As a rule of thumb, FDA approvals are a snapshot applicable only to the product as it exists at the time of review and approval. So, when the product undergoes significant changes, it often triggers … [Read more...]
FDA
Case of the Month: FDA Issues Warning Letter for Unapproved Changes to Approved Assay
May 21, 2019
COMPLIANCE GUIDANCE
HIPAA: New HIPAA Penalties System Rewards Labs that Try to Comply
May 21, 2019
New HHS rules significantly increase the amount of money your lab can save by making diligent and demonstrable efforts to prevent HIPAA violations even when those efforts don't succeed. We're … [Read more...]
INDUSTRY BUZZ
Google This: Labs Partner with Tech Giant
May 21, 2019
In recent months, several diagnostic companies have announced alliances with Google, and all involve Google Cloud Platform. Here is how four companies are using Google's … [Read more...]
NEWS
DNA Testing at the Border
May 21, 2019
The Department of Homeland Security (DHS) is piloting a DNA testing program at the U.S.-Mexico border. The program aims to establish "DNA-based family relationship (kinship) verification to improve … [Read more...]
COURT CASES
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
May 21, 2019
New York Breaks Up Massive $28 Million Medicaid Diagnostics Mill Case: One of the biggest Medicaid diagnostics fraud schemes in recent memory has resulted in multiple convictions, including two … [Read more...]
COVERAGE
Medicare Coverage: NGS Testing of Early-Stage Cancer Patients Is Back in Play
May 21, 2019
The reimbursement outlook for those who provide next generation sequencing (NGS) testing to early-stage cancer of Medicare patients with hereditary risks is far brighter today than it was a few weeks … [Read more...]
FALSE CLAIMS
Enforcement Trends: Feds Targeting Commercial & Private-Pay, Not Just Medicare Fraud
May 21, 2019
Risk of federal prosecution for health fraud and abuse applies only when you deal with Medicare, TRICARE or other federal health programs. Right? Wrong! While that used to be true, the times they … [Read more...]
ENFORCEMENT
Case of the Month: Milwaukee Clinic the Latest MD-Owned Lab Busted for Urine Drug Test Abuses
May 13, 2019
Fraudulent utilization and billing of urine drug screening has become a priority for federal enforcers since the $256 million Millennium settlement of 2016. Subsequent cases have targeted abuses … [Read more...]
NEWS
The President’s Proposed 2019 Federal Budget: The 6 Things Labs Must Know
May 6, 2019
While President Trump's proposed $4.75 trillion budget may be the largest in U.S. history, it calls for important cuts affecting health care in general and labs in particular. Here are the six things … [Read more...]
OIG
Medicaid Fraud Enforcement Trends By the Numbers
April 29, 2019
A new report from OIG details Medicare Fraud Control Unit (MCFU) enforcement activity in fiscal year 2018. Bottom Line on Top: The numbers were pretty consistent with previous trends with little in … [Read more...]
