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Lessons From Omnicare Settlement In 'Swapping' Cases

On June 25, the U.S. Department of Justice announced that it had settled with Omnicare Inc. in two matters alleging that kickbacks resulted from below-cost discounts offered to skilled nursing homes as an inducement to select...more

Health Alert (Australia) - July 28, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales (NSW) - 22 July 2014 - Lane v Northern NSW Local Health District (No 3) [2014] NSWCA 233 - This...more

Under the Dome: Inside the Maine State House

In recent months, a federal political issue has developed regarding undocumented immigrants crossing into the United States. This week, it was revealed that this issue touches on Maine, when Governor LePage was notified by...more

The FDA’s Informed Consent Draft Guidance: Insights and Challenges for IRBs, Clinical Investigators and Sponsors

On July 15, 2014, the FDA released a draft guidance document (“Guidance”), proposing recommendations to Institutional Review Boards (IRBs), clinical investigators and research sponsors relating to the informed consent process...more

Are your HIPAA ducks in a row? The next round of OCR HIPAA audits is approaching

In 2011 the Department of Health and Human Services’ Office for Civil Rights (OCR) established the HIPAA Pilot Audit Program to ensure compliance with HIPAA’s privacy, security and breach notification rules. The first...more

Health Care: As Sunshine Act Deadlines Approach Physicians and Hospitals Should Prepare for Transparency in Their Financial...

On September 30, 2014, in accordance with the Federal Sunshine Act (the Sunshine Act), the Centers for Medicare and Medicaid Services (CMS) will publically disclose payments and "other transfers of value" by pharmaceutical,...more

California Appellate Court Requires Actual Viewing of Confidential Information in Data Breach Case Under the California Medical...

In a case against Sutter Health involving records from a stolen office computer, the California Court of Appeal recently issued a decision limiting plaintiffs’ ability to state a claim and obtain statutory damages under the...more

Is Off-Label Drug Promotion Protected Free Speech?

It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more

Health Headlines: Also in the News - July 2014 #3

CMS Revises Medicare Advantage and Part D Prescription Drug Plan Prior Authorization Requirement for Hospices – On July 18, 2014, CMS released a revised a memorandum outlining responsibility for drug payments for hospice...more

CMS Proposes Elimination of CME Exemption From Sunshine Act

Teaching hospitals and physicians who speak at continuing medical education (CME) programs should be interested in a July 11, 2014, announcement by the Centers for Medicare & Medicaid Services (CMS). The announcement proposes...more

HHS Relabels Invalidated 340b Regulation As “Interpretative Rule”

Earlier this week HHS came out swinging in the latest round of its battle with the Pharmaceutical Research & Manufacturers of America (PhRMA) over the Affordable Care Act’s provisions on 340B and orphan drugs. HHS reasserted...more

HHS Says It Has Authority to Issue Interpretive Guidance on Contested 340B Orphan Drug Rule Despite Court Order Vacating Final...

According to a recent court filing by HHS, the agency should not be precluded from issuing interpretative guidance regarding a provision of the 340B Drug Pricing Program even though a federal district court previously vacated...more

We Don’t Need No Intervention: Qui Tam Relator in Omnicare Wins Big Without DOJ

The United States Department of Justice (DOJ) recently announced the settlement of two qui tam whistleblower lawsuits against Omnicare Inc., the largest nursing home pharmaceutical and pharmacy services vendor in the nation....more

HRSA Issues Interpretive Rule on 340B Drug Pricing Program

On July 21, 2014, the Health Resource and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) issued a new interpretive rule addressing the treatment of orphan drugs by certain...more

FDA Draft Guidance Aims to Clarify Appropriate Character-Space-Limited Social Media Use by Drug and Device Firms: Part One of Two

As technology continues to evolve, so do the ways in which patients and healthcare providers obtain information pertaining to medical products regulated by the Food and Drug Administration (FDA). Thomas Abrams, Director of...more

Health Update - July 2014

Avoiding the Regulatory Land Mines of Commercial ACOs - While providers are showing great interest in creating ACOs to participate in the Medicare Shared Savings Program (MSSP), they are showing even greater enthusiasm...more

The Orphan Drug Wars: HHS Interpretive Rule Clarifies Orphan Drug Exclusion

On July 21, 2014, the U.S. Department of Health and Human Services (HHS) released an “Interpretive Rule” in response to a recent U.S. District Court decision that vacated the July 23, 2013, orphan drug rule on the grounds...more

FDA Issues Draft Guidance on Communications Over Internet and Social Media Platforms

On June 17, 2014, the U.S. Food and Drug Administration (FDA or the Agency) issued two draft guidance documents, providing recommendations for two types of communication over internet and social media platforms. The first...more

EC and SCENIHR Begin Public Consultation on Preliminary Opinion on Guidance on the Determination of Potential Health Effects of...

The European Commission (EC) and the Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) have begun a public consultation on the preliminary opinion concerning “Guidance on the Determination of Potential...more

New Massachusetts Law Targets Self-Referrals of Clinical Laboratory Services

The Fiscal Year 2015 budget for the Commonwealth of Massachusetts, which was signed into law earlier in the week, included a broad prohibition on clinical laboratory self-referrals. This legislation (the “Bill”) originally...more

How is Graphene Currently Used and What is the Hope for the Future? [Video]

In the second video of a three-part series, Fenwick attorney Paul Smith talks about the growing anticipation surrounding this strong, conductive and flexible material. Why the excitement? Simply put, graphene is easy. It’s...more

Health Headlines: Also in the News - July 2014 #2

CMS Proposes Changes to Physician Payments Sunshine Act Implementing Regulations – On July 3, 2014, CMS released four proposed changes for comment to the implementing regulations for the Physician Payments Sunshine Act. ...more

OIG issues special fraud alert on laboratory payments to referring physicians

On June 25, 2014, the U.S. Department of Health and Human Services Office of the Inspector General (“OIG”) released a Special Fraud Alert addressing Laboratory Payments to Referring Physicians. ...more

Teaching Hospitals and Physicians Must Take Action Now to Correct Erroneous Reports about them Submitted Under the Sunshine Act

On September 1, 2014, the Centers for Medicare and Medicaid Services (CMS) will make public the reports submitted by pharmaceutical and medical device manufacturers under the Sunshine Act. These reports will disclose...more

FDA Promises Guidance on Lawful Off-Label Promotion

In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The...more

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