Health Science, Computers & Technology

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Amicus Briefs on Biosimilar Patent Litigation

Amgen has appealed the district court decision denying its motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market. The appeal is on an expedited briefing schedule at the Federal...more

Zarxio®, First BPCIA Approved Biosimilar, Added to Purple Book

In September 2014, the FDA published the first edition of the Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (“Purple Book”), the...more

Regulators Examining Cybersecurity Policies and Practices for the Insurance Industry

Shortly after the discovery of a cybersecurity breach at the health insurance company Anthem, Inc., the National Association of Insurance Commissioners (NAIC) called for a multi-state examination of Anthem’s cybersecurity...more

Cardinal Health Agrees to Settle Monopolization Claims

The Federal Trade Commission ("FTC") announced on April 20, 2015 that it had entered into a stipulated consent order ("Order") with Cardinal Health, Inc. ("Cardinal"). The Order, which is pending court approval, requires...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

Data Breach Class Actions: Don’t Overlook Standing Defense Just Because Plaintiff Alleges Identity Theft

A New Jersey federal district court recently dismissed the putative class action claims of four plaintiffs against a health care defendant following the theft of two password-protected laptops allegedly containing personal...more

TMB Limits Telemedicine in Texas

The Texas Medical Board has issued limits on telemedicine, stating that a physician-patient relationship can be established through a “face-to-face” visit held either in person or via telemedicine. ...more

CMS Announces Recompete of Round 1 of the Medicare DMEPOS Competitive Bidding Program for 2017

On April 21, 2015, CMS announced its plans to recompete the supplier contracts awarded under the Round 1 Recompete of the Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding...more

Latest Spike in Prescription Drug Spending Prompts OIG Investigation

A new report released by the IMS Institute for Healthcare Informatics shows that U.S. spending on pharmaceuticals increased in 2014 by 13.1 percent, reaching $373.9 billion. This is the highest increase since 2001 when drug...more

Following FDA’s First Biosimilar License, CMS Issues Guidance on Reimbursement for Biosimilars

On March 6, 2015, FDA released a statement announcing its issuance of the first biosimilar license to Zarxio. In the same month, CMS issued a number of guidance documents addressing reimbursement for biosimilars under the...more

The FDA Gets an EARful on Label Changes

We’ve blogged several times about the FDA’s pending proposal to gut preemption with respect to generic drugs, and that proposal’s numerous flaws. We have been remiss, however, in not mentioning the industry’s 2014...more

Breaking News - Caplinger Infuse Preemption Dismissal Affirmed

We thought our readers would like to know that today the InFuse preemption decision in Caplinger was affirmed by the 10th Circuit in a 2-1 opinion (here’s a link). Our non-Reed Smith bloggers will undoubtedly have more to...more

FTC Settles Radioactive Allegations Against Cardinal Health with a Near Record-Breaking Disgorgement Agreement

In a 3-2 decision, as part of its aggressive antitrust enforcement in health care industries, the Federal Trade Commission (FTC or the Commission) announced that Cardinal Health, Inc. (Cardinal) agreed to pay $26.8 million to...more

Pharmacists: Aren’t you really providers already? – Part One

While the passage of the Patient Protection and Affordable Care Act (“ACA”) ushered in a new era of access to health care, it only served to exacerbate a growing crisis in the provision of health care – lack of providers....more

Maryland, My Maryland: Aldara Case Dismissed for Multiple Reasons

Today’s date is rich in literary history. It is the birthday of Vladimir Nabokov, one of two writers whose prose style makes us want to snap our Pilot Varsity pens in despair, so great is the gap between those authors'...more

FTC Seeks to Secure First Disgorgement in Nearly a Decade

The FTC announced yesterday that Cardinal Health, Inc. (“Cardinal”) has agreed to pay $26.8 million to resolve its investigation into the company’s alleged anticompetitive behavior. If approved by a federal court, the...more

Health Care E-Note - April 2015

In This Issue: - New Smartphone Software Provides Groundbreaking Opportunity for Medical Research - The Many Levels of Supervision - Health Care Business Today: A Historical Perspective on Health Care...more

Washington Healthcare Update

This Week: Energy and Commerce Health Subcommittee Explores Post-Acute Bundling…CMS Releases First-ever Hospital Compare Star Ratings…Fiscal Year 2016 Proposed Inpatient and Long-term Care Hospital Policy and Payment Changes....more

CMS Fines Insurer for Misleading Medicare Part D Beneficiaries

The federal agency that oversees Medicare’s prescription drug program has alleged that a major U.S. insurance company misled beneficiaries about the pharmacies included in the company’s drug plan, and imposed a $1 million...more

Does the "Doc Fix" Bill Help Telemedicine and Telehealth?

In a word: yes. Telemedicine was one of the many beneficiaries of changes introduced by the so-called “doc fix” bill, formally titled the Medicare Access and CHIP Reauthorization Act (H.R. 2). The legislation was passed by...more

OMB Reviewing HRSA Proposed Rule For Civil Monetary Penalties And Ceiling Price Regulations For 340B Drug Discount Program

The agency that oversees the 340B Drug Discount Program (340B program) is seeking review by the White House Office of Management and Budget (OMB) of a proposed rule that would use civil monetary penalties to enforce ceiling...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

HHS/Office of the National Coordinator issues report that health information sharing is being blocked to gain a competitive edge

In a scathing report released last Friday, the Department of Health and Human Services Office of the National Coordinator (ONC) accused hospitals and software vendors of preventing the sharing of health information in order...more

Are hospitals or medical scope companies to blame for Superbug breakouts?

The price of liability can be extremely high. A medical malpractice lawyer in Lake County understands that when doctors, staff or manufacturers make medical mistakes, they are not likely to readily admit their errors. ...more

Health Alert (Australia) - April 20, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales (NSW) - 13 April 2015 - Sarah White v The Local Health Authority & Anor - [2015] NSWC 417 - The New South...more

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