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Court Strikes Down FDA Rule Regulating Laboratory-Developed Tests

On March 31, 2025, the U.S. District Court for the Eastern District of Texas, in American Clinical Laboratory Association v. U.S. Food and Drug Administration, vacated the U.S. Food and Drug Administration’s (FDA’s) May 6,...more

CMS Issues 2025 End-Stage Renal Disease Prospective Payment System Final Rule

On Nov. 1, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that will increase payments to end-stage renal disease (ESRD) facilities in calendar year 2025. The ESRD prospective payment system (PPS)...more

CMS Issues End-Stage Renal Disease Prospective Payment System Final Rule for 2024

On Oct. 27, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that will increase payments to end-stage renal disease (ESRD) facilities in calendar year (CY) 2024. The ESRD prospective payment system...more

End of COVID-19 Emergency: Legal Implications for Healthcare Providers

On Jan. 30, 2023, President Joe Biden announced that the COVID-19 public health emergency (PHE) will end May 11, 2023. Under the PHE, the federal government implemented a range of modifications and waivers impacting Medicare,...more

CMS Issues ESRD Prospective Payment System Final Rule for 2023

Rule Addresses Rate Increases, Outlier, Add-On and ETC Model Payments, Oral-Only Drugs and QIP Reporting - On Oct. 31, 2022, the Centers for Medicare & Medicaid Services issued a final rule implementing an increase in...more

CMMI Releases Request for Applications for Kidney Care Choices Model, Performance Year 2023

On Feb. 28, 2022, the Center for Medicare and Medicaid Innovation (CMMI) published a Request for Applications for the second cohort of the Kidney Care Choices (KCC) Model, including the Centers for Medicare & Medicaid...more

CMS Grants ESRD Facilities More Flexibility, Waives Certain Conditions For Coverage During COVID-19

On March 28, 2020, the Centers for Medicare & Medicaid Services (CMS) announced it was providing additional flexibility to end-stage renal disease (ESRD) facilities under the Medicare conditions for coverage at 42 CFR §§...more

CMS Announces Enforcement Discretion for Late Open Payments Reporting Due to COVID-19

On March 25, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an Open Payments Program COVID-19 announcement and released an updated comprehensive list of frequently asked questions about the Open Payments...more

CMS Proposes Revising Physician Payments Sunshine Act Reporting Requirements

On July 29, 2019, the Centers for Medicare and Medicaid Services (CMS) released the Medicare CY 2020 Physician Fee Schedule proposed rule (the Proposed Rule), including proposed changes to regulations implementing the...more

CMS Adopts ESRD PPS and QIP Final Rule for Dialysis Services

On November 6, 2015, the Centers for Medicare and Medicaid Services (CMS) published the final rule regarding the end-stage renal disease (ESRD) prospective payment system (PPS) for renal dialysis services furnished to...more

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