FDA Medwatch : Certain Implantable Cardiac Devices by Abbott (formerly St. Jude Medical): FDA Safety Communication - Battery Performance Alert and Cybersecurity Firmware Updates


AUDIENCE: Cardiology

ISSUE: On April 11, 2018, the FDA approved a firmware update that is now available and is intended as a corrective action (recall), to reduce the risk of patient harm due to premature battery depletion and potential exploitation of cybersecurity vulnerabilities for certain Abbott ICDs and CRT-Ds. "Firmware" is a specific type of software embedded in the hardware of a medical device (e.g. a component in the defibrillator).

FDA Medwatch : Acrodose PLus and PL Systems by Haemonetics: Recall - Low pH Readings for Platelets Stored in CLX HP Bag


AUDIENCE: Laboratory

ISSUE: Haemonetics recently received reports of low pH readings for platelets stored in the CLX HP bag in certain lots of the Acrodose PLus and PL systems. In some instances the drop in pH is accompanied by a yellow discoloration of the storage bag.

Platelets with pH lower than 6.2 and a lack of “swirl” may not be viable. Transfusion of these platelets may lead to delayed correction of coagulopathy or low quality prophylactic platelet transfusion, increasing risk of morbidity and mortality.

CGS Publishes Documentation Checklists for DME


To assist providers in collecting the proper documentation when dispensing and billing for DME products, CGS Medicare has published a set of documentation checklists. The checklists are in PDF format and include:

Surgical Dressings
Therapeutic Shoes for Persons with Diabetes
Lower Limb Prostheses
Negative Pressure Wound Therapy Pumps
and many other DME items.

To get the checklists click here to visit the CGS Website

Performance Scores for 2017 Claims Data Available on Quality Payment Program Website


Performance Scores for 2017 Claims Data Available on Quality Payment Program Website

MIPS Eligible Clinicians Can Now View Performance Scores for 2017 Claims Data on qpp.cms.gov

If you’re an eligible clinician who submitted 2017 Quality performance data for MIPS via claims, you’ll now be able to view your performance scores through the MIPS data submission feature. Reminder: claims data submission is only an option if you’re participating in MIPS as an individual (not as part of a group).


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