LETTER OF MEDICAL NECESSITY: Vitaflo Glycosade
DATE:
TO:
FROM:
PATIENT NAME:
PATIENT DOB:
ICD DIAGNOSIS CODE:
HT:
WT:
MEDICAL FOOD ORDER:
INSURANCE ID:
SUBSCRIBER:
GROUP NO:
To Whom It May Concern:
[Patient name] is a _________year old diagnosed with Type ____ Glycogen Storage Disease
(GSD), an inborn error of metabolism. The purpose of this letter is to explain the medical
necessity and request insurance coverage for Glycosade, a prescription medical food designed
to decrease the risk of hypoglycemia in this condition.
Glycogen storage disease Type ____ is a life-long inherited metabolic disease. Patients with
this disorder are unable to release glucose from glycogen during periods of fasting, resulting in
hypoglycemia (low blood sugar levels). Hypoglycemia is common even in well-controlled
patients with GSD, and overnight hypoglycemia puts patients at risk for seizures, brain damage,
and even death. In addition, hospitalizations due to metabolic instability are common since
hypoglycemia is associated with lactic acid elevation and vomiting.
Glycosade is a prescription therapy that offers best chance of avoiding overnight hypoglycemia.
Studies on the efficacy of this therapy have been published in highly respected journals
including the Journal of Inherited Metabolic Disease and the American Journal of Clinical
Nutrition. The successful use of Glycosade the USA, Europe and Canada has also been
presented at international GSD symposiums and scientific meetings in 2011, 2012 and 2013.
I am requesting this critical therapy for [patient name]. Not only is Glycosade the best therapy for
[patient name], it may reduce the frequency of emergency department visits and hospitalizations due
to improved control of hypoglycemia. Glycosade may also improve long term metabolic control.
Metabolic control in GSD has been demonstrated to be inversely related to long-term complications,
and failure to maintain good control will place my patient at greater risk in the future for hepatic
adenomas, hepatocellular carcinoma, renal dysfunction, and even kidney failure.
Glycosade is a medical food manufactured in the UK for Vitaflo USA, LLC (1-888-VITAFLO/8482356). Glycosade is a medical food that is not available “over the counter” as it can only be
obtained with a prescription and must only be used under strict medical supervision. It is
currently the only available product with reimbursement codes indicated specifically for
Glycogen Storage Disease. HCPCS is B4157 and B4162. Reimbursement code: 50600-051400.
I appreciate your consideration of this request. Your authorization of this prescribed order will
provide this patient the treatment needed to improve his/her medical situation.
Please feel free to contact me for additional questions.
Sincerely,
Name of Physician
Institution
Contact Information
Attachments: Prescription
Clinic Notes
To personalize and strengthen this LOMN, you may include additional information
that is applicable to your patient’ situation, such as:
Mention the Glycosade Trial and Results: I admitted PT NAME to HOSPITAL NAME on DATE for
an overnight trial on Glycosade. The results showed this patient was able to maintain normoglycemia
for X HRS per night, thereby preventing a nighttime hypoglycemia episode.
Mention Patient’s History of Erratic Blood Sugars
The trial proved to be a marked improvement for this patient who has needed to be awakened X
times per night at home due to blood sugar levels that drop below the desired NAME LEVEL . The
risk of an admission to correct dangerously low blood sugar levels is high in this patient’s situation.
Patient Lives Far From Medical Center: Adding to the risk are these other factors: The patient lives
X miles from our medical center thereby delaying the possibility of prompt medical care. GSD
patients who have a fast drop in blood glucose are at extremely high risk for …..specify the risks and
even death.
Alternative Treatments More Costly: Without the approval of this therapy other treatments such as
placement of a g-tube (if the pt does not have one currently) will need to be considered for safety.
This will require the placement of a tube and a home health care referral for supplies and ongoing
monitoring. The risk of other problems such as the tube dislodging in the night and the family’s ability
to care for this patient are also factors that would need to be considered by using this therapy as an
alternative.
Depending on the state formulary programs in the state where the patient resides, an
additional statement can be added also as applicable:
Glycosade is on the State of XYZ’s Medicaid/BCMH formulary.
NOTE: Not every state has an approved formulary list. Some states simply require the
physician’s order for consideration and approval. This product is not included on metabolic
formularies that include products for newborn- screened disorders.