[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]
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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
Statutory 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
