Laboratories

News & Analysis as of

Fundamentals of Hospital/Medical Staff Issues: Minimizing Risk and Maximizing Collaboration

In this presentation: - Health System Structure and Governance - Medical Staff Structure and Governance - Committee Structure - Medical Staff Categories - Medical Staff Governance...more

Laboratory Discount Arrangements Survive Antikickback Statute Scrutiny

There has been question for some time whether in evaluating certain discount arrangements involving clinical laboratory tests under the federal antikickback statute (FAS), discount charges should be measured against the...more

Laboratory Payments to Physicians for Specimen Processing Present Substantial Risk of Fraud and Abuse

The United States Office of Inspector General (“OIG”) recently issued a “Special Fraud Alert” focusing on two potentially illegal trends that it has detected in arrangements between laboratories and their referring...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

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

The Academic Laboratory Exception

Part One: Determining Eligibility - The federal Resource Conservation and Recovery Act, usually referred to as “RCRA”, governs the storage and disposal of hazardous waste, including hazardous medical waste. In addition...more

Final Rule Expands Access to Laboratory Records

On February 6, 2014, the Department of Health and Human Services (HHS) released a Final Rule that amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and Accountability...more

Final EHR Donation Rules Issued in Time for the New Year

On December 27, 2013, the U.S. Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) issued final rules revising the Stark exception (42 CFR...more

CMS Announces Plans to Modernize and Update the Clinical Laboratory Fee Schedule

On November 27, 2013, Centers for Medicare & Medicaid Services posted the final 2014 Medicare physician fee schedule and, in it, announced plans to change how and how much Medicare pays for clinical diagnostic laboratory...more

New York Court Of Appeal Rules: Laboratory Suable For False Positive Test Results

Last Thursday, the New York Court of Appeals ruled in a 4-3 decision that a man may bring a negligence claim against a drug testing company for a false positive drug test. At the time of the disputed test results, Eric...more

OCR Delays Required Changes to Notices of Privacy Practices for Laboratories

The HHS Office of Civil Rights (OCR) has granted certain clinical laboratories a temporary reprieve from the requirement to update their Notices of Privacy Practices (NPPs) by September 23, 2013, the deadline imposed by the...more

OIG Rejects Pod Lab Arrangement for Non-Federal Healthcare Program Business

In OIG Advisory Opinion No. 13-03, the Office of Inspector General had the opportunity to deal with two issues which have always raised concerns in the past, i.e. pod labs and swapping. It is no surprise that OIG refused to...more

CMS Issues Proposed Rule to Reform "Unnecessary, Obsolete, or Excessively Burdensome" Medicare Participation Standards

On February 4, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to reform Medicare regulations that CMS views as unnecessary, obsolete, and/or excessively burdensome on hospitals and health care...more

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