Diagnostic Tests

News & Analysis as of

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

PTO Releases Report on Confirmatory Genetic Diagnostic Testing

More than three years after the June 15, 2012 deadline for providing it, the U.S. Patent and Trademark Office has issued its report on so-called "second opinion" genetic diagnostic testing, mandated by Section 27 of the...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 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

Diagnostic Errors: Overlooked and Critically Important

People make mistakes in any line of work, and diagnosing a medical problem is no exception. But new research shows that diagnostic errors not only aren’t rare, they’re disturbingly common. Almost all U.S. residents will be...more

FDA Oversight of Diagnostic Medicine – A Trap for the Unwary

Diagnostic medicine is experiencing new challenges at the USPTO and the U.S. Food and Drug Administration (FDA). Under a new FDA proposal, laboratory developed test providers, previously exempt from FDA oversight, must now...more

Precision Medicine - Even Medicare Will Pay for It!

President Barack Obama announced in his 2015 State of the Union address that he was introducing a new Precision Medicine Initiative, supported with over $200 million in the proposed 2016 federal budget. "Precision Medicine"...more

AmerisourceBergen Guest Post: Solutions to Overcome Reimbursement Challenges in Personalized Medicine

The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is...more

Protecting Diagnostic Innovation – Two Actor Infringement Liability

In Akamai Techs. Inc. v. Limelight Networks, Inc., (August 13, 2015 Fed. Cir.) an en banc Federal Circuit unanimously held that direct infringement under Section 271(a) can occur...more

Federal Circuit Invalidates Diagnostic Method Claims for Prenatal Test Under 35 U.S.C. 101

On June 12, 2015, the Federal Circuit affirmed the finding of U.S. District Court for the Northern District of California (“District Court”) that the method claims in U.S. Patent 6,258,540 (‘540 patent) for detecting...more

Federal Circuit Holds Medical Diagnostic Method Patent Invalid as Claiming Ineligible Subject Matter

Background - In two recent cases, Mayo v. Prometheus and Alice v. CLS Bank, the Supreme Court established a two-part test for determining eligibility for patenting. In step one, the court asks whether the claim is...more

The Life Sciences Report - Spring 2015

In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more

Patent for Technology that “Revolutionized Prenatal Care” Nonetheless Invalid as Patent Ineligible

The Federal Circuit Friday held in Ariosa Diagnostics, Inc. v. Sequenom, Inc. that Sequenom’s patent directed toward its MaterniT21 test—involving methods of detecting and using cell-free fetal DNA— was invalid for lack of...more

OIG Releases Mid-Year Update to its Work Plan

On May 28, 2015, the OIG published a revised version of its Work Plan for Fiscal Year (FY) 2015. As previously reported, the original version of the FY 2015 Work Plan was published in October and summarized the OIG's ongoing...more

Illinois joins growing list of states to adopt anti-markup legislation; statute impacts all payors

After three years of negotiations between several constituencies, including pathologists, dermatologists and other specialist associations, Illinois has joined 25 states that have enacted laws addressing the practice of some...more

Medicare Will Cover Lung Cancer Screening

On February 5, 2015, CMS announced that it will cover lung cancer screening with low dose computed tomography (LDCT). “This is the first time that Medicare has covered lung cancer screening. ...more

FDA Considering New Regulatory Approaches for NGS – Part II

The Food and Drug Administration (“FDA”) announced a workshop to be held February 20th, 2015, entitled “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests” to obtain public input regarding...more

FDA Considering New Regulatory Approaches for NGS – Part I

The Food and Drug Administration (“FDA”) announced a workshop to be held February 20th, 2015, entitled “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests” to obtain public input regarding...more

Another Patent Challenge for Personalized Medicine

The U.S. Supreme Court’s recent trilogy of patent-eligibility decisions (Prometheus, Myriad and Alice) have called into question the validity of many U.S. patents on diagnostic medical methods. Nevertheless, legal battles...more

Patients now have the right to access laboratory reports directly from the laboratory

Effective as of October 6, 2014, amendments to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations give patients, upon request,...more

FDA Notifies Congress of Framework for Long-Awaited Guidance on Laboratory Developed Tests and Issues Final Guidance on Companion...

Laboratory Developed Tests - After many years of promising that it would be providing guidance on the regulation of laboratory developed tests (LDTs), the Food and Drug Administration (FDA) provided notice to Congress...more

FDA Takes First Steps Towards Regulating Laboratory Developed Tests

On July 31, the Food and Drug Administration (FDA or “the Agency”) notified Congress that it intends to issue draft guidance proposing a Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (“Draft...more

FDA Set to Regulate LDTs - Citing Safety Concerns and Advanced Technologies

Advances in medical technology have increased the use of diagnostic tests to guide therapeutic decisions for many diseases and conditions, especially in the context of personalized medicine. Citing the need to ensure that...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

Regulating Point of Care Diagnostics

Personalized medicine relies on diagnostic medicine to identify the best therapy for the patient at the right time. Tests that match a therapy to the patient fall into one of two categories. In vitro diagnostic devices or...more

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