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.