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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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
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.
How the Roe v. Wade Ruling Will Impact Prenatal Testing
Without abortion rights, basic lab testing applications for those who are or want to become pregnant have new and ominous legal implications.
ML Model Predicts Cancer Patient Response to Immunotherapy
New tool helps determine whether immunotherapy is a better option for patients than chemotherapy or radiotherapy.
GAO: FDA Needs Policy to Avoid Repeating EUA COVID-19 Test Mistakes
In a recent report, the GAO says the agency needs a policy when it comes to enforcement discretion regarding tests approved via EUA.
