News & Analysis as of

Laboratories

Top Takeaways for Medicare Physician and Hospital Payments in 2018

by Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) on Nov. 1, 2017, released the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) Payment System Final Rule for...more

Nationwide Healthcare Prosecutions Targeting an Array of Practices . . . Is "Just The Beginning"

by Bracewell LLP on

On July 13, 2017, the Department of Justice ("DOJ"), in conjunction with the Department of Health and Human Services ("HHS"), continued its annual tradition of coordinating the filing of charges and sweeping arrests in...more

Joint Venture to Open Biosimilar Lab in Brazil

by Goodwin on

PlantForm Corporation, a Canadian biotech firm, has announced that it will begin construction this summer on a new biopharmaceutical lab in Rio de Janeiro with its partner, Brazil-based Axis Biotec Brasil. According to...more

FDA 2016 Year in Review

by McDermott Will & Emery on

The enactment of the 21st Century Cures Act signaled the close of a multi-year bipartisan effort on Capitol Hill to grant the US Food and Drug Administration (FDA) new authorities to expedite product development and reform...more

OIG Still Rejects Lab's Free Labeling Services for Dialysis Facilities in Advisory Opinion No. 16-12

by Baker Ober Health Law on

8 Years and New Reimbursement Methodology Later - On November 28, 2016, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) issued an unfavorable advisory opinion, No. 16-12, regarding a...more

FDA Proposes to Modify Good Laboratory Practice Regulations, Broaden Application and Authority

by McDermott Will & Emery on

On August 24, 2016, the US Food and Drug Administration (FDA) issued a Proposed Rule on Good Laboratory Practice for Nonclinical Laboratory Studies (Proposed Rule), which broadens the application and authority of Good...more

Medical Marijuana in Massachusetts – DPH Proposes Amendments to Regulations

The Massachusetts Department of Public Health (DPH) has released for public comment proposed amendments to DPH’s Medical Marijuana Regulations (105 CMR 725) (the “regulations”). DPH believes that believes the proposed...more

Accutest Laboratories New England Notifies Clients of Potential Data Concerns

by Beveridge & Diamond PC on

Notification of potential data quality issues by a Massachusetts laboratory is raising concerns about the possible impact on current and closed remediation sites in Massachusetts that relied on that data. Accutest...more

What’s Lurking in Your Lab? Legal Risks for Hospital Laboratories

by Mintz Levin on

Most health-care lawyers are accustomed to monitoring the high profile areas of regulatory enforcement in health care. However, many hospital lawyers, whether in-house or outside counsel, are unaware of the potential...more

Massachusetts State Building Code Update: 9th Edition Anticipated to be Issued without Concurrency Period

by Goulston & Storrs PC on

The Massachusetts State Board of Building Regulations and Standards (the “State Board”) has announced that it expects to issue the 9th Edition of the Massachusetts State Building Code in the first half of 2016, which will...more

Guest Post -- The Emergent Microbiome: A Revolution for the Life Sciences – Part II, 2015 Patent Trends

This is the second article in a series on advancements in microbiome research and development. This installment reviews US patents issued in 2015 in "Microbiomics." Upcoming articles will continue to review important topics...more

Guest Post -- The Emergent Microbiome: A Revolution for the Life Sciences – Part I, R&D Leaders

This is the first installment in a series on advancements in microbiome research and development. Our goal with this series is to inform readers about developments in this important and growing field and to highlight, where...more

Private Equity Investment in Healthcare: 15 Healthcare Investment Niches – A Review of Key Sectors for 2015

by McGuireWoods LLP on

Private equity investment in healthcare continues to grow considerably. This article provides thoughts, observations and insights on 15 investment niches. It also provides some initial thoughts on the market as a whole....more

Also In The News - Health Headlines - July 2015 #4

by King & Spalding on

The Joint Commission Revises Nursing Care Center Requirements, Laboratory Requirements, and Outpatient Record Review Requirements for CAHs – On July 9, 2015, the Joint Commission announced revised requirements, effective...more

Health Law Wire: CMS Proposes Major Overhaul of LTC Survey Regulations (7/15)

On July 16, 2015, CMS filed over 400 pages of regulatory comment and proposed revisions to the requirements that Long-Term Care facilities must meet to participate in the Medicare and Medicaid programs. CMS stated that these...more

Connecticut legislation establishes statewide Health Information Exchange

Effective October 1, 2015, this legislation contains several provisions to encourage the free exchange of patient health information among providers and consumers. Hospitals, health systems, and electronic health record (EHR)...more

Tennessee CON Report

In This Issue: - I. May 2015—Tennessee Certificate of Need Meeting - II. Certificate of Need Program Report—Filings in May 2015 - III. Projects Deemed Complete for Review at June 2015 Meeting - Excerpt...more

Watch Out! Recent Government Settlements Implicate Referring Physicians and Laboratories

$48.5 million settlement with Health Diagnostics Laboratory, Inc. and Singulex, Inc. - On April 9, 2015, the U.S. Department of Justice ("DOJ") announced a $48.5 million settlement with two cardiovascular diagnostic...more

Two Laboratories Settle Claims Regarding Specimen Processing Fees

by Baker Ober Health Law on

Continuing the scrutiny of laboratory arrangements with referring physician practices, the United States Department of Justice (DOJ) recently announced the settlement of False Claims Act allegations against two cardiovascular...more

OIG Nixes Arrangements Involving Free Tests

by Baker Ober Health Law on

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

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

by Baker Ober Health Law on

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

by Dickinson Wright on

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

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?

by Foley & Lardner LLP on

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

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