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Americans’ healthcare paradox: ‘angst’ on costs, overconfidence on quality

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https://www.healthcaredive.com/news/americans-healthcare-paradox-angst-on-costs-overconfidence-on-quality/551876/

Dive Brief:

  • More than three in four Americans expect healthcare costs to increase over the next few years and result in “significant and lasting damage” to the U.S. economy, according to a survey by nonprofit West Health and Gallup. And 69% were “not at all” confident policymakers will fix the situation.
  • Given the choice between a 10% increase in income or a complete five year freeze of healthcare costs, 61% of people said they’d choose the latter, in line with the almost half of Americans concerned that a major health event would lead to bankruptcy for their family. In the past year alone, 12% have borrowed money to pay for care and 10% had foregone treatment due to cost.
  • However, although just 39% of those surveyed were pleased with the U.S. healthcare system as a whole, 64% were satisfied in how it worked for their households. Roughly half believe the quality of U.S. healthcare is either the “best in the world” or “among the best.”

Dive Insight:

Frustrations faced by Americans in paying for healthcare are understandable given that the U.S. ranks first among the 36 OECD developed nations in healthcare cost per person.

But their belief in the supremacy of the U.S. healthcare system is misplaced at best.

The U.S. ranks 31st among the OECD group in terms of infant mortality, a key indicator of overall quality, and a depressing 28th in overall life expectancy.

While healthcare is more regulated in nearly every other developed country, mammoth bills pack a bigger punch because they can come out of nowhere in the U.S. Some 47% of Americans reported never knowing what a visit to the emergency room will cost before receiving care. Just 19% of respondents said they “always” knew their out-of-pocket costs before visiting the ER.

Outpatient surgery, visits to a physical therapist or chiropractor, and check-ups and physicals didn’t fare much better, with only 17%, 23% and 39% of respondents respectively saying they always knew their out-of-pocket costs at those sites of care.

Obfuscation of prices may lead to “risky and unhealthy behavior,” according to the West Health report. It found 41% of Americans surveyed reported forgoing a visit to the ER over the past year due to cost concerns.

And this fear over costs is affecting people at every rung of the socioeconomic ladder. West Health and Gallup found the concern wasn’t just unique to people struggling financially — it was consistent up to the top 10% of earners.

“Angst is a very appropriate word to use when you see the data,” Mike Ellrich, healthcare portfolio leader at Gallup said at the West Health Healthcare Costs Innovation Summit on Tuesday.

Political debate over fixing this problem has centered of late on drug prices, surprise medical bills, pre-existing conditions and lowering insurance premiums, which are rising faster than income. And CMS has prodded providers and payers to make out-of-pocket costs more transparent for patients.

But Americans largely don’t think politicians will be able to fix the problem, with more than two-thirds of Republicans and Democrats alike not at all confident that elected officials will be able to achieve bipartisan legislation to lower costs.

However, perceptions of quality diverged among party lines. West Health and Gallup found 67% of Republicans view the U.S. healthcare system as delivering the best or among the best care in the world. Just 38% of Democrats agreed.

“I’m all for patriotism, but this is a disconnect from reality,” Ellrich said. “This issue is not red or blue.”

 

 

 

Obamacare fight obscures America’s real health care crisis: Money

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https://www.politico.com/story/2019/04/03/obamacare-health-care-crisis-1314382

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The ceaseless battle over the 2010 law has made it difficult to address the high cost of American health care.

The Obamacare wars have ignored what really drives American anxiety about health care: Medical costs are decimating family budgets and turning the U.S. health system into a runaway $3.7 trillion behemoth.

Poll after poll shows that cost is the number one issue in health care for American voters, but to a large extent, both parties are still mired in partisan battles over other aspects of Obamacare – most notably how to protect people with pre-existing conditions and how to make insurance more affordable, particularly for people who buy coverage on their own.

That leaves American health care consumers with high premiums, big deductibles and skyrocketing out-of-pocket costs for drugs and other services. Neither party has a long-term solution — and the renewed fight over Obamacare that burst out over the past 10 days has made compromise even more elusive.

Democrats want to improve the 2010 health law, with more subsidies that shift costs to the taxpayer. Republicans are creating lower-cost alternatives to Obamacare, which means shifting costs to older and sicker people.

Neither approach gets at the underlying problem — reducing costs for both ordinary people and the health care burden on the overall U.S. economy.

Senate HELP Committee chair Lamar Alexander, the retiring Tennessee Republican with a reputation for deal-making, has reached out to think tanks and health care professionals in an attempt to refocus the debate, saying the interminable fights about the Affordable Care Act have “put the spotlight in the wrong place.”

“The hard truth is that we will never get the cost of health insurance down until we get the cost of health care down,” Alexander wrote, soliciting advice for a comprehensive effort on costs he wants to start by summer.

But given the partisanship around health care — and the fact there have been so many similar outreaches over the years for ideas, white papers and commissions — it’s hard to detect momentum. Truly figuring how to fix anything as vast, complex and politically charged as health care is difficult. Any serious effort will create winners and losers, some of whom are well-protected by powerful K Street lobbies.

And the health care spending conversation itself gets muddled. People’s actual health care bills aren’t always top of mind in Washington.

“Congress is looking at federal budgets. Experts are looking at national health spending and the GDP and value. And the American people look at their own out-of-pocket health care costs and the impact it has on family budgets,” said Drew Altman, the president and CEO of the Kaiser Family Foundation, which extensively tracks public attitudes on health.

But Congress tends to tinker around the edges — and feud over Obamacare.

“We’re doing nothing. Nothing. We’re heading toward the waterfall,” said former CBO director Doug Elmendorf, now the dean of the Harvard Kennedy School, who sees the political warfare over the ACA as a “lost decade,” given the high stakes for the nation’s economic health.

The solutions championed by the experts — a mix of pricing policies, addressing America’s changing demographics, delivering care more efficiently, creating the right incentives for people to use the right care and the smarter use of high-cost new technologies — are different than what the public would prescribe. The most recent POLITICO-Harvard T.H. Chan School of Public Health poll found the public basically wants lower prices, but not a lot of changes to how — or how much — they consume health care, other than spending more on prevention.

Lawmakers are looking at how to start chipping away at high drug prices, or fix “surprise” medical bills that hit insured people who end up with an out-of-network doctor even when they’re at an in-network hospital. Neither effort is insignificant, and both are bipartisan. While those steps would help lower Americans’ medical bills, health economists say they won’t do enough to reverse the overall spending trajectory.

Drug costs and surprise bills, which patients have to pay directly, “have been a way the public glimpses true health care costs,” said Melinda Buntin, chair of the Department of Health Policy at Vanderbilt University School of Medicine. “That information about how high these bills and these charges can be has raised awareness of health care costs — but it has people focused only on that part of the solution.”

And given that President Donald Trump has put Obamacare back in the headlines, the health law will keep sucking up an outsized share of Washington’s oxygen until and quite likely beyond the 2020 elections.

Just in the last week, the Justice Department urged the courts to throw out Obamacare entirely, two courts separately tossed key administration policies on Medicaid and small business health plans, and Trump himself declared he wants the GOP to be the “party of health care.” Facing renewed political pressure over the party’s missing Obamacare replacement plan, Trump last week promised Republicans would devise a grand plan to fix it. He backtracked days later and said it would be part of his second-term agenda.

Democrats say Trump’s ongoing assaults on the ACA makes it harder to address the big picture questions of cost, value and quality. “That’s unfortunately our state of play right now,” said Rep. Raul Ruiz (D-Calif.). “Basic health care needs are being attacked and threatened to be taken away, so we have to defend that.”

The ACA isn’t exactly popular; more than half the country now has a favorable view of it, but it’s still divisive. But for Republicans and Democrats alike, the new POLITICO-Harvard poll found the focus was squarely on health care prices — the cost of drugs, insurance, hospitals and doctors, in that order.

The Republicans’ big ideas have been to encourage less expensive health insurance plans, which are cheaper because they don’t include the comprehensive benefits under Obamacare. That may or may not be a good idea for the young and healthy, but it undoubtedly shifts the costs to the older and sicker. The GOP has also supported spending hundreds of millions less each year on Medicaid, which serves low-income people — but if the federal government pays less, state governments, hospitals and families will pay more.

Last week, courts blocked rules in two states that required many Medicaid enrollees to work in order to keep their health benefits, and also nixed Trump’s expansion of association health plans, which let trade groups and businesses offer coverage that doesn’t include all the benefits required under the ACA.

House Democrats last week introduced a package of bills that would boost subsidies in the Obamacare markets and extend that financial assistance to more middle-class people. The legislation would also help states stabilize their insurance markets — something that the Trump administration has also helped some states do through programs backstopping health insurers’ large costs.

These ideas may also bring down some people’s out-of-pocket costs, which indirectly lets taxpayers pick up the tab. These steps aren’t meaningless — more people would be covered and stronger Obamacare markets would stabilize premiums — but they aren’t an overall fix.

The progressive wing of the Democratic party backs “Medicare for All,” a brand new health care system that would cover everyone for free, including long-term care for elderly or disabled people. Backers say that the administrative simplicity, fairness, and elimination of the private for-profit insurance industry would pay for much of it.

The idea has moved rapidly from pipe dream to mainstream, but big questions remain even among some sympathetic Democrats about financing and some of the economic assumptions, including about how much of a role private insurance plays in Medicare today, and how much Medicare puts some of its costs onto other payers. Already a political stretch, the idea would face a lot more economic vetting, too.

The experts, as well as a smattering of politicians, define the health cost crisis more broadly: what the country spends. Health care inflation has moderated in recent years; backers of the Affordable Care Act say the law has contributed to that. But health spending is still growing faster than the overall economy. CMS actuaries said this winter that if current trends continue, national health expenditures would approach nearly $6 trillion by 2027 — and health care’s share of GDP would go from 17.9 percent in 2017 to 19.4 percent by 2027. There aren’t a lot of health economists who’d call that sustainable.

And ironically, the big fixes favored by the health policy experts — the ones that Alexander is collecting but most politicians are ignoring — might address many of the problems that keep aggravating U.S. politics. If there were rational prices that reflected the actual value of care provided for specific episodes of illness and treatment, instead of the fragmented system that largely pays for each service provided to patients, then no medical bill would be a surprise, noted Mark McClellan, who was both FDA and CMS chief under the President George W. Bush and now runs the Duke-Margolis Center for Health Policy.

“But taking those steps take time and will be challenging,” McClellan noted. “And they’ll be resisted by a lot of entrenched forces.”

 

 

 

Philadelphia hospital to lay off 175 employees amid financial troubles

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https://www.beckershospitalreview.com/hospital-management-administration/philadelphia-hospital-to-lay-off-175-employees-amid-financial-troubles.html?origin=cfoe&utm_source=cfoe

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Philadelphia-based Hahnemann University Hospital plans to lay off 175 nurses, support staff and managers as it struggles to keep its doors open, hospital officials told philly.com.

“We are in a life-or-death situation here at Hahnemann,” said Joel Freedman, chairman and founder of American Academic Health System, which bought Hahnemann and St. Christopher’s Hospital for Children from Dallas-based Tenet Healthcare in January 2018.

“We’re not Tenet with endless cash. We’re running out of money,” Mr. Freedman added.

He told philly.com Hahnemann won’t stay afloat without help from government, insurers and its academic partner, Philadelphia-based Drexel University.

The layoffs, which represent about 6 percent of Hahnemann’s total workforce of 2,700, reportedly affect 65 nurses, 22 service and technical employees, and 88 nonunion workers and managers.

They come as Hahnemann has struggled financially. The hospital and and St. Christopher’s combined have $600 million to $700 million in annual revenue, compared to $790 million at the time of American Academic Health System’s purchase, according to philly.com.

Mr. Freedman, who is also CEO of healthcare investment firm and American Academic Health System affiliate El Segundo-based Paladin Healthcare, partially attributed the struggles at Hahnemann to a lower volume of patients. He also cited information technology and documentation problems at the hospital.

He expects the layoffs, along with other cost-cutting initiatives, such as the closure of some primary care offices, to save Hahnemann $18 million annually.

Read the full philly.com report here.

 

 

Amid labor talks, union unveils billboards highlighting Cedars-Sinai profits, CEO pay

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https://www.beckershospitalreview.com/human-capital-and-risk/amid-labor-talks-union-unveils-billboards-highlighting-cedars-sinai-profits-ceo-pay.html

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Healthcare workers at Los Angeles-based Cedars-Sinai Medical Center revealed a series of billboards that highlights profits and CEO pay at the hospital.  

The workers, who are represented by Service Employees International Union-United Healthcare Workers West, announced the billboards April 2 amid contract negotiations. The billboards are scheduled to appear throughout April at seven locations that are all within 1.5 miles of the hospital.

A union news release says the billboards aim to draw attention to “excessive profits and CEO compensation,” as well as the amount of charity care the nonprofit hospital provides.

“The public deserves to know that this elite hospital with huge profits and obscene CEO compensation, isn’t acting in the public’s best interests,” Dave Regan, president of SEIU-UHW, said in the release. “On top of paying no income or property taxes, Cedars-Sinai skimps when it comes time to care for the poorest people in our community.”

The hospital  addressed the union’s claims.

“The Cedars-Sinai Board of Directors believes in providing every one of our employees with compensation that is based upon merit of their individual performance, a rigorous review of each position’s responsibilities, and comparisons with other organizations for positions with similar responsibilities. For the president and CEO, the review process is even more extensive,” the statement said.

“[CEO]Tom Priselac’s compensation appropriately reflects his more than two-decade tenure of successfully presiding over the western United States’ largest nonprofit hospital. Under his leadership, Cedars-Sinai has earned national recognition for delivering the highest quality care to patients and has been ranked among the top medical centers in the country.

“Over the last 10 years alone, Cedars-Sinai has invested nearly $6 billion to benefit the local community by, among other things, providing free or part-pay care for patients who cannot afford treatment; by losses caring for Medicare and Medi-Cal patients; and by providing a wide range of free health programs and clinics in neighborhoods as well as education, health and fitness services in dozens of local schools.”

SEIU-UHW represents more than 1,800 service and technical workers at the hospital. The last contract with Cedars-Sinai expired March 31.

 

 

 

Trump is reading the GOP base wrong on the Affordable Care Act

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https://www.axios.com/trump-reading-base-wrong-aca-b6e2521c-d386-4c94-81e8-b018a6aaf3b1.html?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosvitals&stream=top

Image result for Trump is reading the GOP base wrong on the Affordable Care Act

 

The only plausible explanation for President Trump’s renewed effort through the courts to do away with the Affordable Care Act, other than muscle memory, is a desire to play to his base despite widely reported misgivings in his own administration and among Republicans in Congress.

Reality check: But the Republican base has more complicated views about the ACA than the activists who show up at rallies and cheer when the president talks about repealing the law. The polling is clear: Republicans don’t like the ACA, but just like everyone else, they like its benefits and will not want to lose them.

The big picture: About three quarters of Republicans still have an unfavorable view of the ACA, and seven in 10 say repealing the law is a top health priority for Congress — higher than other priorities such as dealing with prescription drug costs. And yes, 7 in 10 Republicans still want to see the Supreme Court overturn the law.

But as the chart shows, majorities of Republicans like many elements of the ACA —especially closing the “donut hole” in Medicare prescription drug coverage (80%), eliminating copayments for preventive services (68%), keeping young adults under 26 on their parents’ plans (66%) and subsidies for low and middle-income households (63%).

  • Nearly half of Republicans want the Supreme Court to keep the protections for pre-existing conditions (49%), and even more show general support for the pre-existing conditions protections (58%).
  • During the repeal and replace debate in 2017, even Republicans were nervous to hear that these sorts of things would go away. The 2020 campaign would drive home to the public, and to Republicans, what they have to lose — and it would become especially real to them if the 5th Circuit Court of Appeals upholds the ruling striking down the ACA.

Maybe Republicans would forget about these lost benefits if they could agree on a replacement plan they liked? But there isn’t one, and many of the ideas thought to be elements of one — such as cutting and block granting both Medicaid and ACA subsidies — are non-starters with Democrats and moderate Republicans on Capitol Hill. They’re unpopular with the public, too. 

The bottom line: It is widely accepted that a renewed debate about repeal hands Democrats a powerful new political opportunity. Deeper in the polling, it’s also clear that’s it’s more of a mixed bag for Republicans than President Trump may realize.  

 

 

 

So, about being the “party of health care”

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https://www.axios.com/newsletters/axios-vitals-4b66c0e1-2525-4bb1-a974-f97c9e3e5392.html?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosvitals&stream=top

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GOP leaders are trying their best to put a lid on President Trump’s talk of a new and wonderful health care plan that would define the Republican Party for 2020.

“Not any longer,” Senate Majority Leader Mitch McConnell said yesterday when asked whether he and Trump differ on health care.

  • McConnell said he spoke to Trump Monday and “made it clear to him that we were not going to be doing that in the Senate.”
  • RNC Chair Ronna McDaniel and Trump campaign manager Brad Parscale also “tried to tell the president they could not understand what he was doing,” The New York Times reports.

Rhetorically, Trump has kicked the can past 2020, just after pushing his administration to dive back into — and escalate — the legal fight that hurt Republicans so badly in 2018.

  • “I wanted to delay it myself,” Trump said in the Oval Office yesterday, denying that McConnell forced his hand. “I want to put it after the election, because we don’t have the House.”

Reality check: It’s still the Justice Department’s position that the courts should strike down the Affordable Care Act. As long as this lawsuit is still active — and that will be a while — it’ll be accurate for Democrats to say on the campaign trail that Trump is trying to end protections for pre-existing conditions.

  • In the short term, Trump’s rhetorical punt to 2021 may dampen the intensity of questions about how Republicans would rebuild a new system for individual coverage — questions the party has struggled to answer for the past 9 years.
  • But in the end, the only good way out is for the Trump administration to lose this case.

 

 

 

A motley crew in Texas v. Azar

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A motley crew in Texas v. Azar

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Together with Jonathan Adler, Abbe Gluck, and Ilya Somin, I’ve filed an amicus brief with the Fifth Circuit in Texas v. Azar. Those of you who’ve been closely following health-reform litigation know that Abbe and I often square up against Jonathan and Ilya. It’s a testament to the outlandishness of the district court’s decision that we’ve joined forces. Like our original district court filing, the brief focuses on severability.

In 2017, Congress zeroed out all the penalties the ACA had imposed for not satisfying the individual mandate. Yet it left everything else undisturbed, including the guaranteed-issue and community-rating provisions. That simple fact should be the beginning and end of the severability analysis. It was Congress, not a court, that made the mandate unenforceable. And when Congress did so, it left the rest of the scheme, including those two insurance reforms, in place. In other words, Congress in 2017 made the judgment that it wanted the insurance reforms and the rest of the ACA to remain even in the absence of an enforceable individual mandate.

Because Congress’s intent was explicitly and duly enacted into statutory law, consideration of whether the remaining parts of the law remain “fully operative”—an inquiry courts often use in severability analysis as a proxy for congressional intent—is unnecessary.

Nor does the district court’s incessant focus on findings that Congress made about a mandate backed by financial penalties hold water.

The 2010 Congress believed that 2010’s penalty-backed mandate was necessary to induce a significant number of healthy people to purchase insurance, and thereby “significantly reduc[e] the number of the uninsured.” 42 U.S.C. § 18091(2)(E). But because the neutered mandate of 2017 lacks a penalty, it could not have been based on those earlier findings. They are thus irrelevant. The earlier findings have been overtaken by Congress’s developing views—based on years of experience under the statute—that the individual marketplaces created by the ACA can operate without penalizing Americans who decline to purchase health insurance.

At bottom, a toothless mandate is essential to nothing. A mandate with no enforcement mechanism cannot somehow be essential to the law as a whole. That is so regardless of the finer points of severability analysis or congressional intent. The district court’s conclusion makes no sense.

There are (at least!) two other notable amicus briefs in the case.

The first is from Sam Bray, Michael McConnell, and Kevin Walsh. In a terse 1,000 words, they argue—correctly, in my view—that “Congress has not vested the federal courts with statutory subject-matter jurisdiction to opine whether an unenforceable statutory provision is unconstitutional.” In this, they sound many of the same themes that Jonathan Adler and yours truly sounded in arguing that plaintiffs lack standing under the Constitution. But Bray, McConnell, and Walsh hitch their argument not to Article III, but to the jurisdictional reach of the Declaratory Judgment Act.

The second is from the Republican attorneys general of Ohio and Montana. They agree that the mandate is unconstitutional, but they have no truck with the argument that all or part of the Affordable Care Act should be struck down. “At the same time that Congress made the mandate inoperative, it left in place the remainder of the Affordable Care Act. As a result, the application of the severability doctrine in this case requires no ‘nebulous inquiry into hypothetical congressional intent.’ … To the contrary, the Court can see for itself what Congress wanted by looking to what it did.” Their participation suggests deep fractures in the down-with-the-ACA-at-all-costs coalition.

So, by my count, the parties and amici have pressed at least four independent reasons for getting rid of this case. First, because plaintiffs lack standing. Second, because the courts lack jurisdiction under the Declaratory Judgment Act. Third, because there is no “mandate” and thus no constitutional problem (as Marty Lederman has rightly argued). And fourth, because even if there is a mandate and it’s unconstitutional, it’s fully severable.

This isn’t a federal case. It’s a choose-your-own-adventure book where all the adventures lead to the end of this misbegotten litigation.

 

 

 

Western Maryland Health System, UPMC to pursue merger

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https://www.beckershospitalreview.com/hospital-transactions-and-valuation/western-maryland-health-system-upmc-to-pursue-merger.html?origin=cfoe&utm_source=cfoe

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Cumberland, Md.-based Western Maryland Health System has signed a nonbinding letter of intent with Pittsburgh-based UPMC to pursue a merger.

The systems entered a clinical affiliation in February 2018.  Over the next few months they will engage in further due diligence and research to reach a definitive merger agreement.

A merger would “allow WMHS to maintain clinical excellence in western Maryland and throughout the region for years to come,” said Barry Ronan, president and CEO of the Maryland health system. “Since we became clinically affiliated with UPMC in 2018, we have a stronger clinical and operational position, allowing a broad range of nationally recognized care here locally for the people of Allegany County and surrounding counties in Maryland, Pennsylvania and West Virginia.”

 

 

HRSA rolls out drug pricing site for 340B hospitals

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https://www.fiercehealthcare.com/hospitals-health-systems/hrsa-rolls-out-drug-pricing-site-for-340b-hospitals?mkt_tok=eyJpIjoiWldVeU5HSmtZek5oT1dSaiIsInQiOiJYUXRUNlZ3dGc2aVBWOVdtZ1BGb3Y2bUZNOFowbFwvQ2Y3SzZBcTB6aWswRFJtSEZ5eWFFVStCWmt1TFprZ2V4bDIzS29idkZoZ2dcL1dPbDhQV3NuV0dZXC9cL1M4XC9rc0hKMkNvY3JFa1B6OHlHeWFRZm5YcjdZa1hCdEl0bU9sdkgxIn0%3D&mrkid=959610&utm_medium=nl&utm_source=internal

Drug prices

After multiple delays, the Health Resources & Services Administration (HRSA) has finally launched an online tool that 340B hospitals can use to determine the maximum that pharmaceutical companies can charge for drugs.

HRSA’s new pricing site went live on Monday morning and is one of the elements mandated in the long-delayed final rule for the 340B drug discount program. That rule, which took effect on Jan. 1, also adds monetary penalties for drug companies that overcharge hospitals in the program.

The final rule was first issued in January 2017 and was delayed five times by the Trump administration before going into effect this year. HRSA finally rolled out the rule as it determined the provisions would not interfere with the administration’s broader drug pricing policy. 

Provider groups and 340B advocates cheered the website’s launch. Maureen Testoni, CEO of 340B health, a group that represents more than 1,300 providers participating in the program, said in a statement that the new tool’s release “marks a positive milestone in the history of the 340B program.” 

“Today’s launch of a secure website listing the maximum allowable prices for all 340B covered drugs brings a healthy dose of sunshine into a marketplace that has, for far too long, been a black box,” Testoni said. “Until today, hospitals, clinics and health centers participating in 340B had no way to be sure they were paying the correct amount for the drugs they purchase.” 

340B Health was joined by the American Hospital Association (AHA), America’s Essential Hospitals and the Association of American Medical Colleges on a lawsuit filed in September with the goal of pushing HRSA to implement the rule.

Tom Nickels, executive vice president at AHA, said in a statement that the group was “pleased” that its lawsuit led to the site’s launch.

“As prescription drug prices continue to skyrocket, the 340B program is as crucial as ever in helping hospitals provide access to healthcare services for patients in vulnerable communities,” Nickels said. 

Amid the drug price debate, the 340B program has been under the microscope. The program has enjoyed traditionally bipartisan support, but intense lobbying from the pharmaceutical industry has led to criticism that it has grown too large.

The Centers for Medicare & Medicaid Services also slashed the program’s payment rate in 2017, a shift in a longstanding Medicare policy that culled $1.6 billion in payments from the program. Hospital groups are currently battling the payment changes in court. 

 

 

ELITE HOSPITALS PLUNGE INTO UNPROVEN STEM CELL TREATMENTS

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Hospitals say they’re providing options to patients who have exhausted standard treatments. But critics suggest the hospitals are exploiting desperate patients and profiting from trendy but unproven treatments.

The online video seems to promise everything an arthritis patient could want.

The six-minute segment mimics a morning talk show, using a polished TV host to interview guests around a coffee table. Dr. Adam Pourcho extols the benefits of stem cells and “regenerative medicine” for healing joints without surgery. Pourcho, a sports medicine specialist, says he has used platelet injections to treat his own knee pain, as well as a tendon injury in his elbow. Extending his arm, he says, “It’s completely healed.”

Brendan Hyland, a gym teacher and track coach, describes withstanding intense heel pain for 18 months before seeing Pourcho. Four months after the injections, he says, he was pain-free and has since gone on a 40-mile hike.

“I don’t have any pain that stops me from doing anything I want,” Hyland says.

The video’s cheerleading tone mimics the infomercials used to promote stem cell clinics, several of which have recently gotten into hot water with federal regulators, said Dr. Paul Knoepfler, a professor of cell biology and human anatomy at the University of California-Davis School of Medicine. But the marketing video wasn’t filmed by a little-known operator.

It was sponsored by Swedish Medical Center, the largest nonprofit health provider in the Seattle area.

Swedish is one of a growing number of respected hospitals and health systems — including the Mayo Clinic, the Cleveland Clinicand the University of Miami — that have entered the lucrative business of stem cells and related therapies, including platelet injections. Typical treatments involve injecting patients’ joints with their own fat or bone marrow cells, or with extracts of platelets, the cell fragments known for their role in clotting blood. Many patients seek out regenerative medicine to stave off surgery, even though the evidence supporting these experimental therapies is thin at best, Knoepfler said.

Hospitals say they’re providing options to patients who have exhausted standard treatments. But critics suggest the hospitals are exploiting desperate patients and profiting from trendy but unproven treatments.

The Food and Drug Administration is attempting to shut down clinics that hawk unapproved stem cell therapies, which have been linked to several cases of blindness and at least 12 serious infections. Although doctors usually need preapproval to treat patients with human cells, the FDA has carved out a handful of exceptions, as long as the cells meet certain criteria, said Barbara Binzak Blumenfeld, an attorney who specializes in food and drug law at Buchanan Ingersoll & Rooney in Washington.

Hospitals like Mayo are careful to follow these criteria, to avoid running afoul of the FDA, said Dr. Shane Shapiro, program director for the Regenerative Medicine Therapeutics Suites at Mayo Clinic’s campus in Florida.

‘EXPENSIVE PLACEBOS’

While hospital-based stem cell treatments may be legal, there’s no strong evidence they work, said Leigh Turner, an associate professor at the University of Minnesota’s Center for Bioethics who has published a series of articles describing the size and dynamics of the stem cell market.

“FDA approval isn’t needed and physicians can claim they aren’t violating federal regulations,” Turner said. “But just because something is legal doesn’t make it ethical.”

For doctors and hospitals, stem cells are easy money, Turner said. Patients typically pay more than $700 a treatment for platelets and up to $5,000 for fat and bone marrow injections. As a bonus, doctors don’t have to wrangle with insurance companies, which view the procedures as experimental and largely don’t cover them.

“It’s an out-of-pocket, cash-on-the-barrel economy,” Turner said. Across the country, “clinicians at elite medical facilities are lining their pockets by providing expensive placebos.”

Some patient advocates worry that hospitals are more interested in capturing a slice of the stem-cell market than in proving their treatments actually work.

“It’s lucrative. It’s easy to do. All these reputable institutions, they don’t want to miss out on the business,” said Dr. James Rickert, president of the Society for Patient Centered Orthopedics, which advocates for high-quality care. “It preys on people’s desperation.”

In a joint statement, Pourcho and Swedish defended the online video.

“The terminology was kept simple and with analogies that the lay person would understand,” according to the statement. “As with any treatment that we provide, we encourage patients to research and consider all potential treatment options before deciding on what is best for them.”

But Knoepfler said the guests on the video make several “unbelievable” claims.

At one point, Dr. Pourcho says that platelets release growth factorsthat tell the brain which types of stem cells to send to the site of an injury. According to Pourcho, these instructions make sure that tissues are repaired with the appropriate type of cell, and “so you don’t get, say, eyeball in your hand.”

Knoepfler, who has studied stem cell biology for two decades, said he has never heard of “any possibility of growing eyeball or other random tissues in your hand.” Knoepfler, who wrote about the video in February on his blog, The Niche, said, “There’s no way that the adult brain could send that kind of stem cells anywhere in the body.”

The marketing video debuted in July on KING-TV, a Seattle station, as part of a local lifestyles show called “New Day Northwest.” Although much of the show is produced by the KING 5 news team, some segments — like Pourcho’s interview — are sponsored by local advertisers, said Jim Rose, president and general manager of KING 5 Media Group.

After being contacted by KHN, Rose asked Swedish to remove the video from YouTube because it wasn’t labeled as sponsored content. Omitting that label could allow the video to be confused with news programming. The video now appears only on the KING-TV website, where Swedish is labeled as the sponsor.

“The goal is to clearly inform viewers of paid content so they can distinguish editorial and news content from paid material,” Rose said. “We value the public’s trust.”

INCREASING SCRUTINY

Federal authorities have recently begun cracking down on doctors who make unproven claims or sell unapproved stem cell products.

In October, the Federal Trade Commission fined stem cell clinics millions of dollars for deceptive advertising, noting that the companies claimed to be able to treat or cure autism, Parkinson’s disease and other serious diseases.

In a recent interview Scott Gottlieb, the FDA commissioner, said the agency will continue to go after what he called “bad actors.”

With more than 700 stem cell clinics in operation, the FDA is first targeting those posing the biggest threat, such as doctors who inject stem cells directly into the eye or brain.

“There are clearly bad actors who are well over the line and who are creating significant risks for patients,” Gottlieb said.

Gottlieb, set to leave office April 5, said he’s also concerned about the financial exploitation of patients in pain.

“There’s economic harm here, where products are being promoted that aren’t providing any proven benefits and where patients are paying out-of-pocket,” Gottlieb said.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said there is a broad “spectrum” of stem cell providers, ranging from university scientists leading rigorous clinical trials to doctors who promise stem cells are “for just about anything.” Hospitals operate somewhere in the middle, Marks said.

“The good news is that they’re somewhat closer to the most rigorous academics,” he said.

The Mayo Clinic’s regenerative medicine program, for example, focuses conditions such as arthritis, where injections pose few serious risks, even if that’s not yet the standard of care, Shapiro said.

Rickert said it’s easy to see why hospitals are eager to get in the game.

The market for arthritis treatment is huge and growing. At least 30 million Americans have the most common form of arthritis, with diagnoses expected to soar as the population ages. Platelet injections for arthritis generated more than $93 million in revenue in 2015, according to an article last year in The Journal of Knee Surgery.

“We have patients in our offices demanding these treatments,” Shapiro said. “If they don’t get them from us, they will get them somewhere else.”

Doctors at the Mayo Clinic try to provide stem cell treatments and similar therapies responsibly, Shapiro said. In a paper published this year, Shapiro described the hospital’s consultation service, in which doctors explain patients’ options and clear up misconceptions about what stem cells and other injections can do. Doctors can refer patients to treatment or clinical trials.

“Most of the patients do not get a regenerative [stem cell] procedure,” Shapiro said. “They don’t get it because after we have a frank conversation, they decide, ‘Maybe it’s not for me.'”

LOTS OF HYPE, LITTLE PROOF

Although some hospitals boast of high success rates for their stem cell procedures, published research often paints a different story.

The Mayo Clinic website says that 40 to 70% of patients “find some level of pain relief.” Atlanta-based Emory Healthcare claims that 75 to 80% of patients “have had significant pain relief and improved function.” In the Swedish video, Pourcho claims “we can treat really any tendon or any joint” with PRP.

The strongest evidence for PRP is in pain relief for arthritic knees and tennis elbow, where it appears to be safe and perhaps helpful, said Dr. Nicolas Piuzzi, an orthopedic surgeon at the Cleveland Clinic.

But PRP hasn’t been proven to help every part of the body, he said.

PRP has been linked to serious complications when injected to treat patellar tendinitis, an injury to the tendon connecting the kneecap to the shinbone. In a 2013 paper, researchers described the cases of three patients whose pain got dramatically worse after PRP injections. One patient lost bone and underwent surgery to repair the damage.

“People will say, ‘If you inject PRP, you will return to sports faster,'” said Dr. Freddie Fu, chairman of orthopedic surgery at the University of Pittsburgh Medical Center. “But that hasn’t been proven.”

A 2017 study of PRP found it relieved knee pain slightly better than injections of hyaluronic acid. But that’s nothing to brag about, Rickert said, given that hyaluronic acid therapy doesn’t work, either. While some PRP studies have shown more positive results, Rickert notes that most were so small or poorly designed that their results aren’t reliable.

In its 2013 guidelines for knee arthritis, the American Academy of Orthopaedic Surgeons said it is “unable to recommend for or against” PRP.

“PRP is sort of a ‘buyer beware’ situation,” said Dr. William Li, president and CEO of the Angiogenesis Foundation, whose research focuses on blood vessel formation. “It’s the poor man’s approach to biotechnology.”

Tests of other stem cell injections also have failed to live up to expectations.

Shapiro published a rigorously designed study last year in Cartilage, a medical journal, that found bone marrow injections were no better at relieving knee pain than saltwater injections. Rickert noted that patients who are in pain often get relief from placebos. The more invasive the procedure, the stronger the placebo effect, he said, perhaps because patients become invested in the idea that an intervention will really help. Even saltwater injections help 70% of patients, Fu said.

A 2016 review in the Journal of Bone and Joint Surgery concluded that “the value and effective use of cell therapy in orthopaedics remain unclear.” The following year, a review in the British Journal of Sports Medicine concluded, “We do not recommend stem cell therapy” for knee arthritis.

Shapiro said hospitals and health plans are right to be cautious.

“The insurance companies don’t pay for fat grafting or bone-marrow aspiration, and rightly so,” Shapiro said. “That’s because we don’t have enough evidence.”

Rickert, an orthopedist in Bedford, Ind., said fat, bone marrow and platelet injections should be offered only through clinical trials, which carefully evaluate experimental treatments. Patients shouldn’t be charged for these services until they’ve been tested and shown to work.

Orthopedists — surgeons who specialize in bones and muscles — have a history of performing unproven procedures, including spinal fusion, surgery for rotator cuff disease and arthroscopy for worn-out knees, Turner said. Recently, studies have shown them to be no more effective than placebos.

MISLEADING MARKETING

Some argue that joint injections shouldn’t be marketed as stem cell treatments at all.

Piuzzi said he prefers to call the injections “orthobiologics,”noting that platelets are not even cells, let alone stem cells. The number of stem cells in fat and bone marrow injections is extremely small, he said. In fat tissue, only about 1 in 2,000 cells is a stem cell, according to a March paper in The Bone & Joint Journal. Stem cells are even rarer in bone marrow, where 1 in 10,000 to 20,000 cells is a stem cell.

Patients are attracted to regenerative medicine because they assume it will regrow their lost cartilage, Piuzzi said. There’s no solid evidence that the commercial injections used today spur tissue growth, Piuzzi said. Although doctors hope that platelets will release anti-inflammatory substances, which could theoretically help calm an inflamed joint, they don’t know why some patients who receive platelet injections feel better, but others don’t.

So, it comes as no surprise that many patients have trouble sorting through the hype.

Florida resident Kathy Walsh, 61, said she wasted nearly $10,000 on stem cell and platelet injections at a Miami clinic, hoping to avoid knee replacement surgery.

When Walsh heard about a doctor in Miami claiming to regenerate knee cartilage with stem cells, “it seemed like an answer to a prayer,” said Walsh, of Stuart, Fla. “You’re so much in pain and so frustrated that you cling to every bit of hope you can get, even if it does cost you a lot of money.”

The injections eased her pain for only a few months. Eventually, she had both knees replaced. She has been nearly pain-free ever since. “My only regret,” she said, “is that I wasted so much time and money.”