The Tolerance Induction Program™ (TIP)

Pre-treatment will include a recommended diet of foods, some of which your child likely already eats, in a set amount 3-5 times per week.

Conditioning involves passing a “high dose” of foods in the sensitized column on your child's snapshot. After safely passing challenges to these foods that contain key or biosimilar proteins, such as albumins, your child's “food cluster” is pulled toward the tolerant column. Treating these biosimilar proteins shifts anaphylactic proteins from the anaphylactic column to the sensitized column, making treatment of these proteins safer and more successful. 

 

Using complex data analytics and statistics, your child will undergo tolerance induction for the proteins they are anaphylactic to. The first dose is introduced in the Food Allergy Institute clinic, and every subsequent dose is administered at home. Passing every up-dose predicts your child's ability to pass the next up-dose, eventually leading to a full challenge pass. No guesswork is done here. Your child's data analysis predicts their path to success. Once a challenge is passed, your child will eat a maintenance dose of that food for a period of time until their blood work reveals tolerance. At this point, daily dosing will become less frequent.

Remission is achieved when all food allergens are moved to the tolerant column. This means your child will only have weekly maintenance dosing and can eat food safely whenever they want without restrictions or the need to read labels.

Onboarding Process

Onboarding is the first direct interaction your child has with our program. This process includes an interview based on the information provided in your enrollment intake forms. During this visit, your child will also undergo a physical exam, a skin prick test, and blood testing. The results from these diagnostic tests, along with other data analytics, will help us determine the safest treatment plan for your child. These results will be discussed at your next appointment, the Launch Visit.

All patients receiving TIP treatment require a comprehensive evaluation of their immune system. This evaluation involves skin prick and blood testing, allowing our medical team to assess over 300 biomarkers for your child. The outcome of the intake process is a molecular snapshot of how your child's immune system responds to allergens, which will be presented at your Launch Visit.

During the onboarding visit, we will validate the information from the Food Intake Questionnaire to ensure the accuracy of your child's food dosing strategy. Additionally, we will address medical questions, particularly concerning medications that may impact treatment and any other medical conditions related to the lungs, GI tract, and skin.

Food Intake Questionnaire 
During enrollment, you will be asked to fill out a detailed history of your child's consumption. This is the most important first step in the program, understanding consumption patterns and food introduction is crucial to the creation of your child's medical plan. The foods that your child is currently eating will be recorded. You will be asked details about how much they eat and how often they are consumed.

Medical history Questionnaire
Collecting your child's medical history and evaluating them for potentially undiagnosed conditions is important at this stage. Although it may not seem applicable, almost any condition can potentially affect the success of their treatment plan. It is important for us to know as much about their medical history as possible, both regarding their allergies but also in all other areas such as gastrointestinal, pulmonary, cardiovascular, endocrine, and psychological.

Type of Testing During Visit
Blood Testing: Maximum blood laboratory testing is completed at our facility. We collect third-generation component-resolved diagnostic blood tests to identify IgE specific to individual proteins within an allergic food. This improves predictive clinical reactivity. Additionally, specific IgE blood testing (RAST or immunoassays) identifies IgE to whole allergens.

Skin Prick Test: Skin prick tests provide important information about IgE-mediated allergies, which are one of the many data points that help us design a custom treatment plan for each patient. This diagnostic tool utilizes a sharp prong to superficially break the skin and allow measurement of the histamine response to specific food allergens.

Patients will have the skin prick test performed on their back at our clinic. The pricks are made with a sharp edge, not a needle. Results are collected and given to parents at their Onboarding Visit. While this test provides useful data, it is only one aspect of the patient's complete allergic profile.

Frequently Asked Questions
Although you will likely have lots of questions during the Tele-Boarding call regarding your child and TIP, we may not be able to answer all of them without having all of your child's data. This is our discovery call, learning about your child and collecting all of the information allows us to tailor the diagnostic testing and build their unique allergic profile. Once this information is collected and analyzed at your Launch Visit, we will be better equipped to answer all of your questions. 

How long will my program be?
There are a number of factors that determine the length of treatment. Age, severity of allergens, type of allergen, family history, health history, etc. are all considered when designing your child's unique protocol. The length of treatment will vary based on each child's individual plan.

Why do I have to test at/with TPIRC Diagnostics? 
TPIRC Diagnostics is a CLIA and COLA Certified, high complexity laboratory focused on supporting the diagnostic requirements for our treatment. Our lab is currently the only diagnostic facility that is able to perform the complete set of tests necessary to develop and maintain the treatment plans utilized in the Tolerance Induction Program. Our pediatric phlebotomists perform the blood draw at the clinic after you have completed your clinic appointment. 

When will I get the results?
You will receive a complete copy of your child's test results at your Launch Visit.

How often will my child need repeat blood testing? 
Generally, patients have repeat labs and a full analysis completed every 1-2 years. Like other medical conditions, therapeutic monitoring is key to safety and successful treatment.

Why does there need to be repeat lab testing?
Tests will be compared to the same tests that were obtained before starting treatment so we can evaluate changes in your child's immune system and see how it has responded to conditioning treatment in preparation for tolerance induction. The results will be analyzed to confirm the appropriate response of the immune system has occurred. TIP is based on mathematical data analytics, not guesswork. Tracking these changes over time ensures the safety of our patients. Adjustments to the treatment of anaphylactic food will be made based on these lab results.

Will I see the same physician throughout my treatment?
While in our program, your child will meet with many members of our team. Through our Pod Model, we use data analytics to assign your child to the pod that is best for them after their Launch appointment. The pod allows your child to see the same medical assistants and providers during each visit.

Will we get to meet Dr. Randhawa?
Though Dr. Randhawa is not able to see every patient, he is very involved in the program and creates the treatment plans for every patient. All of our providers are trained to execute and implement the treatment plans in a safe manner. 

Does my child have to stop eating certain foods during the program?
Generally, we recommend continuing your child's current diet. The physician may make recommendations based on your child's specific case, but we typically recommend to continue to eat the foods they have been consuming previously without symptoms. Remember that decisions made for treatment consider a combination of all data that is being collected.

When and Where Will My Onboarding Visit Be?
Your Onboarding Visit will occur 2 - 4 weeks after your Tele-Boarding Visit at one of our California clinics. 

Will my child need SLIT?
Pre-treatment may also include targeted treatment (specific to your child's case) of environmental allergies utilizing Sublingual Immunotherapy (SLIT). SLIT is a safe and effective approach that has been used to treat environmental allergies for over 60 years. Approximately 45% of our patients are required to go on SLIT to facilitate their food allergy treatment process. Your family will be instructed if your plan requires SLIT. This is generally discussed at your Launch Visit.

Do I have to stop all antihistamines prior to Onboarding?
Please stop using topical antihistamines and oral antihistamines 7 days prior to the skin prick test as these medications can interfere with the accuracy of results.

Next Visit
You will schedule your next visit, which is your Launch appointment at the conclusion of your Onboarding appointment:

Zone 1: This appointment is 2 days in length, approximately 8 weeks from your onboarding. 
Zones 2/3: This appointment is 5 days in length, approximately 12 weeks from your onboarding.

During your Launch Visit, a physician will review your child's results and TIP treatment plan with you.

Purpose
The Launch Visit allows our providers to collect your child's data, create their individualized dosing strategy, and make recommendations to prepare their system for food immunotherapy.

What will I receive at my Launch appointment?

• Your child's blood test results
• Your child's snapshot
• Your child's food dosing strategy

Throughout your child's 2-5 day Launch Visit, your child will undergo a 24-hour patch test and meet with one of our physicians to review the results and their treatment plan, based on our analytics. Patients will also complete their first Food Challenge at this visit.

 

Zone 1: This appointment is 2 days in length, approximately 8 weeks from your onboarding. 
Zones 2/3: This appointment is 5 days in length, approximately 12 weeks from your onboarding.

Day 1: Patch Day
During day 1, a patch that contains physical food allergens will be placed on your child's back. This enclosed patch will remain on your child's back for 24 hours. This allows us to assess how your child's GI tract reacts to various allergens. Please keep the patch clean and dry, avoiding bathing and any heavy activity or sweating during the test. Children 7 years of age and older will have a Pulmonary Function Test (PFT). 

What is a Patch Test?
Patch tests are used to detect possible food allergies and gastrointestinal sensitivities. The patch test measures conserved, innate immune responses to food allergens via the closed (air-tight) application of food allergens to the skin, followed by measurement of the immune response 24 hours later.

The patch test allows FAI to assess how the patient's gastrointestinal tract reacts to various allergens, as the dendritic cells in the skin mimic those in the stomach. This test differs from ImmunoCap blood tests or skin prick tests, which are used to evaluate immediate reactions that may result in symptoms such as hives or anaphylaxis.

Combining patch testing and skin prick testing helps us identify foods that are causing allergic symptoms. This appointment lasts approximately 30 minutes. The enclosed patch will remain on your child's back for 24 hours, and the results will be ready the next day, at your Launch appointment.

What allergens are in the patch test?
The same allergens on the skin prick test are on the patch test. The patch test is testing for a different immune response than the skin prick test.

Has anyone had anaphylaxis due to the patch test?
We have placed thousands of patch tests and have never had a patient who developed anaphylaxis due to a patch test.

Can I give an antihistamine if it is itchy?
Yes, you can give Benadryl if your child is experiencing itching. This will not interfere with the test results.

Pulmonary Function Testing (PFT)

What is a PFT?
Pulmonary Function Testing (PFT) is a well-established modality of testing for evaluating lung volume, capacity, rates of flow, and gas exchange. An exhaled Nitric Oxide test (Fractional Concentration of Exhaled Nitric Oxide Oxide - FeNO) can assist with determining how much inflammation is present in the airways.

Why does my child need a PFT?
Children 7 years of age and older will have a Pulmonary Function Test (PFT) and exhaled Nitric Oxide (ENO) test completed. Children younger than 6 are generally not developmentally capable of completing the tests as they require a level of coordination. These tests are performed so that we can evaluate your child's airway reactivity and identify potential complications in an effort to maximize safety.

How often will my child need a PFT?
These tests will be performed periodically throughout treatment based on your child's specific needs.

Day 2: Launch Day
During your Launch day, your patch is removed and results are recorded while you meet with one of our physicians to review the results and your child's treatment plan. Our staff will thoroughly review your at-home dosing regimen with you, and your child will complete their first food challenge.

Day 3-5: Food Challenges
Zone 2/3 patients will have 3 additional days of food challenge appointments scheduled during their Launch Visit. 

With a complete diagnostic profile completed at the Launch Visit, our physicians are now able to better answer questions about your child and their individual plans. If you have any questions about the program, our physician will be happy to answer those for you at this visit.

Next Visit 
Once your Launch Visit is complete, you will enter the next phase of the program - Food Challenges.

Purpose
The goal of a Food Challenge Visit is to appropriately cross-match your child's highest-risk food allergens to associated biosimilar proteins, which were measured during the intake process of the program.

If your child is successfully exposed to proteins at home, their chance of passing their calculated challenge is over 95%. However, safety is always our top priority. Your child's first exposure to any food will always occur in our center. Subsequent dose exposure will be graded and targeted against the amount of time it takes for your child's system to adapt.

At the end of a treatment cycle, your child will undergo a monitored, safe, comprehensive food challenge to a predetermined large amount of food protein, which then closes that cycle of treatment. Your child will repeat these cycles over months to years, ultimately reaching tolerance visits and remission.

What is a challenge? 
A food challenge is a monitored office visit where your child will consume a large amount of a sensitized allergen followed by exercise to ensure safe consumption at home. After each challenge, these foods will move into your child's maintenance plan.

What is an Introduction?
Introductions are monitored office visits where we will introduce a new conditioning food in small amounts. These allergens are always given in higher amounts in the office compared to at-home dosing and will be monitored for 15 minutes. Introduction foods will be taken home and built up over the treatment weeks before returning to the clinic to challenge larger dose amounts.

The Visit - Food Challenges
During Food Challenge Visits, your child will come into the clinic for a monitored consumption of an allergen they have been sensitized to with previous dosing.

After each successful challenge, these foods will move from dosing into your child's maintenance plan. We will also introduce new conditioning foods to your child during these visits, adding new allergens into your at-home dosing plan.

Each treatment plan requires a different number of visits to complete all Food Challenges. There will be a period of weeks (depending on zone) between each visit for your child to complete their at-home dosing plan before the next challenge.

Who will my challenge be with? 
Food Challenges are conducted by specialty, food allergy-trained Nurse Practitioners and Physician Assistants. Due to our specialty niches within allergy, our providers complete a specialized curriculum, training, and certification here at FAI.

How long are my visits? 
Challenge Visits are 60 minutes long. We can challenge a total of 3 foods safely. If your child is a slow eater or requires more time, please consider booking additional challenge days to complete these foods.

What will my challenge visit look like?
At the beginning of the visit, your provider will review your child’s progress, illnesses, and issues. Your provider will perform a physical exam to make sure he/she is ready for the visit. Your child will challenge foods you have been dosing at home in higher amounts and introduce new foods while our providers monitor how your child’s system responds. After the challenges and introduction are complete, your provider will review your child’s plan for the next dosing cycle.

Gummy Dosing
While your child is building on small, milligram amounts of doses, they will be provided in gummy form until your child is ready to start larger doses. The Tolerance Induction Program fee will include the food dosing for at-home dosing and in-house food challenges. We provide our patients with pharmaceutical-grade gummy doses for their at-home regimens for all doses that cannot be measured on a traditional measuring spoon set. 

What is a TIP Gummy?
TIP gummies are a fun and tasty way to fight food allergies! Each of our gummies contain a milligram amount of a nut, grain, seed, or legume. They also come in a variety of colors, shapes, flavors, and sizes so our patients can easily know what they're eating! In total, we have 143 unique gummy products that we provide our patients! Each of these products were developed specifically for our patients by our TIP specialized Food Laboratory Scientists.

Why a gummy?
Safety is our top priority. Through the use of mathematics and predictive analytics, we use each child's data to devise a treatment process that is specifically tailored to his or her immune system -- down to the milligram of food protein for each dose throughout the program. As we expand, it is vital to the program that we continue to produce these doses with near-zero error and that we continue to automate the process in order to meet the growing demand as we increase access to more families. The gelatin process allows for accomplishing each of these objectives.

What is in the gummy?
Aside from the specific nut proteins, which are sourced from organic companies and prepared to avoid cross-contamination, they are beef gelatin-based and required for the program. Gummies contain beef gelatin, sugar, food coloring, and safe preservatives (ingredients are consistent with those found in Jello brand gelatin found at grocery stores). These ingredients are used to differentiate each nut, provide the appropriate doses, and extend the gummies' shelf lives. Gummies are required for the program. 

Do I have to use the gummy?
Certain allergy doses are required to be given in gummy form. Gummy dosing is not optional. Gummy doses are a component of quality control and part of the TIP program. Preferences to avoid sugar and/or food dyes are not approved exceptions.

Please be advised that all gummies are beef gelatin based, no exceptions. If the consumption of animal products is necessary to ensure the patient safely reaches tolerance, we may ask the patient to consume animal products.  For religious purposes, patients are asked to request an exemption from their religious leader. 

In some cases, patients with severe beef allergy will not be given gummies until successfully clearing their beef allergy with microdosing of the actual protein. This is determined on a case by case basis.
How long will I be on gummy dosing?
When dosing small milligram amounts, your child will be treated with gummies. Once your child successfully progresses to large protein amounts, you will no longer dose with gummies and instead measure these proteins in teaspoon amounts.

Next Visit
You will repeat Food Challenge cycles over months to years of time. Once you have successfully challenged and moved each allergen to Tolerant on your snap shot, you will schedule your first of two Tolerance appointments. 

Purpose
Tolerance is defined as an immunological state where your child can consume previously anaphylactic foods at large dose exposures without any clinical reactivity or negative immunological responses.

The process of tolerance is measured from the beginning of the program, through analytics and lab results, to Tolerance Visits. At this time, the immune system is put through a state of stress, preparing it for remission.

During this phase of your program, your provider will encourage you to try something new one day of every week! Stop reading food labels, eat cross-contaminated foods, and enjoy the final step towards food freedom.

Tolerance Challenges ramp up your child's most allergic protein or proteins followed by a scheduled day to stress the immune system with a variability of protein exposure. This is an important step in long-term Remission success.

Tolerance Visit 1 
Tolerance Visit 1 is generally the last “visit” listed on your child's food dosing strategy.

Tolerance Visit 2 
Tolerance Visit 2 is the following visit and the visit prior to reaching Remission.

Why are there Tolerance Visits?
During the challenge cycles, your child needs daily exposure to proteins. In the next stage of TIP, your child will undergo a systematic transition away from daily protein exposure and will reduce their frequency of maintenance foods. This crucial transition phase prepares their immune system for successful sustained immune unresponsiveness during Remission. Routine exposure is key in keeping the tolerance your child has built up during the program.

The end of recommended foods
With a successful transition into Tolerance, the good news is that recommended foods will be a thing of the past! Although we always encourage a healthy snack, these foods will no longer be an important part of your TIP journey.

Next 
You will then come for your Remission Visit, the final visit before achieving Food Freedom! 

Purpose
Remission is a scientific and immunologic term defined as sustained unresponsiveness. Remission is signaled by a seven-day period between which your child ingests a very large serving of a previously anaphylactic food without any clinical or immunologic reaction. Seven days later, the same ingested amount results in the same response without any exposure in between the seven-day period.

This model of weekly dose exposure at high amounts inducing sustained unresponsiveness is critical to the Tolerance Induction Program. Your child will be reevaluated on an annual basis to review their state of remission.

What is TIP Remission?
Remission is the absence of signs or symptoms of a disease process. TIP Remission is a state of immune unresponsiveness with once-weekly protein exposures. This simply means that your child will essentially eat like a non-allergic person.

Remission Visit 1
This visit is your first Remission Visit. This is a large challenge to your child's highest allergen or allergens. Once your child successfully completes this challenge, all of the maintenance foods move to once weekly. The Remission Visit is essentially a stress test of your child's immune system. We are testing its ability to handle normal variations of exposure in your child's regular diet. Once your child has successfully completed the challenge and monitoring period, they are in Remission and free to eat whatever they want!

Maintenance Changes
Your provider will go over any additional maintenance and plan changes. They will review how to handle changes in your day-to-day routine. Since this will be the last time we see you until next year, we want to ensure you have the information you need.

What's Next?
Remission is the final TIP phase. This is when your child reaches food freedom! Once you have reached Remission, your child can eat like a non-allergic person. We do require annual visits and diagnostic testing so we can continue to monitor your child's system and adjust their maintenance plan as needed.

Annual Remission Visits
Like all other medical conditions, it is important to have annual checkups to ensure that your child's tolerance levels are on the right track. These visits ensure that all of your hard work, time, and investment into food freedom lasts a lifetime. If consuming your child's prior allergen weekly is going well, there is a good chance we can space out your dose intervals to every two weeks and beyond once their body is ready. 

Once in Remission, it is still important for your child to continue consuming their dosing/allergens, since we want them to maintain their state of immune unresponsiveness. 

Lifelong Remission
We are committed to lasting Food Freedom for all of our patients. We understand the amount of time and effort that went into reaching Remission. Our journey with you doesn't end there. We are committed to keeping our patients in Remission for life. That means we will continue to follow patients for the rest of their lives to ensure that they stay in Remission.

 

To obtain details about insurance coverage, we recommend reaching out to your insurance provider by using the contact number provided on the back of your insurance card. Please provide them with the CPT codes listed and the information below.

Zone 1 patients visit the clinic in person every 6 - 8 weeks for 1 - 2 days of challenge appointments.

 

Estimated cost of  TIP years 2 +

 

*Number of in-clinic food challenges may vary depending on the individual patient and their plan; patients can expect 8 - 12 in-clinic food challenges per year.

Additional Out-of-Pocket Costs

Some patients will require the use of SLIT (Sublingual Immunotherapy) during the course of treatment; the cost of SLIT averages $300 per quarter / $1200 per year.  

 

To obtain details about insurance coverage, we recommend reaching out to your insurance provider by using the contact number provided on the back of your insurance card. Please provide them with the CPT codes listed and the information below.

 Zone 2/3 patients visit the clinic in person every 9 - 12 weeks for 3 - 5 days of appointments. 

 

 

Estimated cost of TIP year 2 +

 

*Number of in-clinic food challenges may vary depending on the individual patient and their plan; patients can expect 8 - 12 in-clinic food challenges per year.

Additional Out-of-Pocket Costs

Some patients will require the use of SLIT (Sublingual Immunotherapy) during the course of treatment; the cost of SLIT averages $300 per quarter / $1200 per year.

Dependent on your exact plan, Food Allergy Institute clinical services is typically in-network with the following carriers:

• Aetna 
• Meritain Health (Aetna)
• Cigna
• Health Partners (Cigna)
• Blue Shield of California
• Anthem Blue Cross of California
• United Healthcare
• Oxford Health 
• UMR
• Healthnet of California
• Multiplan
• First Health 
• Blue Cross Blue Shield (Outside of CA)
• Tricare

The following information has been prepared to help you understand how we work together to make sure you have the information you need to meet your financial responsibilities for the care and services you receive. 

Portions of Clinical and TPIRC Diagnostic Services fees may be covered by your insurance. Food Allergy Institute is in network with most major PPOs. Kaiser and most HMOs are out of network plans and will not be covered, you will be billed at cash pay rates.

Know Which Services Your Insurance Will Cover  
Insurance may cover portions of your clinic fees and lab draw. The TIP Fee will always be an out of pocket expense. To determine your clinic and lab financial responsibility in advance of your consultation, please submit your insurance card using the link provided. You can also use the list of CPT codes to contact your insurance company directly.

Health insurance coverage is a contract between you and your insurance company. It is best if you know which services your insurance will cover before you receive care. If you’re not sure of your coverage, please ask your insurance company. Please refer to the information on the back of your insurance card for the contact number to member services.    

Insurance Billing

Contracted coverage: FAI contracts with several national insurance companies in the California region. If we are in your health plan’s network, our billing office will submit claims to your insurance company for the care and services you receive from us. You will be expected to pay any cost shares at the time of service.  

Non-contracted: You are responsible for the full cost of the care and services you receive. If you owe a balance, or if your insurance company does not pay your claim within 45 days, the balance will be billed to you. 

Copayments, Deductibles and Other Patient Cost Shares: Please plan to pay your copayment at the time you receive care or services. The amount charged will be based on your specific insurance plan. We may also ask you to pay any money owed for non-covered services, and any other cost shares at the time of service. If you are not able to pay these amounts at the time you receive care or services, you will receive a bill. The total amount you owe might change after your appointment, depending on the actual care or services you receive. You are responsible for all or part of the charges, based on your coverage and insurance plan. It is important to know that even if a service is covered, your insurance plan might not pay the charges in full.    

Care or Services Not Covered by Your Insurance Plan  
Not every service is covered by every insurance plan. Some or all the care or services you receive might not be covered or might not be considered medically necessary by your insurance plan. If that is the case, you will be responsible for the full cost. If you receive a service that is not covered, we will expect payment in full at the time of your visit.