Carrie Lester looks forward to the phone call every Thursday from her doctors’ medical assistant, who asks how she’s doing and if she needs prescription refills. The assistant counsels her on dealing with anxiety and her other health issues.

Lester credits the chats for keeping her out of the hospital and reducing the need for clinic visits to manage chronic conditions including depression, fibromyalgia, and hypertension.

“Just knowing someone is going to check on me is comforting,” said Lester, 73, who lives with her dogs, Sophie and Dolly, in Independence, Kansas.

At least two-thirds of Medicare enrollees have two or more chronic health conditions, federal data shows. That makes them eligible for a federal program that, since 2015, has rewarded doctors for doing more to manage their health outside office visits.

But while early research found the service, called Chronic Care Management, reduced emergency room and in-patient hospital visits and lowered total health spending, uptake has been sluggish.

Federal data from 2019 shows just 4% of potentially eligible enrollees participated in the program, a figure that appears to have held steady through 2023, according to a Mathematica analysis. About 12,000 physicians billed Medicare under the CCM mantle in 2021, according to the latest Medicare data analyzed by KFF Health News. (The Medicare data includes doctors who have annually billed CCM at least a dozen times.)

By comparison, federal data shows about 1 million providers participate in Medicare.

Even as the strategy has largely failed to live up to its potential, thousands of physicians have boosted their annual pay by participating, and auxiliary for-profit businesses have sprung up to help doctors take advantage of the program. The federal data showed about 4,500 physicians received at least $100,000 each in CCM pay in 2021.

Through the CCM program, Medicare pays to develop a patient care plan, coordinate treatment with specialists, and regularly check in with beneficiaries. Medicare pays doctors a monthly average of $62 per patient, for 20 minutes of work with each, according to companies in the business.

Without the program, providers often have little incentive to spend time coordinating care because they can’t bill Medicare for such services.

Health policy experts say a host of factors limit participation in the program. Chief among them is that it requires both doctors and patients to opt in. Doctors may not have the capacity to regularly monitor patients outside office visits. Some also worry about meeting the strict Medicare documentation requirements for reimbursement and are reluctant to ask patients to join a program that may require a monthly copayment if they don’t have a supplemental policy.

“This program had potential to have a big impact,” said Kenneth Thorpe, an Emory University health policy expert on chronic diseases. “But I knew it was never going to work from the start because it was put together wrong.”

He said most doctors’ offices are not set up for monitoring patients at home. “This is very time-intensive and not something physicians are used to doing or have time to do,” Thorpe said.

For patients, the CCM program is intended to expand the type of care offered in traditional, fee-for-service Medicare to match benefits that — at least in theory — they may get through Medicare Advantage, which is administered by private insurers.

But the CCM program is open to both Medicare and Medicare Advantage beneficiaries.

The program was also intended to boost pay to primary care doctors and other physicians who are paid significantly less by Medicare than specialists, said Mark Miller, a former executive director of the Medicare Payment Advisory Commission, which advises Congress. He’s currently an executive vice president of Arnold Ventures, a philanthropic organization focused on health policy. (The organization has also provided funding for KFF Health News.)

Despite the allure of extra money, some physicians have been put off by the program’s upfront costs.

“It may seem like easy money for a physician practice, but it is not,” said Namirah Jamshed, a physician at UT Southwestern Medical Center in Dallas.

Jamshed said the CCM program was cumbersome to implement because her practice was not used to documenting time spent with patients outside the office, a challenge that included finding a way to integrate the data into electronic health records. Another challenge was hiring staff to handle patient calls before her practice started getting reimbursed by the program.

Only about 10% of the practice’s Medicare patients are enrolled in CCM, she said.

Jamshed said her practice has been approached by private companies looking to do the work, but the practice demurred out of concerns about sharing patients’ health information and the cost of retaining the companies. Those companies can take more than half of what Medicare pays doctors for their CCM work.

Physician Jennifer Bacani McKenney, who runs a family medicine practice in Fredonia, Kansas, with her father — where Carrie Lester is a patient — said the CCM program has worked well.

She said having a system to keep in touch with patients at least once a month has reduced their use of emergency rooms — including for some who were prone to visits for nonemergency reasons, such as running out of medication or even feeling lonely. The CCM funding enables the practice’s medical assistant to call patients regularly to check in, something it could not afford before.

For a small practice, having a staffer who can generate extra revenue makes a big difference, McKenney said.

While she estimates about 90% of their patients would qualify for the program, only about 20% are enrolled. One reason is that not everyone needs or wants the calls, she said.

While the program has captured interest among internists and family medicine doctors, it has also paid out hundreds of thousands of dollars to specialists, such as those in cardiology, urology, and gastroenterology, the KFF Health News analysis found. Primary care doctors are often seen as the ones who coordinate patient care, making the payments to specialists notable.

A federally funded study by Mathematica in 2017 found the CCM program saves Medicare $74 per patient per month, or $888 per patient per year — due mostly to a decreased need for hospital care.

The study quoted providers who were unhappy with attempts to outsource CCM work. “Third-party companies out there turn this into a racket,” the study cited one physician as saying, noting companies employ nurses who don’t know patients.

Nancy McCall, a Mathematica researcher who co-authored the 2017 study, said doctors are not the only resistance point. “Patients may not want to be bothered or asked if they are exercising or losing weight or watching their salt intake,” she said.

Still, some physician groups say it’s convenient to outsource the program.

UnityPoint Health, a large integrated health system based in Iowa, tried doing chronic care management on its own, but found it administratively burdensome, said Dawn Welling, the UnityPoint Clinic’s chief nursing officer.

For the past year, it has contracted with a Miami-based company, HealthSnap, to enroll patients, have its nurses make check-in calls each month, and help with billing. HealthSnap helps manage care for over 16,000 of UnityHealth’s Medicare patients — a small fraction of its Medicare patients, which includes those enrolled in Medicare Advantage.

Some doctors were anxious about sharing patient records and viewed the program as a sign they weren’t doing enough for patients, Welling said. But she said the program has been helpful, particularly to many enrollees who are isolated and need help changing their diet and other behaviors to improve health.

“These are patients who call the clinic regularly and have needs, but not always clinical needs,” Welling said.

Samson Magid, CEO of HealthSnap, said more doctors have started participating in the CCM program since Medicare increased pay in 2022 for 20 minutes of work, to $62 from $41, and added billing codes for additional time.

To help ensure patients pick up the phone, caller ID shows HealthSnap calls as coming from their doctor’s office, not from wherever the company’s nurse might be located. The company also hires nurses from different regions so they may speak with dialects similar to those of the patients they work with, Magid said.

He said some enrollees have been in the program for three years and many could stay enrolled for life — which means they can bill patients and Medicare long-term.

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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A pair of heart devices linked to hundreds of injuries and at least 14 deaths has received the FDA’s most serious recall, the agency announced Monday.

Related Article Patients Facing Death Are Opting for a Lifesaving Heart Device — But at What Risk?

The HeartMate 3 is considered the safest mechanical heart pump of its kind, but a federal database contains more than 4,500 reports in which the medical device may have caused or contributed to a patient’s death.

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The recall comes years after surgeons say they first noticed problems with the HeartMate II and HeartMate 3, manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories. The devices are not currently being removed from the market. In an emailed response, Abbott said it had communicated the risk to customers this year.

The delayed action raises questions for some safety advocates about how and when issues with approved medical devices should be reported. The heart devices in question have been associated with thousands of reports of patients’ injuries and deaths, as described in a KFF Health News investigation late last year.

“Why doesn’t the public know?” said Sanket Dhruva, a cardiologist and an expert in medical device safety and regulation at the University of California-San Francisco. Though some surgeons may have been aware of issues, others, particularly those who do not implant the device frequently, may have been in the dark. “And their patients are suffering adverse events,” he said.

The recall involves a pair of mechanical pumps that help the heart pump blood when it can’t do so on its own. The devices, small enough to fit in the palm of a hand, are implanted in patients with end-stage heart failure who are waiting for a transplant or as a permanent solution when a transplant is not an option. The recall affects nearly 14,000 devices.

Amanda Hils, an FDA press officer, said the agency is working with Abbott to investigate the reported injuries and deaths and determine if further action is needed.

“To date, the number of deaths reported appears consistent with the adverse events observed in the initial clinical trial,” Hils said in an email.

According to the FDA’s recall notice, the devices can cause buildup of “biological material” that reduces their ability to help the heart circulate blood and keep patients alive. The buildup accumulates gradually and can appear two years or more after a device is implanted in a patient’s chest.

Doctors were advised to watch out for “low-flow alarms” on the devices and, if they do diagnose the obstruction, to either monitor the patient or perform surgery to implant a stent, release the blockage, or replace the pump. “Rates of outflow obstruction are low,” Abbott spokesperson Justin Paquette said in an email, adding that patients whose devices are functioning normally “have no reason for concern.”

A review of the FDA device database shows at least 130 reports related to HeartMate II or 3 that mention the complication reported by regulators. The earliest such report filed with the FDA dates to at least 2020, according to a KFF Health News review of the database.

Monday’s alert is the second Class 1 recall of a HeartMate device this year.

In January, Abbott issued an urgent “correction letter” to hospitals about a separate issue in which the HeartMate 3 unintentionally starts and stops due to the pump’s communication system, which cardiologists use to assess patients’ status. The FDA alerted the public in March.

In February, Abbott issued another urgent letter to hospitals about the blockage problem, asking them to inform physicians, complete and return an acknowledgment form, and pay attention to low-flow alarms on the device’s monitor that may indicate an obstruction. The company said in the letter that it is working on “a design solution” to prevent the blockages.

A study published in 2022 in the Journal of Thoracic and Cardiovascular Surgery reported the obstruction in about 3% of cases, though the incidence rate was higher the longer a patient had the device.

The only other Class 1 recall issued for the HeartMate 3 was in May 2018, when the company issued corrective action notices to hospitals and physicians warning that the graft line that carries blood from the pump to the aorta could twist and stop blood flow.

The FDA recall notice issued Monday includes additional guidance for physicians to diagnose the blockage using an algorithm to detect obstructions and, if needed, a CT angiogram to verify the cause.

At present, the HeartMate 3, which was first approved by the FDA in 2017, is the only medical option for many patients with end-stage heart failure and who do not qualify for a transplant. The HeartMate 3 has supplanted the HeartMate II, which received FDA approval in 2008.

If the new recall leads to the device being removed from the market, end-stage heart failure patients could have no options, said Francis Pagani, a cardiothoracic surgeon at the University of Michigan who also oversees a proprietary database of HeartMate II and HeartMate 3 implants.

If that happens, “we are in trouble,” Pagani said. “It would be devastating to the patients to not have this option. It’s not a perfect option — no pump ever is — but this is as good as it’s ever been.”

It’s not known precisely how many patients have received a HeartMate II or HeartMate 3 implant. That information is proprietary. The FDA recall notices show worldwide distribution of more than 22,000 HeartMate 3 devices and more than 2,200 of the HeartMate II.

The blockage complication may have gone unreported to the public for so long partly because physicians are not required to report adverse events to federal regulators, said Madris Kinard, a former FDA medical device official and founder of Device Events, a company that makes FDA device data more user-friendly for hospitals, law firms, and investors.

Only device manufacturers, device importers, and hospitals are required by law to report device-related injuries, deaths, and significant malfunctions to the FDA.

“If this is something physicians were aware of, but they weren’t mandated to report to the FDA,” Kinard said, “at what point does that communication between those two groups need to happen?”

Dhruva, the cardiologist, said he is looking for transparency from Abbott about what the company is doing to address the problem so he can have more thorough conversations with patients considering a HeartMate device.

“We’re going to expect to have some data saying, ‘Hey we created this fix, and this fix works, and it doesn’t cause a new problem.’ That’s what I want to know,” he said. “There’s just a ton more that I feel in the dark about, to be honest, and I’m sure that patients and their families do as well.”

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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More than $4.3 billion in opioid settlement money has landed in the hands of city, county and state officials to date — with billions more on the way. But instead of using the cash to add desperately needed treatment, recovery and prevention services, some places are using it to replace existing funding.

Local officials say they’re trying to stretch tight budgets, especially in rural areas. But critics say it’s a lost opportunity to bolster responses to an ongoing addiction crisis and save lives.

“To think that replacing what you’re already spending with settlement funds is going to make things better — it’s not,” said Robert Kent, former general counsel for the Office of National Drug Control Policy. “Certainly, the spirit of the settlements wasn’t to keep doing what you’re doing. It was to do more.”

The debate is playing out in Scott County, Ind. The rural community made headlines in 2015 after intravenous drug use led to a massive HIV outbreak and then-Gov. Mike Pence (R) legalized syringe service programs. (The county has since shuttered its syringe program.) 

In 2022, the county received more than $570,000 in opioid settlement funds. It spent about 45 percent of that on salaries for its health director and emergency medical services staff, according to reports it filed with the state. The money usually budgeted for those salaries was freed to buy an ambulance and create a rainy-day fund for the health department.

In public meetings, Scott County leaders said they hoped to reimburse the departments for resources they dedicated to the HIV outbreak years ago. 

Their conversations echo the struggles of other rural counties, which have tight budgets in part because for years they poured money into combating the opioid crisis. Now they want to recoup some of those expenses.

But many families affected by addiction, recovery advocates, and legal and public health experts say that misses the point, that the settlements were aimed at helping the nation make progress against the overdose epidemic.

Thirteen states and Washington, D.C., have restricted substituting opioid settlement funds for existing government spending, according to state guides created by OpioidSettlementTracker.com and the public health organization Vital Strategies. A national set of principles created by Johns Hopkins University also advises against the practice, known as supplantation.

But it’s happening anyway. 

County commissioners in Blair County, Pa., used about $320,000 of settlement funds for a drug court that has been operating with other sources of money for more than two decades, according to a report the county filed with a state council overseeing settlement funds.

In New York, some lawmakers and treatment advocates say the governor’s proposed budget substitutes millions of opioid settlement dollars for a portion of the state addiction agency’s normal funding.

Given the complexities of state and local budgets, it’s often difficult to spot supplantation. But one place to start is identifying how much opioid settlement money your community has received so far. Use our searchable database to find out. Then ask elected officials how they’re spending those dollars. In many places, dedicated citizens are the only watchdogs for this money.

If you discover anything interesting, shoot me a note.

This article is not available for syndication due to republishing restrictions. If you have questions about the availability of this or other content for republication, please contact NewsWeb@kff.org.

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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MODESTO, Calif. — When American Advanced Management made a bid for the bankrupt Madera Community Hospital last year, many local officials and others involved in trying to reopen the facility didn’t take the company seriously.

The 11-year-old firm, based in Modesto, was already running a handful of small, rural hospitals, but Madera had far larger and more prestigious suitors, including Trinity Health and then Adventist Health.

After those two entities had backed out, the bankruptcy judge tentatively greenlighted the AAM proposal. But a nonprofit community group later objected in a court filing, citing concerns about AAM’s commitment to fully reopen the hospital and airing allegations of “dishonesty, fraud, perjury, and maladministration.”

The Madera Coalition for Community Justice and other critics of the AAM deal hoped that Adventist and the University of California-San Francisco, which made a last-minute joint proposal in February to take over the hospital, might get another look.

But Gov. Gavin Newsom all but ended the drama on April 8 by announcing the state had approved the AAM plan and would provide a $57 million loan from a fund for distressed hospitals to help reopen and operate the Madera facility.

The same day, AAM, along with the Madera hospital and its creditors, asked the court to strike MCCJ’s objection from the record and requested an April 11 hearing for the judge to consider the motion. MCCJ pushed back with its own filing objecting to the request.

The closure of the hospital in January 2023 left Madera County, home to 160,000 people, largely Hispanic agricultural workers, without a general acute care facility. Like many rural hospitals in California and around the country, the Madera hospital had suffered financial and demographic challenges, including a large proportion of patients on low-paying government insurance programs, low patient volumes, and difficulty attracting talent, in addition to pandemic-related pressures.

AAM has committed to pay up to $30 million to creditors and reopen the hospital as soon as late summer. The company has a portfolio of nine hospitals, many of them in underserved regions of California.

“American Advanced Management has a proven track record of reopening closed hospitals in California and saving others from the brink of closure,” said Matthew Beehler, the company’s chief strategy officer.

It remains uncertain whether AAM can make the Madera hospital financially viable. Reopening alone will cost millions, and many of the same constraints that led to the bankruptcy remain. In its final two years of operations, the Madera hospital lost $14 million.

Beehler said AAM would aim for “operational efficiency” through centralized administration and “elevate the quality of care” to attract more patients. “These strategic investments and improvements are designed to stabilize the hospital’s financial footing and ensure its sustainability in the long term,” he said.

According to a recent study by the Pittsburgh-based Center for Healthcare Quality and Payment Reform, 30% of California’s 56 rural hospitals and the same percentage of rural hospitals nationwide are at risk of closing.

“The economics of small hospitals is such that it is unlikely they are going to be highly profitable,” said Harold Miller, the center’s CEO.

The group objecting to AAM, along with many members of the community, are particularly worried that the company won’t reopen the Madera hospital’s labor and delivery department, where over 700 babies were born in 2022.

Labor and delivery at many rural hospitals are among the first services new owners cut because they tend to lose money, said Ge Bai, professor of health policy and management at Johns Hopkins University’s Bloomberg School of Public Health.

Beehler said a reopened Madera would provide “many of the ancillary services” related to pregnancy and that AAM would “regularly evaluate” whether it makes financial and clinical sense to have a labor and delivery unit at the hospital.

‘Someone Has to Take a Stand’

AAM is the brainchild of Gurpreet Singh Randhawa, who says he is its sole owner.

Singh, a gastroenterologist-turned-entrepreneur, has amassed hospitals and other health care-related companies, as well as numerous real estate holdings. Public records show dozens of businesses that are or have been associated with Singh.

After graduating from medical school in India in 2000, Singh completed further training in New York and New Jersey before moving to California in 2008. In an interview, Singh said he was inspired to open his first hospital after seeing a friend drive three hours round trip to the Sacramento area every day to visit his father in a long-term acute care hospital because Modesto didn’t have one of its own.

Singh said he thought “‘someone has to take a stand,’ so I took that stand.” He said he spent $36 million to open Central Valley Specialty Hospital at the site of a shuttered facility in Modesto. It opened in mid-2013, marking the beginning of AAM.

Since then, AAM has acquired numerous hospitals and clinics in Northern California and the Central Valley, including Colusa Medical Center and Glenn Medical Center in 2017, Sonoma Specialty Hospital in 2019, and Coalinga Regional Medical Center in 2020.

In 2023, the firm took over management of the troubled Orchard Hospital in Gridley, California. Last September, AAM announced it had taken over operations of Kentfield Specialty Hospital, with locations in San Francisco and Marin County. It also owns a rehabilitation hospital in Amarillo, Texas.

AAM lost a combined $22.3 million in 2021 and 2022, state data shows. But Beehler said the company returned to profitability in 2023 and expects profit margins in the high single digits this year. He estimated that AAM’s total operating revenue will jump to approximately $400 million in 2024 from $290 million in 2023, mainly due to the addition of three hospitals.

The source of the funds to finance the company’s growth is not entirely clear. Singh cited family wealth and real estate, but he declined to discuss his family’s money. The firm’s agreement with the Madera hospital says AAM will have “immediately available funds in cash” to meet its obligations. The $57 million approved by the state this week will be a key source of funding.

Beehler said another source of cash to finance growth is AAM’s earnings on longer-term care. Central Valley Specialty Hospital has been profitable since its first full year of operations in 2014, posting cumulative earnings of over $66 million through 2022, according to data from the state’s Department of Health Care Access and Information. Coalinga Regional Medical Center has a 99-bed skilled nursing facility in addition to its acute care beds, and Sonoma Specialty Hospital recently added 21 beds, according to Beehler.

Acute vs. Long-Term Care

Critics fear AAM might take the Madera hospital in the direction of long-term care, depriving the community of a viable acute care facility. Cece Gallegos, who recently lost her bid for a seat on the Madera County Board of Supervisors, said in a campaign mailer that the firm would turn Madera into “a glorified nursing home.”

Beehler rebuffed that notion, saying the company couldn’t do that even if it wanted to. He said the conditions imposed by the state attorney general “require an acute care hospital with fully functional ER and ancillary services.” The attorney general’s conditions, however, require AAM only to make “commercially reasonable efforts” to provide those services.

Singh and his health care businesses have hit plenty of bumps as they’ve grown.

In 2018, AAM took over management of Sonoma West Medical Center, a publicly owned hospital in the city of Sebastopol that had declared bankruptcy. In 2019, AAM acquired it outright and changed its name to Sonoma Specialty Hospital. Later that year, a bankruptcy trustee sued Singh, AAM, and the hospital for allegedly taking money that belonged to its predecessor, and the parties settled for $1.15 million. Beehler said AAM did not retain any of the money but used it for hospital operations and became “an unintended victim.” The company chose to settle, he said, “to bring finality to this complex issue.”

In 2021, the state fined AAM’s Pacific Gardens Medical Center $276,000 for four situations that put patients in “immediate jeopardy,” including one in which inadequate training caused an intravenous dose of fentanyl to drip into a patient nearly seven times as rapidly as the doctor had ordered.

AAM had reopened the hospital in January 2021, about three years after buying it out of bankruptcy. Its license was suspended less than five months later, according to the California Department of Public Health. Beehler said the hospital had reopened as a pandemic surge hospital with support, including the provision of nurses and physicians, from the state’s Emergency Medical Services Authority. “By its nature, a surge facility opening is temporary,” he said.

The accelerated timeline for getting it open contributed to the patient-jeopardy situations, he said.

In 2022, the California Department of Health Care Services sued Sonoma Specialty Hospital, Singh, and AAM, accusing them of illegitimately seeking, and accepting, $270,000 from a program that provides federal financing for certain public hospitals.

DHCS said it had told AAM that it wasn’t eligible for the money, because it was now a for-profit facility, but that the company refused to pay it back. In February, a Sonoma County judge sided with DHCS. DHCS spokesperson Leah Myers said in an emailed statement that the state does not typically have to sue to recover money. Beehler said AAM “disputes that there is any liability” and is appealing the decision.

Another Singh venture was Advanced College, a private vocational school for health care professionals with three locations in central and Southern California. After receiving numerous complaints, state regulators ordered the school to cease operations in December 2022, alleging it had falsified records and test results, and “failed to provide documentation of sufficient financial resources.”

Joshua Maruca, the school’s custodian of records, said Advanced College disagreed with the state’s allegations but had already been planning to shut down for other reasons, so it did not contest them.

Bank of the West also sued Singh and several of his businesses for repeated defaults on over $4.7 million in loans, mostly related to the college. The lawsuit was settled, but one of the bank’s lawyers, Wayne Terry, said he could not discuss the settlement. Beehler said the loans were not part of AAM’s financials. The bank was “paid fully,” he said.

The company’s critics say the state didn’t sufficiently scrutinize AAM before approving the loan and the operating plan this week.

“The state agencies and the Attorney General, all tasked here with protecting the public interest, have utterly failed to do the basic due diligence that would ensure Madera Community Hospital is resurrected as a viable going concern, under the stewardship of a reliable, trustworthy, and capable operator,” the MCCJ said in the court filing opposing the challenge to its objection.

AAM said in a statement that it was “grateful” to Newsom and the state for approving the deal, and “honored to serve the Madera community.” The bankruptcy court is likely to give its final blessing next week.

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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