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
Already a Subscriber? Log in Here
Lab Industry Advisor Subscription
Struggling with Staying Informed? In the fast-paced world of diagnostic medicine, staying updated with the latest legal, compliance, regulatory, and industry insights is crucial. Yet, finding reliable and comprehensive information can be overwhelming and time-consuming.
Lab Industry Advisor to the Rescue! Lab Industry Advisor provides comprehensive, up-to-date insights and analyses tailored to your needs. With expert commentary and actionable advice, you’ll stay ahead of the curve. No more sifting through endless sources—everything you need is right here!
Start your free trial today and see how Lab Industry Advisor can transform your approach. Get instant access to invaluable resources designed to keep you informed and competitive. Explore detailed reports, in-depth articles, and exclusive industry insights that help you make better decisions faster. Choose from three subscription levels tailored to fit your needs: Essential, Premium, and Elite.
![Essential](https://www.g2intelligence.com/wp-content/uploads/2023/11/Essential.png)
![62934_G2_Subscription Website Images_JL V1](https://www.g2intelligence.com/wp-content/uploads/2023/11/62934_G2_Subscription-Website-Images_JL-V1.png)
![Special-Report](https://www.g2intelligence.com/wp-content/uploads/2023/11/Special-Report.png)
![62934_G2_Subscription Website Images_JL V12](https://www.g2intelligence.com/wp-content/uploads/2023/11/62934_G2_Subscription-Website-Images_JL-V12.png)
![Special-Analysis](https://www.g2intelligence.com/wp-content/uploads/2023/11/Special-Analysis.png)
![Elite](https://www.g2intelligence.com/wp-content/uploads/2023/11/Elite.png)
Additional Business Intelligence Offerings
Lab Industry Advisor Subscriptions Include
![paper_magnifing_glass_512](https://www.g2intelligence.com/wp-content/uploads/2023/11/paper_magnifing_glass_512.png)
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 Enforcers Crack Down on Telehealth Genetic Testing Scams
After the DOJ announced a massive National Health Care Fraud Enforcement Action on July 20 targeting telehealth and telemarketing scams, labs need to be extremely wary, especially if they provide genetic testing.
OCR Doles Out Record Fine for Right of Access Violation
On July 15, the Department of Health & Human Services Office for Civil Rights announced 11 new enforcement actions, including the biggest penalty doled out since the agency began the right of access program back in April 2019—$240,000 against Texas nonprofit Memorial Hermann Health System.
Don’t Trust a Negative At-Home COVID-19 Test Result, FDA Warns
The agency is recommending repeat testing with at home COVID-19 antigen tests, regardless of actual symptoms.
Be Sure to Use New ABN Form, Starting August 31
As of August 31, 2022, labs and other providers must use the new ABN labeled with the appropriate federal OMB Number (0938-0566) and CMS-R-131 to ensure they can bill Medicare beneficiaries for any lab tests or other services that Medicare doesn’t cover.
CMS Bristles at Criticism It’s Not Recovering Medicare Overpayments
According to a recent OIG report, CMS is not doing a good job collecting the Medicare overpayments OIG auditors are uncovering. However, CMS recently rejected almost all of the recommendations in that report, suggesting all is not well between the two federal agencies.
LDTs Legislation Inches Closer to Passage, but Major Hurdles Remain
The VALID Act for FDA regulation of laboratory developed tests is working its way through the final stages of the legislative process, but not everyone is loving it.
CMS Proposes CLIA Fee Increases and Nurses Doing High-Complexity Testing
In addition to increasing and imposing new user fees, the proposed rule would allow nurses to perform high and moderate complexity testing, essentially placing nursing degrees on the same level as degrees in clinical laboratory science, biology, and chemistry. Here's what lab managers need to know about the proposed rule.
OIG and CMS Clash on Medicare Overpayment Recoveries
OIG says the agency is leaving millions of dollars on the table, but CMS doesn’t want to hear it.
Eight Charged in Alleged $150M Crestar Labs Fraud Scheme
Individuals were supposedly paid kickbacks to obtain genetic samples for unnecessary genetic testing, which was then falsely billed to federal healthcare programs.
Most Lab Professionals Work in Understaffed Labs, Are Burnt Out
According to a recent survey of 1,112 respondents, despite modest salary increases, most medical lab professionals are struggling in understaffed labs.