HQC Strategic Blueprint VIEW

Transcript

1 HYPOGLYCEMIA QUALITY COLLABORATIVE STRATEGIC BLUEPRINT A RESOURCE TO INCREASE AWARENESS OF HYPOGLYCEMIA AND PROMOTE ACTIVITIES TO REDUCE ITS INCIDENCE REPORT AND STRATEGIC RECOMMENDATIONS

2 To prevent and manage hypoglycemia, current clinical I. OVERVIEW OF THE STATE guidance recommends the use of individualized HbA1c goals OF HYPOGLYCEMIA based upon patient characteristics such as health status and Diabetes mellitus (DM) is a disease of two forms xii life expectancy . Clinicians also have access to treatment characterized by high blood glucose. Type 1 diabetes algorithms, such as those developed by the American (T1D) results from insulin deficiency due to autoimmune Association of Clinical Endocrinologists (AACE) and new destruction of pancreatic β -cells. Type 2 diabetes (T2D) technologies for continuous blood glucose monitoring that is a consequence of either cellular insulin resistance or support the targeting of preventative interventions in real-time. i relative deficiencies in insulin production . The Centers For patients, diabetes self-management education for Disease Control and Prevention (CDC) estimate that (DSME) that includes self-monitoring blood glucose 9.3 percent (29.1 million people) of the US population (SMBG) instruction (e.g., evaluation of fasting, pre-meal, is affected by DM and each year approximately 1.7 post-prandial and bedtime blood glucose), healthy ii million new cases are diagnosed among adults . eating choices, and physical activity is important for Treatment to control blood glucose and reduce long-term xiii hypoglycemia prevention . However, low referral rates microvascular, neurologic, and macrovascular complications to DSME by clinicians, low completion rates by patients, includes exercise, dietary modifications, weight control and and varying payer coverage of DSME result in poor the use of medications. Blood glucose-lowering medications glucose pattern and hypoglycemia symptom recognition. include: insulins, dipeptidyl peptidase-4 inhibitors (DPP-4), These factors cause delays in treatment and a high glucagon-like peptide-1 (GLP-1) analogues, sodium-glucose xiv frequency of preventable hypoglycemic events . co-transporter 2 (SGLT2) inhibitors, and thiazolidinediones For policymakers and payers, new policies for preventing (TZDs) in combination with metformin and a sulfonylurea. and managing hypoglycemia are important, such as Following evidence from the landmark Diabetes Control and evidence-based reimbursement design that includes iv iii Complications Trial for blood glucose , clinical guidance the use of quality measures to benchmark care. management was updated to recommend strict glycemic Recently, because of the increasing prevalence and urgency control targets using HbA1c values of <6.5 or <7.0 percent. of the problem, federal regulators and DM stakeholders More recent evidence has shown that the use of intensive have increased their focus on hypoglycemia. In October glycemic control targets when treated with oral agents, 2014, the Department of Health and Human Services insulin-based therapies, or SLGT-2 combined with insulin puts (DHHS) National Action Plan for Adverse Drug Event patients at greater risk for hypoglycemia. These findings are (ADE) Prevention highlighted diabetes agent-associated vi v particularly pronounced for elderly patients. and critically-ill hypoglycemia as a primary concern. This report cited Hypoglycemia is associated with loss of consciousness the lack of a consensus definition for different levels of and dementia leading to hospitalization, including nearly hypoglycemia severity as a major barrier to reducing the vii 300,000 emergency department (ED) visits in 2009 . For xv incidence of hypoglycemia . Following release of the DHHS persons with DM, the threat and fear of hypoglycemia, National Action Plan, the Endocrine Society convened a whether spontaneous or therapy-associated, is one of stakeholder roundtable to discuss opportunities to advance viii the most significant barriers to glycemic control . care related to hypoglycemia. In addition, beginning in April 2016, the Juvenile Diabetes Research Foundation Patients and providers including specialists, primary care (JDRF) launched a multi-stakeholder initiative to address physicians, and nurses are often undereducated and gaps in care for T1D that includes efforts to develop ill-equipped to prevent and manage therapy-associated consensus definitions for differing hypoglycemia severity. or spontaneous hypoglycemia that may be caused by dietary or exercise pattern modifications. In addition, issues Despite the availability of evidence-based prevention of access and health literacy among low socioeconomic and management techniques, policy mechanisms, ix status individuals contribute to poor outcomes . For and digital health tools, hypoglycemia outcomes in example, the 30-day mortality for hypoglycemia admissions individuals with DM remain poor and the incidence and for Medicare beneficiaries in 2010 was 5.0 percent and effects of long-term and recurrent hypoglycemia are not x the 30-day readmission rate was 18.1 percent . Further, fully understood. These facts necessitate joint action the cost of hypoglycemia is significant. Between January by DM stakeholders to increase national awareness 2007 and December 2011, ED visits for therapy-associated and to execute tactics that improve the prevention and xi hypoglycemia resulted in spending of more than $600 million . management of hypoglycemia in the United States. HYPOGLYCEMIA QUALITY COLLABORATIVE STRATEGIC BLUEPRINT

3 • Advocating for Increased Focus on Hypoglycemia; II. INTRODUCTION TO THE HYPOGLYCEMIA QUALITY • Delivering Hypoglycemia Prevention and Management Education; COLLABORATIVE (HQC) AND STRATEGIC BLUEPRINT • Recognizing Hypoglycemia as a Public Health Issue The Endocrine Society established the Hypoglycemia Quality As shown below, each Blueprint domain contains three Collaborative (HQC) to signal its continued commitment to strategic areas. Using the expertise of its participants, improving care for individuals with DM. The HQC is a coalition the HQC has developed recommendations for DM of DM stakeholders including: medical specialty societies, stakeholders conducting efforts in a specific strategic payers, industry, patient advocates, diabetes educators, area. Each of the domains and strategic areas, whether and research organizations with the goal to increase it be developing new quality measures or conducting national awareness of hypoglycemia in persons with DM hypoglycemia education, have been identified as and to foster initiatives focused on reducing its incidence. absolutely necessary to improve national awareness of hypoglycemia and promote tactics to reduce its incidence. The HQC created the HQC Strategic Blueprint (“the Blueprint”). The Blueprint is designed as an actionable Diabetes stakeholders should execute tactics in document and evergreen resource for DM stakeholders the strategic areas of the Blueprint individually or in to identify and contextualize opportunities to work partnership. In some areas, efforts are already underway. together to reduce the incidence of hypoglycemia. For example, by developing consensus definitions for differing hypoglycemia severity, the Juvenile Diabetes The Blueprint contains six key domains that Research Foundation (JDRF) is currently leading efforts in together create a comprehensive framework for the “Create a New Definition” strategy of the “Define and reducing the incidence of hypoglycemia: Describe Hypoglycemia to Support Standards of Care” • Defining and Describing Hypoglycemia domain (See Appendix A for efforts identified by the HQC). to Support Standards of Care; As such, over the next 12 months, DM stakeholders can determine how to complement the work of JDRF by pursuing • Advancing Hypoglycemia Evidence efforts in the “Implement the Definition” strategy or focus to Reduce Gaps in Care; their efforts in a different domain and strategy area. • Measuring and Improving Quality of Care for Patients who Experience Hypoglycemia; III. THE HYPOGLYCEMIA QUALITY COLLABORATIVE (HQC) STRATEGIC BLUEPRINT HYPOGLYCEMIA QUALITY COLLABORATIVE STRATEGIC BLUEPRINT

4 DEFINING AND DESCRIBING HYPOGLYCEMIA Maintain the Definition: The definition of hypoglycemia TO SUPPORT STANDARDS OF CARE will require a consensus body that periodically monitors and conducts targeted literature reviews to update the The current definition of hypoglycemia does not support evidence base and support definition maintenance. differentiation of hypoglycemic episodes by severity. The foundation for improving the prevention and management ADVANCING HYPOGLYCEMIA EVIDENCE of hypoglycemia is an updated definition that accounts TO REDUCE GAPS IN CARE for differing hypoglycemia severity. A comprehensive Current research related to glycemic control often focuses and standardized definition can then be adopted in on the prevention and management of hyperglycemia. The research, clinical guidance and decision support tools, federal government must increase funding for research at the and reimbursement models that reward quality. National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) to reduce gaps in evidence related to hypoglycemia prevention and management. This research should elucidate the short-term and long term effects of hypoglycemia on patient outcomes so that standards of care can be updated or newly developed. A new definition of hypoglycemia Create a New Definition: must be created through a review of evidence and include both clinical values and descriptions of positive and negative symptoms. The definition should have consensus support and facilitate the recognition, tracking, and treatment of different hypoglycemia severity (Note: JDRF is currently leading efforts to develop a consensus Identify Areas for Research: Major gaps in hypoglycemia definition for differing hypoglycemia severity). evidence should be identified so that research may A new definition should • HQC Recommendation: be conducted to design prevention and management include both a symptom-complex and a biochemical strategies that reduce gaps in care for hypoglycemia. definition since there are many factors that may HQC Recommendation: • Major gaps in evidence include: affect whether a patient has symptoms. • The pre-cursor clinical indicators of severe hypoglycemia • To support prevention HQC Recommendation: such as frequent or protracted non-severe hypoglycemia; and management, a new definition should allow for capture of data related to pre- and post-hypoglycemia • The incidence of hypoglycemia by severity level events in acute, post-acute, and community care including events in emergency and outpatient settings; settings (e.g., outpatient or home), including patient • The short-term effects of hypoglycemia on factors such as fears and beliefs of hypoglycemia. outcomes (e.g., arrhythmias, cardiovascular events, and cerebrovascular events); Implement the Definition: The new definition will require a technical expert panel to establish data standards and a • The long-term effects of hypoglycemia set of standardized data elements for consistent electronic (e.g., quality of life, functional status); capture and transfer of hypoglycemia data by severity. • The patient characteristics that increase hypoglycemia Similarly, diagnostic and procedural coding (e.g., ICD, CPT) risk such as age, ethnicity, beliefs and fears of must be evaluated to support comprehensive capture of hypoglycemia, DSME status, and therapy choices hypoglycemic episodes by severity. These steps provide (e.g., insulin, sulfonylurea, analog insulin, or bolus insulin); the foundation for development of survey-based tools • The indirect costs of hypoglycemia and testing of new hypoglycemia quality measures. (e.g., lost productivity/absenteeism); • To accelerate the adoption HQC Recommendation: • The best practices for using continuous glucose of a new definition, large commercial payers and monitor (CGM) data to inform appropriate provider organizations should be engaged to adopt medication or lifestyle modifications; the consensus definition and disseminate it to • The best practices for standardized members within their organizational network such as reporting of CGM data. through the organization’s DM standards of care. HYPOGLYCEMIA QUALITY COLLABORATIVE STRATEGIC BLUEPRINT

5 Conduct Research: Research that is conducted should have the objective of informing prevention, surveillance, and management approaches that account for differing hypoglycemia severity. • HQC Recommendation: Research on patient beliefs and attitudes impacting behavior is a high priority in order to improve prevention and management strategies, especially for patients at risk for recurrent severe hypoglycemia. • HQC Recommendation: Research to improve Review Current Quality Measures: Current claims, surveillance should focus on elucidating the incidence electronic, and patient-reported outcomes measures for DM of hypoglycemia by severity and across settings of should be reviewed and updated, if necessary, to improve care such as the utilization of emergency medical alignment of the measures with current clinical guidance and outpatient services related to hypoglycemia. for preventing and managing severe hypoglycemia. Adopt Best Practices from Research: Action by all HQC Recommendation: • Current measures should stakeholders is needed for comprehensive adoption of be reviewed and updated to promote the use of best practices from research. Medical specialty societies individualized HbA1c target goals and SMBG targets must make timely updates to clinical guidance documents (e.g., fasting, pre-meal, post prandial and bedtime blood and educational materials; primary care teams must glucose), distinguish differing hypoglycemia severity, and incorporate new surveillance strategies; diabetes educators evaluate whether DSME was received/completed. and patient advocates must update educational materials; New quality Develop New Quality Measures: commercial and public payers must review and adjust measures are needed that support surveillance of reimbursement and benefit designs; and health information individuals at risk for hypoglycemia across settings of technology vendors and digital health manufacturers care, use of shared decision-making for medication must provide tools that support new standards of care. selection, and evaluation of patient attitudes, fears, and • To encourage adoption of HQC Recommendation: behaviors related to blood glucose management. new best practices for prevention and management of Structural measures should HQC Recommendation: • hypoglycemia based on severity, medical specialty societies be developed to support timely communication should develop a communication strategy with key to notify a patient’s primary care provider of a messaging for engagement with regulators and payers. hypoglycemia-related emergency room visit or a • HQC Recommendation: Medical specialty societies should medication switch following an inpatient admission. engage with primary care providers to identify opportunities Process measures should • HQC Recommendation: to support primary care providers in adopting best be developed to improve outpatient hypoglycemia practices for hypoglycemia prevention and management. risk evaluation, including less severe hypoglycemia, Payers and providers HQC Recommendation: • and use of individualized HbA1c targets goals. should actively consider ways to incorporate CGM HQC Recommendation: Patient-reported • data into clinical decision making for prevention and outcomes measures are needed to evaluate fears management of hypoglycemia in high risk individuals. of hypoglycemia, effect on quality of life, loss of productivity, and confidence with self-management. MEASURING AND IMPROVING HYPOGLYCEMIA QUALITY OF CARE HQC Recommendation: • Outcome measures Quality measures for DM that specifically assess prevention that use clinical endpoints other than HbA1c are and management of hypoglycemia are lacking. Evidence- needed to better understand glycemic control. based quality measures are needed that support New measures could use multiple metrics including coordinated, timely, and safe prevention and management of HbA1c, time-in-range, and hypoglycemia as potential hypoglycemia. DM stakeholders must coordinate to develop endpoints for evaluating glycemic control. and test hypoglycemia quality measures with appropriate risk Adopt Current and New Quality Measures: adjustment to support improved hypoglycemia outcomes. Evidence-based measures that are closely tied to outcomes and patient-centered interests must be adopted in national quality improvement, provider accreditation, and public reporting programs. HYPOGLYCEMIA QUALITY COLLABORATIVE STRATEGIC BLUEPRINT

6 • HQC Recommendation: Physician Consortium for • HQC Recommendation: Providers should be xvi Practice Improvement (PCPI) measures for DSME engaged regarding the impact of hypoglycemia should be submitted for adoption in Centers for relative to hyperglycemia and the importance of Medicare & Medicaid Services (CMS) inpatient managing hypoglycemia by setting appropriate HbA1c and outpatient quality improvement programs and SMBG targets, using appropriate medications, as well as for use by commercial payers. educating on diet and exercise, and providing blood glucose monitoring education and tools. • These measures can be submitted to CMS for adoption in the Physician Quality Reporting System (PQRS) • HQC Recommendation: Members of medical specialty or future Merit-Based Incentive Payment System societies should be engaged regarding the importance (MIPS) using mechanisms such as the Qualified of legislative mechanisms for improving diabetes care Clinical Data Registry (QCDR) reporting option. such the Diabetes Clinical Care Commission Act. Quality measures such as HQC Recommendation: • Support Payment and Delivery Reform: Care NQF 2363: Glycemic Control should be submitted for models that incentivize coordinated, timely, safe, and adoption in the National Committee for Quality Assurance’s accessible care for DM should be promoted through (NCQA) Diabetes Recognition Program and The Joint engagement with state health officials, federal rule- Commission (TJC) disease specific certification programs. making, and outreach to commercial payers. HQC Recommendation: States with Diabetes • ADVOCATING FOR INCREASED Action Plans (Kentucky, Texas Illinois, Louisiana, New FOCUS ON HYPOGLYCEMIA Jersey, North Carolina, North Dakota, Oregon and Advocacy is an effective tool to increase national focus Washington) should be engaged to include explicit on hypoglycemia. Through advocacy, DM stakeholders tactics for preventing and managing hypoglycemia. become more aware of the need to devote resources and attention towards preventing and managing hypoglycemia. • States without Diabetes Action Plans should be encouraged to develop action plans that specifically include tactics for preventing and managing hypoglycemia. HQC Recommendation: Public and commercial • payers should be engaged regarding the value of reimbursement strategies that promote evidence-based care for hypoglycemia. • Policy makers should HQC Recommendation: be engaged regarding the value of reimbursement that promotes evidence-based prevention and management for hypoglycemia to reduce the significant costs and poor outcomes of hypoglycemia. Increase Awareness of Hypoglycemia: Advocacy through Promote Use of Innovative Technology: Advocacy the development of policy positions, educational events, to federal regulators, commercial payers, and providers and engagement with other DM stakeholders should should promote patient access to glucose monitoring improve awareness of the harm of hypoglycemia, describe tools (e.g., CGMs, strip meters) and education to methods for prevention and management, and promote support providers to utilize data from these tools to increased funding of research that supports provider inform prevention and management decisions. and patient clinical decision-making for hypoglycemia. • HQC Recommendation: Public and commercial payers • HQC Recommendation: Patients/caregivers should should be engaged regarding the importance of digital be engaged by diabetes educators, patient advocacy health and remote monitoring technologies for evaluating groups, and social workers regarding self-management techniques as well as protective rights in the workplace. the burden of hypoglycemia, improving provider care coordination, and promoting shared decision-making. • HQC Recommendation: Primary care providers/ organizations and advanced practice providers should be Public and commercial HQC Recommendation: • engaged to expand their role in both DM management payers should be engaged to promote access and and hypoglycemia prevention by referring patients use of active surveillance tools such as CGMs for to certified diabetes educators or patient education patients at high risk for severe hypoglycemia. programs that are typically covered services. HYPOGLYCEMIA QUALITY COLLABORATIVE STRATEGIC BLUEPRINT

7 • HQC Recommendation: Electronic medical record • Patient education initiatives HQC Recommendation: should meet the National Standards for Diabetes vendors should be engaged to integrate clinical . Self-Management Education and Support decision support tools that allow for capture and transfer of hypoglycemia data by severity. Hypoglycemia-specific HQC Recommendation: • education should be targeted by age and gender, DELIVERING HYPOGLYCEMIA PREVENTION sensitive to the number of hours a patient has AND MANAGEMENT EDUCATION available, and ideally include training from behaviorists, Stakeholder education is a significant activity that nurses, dietitians and exercise physiologists. is necessary to increase the use of evidence-based Hypoglycemia-specific HQC Recommendation: • standards of care for prevention and management of training should include education on glucose pattern hypoglycemia. Such education is important across recognition and self-management actions, medication settings of care and especially for patients and safety, fears of hypoglycemia, hypoglycemia providers directly involved in the delivery of care. unawareness, nutrition and lifestyle strategies, and strategies for appropriate glucose monitoring. The use of telephonic / mobile HQC Recommendation: • patient education should be expanded with digital education targeted to those who will benefit most. • HQC Recommendation: Patient-centered perspectives that encompass the experience of hypoglycemia, impact on quality of life, and strategies for self- management should be provided to patients. Conduct Health Plan Education: Health plans have the ability directly influence provider and patient Conduct Provider Education: All primary care healthcare behavior based on reimbursement and benefit design. professionals should receive hypoglycemia prevention Education of both regional and national health plans and management education regardless of care setting. on reimbursement and benefit design that improves Hypoglycemia-specific education is needed to increase hypoglycemia prevention and management is needed. the use of individualized HbA1c and SMBG targets, referral of patients to DSME programs/diabetes educators, Regional payers and • HQC Recommendation: payers should be educated on the importance of shared decision-making for management goals such as reimbursement and benefit design that includes case medication selections, discussion of barriers to medication management for individuals with DM from nurses or adherence such as patient fears, and appropriate use dietitians as mechanisms to reduce the frequency, of technology to prevent and manage hypoglycemia. impact, and incidence of severe hypoglycemia. HQC Recommendation: Initiatives to educate on new • prevention and management approaches for hypoglycemia RECOGNIZING HYPOGLYCEMIA must be updated to include recommendations by AS A PUBLIC HEALTH ISSUE hypoglycemia severity. These initiatives should also Many DM public health programs currently exist at consider modifications to the provider’s workflow. federal, state, and local levels. Within these programs, • HQC Recommendation: Providers should the topic of hypoglycemia must become a point of receive education regarding the interpretation emphasis. By elevating the topic of hypoglycemia and use of CGM and SMBG tools, including as a public health issue, DM stakeholders have a mechanism to significantly improve national awareness of use and definition of multiple basal rates. hypoglycemia and reduce its incidence for any severity. Improve Patient Education: Patient education is vital for improving outcomes, however, referral rates xvii to educational programs are too low . Patients should be referred to an accredited or recognized diabetes education program with the overall objective to support self-care behaviors, problem solving, and shared decision-making with the health care team. HYPOGLYCEMIA QUALITY COLLABORATIVE STRATEGIC BLUEPRINT

8 Federal agencies Incorporate in Federal Initiatives: Community and socio- HQC Recommendation: • must ensure that hypoglycemia is consistently ethnic factors that contribute to hypoglycemia should reflected in research programs, surveillance systems, be identified and targeted strategies must be used to regulation, drug safety, and quality programs. prevent and manage hypoglycemia at a local level. DM stakeholders should HQC Recommendation: • engage with the agencies of the Department of Health IV. CONCLUSION and Human Services (HHS) to promote focus on The battle to improve the prevention and management hypoglycemia in federal programs and regulations. of DM in the United States is critical given the high • HQC Recommendation: The National Institutes of prevalence of the disease with more than 29.1 million Health (NIH) should increase funding for research to people affected. In addition, an estimated 86 million people improve prevention and management of hypoglycemia. are living with prediabetes placing them at increased risk xix HQC Recommendation: • The programs of the Centers for developing type 2 diabetes . Individuals affected by for Disease Control and Prevention (CDC) should DM are at risk for a number of long-term microvascular, supporting support national hypoglycemia surveillance. neurologic, and macrovascular complications as well as acute short-term complications such as hypoglycemia. • HQC Recommendation: Important topics such as hypoglycemia in a public health context should Prevention and management of hypoglycemia is be submitted to the Diabetes Mellitus Interagency complex. To reduce its incidence, explicit tactics are Coordinating Committee, a workgroup of federal needed by all DM stakeholders whether they are agencies that coordinates government components involved in research, education, treatment, payment, or to work together to address issues in diabetes. policy. The HQC Strategic Blueprint facilitates action by highlighting six domains and strategic areas to improve Engage State Level Initiatives: Medicaid providers and hypoglycemia prevention and management. By following state-level Departments of Health and Human Services the Blueprint, DM stakeholders can identify and engage (DHHS) should incorporate hypoglycemia awareness potential partners to jointly pursue strategic efforts and risk reduction into public health initiatives. recommended in the domains of the HQC Blueprint. To affect change at the state HQC Recommendation: • Success in increasing awareness and reducing level, important topics in diabetes such as hypoglycemia incidence will require the ability of the entire healthcare, awareness and risk reduction should be reflected medical, and patient community to elevate the issue xviii in state-level Diabetes Action Plan legislation. of hypoglycemia in the national consciousness and • HQC Recommendation: State-level initiatives should work together to design, implement, and evaluate be delivered in a culturally sensitive format based initiatives to improve the prevention and management of upon the state’s DM population and educate on the hypoglycemia. This Blueprint provides a starting point. use of technology, health literacy, and numeracy. HQC Recommendation: • State-level DHHS should coordinate with prominent health systems and health plans in the high-priority regions of the state. Engage Local Level Initiatives: In collaboration with state agencies, local entities can promote hypoglycemia public The Hypoglycemia Quality Collaborative Blueprint is health awareness and distribute educational resources an initiative spearheaded by the Endocrine Society in through clinics, local government, and schools. conjunction with: Abbott Diabetes Care Inc., Aetna Inc., American Association of Clinical Endocrinologists, • To effectively deliver HQC Recommendation: American Association of Diabetes Educators, American information and educate communities on College of Physicians, American Diabetes Association, pediatric diabetes hypoglycemia prevention and Astrazeneca LP, Close Concerns, Dexcom, Inc., Lilly management, programs should be developed in USA, LLC, JDRF, Johnson & Johnson, Joslin Diabetes collaboration with school nursing organizations Center, Medtronic Diabetes, Merck & Co., Inc., Novo such as National Association of School Nurses. Nordisk Inc., PQA Alliance, and T1D Exchange. DM and hypoglycemia HQC Recommendation: • Endocrine Society would like to thank Merck public health resources should be culturally and & Co. for their generous support of the linguistically appropriate to successfully engage Hypoglycemia Quality Collaborative Blueprint. an ethnically diverse DM patient population. HYPOGLYCEMIA QUALITY COLLABORATIVE STRATEGIC BLUEPRINT

9 for Meaningful Use Stage 3, including (1) Percentage V. APPENDIX of patients on sulfonylurea / insulin therapy with A. Current Efforts Identified Through out-of-range HbA1c, (2) Alert to potential risk for Development of the HQC Strategic Blueprint hypoglycemic events, (3) Shared-decision making for Efforts to Define and Describe Hypoglycemia hypoglycemic events, (4) Hypoglycemic event, serious, to Support Standards of Care: (5) Hypoglycemia, mild, (6) Recurrent Hypoglycemia, (7) Documentation of etiology of hypoglycemic event, 1. The Juvenile Diabetes Research Foundation (8) Alert to potential risks for hypoglycemic event. (JDRF) is developing definitions for hypoglycemia that account for differing severity levels. JDRF Efforts to Advocate for Increased will publish the final definitions in June 2017. Focus on Hypoglycemia: xxi 2. The International Hypoglycemia Study Group 1. The National Diabetes Clinical Care Commission Act has previously classified severe, symptomatic, is proposed legislation to establish a commission of and asymptomatic hypoglycemia and DM experts including healthcare professionals, patient th presented the classification at the 76 ADA advocates, and leaders from federal agencies who are Scientific Session in June 2016. responsible for streamlining federal activities related to DM. xxii 2. The Medicare CGM Access Act is proposed Efforts to Advance Hypoglycemia legislation that would expand Medicare beneficiary Evidence to Reduce Gaps in Care: xxiii access to continuous glucose monitors . 1. The American Association of Clinical Endocrinologists Efforts to Deliver Hypoglycemia Prevention (AACE) recently updated its Comprehensive T2D and Management Education: Treatment Algorithm that includes algorithms for xx glycemic control and intensifying insulin use . 1. The University of Virginia’s Blood Glucose Awareness Training pilot-program has been translated by the 2. Linda Gonder-Frederick of the University of Virginia has Joslin Diabetes Center into a condensed half or full numerous publications on the fear of hypoglycemia day patient education program on hypoglycemia and adherence to self-management training. xxiv prevention that includes training from behaviorists, 3. William Polonsky of the Behavioral Diabetes Institute nurses, dietitians and exercise physiologists. has developed the 14-item Hypoglycemic Attitudes 2. Organizations such as the National Diabetes and Behavior Scale (HABS), finding significant Education Initiative provide a centralized place hypoglycemic concerns in T2D adults that are xxv to access evidence-based provider and associated with emotional distress and HbA1c. xxvi patient education resources for DM. 4. The Joslin Diabetes Center is conducting a 3. CMS recently launched the Everyone with Diabetes national study to evaluate the association between xxvii Counts program that offers evidence-based hypoglycemia and motor-vehicle-accidents. self-management training using the Diabetes Efforts to Measure and Improve xxviii Self-Management Education curriculum . Hypoglycemia Quality of Care: xxix 4. The NIDDK’s National Diabetes Education Program 1. The Pharmacy Quality Alliance (PQA) is testing facilitates the adoption of DM management new measures such as Serious Hypoglycemic approaches at federal, state, and local levels for Events Requiring Hospital Admission or ED Visit healthcare professionals, patients, and payers. Associated with Anti-Diabetic Medications. xxx 5. Project Endo Echo is a recently launched 2. The T1D Exchange Enhanced Registry is currently collaborative educational program that includes developing measures that incorporate data from endocrinologists and primary care physicians who continuous glucose monitoring (CGM) technologies. conduct case rounds via teleconference. This program is working to develop standards for Efforts to Recognize Hypoglycemia data elements that receive data from CGMs. as a Public Health Issue: 3. The University of Virginia uses the low blood 1. The Centers for Disease Control and Prevention glucose index and average daily range index as xxxi (CDC) funds the Diabetes Prevention Program in methods for measurement of hypoglycemia risk. every state. These programs monitor DM prevalence 4. Measures related to hypoglycemia were proposed by and implement interventions to increase access the Centers for Medicare & Medicaid Services (CMS) to care and identify high risk populations. HYPOGLYCEMIA QUALITY COLLABORATIVE STRATEGIC BLUEPRINT

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