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Local Coverage Determination for Amyotrophic Lateral Sclerosis (ALS)


Amyotrophic Lateral Sclerosis (ALS) is a neurological disease with severe functional, respiratory, and nutritional deficits. While the disease takes a few years for death to occur, the Medicare Administrative Contractors (MACs) Cigna Government Services (CGS) and National Government Services (NGS) have set specific criteria for when the terminal stage of the disease is met. At the same time, Palmetto uses the neurologic condition criteria with less specific requirements to identify eligibility under this disease.

Both CGS and NGS have identical criteria stating that the disease progression is linear and predictable, but different from patient to patient. The rate of disease progression in each individual is a significant factor in determining prognosis.

Consulting a Neurologist Is Necessary for a Prognosis

Respiratory and swallowing status deterioration are highly prognostic, although NGS states that artificial ventilation through a tracheostomy may cause the patient to be ineligible. CGS states that the presence of artificial ventilation and feeding does not make a patient ineligible for hospice, however they can significantly impact prognosis. CGS also states that the presence of artificial ventilation support for comfort should only be by external means. Both CGS and NGS recommend evaluation by a neurologist within three months prior to hospice admission to assist with determining prognosis.

Documenting Critical Impairment Statuses

CGS has the most specific criteria for showing critical impairment in functional, respiratory and nutritional status. They require documentation in the hospice software of either:

  • severe respiratory impairment;
  • rapid progression of functional status, including poor ability to verbally communicate and impaired swallowing with critical nutritional impairment; or
  • rapid progression of functional status, including poor ability to verbally communicate and impaired swallowing with the presence of life-threatening complications, including:
    • sepsis
    • stage 3-4 pressure ulcers
    • upper urinary tract infection
    • aspiration pneumonia or
    • fever after antibiotics in the 12 months prior to the initial hospice certification.

Critical nutritional impairment is defined as either:

  • oral intake of nutrients and fluids insufficient to sustain life;
  • continuing weight loss;
  • dehydration or hypovolemia or
  • absence of artificial feeding methods, enough to sustain life, but not for relieving hunger in the 12 months prior to the initial hospice certification.

NGS has a more specific definition of critically impaired respiratory function that includes a forced vital capacity (FVC) of less than 40% if available and two or more of the following symptoms:

  • dyspnea at rest
  • orthopnea
  • use of accessory respiratory musculature
  • paradoxical abdominal motion
  • respiratory rate greater than 20
  • reduced speech and vocal volume
  • weakened cough
  • symptoms of sleep-disordered breathing (SDB)
  • frequent awakening
  • excessive daytime sleepiness
  • unexplained headaches
  • unexplained confusion
  • unexplained anxiety
  • unexplained nausea

The definition of severe nutritional insufficiency for NGS is that the patient has impaired swallowing with at least 5% weight loss with or without gastrostomy tube insertion.

LCD Criteria Through Palmetto

Palmetto discusses all neurological conditions (except Dementia/Alzheimer’s Disease) in one LCD. If Palmetto is your MAC, your hospice software documentation must have significant information on the presence of secondary and comorbid conditions that impact the plan of care by adding to symptom burden, functional decline, activity limitations, and ultimately the overall prognosis.

Secondary and Comorbid Conditions

Secondary conditions are directly related to and caused by the terminal diagnosis. An example is an ALS patient who has resultant dysphagia and pressure ulcers from poor mobility and nutritional intake.

Comorbid conditions are distinct from the terminal disease itself but impact the functional status and decline. This would be a patient with ALS who also has COPD and is at greater risk for pneumonia due to the underlying pulmonary disease process. The combination of a terminal disease, secondary conditions, and comorbidities will impact the prognosis of a patient and should be addressed in the certification of terminal illness (CTI) narrative.

All MACs expect the hospice to determine the diagnoses related to the patient’s terminal prognosis and address all in the CTI narrative to accurately illustrate the reasons the physician believes the patient has a prognosis of six months or less. Furthermore, accurately identifying and assessing the patient’s full diagnoses will assist agencies with developing the most accurate and proactive plan of care for addressing the patient’s current needs and during the hospice admission.

For patients who have ALS, obtaining a neurologist evaluation to confirm the diagnosis and assist with prognosticating will be helpful in determining if the patient is at the terminal stage of the disease.

Documenting the respiratory, functional, and nutritional status thoroughly in your hospice software is essential to demonstrate your patient’s eligibility for hospice services.

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