NEWS UPDATES OF INTEREST TO PLAN ADMINISTRATORS

 In this section, you'll find articles and news releases that may be pertinent to your plan operations, risks and outcomes.

  

 

 

 

 

 

Quality & Safety Matters

PRODUCT & SAFETY RECALLS

In a medical tourism context, patient notification procedure integrity is our greatest concern. The patient may have traveled outside the USA to a healthcare facility. We review their procedures to make prompt notification to patients, but practices and procedures vary and medical records retention also varies by local laws. As a backup, Mercury Health Travel's case management team monitors recall and contamination notices.  If the recall triggers an alarm in our system relevant to a case we've managed, we notify the patient to contact the provider for more information.

Product & Safety Recalls (FDA/CDC)

2016 Medical Device Recalls (FDA)
Device Name Date
Leonhard Lang Multi-function Defibrillation Electrodes DF29N Will Not Work with Welch Allyn Automatic External Defibrillator model AED 10 10/14/16
Baxter Corporation Recalls 50 mm 0.2 Micron Filter Due to the Potential for a Missing Filter Membrane and Possible Particulate Matter Contamination 10/06/16
DePuy Synthes Recalls Power Tool System Battery Adaptors Due to Possible Explosion Risk 09/28/16
Cook Medical Recalls Roadrunner® UniGlide® Hydrophilic Wire Guide Because of Potential Coating Contamination 09/06/16
Alere Recalls INRatio® and INRatio2® PT/INR Monitoring System Due to Incorrect Test Results 08/25/16
BioMerieux SA Alerts Customers about Potential Inaccurate Test Results When using NucliSENS® easyMAG® Magnetic Silica for Nucleic Acid Extraction 08/12/16
Dräger Recalls VentStar Oxylog 3000 Pediatric Patient Breathing Circuit Due to Potential Valve Leakage 08/04/16
CareFusion Recalls AVEA Ventilator Due to an Electrical Issue Which May Cause an Unexpected Shutdown 07/28/16
Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) Recalls Flush Angiographic Catheter Due to Tip Separation 07/22/16
HeartWare Inc. Extends Recall to Include Batteries Used in the Ventricular Assist Device Due to Premature Power Depletion 06/29/16
Medtronic Respiratory and Monitoring Solutions Recalls Battery Pack Used on Patient Monitors Due to Potential Fire Risk 05/27/16
Hummingbird Med Devices Inc. Recalls Hummi Micro-Draw Blood Transfer Device Due to Potential for Parts to Disconnect 05/26/16
B. Braun Medical Inc. Recalls Dialog+ Hemodialysis Systems Due Defective Conductivity Sensors 05/04/16
Boston Scientific Corporation Recalls Fetch 2 Aspiration Catheter Due to Shaft Breakage 04/19/16
Vascular Solutions Recalls Guardian II Hemostasis Valve Due to Low Pressure Seal Defect 04/13/16
Focus Diagnostics Recalls Laboratory Examination Kits Due to Inaccurate Test Results 04/13/16
Dexcom Inc. Recalls G4 Platinum and G5 Mobile Continuous Glucose Monitoring System Receivers Due to Audible Alarm Failure 04/11/16
Cook Medical Recalls Central Venous Catheter and Pressure Monitoring Sets and Trays due to Tips that May Split or Separate 03/30/16
Verathon Inc. Recalls GlideScope Titanium Single-Use Video Laryngoscope Due to Potential Video Feed Disruption 03/18/16
Arrow International Inc. Recalls Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits Due to Sheath Separation Issue 03/17/16
Abbott Vascular Recalls MitraClip Clip Delivery System Due to Issue with Delivery System Deployment Process 03/15/16
Dräger Evita V500 and Babylog VN500 Ventilators - Recall Expanded to Include Optional PS500 Batteries with New Power Supply Firmware 03/03/16
Cook Medical Expands Recall for Beacon Tip Angiographic Catheters to Include Additional Product Lots 02/25/16
Dräger Medical Inc. Recalls Emergency Transport Ventilators Due to a System Error that may lead to a Halt in Ventilation Therapy 02/10/16
Arkray Recalls SPOTCHEM II Test Strips Due to Inaccurate Blood Sugar Readings 01/28/16
Thornhill Research Inc. Recalls MOVES Ventilator System Due to Battery Problem 01/27/16
St. Jude Medical Recalls Optisure Dual Coil Defibrillation Leads Due to Damage that May Prevent Patient Therapy 01/26/16
Brainlab Cranial Image-Guided Surgery (IGS) System - Navigation Inaccuracy 01/15/16
Stryker Fuhrman Pleural and Pneumopericardial Drainage Sets - Catheter May Break During Insertion 01/11/16
Dräger Evita V500 and Babylog VN500 Ventilators - Issue with Optional PS500 Battery Power Supply May Cause Ventilators to Shut Down Unexpectedly 01/05/16

Page Last Updated: 10/14/2016

2015 Medical Device Recalls (FDA)
Device Name Date
bioMérieux SA Etest® PIP/TAZO/CON-4 PTC 256 – Potential for Test Result Error 12/29/15
Boston Scientific Corporation, Chariot Guiding Sheath May Break off During the Procedure 12/23/15
Insulet Corporation OmniPod Insulin Management System: Needle May Fail to Deliver Insulin 12/23/15
Dräger Perseus A500 Anesthesia Workstation - Faulty Power Switch May Cause Device to Stop Working 12/23/15
eVent Medical LS, 5i, or 7i Inspiration Ventilators May Shut Down without Alarm 12/07/15
Boston Scientific’s RotaWire Elite Guidewire and wireClip Torquer Guidewire May Break and Separate from the Rotablator System 11/27/15
Hamilton Recalls G5 Ventilator Because of Ventilation and Alarm Failure 11/13/15
MicroPort Orthopedics Inc., PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254 10/02/15
SynCardia Systems, Freedom Driver System - Part May Fail Causing Device to Stop Working 09/18/15
Insulet Corporation OmniPod Insulin Management System May Fail to Deliver Insulin 09/10/15
Covidien, Puritan Bennett 980 Ventilators - Amount of Air Delivered May Be Lower Than Programmed 09/02/15
Dräger Medical, Evita V500 and Babylog VN500 Ventilators - Faulty Batteries 09/02/15
CareFusion Alaris Syringe Pump Alarm Error May Cause Interruption of Therapy 08/27/15
Elite Biomedical Solutions, Alaris Medley Large Volume Pump (LVP) Frame Membrane, Frame Membrane May Allow Over or Under Delivery of Fluid by an Infusion Pump 08/27/15
Teleflex Medical, Hudson RCI Sheridan Sher-I-Bronch Endobronchial Tube - Connector May Crack or Separate 08/26/15
Western/Scott Fetzer Company OxyTOTE Portable Oxygen Unit May Ignite and Burst 08/18/15
Cook Medical, Beacon Tip Angiographic Catheters, Catheter Tip May Split or Separate 08/07/15
Medtronic Shiley Neonatal and Pediatric Tracheostomy Tubes: Switching Tubes May Cause Breathing Issues 07/15/15
Teleflex Hudson RCI Lifesaver Single Patient Use Manual Resuscitator Intake Port Blockage 07/02/15
FLOW-i Anesthesia Systems - Dislodged Patient Cassette May Stop Patient Ventilation 07/01/15
Zimmer M/L Taper with Kinectiv Technology Prosthesis Femoral Stems and Necks Higher than Expected Levels of Manufacturing Residues 06/19/15
HeartWare Ventricular Assist System – Updated with Multiple Reasons for Recalls 06/19/15
Baxter Healthcare, VASCU-GUARD Peripheral Vascular Patch - May Cause Blood Clots 06/05/15
LuSys Laboratories, Inc., Ebola Virus One-Step Test Kits - Not Cleared for Marketing 04/23/15
Maquet Medical Systems, Tiger Paw System II - May Cause Tears and Bleeding in Heart Tissue 03/25/15
Hospira Plum A+ and Plum A+3 Infusion Systems Alarm Volume Failure 03/05/15
HeartWare Ventricular Assist System (VAS) – Electrostatic Discharge May Cause Pump Failure 02/27/15
Teleflex Medical, MAQUET Servo Humidifier 163 - Cracks in Connector Tubes May Lead to Leak Failures 02/25/15
Teleflex Medical, MAQUET Servo Humidifier 163 - Connector Cracks May Lead to Leak Failure 02/25/15
GE Healthcare Magnetic Resonance Imaging (MRI) Systems with Magnet Rundown Unit 02/25/15
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems Labeling Issue 02/10/15
Alere San Diego Inc., Alere INRatio and INRatio2 PT/INR Monitor System (Professional and Prescription Home Use) - Falsely Low INR Test Results 01/08/15

Page Last Updated: 01/05/2016

2014 Medical Device Recalls (FDA)
Device Name Date
Halyard Health, KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes - Component May Detach During Use 12/31/14
Nellcor Puritan Bennett, 980 Ventilator System - Component Failure May Cause Burning Odor 12/31/14
Heart Sync, Multi-function Defibrillation Electrodes Will Not Work with Philips FR3 and FRx AEDs 12/24/14
Customed Inc., Surgical Convenience Packs - Compromised Sterility Due to Multiple Problems 12/24/14
CONMED Corporation, PadPro and R2 Multi-Function Defibrillation Electrodes Will Not Work with Philips FR3 and FRx AEDs 12/03/14
Philips / Children's Medical Ventures, Gel-E Donut and Squishon 2 - Possibility of Mold 12/01/14
Siemens Healthcare Diagnostics, Rapid Gram Negative Combo Panels - May Produce Incorrect Results 12/01/14
Baxter Healthcare Corporation, INTRAVIA Empty Containers with PVC Ports – Particles Found in Patient Solution 11/20/14
Respironics California, Esprit V1000 and V200 Ventilators - Power Failure May Occur 11/19/14
Nellcor Puritan Bennett, 980 Ventilator System - Software Issue May Stop Ventilator 11/07/14
Hospira, GemStar Power Supply, 3VDC - Power Supply for GemStar Infusion Pumps May Not Deliver Enough Electricity 11/05/14
Richard-Allan Scientific, 10% Neutral Buffered Formalin - May Contain Incorrect Concentration of Formalin 10/31/14
Covidien, Medi-Trace Cadence and Kendall Defibrillation Electrodes – Electrodes will Not Work with Philips FR3 and FRx Automated External Defibrillators (AEDs) 10/21/14
CareFusion 203, Inc., EnVe and ReVel ventilators - Power Connection Failure 10/17/14
ICU Medical, Inc., ConMed Stat2 Flow Controller – Delivers Higher Flow Rate than Intended 10/09/14
Teleflex Medical, Hudson RCI Pediatric Anesthesia Breathing Circuits - Circuit Ends May Crack or Break 10/07/14
Customed Inc., Surgical Convenience Packs - Damaged Packaging 09/05/14
Cook CloverSnare 4-Loop Vascular Retrieval Snare - Snare Tip May Break During Use 09/04/14
DePuy Synthes Craniomaxillofacial Distraction System - May Reverse Directions After Surgery 08/26/14
Children’s Medical Ventures, Gel-E Donut and Squishon 2 - Possibility of Mold 08/21/14
Cardiovascular Systems Diamondback 360 Peripheral Orbital Atherectomy System - Sheath May Fracture During Use 08/19/14
Enhancement Medical, Expression – Hyaluronic Acid Concentration 08/14/14
Wellspring Pharmaceutical Corporation, IPM Wound Gel - Microbial Contamination 08/12/14
GE Healthcare, LLC, Single-Width Airway Modules (E-MiniC) and Accessories and Extension Modules (N-FC, N-FCREC) - CO2 Detector May Fail Leading to Injury 07/25/14
Diabetic Supply of Suncoast, Inc., Advocate Redi-Code+ BMB-BA006A Blood Glucose Test Strips – Labeling Error May Lead to Use of Incorrect Glucose Meters 07/22/14
Ventlab, LLC., Ventlab Manual Resuscitator, Duckbill Valve May Stick and Prevent Air from Getting to the Patient 07/10/14
Vascular Solutions Langston V2 Dual Lumen Catheters (Models 5540 and 5550) - Inner Catheter May Separate During Use and Cause Injury 07/07/14
Medtronic Neurosurgery, Medtronic Duet External Drainage and Monitoring System - Patient Line Tubing May Disconnect and Lead to Injury 07/02/14
Nitinol Devices and Components, Inc., HydroFinity Hydrophilic Guidewire - May be Damaged during Use and May Lead to Injury 06/25/14
ConvaTec, Inc., Flexi-Seal CONTROL Fecal Management System Kit - Not Cleared for Marketing 06/20/14
Smiths Medical - Portex Low Dead Space Connector with Sideport, 3.5mm 06/12/14
Fresenius NaturaLyte Liquid Bicarbonate Concentrate (Part Number: 08-4000-LB) - Bacterial Contamination 05/28/14
Fisher and Paykel Healthcare, Ltd., Infant Nasal CPAP Prongs - May Detach from Nasal Tubing and Interrupt Therapy 05/23/14
Maquet Datascope Corporation, Intra-Aortic Balloon Pumps, System 98/98XT, CS100/CS100i, and CS300 - Potential Failure of Fan Assembly May Cause Pumps to Shut Down Without Any Alarm 05/22/14
Baxter Corporation Englewood, ABACUS Total Parenteral Nutrition Calculation Software, Versions 3.1, 3.0, 2.1, and 2.0 - Software Errors May Cause Toxic or Overdose Symptoms 05/22/14
CareFusion 303, Inc., Alaris Pump Module (Model 8100), Version 9.1.18 - Software May Not Properly Delay an Infusion with "Delay Until" Option or "Multidose" Feature 05/20/14
Alere INRatio2 PT/INR Professional Test Strips - Results Disagree with the Confirmed PT/INR Reference Test Results Performed by Central Laboratory 05/15/14
Hospira Inc., GemStar Docking Station (List Number 13075) – Potential for Error or Failure to Power Up 05/09/14
Hospira Inc., Abbott Acclaim Infusion Pumps and Hospira Acclaim Encore Infusion Pumps - Broken Door Assemblies May Result in Over-Infusion or Delay of Therapy 05/02/14
Baxter Healthcare Corporation, Sigma Spectrum Infusion Pumps with Master Drug Library Model No. 35700BAX and 35700ABB - System Error May Interrupt or Delay Therapy 05/01/14
HeartWare, Inc., Heartware Ventricular Assist System - Locking Mechanism of Pump Driveline Connector May Fail to Engage 04/29/14
Covidien, Pipeline Embolization Device and Alligator Retrieval Device - (Certain Catalog / Lot Numbers) - Coating on Delivery Wire Could Delaminate and Detach 04/21/14
Spacelabs Healthcare Ltd., ARKON Anesthesia Delivery System with Version 2.0 Software - Software Defect May Cause System to Stop Working 04/16/14
Abbott Diabetes Care, Inc. FreeStyle and FreeStyle Flash Blood Glucose Meters including the FreeStyle Blood Glucose Meter built into the OmniPod Personal Diabetes Manager (PDM) - Erroneously Low Blood Glucose Results 04/11/14
Dräger Medical Inc., Evita V500 and Babylog VN500 Ventilators with Optional PS500 Power Supply Units - Battery Depletion 04/03/14
Thoratec Corporation, HeartMate II LVAS Pocket System Controller – Insufficient Labeling and Training for Patients Switched from the EPC Controller 04/01/14
McKesson Technologies, McKesson Anesthesia Care – Patient Case Data May Not Match Patient Data 03/14/14
Merit Medical Systems, Custom Procedural Trays/Kits Containing 1% Lidocaine HCl Injection, USP, 10mg/mL - Particulates Found in Hospira supplied 1% Lidocaine HCl 03/13/14
Greatbatch Medical, Offset Cup Impactor - Inadequate Sterilization 03/12/14
Philips Respironics, Trilogy Ventilator, Models 100, 200, and 202 - Failure to Deliver Mechanical Breaths 03/07/14
GE Healthcare, Giraffe Warmer with Resuscitation System, Panda Warmer with Resuscitation System, Giraffe Stand-Alone Infant Resuscitation System, Resuscitation System Upgrade Kits, Panda Freestanding with Resuscitation System – Issue – Oxygen and Air inlet Fittings Were Reversed During Assembly 02/28/14
Medline Industries – ACME Monaco Guidewire .035x150 3MMJ TCFC, Item 88241 02/25/14
Teleflex Medical, ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port (with and without Preloaded Stylet) - Potential Kinking During Patient Use 02/24/14
Codman Neuro, TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System - Incorrect Instructions for Use 01/30/14
Tandem Diabetes Care, t:slim Insulin Cartridges (Specific Lots) - Potential for Cartridge Leak 01/10/14
Covidien, Puritan Bennett 840 Series Ventilator - Software Problem 01/09/14
Abbott Diabetes Care, FreeStyle and FreeStyle Lite Blood Glucose Test Strips - Erroneously Low Blood Glucose Results 01/06/14
GE Healthcare, LLC - Multi Absorber Original, Disposable - Model M1173310 01/06/14
Nephros Filtration Products (labeling promoting medical claims) 01/06/14
Nephros Water Filtration Products (exposure to bacteria or virus) 01/06/14

Page Last Updated: 03/05/2015 

Regulatory Updates

PERTINENT UPDATES

This section is courtesy of the Center for Health Tourism Strategy, the research and educational division of the Mercury Advisory Group Medical Tourism Consulting Practice.  As strategists in the health tourism industry, Mercury Advisory Group experts monitor regulatory updates to create innovative solutions in health delivery.  These are some of the updates they monitor with relevance to Mercury Health Travel clients and team members.

Self-funded Employer Program Issues

ERISA and the ACA

EBSA / USDOL Technical Release No. 2013-03
Application of Market Reform and other Provisions of the Affordable Care Act to HRAs, Health FSAs, and Certain other Employer Healthcare Arrangements

IRS FAQs on Employer Health Care Arrangements

IRS Notice 2015-07 – Guidance on the Application of Code §4980D to Certain Types of Health Coverage Reimbursement Arrangements

IRS Notice 2015-87 – Further Guidance on the Application of the Group Health Plan Market Reform Provisions of the Affordable Care Act to Employer-Provided Health Coverage and on Certain Other Affordable Care Act Provisions

Notice to Employees of Coverage Options Notices for employees when employers do or don't offer health coverage to some or all employees

Can an employer be fined for failing to provide employees with notice about the Affordable Care Act's new Health Insurance Marketplace?

MEWAs

EBSA Public Disclosure System Form M-1 Search   MEWA registration Due Diligence database

Expatriate Health
Workplace Wellness Programs

"Approximately half of U.S. employers with 50 or more employees offer wellness promotion initiatives. Larger employers are more likely to offer programs than smaller employers and larger employers offer a greater variety of options.  Seventy-five percent of employees in organizations with 50 or more employees work for employers offering wellness programs. Programs often include a combination of wellness screening activities to identify health risks and interventions to reduce risks and promote healthy lifestyles.  Wellness benefits can be offered by employers directly to all employees or through group health plans to plan members.  According to the survey, less than half of employees (46 percent) in those organizations with a wellness program undergo clinical screening and/or complete a Health Risk Assessment (HRA), and fewer participate in interventions (ranging from 7 to 21 percent). "

"Wellness programs can also provide direct access to care through on-site vaccination activities or health or occupational clinics.  Of those employers offering a wellness program, 76 percent offered on-site vaccinations.  Over 40 percent of employers, regardless of whether they offer a wellness program, reported having an Employee Assistance Program (EAP), which provides access to counseling and assistance for personal issues, and over 24 percent an occupational health service. About five percent of employers nationally maintain an on-site clinic. "

RAND Corporation focus group participants indicate that poor accessibility of wellness activities due to rigid work schedules and wait times limit access to wellness benefits.

REPORT TO CONGRESS ON WORKPLACE WELLNESS - 05/01/2013  [Rand Health]

Affordable Care Act
Annual Report to Congress on Self-Insured Group Health Plans

Annual Report to Congress on Self-Insured Group Health Plans - 2016

The Annual Report to Congress on Self-Insured Group Health Plans (March 2016), together with its Appendices, provides the most detailed statistics currently available on self-insured group health plans filing a Form 5500 and on the sponsors of such plans that issue publicly-traded equity or debt.

Employer Self-Insurance Decisions and the Implications of the Affordable Care Act (ACA) (180 PDF pages)

Large Group Health Plans Study (26 PDF pages)

Denied Claims Issues

Both self-insured and fully-insured plans are subject to ERISA requirements for internal claims appeals, with fully-insured plans also subject to any state appeal requirements.  Under the Affordable Care Act, both plan funding types are subject to new standards for internal appeals, increasing consumer protections.

ERISA does not require any particular type of external review or independent medical review to be available to consumers who experience adverse claims decisions, and ERISA preempts states from requiring external review options for consumers in self-insured plans.  But the story does not end there with a flat "no".  Consumers who feel their claims were wrongfully denied by a self-funded health benefit plan are able to appeal to the Internal Revenue Service for a review of fiduciary decision making and potential confilct of interest.

For fully-insured plans, states may impose external review requirements, and all but six have done so in varying degrees.  The implementation of the Affordable Care Act requires that an external review be available to consumers in all states for fully-insured and self-insured plans. This requirement applies to all non-grandfathered plans, irrespective of funding status.

The Affordable Care Act narrows the gap that had emerged in recent decades between the external review rights of consumers in self-insured and fully-insured plans.  As grandfathered status becomes less common over time, the review processes will be more similar.  The remaining differences will stem from any differences between state programs that apply to fully-insured plans and the federal programs that cover the self-insured.

A potential conflict of interest arises in health insurance claims adjudication because the same insurance company that decides which claims to pay is also financially responsible for making the payments.  Similarly, there may be conflicts of interest in the administration of self-insured plans.  To assess the extent to which conflicts of interest operate differently in self-insured and fully-insured plans, RAND researchers held discussions with stakeholders including consumer groups, self-insured companies, third party administrators (TPAs), stop loss insurers, and experts on self-insurance.  Among the stakeholders interviewed, there was no perception of a greater conflict of interest in claims adjudication among self-insured than among fully-insured plans.  Insurance companies reported no difference in their rules for initial determinations of claims from fully-insured plans versus claims processed through an Administrative Services Only (ASO) contract handling self-insured plans.  Employers that changed coverage between self-insured and fully-insured similarly reported no systematic differences in the handling of claims.  While the prospect of lower benefit payments might appear to result in a greater incentive to deny claims for self-insured plans than fully-insured plans, because the financial benefit accrues directly to the employer, stakeholders noted that the financial incentives to deny medical claims might be smaller for self-insured plans for two reasons.  First, self-insured employers are generally willing to invest in medical spending because of their financial stake in the health and well-being of their employees and in employee satisfaction.  Second, although the self-insured plan sponsor often is the ultimate decision maker, industry experts indicate that employers rarely dispute claims that a TPA has approved. Further, in accordance with an NAIC model act, contracts with TPAs rarely (if ever) tie payment to any metric concerning claims denials.