Health Constitutional Law

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Federal Court Strikes Down ACA Cost Sharing Reduction Payments

In Depth - A federal district court judge in Washington, DC ruled on May 12, 2016, that Congress did not appropriate funds for the Affordable Care Act’s (ACA) cost-sharing reduction (CSR) subsidies. See United States...more

U.S. Supreme Court Declines to Rule on Merits in ACA Religious Accommodation Case

The United States Supreme Court has declined to rule on the merits in a case brought by religious non-profit entities challenging the “religious accommodations” to the contraception mandate under the Affordable Care Act...more

Supreme Court Update: Zubik V. Burwell (14-1418) And Spokeo V. Robbins (13-339)

While a potential ninth justice made plans to give a high school commencement address, The Eight continued to demonstrate that, without a full complement of justices, this may be the Term Without Blockbusters. (Although, with...more

House of Representatives v. Burwell: Another Blow to Obamacare

Federal Judge Rosemary Collyer’s May 12, 2016 ruling in House of Representatives v. Burwell, found that the Obama administration (the “Administration”) has been improperly funding an Obamacare subsidy program. House of...more

Class Action Lawsuit Seeks Payments from All Illinois Hospitals for Unconstitutional Tax Exemption

You can add one more lawsuit to the mountain of litigation concerning how and when Illinois hospitals are entitled to a property tax exemption. Earlier this month a limited partnership filed a class action lawsuit naming...more

District Court Rules One Aspect of ACA is Unconstitutional—No Change for Employers

You may have heard that a federal District Court ruled that the ACA was unconstitutional today. Do not start making any changes. This decision will not directly impact most employers and their health plans. We are sending...more

Proposed West Virginia Hospital Merger Could Have Nationwide Effects

West Virginia recently passed legislation aimed at shielding an in-state hospital merger from antitrust review by the Federal Trade Commission, and if the West Virginia Health Care Authority and West Virginia Attorney General...more

Religious Institutions Update: May 2016

Timely Topics - Has your nonprofit received a donation for a restricted purpose that has become impractical, impossible to achieve, wasteful or even unlawful? A donor may restrict a contribution to a charity for a...more

The Challenges of the Evolving Marijuana Industry: Reconciling State Legislation with Federal Prohibition

Cultivation, production, distribution, or possession of marijuana is a federal criminal offense under the Controlled Substances Act (the CSA). Yet, despite federal prohibition, state-sanctioned marijuana industries have...more

Anti-SLAPP Statute Raised in Planned Parenthood Protest Lawsuit

The DC anti-SLAPP statute has been invoked in a Superior Court lawsuit in which plaintiffs arguing that students need to be free from disruptions in the school environment are facing off against anti-abortion protestors....more

Settle or Fight FDA/DOJ Off-Label Use Allegations? WSJ Editorial Looks at Vascular Solutions Trial Win and Asks What's Next?

In an editorial this weekend entitled “No Justice for Business,” The Wall Street Journal hailed a recent trial win by medical device maker Vascular Solutions, Inc. (VSI) as a “victory for common sense and the First Amendment”...more

Another Successful First Amendment Challenge to the Prohibition of Off-Label Promotion for FDA-Approved Drugs: Part Two

The Free Speech Clause notched another victory in the latest and, perhaps, final chapter of the lawsuit between the FDA and Amarin Pharma, Inc. concerning off-label marketing of an FDA-approved drug. On March 8, 2016, the FDA...more

Court Rejects End-Run of Medicare Appeals Rules

The Indiana Health Department sent a team to the Nightingale home health care and hospice group, in response to complaints. When CMS received the team’s report, it notified Nightingale that its Medicare certification was...more

You Can Pay Your Lawyer: Supreme Court Recognizes Limits on Pretrial Asset Restraints

Before the U.S. Supreme Court’s ruling last week in Luis v. United States, the government could freeze a criminal defendant’s assets before trial even if they bore no connection to the alleged crimes. With the ruling, if the...more

Supreme Court Update: Luis V. United States (14-419)

Here's a line-up you don't see in every (read: any) syllabus: "BREYER, J., announced the judgment of the Court and delivered an opinion, in which ROBERTS, C.J., and GINSBURG and SOTOMAYOR, JJ., joined. THOMAS, J., filed an...more

Proposed Enrollment Rule Changes - de Facto Exclusion?

Proposed rules, touted as enhancing the provider enrollment process, would provide CMS with sanction authority that closely parallels the OIG’s exclusion authority. Under the proposed rules, CMS would have expanded bases to...more

FDA and Amarin Pharma Reach Milestone Settlement Allowing Off-Label Drug Promotion

A milestone Settlement Agreement was reached March 8, 2016 between the Food and Drug Administration and Amarin Pharma, Inc. that expressly allows Amarin to promote its drug product, Vascepa®, for unapproved – i.e.,...more

Fight the Good Fight Every Moment: Do Recent First Amendment Court Developments Deal a Blow to the Government?

In the last month, the Food and Drug Administration has suffered setbacks relating to off-label promotion oversight. In both cases, one involving a pharmaceutical company and the other a medical device firm and its Chief...more

New Jersey Township Files Challenge to Nonprofit Hospital’s Tax Exemption

On February 19, 2016, the Township of North Bergen in New Jersey filed a complaint challenging the constitutionality of a nonprofit hospital’s – Palisades Medical Center – property tax exemption. The complaint alleges that...more

Eighth Circuit Rejects Hospice’s Fifth Amendment Plea

But not the Fifth Amendment plea you’re thinking of. It was the takings clause, not the self-incrimination clause, that Southeast Arkansas Hospice (SAH) was pleading. And the Eighth Circuit wasn’t buying it....more

Governor Brown Signs Bill Giving Local Entities More Time to Ban or Regulate Medical Marijuana

History. Shortly after the Compassionate Use Act (CUA) became law in 1996 by California voter initiative, the Medical Marijuana Program Act (MMPA) (Health & S C §§11362.7–11362.83) was enacted by the legislature to clarify...more

Texas Open Carry Law: FAQs for Hospitals and Healthcare Facilities

As of January 1, 2016, concealed license holders in Texas can now legally carry their handguns visibly in hip or shoulder holsters. This comes at a time when violence in hospitals and healthcare facilities is on the rise....more

FDA and Amarin Reach Settlement on First Amendment and Off-Label Statements

FDA agrees to allow truthful and non-misleading off-label promotion. On March 8, the US District Court for the Southern District of New York approved settlement terms in connection with Amarin Pharma, Inc., et al. v....more

"One-Two Punch: Amarin Settlement Order and Vascular Solutions Acquittal Further Erode Off-Label Promotion Enforcement Regime"

In an apparent first, the U.S. Food and Drug Administration (FDA) has conceded that a pharmaceutical company may engage in truthful and nonmisleading speech promoting the off-label use of a prescription drug. This concession...more

K&S Effort Leads to Acquittal in Conspiracy and Misbranding Case Against Medical Device Company

On February 29, 2016, Minneapolis-based medical device company Vascular Solutions, Inc. (“VSI”) and its CEO Howard Root were acquitted by a jury of conspiracy and misbranding charges in a closely-followed trial in San...more

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