Health Care Firms Were Pushed to Confront Racism. Now Some Are Investing in Black Startups.

NASHVILLE, Tenn. — Marcus Whitney stands out in Nashville’s $95 billion health care sector as an investor in startups. In addition to co-founding a venture capital firm, he’s organized an annual health tech conference and co-founded the city’s professional soccer club.

And, often, he’s the only Black man in the room.

So in summer 2020, as Black Lives Matter protesters filled city streets around the country following George Floyd’s murder, Whitney pondered the racial inequalities that are so obvious in his industry — especially locally.

“I sat at the intersection of two communities — one that I was born into and one that I had matriculated into,” he said.

On a quiet Sunday morning after the protests died down, he pounded out a long letter to his peers that pointed out those making the most money from Nashville’s for-profit health care industry are still almost all white men.

Whitney hit publish on Monday, leading to weeks of intense conversations.

The racial reckoning of the past couple of years has inspired many industries to take a look at their histories and practices. In health care, there are long-standing and well-documented disparities in care for Black and white patients.

Those disparities have carried over into who gets funding for research and health startups. Of the nation’s more than 900,000 health care and social assistance companies, which include home health and other health services, roughly 35,000 — or fewer than 4% — are Black-owned, according to data from the U.S. Census Bureau. 

Whitney wrote that this problem isn’t his to fix, but he realized he’s in a unique position as one of the few Black venture capitalists in health care. So his firm, Jumpstart Foundry, launched a dedicated fund to get behind Black entrepreneurs in health care. The letter was “pretty key” to pulling in investors, he said.

The fund is called Jumpstart Nova. It’s a tiny slice of the estimated $42 billion of venture funding invested last year in health tech. But it did exceed its initial goal, raising $55 million from the likes of pharmaceutical giant Eli Lilly, medical supplier Cardinal Health, and the hospital chain that started Nashville’s health care industry, HCA. 

Each corporation measures its annual profits in the billions of dollars, so the fund represents only a sliver of their investments. But Jumpstart is also just one part of their broader diversity investment initiatives. For example, Indianapolis-based Eli Lilly has committed $92 million to Black-led venture capital firms since December 2020, according to company spokesperson Carrie Martin Munk.

Whitney said he didn’t have to convince those blue-chip firms that investing in Black founders was a wise move, but he did have to make the case that they would have enough promising startups from which to choose.

“That was really emblematic of the fact that there was a disconnect between the communities. These investors simply did not know enough Black people to know whether or not there were enough deals out there,” Whitney said. “This is not like an indictment of them. This is the reality of our country.”

Jumpstart Nova is the lead investor in three of the four companies it’s working with so far. That means Whitney’s team scrutinizes the business plan, vouches for the founder, and draws up all the financial and legal documents so it’s easier for others to come along.

“It’s validation. You need someone to say, ‘We’re in,’” said Dr. Derrell Porter, founder of San Francisco-based Cellevolve Bio, one of the first startups to land a lead investment from Jumpstart Nova. 

His firm is trying to streamline the process of commercializing promising cell therapies. Hundreds are in development, and of those, each is customized for a patient by using the patient’s own cells. The therapies target cancer, central nervous system diseases, or viruses. Cellevolve is partnering with academic medical centers and small biotech companies in an attempt to make the commercializing process more similar to how a pharmaceutical company shepherds a drug to market.

“Marcus was one of the few investors that I spoke to that immediately got what we’re talking about,” Porter said. “He was like, ‘This is either not going to work at all, or it’s going to be massive. It’s nowhere in between.’”

Porter said his only discomfort has been feeling pressured at times to play the role of a Black entrepreneur with a hard-scrabble upbringing. “Folks are looking for the story to tug on their heart strings,” he said. “But that wasn’t my life.”

He grew up in Compton, California, in a middle-class family, with a mother who is a nurse and a father in construction. “I can’t tell you this traumatic, inner-city, drama-filled narrative,” said Porter, who has an M.D. and an MBA from the University of Pennsylvania. 

Jumpstart is primarily looking for Black-led companies with untapped profit potential. But the venture fund’s backers also say they expect some startups will work on fixing health inequities.

One of the fund’s initial investments is in DrugViu, which consolidates the medical records of people with autoimmune diseases — particularly underrepresented people of color — so their personal health data can more easily be included in scientific research.

Dr. James Hildreth, president of Meharry Medical College in Nashville, said he hopes some startups will work to ensure health inequities don’t get worse, especially now that so many new companies in health care are built around using artificial intelligence. Hildreth said he fears what big data could do without Black representation in the decision-making process or — as DrugViu is trying to resolve — in the clinical data.

“The people designing the algorithms can unconsciously sometimes put their own biases into how the algorithms are designed and how they function,” he said.

The historically Black medical school launched its own for-profit arm in 2021 to seek “profitable activities that align with Meharry’s mission of eliminating health disparities.” Meharry has also invested in the Jumpstart Nova fund. Hildreth said he sees it as an opportunity to make money and to make a statement to students.

“We believe enough in the ingenuity, the innovation, and the intelligence of folks who look like us that we’re willing to invest in them,” Hildreth said. “With the expectation that the companies that come out of this fund are going to have a huge impact, not just on our communities, but people in general.” 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Readers and Tweeters Have Mental Health Care on Their Minds

Letters to the Editor is a periodic feature. We welcome all comments and will publish a selection. We edit for length and clarity and require full names.

Therapists Aren’t Psychic

Your article on the No Surprises Act offered clarity into some difficulties faced by therapists and their patients in determining financial parameters of treatment (“Mental Health Therapists Seek Exemption From Part of Law to Ban Surprise Billing,” Feb. 3). Most people (therapists included) agree that surprise bills are not a pleasant surprise. What seems missing in this otherwise nuanced article, however, is an articulation of the difficulty in “estimating” the cost of a therapeutic endeavor and how this, too, is a frequent objection to the act.

A therapist cannot usually guess at the length or frequency of therapy in advance of the treatment. It is unreasonable to say, “It will cost you X for the whole episode of care.” To apply a template ahead of time and say, for example, that a patient will need 10 sessions (or 10 years) of care misses the point.

Patients are unique and their needs will evolve during the course of their treatment. Some will find they need more frequent sessions. Some will decide they might want a different therapeutic approach. Some want changes at a very deep level; some are hoping for a few meetings to clarify an emergent crisis. To offer an upfront cost estimation would severely disrupt many evidence-based treatments, including those treatments that offer an in-depth opportunity to get to the intricate roots of complex emotional problems (problems that might seem deceptively “simple” at first glance).

Patient and therapist make decisions together. This collaboration should never be a “surprise.” The new insistence on an initial cost estimate prioritizes short-term and quick-fix treatments at the expense of the kind of therapy that many patients might want and need.

— Betsy Nettleton, licensed clinical psychologist, Chicago

We love our mental health providers in CT. We need more of them!But yes, if you're out-of-network (as so many are b/c they know they can fill their panel), you're gonna have to give patients a reasonable idea of the cost of care as soon as you know it.https://t.co/PxGvxuMfbV

— Ted Doolittle (@TedDoolittle2) February 3, 2022

— Ted Doolittle, health care advocate for the state of Connecticut, Hartford, Connecticut

As a mental health provider, I feel that journalist Julie Appleby misrepresented our objections to the No Surprises Act. The article implies that therapists want to avoid transparency and keep costs high for consumers, which is wildly inaccurate.

The fact is that we have always been transparent in our fees — that has never been an issue. However, we do have serious objections to the law as it is being applied to us:

1) It is impossible to estimate the cost of a “total course” of treatment, as this is almost entirely up to the client. Services are completely voluntary, and clients pay at the time of the session — there is no situation, ever, where they could be surprised with a large bill, and they are free to decrease the frequency of appointments or discontinue at any time. Due to this impossible requirement, some therapists have opted to provide an “estimate” for a full year of weekly therapy — providing a lump sum, which is both overwhelming and useless. Some clients may view it as an obligation to commit to a full year of weekly sessions, while most do not need/desire that level of care. This can be harmful at a time when we are working to build trust and a therapeutic alliance with the individual. Imagine struggling to prioritize your mental health, and then facing an arbitrary “estimate” consisting of thousands of dollars — many people will be discouraged enough to forgo treatment.

2) Because we are already providing a document that lists our per-session fees (in addition to discussing them before scheduling, during intake, and prior to any periodic increases), the good faith estimate creates a redundant administrative burden on us and does nothing to improve client care.

3) Clients choose to go out of network for a number of reasons, including increased provider choice/specialization, control over their treatment (no managed-care constraints), and privacy. Often, going out of network means that a client can be helped immediately vs. being placed on a waitlist for an in-network provider, and their insurance benefits may still reimburse most or all of the cost. The implication that we need to put “cost pressure on providers” in this field is simply false — therapists are already among the lowest-paid health care workers (despite the requirement of a postgraduate degree and continuing education), and we already spend several hours per week on unpaid administrative tasks, both of which have contributed to a devastating shortage of mental health providers during a time of unprecedented need. According to payscale.com, the average mental health therapist makes $47,576 a year — well below the average salary in the U.S.

While I support the intention of the NSA, it simply does not make sense to apply it to mental health outside of a “facility” or emergency setting. The tone of this article is biased and should be revised to accurately reflect our objections.

As written, the NSA favors insurance companies, discourages out-of-network benefit use, and, frankly, is patronizing to clients, who are perfectly aware of what each session costs. The only time clients are “surprised” is when their insurance unexpectedly does not cover their treatment or reimbursement. My fees have always been crystal clear — where is the transparency from the insurance companies?

— Michelle Stevenson, Syracuse, New York

I am not surprised at the challenges being faced. Students looking for help amid the disruptions caused by the pandemic is to be expected. I recall early in the pandemic discussions over how to phrase a focus on student health in…https://t.co/cZl8oWOWoR https://t.co/padezLGq9F

— Kevin Frick (he/him) (@ProfKevinFrick) February 2, 2022

— Kevin Frick, Baltimore

Mental Health Care: Access vs. Quality

A top challenge in behavioral health is shifting focus from access to care to quality of care largely due to the increased demand for services throughout the pandemic. And quality starts and ends with evidence-based data. The question has been: How can we provide behavioral health services to everyone who needs it, regardless of location? While this should and will remain a priority in 2022, there will be an additional focus moving forward on quality of care. After all, what is the purpose of providing access to care if the quality of care isn’t addressed? Providers need to be asking themselves: Are people actually getting better through our behavioral health services, can we reduce readmissions, can we eliminate treatment failures?

To ensure high-quality care, behavioral health organizations will increasingly rely on measurable data to track patient and population outcomes. Data, derived from evidence-based assessments, intake forms, including social determinants of health insights, is ultimately what will inform clinical and operational executives if their programs and treatment plans are working. This information is also essential in determining how to make meaningful improvements to deliver the most effective and efficient care.

Delivering high-quality care starts and ends with data. Measurement-based care (MBC) — defined as the practice of providing clinical care based upon client data collected throughout treatment — will gain popularity as more behavioral health organizations rely on this methodology to improve the quality and consistency of care. With their ultimate business goal to improve clinical outcomes, hospitals and health systems will further recognize that incorporating MBC into their practices is the best way to confirm and document patient progress.

As far as value-based care: Value-based care models center on patient outcomes rather than the number of services or visits. Unlike the traditional fee-for-service model, value-based models align payer and provider incentives toward well care rather than sick care. Under this model, the focus is on quality and outcomes performance rather than patient/member utilization of services.

The year 2022 will bring in defined milestones and clear progress toward value-based care in behavioral health. There will be more pilots and programs of value-based reimbursement contracts between payers and providers.

— Eric Meier, president and CEO of Owl, Portland, Oregon

@KHNews. The #NoSurprisesAct does protect consumers. Except, it does it by giving a huge win to insurance companies at the expense of #doctors. This may well turn out to be a situation where the cure is worse than the disease.https://t.co/54elq1oVzA

— Ron Howrigon (@RonHowrigon) February 3, 2022

— Ron Howrigon, Raleigh, North Carolina

No Surprise the Law Is Confusing?

The description for the podcast “‘An Arm and a Leg’: Know Your ‘No Surprises’ Rights” (Feb. 2) says the No Surprises Act applies only to hospitals. It also applies to independent free-standing ERs. And the protections against balance billing at an in-network facility apply to both hospitals and ambulatory surgical centers.

— Kathy Bakich, Bethesda, Maryland

[Editor’s note: Thanks for your sharp eye and insight. The article has been corrected.]

$38.92: that’s how much professionals get for evaluating you in the ER — that should be ⁦@NoamLevey⁩’s headline https://t.co/BghI5AoQx9

— Cedric Dark, MD, MPH, FACEP (@RealCedricDark) February 8, 2022

— Dr. Cedric Dark, Houston

Nutritional Basics and Basic Rights

Thanks for the very important column by Chaseedaw Giles on the problems of quality food availability in certain urban neighborhoods (“What Does It Say About Your Neighborhood If the Supermarket Isn’t So Super?” Feb. 16). Boston is much better off in that regard than most other cities, but it is the rural areas that suffer the most. Most small towns across the country have very low-quality food choices; Dollar Generals and other similar stores — with their food (if one can call it that) that’s high in refined sugar — dominate the available stores. This is just one more reason that rural America is suffering so much with chronic lifestyle diseases, unemployment, and substance abuse. We need more reporting and action to resolve this existential problem.

— Alan Wright, Roslindale, Massachusetts

How a store is stocked depends on size, product movement, shelf size, and a mix of customer feedback and data. But stores' commercial decisions encourage low income people with poor diets to continue the habits that caused their diet-related illnesses. https://t.co/m6Skebkkco?

— Julian Agyeman (@julianagyeman) February 15, 2022

— Julian Agyeman, Cambridge, Massachusetts

Checking Up on Kaiser Permanente

I must say I am biased with regards to Kaiser Permanente (“California Inks Sweetheart Deal With Kaiser Permanente, Jeopardizing Medicaid Reforms,” Feb. 3). It is the worst health care provider ever. Doctors are not available, not enough locations, bad medical services department, phone service, hold times, wait times for appointments, the pharmacies are a joke.

The fact that Kaiser Permanente and Gov. Gavin Newsom are having backroom deals irks me to no end. KP’s goal is to own the Medi-Cal system in California. Poor Newsom has so much money in California, thanks to overtaxation, he won’t pay to have the poor, elderly, and disabled properly cared for.

Yes, I plan on sharing this info with all. This is just like the mob. No joke. Both should be ashamed and humiliated by these actions. I could see these bad practices extended to all cities in the U.S., called socialized medicine. Terrifying.

If you are young and have a family, it’s just great. But don’t age or fall prey to some terrible disease for which you need proactive care. You won’t get it.

— Kim Carrasco, Folsom, California

Actionable intervention targets identified in this piece by @besables. Start-up bonuses are nice, but they go away. What can endure & attract nurses long term is committing to improving the work environments for long-run safety and quality. https://t.co/NWXj03WA06 via @khnews

— Dr. Chris Friese, RN (@ChrisFriese_RN) February 8, 2022

— Chris Friese, Ann Arbor, Michigan

Poaching of Staff Is Widespread

Great article on the effects of staffing shortages on rural hospitals (“Bounties and Bonuses Leave Small Hospitals Behind in Staffing Wars,” Feb. 7). I am concerned that all the press focus has been on hospital effects because they have great teams that can provide support for getting the article written. However, I work with safety-net clinics that are not federally qualified health centers. Our clinics that predominantly serve uninsured and Medicaid community members are also being affected and that is reducing access to care for these underserved communities.

Employees don’t even have to have certification to be poached, they just have to have done their practicum (they can use an oximeter, blood pressure cuff, and understand loading data into an electronic health record) and they can get an $8,000 bonus just for showing up at the hospital down the street. That means our clinics are doing the basic training for hospitals and losing all that benefit in communities most in need. Some of our clinics are having to reduce hours because they simply don’t have the staff to provide care to uninsured/Medicaid patients. This is incredibly frustrating and painful for underserved communities to face this, just as in rural communities. I hope we will not forget these communities in our efforts to explain the challenges in health care today.

— Phyllis Albritton, Colorado Safety Net Collaborative, Westminster, Colorado

Does the military really not know?“We don’t know why that data isn’t showing up in the FPDS database, as it should be visible and searchable. Army Contracting Command is looking into the issue and working to remedy it as quickly as possible,” https://t.co/gntAKkPWej

— David Balat (@DavidBalatHC) February 11, 2022

— David Balat, Austin, Texas

‘Rapid’ At-Home Tests: Too Little, Too Late

I, like many others, on Jan. 19 signed up on the government site for the free at-home tests. I waited weeks for any word of delivery — nothing. They finally showed up on Feb. 15. Still, two kits for four (!) at-home tests per family are ridiculously inadequate. Especially for a family of over, say, two members.

I grade this effort by the government totally inadequate. Too little, too late. Sound bites vs. actual results.

— Evan Hassiotis, Roswell, Georgia

What are taxpayers spending for ‘Free’ Covid tests? The government won’t say. 380M tests for $2B would suggest ~$5.25 per kit (available globally for <$1-$2; comparable HIV antibody are < $1) but need exact amounts to be sure. Contracts are secret?https://t.co/gzFMg7j3l9

— Dr. Ali Khan (@DrAliSKhan) February 14, 2022

— Dr. Ali Khan, Omaha, Nebraska

Free But Unpatriotic

Regarding the article “What Are Taxpayers Spending for Those ‘Free’ Covid Tests? The Government Won’t Say (Feb. 11): Why did the government buy kits from another country instead of ones made in the USA? Is there a reason why the United States government can’t spend the taxpayers’ money on U.S.-made products? I am now wondering if the N95 masks that are going to be free to us from the government will be purchased from U.S. companies. We have not been able to find any in our area.

— Beverly Neibert, Marysville, Pennsylvania

Speaking from personal experience…this is a quiet crisis.Endured by families at the brink. Problem is…they’re among the very few who know just how big of a problem this is. https://t.co/3M2ShrsGRY

— Chris Vanderveen (@chrisvanderveen) February 3, 2022

— Chris Vanderveen, Denver

Strengthening the Foundation for Home Health Care

No patient in need should be left without care — period. Home health agencies must have the resources they need to meet the demands of today’s health care workforce. As demand for home health care continues to grow, Medicare must address the way it reimburses agencies for care in order to help us meet patients’ current and future needs through the recruitment and retention of a skilled workforce (“Pandemic-Fueled Shortages of Home Health Workers Strand Patients Without Necessary Care,” Feb. 3).

Home health care, which has always been a popular option for seniors and families, has shown its value during the pandemic. That’s because it has helped many seniors recover from serious illness and injury without needing to be admitted to skilled nursing facilities, which have been challenged with covid-19 outbreaks. According to analyses, the demand for home health will increase rapidly in the years ahead as America’s Medicare-aged population continues to surge.

Unfortunately, Medicare policy contributes to serious labor shortages because Medicare’s payment adjustments have not been reflective of labor and administrative price trends in the home health sector. Though the pandemic and creeping inflation have both caused labor costs (including wages, benefits, hiring, and retention) to jump sharply, annual home health payment updates declined from CY 2019 to CY 2022. This trend is simply unsustainable: If the annual payment rate update continues to fall below rising workforce, labor, and care delivery costs, Medicare risks undermining the sustainability of America’s home health system.

By keeping pace with rising labor costs, Medicare and other payors can ensure home health agencies are better prepared to meet the demands of more American seniors who want to be cared for at home.

— Joanne E. Cunningham, executive director of the Partnership for Quality Home Healthcare, Washington, D.C.

https://t.co/mUw9ahV6Pe I'm sure this plays a role in the high numbers of deaths due to COVID.

— Beatrice Westrate (@beeinchicago) February 3, 2022

— Beatrice Westrate, Chicago

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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An $80,000 Tab for Newborns Lays Out a Loophole in the New Law to Curb Surprise Bills

When Greg and Sugar Bull were ready to start a family, health challenges necessitated that they work with a gestational surrogate. The woman who carried and gave birth to their twins lived two states away.

The pregnancy went well until the surrogate experienced high blood pressure and other symptoms of preeclampsia, which could have harmed her and the babies. Doctors ordered an emergency delivery at 34 weeks’ gestation. Both infants had to spend more than a week in the neonatal intensive care unit.

It was April 2020, early in the pandemic. Unable to take a plane, the Bulls drove from their home in Huntington Beach, California, to the hospital in Provo, Utah. They had to quarantine in Utah before they could see the children in the hospital.

A couple of weeks later, after the babies could eat and breathe on their own, the Bulls took them home to California.

Then the bills came.

The Patients: Scarlett and Redford Bull, newborn twins covered by a Cigna policy sponsored by Greg Bull’s employer. The gestational surrogate had her own insurance, which covered her care.

Medical Service: Neonatal intensive care when the babies were born prematurely after emergency induced labor. Scarlett spent 16 days in the NICU; Redford, 10.

Total Bill: $117,084. The hospital was out of network for the infants. Cigna paid for some of Scarlett’s care, for reasons the Bulls couldn’t figure out. The Bulls were left on the hook for about $80,000, for both babies. Their account was ultimately sent to collections.

Service Provider: Utah Valley Hospital in Provo, Utah, one of 24 hospitals run by Intermountain Healthcare, a nonprofit with about $8 billion in revenue.

What Gives: The Bulls’ ordeal points up a loophole in coverage for emergency care — even under the No Surprises Act, which took effect Jan. 1 and outlaws many kinds of surprise medical bills.

Patients who need prompt, lifesaving treatment often don’t have time to find an in-network hospital. In the past, health plans sometimes have said they would pay for emergency care even if it’s out of network. The No Surprises Act now makes this a legal requirement in every state. The provider and insurer are supposed to negotiate a reasonable payment, leaving the patient out of the equation.

But what if the insurance company denies that the care is for an emergency? Or the hospital doesn’t supply the paperwork to prove it?

That’s what happened to the Bulls. Cigna said it lacked documentation that the NICU care for the twins qualified as an emergency.

So the Bulls began receiving insurance explanations showing huge balances owed to Utah Valley. The family had expected to owe its out-of-network, out-of-pocket maximum of $10,000 for the twins’ care. They assumed most of the bills would be paid by Cigna soon. They weren’t.

“I was, like, there is no way this can be real,” said Sugar Bull, an interior designer.

“Dear Scarlett Bull,” began one of Cigna’s letters, addressed to a 6-month-old baby. “We found the service requested is not medically necessary.”

How could NICU care not qualify? The gestational surrogate was admitted to obstetrics by her doctor without going through the emergency department, which prompted Cigna to initially conclude there was no emergency, said Dylan Kirksey of Resolve Medical Bills, a consultancy that eventually worked with the Bulls to resolve the claims.

To establish that there was, Cigna asked for daily progress notes and other medical records on the infants. The Bulls tried to get the hospital to comply. Cigna kept saying it hadn’t received the necessary documentation.

The Bulls appealed. Sugar spent hours with insurance paperwork and hold music. But almost a year later, about $80,000 in bills remained. Utah Valley sent the accounts to collections, Sugar Bull said. It was the last thing she had time for.

“I own a company, and I am super busy, and we had twins,” she said. “Every two weeks or so, I would feel a panic and righteous anger about it. And I would keep pushing and calling, and it would take like five hours every time.”

Though they disputed what they were being charged, the Bulls agreed to pay the hospital $500 a month for five years to settle just one of the babies’ bills, in an attempt to keep their good credit.

Resolution: With seemingly nowhere else to turn, the family hired Resolve, which beats a path through the claims jungle in return for a portion of the money it saves clients.

“It was a lot of prodding” to get Utah Valley to give Cigna the information it needed to pay the hospital, said Kirksey, a senior advocate with Resolve, which was founded in 2019 and has 16 employees. He said he had to give the hospital a detailed list of steps to take and then follow up with multiple calls and emails per week.

In the end, most of the errors causing the Bulls’ nightmare were on the hospital’s side, Kirksey said. But instead of supplying what Cigna needed, Utah Valley went after the Bulls.

“The hospital repeatedly failed to provide a detailed list of services and important clinical information, despite our continuous efforts to secure the information,” said Cigna spokesperson Meaghan MacDonald.

“There were no errors on the hospital’s part,” said Utah Valley spokesperson Daron Cowley. “Utah Valley Hospital properly billed for services provided to the twins and provided the requested information to Cigna in a timely manner.”

The hospital didn’t bill the Bulls for outstanding balances until nine months after the twins were born and didn’t send the accounts to collections until six months after that, “after the family did not return the legally required paperwork to set up a payment plan,” he said.

Finally, in fall 2021, the bills were settled. The twins were 1½ years old. To compensate Resolve for curing the balance, the Bulls paid the company about 10% — $8,000.

The fee, though substantial and unrelated to medical care, was worth it to avoid the much larger debt, said Greg Bull, who works in finance. “At the end of the day, it was such a relief for it to be a smaller amount,” he said. Still, many families could not have afforded it.

The Takeaway: About 1 in 5 emergency room visits are at facilities that are out of network for the patient’s insurance, research has shown. The No Surprises Act requires insurers to cover non-network emergency treatment with the same patient cost sharing as in-network care. It also prohibits hospitals from billing patients extra.

But if the insurer denies that the care was for an emergency or doesn’t obtain documentation to prove it, the claim can still be rejected and the patient left on the hook.

“That’s a coding issue we see a lot,” said Kirksey, especially “if the person didn’t literally check in through the emergency room.”

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If this happens, insurance experts urge patients to immediately appeal the decision to the insurance company, a process the law requires to be available. Unfortunately, that usually requires more phone calls, paperwork, and waiting. (If the appeal with the insurer fails, patients can then turn to an independent reviewer, like their state insurance board, state attorney general’s office, or the No Surprises Help Desk.)

“It would be a critical step for the consumer to leverage their appeal rights … and get the determination that it was an emergency service from the get-go,” said Kevin Lucia, co-director of the Center on Health Insurance Reforms at Georgetown University.

Once it’s established that the visit was for an emergency, he said, protections from the No Surprises Act clearly apply.

The No Surprises Act is a step in the right direction. But it is clear that loopholes and minefields remain.

Stephanie O’Neill contributed the audio portrait with this story.

Bill of the Month is a crowdsourced investigation by KHN and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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‘Injections, Injections, Injections’: Troubling Questions Follow Closure of Sprawling Pain Clinic Chain

HANFORD, Calif. — On May 13 of last year, the cellphones of thousands of California residents undergoing treatment for chronic pain lit up with a terse text message: “Due to unforeseen circumstances, Lags Medical Centers will be closing effective May 19, 2021.”

In a matter of days, Lags Medical, a sprawling network of privately owned pain clinics serving more than 20,000 patients throughout the state’s Central Valley and Central Coast, would shut its doors. Its patients, most of them working-class people reliant on government-funded insurance, were left without ready access to their medical records or handoffs to other physicians. Many patients were dependent on opioids to manage the pain caused by a debilitating disease or injury, according to alerts about the closures that state health officials emailed to area physicians. They were sent off with one final 30-day prescription, and no clear path for how to handle the agony — whether from their underlying conditions or the physical dependency that accompanies long-term use of painkillers — once that prescription ran out.

The closures came on the same day that the California Department of Health Care Services suspended state Medi-Cal reimbursements to 17 of Lags Medical’s 28 locations, citing without detail “potential harm to patients” and an ongoing investigation by the state Department of Justice into “credible allegations of fraud.” In the months since, the state has declined to elaborate on the concerns that prompted its investigation. Patients are still in the dark about what happened with their care and to their bodies.

Even as the government remains largely silent about its investigation, interviews with former Lags Medical patients and employees, as well as KHN analyses of reams of Medicare and Medi-Cal billing data and other court and government documents, suggest the clinics operated based on a markedly high-volume and unorthodox approach to pain management. This includes regularly performing skin biopsies that industry experts describe as out of the norm for pain specialists, as well as notably high rates of other sometimes painful procedures, including nerve ablations and high-end urine tests that screen for an extensive list of drugs.

Those procedures generated millions of dollars in insurer payments in recent years for Lags Medical Centers, an affiliated network of clinics under the ownership of Dr. Francis P. Lagattuta. The clinics’ patients primarily were insured by Medicare, the federally funded program for seniors and people with disabilities, or Medi-Cal, California’s Medicaid program for low-income residents.

Taken individually, the fees for each procedure are not eye-popping. But when performed at high volume, they add up to millions of dollars.

Take, for example, the punch biopsy, a medical procedure in which a circular blade is used to extract a sample of deep skin tissue the size of a pencil eraser. The technique is commonly used in dermatology to diagnose skin cancer but has limited use in pain management medicine, usually involving a referral to a neurologist, according to multiple experts interviewed. These experts said it would be unusual to use the procedure as part of routine pain management.

In Lagattuta’s specialty — physical medicine and rehabilitation, a common pain management field — just six of the nearly 8,000 U.S. physicians treating Medicare patients billed for punch biopsies on more than 10 patients in 2019, the most recent year for which data was available. Four, including Lagattuta, were affiliated with Lags Medical.

Medicare and Medi-Cal data are organized differently, and each provides distinct insights into Lags Medical’s billing practices. For Medicare, KHN’s findings reflect the number of procedures and actual reimbursements billed through Lagattuta’s provider number. But the Medicare figures do not encompass services and billing amounts for other providers across the chain, nor reimbursements for patients enrolled in private Medicare Advantage plans.

KHN used Medi-Cal records to assess the volume of services performed across the entire chain. But the state could not provide totals for how much Lags Medical was reimbursed because of California’s extensive use of managed-care plans, which do not make their reimbursement rates public. Where possible, KHN estimated the worth of Medi-Cal procedures based on the set rates Medi-Cal pays traditional fee-for-service plans, which are public.

Lags Medical clinics performed more than 22,000 punch biopsies on Medi-Cal patients from 2016 through 2019, according to state data. Medi-Cal reimbursement rates for punch biopsies changed over time. In 2019 the state’s reimbursement rate was more than $200 for a set of three biopsies performed on patients in fee-for-service plans.

Laboratory analysis of punch biopsies was worth far more. Lags Medical clinics sent biopsies to a Lags-affiliated lab co-located at a clinic in Santa Maria, according to medical records and employee interviews. From 2016 through 2019, Lags Medical clinics and providers performed tens of thousands of pathology services associated with the preparation and examination of tissue samples from Medi-Cal patients, according to state records. The services would have been worth an estimated $3.9 million using Medi-Cal’s average fee-for-service rates during that period.

In that same period, Medicare reimbursed Lagattuta at least $5.7 million for pathology activities using those same billing codes, federal data shows.

Much of the work at Lags Medical was performed by a relatively small number of nurse practitioners and physician assistants, each juggling dozens of patients a day with sporadic, often remote supervision by the medical doctors affiliated with the clinics, according to interviews with former employees. Lagattuta himself lived in Florida for more than a year while serving as medical director, according to testimony he provided as part of an ongoing malpractice lawsuit that names Lagattuta, Lags Medical, and a former employee as defendants.

Former employees said they were given bonuses if they treated more than 32 patients in a day, a strategy Lagattuta confirmed in his deposition in the malpractice lawsuit. “If they saw over, like, 32 patients, they would get, like, $10 a patient,” Lagattuta testified.

The lawsuit, filed in Fresno County Superior Court, accuses a Lags Medical provider in Fresno of puncturing a patient’s lung during a botched injection for back pain. Lagattuta and the other named defendants have denied the incident was due to negligent treatment, saying, in part, the patient consented to the procedure knowing it carried risks.

Hector Sanchez, the nurse practitioner who performed the injection and is named in the lawsuit, testified in his own deposition that providers at the Lags Medical clinic in Fresno each treated from 30 to 40 patients on a typical workday.

According to Sanchez’s testimony and interviews with two additional former employees, Lags Medical clinics also offered financial bonuses to encourage providers to perform certain medical procedures, including punch biopsies and various injections. “We were incentivized initially to do these things with cash bonuses,” said one former employee, who asked not to be named for fear of retribution. “There was a lot of pressure to get those done, to talk patients into getting these done.”

In his own deposition in the Fresno case, Lagattuta denied paying bonuses for specific medical procedures.

Interviews with 17 former patients revealed common observations at Lags Medical clinics, such as crowded waiting rooms and an assembly-line environment. Many reported feeling pressure to consent to injections and other procedures or risk having their opioid supplies cut off.

Audrey Audelo Ramirez said she had worried for years that the care she was receiving at a Lags Medical clinic in Fresno was subpar. In the past couple of years, she said, there were sometimes so many patients waiting that the line wrapped around the building.

Ramirez, 52, suffers from trigeminal neuralgia, a rare nerve disease that sends shocks of pain across the face so severe it’s known as the “suicide disease.” Over the years, Lags Medical had taken over prescribing almost all her medications. This included not only the opioids and gabapentin she relies on to endure excruciating pain, but also drugs to treat depression, anxiety, and sleep issues.

Ramirez said she often felt pressured to get procedures she didn’t want. “They were always just pushing injections, injections, injections,” she said. She said staffers performed painful punch biopsies on her that resulted in an additional diagnosis of small fiber neuropathy, a nerve disorder that can cause stabbing pain.

She was among numerous patients who said they felt they needed to undergo the recommended procedures if they wanted continued prescriptions for their pain medications. “If you refuse any treatment they say they’re going to give you, you’re considered noncompliant and they stop your medication,” Ramirez said.

She said she eventually agreed to an injection in her face, which she said was administered without adequate sedation. “It was horrible, horrible,” she said. Still, she said, she kept going to the office because there weren’t many other options in her town.

Lagattuta, through his lawyer, declined a request from KHN to respond to questions about the care provided at his clinics, citing the state investigation. “Since there is an active investigation, Dr. Lagattuta cannot comment on it until it is completed,” attorney Matthew Brinegar wrote in an email. Lagattuta’s license remains in good standing, and he said in his deposition in the Fresno lawsuit that he is still seeing patients in California.

Experts interviewed by KHN noted that medical procedures such as injections can have a legitimate role in comprehensive pain management. But they also spoke in general terms about the emergence of a troubling pattern at U.S. pain clinics involving the overuse of procedures. In the 1990s and early 2000s, problematic pain clinics hooked patients on opioids, then demanded cash to continue prescriptions, said Dr. Theodore Parran, who is a professor of medicine at Case Western Reserve University and has served as an expert witness in federal investigations into pain clinics.

“What has replaced them are troubled pain clinics that hook patients with the meds and accept insurance, but overuse procedures which really pay well,” he said. For patients, he added, the consequences are not benign.

“I mean they are painful,” he said. “You’re putting needles into people.”

‘Knee Injections, Hip Injections, Foot Injections’

Before moving to California in 1998, Dr. Francis Lagattuta lived in Illinois and worked as a team doctor for the Chicago Bulls during its 1995-96 championship season. Out West, he opened a clinic in Santa Maria, a Latino-majority city along California’s Central Coast known for its strawberry fields, vineyards, and barbecue. From 2015 to 2020, the chain grew from a couple of clinics in Santa Barbara County to dozens throughout California, largely in rural areas, as well as far-flung locations in Washington state, Delaware, and Florida.

The California portion of the chain is organized as more than two dozen corporations and limited liability corporations owned by Lagattuta. His son, Francis P. Lagattuta II, was a manager for the company.

On the Lags Medical website and in conversation with employees, the elder Lagattuta claimed he was on the vanguard of diagnosing and treating small fiber neuropathy. Much of the website has now been taken down. But pages available via an archival site claim he had pioneered a three-pronged approach to pain management that made minimal use of opioids and surgeries, instead emphasizing testing, injections, mental health, diet, and exercise. “In keeping with his social justice values, Dr. Lagattuta plans to share these findings to the rest of the world, hopefully to help solve the opioid crisis, and end suffering for millions of people struggling with pain,” touted a biography once highlighted on the website.

Numerous Lags Medical patients interviewed by KHN said that even when they were given punch biopsies and a subsequent diagnosis of neuropathy, their treatment plan continued to involve high doses of opioid medications.

Dr. Victor C. Wang, chief of the division of pain neurology at Brigham and Women’s Hospital in Boston, said punch biopsies are occasionally used in research but are not a standard part of pain medicine. Instead, small fiber neuropathy is usually diagnosed with a simple clinical exam.

“The treatment is going to be the same whether you have a biopsy or not,” said Wang. “I always tell the fellows, you can do this test or that one, but is it really going to change the management of the patient?”

Ruby Avila, a mother of three in Visalia, remembers having the punch biopsies done at least three times during her four years as a Lags Medical patient. “I have scars down my leg,” she said. Each time, she said, providers removed a set of three skin specimens that were used to diagnose her with small fiber neuropathy.

Avila, 37, who has lived with pain since childhood, had found it validating to finally have a diagnosis. But after learning more about how common the biopsies were at Lags Medical, she was shaken. “It’s overwhelming to hear that they were doing it on a lot of people,” she said.

Sanchez, the nurse practitioner named in the Fresno lawsuit, spoke of other procedures that garnered bonuses: “Trigger point injections, knee injections, hip injections, foot injections for plantar fasciitis and elbow injections” all qualified for $10 bonuses, he said in his testimony.

Two former employees, who asked not to be named, echoed Sanchez, saying they were incentivized to do certain procedures, including injections and punch biopsies.

In his testimony in the Fresno case, Lagattuta denied paying bonuses for procedures. “It was only for the patients,” he said. “We never did it based on procedures.”

Incentive systems for a specific procedure are “completely unethical,” said Dr. Michael Barnett, an assistant professor of health policy at Harvard. “It’s like giving police officers a quota for speeding tickets. What do you think they’re going to do? I can’t think of any justification.”

Dr. Carl Johnson, 77, is a pathologist who directed Lags Medical’s Santa Maria lab from 2018 to 2021. Johnson said the only specimens he looked at came from punch biopsies, the first time in his long career as a pathologist that he had been asked to run such an analysis. On an average day, he said, he examined the slides of about 40 patients, searching for signs of small fiber neuropathy. Lagattuta gave him papers to read on peripheral neuropathy and assured him they were on the cutting edge of care for pain patients. Johnson said he “never thought there was anything untoward going on” until he arrived on his last day and was told to pack up his belongings because the entire operation was shutting down.

Lags Medical performed other procedures at rates that also set them apart. From 2015 through 2020 — the span for which KHN had state data — Lags Medical performed more than 24,000 nerve ablations, a procedure in which part of a nerve is destroyed to reduce pain, on Medi-Cal patients. That’s more than 1 in 6 of all nerve ablations billed through Medi-Cal during that period.

An analysis of federal data also shows Lagattuta was an outlier. For example, in 2018 he billed Medicare for nerve ablations more often than 88% of the doctors in his field who performed the procedure.

Lags Medical also used the in-house lab to run drug tests on patients’ urine samples. From 2017 through 2019, Lags Medical facilities often ordered the most extensive — and expensive — set of drug tests, which check for the presence of at least 22 drugs, according to state and federal data.

For perspective, in 2019, more than 23,000 of the most extensive drug tests were ordered on Medi-Cal patients under Lagattuta’s provider number, more than double the number tied to the next highest biller. The next five top billers were all lab companies.

Overall, from 2017 through 2019, nearly 60,000 of the most extensive drug tests were billed to Medicare and Medi-Cal under Lagattuta’s provider number. Medicare reimbursed Lagattuta $5.4 million for these tests during that period. Using state fee-for-service rates, the testing billed to Medi-Cal would have been worth an estimated $6.3 million. That doesn’t include less extensive drug screens or those billed under other providers’ numbers.

Pain management experts described the use of extensive screening as unnecessary in routine pain treatment; the overuse of such tests has been the subject of numerous Medicare investigations in recent years.

Private pain clinics like Lags Medical are only loosely regulated and generally are not required to hold a special license from the state. But the physicians who work there are regulated by the Medical Board of California.

In December 2019, a patient who’d visited clinics in both Visalia and the Central Coast filed a complaint against Lagattuta with the medical board claiming, among other things, that she received biopsies that were not properly performed, that she underwent excessive testing, and that positive drug tests had been falsified. The medical board had another pain management doctor review more than 300 pages of documents and found “no deviations from the standard of care” and “did not find any over testing, or improperly performed biopsies.”

He did, however, find some record-keeping problems, including numerous procedures in which patient consent was not documented. He also found instances in which procedures were performed and repeated without documentation that they were effective. The patient who filed the complaint was given a medial branch nerve block in November 2014, followed by a radiofrequency ablation in December, and another in February. No improvements for the patient were ever noted in the charts, the investigating doctor found.

The medical board chalked it up to a record-keeping error and fined Lagattuta $350.

A Halfway-Normal Life

On a warm evening in late July, Leah Munoz drove her power wheelchair around the long plastic tables at the Veterans Memorial Building in Hanford, a dusty farm town in California’s Central Valley. Senior bingo night was crowded with gray-haired players waiting for the game to begin. She found an empty spot and carefully set out $50 worth of bingo cards, alongside her collection of 14 brightly colored daubers.

Munoz, 55 and a mother of six, said she has suffered from a litany of illnesses — thyroid cancer, breast cancer, lupus, osteoarthritis — that leave her in near-constant pain. She’s been playing bingo since she was a little girl, and said it helps distract from the pain and calm her mind. She looks forward to this event all week.

Munoz was a Lags Medical patient for about four years and, while her pain never disappeared, the opioids prescribed provided enough relief for her to continue doing the things she loved. “There’s a difference between addiction and dependence. I need it to live a halfway-normal life,” Munoz said.

After Lags Medical closed in May, her primary care doctor initially refused to refill her opioid prescriptions. She said she called the Lags Medical offices to try to get a copy of her medical records to prove her need, and even showed up in person. But she said she was unable to get them. As the pills dwindled and the pain surged, Munoz said, it became hard to leave her home. “I missed a lot of bingo, a lot of grocery shopping, a lot of going to my grandkids’ birthday parties. You miss out on life,” she said. Ultimately, she said, her primary care doctor referred her to another pain clinic, and she was able to resume her prescription.

Even with pain medications, Munoz said, she never received true relief during her time as a patient at Lags Medical. She said she felt coerced to get several injections, none of which seemed to help. “If I didn’t get the procedures, I didn’t get the pain medication,” she said. Her husband, Ramon, a landscaper who was also a patient, received an injection there that he said left him with permanent stiffness in his neck.

Munoz knows at least five other people at bingo night who were former patients at Lags Medical. One of them, Rick Freeman, came over to her table to chat. He swayed back and forth as he walked, his knees, he explained, swollen after 35 years living with HIV. At Lags Medical, Freeman said, he felt pressured by staff to receive injections if he wanted to continue receiving his opioid prescriptions. “If you don’t cooperate with them, they would reduce your meds down,” he said.

At the front of the room, Gail Soto, who ran the event, sold bingo cards to the latecomers. Soto, 72, said she injured her back while working an administrative job at a construction company years ago and suffers from spinal stenosis, rheumatoid arthritis, and fibromyalgia. She, too, was a patient at Lags Medical for years. In addition to her opioid prescription, Soto said, she received repeated injections and three nerve ablations. At first, the ablations helped, but what staff members didn’t tell her, she said, was that the nerves they destroyed could grow back. Ultimately, she said, the procedures left her in worse pain.

Soto’s biggest concern is the spinal stimulator that she said Lags Medical surgically inserted into her back five years ago. She said the doctors told her the device would work so well that she would no longer need her pain pills. She said they didn’t explain that the device would work only two hours a day, and on one side of her body. She remained in too much pain to give up her meds, she said, and, five years later, the battery is failing.

Soto sleeps in a recliner chair in her three-bedroom mobile home in Lemoore, another small city near Hanford. It’s well kept but humble, and she and her husband keep a collection of wind chimes on the front porch that create a wave of gentle music when a breeze passes by. The couple take good care of each other and their two beloved Chihuahuas, but life has become increasingly difficult for Soto.

As the battery on her spinal stimulator has started to fail, she said, she has sudden electrical pulses that shoot up her body. “My husband says sometimes when I sleep that my body will just jump up in the air,” she said. But now that Lags Medical is closed, she said, she can’t find a doctor willing to remove the device. “Most doctors are telling me right now, ‘We can’t, because we didn’t [put it in]. We don’t want nothing to do with that.’”

Waitlists and Withdrawal

Audrey Audelo Ramirez said she picked up her final refill from Lags Medical on June 4 and by July 4 had no meds left to treat her pain. Ramirez said she called every pain management clinic in Fresno, but none were taking new patients.

“They left us all high and dry,” she said. “Everybody.”

In the weeks that followed the closures, county officials throughout the Central Valley saw a flood of patients on high doses of opioids in search of new providers, they said. Patients couldn’t access their medical records, so other providers had no idea what their treatments had been.

“We had to create a crisis response to it because there was no organized response at that time,” said Dr. Rais Vohra, the interim health officer for Fresno County.

Fresno County’s health system is already lean, Vohra said. Toss in this abrupt closure and you end up in the kind of crisis rarely seen in other fields of medicine: “You’d never do this with a cancer clinic,” he said. “You’d never abruptly stop chemo.”

The state asked Dr. Phillip Coffin, director of substance abuse research for the San Francisco Department of Public Health, to run provider training and persuade doctors to take on new patients. Many practices have rules against taking new patients on opioids, or will refuse to prescribe doses above certain thresholds.

“We know that when you stop prescribing opioids, some people end up with death from suicide, overdose, increased illicit opioid use, pain exacerbations. It’s really important to have a continuity, and that is not really possible in the current opioid-prescribing culture,” Coffin said. The threat to patients is so severe that the FDA issued a warning in 2019 against cutting patients off from prescription opioids.

Gina, a retired nurse who asked to be identified by only her first name for fear she’d be discriminated against by other doctors, had been a Lags Medical patient for six years. She said she called every practice she could find in her Central Coast town, and was put on a waiting list at one. Suffering from a severe case of scoliosis, she started rationing the pain pills she had come to rely on.

When she finally secured an appointment, she said, she was told by the doctor she was on “some very strong meds” and he would fill only one of her two prescriptions. “You’re like a criminal,” she said. “You’re branded as ‘we don’t trust you.’”

She started experiencing withdrawal symptoms — sweating, lost appetite, sleeplessness, anxiety. Worst of all, her pain “came back with a vengeance,” she said.

“I think about this, what I’d have been like if I’d never gone through pain management. I sometimes wonder if I’d be better off.”

As for Ramirez, her primary care doctor finally secured an appointment for her at another pain clinic, she said. It was in the same space as the old Lags Medical clinic, and she said she recognized many of the staff members. But now there was a new name: Central California Pain Management. From her perspective, it was as if nothing had changed. And she still doesn’t know whether she needs to worry about the care she received during more than four years at Lags Medical.

The new clinic’s owner, Dr. Ashok Parmar, said that he is leasing the space and that Lagattuta is his landlord. Parmar said he doesn’t do punch biopsies, nor does he diagnose small fiber neuropathy. After all, he said, he would treat the pain the same way, with or without the diagnosis.

How We Did This

KHN evaluated the billing practices of physicians and clinics associated with Lags Medical Centers using data from both Medicare and Medi-Cal.

KHN did multiple analyses using Medicare Part B records that show, for each medical practitioner or lab, every procedure or service billed to the federal government, along with the number of times a procedure was performed, the number of Medicare beneficiaries who received specific services, and how much Medicare reimbursed. The Part B records include billings from 2015 through 2019, the most recent years available. The records are limited to beneficiaries who have traditional fee-for-service Medicare rather than private Medicare Advantage plans. Medicare suppressed data in cases in which a provider performed a procedure on 10 or fewer beneficiaries in a year.

KHN analyzed Medicare billing records for a range of specific procedures, comparing Dr. Francis P. Lagattuta’s billings with those of other practitioners who also identified themselves in the records as Physical Medicine and Rehabilitation specialists.

Through a public records request, KHN also obtained data from the California Department of Health Care Services for a range of specific medical procedures performed on state Medi-Cal recipients by all California providers from 2015 through 2020, as well as every service rendered through Medi-Cal under Lagattuta’s provider number during that time. The Medi-Cal data is organized to show both the rendering and billing provider for a procedure, allowing KHN to look across the network of Lags Medical clinics. To calculate services provided at Lags Medical Centers, KHN included services performed under Lagattuta’s provider number, as well as active provider numbers of organizations with a mailing address associated with Lags Medical clinics that listed Dr. Francis P. Lagattuta or another Lags employee as their authorized official. DHCS suppressed data for instances in which a provider performed a procedure fewer than 11 times on Medi-Cal patients in a year.

The Medi-Cal data did not include reimbursement amounts for procedures, so KHN obtained historical reimbursement amounts from DHCS to calculate the value of the services based on the fee-for-service reimbursement rate in July of each year. Care received by patients with Medi-Cal is generally reimbursed by the state in one of two ways: a fee-for-service model, in which physicians are reimbursed for services according to a set fee schedule that is public; or a managed-care model, in which the state pays insurers a monthly fee per patient, and the insurers reimburse providers amounts that are not public. Only a small percentage of Lags Medical services were reimbursed through fee-for-service plans during the years reviewed. As a result, the values of procedures calculated by KHN are meant to convey a general estimate of their worth. All estimates are calculated using the Basic Rate.

KHN senior correspondent Jordan Rau and Phillip Reese, an assistant professor of journalism at California State University-Sacramento, contributed to this report.

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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KHN’s ‘What the Health?’: It’s Health Costs, Stupid (2022 Edition)

Can’t see the audio player? Click here to listen on Acast. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts.

The pandemic may be showing signs of winding down, but health care costs are not.

In Massachusetts, a fight is shaping up over whether one of the most prestigious hospital systems needs to save money, while antitrust cases against other hospital systems have been filed in California, Connecticut, and North Carolina.

Meanwhile, the Senate confirmed Dr. Robert Califf to head the FDA, finally filling out the Biden administration’s health leadership. Califf’s nomination was strongly opposed by anti-abortion groups, but, in the end, he won the votes of several Republicans who are not running for reelection.

This week’s panelists are Julie Rovner of KHN, Sarah Karlin-Smith of the Pink Sheet, Tami Luhby of CNN, and Rachel Cohrs of Stat.

Among the takeaways from this week’s episode:

  • Califf’s narrow confirmation vote was in marked contrast to seven years ago when he also headed the FDA. Twenty-six Republicans who supported him then voted no this time. This week, five Democrats who had complained about the FDA’s stance on opioids also voted no.
  • With Califf confirmed, he may join other administration public health officials, such as the National Institutes of Health’s Dr. Anthony Fauci and the Centers for Disease Control and Prevention’s Dr. Rochelle Walensky, in becoming a spokesperson for the administration on covid and other medical issues.
  • Among the major issues facing the FDA are safety and efficacy of covid vaccinations for young children, the pending application by Novavax for authorization for a different type of covid vaccine, and a review of how the agency handles accelerated drug approvals. Sen. Ron Wyden (D-Ore.) secured a promise by Califf before he was confirmed to probe whether drugmakers are living up to their promise to report back on those drugs.
  • While the debate on cutting health care costs often centers on prescription drugs, hospitals are a major driver of spending. A Massachusetts regulatory panel has ordered Mass General Brigham hospital to set up a performance improvement plan to curb the growth in health care costs at the state’s premier hospital system.
  • The disruption of the health care workforce caused by the pandemic is creating major shifts, among them a move by many nurses to take high-paid travel nursing jobs. That has created problems for smaller, less profitable hospitals to recruit full-time nurses. Private equity firms are showing interest in the traveling nurse industry, which is prompting some officials to seek more transparency in how those firms are paid and who gets the money.
  • Federal health officials reported this week that the U.S. has recorded 1 million “excess deaths” as a result of the pandemic.

Also this week, Rovner interviews Hannah Wesolowski of the National Alliance on Mental Illness about how the pandemic has worsened the nation’s mental health crisis and what can be done about it.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read, too:

Julie Rovner: KHN’s “Demand for Service Dogs Unleashes a ‘Wild West’ Market,” by Markian Hawryluk

Sarah Karlin-Smith: Scientific American’s “There Is Nothing Normal About One Million People Dead From COVID,” by Steven W. Thrasher

Tami Luhby: The Philadelphia Inquirer’s “COVID-19 Has Even Ruined Our Feet,” by Sarah Gantz

Rachel Cohrs: Bloomberg’s “Nurses Who Faced Fines, Lawsuits for Quitting Are Fighting Back,” by Josh Eidelson

Also discussed on this week’s podcast:

Stat’s “Private Equity Firms Are Cashing In on the Travel Nursing Business That Has Boomed During the Pandemic,” by Rachel Cohrs

The New York Times’ “Vehicle Crashes, Surging,” by David Leonhardt

CNN’s “More Than 50 Million Households Have Received Free Government Covid-19 Tests,” by Tami Luhby and Naomi Thomas

To hear all our podcasts, click here.

And subscribe to KHN’s What the Health? on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Inside the Tactical Tug of War Over the Controversial Alzheimer’s Drug

The drug industry, patient advocates, and congressional Republicans have all attacked federal officials’ decision to decline routine Medicare coverage for a controversial Alzheimer’s drug. They’ve gone as far as to accuse them of tacit racism, ageism, and discrimination against the disabled — and hinted at a lawsuit — over the decision to pay only for patients taking the drug in a clinical trial.

The drug, Aduhelm, with a listed price tag of $28,500 a year, has had few takers in the medical world. Brain doctors are leery of administering the intravenous drug because it appears dangerous and largely ineffective. Many of the nation’s most prestigious hospitals — such as the Cleveland Clinic, Johns Hopkins Hospital, and Massachusetts General in Boston — have declined to offer it to patients.

While groups representing the pharmaceutical industry and patients press to undo Medicare’s decision, industry critics applaud the Centers for Medicare & Medicaid Services for throwing obstacles in the way of a drug they think the FDA should never have approved in the first place.

For the industry, the campaign has a broader existential target: to prevent CMS from using its payment decisions to keep FDA-approved drugs off the market. In recent years, FDA programs to speed approval of new drugs have led to a rash of entries with often minimal scientifically sound evidence to prove they work, critics say.

The FDA’s own expert panel recommended against approving Aduhelm for that reason. Last June, the agency approved it anyway.

CMS then announced Medicare would pay only when the drug was used in further clinical trials to assess its true benefit. That Jan. 11 announcement has drawn more than 9,000 comments to the agency’s website — a tsunami compared with most approval decisions. The remarks are roughly divided among pros and cons, and many appear to be organized by groups on the pro side of the debate (such as the Alzheimer’s Association) or those opposed (such as the nonprofit More Perfect Union). The agency could change or even reverse its decision, though experts believe the latter is unlikely.

“If the FDA were doing its job, CMS wouldn’t have had to step in. But good for the CMS, they are helping to protect the public from drugs whose harms outweigh benefits,” said Dr. Adriane Fugh-Berman, a Georgetown University professor of pharmacology who directs PharmedOut, a group that publicizes what it sees as poor industry practices.

Aduhelm is the first FDA approval for a class of laboratory-made antibodies designed to clear away so-called amyloid plaques, which gradually accumulate in the brains of people with Alzheimer’s disease.

In clinical trials, Aduhelm did well dissolving the plaques, but its impact on the functioning of patients in earlier stages of Alzheimer’s was so meager that an expert panel voted 10-0 (an 11th panelist was uncertain) in November 2020 to advise FDA to reject it. The science is unclear about whether the presence of such plaques — a so-called surrogate marker — correlates with the mental functioning of patients.

As such, the FDA gave “provisional approval” to Biogen, the maker of Aduhelm, allowing it nine years to provide evidence that the drug slows the progression of Alzheimer’s. In that period, Biogen would make far more money than if the application had been rejected. Even under the CMS decision, it would reap Medicare payments from whatever is used in clinical trials, which would need to include thousands of participants to assess the drug’s performance.

Drug companies and pharma investors have responded to CMS’ ruling with special alarm because they have spent decades improving their relationships with the FDA, only to have CMS seemingly pull the rug out by exerting its own power over an expensive drug.

“The drug companies are worried that this could be a precedent for other drugs. And it should be,” Fugh-Berman said. “This isn’t just about money; it’s about protecting the public.”

This “accelerated approval” employed for Aduhelm got its start in 1992 and is aimed at moving promising new classes of drugs to the public faster. Companies whose drugs go through the process — more than 250 drugs or vaccines have been approved so far — are supposed to quickly gather evidence that the products likely improve health once they’re on the market. But such follow-up studies often lag or are never performed. For example, the makers of the Duchenne muscular dystrophy drug eteplirsen, approved in 2016, didn’t start recruiting patients into a post-marketing trial until 2020 and don’t expect results until 2026.

Biogen originally said it would get confirmatory results for Aduhelm within seven years of approval. In response to the Medicare decision, it promised to trim that to four years. The company also hinted that it might sue the agency, calling its decision “arbitrary and capricious.”

In the meantime, patients eager to get access to the drug are furious about the coverage decision. Jim Taylor, a New Yorker whose wife, Geri, says she improved on Aduhelm during a clinical trial, said Medicare had made an “unconscionable decision” that puts Alzheimer’s patients “on a dark roller coaster.”

Many patients’ groups are organized or at least funded and fueled by drugmakers, providing sympathetic stories that buttress a manufacturer’s commercial interests. Advocacy groups also receive large donations from the makers of certain drugs. A 2020 report by UsAgainstAlzheimer’s shows at least $900,000 in donations from monoclonal antibody producers. The Alzheimer’s Association’s top corporate donors — Biogen, Lilly, Eisai, and Genentech — all have monoclonal antibody candidates and have provided the group $1.6 million in fiscal year 2021.

These donations are a tiny part of the group’s funding, its policy director, Robert Egge, told KHN, and any alignment of its position with industry is “coincidental, because of what we and our constituents believe is right.”

The Taylors appeared at an online news event with activists from UsAgainstAlzheimer’s and the National Minority Quality Forum, a group focused on health inequities, who argued that the decision discriminated against Black and Hispanic patients, who are more likely to suffer from Alzheimer’s and less likely to join clinical trials. In fact, CMS demanded that evidence for Aduhelm be collected more extensively from minority patients. Biogen’s two major trials of the drug included only 19 Black patients out of a total of 3,285.

Groups representing people with Down syndrome wrote more than 1,000 letters to CMS because its decision requires that confirmatory trials exclude people who have additional neurological conditions. Rep. Cathy McMorris Rodgers, a top drug industry cash recipient and the leading Republican on the House Energy and Commerce Committee with significant sway over pharma issues, said at a hearing last week that it was “extremely concerning and unacceptable” that Down syndrome patients would be ineligible.

But neither Biogen nor any other drug company has recruited Down syndrome patients for a major trial of a monoclonal antibody treatment. AC Immune, a Swiss company, conducted a safety study last year on 16 people with Down syndrome.

It’s not surprising that groups representing those suffering from Alzheimer’s placed high hopes on the monoclonal antibody drugs, which have seemed like a ray in the darkness for the estimated 2 million Americans with early Alzheimer’s symptoms.

When asked why his group is so gung-ho about a product in which the medical profession shows such little confidence, Egge said the drug seems to have some benefits and that its risks — especially to patients who lack other means to slow a miserable, deadly disease — may be exaggerated. He acknowledged that 40% of patients in the biggest Aduhelm trial experienced brain swelling or bleeding, but Biogen’s research showed these resolved with no apparent harm in most cases.

That said, the sluggish purchases of the drug — which earned a modest $1 million in the last quarter of 2021 — signal the market is responding to its deficiencies.

In response to the lackluster response, Biogen halved its initial $56,000 price to $28,500. If CMS had granted full approval, that would have been followed by “marketing, marketing, marketing,” said Dr. Joseph Ross, a public health professor at Yale University. Hospitals that wanted to attract patient business for a lucrative infusion — patients receiving the drug also require brain scans and other tests and monitoring — could advertise their willingness to give Aduhelm.

CMS’ decision came under a policy called coverage with evidence development. Though the program began in 2005, Aduhelm is by far the most important product CMS has declined to reimburse without further study.

The agency’s decision “is a little inelegant” because it puts the brakes on an FDA approval, said former CMS chief medical officer Dr. Sean Tunis, now a consultant and senior fellow at Tufts Medical Center, but “it seems completely justifiable since the evidence of benefit is pretty weak and the evidence of harm is pretty strong.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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This Doctor Thought She Could Navigate US Health Care. Then Her Autistic Son Needed Help.

Alexander Roodman was packing up his room, preparing for a gap year before college, when I met him at his family’s Washington, D.C., townhouse.

The room was a typical teenage disaster zone, with clothes and books strewn everywhere.

Then, Alex picked up an origami sculpture that rippled with dozens of ridges and depressions. “It’s kind of a repetitive pattern,” he said. “First, you make the diagonal folds and these lateral folds to cut the paper in half.”

It’s pretty complicated. Alex, a slim teenager with long black hair and penetrating eyes, is gifted with the focus for this. But the way his brain works can be a challenge.

Alex is autistic.

And like many parents of children with autism, Alex’s mother and father have spent years trying to find a doctor or school or therapist who could help.

“I think he always believed we were on his side. But he could also see that we were sometimes helpless,” said Dr. Mai Pham, Alex’s mother. “It’s a little bit like hot potato. Is the school supposed to counsel me? Is the pediatrician supposed to counsel me? … Am I supposed to figure that out?”

The U.S. has made major strides in recent decades in raising awareness about autism and other intellectual and developmental disabilities, which affect as many as 1 in 20 Americans.

Improvements in screening, new therapies, and burgeoning specialty clinics have made available care that was unthinkable a generation ago. But the health care system is still failing millions of Americans from the time they are children, experts and advocates say.

When Alex was born, this world and its frustrations were an abstraction for Pham and her husband, David Roodman, a Harvard-trained policy analyst.

There were signs their second child was a little different. Pham remembers taking Alex on a trip when he was 3 months old.

“In a hotel room in Miami, we put him on the floor thinking, ‘OK, we have five minutes now before the baby acts up,’” Pham said. “He actually spent 20 minutes being nearly still, just his eyes tracking the shadows of a palm frond on the walls.”

In preschool, Alex had difficulty connecting with other kids and sometimes became agitated when classmates didn’t seem interested in what he wanted to talk about.

Still, Pham and Roodman were assured by their pediatrician and others that there was no cause for alarm. Even when a school assessment established that Alex was autistic, Pham and Roodman received few warnings about the challenges ahead.

As Alex got older, he attended a private middle school that specializes in working with students like him. He did well, according to his parents.

The transition to high school proved more difficult, however. Although a gifted math student, Alex increasingly struggled with subjects like English and history that require explaining the perspective of others.

His autism fueled crippling anxiety. Alex had trouble sleeping and picked at his hands until they bled. There were frequent breakdowns.

“He might slam the wall with things. … He broke the tip off a knife,” Pham said. “He always felt contrite afterward. He just didn’t have any other avenue for, you know, adequately expressing how frustrated he was.”

Pham thought she’d be better prepared than most parents to find help. She’s an internist and former senior Medicare and Medicaid official with degrees from Harvard and Johns Hopkins.

Pham scrambled to find help, tapping a wide social and professional network around Washington, D.C. The metropolitan area boasts the highest concentration of child and adolescent psychiatrists in the country, 10 times the level in some rural parts of the country, according to one analysis.

Yet, as Alex struggled, Pham said, their family was lost. Time and again, pediatricians, psychiatrists, and therapists minimized Alex’s symptoms or shuffled him to someone else.

That’s a common experience, said Monica Adler Werner, a counselor who works with patients with autism around Washington, D.C. “The odyssey that parents have to go on in order to find what their children need is really a shame of our society,” she said.

Long waitlists for therapy remain the norm nationwide. So are medical bills that can reach tens of thousands of dollars.

“We were lucky we could afford those services,” Pham said. “We have health insurance. … I had the kind of jobs where I could hop in the car once or twice a week and drive 50 minutes each way to get him to therapy.”

Millions of Americans face even bigger barriers to care. Families in rural areas often travel hours for services. Many Black and Hispanic families face persistent inequities in the U.S. health care system.

Nationally, parents of children with autism are 10 times as likely to say they’re “usually or always” frustrated in their efforts to get services.

Primary care physicians — a convenient option for many families — could fill some of those gaps if the doctors had better training, said Dr. Kristin Sohl, a pediatrician who teaches these skills at the University of Missouri. “We’ve got to make this accessible so that people can have access to what they need when and where they need it,” Sohl said.

But many physicians feel ill equipped to provide this care.

In one survey, just 40% said they were very confident that their care for patients with disabilities was as good as for other patients. Only about half strongly agreed that they welcome patients with a disability.

Training remains one barrier. Even though as many as 16 million Americans have autism or another intellectual or developmental disability, the subject is a small part of the curriculum at most medical schools.

Another obstacle, Sohl and others say, is a tendency in American health care to simply refer patients to specialists. “It’s so hierarchical,” Sohl said.

Changing that has become Mai Pham’s life’s work.

She quit her job at a major health insurer in 2020 to start Institute for Exceptional Care. The nonprofit aims to overhaul the way doctors are trained and paid so they can spend more time with patients with disabilities, instead of rushing through visits because of billing pressures.

“We’ve made huge investments in the science and in some ways the clinical aspects of care,” Pham said. “But we haven’t thought about how to make any of that sustainable.”

Pham said that is particularly important because so many patients are aging — and developing medical conditions such as diabetes, heart disease, and dementia.

“How you communicate to someone like my son or how you manage chronic conditions for him will need to be different,” Pham said. “The health system hasn’t thought about that.”

Help for Alex ultimately came from a specialist. Adler Werner, whom Pham found through friends, became what Pham described as an “autism coach,” helping the family understand what Alex was experiencing.

Adler Werner, now a cognitive behavioral therapist, focused on empowering Alex so he could appreciate his strengths and develop tools to navigate challenging tasks like communicating verbally and managing stress.

“What we want to be doing is working with young people to allow them to understand their differences, accept and own them, not have them be seen … as character flaws,” Adler Werner explained. “Alexander is really extraordinary and unbelievably interesting.”

I caught up with Alex not long ago in Vermont. He’s at a program that helps teenagers like him develop skills to live independently. He’s taking math at the University of Vermont. He’s been rock climbing and hiking with classmates in the Green Mountains.

Alex said he’s been enjoying himself. “I’m learning about muscles I never knew I had,” he said.

Pham and her husband have been cheered by his progress. But they still worry about what’s ahead for Alex in a health care system that’s unprepared for him.

[Editor’s note: KHN aims to use “person-first” language regarding people with autism – describing what they have and not what they are — except when a preference for “identity-first” language is known, such as “he is autistic.” This article reflects that nuance and respects the wishes of the family profiled.]

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

USE OUR CONTENT

This story can be republished for free (details).



from Health Industry – Kaiser Health News

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