By Mike O’Brien bio Department of Labor enters final stage of update to ‘regular rate’ rule under FLSA. As we have discussed previously in these updates, the Department of Labor has been working to … [Read more...]
LEGISLATION
New Laws: Congress Tables Bill to Make Whole-Genome Sequencing Available to Medicaid Kids
August 26, 2019
In early August, Representatives Scott Peters (D-CA) and John Shimkus (R-IL) introduced in the US House of Representatives a bill to provide "certain undiagnosed children under the Medicaid program" … [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...]
TESTING TRENDS
Universal HCV Screening of Pregnant Women Is Cost-Effective, Should Be Adopted Nationally, Study Urges
April 26, 2019
Universal hepatitis C virus (HCV) screening among pregnant women in the United States is cost effective and improves detection of HCV among women and children, according to a study published in … [Read more...]
REIMBURSEMENT
The Newest PAMA Controversy: The GAO Report & Intervention of a Powerful Senator
March 25, 2019
The recent moves by CMS to include certain hospital outreach labs as "applicable laboratories" for purposes of PAMA reporting and pricing (see National Intelligence Report (NIR), Dec. 31, 2018) has … [Read more...]
LEGISLATION
From DAIA to the VALID ACT: The Latest Chapter in FDA Diagnostic Test Oversight Reform
January 28, 2019
While FDA oversight over new diagnostic tests is perfectly acceptable, what is objectionable is the agency's continued reliance on a regulatory regime designed not for lab tests but medical devices. … [Read more...]
ENFORCEMENT
New Law: EKRA Makes Drug Addiction & Rehab Labs Potential Targets for Federal Prosecution
January 15, 2019
Recent federal legislation addressing the opioid crisis may have unintended consequences on the lab industry. The idea was to allow the feds to prosecute a certain kind of abuse banned by the … [Read more...]
FOCUS ON
LDTs: FDA Announces New Approach to 510(k) Approvals
January 7, 2019
Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including diagnostics. Here's a quick … [Read more...]
LEGISLATION
Compliance Alert: New Private-Pay Opioid Law Puts All Drug Addiction & Rehab Labs at Risk of Federal Prosecution
January 7, 2019
Recent federal legislation addressing the opioid crisis may have unintended consequences on the lab industry. The idea was to allow the feds to prosecute a certain kind of abuse banned by the … [Read more...]
HEALTH CARE REFORM
Case of the Month: Texas Court Strikes Down Obamacare—So, Now What?!
December 31, 2018
What came as a Christmas gift to many Republicans could be a lump of coal in the stockings of health insurers and the patients they cover. On Dec. 14, a federal judge in Texas did the unthinkable by … [Read more...]
