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A firestorm of controversy over access to HIV medications and protection against discriminatory insurance practices has been making its way through US district courts for the past 3 years, pitting HIV patients against pharmacy benefits managers and, ostensibly, the healthcare industry itself.

The case, amoxicillin 125mg 5ml dose CVS Pharmacy Inc. v. Doe, scheduled for oral arguments before the Supreme Court of the United States (SCOTUS) in December, is a weighty one for patients with HIV and the practitioners caring for them.

At odds are whether or not mandatory mail-order requirements for specialty medications violate specific provisions of the Patient Protection and Affordable Care Act (ACA) and the Rehabilitation Act of 1973, both of which prohibit discrimination by programs that receive federal funds.

An amicus brief submitted on October 29 by the Center for Health Law and Policy Innovation (CHLPI) of Harvard Law School on behalf of five John Doe’s and a number of medical practitioners and practitioner organizations underscores the degree to which advances in HIV treatment, viral suppression, and care linkage — not to mention the national mandate to end the AIDS epidemic by 2030 — might ultimately be affected.

Maryanne Tomazic

“We decided to file the brief at the Supreme Court level because we wanted to make sure that the perspectives of people living with HIV, their providers, and advocates were in the record,” Maryanne Tomazic, a clinical instructor at CHLPI, told Medscape Medical News.

“It’s important for the court to consider why robust access to prescription drug coverage and pharmacy services are so important for people living with HIV, and why it’s not appropriate to compromise access to antiretroviral therapy,” she explained.

A Bitter Pill, Regardless of Who Swallows It

CVS Pharmacy Inc. v. Doe focuses on a legal concept known as “disparate impact discrimination,” which refers to a policy that appears neutral but unintentionally discriminates against a protected class of people (eg, on the basis of sex, age, or ethnicity).

The Supreme Court’s decision in the case will address a central question: did CVS Pharmacy, Caremark, and Caremark Specialty Pharmacy (“CVS”) discriminate against the respondents by requiring that they obtain specialty medications (including those for HIV) by mail order or drop shipment for pickup, or, alternatively, pay out-of-network prices for these medications at non-CVS pharmacies?

The decision will also address whether the ACA’s inclusion of clause 504 of the Rehabilitation Act, which prohibits protected class discrimination, allows patients to challenge terms and conditions of their healthcare plans, a decision that has broad and far-reaching implications for insurers’ abilities to set plan restrictions and pricing.

A spokesperson for CVS declined to comment when contacted by Medscape Medical News but provided a link to an April 9, 2021 SCOTUS blog post about the filing. In its court filing, CVS contended that the program applies to all specialty medications (not just HIV) and simply reflects the cost/complexity of specialty medications.

Not everyone agrees that cost is the most important issue at play. Indeed, a critical take-away for practitioners is how mandated mail-order pharmacy programs can disrupt coordination of care.

“In the traditional model, the physician is talking to the pharmacists [or] talking with the patient, and you have kind of triangular communication model that helps not only the patient stay engaged in care but [also] allows the healthcare provider team to adjust the medication quickly without delay,” said Tomazic.

The John Doe statements in the original case highlight these concerns. They focus on how mandatory mail orders restrict highly personable relationships with local specialty pharmacists who are familiar with their patients’ medical histories as well as their medication dosing and adjustments and who regularly communicate with the complete care team on the patients’ behalf.

“JOHN DOE THREE and others depend on these types of long standing relationships with local pharmacists to maximize the benefits of HIV/AIDS medications and treat the complex and ever-changing needs of the HIV/AIDS patients,” wrote attorneys in the 2018 class action filing.

Other issues raised by the suit involve the following: privacy with respect to medication pickup; specialty care customer representatives’ lack of understanding and knowledge of HIV medications; incomplete prescription fills; late medication deliveries; exposure of medications to the elements; work and employment interruptions; and restrictions on early fills and reorders, which increase the risk for missed doses and potentially serious health problems, including interruptions in viral suppression and resistance.

Discrimination Issues Also Raised

CHLPI’s amicus joins several others in support of the unique needs of persons with HIV, especially in Black and Hispanic/Latino communities, which are disproportionately affected by HIV.

A press release distributed by the National Association for the Advancement of Colored People Legal Defense and Educational Fund (LDF) reinforces the idea that not only are Black people more likely to have a disability other groups, owing to the country’s legacy of racial inequality, but also that they are likely to encounter unique forms of discrimination and specific barriers to full participation in society, further underscoring the need for disparate impact liability to address unfair policies and practices.

“Inequity in access to resources, including healthcare, further amplifies the instance and persistence of disabilities among Black people,” LDF attorneys wrote in the brief.

“We saw with COVID-19 that [mail-order prescription] programs can serve in a supportive role in access to care,” said Tomazic. “But we don’t want those programs to be mandated, and we don’t want to forget about communities where these kinds of programs are simply not a viable option,” she said.

Oral arguments in the case begin on December 7. A decision is expected some months later.

No relevant financial relationships have been disclosed.

Liz Scherer is an independent journalist specializing in infectious and emerging diseases, cannabinoid therapeutics, neurology, oncology, and women’s health.

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