End-Stage Indicators

These guidelines are extracted from CMS' document LCD for Hospice—Determining Terminal Status (L13653).

Overview/General Guidelines

Disease-Specific Guidelines

Overview/General Guidelines

Medicare coverage of hospice depends on a physician's certification that an individual's prognosis is a life expectancy of six months or less if the terminal illness runs its normal course.

A patient will be considered to have a life expectancy of six months or less if he/she meets the non-disease specific decline in clinical status guidelines described in Part I.

Alternatively, the non-disease specific guidelines described in Part II, plus the applicable disease-specific guidelines, can also establish the necessary expectancy.

Part I. Decline in clinical status guidelines

These changes in clinical variables are listed in order of their likelihood to predict poor survival, the most predictive first and the least predictive last. No specific number of variables must be met, but fewer of those listed first (more predictive) and more of those listed last (least predictive) would be expected to predict longevity of six months or less.

  1. Progression of disease as documented by worsening clinical status, symptoms, signs and laboratory results
    1. Clinical Status
      1. Recurrent or intractable infections such as pneumonia, sepsis or upper urinary tract.
      2. Progressive inanition as documented by:
        1. Weight loss not due to reversible causes such as depression or use of diuretics
        2. Decreasing anthropomorphic measurements (mid-arm circumference, abdominal girth), not due to reversible causes such as depression or use of diuretics
        3. Decreasing serum albumen or cholesterol
      3. Dysphagia leading to recurrent aspiration and/or inadequate oral intake documented by decreasing food portion consumption.
    2. Symptoms
      1. Dyspnea with increasing respiratory rate
      2. Cough, intractable
      3. Nausea/vomiting poorly responsive to treatment
      4. Diarrhea, intractable
      5. Pain requiring increasing doses of major analgesics more than briefly.
    3. Signs
      1. Decline in systolic blood pressure to below 90 or progressive postural hypotension
      2. Ascites
      3. Venous, arterial or lymphatic obstruction due to local progression or metastatic disease
      4. Edema
      5. Pleural / pericardial effusion
      6. Weakness
      7. Change in level of consciousness
    4. Laboratory
      (When available. Lab testing is not required to establish hospice eligibility.)
      1. Increasing pCO2 or decreasing pO2 or decreasing SaO2
      2. Increasing calcium, creatinine or liver function studies
      3. Increasing tumor markers (e.g. CEA, PSA)
      4. Progressively decreasing or increasing serum sodium or increasing serum potassium
  2. Decline in Karnofsky Performance Status (KPS) or Palliative Performance Score (PPS) from <70% due to progression of disease.
  3. Increasing emergency room visits, hospitalizations, or physician's visits related to hospice primary diagnosis
  4. Progressive decline in Functional Assessment Staging (FAST) for dementia (from ≥7A on the FAST)
  5. Progression to dependence on assistance with additional activities of daily living (See Part II, Section 2)
  6. Progressive stage 3-4 pressure ulcers in spite of optimal care

Part II. Non-disease specific baseline guidelines

Both of these guidelines should be met.

  1. Physiologic impairment of functional status as demonstrated by: Karnofsky Performance Status (KPS) or Palliative Performance Score (PPS) <70%. Note that two of the disease specific guidelines (HIV Disease, Stroke and Coma) establish a lower qualifying KPS or PPS.
  2. Dependence on assistance for two or more activities of daily living (ADLs)
    1. Feeding
    2. Ambulation
    3. Continence
    4. Transfer
    5. Bathing
    6. Dressing

See disease-specific guidelines to be used with these (Part II) baseline guidelines. The baseline guidelines do not independently qualify a patient for hospice coverage.

Note: The word "should" in the disease specific guidelines means that on medical review the guideline so identified will be given great weight in making a coverage determination. It does not mean, however, that meeting the guideline is obligatory.

Part III. Co-morbidities

Although not the primary hospice diagnosis, the presence of disease such as the following, the severity of which is likely to contribute to a life expectancy of six months or less, should be considered in determining hospice eligibility.

  1. Chronic obstructive pulmonary disease
  2. Congestive heart failure
  3. Ischemic heart disease
  4. Diabetes mellitus
  5. Neurologic disease (CVA, ALS, MS, Parkinson's)
  6. Renal failure
  7. Liver Disease
  8. Neoplasia
  9. Acquired immune deficiency syndrome
  10. Dementia

Disease Specific Guidelines

Disease-specific guidelines are to be used in conjunction with the non-disease specific guidelines described in Part II above.

Section I: Cancer Diagnoses

  1. Disease with distant metastases at presentation OR
  2. Progression from an earlier stage of disease to metastatic disease with either:
    1. a continued decline in spite of therapy
    2. patient declines further disease directed therapy

Note: Certain cancers with poor prognoses (e.g. small cell lung cancer, brain cancer and pancreatic cancer) may be hospice eligible without fulfilling the other criteria in this section.

Section II: Non-Cancer Diagnoses

  1. Amyotrophic Lateral Sclerosis
    General Considerations:
    1. ALS tends to progress in a linear fashion over time. Thus the overall rate of decline in each patient is fairly constant and predictable, unlike many other non-cancer diseases.
    2. However, no single variable deteriorates at a uniform rate in all patients. Therefore, multiple clinical parameters are required to judge the progression of ALS.
    3. Although ALS usually presents in a localized anatomical area, the location of initial presentation does not correlate with survival time. By the time patients become end-stage, muscle denervation has become widespread, affecting all areas of the body, and initial predominance patterns do not persist.
    4. Progression of disease differs markedly from patient to patient. Some patients decline rapidly and die quickly; others progress more slowly. For this reason, the history of the rate of progression in individual patients is important to obtain to predict prognosis.
    5. In end-state ALS, two factors are critical in determining prognosis: ability to breathe, and to a lesser extent ability to swallow. The former can be managed by artificial ventilation, and the latter by gastrostomy or other artificial feeding, unless the patient has recurrent aspiration pneumonia. While not necessarily a contraindication to Hospice Care, the decision to institute either artificial ventilation or artificial feeding will significantly alter six-month prognosis.
    6. Examination by a neurologist within three months of assessment for hospice is advised, both to confirm the diagnosis and to assist with prognosis.
    Criteria:

    Patients will be considered to be in the terminal stage of ALS (life expectancy of six months or less) if they meet the following criteria. (Should fulfill 1, 2, or 3).

    1. Patient should demonstrate critically impaired breathing capacity.
      1. Critically impaired breathing capacity as demonstrated by all the following characteristics occurring within the 12 months preceding initial hospice certification:
        1. Vital capacity (VC) less than 30% of normal (if available);
        2. Dyspnea at rest;
        3. Patient declines mechanical ventilation; external ventilation used for comfort measures only.
    2. Patient should demonstrate both rapid progression of ALS and critical nutritional impairment.
      1. Rapid progression of ALS as demonstrated by all the following characteristics occurring within the 12 months preceding initial hospice certification:
        1. Progression from independent ambulation to wheelchair to bed bound status;
        2. Progression from normal to barely intelligible or unintelligible speech;
        3. Progression from normal to pureed diet;
        4. Progression from independence in most or all activities of daily living (ADLs) to needing major assistance by caretaker in all ADLs.
      2. Critical nutritional impairment as demonstrated by all the following characteristics occurring within the 12 months preceding initial hospice certification:
        1. Oral intake of nutrients and fluids insufficient to sustain life;
        2. Continuing weight loss;
        3. Dehydration or hypovolemia;
        4. Absence of artificial feeding methods, sufficient to sustain life, but not for relieving hunger.
    3. Patient should demonstrate both rapid progression of ALS and life-threatening complications.
      1. Rapid progression of ALS, see 2.a above.
      2. Life-threatening complications as demonstrated by one of the following characteristics occurring within the 12 months preceding initial hospice certification:
        1. Recurrent aspiration pneumonia (with or without tube feedings);
        2. Upper urinary tract infection, e.g., pyelonephritis;
        3. Sepsis;
        4. Recurrent fever after antibiotic therapy;
        5. Stage 3 or 4 decubitus ulcer(s).
  2. Dementia due to Alzheimer's Disease and Related Disorders
    Patients will be considered to be in the terminal stage of dementia (life expectancy of six months or less) if they meet the following criteria. Patients with dementia should show all the following characteristics:
    1. Stage seven or beyond according to the Functional Assessment Staging Scale;
    2. Unable to ambulate without assistance;
    3. Unable to dress without assistance;
    4. Unable to bathe without assistance;
    5. Urinary and fecal incontinence, intermittent or constant;
    6. No consistently meaningful verbal communication: stereotypical phrases only or the ability to speak is limited to six or fewer intelligible words.
    Patients should have had one of the following within the past 12 months:
    1. Aspiration pneumonia;
    2. Pyelonephritis or other upper urinary tract infection;
    3. Septicemia;
    4. Decubitus ulcers, multiple, stage 3–4;
    5. Fever, recurrent after antibiotics;
    6. Inability to maintain sufficient fluid and calorie intake with 10% weight loss during the previous six months or serum albumin <2.5 gm/dl.
    Note: This section is specific for Alzheimer's Disease and related disorders, and is not appropriate for other types of dementia, such as multi-infarct dementia.
  3. Heart Disease
    Patients will be considered to be in the terminal stage of heart disease (life expectancy of six months or less) if they meet the following criteria. (1 and 2 should be present. Factors from 3 will add supporting documentation.):
    1. At the time of initial certification or recertification for hospice, the patient is or has been already optimally treated for heart disease or are patients who are either not candidates for surgical procedures or who decline those procedures. (Optimally treated means that patients who are not on vasodilators have a medical reason for refusing these drugs, e.g., hypotension or renal disease.)
    2. The patient is classified as New York Heart Association (NYHA) Class IV and may have significant symptoms of heart failure or angina at rest. (Class IV patients with heart disease have an inability to carry on any physical activity without discomfort. Symptoms of heart failure or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.) Significant congestive heart failure may be documented by an ejection fraction of ≤20%, but is not required if not already available.
    3. Documentation of the following factors will support but is not required to establish eligibility for hospice care:
      1. Treatment resistant symptomatic supraventricular or ventricular arrhythmias;
      2. History of cardiac arrest or resuscitation;
      3. History of unexplained syncope;
      4. Brain embolism of cardiac origin;
      5. Concomitant HIV disease.
  4. HIV Disease
    Patients will be considered to be in the terminal stage of their illness (life expectancy of six months or less) if they meet the following criteria. (1 and 2 should be present; factors from 3 will add supporting documentation):
    1. CD4+ Count <25 cells/mcl or persistent (2 or more assays at least one month apart) viral load >100,000 copies/ml, plus one of the following:
      • CNS lymphoma;
      • Untreated, or persistent despite treatment, wasting (loss of at least 10% lean body mass);
      • Mycobacterium avium complex (MAC) bacteremia, untreated, unresponsive to treatment, or treatment refused;
      • Progressive multifocal leukoencephalopathy;
      • Systemic lymphoma, with advanced HIV disease and partial response to chemotherapy;
      • Visceral Kaposi's sarcoma unresponsive to therapy;
      • Renal failure in the absence of dialysis;
      • Cryptosporidium infection;
      • Toxoplasmosis, unresponsive to therapy.
    2. Decreased performance status, as measured by the Karnofsky Performance Status (KPS) scale, of ≤50%
    3. Documentation of the following factors will support eligibility for hospice care:
      • Chronic persistent diarrhea for one year;
      • Persistent serum albumin <2.5;
      • Concomitant, active substance abuse;
      • Age >50 years;
      • Absence of, or resistance to effective antiretroviral, chemotherapeutic and prophylactic drug therapy related specifically to HIV disease;
      • Advanced AIDS dementia complex;
      • Toxoplasmosis;
      • Congestive heart failure, symptomatic at rest;
      • Advanced liver disease.
  5. Liver Disease
    Patients will be considered to be in the terminal stage of liver disease (life expectancy of six months or less) if they meet the following criteria. (1 and 2 should be present; factors from 3 will lend supporting documentation.):
    1. The patient should show both a and b:
      1. Prothrombin time prolonged more than 5 seconds over control, or International Normalized Ratio (INR) >1.5;
      2. Serum albumin <2.5 gm/dl.
    2. End stage liver disease is present and the patient shows at least one of the following:
      1. Ascites, refractory to treatment or patient non-compliant;
      2. Spontaneous bacterial peritonitis;
      3. Hepatorenal syndrome (elevated creatinine and BUN with oliguria (<400 ml/day) and urine sodium concentration <10 mEq/l;
      4. Hepatic encephalopathy, refractory to treatment, or patient non-compliant;
      5. Recurrent variceal bleeding, despite intensive therapy.
    3. Documentation of the following factors will support eligibility for hospice care:
      1. Progressive malnutrition;
      2. Muscle wasting with reduced strength and endurance;
      3. Continued active alcoholism (>80 gm ethanol/day);
      4. Hepatocellular carcinoma;
      5. HBsAg (Hepatitis B) positivity;
      6. Hepatitis C refractory to interferon treatment.
    Patients awaiting liver transplant who otherwise fit the above criteria may be certified for the Medicare hospice benefit, but if a donor organ is procured, the patient should be discharged from hospice.
  6. Pulmonary Disease
    Patients will be considered to be in the terminal stage of pulmonary disease (life expectancy of six months or less) if they meet the following criteria. The criteria refer to patients with various forms of advanced pulmonary disease who eventually follow a final common pathway for end stage pulmonary disease. (1 and 2 should be present. Documentation of 3, 4, and 5, will lend supporting documentation.):
    1. Severe chronic lung disease as documented by both a and b:
      1. Disabling dyspnea at rest, poorly or unresponsive to bronchodilators, resulting in decreased functional capacity, e.g., bed to chair existence, fatigue, and cough: (Documentation of Forced Expiratory Volume in One Second (FEV1), after bronchodilator, less than 30% of predicted is objective evidence for disabling dyspnea, but is not necessary to obtain.)
      2. Progression of end stage pulmonary disease, as evidenced by increasing visits to the emergency department or hospitalizations for pulmonary infections and/or respiratory failure or increasing physician home visits prior to initial certification. (Documentation of serial decrease of FEV1>40 ml/year is objective evidence for disease progression, but is not necessary to obtain.)
    2. Hypoxemia at rest on room air, as evidenced by pO2 ≤55 mmHg; or oxygen saturation ≤88% on supplemental oxygen determined either by arterial blood gases or oxygen saturation monitors; (These values may be obtained from recent hospital records.) OR Hypercapnia, as evidenced by pCO2 ≥50 mmHg. (This value may be obtained from recent [within 3 months] hospital records.)
    3. Right heart failure (RHF) secondary to pulmonary disease (Cor pulmonale) (e.g., not secondary to left heart disease or valvulopathy).
    4. Unintentional progressive weight loss of greater than 10% of body weight over the preceding six months.
    5. Resting tachycardia >100/min.
  7. Renal Disease
    Patients will be considered to be in the terminal stage of renal disease (life expectancy of six months or less) if they meet the following criteria.
    Acute renal failure:
    (1 and either 2 or 3 should be present. Factors from 4 will lend supporting documentation.)
    1. The patient is not seeking dialysis or renal transplant or is discontinuing dialysis;
    2. Creatinine clearance <10 cc/min (<15 cc/min. for diabetics) based on measurement or calculation; or <15cc/min (<20cc/min for diabetics) with comorbidity of congestive heart failure;
    3. Serum creatinine >8.0 mg/dl (>6.0 mg/dl for diabetics);
    4. Comorbid conditions:
      1. Mechanical ventilation;
      2. Malignancy (other organ system);
      3. Chronic lung disease;
      4. Advanced cardiac disease;
      5. Advanced liver disease;
      6. Sepsis;
      7. Immunosuppression/AIDS;
      8. Albumin <3.5 gm/dl;
      9. Cachexia;
      10. Platelet count <25,000;
      11. Disseminated intravascular coagulation;
      12. Gastrointestinal bleeding.
    5. Chronic renal failure:
      (1 and either 2 or 3 should be present. Factors from 4 will lend supporting documentation.)
      1. The patient is not seeking dialysis or renal transplant or is discontinuing dialysis;
      2. Creatinine clearance <10 cc/min (<15 cc/min for diabetics) based on measurement or calculation; or <15cc/min (<20cc/min for diabetics) with comorbidity of congestive heart failure;
      3. Serum creatinine >8.0 mg/dl (>6.0 mg/dl for diabetics);
      4. Signs and symptoms of renal failure:
        1. Uremia;
        2. Oliguria (<400 cc/24 hours);
        3. Intractable hyperkalemia (>7.0) not responsive to treatment;
        4. Uremic pericarditis;
        5. Hepatorenal syndrome;
        6. Intractable fluid overload, not responsive to treatment.
  8. Stroke & Coma
    Patients will be considered to be in the terminal stage of stroke or coma (life expectancy of six months or less) if they meet the following criteria.
    Stroke:
    1. Karnofsky Performance Status (KPS) or Palliative Performance Scale (PPS) of 40% or less;
    2. Inability to maintain hydration and caloric intake with one of the following:
      1. Weight loss >10% in the last 6 months or >7.5% in the last 3 months;
      2. Serum albumin <2.5 gm/dl;
      3. Current history of pulmonary aspiration not responsive to speech language pathology intervention;
      4. Sequential calorie counts documenting inadequate caloric/fluid intake;
      5. Dysphagia severe enough to prevent the patient from receiving good and fluids necessary to sustain life, in a patient who declines or does not receive artificial nutrition and hydration.
    Coma (any etiology):
    Comatose patients with any 3 of the following on day three of coma:
    1. abnormal brain stem response;
    2. absent verbal response;
    3. absent withdrawal response to pain;
    4. serum creatinine >1.5 mg/dl.
    Documentation of the following factors will support eligibility for hospice care:
    Documentation of medical complications, in the context of progressive clinical decline, within the previous 12 months, which support a terminal prognosis:
    1. Aspiration pneumonia;
    2. Upper urinary tract infection (pyelonephritis);
    3. Sepsis;
    4. Refractory stage 3–4 decubitus ulcers;
    5. Fever recurrent after antibiotics.
    Documentation of diagnostic imaging factors which support poor prognosis after stroke include:
    1. For non-traumatic hemorrhagic stroke:
      1. Large-volume hemorrhage on CT:
        1. Infratentorial: ≥20 ml.;
        2. Supratentorial: ≥50 ml.
      2. Ventricular extension of hemorrhage;
      3. Surface area of involvement of hemorrhage ≥30% of cerebrum;
      4. Midline shift ≥1.5 cm.;
      5. Obstructive hydrocephalus in patient who declines, or is not a candidate for, ventriculoperitoneal shunt.
    2. For thrombotic/embolic stroke:
      1. Large anterior infarcts with both cortical and subcortical involvement;
      2. Large bihemispheric infarcts;
      3. Basilar artery occlusion;
      4. Bilateral vertebral artery occlusion.