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.
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).
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.
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.
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.
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.
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and state surveyors administer the Clinical Laboratory Improvement Amendments program, has been revised to remove outdated information and ensure each section matches current policies and procedures.
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.
The California Department of Public Health (CDPH) Center for Health Care Quality will host a meeting Aug. 30 from 2-3:30 p.m. to gather stakeholder feedback on acute care hospital clinical laboratory, pharmaceutical, and dietetic services regulations.
As of June 18, the California Department of Public Health’s Laboratory Field Services (LFS) is using a new method to deliver licenses and certificates for laboratory personnel, allowing them to download and print active licenses directly from the online system. LFS will no longer mail licenses, and licensees will no longer need to request or pay for a duplicate license.