Teva Pharmaceuticals USA, Inc. v. Robert F. Kennedy, Jr.
Split Score
What is a Split Score?
This score (0-100) indicates how likely this case is to be reviewed by the Supreme Court based on:
Case Summary
Disposition
Affirmed in Part
Teva challenged CMS guidance implementing the Inflation Reduction Act’s Medicare Drug Price Negotiation Program, arguing that CMS unlawfully grouped two of its drugs as one “qualifying single source drug,” imposed an extra-statutory “bona fide” marketing requirement, and violated due-process rights. The 12th Circuit held that the statute’s review bar does not prevent courts from reviewing CMS’s general legal standards, upheld CMS’s drug-grouping rule, found Teva’s challenge to the bona-fide-marketing standard ripe and remanded that issue, and rejected Teva’s due-process claim. Accordingly, the panel affirmed most of the district court’s judgment, reversed in part, and remanded on the marketing-requirement claim.
Circuit Split Identified
Legal Issue
Whether 42 U.S.C. § 1320f-7(2) bars judicial review of generally-applicable CMS rules (interpretations and guidance) or only bars review of drug-specific determinations made under the Inflation Reduction Act’s Medicare Drug Price Negotiation Program.
Circuit Positions
Narrow interpretation – § 1320f-7(2) bars review only of the final drug-specific determinations; courts may review CMS’s generally applicable legal standards and guidance.
Broad interpretation – § 1320f-7(2) bars review of both drug-specific determinations and the legal standards/guidance that produce those determinations (‘inextricably intertwined’ approach).
Conflict Summary
The 3rd Circuit reads the IRA review bar broadly, holding that it precludes courts from reviewing both CMS’s drug-specific selections and the general standards or guidance underlying those selections. The 12th Circuit (this opinion) interprets the same provision narrowly, allowing judicial review of CMS’s generally applicable legal standards while accepting that drug-specific selections themselves remain unreviewable.