Appeal: Relates to a request made to the health plan for a reconsideration of an adverse decision or a denied claim. (A health plan could deny coverage due to billing errors, lack of medical necessity, or because the benefit is excluded.)

Co-insurance: A set percentage of costs shared between the insured and the health plan. For an 80/20 co-insurance, the insurer pays 80% and the insured pays 20%. The cost sharing stops when medical expenses reach the plan’s out-of-pocket maximum. Some plans have a 100% co-insurance, and all medical expenses are paid by the health plan after the deductible is met. Co-insurance rates may vary for in or out-ofnetwork providers.

Co-payment (Co-Pay): A set dollar amount the insured pays for each covered service. For a $25 co-pay, the insured pays $25 for every eligible service. Co-payments may vary for in or out-of-network providers.

Deductible: An annual, set dollar amount the insured must pay for medical expenses before their health plan benefits go into effect. After the deductible is met, the insured may pay nothing or they may have to pay a co-insurance. Deductibles may vary for services received in or out-of-network.

Out-of-pocket maximum (Out-of-Pocket Limit): The maximum dollar amount the insured pays, during a policy year, before the health plan pays 100% of the allowed amount. (This amount does not include balance-billed charges, premiums or services not cover by the plan. Some health plans do not apply out-of-network payments, co-insurance payments, co-payments, deductibles or other expenses towards the out-of-pocket maximum.)

Pre-Determination: A review process conducted by the health plan to determine if services are medically necessary and covered under the policy. The pre-determination of benefits is dependent upon information submitted before service. Payment is dependent upon information submitted after service. (A pre-determination approval typically guarantees payment of a claim. However, payment can be affected by the patient’s previous use of benefits, and the insurance company may deny the claim if there is a change in the patient’s condition and the service is no longer determined to be medically necessary.)

Prior Authorization: A request to the health plan for permission of service before service is rendered to the insured. (Prior Authorization requests are very common for rare disease services. A Prior Authorization approval does not guarantee payment. The health plan could grant approval to a specific provider in which case, the service must be rendered and billed by the approved provider. Claims submitted for prior-approved services rendered and billed by a different provider would be denied.)

Procedure Code (HCPCS Code): A 5 digit code that consists of a letter followed by 4 numbers. The code is used by insurance providers to classify a service or a medical supply for coverage a billing purposes.

Reimbursement Code: An 11 digit numerical code used to identify medical foods and enteral formulas. Medical foods and enteral formulas are not considered a drug and therefore are not assigned National Drug Codes (NDC). The reimbursement code simply follows the NDC format and is often referred to as (NDC) by payers. Find your reimbursement code here.

FruitiVits & Single Dose Amino Acids

Formula4Success® is able to assist patients seeking coverage of FruitiVits™ or Single Dose Amino Acids only in combination with an additional Vitaflo™ product. However, some patients may need assistance exclusively for these products (independently of other prescribed Vitaflo products). Therefore, Formula4Success developed the guide below for patients or guardians who independently seek access to FruitiVits or Single Dose Amino Acids.

Private Insurance: Medical Plan

Call the Member Services phone number located on the back of the insurance ID card.
Follow the prompts for Medical Benefits.
Speak with a health plan representative, and state that the intent of the call is to determine Medical Benefits for Enteral Formula Coverage.
Provide the product’s Procedure Code (HCPCS Code). FruitiVits is B4104 and Single Dose Amino Acids are B4155.
If necessary, provide the patient’s Diagnosis Code (ICD10 Code). The diagnosis code is obtained from your healthcare professional.

Private Insurance: Pharmacy Plan

Call the Pharmacy Services phone number located on the back of the insurance ID card.
Follow the prompts for Pharmacy Benefits
Speak with a health plan representative, and state that the intent of the call is to determine Pharmacy Benefits for Enteral Formula, Specialty Formula and/or OTCitems (as part of OTC-Drug coverage plan).
Provide the prescribed product’s Reimbursement Code (NDC-format number). FruitiVits is 50600-0513-25. Single Dose Amino Acids can be found here
If necessary, provide the patient’s Diagnosis Code (ICD10 Code). The diagnosis code is obtained from your healthcare professional.

Be Informed

FruitiVits and Single Dose Amino Acids are classified as “enteral formulas” according to the Procedure Code (HCPCS Code), but health plan representatives may not be familiar with the term. Therefore, when communicating with insurance representatives, it may be helpful to use keywords, such as: medical food, specialty formula, medical formula, nutritional formula, nutritional supplement, OTC-item (as part of OTC-Drug coverage plan), etc. Be sure to state that the product is medically necessary for the dietary management of inborn errors of metabolism and/or metabolic disorder/disease.

Provide Accurate Information

It is extremely important to provide the health plan representative with accurate codes for the product. HCPCS codes and/or Reimbursement Codes (NDC-format numbers) are information that representatives need to assist with benefit research and coverage verification. It’s possible that coverage may be excluded as a “non-covered service”. However, the health plan policy may have an inclusion clause which states coverage is allowed when “medically necessary” or for the dietary management of a specific metabolic disease or inborn errors of metabolism. Therefore, it is also important to state that the patient has a diagnosed inborn error of metabolism (IEM), inherited metabolic disease, or state the specific disorder such as Phenylketonuria (PKU), and provide the Diagnosis Code (ICD10 Code).

Documentation

Take detailed notes of the quoted coverage information. Representatives will typically offer coverage information for in-network benefits only. However, it is important to also request out-of-network benefits, if applicable. Key things to note include: deductible, out of pocket maximum, co-pay, co-insurance, prior authorization, predetermination, Primary Care Physician referral only, self-funded plan, fully insured plan, coverage inclusions and coverage exclusions. Request a hardcopy of the insurance policy, and make sure to obtain a call reference number from the representative.

Notice

The prescribed product(s) might qualify to be purchased with FSA funds. Be aware that product purchased prior to receipt of a determination letter detailing coverage parameters which are required to be followed may not be reimbursed.

***Disclaimer: This resource has been drafted to provide assistance with Vitaflo’s FruitiVits and Single Dose Amino Acids. This information is intended to be used by the patient or guardian. Please note that Vitaflo does not guarantee that use of this resource will result in insurance coverage or reimbursement by any third-party payor. Coverage determinations are ultimately made by the health plan. Information received is not a guarantee of payment. The final determination of coverage and reimbursement is made after the claim is submitted and processed. Vitaflo does not guarantee coverage by any insurance plan and will not reimburse any claims denied by third-party payers.***

Formula4Success®

The Formula4Success program offers step-by-step, detailed information and support to get the Vitaflo™ products you need. From navigating insurance to finding distributors or suppliers, we can help.

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Formula4Success Program

The Formula4Success Program is dedicated to enhancing access to and securing coverage for Vitaflo formulas. Beyond the support we provide to patients and caregivers, we also offer valuable information and resources to home enteral nutrition providers. Our seasoned Reimbursement Specialists are on hand to assist with complex coverage denials. For more information, please reach out to Formula4Success.

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Letters of Medical Necessity

A letter of Medical Necessity may be required to file an insurance claim. It is completed by your healthcare provider and helps to provide the medical justification for potential insurance benefits. You may download the relevant sample Letter of Medical Necessity and provide to your physician or healthcare provider to complete and sign. Sections of each letter have been left unprotected so your physician or healthcare provider may include information specific to your care.

Pediatric Kidney Disease

Ketogenic Diet

Glycogen Storage Disease (GSD)

Fatty Acid Oxidation Disorders

Urea Cycle Disorders (UCD)

Organic Acidemias

Homocystinuria (HCU)

Tyrosinemia

Maple Syrup Urine Disease

Phenylketonuria

Emergency Regimens & Other Products

Useful Resources for Coverage

Recognizing the challenging and frequently changing reimbursement environment, Vitaflo is proud to provide additional resources for health care professionals and providers of nutrition support. Click on resources below for more tools to help ensure proper documentation of nutrition claims including:

Detailed Written Order
Letters of Medical Necessity
Clinical Notes and Lab
Product Code and Reimbursement Information

Vitaflo In Association with You (VIA)

VIA (Vitaflo in Association with You) Education Hub offers healthcare professionals up-to-date resources to support the nutrition management of individuals with rare diseases.

In collaboration with experts around the globe, we provide product and condition-specific clinical resources, as well as programs for Continuing Professional Education (CPE) for Registered Dietitian Nutritionists practicing in the US.

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Our dedicated Reimbursement Specialists are available through every stage of the coverage process. Formula4Success is committed to helping you get the Vitaflo products you need.

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Fruitivits and SDAA are supported when prescribed with a supported Vitaflo formula

Contact Information

Email

Formula4Success@VitafloUSA.com

Phone

1-800-520-6112

Fax

1-888-485-7193

Formula4Success®

Formula4Success Program

Letters of Medical Necessity

Useful Resources for Coverage

Vitaflo In Association with You (VIA)

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