Federal Government Issues Guidance to Insurers on Coverage of HIV Prevention Drugs

Press Release

July 19, 2021

Plans Must Fully Cover Drug & Associated Services Without Charge

Washington DC… Today, the federal government issued guidance to insurers to remind them of their obligation to cover pre-exposure prophylaxis (PrEP), which are drugs that prevent HIV, at no cost to their beneficiaries. The guidance, in the form of an FAQ, also clarifies that associated services with PrEP, such as provider visits and HIV, hepatitis, and STD testing along with other laboratory tests, must also be covered with no patient cost-sharing. This follows previous guidance for the coverage of other preventive services that have associated services and costs, such as colonoscopies.

Beginning in January 2021, almost all private health plans must provide PrEP without cost-sharing based on the U.S Preventive Services Task Force “Grade A” recommendation of June 2019.  Under the Affordable Care Act (ACA), insurers must offer USPSTF recommended services without cost-sharing in the plan year that begins one year after the date of the recommendation.

The HIV+Hepatitis Policy Institute began conducting spot checks of 2021 plans on the federal and state exchanges late last year and found that many were not in compliance with their legal requirement. HIV+Hep has gone back to review those plans and while some violations are still occurring, many plan formularies have been updated and almost all are offering at least one PrEP drug without cost-sharing.

“We are pleased that the federal government has issued this long-awaited guidance to insurers that will reduce barriers to PrEP and help prevent further HIV infections while advancing efforts to end HIV in the United States,” commented Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. “It seems that insurers responded to our earlier analysis. 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.” 

In today’s announcement, the federal government said plans will have 60 days to be in compliance with the coverage of PrEP support services and is asking state governments to help with compliance.

HIV+Hep’s new spot check of 2021 plan formularies, that were all updated in July, found the following plans are still in violation of the ACA:

  • In Connecticut, ConnectiCare places the two brand name PrEP drugs (Truvada and Descovy) on Tier 4, and none on its preventive drug Tier 0. It also notes that there is a generic Truvada.
  • In Ohio, MedMutual places the two brand name PrEP drugs along with generic Truvada on Tier 4, and none on its preventive drug Tier 5.
  • In Georgia, Kaiser Permanente places one brand name PrEP drug on Tier 5 and generic PrEP on Tier 2. None are on its preventive drug Tier ACA.
  • In Washington State, Kaiser Permanente places generic Truvada on the Preferred Generic Tier 1 and the two brand PrEP drugs on Tier 4, rather than on its preventive drug Tier P. However, they have a separate document that lists preventive drugs with zero patient cost-sharing, and it includes PrEP.
  • In Washington DC, Maryland, and Virginia, Kaiser Permanente places Descovy on Tier 2 and generic Truvada on Tiers 1 and 3. In neither instance does it indicate the drug has zero cost-sharing, which should be denoted with a “PRV.” There is a separate document that lists preventive drugs, which includes PrEP.

Some insurers clearly delineate preventive drugs with no cost-sharing on a separate tier, but that tier can be labeled as Tier 0, Tier 1, Tier 5, Tier 7, Tier P, “Prev,” or just “ACA.”  Others place PrEP on a high drug tier but then indicate it has $0 cost-sharing next to it. Anthem, in many states, including Colorado, places generic Truvada, the only PrEP drug they offer, on Tier 3.  However, if one clicks on the drug name, the consumer finds an additional note that it has zero cost-sharing.

Prior to the new federal guidance, some states have taken action to ensure PrEP is covered by insurers without cost-sharing.

  • New York’s insurance regulator acted by requiring compliance one year earlier, in 2020, and issued an order that all ancillary services be covered without cost-sharing.
  • California’s insurance commissioner issued guidance that requires plans to cover all PrEP drugs without prior authorization, along with ancillary services without cost-sharing. All plans must recertify that they are in compliance by August 6, 2021.
  • Colorado’s Insurance Division issued a regulation requiring coverage of clinically appropriate PrEP without cost-sharing and a bulletin encouraging coverage of ancillary services without cost-sharing.

The plan review conducted by HIV+Hep was not able to determine coverage of the associated PrEP services. Additionally, the FAQ requires insurers to cover any form of PrEP without cost-sharing that is medically appropriate as determined by the provider since not all forms of PrEP will work for everyone.

The list of preventive services that private insurers must cover without cost-sharing, which is maintained by CCIIO, was updated earlier this year to include PrEP

“While progress is being made, it is obvious that insurers and regulators must do more to ensure people with private insurance can obtain PrEP without cost-sharing. Additionally, transparency in how insurers display coverage of preventive medications such as PrEP needs further attention. We look forward to conducting additional plan reviews and holding all parties accountable for providing clear, transparent information to make it as easy as possible for people with insurance who need PrEP to access it,” concluded Schmid.

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The HIV+Hepatitis Policy Institute is a national, non-profit organization whose mission is to promote quality and affordable healthcare for people living with or at risk of HIV, hepatitis, and other serious and chronic health conditions.


Contact: Jennifer Burke
(301) 801-9847

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