Indicators and limitations of coverage and/or necessity

Medicare/Medicaid Qualifications

Criteria below must be present at the time of initial certification or recertification for hospice. Alzheimer’s disease and related disorders may support a prognosis of six months or less under many clinical scenarios.

The structural and functional impairments associated with a primary diagnosis of Alzheimer’s disease are often complicated by co-morbid and/or secondary conditions. Co-morbid conditions affecting beneficiaries with Alzheimer’s disease are by definition distinct from the Alzheimer’s disease itself – examples include coronary heard disease (CHD) and chronic obstructive pulmonary disease (COPD).

Secondary conditions, on the other hand, are directly related to a primary condition – in the case of Alzheimer’s disease examples include delirium and pressure ulcers. The Reisberg Functional Assessment Staging (FAST) Scale has been used for many years to describe Medicare beneficiaries with Alzheimer’s disease and a prognosis of six months or less.

The FAST Scale is a 16-item scale designed to parallel the progressive activity limitations associated with Alzheimer’s disease. Stage 7 identifies the threshold of activity limitation that would support six-month prognosis; however all sub stage FAST Scale indicators under stage 7 must be present. The FAST Scale does not address the impact of co-morbid or secondary conditions. The presence of secondary conditions is thus considered separately by this policy and (1) must be present; factors from (2) will add supporting documentation. The FAST Scale is designed to parallel the progressive activity.

1. To be eligible for hospice beneficiaries with Alzheimer’s disease must have a FAST scale of greater than or equal to 7. FAST Scale items:

Stage 1: No difficulty, either subjectively or objectively

Stage 2: Complains of forgetting location of objects; subjective work difficulties

Stage 3: Decrease job functioning evident to coworkers; difficulty in traveling to new locations

Stage 4: Decreased ability to perform complex tasks (e.g., planning dinner for guests, handling finances)

Stage 5: Requires assistance in choosing proper clothing

Stage 6: Decreased ability to dress, bathe and toilet independently

Sub Stage 6a: Difficulty putting clothing on properly

Sub Stage 6b: Unable to bathe properly; may develop fear of bathing

Sub Stage 6c: Inability to handle mechanics of toileting (i.e., forgets to flush, does not wipe properly)

Sub Stage 6d: Urinary incontinence

Sub Stage 6e: Fecal incontinence

Stage 7: Loss of speech, locomotion and consciousness

Sub Stage 7a: Ability to speak limited (1 to 5 words a day)

Sub Stage 7b: All intelligible vocabulary lost

Sub Stage 7c: Non-ambulatory

Sub Stage 7d: Unable to sit up independently

Sub Stage 7e: Unable to smile

Sub Stage 7f: Unable to hold head up

2. Documentation of specific secondary conditions (i.e. Pressure ulcers, UTI, dysphagia, aspiration pneumonia) related to Alzheimer’s disease will support eligibility for hospice care.

Indicators and limitations of coverage and/or necessity

Medicare Qualifications

The medical criteria listed below would support a terminal prognosis for individuals with a diagnosis of heart disease. Medical criteria 1 and 2 are important indications of the severity of heart disease and would thus support a terminal prognosis if met:

1. At the time of initial certification or recertification
2. Patient is already optimally treated with diuretics and vasodilators, which may include angiotensin-converting enzymes (ACE) inhibitors or the combination of hydralazine and nitrates. If side effects, such as hypotension or hyperkalemia, prohibit the use of ACE inhibitors or the combination of hydralazine and nitrates, this must be document in the medical records

OR

1. Patients having angina pectoris, at rest, resistant to standard nitrate therapy and are either not candidates or decline invasive procedures
2. The patient has significant symptoms of recurrent congestive hear failure (CHF) at rest, and is classified as a New York Heart Association (NHYA) Class IV:
3. Unable to carry on any physical activity without symptoms
4. Symptoms are present even at rest
5. If any physical activity is undertaken, symptoms are increased
6. Documentation of the following factors may provide additional support for end stage heart disease:
7. Treatment resistant symptomatic supraventricular or ventricular arrhythmias
8. History of cardiac arrest or resuscitation
9. History of unexplained syncope
10. Brain embolism of cardiac origin
11. Concomitant HIV disease
12. Documentation of ejection fraction of 20% or less

Medicaid Qualifications

Medical criteria (i) and (ii) must be present as they are important indicators of the severity of heart disease and would thus support a terminal prognosis if met.

1. When the recipient is approved or recertified the:
2. Patient is already optimally treated with diuretics and vasodilators, which may include angiotensin-converting enzymes (ACE) inhibitors or the combination of hydralazine and nitrates. If side effects, such as hypotension or hyperkalemia, or evidence of treatment failure prohibit the use of ACE inhibitors or the combination of hydralazine and nitrates, or patient voluntary declines the treatment the documentation must be present in the medical records or with lab results and medical records submitted upon request.
3. Patient has angina pectoris, at rest, resistant to standard nitrate therapy and are either not candidates or decline invasive procedures. This must be supported by documentation contained in the medical record.
4. The patient has significant symptoms of recurrent congestive heart (CHF) at rest, and is classified as a New York Heart Association Class IV:
5. Unable to carry on any physical activity without symptoms
6. Symptoms are present even at rest
7. If any physical activity is undertaken, symptoms are increased

iii. Documentation of the following factors may provide additional support for end stage heart disease:

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
6. Documentation of ejection fraction of 20% or less

Indicators and limitations of coverage and/or necessity

Medicare/Medicaid Qualifications

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 must be present; Documentation of 3,4 and/or 5 will lend supporting documentation):

1. Severe chronic lung disease as documented by both a and b:
2. 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, not necessary to obtain for Medicare but IS necessary for Medicaid).
3. Progression of end stage pulmonary disease, as evidenced by prior increasing visits (six or more within the last 12 months for Medicaid) to the emergency department or prior hospitalizations (two or more for Medicaid) for pulmonary infections and/or respiratory failure (documentation for serial disease of FEV1>40 ml/year is objective evidence for disease progression, but is not necessary to obtain).

Medicaid Note: Also includes one or more Intensive Care Unit admissions within the last six months. The hospitalizations or emergency room visits must be related to the terminal illness.

2. Hypoxemia at rest on room air, (Medicaid only: with a current ABG and PO2 at or below 59 mmHg or oxygen saturation at or below 89% taken at rest may be obtained either from recent hospital records or hypercapnia) as evidenced by pO2 greater than or equal to 88% (these values may be obtained from recent hospital records) or hypercapnia, as evidenced by pCO23 50 mmHg (this value may be obtained from recent hospital records).
3. Cor pulmonale and right heart failure (RHF) secondary or pulmonary disease (e.g., not secondary to left heart disease or valvulopathy).
4. Unintentional progressive weight loss or greater than 10% of body weight over the preceding six months.
5. Resting tachycardia >100/min

Indicators and limitations of coverage and/or necessity

Medicare/Medicaid Qualifications

The medical criteria listed below would support a terminal prognosis for individuals with a diagnosis of stroke. Medical criteria 1 and 2 are important indicators of functional and nutritional status respectively, and would thus support a terminal prognosis if met.

1. A Palliative Performance Scale (PPS) of greater than or equal to 40
2. Degree of ambulation

• Mainly in bed

1. Activity/extent of disease

• Unable to do work; extensive disease

1. Ability to do self-care

• Mainly assistance

1. Food/fluid intake

• Normal to reduced

1. State of consciousness

• Either fully conscious or drowsy/confused

2. Inability to maintain hydration and caloric intake with one of the following:
3. Weight loss >10% during previous six months (previous 3 months for Medicaid)
4. Weight loss >7.5% in previous three months (previous six weeks for Medicaid)
5. Serum albumin <2.5 gm/dld

Current history of pulmonary aspiration without effective response to speech language pathology interventions to improve dysphagia and decrease aspiration events.

Calorie counts documenting inadequate caloric/fluid intake if a beneficiary does not meet both medical criteria 1 and 2 the documentation should describe a relevant comorbidity and/or rapid decline.

The medical criteria listed below would support a terminal prognosis for individuals with a diagnosis of coma (any etiology):

1. Comatose patients with any 3 of the following on day three of coma:
2. Abnormal brain stem response
3. Absent verbal response
4. Absent withdrawal response to pain
5. Serum creatinine >1.5 mg/dl

Indicators and limitations of coverage and/or necessity

Medicare Qualifications

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, 2 and 3 must be present; factors from 4 will lend supporting documentation)

1. The patient is not seeking dialysis or renal transplant
2. Creatinine clearance <10 cc/min (<15 cc/min. for diabetes)
3. Serum creatinine >8.0 mg/dl (>6.9 mg/dl for diabetes)
4. Comorbid conditions:
5. Mechanical ventilation
6. Malignancy (other organ system)
7. Chronic lung disease
8. Advanced cardiac disease
9. Advanced liver disease
10. Sepsis
11. Immunosuppression/AIDS
12. Albumin <3.5 gm/dl
13. Cachexia
14. Platelet count <25,000
15. Disseminated intravascular coagulation
16. Gastrointestinal bleeding

Chronic renal failure 1, 2 and 3 must be present; factors from 4 will lend supporting documentation

1. The patient is not seeking dialysis or renal transplant
2. Creatinine clearance <10 cc/min (<15 cc/min. for diabetes)
3. Serum creatinine >8.0 mg/dl (>6.9 mg/dl for diabetes)
4. Signs and symptoms of renal failure:
5. Uremia
6. Oliguria (<400 cc/day)
7. Intractable hyperkalemia (>7.0) not responsive to treatment
8. Uremic pericarditis
9. Hepatorenal syndrome
10. Intractable fluid overload, not responsive to treatment

Indicators and limitations of coverage and/or necessity

Medicare Qualifications

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 must be present; factors 3 will lend supporting documentation).

1. The patient should show both a and b:
2. Prothrombin time prolonged more than 5 seconds over control, or International Normalized Ratio (INR)>1.5
3. Serum albumin <2.5gm/dl
4. End stage liver disease if present and the patient shows at least one of the following:
5. Ascites, refractory to treatment or patient non-complaint
6. Spontaneous bacterial peritonitis
7. Hepatorenal syndrome (elevated creatinine and BUN with oliguria (<400ml/day) and urine sodium concentration <10 mEq/1
8. Hepatic encephalopathy, refractory to treatment or patient non-complaint
9. Recurrent variceal bleeding, despite intensive therapy
10. Documentation of the following factors will support eligibility for hospice care:
11. Progressive malnutrition
12. Muscle wasting with reduced strength and endurance
13. Continued active alcoholism (>80 gm/ethanol/day)
14. Hepatocellular carcinoma
15. HBsAg (Hepatitis B) positivity
16. Hepatitis C refractory to interferon treatment

Indicators and limitations of coverage and/or necessity

Medicare Qualifications

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 (must fulfill 1, 2 or 3).

1. The patient must demonstrate critically impaired breathing capacity:
2. Critically impaired breathing capacity as demonstrated by all of the following characteristics occurring within the 12 months preceding initial hospice certification
3. Vital capacity (VC) less than 30% of normal
4. Significant dyspnea at rest

iii. Requiring supplemental oxygen at rest

1. Patient declines artificial ventilation
2. Patient must demonstrate both rapid progression of ALC and critical nutritional impairment:
3. Rapid progression of ALS as demonstrated by all of the following characteristics occurring within the 12 month preceding initial hospice certification:
4. Progression from independent ambulation to wheelchair or bedbound status
5. Progression from normal barely intelligible or unintelligible speech

iii. Progression from normal to pureed diet

1. Progression from independent in most or all activities of daily living (ADL) to needing major assistance by caretaker in all ADLs.
2. Critical nutritional impairment as demonstrated by all of the following characteristics occurring within the 12 months preceding initial hospice certification
3. Oral intake of nutrients and fluids insufficient to sustain life
4. Continuing weight loss

iii. Dehydration or hypovolemia

1. Absence of artificial feeding methods
2. Patient must demonstrate both rapid progression of ALS and life-threatening complications:
3. Rapid progression of ALS, see 2a above
4. Life-threatening complications as demonstrated by one of the following characteristics occurring within the 12 months preceding initial hospice certification
5. Recurrent aspiration pneumonia (with or without tube feedings)
6. Upper urinary tract infection, e.g. pyelonephritis

iii. Sepsis

1. Recurrent fever after antibiotic therapy

Medicaid Qualifications

ALS tends to progress in a linear fashion over time. By the time patients become end stage, muscle deterioration has become widespread, affecting all areas of the body, although initial predominance patterns do not persist. In end-stage ALS, two factors are critical in determining prognosis: ability to breathe, and to a lesser extent ability to swallow.

The patient must demonstrate critically impaired breathing capacity. Critically impaired breathing capacity as demonstrated by all of the following characteristics occuring within 12 months preceding initial hospice certification:

1. Vital capacity (VC) less than 30% of normal
2. Continuous dyspnea at rest
3. Requiring supplemental oxygen at rest PO2<55 or O2 Sat <89% so that Medicaid supplemental O2 criteria is met
4. Patient declines artificial ventilation. Patient must demonstrate both rapid progression of ALS and critical nutritional impairment
5. Rapid progression of ALS as demonstrated by all of the following characterisitics occurring within the 12 months preceding initial hospice certification:

i. Progression from independent ambulation to wheelchair or bed bound status

Indicators and limitations of coverage and/or necessity

Medicare/Medicaid Qualifications

Patients will be considered to be in the terminal stage the illness (life expectancy of six months or less) if they meet the following criteria (1 and 2 must be present; factors from 3 will add supporting documentation):

1. CD4+Count <25 cells/mcL or persistent viral load >100,000 copies/ml, plus one of the following:
2. CNS lymphoma
3. Untreated, or not responsive to treatment, wasting (loss of 33% lean body mass)
4. Mycobacterium avium complex (MAC) bacteremia, untreated, unresponsive to treatment, or treatment refused
5. Progressive multifocal leukoencephalopathy
6. Systemic lymphoma, with advanced HIV disease and partial response to chemotherapy
7. Visceral Kaposi’s sarcoma unresponsive to therapy
8. Renal failure in the absence of dialysis
9. Cryptosporidium infection
10. Toxoplasmosis, unresponsive to therapy
11. Decreased performance status, as measured by the Karnofsky Performance Status (KPS) scale, of greater than or equal to 50
12. Documentation of the following factors will support eligibility for hospice care:
13. Chronic persistent diarrhea for one year
14. Persistent serum albumin <2.5
15. Concomitant, active substance abuse (Medicare only)
16. Age >50 years
17. Absence of antiretroviral, chemotherapeutic and prophylactic drug therapy related
18. Advance AIDS dementia complex
19. Toxoplasmosis
20. Congestive heart failure, symptomatic at rests, New York Heart Association (NYHA) classification Stage IV (Medicaid only)

Documentation Requirements

1. Documentation certifying terminal status must contain enough information to confirm terminal status upon review. Documentation meeting the above criteria would meet this requirement.
2. If the patient does not meet the above criteria, yet is deemed appropriate for hospice care, sufficient documentation of the patient’s condition that justifies terminal status, in the absence of meeting the above criteria, would be necessary.
3. Recertification for hospice care requires that the same standards be met for initial.