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Wednesday, July 8, 2020

Health Care Reform Articles - July 8, 2020


Opinion | How a Covid-19 Vaccine Could Cost Americans Dearly

By Elisabeth Rosenthal - NYT - July 6, 2020

Yes, of course, Americans’ health is priceless, and reining in a deadly virus that has trashed the economy would be invaluable.
But a Covid-19 vaccine will have an actual price tag. And given the prevailing business-centric model of American drug pricing, it could well be budget breaking, perhaps making it unavailable to many.
The last vaccine to quell a global viral scourge was the polio inoculation, which ended outbreaks that killed thousands and paralyzed tens of thousands each year in the United States. The March of Dimes Foundation covered the drug cost for a free national vaccination program.
It came in the mid-1950s, before health insurance for outpatient care was common, before new drugs were protected by multiple patents, before medical research was regarded as a way to become rich. It was not patented because it was not considered patentable under the standards at the time.
Now we are looking for viral deliverance when drug development is one of the world’s most lucrative businesses, ownership of drug patents is disputed in endless court battles, and monopoly power often lets manufacturers set any price, no matter how extraordinary. A new cancer treatment can cost a half-million dollars and old staples like insulin have risen manifold in price to thousands of dollars annually.
And the American government has no effective way to fight back.
Recent vaccines targeting more limited populations, such as a meningitis B vaccine for college students and the shingles vaccine for older adults, have a retail cost of $300 to $400 for a full course.
If a Covid-19 vaccine yields a price of, say, $500 a course, vaccinating the entire population would bring a company over $150 billion, almost all of it profit.
Kevin Schulman, a physician-economist at the Stanford Graduate School of Business, called that amount “staggering.” But Katherine Baicker, dean of the University of Chicago Harris School of Public Policy, said that from society’s perspective “$150 billion might not be an unreasonable sum” to pay to tame an epidemic that has left millions unemployed and cost the economy trillions.
Every other developed country has evolved schemes to set or negotiate prices, while balancing cost, efficacy and social good. The United States instead has let business calculations drive drug price tags, forcing us to accept and absorb ever higher costs. That feels particularly galling for treatments and vaccines against Covid-19, whose development and production is being subsidized and incentivized with billions in federal investment.
When AZT, the first effective drug for combating the virus that causes AIDS, was introduced in 1992, it was priced at up to $10,000 a year or about $800 a month. It was the most expensive prescription drug in history, at that time. The price was widely denounced as “inhuman.” Today that price gets you some drugs for toenail fungus.
Investors already smell big money for a Covid-19 vaccine.
The market cap of Moderna, a small Boston area company that has partnered with the National Institutes of Health in the vaccine race, has tripled since Feb. 20, to $23 billion from $7 billion, turning its chief executive into an overnight billionaire. While Moderna’s vaccine is regarded as a strong contender, the company has never brought a successful drug to market.
Manufacturers have traditionally claimed that only the lure of windfall profits would encourage them to take the necessary risks, since drug development is expensive and there’s no way of knowing whether they’re putting their money on a horse that will finish first, or scratch.
More recently they have justified high prices by comparing them to the costs they would prevent. Expensive hepatitis C drugs, they say, avoid the need for a $1 million liver transplant. No matter that the comparison being made is to the highly inflated costs of treating disease in American hospitals.
Such logic would be disastrous if it were applied to a successful Covid vaccine. Covid-19 has shut down countless businesses, creating record-high unemployment. And the medical consequences of severe Covid-19 mean weeks of highly expensive intensive care.
“Maybe the economic value of the Covid vaccine is a trillion and even if the expense to the company was a billion. That’s 1,000 times return on investment,” said Dr. Schulman. “No economic theory would support that.”
In 2015, the Senate Finance Committee came up with a simpler explanation for high drug prices. After reviewing 20,000 pages of company documents, it found that Gilead had, what the committee’s ranking Democratic member Ron Wyden of Oregon called, “a calculated scheme for pricing and marketing its hepatitis C drug based on one primary goal, maximizing revenue.”
In setting prices, drug makers rarely acknowledge the considerable federal funding and research that has helped develop their products; they have not offered taxpayer-investors financial payback.
The Biomedical Advanced Research and Development Authority, a federal agency known as Barda, is giving Moderna up to $483 million for late-stage development of its vaccine.
The basic science that has allowed the small company to move so rapidly was developed with a huge prior infusion of federal money to develop a treatment for diseases like Zika.
Francis Collins, the head of the National Institutes of Health, has said the government has some intellectual property rights. Moderna seems to dispute that view, saying that it is “not aware of any I.P. that would prevent us from commercializing” a Covid-19 vaccine.
Likewise, AstraZeneca, another top competitor, has received a Barda promise of up to $1.2 billion for commercializing a product derived from research at the University of Oxford.
There is no simple, direct mechanism for regulators or legislators to control pricing. Our laws, in fact, favor business: Medicare is not allowed to engage in price negotiations for medicines covered by its part D drug plan. The Food and Drug Administration, which will have to approve the manufacturer’s vaccine for use as ‘safe and effective,’ is not allowed to consider proposed cost. The panels that recommend approval of new drugs generally have no idea how they will be priced.
“The idea that we would allow ourselves to be held hostage in an emergency is mind boggling,” said David Mitchell, head of Patients for Affordable Drugs, an advocacy group.
That’s why a bipartisan coalition in the House recently proposed two new bills to prevent “price gouging” for “taxpayer funded Covid-19 drugs” to ensure affordable pricing.
The exact mechanisms for enacting the provisions therein — such as requiring manufacturers to reveal their actual development costs — remain unclear. The industry has previously protected development data as a trade secret. The bills would also require “reasonable pricing clauses” be included in agreements between drug companies and agencies funding their work. They propose waiving exclusive licenses for Covid-19 drugs, allowing competitors to sell the same products so long as they paid the patent holder royalties.
Other countries, such as Britain, take a more head on approach: a national body does a cost-benefit analysis regarding the price at which a new drug is worth being made available to its citizens. Health authorities then use that information to negotiate with a drug maker on price and to develop a national reimbursement scheme.
We could too, but would need to consider mechanisms outside of our current box — at least for this national emergency.
The federal government could, for example, invoke a never-before-used power called “march-in rights,” through which it can override a patent holder’s rights if it doesn’t make its medicines “available to the public on reasonable terms.” (Unfortunately, in already-signed agreements with Barda, some drug makers have explicitly watered down or eliminated that proviso.)
We could, alternatively, allow Medicare to negotiate drug prices — a proposal that has been raised by politicians and beaten back by industry again and again. We would then need to restrict markup for a Covid-19 vaccine for the private market. Otherwise we’d get the kinds of results emerging from the Covid testing industry, where Medicare pays $100 for the test but some labs charge insurers over $2,000.
There is already reason to worry that our deliverance from coronavirus will cost us plenty. Barda paid AztraZeneca up to $1.2 billion toward development, production and delivery of its candidate vaccine, in order to secure 300 million doses in October. Britain paid the equivalent of $80 million to secure 100 million doses in September — one-fifth of what the United States government agreed to pay per dose.
Ms. Baicker, the public policy school dean, thinks public scrutiny will prevent outrageous pricing. The industry has made various pledges, trying to balance corporate citizenry, while making eager investors happy: Astra Zeneca has promised one billion doses for low- and middle-income countries. Johnson and Johnson says it would make the Covid-19 vaccine available on a “not for profit basis” at $10 for “emergency pandemic use.”
We’ve heard such offers before. Pharmaceutical companies routinely provide coupons to cover patient co-payments for expensive drugs, so that we don’t squawk when they charge our insurance company tens of thousands for the medicine, driving up premiums year after year. A naloxone injector to reverse heroin overdoses is given free to some clinics, but priced at thousands for the rest.
And it won’t feel like a bargain if we get free or cheap vaccines during a pandemic, but pay dearly for annual Covid-19 shots thereafter.
Drug companies deserve a reasonable profit for taking on this urgent task of creating a Covid-19 vaccine. But we deserve a return, too.
So before these invaluable vaccines hit the market, we should talk about an actual price. Otherwise we will be stuck paying dearly for shots that the rest of the world will get for much less.
https://www.nytimes.com/2020/07/06/opinion/coronavirus-vaccine-cost.html?referringSource=articleShare

U.S. Will Pay $1.6 Billion to Novavax for Coronavirus Vaccine

The Maryland-based company, which has never brought a product to market before, just made the biggest deal to date with the Trump administration’s Operation Warp Speed.

by Katie Thomas - NYT - July 7, 2020


The federal government will pay the vaccine maker Novavax $1.6 billion to expedite the development of 100 million doses of a coronavirus vaccine by the beginning of next year, the company said on Tuesday.
The deal is the largest that the Trump administration has made so far with a company as part of Operation Warp Speed, the sprawling federal effort to make coronavirus vaccines and treatments available to the American public as quickly as possible. In doing so, the government has placed a significant bet on Novavax, a company based in Maryland that has never brought a product to market.
Operation Warp Speed is a multiagency effort that seeks to carry out President Trump’s pledge to make a coronavirus vaccine available by the end of the year, but the full extent of the project is still unclear. Officials have declined to list which vaccines and treatments are part of Operation Warp Speed.
In an interview on Sunday, Novavax’s president and chief executive, Stanley C. Erck, initially said he was not sure where in the government the $1.6 billion was coming from. A Novavax spokeswoman later said the money was coming from a “collaboration” between the Health and Human Services Department and the Defense Department.
In May, the administration announced it was awarding up to $1.2 billion as part of Operation Warp Speed to the British drugmaker AstraZeneca, which has said that its vaccine could be available by October. Four other companies — Moderna Therapeutics, Johnson & Johnson, Merck and Sanofi — have also received federal assistance for their experimental coronavirus vaccines.
“Adding Novavax’s candidate to Operation Warp Speed’s diverse portfolio of vaccines increases the odds that we will have a safe, effective vaccine as soon as the end of this year,” Alex M. Azar II, the health and human services secretary, said in a statement.
Mr. Erck said Novavax’s coronavirus vaccine uses the same technology as its other experimental vaccines, such as one for the flu, that have been tested in late-stage clinical trials. Novavax has recently brought in senior executives from established manufacturers like AstraZeneca and GlaxoSmithKline, he said.
“The risk they’re taking is that a company like ours — which doesn’t have a pipeline of already commercialized products — can we get to the big leagues and scale up?” he said. “And I think they’re placing the bet that we can.”
The U.S. investment comes after an international group, the Coalition for Epidemic Preparedness Innovations, awarded up to $388 million to Novavax in May to make its coronavirus vaccine available globally.
Several vaccine experts said Novavax’s vaccine would help diversify the federal portfolio by including another candidate that uses a protein-based vaccine that has worked against other pathogens, like hepatitis B. The Novavax vaccine uses microscopic particles that carry fragments of the coronavirus, prompting the body’s immune system to respond. Sanofi, which has received nearly $31 million in government funding, is also developing a vaccine that is based on viral proteins.
Other leading candidates are relying on less proven technologies. For example, Moderna is using genetic material from the coronavirus called mRNA to provoke an immune response, and AstraZeneca and Johnson & Johnson are both testing vaccines that use a harmless virus to deliver coronavirus genes into cells.
“This is a sort of diversification from other approaches, which makes a certain amount of sense,” said John P. Moore, a professor of microbiology and immunology at Weill Cornell Medical College in New York City. “You don’t want all of your eggs in one basket.”
Mr. Erck said the deal with the United States would allow Novavax to begin manufacturing the vaccines before the company concludes late-stage clinical trials, expected by the end of the year. The company would ensure that 100 million doses — enough for 50 million people to receive an initial shot and a booster — are delivered by the first quarter of 2021, if its coronavirus vaccine is proved safe and effective. In June, Novavax secured a $60 million contract from the Defense Department to guarantee the delivery of 10 million doses to vaccinate American troops for the coronavirus.
Novavax began early-stage safety trials in Australia in May, and the company has said it expects to make the results available this month. It said it planned to begin so-called Phase 3 efficacy trials by the fall of this year and could release interim data by the end of 2020.
There is no vaccine for the coronavirus, and many clinical trials fail when vaccines turn out to be ineffective or to cause serious side effects. Until now, new vaccines have taken years to develop, and many experts have said the aggressive timelines set by companies and government officials for a coronavirus vaccine are overly optimistic.
Through its deal with the Coalition for Epidemic Preparedness Innovations, Novavax is also setting up manufacturing in other sites around the world, including in Europe and Asia, to serve populations outside the United States. The company is using its own facilities to scale up manufacturing and will also contract with outside companies, Mr. Erck said.
He and others have noted that more than one vaccine will need to succeed in order to vaccinate the entire world. “Right now, we need and want everybody’s to work,” he said.
https://www.nytimes.com/2020/07/07/health/novavax-coronavirus-vaccine-warp-speed.html?action=click&module=Top%20Stories&pgtype=Homepage 


In a new hospital ranking, doing good counts nearly as much as doing well

By Sharon Begley- STAT - July 7, 2020
You won’t find the usual suspects like Massachusetts General Hospital or the Mayo Clinic at the top of a new ranking of U.S. hospitals. That’s because the rating system relies not just on traditional quality measures, but also on a hospital’s community-minded policies and avoidance of unnecessary care.
The rankings show that those hospitals with good clinical outcomes tend to score poorly in addressing inequities that affect the health of their communities. And even when hospitals perform many low-value procedures — those that research has shown to be of limited or no benefit — their patients generally have a low risk of dying both in the hospital and after being discharged, as well as a low risk of having to be readmitted.
No previous hospital rankings use “civic leadership,” which includes community-minded policies such as charity care, financial aid, and paying all staffers a living wage, or “value of care,” meaning whether a hospital avoids 13 procedures of questionable or clearly absent clinical benefit. The Lown Institute, a nonprofit think tank in Brookline, Mass., incorporated both measures into its rankings of 3,282 hospitals because “it is time for hospitals to rethink what it means to be great,” said Lown’s president, physician Vikas Saini.
Civic leadership matters because the health of the people in a hospital’s community “reflect things outside the four walls of a hospital,” he said. “If one patient is going back to a community without a lot of resources, where health equity is low, and another is going back to a wealthier community, their [long-term] health will be very different even if the quality of care in the hospital was identical. Hospitals have an obligation to improve the health of the outside community.”
Veterans of hospital rankings generally applauded Lown’s efforts, with caveats.
“I love that they’re measuring civic leadership,” said Sara Singer of Stanford University School of Medicine, an expert in health care management. “I also think they’re right to evaluate overuse of low-value procedures: You want to be sure you aren’t going to receive treatments you shouldn’t be receiving.”
She questioned, however, whether those measures should be bundled into a composite score, as Lown did. Quality of care indicators such as staffing levels and patient outcomes such as surgical mistakes and bedsores account for 50% of a hospital’s composite ranking and associated letter grade, while civic leadership counts for 30% and value of care 20%.
“I’m not sure civic leadership should influence where a patient chooses to get care as much as quality measures should,” Singer said, “though I can see using it to decide where you might make a charitable contribution.”
In contrast, patients would do well to consider a hospital’s overuse of procedures that research has shown to have little clinical benefit, she said, such as knee arthroscopy, spinal fusions, EEG for headache, hysterectomies for benign conditions such as uterine fibroids or pelvic organ prolapse, and putting stents in renal arteries.
Although a patient having, say, a hip replaced might not care whether a hospital performs many vertebroplasties (injecting bone “cement” into vertebrae to treat osteoporosis) or other low-value procedures unrelated to her planned surgery, Singer said, “I can imagine that if a hospital is overtreating patients with these particular procedures, it might overmedicate, oversedate, or overtreat you for what you’re there for, too.” In addition, some low-value care disproportionately affects people of color: Black women are more likely to have unnecessary hysterectomies than white women are.
Many hospitals perform high numbers of low-quality procedures, which tend to be lucrative (and waste an estimated $100 billion per year in health care spending). “The right thing to do financially isn’t necessarily the right thing to do for patients,” said Leah Binder, president and CEO of the Leapfrog Group, a nonprofit backed by large employers that aims to identify and promote high-quality, high-value health care and whose hospital ratings emphasize patient safety.
She called Lown’s decision to downgrade a hospital for performing many low-quality procedures “a breakthrough” in hospital ratings. “We know inappropriate care is an extremely significant problem for the health care system,” Binder said. “It’s also a terrible tragedy for individual patients to go through an unnecessary procedure.”
The American Hospital Association, however, said in a statement that the report offers consumers no “accurate and useful information,” instead offering “a hodgepodge of composite score, ranking, star ratings, and letter grades that will, at best, confuse consumers and likely mislead them.”
In Lown’s composite rankings, which are based on 2017 data from Medicare and other government sources, the top hospitals are JPS Health Network in Fort Worth, Texas; Marshall Medical Center in Placerville, Calif.; UPMC McKeesport in Pennsylvania; Seton Northwest Hospital in Austin, Texas; and Mercy Health-West Hospital in Cincinnati. Each scored A or A+ on all three measures, showing it is possible to do well by the community while also delivering excellent patient care, Saini said.
Of course, hospital rankings reflect the values of the groups that produce them. For instance, JPS gets an underwhelming C  from Leapfrog, due to safety failures (patient bedsores and falls), unresponsive doctors and nurses, and surgical problems (wounds splitting open and dangerous blood clots).
Of the top 100 in the Lown ranking, 91 are nonprofits. Only nine are safety-net hospitals, even though they account for 21% of the total. That’s probably because these hospitals tend to serve poorer communities, and even if they provide excellent care, patients might not receive the high-quality follow-up care that can keep them alive and healthy. Quality of care includes the percentage of patients who die one month, three months, and one year after their hospital stay.
“Life expectancy,” said Saini, often “depends more on your ZIP code than your genetic code” — an argument for hospitals to contribute to community groups that make a ZIP code healthier.
The top 100 also includes 53 teaching hospitals, which make up only one-third of all hospitals. Their overrepresentation reflects generally excellent patient outcomes and a culture of avoiding procedures that lack scientific evidence of efficacy.
The starkest disparity is between many hospitals’ excellent patient outcomes and their poor civic leadership, as measured by Lown. (It used Internal Revenue Service and other government data for CEO pay and spending on charity care and community organizations.) The leaders for civic leadership were Harris Health System in Houston and five New York City public hospitals.
On average, 2.8% of hospital expenses went to charity care. But while the most charitable spent 15% or more, about 150 spent less than 0.1%. And although some nonprofit hospitals, whose tax-exempt status requires them to provide “community benefits,” spent 20% or more on their community, some spent less than 1%.
A number of hospitals renowned for their quality of care got A+ or A for patient outcomes but a D for civic leadership, including Massachusetts General Hospital, the Cleveland Clinic, the Mayo Clinic, and the University of Washington in Seattle. Teaching hospitals such as these do pretty well on supporting their communities, but pay equity — multimillion-dollar salaries for top executives — sinks them in Lown’s calculation of civic leadership. Not a single hospital in the top 100 for patient outcomes was in the top 100 for civic leadership, and vice versa.
Few patients are likely to reject a hospital based on how much it pays its CEO relative to its custodians. But Binder called civic leadership an important metric. “If there is anything you want out of a hospital, it’s ethics,” she said. Charity care, community support, and pay equity “are informative about a hospital’s culture.”
https://www.statnews.com/2020/07/07/new-hospital-ranking-counts-doing-good-nearly-as-much-as-doing-well/ 
 

Voters in deep-red Oklahoma approve Medicaid expansion

by Amy Goldstein - The Washington Post - July 1, 2020



Oklahomans voted Tuesday to alter their state constitution to expand Medicaid over nearly a decade of opposition by Republican governors, making their state the first to widen the safety-net insurance program as the coronavirus pandemic steals jobs and health benefits.
The expansion’s approval, by a slender margin, means that an estimated 250,000 additional Oklahoma residents will be eligible for the public insurance, including nearly 50,000 who have lost coverage as unemployment has soared this year.


The decision in a Republican-leaning state is rich in political significance. Oklahoma becomes the fifth state in which voters have passed ballot initiatives to expand Medicaid by employing a tool to circumvent the will of GOP governors and legislatures. Another Medicaid-expansion vote is pending in Missouri early next month.
The 50.5 percent vote in favor of Oklahoma’s ballot question, announced late Tuesday night, shows that, even in red states, voters are significantly less hostile to the Affordable Care than President Trump, whose administration is trying to invalidate the law in a case before the Supreme Court. The ACA is the law that gives states the ability to expand Medicaid, a program run jointly by states and the federal government that originated out of the 1960s’ War on Poverty. With Tuesday’s vote, all but 13 states have decided to allow adults without children at home and those with slightly higher incomes into the program.
“It’s important for the country to know what happened in Oklahoma last night,” Amber England, campaign manager for Yes on 802, the grass-roots group leading the effort to pass the measure, said Wednesday. “In the middle of the pandemic, Oklahomans stood up to deliver health care to our friends, families and neighbors.”
Question 802 was the number of the initiative on the state’s primary ballot. She said volunteers collected 313,000 signatures — a state record — to get the question before voters, and hosted Zoom happy hours instead of house parties in this pandemic spring. Both proponents and opponents ran ads.
The vote results do not expand Medicaid in the Sooner State immediately or automatically. Under the wording change to the state constitution, the expansion will start in one year. The state is required within 90 days to submit to federal health officials a request to make the change to its Medicaid program. And the state legislature would need to agree to pay for the state’s portion of funding for the expansion, at least 90 percent of which is covered by federal money under ACA rules.
Approving the change “is huge, but it’s also just the start,” said Carly Putnam, policy director of the Oklahoma Policy Institute, which favors the expansion. “We are finally at the point where we can do the hard work to get this implemented.”
Oklahoma Gov. Kevin Stitt (R) immediately made his opposition clear.
“Our Oklahoma legislators now have the difficult job of deciding where we will find an estimated $200 million in funding to support this constitutional mandate,” Stitt said in a statement Wednesday.
With states’ finances eroded from shutting down large parts of their economy to help protect people from the coronavirus, Stitt said, “we are currently looking at a $1 billion deficit for this upcoming year, and the options on the table are raise taxes on hard working Oklahomans or cut finding to core services, such as education, roads and bridges or public safety.”
In Oklahoma, the Medicaid vote occurred against a complicated backdrop. The state is the only one so far that had taken the Trump administration up on an offer to abandon the program’s traditional status as a federal entitlement, in which each state is paid a fixed amount for each person who qualifies. Instead, the administration has said it is willing to free states from a lot of federal rules if they switch to a per-person cap — or a block grant, in which a state’s federal money would be fixed in times of economic crisis, such as a pandemic, when more people would qualify. Oklahoma applied for such a switch this spring, and it is unclear how the expansion vote will affect that.
According to the federal Bureau of Labor Statistics, Oklahoma’s unemployment rate for the civilian labor force shot up from 3.2 percent in February to 14.7 percent in April.
Stitt cited the sharp rise in unemployment — and a bigger pool of residents who now qualify for Medicaid — in May when he vetoed a bill that would have provided money for the first phase of the Medicaid transition to a block grant the governor has asked federal officials to approve.
In embracing a more expansive version of Medicaid, residents of Oklahoma — a state in which about two-thirds of voters supported Trump in the 2016 election — fit within a broad political shift. A May poll by the Kaiser Family Foundation, a nonpartisan health research organization, showed that two-thirds of people in states that had not expanded Medicaid thought their state should do so. That preference was even more common (72 percent) among adults in those states who said they or someone in their home had lost pay or a job during the pandemic.
Oklahoma’s Medicaid ballot initiative was different from the four others, because it called for a change to a state constitution rather than state laws. Others have hit snags after the vote. Maine passed a ballot initiative in late 2017, but Medicaid did not expand there until a Republican governor was succeeded by a Democrat in early 2019. Political wrangling ensued in Utah and Idaho before the expansions began there. Like those two states, Nebraska approved an expansion in November 2018, but it is not scheduled to take effect until this fall.

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