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
CMS Releases Physician Fee Schedule and Hospital Outpatient/Ambulatory Surgical Center Proposed Rules for Calendar Year 2014
The first rule is the Medicare physician fee schedule proposed rule. This proposed rule would update payment policies and payment rates for services paid under the Medicare physician fee schedule on or after January 1, 2014. In addition, the rule proposes changes to several quality reporting initiatives that relate to physician fee schedule payments, and continues the implementation of the physician value-based payment modifier that affects payments to physician groups based on the quality and cost of care they furnish to Medicare beneficiaries.
The second rule issued today is the proposed rule addressing the payment system and policy changes for the hospital outpatient prospective payment system (OPPS) and the ambulatory surgical center (ASC) payment system. This rule would update Medicare payment policies and rates for hospital outpatient and ASC services furnished on or after January 1, 2014. The OPPS portions of the proposed rule include a proposed payment update, proposals for additional packaging of services, and a proposal to continue to pay for non-pass-through drugs at average sales price plus 6%. The ASC portions of the proposed rule address the ASC payment update, additional packaging of services, and the failure of ASCs to meet quality reporting requirements.
The above topics are just glimpses of what is contained in these two proposed rules that total more than 1300 pages. Both rules are subject to a 60 day comment period and CMS will accept comments on both until September 6, 2013. The proposed rules will be published in the Federal Register on July 18, 2013. In the interim, the rules should be available in the links provided above. While there have been difficulties accessing the rules through these links, that is likely due to high traffic which should resolve shortly.
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