Comments were received from a company that produces nutrition products and from a council that represents manufacturers of parenteral and enteral nutrition formulas, supplies, and equipment. Their recommendations for changes to the proposed regulation were identical.

The commenters suggested that the regulation should specifically provide coverage for persons with certain medical conditions that involve intestinal malabsorption, or who have reduced appetite/anorexia or dental/mouth problems. The Department has concluded that the current regulation would cover the conditions cited by the commenters, assuming the coverage criteria set forth in the proposed regulation are met. This is consistent with the authorizing statute, Social Service Law § 365-a(2)(g), which requires the Department to establish standards for coverage of enteral formula therapy and nutritional supplements for “persons with a diagnosis of HIV infection, AIDS or HIV- related illness or other diseases or conditions” (emphasis added). A modification to the existing language solely to list specific diagnoses or conditions is unnecessary. No change was made to the regulation as a result of this comment.

The commenters recommended an expanded set of criteria in those instances where a beneficiary demonstrates acute weight loss. The proposed regulation would cover individuals with a body mass index (BMI) under 22 who also demonstrate an unintentional weight loss of 5 percent or more within the previous six-month period. The commenters recommended eliminating the requirement for a BMI under 22, and providing coverage for any individuals with a chronic medical diagnosis who have a 5 percent weight loss within a one-month period, a 7.5 percent weight loss within a three-month period, or a 10 percent weight loss within a six-month period. It is the Department’s position that the proposed regulation is consistent with its intent to cover enteral nutritional formula for the most medically compromised and at-risk beneficiaries suffering acute weight loss, and that the nutritional needs of most Medicaid beneficiaries can be maintained without the use of enteral nutritional formulas through proper diet and/or nutritional modifications. No change was made to the regulation as a result of this comment.

The commenters recommended expanding coverage to patients with swallowing or chewing difficulty due to cancer of the mouth, throat, or esophagus, or due to injury or surgery involving the head and neck. However, the proposed regulation provides coverage for persons who have a permanent structural limitation that prevents the chewing of food and for whom the placement of a feeding tube is medically contraindicated. This is consistent with the Department’s intent to limit coverage to individuals who will have a long-term reliance on enteral nutritional support as their sole means of nutrition. Individuals who do not have a permanent limitation preventing the chewing of food would typically be capable of eating solid foods, or other forms of solid food, such as liquefied, mashed, or pureed foods, to meet their nutritional needs. No change was made to the regulation as a result of this comment.

In addition, one commenter suggested that coverage under the proposed regulation should not be limited to underweight persons, citing a research paper on hospital malnutrition stating that overweight or obese adults who develop a severe acute illness may require nutritional intervention. However, any hospitalized Medicaid recipient is covered for nutritional support, if medically necessary, through the inpatient hospital benefit. No change was made to the regulation as a result of this comment.