New Enhancing CLIA Act: What Lab Directors Need to Know
The proposal seeks to move any future LDT authority away from the FDA
Already a member? Log in here
Legislation-nir
Subscribe today for access to
Articles and Reports
Four Federal Efforts to Monitor, Including RESULTS Act Progress
Other proposals aim to increase fraud enforcement, temper prior authorization, and modernize CLIA
Already a member? Log in here
PAMA Delay Proposed Until 2027 Under a New Federal Spending Bill
However, attorney Danielle Sloane urges labs to be proactive about potential PAMA reporting requirements on Jan. 31 if the bill doesn’t pass quickly
Already a member? Log in here
Despite MDUFA Setback, VALID Act Is Back on Track for Passage
Though Congress didn’t pass VALID as part of the medical devices user fees bill, there’s still a good chance it will pass before year’s end.
Already a member? Log in here
Final Surprise Billing Regulations Cut Insurer Control—Sort Of
It remains far from clear whether the new surprise billing rule goes far enough to fix the problem of insurers having too much power in disputes.
Already a member? Log in here
LDTs Legislation Inches Closer to Passage, but Major Hurdles Remain
The VALID Act for FDA regulation of laboratory developed tests is working its way through the final stages of the legislative process, but not everyone is loving it.
Congress Acts to End PAMA Price Cutting Reign of Terror
After years of resistance, the lab industry’s hopes and prayers for relief from the flawed pricing scheme may soon be answered.
Already a member? Log in here
Revised VALID Act Proposes Risk-Based FDA Regulation of LDTs
The most recent congressional effort to pass LDT legislation may prove to be the one that finally comes to fruition.
Already a member? Log in here
How the End of the COVID-19 PHE Will Impact Lab Compliance
A briefing on how labs should prepare for the inevitable end of the PHE after more than two years of unprecedented relief.
Already a member? Log in here
Lawmakers Squabble as Country Runs Out of COVID-19 Response Money
The relief package agreed to on April 4 appears to have become a collateral victim of a politically incendiary issue regarding immigration.
Already a member? Log in here
New Act Would Mean Wider Medicare Coverage of Genetic Cancer Screening
Legislation would require Medicare to cover genomic cancer testing and follow-up screening for those with a family history of cancer.
Already a member? Log in here
The Sun Is About to Set on the Controversial Trump Era “SUNSET” Rule
...
Already a member? Log in here
