Summary Of Evidence

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Analysis of Evidence

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The goal of this Local Coverage Determination (LCD) is to ensure that evidence-based medicine addressing the risks of acute and chronic complications of diabetes mellitus (DM) are integrated into the delivery of home health (HH) services for Medicare beneficiaries with Type II DM. Initial treatment of individuals diagnosed with DM must take into account many factors, including the level of hyperglycemia/hypoglycemia and comorbidities. Physicians often recommend diet, exercise and medications alone or in combination to help reduce long-term risks of hyperglycemia.

Skilled nurse visits are permitted for the administration of daily insulin injections for the population of Medicare beneficiaries that are “either physically or mentally unable to self-inject insulin” and there is no other person who is able and willing to inject the beneficiary. Reasonable and necessary plans of care must contain sufficient information concerning the identified functional limitations to explain why an individual is physically or mentally unable to self-inject insulin. In the absence of another skilled service, failure to include the specific structural or functional impairments, together with the related activity limitations to support the determination that the individual beneficiary is either physically or mentally unable to self-inject insulin will result in a claim denial.

Evidence-based medicine supports ascertaining glucose control and the risk of secondary conditions known to occur in individuals with DM by monitoring glucose and hemoglobin A1c (HbA1c) levels in individuals with DM. This information and its communication between the physician and HH agency caring for a given beneficiary helps ensure that a HH plan of care (POC) is not only patient-centered, but also addresses prognosis - as required by the Medicare Benefit Policy Manual. Performing the HbA1c test quarterly in patients whose therapy has changed or who are not meeting glycemic goals is supported by the American Diabetes Association Standards of Medical Care in Diabetes - 2016 (ADA Standards). Based on Palmetto GBA’s claims data and the increased risk of emergency department (ED) encounters and acute inpatient admissions related to hypoglycemia in this population, physicians and HH agencies should consider the inclusion of HbA1c testing in the HH POC.

For other beneficiaries with stable glycemic control (defined as 2 consecutive HbA1c results meeting the treatment goals specified in the POC) performing the HbA1c test at least 2 times a year may be considered. The Americans with Disabilities Act (ADA) framework for considering treatment goals recognizes that “patient characteristics/health status” are important factors when considering glycemic goals. Beneficiaries eligible for the Medicare HH benefit often have multiple coexisting chronic illnesses that would support a higher target goal for the HbA1c (e.g., < 8.5%) in order to avoid adverse events (e.g., hypoglycemia-related ED visits and acute inpatient hospitalization).

Reducing Hypoglycemia-related ED visits/Inpatient Hospitalizations among Beneficiaries with DM

Hypoglycemia-related ED visits and acute inpatient hospitalizations among elderly patients with DM are recognized as potentially preventable adverse drug events (ADE). The United States (U.S.) Department of Health and Human Services (HHS) Healthy People 2020, a decade-long work plan for improving the health of the U.S. population, contains a specific Medical Product Safety (MPS) objective [MPS-5.2 reduce ED visits for overdose from injectable antidiabetic agents] aimed at reducing the baseline rate by 10% by 2020. Insulin-related hypoglycemia and errors (IHEs) are especially prevalent in individuals with advanced age, limited life expectancy and frailty. This LCD seeks to help reduce these adverse events by promoting evidence-based HH plans of care.