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Sixth Circuit Holds That Michigan Health Insurance Claims Assessment Act Falls Outside of ERISA’s Preemptive Reach

Whether state common law claims are preempted by the Employee Retirement Income Security Act of 1974 (ERISA) is a common issue in reimbursement disputes involving health care providers and insurance companies. In cases when...more

New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.” It’s long, and anyone interested in reviewing the whole thing can download it from the FDA’s...more

The silver lining in the DEA’s refusal to reclassify cannabis

As far back as 2011, elected officials have sent letters to the U.S. Drug Enforcement Administration urging it to reclassify cannabis by removing it from the list of Schedule I controlled substances. After promising a...more

DEA Just Said No to Rescheduling Cannabis: Why It Matters

The U.S. Drug Enforcement Agency (DEA) recently denied a petition to initiate proceedings to reschedule cannabis under the Controlled Substances Act (CSA). Thus, Cannabis will remain a Schedule I substance under the CSA. ...more

The DEA Is Getting Past Just Saying No: Scientific Research Into Medical Uses of Marijuana Is a Bridge Toward a Policy Shift

The U.S. Drug Enforcement Agency (DEA)’s recent decision declining to reschedule cannabis is a step bridging the national discussion — a step toward a possible agreement on medical cannabis through scientific research. The...more

DEA Rejects Petitions Seeking to Reschedule Marijuana

The long-awaited decision maintains the illegal status of marijuana under federal law. On August 12, the US Drug Enforcement Agency (DEA), despite much speculation to the contrary, published in the Federal Register its...more

DEA Rejects Petitions to Reclassify Marijuana, but Opens the Door to Expanded Marijuana Research Efforts

In a long-awaited decision released this morning, the United States Drug Enforcement Administration announced that it has denied two petitions to reschedule marijuana under the Controlled Substances Act (the “CSA”). The DEA...more

DEA Declines to Change Stance on Marijuana but Opens Door to Federally Sanctioned Marijuana Research

On August 11, 2016, the Drug Enforcement Administration (DEA) formally declined to change its position on the medical or recreational use of marijuana, denying two petitions urging the federal government to change marijuana’s...more

President Obama Signs Federal GMO Law, Preempts Vermont Law

On July 29, 2016, U.S. President Barack Obama signed into law the first U.S. federal law requiring food manufacturers and distributors to label products that contain genetically modified organisms (“GMO”).[1] The law...more

First-Ever Federal Labeling Requirements for Bioengineered Foods Signed Into Law

On July 29, President Obama signed into law a bill establishing first-ever federal requirements for the labeling of food containing genetically engineered ingredients. The bill, known as S.764, directs the U.S. Department of...more

FTC Encourages VA to Adopt Proposed Rule Preempting State Laws to Allow Advanced Practice Registered Nurses to Provide Services...

On July 25, 2016, the Federal Trade Commission (FTC) submitted comments to the Department of Veterans’ Affairs (VA) supporting a proposed rule only affecting VA facilities that would authorize Advanced Practice Registered...more

Congress Passes GMO Labeling Bill – Preempting State Labeling Laws

In response to recent state efforts to regulate the labeling of food products containing genetically modified organisms (GMOs), the U.S. House of Representatives, on July 14, passed S. 764, a Senate-initiated bill...more

ColoradoCare Stands to Significantly Alter Health Care Services

In November, Colorado voters will cast ballots on Amendment 69, also known as ColoradoCare. ColoradoCare is an ambitious, far-reaching plan to amend the Colorado constitution which would establish a statewide universal...more

HIPAA Does Not Preempt Statutory Right to Ex Parte Interviews of Treating Physicians in Tennessee Health Care Liability Actions

A key tool for the defense of medical providers in Tennessee facing malpractice liability has been held to be not preempted by federal law. On June 3, 2016, the Tennessee Court of Appeals, in Caldwell v. Baptist Memorial...more

Governor Kasich Signs Bill to Legalize Marijuana for Medicinal Use in Ohio

On June 8, 2016, Governor John R. Kasich signed into law HB 523, which legalizes marijuana in Ohio for specified medicinal purposes. The bill moved swiftly through the Legislature as lawmakers acted to preempt a marijuana...more

OCR Clarifies Parameters of Covered Entities' Fees for PHI Copies

The Office for Civil Rights (OCR) recently released new guidance and FAQs (OCR Guidance) addressing individuals’ rights to access their protected health information (PHI) under the Health Insurance Portability and...more

California Court Rules Medicare Does Not Preempt Hospital Claims Against Payer

On April 27, 2016, a California state court judge in a Complex Litigation department for the County of Los Angeles, ruled in favor of 13 of our hospital clients on an important matter involving substantive and financial...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

Plaintiff’s Claim that Manufacturer Improperly Trained Physician in use of Class III Medical Device Preempted by Federal Law

In Ashley Glennen v. Allergan, Inc., 2016 Cal. App. LEXIS 347, published April 29, 2016, the California Court of Appeal, First District, affirmed the trial court’s sustaining of a demurrer in a Lap-Band injury case on the...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

Employee Benefit Plans and Data Security Issues

In recent weeks, much of the discussion around a recent Supreme Court case, Gobeille, has focused on ERISA preemption. But for fiduciaries of benefit plans the case can serve as a reminder of important duties that often go...more

Employee Health Plans: Good News / Bad News – State Claims Reporting Laws Do Not Apply, but Recovery of Overpayments Made More...

Employee health plans recently received good and bad news from the Supreme Court. On the upside, the Court invalidated a State law that required self-insured employee health plans (and their third-party administrators) to...more

Supreme Court Exempts ERISA Plans from a State Reporting Law

In Gobeille, Chair of the Vermont Green Mountain Care Board v. Liberty Mutual Insurance Co., decided on March 1, 2016, the Supreme Court held that the Employee Retirement Income Security Act of 1974 (“ERISA”) preempts...more

Gobeille v. Liberty Mutual: The Dog That Didn’t Bark, and the Next Front in the Preemption War

Recently, we reported on Gobeille v. Liberty Mutual, in which the Supreme Court invalidated the Vermont all-payer claims data base law. Applying what appeared to us as a straight-forward application of existing ERISA...more

Providers Beware: In ERISA Land, a Right May Not Have a Remedy

A recent U.S. Supreme Court decision reminds us that straying into the land of the Employee Retirement Income Security Act of 1974 (“ERISA”) can be hazardous for an unwary state or health care provider. When ERISA preempts a...more

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