MediRegs Weekly Regulatory Highlights

Final and Proposed Regulations

Final rule; correction: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories; Correction

As stated by CMS:

"This document corrects technical and typographical errors in the final rule that appeared in the December 28, 2023, Federal Register entitled, «Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories» (referred to hereafter as the «December 2023 final rule»)."

Rule: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories; Correction [6431-6432]

Final rule; correction: Medicare Program; Calendar Year (CY) 2024 Home Health (HH) Prospective Payment System Rate Update; HH Quality Reporting Program Requirements; HH Value-Based Purchasing Expanded Model Requirements; Home Intravenous Immune Globulin Items and Services; Hospice Informal Dispute Resolution and Special Focus Program Requirements, Certain Requirements for Durable Medical Equipment Prosthetics and Orthotics Supplies; and Provider and Supplier Enrollment Requirements; Correction

As stated by CMS:

"This document corrects technical errors in the final rule that appeared in the November 13, 2023 Federal Register titled «Medicare Program; Calendar Year (CY) 2024 Home Health (HH) Prospective Payment System Rate Update; HH Quality Reporting Program Requirements; HH Value-Based Purchasing Expanded Model Requirements; Home Intravenous Immune Globulin Items and Services; Hospice Informal Dispute Resolution and Special Focus Program Requirements, Certain Requirements for Durable Medical Equipment Prosthetics and Orthotics Supplies; and Provider and Supplier Enrollment Requirements» (referred to hereafter as the «CY 2024 HH PPS final rule»)."

Rule: Medicare Program; Calendar Year (CY) 2024 Home Health (HH) Prospective Payment System Rate Update; HH Quality Reporting Program Requirements; HH Value-Based Purchasing Expanded Model Requirements; Home Intravenous Immune Globulin Items and Services; Hospice Informal Dispute Resolution and Special Focus Program Requirements, Certain Requirements for Durable Medical Equipment Prosthetics and Orthotics Supplies; and Provider and Supplier Enrollment Requirements; Correction [6019-6021]

FDA

Rule: Medical Devices; Quality System Regulation Amendments [7496-7525]
Proposed Rule: Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability [7315-7317]
Rule: Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate [5767-5768]

HHS

Rule: Medications for the Treatment of Opioid Use Disorder [7528-7563]
Rule: Medical Devices; Quality System Regulation Amendments [7496-7525]
Proposed Rule: Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability [7315-7317]
Rule: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories; Correction [6431-6432]
Rule: Medicare Program; Calendar Year (CY) 2024 Home Health (HH) Prospective Payment System Rate Update; HH Quality Reporting Program Requirements; HH Value-Based Purchasing Expanded Model Requirements; Home Intravenous Immune Globulin Items and Services; Hospice Informal Dispute Resolution and Special Focus Program Requirements, Certain Requirements for Durable Medical Equipment Prosthetics and Orthotics Supplies; and Provider and Supplier Enrollment Requirements; Correction [6019-6021]
Proposed Rule: Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins [5823-5842]
Rule: Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate [5767-5768]