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
Rules Reducing Provider Burden Could Save Them More than $1.1 Billion
The first rule, which CMS estimates will save hospitals as much as $900 million annually, modifies the Conditions of Participation (CoPs) that hospitals and critical access hospitals must meet to participate in both Medicare and Medicaid. Key revisions include:
- Permitting one governing body to oversee multiple hospitals in a multi-hospital system, with the requirement that member(s) of the hospital’s medical staff be part of the body;
- Expanding the definition of “medical staff”, and permitting hospitals to grant other practitioners hospital privileges;
- Giving hospitals the discretion to have an optional program that would allow patients or a support person to administer certain medications; and
- Removing the requirement that a single Director of Outpatient Services oversee all outpatient departments in a hospital.
The second rule is intended to improve efficiency in both the Medicare and Medicaid programs by removing unnecessary and burdensome requirements and either removing obsolete or duplicative regulations or providing clarifying information. Among other things, the rule:
- Limits the applicability of the Life Safety Code to certain End Stage Renal Disease Facilities;
- Eliminates the outdated list of emergency equipment that must be available in ambulatory surgical centers;
- Removes an “unnecessarily punitive enrollment bar for providers and suppliers” when triggered by provider or supplier’s failure to respond in a timely manner to revalidation or other requests for information;
- Removes obsolete pre-BIPA regulations that apply to initial determinations, re-openings and appeals of claims under original Medicare; and
- Updates and streamlines definitions and regulations pertaining to Organ Procurement Organizations.
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