On Friday, HHS announced a temporary delay of the final rule “Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees,” better known as the “rebate rule.” The final rule, which was finalized Nov. 30, amends safe harbors to pass manufacturer rebates for Part D pharmaceuticals to patients at point of sale. Under the memorandum “Regulatory Freeze Pending Review” by the Assistant to the President and the Chief of Staff and the pending litigation filed by PCMA, HHS is reviewing the effects of the rule and delaying its effective date from Jan. 29, 2021, to March 22, 2021. As the administration conducts its review, NCPA will continue to provide input on the effects of the rebate rule on community pharmacy as well as continue to advocate for the inclusion of a DIR fix.
NCPA
