December 2, 2020 – Federal Register Recent Federal Regulation Documents

The DoD has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

This document corrects technical and typographical errors that appeared in the final rule published in the September 29, 2020 Federal Register entitled ``Medicare Program; Specialty Care Models To Improve Quality of Care and Reduce Expenditures,'' which established the Radiation Oncology Model and the End-Stage Renal Disease Treatment Choices Model.

EPA (or the Agency) is finalizing its proposed decisions to not impose financial responsibility requirements under section 108(b) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) for facilities in three industry sectors: The electric power generation, transmission, and distribution industry, pursuant to EPA's proposal of July 29, 2019; the petroleum and coal products manufacturing industry, pursuant to EPA's proposal of December 23, 2019; and the chemical manufacturing industry, pursuant to EPA's proposal of February 21, 2020. Today's final rulemakings are based on the individual administrative records for each of the three proposed rulemakings, supported by additional analysis conducted in consideration of comments received in the public comment period for each proposed rule. In particular, after examining the existing environmental protections and regulations in place today and analyzing the Superfund program's experience cleaning up sites in each industry, the Agency concluded that facilities in these three industries operating under a modern regulatory framework do not present a level of risk that warrants financial responsibility requirements under CERCLA section 108(b). Today's final rulemakings are based on the record for these rulemakings, and do not affect EPA's authority to take a response or enforcement action under CERCLA with respect to any particular facility or industry, and do not affect the Agency's authorities that may apply to particular facilities under other environmental statutes. This combined final rulemaking comprises the Agency's final actions on each of the three proposed rules.

This final rule revises the Organ Procurement Organizations (OPOs) Conditions for Coverage (CfCs) to increase donation rates and organ transplantation rates by replacing the current outcome measures with new transparent, reliable, and objective outcome measures and increasing competition for open donation service areas (DSAs).

This final rule addresses any undue regulatory impact and burden of the physician self-referral law. This final rule is being issued in conjunction with the Centers for Medicare & Medicaid Services' (CMS) Patients over Paperwork initiative and the Department of Health and Human Services' (the Department or HHS) Regulatory Sprint to Coordinated Care. This final rule establishes exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. It also establishes a new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician; establishes a new exception for donations of cybersecurity technology and related services; and amends the existing exception for electronic health records (EHR) items and services. This final rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and regulations.

This final rule amends the safe harbors to the Federal anti- kickback statute by adding new safe harbors and modifying existing safe harbors that protect certain payment practices and business arrangements from sanctions under the anti-kickback statute. This rule is issued in conjunction with the Department of Health and Human Services' (HHS's) Regulatory Sprint to Coordinated Care and focuses on care coordination and value-based care. This rule also amends the civil monetary penalty (CMP) rules by codifying a revision to the definition of ``remuneration'' added by the Bipartisan Budget Act of 2018 (Budget Act of 2018).

We, the U.S. Fish and Wildlife Service (Service), propose to list whitebark pine (Pinus albicaulis), a high-elevation tree species found across western North America, as a threatened species under the Endangered Species Act of 1973 (Act), as amended. If we finalize this rule as proposed, it would extend the Act's protections to this species. We also propose a rule issued under section 4(d) of the Act that is necessary and advisable to provide for the conservation of the species. We have determined that designation of critical habitat for the whitebark pine is not prudent at this time.

On September 28, 2020, the Farm Credit Administration (FCA) published a final rule that repealed the regulatory requirement that production credit associations (PCAs) amortize their loans in 15 years or less, while requiring all Farm Credit System (FCS or System) associations to address amortization through their credit underwriting standards and internal controls. In that publication, FCA inadvertently omitted a statement that the Office of Management and Budget's Office of Information and Regulatory Affairs determined that the final rule is not a major rule under the applicable provisions of the Congressional Review Act. This document corrects that error.