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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

CMS Publishes Updated PQRI Documents

Physician Quality Reporting Initiative (PQRI)


January 3, 2008 - CMS publishes updated PQRI documents

The Centers for Medicare and Medicaid Services (CMS) has published updated PQRI documents:
  • 2008 PQRI Coding for Quality Handbook – provides coding and reporting principles and describes successful reporting for each measure. 
  • 2008 Measure Specifications Release Notes – describe recent changes to measure specifications due to recent technical corrections posted in November on the CMS PQRI Web site.
  • PQRI Data Collection Worksheets were developed for each 2008 PQRI measure, through a partnership with the American Medical Association. (These worksheets provide a step-by-step description on how to document and code each PQRI measure.)
Funding will continue for the 2008 PQRI, which will contain three measures specific to anesthesiology: #30, #75 and #76. 

January 2, 2008 - New links for 2008 PQRI

The 2008 Physician Quality Reporting Initiative (PQRI) program began on January 1, 2008. This program, initially launched by the Centers for Medicare and Medicaid Services (CMS) in July 2007, encourages quality improvement through the use of clinical performance measures on a variety of clinical conditions.

Please use the following links for information about the measures:
  • 2008 measures: http://www.ama-assn.org/ama/pub/category/17493.html
  • Participation tools: www.ama-assn.org/go/toolsMedicarePQRI
  • Technical specifications and release notes: http://www.cms.hhs.gov/PQR

November 8, 2007 - PQRI Participation and Coding Tips

The Centers for Medicare & Medicaid Services has developed a Tip Sheet to assist eligible professionals participating in PQRI with reporting accuracy. Successful participation in PQRI is dependent on accurate submission of information provided on Medicare claims. This new resource provides helpful tips on the PQRI reporting process and is available on the PQRI web page at: http://www.cms.hhs.gov/PQRI/Downloads/2007PQRITipSheet.pdf.


Other PQRI Resources

New information is continually added to the most reliable source of information about PQRI, the CMS website: http://www.cms.hhs.gov/PQRI. Here you will find new and revised Frequently Asked Questions (FAQ), updates on issues related to both the 2007 and 2008 PQRI, new educational products, and access to the latest information you need to successfully participate in PQRI. Many of the FAQs have been recently updated, so be sure to check the website if you have any questions.

Two of the newest FAQs are:

8691 – Question: Where do I place the Physician Quality Reporting Initiative (PQRI) quality-data codes on the CMS-1500 claim form?

Answer: The 2007 PQRI quality-data codes are HCPCS codes and reporting requirements for these codes follow current rules for reporting other HCPCS codes (e.g. CPT Category I codes). For additional information, see FAQ #8255.

8687 – Question: Are Medicare patients who are covered under Railroad Retirement Benefits and Postal Worker benefits included in the Physician Quality Reporting Initiative (PQRI)?

Answer: Yes.