New Waived Tests

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Listed below are the latest tests approved by the Food and Drug Administration (FDA) as waived tests under CLIA (Clinical Laboratory Improvement Amendments of 1988). The CPT code, effective date and description for the latest tests approved by the FDA as waived tests under CLIA are as follows (most are drug tests):  Some home health […]

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New Waived Tests

By:

Listed below are the latest tests approved by the Food and Drug Administration (FDA) as waived tests under CLIA (Clinical Laboratory Improvement Amendments of 1988). The CPT code, effective date and description for the latest tests approved by the FDA as waived tests under CLIA are as follows (most are drug tests):  Some home health […]

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New Waived Tests

By:

Listed below are the latest tests approved by the Food and Drug Administration (FDA) as waived tests under CLIA (Clinical Laboratory Improvement Amendments of 1988). The CPT code, effective date and description for the latest tests approved by the FDA as waived tests under CLIA are as follows: 87633QW, February 3, 2023, BIOFIRE Diagnostics, BIOFIRE […]

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FDA to Require Supply of Mail-back Envelopes for Outpatient-dispensed Opioids

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Examination of In-home Disposal Products also Planned; Notes on New DEA Registration Requirements On April 3, 2023, the U.S. Food and Drug Administration announced it is requiring manufacturers of opioid analgesics dispensed in outpatient settings (which includes home hospice care) to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional […]

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Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks

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The U.S. Food and Drug Administration (FDA) is recommending consumers, health care providers, and facilities to not use certain surgical N95 respirators manufactured by O&M Halyard, and to use caution with certain surgical masks and pediatric face masks manufactured by O&M Halyard. The FDA is aware of laboratory test results that show certain models of […]

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FDA Removes REMS Requirement for BLINCYTO®

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A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.  The BLINCYTO® REMS was first approved by the FDA in 2014 and last updated in […]

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New Waived Tests for Home Health and Hospice

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Listed below are the latest tests approved by the Food and Drug Administration (FDA) as waived tests under CLIA (Clinical Laboratory Improvement Amendments of 1988). The CPT code, effective date and description for the latest tests approved by the FDA as waived tests under CLIA are as follows: 82010QW, 82962, May 27, 2022, AmVentureX Inc. […]

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Recall of Certain Medfusion 3500 and 4000 Syringe Infusion Pumps

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Smiths Medical Recalls Certain Medfusion 3500 and 4000 Syringe Infusion Pumps for Software Issues That May Impact Infusion Delivery The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death Recalled Product Product Name: Medfusion Syringe Infusion Pumps Models, Product […]

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Medicare to Cover Free Over-the-Counter COVID-19 Tests

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People enrolled in either Original Medicare or Medicare Advantage will be able to get over-the-counter COVID-19 tests at no cost starting in early spring, the Biden administration recently announced. Under the new initiative, Medicare beneficiaries will be able to access up to eight over-the-counter COVID-19 tests per month for free. Tests will be available through […]

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Medicare to Cover Free Over-the-Counter COVID-19 Tests

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People enrolled in either Original Medicare or Medicare Advantage will be able to get over-the-counter COVID-19 tests at no cost starting in early spring, the Biden administration recently announced. Under the new initiative, Medicare beneficiaries will be able to access up to eight over-the-counter COVID-19 tests per month for free. Tests will be available through […]

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Medicare to Cover Free Over-the-Counter COVID-19 Tests

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People enrolled in either Original Medicare or Medicare Advantage will be able to get over-the-counter COVID-19 tests at no cost starting in early spring, the Biden administration recently announced. Under the new initiative, Medicare beneficiaries will be able to access up to eight over-the-counter COVID-19 tests per month for free. Tests will be available through […]

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New Waived Tests

By:

Listed below are the latest tests approved by the Food and Drug Administration (FDA) as waived tests under CLIA (Clinical Laboratory Improvement Amendments of 1988). The CPT code, effective date and description for the latest tests approved by the FDA as waived tests under CLIA are as follows: 81003QW, September 23, 2021. Teco Diagnostics Inc. Uritek […]

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