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Supreme Court rules insurers can collect $12 billion under Obamacare

The Supreme Court says insurance companies can collect $12 billion from the U.S. government to cover losses in the early years of Obamacare.




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Carlos Ghosn: Turkey charges seven over escape from Japan

The former Nissan chief's sensational escape involved being smuggled from Tokyo to Lebanon via Istanbul.




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How Irrfan Khan helped Slumdog Millionaire to become an Oscar winner

Danny Boyle credits Irrfan Khan with propelling Slumdog Millionaire to Oscar glory.




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UFC's Jacare Souza Tests Positive for COVID-19, Out of UFC 249

UFC fighter Jacare Souza has tested positive for coronavirus and will NOT participate in his scheduled fight at UFC 249 on Saturday, the UFC confirms to TMZ Sports. The 40-year-old Brazilian was slated to fight Uriah Hall on the undercard of the…




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Carnival Bookings Spike as Cruises Set to Resume in August

This is kinda shocking, but Carnival Cruise enthusiasts aren't letting the pandemic scare 'em away from boarding ships with hundreds of passengers. A rep with Cruise Planners, an American Express travel franchise, tells TMZ ... after Carnival…




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Stars and Scars -- You Be the Judge

The brutal killing of Ahmaud Arbery is gut-wrenching and outrageous. And, the virus is causing many to choose between financial and physical health. So we gotta ask ...




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Geneva Healthcare Garners $6,193,845 New Financing Round

Revolutionizing cardiac device data management




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Geneva Healthcare Receives $60,000 New Funding

Revolutionizing cardiac device data management




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New Opportunities for OTC Monograph Drugs under the CARES Act

By: Daniel Dwyer and Daniel Logan On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act, or “CARES” Act (Pub. Law 116-136), which includes a comprehensive revision of the rules governing over-the-counter (OTC) drugs currently marketed under monographs published by the Food and Drug Administration (FDA).  This law

The post New Opportunities for OTC Monograph Drugs under the CARES Act appeared first on Kleinfeld Kaplan & Becker LLP.




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Changes Made to the Federal Food, Drug, and Cosmetic Act by the CARES Act

By: Daniel Logan and Justine Johnson The Coronavirus Aid, Relief, and Economic Security Act, or “CARES” Act (Pub. L. No. 116–136) makes numerous changes to the Federal Food, Drug, and Cosmetic Act (FDCA).  The CARES Act made substantial changes related to the regulation of over-the-counter (OTC) drugs (see KKB’s alert here dedicated to summarizing these

The post Changes Made to the Federal Food, Drug, and Cosmetic Act by the CARES Act appeared first on Kleinfeld Kaplan & Becker LLP.




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KRPA urges state govt to bring pharmacists under insurance cover on lines of healthcare workers engaged in treating COVID─19 patients




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VitalPatch Wins FDA Emergency Use Authorization for Cardiac Monitoring in COVID Patients

VitalConnect announced that it has received FDA Emergency Use Authorization status for use of its VitalPatch to detect changes in the QT interval of hospitalized patients undergoing drug treatment for COVID-19. Hydroxychloroquine and chloroquine, used to treat some COVID-19 patients, are associated with risk of prolonged QT interval that can lead to life-threatening arrhythmias. VitalPatch allows […]




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Scuba mask used to create PPE for healthcare workers

Mack Molding and Southwestern Vermont Health Care (SVHC) have partnered to develop an innovative alternative for Personal Protective Equipment (PPE) for healthcare workers.




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Manufacturer vows to work ‘round-the-clock' to provide healthcare workers with PPE

To help with the increased demand for Personal Protective Equipment (PPE), Suffolk based manufacturer Broadwater Mouldings have turned over its 3D printer to produce protective shield frames for healthcare workers.




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Thumbs Up to Latest CAR T-Cell Approval

New era for lymphoma, leukemia, possibly other cancers




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Morning Break: Is the IRS an Obamacare Savior? No Mugabe at WHO; Price on HIV Quarantine

Health news and commentary from around the Web gathered by the ALLMedPage Today staff




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Morning Break: Shingrix Gets CDC Blessing; Judge Won't Reinstate ACA Subsidies; Obamacare Fix Score

Health news and commentary from around the Web gathered by the ALLMedPage Today staff




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Morning Break: Black Licorice Warning; Obamacare Questions; Haunted Hospitals

Health news and commentary from around the Web gathered by the ALLMedPage Today staff




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Debunking the Myth: ‘Gene Patents’ are not necessary for healthcare innovation.

Myth: ‘Gene Patents’ are not necessary for health care innovation. Facts: Patents on DNA preparations or sequences are often the first patents upon which a later technology platform or portfolio is built.  These patents are often in-licensed from universities by small start-up companies for the purpose of additional R&D, evidencing that the public/non-profit university sector cannot bear […]




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Pallone and Neal Demand Transparency into Methodology and Distribution of COVID-19 Health Care Provider Relief Funds

Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and Ways and Means Chairman Richard E. Neal (D-MA) sent a letter to Health and Human Services (HHS) Secretary Alex Azar and Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma today raising a series of concerns over the methodology used to distribute and the lack of transparency into how COVID-19 relief funds and loans for health care providers are being spent.  “We write to raise serious concerns about the Provider Relief Fund and the Accelerated and Advance Payment Programs,” Pallone and Neal wrote.  “With respect to each, we are concerned about the lack of transparency with Congress and the American people about how funds are being spent or loans are being made.  We also have grave concerns regarding the methodology being used to distribute $175 billion Congress appropriated for the Provider Relief Fund.” The Chairmen’s letter documents concerns with how the programs are being run, in particular the Administration’s methodologies for distributing funding that has shortchanged a number of critical providers and makes clear that more transparency is needed for Congress to accurately assess the ongoing needs of health care providers as the COVID-19 crisis unfolds. “The Administration’s efforts to establish the Provider Relief Fund to date has been at best, a series of missteps, and at worst, a disregard of Congress’ intent for the program,” Pallone and Neal continued in their letter. Pallone and Neal wrote that when Congress passed the CARES Act, it was clear that the funding provided to HHS for the Provider Relief Fund was for the express purpose, “to prevent, prepare for, and respond to coronavirus.”  The two Chairs voiced concern that some of the funding formulas adopted to date fail to target funding based on the statutory framework relating to COVID-19 driven costs.  In fact, the Chairs write that the level of funding appears to be, “completely disconnected from need.” The Chairmen requested an immediate response from HHS regarding documents and information pertaining to the Provider Relief Fund and the Accelerated and Advanced Payment Program.  Pallone and Neal also wrote that if HHS is unable to immediately provide the information, it should provide a timeline of when the Committees would receive the requested information. While recognizing the incredible demands on the Department at this difficult time, the Chairmen emphasized that, “This crisis demands that we work swiftly and based on the best data available.  Currently, despite repeated requests, this Administration has prevented Congress from obtaining the data that the Department has available on funding for our health care system, data that is necessary to inform near future legislation.  We look forward to receiving this information so that we can conduct the business the American people expect of us.  We look forward to having you join us at the earliest possible date in each of our Committees to discuss these and other COVID-related issues.” To read the full letter, click HERE. ###




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Trovagene Rebrands as Cardiff Oncology, Promotes Longtime Exec to CEO

Trovagene (NASDAQ: TROV), which started out as a diagnostics company, has renamed itself Cardiff Oncology to better reflect its focus on the cancer drug it is advancing in three clinical trials. In 2017 the San Diego area-based biotech made the first step in its transformation into a drug development-focused organization, licensing rights to an investigational […]




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Jerome Carle steps down as Julphar Chief Executive

Chief Executive of Gulf Pharmaceutical Industries, Jerome Carle, is stepping down from his post at the United Arab Emirates drug manufacturer facing mounting pressure.

Julphar, one of the biggest generic drugs manufacturers in the Middle East and North Africa said Jerome Carle has “tendered his resignation” and the board has accepted it. His last working day will be December 8th.

read more




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How States are Protecting Health Care Providers from Legal Liability in the COVID-19 Pandemic

Clinicians and policymakers alike are raising the alarm about potential legal liability for following crisis standards of care during the COVID-19 pandemic.

The post How States are Protecting Health Care Providers from Legal Liability in the COVID-19 Pandemic appeared first on Bill of Health.




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When and How to Resume Non-Urgent Care During COVID-19

The question must be: can we accommodate non-emergent/non-urgent care safely or not, and if yes, which care do we address first as we re-open?

The post When and How to Resume Non-Urgent Care During COVID-19 appeared first on Bill of Health.




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Cleaner Air Courtesy of Coronavirus Provides Window into a Car-Free Future

With cars off the roads, scientists can study how smog and other types of pollution change  

-- Read more on ScientificAmerican.com




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Soils Store Huge Amounts of Carbon, Warming May Unleash It

Higher temperatures and wetter weather may spur soil microbes to release more carbon into the atmosphere

-- Read more on ScientificAmerican.com




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Bristol-Myers' CAR-T cell therapy meets with FDA delay

The submission of additional information, upon the request of the US regulator, has delayed the action…



  • Biotechnology/Bristol-Myers Squibb/Focus On/Immuno-oncology/lisocabtagene maraleucel/Regulation/Research/US FDA/USA

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Novartis taps real-life Cosentyx patients to thank healthcare workers, pledge patient support

Novartis is using familiar faces—real patients from its Cosentyx TV commercials—to thank healthcare workers and promise support for patients. It’s a shift away from product-centered TV ads as Novartis adjusts its Cosentyx DTC effort during the COVID-19 crisis to highlight resources for patients, the drugmaker said.




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LAN Cargo S.A., Aerolinhas Brasileiras S.A. and EL AL Israel Airlines Ltd. Agree to Plead Guilty for Fixing Prices on Air Cargo Shipments

Three air cargo carriers, LAN Cargo S.A. (LAN Cargo), Aerolinhas Brasileiras S.A. (ABSA), and EL AL Israel Airlines Ltd. (EL AL), have each agreed to plead guilty and pay criminal fines totaling $124.7 million for their roles in a conspiracy to fix prices in the air cargo industry.



  • OPA Press Releases

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Owner of Pharmaceutical Wholesale Company Pleads Guilty to Medicare Fraud

The owner and operator of HME Solutions Inc., dba Lifecare Medical (Lifecare Medical), a licensed pharmaceutical wholesale company in Miami, pleaded guilty today to defrauding the Medicare program in connection with a $5.3 million HIV-infusion fraud scheme.



  • OPA Press Releases

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Three Miami Physicians and Three Medical Workers Charged with $10 Million Medicare Fraud Scheme

Six Miami-Dade County residents have been indicted in connection with an alleged $10 million Medicare fraud scheme operated out of Midway Medical, a Miami clinic that purported to specialize in treating HIV/AIDS patients.



  • OPA Press Releases

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North Carolina Man Pleads Guilty to Possessing Child Pornography

Timothy Christenbury, of Charlotte, N.C., pleaded guilty today to possessing child pornography. Christenbury, 46, pleaded guilty before U.S. Magistrate Judge Carl Horn III to one count of possession of child pornography. He was indicted on those charges on Dec. 16, 2008. According to the indictment, Christenbury possessed computer files containing child pornography from on or about Sept. 2 to Sept. 4, 2007.



  • OPA Press Releases

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Japanese Corporate Operator of Cargo Vessel Sentenced to Pay $1.75 Million for Conspiracy and Falsifying Records

U. S. District Judge Steven D. Merryday today sentenced the Japanese corporation Hiong Guan Navegacion Japan Co. Ltd., that operates the commercial cargo ship M/V Balsa-62, to three years probation and $1.75 million in penalties for conspiring to falsify and falsifying environmental compliance records.



  • OPA Press Releases

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Justice Department Settles Lawsuit Alleging Military Discrimination Against the North Carolina Administrative Office of the Courts and Senior Resident Court Judge

The Department announced today that it has reached a settlement that, if approved by the court, will resolve a lawsuit filed by the Department against the Administrative Office of the Courts of the State of North Carolina and the Honorable Jerry Braswell, Senior Resident Superior Court Judge for North Carolina Judicial District 8-B, in his official capacity.



  • OPA Press Releases

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Former Cartel Leader Extradited from Mexico

Miguel Caro Quintero, the alleged former leader of the now-defunct Sonora Cartel, was extradited by the government of Mexico to the United States on Feb. 25, 2009. Miguel Caro Quintero arrived in the United States yesterday and has been transferred to the District of Colorado to face charges including racketeering and narcotics trafficking.



  • OPA Press Releases

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Kansas Cardiologist to Pay U.S. $1.3 Million to Settle False Claims Act Allegations

Joseph P. Galichia, M.D. and Galichia Medical Group P.A., a Kansas cardiologist and his practice group, have agreed to pay the United States $1.3 million to settle claims that the physician and his group violated the False Claims Act between 2001 and 2006, by submitting false claims to Medicare.



  • OPA Press Releases

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U.S. Asks Courts in California & South Carolina to Shut Down Promoters of Allegedly Fraudulent $39.2 Million Tax Refund Scam

The United States has sued tax return preparers in Placerville, Calif., and Columbia, S.C., seeking to bar them from preparing federal tax returns for others. According to the government complaints in the two cases, Teresa Marty of Pollock Pines, Calif., and Winston Able of Blythewood, S.C., prepare federal income tax returns for their customers that claim fraudulent tax refunds.



  • OPA Press Releases

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Federal Court Shuts Down North Carolina Tax Preparer

A federal court has permanently barred Raymond A. Renfrow of Elm City, N.C., from preparing federal income tax returns for others. The U.S. District Court for the Eastern District of North Carolina entered the civil injunction order, which also stops Renfrow from promoting a tax fraud scheme that used sham trusts to falsely deduct customers’ non-deductible personal expenses.



  • OPA Press Releases

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Justice Department Files Lawsuit Against Americraft Carton Inc., to Enforce the Employment Rights of Michigan Army National Guardsman

The Department today filed a lawsuit on behalf of David D. Sweatt, a Michigan Army National Guard member currently serving in Iraq, against Americraft Carton Inc. (Americraft), alleging violations of the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA).



  • OPA Press Releases

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Jury Convicts Two Doctors and Two Medical Assistants in $5.3 Million Medicare Fraud Scam

A federal jury in Miami today convicted two physicians and two medical assistants in connection with a $5.3 million Medicare fraud scheme. After a two-week trial in federal court in Miami, a jury found David Rothman, M.D., 66; Keith Russell, M.D., 65; Eda Marietta Milanes, 43; and Jorge Luis Pacheco, 50; guilty on all charged counts, including conspiracy to commit health care fraud and multiple counts of health care fraud for submitting claims to Medicare for unnecessary medications.



  • OPA Press Releases

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U.S. Sues Union Pacific R.R. for $37 Million for Allegedly Failing to Prevent Use of Rail Cars to Smuggle Narcotics Across Border

The government has filed two lawsuits against the Union Pacific Railroad Company for allegedly failing to prevent the use of its rail cars to smuggle large quantities of narcotics into the United States. The complaints, filed in San Diego and Houston, seek more than $37 million in monetary penalties. The government alleges the rail cars were brought across the border at the ports of entry at Calexico, Calif., and Brownsville, Texas.



  • OPA Press Releases

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Two Doctors and Two Medical Assistants Plead Guilty in $10 Million Medicare Fraud Scheme

Four Miami-area residents pleaded guilty today in connection with a $10 million Medicare fraud scheme involving HIV infusion clinics. Dr. Roberto Rodriguez, 54; Dr. Carlos Garrido, 69; Gonzalo Nodarse, 38; and Alexis Carrazana, 41; all pleaded guilty before U.S. District Judge Paul C. Huck to one count of conspiracy to commit health care fraud.



  • OPA Press Releases

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California Couple Plead Guilty in Alien Smuggling Scheme in Which Some Were Forced to Work at Elder Care Homes

The owner of two elder care homes in Long Beach, Calif., has pleaded guilty on March 23, 2009 to bringing undocumented aliens into the United States and forcing two of them to work at her businesses. Evelyn Pelayo, 53, a resident of Long Beach, pleaded guilty on March 23, 2009 to forced labor and unlawful conduct of holding passports to further forced labor.



  • OPA Press Releases

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Houston’s Methodist Hospital to Pay U.S. More Than $9 Million to Resolve Allegations of Overcharging Medicare

Methodist Hospital in Houston has agreed to pay the United States $9.99 million to settle allegations that it defrauded the federal Medicare program. The settlement resolves allegations that Methodist improperly increased charges to Medicare patients in order to obtain enhanced reimbursement from Medicare.



  • OPA Press Releases

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Fact Sheet: Department of Justice Efforts to Combat Mexican Drug Cartels

The increased efforts and reallocation of personnel recently announced by the Department of Justice builds on the foundation of expertise and experience gained from ongoing efforts to combat Mexican drug cartels in the United States and to help Mexican law enforcement battle cartels in its own country.



  • OPA Press Releases

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Three International Airline Companies Agree to Plead Guilty to Price Fixing on Air Cargo Shipments

Three international airline companies—Luxembourg-based Cargolux Airlines International S.A., Japan-based Nippon Cargo Airlines Co. Ltd. (NCA), and Korea-based Asiana Airlines Inc.—have each agreed to plead guilty and pay criminal fines totaling $214 million for conspiring to fix prices in the air cargo industry. In addition, Asiana was charged with fixing the passenger fares charged on flights from the United States to Korea.



  • OPA Press Releases

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Owner of Korean Commercial Cargo Vessel & Chief Engineer Plead Guilty to Marine Pollution Related Charges

STX Pan Ocean Co. Ltd. (STX), headquartered in Seoul, Korea, and the owner of the commercial cargo ship, M/V Ocean Jade, pleaded guilty today to conspiracy as well as falsifying and failing to properly maintain records meant to ensure compliance with maritime pollution laws. The chief engineer of the M/V Ocean Jade, Hong Hak Kang, a Korean citizen, also pleaded guilty today to failing to maintain environmental records and making false statements.



  • OPA Press Releases

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Dutch Airline Executive Agrees to Plead Guilty for Fixing Prices on Air Cargo Shipments

A Dutch citizen and executive of Martinair Holland N.V. (Martinair) has agreed to plead guilty, serve time in jail and pay a criminal fine for participating in a conspiracy to fix cargo rates for international air shipments. Including today’s charge, a total of 15 airlines and four executives have pleaded guilty or agreed to plead guilty in the Justice Department’s ongoing investigation into price fixing in the air transportation industry.



  • OPA Press Releases

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Three South Carolina Men Indicted on Federal Civil Rights Charges

A federal grand jury in Florence, S.C., indicted three men from Marlboro County, S.C., on charges relating to their attack on an African-American man and two white men in December 2007.



  • OPA Press Releases

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Justice Department Settles Lawsuit Against Americraft Carton Inc. on Behalf of Michigan Army National Guardsman

The Department announced a settlement that, if approved by the court, will resolve its lawsuit filed on behalf of David D. Sweatt, a Michigan Army National Guard member currently serving in Iraq, against his former employer, Americraft Carton Inc. (Americraft).



  • OPA Press Releases