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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: CMS directs carriers to hold claims through June 17 while Congress debates SGR options

Monday, June 14, 2010

Since Congress has failed to pass legislation to avert the 21 percent Medicare payment cut, CMS has directed carriers to hold claims through Thursday, June 17. The hold only affects claims with dates of service June 1, 2010, and later.

The SGR-related 21 percent cut took effect June 1, but CMS delayed processing claims through June 14. Today the agency announced that it will further delay processing through June 17.

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.

Notification from CMS to Capitol Hill:

U.S. House and Senate Notification
Monday, June 14, 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 (0%) update to the 2010 Medicare Physician Fee Schedule (MPFS) through May 31, 2010. At this time, Congress is debating the elimination of the negative update that took effect June 1, 2010. The Centers for Medicare & Medicaid Services (CMS) is hopeful that Congressional action will be taken within the next several days to avert the negative update.

To avoid disruption in the delivery of health care services to beneficiaries and payment of claims for physicians, non-physician practitioners, and other providers paid under the MPFS, CMS had instructed its contractors on May 27th to hold claims for services paid under the MPFS for the first 10 business days of June (i.e., through June 14, 2010). This hold only affects MPFS claims with dates of service of June 1, 2010, and later.

Given the possibility of Congressional action in the very near future, CMS is now directing its contractors to continue holding June 1 and later claims through Thursday, June 17, lifting the hold on Friday, June 18.

This action will facilitate accurate claims processing at the outset and minimize the need for claims reprocessing if Congressional action changes the negative update. It also should minimize the provider and beneficiary burdens and costs associated with reprocessing claims.

We understand that the delayed processing of Medicare claims may present cash flow problems for some Medicare providers. However, we expect that the delay, if any, beyond the normal processing period will be only a few days. Be on the alert for more information regarding the 2010 Medicare Physician Fee Schedule Update.

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