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
Do Those on Medicare Advantage Receive Better Care?
Study shows that those enrolled in Medicare Advantage have lower rates of “low-value care” than those enrolled in traditional Medicare.
Medicare Part B to Cover New CLIA-Waived Tests on Oct. 1
Make sure your lab billing staff is aware of the changes to ensure full reimbursement.
First Diagnostic Test for Long COVID Receives CE-IVD Marking
Based on validation study data, the test offers 90 percent accuracy and is unaffected by the emergence of new COVID-19 variants.
Rebounds in Core Lab Services Offset Declines in COVID-19 Test Revenues
Second quarter diagnostics earnings were down, but not as much as predicted.
New Patient Guidelines Released for Breast Cancer Screening and Diagnosis
The new guidelines offer patients advice on when they should start their screening, and how often they should have it done.
CMS Proposes Significant Increases to CLIA Fees
While the rule is not yet final, it’s likely that labs will have to pay more in direct CLIA compliance expenses, starting in October.
FDA Extends Shelf Life of At-Home Rapid COVID-19 Tests
Users should realize that the FDA can extend the shelf life of a test when and if it receives additional data supporting such an extension.
New Guidelines Recommend Molecular Testing for Pediatric Brain Cancer Treatment
For labs, the big takeaway is how prominently molecular testing and profiling figures in so many aspects of the NCCN’s recommendations.
Unnecessary Drug and Genetic Tests the Theme in Recent Enforcement Actions
Most healthcare-related enforcement actions from July and August involved urine drug tests and genetic testing.
HHS Issues Final Rules for Surprise Billing Price Dispute Resolution
The process is now slightly less rigged in insurers’ favor.
