Date:________________

To: ___________________________
                (Insurance Company Name)
      ____________________________
                (Insurance Company Address)
      ____________________________
                (Insurance Company Address)

Dear Sir or Madam:

Methylmalonic acidemia (MMA) is a rare inherited genetic disorder of propionate metabolism characterized by greatly increased concentrations of methylmalonate in blood and urine.  The disorder is caused by a defective enzyme that is responsible for the metabolism of the amino acids methionine, threonine, valine, and isoleucine, and certain fats, leading to elevated blood and tissue concentrations of related organic acids.

Clinical symptoms of MMA include metabolic acidosis, hyperammonemia, vomiting, failure to thrive, lethargy, respiratory distress, and coma.  If MMA is untreated, a child can suffer from irreversible brain damage.  This disorder can be managed by early diagnosis and nutrition support.

The treatment of MMA consists of strict dietary control of methionine, threonine, valine, and isoleucine intake.  High protein foods are restricted in this diet (i.e., meat products, milk products, legumes, nuts, etc.).  Low protein medical foods, minimal quantities of low protein grains, fruits, and vegetables, in combination with fat and sugar, are permitted.  Without additional calories and amino acids (excluding the above mentioned), a MMA patient would experience malnutrition.  Thus, the majority of the patient’s daily intake must come from a medical food free of methionine, threonine, valine, and isoleucine, but complete with vitamins, minerals, trace elements, and essential and nonessential amino acids.

I am requesting insurance coverage and reimbursement for my patient, ________________________________, for whom I have prescribed the use of XMTVI Analog™ (manufactured by SHS North America).

XMTVI Analog is an unflavored, methionine-, threonine-,  valine-, and isolecuine-free powdered infant formula for the dietary management of MMA.  XMTVI Analog is -, threonine-,  valine-, and isolecuine-free but contains a balanced mixture of all other essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals, and trace elements (including iron, selenium and chromium).  XMTVI Analog is indicated for children under the age of 1. 

XPTVI Analog has been prescribed and is medically necessary as the optimum treatment for ________________________________________________________ with a diagnosis of
                                                        (Patient’s Name)
_______________________________________. I respectfully request insurance reimbursement/coverage for XPTVI Analog. The reimbursement code for this product is 49735-0118-87.

Sincerely,

_______________________________________

XPTVI ANALOG™ AND REIMBURSEMENT

Third-party payers such as Medicaid and HMOs will reimburse for the cost of XPTVI Analog.  To process claims for XPTVI Analog, payers require a reimbursement code to identify the nutritional product/category.  Some states have enacted legislation, which require that reimbursement be provided based on the patient’s diagnosis.

Claims are usually processed in one of two ways.  A code is used to identify XPTVI Analog through the HCFA Common Procedure Coding System (HCPCS), or through the National Drug Code (NDC) system.  Most states will use one of these systems to classify XPTVI Analog for reimbursement purposes.  Individual insurance plans will also choose one of these systems to reimburse patients for nutritional products.

CODING SYSTEMS:

MEDICARE (HCPCS)

XPTVI Analog is classified as enteral formula, for pediatrics, special metabolic needs for inherited disease of metabolism, includes protein, fats, carbohydrates, vitamins and mineral, and may include fiber.  Code # B4162

NATIONAL DRUG CODE (NDC)

XPTVI Analog is not a drug but is classified by the FDA as a “Medical Food”, which requires strict medical supervision.  The NDC code for the XPTVI Analog is 49735-0118-87.