Administrative Agency Health

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On August 27, 2015, FDA released a long-awaited draft guidance entitled “Nonproprietary Naming of Biological Products” (the “Draft Guidance”). The Draft Guidance sets forth a naming convention for all biological products –...more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

Another One Bites the Dust: FDA Doesn’t Like the Fishy Smell of the Latest Court Decision on Off-Label Dissemination

In the most recent court decision, Amarin Pharma, Inc. v. United States Food and Drug Administration, No. 15 Civ. 3588 (PAE) (S.D. N.Y. August 5, 2015), a U.S. District Court granted Amarin's preliminary injunction to...more

FDA Announces 2016 Medical Device Fees

The Food and Drug Administration (FDA) recently issued a notice announcing the fiscal year (FY) 2016 medical device user fees, which apply to, among other things, applications for medical device approval. The National Law...more

How Far Is Too Far? Court Rules for Amarin in Off-Label Marketing Fight against FDA

Drugmaker Amarin Pharma, Inc. (Amarin), recently received a victory in its fight against the Food and Drug Administration (FDA). On August 7, 2015, the U.S. District Court for the Southern District of New York ruled that...more

Zyga Receives 510(k) Clearance

Zyga Technology, Inc., a medical device company dedicated to the research, development, and commercialization of surgical solutions to treat conditions of the lumbar spine, recently announced that it has received 510(k)...more

DOJ Announces First Settlement Based on Failure to Investigate Credit Balances

On August 3, 2015, the Department of Justice (DOJ) announced a $6.88 million settlement with a home health company, noting that this “is the first settlement under the False Claims Act involving a health care provider’s...more

FDA Issues Guidance to Streamline Review of 510(k) Submissions. A Clear Path Forward?

On August 4, 2015, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health released a new guidance document intended to provide applicants with clear and consistent guidance in the submission...more

AbbVie Requests Biosimilar Labeling Modification

On August 10, AbbVie, Inc. filed a supplement to its earlier filed Citizen Petition, levying another challenge to FDA’s implementation of the Biologics Price Competition and Innovation Act (BPCIA). This supplemental filing...more

First Amendment Protects Truthful Off-Label Speech by Drug Manufacturers

Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained...more

FDA issues first medical device hacking alert

Reportedly for the first time ever, the FDA recently issued a declaration that hospitals should not use a medical device manufactured by Hospira Inc. because of security flaws that could allow hackers to penetrate hospital...more

Also In The News - Health Headlines - August 2015 #2

House Report Highlights Cybersecurity Concerns At The Department Of Health and Human Services – The U.S. House of Representatives Committee on Energy and Commerce released a report revealing that five operating divisions at...more

Blog: HHS OIG Approves Drug Company Program Providing Free Cancer Treatment Drugs

On Tuesday, the Health and Human Services (HHS) Office of Inspector General (OIG) issued an Advisory Opinion regarding a program to provide a 30-day supply of cancer drugs free of costs to patients who experience an insurance...more

FDA's Cybersecurity Alert Puts Medical Device Users on Notice

On July 31, 2015, the United States Food and Drug Administration (FDA) issued a cybersecurity alert to health care facilities currently using certain infusion pumps manufactured by Hospira, Inc. The alert warns health care...more

Animal supplements still in limbo, facing increased FDA scrutiny

The thousands of food, agriculture and life sciences companies regulated by the federal government already face a barrage of complicated regulations. Add in significant regulatory uncertainty and a major reorganization of the...more

FDA Cites Drug Company for Kim Kardashian Endorsement

This week might have been the first time that an FDA regulatory issue hit the headlines on TMZ and other “celebrity watcher” websites. In an August 7 Warning Letter sent to the drug company Duchesnay, Inc., FDA complains...more

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