Episode 335 -- The New DOJ Whistleblower Program
DOJ’s New Self-Disclosure Policy and Corporate Whistleblower Awards Pilot Program
Understanding the Whistleblower Pilot Program in the Southern District of New York
On Feb. 9, the Department of the Treasury’s Office of Investment Security issued a request for information (RFI) seeking public comment on a proposed “Known Investor Program” and additional opportunities to streamline the...more
On February 1, 2026, the Food and Drug Administration (FDA) officially started accepting requests to participate in the FDA PreCheck pilot program. The goal of the program is to strengthen the domestic pharmaceutical supply...more
The Centers for Medicare & Medicaid Services (CMS) has been using prior authorization for selected Hospital Outpatient Department (OPD) services for several years as part of its broader effort to curb improper payments and...more
The Center for Medicare & Medicaid Services Innovation ("CMMI") announced the Make America Healthy Again: Enhancing Lifestyle and Evaluating Value-Based Approaches Through Evidence ("MAHA ELEVATE") Model, designed to improve...more
Key Takeaways - Utah’s approval of a new Regulatory Mitigation Agreement (RMA) to pilot AI in the prescription refill process adds to a growing wave of state activity, as the speed and scale of AI adoption has prompted...more
The patent examination process can often take far too long, and the United States Patent and Trademark Office (USPTO) is determined to do something about it in 2026. This past October, the USPTO started a one-year pilot...more
On December 29, 2025, the PTO announced the creation of a new Standard-Essential Patent (SEP) Working Group. The stated purpose of the SEP Working Group is “to ensure that all patent holders … are treated fairly and that...more
The recent litigation concerning the government’s 340B Rebate Model Pilot Program (the Rebate Program), as further described below, took an unexpected turn as the federal government recently signaled that it intended to...more
What Are Trump Accounts? A Trump account is a type of individual retirement account (IRA) established for the exclusive benefit of a child and designated as a “Trump account” at inception. Created by the One Big...more
Governor Phil Murphy signed into law Senate Bill No. 2283 (2R), establishing the Psilocybin Behavioral Health Access and Therapy Pilot Program (the Pilot Program). The legislation appropriates $6 million and positions New...more
On January 2, 2026, the US Food and Drug Administration (FDA) began accepting statements of interest for its Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot, a program designed to accelerate access to digital...more
The Center for Medicare and Medicaid Innovation (CMMI) recently released information about three new models aimed at testing alternative calculations for manufacturer rebates, to ensure net drug prices are closer to those in...more
On January 7, 2026, the First Circuit Court of Appeals denied the federal government’s emergency motion to stay a district court injunction blocking implementation of HRSA’s 340B Rebate Model Pilot Program, leaving the...more
A federal judge has issued a preliminary injunction halting the Department of Health and Human Services’ (HHS) 340B Rebate Model Pilot Program, which was scheduled to take effect on January 1, 2026. The December 29, 2025...more
On December 21, 2025, the CFTC’s Market Participants Division (“MPD”) issued a no‑action letter that could materially expand hedging options for commercial energy companies by allowing firms to exclude certain “Energy...more
UPDATE: On January 12, 2026, the federal government announced it would drop its appeal of Judge Walker’s order blocking implementation of the Pilot Program and return it back to HRSA for reconsideration. In a court filing...more
A client calls and says, “We’re cooking up a bispecific antibody. We want to mix and match binding sequences like a molecular gastronomy tasting menu. Some will go into CAR-T dishes. And of course, we want patents...more
Utah has issued a policy, through the Utah Department of Commerce and its Office of Artificial Intelligence Policy, authorizing a pilot program that allows an artificial intelligence (AI) system to autonomously renew certain...more
The U.S. Department of State announced an update to its “Countries Subject to Visa Bonds” notice on January 6, 2026, expanding the pilot program to include thirty-two additional nations—including Bangladesh, Nepal, Nigeria,...more
The Centers for Medicare & Medicare Services’ (“CMS”) Innovation Center will begin accepting applications on January 12 for the recently announced Advancing Chronic Care with Effective, Scalable Solutions (“ACCESS”) Model—a...more
I. Executive Summary - On December 19, 2025, the CFTC’s Market Participants Division (“MPD”) issued Staff No-Action Letter No. 25-51, establishing a three-month pilot program under which certain energy commodity end-user...more
On December 29, 2025, Judge Lance Walker of the U.S. District Court of Maine issued a preliminary injunction halting the Health Resources and Services Administration’s (“HRSA”) implementation of the 340B Rebate Model Pilot...more
On December 29, a federal district court in Maine granted a preliminary injunction to prevent the Health Resources and Services Administration (HRSA) from implementing the 340B Rebate Pilot Program on January 1, 2026, when it...more
What Are Trump Accounts? The term “Trump Accounts” comes directly from the Notice, which instructs that these accounts be designated as such in a manner outlined by the Secretary. While initially it seemed the label might be...more
The United States Department of Agriculture’s Natural Resources Conservation Service (“NRCS”) announced he Regenerative Pilot Program (“RPP”). NRCS states that the RPP will provide $700 million to help American farmers: ...more