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...]

PUBLIC HEALTH

Industry Buzz: Obamacare Repeal Sends Tremors through Insurance Markets

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

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

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

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...]


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