Clinical Laboratories

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Navigating the Diagnostic Commercialization Process

Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more

Clinical Laboratories: Proposed Rule Implements Requirements for Reporting and Payment Based on Private Payer Rates

As required by a 2014 statute, CMS has issued proposed regulations (Proposed Rule) implementing new requirements for laboratory reporting of, and eventually basing Medicare payment on, rates for clinical laboratory services...more

New CMS Proposed Rule Provides Who/What/When for Clinical Laboratory Reporting Requirements Starting January 1, 2016

Clinical laboratories will see significant changes to their Medicare payments for clinical diagnostic laboratory tests (CDLTs) starting January 1, 2017, but the basis for new payment rates will come from “applicable data”...more

CMS Proposes Major Changes to Medicare Clinical Lab Test Payment Policy

On October 1, 2015, the Centers for Medicare & Medicaid Services (CMS) published its long-awaited proposed rule to base Medicare clinical laboratory fee schedule (CLFS) reimbursement on private insurance payment amounts...more

CMS Proposes Lab Data Collection Requirements to Update Fee Schedule

On September 25, 2015, CMS released proposed rulemaking that would extensively revise payment and reporting requirements for clinical diagnostic laboratory tests (CDLTs), as paid on the Clinical Laboratory Fee Schedule...more

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

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