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...]
LEGISLATION
From DAIA to the VALID ACT: The Latest Chapter in FDA Diagnostic Test Oversight Reform
January 28, 2019
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...]
HEALTH CARE REFORM
Compliance Perspectives: PAMA Pitfalls & Survival Strategies
December 31, 2018
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...]
PUBLIC HEALTH
Industry Buzz: Obamacare Repeal Sends Tremors through Insurance Markets
December 18, 2018
What came as a Christmas gift to many Republicans may be a lump of coal in the stocking of many others. On December 14, a federal judge in Texas ruled that the entire Affordable Care Act (aka, … [Read more...]
LEGISLATION
New Laws: Proposed Federal Legislation Would Allow Medicare Payment for Genetic Counselling
December 14, 2018
A new bill introduced in the U.S. House of Representatives in October calls for CMS to recognize certified genetic counselors as healthcare providers. Here's a quick overview of the bill and why it … [Read more...]
REIMBURSEMENT
Labs Need to Prepare for Upcoming PAMA Data Collection Period
October 30, 2018
The impact of PAMA (the Protecting Access to Medicare Act) is already being felt in the laboratory industry. The estimates are bleak. Three-fourths of codes on the Clinical Lab Fee Schedule are now … [Read more...]
FALSE CLAIMS
PAMA: ACLA Loses Court Lab Fees Battle But May Still Win Regulatory War
October 11, 2018
It was a long shot to begin with. But that doesn't ease the disappointment of what happened in a Washington, DC courtroom when a federal judge tossed a lab industry lawsuit challenging the legality of … [Read more...]
