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FDA Issues Draft Guidance on Communications Over Internet and Social Media Platforms

On June 17, 2014, the U.S. Food and Drug Administration (FDA or the Agency) issued two draft guidance documents, providing recommendations for two types of communication over internet and social media platforms.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

Software Glitch Sparks FCA Suit Against Hospitals for Late Repayment of Medicaid Reimbursements

On June 27, the New York Attorney General’s Office and the U. S. Attorney’s Office for the Southern District of New York intervened in a qui tam suit against Continuum Health Partners, Inc., Beth Israel Medical Center and St....more

FDA Hosts Webinar Addressing Social Media Draft Guidance

The Food and Drug Administration hosted a Social Media Draft Guidance Webinar. The July 10 webinar included summary review of the three draft guidances issued this year to date followed by a brief Q&A. Thomas Abrams, director...more

Even in Privacy Cases, Risk of Injury Does not Always Equal Injury

It’s an ancient conundrum; if a tree falls in the forest, and no one is there to hear it, does it make a sound? Privacy litigation may well offer the closest jurisprudential equivalent; if data is stolen, but no one does...more

Medicaid Claims And Health Care Fraud: As The Data Flows, New Cracks Emerge

As we noted in two of our prior posts in the Insider blog, the government has long touted its ability to rely upon data mining as a means of detecting fraud in the federal health care system, and has initiated a host of...more

California Court Grants Hospital Summary Judgment on Data Breach Claim

In its recent decision in Eisenhower Medical Center v. Superior Court, 226 Cal. App. 4th 430(Cal. App. 4th Dist. 2014), the Court of Appeal of California, Fourth District, had occasion to consider whether a medical facility’s...more

Capital Thinking: Technology and Communications

Legislative Activity - House Commerce SUBCommittees Will Hold Hearing ON 21st Century Technology for 21st Century Cures - The House Energy and Commerce Subcommittees on Communications and Technology and Health...more

What is Graphene? Fenwick Patent Attorney Has the Answer [Video]

The technology and life sciences communities alike have been raving about new "wonder material" graphene for the past year. From applications for wearable devices to the creation of lightweight, bendable televisions and...more

A Legal Guide to Privacy and Data Security

A Legal Guide to Privacy and Data Security, a new book offering guidance on a wide variety of privacy and data security laws and how those laws may impact your business, is now available from the Minnesota Department of...more

You Are Now on the Clock — Sunshine Act Dispute Window Now Open

Beginning Monday, July 14, 2014, the review, dispute and correction process outlined the National Physician Payment Transparency Program (also known as the "Sunshine Act") opens on CMS's Open Payments website. Physicians and...more

False claims by any other name: Medtronic and Omnicare cases illustrate the interplay between the False Claims Act and other...

- Government allegations of Medtronic’s alleged incentives to physicians for prescribing its medical devices lead company, while denying wrongdoing, to settle False Claims Act suit predicated on Anti-Kickback...more

FDA Gives Guidance on Compounding for Human Use

In July 2014, the U.S. Food and Drug Administration (FDA) released five documents containing policies and proposals that affect both traditional compounding pharmacies and outsourcing facilities that compound drugs for human...more

Health Care Update - July 2014 #2

In This Issue: - Obama Administration Ramps up Efforts to Reduce Medicaid Spending - Senators Press Gilead on Sovaldi - Implementation of the Affordable Care Act - Other Federal Regulatory...more

Two Tips for Inventors Filing Patent Applications [Video]

The intense patent activity in graphene stems from its enormous technological and commercial potential. But because much of the territory underlying the graphene cross-roads has already been claimed, patenting graphene poses...more

OIG Report Recommends Increased Scrutiny of Over 1000 Laboratories With Questionable Billing for Medicare Part B Clinical...

According to a recently released report by the HHS Office of Inspector General (OIG), over 1,000 labs had unusually high billing for Medicare Part B Clinical Laboratory Services for dates of service in 2010. Increased...more

CMS Releases New Resources, Schedules Teleconference for Sunshine Review and Dispute Process

As we informed you last week, the Open Payments review, dispute and correction process started today and will continue through September 11, 2014. This is the process that allows physicians and teaching hospitals to review...more

OIG Sticks It to Physician Specimen Collectors

On June 25, the U.S. Department of Health & Human Services, Office of the Inspector General ("OIG") issued a Special Fraud Alert updating the previous guidelines concerning compensation by clinical laboratories to referring...more

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