Susan Cook

Oct 2, 2024 | lexology.com | Michael Theis |Katie Wellington |Jessica Ellsworth |Katy Forsstrom |Danielle Stempel |Susan Cook | +2 more

In Loper Bright Enterprises v. Raimondo, the Supreme Court overruled the 40-year-old Chevron deference doctrine. Under Chevron U.S.A. Inc. v. National Resources Defense Council, courts were required to defer to an agency’s reasonable interpretation of an ambiguous statute administered by the agency in certain circumstances.

Jul 15, 2024 | jdsupra.com | Deborah Cho |Susan Cook |Danielle Stempel

The Chevron doctrine reflected a two-step analysis courts employed when confronted with certain legal challenges to an agency’s statutory interpretation. At Step One, courts analyzed whether the statute was clear on the precise question at issue. If so, the statute’s plain language won out, and the analysis ended.

May 7, 2024 | jdsupra.com | Mahmud Brifkani |Ken Choe |Susan Cook

CMS is seeking comment on this draft guidance for the drug price negotiation process for IPAY 2027, for which the next 15 Part D drugs will be selected by February 1, 2025. CMS also issued a proposed template MFP file, definitions document, and updated Information Collection Request (ICR) form for data submission for small biotech exemption and biosimilar delay requests. Comments on all these documents are due July 2, 2024.

May 6, 2024 | lexology.com | Alice Valder Curran |Ken Choe |Susan Cook |Kathleen Peterson |Samantha Marshall |Lindsey Johnson | +3 more

On May 3, 2023, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the IRA. Notwithstanding the agency’s oft-stated claim in litigation that its guidance for IPAY 2027 may differ from that for IPAY 2026, the draft guidance largely represents a continuation of CMS’s IPAY 2026 approach.

Nov 7, 2023 | jdsupra.com | Mahmud Brifkani |Ken Choe |Susan Cook

On June 28, 2018, Genesis, a federally qualified health center (FQHC) and 340B covered entity, brought litigation against HRSA after a HRSA audit led to Genesis’s termination from the 340B program. The audit found, among other things, that Genesis dispensed 340B drugs to individuals who did not qualify as “patients” under HRSA’s interpretation of the statutory term.