Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
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”
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
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.
FDA Watch: New Guidance on Charging for Investigational Drugs
On August 21, the FDA proposed new guidelines on charging for investigational drugs; here are the key highlights.
Final Surprise Billing Rules Seek to Provide Fairer Price Dispute Resolution
Revised final rule essentially disarms the threat of insurers having the advantage in out-of-network price disputes.
Labcorp Continues Its Outreach Labs Buying Spree
While the overall M&A market has been slow in 2022, Labcorp has been on a bit of an acquisitions binge.
Amazon Ends Telehealth Services, but Forges Ahead with Healthcare Disruption
In a surprise move, the e-retail giant announced it will close down its Amazon Care Primary Health Services for employees at the end of 2022.
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.
