Local Coverage Determinations Guide

A. Disease with distant metastases at presentation OR

B. Progression from an earlier stage of disease to metastatic disease with either:

1. A continued decline despite 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.

Patients will be considered to be in terminal stage of heart disease based on 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 is not a candidate for a surgical procedure or has declined a procedure. (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 following factors will support but not required to establish eligibility for hospice care:
   a. Treatment resistant symptomatic supraventricular or ventricular arrhythmias;
   b. History of cardiac arrest or resuscitation;
   c. History of unexplained syncope;
   d. Brain embolism of cardiac origin;
   e. Concomitant HIV disease.

Patients will be considered in the terminal stage of pulmonary disease (life expectancy of 6 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:
   a. 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.)
   b. 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%, 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.

Patients will be considered to be in the terminal stage of their illness (life expectancy of 6 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 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 gm/dl;
   • 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.

Patients will be considered to be in the terminal stage of liver disease (life expectancy of 6 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:
   a. Prothrombin time prolonged more than 5 seconds over control, or International Normalized Ratio (INR) >1.5;
   b. Serum albumin <2.5 gm/dl.
2. End stage liver disease is present and the patient shows at least one of the following:
   a. Ascites, refractory to treatment or patient non-compliant;
   b. Spontaneous bacterial peritonitis;
   c. Hepatorenal syndrome (elevated creatinine and BUN with oliguria;
   d. Hepatic encephalopathy, refractory to treatment, or patient non-compliant;
   e. Recurrent variceal bleeding, despite intensive therapy.
3. Documentation of the following factors will support eligibility for hospice care:
   a. Progressive malnutrition;
   b. Muscle wasting with reduced strength and endurance;
   c. Continued active alcoholism (>80 gm ethanol/day);
   d. Hepatocellular carcinoma;
   e. HBsAg (Hepatitis B) positivity;
   f. 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.

Patient will be considered to be in the terminal stage of renal disease (life expectancy of 6 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 GFR <15 ml/min;
3. Serum creatinine >8.0 mg/dl (>6.0 mg/dl for diabetics);
4. Comorbid conditions:
   a. Mechanical ventilation;
   b. Malignancy (other organ system);
   c. Chronic lung disease;
   d. Advanced cardiac disease;
   e. Advanced liver disease;
   f. Sepsis;
   g. Immunosuppression/AIDS;
   h. Albumin;
   i. Cachexia;
   j. Platelet count <25,000;
   k. Disseminated intravascular coagulation;
   l. Gastrointestinal bleeding.

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 GFR <15 ml/min;
3. Serum creatinine >8.0 mg/dl (>6.0 mg/dl for diabetics);
4. Signs and symptoms of renal failure:
   a. Uremia;
   b. Oliguria;
   c. Intractable hyperkalemia (>7.0) not responsive to treatment;
   d. Uremic pericarditis;
   e. Hepatorenal syndrome;
   f. Intractable fluid overload, not responsive to treatment.

Patients will be considered to be in the terminal stage of stoke or coma (life expectancy of 6 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:
   a. Weight loss >10% in the last 6 months or >7.5% in the last 3 months;
   b. Serum albumin <2.5 gm/dl;
   c. Current history of pulmonary aspiration not responsive to speech language pathology intervention;
   d. Sequential calorie counts documenting inadequate caloric/fluid intake;
   e. Dysphagia severe enough to prevent the patient from receiving food and fluids necessary to sustain life, in a patient who declines or does not receive artificial nutrition and hydration.

Documentation of diagnostic imaging factors which support poor prognosis after stroke include:

1. For non-traumatic hemorrhagic stroke:
   a. Large-volume hemorrhage on CT:
        i. Infratentorial: ≥20 ml.;
        ii. Supratentorial: ≥50 ml.
   b. Ventricular extension of hemorrhage;
   c. Surface area of involvement of hemorrhage ≥30% of cerebrum;
   d. Midline shift ≥1.5 cm.;
   e. Obstructive hydrocephalus in patient who declines, or not candidate for ventriculoperitoneal shunt.
2. For thrombotic/embolic stroke:
   a. Large anterior infarcts with both cortical and subcortical involvement;
   b. Large bihemispheric infarcts;
   c. Basilar artery occlusion;
   d. Bilateral vertebral artery occlusion.

Coma (any etiology):

1. Comatose patients with any 3 of the following on day three of coma:
   a. abnormal brain stem response;
   b. absent verbal response;
   c. absent withdrawal response to pain;
   d. serum creatinine >1.5 mg/dl.
2. Documentation of medical complications, in the context of progressive clinical decline, within the previous 12
   months, which support a terminal prognosis:
   a. Aspiration pneumonia;
   b. Upper urinary tract infection (pyelonephritis);
   c. Sepsis;
   d. Refractory stage 3-4 decubitus ulcers;
   e. Fever recurrent after antibiotics.

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.

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.
   a. Critically impaired breathing capacity as demonstrated by all the following characteristics occurring within the 12 months preceding initial hospice certification:
        i. Vital capacity (VC) less than 30% of normal (if available);
        ii. Dyspnea at rest;
        iii. Patient declines mechanical ventilation; external ventilation used for comfort measures only.
2. Patient should demonstrate both rapid progression of ALS and critical nutritional impairment.
   a. Rapid progression of ALS as demonstrated by all the following characteristics occurring within the 12 months preceding initial hospice certification:
        i. Progression from independent ambulation to wheelchair to bed bound status;
        ii. Progression from normal to barely intelligible or unintelligible speech;
        iii. Progression from normal to pureed diet;
        iv. Progression from independence in most or all activities of daily living (ADLs) to needing major assistance
        by caretaker in all ADLs.
   b. Critical nutritional impairment as demonstrated by all the following characteristics occurring within the 12 months preceding initial hospice certification:
        i. Oral intake of nutrients and fluids insufficient to sustain life;
        ii. Continuing weight loss;
        iii. Dehydration or hypovolemia;
        iv. 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.
   a. Rapid progression of ALS, see 2.a above.
   b. Life-threatening complications as demonstrated by one of the following characteristics occurring within the
   12 months preceding initial hospice certification:
        i. Recurrent aspiration pneumonia (with or without tube feedings);
        ii. Upper urinary tract infection, e.g., pyelonephritis;
        iii. Sepsis;
        iv. Recurrent fever after antibiotic therapy;
        v. Stage 3 or 4 decubitus ulcer(s).

Patients will be considered to be in the terminal stage of dementia (life expectancy of 6 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.

FUNCTIONAL ASSESSMENT STAGING (FAST) Check highest consecutive level of disability

1. No difficulty either subjectively or objectively.
2. Complains of forgetting location of objects. Subjective work difficulties.
3. Decreased job functioning evident to co-workers. Difficulty traveling to new locations. Decreased organizational capacity.
4. Decreased ability to perform complex tasks, e.g., planning dinner for guests, handling personal finances, etc.
5. Requires assistance in choosing proper clothing to wear for the day, season, or occasion.
6. A. Improperly putting on clothes w/o assistance or cueing occasionally or more frequently over the past weeks.
   B. Unable to bathe properly occasionally or more frequently over the past weeks.
   C. Inability to handle mechanics of toileting occasionally or more frequently over the past weeks.
   D. Urinary incontinence occasionally or more frequently over the past weeks.
   E. Fecal incontinence occasionally or more frequently over the past weeks.
7.  A. Ability to speak limited to approximately a half a dozen intelligible words in an average day
   B. Speech ability is limited to the use of a single intelligible word in an average day.
   C. Ambulatory ability is lost/cannot walk w/o assistance.
   D. Cannot sit up w/o assistance.
   E. Loss of ability to smile.
   F. Loss of ability to hold up head independently.

Patients will be considered to have a life expectancy of six months or less if there is documented evidence of decline in clinical status based on the guidelines listed below. Since determination of decline presumes assessment of the patient’s status over time, it is essential that both baseline and follow-up determinations be reported where appropriate. Baseline data may be established on admission to hospice or by using existing information from records. Other clinical variables not on this list may support a six-month or less life expectancy. These should be documented in the clinical record.
These changes in clinical variables apply to patients whose decline is not considered to be reversible. They 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 documented by worsening clinical status, symptoms, signs & lab results
   A. Clinical Status
        1. Recurrent or intractable infections such as pneumonia, sepsis or upper urinary tract.
        2. Progressive inanition as documented by:
             a. Weight loss not due to reversible causes such as depression or use of diuretics;
             b. Decreasing anthropomorphic measurements (mid-arm circumference, abdominal girth), not due to
             reversible causes such as depression or use of diuretics;
             c. Decreasing serum albumin or cholesterol.
        3. Dysphagia leading to recurrent aspiration and/or inadequate oral intake documented by decreasing food
        portion consumption.
   B. 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.
   C. 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.
   D. 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 despite optimal care.

(both should be met)

1. Physiologic impairment of functional status as demonstrated by: Karnofsky Performance Status (KPS) or Palliative Performance Score (PPS) <70%.
   Note: Two disease specific guidelines (HIV Disease, Stroke & Coma) establish a lower qualifying KPS or PPS.
2. Dependence on assistance for two or more activities of daily living (ADLs)
   A. Feeding;
   B. Ambulation;
   C. Continence;
   D. Transfer;
   E. Bathing;
   F. 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.

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 eligibility.

A. Chronic obstructive pulmonary disease;
B. Congestive heart failure;
C. Ischemic heart disease;
D. Diabetes mellitus;
E. Neurologic disease (CVA, ALS, MS, Parkinson’s);
F. Renal failure;
G. Liver Disease;
H. Neoplasia;
I. Acquired immune deficiency syndrome;
J. Dementia.

Medical review of records of hospice patients that do not document that patients meet the guidelines set forth herein may result in denial of coverage unless other clinical circumstances reasonably predictive of a life expectancy of six months or less are provided.

A. Chronic obstructive pulmonary disease;
B. Congestive heart failure;
C. Ischemic heart disease;
D. Diabetes mellitus;
E. Neurologic disease (CVA, ALS, MS, Parkinson’s);
F. Renal failure;
G. Liver Disease;
H. Neoplasia;
I. Acquired immune deficiency syndrome;
J. Dementia.

The condition of some patients receiving hospice care may stabilize or improve during or due to that care, with the expectation that the stabilization or improvement will not be brief and temporary. In such circumstances, if the patient’s condition changes such that he or she no longer has a prognosis of life expectancy of six months or less, and that improvement can be expected to continue outside the hospice setting, then that patient should be discharged from hospice.

On the other hand, patients in the terminal stage of their illness who originally qualify for the Medicare hospice benefit but stabilize or improve while receiving hospice care, yet have a reasonable expectation of continued decline for a life expectancy of less than six months, remain eligible for hospice care.

Definition of Terms for PPS:

As noted below, some of the terms have similar meanings with the differences being more readily apparent as one reads horizontally across each row to find an overall ‘best fit’ using all five columns.

1. Ambulation (Use item Self-Care to help decide the level)
   • Full — no restrictions or assistance
   • Reduced ambulation — degree to which the patient can walk and transfer with occasional assistance
   • Mainly sit/lie vs Mainly in bed — the amount of time that the patient is able to sit up or needs to lie down.
   • Totally bed bound — unable to get out of bed or do self-care
   
2. Activity & Evidence of Disease (Use Ambulation to help decide the level.)
   • Activity — Refers to normal activities linked to daily routines (ADL), house work and hobbies/leisure.
   • Job/work — Refers to normal activities linked to both paid and unpaid work, including homemaking and volunteer activities.
   • Both include cases in which a patient continues the activity but may reduce either the time or effort involved.
   Evidence of Disease
   • No evidence of disease — Individual is normal and healthy with no physical or investigative evidence of disease.
   • ‘Some,’ ‘significant,’ and ‘extensive’ disease — Refers to physical or investigative evidence which shows disease progression, sometimes despite active treatments.
   • Example 1: Breast cancer:
      some = a local recurrence
      significant = one or two metastases in the lung or bone
      extensive = multiple metastases (lung, bone, liver or brain), hypercalcemia or other complication
   Example 2: CHF:
      some = regular use of diuretic &/or ACE inhibitors to control
      significant = exacerbations of CHF, effusion or edema necessitating increases or changes in drug management
      extensive = 1 or more hospital admissions in past 12 months for acute CHF & general decline with effusions, edema, SOB
3. Self-Care
   • Full — Able to do all normal activities such as transfer out of bed, walk, wash, toilet and eat without assistance.
   • Occasional assistance — Requires minor assistance from several times a week to once every day, for the activities noted above.
   • Considerable assistance — Requires moderate assistance every day, for some of the activities noted above (getting to the bathroom, cutting up food, etc.)
   • Mainly assistance — Requires major assistance every day, for most of the activities noted above (getting up, washing face and shaving, etc.). Can usually eat with minimal or no help. This may fluctuate with level of fatigue.
   • Total care — Always requires assistance for all care. May or may not be able to chew and swallow food.
4. Intake
   • Normal — eats normal amounts of food for the individual as when healthy
   • Normal or reduced — highly variable for the individual; ‘reduced’ means intake is less than normal amounts when healthy
   • Minimal to sips — very small amounts, usually pureed or liquid, and well below normal intake.
   • Mouth care only — no oral intake
5. Conscious Level
   • Full — fully alert and orientated, with normal (for the patient) cognitive abilities (thinking, memory, etc. )
   • Full or confusion — level of consciousness is full or may be reduced. If reduced, confusion denotes delirium or dementia which may be mild, moderate or severe, with multiple possible etiologies.
   • Full or drowsy +/- confusion — level of consciousness is full or may be markedly reduced; sometimes included in the term stupor. Implies fatigue, drug side effects, delirium or closeness to death.
   • Drowsy or coma +/- confusion — no response to verbal or physical stimuli; some reflexes may or may not remain. The depth of coma may fluctuate throughout a 24 hour period. Usually indicates imminent death

The Karnofsky Performance Scale Index allows patients to be classified as to their functional impairment. This can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for more serious illnesses.