. As the DOJ is still in talks with SafeHouse to establish a safe consumption site, a harm reduction facility in which people who inject drugs may receive sterile supplies or medical supervision with the explicit purpose to intervene in overdoses, reduce transmission of infectious diseases, and offer linkage to care, including recovery services. If treatment facilities are protected under the ADA, would treatment referral entities also be protected? Indeed, in paragraph 5 (five) of the document, the DOJ explicitly states “…an individual cannot be denied health services, or services provided in connection with drug rehabilitation, on the basis of that individual’s current illegal use of drugs…”.

This is a clear sign the Biden administration has decided that part of combating the country’s “Opioid Crisis” means combating social stigma by providing protections to people with substance use disorder. This is the rather blunt and litigious means of moving the needle on stigma associated with substance use, but when empathy fails, policy priorities must speak through litigation.

DOJ and other enforcement entities generally do not initiate investigations or enforcement actions on their own and are highly dependent on the public to file complaints. If you suspect you have been discriminated against on the basis of a perceived or actual disability and/or perceived or actual impacts to your daily living, you may file a complaint by clicking here.

Medicaid Access: HCV Medication Stalls

In November 2015, the Centers for Medicare and Medicaid Services (CMS) issued a stark warning to state managers of Medicaid programs regarding restrictive limits on accessing newly developed and emerging direct acting agents (DAAs) for the therapeutic and curative treatment of Hepatitis C. Since then, Harvard’s Center for Health Law and Policy Innovation (CHLPI) has steadily tracked the three most impactful methods of restricting access to DAAs in Medicaid programs: fibrosis restrictions, sobriety requirements, and prescribing provider requirements.

Briefly, fibrosis restrictions require a patient to have advanced in the amount of liver damage to a specific degree in order to qualify for care, sobriety requirements restrict access to DAAs based on a person’s self-attested stated or clinically documented sobriety, and prescribing provider requirements restrict recognition of “medical necessity” to that of a specialist or with consultation of specialist in order to receive coverage of a particular DAA. CHLPI’s most recent survey of Medicaid programs outlines progress of the policies of restriction by state. As of the date of the survey, 4 states maintain fibrosis restrictions, 13 states require some period of abstinence/sobriety with an additional 15 states requiring a patient to participate in some level of alcohol and/or drug screening and counseling, and 18 sates have some level of specialist prescriber requirements. Additionally, Community Access National Network’s quarterly HIV-HCV Coinfection Watch Report details which states cover which Hepatitis C therapies and DAAs under their Medicaid preferred drug lists (PDLs).

Of particular note, the 2015 CMS notice specifically highlight the practices of fibrosis stage and sobriety requirements as running counter to various provisions under Section 1927 of the Social Security Act. A 2020 legal review by CHLPI’s Phil Waters describes various case law and potential enforcement mechanisms in which to combat these restrictions, which may prove prescient for federal enforcement agencies and advocates alike. Of particular note, Waters argues the Americans with Disability Act (ADA) presents a “novel” approach in addressing the most caustic and immediate barrier to accessing DAAs by Medicaid recipients: sobriety restrictions/abstinence requirements. Waters notes opposition to this method of seeking enforcement may argue such policies “benefit” the class of persons affected by same. While 2018 guidance from the Department for Health and Human Services (HHS) recognizes substance use disorder as a disability, the same guidance specifically exempts people currently using illicit and illegal drugs from the protections afforded by the ADA.

As we referenced in a blog earlier this year, the Centers for Disease Control and Prevention (CDC) Hepatitis C surveillance data indicates an extraordinary increase in new HCV diagnoses relative to the opioid epidemic. Arguably, requiring an otherwise qualified Medicaid client to undergo additional, non-emergency treatment or engage in non-medical activities in order to gain coverage of a live saving therapy is necessarily discriminatory. After all, a particular Medicaid pharmacy and therapeutics committee cannot evaluate the degree of limitations a person’s experience with substance use disorder causes and imposing additional requirements that specifically target this particular is counter to best practices. Indeed, requiring a person to “get clean” before receiving life-saving medical care is the exact opposite of managing substance use recovery. Relieving pressures of medical need, housing, and other negative pressures related to determinants of health are what set people up for success in combating substance use.

In order for the Biden administration to fulfill its promises with regard to combating the opioid epidemic, for states to fulfill their responsibilities under the National Viral Hepatitis Strategy, and to meaningfully address the intersection of these syndemics, federal agencies tasked with enforcement of these rules and Medicaid directors should consult and act in alignment with advocates with lived experience and best practices in combating both the opioid epidemic and resulting infectious disease outbreaks and diagnosis, including HIV and Hepatitis C. Just as with strategic, culturally competent approaches to combatting HIV and STIs focus on sex-positive education and access to resources, including prevention and treatment interventions, barrier reduction is critically necessary in order to succeed in this fight. As it stands, Medicaid programs present one of the best opportunities to ensure and enact meaningful access to care in an effort to eliminate Hepatitis C. These access limiting policies also present the biggest barriers to achieving that goal.