Agency Rulemaking Highlights
The Drug Enforcement Administration issued a final rule expanding access to medications for the treatment of opioid use disorder, pursuant to the Easy Medication Access and Treatment for Opioid Addiction Act. The law makes less restrictive the dispensing of narcotic medications to treat opioid withdrawal. Practitioners may now dispense up to a 3-day supply of medications. Effective August 8.
Medicare Program Changes
The Centers for Medicare & Medicaid Services (CMS) is proposing changes to a wide array of fee schedules, payment policies, enrollment policies, and program requirements for calendar year 2024. Comments due September 11.
CMS also issued a final rule updating payment rates and implementing the second phase of its Patient Driven Payment Model parity adjustment recalibration. Effective October 1.
The Environmental Protection Agency (EPA) is proposing revisions to its Air Emissions Reporting Requirements. Under this proposed rule, EPA would require certain sources to report hazardous air pollutants emissions; prescribed fire data; add requirements for reporting fuel use for electrical generation; and change reporting for transportation sources. The revisions would also make the requirements for point sources consistent and phase in earlier deadlines for point source reporting. Comments due October 18.
Safety of Partially Hydrogenated Oils
The Food and Drug Administration (FDA) issued a direct final rule revoking uses of partially hydrogenated oils in foods after determining in 2015 that such uses were no longer generally recognized as safe. The final rule is effective December 22. Concurrently, FDA is proposing a companion rule to address some uses of partially hydrogenated oils which may be recognized by prior sanction and thus could not be regulated as food additives. Comments due October 23.
The Securities and Exchange Commission issued a final rule enhancing and standardizing disclosures regarding cybersecurity risk management, strategy, governance, and incidents by public companies. Effective September 5.
The Department of Justice is proposing to establish specific requirements and technical standards for making accessible the services, programs, and activities offered by state and local government entities to the public through the web and mobile apps. Comments due October 3.
President Biden issued a proclamation declaring lands surrounding the Grand Canyon as a new national monument and instructing agencies to work in consultation with tribal nations to ensure the protection of sacred sites and cultural properties in the monument. Access for tribal members will be provided for traditional cultural, spiritual, and customary uses on these lands, now named the “Baaj Nwaavjo I’tah Kukveni-Ancestral Footprints of the Grand Canyon National Monument.”