CMS ACCESS Model and FDA TEMPO Pilot: Outcome-Based Payments and Digital Health

Offit Kurman analyzes CMS's ACCESS Model (a CMMI initiative) testing outcome-aligned payments tied to measurable clinical improvements for Medicare Part B providers, running concurrently with FDA's TEMPO pilot supporting digital health technology integration. The article details participation requirements, payment structures involving 50% upfront and 50% withheld amounts subject to reconciliation, and FDA enforcement discretion possibilities for digital health devices used within the model.

CMS Reaches $100 Million in Stark Self-Disclosure Settlements

CMS released 2025 settlement data for voluntary self-disclosures under the physician self-referral law (Stark Law), settling 244 cases totaling over $20.4 million. Aggregate settlements since the SRDP's inception in 2011 have now exceeded $105 million. A record single settlement of $2.68 million more than doubled the previous high from 2018.

FDA Draft Guidance on 483 Responses for Drug Manufacturers

Cooley LLP summarizes FDA's new draft guidance providing, for the first time, formal recommendations for drug manufacturers on responding to Form FDA 483 observations following cGMP inspections. The guidance applies to domestic and foreign facilities manufacturing human or animal drugs regulated by CDER, CBER, or CVM, including combination-product manufacturers when CDER or CBER is the lead center. Key recommendations include structured response formatting, executive summaries, detailed remediation plans, risk assessments, and interim reporting requirements.

Executive Order Imposing Section 232 Tariffs on Patented Pharmaceuticals

President Trump issued an Executive Order imposing Section 232 tariffs on imports of patented pharmaceuticals and associated pharmaceutical ingredients, citing national security concerns over U.S. reliance on foreign pharmaceutical supply. The Secretary of Commerce found that pharmaceutical imports threaten access to life-saving medications during supply chain disruptions. Tariffs take effect July 31, 2026 for certain companies and September 29, 2026 for others.

Florida Appeals Court Invalidates DFS Rules on Physician Dispensing in Workers' Compensation

Florida's First District Court of Appeal invalidated two rules from the Department of Financial Services (DFS) that protected physician dispensing in workers' compensation cases. In Publix Super Markets v. Dep't of Fin. Servs., the court held the rules exceeded DFS's authority because the statutory "absolute choice" provision applies only to pharmacies and pharmacists, not dispensing practitioners. Workers' compensation insurers may now require injured workers to use pharmacies instead of receiving medications directly from treating providers.

ASIC v Electro Optic Systems Holdings Limited - Continuous Disclosure Contravention

ASIC obtained a declaration that Electro Optic Systems Holdings Limited contravened s 674A(2) of the Corporations Act 2001 (Cth) by failing to notify ASX of a material change to its revenue forecast that could reasonably be expected to materially affect share value. The Federal Court ordered an agreed penalty against the company. This case reinforces ASIC's enforcement focus on continuous disclosure obligations for ASX-listed entities.

Leslie (Trustee) v White (Bankrupt) - Section 73 Proposal and Vacant Possession

The Federal Court of Australia ordered Luke Anthony White (bankrupt) to deliver vacant possession of real property at 11-23 Herriman Court, Jimboomba, Queensland to his bankruptcy trustee within 56 days. The court also ordered removal of all personal property from the premises, with the trustee empowered to dispose of unremoved items. The application for adjournment of a Section 73 proposal was declined.

Kevin Wilkins LG&E Complaint Dismissed by PSC

The Kentucky Public Service Commission dismissed without prejudice a complaint filed by Kevin Wilkins against Louisville Gas and Electric Company concerning gas service connection at a Louisville property. The complaint was dismissed because it failed to state a violation, was filed by someone other than the property owner (Wilkins LLC), lacked required legal representation under Kentucky administrative law, and the complainant failed to amend the complaint within the allotted 20-day period.

Delta Natural Gas Confidential Supplier Treatment Order

The Kentucky Public Service Commission granted Delta Natural Gas Company, Inc.'s motion for confidential treatment of redacted portions of its Gas Cost Recovery Rate Quarterly Report, specifically supplier identities, invoices, pricing, interconnections, and volumes. The Commission found the information meets the criteria for exemption from public disclosure under KRS 61.878(1)(c)(1) as confidential proprietary information that would cause competitive harm if disclosed.

Big Rivers Electric withdraws fossil fuel unit retirement filing, case closed

The Kentucky Public Service Commission granted Big Rivers Electric Corporation's motion to withdraw its filing seeking approval to retire a fossil fuel-fired electric generating unit and establish a regulatory asset. The Commission entered the order on April 7, 2026, closing Case No. 2025-00314 and removing it from the docket without prejudice. BREC indicated plans to refile after completing additional internal review and preparation of supporting documentation.