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CMS also notes that as proposed at 427.303(b)(3) and as stated in the revised Medicare Part B Drug Inflation Rebate Guidance on page 38, in accordance with section 1847A(i)(3)(B)(ii)(II) of the Act, CMS will exclude units of drugs that are packaged into the payment amount for an item or service and are not separately payable. We also note that claim lines ( for drugs for which payment is bundled under the ESRD PPS would not have a Medicare allowed amount that is greater than zero, and so such units will be excluded

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Risk of B12 insufficiency can be assessed through measurement of dietary vitamin B12 intake, a biomarker of exposure

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