PhRMA also opposes adding more tiers to formularies, saying it would make costs less predictable and lead to higher patient cost-sharing. A group of 71 patient advocacy groups also signed on to a response to the NPBB, led by the HIV+Hepatitis Policy Institute. Though they criticized other aspects of the proposed rule, they wrote in support of the tiering proposal. “Generic drugs should, for the most part, be on the generic tier,” the comments say. “We do not support the option that certain generics, such as those with a higher cost, be on the specialty tier. Reason would conclude that it should be on a lower tier than the brand, but other factors lead to drug tier placement.” The groups appreciate CMS’ steps to address adverse tiering, the comments say, but are “disappointed that there has been a lack of enforcement and actions against insurers and pharmacy benefit managers (PBMs) that discriminate against beneficiaries with chronic health conditions.”
Payers, providers clash over scope of CMS review of ACA’s essential health benefits
Chief among the requests is that CMS increase the number of drugs an insurer has to cover in a certain class. Currently, the minimum requirement is for a plan to cover either one drug per category or class or at least the same number of drugs in every U.S. Pharmacopeia category and class as covered by the essential health benefits benchmark plan. “Often times this is not a sufficient number of drugs to meet the needs of patients with complex and severe health conditions,” according to the letter which includes groups such as the HIV+Hepatitis Policy Institute and the Alliance for Patient Access.
FDA to allow more gay and bisexual men to donate blood
Carl Schmid, the executive director of the HIV+Hepatitis Policy Institute, praised what he called the “long, overdue” decision. “This marks a monumental shift and ends a long and painful era of blanket discrimination against gay men,” Schmid said. “No longer will eligibility to donate blood be based on sexual orientation. Instead, every person, no matter their sexuality, will be reviewed individually in order to determine their eligibility to donate.”
FDA proposes new blood donation policy for men who have sex with men
The FDA issued a draft policy Friday that proposes easing restrictions on blood donation from men who have sex with men. The policy is expected to be finalized in a way that would allow men who have sex with men to donate blood if they report in a questionnaire that they haven’t had sex with a new partner or multiple people in the past three months, in addition to other eligibility criteria.
FDA guidance eases blood donation restrictions for gay, bi men
Carl Schmid, executive director of the HIV+ Hepatitis Policy Institute, said: “While this long-overdue change is being made based on the science and the facts, which have been clear for years, it is the result of the leadership of the Biden administration that continues to tear down discriminatory government policies.”