Final Rule on Affordable Insulin and Injectable Epinephrine

Last summer, the President issued an Executive Order on Access to Affordable Life-saving Medications.  This order directed Health and Human Services (HHS) to ensure Federally Qualified Health Centers (FQHCs) obtaining insulin or injectable epinephrine under the 340B Prescription Drug Program do not overcharge these life-saving drugs to low-income Americans due to either lack of insurance or high cost sharing requirements.  Low-income is defined as up to 350% of the federal poverty level (FPL).

HHS has now issued a final rule in compliance with that order, slated to take effect January 22, 2021.  This directs certain health centers and pharmacies to charge their low-income patients no more than they paid for these drugs under the 340B program when they are uninsured or have unmet cost-sharing that would exceed 20% of the price the health provider paid for the drug under 340B.

We wanted employers to be aware of this rule benefiting their low-income employees in a few weeks and the potential for these two drugs to get more emphasis for broader application in the future.  At least seven states have enacted similar laws, and US Senator Mark Warner (D) of Virginia is drafting a bill for the new Congress to consider implementing similar rules nationwide.

IMA will continue to monitor regulator guidance and offer meaningful, practical, timely information.

This material should not be considered as a substitute for legal, tax and/or actuarial advice. Contact the appropriate professional counsel for such matters. These materials are not exhaustive and are subject to possible changes in applicable laws, rules, and regulations and their interpretations.