General Business Health

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Pharmacy Benefit Managers Face New Licensing Requirements

Two states recently enacted new pharmacy benefit manager licensing requirements that affect pharmacy benefit managers in Kentucky and New Mexico. It is important for Pharmacy Benefit Managers to ensure they are in compliance...more

Additional Clarifying Amendments to the Nonprofit Revitalization Act Signed Into Law

On November 28, 2016, Governor Cuomo signed into law Chapter 466 of the Laws of New York of 2016 (Assemb. Bill 10365B) (the “2016 Amendment”). The 2016 Amendment is intended to “improve and make clarifying amendments to the...more

FDA Regulatory and Compliance Monthly Recap — November 2016

OPDP issues fifth untitled letter of the year to Supernus for misrepresenting Oxtellar XR in KOL video - In its fifth untitled letter in 2016, the OPDP raised concerns about a Spanish KOL video suggesting Supernus’...more

White Collar Crime Law Enforcement in a Trump Justice Department - 8 Predictions

After a conventional presidential campaign, determining the policy priorities and direction of the incoming administration with respect to the Justice Department’s white collar law enforcement responsibilities can be a...more

Employment Law - November 2016 #2

AARP Challenges EEOC’s Wellness Program Regulations - Why it matters - The AARP filed suit against the Equal Employment Opportunity Commission (EEOC) in D.C. federal court, requesting an injunction to halt the...more

President-elect Trump's potential priorities for insurance regulation

Apart from a fundamental disagreement between the parties as to whether the Affordable Care Act ("ACA") should be repealed and replaced, insurance regulatory issues did not play a large role in the Presidential campaign. That...more

New York State Office of the Medicaid Inspector General Releases Guidance on Compliance Program Reviews

In the 1990s, as part of the Federal Sentencing Guidelines, the U.S. Sentencing Commission developed for the first time the criteria upon which it will view an organization’s compliance program to be “effective.” In October...more

Highlights from McDermott’s 2016 Pharmaceutical/Medtech Dealmaking Symposium

On October 25, 2016, McDermott Will & Emery held its fifth annual Pharmaceutical/Medtech Dealmaking Symposium in Cambridge, Massachusetts. The day consisted of a series of thought-provoking panels with leading dealmakers in...more

Federal Judge Blocks CMS Rule Banning Arbitration In Nursing Home Disputes

In September, CMS announced a final rule that bans pre-dispute binding arbitration agreements related to care received in long-term care facilities. Among other things, the rule preserves the right of patients and their...more

Health Care E-Note - November 2016

You just formed your medical practice inAlabama, and you either chose a professional corporation (a “PC”) or an LLC. If you went with a PC, you got to choose between an “S” corporation (“S corp”) or a “C” corporation (“C...more

Also In The News - Health Headlines - November 2016

CMS Names Latest Round of RAC Contracts – On October 31, 2016, CMS announced it awarded contracts for its Medicare Fee-for-Service Recovery Audit Contractors (RAC) to Performant Recovery, Inc. (Region 1), Cotiviti, LLC...more

Seventh Circuit Recognizes “Substantial Truthfulness” Defense to Tortious Interference Claims under Wisconsin Law

As we wrap up another election cycle that has kept “fact checkers” working overtime analyzing the many dubious claims by candidates of all political persuasions, the Seventh Circuit has issued a decision that reminds us of...more

Mississippi District Court Halts Implementation of New CMS Rule Banning Use of Arbitration Agreements in Long-Term Care Facilities

Anyone familiar with long-term care litigation knows that the number of disputes regarding the use and enforcement of arbitration agreements in the context of assisted living/nursing home admissions has risen sharply over the...more

Ninth Circuit Smells a Rat and Reinstates Claim That Pharmaceutical Company Failed to Disclose Cancers in Animal Testing

The Ninth Circuit recently revived a securities class action against Arena Pharmaceuticals, issuing a decision with important guidance to pharmaceutical companies speaking publicly about future prospects for FDA approval of...more

Optometrists Who Leased Space at Texas Wal-Mart Stores Cannot Recover Damages for Technical Violation of State Licensing Law Under...

The United States Court of Appeals for the Fifth Circuit, in a per curium decision issued October 27, 2016 in Forte v. Wal-Mart Stores, Inc., vacated approximately $1.4 million in statutory civil penalties awarded by the...more

Election 2016:  WOW, Just WOW

I had a blog piece almost done. It was going to give an overview of another NLRB case which threatened to overturn settled law and expand the rights of unions to organize. I was going to use it as another “Year of Change”...more

Federal Court Blocks CMS Ban on Pre-Dispute Nursing Home Arbitration Agreements Pending Legal Challenge: What the Ruling Means for...

Earlier this week, a federal court enjoined the federal Centers for Medicare and Medicaid Services (“CMS”) from enforcing a rule, promulgated on September 28, 2016, which barred pre-dispute arbitration agreements between...more

Marijuana Legalization Efforts Enjoy Success, Demonstrating Major Shift in Approach to Drug Regulation and Use

Election Day 2016 proved to be a historic occasion for initiatives favoring expanded access to marijuana. On November 8, California and Nevada joined West Coast early adopters Alaska, Oregon, and Washington in choosing to...more

What Kind of Tax Changes Can We Expect From Trump's Presidency?

The tears have not yet dried for some, and the celebrating is not yet over for others, but let's turn our attention to taxes. With a Republican Congress and a Republican president, some measure of tax relief is a given. What...more

Federal Court Enjoins U.S. Agency’s Nursing Home Arbitration Agreement Ban

The Centers for Medicare and Medicaid Services (CMS), an agency within the U.S. Health and Human Services Department, recently issued a final rule prohibiting nursing homes and other long-term care facilities from utilizing...more

FTC's Winning Streak Restored: Seventh Circuit Reverses Denial of Preliminary Injunction in Chicago Hospital Merger, Competition...

Recent appellate decisions confirm the uphill battle hospitals face when merging with other hospitals. On October 31, the U.S. Court of Appeals for the Seventh Circuit overturned the district court’s ruling in Federal Trade...more

The Empire Strikes Back – Nursing Homes Enjoin Government’s Rule Barring Arbitration Clauses in Agreements with Residents

The way to stop a runaway train is to push the brake. The way to stop a runaway horse is to pull the reins. The way to stop a runaway jury is to demand arbitration. This September, the Centers for Medicare & Medicaid...more

IRS Eases Safe Harbor Conditions Under Which a Contract with a Hospital Will Not Result in Private Business Use of Tax-Exempt...

Under federal income tax law, the tax-exempt status of a bond is jeopardized if the proceeds of the bond are used for a private business use. Because hospital facilities are often financed with tax-exempt bonds, hospital...more

Recent HIPAA Settlements Highlight Importance Of Business Associate Agreements

Two related healthcare companies were forced to pay settlements with the federal government totaling over $500,000 over allegations relating to a data breach involving patient health information. Much of the negative...more

FDA Regulatory and Compliance Monthly Recap — October 2016

FDA sends warning letters to two New Jersey companies for insufficient PADE reporting - The warning letters raise issues concerning the standard operating procedures in place to monitor, receive, evaluate and report...more

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