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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: Scheduled 21 percent Medicare Physician Payment Cut to be Implemented

Friday, February 26, 2010

As a result of U.S. House and Senate negotiators failing to reach consensus, the pending 21 percent Medicare physician payment cut will be implemented on March 1st.   The implementation is expected to be temporary.

Over the last few days, Senate negotiators attempted to advance a 30-day “patch” as part of legislation to extend a series of expiring tax provisions.  This “extenders” package was blocked from consideration by Senator Jim Bunning (R-KY).  Senator Bunning objected to the package for budgetary reasons.

The House of Representatives successfully passed a 30-day “patch” as part of its “extenders” package, H.R. 4691, the Temporary Extension Act of 2010, the evening of February 25th.

Discussions regarding advancing legislation to avoid the 21 percent payment cut are expected to continue over the weekend and into early next week.  Senate Majority Leader Harry Reid has crafted an “extenders” package that includes a 7-month physician payment “patch.”  It is expected he will attempt to advance the proposal Tuesday, March 2nd.

The American Medical Association has informed medical specialty organizations that the Centers for Medicare and Medicaid Services (CMS) intends to notify their contractors to hold Medicare physician claims for 10 additional business days, effective Monday, March 1st. 

ASA continues to push for a full repeal of the current SGR formula and the implementation of a new Medicare physician payment update mechanism that accurately reflects the increasing annual costs of providing services to Medicare beneficiaries.

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