On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
Going Over the Overpayment Cliff
The responsibility to reopen and recover non-fraudulent overpayments lies with the entity that rendered the final determination to make a Medicare payment, which typically is the Medicare contractor. A contractor may reopen an original payment determination to recover any questionable Medicare payments. Medicare contractors can reopen a payment determination “for good cause” within four years of the date of the original payment determination. See 42 C.F.R. § 405.980(b)(2). However, 42 U.S.C. § 1395gg(b) bars the recovery of overpayments from providers that are “without fault,” and prior to the ATRA amendment, a provider was deemed to be without fault three years after the original payment was made unless there was evidence to the contrary. According to HHS-OIG, the one year difference between the reopening and recovery periods in effect left CMS without the ability to collect overpayments for reopened claims in year four. In accordance with HHS-OIG’s recommendation, ATRA extends the statute of limitations period so that the recovery period, now five years, exceeds the individual claim reopening period, which remains at four years.
The limited legislative history available for this statutory change fails to offer specific insight as to why HHS-OIG thought the recovery period needed to exceed the reopening period rather than simply match it. Moreover, significant uncertainty exists over how this change relates to other overpayment provisions such as cost report overpayments, which have a three-year reopening period, and CMS’s proposed ten-year reopening period for overpayments reported in accordance with PPACA’s amendment of the Social Security Act adding an explicit overpayment reporting and return obligation. Providers are encouraged to pay careful attention to future regulatory developments on this front.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017