Quick Guide to Administrative Hearings
Consumer Finance Monitor Podcast Episode: Prominent Journalist, David Dayen, Describes his Reporting on the Efforts of Trump 2.0 to Curb CFPB
Notorious: The RBG Podcast - Episode 11: Three Cheers for Beer: A Discussion of Craig v. Boren
The M&A Word of the Day® from the Book of Jargon® – Global Mergers & Acquisitions Is Revlon Doctrine
Konczal: Dodd-Frank Reforms Get Roughed Up in Court
On May 8, 2025, the Court of Appeals for the Third Circuit affirmed the district court’s dismissal of AstraZeneca’s challenges to the Inflation Reduction Act’s Drug Price Negotiation Program and CMS’s Guidance implementing...more
A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the Inflation Reduction Act of 2022's (IRA) Medicare Drug Negotiation Program...more
In another rebuke to federal regulatory overreach, the U.S. District Court for the Eastern District of Texas (“District Court”) has vacated the Food and Drug Administration’s (“FDA”) 2024 final rule that sought to bring...more
On March 31, a judge in the Eastern District of Texas vacated the US Food and Drug Administration’s (FDA) rule that sought to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and...more
Last Monday, the U.S. District Court for the Eastern District of Texas (the “District Court”) issued a highly anticipated – and unsurprising – opinion invalidating the U.S. Food & Drug Administration’s (“FDA’s” or the...more
As Wilson Sonsini previously reported,1 the U.S. Food and Drug Administration (FDA) had been preparing the industry to comply with the 2024 LDT Final Rule, which phases out the FDA’s enforcement discretion policy for...more
Now that the final rule on laboratory developed tests (LDTs) has been available for over a month and the stages of the enforcement discretion phaseout process and the Food and Drug Administration’s (FDA’s) newly proposed...more
Our firm is seeing an uptick in Medicare demand letters for the recovery of overpayment for skin substitutes, such as WoundFixTM, Biobrane, Dermagraft®, AmnioBand®, or AlloPatch®, used in the treatment of wounds. CMS auditors...more
Developments immediately before the holiday break have many employers scrambling as the OSHA ETS has seemingly come back to life. The Sixth Circuit, in a 2-1 decision by a 3-member panel, dissolved the temporary stay...more
On September 17, 2019, U.S. District Judge Rosemary M. Collyer of the U.S. District Court for the District of Columbia awarded summary judgment in favor a group of more than 40 hospitals on their challenge to CMS’s decision...more
On July 30, 2019, the D.C. Circuit issued a favorable jurisdictional decision on behalf of King & Spalding client the American Clinical Laboratory Association (ACLA), reversing the district court. Accepting ACLA’s arguments,...more
In Northeast Hosp. Corp. v Sebelius, 657 F.3d 1 (D.C. Cir. 2011), the United States Court of Appeals for the District of Columbia Circuit upheld hospitals' challenge to CMS's disproportionate share hospital (DSH) calculation...more
A federal court has handed CMS an initial legal victory enabling drastic cuts in Medicare Part B payment to take effect for separately payable drugs and biologicals purchased by hospitals under the 340B Drug Discount Program...more
Last week, the United States District Court for the District of Columbia denied CMS’s request to remand to the Provider Reimbursement Review Board (PRRB) the claims of several hospitals who sought expedited judicial review...more
On July 26, 2016, the United States Court of Appeals for the District of Columbia Circuit decided Fla. Health Sciences Ctr. v. Burwell. In that case, the Court analyzed a statutory bar against judicial review of estimates...more
In Banner Heart Hospital, et al. v. Burwell, the United States District Court for the District of Columbia (Court) held on August 19, 2016, that the Provider Reimbursement Review Board (PRRB) incorrectly declined to hear an...more
On July 25, 2016, Judge John D. Bates of the United States District Court for the District of Columbia issued a memorandum opinion broadly construing 42 U.S.C. § 1395ww(j) to prohibit administrative or judicial review of a...more
Before a Medicare contractor can use extrapolation to determine an overpayment amount, the Medicare statute requires that it must make a finding that there is a sustained or high level of payment error or that documented...more