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Agency Rulemaking Highlights
Notable ActionsSecuring the Technology Supply Chain
The Bureau of Industry and Security is proposing to prohibit transactions involving Vehicle Connectivity System hardware and covered software designed, developed, manufactured, or supplied by persons owned by, controlled by, or subject to the jurisdiction or direction of certain foreign adversaries. The proposed rule is intended to address undue or unacceptable risks to national security and U.S. persons posed by prohibited transactions, pursuant to Executive Order 13873. Comments due October 28.
Energy Conservation Standards
The Department of Energy (DOE) confirmed the effective and compliance dates of two direct final rules published in May 2024 that establish energy conservation standards for miscellaneous refrigeration products and certain air-cooled commercial package air conditioners and heat pumps. DOE determined that the comments received in response to the direct final rules do not provide a reasonable basis for withdrawing the rules. The direct final rules are effective September 4 and September 17, respectively.
Medicare & Medicaid Updates
The Centers for Medicare & Medicaid Services (CMS) issued two final rules. One final rule addresses the misclassification of drugs and program updates under the Medicaid Drug Rebate Program. The rule aims to address drug misclassification, drug pricing, and product data misreporting by manufacturers under legislative requirements from the Medicaid Services Investment and Accountability Act of 2019. The rule also finalizes several proposed program integrity and program administration provisions under the Medicaid Drug Rebate Program. Effective November 19.
The other final rule addresses policies for assessing the financial performance of the Medicare Shared Savings Program Accountable Care Organizations (ACOs) for performance year 2023; establishing benchmarks for ACOs for 2024, 2025, and 2026; and calculating factors used in the application cycle for ACOs, as a result of “significant, anomalous, and highly suspect billing activity” for some urinary catheters under Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies claims. In this final rule, CMS responded to comments regarding mitigation of the impact of significant, anomalous, and highly suspect billing activity on Medicare Shared Savings Program financial calculations. Effective October 15.
Use of AI in Campaigns
The Federal Election Commission (FEC) issued two documents regarding the use of artificial intelligence (AI) in campaigns. FEC disposed of a petition for rulemaking that asked the commission to revise rules on fraudulent misrepresentation of campaign authority so that the rules clearly prohibited creating campaign ads using artificial intelligence. The statute regarding fraudulent misrepresentation of campaign authority is technology-neutral, so the commission declined to initiate a rulemaking.
FEC instead issued an interpretive rule regarding the fraudulent misrepresentation of campaign authority. In the interpretive rule, FEC clarifies that the relevant statutes “apply irrespective of the technology used to conduct fraudulent misrepresentation,” which inherently includes fraudulent misrepresentation created using AI. Effective September 26.
Personal Protective Equipment Acquisition
The Department of Homeland Security (DHS) issued a proposed rule that would amend the Homeland Security Acquisition Regulation to codify how DHS complies with the Make Personal Protective Equipment (PPE) in America Act. DHS expects that these changes would help sustain and expand domestic manufacturing of PPE critical to a national response to public health crises. Comments due December 2.
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