Agendia, Inc. v. Xavier Becerra, Secretary of Health and Human Services

In Azar v. Allina Health Services, 139 S. Ct. 1804 (2019) (“Allina”), this Court confirmed that the Department of Health and Human Services (“HHS”) must use notice-and-comment rulemaking to promulgate rules, requirements, or statements of policy that “establish[ ] or change[ ]” a “substantive legal standard” governing the scope of benefits and payment for services under the Medicare Act, 42 U.S.C. § 1395hh(a)(2). See 42 U.S.C. § 1395hh(b)(1). In the instant case, an HHS private contractor established a Medicare “coverage policy,” known as a Local Coverage Determination (“LCD”). The LCD was not promulgated as a regulation under 42 U.S.C. § 1395hh(a)(2). The Court of Appeals’ majority decided that “1395hh’s notice-and-comment requirement does not apply to” LCDs. The dissent disagreed, characterizing the majority’s opinion as a “missed opportunity” and urged that “[p]erhaps the Supreme Court may now decide to address th[e] important and unresolved issue” presented by this case. The two questions presented for review are therefore: Whether the rulemaking requirements of 42 U.S.C. § 1395hh(a)(2) apply to a Medicare policy deeming all molecular diagnostic laboratory tests “investigational” and thus not covered by Medicare because it was issued by a Medicare Administrative Contractor (“MAC”) as an LCD.