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Medicaid managed care proposed rule expands program integrity obligations

On June 1, 2015, the US Centers for Medicare & Medicaid Services (“CMS”) published its proposed rule on Medicaid managed care (CMS-2390-P). As noted in our two earlier advisories, which provided an overview of the proposed...more

Alert: Second Circuit Rules that "Product Hopping" May Constitute Unlawful Monopolization; Pharmaceutical Companies are Likely...

Recent antitrust challenges to pharmaceutical companies' efforts to transition patients from drugs nearing the end of their patent life to next-generation drugs have increased the risk of pursuing such "product hopping"...more

Blog: General Wellness Products: Will the FDA Regulate Your Medical App or Device?

In January 2015, the U.S. Food and Drug Administration (FDA) released its draft guidance on general wellness products, a reassuring indication that the FDA will focus its efforts on regulating higher risk products rather than...more

How to Keep What is Yours: Practical Considerations for Healthcare IT Protection

One of the worst kept secrets is the experienced and expected growth in healthcare IT. In 2013, over $650 million was invested into healthcare IT companies, and the trend is continuing to grow. Combined with the fact that...more

Is Your Pharmacy Ready for Drug Supply Chain Integrity?

Beginning July 1, 2015, most pharmacies in the U.S. will be required to have systems in place to receive transaction information regarding the prescription drugs they purchase from suppliers. The requirement stems from a...more

Gavel to Gavel: Protect your data

The ever-increasing expense of corrective actions taken by companies after data breaches is often publicized. What’s not as apparent, or as publicized, are steps companies can take that may reduce the costs and the likelihood...more

Cloud Computing Contracts Top Issues for Healthcare Providers

In this Issue: - Summary - Overview - Cloud - Use - Security - Privacy - Functions - Availability - Performance - Location - Services -...more

Life Sciences Spotlight - Asia Pacific - Issue 5, 2015

In This Issue: - Harper Review Dispenses Important Recommendations For The Life Sciences Sector - Pharmaceutical Patent Term Extensions In Australia - PRC Anti-Corruption Regime 101 - Revisions To The Medicines...more

Blog: Changes to Sunshine Law Included in Proposed 21st Century Cures Legislation

As we recently discussed, a bipartisan group of representatives from the House of Representatives’ Energy and Commerce Committee released a new discussion draft of the 21st Century Cures initiative (Legislation) that seeks to...more

HIPAA Enforcement Remains a Concern for Providers of All Sizes

On Monday, April 27, 2015, the Department of Health and Human Services ("HHS"), Office for Civil Rights ("OCR") announced a settlement with Cornell Prescription Pharmacy ("Cornell"). Under the Resolution Agreement, Cornell...more

OCR Settles Alleged HIPAA Violations with Small, Single Location Pharmacy for $125,000 – Emphases Importance for Secure Disposal...

The U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) announced yesterday a new settlement relating to potential violations of the Health Insurance Portability and Accountability Act of 1996...more

Colorado Compounding Pharmacy Enters Six-Figure Settlement Agreement to Settle Alleged HIPAA Privacy Rule Violations

On April 27, 2015, the U.S. Department of Health and Human Services (HHS) announced that Cornell Prescription Pharmacy (CPP), a single-location pharmacy in the Denver, Colo. metropolitan area, agreed to settle alleged HIPAA...more

FTC Obtains $26.8 Million in Disgorgement to Settle Monopolization Claims

On April 17, 2015, the Federal Trade Commission (FTC) entered into a settlement with Cardinal Health, Inc. (Cardinal) to resolve allegations that Cardinal, the largest and in certain areas the sole operator of...more

ONC Updated Electronic Health Information Privacy/Security Guidance

The Office of the National Coordinator for Health Information Technology (ONC) has released a revised Guide to Privacy and Security of Electronic Health Information. The guide is intended to help health care providers –...more

Regulators Examining Cybersecurity Policies and Practices for the Insurance Industry

Shortly after the discovery of a cybersecurity breach at the health insurance company Anthem, Inc., the National Association of Insurance Commissioners (NAIC) called for a multi-state examination of Anthem’s cybersecurity...more

Cardinal Health Agrees to Settle Monopolization Claims

The Federal Trade Commission ("FTC") announced on April 20, 2015 that it had entered into a stipulated consent order ("Order") with Cardinal Health, Inc. ("Cardinal"). The Order, which is pending court approval, requires...more

Significant Guidance Released Regarding HIPAA Compliance

The Office of the National Coordinator for Health IT (ONC) released an updated version of the 2011 Guide to Privacy and Security of Electronic Health Information (Guide). The 62-page Guide provides significant guidance to...more

Legislation to Curb Medicare and Medicaid Fraud Would Increase Cost and Compliance Burdens on Health Care Providers

On March 25, 2015, a bipartisan group of U.S. Senators reintroduced the Preventing and Reducing Improper Medicare and Medicaid Expenditures Act (“PRIME Act” or “Act”) following the lead of the U.S. House of Representatives,...more

Prosecutors Strike Gold in Retailers’ Dumpsters with Hazardous Waste Enforcement Action

Retailers should implement hazardous waste management plans, even for simple consumer goods, as California, New York and other states launch aggressive enforcement campaigns. In recent years, California prosecutors...more

Intellirod Spine Signs Licensing and Distribution Agreements With X-Spine Systems Inc.

Intellirod Spine LLC is, according to its website, a medical device company developing wireless sensing technologies for use in spinal care.  According to Orthopedic Design and Technology, Loadpro is the company’s forthcoming...more

Software Company to Face Suit Over Contract Restructuring

The United States District Court for the Northern District of California sustained a securities fraud complaint alleging that the defendants, a software company and its executives, had defrauded investors by failing to...more

Fourth Circuit Sustains Securities Fraud Claim Against Drug Manufacturer

On March 6, the US Court of Appeals for the Fourth Circuit found that the United States District Court for the Western District of North Carolina had erred in dismissing a class action lawsuit filed under Section 10(b) of the...more

Locke Lord QuickStudy: Montana and Wyoming Update Data Breach Laws

Montana and Wyoming have recently revised their data breach notification laws including their definitions of what constitutes Personally Identifiable Information (PII) subject to breach notification. ...more

Healthcare & Life Sciences Private Equity Deal Tracker: OrthoSensor Secures $19 Million in Financing

OrthoSensor has announced it has raised $19 million in a private placement of series C preferred stock. OrthoSensor, based in Dania Beach, FL, is a developer of intelligent orthopedic devices and data services....more

Omnicare: Section 11 Liability and Opinions

The Supreme Court defined the circumstances under which liability can be imposed for opinion statements under Securities Act Section 11. Specifically, the Court held that such liability could be imposed on two theories: One...more

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