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Section 1861(ddd)(2) of the Act states that, in making determinations under section 1861(ddd)(1) of the Act, the Secretary should use the process for making National Coverage Determinations (NCD) in the Medicare program

And thats just a few of the cases we know about

In the CY 2023 PFS final rule, we clarified the circumstances in which CMS would exercise discretion to reopen the initial determination of an ACO's financial performance for good cause to correct errors in the determination of MIPS Quality performance category scores that affect the determination of whether an ACO is eligible for shared savings, the amount of shared savings due to the ACO, or the amount of shared losses owed by the ACO (see 87 FR 69868 through 69869)

VELO's product line includes: Standard: Circular VELO cans and pouches with tobacco-derived nicotine