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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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
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.
FY 2022 Q2 Earnings Trend Down, but Much Less than Predicted
While not nearly as robust as a year ago, diagnostic companies’ revenues held up surprisingly well in Q2 2022.
Is an Antibody Test for Early Detection of Lyme Disease Feasible?
Recent study suggests a new test may help doctors detect Lyme disease during the early stages when treatment is likely to be more effective.
Pancreatic Cancer Is Caught Sooner When Regular Screening Done
A recent study shows that most patients who underwent such screening were diagnosed at an earlier stage than those who did not.
Combining Certain Genetic Tests for Heart Conditions Provides Better Results
A recent study shows that combined cardiomyopathy and arrhythmia genetic testing catches things disease-specific testing would miss.
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.
Repeat At-Home COVID-19 Antigen Tests to Avoid False Negatives, FDA Says
The agency is advising people to perform repeat, or serial testing after a negative result, regardless of symptoms.
Telehealth Doesn’t Discourage In-Person Care or Drive Wasteful Use
Two recent studies show that most people see telehealth as a supplement to in-person visits, rather than a replacement.
Getting Paid: How to Complete the ABN Form
Completing the Advance Beneficiary Notice of Noncoverage form can be extremely complex; this guide helps simplify the process.
Inform Diagnostics Pays $16M to Settle False Billing Allegations
In this Labs in Court monthly roundup, the Texas-based pathology lab was accused of falsely billing Medicare for unnecessary tests on biopsy specimens.
