#but Washington is an outlier in terms of Medicare!

[crippl-hacker]

Can we talk about how expensive it is in the USA to be a complicated patient? I have 11 specialists I need to see - and a $40 copay for each appointment. Just seeing all of them *once* puts me out $440.

Adding up all my appointments for the year (167) puts me at $6680 and that’s not even taking into account how much my insurance costs and the premiums.

I’m on my mom’s healthcare - it costs $1500 a month and has a deductible of $13,000. For non-USA citizens that’s how much you have to pay out of pocket before insurance starts paying for things.

It doesn’t even include dental or vision! Those are separate! It also doesn’t include total coverage for medicine, mobility aids, hearing aids, or any of the other things that I need to manage my disability in my daily life.

At this point in my life I have racked up over $1.5million in medical bills. I am only 23.

We are paying more money for worse healthcare and it’s absolutely bullshit.

Feel free to chime in with your own experience.

[nando161mando]

Summary of the presidential debate, by someone who used to actually watch political debates:

Two geriatric, reactionary demagogues stand behind two podiums and tell lies back and forth as a competitive sport. Neither of the men has the interest of any American at heart, whether foreign or born, whether legal or illegal, etc.. Both of the men represent the interests of elitist parties of propagandists, and the American public overwhelmingly polls in favor of replacing one or even both of them as the potential representative of their party in the oval office. Both men will set up unspoken and crooked goals; they will brutalize everyone outside of our borders to get their goals achieved; they will brutalize anyone within our borders who stands up and acts in the interest of the masses.

You do not live in a democracy.

Don't bother.

I watched Trump violate basically all the common sense foundations of any form of conservatism that wasn't constructed to excuse state violence and exploitation, and so I went left.

And then I watched Biden absolutely shit all over any idea of the Democrats being a progressive party, offering virtually no support to marginalized groups being victimized by their political opponents. I wasn't surprised by that, I warned people about how this term would go and nobody cared, but it's still worth mentioning that this trainwreck just happened in front of all our eyes.

I am 25; We replace our presidents every 4-8 years. I haven't lived to see an American president that shouldn't be publically hanged from the top of the Washington Monument. As far as I'm aware, neither did my parents.

You do not live in a democracy.

Every single thing that they're offering you from behind those podiums is something they *can* give you and won't.

They could have codified Roe when I was still an actual fucking child. Instead I watched it overturned as an adult.

Or they'll tell you that they're going to bail out the little guy, protect small businesses, shit like that. And then the conservatives spend the entire term trying to wage war against a social media app because it's from China, ignoring every actual working class concern along the way.

You do not live in a fucking democracy.

They *can* give it to you. Who is bankrolling them? The bourgeois as a class have enough wealth among handfuls of individuals to overwhelm the wealth of millions of the working poor. They have the money to bail out small businesses and homeowners people who struggle at risk to their life, and instead every time they choose to bail out banks and corpos. They are a statistical anomaly in every kind of economic average who thrive by selling the illusion that people beside themselves can live that well, but they don't, they can't, the elites are outliers.

They have the money for Medicare for all, they have the money to annihilate *everyone's* student debt, they have the money to put the entire fucking homeless population in a settled address.

They're not going to because they need something to offer you next year. You are trying and failing to eat a carrot from a stick.

You do not live in a democracy.

i know lifelong democrats that are sitting on couches around the country rn right

are they watching this shit out of hope or concern for the future?

no, they're high, laughing. a moment of morbid, pessimistic entertainment is all it's really worth.

"Look at these idiots."

[berniesrevolution]

With their huge improvements in special elections across the country, it looks increasingly probable that Democrats will win big in the 2018 midterms, and perhaps take control of both Congress and the presidency in 2020. That raises a logical question: In an ideal world, what should they do?

American society is in dire straits, and things will likely be even worse by the time a Democrat takes office. They will have a brief window to fix multiple screaming policy emergencies, and reform American political institutions to prevent a resurgence of the diseased Republican Party.

Below, I will outline a draft platform that would both accomplish worthy goals and provide political benefits. Since the conventional wisdom on political feasibility and popularity has proved to be highly unreliable of late (see: President Donald J. Trump), I have focused on things that will provide immediate and concrete partisan benefits, while strengthening democratic liberties. The ideas are grouped under three headings: political reform, domestic policy, and foreign policy. Let's get cracking.

Political reform:

Now, Democrats should not cheat like Republicans do. It would be wrong to do a reverse Kris Kobach, and suppress the votes of old white people by making Fox News watchers present 14 different forms of photo ID before they can vote. However, there is nothing wrong with strengthening America's democratic institutions — making it simpler and easier for allAmericans to vote and obtain political representation — in part because it would provide a partisan benefit. To wit:

1. Make Puerto Rico and Washington, D.C., states. 

This step would both address the greatest structural violation of democratic liberties in American society and provide the largest tangible partisan benefit to Democrats. D.C. residents and Puerto Ricans are quite literally oppressed colonial subjects, taxed without representation.

In D.C.'s case that creates frequent dysfunction and annoyance, but in Puerto Rico's case it is a full-blown emergency. It is obvious that the Republican government's ongoing failure to rebuild the island after it was flattened by Hurricane Maria (much less address its ongoing debt crisis) has a great deal to do with the fact that they have no congressional representation. Instead of futilely appealing to Paul Ryan's nonexistent conscience, actual Puerto Rican senators and representatives could vote, grab the ear of national media, trade favors, argue with other national politicians, and credibly threaten to gum up the wheels of Congress if their state was not fixed. (In other words, they would have power.)

2. Abolish the filibuster. 

Many big and controversial bills will need to be passed very quickly. Democrats cannot afford the swing vote in the Senate to be some quisling Blue Dog in the pocket of Wall Street, as Joe "The ObamaCare Hamstringer" Lieberman was in 2009-10. This should be done at the earliest possible moment.

3. Resurrect and strengthen the Voting Rights Act. 

Republican vote suppression and district boundary cheating has become their ace in the political hole, hugely enabled by Supreme Court Chief Justice John Roberts' decision gutting the Voting Rights Act. Roberts' decision struck down the preclearance portion of the VRA — which forbade certain jurisdictions from making any changes to their voting procedure without first getting federal certification that they would not disenfranchise minorities — on the grounds that Jim Crow was a long time ago and so it was an unfair burden. That obstacle removed, Republicans immediately set about disenfranchising as many minorities as possible.

Roberts' "reasoning" was obviously 100 percent partisan pretext. But one solution that fits with his logic is to extend preclearance to the entire country. In keeping with Article Four, Section Four, an inalienable right to vote for all citizens and legal residents should be established, including for ex-cons and current prisoners, and all jurisdictions should be required to submit a plan to the federal government ensuring easy and universal access to the franchise. (This can be made easier by establishing a federal template for all levels of government, which would include universal mail-in voting, if people would rather not bother.) Any changes will have to be pre-cleared. Election Day itself should also be moved to a Friday and made a national holiday.

Incidentally, this will have the salutary effect of sharply improving the voting rights in many blue states like New York, where the corrupt Democratic regime is none too eager to have millions of poor people casting ballots.

Finally, as part of the voting rights package, both national and state-level district boundaries should be taken out of the hands of partisan legislatures, and put under control of nonpartisan committees required to draw maps which produce a legislature whose partisan composition at least approximates the raw vote totals.

All this aligns high moral principle with grubby partisan motives. It would mean probably four more Democratic senators and several representatives, and sharply improve Democratic prospects in several states with preposterously unfair gerrymandering or where a huge proportion of minorities have been permanently disenfranchised. However, that is no reason to get squeamish about it. On the contrary, the likeliest way that D.C. residents and Puerto Ricans are going to get their freedom, and the effectively tyrannical aspects of many American political institutions are going to be expunged, is if it can be successfully clubbed into the heads of the Democratic leadership that it is in their partisan interest to do so.

Domestic policy:

1. Climate change. 

This is one area where politics absolutely must take a back seat to principle. If Democrats believe what they're saying about climate science, and they accumulate some political capital with the above program, this is where it must be spent first. As I've argued before, this is by far the most important problem facing American society, because it is a serious emergency that will require a top-to-bottom overhaul of society. Trump's climate denier presidency almost could not have come at a worse time. The next administration will have to cut emissions as fast as it possibly can, both to slow climate change and to avoid the risk of tripping feedback loops that could push warming into an uncontrollable self-sustaining spiral.

People can and do argue all day about precisely the best way forward on climate, but one simple way of thinking about it is to take what China is doing with decarbonization, energy efficiency, and renewables, and aim to beat them by 50 percent. That both gets in the right ballpark of what needs to happen (China's climate policy is extremely aggressive, though still not good enough), and indicates the international nature of the issue. Such a "competition" — in reality, a mutually-beneficial international coordination — would be both excellent policy and a worthy national project. If we're lucky, it might even inspire China to up their game even more as well.

2. Health-care reform. 

This has been the main policy axis of mobilization for lefties during the Trump presidency, and it's not hard to see why. The ObamaCare policy approach has proved to be a massive headache with multiple pitfalls and unforeseen consequences. Its political bargain — that a more conservative, free-market road to universal coverage would be more politically stable — turned out to be wrong. Though Republicans have not managed to repeal the law outright, it is suffering major damagewith the repeal of the individual mandate and regulatory attacks. Tellingly, the market-oriented part of the law — the individual exchanges — are doing the worst.

Democrats should aim for something like an upgraded Medicare-for-all system, with complete medical coverage and no cost-sharing. It both makes the best policy sense and has steadily increased in popularity. What precisely that should look like is not to be hashed out now — the Sanders and Ellison bills and the "Medicare Extra" plan from the Center for American Progress are reasonable — but the best direction to head is obvious: away from markets, and towards traditional social insurance.

Doing so would both address an ongoing humanitarian crisis and deliver a major win to Democratic base voters who have been advocating for this for generations. Moreover, after the dust settles most people would be immensely relieved by being permanently placed on a high-quality Medicare-type system. Democrats should have the confidence to ignore the lobbyists and simply ram through as good a bill as possible.

3. Family policy. 

The structure of American society is deeply hostile to parents even very far up into the upper class. Paid family and sick leave, a child allowance, universal pre-K, and some kind of universal daycare would go a great deal towards ensuring parents don't have a near-impossible struggle between raising their children and being forced to go back to work. This would further advance the U.S. welfare state and deliver meaningful goods to an important Democratic voting bloc: young people.

And while one can't say for sure what people would think about this, the fact that the United States is literally one of two countries in the world (the other being Papua New Guinea) without paid family leave shows you how much of an outlier we are on this. Like Medicare for all, once they figured out how great it is, people would love a family benefits package.

4. Sharp tax increases on the rich and corporations. 

It's not immediately obvious that this would be a win in terms of public opinion, though polls do consistently find a large majority of people saying the rich pay too little in taxes. But it would help pay for Democratic priorities, and may well end up strengthening growth by diverting money away from shareholders and executives, and towards workers and investment. And in tangible political terms, it would definitely take money out of the pockets of the ultra-wealthy, who spend ungodly sums subsidizing right-wing propaganda and dirty tricks operations.

5. Labor law reform. 

Again public opinion is muddled on this one, since unions barely exist throughout much of the country. But passing a pro-union legal package — by, for example, banning so-called "right-to-work" laws at the national level, passing card check, or, most aggressively, mandating what's called sectoral bargaining to unionize whole swathes of the economy at a stroke — would benefit workers and raise wages.

It would also directly benefit Democrats, as newly-revitalized unions saw their power, money, and influence grow by leaps and bounds. They would surely direct their votes and campaign donations to the party that secured those benefits, as they did in FDR's time.

6. Antitrust and other corporate regulation. 

Concentration is a grave problem in the American economy, where a handful of businesses have rolled up control over everything from computer chips to chicken. Breaking up these business will both provide more options for consumers, push economic activity into places other than a handful of very large cities, and help workers, who face labor market monopsony and hence lower wages. That could assist the genuinely left-behind Americans in rural areas and smaller towns Trump championed in his campaign but utterly failed to help as president.

Wall Street should come under special attention. The biggest banks should be broken up, and heavy new regulations, deliberately designed to keep financial businesses small and less profitable, should be levied. In contrast to Dodd-Frank, these should be simple and difficult to avoid, not complicated and take years to implement. This would benefit not just the actually productive parts of the economy, from which much financial profit is parasitically extracted, but also sharply reduce the risk of another global financial crisis.

Politically, antitrust and financial regulation would knock out one prop of reactionary politics. As we've seen in President Trump's Cabinet, Wall Street has been eager and willing to help along a truly vile president, so long as it get its tax cuts. Cutting finance's share of GDP by half would considerably reduce the amount they could dedicate to electing the next future conservative lunatic.

Meanwhile, vigorous antitrust in the media space, coupled to regulation of platforms like Facebook and YouTube, will also help break the influence of deep-pocketed right-wing propaganda. Restrictions on the number of TV or radio stations any one entity can own will further prevent reactionary businessmen pushing pro-Trump propaganda throughout the nation. It would not completely disable the grifting machine that is eating the Republican Party alive, but it would help quite a bit.

Foreign policy:

1. Defense spending cuts. 

The easiest step to take on foreign policy is to cut the bloat and waste in military spending. Back in 2016, The Washington Post reported that a study commissioned by the Pentagon itself had found $25 billion per year in pure administrative waste at the Defense Department, which it then suppressed due to fear of budget cuts. Even if that's overstated, there is still the psychotically expensive and dubiously necessary B-21 heavy bomber, the even more expensive and already outdated F-35 fighter jet, the $1 trillion-plus earmarked for new nuclear weapons and upgrades of the existing stockpile, and much more burning through government cash for little or no benefit. Every big-ticket defense project needs to be examined with acidic skepticism, to see what might be scaled back or canceled outright.

2. Imperial rollback. 

Further savings can be found by ending the hundreds of pointless overseas operations throughout the world. U.S. troops should be removed from Germany, Japan, Afghanistan, Iraq, and several other countries, Special Forces deployments largely ended, and the enabling of the Saudi war in Yemen should cease immediately. The drunken colonialism of the so-called War on Terror must end.

All this would free up immense resources for Democrats' other policy priorities. Just the $80 billion military spending increase passed in 2017 would more than pay for free tuition at every public college across the country. Returning to a pre-Iraq War spending level (if anything, a modest ask) would free up another roughly $200 billion per year.

And far from harming national security, it would probably help. At a minimum, it would remove U.S. troops from several places where they are inflaming violent anti-American extremism. And forcing the Pentagon to economize might actually get them to focus on genuine needs rather than expensive, useless toys.

(Continue Reading)

An incomplete blueprint for a progressive landslide.

[gordonwilliamsweb]

Pandemic Hampers Reopening of Joint Replacement Gold Mine

Dr. Ira Weintraub, a recently retired orthopedic surgeon who now works at a medical billing consultancy, saw a hip replacement bill for over $400,000 earlier this year.

“The patient stayed in the hospital 17 days, which is only 17 times normal. The bill got paid,” mused Weintraub, chief medical officer of Portland, Oregon-based WellRithms, which helps self-funded employers and workers’ compensation insurers make sense of large, complex medical bills and ensure they pay the fair amount.

Charges like that go a long way toward explaining why hospitals are eager to restore joint replacements to pre-COVID levels as quickly as possible — an eagerness tempered only by safety concerns amid a resurgence of the coronavirus in some regions of the country. Revenue losses at hospitals and outpatient surgery centers may have exceeded $5 billion from canceled knee and hip replacements alone during a roughly two-month hiatus on elective procedures earlier this year.

The cost of joint replacement surgery varies widely — though, on average, it is in the tens, not hundreds, of thousands of dollars. Still, given the high and rapidly growing volume, it’s easy to see why joint replacement operations have become a vital chunk of revenue at most U.S. hospitals.

The rate of knee and hip replacements more than doubled from 2000 to 2015, according to inpatient discharge data from the Agency for Healthcare Research and Quality. And that growth is likely to continue: Knee replacements are expected to triple between now and 2040, with hip replacements not far behind, according to projections published last year in the Journal of Rheumatology.

Joint procedures are usually not emergencies, and they were among the first to be scrubbed or delayed when hospitals froze elective surgeries in March — and again in July in some areas plagued by renewed COVID outbreaks. Loss of the revenue has hit hospitals hard, and regaining it will be crucial to their financial convalescence.

“Without orthopedic volumes returning to something near their pre-pandemic levels, it will make it difficult for health systems to get back to anywhere near break-even from a bottom-line perspective,” said Stephen Thome, a principal in health care consulting at Grant Thornton, an advisory, audit and tax firm.

It’s impossible to know exactly how much knee and hip replacements are worth to hospitals, because no definitive data on total volume or price exists.

But using published estimates of volume, extrapolating average commercial payments from published Medicare rates based on a study, and making an educated guess of patient coinsurance, Thome helped KHN arrive at an annual market value for American hospitals and surgery centers of between $15.5 billion and $21.5 billion for knee replacements alone.

That suggests a revenue loss of $1.3 billion to $1.8 billion per month for the period the surgeries were shut down. These figures include ambulatory surgery centers not owned by hospitals, which also suspended most operations in late March, all of April and into May.

If you add hip replacements, which account for about half the volume of knees and are paid at similar rates, the total annual value rises to a range of $23 billion to $32 billion, with monthly revenue losses from $1.9 billion to $2.7 billion.

The American Hospital Association projects total revenue lost at U.S. hospitals will reach $323 billion by year’s end, not counting additional losses from surgeries canceled during the current coronavirus spike. That amount is partially offset by $69 billion in federal relief dollars hospitals have received so far, according to the association. The California Hospital Association puts the net revenue loss for hospitals in that state at about $10.5 billion, said spokesperson Jan Emerson-Shea.

Hospitals resumed joint replacement surgeries in early to mid-May, with the timing and ramp-up speed varying by region and hospital. Some hospitals restored volume quickly; others took a more cautious route and continue to lose revenue. Still others have had to shut down again.

At the NYU Langone Orthopedic Hospital in New York City, “people are starting to come in and you see the operating rooms full again,” said Dr. Claudette Lajam, chief orthopedic safety officer.

At St. Jude Medical Center in Fullerton, California, where the coronavirus is raging, inpatient joint replacements resumed in the second or third week of May — cautiously at first, but volume is “very close to pre-pandemic levels at this point,” said Dr. Kevin Khajavi, chairman of the hospital’s orthopedic surgery department. However, “we are constantly monitoring the situation to determine if we have to scale back once again,” he said.

In large swaths of Texas, elective surgeries were once again suspended in July because of the COVID-19 resurgence. The same is true at many hospitals in Florida, Alabama, South Carolina and Nevada.

The Mayo Clinic in Phoenix suspended nonemergency joint replacement surgeries in early July. It resumed outpatient replacement procedures the week of July 27, but still has not resumed nonemergency inpatient procedures, said Dr. Mark Spangehl, an orthopedic surgeon there. In terms of medical urgency, joint replacements are “at the bottom of the totem pole,” Spangehl said.

In terms of cash flow, however, joint replacements are decidedly not at the bottom of the totem pole. They have become a cash cow as the number of patients undergoing them has skyrocketed in recent decades.

The volume is being driven by an aging population, an epidemic of obesity and a significant rise in the number of younger people replacing joints worn out by years of sports and exercise.

It’s also being driven by the cash. Once only done in hospitals, the operations are now increasingly performed at ambulatory surgery centers — especially on younger, healthier patients who don’t require hospitalization.

The surgery centers are often physician-owned, but private equity groups such as Bain Capital and KKR & Co. have taken an interest in them, drawn by their high growth potential, robust financial returns and ability to offer competitive prices.

“[G]enerally the savings should be very good — but I do see a lot of outlier surgery centers where they are charging exorbitant amounts of money — $100,000 wouldn’t be too much,” said WellRithm’s Weintraub, who co-owned such a surgery center in Portland.

After canceling his hip replacement surgery in March because of COVID-19, Matthew Davis overcame his concerns and rescheduled in June because the procedure was performed at an outpatient surgery center, which meant no overnight hospital stay. (Matthew Davis)

Fear of catching the coronavirus in a hospital is reinforcing the outpatient trend. Matthew Davis, a 58-year-old resident of Washington, D.C., was scheduled for a hip replacement on March 30 but got cold feet because of COVID-19, and canceled just before all elective surgeries were halted. When it came time to reschedule in June, he overcame his reservations in large part because the surgeon planned to perform the procedure at a free-standing surgery center.

“That was key to me — avoiding an overnight hospital stay to minimize my exposure,” Davis said. “These joint replacements are almost industrial-scale. They are cranking out joint replacements 9 to 5. I went in at 6:30 a.m. and I was walking out the door at 11:30.”

Acutely aware of the financial benefits, hospitals and surgery clinics have been marketing joint replacements for years, competing for coveted rankings and running ads that show healthy aging people, all smiles, engaged in vigorous activity.

However, a 2014 study concluded that one-third of knee replacements were not warranted, mainly because the symptoms of the patients were not severe enough to justify the procedures.

“The whole marketing of health care is so manipulative to the consuming public,” said Lisa McGiffert, a longtime consumer advocate and co-founder of the Patient Safety Action Network. “People might be encouraged to get a knee replacement, when in reality something less invasive could have improved their condition.”

McGiffert recounted a conversation with an orthopedic surgeon in Washington state who told her about a patient who requested a knee replacement, even though he had not tried any lower-impact treatments to fix the problem. “I asked the surgeon, ‘You didn’t do it, did you?’ And he said, ‘Of course I did. He would just have gone to somebody else.’”

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

USE OUR CONTENT

This story can be republished for free (details).

Pandemic Hampers Reopening of Joint Replacement Gold Mine published first on https://nootropicspowdersupplier.tumblr.com/

[dinafbrownil]

Pandemic Hampers Reopening of Joint Replacement Gold Mine

Dr. Ira Weintraub, a recently retired orthopedic surgeon who now works at a medical billing consultancy, saw a hip replacement bill for over $400,000 earlier this year.

“The patient stayed in the hospital 17 days, which is only 17 times normal. The bill got paid,” mused Weintraub, chief medical officer of Portland, Oregon-based WellRithms, which helps self-funded employers and workers’ compensation insurers make sense of large, complex medical bills and ensure they pay the fair amount.

Charges like that go a long way toward explaining why hospitals are eager to restore joint replacements to pre-COVID levels as quickly as possible — an eagerness tempered only by safety concerns amid a resurgence of the coronavirus in some regions of the country. Revenue losses at hospitals and outpatient surgery centers may have exceeded $5 billion from canceled knee and hip replacements alone during a roughly two-month hiatus on elective procedures earlier this year.

The cost of joint replacement surgery varies widely — though, on average, it is in the tens, not hundreds, of thousands of dollars. Still, given the high and rapidly growing volume, it’s easy to see why joint replacement operations have become a vital chunk of revenue at most U.S. hospitals.

The rate of knee and hip replacements more than doubled from 2000 to 2015, according to inpatient discharge data from the Agency for Healthcare Research and Quality. And that growth is likely to continue: Knee replacements are expected to triple between now and 2040, with hip replacements not far behind, according to projections published last year in the Journal of Rheumatology.

Joint procedures are usually not emergencies, and they were among the first to be scrubbed or delayed when hospitals froze elective surgeries in March — and again in July in some areas plagued by renewed COVID outbreaks. Loss of the revenue has hit hospitals hard, and regaining it will be crucial to their financial convalescence.

“Without orthopedic volumes returning to something near their pre-pandemic levels, it will make it difficult for health systems to get back to anywhere near break-even from a bottom-line perspective,” said Stephen Thome, a principal in health care consulting at Grant Thornton, an advisory, audit and tax firm.

It’s impossible to know exactly how much knee and hip replacements are worth to hospitals, because no definitive data on total volume or price exists.

But using published estimates of volume, extrapolating average commercial payments from published Medicare rates based on a study, and making an educated guess of patient coinsurance, Thome helped KHN arrive at an annual market value for American hospitals and surgery centers of between $15.5 billion and $21.5 billion for knee replacements alone.

That suggests a revenue loss of $1.3 billion to $1.8 billion per month for the period the surgeries were shut down. These figures include ambulatory surgery centers not owned by hospitals, which also suspended most operations in late March, all of April and into May.

If you add hip replacements, which account for about half the volume of knees and are paid at similar rates, the total annual value rises to a range of $23 billion to $32 billion, with monthly revenue losses from $1.9 billion to $2.7 billion.

The American Hospital Association projects total revenue lost at U.S. hospitals will reach $323 billion by year’s end, not counting additional losses from surgeries canceled during the current coronavirus spike. That amount is partially offset by $69 billion in federal relief dollars hospitals have received so far, according to the association. The California Hospital Association puts the net revenue loss for hospitals in that state at about $10.5 billion, said spokesperson Jan Emerson-Shea.

Hospitals resumed joint replacement surgeries in early to mid-May, with the timing and ramp-up speed varying by region and hospital. Some hospitals restored volume quickly; others took a more cautious route and continue to lose revenue. Still others have had to shut down again.

At the NYU Langone Orthopedic Hospital in New York City, “people are starting to come in and you see the operating rooms full again,” said Dr. Claudette Lajam, chief orthopedic safety officer.

At St. Jude Medical Center in Fullerton, California, where the coronavirus is raging, inpatient joint replacements resumed in the second or third week of May — cautiously at first, but volume is “very close to pre-pandemic levels at this point,” said Dr. Kevin Khajavi, chairman of the hospital’s orthopedic surgery department. However, “we are constantly monitoring the situation to determine if we have to scale back once again,” he said.

In large swaths of Texas, elective surgeries were once again suspended in July because of the COVID-19 resurgence. The same is true at many hospitals in Florida, Alabama, South Carolina and Nevada.

The Mayo Clinic in Phoenix suspended nonemergency joint replacement surgeries in early July. It resumed outpatient replacement procedures the week of July 27, but still has not resumed nonemergency inpatient procedures, said Dr. Mark Spangehl, an orthopedic surgeon there. In terms of medical urgency, joint replacements are “at the bottom of the totem pole,” Spangehl said.

In terms of cash flow, however, joint replacements are decidedly not at the bottom of the totem pole. They have become a cash cow as the number of patients undergoing them has skyrocketed in recent decades.

The volume is being driven by an aging population, an epidemic of obesity and a significant rise in the number of younger people replacing joints worn out by years of sports and exercise.

It’s also being driven by the cash. Once only done in hospitals, the operations are now increasingly performed at ambulatory surgery centers — especially on younger, healthier patients who don’t require hospitalization.

The surgery centers are often physician-owned, but private equity groups such as Bain Capital and KKR & Co. have taken an interest in them, drawn by their high growth potential, robust financial returns and ability to offer competitive prices.

“[G]enerally the savings should be very good — but I do see a lot of outlier surgery centers where they are charging exorbitant amounts of money — $100,000 wouldn’t be too much,” said WellRithm’s Weintraub, who co-owned such a surgery center in Portland.

After canceling his hip replacement surgery in March because of COVID-19, Matthew Davis overcame his concerns and rescheduled in June because the procedure was performed at an outpatient surgery center, which meant no overnight hospital stay. (Matthew Davis)

Fear of catching the coronavirus in a hospital is reinforcing the outpatient trend. Matthew Davis, a 58-year-old resident of Washington, D.C., was scheduled for a hip replacement on March 30 but got cold feet because of COVID-19, and canceled just before all elective surgeries were halted. When it came time to reschedule in June, he overcame his reservations in large part because the surgeon planned to perform the procedure at a free-standing surgery center.

“That was key to me — avoiding an overnight hospital stay to minimize my exposure,” Davis said. “These joint replacements are almost industrial-scale. They are cranking out joint replacements 9 to 5. I went in at 6:30 a.m. and I was walking out the door at 11:30.”

Acutely aware of the financial benefits, hospitals and surgery clinics have been marketing joint replacements for years, competing for coveted rankings and running ads that show healthy aging people, all smiles, engaged in vigorous activity.

However, a 2014 study concluded that one-third of knee replacements were not warranted, mainly because the symptoms of the patients were not severe enough to justify the procedures.

“The whole marketing of health care is so manipulative to the consuming public,” said Lisa McGiffert, a longtime consumer advocate and co-founder of the Patient Safety Action Network. “People might be encouraged to get a knee replacement, when in reality something less invasive could have improved their condition.”

McGiffert recounted a conversation with an orthopedic surgeon in Washington state who told her about a patient who requested a knee replacement, even though he had not tried any lower-impact treatments to fix the problem. “I asked the surgeon, ‘You didn’t do it, did you?’ And he said, ‘Of course I did. He would just have gone to somebody else.’”

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

USE OUR CONTENT

This story can be republished for free (details).

from Updates By Dina https://khn.org/news/pandemic-hampers-reopening-of-joint-replacement-gold-mine/

[stephenmccull]

Pandemic Hampers Reopening of Joint Replacement Gold Mine

Dr. Ira Weintraub, a recently retired orthopedic surgeon who now works at a medical billing consultancy, saw a hip replacement bill for over $400,000 earlier this year.

“The patient stayed in the hospital 17 days, which is only 17 times normal. The bill got paid,” mused Weintraub, chief medical officer of Portland, Oregon-based WellRithms, which helps self-funded employers and workers’ compensation insurers make sense of large, complex medical bills and ensure they pay the fair amount.

Charges like that go a long way toward explaining why hospitals are eager to restore joint replacements to pre-COVID levels as quickly as possible — an eagerness tempered only by safety concerns amid a resurgence of the coronavirus in some regions of the country. Revenue losses at hospitals and outpatient surgery centers may have exceeded $5 billion from canceled knee and hip replacements alone during a roughly two-month hiatus on elective procedures earlier this year.

The cost of joint replacement surgery varies widely — though, on average, it is in the tens, not hundreds, of thousands of dollars. Still, given the high and rapidly growing volume, it’s easy to see why joint replacement operations have become a vital chunk of revenue at most U.S. hospitals.

The rate of knee and hip replacements more than doubled from 2000 to 2015, according to inpatient discharge data from the Agency for Healthcare Research and Quality. And that growth is likely to continue: Knee replacements are expected to triple between now and 2040, with hip replacements not far behind, according to projections published last year in the Journal of Rheumatology.

Joint procedures are usually not emergencies, and they were among the first to be scrubbed or delayed when hospitals froze elective surgeries in March — and again in July in some areas plagued by renewed COVID outbreaks. Loss of the revenue has hit hospitals hard, and regaining it will be crucial to their financial convalescence.

“Without orthopedic volumes returning to something near their pre-pandemic levels, it will make it difficult for health systems to get back to anywhere near break-even from a bottom-line perspective,” said Stephen Thome, a principal in health care consulting at Grant Thornton, an advisory, audit and tax firm.

It’s impossible to know exactly how much knee and hip replacements are worth to hospitals, because no definitive data on total volume or price exists.

But using published estimates of volume, extrapolating average commercial payments from published Medicare rates based on a study, and making an educated guess of patient coinsurance, Thome helped KHN arrive at an annual market value for American hospitals and surgery centers of between $15.5 billion and $21.5 billion for knee replacements alone.

That suggests a revenue loss of $1.3 billion to $1.8 billion per month for the period the surgeries were shut down. These figures include ambulatory surgery centers not owned by hospitals, which also suspended most operations in late March, all of April and into May.

If you add hip replacements, which account for about half the volume of knees and are paid at similar rates, the total annual value rises to a range of $23 billion to $32 billion, with monthly revenue losses from $1.9 billion to $2.7 billion.

The American Hospital Association projects total revenue lost at U.S. hospitals will reach $323 billion by year’s end, not counting additional losses from surgeries canceled during the current coronavirus spike. That amount is partially offset by $69 billion in federal relief dollars hospitals have received so far, according to the association. The California Hospital Association puts the net revenue loss for hospitals in that state at about $10.5 billion, said spokesperson Jan Emerson-Shea.

Hospitals resumed joint replacement surgeries in early to mid-May, with the timing and ramp-up speed varying by region and hospital. Some hospitals restored volume quickly; others took a more cautious route and continue to lose revenue. Still others have had to shut down again.

At the NYU Langone Orthopedic Hospital in New York City, “people are starting to come in and you see the operating rooms full again,” said Dr. Claudette Lajam, chief orthopedic safety officer.

At St. Jude Medical Center in Fullerton, California, where the coronavirus is raging, inpatient joint replacements resumed in the second or third week of May — cautiously at first, but volume is “very close to pre-pandemic levels at this point,” said Dr. Kevin Khajavi, chairman of the hospital’s orthopedic surgery department. However, “we are constantly monitoring the situation to determine if we have to scale back once again,” he said.

In large swaths of Texas, elective surgeries were once again suspended in July because of the COVID-19 resurgence. The same is true at many hospitals in Florida, Alabama, South Carolina and Nevada.

The Mayo Clinic in Phoenix suspended nonemergency joint replacement surgeries in early July. It resumed outpatient replacement procedures the week of July 27, but still has not resumed nonemergency inpatient procedures, said Dr. Mark Spangehl, an orthopedic surgeon there. In terms of medical urgency, joint replacements are “at the bottom of the totem pole,” Spangehl said.

In terms of cash flow, however, joint replacements are decidedly not at the bottom of the totem pole. They have become a cash cow as the number of patients undergoing them has skyrocketed in recent decades.

The volume is being driven by an aging population, an epidemic of obesity and a significant rise in the number of younger people replacing joints worn out by years of sports and exercise.

It’s also being driven by the cash. Once only done in hospitals, the operations are now increasingly performed at ambulatory surgery centers — especially on younger, healthier patients who don’t require hospitalization.

The surgery centers are often physician-owned, but private equity groups such as Bain Capital and KKR & Co. have taken an interest in them, drawn by their high growth potential, robust financial returns and ability to offer competitive prices.

“[G]enerally the savings should be very good — but I do see a lot of outlier surgery centers where they are charging exorbitant amounts of money — $100,000 wouldn’t be too much,” said WellRithm’s Weintraub, who co-owned such a surgery center in Portland.

After canceling his hip replacement surgery in March because of COVID-19, Matthew Davis overcame his concerns and rescheduled in June because the procedure was performed at an outpatient surgery center, which meant no overnight hospital stay. (Matthew Davis)

Fear of catching the coronavirus in a hospital is reinforcing the outpatient trend. Matthew Davis, a 58-year-old resident of Washington, D.C., was scheduled for a hip replacement on March 30 but got cold feet because of COVID-19, and canceled just before all elective surgeries were halted. When it came time to reschedule in June, he overcame his reservations in large part because the surgeon planned to perform the procedure at a free-standing surgery center.

“That was key to me — avoiding an overnight hospital stay to minimize my exposure,” Davis said. “These joint replacements are almost industrial-scale. They are cranking out joint replacements 9 to 5. I went in at 6:30 a.m. and I was walking out the door at 11:30.”

Acutely aware of the financial benefits, hospitals and surgery clinics have been marketing joint replacements for years, competing for coveted rankings and running ads that show healthy aging people, all smiles, engaged in vigorous activity.

However, a 2014 study concluded that one-third of knee replacements were not warranted, mainly because the symptoms of the patients were not severe enough to justify the procedures.

“The whole marketing of health care is so manipulative to the consuming public,” said Lisa McGiffert, a longtime consumer advocate and co-founder of the Patient Safety Action Network. “People might be encouraged to get a knee replacement, when in reality something less invasive could have improved their condition.”

McGiffert recounted a conversation with an orthopedic surgeon in Washington state who told her about a patient who requested a knee replacement, even though he had not tried any lower-impact treatments to fix the problem. “I asked the surgeon, ‘You didn’t do it, did you?’ And he said, ‘Of course I did. He would just have gone to somebody else.’”

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Pandemic Hampers Reopening of Joint Replacement Gold Mine published first on https://smartdrinkingweb.weebly.com/

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How the baby boomers broke America

New Post has been published on https://thebiafrastar.com/how-the-baby-boomers-broke-america/

How the baby boomers broke America

The offering includes outliers like Pete Buttigieg, the millennial South Bend, Ind. mayor running openly on generational change. But the most likely outcome as it stands now is that the nation will yet again ask a baby boomer to fix what the baby boom broke. And it’s a lot to fix.

“We have Social Security. We have the national debt. We have what’s called ‘deferred maintenance’ in infrastructure. And of course we have the climate,” Bruce Gibney, author of “A Generation of Sociopaths,” said in the first episode of “Baby Bust,” the new POLITICO Money podcast series on the political and financial legacy of the baby boom generation. “I think the main impediment right now is the death grip the boomers have had over the political system.”

What went wrong

That death grip could hold at least another four and perhaps eight years in the White House.

Gibney and other critics of the baby boom generation argue that the huge cohort that came of age in the prosperous years after World War II spent much of their time in power cutting their own taxes, ensuring that giant entitlement programs are protected — at least for themselves — and doing little to protect the environment or invest in American infrastructure or address the mounting student loan crisis.

It wasn’t entirely their fault, students of the generation say. Boomers just grew up at a time when everything was fairly awesome and people assumed they would stay that way.

The baby boomers “grew up in an era when there was something close to full employment almost all the time. Wages were going up with productivity, and productivity was going up very fast. Incomes were growing at the rate of 2 percent a year, something that we haven’t seen since,” said Ruy Teixeira, a senior fellow at the Center for American Progress and himself a boomer. “The baby boom happened to get older at the same time that America adopted an economic model that was actually pretty counter-productive, which did not actually produce rising wages and incomes for people at a very good clip, that enhanced inequality.”

A bipartisan generational critique

The first boomer president, Bill Clinton, did raise taxes in the early 1990s and briefly created government surpluses after all the charts and warnings and televised lectures from Ross Perot. But he also suffered an ugly impeachment over personal misbehavior and efforts to cover it up.

And progressives blame him for expanding the penal state, cutting capital gains taxes for the rich and engaging in petty personal feuds with then-House Speaker Newt Gingrich — another boomer — leading to government shutdowns and the dawn of the kind of scorched earth, Forever War politics that now dominate Washington.

President George W. Bush, far from addressing government funding problems, engaged in a short-lived movement to privatize Social Security and added an expensive prescription drug program to Medicare whose main beneficiary was older Americans. His presidency was then largely consumed by the massive and costly post-9/11 war on terror, leaving concerns about climate, entitlements and infrastructure spending aside.

Barack Obama — technically a late-era boomer but more Gen X by personal temperament — attempted to strike a “grand bargain” with tea party-led Republicans and then-House Speaker John Boehner to address long-term entitlement sustainability and spending issues along with significant tax hikes.

But it all fell apart when progressives balked at entitlement overhauls and Republicans at tax hikes. The brief bipartisan moment when it seemed like some real change might happen vanished as quickly as it appeared.

The rise of Trump

Following Obama — whom many Gen Xers claim as one of their own — boomers helped elect another boomer, Donald Trump, partly on his promises to restore manufacturing greatness while also not touching any entitlements for those at or nearing retirement.

Trump essentially junked the entire approach of the tea party movement in favor of far greater spending on the military — along with Democratic priorities to secure the Pentagon money — and signed a $2 trillion tax cut that slashed rates for corporations and rich people with a little thrown in for everyone else. Under Trump’s watch, the annual deficit has grown close to $1 trillion and the national debt to over $22 trillion.

The GOP has essentially returned to the ethos of former vice president Dick Cheney — that deficits don’t matter — after they spent the Obama presidency threatening shutdowns and debt defaults over out-of-control spending. Critics of Trump’s fiscal approach argue the tax cut was the last gasp of the baby boom attempting to direct money to itself.

“The tax cut that was passed [in 2017] is the best example,” said author and attorney Steven Brill, also a baby boomer. “Most of the money the corporations have saved through that tax cut have gone to buybacks of stocks, which make the shareholders richer.”

Trump also pledged to pull the U.S. out of the Paris climate agreement aimed at sharply reducing emissions and rolled back many environmental regulations of the Obama White House.

Through all of this, presidents and Congresses of both parties, largely governed by baby boomers, did little to address what engineers suggest are nearly $5 trillion in infrastructure updates needed in the U.S. as rising powers like China pour massive resources into such projects. Calling every week “infrastructure week” has become a running joke in political circles.

Baby boomers in power, according to their critics, have done a fairly good job of ensuring that Social Security and Medicare will be protected for those at or near retirement — including tens of millions of boomers — but much less to ensure they will be fully funded for later retirees including Gen X, millennials and Gen Z.

Social Security and Medicare might not be going broke. But the outlook isn’t great.

“As long as people are working there will be at least money coming into Social Security,” said Nancy Altman, chair of the board of directors of the Pension Rights Center. “Even if Congress did nothing whatsoever, people would get three-quarters of their scheduled benefits, which is not good enough, but it isn’t nothing.”

Boomers defended

Many baby boomers defend the generation’s contributions, citing advances in gender equality, the protest movement against the Vietnam war and the civil rights movement (even though most landmark civil and voting rights laws were passed when the median boomer was around 12 years old).

Some also argue that it’s not fair to look at political failures through a purely generational lens, arguing that plenty of boomers (including Warren and Sanders) have long argued for more forward-thinking, less self-interested policies but failed to win enough power to enact them. And they say there is still a legacy the baby boom can leave to Gen X, millennials and Gen Z as those generations finally take over political power.

“Typical Xer, you’re saying, ‘Yeah, they gave us diet foods and yoga,’” said Neil Howe, managing director of demography at Hedgeye and a leading theorist on generational cycles. “I think boomers gave younger generations a language of communitarianism and whole-ism that they are going to use when it comes time to bind this country back together again.”

The boomer Democrats

The current crop of Democratic candidates is dominated by boomers and near-boomers including Biden, Warren and Sanders who are one, two and three in nearly every national and state poll. Biden has largely based his campaign around taking another shot at the Obama approach that sought to address major structural problems like climate change, entitlements and debt through coalition-building, both domestically and in international accords like the Paris treaty and the Trans-Pacific Partnership, a giant trade deal meant in part to counter China’s rise as a global economic and military power.

Obama’s biggest legacy, the Affordable Care Act, was more of an incremental approach to driving down costs and making care more accessible. Biden has defended the law but is struggling to beat back challenges from the left that what is needed is not incrementalism but radical change including wealth taxes, “Medicare for All,” student loan forgiveness and free college. Entire industries, including big tech and Wall Street, need to be busted up and reformed, according to the Warren and Sanders view of the world.

For progressives and economists who believe deficits and debt really don’t matter at all, this is a welcome change in political direction. And Warren and Sanders both have widespread support from many younger voters.

But Warren has now found herself in something of a political quagmire as she promises to explain how she would pay for government-funded health care for all with estimates of the cost at around $3 trillion a year without boosting taxes on the middle class.

The millennial Democrat

Into all this comes Buttigieg, running as a millennial alternative to all the older candidates as well as more of a centrist who wants to take on structural problems left by the boomers but not in ways that send deficits and debt into the stratosphere.

“You have a different sense of urgency around these issues if you’re expecting in your lifetime to be dealing with them personally,” Buttigieg said on the podcast. “So by 2054, when I get to the current age of the current president, the shape of the world then, both environmentally, economically and beyond, that’s not a theoretical question; it’s a personal one that I have to prepare for just as a human being.”

Buttigieg added that, “There’s just no way we can get very far into the next few decades on this tax policy without a fiscal time bomb going off.”

And as for the baby boom legacy? “I think a lot of wrong decisions get made out of just a kind of political or moral laziness that says that certain consequences, because they’re going to hit down the road, aren’t consequences for the politicians who are dealing with them, especially politicians who work one election cycle at a time,” Buttigieg said.

What about Gen X?

Generation X, those born between 1965 and 1980, may never find themselves with a president to call their own, even if they lay claim to Obama, who was born in 1961. But that doesn’t mean the generation won’t have a significant role to play in future elections and political debates that increasingly pit baby boomers bent on protecting their investments and entitlements against millennials and members of Gen Z seeking to significantly alter the structure of taxation and federal benefits.

The role may wind up being quintessential Gen X, attempting to referee between much bigger generations to find some kind of compromise where everyone can win.

“I guess we’re going to have to choose, in some of these presidential elections, if it pits a baby boomer against a millennial with very different ideas, and I think there is significant political weight to Gen X and how those decisions are ultimately made, right?” said Amy Walter, a Gen Xer and national editor of the Cook Political Report.

“Like, we’re not meaningless in terms of which way we go in the coming presidential elections of the next four, eight, 12 — even longer than that. There is some significant political importance to how Gen X decides on a lot of these things.”

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[theliberaltony]

via Politics – FiveThirtyEight

Kamala Harris was being described by some pundits as the Democratic front-runner before she even formally announced her candidacy. By early July, she seemed poised to challenge the polling leader, Joe Biden, who she had sharply criticized in the first Democratic debate. Harris stood at 15 percent in the RealClearPolitics average of national polls, narrowly ahead of Bernie Sanders and Elizabeth Warren. Everything was coming up peaches.

Since then, however, Harris’s support has plunged. She’s down to mid-single digits in most national polls, trailing Biden, Sanders, Warren and even Pete Buttigieg. Her numbers are also dismal in the early states, Iowa, New Hampshire, Nevada and South Carolina.

So, what went wrong?

It’s too early to write Harris off; she remains well-liked by Democratic voters and has raised enough money to keep her campaign running for months. In other words, she is decently positioned to make gains if one of the top three candidates falters, or if she can create another moment, like in the first debate, that gets Democrats excited about her.

But it’s worth thinking about why Harris has stumbled from that post-first-debate high. We can’t know for sure, but here are some theories (most of these are not mutually exclusive, and many likely played a role, but I ordered them from strongest to weakest, in my view):

1. 2020 was never going to be her year in the first place

This theory views Harris’s brief rise to 15 percent in national polls as something of a fluke. Instead, Harris’s “theory of the case” was never going to truly work in 2020 — the problem isn’t Harris, really, it’s that Democratic voters are looking for something else.

At least four 2020 candidates — Beto O’Rourke, Cory Booker, Buttigieg and Harris — have run campaigns that echo Barack Obama’s 2008 run: a youthful candidate without much Washington experience runs on charisma and personality more than a defined ideology or particular policy stands. Obama is beloved by Democrats, and his 2008 campaign was iconic, so it’s natural that 2020 candidates would try to emulate him. But Harris, Booker, Buttigieg and O’Rourke are at 14 percent combined in national polls, suggesting that Democratic voters aren’t looking for an Obama re-run.

In some ways, Harris has the same problem that Ted Cruz and Marco Rubio had in the 2016 Republican primary, when they (wrongly) thought that the GOP would be excited about nominating a youngish, non-white standard-bearer with a solid conservative record.

There is evidence to support the theory that Harris just isn’t a good fit for 2020. To take just one example, Obama was 47 years old in 2008. (Harris is 54.) The three leading Democratic candidates are 78 years old (Sanders), 76 (Biden) and 70 (Warren.) Moreover, Harris’s uptick in national polls was an outlier. She was in only the high single digits for most of February, March, April, May and June, and has gradually receded back to single digits after surging in early July. Also, as mentioned, the other Obama-esque candidates aren’t really doing any better.

Even on ideological grounds, Harris has had “fit” issues. In her rise through California politics, Harris positioned herself as a left-but-not-that-left, establishment-friendly figure. But that may not be a great profile in today’s Democratic Party, which has grown increasingly liberal. Indeed, Harris has struggled to defend her sometimes more conservative decisions as a district attorney and later attorney general of California and even her choice of becoming a prosecutor in the first place. Her positioning might be just fine if Biden were not in the race winning the votes of African-Americans and Democrats to the right of Warren and Sanders, but Biden is in the race.

Speaking of …

2. Biden and Warren are just really strong candidates

OK, forget Obama, the Democratic “mood” and the type of candidate best suited to that mood. Maybe Harris’s issues have more to do with brass-tacks electioneering.

The logical path for Harris was to win with a coalition of black voters and urban, college-educated white voters. But Biden and Warren have foreclosed those paths, respectively. Biden entered the race with sky-high popularity among black voters — as Obama’s vice president, he had an eight-year head start over Harris in establishing national ties with the black community. Warren, meanwhile, has surged in the last two months. Her strategy of rolling out policy plans and taking aggressively liberal stands — such as calling for Trump’s impeachment back in April — appears to have been a shrewd one in terms of wooing white, white-collar voters. Her rise has coincided pretty perfectly with Harris’s decline.

Remember that in the run-up to the 2016 Democratic primary election, liberal activists were begging Warren to run, while the center-left of the party was urging Biden to enter the race. With strong candidates monopolizing the left and the center-left, Harris has simply been crowded out.

3. Harris has not run a good campaign

This theory takes the Harris surge in July more seriously — it was real and represented a real opportunity for the California senator. Her campaign simply squandered it.

Harris’s campaign launch speech was widely praised, and she was strong in the first debate. But she has not had a strategy of keeping herself in the news, the way Warren’s policy rollouts and liberal stances did earlier in the year. And Harris hasn’t built a clear brand and rationale for her candidacy along the lines of Buttigieg��s (“I’m young”), Biden’s (“I can beat Trump”), or Sanders and Warren (“I will take on the wealthy”).

I think this lack of clarity about the rationale for her candidacy — beyond appealing to a broad coalition of Democrats — has led to some of Harris’s stumbles. Her months-long waffling on Medicare for All likely stemmed from a desire to appease both the party’s left-wing (which favors MFA) and the center-left wing (which opposes MFA). But this field may be too big for anyone to straddle the left and center-left — and perhaps health care is an issue where you can’t equivocate. Similarly, while Harris attacked Biden’s past opposition to aggressive school integration plans, she was hesitant to offer much of a proposal of her own on that issue. It seemed like Harris wanted to use that issue to nod at her racial liberalism but wasn’t prepared to commit to a big school integration plan, which might be controversial.

4. She’s a woman of color in a party wary of nominating someone who it feels won’t connect with white voters in the Midwest in the general election

“Electability” has been a bigger issue for Democrats in 2020 than perhaps any presidential primary in modern history. Democrats want to beat Trump. And in the wake of his Electoral College win in 2016, many Democratic voters are concerned about winning over white swing voters, especially in the Midwest. Perhaps not coincidentally, Biden is viewed as the most electable — maybe because of his more moderate stances and vast political experience, but also maybe because he’s white and a man.

If Biden and Sanders and O’Rourke were the three leading candidates, I would have argued that this was Harris’s biggest barrier — Democratic voters are behaving like pundits and determining that only a white man can win the general election. But Warren’s rise at least suggests that many Democrats are open to nominating a woman.

Still, that doesn’t mean that this isn’t an issue for Harris’s campaign. Being a woman of color — Harris is the daughter of Jamaican and Indian immigrants — may be a bigger barrier than being a white woman. Why? Well, Harris’s strategy, more than Warren’s, depends on her doing really well with black voters. (I’m not saying this just because Harris is black, her campaign has made a strong showing in heavily black South Carolina a focal point.) It may be extra hard to succeed if you are black woman trying to win over black Democrats, many of whom feel like America embraced Trump as part of a racist backlash against Obama. Black voters in particular may like Harris but truly feel that Biden is much more likely to win a general election.

Here’s the thing: I don’t think Harris is out of this race. She has a clear and kind of obvious path back into the top tier if she can just win over some of the people who are now behind Biden (particularly black voters), Warren (college-educated whites) and the other candidates who are of her general ilk (Julián Castro, Booker, Buttigieg and O’Rourke have a combined 10 percent of the vote.) It’s entirely possible that in December or January, Democrats feel like Biden is not inspiring enough but also that Sanders and Warren have taken too many left-wing positions and are risky bets in the general. In such a scenario, Harris, along with Buttigieg, are the best positioned candidates to rise.

But a lot would have to happen for Harris to pull off such a comeback. Right now, she seems more likely to finish behind Andrew Yang than to win the Democratic nomination. That’s pretty stunning, and makes me think that perhaps all four of these things are happening at once. Maybe the best explanation for Harris’s struggles is that she hasn’t been a great candidate and also faced three things that were out of her control: the strong performances of Biden and Warren, doubts from some Democrats about a woman of color’s ability to win the general election and a Democratic electorate looking for either a really leftward shift (Warren, Sanders) or someone decidedly against that shift (Biden.)

[takebackthedream]

How the "People's Budget" Can Help Redress Inequality by Robert Borosage

The Congressional Progressive Caucus released “The People’s Budget” this week, which it dubs a “roadmap for the resistance.” Maybe the mere mention of a federal budget plan makes your eyes glaze over, but the “People’s Budget” is a dramatic document.

Representative Mark Pocan of Wisconsin at a press conference for the “People’s Budget” on Capitol Hill on Tuesday, May 2, 2017. (Photo via Congressional Progressive Caucus)

  It presents a compelling alternative to Donald Trump’s “skinny budget.” Unlike Trump’s fanciful promises, it offers a sensible path out of the hole that we are in. Its values and priorities reflect those of the majority of Americans. The Progressive Caucus frames its budget around the central challenge of our time: how to make this economy work for working people, and redress the savage inequality that is undermining our democracy. It offers a strategy to get there, and a budget framed to support that strategy.

Not surprisingly, this makes it an outlier in the beltway debate.

Full Employment: The First Priority

With wages stagnant and worker participation in the economy still depressed, moving to full employment should be Washington’s first priority. That requires shedding the straightjacket of fiscal austerity that has slowed growth, hurt unemployment, and added to deficits.

The “People’s Budget” calls for public investment, sustained over the long run by insuring that corporations and the wealthy pay their fair share of taxes. The budget calls for an immediate boost of domestic spending over the next two years for investments in teachers and K–12 schools, aid to states to hire first responders, expanding Medicaid, public works jobs programs targeted at distressed communities, and more.

Public investments are far more effective, dollar-for-dollar, at boosting the economy and putting people to work than the Trump-favored top-end tax cuts. The federal investments laid out in the “People’s Budget” addressed urgent needs, as opposed to handing more money to the already wealthy—which adds to our obscene and corrosive inequality.

Rebuilding America

Over the longer term, the progressive budget blueprint would sustain a full employment economy by rebuilding America. It calls for spending $2 trillion in rebuilding our public infrastructure—from water systems to roads and mass transit—over 20 years. This comes close to meeting the sums the American Society of Civil Engineers argues are needed simply to bring our infrastructure up to sound standards. (We still have seen no glimmer of Trump’s oft-promised infrastructure program.)

The Progressive Caucus would return domestic discretionary spending—what government spends on everything outside of defense, social insurance, and interest on the national debt—to its average historical levels: 3.5 percent of GDP. Simply returning to the norm requires $2 trillion dollars over 10 years. Trump’s budget, in contrast, calls for savage cuts of 20 percent in domestic spending over the next 18 months.

This spending commitment is vitally important, and easy to underestimate. Conservative legislatures have been starving basic government functions for decades. The “People’s Budget” would provide increased funds for impoverished schools, vital investments in affordable housing, and job training. It would boost the United States in the global green industrial revolution. Public parks would get the care they need. Toxic waste sites and poisonous water systems would be cleaned up faster. Students would get substantial debt relief and college affordability.

Public financing of campaigns and funding for voter protection would help strengthen our democracy—both things are included in the “People’s Budget.” Overall, Americans would get a government able to function more efficiently, from administering Social Security to enforcing safety rules at work.

Expand Shared Security

The “People’s Budget” protects protects Social Security, Medicare, and Medicaid. It provides a new commitment for affordable child care for all, at the cost of nearly $1 trillion over 10 years. It adopts Obama’s preschool-for-all proposal, and Representative Jan Schakowsky’s bill to end family homelessness. It would expand Earned Income Tax Credits to cover low-wage workers who are childless. Trump, in contrast, supports a health-care plan that would have cut billions out of Medicaid and deprived millions of health care to pay for tax breaks for the rich.

Sensible Savings

The CPC seeks to pare government spending in areas of obvious excess. It slows the growth of the military budget, the largest source of waste, fraud, and abuse in the federal government. After providing funds for one year to facilitate withdrawal from Afghanistan, it ends the Pentagon’s off-budget slush fund for “Overseas Contingency Operations.” It reduces health care costs by taking on the drug companies, empowering Medicare to negotiate bulk discounts, and creating a public option in Obamacare.

Trump, meanwhile, wants to fatten the Pentagon with even more money while escalating military involvement in Afghanistan and elsewhere in the Middle East. He also quickly abandoned his pledge to crack down on the drug companies.

FAIR TAXES

The “People’s Budget” accomplishes all this while still lowering the projected US debt and deficit levels, by making corporations and the wealthy pay their fair share.

The budget would add new five new marginal tax rates for millionaires: 45 percent for those with $1 million in annual income, and 49 percent for those with $1 billion. It would tax capital gains and dividends at the same rate as ordinary income. These reforms raise $1.6 trillion over the next 10 years.

Trump wants to lower tax rates on the rich and continue to tax the income of investors at lower rates than ordinary income.

The Progressive Caucus plan would close egregious loopholes, end deferral of taxes on income corporations report as earned abroad, cap the value of itemized deductions, and keep the Alternative Minimum Tax that Trump wants to eliminate. The “People’s Budget” would end the home-mortgage deduction for yachts and vacation homes.

It taxes corporations for CEO excesses, curbs the deduction on stock options and bonus pay, eliminates deductions for corporate jets, and limits the meals and travel perks. It ends the billions that go to Big Oil in fossil-fuel subsidies.

Trump’s tax plan didn’t reveal what corporate loopholes he would close, but did suggest expanding the incentive to offshore jobs by making all income reported as earned abroad free of US taxes. That is a full employment program for accountants.

The Progressive Caucus proposes taxing “bads,” that is, activities we want to discourage: a financial transaction tax to curb the destabilizing financial casino; a tax on big banks—“systematically important financial institutions”—to help even the playing field; a tax on carbon emissions that sends revenues to low- and moderate-wage workers. It at least tempers the accumulation of dynastic wealth, adopting Bernie Sanders’s “Responsible Estate Tax” rate, which exempts estates up to $3.5 million, and then imposes a progressive rate on estates up to $50 million, with a surcharge on those over $500 million. Trump wants to eliminate the estate tax and the Alternative Minimum Tax.

A Modest Proposal

In this conservative era, federal policy has moved so far to the right that the spending and taxes in the “People’s Budget” seem fanciful. Yet this is a remarkably modest proposal. The plan champions Medicare for All, but chooses only to support state transitions to single-payer plans in the budget. Most Progressive Caucus members want expanded Social Security benefits, but decided that Social Security is better addressed separately from the budget mosh pit. They slow the growth of our outlandish military budget (nearly 40 percent of the world’s military spending), but chose not to offer a plan to restructure our military and cut it to sensible levels.

The “People’s Budget” turns the priorities of most Americans into budget figures. If adopted, it would move the country toward full employment and less extreme inequality, even as it reduced projected deficits and debt. It would strengthen the shared security that families can count on. It would rebuild vital public capacity and infrastructure.

Last year’s version of the “People’s Budget” didn’t get a vote, since Republicans never brought their budget to the floor. The year before, it did gain support from a (slim) majority of House Democrats. This year, over 60 groups are driving a large national push to see it gain 100 votes in the House. (You can join the petition drive here.)

Road Map to Resistance

The People’s Budget provides a basic road map for where we have to go. It outlines what we are for, not simply what we are against. Prepared in conjunction with the Economic Policy Institute, it is bolstered by supporting charts and documents, as well as the EPI’s detailed economic analysis—which by comparison makes a mockery of the shoddy “skinny budget” and one-page tax “plan” that the Trump administration released.

The Progressive Caucus has provided a stark contrast to the assumptions, magical thinking, and priorities of the right. It demonstrates that there is an alternative that adds up. Under the leadership of co-chairs Keith Ellison and Raul Grijalva and vice chair Mark Pocan, the Progressive Caucus is gaining in members and influence. Against Trump, its members will not only help spearhead the resistance, they will help define the reconstruction. And the People’s Budget provides a good start.

Cross-posted from The Nation

[96thdayofrage]

The world will change tomorrow when Donald Trump becomes president -- and so, too, must the movement for social justice. It is this reality that prompted Mariame Kaba, who for years has been organizing on issues such as the criminal punishment system and domestic violence, to shift gears in the lead-up to the inauguration.

"I have been thinking about how to organize in this current moment, and figure out ways to build the power to resist on various fronts," she said in a Truthout interview. "I was thinking of an issue that can reach a broad range of people, regardless of where they stand ideologically, racially [or] economically."

This search led her to the issue of health reform and the need for a public system that guarantees care to everyone. The result will be tomorrow's Medicare for All National Day of Action, a nationwide online event to be held on Inauguration Day. While Trump is giving his oath of office, thousands of activists across the country will be working online (using the hashtag #medicare4all) to push for the reform: contacting Congress, making memes and forming relationships with other like-minded people.

Participants are encouraged to make use of the official website, Facebook page, Twitter feed and pre-made graphics that can be shared on social media -- all devoted to what Kaba calls a "virtual" day of action. "I wanted those who are unable to go down to Washington, DC, where there will be lots of resistance activities, to have a chance to participate," she said. The long-term goal, Kaba elaborates, is bigger than just health care reform. She sees the fight for Medicare for All as having the potential to play a central role in building a mass movement against the inequities of capitalism more broadly. "This is ultimately what the struggle is against, and we need to start talking in those terms," she said, adding that those in power "want to take away your health care and give a tax break to people who are already rich. People can understand redistribution upward." We Are All Patients: the Broad Appeal of Medicare for All

There is no shortage of issues that activists can organize around. Trump's victory has further exposed the world to environmental, media and immigration crises, to name just a few. But the fight for a real health care system, organizers believe, has unique potential to be the hub of a wider movement.

"We have all been patients at one point or another," said Dr. Carol Paris, the current president of Physicians for a National Health Program (PNHP) in an interview with Truthout. "So, yes, reforming the delivery of health care is something we all need ... what many people have now is just an insurance card and the illusion of care."

Indeed, health care policy is a major concern for workers seeing their paychecks shrink due to the rising cost of health care, as well as the 30 million Americans who remain uninsured despite progress on access from the Affordable Care Act (ACA). It is also a problem for those who have health insurance but are still exposed to massive debt and potential bankruptcy. This exposure causes millions of insured Americans to forego care they need.

The lack of a universal health system has also led to serious racial disparities, the Harvard Business Review observed in 2015, with Black Americans having a shorter life span and worse outcomes than whites on a number of ailments, including "heart disease, diabetes, and cancer, as well as higher risks for HIV infection, homicide, and infant mortality." The seriousness of the crisis cannot be understated. A 2012 study by consumer advocacy group Families USA concluded that 26,000 people die each year due to a lack of insurance. Paris has a long history as a health care activist, extending long past her current role as a physician who is president of an organization that provides much of the seminal research on the subject. In May 2009, she was one of the "Baucus 8," who stepped up at the US Senate Finance Committee hearing on health care reform chaired by Sen. Max Baucus to ask why there wasn't a single advocate for single-payer health care on a 41-person panel. Baucus had all eight peaceful protesters, including Dr. Paris, arrested. The Nashville-based doctor was arrested again -- which can be seen on video at PNHP.org -- two days after President Obama said in his 2010 State of the Union that he would listen to anyone with a "better approach" to reform. "Well, we had a serious set of proposals and tried to let him know," she said of her arrest, which occurred in Baltimore outside a conference featuring the president. They attempted to give him a letter that urged him to consider Medicare for All to save thousands "of American lives each year, not to mention the prevention of unnecessary suffering." "It is important not just to rely on research and data but to organize, to protest and to fight for single-payer," Paris said to Truthout on the role of activism and organizing. "We have worked with many organizations [that] aren't solely focused on health care, such as labor groups, who know to get economic justice, creating a Medicare for All system would be an important step."

The Coming National Debate on Health Reform

While health care is always an important issue, it is going to be front and center in the national debate as Trump and the new GOP Congress seek to rapidly repeal (and supposedly replace) the ACA. This will be a messy, complex process and could cost more than 20 million people their health insurance, according to the Congressional Budget Office. But it will provide a chance for advocates to spread their message. "In a back-handed way, [the GOP efforts to repeal the ACA] will provide advocates a chance to get our message across," Paris told Truthout on the phone while watching Bernie Sanders speak at the confirmation hearing for Tom Price, Trump's appointment for head of Health and Human Services.

"It is going to be up to activists and independent media [outlets] to give legitimacy to Medicare for All as a reasonable, cost-effective alternative to the status quo," Paris added. Democrats are promising to fight the repeal and possibly minimize some of the consequences of the GOP's approach. Even if the repeal could somehow be stopped, however, the fight for Medicare for All remains the ultimate goal for many progressive activists. "Our job today is to defend the Affordable Care Act," Bernie Sanders recently said on Twitter. "Our job tomorrow is to create a single-payer system." Certainly, Sanders has his detractors, including many in the Democratic Party, some of them beneficiaries of large donations from Pharma and the private insurance industry. This bipartisan opposition to Medicare for All is a reality that organizers say the movement must tackle head on. "Politicians from both parties say it is politically impossible," Paris said. "But what does that mean? It means that our representatives won't vote for it. It means many won't risk alienating their donors at the pharmaceutical and health industries, who fund their campaigns."

Education and Class Consciousness

Certainly, education must be central to building a movement, which is why organizers' use of the term "Medicare for All," over "single-payer" is deliberate. While policy wonks are familiar with the term single-payer, it is still a phrase that confuses many people. "Most people know what Medicare is," Kaba said.

Amazingly, despite a narrow debate in the media and in Washington that villainizes or ignores the policy, the public is still broadly supportive of Medicare for All (when the question is asked in those terms), and has been for years. In December of 2015, a Kaiser poll showed 58 percent of the public supported the policy, including 81 percent of Democrats. But polls using the term "single-payer" do not fare as well as ones using the term "Medicare for All."

"Medicare for All has the potential for extremely broad appeal because it would help the vast majority of Americans, including many with quite conservative views," said PNHP founders David Himmelstein and Steffie Woolhander, in an email to Truthout.

A lack of understanding single-payer and how it is financed has been an obstacle for the movement in the recent past. "If you find that you have to keep explaining what your proposal is, you haven't done enough, and your opponents can and will destroy your efforts with a few soundbites," explained Dr. Don McCanne, of PNHP, in response to a failed health reform effort in Colorado that was supported by single-payer activists.

And with a rigid ideological adherence to market-based solutions in the media and in Washington, many Americans are not aware that the United States is an outlier in its lack of a public health care system: The only member of the Organization of Economic Cooperation and Development (a coalition of wealthy nations) without universal care.

An explanation of how outside the norm the US is in terms of providing a safety net -- the US ranks 25 out of 34 OECD nations on social spending -- can provide a stunning contrast to those who are trying to understand how American capitalism functions, raising class consciousness.

The Sanders presidential campaign, as Truthout observed in August, did help to educate the public about these differences. At times, Sander's message broke into the dominant media narrative, which typically ignores or wrongly dismisses Medicare for All as impossible, radical or unaffordable. Some recent coverage is laughably bad. Last Friday's David Brooks column in The New York Times made the ridiculous claim that the Republican Party has granted "the Democratic point that health care is a right." But despite these falsehoods being so pervasive in the media, the fruits of a growing class awareness are evident in the rising number of people challenging Democrats' reluctance to make real changes on the health care front. Last week, a public outcry erupted when 13 Senate Democrats voted against an amendment by Sanders to allow drugs to be imported from Canada, lowering prices for Americans. Sen. Cory Booker, a high-profile Senator who is rumored to have presidential ambitions, was among the group that sided with Republicans to kill the amendment.  In the aftermath of Sanders' presidential campaign, a vocal and aggressive group of progressives were paying attention to the amendment, and when they saw that Booker received big money from Big Pharma, they connected the dots between campaign finance, Congress and health policy. The result was a flood of indignation toward Booker on social media.

There has been pushback from the establishment, mocking the critiques leveled by the "Sanders Wing" toward the Democratic Party. The surge of opposition to Booker's vote, however, is promising. It demonstrates not only how many Americans are aware of how private capital can influence health policy, but also how the internet can serve as an effective tool for vocal protest of the congressional machinations that too often happen behind closed doors. The fallout from Booker's vote is something that Democrats will remember, especially as they plan for the need to connect with progressives in future elections. What Lies Ahead

After the Medicare for All National Day of Action is over, the work of organizing, educating and agitating will continue. Kaba has plans to create curriculum -- a sort of Medicare for All 101 -- on the website in the weeks following the inauguration. Organizers are also encouraging activists to get involved at the local level. There are organizations advocating for Medicare for All across the country. Physicians for a National Health Plan, for instance, has chapters in 43 states. Healthcare-Now has chapters in 38 states and is seeking to start chapters where none exist. Single-payer actions are also being organized by a variety of other organizations across the country.

We are in the process of entering a scary new world. But if activists and organizers can keep one another engaged and active, there is a chance that this moment will also be an important occasion for social justice -- and the fight for a humane health care system could have impacts for generations to come.

[stephenmccull]

As Problems Grow With Abbott’s Fast COVID Test, FDA Standards Are Under Fire

In mid-May, the Food and Drug Administration issued a rare public warning about an Abbott Laboratories COVID-19 test that for weeks had received high praise from the White House because of its speed: Test results could be wrong.

The agency at that point had received 15 “adverse event reports” about Abbott’s ID NOW rapid COVID test suggesting that infected patients were wrongly told they did not have the coronavirus, which had led to the deaths of tens of thousands of Americans. The warning followed multiple academic studies showing higher “false negative” rates from the Abbott device, including one from New York University researchers who found it missed close to half of the positive samples detected by a rival company’s test.

But then, in a move that confounded lab officials and other public health experts, a senior FDA official later that month said coronavirus tests provided outside lab settings would be considered useful in fighting the pandemic even if they miss 1 in 5 positive cases — a worrisome failure rate.

The FDA has now received a total of 106 reports of adverse events for the Abbott test, a staggering increase. The agency has not received a single adverse event report for any other point-of-care tests meant to diagnose COVID-19, an agency spokesperson said.

In a statement, Abbott Laboratories said the NYU research was “flawed” and “an outlier,” citing studies with higher accuracy rates.

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Though the Abbott rapid test is one of over 100 COVID-19 diagnostic tests to receive FDA emergency use authorization during the pandemic, President Donald Trump has featured the product in the White House Rose Garden and the Health and Human Services Department’s preparedness and response division has issued more than $205 million worth of contracts to buy the test, according to federal contract records.

“Everybody was raving about it,” a former administration official said, speaking on the condition of anonymity to discuss internal deliberations. “It’s an amazing test, but it has limitations which are now being better understood.”

In its own COVID-19 testing policy for labs and commercial manufacturers, the FDA says a diagnostic test should correctly identify at least 95% of positive samples.

But medical professionals are split over the lower 80% threshold for the Abbott and other point-of-care tests’ “sensitivity” — a metric showing how often a test correctly generates a positive result. They are debating whether it’s sufficient, given the risks that an infected person unwittingly spreads COVID-19 after receiving a negative result.

False negatives increase the risk that patients will not self-isolate or exercise other precautions — such as wearing a mask — and make more people sick than if they had had an accurate diagnosis. Evaluations of the Abbott test have been among the most mixed, with some researchers finding that the test has bigger accuracy problems, but others saying it isn’t likely to miss sicker patients.

“There’s no way I would be comfortable missing 2 out of 10 patients,” said Susan Whittier, director of clinical microbiology at NewYork-Presbyterian/Columbia University Medical Center. Whittier and co-authors found that the Abbott test correctly identified 74% of positive samples compared with a rival test from Roche, another diagnostics giant. A point-of-care test from Cepheid, a rival company, correctly identified 99% of positives.

An FDA official cited the 80% accuracy minimum for point-of-care tests in late May even after two White House aides tested positive for the virus. The Executive Office of the President has spent roughly $140,000 on Abbott test kits, according to contract records.

In a statement, Abbott said when its test is used as intended it “is delivering reliable results and is helping to reduce the spread of infection in society by detecting more positive results than would otherwise be found.” Studies from University Hospitals Cleveland Medical Center and OhioHealth found that its test detected at least 91% of positives.

In March, HHS officials announced that Cepheid would receive approximately $3.7 million through its Biomedical Advanced Research and Development Authority for coronavirus diagnostic development work; the Strategic National Stockpile also made a one-time $2.3 million purchase of Cepheid’s point-of-care tests, according to an agency spokesperson.

“Knowing the true performance of such a point-of-care test and knowing that it may be less sensitive than a central lab molecular test is important, but also can play a role in triaging patients who are suspected of having COVID-19,” Dr. Timothy Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the call when discussing the Abbott warning. “If we are able to determine that sensitivity of the assay in controlled trial circumstances is at least 80%, we feel like that test has a valuable place going forward in this pandemic.”

Until the FDA can complete post-market studies to verify performance, he said, negative results with the Abbott rapid test will be treated as “presumptive” negatives.

Despite that note of caution, governors were also told during a June 3 call with Vice President Mike Pence that the fast Abbott test should be used to test residents and staff in long-term care settings, according to two sources with knowledge of the discussions. As of May 31, more than 95,000 people in nursing homes have tested positive for COVID-19 and nearly 32,000 have died, according to the Centers for Medicare & Medicaid Services. If 20% of tests are false negatives, personnel with COVID-19 could be going about their normal activities, spreading the virus.

Spokespeople for Pence did not respond to requests for comment.

No test is perfect, whether it’s for a common illness like the flu or for COVID-19, which has killed nearly 120,000 Americans. Federal officials contend that the trade-off with point-of-care tests — especially ones as fast as Abbott’s, which can turn around a positive result in as little as five minutes and a negative one in 13 minutes — is that the tests can be used in spots where traditional lab tests aren’t as accessible. There’s also a greater risk of operator error when administering the test in the real world given the way patient specimens are collected and handled.

An FDA spokesperson said officials’ “general expectation” is that companies’ test validation data indicate a sensitivity of at least 95%; however, “based on the available information, FDA has issued EUAs [emergency use authorizations] to some tests that presented data indicating a sensitivity below 95%.”

“Rapid and reliable detection of positive patients can be important for public health,” the spokesperson said.

Cepheid would not comment on FDA’s 80% standard but pointed to a Northwell Health Laboratories study finding its test was 98% accurate in detecting positives. The company has shipped approximately 6 million tests since getting FDA authorization in March.

“Experience has shown that in COVID testing, pre-analytical variables such as the site of sample collection (nasal, nasopharyngeal, throat, saliva) and the quality of the sample collected can have a large impact on test performance,” Dr. David Persing, Cepheid’s chief medical and technology officer, said in a statement. “Tests with higher sensitivity have a natural advantage in this setting.”

As far as Abbott’s test, “there are certainly some elements of it that could be improved, but I think it’s a great assay,” said Michael Mina, an assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health, who said the NYU study was “flawed” in part because of the number of patients researchers included with such low viral loads that they wouldn’t be infectious. An NYU spokesperson has defended the research.

Mina and others also took issue with the FDA’s threshold.

“For them to just say 80%, it lets people game the system,” he said. Companies presented with a single figure for sensitivity could manipulate which patients they test to exceed the minimum — for example, by including only very sick patients, which most tests would have an easier time detecting as a positive.

“They really need to fix this issue,” Mina said.

Abbott has already made several revisions to its materials for how its test should be performed. It removed prior language in its instructions saying swabs could be placed in a type of liquid — known as viral transport medium — before the test is run because doing so caused patient specimens to be too diluted. Now, the company says only direct swabs from patients should be inserted into the machine. It also revised its instructions for handling patient specimens following a KHN story in which lab professionals voiced safety concerns.

Christopher Polage, the medical director of Duke University Health System’s clinical microbiology lab, said experts have known for years that point-of-care tests are not as good at identifying known positives, but there are still legitimate situations in which they are used clinically.

“The difference now,” he said, “is that people are so fearful and tolerance for false negatives is just zero.”

Abbott’s rapid COVID-19 test isn’t the only point-of-care test to receive FDA authorization during the pandemic, but Trump has touted it the most by far, hailing the speed at which results can be given. To date, Abbott has delivered more than 3.6 million of the rapid tests to customers in all 50 states, including urgent care clinics, physicians’ offices, the federal government and hospital emergency departments.

In Washington, D.C., the city government has distributed 11 Abbott testing instruments across homeless shelters, jails, long-term care facilities, a clinic that largely serves lower-income Latinos and two public hospitals in the district’s poorest neighborhoods. Mobile testing units were also equipped with five Abbott machines, using them to test 40 to 50 people per site mostly at long-term care facilities, according to city officials.

The district has not found that the Abbott test has a higher rate of false negatives compared to other tests, said Dr. Jenifer Smith, director of the city’s Department of Forensic Services, which oversees the city’s public health lab.

“We test every test before we put it online,” she said. “We didn’t find the successively high rate of false negatives. In fact, we found we were getting the same results.”

But several labs have found the test with the presidential seal of approval to be less accurate than some of its competitors in detecting known positives.

“Without confirmation of negatives, I wouldn’t want to use it in hospitals,” said Gregory Berry, director of molecular diagnostics at Northwell Health Laboratories in New York. Berry co-authored the analysis finding that the Abbott ID Now test detected nearly 88% of positive samples compared with 98% from Cepheid, whose point-of-care test takes 45 minutes. Abbott contested the findings of the Northwell and Columbia papers because it said the tests were run in a way that diluted the specimens.

Berry and other lab personnel also said that a key metric Abbott reported as part of the process for receiving FDA authorization — known as the limit of detection, which specifies how little of the virus is needed for the test to reliably detect it — doesn’t match up with their own findings, and, in at least one instance, by a huge margin. A higher limit of detection means more viral material is needed for the test to detect the coronavirus. And a higher limit of detection increases the risk of false-negative results if a patient’s viral burden isn’t high.

Berry’s analysis determined that the lowest quantity of the virus needed to identify 100% of positive cases was 20,000 copies per milliliter. Abbott’s self-reported standard is a fraction of a percent of that.

Abbott said the limit of detection it provided to the FDA is accurate.

Of Abbott’s stated limit, Polage said: “I’m not sure what they were thinking.”

As Problems Grow With Abbott’s Fast COVID Test, FDA Standards Are Under Fire published first on https://smartdrinkingweb.weebly.com/

[gordonwilliamsweb]

As Problems Grow With Abbott’s Fast COVID Test, FDA Standards Are Under Fire

In mid-May, the Food and Drug Administration issued a rare public warning about an Abbott Laboratories COVID-19 test that for weeks had received high praise from the White House because of its speed: Test results could be wrong.

The agency at that point had received 15 “adverse event reports” about Abbott’s ID NOW rapid COVID test suggesting that infected patients were wrongly told they did not have the coronavirus, which had led to the deaths of tens of thousands of Americans. The warning followed multiple academic studies showing higher “false negative” rates from the Abbott device, including one from New York University researchers who found it missed close to half of the positive samples detected by a rival company’s test.

But then, in a move that confounded lab officials and other public health experts, a senior FDA official later that month said coronavirus tests provided outside lab settings would be considered useful in fighting the pandemic even if they miss 1 in 5 positive cases — a worrisome failure rate.

The FDA has now received a total of 106 reports of adverse events for the Abbott test, a staggering increase. The agency has not received a single adverse event report for any other point-of-care tests meant to diagnose COVID-19, an agency spokesperson said.

In a statement, Abbott Laboratories said the NYU research was “flawed” and “an outlier,” citing studies with higher accuracy rates.

Email Sign-Up

Subscribe to KHN’s free Morning Briefing.

Sign Up

Please confirm your email address below:

Sign Up

Though the Abbott rapid test is one of over 100 COVID-19 diagnostic tests to receive FDA emergency use authorization during the pandemic, President Donald Trump has featured the product in the White House Rose Garden and the Health and Human Services Department’s preparedness and response division has issued more than $205 million worth of contracts to buy the test, according to federal contract records.

“Everybody was raving about it,” a former administration official said, speaking on the condition of anonymity to discuss internal deliberations. “It’s an amazing test, but it has limitations which are now being better understood.”

In its own COVID-19 testing policy for labs and commercial manufacturers, the FDA says a diagnostic test should correctly identify at least 95% of positive samples.

But medical professionals are split over the lower 80% threshold for the Abbott and other point-of-care tests’ “sensitivity” — a metric showing how often a test correctly generates a positive result. They are debating whether it’s sufficient, given the risks that an infected person unwittingly spreads COVID-19 after receiving a negative result.

False negatives increase the risk that patients will not self-isolate or exercise other precautions — such as wearing a mask — and make more people sick than if they had had an accurate diagnosis. Evaluations of the Abbott test have been among the most mixed, with some researchers finding that the test has bigger accuracy problems, but others saying it isn’t likely to miss sicker patients.

“There’s no way I would be comfortable missing 2 out of 10 patients,” said Susan Whittier, director of clinical microbiology at NewYork-Presbyterian/Columbia University Medical Center. Whittier and co-authors found that the Abbott test correctly identified 74% of positive samples compared with a rival test from Roche, another diagnostics giant. A point-of-care test from Cepheid, a rival company, correctly identified 99% of positives.

An FDA official cited the 80% accuracy minimum for point-of-care tests in late May even after two White House aides tested positive for the virus. The Executive Office of the President has spent roughly $140,000 on Abbott test kits, according to contract records.

In a statement, Abbott said when its test is used as intended it “is delivering reliable results and is helping to reduce the spread of infection in society by detecting more positive results than would otherwise be found.” Studies from University Hospitals Cleveland Medical Center and OhioHealth found that its test detected at least 91% of positives.

In March, HHS officials announced that Cepheid would receive approximately $3.7 million through its Biomedical Advanced Research and Development Authority for coronavirus diagnostic development work; the Strategic National Stockpile also made a one-time $2.3 million purchase of Cepheid’s point-of-care tests, according to an agency spokesperson.

“Knowing the true performance of such a point-of-care test and knowing that it may be less sensitive than a central lab molecular test is important, but also can play a role in triaging patients who are suspected of having COVID-19,” Dr. Timothy Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the call when discussing the Abbott warning. “If we are able to determine that sensitivity of the assay in controlled trial circumstances is at least 80%, we feel like that test has a valuable place going forward in this pandemic.”

Until the FDA can complete post-market studies to verify performance, he said, negative results with the Abbott rapid test will be treated as “presumptive” negatives.

Despite that note of caution, governors were also told during a June 3 call with Vice President Mike Pence that the fast Abbott test should be used to test residents and staff in long-term care settings, according to two sources with knowledge of the discussions. As of May 31, more than 95,000 people in nursing homes have tested positive for COVID-19 and nearly 32,000 have died, according to the Centers for Medicare & Medicaid Services. If 20% of tests are false negatives, personnel with COVID-19 could be going about their normal activities, spreading the virus.

Spokespeople for Pence did not respond to requests for comment.

No test is perfect, whether it’s for a common illness like the flu or for COVID-19, which has killed nearly 120,000 Americans. Federal officials contend that the trade-off with point-of-care tests — especially ones as fast as Abbott’s, which can turn around a positive result in as little as five minutes and a negative one in 13 minutes — is that the tests can be used in spots where traditional lab tests aren’t as accessible. There’s also a greater risk of operator error when administering the test in the real world given the way patient specimens are collected and handled.

An FDA spokesperson said officials’ “general expectation” is that companies’ test validation data indicate a sensitivity of at least 95%; however, “based on the available information, FDA has issued EUAs [emergency use authorizations] to some tests that presented data indicating a sensitivity below 95%.”

“Rapid and reliable detection of positive patients can be important for public health,” the spokesperson said.

Cepheid would not comment on FDA’s 80% standard but pointed to a Northwell Health Laboratories study finding its test was 98% accurate in detecting positives. The company has shipped approximately 6 million tests since getting FDA authorization in March.

“Experience has shown that in COVID testing, pre-analytical variables such as the site of sample collection (nasal, nasopharyngeal, throat, saliva) and the quality of the sample collected can have a large impact on test performance,” Dr. David Persing, Cepheid’s chief medical and technology officer, said in a statement. “Tests with higher sensitivity have a natural advantage in this setting.”

As far as Abbott’s test, “there are certainly some elements of it that could be improved, but I think it’s a great assay,” said Michael Mina, an assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health, who said the NYU study was “flawed” in part because of the number of patients researchers included with such low viral loads that they wouldn’t be infectious. An NYU spokesperson has defended the research.

Mina and others also took issue with the FDA’s threshold.

“For them to just say 80%, it lets people game the system,” he said. Companies presented with a single figure for sensitivity could manipulate which patients they test to exceed the minimum — for example, by including only very sick patients, which most tests would have an easier time detecting as a positive.

“They really need to fix this issue,” Mina said.

Abbott has already made several revisions to its materials for how its test should be performed. It removed prior language in its instructions saying swabs could be placed in a type of liquid — known as viral transport medium — before the test is run because doing so caused patient specimens to be too diluted. Now, the company says only direct swabs from patients should be inserted into the machine. It also revised its instructions for handling patient specimens following a KHN story in which lab professionals voiced safety concerns.

Christopher Polage, the medical director of Duke University Health System’s clinical microbiology lab, said experts have known for years that point-of-care tests are not as good at identifying known positives, but there are still legitimate situations in which they are used clinically.

“The difference now,” he said, “is that people are so fearful and tolerance for false negatives is just zero.”

Abbott’s rapid COVID-19 test isn’t the only point-of-care test to receive FDA authorization during the pandemic, but Trump has touted it the most by far, hailing the speed at which results can be given. To date, Abbott has delivered more than 3.6 million of the rapid tests to customers in all 50 states, including urgent care clinics, physicians’ offices, the federal government and hospital emergency departments.

In Washington, D.C., the city government has distributed 11 Abbott testing instruments across homeless shelters, jails, long-term care facilities, a clinic that largely serves lower-income Latinos and two public hospitals in the district’s poorest neighborhoods. Mobile testing units were also equipped with five Abbott machines, using them to test 40 to 50 people per site mostly at long-term care facilities, according to city officials.

The district has not found that the Abbott test has a higher rate of false negatives compared to other tests, said Dr. Jenifer Smith, director of the city’s Department of Forensic Services, which oversees the city’s public health lab.

“We test every test before we put it online,” she said. “We didn’t find the successively high rate of false negatives. In fact, we found we were getting the same results.”

But several labs have found the test with the presidential seal of approval to be less accurate than some of its competitors in detecting known positives.

“Without confirmation of negatives, I wouldn’t want to use it in hospitals,” said Gregory Berry, director of molecular diagnostics at Northwell Health Laboratories in New York. Berry co-authored the analysis finding that the Abbott ID Now test detected nearly 88% of positive samples compared with 98% from Cepheid, whose point-of-care test takes 45 minutes. Abbott contested the findings of the Northwell and Columbia papers because it said the tests were run in a way that diluted the specimens.

Berry and other lab personnel also said that a key metric Abbott reported as part of the process for receiving FDA authorization — known as the limit of detection, which specifies how little of the virus is needed for the test to reliably detect it — doesn’t match up with their own findings, and, in at least one instance, by a huge margin. A higher limit of detection means more viral material is needed for the test to detect the coronavirus. And a higher limit of detection increases the risk of false-negative results if a patient’s viral burden isn’t high.

Berry’s analysis determined that the lowest quantity of the virus needed to identify 100% of positive cases was 20,000 copies per milliliter. Abbott’s self-reported standard is a fraction of a percent of that.

Abbott said the limit of detection it provided to the FDA is accurate.

Of Abbott’s stated limit, Polage said: “I’m not sure what they were thinking.”

As Problems Grow With Abbott’s Fast COVID Test, FDA Standards Are Under Fire published first on https://nootropicspowdersupplier.tumblr.com/

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As Problems Grow With Abbott’s Fast COVID Test, FDA Standards Are Under Fire

In mid-May, the Food and Drug Administration issued a rare public warning about an Abbott Laboratories COVID-19 test that for weeks had received high praise from the White House because of its speed: Test results could be wrong.

The agency at that point had received 15 “adverse event reports” about Abbott’s ID NOW rapid COVID test suggesting that infected patients were wrongly told they did not have the coronavirus, which had led to the deaths of tens of thousands of Americans. The warning followed multiple academic studies showing higher “false negative” rates from the Abbott device, including one from New York University researchers who found it missed close to half of the positive samples detected by a rival company’s test.

But then, in a move that confounded lab officials and other public health experts, a senior FDA official later that month said coronavirus tests provided outside lab settings would be considered useful in fighting the pandemic even if they miss 1 in 5 positive cases — a worrisome failure rate.

The FDA has now received a total of 106 reports of adverse events for the Abbott test, a staggering increase. The agency has not received a single adverse event report for any other point-of-care tests meant to diagnose COVID-19, an agency spokesperson said.

In a statement, Abbott Laboratories said the NYU research was “flawed” and “an outlier,” citing studies with higher accuracy rates.

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Though the Abbott rapid test is one of over 100 COVID-19 diagnostic tests to receive FDA emergency use authorization during the pandemic, President Donald Trump has featured the product in the White House Rose Garden and the Health and Human Services Department’s preparedness and response division has issued more than $205 million worth of contracts to buy the test, according to federal contract records.

“Everybody was raving about it,” a former administration official said, speaking on the condition of anonymity to discuss internal deliberations. “It’s an amazing test, but it has limitations which are now being better understood.”

In its own COVID-19 testing policy for labs and commercial manufacturers, the FDA says a diagnostic test should correctly identify at least 95% of positive samples.

But medical professionals are split over the lower 80% threshold for the Abbott and other point-of-care tests’ “sensitivity” — a metric showing how often a test correctly generates a positive result. They are debating whether it’s sufficient, given the risks that an infected person unwittingly spreads COVID-19 after receiving a negative result.

False negatives increase the risk that patients will not self-isolate or exercise other precautions — such as wearing a mask — and make more people sick than if they had had an accurate diagnosis. Evaluations of the Abbott test have been among the most mixed, with some researchers finding that the test has bigger accuracy problems, but others saying it isn’t likely to miss sicker patients.

“There’s no way I would be comfortable missing 2 out of 10 patients,” said Susan Whittier, director of clinical microbiology at NewYork-Presbyterian/Columbia University Medical Center. Whittier and co-authors found that the Abbott test correctly identified 74% of positive samples compared with a rival test from Roche, another diagnostics giant. A point-of-care test from Cepheid, a rival company, correctly identified 99% of positives.

An FDA official cited the 80% accuracy minimum for point-of-care tests in late May even after two White House aides tested positive for the virus. The Executive Office of the President has spent roughly $140,000 on Abbott test kits, according to contract records.

In a statement, Abbott said when its test is used as intended it “is delivering reliable results and is helping to reduce the spread of infection in society by detecting more positive results than would otherwise be found.” Studies from University Hospitals Cleveland Medical Center and OhioHealth found that its test detected at least 91% of positives.

In March, HHS officials announced that Cepheid would receive approximately $3.7 million through its Biomedical Advanced Research and Development Authority for coronavirus diagnostic development work; the Strategic National Stockpile also made a one-time $2.3 million purchase of Cepheid’s point-of-care tests, according to an agency spokesperson.

“Knowing the true performance of such a point-of-care test and knowing that it may be less sensitive than a central lab molecular test is important, but also can play a role in triaging patients who are suspected of having COVID-19,” Dr. Timothy Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the call when discussing the Abbott warning. “If we are able to determine that sensitivity of the assay in controlled trial circumstances is at least 80%, we feel like that test has a valuable place going forward in this pandemic.”

Until the FDA can complete post-market studies to verify performance, he said, negative results with the Abbott rapid test will be treated as “presumptive” negatives.

Despite that note of caution, governors were also told during a June 3 call with Vice President Mike Pence that the fast Abbott test should be used to test residents and staff in long-term care settings, according to two sources with knowledge of the discussions. As of May 31, more than 95,000 people in nursing homes have tested positive for COVID-19 and nearly 32,000 have died, according to the Centers for Medicare & Medicaid Services. If 20% of tests are false negatives, personnel with COVID-19 could be going about their normal activities, spreading the virus.

Spokespeople for Pence did not respond to requests for comment.

No test is perfect, whether it’s for a common illness like the flu or for COVID-19, which has killed nearly 120,000 Americans. Federal officials contend that the trade-off with point-of-care tests — especially ones as fast as Abbott’s, which can turn around a positive result in as little as five minutes and a negative one in 13 minutes — is that the tests can be used in spots where traditional lab tests aren’t as accessible. There’s also a greater risk of operator error when administering the test in the real world given the way patient specimens are collected and handled.

An FDA spokesperson said officials’ “general expectation” is that companies’ test validation data indicate a sensitivity of at least 95%; however, “based on the available information, FDA has issued EUAs [emergency use authorizations] to some tests that presented data indicating a sensitivity below 95%.”

“Rapid and reliable detection of positive patients can be important for public health,” the spokesperson said.

Cepheid would not comment on FDA’s 80% standard but pointed to a Northwell Health Laboratories study finding its test was 98% accurate in detecting positives. The company has shipped approximately 6 million tests since getting FDA authorization in March.

“Experience has shown that in COVID testing, pre-analytical variables such as the site of sample collection (nasal, nasopharyngeal, throat, saliva) and the quality of the sample collected can have a large impact on test performance,” Dr. David Persing, Cepheid’s chief medical and technology officer, said in a statement. “Tests with higher sensitivity have a natural advantage in this setting.”

As far as Abbott’s test, “there are certainly some elements of it that could be improved, but I think it’s a great assay,” said Michael Mina, an assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health, who said the NYU study was “flawed” in part because of the number of patients researchers included with such low viral loads that they wouldn’t be infectious. An NYU spokesperson has defended the research.

Mina and others also took issue with the FDA’s threshold.

“For them to just say 80%, it lets people game the system,” he said. Companies presented with a single figure for sensitivity could manipulate which patients they test to exceed the minimum — for example, by including only very sick patients, which most tests would have an easier time detecting as a positive.

“They really need to fix this issue,” Mina said.

Abbott has already made several revisions to its materials for how its test should be performed. It removed prior language in its instructions saying swabs could be placed in a type of liquid — known as viral transport medium — before the test is run because doing so caused patient specimens to be too diluted. Now, the company says only direct swabs from patients should be inserted into the machine. It also revised its instructions for handling patient specimens following a KHN story in which lab professionals voiced safety concerns.

Christopher Polage, the medical director of Duke University Health System’s clinical microbiology lab, said experts have known for years that point-of-care tests are not as good at identifying known positives, but there are still legitimate situations in which they are used clinically.

“The difference now,” he said, “is that people are so fearful and tolerance for false negatives is just zero.”

Abbott’s rapid COVID-19 test isn’t the only point-of-care test to receive FDA authorization during the pandemic, but Trump has touted it the most by far, hailing the speed at which results can be given. To date, Abbott has delivered more than 3.6 million of the rapid tests to customers in all 50 states, including urgent care clinics, physicians’ offices, the federal government and hospital emergency departments.

In Washington, D.C., the city government has distributed 11 Abbott testing instruments across homeless shelters, jails, long-term care facilities, a clinic that largely serves lower-income Latinos and two public hospitals in the district’s poorest neighborhoods. Mobile testing units were also equipped with five Abbott machines, using them to test 40 to 50 people per site mostly at long-term care facilities, according to city officials.

The district has not found that the Abbott test has a higher rate of false negatives compared to other tests, said Dr. Jenifer Smith, director of the city’s Department of Forensic Services, which oversees the city’s public health lab.

“We test every test before we put it online,” she said. “We didn’t find the successively high rate of false negatives. In fact, we found we were getting the same results.”

But several labs have found the test with the presidential seal of approval to be less accurate than some of its competitors in detecting known positives.

“Without confirmation of negatives, I wouldn’t want to use it in hospitals,” said Gregory Berry, director of molecular diagnostics at Northwell Health Laboratories in New York. Berry co-authored the analysis finding that the Abbott ID Now test detected nearly 88% of positive samples compared with 98% from Cepheid, whose point-of-care test takes 45 minutes. Abbott contested the findings of the Northwell and Columbia papers because it said the tests were run in a way that diluted the specimens.

Berry and other lab personnel also said that a key metric Abbott reported as part of the process for receiving FDA authorization — known as the limit of detection, which specifies how little of the virus is needed for the test to reliably detect it — doesn’t match up with their own findings, and, in at least one instance, by a huge margin. A higher limit of detection means more viral material is needed for the test to detect the coronavirus. And a higher limit of detection increases the risk of false-negative results if a patient’s viral burden isn’t high.

Berry’s analysis determined that the lowest quantity of the virus needed to identify 100% of positive cases was 20,000 copies per milliliter. Abbott’s self-reported standard is a fraction of a percent of that.

Abbott said the limit of detection it provided to the FDA is accurate.

Of Abbott’s stated limit, Polage said: “I’m not sure what they were thinking.”

from Updates By Dina https://khn.org/news/abbott-rapid-test-problems-grow-fda-standards-on-covid-tests-under-fire/