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CMS may review an ACO's spend plan at any time and require the ACO to modify its spend plan to comply with the requirements of this paragraph (d) and paragraph (e) of this section

At 427.401(b)(2), we proposed to codify the policy set forth in section 50.11 of the revised Medicare Part B Drug Inflation Rebate Guidance to apply a greater applicable percent reduction for plasma-derived products than non-plasma derived products because the former rely on a variable supply of donated blood plasma that can impact downstream production and therefore hamper the ability to promptly resolve a shortage

Still to come are results from ongoing clinical trials of the drug in people who inject drugs and cisgender women in the U.S

Additionally, individual results may vary, and further research is needed to fully understand the long-term effects and optimal usage of these peptides