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FDA MEDWATCH ALERTS

November 07, 2014

FDA MedWatch - Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall - Software Issue May Stop Ventilator

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FDA MedWatch Nellcor Puritan Bennett 980 Ventilator System Class I Recall

October 25, 2014

FDA MedWatch - Intravia Containers by Baxter: Recall - Particulate Matter

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FDA MedWatch Intravia Containers by Baxter Recall

October 20, 2014

Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall - Particulate Matter

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FDA Medwatch Alert 10-20-14

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ASA Joins Coalition Partners Opposing Proposed Expansion of CMS Authority over Prescribing Practices

Friday, March 14, 2014

In a formal comment letter to the Centers for Medicare & Medicaid Services (CMS), ASA joined Pain Care Coalition (PCC) partners - the American Academy of Pain Medicine and the American Pain Society - in strongly opposing proposed changes to Medicare prescription drug fraud provisions that would represent a major expansion of CMS authority over the practice of medicine.  Part of a larger proposed rule revising Medicare Part D regulations, the proposed changes allow CMS to revoke a physician’s or eligible professional’s Medicare enrollment if:

  • CMS determines that he or she has a pattern or practice of prescribing Part D drugs that is abusive and represents a threat to the health and safety of Medicare beneficiaries or otherwise fails to meet Medicare requirements; or  
  • His or her Drug Enforcement Administration Certificate of Registration is suspended or revoked; or
  • The applicable licensing or administrative body for any state in which a physician or eligible professional practices has suspended or revoked the physician or eligible professional’s ability to prescribe drugs.

PCC contended that “these changes would substitute the judgment of CMS and presumably its claims processing contractors for that of state licensure authorities and other professional oversight bodies traditionally responsible for regulating professional practice, including prescribing practices.”  PCC further argued that CMS proposed these changes:

“(1) without demonstrating that CMS and its contractors have the expertise to make appropriate judgments about a clinician’s prescribing practices, (2) without clear and evidence-based criteria for making those judgments, and (3) without reasonable due process protections for clinicians whose prescribing practices come under scrutiny.”

PCC reasoned that the proposal, if implemented, “could have a pronounced negative effect on clinician behavior, with a corresponding restriction on the access of Medicare patients to necessary, and covered, items and services.”

ASA will continue working with its Coalition partners to ensure that physician anesthesiologists are able to provide quality pain care to the millions of Medicare beneficiaries afflicted with pain. 

Read the comment letter.

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