While pharmacies dispense Part D medications, many of them do not bill for Part B drugs, notes Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. “This was a major concern to us and the 45,000 current oral PrEP users in the Medicare Part D program. We did not want them to lose their coverage if their pharmacy was not ready. We worked with CMS for over a year to slow down the process and address our concerns. Legally they said they could not offer a transition period or keep PrEP in both D and B.”
Twice-yearly PrEP shows promise, could boost adherence
“The entire goal of PrEP is to reduce new HIV transmissions, and the clinical trials for long-acting PrEP are demonstrating an extraordinary decrease in HIV,” observes Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. “It will greatly reduce a person’s need to physically take PrEP and help with adherence. These new PrEP options will also help different populations, such as women, who may not always want to share with their partner that they are taking a daily PrEP drug, or with those who are unstably housed or struggle with mental health and substance use. It just makes taking PrEP so much easier for everyone.”
Access questions hang over Gilead’s HIV shot
In the U.S., most private health insurance plans must cover PrEP without cost-sharing, but more federal guidance is needed to make sure plans cover both pills and injectables without prior authorization, said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute.
CMS crackdown
“Coming from an administration that prides itself on supporting patients and lowering their prescription drug costs, this is a huge disappointment. While they have gone on record that they will issue these rules, the clock is ticking and there isn’t much time left,” said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, in a statement.
CMS proposes risk adjustment changes, broker fraud crackdown for 2026 plan year
HIV+Hepatitis Policy Institute, an advocacy group, criticized the proposed rules impact on patients, saying the government is still letting pharmacy benefit managers (PBMs) profit from copay assistance. The rule included no requirements that copay assistance be counted as part of patient cost-sharing, and no provision closing an essential health benefits loophole. “Coming from an administration that prides itself on supporting patients and lowering their prescription drug costs, this is a huge disappointment,” said Carl Schmid, executive director at the institute. “While they have gone on record that they will issue these rules, the clock is ticking and there isn’t much time left.”