Rhode Island Leads on HIV Prevention with Game-Changing PrEP Access Law

By Joseph Metmowlee Garland, MD AAHVS, GLAD Law Board Vice President

As a doctor who has spent 18 years caring for people living with and vulnerable to HIV, one of the most frustrating and heartbreaking aspects of my work is knowing that despite the availability of drugs to prevent HIV infection, many people continue to contract HIV because they cannot access these medications.

In June the Rhode Island legislature passed, and Governor McKee signed, a law that will mean fewer people will get HIV.

While we have made great strides toward ensuring access to HIV treatment across the U.S., the availability of preventive medications has greatly lagged behind. PreExposure Prophylaxis (PrEP) — medications that prevent HIV transmission with nearly 100% effectiveness when taken correctly — has been around for over a decade, yet access is not assured for many people. And it is the most vulnerable among us — people living in poverty or experiencing homelessness, those with substance use disorder, and racial and sexual minorities — who most often encounter barriers to receiving this medication that can protect them from a profoundly life-altering diagnosis.

Wonderfully, in June the Rhode Island legislature passed, and Governor McKee signed, a law that will mean fewer people will get HIV. “An Act Relating To Insurance – Accident And Sickness Insurance Policies – Insurance Coverage For Prevention Of HIV Infection” (S.2255/H.7625) will ensure Rhode Islanders who can benefit from PrEP will have easier and more timely access to the form of PrEP that works best for them.

This new law prohibits health insurance companies from requiring patients to make co-pays or meet a deductible in order to receive PrEP — including long-acting injectable PrEP — or any HIV prevention drug, practices known as cost sharing. Cost sharing can essentially make medications inaccessible to patients because of high co-pays or the need to meet a high deductible.

Importantly, the new law also bars prior authorization and step therapy for current and future injectable forms of PrEP. Prior authorization is an insurance practice that requires patients to wait for prior approval from their insurer in order to receive a specific medication. Step therapy is a practice in which insurers require patients to try alternative medications before they can receive the medicine their health care provider actually prescribed for them.

[This law] reflects a valuable lesson we have learned time and again in the fight against HIV: the more varied options we can offer people to access prevention and treatment methods, the more people will get the prevention services and treatment they need. People need options that fit with their lives.

Both of these processes create barriers for patients and health care providers.

Prior authorization requires the clinician to complete and submit additional paperwork to the insurer to justify the prescription – these additional forms are separate to the medical record and ask questions about the clinical indication, what alternatives have been tried, and often many other details. They are often time-consuming and can be frankly just confusing. Only after receiving the completed form will the insurer then determine whether they will cover the medication.

Step therapy can be similarly onerous – insurers can require the patient to try and “fail” a different medication (usually a cheaper option) before they would approve the prescribed medication. The reason for failure – side effects, ineffectiveness, etc. – will then need to be documented and submitted as part of a prior authorization to get approval of the originally-prescribed medication.

Both of these processes can be time-consuming and frustrating for clinicians and patients, and can effectively discourage both the provider and the patient from getting the medication. In a study by the American Medical Association on prior authorization practices, 91% of physicians reported that such requirements negatively impacted clinical outcomes for their patients. Another study found that prior authorization requirements exacerbated medical nonadherence, resulting in patients abandoning prescriptions almost 40% of the time. And the average physician completes 43 prior authorizations and spends 12 hours filling out these forms every week.

In my role as the Medical Director of the Infectious Diseases and Immunology Center at The Miriam Hospital, I have seen firsthand how cost sharing and prior authorization function as barriers to patients accessing PrEP and the form of the drug that is best for them.

In order to meet insurer prior authorization requirements for HIV and PrEP medications for patients at our clinic, we had to hire two additional staff members to handle the workload. Smaller clinics that don’t have the support of a larger health system obviously have a much harder time securing prior authorization for their patients, and often those patients just stop trying to get it. In fact, according to the CDC, in 2023 just 35% of people in Rhode Island for whom PrEP was indicated to prevent HIV were taking it. And while prior authorization and step therapy are not the only reasons for this access issue, they play a large role.

One critical aspect of S.2255/H.7625 is that it ensures that different forms of HIV prevention drugs be accessible to those who need them. This provision reflects a valuable lesson we have learned time and again in the fight against HIV: the more varied options we can offer people to access prevention and treatment methods, the more people will get the prevention services and treatment they need. People need options that fit with their lives.

Just think about it and you can imagine many scenarios where an injectable therapy would be the right option for a patient — people who have difficulty swallowing pills, people who can’t tolerate side effects to oral PrEP, people living in group or roommate settings with concerns about privacy around their medication, people who struggle to remember to take daily medications, and people who are unstably housed making medication adherence much harder. 

This concept is particularly important as injectable forms of PrEP become more widely available, including one anticipated medication that appears to prevent HIV transmission for up to six months per dose. Multiple studies have demonstrated that long-acting injectable medication are as effective at preventing HIV transmission as a daily oral PrEP medication, and often superior because of better adherence in people who can’t adhere to a daily pill regimen.

Yet as of March 2024, just 35 patients in Rhode Island were getting injectable PrEP, largely because of prohibitive insurer restrictions. But thanks to S.2255/H.7625, this powerful form of prevention will now be more immediately accessible to many for whom PrEP was previously unfeasible.

Just think about it and you can imagine many scenarios where an injectable therapy would be the right option for a patient — people who have difficulty swallowing pills, people who can’t tolerate side effects to oral PrEP, people living in group or roommate settings with concerns about privacy around their medication, people who struggle to remember to take daily medications, and people who are unstably housed making medication adherence much harder. And many others – the point is, patients and their health care providers should be able to decide what prevention option works best for them.

The HIV prevention medications we have today are amazing scientific advances. But they’re no good if they cannot be accessed by the people who need them, when they need them. Rhode Island is the first state in the nation to enact comprehensive bans on prior authorization for current and soon-to-be-developed long-acting injectable PrEP medications, and hopefully many more states will follow.

S.2255/H.7625 is groundbreaking and incredibly meaningful to our community and it will completely change the landscape of PrEP access in the state. With this law, Rhode Island is demonstrating its commitment to compassionate, high-quality, evidence-based care, and to ensuring that we make every possible tool available to those who need them in the fight against HIV.

Learn more about GLAD Law’s work to expand access to PrEP.