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The clinical evidence supports that the medically necessary dental care may similarly advance the clinical success of dialysis services in the treatment of ESRD because an oral or dental infection can present substantial risk to the success and outcomes of these procedures (including the risk of systemic infection, BSI, sepsis, and death)

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(1) For a Part B rebatable drug, subject to paragraphs (d)(1)(i) and (ii) of this section and except as provided in paragraph (d)(2) of this section, CMS will identify the payment amount in the payment amount benchmark quarter using the published payment limit for the billing and payment code for the applicable payment amount benchmark quarter determined in accordance with section 1847A of the Act

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As proposed in 427.402(b)(1), CMS would provide a time-limited standard reduction of 75 percent in the total rebate amount for a Part B rebatable biosimilar biological product when CMS determines there is a severe supply chain disruption during the calendar quarter, such as that caused by a natural disaster or other unique or unexpected event

In the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), we discussed a variety of methodologies and approaches used to develop work RVUs, including survey data, building blocks, crosswalks to key reference or similar codes, and magnitude estimation (see the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329) for more information)