nt that patients demonstrate a full year of addiction before being eligible for treatment;Expand access to interim treatment and allow patients to initiate medication treatment while awaiting further services; andPromote patient-centered models of care.In addition, the rule removes outdated language among regulations and implements new definitions reflecting current medical usage.The final rule will go into effect on April 2, 2024. For more information, click here.FDA Final Rule Amends Quality System Regulation Device CGMP Practice Requirements On Jan. 31, the Food and Drug Administration (FDA) released a final rule that amends the medical device current good manufacturing practice requirements of the Quality System Regulation and aligns them with device quality management system standards set by the International Organization for Standardization. The final rule will:Incorporate by reference, ISO 13485 standards for medical device quality management systems;Rename the title of Code of Federal Regulations Part 820 – Quality System Regulation to Quality Management System Regulation; andEstablish additional requirements that clarify certain expectations and concepts used in ISO 13485.The final rule will go into effect and the FDA will begin enforcing the new management system standard requirements on Feb. 2, 2026.For more information, click here.CMS Final Rule Improves Prior Authorization Process and Access to Health InformationOn Jan. 17, the Centers for Medicare and Medicaid Services released a final rule that seeks to expand access to health information and improve the prior authorization process. The final rule will:Require Medicare Advantage organizations, Medicaid and Children’s Health Insurance Program fee-for-service programs and managed care plan entities to send prior authorization decisions within 72 hours for expedited requests and seven calendar days for standard requests for medical items and services;Require impacted payers to include a specific reason for denying a prior authoriza

nt that patients demonstrate a full year of addiction before being eligible for treatment;Expand access to interim treatment and allow patients to initiate medication treatment while awaiting further services; andPromote patient-centered models of care.In addition, the rule removes outdated language among regulations and implements new definitions reflecting current medical usage.The final rule will go into effect on April 2, 2024. For more information, click here.FDA Final Rule Amends Quality System Regulation Device CGMP Practice Requirements On Jan. 31, the Food and Drug Administration (FDA) released a final rule that amends the medical device current good manufacturing practice requirements of the Quality System Regulation and aligns them with device quality management system standards set by the International Organization for Standardization. The final rule will:Incorporate by reference, ISO 13485 standards for medical device quality management systems;Rename the title of Code of Federal Regulations Part 820 – Quality System Regulation to Quality Management System Regulation; andEstablish additional requirements that clarify certain expectations and concepts used in ISO 13485.The final rule will go into effect and the FDA will begin enforcing the new management system standard requirements on Feb. 2, 2026.For more information, click here.CMS Final Rule Improves Prior Authorization Process and Access to Health InformationOn Jan. 17, the Centers for Medicare and Medicaid Services released a final rule that seeks to expand access to health information and improve the prior authorization process. The final rule will:Require Medicare Advantage organizations, Medicaid and Children’s Health Insurance Program fee-for-service programs and managed care plan entities to send prior authorization decisions within 72 hours for expedited requests and seven calendar days for standard requests for medical items and services;Require impacted payers to include a specific reason for denying a prior authoriza

nt that patients demonstrate a full year of addiction before being eligible for treatment;Expand access to interim treatment and allow patients to initiate medication treatment while awaiting further services; andPromote patient-centered models of care.In addition, the rule removes outdated language among regulations and implements new definitions reflecting current medical usage.The final rule will go into effect on April 2, 2024. For more information, click here.FDA Final Rule Amends Quality System Regulation Device CGMP Practice Requirements On Jan. 31, the Food and Drug Administration (FDA) released a final rule that amends the medical device current good manufacturing practice requirements of the Quality System Regulation and aligns them with device quality management system standards set by the International Organization for Standardization. The final rule will:Incorporate by reference, ISO 13485 standards for medical device quality management systems;Rename the title of Code of Federal Regulations Part 820 – Quality System Regulation to Quality Management System Regulation; andEstablish additional requirements that clarify certain expectations and concepts used in ISO 13485.The final rule will go into effect and the FDA will begin enforcing the new management system standard requirements on Feb. 2, 2026.For more information, click here.CMS Final Rule Improves Prior Authorization Process and Access to Health InformationOn Jan. 17, the Centers for Medicare and Medicaid Services released a final rule that seeks to expand access to health information and improve the prior authorization process. The final rule will:Require Medicare Advantage organizations, Medicaid and Children’s Health Insurance Program fee-for-service programs and managed care plan entities to send prior authorization decisions within 72 hours for expedited requests and seven calendar days for standard requests for medical items and services;Require impacted payers to include a specific reason for denying a prior authoriza