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However, we noted that, as discussed in section III.A.2.a of this final rule, CMS already has a policy in place for multiple source drugs for which the absence of ASP data would result in a significant change (that is, a 10 percent or greater change) in the ASP payment limit compared to the payment limit of the previous quarter, as finalized in the CY 2011 PFS final rule (75 FR 73461 through 73465)

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With these conditions, and others, the product used for bowel care management must work quickly, effectively, and with little to no side effects