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
Physician Jailed for Unnecessary Diagnostic Tests, Office Visits and Prescriptions
From - G2 Compliance Advisor
A Michigan physician has been sentenced to 45 months in prison as part of what the government claims is a…
Anticipate Health IT Changes in Order for Labs to Participate in Payment Reform, Coordinated Care
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CMS Final Rule Clarifies 60-Day Deadline for Returning Overpayments
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Labs Urged to Examine Internal Processes to Ensure Accuracy of Patient Identification
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Make Sure Disciplinary Action Doesn’t Equal Retaliation
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Marketing of Laboratory Tests to Consumers: Is a Practitioner Order Enough to Avoid FDA Enforcement?
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News at a Glance – March 2016
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Second Doctor Indicted in Biodiagnostic Kickback Case
From - Laboratory Industry Report
Another physician has been indicted in the long-running Biodiagnostic Laboratory Services case. Bernard Greenspan, M.D., a family physician in Northern New Jersey, was indicted on…
Federal Fraud and Abuse Recoveries Down from Prior Fiscal Year
From - G2 Compliance Advisor
Despite robust enforcement efforts and large scale investigations and takedowns, the overall recovery received in government coffers last year was…
Kickback Case Settles for Record-breaking $646 Million
From - G2 Compliance Advisor
It has been billed as the largest total amount in U.S. history paid for alleged violations of the Anti-kickback Statute by…
