SAMPLE LETTER FOR
XPhe, XTyr Analog

Date:________________

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

Dear Sir or Madam:
Tyrosinemia Type I affects approximately 1:100,000 live births in the U.S.. Due to an enzyme defect, blood and tissue levels of the amino acids tyrosine and phenylalanine as well as related toxic metabolites are elevated. The disease is characterized by severe impairment of liver and renal tubular function, failure to thrive, rickets, cataracts, hypertension, and peripheral nerve deficiencies. Mental retardation may occur. If untreated, tyrosinemia may lead to progressive liver, renal, and brain damage and often fatal pathogenesis.

Tyrosinemia Type II is a rare metabolic disorder caused by a defect of another enzyme responsible for the tyrosine metabolism. Blood and tissue levels of tyrosine are elevated and the excretion of phenolic acids is increased. Untreated children suffer from skin lesions on the fingers, palms of the hands, and soles of the feet; corneal erosions have been reported. Mental retardation often occurs. If diagnosed and treated during infancy, these symptoms may be prevented and the disorder may be managed by diet.

Dietary treatment for both types of tyrosinemia consists of a diet restricted in tyrosine and phenylalanine. Type I also requires monitoring of methionine. Such a diet restricts all foods high in protein (meat, dairy, fish, poultry, etc.) and includes prescribed amounts of low protein medical foods, low protein cereals, fruits, and vegetables. Without additional calories, nutrients, and essential and non-essential amino acids (excluding tyrosine, phenylalanine and where necessary methionine), the patient would experience malnutrition. Therefore, an important part of the patient's daily intake must come from a medical food lacking the amino acids phenylalanine and tyrosine, but containing all other nutrients and essential and non-essential amino acids.

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

XPhe, XTyr Analog is an unflavored, phenylalanine- and tyrosine-free powdered infant formula for the dietary management of tyrosinemia when plasma methionine levels are normal.  XPhe, XTyr Analog is phenylalanine- and tyrosine-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).  XPhe, XTyr Analog is indicated for children under the age of 1. 

XPhe, XTyr Analog has been prescribed and is medically necessary as the optimum treatment for ______________________________ (Patient’s Name) with a diagnosis of ____________________________.

I respectfully request insurance reimbursement/coverage for XPhe, XTyr Analog. The reimbursement code for this product is 49735-0118-85.

Sincerely,

______________________________

XPHE, XTYR ANALOG™ AND REIMBURSEMENT

Third-party payers such as Medicaid and HMOs will reimburse for the cost of XPhe, XTyr Analog.  To process claims for XPhe, XTyr 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 XPhe, XTyr 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 XPhe, XTyr Analog for reimbursement purposes.  Individual insurance plans will also choose one of these systems to reimburse patients for nutritional products.

CODING SYSTEMS:

MEDICARE (HCPCS)

XPhe, XTyr 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)

XPhe, XTyr 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 XPhe, XTyr Analog is 49735-0118-85.