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
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
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
Federal Court Calls PAMA Rule “Arbitrary,” but Refuses to Strike It Down
D.C. Circuit Court of Appeals agrees with lab industry that CMS got Medicare lab pricing all wrong, but says it’s unable to intervene.
Nationwide Takedown Headlines Busy Enforcement Week
Last week saw a takedown of $1.2B worth of alleged fraud schemes involving labs, genetic testing, and telemedicine.
Regular Screening Finds Pancreatic Cancer at Earliest Stage
A recent study shows that the disease was detected sooner in high-risk individuals who underwent screening than those who did not.
Lab Companies Launch New Tests for Monkeypox
Centers for Disease Control and Prevention spearheads US effort to quickly increase lab testing capacity and access.
Prior Authorization and Benefits Verification Automation for Diagnostic Labs
In this Q&A, Tyler Wince of Myndshft discusses the key issues labs face when it comes to benefits and prior authorization, and how technology can help.
How to Guard Your Lab from Telehealth Liability Risk
The OIG’s new Fraud Alert can help labs and other providers steer clear of potentially suspect arrangements with telemedicine companies.
OIG Warns Providers to Steer Clear of Telehealth Scams
First Special Fraud Alert in nearly two years cites six red flags of suspect arrangements with telehealth companies.
Mitigating Biotin Interference in Lab Tests
Biotin interference can lead to erroneous lab results in certain IVDs, including some troponin tests.
Guidance on HIPAA Abortion Privacy Rights Post-Roe-v-Wade
Loss of constitutional abortion rights undermines privacy protection of patients seeking reproductive care.
When & How to Use Changed Clinical Laboratory Consult Codes
Use of these codes has frequently raised concerns for compliance due to a lack of clarity regarding when they’re appropriate.