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Specifically, section 11101 of the IRA amended section 1847A of the Social Security Act (the Act) by adding new subsection (i) which establishes a requirement for drug manufacturers to pay rebates into the Federal Supplementary Medical Insurance Trust Fund for Part B rebatable drugs for each calendar quarter beginning on or after January 1, 2023, if the specified amount, as determined under section 1847A(i)(3)(A)(ii) of the Act, exceeds the inflation-adjusted payment amount, which is calculated as set forth in section 1847A(i)(3)(C) of the Act

"The oversight is rigorous and appropriate for a pharmacy making one drug for one patient" that's been prescribed by a doctor, he says

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6A and Supplementary Fig