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
Medicare Inpatient Hospital Final Rule for Fiscal Year 2014 Released; Includes Changes to Inpatient Admission and Rebilling Policies
Overall hospital payments under the IPPS will increase by $1.2 billion. The final rule increases IPPS operating rates by 0.7 percent after accounting for inflation and other adjustments required by the law. CMS will increase payments to long-term care hospitals by 1.3 percent, or approximately $72 million.
CMS also responds to comments on a proposed rule, released in March 2013, in which CMS changed its policy to allow hospitals to bill Medicare Part B for the reasonable and necessary care provided to patients after a Medicare review contractor has denied payment under Part A, or the hospital has determined through a self-audit, that the care should have been provided in the outpatient setting, rather than in an inpatient setting. CMS finalizes its proposal to allow hospitals to bill Medicare Part B in such cases only when the Part B claims are submitted within one year of the date of service, and CMS clarifies that this policy applies to admissions with dates of service on or after October 1, 2013.
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