Algunos médicos e investigadores que están interesados en un enfoque más individualizado para encontrar tumores problemáticos se muestran escépticos y plantean preguntas sobre los datos y el razonamiento detrás del cambio radical del Grupo de Trabajo de Servicios Preventivos de Estados Unidos con respecto a sus pautas de 2016.

“La evidencia para que todas comiencen a los 40 no es convincente”, dijo Jeffrey Tice, profesor de medicina en la Universidad de California-San Francisco.

Tice es parte del equipo de investigación del estudio WISDOM, que tiene como objetivo, en palabras de Laura Esserman, cirujana de cáncer de seno y líder del equipo, “hacer pruebas de manera más inteligente, no probar más”. Esserman lanzó el estudio en curso en 2016 con el objetivo de adaptar las pruebas de detección al riesgo de una mujer, y poner fin al debate sobre cuándo iniciar las mamografías.

Los defensores de un enfoque personalizado enfatizan los costos de la detección universal a los 40, no en dólares, sino en resultados falsos positivos, biopsias innecesarias, sobretratamiento y ansiedad.

Las pautas provienen del Grupo de Trabajo de Servicios Preventivos de Estados Unidos, parte del Departamento de Salud y Servicios Humanos (HHS) federal, un panel independiente de 16 expertos médicos voluntarios que se encargan de ayudar a guiar a los médicos, aseguradoras de salud y legisladores.

En 2009, y de nuevo en 2016, el grupo presentó el aviso actual, que elevó la edad para comenzar la mamografía de rutina de 40 a 50 años e instó a las mujeres de 50 a 74 a hacérselas cada dos años.

Las mujeres de 40 a 49 años que “le otorgan un mayor valor al beneficio potencial que a los daños potenciales” también deberían someterse al procedimiento de detección, dijo el grupo de trabajo.

Ahora, el grupo ha publicado un borrador de una actualización de sus directrices, recomendando la detección para todas las mujeres a partir de los 40 años.

“Esta nueva recomendación ayudará a salvar vidas y evitará que más mujeres mueran debido al cáncer de mama”, dijo Carol Mangione, profesora de medicina y salud pública en UCLA, quien presidió el panel.

Pero la evidencia no es clara. Karla Kerlikowske, profesora de la UCSF que ha estado investigando la mamografía desde la década de 1990, dijo que no vio una diferencia en los datos que justificara el cambio. Dijo que la única forma en que podía explicar las nuevas pautas era un cambio en el panel.

“Son diferentes miembros del grupo de trabajo”, dijo. “Interpretaron los beneficios y los daños de manera diferente”.

Sin embargo, Mangione citó dos puntos de datos como impulsores cruciales de las nuevas recomendaciones: el aumento de la incidencia de cáncer de mama en mujeres más jóvenes, y modelos que muestran la cantidad de vidas que podrían salvar las pruebas de detección, especialmente entre las mujeres negras.

No hay evidencia directa de que evaluar a mujeres de 40 años salve vidas, dijo. La cantidad de mujeres que murieron de cáncer de mama disminuyó de manera constante desde 1992 hasta 2020, debido en parte a una detección más temprana y a mejores tratamientos.

Pero los modelos predictivos que construyó el grupo de trabajo, basados en varias suposiciones en lugar de datos reales, encontraron que expandir la mamografía a mujeres de 40 años podría evitar 1.3 muertes adicionales por cada 1,000 en esa cohorte, dijo Mangione. Lo más crítico, agregó, es que un nuevo modelo que incluye solo mujeres negras mostró que se podría salvar 1.8 por 1,000.

Un aumento anual del 2% en la cantidad de personas de 40 a 49 años diagnosticadas con cáncer de mama en el país entre 2016 y 2019 alertó al grupo de trabajo sobre una tendencia preocupante, dijo.

Mangione lo llamó un “salto realmente considerable”. Pero Kerlikowske lo llamó “bastante pequeño” y Tice lo llamó “muy modesto”: percepciones contradictorias que subrayan cuánta subjetividad está involucrada en la ciencia de las pautas de salud preventiva.

A los miembros del grupo de trabajo los designa la Agencia para la Investigación y la Calidad de la Atención Médica del HHS, y cumplen mandatos de cuatro años. El nuevo borrador de las pautas está abierto para comentarios públicos hasta el 5 de junio. Después de incorporar los comentarios, el grupo de trabajo planea publicar su recomendación final en JAMA, la revista de la Asociación Médica Estadounidense.

Cerca de 300,000 mujeres serán diagnosticadas con cáncer de mama en el país este año, y morirán más de 43,000 por este mal, según proyecciones del Instituto Nacional del Cáncer. Muchos consideran que expandir la detección para incluir a mujeres más jóvenes es una forma obvia de detectar el cáncer antes y salvar vidas.

Pero los críticos de las nuevas pautas argumentan que hay verdaderas concesiones.

“¿Por qué no empezar al nacer?”, ironizó Steven Woloshin, profesor del Instituto de Políticas de Salud y Práctica Clínica de Dartmouth. “¿Por qué no todos los días?”.

“Si no hubiera inconvenientes, eso podría ser razonable”, dijo. “El problema son los falsos positivos, que dan mucho miedo. El otro problema es el sobrediagnóstico”. Algunos tumores de mama son inofensivos y el tratamiento puede ser peor que la enfermedad, enfatizó.

Tice estuvo de acuerdo en que el sobretratamiento es un problema subestimado.

“Estos cánceres nunca causarían síntomas”, dijo, refiriéndose a ciertos tipos de tumores. “Algunos simplemente retroceden, se encogen y desaparecen, son de crecimiento tan lento que una mujer muere de otra cosa antes de que causen problemas”.

Las pruebas de detección tienden a encontrar cánceres de crecimiento lento que tienen menos probabilidades de causar síntomas, dijo. Por el contrario, las mujeres a veces descubren cánceres letales de crecimiento rápido poco después de haberse realizado mamografías que salieron normales.

“Nuestro fuerte sentimiento es que una sola talla no sirve para todos y que debe personalizarse”, dijo Tice.

WISDOM, que significa “Mujeres informadas para evaluar según las medidas de riesgo”, evalúa el riesgo de las participantes a los 40 mediante la revisión de los antecedentes familiares y la secuenciación de nueve genes. La idea es comenzar con mamografías periódicas de inmediato para las mujeres de alto riesgo mientras que esperar para las de menos.

Las mujeres negras no hispanas tienen más probabilidades de hacerse mamografías de detección que las mujeres blancas no hispanas. Sin embargo, tienen un 40% más de probabilidades de morir de cáncer de seno y de que les diagnostiquen cánceres mortales a edades más tempranas.

El grupo de trabajo espera que las mujeres negras se beneficien más de la detección temprana, dijo Mangione.

No está claro por qué las mujeres negras tienen más probabilidades de sufrir cánceres de mama más letales, pero las investigaciones apuntan a disparidades en el tratamiento.

“Las mujeres negras no obtienen un seguimiento de las mamografías tan rápido ni un tratamiento adecuado tan rápido”, dijo Tice. “Eso es lo que realmente impulsa las discrepancias en la mortalidad”.

También continúa el debate sobre la detección en mujeres de 75 a 79 años. El grupo de trabajo optó por no pedir pruebas de detección de rutina en el grupo de mayor edad porque un estudio observacional no mostró ningún beneficio, dijo Mangione. Pero el panel emitió un llamado urgente para investigar si las mujeres de 75 años o más deberían hacerse una mamografía de rutina.

Los modelos sugieren que evaluar a las mujeres mayores podría evitar 2,5 muertes por cada 1,000 mujeres en ese grupo de edad, más de las que se salvarían al expandir la evaluación a las mujeres más jóvenes, apuntó Kerlikowske.

“Siempre decimos que las mujeres mayores de 75 años deberían decidir junto con sus médicos si se hacen mamografías, según sus preferencias, valores, historial familiar y de salud”, dijo Mangione.

Tice, Kerlikowske y Woloshin argumentan que lo mismo es cierto para las mujeres de 40 años.

Esta historia fue producida por KFF Health News, que publica California Healthline, un servicio editorialmente independiente de la California Health Care Foundation.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Some doctors and researchers who are invested in a more individualized approach to finding troublesome tumors are skeptical, raising questions about the data and the reasoning behind the U.S. Preventive Services Task Force’s about-face from its 2016 guidelines.

“The evidence isn’t compelling to start everyone at 40,” said Jeffrey Tice, a professor of medicine at the University of California-San Francisco.

Tice is part of the WISDOM study research team, which aims, in the words of breast cancer surgeon and team leader Laura Esserman, “to test smarter, not test more.” She launched the ongoing study in 2016 with the goal of tailoring screening to a woman’s risk and putting an end to the debate over when to get mammograms.

Advocates of a personalized approach stress the costs of universal screening at 40 — not in dollars, but rather in false-positive results, unnecessary biopsies, overtreatment, and anxiety.

The guidelines come from the federal Department of Health and Human Services’ U.S. Preventive Services Task Force, an independent panel of 16 volunteer medical experts who are charged with helping guide doctors, health insurers, and policymakers. In 2009 and again in 2016, the group put forward the current advisory, which raised the age to start routine mammography from 40 to 50 and urged women from 50 to 74 to get mammograms every two years. Women from 40 to 49 who “place a higher value on the potential benefit than the potential harms” might also seek screening, the task force said.

Now the task force has issued a draft of an update to its guidelines, recommending the screening for all women beginning at age 40.

“This new recommendation will help save lives and prevent more women from dying due to breast cancer,” said Carol Mangione, a professor of medicine and public health at UCLA, who chaired the panel.

But the evidence isn’t clear-cut. Karla Kerlikowske, a professor at UCSF who has been researching mammography since the 1990s, said she didn’t see a difference in the data that would warrant the change. The only way she could explain the new guidelines, she said, was a change in the panel.

“It’s different task force members,” she said. “They interpreted the benefits and harms differently.”

Mangione, however, cited two data points as crucial drivers of the new recommendations: rising breast cancer incidence in younger women and models showing the number of lives screening might save, especially among Black women.

There is no direct evidence that screening women in their 40s will save lives, she said. The number of women who died of breast cancer declined steadily from 1992 to 2020, due in part to earlier detection and better treatment.

But the predictive models the task force built, based on various assumptions rather than actual data, found that expanding mammography to women in their 40s might avert an additional 1.3 deaths per 1,000 in that cohort, Mangione said. Most critically, she said, a new model including only Black women showed 1.8 per 1,000 could be saved.

A 2% annual increase in the number of 40- to 49-year-olds diagnosed with breast cancer in the U.S. from 2016 through 2019 alerted the task force to a concerning trend, she said.

Mangione called that a “really sizable jump.” But Kerlikowske called it “pretty small,” and Tice called it “very modest” — conflicting perceptions that underscore just how much art is involved in the science of preventive health guidelines.

Task force members are appointed by HHS’ Agency for Healthcare Research and Quality and serve four-year terms. The new draft guidelines are open for public comment until June 5. After incorporating feedback, the task force plans to publish its final recommendation in JAMA, the Journal of the American Medical Association.

Nearly 300,000 women will be diagnosed with breast cancer in the U.S. this year, and it will kill more than 43,000, according to National Cancer Institute projections. Expanding screening to include younger women is seen by many as an obvious way to detect cancer earlier and save lives.

But critics of the new guidelines argue there are real trade-offs.

“Why not start at birth?” Steven Woloshin, a professor at the Dartmouth Institute for Health Policy and Clinical Practice, asked rhetorically. “Why not every day?”

“If there were no downsides, that might be reasonable,” he said. “The problem is false positives, which are very scary. The other problem is overdiagnosis.” Some breast tumors are harmless, and the treatment can be worse than the disease, he said.

Tice agreed that overtreatment is an underappreciated problem.

“These cancers would never cause symptoms,” he said, referring to certain kinds of tumors. “Some just regress, shrink, and go away, are just so slow-growing that a woman dies of something else before it causes problems.”

Screening tends to find slow-growing cancers that are less likely to cause symptoms, he said. Conversely, women sometimes discover fast-growing lethal cancers soon after they’ve had clean mammograms.

“Our strong feeling is that one size does not fit all, and that it needs to be personalized,” Tice said.

WISDOM, which stands for “Women Informed to Screen Depending On Measures of risk,” assesses participants’ risk at 40 by reviewing family history and sequencing nine genes. The idea is to start regular mammography immediately for high-risk women while waiting for those at lower risk.

Black women are more likely to get screening mammograms than white women. Yet they are 40% more likely to die of breast cancer and are more likely to be diagnosed with deadly cancers at younger ages.

The task force expects Black women to benefit most from earlier screening, Mangione said.

It’s unclear why Black women are more likely to get the most lethal breast cancers, but research points to disparities in cancer management.

“Black women don’t get follow-up from mammograms as rapidly or appropriate treatment as quickly,” Tice said. “That’s what really drives the discrepancies in mortality.”

Debate also continues on screening for women 75 to 79 years old. The task force chose not to call for routine screening in the older age group because one observational study showed no benefit, Mangione said. But the panel issued an urgent call for research about whether women 75 and older should receive routine mammography.

Modeling suggests screening older women could avert 2.5 deaths per 1,000 women in that age group, more than those saved by expanding screening to younger women, Kerlikowske noted.

“We always say women over 75 should decide together with their clinicians whether to have mammograms based on their preferences, their values, their health history, and their family history,” Mangione said.

Tice, Kerlikowske, and Woloshin argue the same holds true for women in their 40s.

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

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If the experience and the insurer’s explanation often seem arbitrary and absurd, that might be because companies appear increasingly likely to employ computer algorithms or people with little relevant experience to issue rapid-fire denials of claims — sometimes bundles at a time — without reviewing the patient’s medical chart. A job title at one company was “denial nurse.”

It’s a handy way for insurers to keep revenue high — and just the sort of thing that provisions of the Affordable Care Act were meant to prevent. Because the law prohibited insurers from deploying previously profit-protecting measures such as refusing to cover patients with preexisting conditions, the authors worried that insurers would compensate by increasing the number of denials.

And so, the law tasked the Department of Health and Human Services with monitoring denials both by health plans on the Obamacare marketplace and those offered through employers and insurers. It hasn’t fulfilled that assignment. Thus, denials have become another predictable, miserable part of the patient experience, with countless Americans unjustly being forced to pay out-of-pocket or, faced with that prospect, forgoing needed medical help.

A recent KFF study of ACA plans found that even when patients received care from in-network physicians — doctors and hospitals approved by these same insurers — the companies in 2021 nonetheless denied, on average, 17% of claims. One insurer denied 49% of claims in 2021; another’s turndowns hit an astonishing 80% in 2020. Despite the potentially dire impact that denials have on patients’ health or finances, data shows that people appeal only once in every 500 cases.

Sometimes, the insurers’ denials defy not just medical standards of care but also plain old human logic. Here is a sampling collected for the KFF Health News-NPR “Bill of the Month” joint project.

• Dean Peterson of Los Angeles said he was “shocked” when payment was denied for a heart procedure to treat an arrhythmia, which had caused him to faint with a heart rate of 300 beats per minute. After all, he had the insurer’s preapproval for the expensive ($143,206) intervention. More confusing still, the denial letter said the claim had been rejected because he had “asked for coverage for injections into nerves in your spine” (he hadn’t) that were “not medically needed.” Months later, after dozens of calls and a patient advocate’s assistance, the situation is still not resolved.
• An insurer’s letter was sent directly to a newborn child denying coverage for his fourth day in a neonatal intensive care unit. “You are drinking from a bottle,” the denial notification said, and “you are breathing on your own.” If only the baby could read.
• Deirdre O’Reilly’s college-age son, suffering a life-threatening anaphylactic allergic reaction, was saved by epinephrine shots and steroids administered intravenously in a hospital emergency room. His mother, utterly relieved by that news, was less pleased to be informed by the family’s insurer that the treatment was “not medically necessary.”

As it happens, O’Reilly is an intensive-care physician at the University of Vermont. “The worst part was not the money we owed,” she said of the $4,792 bill. “The worst part was that the denial letters made no sense — mostly pages of gobbledygook.” She has filed two appeals, so far without success.

Some denials are, of course, well considered, and some insurers deny only 2% of claims, the KFF study found. But the increase in denials, and the often strange rationales offered, might be explained, in part, by a ProPublica investigation of Cigna — an insurance giant, with 170 million customers worldwide.

ProPublica’s investigation, published in March, found that an automated system, called PXDX, allowed Cigna medical reviewers to sign off on 50 charts in 10 seconds, presumably without examining the patients’ records.

Decades ago, insurers’ reviews were reserved for a tiny fraction of expensive treatments to make sure providers were not ordering with an eye on profit instead of patient needs.

These reviews — and the denials — have now trickled down to the most mundane medical interventions and needs, including things such as asthma inhalers or the heart medicine that a patient has been on for months or years. What’s approved or denied can be based on an insurer’s shifting contracts with drug and device manufacturers rather than optimal patient treatment.

Automation makes reviews cheap and easy. A 2020 study estimated that the automated processing of claims saves U.S. insurers more than $11 billion annually.

But challenging a denial can take hours of patients’ and doctors’ time. Many people don’t have the knowledge or stamina to take on the task, unless the bill is especially large or the treatment obviously lifesaving. And the process for larger claims is often fabulously complicated.

The Affordable Care Act clearly stated that HHS “shall” collect the data on denials from private health insurers and group health plans and is supposed to make that information publicly available. (Who would choose a plan that denied half of patients’ claims?) The data is also supposed to be available to state insurance commissioners, who share with HHS the duties of oversight and trying to curb abuse.

To date, such information-gathering has been haphazard and limited to a small subset of plans, and the data isn’t audited to ensure it is complete, according to Karen Pollitz, a senior fellow at KFF and one of the authors of the KFF study. Federal oversight and enforcement based on the data are, therefore, more or less nonexistent.

HHS did not respond to requests for comment for this article.

The government has the power and duty to end the fire hose of reckless denials harming patients financially and medically. Thirteen years after the passage of the ACA, perhaps it is time for the mandated investigation and enforcement to begin.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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The federal system meant to stop health care business owners and executives from repeatedly bilking government health programs fails to do so, a KHN investigation has found.

That means people are once again tapping into Medicaid, Medicare, and other taxpayer-funded federal health programs after being legally banned because of fraudulent or illegal behavior.

In large part that’s because the government relies on those who are banned to self-report their infractions or criminal histories on federal and state applications when they move into new jobs or launch companies that access federal health care dollars.

The Office of Inspector General for the U.S. Department of Health and Human Services keeps a public list of those it has barred from receiving any payment from its programs — it reported excluding more than 14,000 individuals and entities since January 2017 — but it does little to track or police the future endeavors of those it has excluded.

The government explains that such bans apply to “the excluded person” or “anyone who employs or contracts with” them. Further, “the exclusion applies regardless of who submits the claims and applies to all administrative and management services furnished by the excluded person,” according to the OIG.

Federal overseers largely count on employers to check their hires and identify those excluded. Big hospital systems and clinics typically employ compliance staff or hire contractors who routinely vet their workers against the federal list to avoid fines.

However, those who own or operate health care businesses are typically not subject to such oversight, KHN found. And people can sidestep detection by leaving their names off key documents or using aliases.

“If you intend to violate your exclusion, the exclusion list is not an effective deterrent,” said David Blank, a partner at Arnall Golden Gregory who previously was senior counsel at the OIG. “There are too many workarounds.”

KHN examined a sample of 300 health care business owners and executives who are among more than 1,600 on OIG’s exclusion list since January 2017. Journalists reviewed court and property records, social media, and other publicly available documents. Those excluded had owned or operated home health care agencies, medical equipment companies, mental health facilities, and more. They’d submitted false claims, received kickbacks for referrals, billed for care that was not provided, and harmed patients who were poor and old, in some cases by stealing their medication or by selling unneeded devices to unsuspecting Medicare enrollees. One owner of an elder care home was excluded after he pleaded guilty to sexual assault.

Among those sampled, KHN found:

• Eight people appeared to be serving or served in roles that could violate their bans;
• Six transferred control of a business to family or household members;
• Nine had previous, unrelated felony or fraud convictions, and went on to defraud the health care system;
• And seven were repeat violators, some of whom raked in tens of millions of federal health care dollars before getting caught by officials after a prior exclusion.

The exclusions list, according to Blank and other experts, is meant to make a person radioactive — easily identified as someone who cannot be trusted to handle public health care dollars.

But for business owners and executives, the system is devoid of oversight and rife with legal gray areas.

One man, Kenneth Greenlinger, pleaded guilty in 2016 to submitting “false and fraudulent” claims for medical equipment his California company, Valley Home Medical Supply, never sent to customers that totaled more than $1.4 million to Medicare and other government health care programs, according to his plea agreement. He was sentenced to eight months in federal prison and ordered to pay restitution of more than $1 million, according to court records. His company paid more than $565,000 to resolve allegations of false claims, according to the Justice Department website.

Greenlinger was handed a 15-year exclusion from Medicare, Medicaid, and any other federal health care program, starting in 2018, according to the OIG.

But this October, Greenlinger announced a health care business with government contracts for sale. Twice on LinkedIn, Greenlinger announced: “I have a DME [durable medical equipment] company in Southern California. We are contracted with most Medicare and Medi-Cal advantage plans as well as Aging in Place payers. I would like to sell,” adding a Gmail address.

Reached by phone, Greenlinger declined to comment on his case. About the LinkedIn post, he said: “I am not affiliated directly with the company. I do consulting for medical equipment companies — that was what that was, written representing my consulting business.”

His wife, Helene, who previously worked for Valley Home Medical Supply, is now its CEO, according to LinkedIn and documentation from the California Secretary of State office. Although Helene has a LinkedIn account, she told KHN in a telephone interview that her husband had posted on her behalf. But Kenneth posted on and commented from his LinkedIn page — not his wife’s.

At Valley Home Medical Supply, a person who answered the phone last month said he’d see whether Kenneth Greenlinger was available. Another company representative got on the line, saying “he’s not usually in the office.”

Helene Greenlinger said her husband may come by “once in a while” but “doesn’t work here.”

She said her husband doesn’t do any medical work: “He’s banned from it. We don’t fool around with the government.”

“I’m running this company now,” she said. “We have a Medicare and Medi-Cal number and knew everything was fine here, so let us continue.”

No Active Enforcement

Federal regulators do not proactively search for repeat violators based on the exclusion list, said Gabriel Imperato, a managing partner with Nelson Mullins in Florida and former deputy general counsel with HHS’ Office of the General Counsel in Dallas.

He said that for decades he has seen a “steady phenomenon” of people violating their exclusions. “They go right back to the well,” Imperato said.

That oversight gap played out during the past two years in two small Missouri towns.

Donald R. Peterson co-founded Noble Health Corp., a private equity-backed company that bought two rural Missouri hospitals, just months after he’d agreed in August 2019 to a five-year exclusion that “precludes him from making any claim to funds allocated by federal health care programs for services — including administrative and management services — ordered, prescribed, or furnished by Mr. Peterson,” said Jeff Morris, an attorney representing Peterson, in a March letter to KHN. The prohibition, Morris said, also “applies to entities or individuals who contract with Mr. Peterson.”

That case involved a company Peterson created called IVXpress, now operating as IVX Health with infusion centers in multiple states. Peterson left the company in 2018, according to his LinkedIn, after the settlement with the government showed a whistleblower accused him of altering claims, submitting false receipts for drugs, and paying a doctor kickbacks. He settled the resulting federal charges without admitting wrongdoing. His settlement agreement provides that if he violates the exclusion, he could face “criminal prosecution” and “civil monetary penalties.”

In January 2020, Peterson was listed in a state registration document as one of two Noble Health directors. He was also listed as the company’s secretary, vice president, and assistant treasurer. Four months later, in April 2020, Peterson’s name appears on a purchasing receipt obtained under the Freedom of Information Act. In addition to Medicare and Medicaid funds, Noble’s hospitals had received nearly $20 million in federal covid relief money.

A social media account with a photo that appears to show Peterson announced the launch of Noble Health in February 2020. Peterson identified himself on Twitter as executive chairman of the company.

It appears federal regulators who oversee exclusions did not review or approve his role, even though information about it was publicly available.

Peterson, whose name does not appear on the hospitals’ Medicare applications, said by email that his involvement in Noble didn’t violate his exclusion in his reading of the law.

He said he owned only 3% of the company, citing OIG guidance — federal regulators may exclude companies if someone who is banned has ownership of 5% or more of them — and he did not have a hand in operations. Peterson said he worked for the corporation, and the hospitals “did not employ me, did not pay me, did not report to me, did not receive instructions or advice from me,” he wrote in a November email.

A 2013 OIG advisory states that “an excluded individual may not serve in an executive or leadership role” and “may not provide other types of administrative and management services … unless wholly unrelated to federal health care programs.”

Peterson said his activities were apart from the business of the hospitals.

“My job was to advise Noble’s management on the acquisition and due diligence matters on hospitals and other entities it might consider acquiring. … That is all,” Peterson wrote. “I have expert legal guidance on my role at Noble and am comfortable that nothing in my settlement agreement has been violated on any level.”

For the two hospitals, Noble’s ownership ended badly: The Department of Labor opened one of two investigations into Noble this March in response to complaints from employees. Both Noble-owned hospitals suspended services. Most employees were furloughed and then lost their jobs.

Peterson said he left the company in August 2021. That’s the same month state regulators cited one hospital for deficiencies that put patients “at risk for their health and safety.”

If federal officials determine Peterson’s involvement with Noble violated his exclusion, they could seek to claw back Medicaid and Medicare payments the company benefited from during his tenure, according to OIG records.

Enforcement in a Gray Zone

Dennis Pangindian, an attorney with the firm Paul Hastings who had prosecuted Peterson while working for the OIG, said the agency has limited resources. “There are so many people on the exclusions list that to proactively monitor them is fairly difficult.”

He said whistleblowers or journalists’ reports often alert regulators to possible violations. KHN found eight people who appeared to be serving or served in roles that could violate their bans.

OIG spokesperson Melissa Rumley explained that “exclusion is not a punitive sanction but rather a remedial action intended to protect the programs and beneficiaries from bad actors.”

But the government relies on people to self-report that they are banned when applying for permission to file claims that access federal health care dollars through the Centers for Medicare & Medicaid Services.

While federal officials are aware of the problems, they so far have not fixed them. Late last year, the Government Accountability Office reported that 27 health care providers working in the federal Veterans Affairs system were on the OIG’s exclusion list.

If someone “intentionally omits” from applications they are an “excluded owner or an owner with a felony conviction,” then “there’s no means of immediately identifying the false reporting,” said Dara Corrigan, director of the center for program integrity at CMS. She also said there is “no centralized data source of accurate and comprehensive ownership” to check for violators.

The OIG exclusion list website, which health care companies are encouraged to check for offenders, notes that the list does not include altered names and encourages those checking it to vet other forms of identification.

Gaps in reporting also mean many who are barred may not know they could be violating their ban because exclusion letters can go out months after convictions or settlements and may never reach a person who is in jail or has moved, experts said. The exclusion applies to federal programs, so a person could work in health care by accepting only patients who pay cash or have private insurance. In its review, KHN found some on the exclusion list who were working in health care businesses that don’t appear to take taxpayer money.

OIG said its exclusions are “based largely on referrals” from the Justice Department, state Medicaid fraud-control units, and state licensing boards. A lack of coordination among state and federal agencies was evident in exclusions KHN reviewed, including cases where years elapsed between the convictions for health care fraud, elder abuse, or other health-related felonies in state courts and the offenders’ names appearing on the federal list.

ProviderTrust, a health care compliance group, found that the lag time between state Medicaid fraud findings and when exclusions appeared on the federal list averaged more than 360 days and that some cases were never sent to federal officials at all.

The NPI, or National Provider Identifier record, is another potential enforcement tool. Doctors, nurses, other practitioners, and health businesses register for NPI numbers to file claims to insurers and others. KHN found that NPI numbers are not revoked after a person or business appears on the list.

The NPI should be “essentially wiped clean” when the person is excluded, precluding them from submitting a bill, said John Kelly, a former assistant chief for health care fraud at the Department of Justice who is now a partner for the law firm Barnes & Thornburg.

Corrigan said the agency didn’t have the authority to deactivate or deny NPIs if someone were excluded.

The Family ‘Fronts’

Repeat violators are all too common, according to state and federal officials. KHN’s review of cases identified seven of them, noted by officials in press releases or in court records. KHN also found six who transferred control of a business to a family or household member.

One common maneuver to avoid detection is to use the names of “family members or close associates as ‘fronts’ to create new sham” businesses, said Lori Swanson, who served as Minnesota attorney general from 2007 to 2019.

Blank said the OIG can exclude business entities, which would prevent transfers to a person’s spouse or family members, but it rarely does so.

Thurlee Belfrey stayed in the home care business in Minnesota after his 2004 exclusion for state Medicaid fraud. His wife, Lanore, a former winner of the Miss Minnesota USA title, created a home care company named Model Health Care and “did not disclose” Thurlee’s involvement, according to his 2017 plea agreement.

“For more than a decade” Belfrey, his wife, and his twin brother, Roylee, made “millions in illicit profits by cheating government health care programs that were funded by honest taxpayers and intended for the needy,” according to the Justice Department. The brothers spent the money on a Caribbean cruise, high-end housing, and attempts to develop a reality TV show based on their lives, the DOJ said.

Federal investigators deemed more than $18 million in claims Model Health Care had received were fraudulent because of Thurlee’s involvement. Meanwhile, Roylee operated several other health care businesses. Between 2007 and 2013, the brothers deducted and collected millions from their employees’ wages that they were supposed to pay in taxes to the IRS, the Justice Department said.

Thurlee, Lanore, and Roylee Belfrey all were convicted and served prison time. When reached for comment, the brothers said the government’s facts were inaccurate and they looked forward to telling their own story in a book. Roylee said he “did not steal people’s tax money to live a lavish lifestyle; it just didn’t happen.” Thurlee said he “never would have done anything deliberately to violate the exclusion and jeopardize my wife.” Lanore Belfrey could not be reached for comment.

Melchor Martinez settled with the government after he was accused by the Department of Justice of violating his exclusion and for a second time committing health care fraud by enlisting his wife, Melissa Chlebowski, in their Pennsylvania and North Carolina community mental health centers.

Previously, Martinez was convicted of Medicaid fraud in 2000 and was excluded from all federally funded health programs, according to DOJ.

Later, Chlebowski failed to disclose on Medicaid and Medicare enrollment applications that her husband was managing the clinics, according to allegations by the Justice Department.

Their Pennsylvania clinics were the largest providers of mental health services to Medicaid patients in their respective regions. They also had generated $75 million in combined Medicaid and Medicare payments from 2009 through 2012, according to the Justice Department. Officials accused the couple of employing people without credentials to be mental health therapists and the clinics of billing for shortened appointments for children, according to the DOJ.

They agreed, without admitting liability, to pay $3 million and to be excluded — a second time, for Martinez — according to court filings in the settlement with the government. They did not respond to KHN’s attempts to obtain comment.

‘Didn’t Check Anything’

In its review of cases, KHN found nine felons or people with fraud convictions who then had access to federal health care money before being excluded for alleged or confirmed wrongdoing.

But because of the way the law is written, Blank said, only certain types of felonies disqualify people from accessing federal health care money — and the system relies on felons to self-report.

According to the DOJ court filing, Frank Bianco concealed his ownership in Anointed Medical Supplies, which submitted about $1.4 million in fraudulent claims between September 2019 and October 2020.

Bianco, who opened the durable medical equipment company in South Florida, said in an interview with KHN that he did not put his name on a Medicare application for claims reimbursement because of his multiple prior felonies related to narcotics.

And as far as he knows, Bianco told KHN, the federal regulators “didn’t check anything.” Bianco’s ownership was discovered because one of his company’s contractors was under federal investigation, he said.

Kenneth Nash had been convicted of fraud before he operated his Michigan home health agency and submitted fraudulent claims for services totaling more than $750,000, according to the Justice Department. He was sentenced to more than five years in prison last year, according to the DOJ.

Attempts to reach Nash were unsuccessful.

“When investigators executed search warrants in June 2018, they shut down the operation and seized two Mercedes, one Land Rover, one Jaguar, one Aston Martin, and a $60,000 motor home — all purchased with fraud proceeds,” according to a court filing in his sentencing.

“What is readily apparent from this evidence is that Nash, a fraudster with ten prior state fraud convictions and one prior federal felony bank fraud conviction, got into health care to cheat the government, steal from the Medicare system, and lavishly spend on himself,” the filing said.

As Kelly, the former assistant chief for health care fraud at the Justice Department, put it: “Someone who’s interested in cheating the system is not going to do the right thing.”

KHN Colorado correspondent Rae Ellen Bichell contributed to this report.

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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