2. APIC GC APIC GC Chapter Legislative Representative Overview March 18, 2016 Lisa Tomlinson, Vice President of Government Affairs and Practice Guidance Nancy Hailpern, Director, Regulatory Affairs Laura Evans, Legislative Affairs Representative

3. Objectives CLRs Provide updates on: –Federal Legislative Issues –Federal Regulatory issues –State Legislative Issues

4. APIC Overview

5. Strategic Goals Patient Safety: Demonstrate and support effective infection prevention and control as a key component of patient safety. Implementation Science: Promote and facilitate the development and implementation of scientific research to prevent infection. IP Competencies and Certification: Define, develop, strengthen, and sustain competencies of the IP across the career span and support board certification in infection prevention and control (CIC®) to obtain widespread adoption. Advocacy: Influence and facilitate legislative, accreditation, and regulatory agenda for infection prevention with consumers, policy makers, health care leaders, and personnel across the care continuum. Data Standardization: Promote and advocate for standardized, quality and comparable HAI data. Strategic Goals 2020 Vision: Healthcare without infection Mission: Create a safer world through prevention of infection

6. APIC Advocacy Team

7. APIC Government Affairs Team Staff Primary Role: background in government affairs and advocacy Public Policy Committee (PPC) Primary Role: clinical background with volunteer public policy experience Chapter Legislative Representatives (CLRs): APIC Staff Chapters (CLRS) Public Policy Committee clinical and chapter/local volunteer experience APIC Policy Influence APIC Advocacy Triangle This is me! (Cary)

8. 2016 Public Policy Committee Committee Chair D. Kirk Huslage RN, BSN, MSPH, CIC Committee Vice Chair Mary Alice Lavin RN, MJ, CIC Members Barbara Goss-Bottorff RN, MPH, MSN, CNS, CIC Rebecca Fitzpatrick DNP, RN, CIC Linda Johnson RN, MSN, CIC Patrick Kleinkort RN, BSN, MHA, CIC Rosie Lozano MPH, CIC C. Nancy O’Connor MBSA, BSN, RN, CIC Sarah Smathers MPH Senior Advisor Annemarie Flood RN, BSN, MPH, CIC

9. CLR Roles and Responsibilities

10. Legislation notification If a bill related to infection prevention has been introduced in a state represented by your chapter, you will receive an email that includes: Link to the bill Synopsis of the bill and how it relates to infection prevention Link to bill sponsor website Any relevant information on the bill and/or sponsor

11. What to do if you receive a legislative notification If you receive a legislative notification, you should: Read through the entire notification and the bill links. If you have any questions, email legislation@apic.org or call APIC staff legislation@apic.org Share this information with your chapter Your chapter should discuss if they support the legislation or have concerns. Please note that decisions regarding supporting or opposing legislation are made by APIC HQ in conjunction with the Public Policy Committee and the Board of Directors. Contact APIC staff to discuss chapter support/concerns and next steps (such as a support letter, or letter requesting changes to the legislation.

12. If you are aware of a bill but you never received a legislative notification about it, then contact APIC staff! Email staff or legislation@apic.org:legislation@apic.org Bill information, including bill text, news articles on the bill, or anything else that may be helpful to understanding the bill. Detail your concerns (or support) Remember: Do not take any action on your own without contacting APIC HQ first When representing your APIC chapter, you must support the APIC position What to do if you are aware of legislation that APIC hasn’t alerted you to

13. What to do if you have questions/concerns about legislation If you have questions/concerns about legislation: Contact APIC staff to discuss Discuss your concerns with your chapter members/leadership If you chapter has questions, relay those questions to APIC staff If you chapter has come to a consensus on the legislation, relay the information to APIC staff

14. your chapter’s lobby day interested in having a lobby day?: Determine the objective of the lobby day Find the best time to have the lobby day Engage chapter members to participate http://www.apic.org/Advocacy/advocacy- toolkit

15. Federal Regulations

16. Key federal legislative actions on HAIs Deficit Reduction Act Enacted ‒ HAC Policy to impact 2008 payment –Uses funding as incentive for quality improvement House Committee and GAO Issues Report on Need for HAI Coordination American Recovery and Reinvestment Act (ARRA) –Grants to States for HAI Coordinators and activities Omnibus Appropriations Act –States to develop HAI Plans (or lose block grant funds) National Action Plan to Prevent HAIs –Response to Congressional Hearing and GAO report –Plan to better coordinate federal HAI activities Affordable Care Act (Obamacare) –Required HAI reporting as part of healthcare quality improvement programs 2008 2009 2010 2006

17. CMS hospital quality improvement programs Hospital-Acquired Conditions (HAC)/ Present on Admission (POA) indicators Hospital Inpatient Quality Reporting (IQR) Program Hospital Value-Based Purchasing (VBP) Program HAC Reduction Program

18. CMS HAI reporting requirements for acute care hospitals MeasureReporting to NHSN begin (CY) IQR payment (FY)VBP payment (FY)HAC Reduction (FY) CLABSI – ICU201120132015 CAUTI – ICU2012201420162015 SSI – Colo, Ab. Hyst.201220142016 MRSA Bacteremia – FacWide LabID 201320152017 C.Diff Infection – FacWide LabID 201320152017 HCP Influenza Vaccination 20132015 CLABSI – Med/Surg/MedSurg 201520172019 Baseline period 1/1/15 – 12/31/15 Performance period 1/1/17 – 12/31/17 2018 CAUTI – Med/Surg/MedSurg 201520172019 Baseline period 1/1/15 – 12/31/15 Performance period 1/1/17 – 12/31/17 2018

19. VBP FY 2016 domain weights Used with permission of Premier, Inc.

20. VBP FY 2017 domain weights Used with permission of Premier, Inc.

21. VBP FY 2018 domain weights Used with permission of Premier, Inc.

22. Domain 2: HAI Measures CLABSI – ICU (FY 2015 onward) CAUTI – ICU (FY 2015 onward) SSI Following colon surgery (FY 2016 onward) Following abdominal hysterectomy (FY 2016 onward) MRSA Bacteremia (FY 2017 onward) C.diff. (FY 2017 onward) CLABSI – non-ICU (FY 2018 onward) CAUTI – non-ICU (FY 2018 onward) Domain 2: HAI Measures CLABSI – ICU (FY 2015 onward) CAUTI – ICU (FY 2015 onward) SSI Following colon surgery (FY 2016 onward) Following abdominal hysterectomy (FY 2016 onward) MRSA Bacteremia (FY 2017 onward) C.diff. (FY 2017 onward) CLABSI – non-ICU (FY 2018 onward) CAUTI – non-ICU (FY 2018 onward) Domain 1: PSI-90 Composite PSI-3 PSI 6 PSI-7 (CVC-related BSI rate) PSI-8 (Postoperative hip fracture rate) PSI-12 PSI-13 (Postoperative sepsis rate) PSI-14 (Wound dehiscence rate) PSI-15 Domain 1: PSI-90 Composite PSI-3 PSI 6 PSI-7 (CVC-related BSI rate) PSI-8 (Postoperative hip fracture rate) PSI-12 PSI-13 (Postoperative sepsis rate) PSI-14 (Wound dehiscence rate) PSI-15 HAC Reduction Program measures

23. Quality programs outside of acute care PPS-Exempt Cancer Hospital Quality Reporting Program (PCHQRP) CLABSI (2012), CAUTI (2012), SSI -COLO, AB/HYST (2014), HCP flu vaccination (2016-17 flu season), MRSA (2016), C.diff (2016) Long-Term Care Hospital Quality Reporting Program (LTCQRP) CLABSI (2012), CAUTI (2012), HCP flu vacc. (2013), MRSA (2015), C.diff. (2015), VAE (2016) End-Stage Renal Disease (ESRD) Quality Incentive Program BSI in outpatient hemodialysis, HCP flu vaccination (2015-16 flu season) Hospital Outpatient Quality Reporting Program HCP flu vaccination (2014-15 flu season) Ambulatory Surgical Center Quality Reporting Program (ASCQRP) HCP flu vaccination (2014-15 flu season) Inpatient Rehabilitation Facility (IRF) Quality Reporting Program CAUTI (2012), HCP flu vaccination (2014), MRSA (2015), C.diff (2015) Inpatient Psychiatric Facility (IPF) Quality Reporting Program HCP flu vaccination (2015-16 flu season)

24. Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014 –Established standardized post-acute care assessment tool across care settings –So far this has influenced: Proposed revisions to Conditions of Participation for home health, dialysis facilities, and long-term care facilities Proposed update to discharge planning requirements NQF care coordination measure updates AHRQ comparative effectiveness study on patient safety in nursing homes Probably more to come Influences on new regulations

25. HHS announcement in 2015 to increase rate of movement from Medicare payment based on fee-for- service to pay-for performance. –Goal: by 2018, 90% of Medicare payment based on value or quality of care. –Likely to see this reflected in annual Medicare payment system updates; hospital/CAH practices to promote innovation, flexibility and improved patient care Influences on new regulations

26. Federal agency FY 2017 budget request narratives –OSHA: FY 2017 funding to implement an infectious disease standard; regulatory plan to introduce proposed ID standard rule in 2016 –FDA: Priorities include: Compounded drug safety Medical device safety Antimicrobial use in animals Influences on new regulations

27. White House –National Action Plan for Combatting Antibiotic-Resistant Bacteria (2014) –National Action Plan for Combatting Multidrug-Resistant Tuberculosis (2015) Influences on new regulations

28. CDC –Focus: Evidence-based guidelines for infection prevention and control practice OSHA –Focus: Worker safety –Examples: Bloodborne Pathogens Standard, Respiratory Protection Standard FDA –Focus: Regulation of drugs; medical devices; human blood, tissue and cell products EPA –Focus: Regulation of disinfectants and sterilants; medical waste incinerators State and local health departments Other agencies impacting infection prevention and control programs

29. Federal Legislation

30. Federal Legislation under review by the APIC Public Policy Committee Federal legislation under review by the APIC Public Policy Committee: Preventing Superbugs and Protecting Patients Act: Would require manufacturers of reusable medical devices like duodenoscopes to submit proposed cleaning instructions and validation data to FDA before marketing the devices Status: APIC endorsed, currently pending in Senate Strategies to Address Antibiotic Resistance (STAAR) Act: Would expand programs to address antibiotic resistance Status: Under review by the APIC Public Policy Committee, currently pending in Senate Patient Safety Improvement Act of 2016: Would require report on HAIs and antibiotic resistance Status: Under review by the APIC Public Policy Committee, currently pending in Senate

31. Centers for Disease Control and Prevention (CDC) $21 million for NHSN and the Prevention Epicenters Program $30 million for Advanced Molecular Detection (AMD) and response to infectious diseases program $427.9 million Core Infectious Diseases, which would include funding for: − HAIs − Emerging Infections Program (EIP) − $200 million Antibiotic Resistance Solutions Initiative Agency for Healthcare Research and Quality (AHRQ) $34 million for HAI research National Institutes of Health (NIH) $4.7 billion for the National Institute of Allergy and Infectious Diseases’ (NIAID) antibacterial and related diagnostics efforts The President’s budget request for fiscal year 2017 federal programs

32. State Legislation

33. Pending state legislation ARIZONA We have no Infection Prevention related legislation pending

34. Looking ahead: NHSN State Competition The NHSN competition is back! The winner of the CLR engagement contest is Troy Cutler of the APIC 126 Pine Tree Chapter. Over 60% of Maine’s APIC members sent a letter to Congress supporting NHSN funding! APIC will soon restart the competition for fiscal year 2017. The state with the highest percentage of letters sent will win a prize! Alert your chapter today!

35. Lisa Tomlinson, MA, Vice President of Government Affairs and Practice Guidance ltomlinson@apic.org Overall government affairs and practice guidance strategy Nancy Hailpern, Director of Regulatory Affairs nhailpern@apic.org Federal regulatory issues HAI reporting at the federal level Laura Evans, Legislative Affairs Representative levans@apic.org Federal and state legislation Legislative maps Cary B Heath, APIC GC Chapter Legislative Representative cary.blankheath@bannerhealth.com Questions? When in doubt, e-mail: legislation@apic.org

36. What’s New in Public Policy? (as of March 2016) Olympus issues new reprocessing instructions for TJF-160 F/VF duodenoscopes Teva recalls Amikacin Sulfate Injection FDA releases environmental assessment for field trial of genetically engineered mosquitoes FDA issues donor screening guidance to protect against Zika transmission Sagent recalling Fluconazole Injection Olympus reaches settlement in criminal payment scheme GAO report identifies patient safety implementation challenges