Clinical Laboratories

News & Analysis as of

New Massachusetts Law Targets Self-Referrals of Clinical Laboratory Services

The Fiscal Year 2015 budget for the Commonwealth of Massachusetts, which was signed into law earlier in the week, included a broad prohibition on clinical laboratory self-referrals. This legislation (the “Bill”) originally...more

News from the Health Law Gurus™: July 2014

Survey of ACA Navigators Finds 10.6 Million People Sought Enrollment Help — In a survey released this week, the Kaiser Family Foundation (“Kaiser”) estimates that approximately 10.6 million people received assistance...more

OIG issues special fraud alert on laboratory payments to referring physicians

On June 25, 2014, the U.S. Department of Health and Human Services Office of the Inspector General (“OIG”) released a Special Fraud Alert addressing Laboratory Payments to Referring Physicians. ...more

OIG Report Recommends Increased Scrutiny of Over 1000 Laboratories With Questionable Billing for Medicare Part B Clinical...

According to a recently released report by the HHS Office of Inspector General (OIG), over 1,000 labs had unusually high billing for Medicare Part B Clinical Laboratory Services for dates of service in 2010. Increased...more

OIG Sticks It to Physician Specimen Collectors

On June 25, the U.S. Department of Health & Human Services, Office of the Inspector General ("OIG") issued a Special Fraud Alert updating the previous guidelines concerning compensation by clinical laboratories to referring...more

OIG Report: Questionable Billing for Medicare Part B Clinical Laboratory Services

Perhaps not coincidentally, immediately following the release of the Questionable Laboratory Payments Special Fraud Alert by the OIG, posted yesterday on the Med Law Blog, the OIG has followed up with Audit Report OIG –...more

OIG issues Special Fraud Alert on laboratory payments to referring physicians

The Health and Human Services Office of the Inspector General (OIG) recently issued a Special Fraud Alert on laboratory payments to referring physicians. Specifically, the alert is concerned with Specimen Processing...more

OIG Special Fraud Alert Questions Laboratory Payments to Physicians

On June 25, 2014, the Office of the Inspector General (OIG) issued a Special Fraud Alert addressing the issue of remuneration offered and paid by laboratories to referring physicians. The Special Fraud Alert expands upon...more

Begin Preparing for Pennsylvania’s Enforcement of Act 122

The Pennsylvania Department of Health (“DOH”) Bureau of Laboratories (“Bureau”) recently announced that it will begin to phase-in enforcement of Act 122, which amended the Pennsylvania Clinical Laboratory Act (“Lab Act”),...more

OIG Special Fraud Alert on Laboratory Payments to Referring Physicians

On June 25, 2014, the Office of Inspector General (OIG) published a Special Fraud Alert titled “Laboratory Payments to Referring Physicians” in which it addresses compensation arrangements and potential anti-kickback statute...more

OIG Issues Special Fraud Alert About Laboratory Payments to Referring Physicians

On Wednesday, June 25, 2014, the Office of Inspector General (OIG) issued a Special Fraud Alert (the Alert) addressing compensation paid by laboratories to referring physicians. The latest in a series of guidance documents...more

OIG Issues Special Fraud Alert Regarding Laboratory Payments To Referring Physicians

On June 25, 2014, the United States Department of Health and Human Services, Office of the Inspector General ("OIG"), issued a Special Fraud Alert that addressed its concerns about compensation paid by clinical laboratories...more

OIG Issues Special Fraud Alert on Lab/Physician Arrangements

The Office of the Inspector General (“OIG”) has issued another Special Fraud Alert, this time specifically targeting a recent trend in arrangements between laboratories and physicians. The alert describes two types of...more

OIG Publishes Special Fraud Alert Regarding Laboratory Payments To Referring Physicians – Some Arrangements May Violate the...

The laboratory market has become quite competitive in recent years, raising compliance concerns and investigations into lab relationships with referring physicians. Accordingly, on June 25, 2014, the OIG released a Special...more

OIG Releases Special Fraud Alert on Laboratory Payments to Physicians

The Office of the Inspector General (OIG) for the Department of Health and Human Services recently issued a Special Fraud Alert regarding laboratory payments to referring physicians. The Special Fraud Alert reaffirms OIG’s...more

Anti-Kickback and Stark Law Violations Form Basis for Unfair Competition Claims

On June 16, 2014, a federal district court jury in Florida awarded $14.755 million to plaintiff Ameritox, Ltd., a Maryland-based clinical lab, for state law claims alleging tortious interference with business relationships...more

Insurance Recovery Law - June 2014

Lab’s “Body Bag” Presentations Triggered Coverage For Defamation Claims: Why it matters - We’ve all sat through some pretty boring PowerPoint presentations. But the lesson from a recent decision: it might be a...more

FTC Uses Its "Unfair Acts" Power to Go After PHI Security Breach

The Federal Trade Commission (FTC) is moving forward with an administrative action against a small medical laboratory that suffered two data security breaches, resulting in its patients’ protected health information falling...more

Pricing Issues Affecting Laboratories

Craig Holden co-presented "New Compliance Red Flags Workshop," a workshop hosted by G2 Intelligence. Over the past five years, the Departments of Justice and Health and Human Services have recovered $19.2 billion from...more

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act (FCA) Cases: May 2014

Trends & Analysis: ..We have identified 58 health care–related qui tam cases that have been unsealed since our last Qui Tam Update. Of those, 33 cases were initiated after the start of 2012, with the remaining 25 cases...more

Is Next Generation Sequencing Ready for Personalized Medicine?

Next generation sequencing (NGS) promises to transform the delivery of health care by providing in one test diagnostic and prognostic information that had previously only been available in multiple analyses. One application...more

Complaint Filed Against HHS Alleges Medicare LCDs Deprive Beneficiaries of Necessary Clinical Laboratory Services

On April 18, 2014, California Clinical Laboratory Association (“CCLA”) and “Jane Doe” (collectively, “Plaintiffs”) filed a lawsuit against HHS for equitable relief in the United States District Court for the District of...more

Summary of Clinical Laboratory Fee Schedule Reform Provisions in the Protecting Access to Medicare Act of 2014

On April 1, the Protecting Access to Medicare Act of 2014 was enacted into law (Pub. L. 113-93). Section 216, entitled Improving Medicare Policies for Clinical Diagnostic Laboratory Tests, modernizes the Medicare payment...more

Medicare OPPS Lab "Packaging" Policy Raises Bundle of Issues

In previous Payment Matters articles, we described a policy included in the 2014 hospital outpatient prospective payment system (OPPS) final rule that would “package” certain clinical laboratory tests into OPPS, and CMS...more

Provisions of Interest to Labs in the Protecting Access to Medicare Act of 2014

The Protecting Access to Medicare Act of 2014 (HR 4302), signed by President Obama yesterday, contains a number of provisions that are important to clinical laboratories, and they include...more

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