The Biden administration has implemented a regulatory rule freeze affecting on all rules that had not gone into effect. They will now be reviewed.
The Biden administration implemented a regulatory rule freeze affecting all federal agency rules that had not gone into effect as of January 20, 2021. According to National Law Review, "At its core, the regulatory rule freeze requires all pending final rules to be delayed at least 60 days in order for the Biden administration to review and opine on the necessity and scope of affected rules. During this delay period, the administration may review, revise, and possibly rescind federal administrative rules".
Modern Healthcare reported that, under this rule, the Department of Health and Human Services (HHS) has frozen "a final rule that would have blocked community health centers, which are federally qualified health centers, from receiving future grant funding unless the centers provided a complete pass-through of 340B discounts on insulin and epi-pens to low-income patients under the 340B Insulin Pass-Through Rule." Community health centers opposed the 340B Insulin Pass-Through Rule, arguing that it would have added significant bureaucratic obligations to centers’ operations while making a relatively minimal impact on the costs of drugs provided to center patients. The 340B Insulin Pass-Through Rule was meant to go into effect on January 22, 2021.
Due to HHS’ freeze, the 340B Insulin Pass-Through Rule's effective date has now been pushed to at least March 22, 2021. Moreover, there is currently no indication whether the Biden administration will ultimately repeal or amend the 340B Insulin Pass-Through Rule. This delay also offers community health centers additional time to develop plans to comply with the 340B Insulin Pass-Through Rule.