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PrEP, the HIV prevention pill, must now be completely free in almost all insurance plans

In a move that should prove transformative for the national HIV prevention effort, the federal government has announced that almost all health insurers must cover the HIV prevention pill, known as PrEP, or pre-prophylaxis. -exposure, without cost sharing – including for the drug itself and, most importantly, for clinic visits and laboratory tests.

This means that the entire experience of keeping a prescription for Truvada or Descovy, the two approved forms of PrEP, should now be completely free for almost everyone. A prescribing physician, however, must persuade an insurer that Descovy in particular is medically necessary for a specific patient to qualify for zero cost sharing for the use of that drug for HIV prevention.

Guidelines that the Centers for Medicare and Medicaid Services, as well as the Department of Labor and the Department of the Treasury, sent to health insurers on Monday indicate that insurers have 60 days to comply with the mandate. The rule states that insurers should not charge a co-payment, coinsurance, or deductible for quarterly clinic visits and lab tests required to maintain a prescription for PrEP.

Insurers were already required to stop billing reimbursable expenses for drugs by January 1, 2021.

These additional requirements, which will remove what has likely been a substantial barrier to accessing PrEP for low-income people in particular, are the result of the US task force awarding preventive services to a rating. “A” to this form of HIV prevention in 2019. Under the Affordable Care Act, such a rating for preventive health care services, including testing for various diseases such as HIV itself, means that ‘they should be covered by almost all insurers at no cost to the insured patient.

HIV prevention advocates have hailed the new guideline as a change in the effort to promote PrEP among people at risk of HIV.

“While we need state Medicaid authorities and insurance departments to monitor implementation, this memo from the federal government literally blew me away with joy,” said Jim Pickett, senior advocacy director for the. Prevention and Gay Men’s Health at the AIDS Foundation Chicago. “This has the potential to remove many of the access barriers we face with the provision of PrEP. I look forward to dramatic improvements in access to PrEP, especially for communities most vulnerable to HIV.

However, Carl Schmid, executive director of the HIV + Hepatitis Policy Institute, pointed out that many insurers are still not complying with the rule that they cannot charge consumers for their Truvada or Descovy prescriptions.

Robert Greenwald, clinical professor of law at Harvard Law School, pledged to “work to enforce the new guidelines and ensure that the promise of this free preventive service to reduce HIV acquisition is fulfilled.”

Truvada, which contains a pair of antiretroviral drugs also used to treat HIV, was approved for HIV prevention in 2012. Research indicates that when taken daily, the tablet reduces the risk of getting HIV by more than 99%. virus during sex with other men. percent. PrEP reduces the risk of HIV in women by at least 90 percent.

After a slow start, PrEP began to gain popularity in 2014, as media attention on PrEP’s potential to turn the tide against the epidemic in the United States increased. Descovy, which is associated with improvements in bone density and kidney function tests compared to Truvada, was cleared by the Food and Drug Administration in 2019.

Both drugs are manufactured by Gilead Sciences, which is the dominant player in the HIV treatment market. As of this spring, Truvada has been available in generic form with a list price as low as $ 30 per month. By comparison, Descovy’s list price is currently $ 1,930 and Truvada’s is $ 1,842.

In May, the Centers for Disease Control and Prevention released an estimate that in 2019, some 285,000 people were taking PrEP. This promising news has been tempered by the fact that PrEP use remains largely restricted to gay and bisexual white men.

It is possible that the complete elimination of out-of-pocket costs for a PrEP prescription by insureds could improve PrEP use among black and Latino men who have sex with men in particular. Together, these demographics accounted for 46% of new HIV diagnoses in 2019, according to the CDC. Overall, about 70 percent of new HIV transmissions occur among gay and bisexual men.

The CDC also released a new estimate in May that in the mid-2010s, the annual rate of new HIV transmissions in the United States remained constant for a few years before declining by about 8% between 2015 and 2019, to some 34,800 new cases.

A recent article published in Annals of Epidemiology by Aaron J. Siegler, associate professor at the Rollins School of Public Health at Emory University, and colleagues found that states that have expanded their Medicaid programs under the Act affordable care and those who offered programs to offset the costs of PrEP benefited from greater use of the prevention modality. In other words, if people can access PrEP for less or for free, they are more likely to take it.

“Now it’s important that those who are eligible for PrEP, as well as their providers, are aware of these new requirements,” Schmid said of the new guidelines for insurers on sharing the costs of PrEP. “We also need to hold insurers accountable for ensuring that they do their job by complying with their legal obligations. Plan reviews continue to show that many insurers are not in compliance, and we need state insurance regulators to enforce the law and the new guidelines. “

As the future looks bright for access to PrEP for those with health insurance, a fiscal crisis awaits clinics offering this form of HIV prevention to the uninsured population, as reported. NBC News previously. Gilead gladly provides PrEP for free to low-income people who don’t have health insurance, but the drug company does not cover clinic visits and associated lab tests. And thanks to a crucial change in tax policy, the company has pledged from January 1, 2022, at least $ 100 million in funds that clinics that care for underserved populations have used to cover these costs. accessories should drain their budgets.

The leaders of these clinics expect access to PrEP for those without health insurance to shrink as a result, which could offset the improved access that their insured counterparts will now enjoy thanks to the news. federal guidelines.

Kenyon Farrow, general manager of advocacy and organizing at activist group PrEP4All, called on the federal government “to seek ways to cover the uninsured, especially in states without Medicaid expansion, so that they can access health care services. PrEP services ”.

“If we are serious about ending the HIV epidemic,” said Farrow, “we need to ensure equal access to PrEP in all communities and not just for those who are insured.

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