Rep. Cliff Sterns Requests More Information on Single Dose Vials Guideline

Representative Cliff Stearns (R-Fla.) has submitted a letter to HHS requesting information from CMS on its guideline regarding single dose vials.

Rep. Stearns' letter asks HHS Secretary Kathleen Sebelius to answer variety of questions on how current guidelines came into existence. The questions include:

• Did CMS or the Centers for Disease Control and Prevention perform any type of analysis estimating the effect these guidelines would have on patient access?
• What evidence suggests single dose vials are responsible for infections when applied with all infection control procedures? Please provide the data that was used.
• Did CMS comply with President Obama's Executive Order #13563, which specifically ensures regulations "must be based on the best available science, allow for public participation, and take into account benefits and costs, both quantitative and qualitative?"

The guideline took effect in January 2010 and is based on guidance from the CDC prohibiting multiple usages of drugs from a vial labeled for single use. ASCA staff is working to schedule a meeting with CDC staff to discuss this guideline and the effects it has on ASCs.

Click here to read the letter.

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