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The new mandate covers the cost of all associated services, including office visits and lab tests needed to maintain the prescription. Yakubov Alim/Getty Images
  • New federal guidance states insurance providers must cover the cost of the HIV prevention pill PrEP and all associated services at no cost to patients.
  • The move is being hailed by HIV prevention advocates, as cost is a major barrier to accessing the drug.
  • Issues with compliance by insurers remain, as watchdog groups call for federal and state regulators to enforce new rules.

The U.S. federal government recently announced that almost all health insurers must cover the HIV prevention pill preexposure prophylaxis, also known as PrEP, with no cost-sharing to patients for the drug itself or, crucially, for clinic visits and lab visits.

The move is being hailed by HIV prevention advocates as transformative to the national HIV prevention effort.

“PrEP is an amazing prevention tool against HIV, but there’s been a number of barriers to accessing it, and one of the barriers has been the cost of the drug and associated lab services, periodic testing, and office visits,” said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, a nonprofit organization dedicated to promoting quality and affordable care to individuals living with or at risk of HIV, hepatitis, and other chronic health conditions.

“Having these costs wiped away will be tremendously beneficial in the prevention of HIV in the United States,” he continued.

The guidance, issued by the Centers for Medicare and Medicaid Services along with the Department of Labor and the Department of the Treasury, was sent to health insurers in mid-July. It states that insurers must not charge copays, coinsurance, or deductible payments for the clinic visits and lab tests patients must undergo to maintain a prescription for PrEP.

The drug itself was already required to be fully covered as of January 1, 2021, by insurers thanks to an “A” rating by the U.S. Preventive Services Task Force granted in 2019. Under the Affordable Care Act, an “A” rating means the preventive treatment is to be completely covered by the insurer at no cost to the patient.

Now, the new guidance means most insured individuals in the United States will be able to get access to PrEP — and all associated services — entirely for free.

Insurers have 60 days to comply with the latest rules.

PrEP is a daily pill that reduces the risk of contracting HIV from sex by 99 percent when taken as prescribed, according to the Centers for Disease Control and Prevention (CDC). It reduces the risk of contracting HIV through injection drug use by at least 74 percent.

A doctor may prescribe PrEP to a patient for a variety of reasons, said Dr. Antonio Urbina, professor of medicine at the Icahn School of Medicine at Mount Sinai and medical director for the Clinical Education Initiative of the New York State Department of Health AIDS Institute.

The medication is indicated for individuals who have a sexual partner with HIV or who engage in sex without a barrier method with a person who may be at risk of having HIV.

“Anyone diagnosed with a sexually transmitted infection may also have an indication to start on preexposure prophylaxis,” Urbina said.

PrEP is also recommended for people using injectable drugs who share equipment like needles and syringes.

Yet, despite its effectiveness at reducing the risk of HIV, PrEP is not reaching many Americans who can benefit from it. A 2018 analysis from the CDC found that about 1.1 million adults in the United States are at risk for HIV and should be offered PrEP, but only 78,360 PrEP prescriptions were filled in commercial pharmacies the year the study took place.

“Where [PrEP use] has scaled up most is in white gay men,” Urbina said. “But there’s a big gap. While the majority of new HIV infections are in gay men, they are more in brown and Black gay men of color.”

“Similarly, in cisgender women, the majority of new infections are in Black and brown women,” he continued. “There’s also the transgender community, and uptake in all of these communities has been disproportionately lower than in white gay [cisgender] men.”

While there are a number of barriers at play when it comes to addressing the gaps in who receives PrEP — from lack of awareness about the drug to stigma — cost plays a major role.

The average cost of a month’s supply of Truvada or Descovy is around $2,000. A generic version of Truvada is also available for as low as about $40 per month.

But it’s the cost of associated services required to maintain a PrEP prescription that can hit certain insured patients hardest.

“PrEP is not a drug where you go to your doctor and get a prescription for a month with 11 refills,” Urbina explained. “Patients have to be seen every 3 to 4 months.”

At these appointments, patients may have to undergo renal testing and liver testing, as well as hepatitis, STI, and HIV testing.

“Those lab tests and office visits add up to several hundred dollars,” Schmid said.

As it stands now, individuals on a high deductible health insurance plan may be billed these costs up front, perhaps several times over, before their insurance kicks in. Patients with high copays may also face expensive bills.

“So you can see how it could be out of reach for a lot of people depending on what type of insurance plan they have,” Schmid said. “Now, [with the new mandate] we don’t have to worry about that.”

While the new guidance has been widely praised as a major milestone in HIV prevention, one issue to contend with is compliance from insurance companies.

After the “A” rating from the U.S. Preventive Services Task Force, the HIV+Hepatitis Policy Institute carried out spot checks of 2021 plans on the federal and state exchanges and found that many were not compliant with the legal requirement to cover the cost of the drug PrEP without any cost-sharing.

After a recent review, the organization found that while some violations are still occurring, many plans have updated their offerings to cover at least one PrEP drug without cost to the patient.

But for Schmid and other HIV advocates, this is a concern moving forward.

“It seems that insurers responded to our earlier analysis,” Schmid said in a statement on the HIV+Hepatitis Policy Institute’s website. “However, now we must ensure all are fully complying with their legal requirements, including those spelled out in the new guidance, and federal and state regulators enforce them.”