Special Report: Preparing for Stage 1 of the FDA’s LDTs Final Rule
Considerations for addressing compliance with Stage 1 of the FDA’s lab-developed tests final rule
Lab Compliance Advisor
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Articles and Reports
How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
News at a Glance – September 2016
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Drug Testing Case Settles for $7.4 Million
From - G2 Compliance Advisor
A Florida clinic has settled a False Claims Act case relating to drug testing for $7.4 million. Quantitative drug tests that…
Train Staff to Be Alert to Phishing Attacks
From - G2 Compliance Advisor
When asked why he robbed banks, the notorious outlaw Willie Sutton famously replied: "Because that's where they keep…
Industry Questions How Many Hospital Labs Will Be Reporting Under PAMA
From - G2 Compliance Advisor
When the Centers for Medicare & Medicaid Services (CMS) announced in mid-June the final rules governing the Protecting the…
Theranos Announces Appeal of CMS Sanctions
From - G2 Compliance Advisor
Theranos has announced that it is appealing the Centers for Medicare & Medicaid's threatened sanctions. The announcement also indicated that…
No One-Size-Fits-All Answer for Frequency of Billing and Coding Audits
From - G2 Compliance Advisor
The Office of Inspector General's Compliance Program Guidance for Clinical Laboratories includes among its seven elements for a comprehensive compliance program…
Check Compliance Policies Against Current Operations
From - G2 Compliance Advisor
While labs may draft a comprehensive compliance plan and policies and procedures, those policies, procedures and plan can be a liability if…
Remember Compliance Risks When Hiring and Firing
From - G2 Compliance Advisor
Hiring and firing staff are difficult challenges. While there are many factors to consider in making either decision, compliance should be front of mind in…
Senate Hearing Addresses Potential Stark Law Changes
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Liquid Biopsies Get FDA Attention
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