From: Reed Smith
On July 18, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) submitted to the Office of Management and Budget (OMB) for regulatory review a proposed rule entitled “Removal Of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection.” This proposed rule, if released, appears to follow through on various statements made by HHS Secretary Azar suggesting that safe harbor protection under the Federal Anti-Kickback Statute should be removed for prescription drug rebates—a potential action on which HHS requested comment in the Administration’s Drug Pricing Blueprint.
At this stage we have a few initial observations:
- While a proposed rule could be at OMB for hours or for months before being released (or might never be released), we note that the period for submission of comments on the Drug Pricing Blueprint ended on July 16, 2018, only two days prior to the submission of this proposed rule to OMB. As such, this rule must have been in the works for some time, and the Administration does not appear to have waited to review and consider comments before deciding to move forward with it.