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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 Proposes to Cut Values for Pain Services – Submit Comments by Aug. 31

Chicago — (August 24, 2009) 

Dear Colleagues:

We want to make you aware of an element in the Centers for Medicare and Medicaid Services (CMS) proposed rule for the 2010 Physician Fee Schedule which will affect your pain practice.

CMS is proposing to reduce the values for specific pain services, including spinal pumps and stimulators.  The RUC reviewed these codes in 2008, and CMS implemented reduced values for these services effective Jan. 1, 2009.  Now, CMS is proposing to reduce the values even further using a suspect methodology, widely-rejected by other groups including ASA, AMA and other pain societies.

Please take action against this harmful proposal by submitting a comment letter to CMS.  Comment letters must be received by August 31, 2009—just 10 days from today.  Please don’t delay in submitting your comments.

ASA will address this issue in its comment letter to CMS, but is important that the Agency hear from you—the physician—representing the patients who need these services.

  1. Go to this link
  2. Complete your personal information.  For “category,” make sure you scroll down to select “Physician.”
  3. Copy the sample letter provided at the end of this message.
  4. Paste the sample letter in the comment box on the CMS website.
  5. Click “Submit.”
  6. When you successfully submit comments, you will receive a confirmation code.  Please retain this information for your records as it will not be emailed to you.
  7. Tell your colleagues/partners/administrators/practice managers/students that we need their help, too.  Please encourage others to take this important action.
  8. Let ASA know that you’ve done your part! To report that your comments have been sent, please email Moriah Merkel in the ASA Washington Office at m.merkel@asawash.org

Please note:

  • CMS has changed the link and commenting procedure twice since the proposed rule was released.  If you have difficulty submitting comments, please contact Moriah Merkel (m.merkel@asawash.org) or Sarah Byun (s.byun@asawash.org) in the ASA Washington Office at 202-289-2222
  • There is a 2,000 character limit on comments.  Please keep this in mind if you choose to edit the sample message.
  • Instead of submitting comments electronically, you may choose to mail written comments to CMS.  Please use the following address, and be sure to allow sufficient time for mailed comments to be received by Aug. 31:

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1413-P
P.O. Box 8013
Baltimore, MD 21244-8013

Sincerely,

Roger A. Moore, M.D.
President

 

Comment Letter

RE: AMA RUC Review of Potentially Misvalued Codes – Site of Service Anomalies

I am writing to express my grave concerns about CMS’ proposal to further reduce the values of CPT codes associated with spinal pumps and stimulators, CMS-1413-P.  I strongly urge CMS to maintain the current values, which were recommended by the RUC in 2008 and implemented by CMS in 2009.  Further reduction in these values would:

  • Compromise access to pain care because the proposed values would not cover the cost of the resources required to provide the services
  • Skew the fee schedule as the methodology used to arrive at these reduced values completely ignores relativity
  • Limit the availability of pain services that have been established as safe and effective

Furthermore, the methodology CMS used to arrive at these values is so flawed that it results in negative values for some of the services to which it was applied.  CMS itself acknowledges this weakness when it suggests maintaining current values for those codes for which the methodology results in negative values.  It is essential that the Fee Schedule be based on methodologies that are statistically valid and can be consistently applied.  This is clearly not the case in this instance. 

I urge CMS to maintain the existing values for these codes for the 2010 Physician Fee Schedule.

THE AMERICAN SOCIETY OF ANESTHESIOLOGISTS

Anesthesiologists: Physicians providing the lifeline of modern medicine. Founded in 1905, the American Society of Anesthesiologists is an educational, research and scientific association with 46,000 members organized to raise and maintain the standards of the medical practice of anesthesiology and improve the care of the patient.

For more information on the field of anesthesiology, visit the American Society of Anesthesiologists Web site at www.asahq.org. For patient information, visit LifeLineToModernMedicine.com

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Contact:

Jennifer Gremmels
j.gremmels@asahq.org
847-268-9128