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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

... Read more »

Single Copies, Member Price: $300

CMS Directs Carriers to Process Claims with the 21 Percent Cut

Friday, June 18, 2010

Immediately following Senate passage of the 6-month “doc fix,” CMS released information informing lawmakers that carriers have been directed to process claims for services provided on June 1 and later with the 21 percent cut. CMS Indicated that once a payment fix is enacted into law, they are “prepared to act expeditiously to make the appropriate changes to Medicare claims processing systems.”

U.S. House and Senate Notification
Friday, June 18, 2010

To: Congressional Health Staff

Re: The 2010 Medicare Physician Fee Schedule

The Continuing Extension Act of 2010, enacted on April 15, 2010, extended the zero percent update to the 2010 Medicare Physician Fee Schedule (MPFS) through May 31, 2010.

On May 27, 2010, the Centers for Medicare & Medicaid Services (CMS) initially instructed contractors to hold claims for services paid under the MPFS for the first 10 business days of June. On June 14, CMS extended this hold for an additional three business days (i.e., through June 17, 2010). This hold only affected MPFS claims with dates of service of June 1, 2010 and later.

The CMS today directed contractors to lift the hold and begin processing June 1 and later MPFS claims under the law’s negative update requirement. Held claims will be released and processed on a flow basis, first-in/first-out.

Congress continues to debate the elimination of the negative update that took effect June 1, 2010. The CMS is hopeful that Congressional action will be taken to avert the negative update. We continue to monitor Congressional actions, and if Congress changes the negative update that is currently in effect, we are prepared to act expeditiously to make the appropriate changes to Medicare claims processing systems.

ASA Member, Norman A. Cohen, M.D., speaks about the SGR issue on Oregon Public Broadcasting (mp3 file)

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