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Unemployment and coronavirus: How do European countries protect jobs?

New York Gov. Andrew Cuomo acknowledged frustration with coronavirus stay-at-home orders but compared them with past sacrifices during national crises.

Washington state has a billion pounds of potatoes -- with no destination

Monica Miller explains the alphabet soup of possible recession shapes for the coronavirus-hit global economy.

How bars and restaurants could look when coronavirus restrictions are eased.

R. Kelly is offering an odd bit of reassurance ... informing the judge there's no danger of him harassing his accusers if he gets out of jail, because it's impossible for him to communicate with them. Kelly's legal team fired off a letter that's…

Do not let these two almost identical images of Kelly Osbourne start making you feel confused ... just take a deep breath and get a really good look around to see if you can find the sneaky switches that have been made to this tricky pic! Osbourne…

The Hits Radio host is feeling better than ever

MedTech Europe has issued a statement welcoming the delay for enforcing the European Medical Devices Regulation (EU MDR), and asking for similar action for the In Vitro Diagnostic Regulation (IVDR).

Ashley Philipp, marketing director, Injectech, explains the importance of considering barb styles when choosing a fitting for your medical device.

BIO’s “What Every State Should Know About Bayh-Dole” Webinar The Biotechnology Industry Organization (BIO) recently hosted a webinar entitled: “What Every State Should Know About Bayh-Dole: Leveraging University Research to Create Jobs and Spur Economic Development Benefits.” The Bayh-Dole Act, enacted in 1980, placed patent ownership of federally funded research at universities in the hands […]

May 8, 2020 (WASHINGTON) – Today, several House committee and subcommittee chairs sent a letter to the Departments of Homeland Security (DHS) and Health & Human Services (HHS) regarding recent news reports alleging that the Trump Administration is considering implementing policies that could unnecessarily delay migrant children in HHS care from being reunified with their sponsors.  The chairs again urge the Administration to rescind a Memorandum of Agreement requiring information about sponsors for migrant children be shared by HHS with DHS.  A group of House chairs previously wrote the Administration on this issue last July.  Despite current law, Congressional directives, and the current COVID-19 epidemic, the Administration continues policies that will lengthen the time migrant children spend in HHS care, thus keeping these children in congregate settings and therefore at heightened risk for exposure to COVID-19.  There have been 68 confirmed cases of COVID-19 among children in HHS care. The letter, led by Rep. Bennie G. Thompson (D-MS), Chairman of the Homeland Security Committee, has also been signed by: Rep. Frank Pallone, Jr. (D-NJ), Chairman of the Energy and Commerce Committee; Rep. Jerrold Nadler (D-NY), Chairman of the Judiciary Committee; Rep. Nita Lowey (D-NY), Chairwoman of the Appropriations Committee; Rep. Lucille Roybal-Allard (D-CA), Chairwoman of the Homeland Security Appropriations Subcommittee; Rep. Rosa DeLauro (D-CT), Chair of the Labor, Health and Human Services, and Education Appropriations Subcommittee; Rep. Kathleen Rice (D-NY), Chairwoman of the Homeland Security Committee Border Security, Facilitation, and Operations Subcommittee; Rep. Zoe Lofgren (D-CA), Chair of the Judiciary Committee Immigration and Citizenship Subcommittee; and Rep. Diana DeGette (D-CO), Chair of the Energy and Commerce Committee Oversight and Investigations Subcommittee. Link to letter Letter text: We write with deep concern over recent reporting alleging that Administration officials are considering implementing policies that could unnecessarily delay the reunification of unaccompanied minors in the care of the Department of Health and Human Services (HHS) with their sponsors.  These concerns are heightened by the current COVID-19 epidemic, which poses significant risks for all individuals held in congregate settings. We are particularly wary of expanded information sharing under the Memorandum of Agreement (MOA) between your Departments. As we wrote last summer, we continue to have strong concerns that the MOA, which has been used in the past to deport a child’s family and loved ones, will have a chilling effect on reunifications by forcing migrant families to choose between sponsoring children and risking arrest. The effect of that policy undermines the best interests of children in HHS care. This is particularly dangerous given the ongoing coronavirus pandemic, which has already resulted in 68 confirmed cases of COVID-19 among children in ORR care, including 38 children within just one facility in Illinois. HHS previously fingerprinted all adults in a sponsor’s household for a period of about six months in 2018. However, according to HHS Administration for Children and Families (ACF) Assistant Secretary Lynn Johnson, HHS found that the extra screening did not add to the protection or safety of the children.   In addition, the HHS Office of the Inspector General (OIG) found that the MOA resulted in children spending a significantly increased length of time in HHS care, reaching an average length of stay of 93 days in November 2018. The OIG found that the length of stay declined as HHS reduced fingerprinting requirements.  The Administration must not revisit a policy that has been found to be detrimental to the interests of the children in its care. We find it extremely troubling that both the Department of Homeland Security (DHS) and HHS are reportedly considering ignoring Congressional directives and reimplementing policies that are expected to delay the placement of children in HHS care with sponsors.  The law has been clear – the Administration is not to deter potential sponsors from coming forward by using information shared under the MOA for deportation purposes, except in very limited, specified circumstances.  Yet DHS’ Immigration and Customs Enforcement (ICE) violated the law and utilized the information collected from adults deemed ineligible for sponsorship for deportation purposes.  ICE’s continued use of data collected by HHS for the placement of children in safe homes also represents a violation of the law. In addition, Congress directed HHS in the Fiscal Year 2020 Further Consolidated Appropriations Act not to reverse operational directives from 2018 and 2019 that reduced the length of time children spent in HHS care. Congress also directed HHS to “continue to work on efforts to reduce time in care and to consider additional policy changes that can be made to release children to suitable sponsors as safely and expeditiously as possible.”  We urge you to prioritize the safety and wellbeing of children in your care and rescind the MOA. In the midst of the COVID-19 epidemic, this should also include taking all reasonable measures to release children in your care to sponsors as quickly as possible. Thank you in advance for your consideration of these requests. #  #  #

Neuronetics, Inc and Chris Thatcher, the President and CEO, have mutually agreed that he will step down from his positions in the company. He will provide transition services and advice to the company until 1 May 2020.

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Topics include off-label and compassionate drug use for COVID-19 and utilization and cost of naloxone for patients at high risk of opioid overdose.

The post Monthly Round-Up of What to Read on Pharma Law and Policy appeared first on Bill of Health.

The U.S. economy is in a medically-induced coma. Unemployment is soaring. Companies are teetering on the brink of bankruptcy. It is unclear when our lives will return to their pre-pandemic state.

One thing seems apparent: As people lose jobs and health insurance, Medicaid enrollment will jump, perhaps by as much as 20% to 30%. This will have profound implications for the drug channel.

Today, I focus on how this increase will affect retail pharmacies and pharmacy benefit managers (PBMs). Below, I review Medicaid enrollment trends, how states manage prescriptions, and the factors driving the coming boom in Medicaid enrollment.

As I explain, many (but not all) retail pharmacies will benefit from Medicaid growth. PBMs, however, will not fare as well. Read on and see if you agree.

In early May, Drug Channels Institute will host two live video webinars: Industry Update and COVID-19 Impact: Retail & Specialty Pharmacies (May 1) and Industry Update and COVID-19 Impact: PBMs & Payers (May 8). CLICK HERE TO LEARN MORE AND SIGN UP. DCI will donate 20% of all profits from these events to The Center for Disaster Philanthropy’s COVID-19 Response Fund.

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Today’s guest post comes from Scott Dulitz, Chief Strategy Officer at TrialCard. Scott discusses how combining payer intelligence with market-leading technology can enhance patient access.

TrialCard recently acquired Policy Reporter, a healthcare software solutions company that provides payer intelligence to the biopharmaceutical, medical device, and diagnostics industries. To learn more, schedule a demo of Policy Reporter or contact Scott (scott.dulitz@trialcard.com).

You can also register for Trialcard’s upcoming webinar: Leveraging Payer Intelligence in Patient Service Programs.

Read on for Scott’s insights.
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Will home infusion growth be a long-overdue correction for the buy -and-bill channel or a temporary blip that will soon vanish?

For some time, I have been tracking the evolution of the buy-and-bill system for provider-administered drugs. The data have shown that hospital outpatient departments have been displacing physician offices. Amid this shift, home infusion providers have accounted for a minority of commercial medical benefit spending and a tiny share of Medicare Part B spending.

However, the coronavirus pandemic is triggering new growth in home infusion for buy-and-bill products. Below, I highlight the early signs of a marketplace change. I believe that some of these short-term shifts in the buy-and-bill market will persist even after we have recovered from COVID-19. They may even slow the runaway growth of the 340B Drug Pricing Program.

If not, then I suppose we'll just keep living in a world with limited home infusion over and over.

In early May, Drug Channels Institute will host two live video webinars: Industry Update and COVID-19 Impact: Retail & Specialty Pharmacies (May 1) and Industry Update and COVID-19 Impact: PBMs & Payers (May 8). CLICK HERE TO LEARN MORE AND SIGN UP. DCI will donate 20% of all profits from these events to The Center for Disaster Philanthropy’s COVID-19 Response Fund. Watch my video invitation below.

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This week, I’m rerunning some popular posts while I prepare for this Friday’s video webinar: Industry Update and COVID-19 Impact: PBMs & Payers.

Part D reform has faded from the policy debate. This rerun explains why it is still needed. FYI, this is my favorite article from 2020 (so far).

Click here to see the original post and comments from January 2020.

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Our high-list-price/high-rebate system remains a fundamental source of warped incentives and cascading problems within the Medicare Part D program.

For proof, check out the previously unpublished data below on market share for products that treat hepatitis C. Despite manufacturers offering products with lower list prices, Medicare Part D plans have rejected the therapeutically identical but lower-priced versions of these drugs.

List prices significantly affect seniors’ out of-pocket costs, so Part D plans are needlessly costing many of them thousands of dollars. The federal government's Medicare spending is also unnecessarily higher.

Anyone concerned about drug prices should pay close attention to this situation. Part D plans and seniors who don’t need specialty medications are benefiting, while seniors who need treatment with specialty medications are ripped off. Just another day inside the gross-to-net bubble!
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Big drugs companies have long favoured outsourcing clinical trials to poor countries with lax regulations to cut costs and maximise profit

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Last week, in Oxford, the first volunteers in the first European human trial were injected with a potential coronavirus vaccine. At the same time, Pakistan’s National Institute of Health received an offer from the Chinese pharmaceutical firm Sinopharm International Corp to take part in a trial of another potential coronavirus vaccine.

Related: Africa's Covid-19 research must be tailored to its realities – by its own scientists | Monique Wasunna

In India, many poor people were recruited to HIV trials without knowing that they were taking part in experiments

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Researchers studying malaria in Kenya have discovered a microbe that blocks transmission of malaria from mosquitoes which could pave the way to eradicating the disease.

Brian Carranza, 21, pleaded guilty today before U.S. District Court Judge Carol B. Amon in Brooklyn, N.Y., to conspiring to assault African-American residents in Staten Island, N.Y., in retaliation for President Barack Obama winning last year’s presidential election.

Gary Moss and Devan Klausegger of Medford, Ore., pleaded guilty today to conspiring to interfere with civil rights. According to facts stipulated in their plea agreements and set forth in the indictment, on May 26, 2008, Moss poured a flammable liquid on the front lawn of the victims’ residence in the shape of a cross and the letters “KKK”.

Three defendants were sentenced to prison today after pleading guilty in January 2008 to federal charges of running an “advance-fee” scheme that targeted U.S. victims with promises of millions of dollars.

Quest Diagnostics Incorporated and its subsidiary, Nichols Institute Diagnostics (NID), have entered into a global settlement with the United States to resolve criminal and civil claims concerning various types of diagnostic test kits that NID manufactured, marketed and sold to laboratories throughout the country until 2006. The payment of $302 million will resolve these allegations and represents one of the largest recoveries ever in a case involving a medical device.

A Virginia man has been sentenced to 63 months in federal prison for participating in a conspiracy that led to more than 10 million pounds of frozen catfish being imported from Vietnam, but fraudulently labeled and sold in the United States as sole, grouper and other species. This sentence is one of the longest imposed by a federal judge for falsely labeling seafood.

The University of Medicine and Dentistry of New Jersey (UMDNJ) has agreed to pay the United States $2 million to resolve federal civil fraud allegations that its hospital defrauded Medicaid. From 1993 to 2004, UMDNJ’s University Hospital submitted claims to Medicaid for outpatient physician services that were also being billed by doctors working in the hospital’s outpatient centers.

Tyson Foods Inc. was sentenced today in U.S. District Court in Arkansas to pay the maximum fine for willfully violating worker safety regulations that led to a worker’s death in its River Valley Animal Foods (RVAF) plant in Texarkana, Ark. The court ordered Tyson Food to pay the $500,000, the maximum criminal fine as well as serve one year probation.

Gary Moss, 37, was sentenced to serve 41 months in federal prison for conspiring to deprive individuals of their civil rights, and co-conspirator Devan Klausegger, 30, was sentenced to serve 51 months for the same charge.

Michael Bullard and Richard Armstrong were convicted yesterday by a jury in Boise, Idaho, on federal hate crime and conspiracy charges in connection with the racially-motivated assault of an African American man outside of a Wal-Mart store in July 2008.

Madhatta Haipe, a citizen of the Philippines, has been extradited from the Philippines to face trial in the District of Columbia for various crimes relating to the hostage taking of U.S. and Philippine citizens in 1995.

A Louisiana man pleaded guilty today to firing three shots from a shotgun at the home of three Hispanic men and, after they fled, entering the home and setting a fire that burned it to the ground.

A federal district court in Richmond, Va., ruled yesterday that Virginia violated the voting rights of American military personnel and other overseas citizens by failing to mail absentee ballots in sufficient time for them to be counted in the Nov. 4, 2008, general election.

Two Chicago men have been arrested on federal charges for their alleged roles in conspiracies to provide material support and/or to commit terrorist acts against overseas targets.

Michael Bullard, Richard Armstrong and James Whitewater were sentenced today in federal court in Boise, Idaho, for hate crime and conspiracy charges in connection with the racially-motivated assault of an African-American man outside of a Wal-Mart store in July 2008

The United States has reached a settlement resolving a housing discrimination lawsuit in Tennessee concerning discrimination against families with children, the Justice Department announced.

The lawsuit, which was filed in the U.S. District Court for the Northern District of Georgia, alleges that since 2003, defendants have violated the False Claims Act.

Consuelo Carreto Valencia, a member of the Carreto family sex trafficking ring that operated between Mexico and Queens, N.Y., was sentenced to 121 months in prison for benefitting financially from her participation in the organization, which transported young Mexican women to the United States and forced them into prostitution.

A federal grand jury has returned multiple indictments arising out of a fatal racially motivated beating and related police corruption in Shenandoah, Pa.

Victor Kaganov, who emigrated from Russia and set up numerous shell corporations in Oregon on behalf of Russian clients, was arrested today on charges of operating an unlicensed money transmitting business.

Norfolk Southern Railway Company has agreed to pay a $4 million penalty to resolve alleged violations of the Clean Water Act (CWA) and hazardous materials laws for a 2005 chlorine spill in Graniteville, S.C.

A federal jury in Sacramento, Calif., today convicted, Eric Clawson, 28, of San Francisco, of a federal hate crime for assaulting an African-American man in a Chico, Calif. bar.

The United States has sued an Ohio man and his company, seeking to bar them from promoting a scheme that allegedly helps customers claim improper theft loss tax deductions.

A federal judge in Kansas City, Mo., has permanently barred Allen R. Davison from promoting a variety of tax fraud schemes, including some that used sham companies, sham chicken-flock contracts, and sham pension plans.

Lee Bentley Farkas, the former chairman of a private mortgage lending company, Taylor, Bean & Whitaker (TBW), was arrested last night in Ocala, Fla., and charged in a 16-count indictment for his alleged role in a more than $1.9 billion fraud scheme that contributed to the failures of Colonial Bank, one of the 50 largest banks in the United States in 2009, and TBW, one of the largest privately held mortgage lending companies in the United States in 2009.

“Faisal Shahzad plotted and launched an attack that could have led to serious loss of life, and today the American criminal justice system ensured that he will pay the price for his actions,” Attorney General Eric Holder said. 

Robert Jackson, 37, of Downsville, La., pleaded guilty in federal court to placing a hangman’s noose in the carport of the home of a family in order “to send a message” to African-American males who had been frequently visiting the victim’s home.

Three alleged members or associates of the Aryan Brotherhood of Texas (ABT) have been indicted for their alleged roles in a 2008 murder in Atascosa County, Texas.

Today in Sacramento, Calif., U.S. District Court Judge John A. Mendez sentenced a couple from Fairfield, Calif., for their roles in a July 2007 beating of an American citizen who is originally from India.

An indictment unsealed today in Philadelphia charged Omelyan Botsvynyuk, Stepan Botsvynyuk, Mykhaylo Botsvynyuk, Dmytro Botsvynyuk, and Yaroslav Botsvynyuk, a/k/a Yaroslav Churuk, with extortion and conspiracy to violate the Racketeer Influenced and Corrupt Organizations Act (RICO) for their alleged involvement in a human trafficking operation.