Date:________________

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

Dear Sir or Madam:

Phenylketonuria (PKU) is an inherited genetic disorder of protein metabolism that affects approximately 1:19,000 infants in the United States. PKU results from a deficiency in the enzyme responsible for metabolizing the amino acid phenylalanine. This results in the toxic build-up of phenylalanine levels in the body. 

An untreated PKU child will suffer irreversible brain damage and severe mental retardation which can lead to learning disabilities and behavioral disturbances.  Other manifestations include vomiting, lethargy, and eczema.  In the U.S., newborn screening tests for PKU are mandatory. Normal growth and development are possible if a PKU patient is managed by life-long nutrition support. 
The only effective treatment currently available for PKU is strict dietary control of phenylalanine intake. Currently, there is no gene replacement therapy available nor is there any effective medication. High-protein foods are restricted in the PKU 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 in the PKU diet. Without additional calories and amino acids (excluding phenylalanine), a PKU patient would experience malnutrition. Thus, the majority of the patient's daily intake must come from phenylalanine-free medical foods, complete with vitamins, minerals, trace elements and essential and nonessential amino acids (excluding the amino acid phenylalanine).

I am requesting insurance coverage and reimbursement for my patient _______________________________, for whom I have prescribed the use of XPhe Maxamum® (manufactured by Nutricia  North America).

XPhe Maxamum is a phenylalanine-free powdered or liquid medical food (available in forest berries or orange) used in the dietary management of Phenylketonuria.  XPhe Maxamum contains a balanced mixture of all other essential and non-essential amino acids, carbohydrate, vitamins, minerals and trace elements (including selenium and chromium). When given in prescribed amounts, XPhe Maxamum should provide the correct amino acid profile for individuals over 8 years of age.

XPhe Maxamum 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 XPhe Maxamum. 

Sincerely,

_________________________________

Reimbursement codes for XPhe Maxamum

XPHE MAXAMUMÒ AND REIMBURSEMENT

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

CODING SYSTEMS:

MEDICARE (HCPCS)

XPhe Maxamum is classified under enteral formula, nutritionally complete, for special metabolic needs for inherited disease of metabolism, includes proteins, fats, carbohydrates, vitamins and minerals and may include fiber.  Code # B4157 or B4162.

NATIONAL DRUG CODE (NDC)

XPhe Maxamum is not a drug but is classified by the FDA as an “Medical Food”, which requires usage under strict medical supervision.