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While the research makes the case that the dental services are medically necessary for patients with diabetes, medical necessity alone does not permit payment for dental services given the broad statutory prohibition under section 1862(a)(12) on payment for services in connection with the care, treatment, filling, removal, or replacement of teeth or structures directly supporting teeth. In the case of patients with diabetes, the research does not appear to show that certain dental services are inextricably linked with certain other covered services for the treatment of diabetes, in accordance with our regulation at 411.15(i)(3) such that the statutory prohibition under section 1862(a)(12) does not apply

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and (2) when either no other biosimilars have been approved for the same reference product or no other biosimilars with the same reference product report positive ASP data for the given quarter, we are proposing to set the payment limit equal to the sum of the volume-weighted average of the most recent available positive ASP data from a previous quarter plus 6 percent (or 8 percent for a qualifying biosimilar biological) of the amount determined under section 1847A(b)(4) of the Act for the reference biological product for the given quarter

For example, there are specialties or clinical topics where clinically coherent measure concepts have not yet been identified or where impact in terms of cost, clinician, or patient coverage is lower than that of other measure concepts that were prioritized for development

Under the CEC model, the CMS Innovation Center worked with groups of health care providers, dialysis facilities, and other suppliers involved in the care of ESRD beneficiaries to improve the coordination and quality of care that these individuals received