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
Lab Compliance Advisor
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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
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
FDA Warns About Biotin Interference With Lab Tests
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PAMA-Geddon: Lab Industry Takes CMS to Court
From - G2 Compliance Advisor
The nearly three-year struggle between HHS and the lab industry over PAMA has entered a new phase. On December 11, the American Clinical Laboratory Association (ACLA) filed…
OIG Work Plan Monthly Review: December 2017
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New Bill Would Make Lab Employees Criminally Liable for Concealing Data Breaches
From - G2 Compliance Advisor
While massive data breaches have existed as long as massive data itself, legal accountability for organizations that commit them is…
CMS Ignored Congressional Intent in Implementing New Clinical Lab Payment System Under PAMA, ACLA Charges in Suit
From - G2 Compliance Advisor
The government agency that runs the Medicare program failed to follow a congressional directive to implement a market-based laboratory payment system…
Medicare Exclusions: One Week, Two Different Labs Get the Boot
From - G2 Compliance Advisor
Exclusion of a clinical lab from participating in Medicare or other government health programs is a relatively rare penalty…
CMS Ignores Flawed Processes, Finalizes 2018 PAMA Pricing; Labs Need to Take Immediate Action to Offset Impending Lean Times
By Kyle Fetter bio
The final 2018 clinical laboratory fee schedule (CLFS) is out, and it is evident that the argument that the Centers for Medicare & Medicaid Services (CMS) PAMA process was…
The 10 Assumptions NOT to Make when Doing Your OSHA 300s
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CLIA Corner: FDA Moves to Boost CLIA Waiver Transparency
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Medicare Reimbursement: CMS Finalizes Hospital Outpatient Prospective Payment Changes for 2018
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