[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 with
    <bullet> Statutory terminology for medical food and food for 
special dietary uses;
    <bullet> Appropriate Use Guidelines (stated below) for substitution 
for a meal component(s) and/or replacement of a conventional meal; and
    <bullet> 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:
    <bullet> Criteria for the allowable medical food or food for 
special dietary use are met;
    <bullet> 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;
    <bullet> 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
    <bullet> If the medical food and/or food for special dietary uses 
is/are used as a:
    <bullet> 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
    <bullet> 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