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While we agree that the purpose of new data is not to test changes in underlying PE/HR measures, utilizing the PPI data would mean, in some cases, changing a specialty's total PFS payments by 10 percentage points or more based on data that cannot rule out PE/HR values consistent with no underlying change

These effects occur in a minority of users and rarely require stopping

The bacteriostatic preservative used is benzyl alcohol (BnOH) at a concentration of 0.9% (9 mg/ml) or 1.1% (11 mg/ml)

Finally, to address the suggestion that the agency determine whether additional guidance would be appropriate for the areas described in the December 2022 OIG report as it relates to how to reallocate discounts associated with sales that may be considered bundled across time periods (for example, outcomes-based arrangements or value-based purchasing arrangements), we did not propose to adopt the portion of the Medicaid definition of bundled sale stating that value-based purchasing arrangements may qualify as a bundled sale because we are continuing to evaluate how value-based purchasing arrangements should be considered for drugs payable under Medicare Part B

Repeated room temperature excursions have cumulative effects on peptide stability