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
OIG Work Plan Monthly Review: April 2018
From - G2 Compliance Advisor
Four of the six new items that the OIG added to its workplan have an impact–albeit indirect–on labs…
PAMA Reimbursement: CMS Tells Labs How to Secure ADLT Status for New Tests
From - G2 Compliance Advisor
Although the 2018 market-based Clinical Laboratory Fee Schedule (CLFS) is officially in effect, implementation of the new…
Getting Paid: Medicare to Cover Next Gen-Sequencing Tests for Advanced Cancer
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Compliance Perspectives: New Stark Rules Offer Some Physician Kickback Relief but Not Nearly Enough
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Brief Your CEO: New Penalties Double the Dollar Value of Protecting Your Lab from Liability
From - G2 Compliance Advisor
You may not realize this, but Congress has just doubled the dollar value of what you do as a compliance manager to keep your…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - G2 Compliance Advisor
Case: A physician coding supervisor for a North Carolina health system that used billing software from Epic filed a qui tam lawsuit against the firm claiming that the…
Diagnostic danger in the lab: Time to reform how we process orders
Recent report examining 10,000 claims to understand the key drivers of medical malpractice suits found 52 percent involved lab-related errors.
CMS to OIG: Get Back the $66.3 Million You Improperly Paid to Labs for Urine Validity Tests
From - G2 Compliance Advisor
As if times were not already tense enough for labs that bill Medicare for urine drug tests, the OIG ratcheted up the pressure another notch on…
You Make the Call: Do Cost-Savings Payments to Referring Physician Violate Kickback Laws?
From - G2 Compliance Advisor
SITUATION
XYZ Consultants recommends that a hospital client cut costs by making 34 changes to its OR spinal fusion surgeries procedures…
Case of the Month: $11.4 Million Natera Settlement Shows Genetic Billing & Coding Remains a False Claims Hot Button
From - G2 Compliance Advisor
Before the opioid crackdown, false billing of genetic tests was the hottest thing in federal fraud enforcement against clinical labs. But while drug testing related to…