The Health Resources and Services Administration (HRSA) has published a final rule to implement civil money penalty (CMP) provisions added to section 340B of the Public Health Service Act under the Affordable Care Act. In particular, the final rule addresses: (i) the calculation of the 340B "ceiling price" that may be charged to covered entities; (ii) the substantive standards applicable to CMPs; and (iii) the procedures applicable to the imposition of CMPs. While the January 5, 2017 final rule sets forth a March 6, 2017 effective date, this rule is presumably impacted by the Trump Administration regulatory review policy, which will push back the effective date to March 21, 2017.
This article is presented for informational purposes only and is not intended to constitute legal advice.