Integrity Rule Injunction Program
A federal judge issued a ruling placing a temporary injunction on several portions of CMS’s recently finalized Program Integrity Rule. Notably, the injunction would void the changes to the AV de minimis levels, $5 minimum net premium, SEP verification, failure to reconcile ban, additional verification for income, and past due premium repayment requirements. HHS has not indicated whether they will appeal. Issuers with plans that would be affected by the injunction (i.e., AV levels that are too low) should discuss with their respective Department of Insurance how to handle the injunction.
Covid Vaccine Guidance
HHS released guidance on the fall Covid vaccine. HHS restricted access to Covid vaccines to those over 65 or to high-risk patients. The new policies don’t cover healthy children under 5. Covid rates have increased in recent weeks, and the changes by RFK Jr. are expected to reduce vaccine take-up.
340b Pilot
The American Hospital Association released a letter to HHS this week criticizing the 340B pilot program. The 340b pilot program is scheduled to start on January 1st, with HHS announcing participants on October 1st. The pilot program would replace 340B drug program discounts with rebates. AHA argues that shifting to 340B would increase the administrative burden and potentially violate bond agreements, thus hurting hospitals.
Prescription Drug Tariff Update
The White House issued a fact sheet clarifying EU tariffs on prescription drugs. The announcement clarified that the 15% tariffs on brand-name drugs would go forward, but the most favored nation tariff rate on generic drugs would be zero or close to zero. Fierce Health reported that further tariffs on prescriptions for other countries were still several weeks away.
