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DOL’s New Companionship Exemption to Take Effect on October 13

As we previously reported, this past August, the D.C. Circuit Court of Appeals upheld the Department of Labor’s Final Rule imposing sweeping changes to the former companionship exemption under the Fair Labor Standards Act. ...more

Update on FDA’s Approach to Labeling Biosimilars Like Generics

The FDA approved label for the first U.S. biosimilar, Sandoz’s Zarxio, has raised concerns. Zarxio was launched on September 3, 2015 with a label that does not state that the product was approved as a biosimilar to Amgen’s...more

District Court Says CMS’s 0.2 Percent IPPS Rate Cut Violated APA

On September 21, 2015, the United States District Court for the District of Columbia ruled that the Secretary of the U.S. Department of Health and Human Services (HHS) failed to provide a meaningful opportunity to comment on...more

FDA Detects That a Screening Tool for Early Detection of Cancer Types Might Require More Sleuthing

The Food and Drug Administration recently issued an untitled letter to a medical device company concerning its non-invasive blood test intended for use as a screening tool for the early detection of certain cancer types. FDA...more

The FDA Takes the Kardashian Endorsement Machine to Task

When Kim Kardashian speaks, the FDA listens. Or, more precisely, when Kardashian, who has 46.8 million followers on Instagram, posts an enthusiastic endorsement—and advertisement—on the social media platform for Diclegis, a...more

Drug and Device Companies May Soon Face Less Burdensome FDA Approval Process

On July 10, 2015, Congress passed H.R. 6, the 21st Century Cures Act, with a bipartisan vote of 344 to 77. The 352-page bill seeks to make the U.S. Food and Drug Administration (FDA) drug and device approval process less...more

First Amendment Right to Off-Label Promotion – Has Pandora’s Box Been Opened for FDA?

A handful of recent court decisions, including one issued just last month, seems to have potentially cracked open the door for pharmaceutical manufacturers to have more leeway to promote off-label uses of their products....more

Only One Short Bite of the Apple: Change in the Medicare Enrollment Appeals Process

In keeping with the trend to strengthen its authority to deny an enrollment or revoke Medicare billing privileges, CMS has modified the appeals process in a manner that will significantly shorten the time allotted to mount an...more

Health Care and Life Sciences Practice Newsletter

Lions and Tigers and Bears, Oh My! The Unexpected Laws that May Affect Your Telehealth Business - An increasing number of health care providers are exploring telemedicine, either as an adjunct to their primary physical...more

FDA’s Proposal for Naming Biosimilars Pleases Some, Disappoints Others

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) created an abbreviated pathway for the approval of biosimilar biological products, but is silent on how to name them. The nonproprietary naming of...more

Blog: “Common Rule” Overhaul Proposed – Intended to Modernize Human Research Subject Protections

On September 2, 2015, sixteen federal agencies and departments jointly issued a Notice of Proposed Rulemaking (“the NPRM”), designed to “modernize, strengthen, and make more effective” the so-called “Common Rule”. The Common...more

First Biosimilar Drug Now Available; Ongoing Legal Dispute Remains

The first biosimilar is now available in the United States. Sandoz announced the availability of Zarxio™ (filgrastim-sndz) earlier today, after the Federal Circuit denied Amgen Inc.'s attempt to stall the launch. The launch...more

CMS Limits the Scope of Review for Certain Redeterminations and Reconsiderations

For providers who have received inconsistent or varying reasons for denial while navigating through the Medicare appeals process, the Centers for Medicare & Medicaid Services (CMS) has provided much-needed relief in the form...more

What’s in a Name? That Which We Call a Biological Product…

The FDA has been gradually issuing guidances to implement the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). One of the most eagerly awaited guidance documents has been that on nonproprietary names to be...more

D.C. Circuit Court of Appeals Upholds USDOL’s Revised Regulations on the “Companionship Exemption” Under the FLSA

On August 21, the United States Court of Appeals for the District of Columbia Circuit upheld the U.S. Department of Labor’s revisions to the “companionship exemption” under the Fair Labor Standards Act, and reversed two...more

Biological/Biosimilar Nonproprietary Naming Guidance and Proposed Rule for Certain Proposed Nonproprietary Names for...

On August 27, 2015, FDA released a long-awaited draft guidance entitled “Nonproprietary Naming of Biological Products” (the “Draft Guidance”). The Draft Guidance sets forth a naming convention for all biological products –...more

Responding to Subpoenas and Other Requests for Personal Health Information: Take Them at Face Value

Healthcare providers and other HIPAA covered entities receive requests for protected health information (“PHI”) from a variety of sources on a daily basis. Such requests can range from informal requests made during the course...more

Change to FLSA Companionship Exemption Extends Minimum Wage and Overtime Protections to Home Health Care Aides

After almost fourteen months of legal challenges, the U.S. Department of Labor has emerged victorious in its attempt to modify the FLSA’s companionship exemption. On August 21, the U.S. Court of Appeals for the D.C. Circuit...more

CMS's "At a Collection Agency" Bad Debt Policy - Confusion Continues

As we reported in previous Payment Matters articles, the United States District Court for the District of Columbia has issued inconsistent opinions regarding Medicare's policy not to allow bad debt when that bad debt is still...more

Massachusetts Proposes New Rules for Nursing Home Sales and Closures

Massachusetts regulators recently announced new rules that, if adopted, will change the requirements for nursing home sales and closures in the state. The proposed new rules require nursing home owners intending to sell a...more

New OSHA Directive to Speed Up Resolution of Whistleblower Complaints Under OSH Act, Dodd-Frank, Other Laws

A directive to establish nationwide policies and procedures aimed at speeding up the resolution of “whistleblower” complaints handled by the Occupational Safety and Health Administration (OSHA) was issued on August 19, 2015....more

FDA is “Keeping up with Kardashians’” Social Media Posts

On August 7, 2015, the FDA sent a warning letter to drug maker, Duchesnay, over Kim Kardashian’s endorsement of its pills for morning-sickness. Kardashian had made an Instagram and Facebook post which vouched for the...more

Off-Label Marketing and the False Claims Act

In a post published earlier this week this week our colleagues Brian Dunphy and Joanne Hawana examined key issues in the recent Amarin decision from the Southern District Court of the New York. The August 7th ruling provided...more

Life Sciences Companies and Free %$&*@# Speech

Irish and NI life sciences companies operating in the US likely are familiar with the concept of “off-label” promotion–providing information about drug/device uses that have not been cleared by the FDA (even where the FDA has...more

FDA Update: New guidance released on mobile medical devices, medical devices data systems

Mobile devices, including cell phones and tablets, have had a major impact on the practice of medicine, how patients interact with their doctors, receive or implement treatments, as well as how software developers view the...more

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