Insights

On April 10, 2026, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule (2026 CMS Interoperability Standards and Prior Authorization for Drugs, or CMS-0062-P) outlining the agency’s plans to impose new interoperability requirements on payors participating in certain Medicare and Medicaid programs. As described by the agency in a recent press release, the proposed rule “builds on” prior rulemaking by clarifying and enhancing interoperability requirements for payors’ prior authorization processes, specifically those associated with coverage requests for pharmaceutical therapies.

The Federal Trade Commission (FTC) recently released its Strategic Plan for Fiscal Years 2026–2030, setting out the agency’s enforcement priorities and operational objectives for the next five years under Chairman Andrew N. Ferguson. The plan reaffirms the FTC’s commitment to vigorously enforcing the nation’s antitrust and consumer protection laws “without fear or favor.” Critically for businesses, the plan returns the phrase “without unduly burdening legitimate business activity” to the agency’s mission statement, signaling a commitment to ending what the agency characterizes as overregulation of businesses that compete fairly and deal honestly with consumers. Despite this business-friendly framing, the plan signals robust enforcement across consumer protection, antitrust, and emerging technology — areas that will directly affect in-house counsel’s compliance planning over the coming years.

The U.S. Court of Appeals for the Federal Circuit recently decided in Bd. of Trs. of Columbia Univ. v. Gen Digital Inc., No. 2024-1243 (Fed. Cir. 2026) that the district court erred in its denial of judgment as a matter of law as to damages resulting from foreign sales of downloadable software. At Columbia University's request, the jury had been instructed that “Columbia [was] entitled to damages based on sales to customers located outside of the United States if . . . the infringing product sold to those customers was made in or distributed from the United States, even if the infringing product [was] delivered to and used by the customer outside the United States.” The court concluded as a matter of law that the software sold to Gen Digital‘s (Norton) foreign customers was made outside the United States, and therefore the $94 million in foreign sales damages could not stand.

As pharmaceutical weight-loss therapies have surged in popularity, health plans, regulators, and courts have found themselves grappling with a set of increasingly pressing and complex questions: who must cover these drugs, under what circumstances, and for whom?

The New Jersey Legislature is considering two bills, that if enacted, would prohibit business entities from using either consumers' personal data or “personalized algorithmic pricing” to set prices for merchandise or services, including groceries. If enacted, the new laws would have broad implications for companies across industries that rely on algorithmic or data-informed pricing strategies. In her recent State Budget Address, New Jersey Governor Mikie Sherrill pledged to sign the proposals into law if they reach her desk.

On March 10, 2026, the Department of Justice released the first-ever Department-wide Corporate Enforcement and Voluntary Self-Disclosure Policy (the “Department-wide CEP” or “Policy”), which applies to all non-antitrust corporate criminal cases across the Department. The new policy has been anticipated since December 2025, when Deputy Attorney General Todd Blanche announced the Department’s plans to release a new, single corporate enforcement policy for all criminal matters. According to the Department, the new policy is designed to “help ensure consistency across the Department” and “transparently describe the Department’s policies and decisionmaking.”

A recent decision by the United States Court of Appeals for the Fifth Circuit, Farmers Texas County Mutual Insurance Co. v. 1st Choice Accident & Injury, LLC, No. 24-20275 (5th Cir. Feb. 24, 2026), offers important lessons for health care payors and other potential plaintiffs considering civil claims under the federal Racketeer Influenced and Corrupt Organizations Act (RICO). Although the Fifth Circuit’s decision focused on a procedural issue, the underlying case turned on a fundamental pleading failure: the plaintiff insurers did not adequately describe the fraudulent network they were suing as a RICO “enterprise.” The result was dismissal of a $14 million fraud case.

On February 10, 2026, California enacted Senate Bill 25 (“SB 25”), known as the California Uniform Antitrust Pre-Merger Notification Act. The new law takes effect on January 1, 2027, making California the third state—following Washington (effective July 27, 2025) and Colorado (effective August 6, 2025)—to implement a “mini-HSR” regime modeled after the Uniform Antitrust Pre-Merger Notification Act (“UAPNA”). The legislation reflects the growing state-level focus on merger oversight, and it signals California’s continuing intent to increase early pre-merger scrutiny and concurrent review of transactions with federal authorities.

By the end of 2025, 16 drug manufacturers had voluntarily negotiated and executed agreements to adopt Most Favored Nation (MFN) pricing for certain high-cost drugs. The Trump Administration highlighted the agreements in its “Great Healthcare Plan,” published on January 15, 2026, and communicated the government’s plans to “codify” such deals as a means of “get[ting] Americans the same low prices that people in other countries pay.” The Administration recently leveraged MFN pricing to establish the TrumpRx website, which helps uninsured or cash-paying consumers find drugs at a discounted price. The website reflects the Administration’s stated commitment to provide more lower-cost drugs directly to consumers. Currently, 40 branded medications are available at reduced prices.

On July 8, 2025, the U.S. Court of Appeals for the Eighth Circuit vacated the Federal Trade Commission’s (FTC) Rule Concerning Subscriptions and Other Negative Option Plans, commonly known as the “Click-to-Cancel” rule. As detailed in a previous client alert, the rule was intended to regulate negative option plans[1]— such as subscriptions and automatic renewals — by imposing stringent requirements on businesses, including streamlined cancellation processes and enhanced disclosure obligations. The Eighth Circuit vacated the Click-to-Cancel rule because it found that the FTC had failed to comply with mandatory procedural requirements. As a result, the rule is no longer in effect, and businesses are not currently subject to its mandates.

On February 3, 2026, President Trump signed a $1.2 trillion spending deal that, among other points, introduced significant regulatory changes for Medicare Part D plans and PBMs providing services to PDP sponsors in the Medicare Advantage and Medicare Part D programs, and imposed significant new restrictions and transparency requirements on PBMs contracting with private group health plans.

New York Governor Kathy Hochul has signed into law the most significant update to New York’s consumer protection law in 45 years — the Fostering Affordability and Integrity through Reasonable Business Practices Act, or FAIR Business Practices Act — expanding the scope of the state’s authority to now challenge unfair and abusive business practices. The measure, backed by New York Attorney General (“AG”) Letitia James and signed on December 19, 2025, amends New York’s General Business Law § 349, giving regulators new tools to protect consumers and promote fair marketplace practices.

California continues its blistering pace in enacting artificial intelligence regulations. In 2024 alone, California enacted 18 AI-related bills seeking to regulate AI tools and increase transparency around AI data disclosure.

On November 12, 2025, Judge King in the U.S. District Court for the Western District of Washington granted in part Haldiram India Ltd.’s (“Plaintiff” or “Haldiram”) motion for a preliminary injunction against Punjab Trading, Inc. (“Defendant” or “Punjab Trading”), a seller alleged to be importing and distributing gray market snack food products not authorized for sale in the United States. The court found that Haldiram was likely to succeed on the merits of its trademark infringement claim because the products at issue, which were intended for sale in India, were materially different from the versions intended for sale in the U.S., and for this reason were not genuine products when sold in the U.S. Although the court narrowed certain overbroad provisions in the requested order, it ultimately enjoined Punjab Trading from importing, selling, or assisting others in selling the non-genuine Haldiram products in the U.S. market.

Patent claims must be clear and definite, as they set the boundaries of the patentee’s rights. Occasionally, however, claim language contains errors, such as typographical mistakes or incorrect numbering. Courts possess very limited authority to correct such errors. The United States Court of Appeals for the Federal Circuit has emphasized that judicial correction is appropriate only in rare circumstances, where (1) the error is evident from the face of the patent, and (2) the proposed correction is the sole reasonable interpretation in view of the claim language, specification, and prosecution history. See Group One, Ltd. v. Hallmark Cards, Inc., 407 F.3d 1297, 1303 (Fed. Cir. 2005) and Novo Indus., L.P. v. Micro Molds Corp., 350 F.3d 1348, 1357 (Fed. Cir. 2003).

Utah Attorney General Derek Brown (R) and North Carolina Attorney General Jeff Jackson (D) have announced a nationwide bipartisan “AI Task Force,” in partnership with major AI developers (including OpenAI and Microsoft) and the Attorney General Alliance (AGA), a bipartisan nonprofit that serves as a forum for attorneys general around the United States to discuss and collaborate on policy and enforcement initiatives.

The Federal Trade Commission (FTC) and National Advertising Division (NAD) of BBB National Programs laid out their enforcement priorities during the 2025 ANA Masters of Advertising Law Conference, at which Crowell & Moring attorneys spoke on and attended various panels.

Earlier this month, California enacted Senate Bill 763 (“SB 763”). The legislation amends the state’s long-standing antitrust statute, the Cartwright Act, to increase both criminal and civil maximum penalties for corporations and individuals.  California Attorney General Rob Bonta, whose office is responsible for enforcing the Cartwright Act and stands to benefit from any civil penalties recovered under the new law, sponsored the bill.

A new series of lawsuits have been filed in California courts alleging violations of the state’s Business and Professions Code § 17529.5 (the “Anti-Spam Law”). These cases target companies that send marketing and promotional emails to California residents, and they could present serious legal and financial risks for businesses engaged in email marketing.

The deadline for Department of Health and Human Services (“HHS”) to notify approved manufacturers of acceptance into the 340B Rebate Model Pilot Program has passed, and stakeholders across the healthcare industry should start planning for compliance and operational changes. The Model Pilot Program may also face legal challenges that could delay or disrupt implementation.