Coverage of preventive services is a legal requirement
Click here to read the original article and comments by Carl Schmid
While it may be of interest to look into different payment models for preventive drugs such as PrEP, we should not ignore the key role played by the legal requirement under the Affordable Care Act that insurers must cover preventive services, including PrEP, without cost-sharing and prior authorization. PrEP, including the first long-acting formulation, was fully reviewed by the US Preventive Services Task Force and received an “A” grade, meaning it must be covered by insurers without cost-sharing. This includes not only the drug but associated services such as medical visits and recommended laboratory testing. Further guidance from the government directed payers, including employer plans, to cover FDA-approved PrEP formulations without prior authorization.
Unfortunately, one reason why there hasn’t been greater uptake of PrEP, including new long-acting formulations, is that payers are not complying with ACA legal requirements, which are also insufficiently enforced by the federal government and other insurance regulators. Recent studies from the CDC and others have found that approximately a third of PrEP users are still being charged for the drug and associated services. My organization is currently battling a major US airline, whose employees can certainly benefit from long-acting PrEP, for only covering daily oral generic PrEP – a clear violation of the law.
Most people who need PrEP have some form of health coverage. While we must also focus on the uninsured and the critical role of the federal government since HIV is a public health issue, we cannot excuse payers from their legal obligation to cover PrEP and other preventive services. Advocates even worked to ensure that PrEP was added to the government’s risk adjustment model for Marketplace plans.
As the authors write, PBMs engage in price negotiations with the manufacturers, but state Medicaid programs can do the same – just as they can do for hepatitis C curative drugs. While I cannot comment on the experience in Australia, the hepatitis C subscription model’s results in the states requires further examination. When a state suddenly loosens access restrictions that were the worst in the country, you are bound to see more people take advantage of the drug, but states who have adopted a subscription model for hepatitis C drugs remain far from attaining their goals.
As the authors note, the Trump administration has expressed an interest in promoting long-acting PrEP. However, ensuring greater access to PrEP, including the new long-acting drugs, will require so much more than focusing on the price of the drug. Even when there was a free PrEP drug program donated by the manufacturer to the federal government, there still was insufficient uptake. In addition to aggressive enforcement of ACA preventive services requirements, we need sustained state and federal government leadership, and continued funding of state, local and community-based infrastructure and programs to provide HIV prevention and testing, and education and outreach to potential PrEP users and clinical providers. Only then can we deliver on the promise of new long-acting PrEP options to help bring the HIV epidemic to an end.