(9) For the first performance year during the term of the agreement period, the ACO's benchmark is adjusted for the following, as applicable: For changes in values used in benchmark calculations in accordance with 425.316(b)(2)(ii)(B) or (C) due to compliance action to address avoidance of at-risk beneficiaries or as a result of issuance of a revised initial determination under 425.315, and for changes in values used in benchmark calculations as a result of the performance year being affected by significant, anomalous, and highly suspect billing under 425.672
Materials matter, but the shape sets the tone
rather, we would base the payment limit of the biosimilar on the volume-weighted average of the its own most recent available positive manufacturer's ASP data from a previous quarter and either 6 or 8 percent, as appropriate, of the amount determined under section 1847A(b)(4) of the Act for the reference biological product for the given quarter
12 Responses Now that is a confusing series of events and evolution of a fine old Tobacco Company
13 Emerging risk factors Human papillomavirus infection (HPV) There is sufficient evidence based on recent studies (mostly conducted in the USA) 14,15 that infection with HPV (subtypes 6 and 16) is a risk factor particularly for the oropharynx (posterior tongue, tonsil and the [visible] part of pharynx in continuity with the oral cavity)