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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

HHS Issues Final ICD-10 Code Sets and Updated Electronic Transaction Standards Rule

On Jan 16, 2009, The U.S. Department of Health and Human Services (HHS) released two final rules related to electronic health reporting.  The first final rule replaces the ICD-9-CM code set with the expanded ICD-10-CM and ICD-10-PCS.  The second final rule adopts an update, Version 5010, to the health care transaction standards established under HIPAA. 

ICD-10

Relevant to physicians, the final rule adopts the ICD-10-CM for diagnosis coding as a replacement for ICD-9-CM Volumes 1 and 2.  This change will provide the opportunity to report patient diagnoses in greater detail, and will also allow for the expansion of the code set as needed in the future.  The new rule does not affect the reporting of professional services, for which physicians and other health care providers will continue using CPT®.   

The rule sets the implementation date at October 2013.  In the time leading up to implementation, ASA will provide its members with information they w ill need to successfully transition to ICD-10-CM.

ICD-10 Final rule

ASA comment letter to CMS regarding ICD-10

5010

Version 5010 includes updated standards for claims, remittance advice, eligibility inquiries, referral authorization, and other administrative transactions.  Version 5010 also accommodates the use of the ICD-10 code sets, which are not supported by the current X12 standard, Version 4010/4010A.

The proposed implementation date for updated Version 5010 has been pushed back to January 2012.  HHS had previously proposed an implementation date of April 2010, but ASA and many other stakeholders advocated for a later date to ensure a smooth transition to the new system.

Also of interest to ASA, the proposed rule suggested that anesthesia time be reported only in minutes instead of providing the option for either minutes or units as is available under the current standard.  ASA commented on this proposal, noting that this specific change would not increase efficiency or result in cost savings.  HHS recognized our concerns, and ASA will work with the X12 Committee toward modification of this proposal before implementation.

5010 Final rule

ASA comment letter to CMS regarding Version 5010