Thanks, I read it over. They’ve tried a very SNEAKY trick in this document, you should call them out on it… by saying that it (letter draft follows)…
"Directly contradicts what the FDA-approved labeling says about using these devices on a continuous basis. They are ABSOLUTELY approved for continuous use by patients.
For example, the original Approval’s “Summary of Safety and Effectiveness Data”, available for them to READ and UNDERSTAND at http://www.fda.gov/ohrms/dockets/dockets/05m0454/05m-0454-aav0001-03-SSED-vol1.pdf, begins section II. INDICATIONS FOR USE, exactly as follows:
“The Guardian RT is indicated for continuous or periodic monitoring…”
And your medical need is for continuous monitoring. Individual Sensors are used for “up to 3 days”, but the usage of the RT CGMS system is indicated for continuous use.
Next, in your letter, if the you are hypo-unaware and DO experience Hypos without awareness (especially at night while sleeping and unable to routinely test bG each 1/2 hour): Warn them that HbA1C is merely an average, and that frequent, severe Hypos make the number “look better”.
Finally, ask them for “the names, medical qualifications, and license numbers (by State) of the persons who are responsible for this breathtakingly inept and incompetent policy.” Follow that with this sentence: “It appears that they are practicing outside the scope of their competence in ‘overturning’ my Physician’s letter of medical necessity, and Medical Board action (e.g., remedial training or disciplinary action) might be needed.”
Finally, say:
“Please provide a written response to defend your denial of my coverage, based on the absurdities and lies in this “policy”, postmarked on or before February 22, 2008. If unable to do so, please provide a written response, postmarked before by February 8, which explains exactly why you need more time to prepare this response.”
(You want to use a few really long-winded sentences with too many commas, like that, so that they hear you switching over to “legaleeze” LOUD AND CLEAR.
Good luck. If you’ve got documented “hypo at night” problems, You’ve already won. Unawareness by itself is a bit harder to argue, because they try to order you to “just test more”.