[Federal Register Volume 61, Number 117 (Monday, June 17, 1996)] [Notices] [Pages 30619-30621] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-15217] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Comment Regarding Proposed Guidance on the Use of Medical Food and Food for Special Dietary Uses in Older Americans Act Nutrition Programs Agency: Administration on Aging, HHS. The Administration on Aging (AoA), Department of Health and Human Services, is requesting public comment on a proposed Program Instruction regarding the use of medical food and food for special dietary uses in Older Americans Act Nutrition Programs. Type of Request: Public comment. Use: To inform the Administration on Aging decision making process regarding the use of medical food and food for special dietary uses in Older Americans Act Nutrition Programs. Additional Information or Comments: The proposed Program Instruction provides guidance regarding the appropriate use and federal funding of medical food and food for special dietary uses in Older Americans Act (OAA) Nutrition Programs for States, Tribes and Area Agencies on Aging. [[Page 30620]] Background The aging network is being challenged to serve an increasing number of frailer, functionally impaired older individuals. Many community dwelling elders are at increased nutritional risk due to chronic/acute diseases and conditions, including, but not limited to, physical, oral and mental health problems, that remain after discharge from acute, subacute or long-term care facilities. With development of home and community-based long-term care services, the aging network has been called upon to meet nutritional needs of elders that go beyond the typical one-meal-a-day service. State Units on Aging (SUAs), Area Agencies on Aging (AAAs), and Nutrition Service Providers (NSPs) have expanded nutrition services beyond meals to meet the varying nutritional needs and functional capabilities of growing numbers of impaired elders. Private industry has also recognized the expanding home and community care market. As care of frailer elders has expanded beyond hospitals and nursing homes, pharmaceutical companies have begun marketing products to home health agencies, home and community-based care providers, nutrition service providers, caregivers, and elders themselves. Companies have developed a wide range of products, such as thickeners, shake-type beverages, soups, bars, puddings, cookies, etc., which are specifically formulated and labeled to meet the nutritional requirements or dietary needs of elders who, due to a disease or health-related condition, cannot meet their nutritional requirements using only conventional food. While often known by a variety of names, such as nutrition supplements, ``liquid meals,'' oral supplements, the most appropriate statutory terms are medical food and food for special dietary uses. Although some SUAs, AAAs, and NSPs across the country have developed policy regarding the use and funding of these special products, AoA has not provided guidance on this topic in the past. Terminology Public Law 100-290, The Orphan Drug Amendment of 1988, April 18, 1988, defines medical food as food which is formulated to be consumed or administered entirely under supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. According to section 201 of the Federal Food, Drug, and Cosmetic Act of 1932, as amended, the term food for special dietary uses, as applied to food for man, means particular (as distinguished from general) uses of food, as follows: (i) uses for supplying particular dietary needs which exist by reason of a physical, physiological, pathological or other condition, including but no limited to the conditions of diseases, convalescence, * * * underweight and overweight; (ii) uses for supplying particular dietary needs which exist by reason of age, * * *; (iii) uses for supplementary or fortifying the ordinary or usual diet with any vitamin, mineral or other dietary property. Food and Health Every effort should be made to meet the special nutritional needs of elders by using conventional food. Food meets physiological needs for energy, nutrients and bulk (fiber). Food also has important physchological, social and functional value. Conventional food and beverages, particularly those that are nutrient dense are always the first therapeutic approach to improving or modifying diets for individuals who can consume regular food and beverages and are not severely malnourished. Texture modification of regular food is the first approach to chewing or swallowing problems. At times, however, regular foods and beverages, even those modified in texture or nutrient content, may not be enough. It may then be appropriate to consider medical food and food for special dietary uses. Medical nutrition therapy is the assessment of the nutritional status of an individual with a condition, illness, or injury that puts them at nutritional risk and the provision of nutrition support either as diet modification and counseling or as specialized nutrition therapies designed to achieve nutritional goals and desired health outcomes. Specialized nutrition therapies may include the use of medical food and food for special dietary uses that are administered by oral (mouth) and non-oral (nasogastrically, enterally (gut)) routes. Medical food and food for special dietary uses that are administered parenterally (by vein) are classified as drugs. Nutrition support may be an important component of the clinical management of chronic diseases, such as heart, lung, kidney diseases, stroke, diabetes, and some types of cancer. Nutrition support may also be a clinical management component used in the treatment of acute conditions, such as fractures, pre/post surgery, burns and other traumas. Oral health problems, more prevalent among older individuals, may require nutrition support. Oral health problems, such as loss of teeth, gingivitis, changes in salivary function and sense of taste, affect chewing and swallowing and alter the type and quantity of food that can be eaten. Mental health problems, such as dementia, depression and Alzheimer's disease, interfere with dietary quality and quantity and therefore may need nutrition support. Medication side effects influence appetite and mental functioning. Texture modification (chopping, pureeing, thickening, blending) and supplementation (additional protein, carbohydrate, fat, fiber) of conventional food are considered nutrition support for some physical, oral and mental problems. Policy Instruction Subpart 132.11 of the current OAA regulations state that: (a) The State agency on aging shall develop policies governing all aspects of programs operated under this part * * * These policies shall be developed in consultation with other appropriate parties in the State * * * A Tribe is likewise expected to develop policies governing program operations. A State or Tribe may choose to allow the provision of medical food and food for special dietary uses and to use OAA and USDA funds if the SUA or Tribal policy complies withStatutory terminology for medical food and food for special dietary uses; Appropriate Use Guidelines (stated below) for substitution for a meal component(s) and/or replacement of a conventional meal; and Federal, State, Tribal, and local laws, regulations, policies and guidelines. Appropriate Use Guidelines AoA would allow funding and USDA would reimburse on a per meal basis for medical food and/or food for special dietary uses when: Criteria for the allowable medical food or food for special dietary use are met; There is a recommendation by an appropriate health professional such as a physician or registered/licensed dietitian as part of an overall medical nutrition therapy plan for the individual and the plan is periodically reevaluated and updated; The individual is provided with a minimum of 33\1/3\ percent of the Recommended Dietary Allowances established by the Food and Nutrition Board of the National Research Council of the National Academy of Sciences, except in cases where the individual's [[Page 30621]] specific medical nutrition therapy plan dictates otherwise; and If the medical food and/or food for special dietary uses is/are used as a: Substitution for part of the conventional meal components, the combination of the medical food or food for special dietary use and conventional foods must meet the above criteria; or Replacement of a conventional meal, they must meet the above criteria and consumption of a conventional meal, even with modifications, had been considered but is contraindicated. When a medical food and/or food for special dietary uses are provided in addition to a conventional meal, AoA and USDA view the meal and medical food or food for special dietary uses together as constituting a single meal and would not reimburse separately. Additional Information A paper, ``Use of Medical Food and Food for Special Dietary Uses in Elderly Nutrition Programs'', authored by the National Policy and Resource Center on Nutrition and Aging (Center), summarizes the appropriate use of medical food and food for special dietary uses in a question and answer format. In addition, the Center has compiled information on state policies on this topic, ``State Policies on Provision of Medical Food and Food for Special Dietary Uses.'' Both publications are available from the Administration on Aging, Office of State and Community Programs; please call (202) 619-0011 for copies of the paper and compilation. Written comments and recommendations regarding the proposed guidance should be sent within 60 days of the publication of this notice directly to the following address: Edwin L. Walker, Director, Office of Program Operations and Development, Administration on Aging, 330 Independence Avenue, SW., Washington, DC 20201. Dated: June 5, 1996. William F. Benson, Deputy Assistant Secretary for Govenmental Affairs and Elder Rights. [FR Doc. 96-15217 Filed 6-14-96; 8:45 am] BILLING CODE 4150-04-M