“While the data demonstrate progress in PrEP usage, which will translate into fewer new HIV transmissions, the low usage of PrEP among the communities most impacted by HIV points to the need for increased and targeted federal resources,” said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, who added he also worries cuts to the program’s funding will increase HIV transmission and long-term costs.
Carl Schmid, executive director for the HIV+HEP Policy Institute, tells Inside Drug Pricing that while his organization expressed concerns about issues that could arise for current PrEP users due to the shift in coverage of PrEP drugs from Part D to Part B, the Institute did not want CMS to delay coverage of long-acting PrEP for beneficiaries. “Coverage of long-acting PrEP by Medicare is of an immediate concern and, until now, we have been pleased on how quickly CMS has been moving to provide this important HIV preventive service to Medicare beneficiaries since, at the moment, it is not available,” Schmid told IDP.
Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, said the ruling was a win for patients and that federal agencies could help further by issuing more guidance. Judge Bates “showed that it costs more money for the drug manufacturers to have copay accumulators, and he also showed that the insurers are collecting more money with copay accumulators,” Schmid said.
The lawsuit was filed in August 2022 by three patient advocacy groups—the HIV+Hepatitis Policy Institute, the Diabetes Leadership Council, and the Diabetes Patient Advocacy Coalition—along with three patients who use manufacturer copay assistance. The plaintiffs argued that provisions in the 2021 Notice of Benefit and Payment Parameters (NBPP) that allowed plans to not count copay assistance (e.g., the definition of cost-sharing) conflict with preexisting statutory and regulatory definitions of the term and that the provisions were “arbitrary and capricious.” The court vacated provisions of the 2021 NBPP and requested the US Department of Health and Human Services (HHS) interpret the statutory definition of the term cost-sharing in all future rulemaking.
Effective immediately, insurers may no longer apply copay accumulators in instances where the couponed brand lacks a generic. They can still use the programs on brands that have a generic alternative, however. The Biden administration has 60 days to appeal the decision. “We hope that will not happen,” said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, one of the groups that brought suit against the Department of Health and Human Services in 2022. “We know that the Biden administration keeps saying, ‘This is one of our priority issues, to make prescription drugs more affordable for patients.’ Well, this [decision] really does.”