HIPAA

First HIPAA Breach Notification Settlement Totals $475,000

Patient health information breaches—whether from hacking, glitches or just plain old carelessness—remain an all too common occurrence in labs and other health care institutions. Four years ago, a new … [Read more...]

REIMBURSEMENT

Update on Palmetto’s Molecular Dx Testing LCDs

Advanced diagnostic tests are emerging faster than the clinicians can document their clinical utility. All of this creates an interesting dilemma for payors as far as coverage is concerned. Normally … [Read more...]

ENFORCEMENT

OIG Targets Sleep Study Tests

If your lab performs sleep studies on Medicare patients, beware. It is now a high-priority target for federal fraud and abuse enforcement. Here is a look at the risk you face and what you can do to … [Read more...]

INDUSTRY BUZZ

Molecular Diagnostics among Top 2016 M&A Deals

Although volume of diagnostics industry mergers and acquisitions was up slightly in 2016, the big story of the year were the deals that did not go through—at least not yet. Abbott Steals the … [Read more...]

NEWS

FDA Watch: Next-Gen Sequencing Companion Test Wins Approval

Last month, the U.S. Food and Drug Administration shelved its longawaited/ dreaded (depending on your point of view) final guidance on laboratory-developed tests. (For the details, see, LIR, Nov. … [Read more...]

INDUSTRY BUZZ

Abbott, Molecular Lab Acquisitions Dominate the Year in Diagnostics Industry M&A

Although volume of diagnostics industry mergers and acquisitions was up slightly in 2016, the big story of the year was the deals that did not go through—at least not yet. Abbott Steals the … [Read more...]

LCDs

Palmetto Latest Medicare Contractor to Loosen Up on Covering Molecular Dx Testing

Advanced diagnostic tests are emerging faster than the clinicians can document their clinical utility. All of this creates an interesting dilemma for payors as far as coverage is concerned. Normally … [Read more...]

NEWS

Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

BLS Bribery Scheme Claims another Physician. Case: A New York internist became the third physician indicted in the Biodiagnostic Laboratory Services (BLS) bribery scheme. The Justice Department claims … [Read more...]

ENFORCEMENT

Enforcement Trends: 5 Insights from the OIG Semi-Annual Report

You can always count on OIG semiannual reports to Congress for two things: self-congratulation and insight into the enforcement priorities for the next six months. The most recent edition, published … [Read more...]

ENFORCEMENT

New OIG Rules Make It Easier to Sock Labs with Civil Monetary Penalties

It may be facing repeal but the Affordable Care Act (ACA) is not going down without a squawk. On Dec. 7, the Office of Inspector General (OIG) accomplished a key piece of ACA business by adopting … [Read more...]


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