Novartis Pays Over $642 Million to Settle Allegations of Improper Payments to Patients and Physicians

Pharmaceutical company Novartis Pharmaceuticals Corporation (Novartis), based in East Hanover, New Jersey, has agreed to pay over $642 million in separate settlements resolving claims that it violated the False Claims Act (FCA). The first settlement pertains to the company’s alleged illegal use of three foundations as conduits to pay the copayments of Medicare patients taking Novartis’s drugs Gilenya and Afinitor. The second settlement resolves claims arising from the company’s alleged payments of kickbacks to doctors.

•Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division. “We will continue to safeguard the Medicare program from kickbacks and their pernicious effects, including the undermining of important cost-control mechanisms instituted by Congress.”

•In the first settlement, Novartis has agreed to pay $51.25 million to resolve allegations that it illegally paid the copay obligations for patients taking its drugs. When a Medicare beneficiary obtains a prescription drug covered by Medicare, the beneficiary may be required to make a partial payment, which may take the form of a copayment, coinsurance, or a deductible (collectively “copays”). Congress included copay requirements in the Medicare program, in part, to serve as a check on health care costs, including the prices that pharmaceutical manufacturers can demand for their drugs.

•Novartis sells Gilenya, which is approved for treatment of relapsing forms of multiple sclerosis (MS). The government alleged that, in October 2012, Novartis learned from the contractor managing Novartis’s free drug program for Gilenya that over 300 patients who were receiving free drugs would be eligible for Medicare in 2013. Novartis and the contractor transitioned those patients to Medicare Part D so that, in the future, Novartis would obtain revenue from Medicare when those patients filled prescriptions for Gilenya. Knowing those patients could not afford the copay for Gilenya, Novartis developed a plan with a foundation so that Novartis could cover the copays for those patients. Specifically, at the same time Novartis made a payment to the foundation, Novartis arranged for the foundation to open its MS fund at 6:00 pm on a Friday and for the contractor to have personnel working overtime to submit applications for those patients who had been receiving free Gilenya. Novartis knew that this coordination would result in a disproportionate share of its funding going to Gilenya patients for 2013.

•Novartis also sells Afinitor, which is a second-line treatment for advanced renal cell carcinoma (RCC) and a treatment for progressive neuroendocrine tumors of pancreatic origin (PNET). The government alleged that Novartis learned that, for the 2010 donation year, it would be the only donor to an RCC copay assistance fund operated by a charitable foundation.

•The government further alleged that, in 2012, Novartis asked another foundation to open a copay assistance fund to pay copays for PNET patients, which Novartis knew would be used only to pay the copays of Afinitor patients.

•“According to the allegations in today’s settlement, Novartis coordinated with three co-pay foundations to funnel money through the foundations to patients taking Novartis’ own drugs,” said U.S. Attorney Andrew E. Lelling for the District of Massachusetts. “As a result, the Novartis’ conduct was not ‘charitable,’ but rather functioned as a kickback scheme that undermined the structure of the Medicare program and illegally subsidized the high costs of Novartis’s drugs at the expense of American taxpayers. At the same time, we recognize that Novartis’ current management has taken constructive steps to address the government’s concerns with the company’s prior relationships with co-pay foundations.”

•In the second matter, Novartis will pay $591,442,008 to resolve FCA claims that it paid kickbacks to doctors to induce them to prescribe the Novartis drugs Lotrel, Valturna, Starlix, Tekturna, Tekturna HCT, Tekamlo, Diovan, Diovan HCT, Exforge, and Exforge HCT. In addition, Novartis will forfeit $38.4 million under the Civil Asset Forfeiture Statute. Novartis also made extensive factual admissions in the settlement and agreed to strict limitations on any future speaker programs, including reductions to the amount it may spend on such programs.

https://www.justice.gov/opa/pr/novartis-pays-over-642-million-settle-allegations-improper-payments-patients-and-physicians

Blowout: The U.S. Economy Added 4.8 Million Jobs in June, Unemployment Fell to 11.1%

The U.S. economy added 4.8 million jobs in June and the unemployment rate fell to 11.1 percent, both better than expected.

The increase in the ranks of employed workers shows that companies ramped up hiring as the economy reopened and consumers came back to stores, restaurants, and other businesses that had been shuttered in March and April.

Job growth was strong in restaurants and bars, reflecting the reopening of those establishments across the country, which added 1.5 million jobs, the Labor Department said Thursday. But employment remains 3.1 million below February’s level, the month before the pandemic hit the U.S. economy.

Retail stores added 740,000. There were big gains in clothing stores, furniture stores, department stores, and auto dealerships. Despite the gains, total employment is around 1.5 million below February’s level.

Manufacturing employment rose by 356,000 but is down by 757,000 since February. June employment increases were concentrated in the durable goods component, with the auto sector adding 196,000 jobs, accounting for over half of the job gain in manufacturing. Construction employment increased by 158,000 in June, following a gain of 453,000 in May.

Despite the increase in the number of employed workers, there are still tens of millions fewer Americans working today than February. Compared with a year ago, there are 12.957 million fewer jobs in the U.S. And a separate report on Thursday showed that over 1.427 million Americans were laid off last week, the fifteenth week in a row of one million-plus new claims for unemployment benefits but the thirteenth week in a row of declining claims.

The previous week’s level of jobless claims was revised up by 2,000 from 1,480,000 to 1,482,000.

Economists had been expecting around 3 million new jobs, although the range of estimates was unusually wide due to the unprecedented nature of the shutdown and reopening. Estimates ranged from 1.9 million jobs to more than 9 million. The unemployment rate was expected to fall to 12.4 percent from 13.3 percent.

A report on private payrolls from ADP and Moody’s Analytics on Wednesday estimated that businesses increased their workforces by 2.37 million in June. The estimate for May, which initially showed a loss of 2.76 million jobs, was revised to show a gain of 3 million.

The government’s nonfarm payroll data, which covers both private and public sector workers, showed the economy gaining 2.5 million jobs in May, far more than expected and indicating an accelerated pace of the recovery.

The labor force participation rate increased by 0.7 percentage points in June to 61.5 percent, but is 1.9 percentage points below its February level. Total employment, as measured by the household survey, rose by 4.9 million to 142.2 million in June. The employment-population ratio, at 54.6 percent, rose by 1.8 percentage points over the month but is 6.5 percentage points lower than in February.

Average hourly wages are up 5 percent compared with a year ago, although they fell 1.3 percent compared with May. Average wages often rise at times of mass layoffs when lower-paid employees are more likely to lose their jobs. The average workweek slipped from 34.7 hours to 34.5 hours.

The Trump administration’s aid programs appear to be working. Direct relief payments to taxpayers and enhanced unemployment have kept incomes up despite the huge rise in unemployment, which in turn has boosted demand for consumer products. The Paycheck Protection Progam, which provides forgivable loans to small businesses that avoid layoffs, also seems to have supported employment and rehiring.

https://www.breitbart.com/economy/2020/07/02/the-u-s-economy-added-4-8-million-jobs-in-june-unemployment-fell-to-11-1/

Blowout: The U.S. Economy Added 4.8 Million Jobs in June, Unemployment Fell to 11.1%

The U.S. economy added 4.8 million jobs in June and the unemployment rate fell to 11.1 percent, both better than expected.

The increase in the ranks of employed workers shows that companies ramped up hiring as the economy reopened and consumers came back to stores, restaurants, and other businesses that had been shuttered in March and April.

Job growth was strong in restaurants and bars, reflecting the reopening of those establishments across the country, which added 1.5 million jobs, the Labor Department said Thursday. But employment remains 3.1 million below February’s level, the month before the pandemic hit the U.S. economy.

Retail stores added 740,000. There were big gains in clothing stores, furniture stores, department stores, and auto dealerships. Despite the gains, total employment is around 1.5 million below February’s level.

Manufacturing employment rose by 356,000 but is down by 757,000 since February. June employment increases were concentrated in the durable goods component, with the auto sector adding 196,000 jobs, accounting for over half of the job gain in manufacturing. Construction employment increased by 158,000 in June, following a gain of 453,000 in May.

Despite the increase in the number of employed workers, there are still tens of millions fewer Americans working today than February. Compared with a year ago, there are 12.957 million fewer jobs in the U.S. And a separate report on Thursday showed that over 1.427 million Americans were laid off last week, the fifteenth week in a row of one million-plus new claims for unemployment benefits but the thirteenth week in a row of declining claims.

The previous week’s level of jobless claims was revised up by 2,000 from 1,480,000 to 1,482,000.

Economists had been expecting around 3 million new jobs, although the range of estimates was unusually wide due to the unprecedented nature of the shutdown and reopening. Estimates ranged from 1.9 million jobs to more than 9 million. The unemployment rate was expected to fall to 12.4 percent from 13.3 percent.

A report on private payrolls from ADP and Moody’s Analytics on Wednesday estimated that businesses increased their workforces by 2.37 million in June. The estimate for May, which initially showed a loss of 2.76 million jobs, was revised to show a gain of 3 million.

The government’s nonfarm payroll data, which covers both private and public sector workers, showed the economy gaining 2.5 million jobs in May, far more than expected and indicating an accelerated pace of the recovery.

The labor force participation rate increased by 0.7 percentage points in June to 61.5 percent, but is 1.9 percentage points below its February level. Total employment, as measured by the household survey, rose by 4.9 million to 142.2 million in June. The employment-population ratio, at 54.6 percent, rose by 1.8 percentage points over the month but is 6.5 percentage points lower than in February.

Average hourly wages are up 5 percent compared with a year ago, although they fell 1.3 percent compared with May. Average wages often rise at times of mass layoffs when lower-paid employees are more likely to lose their jobs. The average workweek slipped from 34.7 hours to 34.5 hours.

The Trump administration’s aid programs appear to be working. Direct relief payments to taxpayers and enhanced unemployment have kept incomes up despite the huge rise in unemployment, which in turn has boosted demand for consumer products. The Paycheck Protection Progam, which provides forgivable loans to small businesses that avoid layoffs, also seems to have supported employment and rehiring.

https://www.breitbart.com/economy/2020/07/02/the-u-s-economy-added-4-8-million-jobs-in-june-unemployment-fell-to-11-1/

Detroit Removes Thousands of Dead Registrants From Voter Rolls

Now they should remove duplicate dems

The city of Detroit has removed thousands of deceased and duplicate registrants from its voter rolls after being hit with a lawsuit.

City officials cleaned up the voter rolls after the Public Interest Legal Foundation, a government watchdog, filed suit against them in December. Nearly 2,500 deceased individuals and 4,800 duplicate registrations were removed from the voter rolls. The officials have also moved to review another 16,465 registrants who lacked actual dates of registration.

"This is another win for election integrity," said J. Christian Adams, the watchdog's president and general counsel. "This case wasn't complicated. The City of Detroit could have started to fix these problems before litigation, but didn't. Other jurisdictions should take note—if you don't act on solid data that your voter rolls are corrupted with dead and duplicate registrations, you will be sued."

Debates over voter fraud have appeared as Democrats across the country push for mail-in voting during the coronavirus pandemic. President Donald Trump claimed that mail-in voting will lead to the "most corrupt Election in USA history." Congressional Democrats, meanwhile, are pressuring Senate Republicans to pass legislation to support such measures. Sen. Roy Blunt (R., Mo.), chair of the Senate Rules Committee, blocked a bill brought forth by Sen. Amy Klobuchar (D., Minn.) on the issue, saying he worried it would lead to a "federal takeover of elections."

The watchdog filed suit against two Detroit officials—City Clerk Janice Winfrey and Director of Elections George Azzouz—after studying Detroit's voter list maintenance efforts dating back to 2017. Outside liberal groups, such as the New York-based Brennan Center for Justice and League of Women Voters of Michigan, swooped into the city to intervene on behalf of the election officials but ultimately did not play much of a role. Adams's group dropped the lawsuit after the officials cleaned up the registrations.

The voter roll cleanup comes just four months before the November elections in a state that Trump carried by just over 10,000 votes in 2016. Michigan could again serve as a battleground state in the 2020 elections.

The voter registration irregularities were not the only time Detroit has faced election-related controversy in recent years. Last year, clerk Sherikia L. Hawkins was charged with several felony counts for altering absentee ballots during the 2018 elections. Past reports also showed voter machine irregularities in the city when 37 percent of its precincts in 2016 registered more votes than the number of voters who were tallied in polling stations.

https://freebeacon.com/policy/detroit-removes-thousands-of-dead-registrants-from-voter-rolls/

Trump Admin Vows to Secure Permanent U.N. Arms Embargo on Iran

Pompeo says arms ban cannot be lifted on Iran as long as it poses global threat

The United States will seek a permanent extension of an arms embargo on Iran that is set to expire later this year, setting up a confrontation at the United Nations with Russia and China, Iranian allies poised to block the Trump administration's efforts.

The October expiration of the United Nations arms embargo on Iran was a key part of the Obama-era nuclear deal that blocked nations from exporting arms to Tehran. The Trump administration has vowed to keep the embargo alive and in recent months expended significant diplomatic capital preparing a U.N. resolution to accomplish that goal. Russia and China promise to veto any such measure and are able to unilaterally do so as permanent members of the U.N. Security Council. Both countries remain close allies of Iran and have already discussed plans to sell Tehran billions of dollars' worth of advanced weaponry once the embargo lifts.

The Trump administration has made extending the arms embargo a centerpiece of its "maximum pressure" campaign on Iran, which includes crippling economic sanctions. The diplomatic push comes as Iran ramps up its contested nuclear work, particularly the enrichment of uranium, the key component in an atomic weapon. For months, Tehran has blatantly violated the nuclear deal by, among other things, preventing international atomic inspectors from accessing key military sites believed to contain undeclared nuclear materials. As the 2020 U.S. presidential election approaches, the arms embargo could be the Trump administration's last chance to prevent Tehran from becoming an international arms dealer.

Amid the showdown between the United States, Russia, and China, European countries on the U.N. Security Council have sought to forge a compromise. Under this proposal, the arms embargo would be extended, but only for a short time, and might be limited in other ways, according to multiple sources familiar with the negotiations.

Secretary of State Mike Pompeo ruled out such a plan on Wednesday in some of his clearest comments on the matter to date. The United States, he said, will not tolerate any plan that only extends the embargo for a limited time.

"Our objective is not to extend the arms embargo for another short period of time," Pompeo said in response to questions from the Washington Free Beacon during a briefing at the State Department.

The embargo is "not a time-limited matter," Pompeo said. "Extending it for six months or a year or two years fundamentally falls into the same trap that the previous administration fell into."

The only other option to extend the arms embargo would involve revoking the nuclear deal itself through a "snapback mechanism" written into the original U.N. resolution that endorsed the deal and lifted the embargo. Iran hawks in Congress have long called for such a move, but Pompeo on Wednesday said snapback "is not our first objective."

As part of the administration's efforts to extend the arms embargo, Brian Hook, the administration's top Iran diplomat, has been meeting with Middle Eastern and European allies. Hook won the support of several key nations, including Israel, the United Arab Emirates, Saudi Arabia, and Bahrain. He also pushed France, Germany, and the United Kingdom—collectively known as the E3—to publicly support U.S. efforts to extend the arms ban.

https://freebeacon.com/national-security/trump-admin-vows-to-secure-permanent-u-n-arms-embargo-on-iran/