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December 18, 2014

0.9 Percent Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container by Baxter: Recall - Particulate Matter


FDA MedWatch Recall - Particulate Matter

November 21, 2014

FDA MedWatch - Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur


FDA MedWatch Respironics California Esprit V1000 and V200 Ventilators Class I Recall

November 21, 2014

FDA MedWatch - Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled


Highly Concentrated Potassium Chloride Injection 10 mEq per 100 mL by Baxter Recall Mislabeled



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CMS Issues Final CoPs and Medicare Regulatory Reform Rules; Notes ASA Objections

Thursday, May 10, 2012

ASA is currently in the process of reviewing 289 pages of two final rules released today by CMS regarding the rule updating the Medicare Conditions of Participation (CoPs) for hospitals and critical access hospitals (CAHs) as well as the Medicare Regulatory Reform rule, addressing Medicare regulatory requirements more broadly.  Preliminarily, these final rules indicate a dramatic and very troubling change in direction.  While the introductory language in the rule for the CoPs states that "the purpose[s] of these conditions are to protect patient health and safety and to ensure that quality care is furnished to all patients in Medicare-participating hospitals," the reality appears far different.  

Conveniently coming on the heels of "National Nursing Week," the CMS press release on the final rules regarding the Medicare Hospital CoPs includes provisions such as:

    "Requiring that all eligible candidates, including APRNs and PAs, must be reviewed by the medical staff
    for potential appointment to the hospital medical staff and then allowing for the granting of all
    the privileges, rights, and responsibilities accorded to appointed medical staff members."

A cursory review indicates that CMS did not make the substantive changes advocated by ASA members from their proposed rule last fall.  Most notably, CMS maintained the proposal “that would allow physicians and non-physician providers to obtain hospital privileges without becoming a member of the medical staff.”  In other words, CMS has declared all eligible candidates, including APRNs and PAs, must be reviewed by the medical staff for potential appointment to the hospital medical staff.  This undermines the axiom that the practice of medicine does not include non-physicians.   

Late last fall, the ASA Grassroots Network mounted a campaign to convey key messages to CMS regarding the proposed rule.  CMS noted that "approximately 1,100 of the [1729] comments were part of a write-in campaign from anesthesiologists that supported what they described as CMS' upholding of physician supervision requirements, but objected to what the letters described as an effort to replace physicians with nurses."  Thank you to the 1,100 ASA Grassroots Network members who participated in our advocacy outreach. 

ASA is closely analyzing the final rules and will provide additional details as soon as possible.

The rules are available here:

Medicare Hospital CoPs Final Rule

Regulatory Reform Final Rule


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