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The Surprise of Familiarity

Watching from afar the Scouts attempting to earn their orienteering merit badges, we could see it on the boys’ faces. They were lost; they were scared. They should have reached their destination an hour ago. Soon, these...more

A Contract Be too Good to Be True

If it sounds too good to be true, it probably is. A Florida Supreme Court decision provides a variation on the adage: if a contract looks too favorable to one side to be valid, it probably isn’t. Thirty-nine weeks...more

Federal district court interprets Stark Laws writing requirement

On March 15, 2017, the US District Court for the Western District of Pennsylvania, ruling on cross motions for summary judgment in U.S. ex rel. Tullio Emanuele v. Medicor Associates Inc. et al., provided the first...more

An Arbitration Agreement That Attempts to Skew a Statutory Arbitration Scheme Is Void as Against Public Policy

Federal public policy favors arbitration and the broad interpretation and enforcement of arbitration agreements. So how can an arbitration agreement be held by a court to be void as against public policy? One answer from a...more

Chicago Proposes Pharma Rep Licensing Rules and Ethical Standards

The City of Chicago Commissioner of Public Health on Friday, March 17, published proposed Rules to implement the highly-publicized pharmaceutical representative licensing ordinance enacted in November 2016....more

The Cross-Industry Promise of Blockchain

The blockchain protocol (a form of a ‘distributed ledger system’) was originally designed as a platform to process Bitcoin transactions. The protocol enables peer-to-peer transactions and eliminates the need for a trusted...more

HIPAA Checkup – How Good Are Your Policies and Procedures?

Although it is not a new requirement, it is important and therefore worth a reminder: HIPAA requires covered entities to establish and implement written policies and procedures that are consistent with its Privacy and...more

"Trends in Corporate Integrity Agreements Reflect New HHS OIG Guidance on Use of Exclusion Authority"

2016 was a year of change for the Department of Health and Human Service's Office of Inspector General's (OIG) approach to corporate integrity agreements (CIA). The OIG began to use its new model CIA format and applied its...more

Top Trends in Business Law that You Need to Know for 2017

Macy’s and Kmart are each closing a Lansing, Michigan location – but did you know that in general, retail spending is up? It’s easier than ever to collect customer data, but business owners beware: you need to...more

Pro Te: Solutio - Vol.9 No.3 – Fall 2016

The Fall 2016 issue of Pro Te is about all things regulatory, including a peek at the newly developing issue of crowdfunding for medical devices. In EMA Guidance on Clinical Data Publication, we discuss recent guidance...more

North Carolina Legislative Update - March, 2017 #2

This week the pace quickens within the House and Senate policy committees while the Appropriations committees received presentations on Governor Cooper's proposed budget recommendations. Regulatory Reform (HB131) -...more

Optum-SCA Merger Could Signal Renewed Payer Interest in Providers

In January, UnitedHealth Group’s health services arm Optum announced it would acquire Surgical Care Affiliates (SCA), one of the nation’s largest and most well-respected ambulatory surgery center (ASC) and surgical hospital...more

Outsourcing of Services in the Medical Device Industry

As the medical device market continues to grow, the medical device industry has strived to reduce costs through outsourcing. An industry report has found that the global medical device outsourcing market was valued at $33.2...more

What Would "Greater Enforcement" Mean for Washington's Cannabis Businesses?

Justice Department has options to crack down, but may galvanize the push for even wider legalization - In statements that were perhaps inevitable but nonetheless surprising to the cannabis industry, White House Press...more

New Medicare Conditional Payment Case: Federal Court Requires CMS To Perform Surgery On Its Primary Plan Reimbursement Demands

Doctors often treat Medicare beneficiaries for accident related injuries (for which a “primary” auto or workers’ compensation carrier must reimburse Medicare) and unrelated maladies at the same visit. Billing for the visit...more

Do Arbitration Agreements Between Nursing Homes and Patients Violate Public Policy-- or Are They Enforceable Under the FAA?

The Federal Arbitration Act (FAA) provides for enforcement of arbitration agreements in a “contract evidencing a transaction involving commerce” in the district court. A nursing home sought to enforce arbitration agreements...more

Fourth Circuit Declines to Address Use of Statistical Sampling in False Claims Act Cases

Court of Appeals panel rules use of statistical sampling is inappropriate for interlocutory appeal, leaving FCA litigants without any direct appellate court guidance. In the closely watched case United States ex rel....more

Your Patient Intake Forms May Need a Checkup

On January 27, 2017, the North Carolina Supreme Court held that a physician and his practice could not enforce an arbitration agreement against a patient where the physician and his practice did not make full disclosure to...more

Insider Trading Around Private Placements: Was Tom Price’s Investment Down Under Above Board?

On February 10, the Senate confirmed Representative Tom Price (R-GA) as Secretary of Health and Human Services, where he will oversee the U.S. Food and Drug Administration (FDA). His nomination has not been without...more

Pennsylvania Accepts Applications for Medical Marijuana Growers, Processors and Dispensaries

The Pennsylvania Department of Health will accept permit applications for medical marijuana grower/processors and dispensaries from February 20, 2017 until March 20, 2017, pursuant to its authority under the Medical Marijuana...more

Insurance Claims Report Spotlights Risks To Assisted Living Facility Operators

Late last year CNA, one of the nation’s largest commercial insurance companies, issued a report summarizing professional liability insurance claims for senior living facilities that it closed between 2011 and 2015. Although...more

Trump administration issues proposed health insurance market stabilization rule: Will it be enough to stabilize exchange...

On 15 February 2017, the Centers for Medicare & Medicaid Services (CMS) took a step toward addressing concerns about the stability of the individual and small group health insurance markets by proposing a modicum of...more

Tokyo Dispute Resolution & Crisis Management Newsletter – February 2017

Product Pricing and Antitrust Law in the United States - A recent US court action by a Japanese company in respect of a competitor’s volume discounts - Introduction - The current position in the US on the rules...more

Restrictions on Advertising with Nutrition and Health Claims Apply to Both Communications Addressed to Consumers and to...

The Court of Justice of the European Union (ECJ) held that the restrictions on promoting foodstuffs with nutrition and health claims not only apply to communications addressed to the general public but also to communications...more

Local Cannabis Regulation: Two Ballot Measures Up for Vote on March 7, 2017

This article examines the two competing ballot measures regarding cannabis regulation in the City of Los Angeles up for vote on March 7, 2017. Following is a brief summary of the current regulatory framework for cannabis in...more

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