Revised Definitions for Patient Outcomes

Now Open for Stak Revised Definitions for Patient Outcomes A Critical Next Step for NHIA s Industry-Wide Data Initiative By Connie Sullivan, RPh 26

eholder Comment: Data Elements As the health care industry continues to shift from a fee-for-service model of reimbursement, to one that includes performance measures and cost savings incentives, home infusion providers must ensure that data collection and reporting is a strategic imperative and a vital part of their everyday business operations. Medicare may have taken the lead in the economic restructuring of the nation s health care system, but the private sector is quickly following suit by establishing payment systems that require providers to furnish evidence that the care they delivered is effective, efficient, timely, and patient-centered. Commercial payers, such as Blue Cross and Blue Shield, are beginning to insert quality performance guarantees into provider agreements for home infusion and specialty services. Undoubtedly, any new Medicare benefit for home infusion will include a data component to measure the federal government s return on investment. Yet, reimbursement incentives are not the only reason to pursue an industry-wide quality-benchmarking program. Through benchmarking, home and specialty infusion providers will improve quality, gain efficiency, and better define the value of the services provided. The collection and reporting of data creates transparency and accountability, and will build improved credibility for home and specialty infusion as a critical component of the health care continuum. Newly Revised Definitions And A Sense of Urgency As part of the Association s ongoing Industry-Wide Data Initiative to acquire meaningful and comprehensive data about the home infusion field, a newly revised set of Definitions for Patient Outcomes Data Elements has been developed and issued for review and comment. This latest iteration builds upon and updates the previous definitions that were originally proposed in the 2012 NHIA Data Definitions Survey conducted by the Association, and takes into consideration the many changes that have occurred in other sectors of health care that are at more advanced stages of quality data reporting. The next step is to solicit and incorporate comments from industry stakeholders, as NHIA finalizes the definitions for use by all providers in the accurate collection of future outcomes data. The results of the first two NHIA data-related surveys (the above referenced 2012 NHIA Data Definitions Survey and the 2010 NHIA Provider Survey, which was a comprehensive first-ever analysis of the alternate-site infusion field that collected demographic information about the industry s size and scope) verified that most providers are consistently collecting and utilizing patient outcome data as part of their organizations quality improvement programs (see the box on p. 29 for more on NHIA s data initiative endeavors thus far). Additionally, the 2012 survey data demonstrated a high degree of agreement with the original definitions proposed for the following patient outcome elements: Unplanned Hospitalization; Emergency Department Use; Adverse Drug Reaction; Access Device Events; and Therapy Complete (see the sidebar on p. 30 for a description of the revised data elements). While further reviewing such data definitions was already on the Association s work plan, recent interest in NHIA s standardized outcome definitions by several commercial payers amplified the sense of need and urgency to actively review and revise the definitions to ensure the industry is well-prepared to respond to rapidly increasing payer demands for data. Following the 2015 NHIA Annual Conference & Exposition, a new Outcomes Task Force was formed to review and revise the initial definitions proposed by the original Outcomes Subgroup of the NHIA Industry-Wide Data Initiative. The objectives of the newly formed Outcomes Task Force were to take a fresh look at the previously crafted definitions, incorporate changes that have occurred in other sectors of health care into their review process, and develop a final version of each definition to publish for industry comment. We are now at that crucial point of soliciting comments from the field. Industry Stakeholder Feedback Is Key During the comment period from early August until September 30 th, 2015, the Association will seek to gain input from all stakeholders from NHIA provider and business firm members to other groups, including payers, accreditation agencies, industry affiliates, and clinical partners who contribute to the care of home-based infusion patients. All interested parties are encouraged to review the revised definitions and submit feedback by visiting the NHIA Industry-Wide Data Initiative webpage at: www.nhia.org/data/index.cfm When the comment period ends, the Task Force will conduct a review of the submissions and incorporate the input into a final version of the definitions that will likely be published in late fall or early winter of 2015. 27

2016 NHIA Annual Conference & Exposition Save The Date March 21-24, 2016 New Orleans, Louisiana

The NHIA Data Road So Far The importance of data to the home and specialty infusion industry cannot be overstated. Over the past five years, NHIA has completed several major initiatives related to the collection of provider data. In 2010, the Association conducted its initial Phase I Provider Survey and published the first report providing comprehensive data regarding the size and scope of the infusion industry. More than 280 individually-licensed pharmacy locations from NHIA member organizations contributed data to this initial survey. As a result of this effort, NHIA learned that successful data collection depends on the use of commonly-accepted industry definitions, thus prompting the next vital undertaking in the NHIA Industry-Wide Data Initiative. In 2012, the NHIA Data Definitions Survey was launched to better understand how providers define key terms used to measure demographics, operational processes, and quality. Developing industry-wide, standard definitions is a critical and necessary step toward developing quality measures that will allow providers across the industry to compare results in a uniform manner. The next provider survey will utilize what was learned from this effort to collect more accurate and reliable data. Then, as part of the Association s legislative efforts to attain a comprehensive Medicare benefit for home infusion therapy, NHIA partnered with Avalere Health, LLC in 2013 to conduct research comparing the cost of receiving IV anti-infectives at home versus in a skilled nursing facility, physician office, or hospital outpatient department. The Avalere study not only quantified the savings associated with providing infusion services in the home setting, but demonstrated that automated processes developed for collecting and mapping the study data could be beneficial to future NHIA data efforts. Once published, providers will be encouraged to adopt the newly standardized patient outcome data elements in their data collection processes. Data from providers who adopt the standard definitions will be eligible for inclusion in future National Home Infusion Foundation (NHIF) pilot studies related to quality benchmarking (to learn more about NHIF, see p. 18 and/or visit: www.nhiafoundation.org). Along with finalizing the standard definitions for common elements used to measure outcomes, the group has developed Reason Codes, Intervention Codes (for Adverse Drug Reactions and Catheter Events), and Outcome Codes that will enable providers to capture further information related to the measured occurrences shown in the sidebar. This additional information will go a step beyond the basic reporting to provide better insight into interventions performed by providers as well as the impact the unplanned hospitalization, emergency department visit, or adverse event had on the patient s home infusion care. The task force also added a recommended definition for Medication Error in this update. Since most providers are capturing data related to errors, the group felt that providers should count events in a consistent way. Using the experience gained from prior survey efforts and the revised definitions for outcomes data elements, the NHIA Industry-Wide Data Initiative is poised to make significant progress toward establishing national benchmarks. Providers are encouraged to participate fully in these efforts by adopting the standard definitions for outcomes data, and by participating in future provider surveys. These initiatives are just the beginning of a data journey that will open doors for the industry and will lay a foundation for demonstrating advantages of health care delivered in the home setting. Home infusion is a leader in home-based, high-tech care delivery. With data, the industry can finally provide evidence of the safe, timely, and effective care patients have been receiving from home infusion providers for decades. Be sure that you and your company become engaged in the work of this vital initiative. Connie Sullivan, RPh, is NHIA s Senior Director of Education & Data and the Vice President of Research for the National Home Infusion Foundation (NHIF). She can be reached at Connie.Sullivan@nhia.org. Poised For Continued Progress Once the final definitions are published, the Outcomes Task Force will turn their focus toward creating quality measures for each data element. Developing measures will require making key decisions about how to define the population parameters, identifying reporting timeframes, assessing the need for risk adjustment, and so on. Simultaneously, NHIA will be assessing the technical infrastructure needed for aggregating, storing, analyzing and reporting outcome data. 29

Revised Definitions for Patient Outcomes Data Elements Unplanned Hospitalization Occurs when an active home infusion patient requires an unplanned, inpatient admission to an acute care hospital for any reason. Related Unplanned Hospitalization An unplanned hospitalization is related when required in response to an event associated with the infused medication, access device or the diagnosis and/or symptoms being treated with home infusion therapy. Unrelated Unplanned Hospitalization An unplanned hospitalization is unrelated when required in response to an event that is NOT associated with the infused medication, access device or the diagnosis and/or symptoms being treated with home infusion therapy. REASON for Unplanned Hospitalizations (one answer) Adverse Event Infused Drug Related Adverse Event Equipment Related Adverse Event Access Device Infection Adverse Event Access Device Related - Other than Infection Change in Eligibility* Insufficient response** Unknown Reason Unrelated to infusion therapy Other: *Change in eligibility includes, but is not limited to: unsafe home environment, lack of caregiver support, reimbursement issues, desire for home treatment or unable to comply with home treatment orders. **Insufficient Response also includes exacerbations of diagnosis and/or symptoms being treated with home infusion therapy OUTCOME for Unplanned Hospitalizations (one answer) Resumption of Home Infusion Services with Therapy Changes Resumption of Home Infusion Services without Therapy Changes Home Infusion Services Discontinued Pending/ Remains Hospitalized Emergency Department Use Any use of the Emergency Department by an active home infusion patient for immediate treatment, which does not result in an inpatient admission. Related Emergency Department Use Emergency department use is related to the infusion therapy when required in response to an event associated with the infused medication, access device or the diagnosis and/or symptoms being treated with home infusion therapy. Unrelated Emergency Department Use Emergency department use is unrelated to the infusion therapy when required in response to an event that is NOT associated with the infused medication, access device or the diagnosis and/ or symptoms being treated with home infusion therapy. REASON for Emergency Department Use (one answer) Adverse Event Infused Drug Related Adverse Event Equipment Related Adverse Event Access Device Infection Adverse Event Access Device Related - Other than Infection Change in Eligibility* Insufficient response** Unknown Reason Unrelated to infusion therapy Other: *Change in eligibility includes, but is not limited to: unsafe home environment, lack of caregiver support, reimbursement issues, desire for home treatment or unable to comply with home treatment orders. **Insufficient Response also includes exacerbations of diagnosis and/or symptoms being treated with home infusion therapy OUTCOME for Emergency Department Use (one answer) Continuation of home infusion services with no interruption with therapy changes without therapy changes Home Infusion services discontinued Adverse Drug Reaction (ADR) A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function. (WHO Technical Report 498, 1972) ADR severity classification system: Serious: Any adverse event occurring that results in any of the following outcomes: Death, a life-threatening adverse event, requires inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Severe: An experience that requires therapeutic intervention. If hospitalization is required for treatment it becomes a serious adverse event. Moderate: An experience that is alleviated with simple therapeutic treatments. Mild: An experience that is usually transient and requires no special treatment or intervention. ADR Intervention (all that apply) Provided additional teaching/ education Dose held Infusion therapy order changed Infusion therapy discontinued Adjunctive treatment administered Unscheduled nursing visit Unplanned hospitalization Emergency Department Use Additional labs drawn Equipment repaired or replaced FDA MedWatch Report submitted Other: 30 ADR Outcomes Continuation of home infusion services with no interruption with therapy changes without therapy changes Home Infusion services discontinued

Revised Definitions for Patient Outcomes Data Elements (continued) Access Device Events Migration/ Dislodgement Occlusion Phlebitis Skin integrity impairment (includes exit site infections, or adhesive-related impairment) Suspected Access Device Related Bloodstream Infection Damage/ breakage Suspected thrombosis / DVT Other: Access Device Categories: Central Venous Catheter (CVC), tunneled Central Venous Catheter (CVC), non-tunneled Implanted port Intrathecal Epidural Peripheral (PIV) PICC Midline Dialysis Access Device Other: Access Device Interventions (all that apply) Provided additional teaching/education Access device repaired/ repositioned Access device removed Anti-infectives administered De-clotting procedure performed Adjunctive treatment administered - other than administering anti-infectives and de-clotting Discontinued home infusion therapy Unscheduled nursing visit Unplanned hospitalization Emergency Department Use Cultures drawn Additional tests (x-ray, labs) Other: Access Device Event Outcomes Continuation of home infusion services with no interruption Interruption of home infusion services, followed by resumption of care with therapy changes Interruption of home infusion services, followed by resumption of care without therapy changes Home Infusion Services Discontinued Suspected Access Device Bloodstream Infection: Patient has an access device in place for at least 2 days, and is exhibiting one or more clinical signs of infection (fever, chills, hypotension). Secondary Data Elements for Suspected Access Device Bloodstream Infections 1. Identify other providers that have accessed the catheter during the 2 days prior to the date of initial sign of infection. o Physician o Out-patient clinic o Hospital o Other 2. Was the suspected access-device related infection laboratory confirmed as per CDC guidelines for central lines (CLABSI)? Secondary Data Elements for Access Device Events 1. Was this a valved access device? 2. Was heparin used in the flushing protocol? a. Volume of heparin flush used b. Concentration of heparin flushed used 3. Name of the device manufacturer Medication Error (from the Institute for Safe Medication Practices, ISMP) Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing, order communication, product labeling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use. Therapy Complete Applies to any patient who completes the prescribed treatment orders at the time of discharge from infusion services. Discharge Reason (to be used when Therapy Complete does not apply) Unexpected Death Hospitalized Change in eligibility Insufficient response/ complication Adverse Drug Reaction Access Device Related Other: WE NEED YOUR FEEDBACK! All interested home and specialty infusion stakeholders are strongly encouraged to review the Revised Definitions for Patient Outcomes Data Elements and submit feedback by visiting the NHIA Industry-Wide Data Initiative webpage at: www.nhia.org/data Should you have any questions or want to learn more about how to become involved in NHIA s data initiative work, please contact Connie Sullivan, RPh, at: Connie.Sullivan@nhia.org 31