Date:________________

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

Dear Sir or Madam:
Homocystinuria is an inherited genetic disorder of protein metabolism. Accurate estimates of incidence are not available. Figures vary from 1:50,000 to 1:350,000 live births in the United States. The most common form of the homocystinurias is caused by cystathionine beta-synthetase deficiency. This deficiency leads to greatly elevated levels of two amino acids, methionine and homocysteine.

Clinical symptoms of homocystinuria include dislocated optical lenses, osteoporosis, severe arterial and venous thromboses, light complexion, heart disease, blood clot formation, mental retardation and seizures may occur. This disorder can be treated by early diagnosis and life-long nutrition support.  Normal growth and development may be achieved by dietary management.
The treatment of cystathionine beta-synthetase deficiency homocystinuria consists of strict dietary control of methionine intake. High-protein foods are restricted in this diet (i.e., meat and meat products, milk and 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 methionine), a homocystinuria patient would experience malnutrition. Thus, the majority of the patient's daily intake must come from a methionine-free medical food, complete with vitamins, minerals, trace elements and essential and nonessential amino acids (excluding methionine). In addition, supplements of cystine/cysteine may be necessary since this amino acid becomes essential. 

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

XMet Analog™ is an unflavored, methionine-free powdered infant formula for the dietary management of vitamin B6 non-responsive homocystinuria or hypermethioninemia.  XMet Analog is methionine-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).  When given in prescribed amounts, XMet Analog should provide the correct amino acid profile for children under 1 year of age.

XMet 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 XMet Analog. The reimbursement code for this product is 49735-0118-81.

Sincerely,

____________________________________ 

XMET ANALOG™ AND REIMBURSEMENT

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

CODING SYSTEMS:

MEDICARE (HCPCS)

XMet 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)

XMet 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 XMet Analog is 49735-0118-81.