Whether 42 U.S.C. 405(h) prohibits a medical products manufacturer from filing a judicial action seeking relief from CMS policies without notice and comment

QUESTION PRESENTED Whether 42 U.S.C. 405(h), incorporated into the Medicare Act by 42 U.S.C. 139511, prohibits a medical products manufacturer who cannot pursue the Medicare administrative appeals process from filing a judicial action seeking relief from policies adopted by Center for Medicare and Medicaid Services without any notice and comment. (i)