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CMS would use the earliest first marketed date of any NDC ever marketed under any FDA application under which any NDCs that have ever been assigned to the billing and payment code for that Part B rebatable drug as of the applicable calendar quarter have ever been marketed
[817] This projection accounts for annual prepaid shared savings (offset by eventual recoupments and/or repayments) of roughly $2 million per ACO participating in the payment option
In fact, the FDA has sent warning letters to certain manufacturers of new oral nicotine products, declaring them in violation of federal law for implying or explicitly stating that their product is lower risk
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