Health Constitutional Law

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Off-Label Promotion And The First Amendment Updates

Although activity around the Amarin and Pacira cases has settled down, questions regarding the FDA’s position on truthful off-label promotion-and whether it comports with First Amendment free speech principles—persist....more

South Carolina Court Decides Key Health Care Case - Physical therapists win in employment lawsuit

The South Carolina Supreme Court has decided a case with great significance in the health care industry. The court overturned a ban on physicians employing physical therapists and gave guidance regarding how state agencies...more

FDA Announces Public Hearing on Off-Label Communications; Registration Deadline October 19, 2016

The US Food and Drug Administration (FDA) will hold a public hearing on November 9 and 10, 2016, to obtain input on manufacturer communications regarding unapproved uses of approved or cleared medical products (off-label...more

California Ballot 2016: Pros and Cons of Props 57-61

This is the second post in our California Ballot 2016 series – providing the “nutshell” versions of each of the 17 state-wide measures voters must decide in November. Please refer to our first post in the series: Props 51-56,...more

FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more

"Privacy & Cybersecurity Update - August 2016"

In this edition of our Privacy & Cybersecurity Update, we highlight guidance issued by the Irish data protection authority regarding the use of location data, as well as the FTC's request for comment on its Standards for...more

HHS Wins Summary Judgment Against Hospitals Disputing CMS’s Treatment of Part C Days as Days “Entitled to Part A” for Purposes of...

On August 17, 2016 the United States District Court for the District of Columbia granted summary judgment in favor of HHS in a dispute over whether Part C days can be treated as “days entitled to benefits under Part A” for...more

Texas Medical Board’s Appeal Must Proceed Under Existing Jurisdiction Arguments

In another procedural defeat for the Texas Medical Board (the “Board”) over its embattled telemedicine rule, last week, a federal judge held that the Board waited too long to request certification of appeal to the Fifth...more

Plaintiffs Cannot Bring Data Breach Lawsuits Without Evidence That Information Will Be Used To Harm

The latest development in how American courts will handle the standing question for data breach class actions came last week when the U.S. District Court for the District of Columbia dismissed for lack of standing a putative...more

A Favorable, New Climate for Challenging Medicare Appeals

Over the past decade, health care providers seeking to challenge Medicare claim denials have faced increasing delays in reaching what many consider the most important step in the Medicare appeals process - a hearing before an...more

Off-Label Marketing – Industry Groups Step into the Breach

We have been waiting, literally for years, for the FDA to revise, clarify, update, or simply pay attention to, its off-label promotion regulatory position in light of repeated governmental First Amendment losses in Sorrell v....more

Health Update - July 2016

The Vulnerability of Healthcare Information - According to a report the Brookings Institute issued in May 2016, 23% of all data breaches occur in the healthcare industry. Nearly 90% of healthcare organizations had some...more

Department of Justice Imposes Almost 100% Increase in Minimum and Maximum Monetary Penalties Under FCA

On June 30, 2016, the U.S. Department of Justice (“DOJ”) announced an interim final rule almost doubling per-claim penalties under the False Claims Act (“FCA”). The FCA still imposes treble damages for government losses in...more

DOJ Doubles FCA Civil Penalties

As required by last November's Bipartisan Budget Act of 2015, the Department of Justice on June 30 released an interim final rule making inflationary adjustments to civil monetary penalties under its jurisdiction, including...more

Court Declines to Prevent Merger of Washington Medical and Recreational Marijuana Markets

Over the last year, the Washington state marijuana industry has anticipated the transition from an unregulated medical marijuana market to an integrated, medical-recreational market on July 1, 2016, under the Cannabis Patient...more

Supreme Court Update: Whole Woman's Health V. Hellerstedt (15-274)

Greetings, Court Fans! We're back with our penultimate Update of OT15, covering one of the biggest decisions (and certainly the longest) of the term, Whole Woman's Health v. Hellerstedt (15-274). Hellerstedt, the first...more

Hospice Requests Supreme Court Review of Medicare Hospice Annual Cap

On June 8, 2016, Southeast Arkansas Hospice, Inc. (SEARK) filed a petition for a writ of certiorari to the Supreme Court to review an Eighth Circuit decision that upheld the annual Medicare payment cap for hospice services. ...more

The Supreme Court - June 2016 #7

The Supreme Court of the United States issued decisions in three cases today: McDonnell v. United States, No. 15-474: Former Virginia Governor Robert McDonnell and his wife, Maureen McDonnell, were federally indicted...more

Supreme Court Decides Whole Woman's Health v. Hellerstedt

On June 27, 2016, the Supreme Court decided Whole Woman’s Health v. Hellerstedt, No. 15-274, holding that both the admitting privileges and the surgical-center requirements of a Texas law regulating abortions place a...more

Why Should Hospitals with “Church Plans” Be Concerned Now? - Hospital Industry Viewpoint

Religiously affiliated hospitals and health systems have recently come under attack by private litigants for exercising the right to remain exempt from ERISA requirements. Such hospitals and health systems should assess their...more

NC Legislative Update - June 2016 #3

This Week - Both chambers accelerated pace in an eventful week as several Committees met more than once throughout the week with some even meeting after the day’s floor session. Senior House Appropriations Chairman Rep....more

Universal Health Services v. Escobar

On Thursday of last week, the Supreme Court for the first time addressed the “implied certification” theory of liability under the False Claims Act. The Court ruled unanimously that the theory is valid in certain...more

Courts Continue to Grapple with Data Breach Claims

Our last few blogs have focused on litigation under the Video Privacy Protection Act, including the recent ruling from the 10th Circuit in Yershov v. Gannett Satellite Information Network, Inc., 2016 U.S. App. LEXIS 7791 (1st...more

False Claims Act Penalties Moving Full Steam Ahead

By August 1, 2016, all federal agencies must adjust their civil monetary penalties, including penalties required by the False Claims Act (“FCA”), to account for inflation. Last month, the Railroad Retirement Board, which...more

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