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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

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FDA MedWatch Recall - Particulate Matter

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

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Additional Analysis of the CMS Final Rule on Medicare Conditions of Participation: Anesthesia Physician Supervision Patient Safety Standard Remains Unchanged

Tuesday, May 15, 2012

Late last week, the Centers for Medicare & Medicaid Services (CMS) released the final rule on revisions to the Medicare Hospital Conditions of Participation (CoPs). Despite the urgings of commenters from some organizations and their members, the Medicare physician supervision patient safety standard remains in place.  ASA and member anesthesiologists aggressively lobbied in support of the interest of patients and in support of maintaining a strong safety standard. CMS noted that "approximately 1,100 of the [1,729] comments [on the rule]…" were from anesthesiologists regarding maintaining the physician supervision standard.

The revised CoPs were one part of two proposed rules issued by the U.S. Department of Health and Human Services.  The two final rules "Regulatory Revision to Promote Program Efficiency, Transparency and Burden Reduction” and “Reform of Hospital and Critical Access Hospital (CAH) Conditions of Participation (CoP)" were the result of an Obama Administration initiative aimed at reviewing and reforming existing federal regulations. A January 18, 2011 Presidential Executive Order directed federal agencies, including the U.S. Department of Health and Human Services and CMS, to analyze rules that may be "outmoded, ineffective, insufficient or excessively burdensome, and to modify, streamline, expand or repeal them in accordance with what has been learned."  In response to the order, CMS proposed changes to existing rules governing ambulatory surgical centers, hospital medical staff, CAH services and other areas of patient care.  In the hospital and CAH rule, CMS specifically proposed changes to the existing CoP, a broad set of rules for hospital and CAH operations of which the physician supervision standard is a part.

As part of the process, the Department of Health and Human Services reported that they were asked to eliminate the supervision requirement.  Commenters were referenced as suggesting that requiring a physician to supervise care was unnecessary because "the work can be done just as easily by Certified Registered Nurse Anesthetists (CRNAs)…"  A commenter is also reported to have stated that the supervision standard requires "unnecessary supervision by an operating practitioner or an anesthesiologist upping costs by increasing staff members but not safety" and to have urged "that all regulations and interpretive guidelines issued by CMS be reviewed with the intent of removing restrictions concerning anesthesia services provided by nurse anesthetists."

ASA, joined by a number of lawmakers, urged CMS to maintain the supervision standard.

ASA believes physician supervision ensures patient access to the safest, cost-efficient anesthesia care. Accordingly, the Society remains strongly committed to maintaining the physician supervision standard on behalf of patients requiring anesthesia services.

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