(a)  As used in this section:

(1)  “Enteral nutrition” means a supplemental feeding that is provided via the gastrointestinal tract by mouth (orally), or through a tube, catheter, or stoma that delivers nutrients distal to the oral cavity.

(2)  “Nutritional risk” means actual or potential for developing malnutrition, as evidenced by clinical indicators, the presence of chronic disease, or increased metabolic requirements due to impaired ability to ingest or absorb food adequately.

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(b)  The department shall provide for vendor payment of enteral nutrition products, in accordance with rules and regulations of the department, when determined to be medically necessary on an individual, case-by-case basis and ordered by a physician in accordance with Rhode Island department of health form(s) on enteral nutrition products.

(c)  Protocols for the use of enteral nutrition as a medically necessary treatment for malabsorption caused by Crohn’s disease, ulcerative colitis, gastroesophageal reflux, chronic intestinal pseudo-obstruction, and inherited diseases of amino acids and organic acids may be developed by the director. The determination of medical necessity for enteral nutrition products shall be based upon a combination of clinical data and the presence of indicators that would affect the relative risks and benefits of the products including, but not limited to:

(1)  Enteral nutrition, whether orally or by tube feeding, is used as a therapeutic regimen to prevent serious disability or death in a person with a medically diagnosed condition that precludes the full use of regular food.

(2)  The person presents clinical signs and symptoms of impaired digestion malabsorption, or nutritional risk, as indicated by the following anthropometric measures:

(i)  Weight loss that presents actual or potential for developing malnutrition, as follows:

(A)  In adults, showing involuntary or acute weight loss of greater than, or equal to, ten percent (10%) of usual body weight during a three-(3) to six-month (6) period, or body mass index (bmi) below 18.5 kg/m2;

(B)  In neonates, infants, and children, showing:

(I)  Very low birth weight (lbw), even in the absence of gastrointestinal, pulmonary, or cardiac disorders;

(II)  A lack of weight gain, or weight gain less than two (2) standard deviations below the age-appropriate mean in a one-month period for children under six (6) months, or two-month (2) period for children aged six (6) to twelve (12) months;

(III)  No weight gain or abnormally slow rate of gain for three (3) months for children older than one year, or documented weight loss that does not reverse promptly with instruction in appropriate diet for age; or

(IV)  Weight for height less than the tenth (10th) percentile; and

(ii)  Abnormal laboratory test pertinent to the diagnosis.

(3)  The risk factors for actual or potential malnutrition have been identified and documented. Risk factors include, but are not limited to, the following:

(i)  Anatomic structures of the gastrointestinal tract that impair digestion and absorption;

(ii)  Neurological disorders that impair swallowing or chewing;

(iii)  Diagnosis of inborn errors of metabolism that require medically necessary formula used for specific metabolic conditions and food products modified low in protein (for example, phenylketonuria (pku) tyrosinemia, homocystinuria, maple syrup urine disease, propionic aciduria and methylmalonic aciduria);

(iv)  Prolonged nutrient losses due to malabsorption syndromes or short-bowel syndromes, diabetes, celiac disease, chronic pancreatitis, renal dialysis, draining abscess, or wounds, etc.;

(v)  Treatment with anti-nutrient or catabolic properties (for example, anti-tumor treatments, corticosteroids, immunosuppressant, etc.);

(vi)  Increased metabolic and/or caloric needs due to excessive burns, infection, trauma, prolonged fever, hyperthyroidism, or illnesses that impair caloric intake and/or retention; or

(vii)  A failure-to-thrive diagnosis that increases caloric needs while impairing caloric intake and/or retention.

(4)  A comprehensive medical history and a physical examination have been conducted to detect factors contributing to nutritional risk.

(5)  Enteral nutrition is indicated as the primary source of nutritional support essential for the management of risk factors that impair digestion or malabsorption, and for the management of surgical preparation or postoperative care.

(6)  A written plan of care has been developed for regular monitoring of signs and symptoms to detect improvement in the person’s condition. Nutritional status should be monitored regularly:

(i)  For improvements in anthropometric measures;

(ii)  For improvements in laboratory test indicators; and

(iii)  In children, to assess growth and weight for height.

(d)  Enteral nutrition products shall not be considered medically necessary under certain circumstances including, but not limited to, the following:

(1)  A medical history and physical examination have been performed and other possible alternatives have been identified to minimize nutritional risk.

(2)  The person is underweight, but has the ability to meet nutritional needs through the use of regular food consumption.

(3)  Enteral products are used as supplements to a normal or regular diet in a person showing no clinical indicators of nutritional risk.

(4)  The person has food allergies, lactose intolerance, or dental problems, but has the ability to meet his or her nutritional requirements through an alternative food source.

(5)  Enteral products are to be used for dieting or a weight-loss program.

(6)  No medical history or physical examination has been taken and there is no documentation that supports the need for enteral nutrition products.