PrEP pill
A bill has been introduced in Congress that would get rid of a major barrier that prevents Ryan White clinics from providing PrEP to those at high risk of contracting the HIV/AIDS virus.

Bill Would Give HIV/AIDS Clinics More Leeway to Use 340B Savings and Other Program Income

U.S. Sens. Rick Scott (R-Fla.) and Ben Ray Luján (D-N.M.) have introduced a bill to let Ryan White clinics use income from being in the HIV/AIDS program to provide pre-exposure prophylaxis, or PrEP, a daily medication used to prevent people at high risk of HIV/AIDS from contracting the virus. A big part of most clinics’ program income comes from billing for 340B-purchased drugs.

Ryan White HIV/AIDS Program (RWHAP) legislation, originally enacted in 1990, lets clinics use program income only for services provided to HIV-positive patients, which excludes people taking PrEP for HIV prevention.

Scott and Luján’s bill, S. 4395, would amend the law to let clinics use program income to provide PrEP and related ancillary services such as lab testing and physician visits to “individuals at risk of acquiring HIV.” It was referred to the Committee on Health, Education, Labor, and Pensions (HELP) and so far has not picked up additional co-sponsors. 

RWHAP “is a law written decades ago before there was an inkling of PrEP,” says Peggy Tighe, principal at Powers Law and legislative counsel to Ryan White Clinics for 340B (RWC-340B). This means Ryan White clinics currently can’t prescribe PrEP, for example, to an HIV-negative partner of an HIV-positive patient, because all patients must be HIV-positive by law, Tighe writes.  

Ryan White clinics are ideally positioned to prescribe PrEP because they have experience and expertise in treating HIV/AIDS and the populations it impacts most. Tighe says the bill makes a “modest change” to the RWHAP law by letting clinics voluntarily reallocate existing funds to provide PrEP. The bill makes no other changes, and requires no additional state or federal funding, she says.

There is a wrinkle, though, says Rob Renzi, CEO of Big Bend Cares, a Ryan White clinic that provides services to the Big Bend region of northern Florida. “For most of us, a huge portion of our program income” comes from 340B program savings, Renzi explains. Drug manufacturers’ restrictions on 340B covered entities’ use of contract pharmacies mean “we don’t have as much program income to do the work,” he says. This will hinder Ryan White clinics’ ability to provide PrEP to people at risk of contracting HIV/AIDS in future, should S. 4395 pass, he says.

Drug manufacturer Gilead’s contract pharmacy limitations on its branded hepatitis C treatments have impacted Big Bend Cares and other Ryan White clinics particularly hard, Renzi says. RWC-340B has asked Gilead to exempt all Ryan White clinics from the restrictions. Being limited to a single contract pharmacy to dispense these drugs would be a problem for Big Bend Cares, as its patients are scattered across a largely rural region made up of eight counties and 1,000 square miles, Renzi says.

Renzi says passing the bipartisan PROTECT 340B Act concurrently with Scott and Luján’s bill would help restore Ryan White clinics’ program income and their capacity to prescribe PrEP. The PROTECT Act, which currently boasts 100 co-sponsors, would prohibit pharmacy benefit managers and health plans from imposing discriminatory actions such as reduced reimbursement on 340B-covered entities. Passing “one [bill] without the other may not be as big a help,” Renzi says.

Renzi notes that S. 4395 would give Big Bend Cares more flexibility to offer preventive services. Clinic-provided transportation is an example. The clinic currently can use program income only for services to HIV-positive people. “I can’t put somebody who’s not [HIV-]positive on the vans,” Renzi says. If he did not have to “segregate” program income any longer, Big Bend Cares would “be able to spread it across wherever the services are needed,” Renzi says.

Tighe is hopeful about the bill’s prospects. “The bill has the support of both sides of the aisle and is without opposition, cost, or controversy,” Tighe says, “so it should be an easy lift for Congress.”