K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
On Friday, January 07, 2022, the United States Supreme Court heard oral arguments on a rule promulgated by the Centers for Medicare & Medicaid Services (“CMS”) requiring healthcare workers at specific facilities participating...more
On December 29, 2020, the United States Court of Appeals for the District of Columbia issued its opinion in American Hospital Association v. Azar (the Opinion) upholding the Hospital Transparency Regulation (the Rule) issued...more
On October 31, 2019, in the face of a federal lawsuit, the Indiana Family and Social Services Administration suspended its enforcement of work requirements under the state’s Medicaid waiver project, the Healthy Indiana Plan...more
President Trump has issued an Executive Order instructing several federal agencies to begin rulemaking processes intended to increase the transparency of hospital pricing. Among other measures, the Executive Order directs the...more
On May 15, 2019, United States District Judge Amy Totenberg ordered HHS to “immediately cease and desist” from further implementing its April 2019 liver allocation policy pending appellate review in Callahan, et al. v. Azar,...more
On April 10, 2019, the Department of Justice filed notices appealing two District Court rulings that struck down Medicaid work requirements in both Kentucky and Arkansas to the U.S. Court of Appeals for the District of...more
The Ninth Circuit held August 7 that the Department of Health and Human Services Secretary erred in approving a Medicaid State Plan Amendment (SPA) that cut reimbursement for outpatient hospital services in California by 10%...more
The U.S. Court of Appeals for the Ninth Circuit Court raised the bar last week for what states must prove to establish that their Medicaid provider reimbursement rates are sufficient to ensure a robust network of providers...more
On July 25, 2017, the United States Court of Appeals for the District of Columbia Circuit held that HHS violated the terms of the Medicare statute by failing to undertake notice-and-comment rulemaking in implementing its...more
On September 10, 2015, District Judge Randolph D. Moss of the U.S. District Court for the District of Columbia issued an opinion in Mountain States Health Alliance v. Burwell (Mountain States) involving Section 310 of the...more
In Shands Jacksonville v. Burwell [PDF], No. CV 14-1477, 2015 WL 5579653, (D.D.C. Sept. 21, 2015), the United States District Court for the District of Columbia gave the Secretary of the Department of Health and Human...more
On September 21, 2015, the United States District Court for the District of Columbia ruled that the Secretary of the U.S. Department of Health and Human Services (HHS) failed to provide a meaningful opportunity to comment on...more
A Federal Judge found that the Department of Health and Human Services (DHHS) failed to comply with the Administrative Procedure Act (APA) when it cut hospital inpatient payments by 0.2% as part of its “two-midnight” rule. ...more