On June 11, 2019, the United States Preventive Services Task Force (USPSTF) provided a Final Recommendation regarding persons at high risk of acquiring Human Immunodeficiency Virus (HIV). The USPSTF recommended that clinicians offer HIV pre-exposure prophylaxis (PrEP) with effective antiretroviral therapy to persons at high risk of HIV acquisition. On July 19, 2021, the Departments of Labor (DOL), Health and Human Services (HHS), and the Treasury (collectively, the Departments) issued a set of Frequently Asked Questions (FAQs) regarding implementation of the Affordable Care Act (ACA). These FAQs answer questions from plan issuers, sponsors and other stakeholders about how plans should cover PrEP.
Health plans with policy years beginning on or after June 30, 2020, must cover PrEP as preventive care under the ACA.
Under the ACA, Public Service Health Act (PHSA) Section 2713 requires non-grandfathered employer health plans, whether fully insured or self-insured, to cover USPSTF recommended items or services that have in effect a rating of “A” or “B” in the current recommendations of the USPSTF without any cost-sharing for plan participants. The USPSTF makes recommendations about the effectiveness of specific preventive care services for patients without obvious related signs or symptoms. Recommendations of the USPSTF have five grades ranging from the highest of Grade A to the lowest grade of “I Statement” (the Grades are A, B, C, D and I Statement). The USPSTF’s Final Recommendations also provide either a High, Moderate or Low level of certainty regarding net benefit. The USPSTF defines certainty as a likelihood that the USPSTF assessment of the net benefit of a preventive service is correct.
The Final Recommendation gives information about whom the USPSTF determined to be at high risk for HIV acquisition.
According to the USPSTF recommendation, only individuals in the high-risk categories need access to HIV PrEP medications and treatment without cost-sharing. The recommendation lists three groups of persons who, if they exhibit one or more accompanying characteristics, are considered high risk for HIV. The Departments drafted the FAQs in response to questions they received from stakeholders on implementing the requirements of the USPSTF recommendation properly.
The Departments’ FAQs explain that plans must provide coverage without cost-sharing for PrEP drugs and items and services included as part of determining whether PrEP is appropriate for the individual and ongoing follow-up and monitoring.
The USPSTF final recommendation statement says that the purpose of PrEP is to decrease the risk of HIV transmission to the identified high-risk individuals. Further, the USPSTF cites CDC guidance that PrEP is not just medications but a comprehensive intervention consisting of antiretroviral medicines and essential support services. These essential support services include medication self-management plans, adherence counseling, risk reduction strategies, and mental health counseling and therapy. Services also include clinical assessments necessary to ensure that a healthcare provider prescribes medications for PrEP to at-risk individuals who are not infected with HIV and who have no medical contraindications. Finally, plans should also cover as preventive services, those that monitor patients taking PrEP drugs to ensure its safe, ongoing use.
Accordingly, the FAQs list the services that the USPSTF’s recommendations contemplate plans should cover as preventive.
The Final Recommendation Statement encompasses FDA-approved PrEP antiretroviral prescription medications and the following six baseline and monitoring services categories. Plans must cover:
- HIV testing used to confirm that a high-risk person is HIV uninfected before starting PrEP and ongoing HIV testing every three months while taking PrEP. Continuous testing is necessary to verify that a person remains uninfected. Thus, their provider can promptly cease PrEP before harmful drug resistance can develop should a person become infected while using PrEP.
- Hepatitis B and C screening related to the administration and maintenance of PrEP drugs. Healthcare providers must test an individual’s hepatitis B virus (HBV) at baseline for the initiation of PrEP consistent with Centers for Disease Control and Prevention (CDC) guidelines. HBV testing is necessary so that when the provider stops PrEP medications, they can monitor the individual to ensure safety and identify any potential injury rapidly. Additionally, providers must screen for hepatitis C virus (HCV) infection at baseline and periodically, consistent with CDC guidelines. Screening for HCV infection is indicated for all people with an ongoing risk of contracting HCV.
- Creatinine testing and calculated estimated creatine clearance (eCrCl) or glomerular filtration rate (eGFR) for persons taking PrEP. People taking PrEP medications must have their estimated eCrCl or eGFR measured and calculated at the beginning of treatment to assess if kidney function is in the range for safe prescribing of PrEP medication. Additionally, a person’s provider must check their creatinine and eCrCL or eGFR periodically consistent with CDC guidelines, at the same time they take PrEP medication, to assess for potential kidney injury and ensure that it is safe to continue PrEP.
- Pregnancy testing for women with childbearing potential taking PrEP must occur at baseline and periodically, consistent with CDC guidelines until they stop taking PrEP medications. Together with their healthcare providers, pregnant patients should make a fully informed and individualized decision about taking PrEP.
- Sexually Transmitted Infection (STI) screening and counseling for persons taking PrEP. STI testing and counseling should occur at baseline and periodically thereafter, consistent with CDC guidelines.
- The counseling offered to PrEP patients. Providers must offer those taking PrEP regular adherence counseling to assess behavior and adherence consistent with CDC guidelines to ensure that they use PrEP as prescribed and maximize PrEP’s effectiveness.
As the FAQs reiterate, the ACA permits plan administrators to implement and manage their plans using reasonable medical management techniques.
For prescription drug plans, reasonable management techniques include prior authorization procedures for specialty drugs, like PrEP, and restrictions on the frequency of benefits. However, the FAQs state that a plan may use reasonable medical management techniques only to the extent not specified in the applicable CDC or Agency recommendation or guideline for a medication. For example, the USPSTF’s final recommendation suggested ongoing follow-up and monitoring, including HIV testing every three months. Accordingly, plans should cover the testing and should not place any frequency restrictions that are greater than the recommended testing schedule. The FAQs also say that when a participant’s healthcare provider determines that PrEP is medically appropriate for that individual, it would not be reasonable to restrict the number of times the individual may start PrEP. Plan sponsors may want to review their plan documents to determine how whether their plan treats PrEP and its baseline and monitoring services as preventive according to the recommendation’s requirements.
The Departments provide guidance on when a plan may use reasonable medical techniques.
According to the Departments’ FAQs, if a plan utilizes reasonable medical management techniques, it must have an easily accessible, transparent and sufficiently expedient exceptions process. In addition, the exceptions process cannot be unduly burdensome on the individual or a provider (or other individual acting as an authorized representative). The Departments state that, for example, such a process should allow prescribing and accessing PrEP medications on the same day that a plan participant, beneficiary or enrollee receives a negative HIV test or decides to start taking PrEP.
The ACA mandates that non-grandfathered plans cover HIV PrEP and the aforementioned baseline and monitoring services at 100%, as preventive items and services, for plan years beginning on or after June 30, 2020. Plan administrators should seek the advice of counsel before making any changes related to its prescription drug plan. Affected stakeholders should review the Final Recommendation Statement and the FAQs for more information about PrEP coverage and recommendations.
EPIC offers this material for general information only. EPIC does not intend this material to be, nor may any person receiving this information construe or rely on this material as, tax or legal advice. The matters addressed in this document and any related discussions or correspondence should be reviewed and discussed with legal counsel prior to acting or relying on these materials.
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Compliance Manager – Atlanta, GA