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New York Certificate of Public Advantage (COPA) Program Alert: Revised Regulations Are Particularly Relevant to DSRIP Participants

On August 27, 2014, the New York State Department of Health ("DOH") issued revisions to its proposed regulations implementing the Certificate of Public Advantage ("COPA") process, which will facilitate immunity for New York...more

New Data Disposal Law in Delaware Requires Action by Impacted Businesses

While the federal government continues its inaction on data security bills pending in Congress, some U.S. states have been busy at work on this issue over the summer. A new Delaware law H.B. 295, signed into law on July 1,...more

Health Care Update - August 2014 #4

In This Issue: - Administration Releases Updated Contraception Coverage Rules - Federal Regulatory Initiatives - Other Congressional and State Initiatives - Other Health Care News - Upcoming...more

Government Agencies Release Further Accommodations to Organizations Opposing Mandated Contraceptive Coverage

In response to the recent U.S. Supreme Court decision in Burwell v. Hobby Lobby, Inc., the U.S. Departments of Health and Human Services (HHS) and Labor (DOL) published proposed rules on August 22, 2014, expanding the...more

Deadline For Business Associate Agreement And Data Use Agreement Compliance Is September 22, 2014

September 22, 2014 is the deadline to have all business associate and data use agreements updated to conform to the new requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Final Omnibus...more

How the US Government is cracking down on Medicare fraud

Medicare fraud is a major problem in the United States, with estimates of fraud and systematic overcharging totaling $60 billion each year. That’s nearly five times the cost of healthcare fraud in Canada, and makes up a...more

Community Health Systems' HIPAA Breach: Significant Lessons for Health Care and Non-Health Care Companies

On August 18, 2014, Community Health Systems, Inc. (CHS) publicly confirmed, in a filing with the Securities and Exchange Commission (CHS filing), that its computer network was attacked between April and June 2014 by hackers...more

Ontario Court Considers Content of Implied Duty of Good Faith in Business Negotiations

In a recent motion seeking an interlocutory injunction to restrain the sale of a business, Justice Wilton-Siegel considered the content of an implied duty of good faith. In SCM Insurance Services Inc. v. Medisys Corporate...more

First Circuit Rejects Talley and Allows a Business Expense Deduction for Settlement Payments Made Under the False Claims Act

On August 13, 2014, the United States Circuit Court for the First Circuit rejected the United States’ request to deny Fresenius Medical Care Holdings Inc. from deducting a portion of a settlement payment to settle civil...more

Don’t forget the September 23, 2014 deadline to ensure your Business Associate Agreements comply with the Omnibus Final Rule

Under the Health Insurance Portability and Accountability Act (HIPAA) Omnibus Final Rule published January 25, 2013, 78 Fed.Reg. 5566, Covered Entities (CEs) with Business Associate Agreements (BAAs) that were entered on or...more

Does Bird’s Eye View Render Executive Non-Compete Unenforceable?

So here’s a good one for healthcare employers to ponder. Let’s say you have an executive subject to a valid and seemingly enforceable non-compete agreement. Because the agreement concerns an executive, we would normally...more

Hobby Lobby ripples still being measured

How can the controversial decision in the Hobby Lobby contraception coverage case impact employers? The U.S. Supreme Court in June decided the controversial case of Burwell v. Hobby Lobby Stores Inc. The court ruled...more

Dark Clouds Over Sunshine Act

Once again the Obama administration has been tripped up in launching a healthcare-related online system. This time the problem concerns the Physician Payments Sunshine Act—the act that is supposed to enable the public to see...more

The Hobby Lobby Decision and Religious-Based Exemptions

On June 30, 2014, the United States Supreme Court issued a ruling which held that a closely held, for-profit entity can object to certain aspects of the birth control mandate imposed by the Patient Protection and Affordable...more

ANDA Preparation (with an Eye toward Approval and Litigation) and the FDA Review

As a manufacturer of generic drug products, undoubtedly one of your goals is to prepare an Abbreviated New Drug Application (ANDA) that will pass regulatory scrutiny efficiently. Your ANDA submission is a culmination of time,...more

Privacy Tuesday – August 2014

We are just two Mondays away from Labor Day, the traditional end of summer in the United States. Here are some privacy tidbits to get your week started. See especially Jake Romero’s piece on the new Delaware data...more

Illinois defines metrics for medical cannabis applicants

Cannabis industry hopefuls in Illinois are poised to begin the application process after the three state agencies administering Illinois’ medical marijuana law released long-awaited metrics on Aug. 8....more

JAMS Dispute Resolution Alert, Summer 2014

In This Issue: - Experts Predict ADR Will Help Resolve Affordable Care Act Claims - ADR News & Case Updates - Domestic Focus ..Supreme Court Ruling Expands Whistleblower Protections - Good...more

Summer 2014 SCOTUS Roundup: Burwell v. Hobby Lobby

To close out our review of the Supreme Court’s summer decisions impacting labor and employment issues, we’ll examine the ramifications of the much-publicized and hotly discussed Burwell v. Hobby Lobby....more

The Reformed Health Care Industry: Creative Structures and Alliances Can Yield Great Benefits, but Also Great Risks

Since the Affordable Care Act (the “ACA”) was enacted in 2010, the health care industry has been on the edge of its proverbial seat waiting to see which care delivery models are best suited to sustain all the changes: to...more

Captive Insurance: Feds Promote Tax Benefits, but Pay Attention to the Details

Recent IRS rulings and a U.S. Tax Court decision continue to lay a solid foundation for captive insurance companies. However, the tax requirements must be strictly followed. Below we provide an update to assist captives in...more

Levick Monthly - July 2014: DAVIS: Jeb Bush a formidable candidate

In This Issue: - COVER STORY: Davis: Jeb Bush a Formidable Candidate - CRISIS: The Real Cancer that Caused the VA Scandal - DIGITAL ENGAGEMENT: Aereo and Meltwater: The Ghost of Napsters Past - FINANCIAL: Dov...more

Medical Marijuana – Latest Draft Regulations

Below is a summary of the changes made by the Florida Department of Health (DOH) to the draft rules to implement the Compassionate Medical Cannabis Act of 2014 (SB 1030)....more

Social Media Policy: It’s Only As Effective as the Social Media Training That Goes With It

With the rise of the internet and mobile technology, people are broadcasting their opinions and beliefs on social media sites. Twitter was established as an outlet for self expression… of the fewer-than-...more

WEBINAR: Preparing for the HITECH September Deadline - Tips for Negotiating Effective Business Associate Agreements under HIPAA

Business Associate Agreements (BAAs), in the current regulatory and technological environment, require careful review and negotiation of the implementation of the regulatory requirements. In meeting the September 23, 2014...more

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