environmental tobacco smoke ets Semi-quantitative assessment of environmental tobacco

The preclusions in section 1860D-14B(f) of the Act on administrative and judicial review apply to the reconciliation process

Billing unit means the identifiable quantity of a drug or biological product associated with a billing and payment code (for example, a HCPCS code), as established by CMS

Such instances would apply to section 505(b)(2) drug products, drugs that were previously multiple source drugs where all other drugs under the same billing and payment code were discontinued (applicable only if the sole remaining product was not approved under an ANDA), and to any other situations where a drug was previously in a grouped billing and payment code (other than a NOC code)

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