Diagnostic Tests

News & Analysis as of

ML Strategies Health Care Update – DNA Sequencing Workshop and Drug Pricing Developments

On Tuesday, ML Strategies (MLS) posted its weekly Health Care Update, which provides information from the previous week on a variety of important health-care-related topics....more

FDA Invites Genome Scientists to Come Play in the precisionFDA “Sandbox” - NGS Technologies Take Center Stage at Agency Campus

On November 12th and 13th, the Food and Drug Administration hosted genome scientists from across the nation at its campus in White Oak, Maryland. Two public workshops engaged presenters and audience members on various...more

Upcoming Health Policy Hearings - November 2015

Several Congressional hearings are scheduled next week and into December on health policy issues, including...more

Also In The News - Health Headlines - November 2015

CMS Publishes Medicaid Access Final Rule – CMS published a Final Rule in the Federal Register today, November 2, 2015, that implements a process for states to determine whether Medicaid payments satisfy what is known as the...more

Why Patients Should Fear Diagnostic Errors

Errors in diagnosis are the top cause for medical malpractice lawsuits in the United States. Despite these staggering statistics, diagnostic errors have not been the subject of attention in Chicago the way that other...more

Three Pressing Challenges for Personalized Medicine

Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

CMS Proposes Sweeping Changes to Medicare Reimbursement for Clinical Diagnostic Laboratory Tests

First Data Collection Period for Clinical Laboratories Is July 1, 2015 to December 31, 2015 - In the October 1, 2015 Federal Register, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule...more

Dueling Records: Are Statements in Your 510(k) Putting Your Patents at Risk?

Laboratory developed test (LDT) providers, previously exempt from U.S. Food and Drug Administration (FDA) oversight, under a new FDA proposal, must now consider if their LDTs constitute moderate-risk (Class II) or high-risk...more

House Energy & Commerce Panel Releases Draft Bill to Regulate Diagnostic Lab Tests, Schedules November 17 Hearing

The House Energy and Commerce Health Subcommittee has scheduled a November 17, 2015 hearing on the regulation of diagnostic tests and laboratory operations. The hearing will feature FDA and CMS officials who will testify on...more

Nov. 10 CMS Call Will Review Clinical Lab Test Payment Proposed Rule

On November 10, 2015, CMS is hosting a public call to discuss its October 1, 2015 proposed rule that would make significant changes to the Medicare clinical diagnostic laboratory test payment system. Registration is required...more

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

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

What impact will the Australian Myriad decision have on patent eligibility of diagnostic tests?

By now most will know that: (a) Australia’s final appeal Court has made adverse findings against Myriad’s patent for utilising the BRCA1 locus to diagnose breast cancer; (b) the rejected claims are only those that...more

Checklist for Avoiding Diagnostic Errors

The “say what?” study last month describing the disturbing frequency of errors in medical diagnoses has prompted much navel-gazing in many quarters. ...more

USPTO Report on State of Confirmatory Genetic Testing Comes off the Waffle Iron

In 2011—after the Fed. Cir. decision in Myriad upholding claims to BRACA1 and 2 genes—the PTO was tasked by a section of the AIA with providing Congress with a report on the effect of patenting on confirmatory genetic...more

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

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

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