The US Food and Drug Administration (“FDA”) announced on November 18, 2016 that it will not release a final guidance to regulate laboratory developed tests (“LDTs”), in vitro diagnostic tests designed, manufactured, and used within a single laboratory. The announcement
CMS Reopens Hospital Appeals Settlement Process
On November 16, 2016, the Centers for Medicare & Medicaid Services (“CMS”) hosted a 2016 MLN Connects National Provider Call (“Provider Call”) for purposes of outlining the parameters of the 2016 Hospital Appeals Settlement Process, which CMS initially launched in
Australia – TGA consults on software as a medical device
The Therapeutic Goods Administration (TGA) has opened consultation on the use of software as a medical device (SaMD) as part of the International Medical Device Regulators Forum working group (IMDRF Working Group).
The IMDRF
Australia – Gene Technology Regulator commences review into Gene Technology Regulations
The Australian Gene Technology Regulator has commenced a technical review of the Gene Technology Regulations (Regulations), which underpin the regulation of a range of gene technologies and genetically modified organisms.
The review is aiming to ‘provide clarity
A first look at the healthcare industry under President Trump
The “100 Day Action Plan” of President-elect Donald Trump promised to bring broad and sweeping change to the current laws governing the healthcare industry in the US Specifically, Trump’s 100 Day Action Plan called for the full repeal of the
Texas Medical Board and Teladoc file a joint request for stay
In an effort to avoid the expense of additional discovery and to give the parties an opportunity to settle their dispute over the TMB’s new rules restricting telemedicine services in Texas, the Texas Medical Board (“TMB”) and Teladoc, Inc. (“Teladoc”)
Mississippi Federal judge temporarily blocks CMS pre-dispute arbitration ban
On November 7, 2016, the U.S. District Court for the Northern District of Mississippi granted a preliminary injunction against CMS’s enforcement of the mandatory pre-dispute arbitration agreement ban, which has recently triggered a flurry of litigation. As the
Stay tuned – CMS plans to consider public comments received on the Sunshine Act
CMS announced that the agency “will consider the public comments received [on the Open Payments / Sunshine Act program] in the future through possible rulemaking or publication of subregulatory guidance” in the recently released “Revisions to Payment Policies under
CMS Issues CY 2017 Final Rule
On November 1, 2016, CMS issued its Calendar Year (CY) 2017 Outpatient Prospective Payment System (OPPS) final rule with comment period. CMS also issued an interim final rule with comment period that establishes Medicare Physician Fee Schedule (MPFS) rates for
CY 2017 OPPS Final Rule and Hospital Off-Campus Outpatient Department Payment Implications
On Tuesday, November 1, CMS published its Calendar Year 2017 Outpatient Prospective Payment System (OPPS) final rule with comment period. The final rule includes provisions implementing the Bipartisan Budget Act of 2015, Section 603. On the same date CMS also