Clinical Laboratories

News & Analysis as of

CMS Releases Preliminary 2016 Determinations for New Clinical Lab Tests, Announces October 19 Open Meeting on Clinical Lab...

CMS has announced its preliminary 2016 clinical laboratory fee schedule (CLFS) payment determinations for new and reconsidered test codes. These preliminary determinations will be the subject of an October 19, 2015 meeting...more

CMS Releases Proposed Rule Reforming Medicare CLFS Payment Rates

The Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule [CMS-1621-P] in accordance with Section 216 of the Protecting Access to Medicare Act of 2014 (“PAMA”), which establishes a new payment methodology...more

CMS Publishes Long-Awaited PAMA Proposed Rule

On September 25, 2015, the Centers for Medicare & Medicaid Services (CMS) announced publication of the proposed rule (the “Proposed Rule”) implementing substantial changes to the Medicare Clinical Laboratory Fee Schedule...more

CMS Proposes Overhaul of Clinical Lab Payment Methodology: What You Need To Know

On Friday, the Centers for Medicare & Medicaid Services (“CMS”) issued a long-awaited proposed rule that would drastically change the payment rates for clinical laboratory services beginning January 1, 2017 (the “Proposed...more

Health Update - September 2015

Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure - As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face...more

Did Recent Changes in the Patent Laws Turn the Page on the Need for Accurate Laboratory Notebooks?

With the enactment of the Leahy-Smith America Invents Act (AIA), the U.S. patent system moved to a “first inventor to file” approach for examining all applications having an effective filing date on or after March 16, 2013....more

Also In The News - Health Headlines - September 2015

CMS Announces New SNF Payment – On August 27, 2015, CMS announced “a new funding opportunity” for SNFs that is intended “to reduce avoidable hospitalizations by funding higher-intensity interventions in nursing...more

True Health Diagnostics Makes Offer to Acquire Health Diagnostic Laboratory

True Health Diagnostics, based in Frisco, Texas, has offered to acquire Health Diagnostic Laboratory (HDL), based in Richmond, Va., for $32 million, according to a Richmond Times Dispatch report....more

OMB Reviewing CMS Proposed Rule on PAMA Clinical Lab Test Payment Policy

CMS is finally taking steps to implement the Medicare clinical laboratory payment reforms mandated by the Protecting Access to Medicare Act of 2014 (PAMA). Under PAMA, CMS must base Medicare payment rates for clinical...more

First Meeting of Advisory Panel on Clinical Diagnostic Laboratory Tests on August 26, 2015

CMS has announced that the first meeting of the Advisory Panel on Clinical Diagnostic Laboratory Tests will be held on August 26, 2015. The Panel will recommend crosswalks for new laboratory codes, recommend an appropriate...more

UW Donation to Morgridge “Fab Lab” For Medical Device Innovations

University of Wisconsin-Madison alums, Dr. James Berbee and Karen Walsh, have agreed to a five-year, $300,000 gift to the Morgridge Institute for Research through their Berbee Walsh Foundation. According to the press...more

Why the Health Care Industry Needs to Focus on Data-Flow Restrictions in China

U.S. health care providers, device manufacturers, lab managers, health information technology and telemedicine/telehealth project investors, and other industry members involved in projects in China, need to be aware of a long...more

April Whistleblower News Digest | Consider Targeted Anti-Retaliation Training as part of Your Ethics and Compliance Training...

If April showers bring May flowers, then May is going to be a veritable hurricane of whistleblower-related fines (and also pollen). Our first three items come to us from the SEC, with awards and fines galore, most notably the...more

CMS Schedules July 16 Meeting on Medicare Clinical Laboratory Fee Schedule Payments

CMS has just announced that it is holding a public meeting on July 16, 2015 to discuss Medicare clinical laboratory fee schedule (CLFS) payment for new or substantially revised HCPCS codes for calendar year 2016. At the...more

Quest Diagnostics and Inserm Launch BRCA Data-Sharing Initiative

Last week, diagnostics services provider Quest Diagnostics and Inserm, the French National Institute of Health and Medical Research institution, announced the launch of BRCA Share, a new datashare initiative that will provide...more

Blog: Fraud Watch: Laboratory Referrals Under Government Scrutiny

Significant recent regulatory and enforcement activity related to laboratory fees and services continues to demonstrate an increased focus on this industry. Government enforcers are active in cases involving both the...more

Third Circuit to Plaintiffs’ Bar: Expert Testimony Necessary for Certification Must Satisfy Daubert

Plaintiff purchasers of traditional blood reagents, products that test the compatibility of donor blood with recipients, brought putative class actions claiming that two defendant companies conspired to fix prices in...more

Health Diagnostics Laboratory Agrees to Pay $47 Million to Settle Claims

Health Diagnostics Laboratory (HDL) of Richmond, Va., has agreed to pay $47 million to resolve allegations it violated the False Claims Act by compensating physicians for ordering tests, according to a U.S. Department of...more

OIG Nixes Arrangements Involving Free Tests

Labs Attempt to Counter Exclusive Lab Arrangements - With increasing frequency, clinical laboratories have found themselves unable to receive any payments for tests performed for individuals whose third-party insurer...more

OIG Issues Unfavorable Advisory Opinion on Proposal for Exclusive Laboratory Services Arrangements

On March 25, 2015, the U.S. HHS Office of Inspector General (OIG) released an unfavorable Advisory Opinion in which it found that it could potentially impose administrative sanctions and exercise its permissive exclusion...more

OIG Warns Lab “Pull-Through” Arrangements May Be Illegal

In an important advisory opinion, the U.S. Department of Health and Human Services Office of Inspector General (OIG) gave a thumbs-down to a proposed clinical laboratory “pull-through” arrangement even though the patients in...more

OIG: Exclusive laboratory arrangement may violate Antikickback Statute and result in exclusion for excessive charges

On March 25, 2015, the Office of Inspector General (“OIG”) issued Advisory Opinion 15-04, which found that an exclusive arrangement between a laboratory and its referring physician practices could violate the Federal...more

Blog: OIG Releases Advisory Opinion Regarding Laboratory and Physician Practice Agreement

On March 25, 2015, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion No. 15-04. In the opinion, the OIG addresses a laboratory’s proposal to enter into agreements...more

OIG Finds Exclusive Lab Arrangement May Violate Anti-Kickback Statute

Yesterday the Office of Inspector General for the Department of Health and Human Services (the “OIG”) issued Advisory Opinion 15-04 (“Advisory Opinion”) in which it found that an exclusive arrangement between a laboratory...more

OIG Advises that Exclusive Lab Referral Arrangement May be a Kickback

The Department of Health and Human Services Office of Inspector General (OIG) released an advisory opinion (No. 15-04) today that states a proposed arrangement to provide free laboratory tests for certain patients of...more

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