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FDA MEDWATCH ALERTS

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January 12, 2012

Respironics, Inc. Trilogy 100 Ventilators: Class I Recall - Device May Stop Delivering Therapy to Patient

Summary:

FDA notified health care professionals of the Class 1 recall of this product due to a manufacturing issue can stop delivering therapy to the patient. Part of the blower that circulates air and other gases through the ventilator may move out of position and cause the device to alarm.  Failure to respond could result in the potential for harm or death of a ventilator-dependent patient.

January 12, 2012

Bedford Laboratories Vecuronium Bromide And Polymyxin B For Injection USP For Injection: Recall - Glass Particles

Summary:

Bedford Laboratories issued guidance on the nationwide voluntary product recalls originally issued on August 2, 2011. The recalls were initiated after the discovery of a visible glass particle in a limited number of vials within the lots listed.

January 09, 2012

Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory - Potential Safety Risk

Summary:

FDA is advising health care professionals and patients of a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site.

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ASA FEATURED PRODUCT

Self-Education and Evaluation (SEE) Program

SKU: 30701-12CE

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Single Copies, Member Price: $300

Update: Congress Fails to Act - CMS to Begin to Process Claims with 21-percent Cut

Friday, June 11, 2010

Presently, Congress has failed to pass legislation to avert the implementation of the current 21 percent cut to Medicare physician payments. As a result, payment cuts will occur.

The scheduled 21 percent Medicare payment cut took effect June 1; however, CMS was directed to hold the processing of claims through Monday, June 14. The "hold" directive is expected to expire on Tuesday, June 15. Accordingly, the processing of claims with the cut will commence.

Members of the House and Senate are continuing to debate possible options for addressing the SGR. Many issues remain unresolved, including the length of the next “patch,” whether the change will be "offset" by spending reductions or tax increases, and the impact of the "patch" on future updates. Alarmingly, some proposals could result in a cut of 35 percent in future years.

ASA has consistently lobbied for a full repeal of the SGR. At this point, however, that option appears to be off the table. Instead, Congress is more likely to consider another short term fix, although even a temporary reprieve is uncertain at this point.

ASA members are urged to check www.ASAhq.org often for updates. We will provide additional information as it becomes available.

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