LEGISLATION

New Laws: Congress Tables Bill to Make Whole-Genome Sequencing Available to Medicaid Kids

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

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

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

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

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

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

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

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?!

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...]

HEALTH CARE REFORM

Compliance Perspectives: PAMA Pitfalls & Survival Strategies

PAMA's deep Medicare reimbursement cuts have had a devastating impact on the lab industry. Recent CMS changes in the 2019 Final Rule should provide a degree of pricing relief but not until 2021. In … [Read more...]


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