Vascular Solutions Inc. (VSI) has agreed to pay $520,000 to resolve allegations that it caused false claims to be submitted to federal health programs by marketing a medical device for the ablation (or sealing) of perforator veins without FDA approval and despite the failure of its own clinical trial, the Justice Department announced today

The Justice Department announced today that Community Health Systems Inc. (CHS), the nation’s largest operator of acute care hospitals, has agreed to pay $98.15 million to resolve multiple lawsuits alleging that the company knowingly billed government health care programs for inpatient services that should have been billed as outpatient or observation services. The settlement also resolves allegations that one of the company’s affiliated hospitals, Laredo Medical Center (LMC), improperly billed the Medicare program for certain inpatient procedures and for services rendered to patients referred in violation of the Physician Self-Referral Law, commonly known as the Stark Law. CHS is based in Franklin, Tennessee, and has 206 affiliated hospitals in 29 states

The Justice Department announced today that it reached an agreement with Isabella Geriatric Center (IGC), a nursing home located in New York City, resolving a claim that IGC engaged in a pattern or practice of citizenship discrimination during the employment eligibility reverification process in violation of the Immigration and Nationality Act (INA).

The Justice Department reached an agreement today with Travel Management Company, a private airplane charter company based in Elkhart, Indiana, resolving claims that the company engaged in citizenship status discrimination in violation of the Immigration and Nationality Act (INA).

McKesson Corporation has agreed to pay $18 million to resolve allegations that it improperly set temperature monitors used in shipping vaccines under its contract with the Centers for Disease Control and Prevention (CDC), the Justice Department announced today. McKesson is a pharmaceutical distributor with corporate headquarters in San Francisco

The Justice Department reached an agreement today with Real Time Staffing Services LLC, doing business as Select Staffing, a company based in Santa Barbara, California. The settlement resolves the department’s claims that Select Staffing discriminated against work-authorized non-U.S. citizens in violation of the Immigration and Nationality Act (INA).

Samsung Electronics America Inc. (Samsung) has agreed to pay $2.3 million to resolve allegations that it caused the submission of false claims for products sold on General Service Administration (GSA) Multiple Award Schedule (MAS) contracts in violation of the Trade Agreements Act of 1979 (TAA), the Justice Department announced today. Samsung is an electronics distributor and marketer headquartered in Ridgefield Park, New Jersey

A Lighthouse Point, Florida, man was sentenced today to serve 12 months and one day in prison for filing a false claim for a tax refund with the Internal Revenue Service (IRS), Deputy Assistant Attorney General Ronald A. Cimino of the Justice Department’s Tax Division and U.S. Attorney Wifredo Ferrer for the Southern District of Florida announced

The United States has partially intervened against defendants in two whistleblower lawsuits in the Federal District Court for the District of Colorado alleging Evercare Hospice and Palliative Care submitted false claims for the Medicare hospice benefit.

The Justice Department announced today that it reached an agreement with Culinaire International, a catering and restaurant management company headquartered in Houston, Texas, resolving a claim that Culinaire engaged in citizenship discrimination during the employment eligibility reverification process in violation of the Immigration and Nationality Act (INA).

Life Care Services LLC, a manager of skilled nursing facilities based in Des Moines, Iowa, and CoreCare V LLP, doing business as ParkVista, a skilled nursing facility in Fullerton, California, have agreed to pay a total of $3.75 million to the government for causing the submission of false claims to Medicare for unreasonable or unnecessary rehabilitation therapy purportedly provided by RehabCare Group East Inc., a subsidiary of Kindred Healthcare Inc.

The United States has filed two complaints under the False Claims Act against Michigan neurosurgeon Dr. Aria Sabit, spinal implant company Reliance Medical Systems, two Reliance distributorships—Apex Medical Technologies and Kronos Spinal Technologies—and the companies’ owners, Brett Berry, John Hoffman and Adam Pike.

Stanley J. Wardle, of Spanish Fork, Utah, was sentenced today to serve 33 months in prison for filing false claims for income tax refunds, the Justice Department and Internal Revenue Service announced.

On January 15, 2009, the U.S. Foreign Intelligence Surveillance Court of Review (FISC-R) published an unclassified version of its opinion in In Re: Directives Pursuant to Section 105B of the Foreign Intelligence Surveillance Act, 551 F.3d 1004 (Foreign Intel. Surv. Ct. Rev. 2008). The classified version of the opinion was issued on August 22, 2008, following a challenge by Yahoo! Inc. (Yahoo!) to directives issued under the Protect America Act of 2007 (PAA). Today, following a renewed declassification review, the Executive Branch is publicly releasing various documents from this litigation, including legal briefs and additional sections of the 2008 FISC-R opinion, with appropriate redactions to protect national security information. These documents are available at the website of the Office of the Director of National Intelligence (ODNI), www.dni.gov; and ODNI’s public website dedicated to fostering greater public visibility into the intelligence activities of the U.S. Government, IContheRecord.tumblr.com. A summary of the underlying litigation follows.

The Department of Justice announced today that it filed a motion to show cause why Bayer Corporation should not be held in civil contempt for violating a court order in the U.S. District Court for the District of New Jersey.

Episcopal Ministries to the Aging Inc., a Maryland not-for-profit corporation that owns skilled nursing facilities, has agreed to pay $1.3 million to the government for submitting false claims to Medicare for unreasonable or unnecessary rehabilitation therapy purportedly provided by RehabCare Group East Inc., a subsidiary of Kindred Healthcare Inc.

A Plus Home Health Care Inc. and its owners, Tracy Nemerofsky and her father, Stephen Nemerofsky, have agreed to pay $1.65 million to the United States to settle allegations that A Plus paid spouses of referring physicians for sham marketing positions in order to induce patient referrals.

Benjamin Pierce Bishop, 60, a former Honolulu, Hawaii, civilian defense contractor and retired lieutenant colonel in the U.S. Army, was sentenced today by U.S. District Judge Leslie E. Kobayashi to serve 87 months imprisonment and three years’ supervised release for willfully communicating classified national defense information to a person not authorized to receive it and unlawfully retaining classified national defense information at his home.

By Alice Li, MD, MSc, RAC (CAN), Regulatory Scientist, Cato Research FDA issued “The Abbreviated 510(k) Program – Guidance for Industry and Food and Drug Administration Staff” on 13 September 2019. The content of this guidance supersedes the content from 1998 guidance “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket …

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Ocean Spray Cranberries, Inc. is recalling Pink Lite Cranberry Juice Drink citing potential for undeclared sulfites, the U.S. Food and Drug Administration said in a statement. The recall involves a single production lot of 5.5oz cans of the drink with lot number MH0030LPK4 and Best Before Date of 24JAN21. The product is sold in boxes containing six 5.5oz cans. They were distributed to retail

Baltimore, Maryland-based Medifast, Inc. is recalling certain Optavia Oatmeal products citing undeclared milk, a known allergen, the U.S. Food and Drug Administration said in a statement. The recall involves around 24,923 boxes of OPTAVIA Essential Old Fashioned Maple & Brown Sugar Oatmeal. The product is packaged in yellow and white cardboard boxes with the brand name.

April 13, 2020 – The Food and Drug Administration (FDA) is responding to the challenges of COVID-19 in new ways that streamline product review and policy approaches, while also ensuring that entities promoting unapproved products that claim to be effective against the virus do not go unchecked. Last week, the FDA and the Federal Trade […]

Inovio Pharmaceuticals’ stock has climbed higher and higher over the past month since it said it was working on a speedy COVID-19 vaccine.

Some producers of essential oils have thrown their hats into the coronavirus claims ring, according to recent warning letters from the US Food and Drug Administration and the Federal Trade Commission.

The video has been viewed millions of times on YouTube via links that are replaced as quickly as the video-sharing service can remove them for violating its policy against "COVID-19 misinformation."

I have blogged before about the effects and possibilities of the Corrigendum of December 2019 for class I medical devices. I refer you to that blog for the background to this discussion, which covers the mechanics of timing. The draft corrigendum discussed in that blog was adopted as described.  The new guidance The MDCG has […]

The coronavirus outbreak has forced the cancellation of myriad life events. Santa Clara County won't even let you celebrate in your car now.

UCLA, the NCAA champion in 2019 and the No. 1 team in 2020 when the COVID-19 pandemic hit, got a boost with the return of Rachel Garcia and Bubba Nickles.

For the high school and college classes of 2020 — and their families — the coronavirus outbreak has left a large, empty space where signature coming-of-age moments should be.

Download the latest CBSE syllabus of all subjects of Class 9. Analyse the syllabus before studyng new chapters in new academic session.

CBSE Result 2020: Amid COVID - 19 pandemic & lockdown, Kendriya Vidyalaya Sangathan (KVS) and many state boards (like Gujarat, Haryana, Puducherry) have decided to promote school students (Classes 1st to 9th & Class 11th). After this, many students & parents are seeking clarity from the Central Board of Secondary Education (CBSE). Check updates.

The company issued a response following “chatter based on an Asian talk show commentary,” it said.

The post Temasek refutes claim CEO Ho Ching makes $70m a year appeared first on DealStreetAsia.

The funding will be used to spruce up technology and expand product offerings.

The post India Deal Monitor: RTP Global leads $9m funding in Classplus and more updates appeared first on DealStreetAsia.

Mar 24, 2020

Patricia (Pat) McLaughlin, our beloved colleague and friend at the Center since 2001, passed away in February after a brief illness. Hired as Faculty Assistant to John Holdren, Co-Director of the Center’s Science, Technology, and Public Policy Program (STPP) nearly 20 years ago, she continued to work with STPP and with John until her illness.

Mar 24, 2020

Patricia (Pat) McLaughlin, our beloved colleague and friend at the Center since 2001, passed away in February after a brief illness. Hired as Faculty Assistant to John Holdren, Co-Director of the Center’s Science, Technology, and Public Policy Program (STPP) nearly 20 years ago, she continued to work with STPP and with John until her illness.

Mar 24, 2020

Patricia (Pat) McLaughlin, our beloved colleague and friend at the Center since 2001, passed away in February after a brief illness. Hired as Faculty Assistant to John Holdren, Co-Director of the Center’s Science, Technology, and Public Policy Program (STPP) nearly 20 years ago, she continued to work with STPP and with John until her illness.

The ruling JD(U) on Saturday slammed AAP for claiming that it bore the cost of ferrying migrant workers from Delhi to their home in Bihar, saying the party was speaking "half-truth" as the Arvind Kejriwal government has sought reimbursement of the payment.

Mar 24, 2020

Patricia (Pat) McLaughlin, our beloved colleague and friend at the Center since 2001, passed away in February after a brief illness. Hired as Faculty Assistant to John Holdren, Co-Director of the Center’s Science, Technology, and Public Policy Program (STPP) nearly 20 years ago, she continued to work with STPP and with John until her illness.

Mar 24, 2020

Patricia (Pat) McLaughlin, our beloved colleague and friend at the Center since 2001, passed away in February after a brief illness. Hired as Faculty Assistant to John Holdren, Co-Director of the Center’s Science, Technology, and Public Policy Program (STPP) nearly 20 years ago, she continued to work with STPP and with John until her illness.

Mar 24, 2020

Patricia (Pat) McLaughlin, our beloved colleague and friend at the Center since 2001, passed away in February after a brief illness. Hired as Faculty Assistant to John Holdren, Co-Director of the Center’s Science, Technology, and Public Policy Program (STPP) nearly 20 years ago, she continued to work with STPP and with John until her illness.

Mar 24, 2020

Patricia (Pat) McLaughlin, our beloved colleague and friend at the Center since 2001, passed away in February after a brief illness. Hired as Faculty Assistant to John Holdren, Co-Director of the Center’s Science, Technology, and Public Policy Program (STPP) nearly 20 years ago, she continued to work with STPP and with John until her illness.

Mar 24, 2020

Patricia (Pat) McLaughlin, our beloved colleague and friend at the Center since 2001, passed away in February after a brief illness. Hired as Faculty Assistant to John Holdren, Co-Director of the Center’s Science, Technology, and Public Policy Program (STPP) nearly 20 years ago, she continued to work with STPP and with John until her illness.

Mar 24, 2020

Patricia (Pat) McLaughlin, our beloved colleague and friend at the Center since 2001, passed away in February after a brief illness. Hired as Faculty Assistant to John Holdren, Co-Director of the Center’s Science, Technology, and Public Policy Program (STPP) nearly 20 years ago, she continued to work with STPP and with John until her illness.

Mar 24, 2020

Patricia (Pat) McLaughlin, our beloved colleague and friend at the Center since 2001, passed away in February after a brief illness. Hired as Faculty Assistant to John Holdren, Co-Director of the Center’s Science, Technology, and Public Policy Program (STPP) nearly 20 years ago, she continued to work with STPP and with John until her illness.

Mar 24, 2020

Patricia (Pat) McLaughlin, our beloved colleague and friend at the Center since 2001, passed away in February after a brief illness. Hired as Faculty Assistant to John Holdren, Co-Director of the Center’s Science, Technology, and Public Policy Program (STPP) nearly 20 years ago, she continued to work with STPP and with John until her illness.