LCD L33393: Hospice - Determining Terminal Status

Abstract 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. This LCD describes guidelines to be used by National Government Services (NGS) in reviewing hospice claims and by hospice providers to determine eligibility of beneficiaries for hospice benefits. Although guidelines applicable to certain disease categories are included, this LCD is applicable to all hospice patients. It is intended to be used to identify any Medicare beneficiary whose current clinical status and anticipated progression of disease is more likely than not to result in a life expectancy of six months or less. Clinical variables with general applicability without regard to diagnosis, as well as clinical variables applicable to a limited number of specific diagnoses, are provided. Patients who meet the guidelines established herein are expected to have a life expectancy of six months or less if the terminal illness runs its normal course. Some patients may not meet these guidelines, yet still have a life expectancy of six months or less. Coverage for these patients may be approved if documentation otherwise supporting a less than six-month life expectancy is provided. Section 322 of BIPA amended section 1814(a) of the Social Security Act by clarifying that the certification of an individual who elects hospice "shall be based on the physician's or medical director's clinical judgment regarding the normal course of the individual's illness.'' The amendment clarified that the certification is based on a clinical judgment regarding the usual course of a terminal illness, and recognizes the fact that making medical prognostications of life expectancy is not always exact. However, the amendment regarding the physician's clinical judgment does not negate the fact that there must be a basis for a certification. A hospice needs to be certain that the physician's clinical judgment can be supported by clinical information and other documentation that provide a basis for the certification of 6 months or less if the illness runs its normal course. If a patient improves and/or stabilizes sufficiently over time while in hospice such that he/she no longer has a prognosis of six months or less from the most recent recertification evaluation or definitive interim evaluation, that patient should be considered for discharge from the Medicare hospice benefit. Such patients can be re-enrolled for a new benefit period when a decline in their clinical status is such that their life expectancy is again six months or less. 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. Indications 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 baseline non-disease specific guidelines described in Part II plus the applicable disease specific guidelines listed in Part III will establish the necessary expectancy. Part I. Decline in clinical status guidelines 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 examples of findings that generally connote a poor prognosis. However, some are clearly more predictive of a poor prognosis than others; significant ongoing weight loss is a strong predictor, while decreased functional status is less so.

• Progression of disease as documented by worsening clinical status, symptoms, signs and laboratory results. Clinical Status:

• Recurrent or intractable serious infections such as pneumonia, sepsis or pyelonephritis;

• Progressive inanition as documented by:

• Weight loss of at least 10% body weight in the prior six months, not due to reversible causes such as depression or use of diuretics;

• Decreasing anthropomorphic measurements (mid-arm circumference, abdominal girth), not due to reversible causes such as depression or use of diuretics;

• Observation of ill-fitting clothes, decrease in skin turgor, increasing skin folds or other observation of weight loss in a patient without documented weight;

• Decreasing serum albumin or cholesterol.

• Dysphagia leading to recurrent aspiration and/or inadequate oral intake documented by decreasing food portion consumption.

Symptoms:

• Dyspnea with increasing respiratory rate;

• Cough, intractable;

• Nausea/vomiting poorly responsive to treatment;

• Diarrhea, intractable;

• Pain requiring increasing doses of major analgesics more than briefly.

Signs:

• Decline in systolic blood pressure to below 90 or progressive postural hypotension;

• Ascites;

• Venous, arterial or lymphatic obstruction due to local progression or metastatic disease;

• Edema;

• Pleural/pericardial effusion;

• Weakness;

• Change in level of consciousness.

Laboratory (When available. Lab testing is not required to establish hospice eligibility.):

• Increasing pCO2 or decreasing pO2 or decreasing SaO2;

• Increasing calcium, creatinine or liver function studies;

• Increasing tumor markers (e.g. CEA, PSA);

• Progressively decreasing or increasing serum sodium or increasing serum potassium.

• Decline in Karnofsky Performance Status (KPS ) or Palliative Performance Score (PPS) due to progression of disease.

• Progressive decline in Functional Assessment Staging (FAST) for dementia (from 7A on the FAST).

• Progression to dependence on assistance with additional activities of daily living (see Part II, Section 2).

• Progressive stage 3-4 pressure ulcers in spite of optimal care.

• History of increasing ER visits, hospitalizations, or physician visits related to the hospice primary diagnosis prior to election of the hospice benefit.

Part II. Non-disease specific baseline guidelines (both A and B should be met)

• Physiologic impairment of functional status as demonstrated by: Karnofsky Performance Status (KPS) or Palliative Performance Score (PPS)

• Dependence on assistance for two or more activities of daily living (ADLs):

• Ambulation;

• Continence;

• Transfer;

• Dressing;

• Feeding;

• Bathing.

• 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.

• Chronic obstructive pulmonary disease

• Congestive heart failure

• Ischemic heart disease

• Diabetes mellitus

• Neurologic disease (CVA, ALS, MS, Parkinson’s)

• Renal failure

• Liver Disease

• Neoplasia

• Acquired immune deficiency syndrome

• Dementia

• Aquired Immune Deficiency Syndrome/HIV

• Refractory severe autoimmune disease (e.g. Lupus or Rheumatoid Arthritis)

• See Part III for disease specific guidelines to be used with these 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 required. The only requirement is that the documentation supports the beneficiary’s prognosis of six months or less, if the illness runs its normal course.

Part III. Disease Specific Guidelines Note: These guidelines are to be used in conjunction with the “Non-disease specific baseline guidelines” described in Part II. Cancer Diagnoses

• Disease with metastases at presentation OR

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

• A continued decline in spite of therapy; or

• 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. Non-Cancer Diagnoses Amyotrophic Lateral Sclerosis General Considerations:

• 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.

• However, no single variable deteriorates at a uniform rate in all patients. Therefore, multiple clinical parameters are required to judge the progression of ALS.

• 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.

• 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.

• 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 may significantly alter six month prognosis.

• Examination by a neurologist within three months of assessment for hospice is advised, both to confirm the diagnosis and to assist with prognosis.

Patients are considered eligible for Hospice care if they do not elect tracheostomy and invasive ventilation and display evidence of critically impaired respiratory function (with or without use of NIPPV) and / or severe nutritional insufficiency (with or without use of a gastrostomy tube). Critically impaired respiratory function is as defined by:

• FVC Dyspnea at rest; Orthopnea; Use of accessory respiratory musculature; Paradoxical abdominal motion; Respiratory rate > 20; Reduced speech / vocal volume; Weakened cough; Symptoms of sleep disordered breathing; Frequent awakening; Daytime somnolence / excessive daytime sleepiness; Unexplained headaches; Unexplained confusion; Unexplained anxiety; Unexplained nausea.

• If unable to perform the FVC test patients meet this criterion if they manifest 3 or more of the above symptoms/signs.

Severe nutritional insufficiency is defined as: Dysphagia with progressive weight loss of at least five percent of body weight with or without election for gastrostomy tube insertion. These revised criteria rely less on the measured FVC, and as such reflect the reality that not all patients with ALS can or will undertake regular pulmonary function tests. 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:

• Stage seven or beyond according to the Functional Assessment Staging Scale;

• Unable to ambulate without assistance;

• Unable to dress without assistance;

• Unable to bathe without assistance;

• Urinary and fecal incontinence, intermittent or constant;

• 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:

• Aspiration pneumonia;

• Pyelonephritis;

• Septicemia;

• Decubitus ulcers, multiple, stage 3-4;

• Fever, recurrent after antibiotics;

• Inability to maintain sufficient fluid and calorie intake with 10% weight loss during the previous six months or serum albumin

Note: This section is specific for Alzheimer’s disease and Related Disorders, and is not appropriate for other types of dementia. 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.)

• 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.)

• Patients with congestive heart failure or angina should meet the criteria for the New York Heart Association (NYHA) Class IV. (Class IV patients with heart disease have an inability to carry on any physical activity. 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 less than or equal to 20%, but is not required if not already available.

• Documentation of the following factors will support but is not required to establish eligibility for hospice care:

N/A