Download Certificate of Medical Necessity

Certificate of Medical Necessity
[Dr. name, medical group name
and address and
Telephone number]
[- date]
RE: [name of patient]
SSN: ___________________
To Whom It May Concern:
The above named patient has a history of Type 1 diabetes mellitus for 40 plus years. With the exception
of two brief periods, during this time the patient has been able to maintain good control of his diabetes
without any serious hypoglycemic events through the use of animal source insulin, specifically porcine
and/or bovine insulin. In the late 1980s the patient was switched to the new human insulin analogs.
Immediately thereafter the patient reported profound hypoglycemic unawareness which was not present
with the use of animal source insulin. Over the following 18 months, the patient experienced several
severe hypoglycemic events resulting in seizures and loss of consciousness. The patient returned to use of
natural animal source insulin and regained good control of his condition. In the mid-1990s the patient
was again placed on another new human insulin analog. Immediately thereafter the patient experienced
severe hypoglycemic unawareness accompanied by additional seizures and loss of consciousness. After
the patient returned to use of animal source insulin he was able to regain good control of his condition and
has experienced no untoward events to this day. While using animal source insulin the patient has never
suffered severe hypoglycemic events in contrast to his experience when using synthetic human analogs.
The patient’s profound hypoglycemic unawareness when using human insulin analogs presents a serious
threat to his personal safety and even his life and interferes with his ability to work and engage in other
activities of daily life. The use of human insulin anologs is clearly contraindicated in this patient. The
unavailability of animal source insulin in the U.S. after July, 2005 requires that the patient obtain an
alternate supplier of insulin overseas.
Because a patient’s insulin requirements can vary widely from day to day it is not possible to project a
patient’s precise insulin needs. At this time, patient would need to use approximately 6 vials 1000 units
each of Hypurin Porcine Neutral (R) every 6 months, and 9 vials 1000 units each of Hypurin Porcine
Isophane (N). If he does not use the specified medications the risk of significant and potentially lifethreatening complications is markedly increased.
I agree to report to Wockhardt Co.U.K. and CP Pharmaceuticals any adverse drug reactions this
patient may experience which I determine to be associated with his use of Hypurin insulin.
If there are any questions, please do not hesitate to contact this office.
Sincerely
__________________________________
[Dr. name /office name]