LGBTQ Agenda: Ongoing suit threatens PrEP coverage as patient groups fight for copay assistance

  • by John Ferrannini, Assistant Editor
  • Tuesday May 16, 2023
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The U.S. District Court for the District of Columbia is hearing a case that could affect how copay assistance is offered for drugs such as those used for PrEP. Photo: Courtesy U.S. District Courts
The U.S. District Court for the District of Columbia is hearing a case that could affect how copay assistance is offered for drugs such as those used for PrEP. Photo: Courtesy U.S. District Courts

Patient groups have filed a statement with a federal court supporting a lawsuit seeking to overturn copay accumulator schemes; however, this suit comes as access to life-saving preventative HIV care faces an existential threat from a separate case.

Carl Schmid, a gay man who is the executive director of the HIV+Hepatitis Policy Institute, told the Bay Area Reporter that a 2021 rule change from the United States Department of Health and Human Services means that health insurance companies can refuse to credit copay assistance funds from drug manufacturers toward deductibles and out-of-pocket maximums from patients, which particularly hurts people living with HIV.

In a May 1 reply to a motion for summary judgment in the case of HIV+Hepatitis Policy Institute v. HHS, the institute, the Diabetes Leadership Council, and the Diabetes Patient Advocacy Coalition stated, "It is hard to overstate the real-world interests present in this case: The government's policy broadly authorizing insurance companies to use copay accumulators inevitably leads to Americans across the country being unable to afford specialized, life-changing medications prescribed by their doctors."

Schmid said that when people can't afford their prescription medications their response is often to stop taking them entirely.

"This is another barrier for people accessing their HIV drugs," he said. "We're optimistic the judge will make these illegal but you never know how courts will decide."

The case is in the United States District Court for the District of Columbia; the basis for the suit is the Administrative Procedure Act of 1946, which governs how executive branch agencies like HHS, as well as independent agencies, can propose and establish regulations.

These cases are usually decided quickly, Schmid said. Oral arguments could begin as early as June.

The plaintiff's attorneys are arguing that the rule is "arbitrary and capricious" and goes beyond what is allowed by statute.

"Prior to the agencies' action here there was no regulation either allowing or disallowing copay accumulators, and only a statute that (in the government's view) was "ambiguous" as to their permissibility," the reply states.

"After the 2021 [Notice of Benefit and Payment Parameters], there is now a binding regulation that expressly permits insurers to impose copay accumulators in any state that does not prohibit them," the reply continues. "That is hardly a 'decision to decline to set a definitive rule'; rather, it is a declaration that federal law does not prohibit accumulators, and that insurers are free to utilize them unless a particular state says otherwise. The 2021 NBPP represents a major change in the law — and as we have explained, one that was adopted through an arbitrary and capricious process."

Federal court allows religious exemption to PrEP coverage

Schmid is more worried about a September decision from a federal judge in Texas that ruled that the Patient Protection and Affordable Care Act mandate that insurers and employers cover PrEP for free is unconstitutional.

PrEP, or pre-exposure prophylaxis, refers to the use of antiviral drugs to prevent people exposed to HIV from becoming infected. The pill Truvada was first approved for PrEP use in 2012 by the federal Food and Drug Administration; since then the FDA has also approved the pill Descovy for some groups, and the drug Apretude as an injectable treatment. According to federal Centers for Disease Control and Prevention statistics, only 25% of the approximately 1.2 million Americans who could benefit from PrEP had prescriptions in 2020.

In the case of Braidwood Management v. Xavier Becerra, a group of business owners argued that covering PrEP made them "complicit in facilitating homosexual behavior, drug use, and sexual activity outside of marriage between one man and one woman." Judge Reed O'Connor of the Northern District of Texas, appointed by then-President George W. Bush, agreed, and in a subsequent March 30 judgment blocked the requirement nationwide to cover preventative services as recommended by the U.S. Preventive Services Task Force after the ACA was signed by then-President Barack Obama.

The United States government is appealing the decision to the 5th U.S. Circuit Court of Appeals. On Monday, the appellate court reinstated the coverage requirement nationwide as the appeals process in the case plays out.

"These conservatives use him and find these cases to go after certain things they don't like and it goes to the 5th Circuit and likely to the [U.S.] Supreme Court," Schmid said, referring to the lower court judge. "Everything we talked about before with insurers not covering PrEP for free — that would all go away, and not only for PrEP but for HIV testing, hepatitis B testing, hepatitis C testing, STD testing, smoking, lung screenings, mental health screening — it would all go away. They are all in jeopardy."

As the B.A.R. previously reported in March, attorneys general from 21 states, including California, and the District of Columbia, signed on to a letter to a CDC committee asking it to create a new diagnostic code for PrEP to ensure clear billing to ensure patients are not improperly charged copays.

At the time of the October ruling, Congressmember Nancy Pelosi (D-San Francisco), who was then House speaker, issued a scathing statement, stating, "This disturbing decision amounts to open homophobia: unleashing unthinkable suffering and death specifically among the LGBTQ community. This decision also threatens vital preventative health services guaranteed under the Affordable Care Act, including birth control, vaccinations and routine health screenings."

LGBTQ Agenda is an online column that appears weekly. Got a tip on queer news? Contact John Ferrannini at [email protected]

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