LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Proposed Rule Would Water Down CLIA Requirements for Lab Directors and Testing Personnel
While the rule has not yet been approved, if it is, nursing degrees would be considered the equivalent of biological science degrees.
Quest Expands into MRD Liquid Biopsy with Haystack Oncology Buy
The acquisition of the Johns Hopkins spin out and its liquid biopsy ctDNA test will significantly strengthen Quest’s oncology offerings.
Convicted Lab Owner Fails to Report to Prison
In addition to the usual FCA-related fare, an arrest warrant was issued for a convicted lab co-owner after he failed to show up for prison.
Pfizer Acquires Lucira Health for $36.4 Million in Bankruptcy Auction
Lucira has fallen on hard times since it secured the first FDA EUA for an at-home COVID-19 test in November 2020.
New Bill Would Guarantee Medicare Coverage of Newly Approved Breakthrough Devices
Congress brings back controversial Trump plan scrapped by the Biden administration.
FDA to Hold Off on Enforcing New Medical Device Cybersecurity Requirements
Although the law officially took effect on March 29, the FDA says it isn’t planning to enforce the new rules until October 1.
Lab Owner Charged in Latest COVID-19 Fraud Crackdown
In the latest major COVID-19-related enforcement action, 18 individuals were charged in various schemes worth more than $490 million.
It’s Decision Day for Makers of FDA-Approved COVID-19 Tests
COVID-19 test makers will either have to get full marketing approval, or take the product off the market.
Compliance Alert: Start Using New ABN Form on June 30
Labs must use the new Advance Beneficiary Notice of Noncoverage (ABN) form starting on June 30, 2023, when the old version expires.
Weekly Enforcement Report: Unlicensed Professionals
Last week’s lone lab-related enforcement action involved a prison sentence for a woman posing as a licensed physician’s assistant.
