We are tracking the progress of all legislation relevant to medical nutrition needs. Legislation refers to a draft of a proposed law; also known as a bill. IFFGD advocates for and promotes improved access to medical foods and nutrition therapy. This page provides information on active medical nutrition bills in the 117th Congress that have an impact on the digestive health community.
What is this a problem?
Many people in need of medical foods and nutrition therapy rely on them for a range of needs. These foods and services help people live day to day with their best quality of life. Some people are partially dependent, while others need medical foods for all their nutrient needs. Nutrients are substances that provide the fuel our bodies need to work. These can be found in all foods and beverages that we eat and drink. People living with gastrointestinal (GI), motility, metabolic, or other disorders are sometimes unable to eat, drink, or properly break down foods. Most people simply eat or drink foods that can be found in grocery stores and at restaurants, while many people cannot. Some people in need of nutrition therapy may be able to eat all or some of their meals by mouth but require strict diets to make sure that they take in enough nutrients. Also, some people may need to take in all or some of their nutrients through a feeding tube or IV catheter. Feeding tubes are inserted into the stomach during surgery and allow food and medicine to go into the stomach through a tube that sticks out of the body. A catheter provided nutrients directly into the blood through a small tube that is inserted in the bloodstream.
These services and foods are very costly. Medical foods are formulated people with specific diet needs. Often nutrients in medical foods are broken down to a simpler level or their most basic level. For any food to be used and absorbed by the body, it needs to be broken down to its basic parts. The stomach and intestines break down the foods we eat, and these foods are designed to feed people when their GI tract cannot break down food. When insurance companies deny coverage of these foods, the lives of those in need are directly impacted. Malnourishment, dehydration, and poor quality of life can occur when people are unable to get the nutrients they need.
What is IFFGD’s Role
The International Foundation for Gastrointestinal Disorders (IFFGD) is a registered nonprofit education and research organization dedicated to informing, assisting, and supporting people affected by GI disorders. IFFGD works with patients, families, healthcare providers, researchers, regulators, employers, and others to broaden understanding about GI disorders, support and encourage research, and improve digestive health in adults and children.
In the 117th Congress there were three bills introduced to improve access to nutrition services. The Medical Nutrition Equity Act, Patient Access to Medical Foods Act, and Medical Nutrition Therapy Act have very similar names but cover different types of nutrition.
- Medically necessary foods:“food, including a low protein modified food product, an amino acid preparation product, a modified fat preparation product, or a nutritional formula” (As defined by the Social Security Act). This includes formulas that provide complete nutrient needs or that have specific nutrients, such as nutrient shakes or formula powders. These can be taken by mouth or through a feeding tube. Broken down foods that are given directly to the bloodstream are also included.
- Medical food: “a food which is formulated to be consumed or administered enterally under the 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.” (As defined by the Orphan Drug Act) This includes formulas that provide complete nutrient needs or that have specific nutrients, such as nutrient shakes or formula powders. These must be taken by mouth or through a feeding tube.
- Medical nutrition therapy: “nutritional diagnostic, therapy, and counseling services for the purpose of disease management which are furnished by a registered dietitian or nutrition professional” (As defined by the Social Security Act). This includes registered dietitian services.
IFFGD is a member of two coalitions with a common goal of supporting those who need medical nutrition therapies and foods. These groups each focus on aspects of the nutrition mentioned above. They are:
- The Patients and Providers for Medical Nutrition Equity Coalition (PPMNE) represents patients and their loved ones maintain their lives and health with medical nutrition products. Members of this coalition include patient organizations, medical centers, and physician societies. This coalition works to educate federal lawmakers about the Medical Nutrition Equity Act, and how important medical foods coverage is for patients. Information on this legislation is found below the comparison table.
- Nutrition and Medical Foods Coalition (NMFC) is dedicated to educating federal lawmakers and the public about medical foods and the communities in need of medical nutrition. Members of this coalition include medical foods companies and patient organizations. This coalition is focused on increasing medical research on how medical nutritional effects diseases. They work to improve regulation, coverage, and reimbursement of medical nutrition and foods. In line with their agenda, this coalition supports all three bills which are described below the comparison table.
Comparing the three Bills:
|Bill Title||Medical Nutrition Equity Act||Medical Nutrition Therapy Act||Patient Access to Medical Foods Act|
|Bill Number||H.R. 3783 / S.2013||H.R. 3108 / S. 1536||H.R. 56|
|Date Introduced||H.R. 6/8/2021 S. 06/10/21||H.R. 5/11/2021 S. 5/10/2021||1/4/2021|
|Sponsor||Rep. McGovern, James P. [D-MA-2] and Rep. Herrera Beutler, Jaime [R-WA-3] Sen. Casey, Robert P., Jr. [D-PA], Sen. Ernst, Joni [R-IA], Sen. Grassley, Chuck [R-IA] and Sen. Rosen, Jacky [D-NV]||Rep. Kelly, Robin L. [D-IL-2] and Rep. Upton, Fred [R-MI-6] Sen. Collins, Susan M. [R-ME] and Sen. Peters, Gary C. [D-MI]||Rep. Andy Biggs [R-AZ-5]|
|Supporting Organizations||Supported by various organizations including Patients and Providers for Medical Nutrition Equity and Nutrition and Medical Foods Coalition.||Supported by Academy of Nutrition and Dietetics.||Supported by the Nutrition and Medical Foods Coalition|
|Legislation Asks||Expands coverage of medical foods.||Expands coverage of medical nutrition therapy services.||Expands coverage of medical foods as prescribed by a healthcare provider.|
|What is Covered||Medical foods defined by the Orphan Drug Act.||Medical nutrition therapy services defined by the Social Security Act.||Medically necessary foods defined by the Orphan Drug Act.|
|Definition of Treatment||
•Prescribed, ordered, or recommended by a physician or other qualified health care professional
• For the partial or exclusive feeding of an individual by means of oral intake or enteral feeding by tube
• Specially formulated and processed product (as opposed to naturally occurring foodstuff used in its natural state)
• For the dietary management of a covered disease or condition
• Used under medical supervision, which may include in a home setting
• By individuals receiving active and ongoing medical supervision
|Expanding disease management to include the prevention, management, or treatment of a disease or condition. These medical nutrition therapy services may be provided by a registered dietitian for individuals with chronic conditions. This may be recommended by a physician, physician assistant, nurse practitioner, clinical nurse specialists, and psychologist.||Medically necessary foods are prescribed by a healthcare provider and are made to be given by tube feeding and by mouth. They are used for managing diseases that have special nutrition needs. These foods must be proven with scientific medical research. This includes people who do not respond to standard treatment. A healthcare provider can decide if treatment with medical foods would be safer option.|
|Insurance Program Included||Medicaid, the Children’s Health Insurance Program, Medicare, the Federal Employee Health Benefit Program, and private insurance||Medicare||Medicare, Medicaid, the Children's Health Insurance Program, TRICARE, and private health insurance.|
|Covered diseases and conditions||
The language in the bill covers the following conditions and leaves additional condition coverage up to the discretion of the Secretary of Health and Human Services.
• Medical or Surgical Condition of Malabsorption
• Inborn Errors of Metabolism and Conditions on the RUSP
• Immunoglobulin E & non-Immunoglobulin E-mediated allergies to food proteins
• Inflammatory or immune mediated conditions of the alimentary tract
• Eating disorders
• Celiac disease
• Any other disease or condition causing unintentional weight loss
• Inherited metabolic conditions
• Conditions with distinctive nutritional requirements that have been recognized by scientific research and medical evaluation • An individual who has failed traditional therapies, and whose physician determines medical foods as the safest treatment option currently available
Medical Nutrition Equity Act
The Medical Nutrition Equity Act of 2021 has been introduced in the House of Representatives as H.R. 3783 and into the Senate as S.2013. This bill seeks to increase coverage of medical foods under Medicare, Medicaid, private insurance, and other specified federal health-care programs. Medical foods include specially formulated and processed products that are designed to treat or manage a specific disease. The table above goes into greater detail of the diseases that would be covered by this proposed bill.
Medical Nutrition Therapy Act
The Medical Nutrition Therapy Act has been introduced in the House of Representatives as H.R. 3108 and in the Senate as S. 1536. This bill seeks to expand coverage of medical nutrition therapy under Medicare. This therapy is provided by a registered dietitian or nutrition professional and is currently covered when prescribed or recommended by a physician. This bill would allow physician assistants, nurse practitioners, and clinical nurse specialists to also recommend these services. The table above goes into greater detail of the diseases that would be covered by this proposed bill.
Patient Access to Medical Foods Act
The Patient Access to Medical Foods Act has been introduced in the House of Representatives as H.R. 56. This bill seeks to change the section of the Orphan Drug Act that defines medically necessary foods and ensure coverage for certain conditions that require them. The medically necessary foods defined in this bill include products that are designed to treat specific diseases. These must be prescribed by a healthcare provider to be covered. The table above goes into greater detail of what would be covered by this proposed bill.
If you would like additional information on these bills, or would like to get involved in supporting one or more, please email firstname.lastname@example.org