HIV Prevention Drug Uptake Threatened in Obamacare Battle

HIV-prevention treatment costs have been an on-and-off burden for Henry Henderson over the past six years.

Pre-exposure prophylaxis medication, or PrEP as it’s more commonly known, has been “a godsend,” Henderson said. A child of the ‘90s, an era when AIDS became the leading cause of death for young Americans, he can’t understate the “peace of mind and feeling free not to worry much” about contracting HIV.

But early on, a trip to the doctor could run him $100 to $300, forcing Henderson to run a “cost-benefit analysis” before every visit. That’s despite the Affordable Care Act’s requirement that private plans fully cover HIV-prevention services.

Lengthy disputes with his insurers ensued, making Henderson reconsider whether the effort was worth it.

“It’s not just the cost. It’s the time and hours going back and forth with different people, different insurance companies, and their portals,” Henderson said.

Henderson’s insurers eventually conceded, though he was sent a copay bill as recently as April. He’s still trying to sort out those costs.

The portion of the ACA that renders PrEP and other preventive services free for those with private insurance was struck down earlier this year.

The effects won’t be immediate, in part because most insurance plans are set for the year. In addition, the Biden administration has appealed the decision to the US Court of Appeals for the Fifth Circuit. The Fifth Circuit heard arguments Tuesday on whether to stay the lower court’s ruling while the appeal plays out.

Should the decision stand, legal experts say some insurers may stop full coverage of HIV-prevention services, given the small percentage of customers who use them. That, activists warn, could prove disastrous, given preventive services’ key role in stopping the spread of HIV. They also note that people would be less likely to get preventive treatment should it not be fully covered.

‘Patchwork’ Coverage

This past March, Judge Reed O’Connor of the US District Court for the Northern District of Texas ruled that Braidwood Management Inc. and other religious objectors wouldn’t have to pay for insurance covering PrEP. That’s because O’Connor determined that Obamacare’s HIV treatment mandate violated employers’ Religious Freedom Restoration Act (RFRA) rights.

The RFRA portion of the Braidwood decision only applies to a select group of plaintiffs, attorneys say. But “other employers who also hold religious objections to PrEP could try to rely on the decision to exclude coverage, knowing there is legal precedent for not covering the drug for religious reasons,” said Joanne Roskey, a benefits litigation attorney with Miller & Chevalier.

The decision is “significant for people that want to have access to the drug and work for an employer who has a religious objection to providing this type of coverage,” Roskey said.

Yet it’s another portion of the decision that spells broader trouble for Americans relying on insurance to cover HIV-prevention treatment. That’s O’Connor’s cutting down Obamacare’s requirement for insurers to pay in full for certain preventive services, including PrEP drugs.

Over a dozen states have laws requiring individual market insurers to cover preventive services without cost sharing, according to the Commonwealth Fund. But states don’t regulate the self-insured employer plans that cover most workers. Those fall under the Employee Retirement Income Security Act of 1974, or ERISA, and are affected by the decision.

Under the decision, PrEP coverage “becomes a very kind of patchwork service,” where people have varying degrees of access, said Sara Collins, vice president of health-care coverage and access at the Commonwealth Fund.

Attorneys note that many insurers may ultimately decide to maintain PrEP coverage as a competitive advantage. They also said the benefits of a long-term healthier workforce may be inspiration to keep PrEP fully covered.

“Sick employees are generally a problem, and so to the extent you could keep your employees healthy it makes business sense,” said Seth Chandler, a University of Houston law professor.

That equation gets complicated when treatment is particularly expensive, or when a disease might not manifest for a decade or more, Chandler said.

Thus, “providing PrEP drugs might be a difficult negotiation because it’s not inexpensive and the benefits to the employer can be after that employee has gone to subsequent jobs.”

“Employees are likely to look at it as something they might want to trim back, maybe not have the employee pay full freight for the drug” but instead pay a portion through a copay, he said.

A prescription for a brand name HIV-prevention drug, without insurance, could add up to more than $21,000 a year.

Photo by Daniel Born/The Times/Gallo Images/Getty Images

‘Major Barrier’

But “having cost sharing is a major barrier” to PrEP drugs, said Carl Schmid, executive director of the HIV + Hepatitis Policy Institute.

“PrEP was a central pillar” of government efforts to end HIV, he said. And the Braidwood decision “would really impact our efforts to end HIV and prevent new infections.”

“PrEP is not just the drug. It’s all these lab visits, lab tests, the medical tests,” he said. “That would go away.”

In 2015, roughly 3% of those recommended for PrEP were prescribed the drugs, according to the Centers for Disease Control and Prevention. Five years later, that rose to 25%, the CDC reported. That’s among the 1.2 million people for whom the treatment regimen is recommended.

According to PrEP Daily, without insurance, a prescription might add up to more than $21,000 a year. KFF pegs the monthly costs at up to $2,000 for a name-brand product like Descovy or Truvada, while a generic comes in at $60.

Some PrEP users also prefer or even need the name brand version over lower cost alternatives, Schmid said, noting the generic leaves some people with renal and bone issues.

‘Vitally Important’

Jose Abrigo, HIV project director at Lambda Legal, who is helping coordinate the national amici strategy in the Braidwood appeal, said there’s “some persuasive precedential effect” in how the plaintiffs got the judge to expand the religious freedom doctrine to deny coverage. That means that while not presently binding in other cases, it could influence a judge’s determination.

“They’re taking it a step further to essentially attenuated religious objections could provide a basis for protection under RFRA,” Abrigo said.

And with the appeal, “we are looking at really significant questions on laws meant to broadly protect public health and guarantee access to health care and how we balance that with religious liberty,” said Richard Hughes, an Epstein Becker & Green PC attorney representing HIV + Hepatitis Policy Institute as amicus curiae in the case.

“We will concentrate on showing the court that Congress’s delegation to the task force is constitutional and that covering HIV prevention is not a religious issue,” Hughes said. In the Braidwood decision, O’Connor determined that the ACA preventive service requirements were recommended by a constitutionally appointed government task force.

“If we lose access to PrEP, we will lose the progress we made to date in ending the HIV epidemic. And that is vitally important.”