actice Professor of Law at the Kline School of Law at Drexel University and President of David Hoffman & Associates in Philadelphia, PA., and Kurt Hopfensperger is a Senior Medical Director, Clinical Decision Support at Optum Insight, Inc.1 The Final Rule, CMS-4201-F, (4201) was published in 88 Fed. Reg. 22,120, Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (April 12, 2023), (https://www.federalregister.gov/documents/2023/04/12/2023-07115/medicare-program-contract-year-2024-policy-and-technical-changes-to-the-medicare-advantage-program), with subsequent corrections in Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly; Correcting Amendment, 88 Fed. Reg. 50,043 (August 1, 2023), (https://www.govinfo.gov/content/pkg/FR-2023-08-01/pdf/2023-16307.pdf. As of the time of writing this article, the Centers for Medicare & Medicaid Services issued one subregulatory guidance document related to the 4201 requirements—a frequently asked questions communication dated February 6, 2024.2 Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly; the Utilization Management section of CMS 4201–F contains new requirements for prior authorization processes and duration of approvals; requirements for adhering to national coverage determinations and jurisdictionally applicable local coverage determinations; requirements for coverage criteria development when existing guidance is not fully established, and Utilization Management Committee requirements.3 Centers for Medicare & Medicaid Service, “Chapter 6 – Hospital S

ts are designated.Section 4 Listings and Critical Habitat Determinations (50 C.F.R. pt. 424) The Services revised the implementing regulations for ESA Section 4 relating to the determination of threatened and endangered species and critical habitat designations in 89 Fed. Reg. 24,300. Particularly, the revisions focus on the procedures and criteria used for listing, delisting and reclassifying species listed on the Lists of Endangered and Threatened Wildlife and Plants and critical habitat designations. Broadly, each of the changes increases the Services’ leeway to designate species as endangered and to designate critical habitat areas.Most importantly for critical habitat designations, the rule revised 50 C.F.R. § 424.12, “Criteria for Designating Critical Habitat,” to remove a limitation on the ability to designate critical habitat. The limitation, which was imposed in 2019, identified circumstances under which the Services may decide it is not prudent to designate critical habitat. 88 Fed. Reg. 50,764, 40,768. Ultimately, the Services concluded that the 2019 revision was not consistent with the ESA and that the 2019 rule had been interpreted by the public as allowing the Services to decline designation of critical habitat for species under threat of climate change. Eliminating this limitation will give the Services greater leeway to designate land as critical habitat.The rule also revised § 424.12(b)(2) to address unoccupied critical habitat designations, which would refer to specific areas not within the geographical area the species occupies at the time it is listed under the ESA. 88 Fed. Reg. at 40,768 (finalized in 89 Fed. Reg. 24,300). The ESA distinguishes between occupied and unoccupied areas in its “critical habitat” definition. This rulemaking changed the standard for determining whether unoccupied areas are considered critical habitat. Particularly, the revision lays out a logical approach for identifying unoccupied critical habitat using the best scientific data avai

the attorneys at Torres Trade Law. 2023 Updates to the Strategy to Prevent the Importation of Goods Mined, Produced, or Manufactured with Forced Labor in the People’s Republic of China, Dept. of Homeland Security, Office of Strategy, Policy, and Plans (July 26, 2023), available athttps://www.dhs.gov/sites/default/files/2023-08/23_0728_plcy_uflpa-strategy-2023-update-508.pdf. Strategy to Prevent the Importation of Goods Mined, Produced, or Manufactured with Forced Labor in the People’s Republic of China, Dept. of Homeland Security, Office of Strategy, Policy, and Plans (June 17, 2022), available at https://www.dhs.gov/sites/default/files/2022-06/22_0617_fletf_uflpa-strategy.pdf. Notice Regarding the Uyghur Forced Labor Prevention Act Entity List, Dept. of Homeland Security, 88 Fed. Reg. 38,080 (June 12, 2023), available athttps://www.govinfo.gov/content/pkg/FR-2023-06-12/pdf/2023-12481.pdf. Notice Regarding the Uyghur Forced Labor Prevention Act Entity List, Dept. of Homeland Security, 88 Fed. Reg. 50,902 (Aug. 2, 2023), available athttps://www.govinfo.gov/content/pkg/FR-2023-08-02/pdf/2023-16361.pdf. Notice Regarding the Uyghur Forced Labor Prevention Act Entity List, Dept. of Homeland Security, 88 Fed. Reg. 66,496 (Sep. 27, 2023), available at https://www.govinfo.gov/content/pkg/FR-2023-09-27/pdf/2023-21131.pdf.

U.S. to understand that large bodies of surface water are a prerequisite for a nuclear reactor. SMRs may expand possible sites for nuclear reactors to geographic regions previously inaccessible to conventional nuclear reactors.Second, SMRs, as their name implies, introduce modularity into the nuclear reactor industry. This means that multiple reactors can be coupled together to provide for greater power output if the intended purpose of the reactor so requires.Third, SMRs produce significantly less nuclear waste than traditional reactor designs. While America is still determining how best to address nuclear waste, a move toward including SMRs could potentially slow the creation of waste while solutions are determined.As exciting as NuScale’s design approval may be, it is only one of several steps in bringing a nuclear reactor online.The U.S. currently utilizes two separate licensing regimes for nuclear reactors. Under the two-step licensing process, outlined at Title 10 of the Code of Federal Regulations, Part 50, a developer must first obtain a construction permit, followed by an operating license.5Developers may begin construction after acquiring a construction permit and before obtaining an operating license, but the operating license must be obtained in order for the construction of the reactor to occur and for it to come online.The other main licensing framework for nuclear reactors is the combined licensing process, outlined under Title 10 of the Code of Federal Regulations, Part 52. The combined licensing process consists of three unique steps: an early site permit, a standard design certification and an operating license.The application for the combined license may incorporate by reference a standard design certification. NuScale’s standard design certification may be incorporated by reference should NuScale choose to pursue a Part 52 license.New Nuclear Fuel Agreement Among G7 MembersOn April 16, five G7 countries — the U.S., U.K., Canada, Japan and France — announced their intention