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For Part B coverage, the injection must satisfy the following criteria: You must have a qualifying diagnosis (for example, pernicious anemia) Your provider must document the medical necessity The injection must be administered in an approved outpatient setting It is important to note that you may still be liable for your Part B deductible and 20% coinsurance, unless you have Medigap (supplemental insurance) to assist with out-of-pocket expenses

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the combination is not clinically validated

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