Palmetto GBA’s Local Coverage Determination (LCD- L35413) regarding monitoring glucose control in patients with Type II Diabetes Mellitus was effective 12/30/14. The LCD contains specific requirements for Type II diabetic patient care in the home care setting. L35413’s goal is to ensure evidenced based medicine to reduce diabetic complications is incorporated into the delivery of home care services. L35132 contains the same requirements as L35413 but includes ICD-10 coding guidelines that is slated to become effective 10/1/15.

The LCD recognizes that many factors, including comorbidities and the patient’s blood glucose levels, must be considered in the initial treatment of a diabetic patient while providing very specific directives relating to patient care. L35413 indicates the first oral glycemic agent to be prescribed if the physician determines the patient would benefit from oral medications to control blood glucose levels. The statement reads “This policy establishes the expectation that for those Medicare beneficiaries requiring medications to achieve long-term control of glucose levels, Metformin shall be considered first-line therapy unless there is a specific contraindication to its use.” Of course this would be the physician’s decision but it is worth mentioning due to specificity of the oral anti-glycemic.

Daily nursing visits to provide insulin injections would only be permitted if the patient is physically or mentally unable to self-inject AND there is no other person who is willing and able to provide the injections. It is imperative the documentation in each of the visit notes address these specific guidelines and ‘paint the picture’ of the patient to support medical necessity. The LCD specified that the POC must contain adequate information related to the patient’s functional limitations to support why the patient cannot self-inject. Without an additional skilled service, denial will occur if the POC does not include the specific structural/functional impairments that prevent the patient from performing self-injections along with related activity limitations. If utilizing form 485, Locators18a (Functional Limitations) and 18b (Activities Permitted) in the POC may be utilized to support the patient’s physical condition but please do not totally rely on the check box documentation to support medical necessity! Remember the entire POC must support the patient’s limitations and CMS has previously discouraged reliance on ‘check box’ responses. Functional limitation, diagnoses and corresponding ICD-9 codes would be appropriate to include in the POC if the documentation supports the physician confirmed the diagnoses. The interventions should also address the patient’s limitations and activities permitted. All of the puzzle pieces must fit together to support medical necessity.

The frequency to obtain Hemoglobin A1c (HbA1c) is also stated as “Reasonable and necessary home care plans of care for Medicare beneficiaries with Type II diabetes must therefore include the monitoring and reporting of not only intermittent capillary blood/serum glucose levels but also quarterly (and no less often than 120 days) HbA1c levels.”Therefore, if the POC does not include a specific intervention (including time parameters) to obtain the HbA1c, documentation to indicate who is monitoring and when the next level is due would be required. The HbA1c results must be included in the chart regardless of who obtained the lab. The communication between the agency and the physician must also be documented to support care coordination and patient centered care.

Many agencies had several questions regarding these new requirements and A53886 contains several comments and responses. In this article, Palmetto clarifies that the LCD applies to all patients with Type II Diabetes regardless of whether or not the patient is taking insulin. The LCD also applies to all patients with DM II documented on their problem list and care plans, including therapy only patients. L35413 states that ideally the lab results would documented up to 3 months prior to admission, but if an HbA1c has not been drawn prior to admission, it should be performed at the time of admission with the results documented in the medical record prior to submitting the final claim for the initial 60 day episode.

The remaining sections of the LCD contain a listing of diagnoses with corresponding ICD-9 codes that support medical necessity.

L35413 may be viewed at the following link: CMS – L35413

A53886 may be viewed at the following link: CMS – A53886