Review of Proposed and Final Updates for FY 2018-2021 MBQIP Updates Review of Proposed and Final Updates for FY 2018-2021 For the next Medicare Rural Hospital Flexibility (Flex) Program three-year project period, Fiscal Years (FY) 2018-2021 (September 1, 2018 – August 31, 2022), the Federal Office of Rural Health Policy (FORHP) is proposing the following three additions to the Medicare Beneficiary Quality Improvement Project (MBQIP): Addition of an antibiotic stewardship program: This addition would fall under the Flex work plan Activity 1.01 and would allow critical access hospitals (CAHs) four years to fully implement an antibiotic stewardship program by the end of FY 2021 (September 1, 2021 - August 31, 2022) Addition of three Centers for Medicare and Medicaid Services (CMS) Hospital Compare Hospital Acquired Infections (HAI) measures (CAUTI, MRSA and CDI) as core measure requirements under the Patient Safety Domain Other HAI Measures, including CLABSI (Central Line Associated Blood Stream Infection) and SSI (Surgical Site Infection measures), will remain on the ‘additional’ MBQIP list. CAHs that provide services relevant to those measures should be encouraged to collect and submit data as appropriate Addition of ED-1 and ED-2 CMS Hospital Compare measures as core measure requirements under the Outpatient Safety Domain

But, first…. CONGRATULATIONS! Health Resources and Services Administration (HRSA) recognized ten states for outstanding quality performance of their Critical Access Hospitals (CAHs) in achieving the highest reporting rates and levels of improvement over the past year. Inpatient, outpatient, and HCAHPS data are from Q1-Q4 2015 The EDTC data are from Q1-Q4 2016. 25 inpatient measures (HF-2, IMM-2, OP-27/ IMM-3, PC-01, PN-6, SCIP-Card, SCIP-Inf-1, SCIP-Inf-2, SCIP-Inf-3, SCIP-Inf-9, SCIPVTE-2, STK-1, STK-2, STK-3, STK-4, STK-5, STK-6, STK-8, STK-10, VTE-1, VTE-2, VTE- 3, VTE-4, VTE-5, VTE-6); 14 outpatient measures (OP-2, OP-4, OP-22, OP-23, OP-29, OP-30, OP-1, OP-3b, OP-5, OP-18b, OP-20, OP-21, ED-1b, ED-2b); 11 HCAHPS measures 7 EDTC measures Note that MI has always been a leader, and this is another example of that.

Review of Current Required MBQIP Measures (current = through 9/1/2018)

Review of Current Required MBQIP Measures (current = through 9/1/2018) ED-1: Median Time from ED Arrival to ED Departure for Admitted ED Patients ED-2: Admit Decision Time to ED Departure Time for Admitted Patients OP-23: ED – Head CT or MRI Scan Results for Acute Ischemic Stroke or Hemorrhagic Stroke Patients who Received Head CT or MRI Scan Interpretation Within 45 Minutes of ED Arrival Surgery/Surgical Care OP-25: Safe Surgery Checklist Use PC-01 – Elective Delivery CLABSI: Central LineAssociated Bloodstream Infection CAUTI: Catheter-Associated Urinary Tract Infection C. diff: Clostridium difficile Infection MRSA: Methicillin-resistant Staphlococcus aureus

Proposed Measures Addition of Antibiotic Stewardship Program Addition of CAUTI, MRSA, and CDI Addition of ED-1 and ED-2 Earlier this year, I sent an email to the MICAH QN letting them know of this proposed rule, and FORHPs request to solicit feedback. Next few slides want to showcase the alignment between FORHPs proposed new measures and other national priorities.

Importance of Incorporating Antibiotic Stewardship Into MBQIP– Federal Office of Rural Health Policy Perspective According to the Centers for Disease Control and Prevention (CDC), 20-50% of all antibiotics prescribed in U.S. acute care hospital are either unnecessary or inappropriate, which leads to serious side effects such as adverse drug reactions and Clostridium difficile infection, and antibiotic resistance. In 2014, CDC released the “Core Elements of Hospital Antibiotic Stewardship Programs” that identifies key structural and functional aspects of effective programs and elements designed to be flexible enough to be feasible in hospitals of any size . Summer 2016 - Proposed Conditions of Participation (CoP) for CAHs In collaboration with FORHP, CDC has taken a proactive approach to gather information from these CAHs to create an implementation guide that identifies common challenges and best practices for an antibiotic stewardship program in a CAH. In 2014, CDC released the “Core Elements of Hospital Antibiotic Stewardship Programs” that identifies key structural and functional aspects of effective programs and elements designed to be flexible enough to be feasible in hospitals of any sizei . In summer 2016, CMS released a proposed rule to update the requirements that hospitals and CAHs must meet to participate in the Medicare and Medicaid programs (often referred to as proposed Conditions of Participation (CoP)). The proposed rule includes a requirement for CAHs to implement an antibiotic stewardship programii . Although the final rule has not yet been released, it is anticipated that this requirement will remain. Discussion FORHP and CDC both understand the unique challenges that rural hospitals face when implementing several of the core elements of an antibiotic stewardship program such as limitations in staffing, resources, and infrastructure: Despite the challenges, more than 200 CAHs (26%) in the U.S. have successfully implemented all seven core elements of the program in 2015iii. In collaboration with FORHP, CDC has taken a proactive approach to gather information from these CAHs to create an implementation guide that identifies common challenges and best practices for an antibiotic stewardship program in a CAH. FORHP is actively tracking updates and talking with CMS about the final ruling on the CAH CoP. Of the 200 comments published from the proposed ruling, 44 were specific to rural. Most comments were based on the unique challenges that rural hospitals face, including the need for flexibility, technical assistance, and time to implement an antibiotic stewardship program. FORHP is also collaborating with the CMS to discuss opportunities for alignment with HIIN and QIO-QIN activities regarding support for CAHs in addressing antibiotic stewardship.

FORHP Alignment with CDC Implementing Antibiotic Stewardship in Rural and Critical Access Hospitals Denise Cardo, MD Director, Division of Healthcare Quality Promotion, CDC Federal Office of Rural Health Policy Reverse Site Visit July 19, 2017

Importance of Incorporating HAIs Into MBQIP– Federal Office of Rural Health Policy Perspective Prevention of HAIs is a critical patient safety issue that has been identified as a top Federal priority. To help ensure CAHs maintain and can document a comparable or better level of quality than larger facilities, CAHs need to demonstrate a willingness to monitor and report HAI data The US Department of Health and Human Services (DHHS) national action plan for elimination of HAIs, aligning a variety of programmatic strategies to support that effort such as: Support and expansion of Centers for Disease Control National Healthcare Safety Network (CDC NHSN) reporting across hospitals, outpatient settings, and nursing homes Partnership For Patients Hospital Innovation Improvement Network (HIIN) priority area for participating hospitals Quality Improvement Network – Quality Improvement Organization (QIN-QIO) priority area, with a focus on outpatient settings and nursing homes CMS aligned payment goals such as the Hospital Acquired Condition Payment Reduction Program (for PPS hospitals) Support for implementation of Agency for Healthcare Research Quality (AHRQ) developed tools and resources such as the Comprehensive Unit-based Safety Program (CUSP) Not going to elaborate on the statistics as you all have heard them before, but showcase how FORHP views this incorporation as aligning with national goals. Healthcare-associated infections (HAIs) are among the leading threats to patient safety, affecting one out of every 25 hospital patients at any one time. Over a million HAIs occur across the U.S. health care system every year, leading to the loss of tens of thousands of lives and adding billions of dollars to health care costs.i  The US Department of Health and Human Services (DHHS) has identified reduction of HAIs and the associated strategy of antibiotic stewardship as a key priorities, and has developed a national action plan for elimination of HAIs, aligning a variety of programmatic strategies to support that effort such as:ii o Support and expansion of Centers for Disease Control National Healthcare Safety Network (CDC NHSN) reporting across hospitals, outpatient settings, and nursing homes o Partnership For Patients Hospital Innovation Improvement Network (HIIN) priority area for participating hospitals o Quality Improvement Network – Quality Improvement Organization (QIN-QIO) priority area, with a focus on outpatient settings and nursing homes o CMS aligned payment goals such as the Hospital Acquired Condition Payment Reduction Program (for PPS hospitals) o Support for implementation of Agency for Healthcare Research Quality (AHRQ) developed tools and resources such as the Comprehensive Unit-based Safety Program (CUSP) o CDC supported state-based HAI programs  Hospital Compare measures for HAI are submitted via CDC NHSN. Over 1100 CAHs have registered for NHSN, many of those in the past year to meet the MBQIP OP-27 reporting requirement (Health Care Worker Immunization).iii  Among these HAIs reported to Hospital Compare via NHSN, CAHs were most likely to report data on CDI (283 CAHs, 21.2%) and MRSA (227 CAHs, 17%), followed by and CAUTI (147 CAHs, 11% e).iv The most recent analysis of CAH reporting on these measures uses CY2013 data. CAH reporting rates are anticipated to have increased since that time.  A review of state statutes and regulations indicates that 34 of the 45 Flex states require hospitals to report data to the state and/or the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) on one or more Healthcare Associated Infections (HAIs).iv o In 12 of these 34 states, the HAI reporting requirement only applies to Prospective Payment System (PPS) hospitals or to hospitals with Intensive Care Units (ICUs); specifically excludes Critical Access Hospitals (CAHs) or low-volume hospitals; or includes a waiver or exemption process. o Presence of a state level HAI reporting requirement does not consistently translate into CAH reporting (it appears several CAHs in states with requirements are not reporting).  Reporting HAI data into NHSN includes three components: o Yearly completion of the Patient Safety Component Annual Hospital Survey o Development of Monthly Reporting Plans (can be completed once at the beginning of the year) o Submission of numerator (patient days and/or device days), and denominator (including event information), or report no events for the denominator. Note: CDC strongly encourages entering data on a monthly basis, but to meet CMS reporting requirements, data submission is required at least quarterly.  The publically reported measure for these HAIs is a Standardized Infection Ratio (SIR). SIRs are calculated by CDC, and are risk adjusted for facility and patient characteristics. The SIR compares the number of reported HAIs to the number of predicted HAIs (OBSERVED/PREDICTED = SIR). Hospitals that have less than one (1) predicted HAI in a given timeframe do not have a SIR calculated. Most CAHs fall into this category, and few CAHs will have a SIR calculated for any of the HAIs in a single quarter. Hospitals that do not have a SIR calculated do not have that data publically reported on Hospital Compare. Additional detail on calculation of SIRs can be found here. According to a Flex Monitoring Team analysis, for the last six months of 2013 and the first six months of 2014 Hospital Compare data, the number of CAHs nationally with calculated SIRs was 0 for CLABSI and SSI-hysterectomy, 1 for MRSA and SSI-colon surgery, 2 for CAUTI, and 170 for CDI.iv Discussion:  Prevention of HAIs is a critical patient safety issue that has been identified as a top Federal priority.ii To help ensure CAHs maintain and can document a comparable or better level of quality than larger facilities, CAHs need to demonstrate a willingness to monitor and report HAI data. Reporting of HAI data aligns well with the parallel focus on Antibiotic Stewardship, as the two efforts are intertwined.  Flex programs should be able to partner with HIINs, QIN-QIOs, and CDC supported state-based HAI programs to help engage and support CAHs. The developing partnership between CDC and FORHP will be crucial in helping align resources and support.  More than 1100 CAHs have already taken the first step of registering for NHSN (which can be a daunting process). CAHs that are using NHSN only for reporting OP-27 just need to access the system annually, which can make keeping access and passwords current a challenge. More frequent use of NHSN for HAI reporting (recommended monthly, but required at least quarterly) may help alleviate some of the issues related to infrequent use, and build capacity as CAH staff become more familiar with the system.  Although they are a significant patient safety issue, with low patient volumes in CAHs, HAIs are a relatively rare occurrence. The majority of CAHs will not have a SIR calculated for any of the HAI metrics, so the SIR is not particularly useful data element at an individual facility level for supporting improvement efforts. For CAUTI, device utilization rates can be used as a proxy metric, but it is unclear if that data will be available to Flex programs via MBQIP. To support improvement efforts, it will be important to explore additional metrics related to implementation of processes for HAI prevention.  Although many CAHs do not have the minimum number of cases to calculate facility-level riskstandardized infection ratios (SIR), analysis of pooled data from groups of similar facilities can help track infection trends and identify potential targets for HAI prevention and quality improvement initiatives at the state level or among groups of CAHs providing similar services. Additional data support may be needed for Flex programs to effectively use HAI data in this manner.  The Rural Quality Improvement Technical Assistance (RQITA) team will provide technical assistance for these measures in FY2017.

Incorporating HAIs Into MBQIP– Federal Office of Rural Health Policy Perspective Over 1100 CAHs have registered for NHSN - Among these HAIs reported to Hospital Compare via NHSN, CAHs were most likely to report data on CDI (283 CAHs, 21.2%) and MRSA (227 CAHs, 17%), followed by and CAUTI (147 CAHs, 11% e). 34 of the 45 Flex states require hospitals to report data to the state and/or the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) on one or more Healthcare Associated Infections (HAIs). CAHs that are using NHSN only for reporting OP-27 just need to access the system annually, which can make keeping access and passwords current a challenge. More frequent use of NHSN for HAI reporting (recommended monthly, but required at least quarterly) may help alleviate some of the issues related to infrequent use, and build capacity as CAH staff become more familiar with the system.

Importance of Incorporating ED-1 and ED -2 Into MBQIP– FORHP Perspective More than 40% of CAHs nationally reported both measures. ED-1 and ED-2 are corollary to the Outpatient Throughput measures (OP-18, OP-20). A significant number of CAHs are already reporting the ED-1 and ED-2 measures even though they are not required by MBQIP. In Q4 2015, 753 CAHs were reporting the Outpatient ED Throughput Measures (OP-18 and OP- 20). A year later (Q4 2016), that had increased to 930 CAHs. In 2015, 540 CAHs reported on ED-1 and ED-2. Data from 2016 is not yet available. The reporting process for the ED-1 and ED-2 measures will be familiar to the majority of CAHs, since they are reported to QualityNet via CART or a vendor tool. Note: CMS considers ED-1 and ED-2 to be Inpatient measures, since the population for the measures is patients with an inpatient stay. MBQIP has included them in the Outpatient measure domain since they more closely align with ED/outpatient processes. suburban and rural healthcare organizations.

Feedback Requested and Provided – Antibiotic Stewardship 15 Comments Many states and CAHs have great working relationships with their HIINs Many CAHs are implementing antibiotic/antimicrobial stewardship programs Four year time frame is feasible Duplication of efforts – those already collaborating with HIINs • Need for technical assistance Infection control person is different from Quality Improvement person Comments Provided on the CAH CoP Final Rural Need for flexibility, TA, and time to implement a program Antibiotic Stewardship 26% of CAHs have successfully implemented all seven core elements of the program Addition of an antibiotic stewardship program: This addition would fall under the Flex work plan Activity 1.01 and would allow critical access hospitals (CAHs) four years to fully implement an antibiotic stewardship program by the end of FY 2021 (September 1, 2021 - August 31, 2022) Addition of three Centers for Medicare and Medicaid Services (CMS) Hospital Compare Hospital Acquired Infections (HAI) measures (CAUTI, MRSA and CDI) as core measure requirements under the Patient Safety Domain Other HAI Measures, including CLABSI (Central Line Associated Blood Stream Infection) and SSI (Surgical Site Infection measures), will remain on the ‘additional’ MBQIP list. CAHs that provide services relevant to those measures should be encouraged to collect and submit data as appropriate Addition of ED-1 and ED-2 CMS Hospital Compare measures as core measure requirements under the Outpatient Safety Domain

Feedback Requested and Provided – HAI Measures 18 Comments Many CAHs are reporting whether through HIIN collaboration or state required Supported reporting through NHSN Reporting burden – reporting num/denom through HIIN work Low-volume, not able to calculate standard infection rate (SIR), small value added

Feedback Requested and Provided – ED-1 and ED-2 15 Comments Many CAHs already reporting ED-1 and ED-2 Complementary to OP-18 and OP-20 Helps with reporting regularly through Inpatient because of IMM-2 Not meaningful for CAHs with low ED volumes, what is the value added? Timeliness is not an issue Clearly distinguish the IP from the OP measures

Final Required MBQIP Measures for FY 2018-2021 Addition of Antibiotic Stewardship Addition of ED-1 and ED-2 What about CAUTI, MRSA, and CDI? NHSN…

Final Required MBQIP Measures for FY 2018-2021 Antibiotic Stewardship: measured via Center for Disease Control National Healthcare Safety Network (CDC NHSN) Annual Facility Survey CAHs will have four years or by August 31, 2022 to fully implement an antibiotic stewardship program following the CDC’s 7 Core Elements Inpatient ED Measures: ED-1 and ED-2 Effective September 1, 2018

Review of MBQIP Resources MCRH Website MBQIP Quick Reference Resource List-This list was compiled as a quick one page reference list of the most used and important resources which can be kept in one easy to find location. MBQIP Measures Fact Sheets  MBQIP Data Submission Guidelines – This grid notes each measure, where it is reported to, and the deadlines for submission. MBQIP Reporting Guide MBQIP Measure Matrix - Measures summary information in an Excel format.

MQBIP Resources MBQIP Monthly - MBQIP Monthly is a monthly e-newsletter that provides critical access hospitals (CAHs) with information and support for quality reporting and improvement and highlights current information about the Medicare Beneficiary Quality Improvement Project (MBQIP). Quality Improvement Basics: A Collection of Helpful Resources for Rural Health Organizations. Quality Improvement Implementation Guide and Toolkit for Critical Access Hospitals This guide and toolkit offers strategies and resources to help critical access hospital (CAH) staff organize and support efforts to implement best practices for quality improvement. It includes: A quality improvement implementation model for small, rural hospital settings A 10-step guide to leading quality improvement efforts Summaries of key national quality initiatives that align with the priorities of the Medicare Beneficiary Quality Improvement Project (MBQIP) Best practices for improvement for current MBQIP measures A simple, Excel-based tool to assist CAHs with tracking and displaying real time data for MBQIP and other quality and patient safety measures to support internal improvement efforts

New MBQIP Resources Antibiotic Stewardship Resources: CDC Website Implementation of Antibiotic Stewardship Core Elements at Small and Critical Access Hospitals - Guidebook Implementation of Antibiotic Stewardship at Rural and CAH Hospitals - Presentation by CDC Director, Denise Cardo, MD Infection Prevention in Rural and Critical Access Hospitals Webinar Hosted by Healthcare Communities Antimicrobial Stewardship for Resource Limited Hospitals - Webinar hosted by Healthcare Communities