Drug companies seek billion-dollar tax deductions from opioid settlement

https://www.washingtonpost.com/business/2021/02/12/opioid-settlement-tax-refund/?arc404=true

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Four companies that agreed to pay a combined $26 billion to settle claims about their roles in the opioid crisis plan to deduct some of those costs from their taxes and recoup around $1 billion apiece.

In recent months, as details of the blockbuster settlement were still being worked out, pharmaceutical giant Johnson & Johnson and the “big three” drug distributors — McKesson, AmerisourceBergen and Cardinal Health —all updated their financial projections to include large tax benefits stemming from the expected deal, a Washington Post analysis of regulatory filings found.

In one example, Dublin, Ohio-based drug distributor Cardinal Health said earlier this month it planned to collect a $974 million cash refund because it claimed its opioid-related legal costs as a “net operating loss carryback” — a tax provision Congress included in last year’s coronavirus bailout package as a way of helping companies struggling during the pandemic.

The deductions may deepen public anger toward companies prosecutors say played key roles in a destructive public health crisis that kills tens of thousands of Americans every year. In lawsuits filed by dozens of states and local jurisdictions, public officials have argued that the companies, among other corporate defendants, flooded the country with billions of highly addictive pills and ignored signs they were being steered to people who abused them.

Under the terms of the proposed settlement — which is being finalized and will ultimately be subject to federal court approval — the four companies would pay between $5 billion and $8 billion each to reimburse communities for the costs of the health crisis. Plaintiffs who support the proposal say it will resolve a highly complex litigation process and make funds available to communities and individuals still struggling with addiction.

Others including Greg McNeil, whose son became addicted to opioids and died from an overdose, have said $26 billion is only a small fraction of the epidemic’s financial toll and argue the proposal doesn’t include what many family members of opioid victims want the most: an admission of guilt.

All four firms disavow any wrongdoing or legal responsibility. The companies have said they produced government-approved prescription pills, distributed them to registered pharmacies and took steps to try to prevent their misuse.

U.S. tax laws generally restrict companies from deducting the cost of legal settlements from their taxes, with one major exception: Damages paid to victims as restitution for the misdeeds can usually be deducted. Still, Congress has placed stricter limits on such deductions in recent years, and some tax experts say the Internal Revenue Service could challenge the companies’ attempts to deduct opioid settlement costs.

Harry Cullen, a Brooklyn-based activist who has worked to hold drug companies accountable for the epidemic, said it is “incredibly insulting” that companies would try deduct the settlement payments. “As if they are donating it to these people who they harmed in the first place.”

Erich Timmerman, a spokesman for Cardinal Health, said in a statement that the company’s tax deductions are permissible under federal law. He also pointed to a statement chief executive Mike Kaufmann made in November, when he said Cardinal takes its role in the pharmaceutical supply chain seriously and remains “committed to being part of the solution to this epidemic.”

AmerisourceBergen declined to comment on its taxes but said in a statement the company takes steps to mitigate the diversion of prescription drugs, including by refusing service to customers it sees as a risk and by making daily reports to federal drug officials.

Johnson & Johnson declined to comment on the opioid settlement and tax deductions beyond its regulatory filings.A spokeswoman for McKesson did not respond to multiple requests for comment.

Cardinal Health’s use of the “carryback” tax break draws attention to what some see as a shortcoming of the $2 trillion U.S. coronavirus bailout known as the Cares Act. In their haste to funnel cash benefits to businesses facing economic peril, lawmakers made billions of dollars in tax breaks broadly available to any company, regardless of whether it suffered during the pandemic.

Cardinal, a company with a $15 billion market capitalization and $4 billion in available cash, surpassed Wall Street expectations for its most recent earnings period. Last week, CEO Kaufmann told investors a rebound in medical treatments and procedures had revived demand for Cardinal’s health devices and drugs. He said the company was boosting its investment in sophisticated supply-chain technology.

On the same day, Cardinal said it was filing for a tax break using the Cares Act provision and expected a nearly $1 billion cash refund from the IRS within the next 12 months. The company plans to pay $6.6 billion in the settlement.

Francine J. Lipman, a tax professor at the University of Nevada at Las Vegas, said Cardinal Health appears to be “getting a bit of a windfall from laws that Congress intended to help companies that are suffering due to a pandemic.”

The “carryback” tax break permits any company that lost money in 2018, 2019 or 2020 to apply those losses to previous, more profitable years. Some form of this provision has been permitted by the U.S. tax code for over a century to help businesses that face ups and downs to even out their taxes.

The Cares Act raised the limit on the amount of losses companies can use to offset taxes and permitted them to apply those losses to earlier periods. Because the corporate tax rate was higher before 2018, companies with recent losses can increase tax refunds they received before that year by up to 67 percent.

Cardinal estimated in August it expected to deduct $488 million from the expected opioid legal settlement. But in its Feb. 5 filing, the company said the amount probably would be higher in part because the Cares Act permitted it to carry back losses related to the opioid litigation to previous years when the tax rate was higher.

UNLV’s Lipman said Cardinal’s decision to apply for a tax refund before any legal settlement has been finalized could face scrutiny from the IRS. Deductions must be made against business expenses that are shown to have “economic effect,” she said, which may preclude deductions against future, unpaid legal settlements.

Timmerman, Cardinal’s spokesman, said the company has already recorded a loss related to the opioid litigation because Cardinal insures itself through a wholly-owned insurance subsidiary. The opioid litigation caused a loss to the insurance company’s reserve, and that is the loss that Cardinal is deducting, he said.

“Tax and accounting rules applicable to insurance companies, including self-insurance companies, require recognition of loss when an insurance reserve is set, thus establishing economic effect, even if the underlying settlement is not final,” Timmerman said.

The three other companies involved in the $26 billion settlement have estimated the tax benefits of the deal but have not filed for tax refunds. They all said the tax benefits could be lower if courts or regulators determined some or all of the payments are not tax-deductible.

McKesson, which expects to pay $8.1 billion in the settlement, said in a Feb. 2 filing that the actual cost of the deal would be $6.7 billion after taxes, implying a $1.4 billion tax benefit. The company also said $497 million in tax benefits were “uncertain” because of the “uncertainty in connection with the deductibility of opioid related litigation and claims.”

AmerisourceBergen, which anticipates a $6.6 billion settlement payment, said in November it expects a $1.1 billion tax benefit. The company said an additional $371.5 million tax benefit was possible but “uncertain.”

“A settlement has not been reached, and, therefore, we applied significant judgment in estimating the ultimate amount of the opioid litigation settlement that would be deductible,” the company said.

Matthew Gardner, a senior fellow at the nonprofit Institute on Taxation and Economic Policy, said these disclaimers suggest the companies are making conservative estimates. “That’s one way of saying they are likely going to claim even bigger tax benefits in their tax returns than they are showing on their financial statements,” he said.

Whether the payments will be deductible may hinge on specific word choices in the final terms of the settlement. Though recent changes to the tax code have attempted to close loopholes that permit companies to deduct taxes when they have committed wrongdoing, many companies now push to make sure their settlements include a “restitution” payment for victims — the “magic word” that often qualifies them for deductions, Gardner said.

In previous opioid-related settlements local governments reached with McKesson, Purdue Pharma and Teva Pharmaceuticals, the companies admitted no fault and agreed to restitution payments that appeared to qualify them for tax deductions, USA Today reported in 2019.

Johnson & Johnson has said it expects it could deduct as much as 21.4 percent of its $5 billion share of the settlement, which would mean a roughly $1.1 billion tax benefit. However, the company said last summer that the deductible amount may be lower if a regulation proposed by the IRS last year came into effect.

The rule, which did take effect Jan. 20, requires companies to meet a long list of specific criteria to qualify government settlements for tax deductions.

Faces on pills are seen at the Provocative Opioid Memorial in 2018 in Washington, D.C. There are 22,000 pills that represent the number of people who died of an opioid overdose in 2015. 

In 2019, The Post analyzed a database maintained by the Drug Enforcement Administration that tracks the path of every pain pill sold in the United States. The database shows that America’s largest drug companies distributed 76 billion oxycodone and hydrocodone pain pills across the country between 2006 and 2012 as the nation’s deadliest drug epidemic spun out of control.

McKesson, Cardinal Health and AmerisourceBergen distributed 44 percent of the nation’s oxycodone and hydrocodone pills — the two most abused prescription opioid drugs — during that time.

An investigation by The Post last year found that near the peak of U.S. opioid production, a Johnson & Johnson subsidiary was manufacturing enough oxycodone and hydrocodone to capture half or more of the U.S. market. The company also lobbied for years to help persuade regulators to loosen a narcotics import rule, allowing Johnson & Johnson’s U.S. subsidiary to produce rising amounts of opioids out of potent poppies harvested by its Tasmanian subsidiary, The Post found.

Attorneys for Johnson & Johnson have said its opioid-producing subsidiaries did not cause the United States’ addiction crisis, that the companies were heavily regulated, and that such companies play only a “peripheral role in the multibillion-dollar market for prescription opioids.”

The pandemic’s coming new normal

Photo illustration of the Freedom from Want image by Norman Rockwell with all the participants of the dinner wearing surgical masks.

As both vaccinations and acquired immunity spread, life will likely settle into a new normal that will resemble pre-COVID-19 days— with some major twists.

The big picture: While hospitalizations and deaths are tamped down, the novel coronavirus should recede as a mortal threat to the world. But a lingering pool of unvaccinated people — and the virus’ own ability to mutate — will ensure SARS-CoV-2 keeps circulating at some level, meaning some precautions will be kept in place for years.

Driving the news: On Tuesday, Johnson & Johnson CEO Alex Gorsky told CNBC that people might well need a new coronavirus vaccine annually in the years ahead, much as they do now for the flu.

  • Gorsky’s comments were one of the clearest signals that even as the number of vaccinated people rises, the mutability of SARS-CoV-2 means the virus will almost certainly be with us in some form for years to come.

Be smartThat sounds like bad news — and indeed, it’s much less ideal than a world in which vaccination or infection conferred close to lifelong immunity and SARS-CoV-2 could be definitively conquered like smallpox.

  • With more contagious variants spreading rapidly, “the next 12 weeks are likely to be the darkest days of the pandemic,” says Michael Osterholm, the director of the University of Minnesota’s Center for Infectious Disease Research and Policy.
  • But the apparent effectiveness of the vaccines in preventing hospitalizations and death from COVID-19 — even in the face of new variants — points the way toward a milder future for the pandemic, albeit one that may be experienced very differently around the world.

Details: From studying what happened after new viruses emerged in the past, scientists predict SARS-CoV-2 will eventually become endemic, most likely in a seasonal pattern similar to the kind of coronaviruses that cause the common cold.

  • That’s nothing to sneeze at — literally, it will make us sneeze — but as immunity levels accumulate throughout the population, our experience of the virus will attenuate, and we’ll be highly unlikely to experience the severe death tolls and overloaded hospitals that marked much of the past year.

Yes, but: The existence of a stubborn pool of Americans who say they won’t get vaccinated — as well as the fact that it may take far longer for children, whom the vaccines have yet to be tested on, to get coverage — will give the virus longer legs than it would otherwise have.

  • “This will be with us forever,” says Osterholm. “That’s not even a debate at this point.”

What’s next: This means we can expect the K-shaped recovery that has marked the pandemic to continue, says Ben Pring, who leads Cognizant’s Center for the Future of Work.

  • With the virus likely to remain a threat, even if a diminished one, “those who are more stuck in the analog world are really going to continue to struggle,” he says.
  • Health security will also become a more ingrained part of daily life and work, which means temperature checks, masks, frequent COVID-19 testing and even vaccine passports for travel are here to stay.

The catch: That’s not all bad — the measures put in place to slow COVID-19 have stomped the flu and other seasonal respiratory viruses, and if we can hold onto some of those benefits in the future, we can save tens of thousands of lives and billions of dollars.

  • If the inequalities seen in the early phase of the vaccine rollout persist, COVID-19 could become a disease of the poor and disadvantaged, argues Mark Sendak, the co-founder and scientific adviser for Greenlight Ready, a COVID-19 resilience system that grew out of Duke Health.
  • Sendak points to the example of HIV, a disease that is entirely controllable with drugs but continues to exert a disproportionate toll on Black Americans, who take pre-exposure prophylactic medicine at much lower rates.

“If we go back to ‘normal,’ then we have failed.”

— Mark Sendak

What to watch: Whether the vaccine rollout can be adapted to reach hard to find and hard to persuade populations.

  • The Biden administration announced yesterday that it will start delivering vaccines directly to community health centers next week in an effort to promote more equity in the vaccine distribution process.
  • As the administration rolls out new COVID-19 plans, it needs to “invest in the community health care personnel” who can ensure that no one is left behind, says Sendak.

The bottom line: While SARS-CoV-2 has proven it can adapt to a changing environment, so can we. But we have to do so in a way that is fairer than our experience of the pandemic has been so far.

Where the pandemic has been deadliest

Image result for Ratio of COVID-19 deaths to population Map: Michelle McGhee and Andrew Witherspoon/Axios

In the seven states hit hardest by the pandemic, more than 1 in every 500 residents have died from the coronavirus.

Why it matters: The staggering death toll speaks to America’s failure to control the virus.

Details: In New Jersey, which has the highest death rate in the nation, 1 out of every 406 residents has died from the virus. In neighboring New York, 1 out of every 437 people has died.

  • In Mississippi, 1 out of every 477 people has died. And in South Dakota, which was slammed in the fall, 1 of every 489 people has died.

States in the middle of the pack have seen a death rate of around 1 in 800 dead.

  • California, which has generally suffered severe regional outbreaks that don’t span the entire state, has a death rate of 1 in 899.
  • Vermont had the lowest death rate, at 1 of every 3,436 residents.

The bottom line: Americans will keep dying as vaccinations ramp up, and more transmissible variants of the coronavirus could cause the outbreak to get worse before it gets better.

  • Experts also say it’s time to start preparing for the next pandemic — which could be deadlier.

What happens after a year without the flu?

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Doctors and scientists have been relieved that the dreaded “twindemic”—the usual winter spike of seasonal influenza superimposed on the COVID pandemic—did not materialize.

In fact, flu cases are at one of the lowest levels ever recorded, with just 155 flu-related hospitalizations this season (compared to over 490K in 2019). A new piece in the Atlantic looks at the long-term ramifications of a year without the flu. 

Public health measures like masking and handwashing have surely lowered flu transmission, but scientists remain uncertain why flu cases have flatlined as COVID-19, which spreads via the same mechanisms, surged.

Children are a much greater vector for influenza, and reduced mingling in schools and childcare likely slowed spread. Perhaps the shutdown in travel slowed the viruses’ ability to hop a ride from continent to continent, and the cancellation of gatherings further dampened transmission.

Nor are scientists sure what to expect next year. Optimists hope that record-low levels of flu could take a strain out of circulation. But others warn that flu could return with a vengeance, as the virus continues to mutate while population immunity declines. 

Researchers developing next year’s vaccines, meanwhile, face a lack of data on what strains and mutations to target—although many hope the mRNA technologies that proved effective for COVID will enable more agile flu vaccine development in the future. 

Regardless, renewed vigilance in flu prevention and vaccination next fall will be essential, as a COVID-fatigued population will be inclined to breathe a sigh of relief as the current pandemic comes under control.

“I got the vaccine…now what can I do?”

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A family member in her 70s called with the great news that she received her first dose of the COVID vaccine this week. She mentioned that she was hoping to plan a vacation in the spring with a friend who had also been vaccinated, but her doctor told her it would still be safest to hold off booking travel for now: “I was surprised she wasn’t more positive about it. It’s the one thing I’ve been looking forward to for months, if I was lucky enough to get the shot.” 

It’s not easy to find concrete expert guidance for what it is safe (or safer?) to do after receiving the COVID vaccine. Of course, patients need to wait a minimum of two weeks after receiving their second shot of the Pfizer or Moderna vaccines to develop full immunity.

But then what? Yes, we all need to continue to wear masks in public, since vaccines haven’t been proven to reduce or eliminate COVID transmission—and new viral variants up the risk of transmission. But should vaccinated individuals feel comfortable flying on a plane? Visiting family? Dining indoors? Finally going to the dentist?
 
It struck us that the tone of much of the available guidance speaks to public health implications, rather than individual decision-making. Take this tweet from CDC director Dr. Rochelle Walensky. A person over 65 asked her if she could drive to visit her grandchildren, whom she hasn’t seen for a year, two months after receiving her second shot. Walensky replied, “Even if you’ve been vaccinated, we still recommend against traveling until we have more data to suggest vaccination limits the spread of COVID-19.” 

From a public health perspective, this may be correct, but for an individual, it falls flat. This senior has followed all the rules—if the vaccine doesn’t enable her to safely see her grandchild, what will? It’s easy to see how the expert guidance could be interpreted as “nothing will change, even after you’ve been vaccinated.”

Debates about masking showed us that in our individualistic society, public health messaging about slowing transmission and protecting others sadly failed to make many mask up.

The same goes for vaccines: most Americans are motivated to get their vaccine so that they personally don’t die, and so they can resume a more normal life, not by the altruistic desire to slow the spread of COVID in the community and achieve “herd immunity”. 

In addition to focusing on continued risk, educating Americans on how the vaccinated can make smart decisions will motivate as many people as possible to get their shots.

Disparities may worsen as vaccine eligibility widens

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Early data on vaccine distribution by race and ethnicity show a mismatch between those population groups receiving the vaccine, and those that have been hardest hit by the pandemic. As the graphic above shows, Black and Hispanic Americans have thus far been vaccinated at considerably lower rates in many states compared to their share of population as a whole—and these disparities are likely to worsen as states shift focus to senior populations for priority access, moving away from prioritizing essential workers, who tend to be more racially diverse.

The White population skews older, which stands to widen disparities in the near-term. Another compounding issue: vaccine hesitancy.

A recent Morning Consult poll found that, despite an overall increase in overall vaccine willingness, Black Americans remain the most hesitant, with only 48 percent willing to get the vaccine.

Meanwhile, Black and Hispanic Americans continue to be disproportionately impacted by COVID, with hospitalization and death rates nearly three to four times greater than those of White Americans.

Hesitancy will become an increasingly urgent problem as larger swathes of the population become eligible for vaccination, especially given that communities of color tend to be younger, as shown above.

Turning the tide in the battle against the virus

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The national COVID indicators all continued to move in the right direction this week, with new cases down 16 percent, hospitalizations down 26 percent, and deaths (while still alarmingly high at more than 3,000 per day) down 6 percent from the week prior.

More good news: both nationally and globallythe number of people vaccinated against COVID now exceeds the total number of people infected with the virus, at least according to official statistics—the actual number of coronavirus infections is likely several times higher.

On the vaccine front, Johnson & Johnson filed with the Food and Drug Administration (FDA) for an Emergency Use Authorization for its single-dose COVID vaccine, which could become the third vaccine approved for use in the US following government review later this month. The J&J vaccine is reportedly 85 percent effective at preventing severe COVID disease, although it is less effective at preventing infection than the Pfizer and Moderna shots.

Elsewhere, TheLancet reported interim Phase III results for Russia’s Sputnik V vaccine trials, showing it to be 91 percent effective at preventing infection, and a new study found the Oxford-AstraZeneca vaccine to be 75 percent effective against the more-contagious UK virus variant.

Amid the positive vaccine news, the Biden administration moved to accelerate the vaccination campaigninvoking the Defense Production Act to boost production and initiating shipments directly to retail pharmacies. With the House and Senate starting the budget reconciliation process that could eventually lead to as much as $1.9T in stimulus funding, including billions more for vaccines and testing, it feels as though the tide may be finally turning in the battle against coronavirus.

While the key indicators are still worrisome—we’re only back to Thanksgiving-week levels of new cases—and emerging variants are cause for concern, it’s worth celebrating a week that brought more good news than bad.

Best to follow Dr. Fauci’s advice for this Super Bowl weekend, however: “Just lay low and cool it.”

How soon can we achieve immunity through vaccinations?

Over the weekend I realized that my son Henry, born in June 2019, has lived more than half of his life in the pandemic era. He’s too young to be cognizant of it, of course, but my wife and I are acutely conscious of the experiences his older brother had already enjoyed by the time he was Henry’s age, things that are impractical or impossible in the moment.

He’s not alone in that, of course. Most Americans are experiencing some ongoing deprivations because of the pandemic. (Most of those for whom the pandemic is not imposing unusual restrictions are, ironically, probably contributing to the pandemic’s extent and duration.) Just about everyone in the United States is eagerly scanning the horizon for signs of normalcy — as we have been for months, occasionally spotting oases that too often turn out to be mirages.

So when will we return to some semblance of normal? It’s hard to say with certainty. The best tool we have to reach that point, though, is the broad deployment of the vaccines approved for emergency use by the government. But even the existence of those vaccines can’t completely answer the question.

For example, the rate at which the vaccines are deployed makes a massive difference. A pace of 2 million shots per day as opposed to 1 million seems like a subtle distinction but, obviously, means achieving immunity for recipients twice as fast.

What level of immunity is necessary is a question of its own. Do we need 70 percent of the country to have been immunized? Or, as infectious-disease expert Anthony S. Fauci has recently said, is the figure closer to 80 or 85 percent?

When doing this calculation, do you include the 26 million Americans who have already had coronavirus infections? What about young people? The vaccine trials included only those age 16 and over. Those younger have constituted about a 10th of the total infections. And what vaccine are we talking about? The Pfizer and Moderna iterations require two shots; the vaccine from Johnson & Johnson requires only one.

All of these factors affect how we can figure out when the country might hit the herd-immunity mark. If we assume that young people will be included among those needed to be vaccinated — a complicated question on its own — the calculator below will allow you to figure out when immunity might be achieved at various immunization rates.

At this rate, the country would reach 70 percent herd immunity through vaccinations by Nov. 10

How we calculate this:
There are about 330 million Americans, meaning that we need 231 million to be resistant to the virus to hit 70 percent immunity. We can take out the 5.8 million Americans who’ve already been vaccinated. That leaves 211.3 million people to be vaccinated.

From there the math is straightforward: doing two-shot vaccinations at a rate of 1.5 million shots per day means it will take 282 days to complete the job.

Bear in mind that sliding the little bar to determine how quickly shots are administered is far easier than actually scaling up the infrastructure to do so. President Biden’s original target for daily vaccinations was 1 million; he recently increased it to 1.5 million. At that rate, we’re still months from resolution. But because administering the vaccine is more complicated and requires more tracking than vaccinations such as that for the seasonal flu, it’s necessarily trickier to scale up.

At this point, the more urgent concern is the efficacy of the vaccine against any variants of the virus that might emerge. Manufacturers have already noted that the vaccine works less well against a virus variant first identified in South Africa, though the vaccines are still broadly effective, particularly at protecting the recipient from severe illness or death after infection.

Well, that and the fact that a fifth of Americans said in a recent Kaiser Family Foundation poll that they won’t get the vaccine or would do so only if it was required. Happily, more Americans are now saying they’re eager to get a vaccine.

The faster we get people immunized, the better we protect against the emergence of new mutations that prove less able to be controlled by the vaccines. The faster we get shots in arms, as the phrasing has it, the faster we get back to normal.

Which would be nice for all of us, including my 1-year-old.

Cartoon – Specimens used for Covid-19 Testing and Experimentation

Letters to editor for Wednesday, Aug. 5, 2020