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
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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
Compliance Tool: Checklist for Avoiding 10 Top CLIA Deficiencies for Labs
Even the best labs can incur CLIA deficiencies when unprepared; this checklist can help your lab avoid some of the most common
OIG Work Plan Monthly Review: July 2018
From - G2 Compliance Advisor
None of the six new items that OIG added to its Work Plan last month directly impact labs…
How PAMA’s Effect in 2018 Molecular Diagnostic Reimbursement Will Make Labs More Money
By Sean McSweeney bio
The year 2018 is slated to be much brighter for molecular diagnostic labs as PAMA fee schedules show a higher payment rate and amount for many cancer genomics and…
Compliance Perspectives: The 12 Things to Include in Your Drug & Alcohol Testing Policy
From - G2 Compliance Advisor
No! No! No! The truth is that state laws on marijuana use and possession have little to no direct impact on workplace drug policies and the testing methods used…
OIG Work Plan Monthly Review: May 2018
From - G2 Compliance Advisor
Of the seven new Work Plan items, none directly impact labs and lab services. However, one item on Medicare Part B reimbursement of outpatient cardiac and…
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…
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…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - G2 Compliance Advisor
Case: The feds charged Mercy Hospital with overbilling Medicare and MaineCare for urinalysis tests. Rather than risk a trial, Mercy has agreed to…
OIG Calls on CMS to Do Better at Medicare Collecting Overpayments
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Beware of Accidental Discrimination in Lab Job Ads
From - G2 Compliance Advisor
Before civil rights laws, job ads like these were seen as perfectly normal. Today, employers aren't allowed to post job ads with phrases that exclude or express preferences based on…
OIG Work Plan Monthly Review: September 2017
From - G2 Compliance Advisor
Many of the 12 new items that the OIG added to its 2017 Work Plan in September target state and federal government agencies, including the…