CMS Final Rule Updates Proficiency Testing Requirements Under CLIA
The Centers for Medicare & Medicaid Services and Centers for Disease Control and Prevention have issued a final rule updating proficiency testing and referral requirements under the Clinical Laboratory Improvement Amendments.
GE Healthcare Provides Update on Shortage of Contrast Media
On May 18, leaders from GE Healthcare joined an American Hospital Association webinar designed to provide members with an update on the contrast dye shortage.
Updates on Temporary Supply Chain Disruption of Contrast Media
The GE Healthcare production facility for iodinated contrast media in Shanghai experienced an unexpected, temporary shutdown that has created temporary supply pressure for radiographic contrast medium used before X-ray imaging.
CMS Resumes Laboratory Survey Activity
The Centers for Medicare & Medicaid Services (CMS) has announced it will fully resume laboratory survey activity — as required by the Clinical Laboratory Improvement Amendments (CLIA) — following a suspension in enforcement action during the COVID-19 public health emergency (PHE).
FDA Withdraws Exceptions for Laboratory-Developed COVID-19 Tests
The Food & Drug Administration (FDA) has reversed the prior administration’s policy on pre-market review exception for COVID-19 laboratory-developed tests that allowed the tests to be offered prior to or without FDA authorization.
CMS to Host Webinar on Medicare Clinical Laboratory Fee Schedule Private Payer Data Collection and Reporting Policies
The Centers for Medicare & Medicaid Services will host a webinar on Nov. 10 at 12:30 p.m. (PT) to provide updates and key information on the Medicare clinical laboratory fee schedule (CLFS) private payer data collection and reporting policies. Registration is required. The next CLFS data reporting period for clinical diagnostic laboratory tests is Jan. 1 through March 31, 2022, and is based on the original data collection period of Jan. 1 through June 30, 2019.
MedPAC Releases June 2021 Report to Congress
The Medicare Payment Advisory Commission (MedPAC) has released its June 2021 Report to the Congress, a mandated report that details analysis and recommendations about the Medicare program and health care delivery system.
CDPH Updates Recommendations for COVID-19 Testing at General Acute Care Hospitals
On June 7, the California Department of Public Health (CDPH) released updated COVID-19 testing recommendations for both health care personnel (HCP) and patients at general acute care hospitals (GACHs). The revised All Facilities Letter (AFL) 20-88.1 reflects updated recommendations in light of HCP and patients now, in many cases, being fully vaccinated.
CMS Revises Surveyor Guidance for Laboratories
The Centers for Medicare & Medicaid Services (CMS) has issued revised guidance for clinical laboratory surveyors, with updates to State Operations Manual (SOM) Chapter 6. That chapter, intended to help regional office and state surveyors administer the Clinical Laboratory Improvement Amendments program, has been revised to remove outdated information and ensure each section matches current policies and procedures.
CMS Revises Guidance for Hospital Outreach Laboratory CLFS Reporting Requirements
The Centers for Medicare & Medicaid Services (CMS) has issued revised guidance for laboratories that are required to report private payer data for laboratory tests under the clinical laboratory fee schedule (CLFS). In response to advocacy from CHA, CMS revised its guidance for hospital outreach laboratories on reporting applicable information attributed to non-patients.