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CMS intends to use the shortage lists maintained by the FDA Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) to determine whether a Part D rebatable drug is currently in shortage [592] during an applicable period

"Even we were surprised by the strength of harm from even a low quantity of cigarettes, and the incredible importance that quitting early had on long-term heart health," said Dr

Almost all the managerial employees (99%) as well as workers (95%) agreed that their organization should have a tobacco-free workplace policy and would be supportive of the policy when implemented (100% and 95%, respectively)

There is no safe form of tobacco

The following formula illustrates how CMS would calculate the AnMP for a Part D rebatable drug as proposed in 428.202(b): (AMP for calendar quarter beginning October) multiplied by (sum of monthly units for October calendar quarter divided by total units for 12-month applicable period) + (AMP for calendar quarter beginning January) multiplied by (sum of monthly units for January calendar quarter divided by total units for 12-month applicable period) + (AMP for calendar quarter beginning April) multiplied by (sum of monthly units for April calendar quarter divided by total units for 12-month applicable period) + (AMP for calendar quarter beginning July) multiplied by (sum of monthly units for July calendar quarter divided by total units for 12-month applicable period) In 428.202(b)(2), CMS proposes that the first applicable period for a Part D rebatable drug will be the earliest applicable period that follows the payment amount benchmark period identified in proposed 428.202(c)(1) through (4)