The safety and efficacy of PrEP for HIV prevention are well established. Even as PrEP access increases, there are legal and policy challenges. Although the FDA recently approved Truvada as PrEP for adolescents, state consent and confidentiality laws nonetheless block adolescents from accessing PrEP without parental consent. This is a concern for minors and legal adults who are covered by a parent’s health insurance, but want to maintain their own confidentiality. Health insurers have also imposed barriers to PrEP coverage and have rejected claims for multi-site STI testing and other services required for PrEP care. Insurers have even denied life, long-term care, and other insurance to PrEP users, prompting litigation and allegations of discrimination. Efforts to make PrEP more convenient and accessible are underway, but raise legal issues. For instance, initiatives spurred by the enduring lack of public information and knowledge about PrEP have sought to ensure that patients receive accurate and timely information about PrEp, but they may be in tension with a recent Supreme Court case on the First Amendment rights of healthcare providers. In addition, there are promising new telehealth models for PrEP, but coverage varies. Almost all states reimburse for telehealth under Medicaid and most require private insurers to cover telehealth, but state laws vary widely and only some laws permit reimbursement for telehealth services originating from a patient’s home. Long-acting PrEP, which would not require daily dosing, is in development and will be subject to complex policy decisions from FDA review to different laws for pharmaceutical coverage in public and private insurance.
PrEP, TelePrEP, and Long-Acting PrEP: Legal and Policy Issues in the Current and Future HIV Landscape
CLE Materials I, II