When HIV, the virus that causes AIDS, was first identified in the 1980s, it almost certainly a death sentence. More than 100,000 Americans died from the new disease in that decade. The idea that one day there might be medicines to prevent infection was a fantasy.
Today, these medicines, called pre-exposure prophylaxis (PrEP), do exist, but most people who could benefit don’t take them. The policies that govern these medicines — and the enforcement of those policies — are largely to blame.
PrEP is wildly effective. PrEP reduces the risk of getting HIV from sex by 99%, and from injection drug use by nearly 75%, when taken as prescribed.
Read: PrEP and PEP: Prevention for HIV >>
An estimated 1.2 million people in the United States could benefit from PrEP. These are people who test negative for HIV, are sexually active and either have a sexual partner with HIV, have not used or do not use a condom consistently, and/or have been diagnosed with a sexually transmitted infection in the past six months. PrEP can also benefit people who inject drugs and share needles or have an injection partner with HIV.
But less than 4 out of 10 people who could benefit were prescribed PrEP in 2022. That’s up from 2 out of 10 in 2019 — but we’re still a long way from accessing its full potential.
Use of PrEP is uneven. Among people who could benefit, 94% of white people have been prescribed PrEP, compared with just 24% of Hispanic/Latino people and 13% of Black people. These statistics are particularly troubling since Black and Hispanic people make up 70% of new HIV cases each year.
The gender split is also stark: In 2022, 41% of men who could benefit from PrEP received a prescription, compared to just 15% of women.
Barriers to PrEP access
One of the biggest barriers to PrEP is cost and insurance coverage. A 2022 report from the HIV+Hepatitis Policy Institute estimates that 55% of people taking PrEP are privately insured and 20% are uninsured. Without insurance, the cost of the drug can be more than $20,000 per year, not including required lab tests, which can be another $15,000.
But cost should not be a barrier. People without insurance can often get PrEP through copayment assistance programs or community-based clinics. Nationwide, 85,000 people get PrEP at community health centers.
Most people with insurance should be fully covered for PrEP medications plus the clinic visits and lab tests needed to get and keep the prescription. The Affordable Care Act requires most insurers to cover preventive care, including PrEP, without copayments. A 2019 U.S. Preventive Services Task Force (USPSTF) recommendation reinforced that PrEP should be covered without consumer costs, and in 2021, the U.S. Department of Labor clarified how the rules about free preventive care apply specifically to PrEP. Many states have also passed laws that ensure PrEP is available without costs to consumers.
Even with clear rules, many patients are still being charged for PrEP, according to Carl Schmid, executive director of the HIV+Hepatitis Policy Institute.
“One of the big pluses is that we now have coverage and $0 cost-sharing,” Schmid said. “The problem is it’s not always implemented. The insurers are still charging lots of people.”
A report commissioned by consumer representatives to the National Association of Insurance Commissioners (NAIC) showed that health plans often provide incomplete information about coverage of preventive services, including PrEP. Among six health plans evaluated, half did not list PrEP as a preventive service available without cost-sharing, and only one provided a comprehensive explanation of coverage for all aspects of PrEP.
Even as advocates fight for enforcement of the rules, the rules themselves may be in jeopardy. A 2020 lawsuit filed by a religiously affiliated business in Texas argued that the requirement to cover PrEP without cost-sharing violated its constitutional rights to religious freedom. In 2022, a federal judge agreed and questioned the validity of using USPSTF recommendations as the basis for the requirements.
While no changes to the rules are in effect yet, the case may go to the U.S. Supreme Court for an ultimate decision. Depending on that decision, insurers and employers may no longer be required to cover PrEP, though they could choose to.
Even today, insurers who adhere to the no-cost-sharing rules for PrEP often put up other barriers, such as prior authorization requirements. Requiring consumers to get insurance approval before the plan will pay for PrEP may be legal, but it violates the spirit of widely accessible preventive care.
Schmid explained that, as part of prior authorization processes, insurers may want to assess the consumer’s risk for HIV. But, he said, that’s between the patient and their healthcare provider, not the business of the insurance company.
“Our goal is to get PrEP to people who need it as easily as possible,” Schmid said. “If you want to be on PrEP, there’s a reason, and you should get it without all these insurance barriers.”
Ironically, he said that he frequently hears that it can be easier to get PrEP for people without insurance than with insurance because of those barriers.
The federal budget for fiscal year 2024 included nearly $600 million in funding for a comprehensive initiative called Ending the HIV Epidemic (EHE). Funds cover HIV prevention and testing, as well as treatment. Spread across hundreds of clinics throughout the country, it’s not a huge amount.
The HIV+Hepatitis Policy Institute report suggested that properly expanding outreach and navigation would cost more than $6 billion over 10 years, and would prevent nearly 75,000 person years of HIV and more than $2 billion in HIV treatment costs.
Instead of expanding funding, though, some members of the U.S. Congress are trying to eliminate the budget for EHE altogether — an initiative that advocates are fighting.
In addition to more funds, Schmid supports better enforcement of existing rules and expanded requirements for PrEP access regardless of insurance type, including Medicare. Other ways to improve access include analyzing claims to quantify (and reduce) health insurance barriers, requiring health plans to clearly communicate what consumers are entitled to and encouraging state-level rules and enforcement. Streamlined medical billing would also make it easier for healthcare providers to prescribe PrEP.
“PrEP is a commitment,” Schmid said. “You are taking a drug for something that you’re not sick [from].”
There’s a lot of room for federal and state policymakers to match that commitment.
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