While we acknowledged the importance of maintaining oral health to prevent complications such as serious gum bleeding, especially problematic for those with hemophilia, we also reiterated that for the purposes of the PFS payment policy for dental services inextricably linked to covered medical services, our statute and regulations require that specific evidence supports the integral connection between dental services and clinical success in managing hemophilia-related medical services, and, therefore, we did not expand the examples under 411.15(i)(3)(i) to include additional covered medical services for hemophilia

We propose to add a new paragraph (d) to 425.304 that notes that CMS has determined that the Federal anti-kickback statute safe harbor for CMS-sponsored model patient incentives (42 CFR 1001.952(ii)(2)) is available to protect remuneration furnished in the prepaid shared savings program option of the Shared Savings Program in the form of direct beneficiary services that meets all safe harbor requirements set forth in 1001.952(ii)(2)
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The connection between pack-years smoked and elevated likelihood of developing reflux esophagitis underscores tobaccos negative impact on gastrointestinal health