SHEA expertise is routinely sought by regulatory and legislative entities. This section showcases public comments and policy communications.

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SHEA submitted comments to FDA on its Guidance for industry regarding enforcement policy for use of FMT to treat Clostridium difficile infection not responsive to standard therapies.

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SHEA and IDSA submitted a joint letter to CMS on March 4 advancing Antimicrobial Stewardship as a Condition of Participation.

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On February 26, SHEA signed on to support the Antibiotic Development to Advance Patient Treatment (ADAPT) Act.

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On August 28, SHEA and the APIC submitted joint comments to CMS on proposed updates to the OPPS and ASC Payment System for CY 2014.

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SHEA is one of 20 organizations urging Congress to enact legislation in support of IDSA’s ‘Support Limited Population Antibacterial Drug (LPAD)’ initiative. The goal of LPAD is to create a new regulatory pathway for antibiotics (similar to that available for Orphan Drugs) that target special or limited patient populations—namely those suffering from serious or life-threatening infections with few or no satisfactory treatment options. The new pathway will encourage the development of antibiotics that address the greatest unmet needs (mainly caused by resistance) and get them to patients faster. SHEA signed onto this letter encouraging introduction of LPAD legislation that was sent to Senators Michael Bennet (D-CO) and Orrin Hatch (R-UT) in the U.S. Senate and Representatives Philip Gingrey (R-GA) and Gene Green (D-TX) in the U.S. House on July 31, 2013.

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On June 25, 2013, SHEA submitted comments to CMS on the Hospital Inpatient Prospective Payment System (IPPS) proposed rule for FY 2014.

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SHEA joined with IDSA in a June 6, 2013 letter thanking Representative Jim Matheson (D-UT) for introducing a revised “Strategies to Address Antimicrobial Resistance (STAAR) Act”. The STAAR act is intended to strengthen the federal response to antimicrobial resistance by appointing an office and director of the existing Interagency Task Force on Antimicrobial Resistance (ITFAR) to better facilitate coordination and ensure success; establishing a Public Health Advisory Board comprised of non-government experts to advise the ITFAR on an on-going basis; and creating a strategic research plan drafted by a blue-ribbon panel of experts, among other things.

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SHEA and APIC, along with two dozen partner organizations, sent correspondence to leaders of the House and Senate Appropriations Committees on May 6 requesting their support of $31.5 million for the CDC’s NHSN and the Prevention Epicenters Program in the FY 2014 Labor HHS Appropriations Bills.

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SHEA has joined with IDSA supporting inclusion of its proposed new antibacterial approval pathway within the FDA Prescription Drug User Fee Act (PDUFA) reauthorization legislation. In an April sent to the House Energy and Commerce Committee and Senate Education, Labor and Pensions Committee leaders, SHEA joins IDSA and other endorsing organizations to make the case that establishment of the Limited Population Antibacterial Drug (LPAD) approval mechanism will complement and significantly strengthen existing antibiotic provisions found in the House and Senate draft PDUFA bills.

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On August 30, 2012, SHEA and APIC submitted joint comments to CMS on the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) quality reporting programs proposed rule for CY 2013.

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On August 22, 2012, SHEA submitted comments on the draft Phase 3 Long-Term Care Chapter of the 5-year National Action Plan to Prevent Healthcare-Associated Infections: Roadmap to Elimination (HAI Action Plan) developed by the U.S. Department of Health and Human Services (HHS).

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On June 25, 2012, SHEA and APIC submitted joint comments to CMS on the Hospital Inpatient Prospective Payment System (IPPS) proposed rule for FY 2013.

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SHEA and APIC submitted joint comments to HHS on June 25, 2012, regarding proposed revisions to Tier 2 of the National Action Plan to Prevent Healthcare Associated Infections including sections on Ambulatory Surgical Centers (ASCs), End-stage Renal Disease (ESRD) Facilities, and Influenza Vaccination of Healthcare Personnel.

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SHEA joined IDSA and other partner organizations in a letter to congressional appropriators in support of an appropriation for the Biomedical Advanced Research and Development Authority (BARDA) of at least $547 million for FY 2013, the level requested by the Administration.

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SHEA is joining with the Advancing Patient Safety Coalition to urge adoption by Congress of legislation requiring release of a proposed rule by the Food and Drug Administration (FDA) implementing a national unique device identification system.

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SHEA submitted a response to HHS’ proposed rules on certification criteria for EHR technology related to HAI data. SHEA recommends that Meaningful Use recognize hospital reporting of HAI data to public health entities via CDC’s NHSN as a core requirement.

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SHEA, CSTE, IDSA and Premier joined APIC in sending letter to Chairs and Ranking Members of Congressional Appropriations Subcommittees on Health in support of President Obama’s FY 2013 Budget Request of $27.5 million for CDC’s NHSN.

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On March 15, 2012, SHEA submitted comments to the Patient-Centered Outcomes Research Institute (PCORI) on its National Priorities and Research Draft Agenda.
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SHEA joined IDSA and a coalition of 50 medical and health groups on February 22, 2012 urging Congressional leadership to boost development of new antibiotics

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SHEA joined IDSA and PIDS on January 13, 2012, in submitting comments on NVAC’s draft recommendations for healthcare personnel influenza vaccination
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NVAC Healthcare Personnel Influenza Vaccination Subgroup’s December 2012 draft recommendations for healthcare personnel influenza vaccination
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