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As specified in regulations at 419.66(b)(1) through (3), to be eligible for transitional pass-through payment under the OPPS, a device must meet the following criteria: If required by FDA, the device must have received FDA approval or clearance and FDA marketing authorization (except for a device that has received an FDA investigational device exemption (IDE) and has been classified as a Category B device by FDA), or meet another appropriate FDA exemption

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This includes some heartburn medicines including proton pump inhibitors (PPIs) such as rabeprazole, omeprazole, esomeprazole, lansoprazole and pantoprazole

This includes: Product release decisions Sterility assurance Environmental monitoring Laboratory testing Stability programs Batch disposition Once confidence in data is lost, FDA must assume that the entire quality system may be compromised

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Appending correct J-Codes in billing forms promises correct reimbursement against administering non-oral drugs