A patient rests comfortably in a hospital bed. Everything seems fine. Neither the patient nor the doctor or nurses realize he is about to take a life-threatening turn for the worse. Within hours, he will be septic, and his care team will race to begin aggressive fluid resuscitation and antibiotics

Yet, although the patient’s doctor and nurses do not see sepsis coming, someone else does — or, more accurately, some

 else does. The patient’s electronic health record (EHR) includes an artificial intelligence (AI) tool that detects patterns imperceptible to the patient’s human caretakers. It duly sends an alert to his doctor and nurses. What could have been a shocking deterioration is instead averted.

It sounds futuristic, this kind of thing that AI could do. But algorithms are already detecting hard-to-anticipate conditions such as sepsis in hospitals, and lives are already being saved. In fact, the underlying idea — that a set of data, put together in context, can help predict outcomes — is already very much a part of medical thinking.

“A lot of these concepts, they’re not new to medicine,” says Yasir Tarabichi, M.D., MSCR, director of clinical informatics for research support at MetroHealth, a safety net healthcare system in Cleveland.

AI and machine learning based on huge medical data sets are just the latest iteration of risk stratification, Tarabichi says, which is something as old as medicine itself. Before AI, patients could be given risk scores based on simple scoring tools and scales. AI has created the opportunity to score patients using thousands of measurements not previously available, much less analyzable. “It was simpler before, because it was more of a point-based system,” Tarabichi says. “Now it (has become) a lot more complicated.”

With opportunity comes challenges. One of the main challenges with AI is dealing with the onslaught of new products. Prem Thomas, M.D., medical director of data analytics and medical information officer at Yale New Haven Health in Connecticut, said he and colleagues get visits from software representatives the way doctors have historically received visits from drug company sales reps. “It’s interesting,” he says. “We have our weekly medical information officers’ meeting, and typically there’s somebody (from a technology vendor who) wants to present to us during that time.”

The companies hawking their AI wares range from entrenched players such as Epic Systems, the largest EHR company in the United States, which markets a sepsis prediction model, to tiny startups that have little, if any, experience in healthcare. Increasingly, tech giants such as Apple and Google have tried to gain a foothold in the healthcare technology sector, often with an
AI focus.

The utility of AI in healthcare settings extends beyond clinical decision support tools such as the sepsis model. One area Thomas has been examining uses AI to make operating room scheduling more efficient. Currently, the time slots that surgeons request for routine procedures such as appendectomies are often imprecise.

“The surgeon asked for two hours,” Thomas says, “but based on the data for that surgeon and the location where they are going to be (performing the operation), can we be more accurate in how long it’s going to take and, hopefully, minimize things like delays for other patients and other surgeons?”

Houston Methodist Hospital turned to AI when it was preparing to receive COVID-19 vaccines, according to LeTesha Montgomery, M.H.A., RN, the hospital’s vice president for operations and patient access. The hospital knew they would be facing a “tsunami of phone calls” from patients and members of the public asking questions or wanting to sign up for the vaccines, Montgomery says. “With predictions of increased volume reaching 300% to 400%, hospital leaders knew we needed a solution that would manage the flood of vaccine-related phone calls without impacting usual operations,” she says.

The hospital used Syllable, a conversation AI voice assistant, to automate work flow and conserve resources by making it easier for patients to find a wide array of answers without needing to speak to a human being. It also used AI to handle in-person traffic. Visitors to the facilities were screened by the temperature-monitoring platform Care.ai by standing in front of a tablet equipped to scan for fevers. “This contactless technology not only helped with conserving staff resources, but it also speeds up screening measures at point of entry,” Montgomery says.

One reason Houston Methodist was able to implement its COVID-19 strategies fast is because it has set up an infrastructure to quickly review and vet new technologies. The Center for Innovation, launched in 2018, has a group called DIOP, which stands for Digital Innovation Obsessed People, made up of roughly half operational staff and half information technology staff. The group is charged with developing strategies for broad-scale implementation or “failing fast” — quickly identifying technology that is not a good fit. “The results of focusing on innovation before it was essential to a pandemic such as COVID-19 enabled our hospital system to embrace new technology, including AI, more seamlessly,” Montgomery says.

Still, the stakes for AI implementation vary depending on its proposed use. A temperature-screening device that stops working might mean a staff member gets temporarily reassigned to thermometer duty. An errant AI system designed to help clinicians make treatment decisions could harm patients, even kill them.

Tarabichi said it is important that the public understands that hospitals do not take AI lightly.

“We don’t just blindly adopt new technology,” he says. “We make sure it’s going to work for us.”

For instance, before implementing the Epic sepsis model, MetroHealth ran the program in the background for an entire year, disabling the alerts but collecting data. Before they toggled it live, the health system wanted to make sure it worked and had a meaningful benefit. At the end of the year, they adopted the technology but limited its use to the emergency department.

Thomas says that kind of slow, evaluative approach is key to AI integration. It means taking the time to understand how an AI system works, getting an idea of the data sets used by the vendor and tailoring the program’s settings to the health system’s needs.

In other words, it takes time and money — and more time. But Thomas says the expense is worth it.

“I would recommend that community hospitals or academic hospitals invest the resources in having a redesign committee review what this model is purported to do for you and then think through how to operationalize it,” he says. Yale New Haven’s redesign committee, for instance, is an interdisciplinary team whose members include intensive-care unit nurses, emergency department doctors, inpatient nurses and other professionals, as well as analytics staff.

But a health system’s ability to carefully evaluate an AI system isn’t just a matter of staff expertise and representation. It also requires having access to enough data and software to fully understand a product. Because AI products are proprietary software marketed by for-profit companies, there can be tension between the company’s desire to keep proprietary information private and a healthcare system’s need to fully understand the tools they are using to take care of patients. 

An example of that kind of conflict had a public airing this summer when investigators from the University of Michigan reported findings of their independent evaluation of Epic’s sepsis prediction tool in 

. Their research suggested that the product is less accurate at predicting sepsis than what the company claims in its marketing materials. The findings were controversial, in part because the sensitivity of the AI tool depends on the settings put in place. Epic disputed the findings, saying that it works closely with users to ensure the product meets their needs and to provide access to the data necessary to evaluate the model.

Tarabichi has submitted his own paper, soon to be published, which contradicts some of what the Michigan investigators found. Yet, even as experts disagree about the particular product, this raises important questions about the limits of using proprietary models.

“The increase and growth in deployment of proprietary models has led to an underbelly of confidential, non-peer-reviewed model performance documents that may not accurately reflect real-world model performance,” wrote the corresponding author of University of Michigan study, Karandeep Singh, M.D., M.M.Sc., and his colleagues.

In the case of Epic’s sepsis model, both Thomas and Tarabichi said they were satisfied that they had access to the information they needed to evaluate the product, though they both said information from the company was just one component of their implementation process.

Tarabichi cautions against hospitals “jumping on the bandwagon,” of using popular AI without first validating it and testing it in their own system. In a smaller community hospital setting, validation may not need to be as complicated as it might at a top academic medical center with a diverse patient population.

“Randomized controlled trials are the highest level of evidence, but lower down that hierarchy is pre- and post- assessment,” he says. “Run it for a couple of months and then evaluate. What changed? Can you do better?”

For Thomas, it is not just about choosing the right AI system but also about being thoughtful about when and where AI is actually needed. He and his colleagues reference a “Mad Lib” created by Michael Draugelis, the chief data scientist at Penn Medicine in Philadelphia. It goes like this, Thomas says: “If I were [a physician, a physician’s assistant, a nurse, an operating room scheduler] in the health system and I knew ____, I would do ___ to change ____. “Before we start on any project now, we say, ‘fill in the blanks,’ ” Thomas says. “Because if we don’t have a good answer for those, then we shouldn’t be investing the time and effort to go through with the project.”

Montgomery agrees, saying technology cannot displace patients’ status “at the center of everything we do.”

“AI isn’t meant to solve all the challenges in the healthcare setting,” she says, “but where these applications make sense, where they provide real benefits to our patients, that means it’s reaching its full potential.”

Articles

Artificial intelligence is improving healthcare methods and insights. But when used incorrectly, AI is rife with pitfalls.

AI: Beyond the Buzz 

More than 30 million Americans have diabetes, according to the American Diabetes Association, and many rely on insulin.

But insulin prices have been rising in recent years, and that has put many people with diabetes at risk because the price leads to people skipping doses or not taking insulin altogether.

The latest figures from the American Action Forum show that the price of insulin rose 14% a year, on average, between 2012 and 2018, and the past few years have followed this growth trajectory.

Many patients, policy makers and experts blame companies that manufacture insulin for dialing up the price of an established therapy. Sally Pipes, president and CEO of the Pacific Research Institute, a California-based think tank that favors free markets and limited government, says it’s easy to point the finger at pharmaceutical companies, but she finds fault elsewhere: in a dysfunctional market for insulin and many other prescription drugs and in pharmacy benefit managers.

“Pharmacy benefit managers — middlemen hired by insurance companies to manage their prescription drug plans — are driving those list prices up,” she asserts. The Pharmaceutical Care Management Association, the trade group for PBMs, says its member have done quite the opposite with programs that cap out-of-pocket costs or eliminate them. A spokesperson for the group says insulin makers have used patent extensions to avoid competiton.

In the summer of 2020, then-President Donald Trump signed an executive order aimed at reining in prescription drug costs, requiring federally qualified health centers and hospitals, which purchase insulin through the 340B Drug Pricing Program, to pass along any savings they receive from discounted drug prices to medically underserved patients. The Biden administration halted its implementation. The National Association of Community Health Centers, among others, expressed support for the new administration’s move, saying the Trump rule would not have lowered the cost of insulin (and EpiPens) for most Americans.

Some states are moving to control insulin prices. This summer, Colorado joined Illinois in passing legislation that caps out-of-pocket costs of insulin. Maine, New Mexico, New York, Utah, Washington and West Virginia are considering
similar legislation.

Prices may also come down if interchangeable biosimilars start coming on the market. In July 2021, the FDA designated Semglee (insulin glargine-yfgn) as an interchangeable biosimilar to Lantus (insulin glargine), a long-acting insulin analog. The designation means a pharmacist can switch the brand-name product for the presumably less expensive biosimilar, although state pharmacy laws can put some limits on interchangeability. Even so, the FDA approval should result in some competition between Semglee and Lantus and price decreases for patients and payers 

Keith Loria is a freelance writer in the Washington, D.C., area.

States are putting caps on prices, and Semglee, the first interchangeable biosimilar in the United States, may exert some downward pressure. 

Stemming the Rising Tide of Insulin Prices 

Retailers such as CVS Health and Walgreens Boots Alliance may force traditional providers to rethink the way they deliver healthcare. The drugstores ramped up care during the heart of the COVID-19 pandemic, often providing more convenient and less costly alternatives.

“Traditional providers have to think like retail providers going forward: convenient, transparent and cost-effective,” says Arielle Trzcinski, a principal healthcare analyst at Forrester, a research and advisory company. The retail clinics tend to be less expensive for consumers than traditional providers and urgent care centers, Trzcinski notes, and the walk-in access is an advantage over having to schedule an appointment.

By offering COVID-19 testing and vaccinations and providing medical care at their in-store clinics, retailers built up “a lot of goodwill that they will carry forward beyond the pandemic,” Trzcinski adds. “It’s an opportunity for them to continue to build on the trust consumers have started to have in them.”

A survey of 2,200 adults conducted in the spring of 2021 by the Morning Consult, a survey company, found that 35% of the respondents had received healthcare in person at a retail clinic since the pandemic began in early 2020 and that 8% had received care at the clinics often.

A different survey of 500 consumers and 250 retail healthcare executives released by the technology company UPshow found consumers were inclined to go to retail health clinics during the pandemic because they wanted to avoid doctors’ offices that might be crowded. The clinics in the chain drugstores also allowed them to combine medical care and shopping so they could limit trips away from home. Not all of the findings from the UPshow survey are positive for retail health clinics. Almost half (47%) of those surveyed indicated that they were not “completely confident” in the quality of care provided at retail health clinics.

Although CVS and Walgreens have made sizable bets on retail healthcare being part of their futures, their approaches vary. CVS is focusing on developing in-store HealthHUBs where its customers can get a variety of healthcare services, including primary care for chronic conditions and behavioral healthcare. Rather than developing its own healthcare services, Walgreens has focused on relationships with other providers, including a partnership created last year with VillageMD to develop doctors’ offices in its stores. But Dan Clarin, managing director at Kaufman Hall, says neither Walgreens nor CVS “offers every service to every customer on their own — they’re a convener of services.” He compares the companies to Amazon as a platform to connect consumers with the products they want.

The drugstore chains don’t have the retail healthcare business entirely to themselves. Walmart has set up clinics in some of its stores, offering a variety of services, including dental, optometry, primary care and X-rays. Walmart has acquired MeMD, a telehealth provider. With that acquisition, Walmart has filed paperwork to do business in 37 states. according to the 

. The retailers are hopeful that their retail clinics will attract younger people, Clarin notes. The Morning Consult survey found that half of 18- to 34-year-olds had gone to a retail clinic during the pandemic, compared with just 1 in 5 of those aged 65 years and older. Younger consumers are less likely to have a primary care physician. They also have “less brand loyalty,” Clarin says, and focus on “experience and convenience.”

CVS has offered healthcare at its MinuteClinics for 25 years and has expanded to hundreds of locations inside its drugstores and in Target’s brick-and-mortar stores. But its more recent focus is on its HealthHUBs, which are billed as providing a wider array of services and services consumers will use over time. not just on an emergent basis. Part of the investment in HealthHUBs is a consequence of the company’s acquisition of Aetna in 2018 for
$69 billion. CVS calls itself “the leading health solutions company.”

“Over the last few years, we have pushed the boundaries to change people’s perception of their neighborhood drugstore, as well as to add value, offer more innovative services and provide convenient, affordable and accessible care,” Ryan Rumbarger, senior vice president of retail store operations for CVS Pharmacy, said in an email to 

.® At the end of the first quarter of 2021, the retailer had about 800 HealthHUBs, Karen Lynch, president and CEO of CVS Health, said in a call with investors. According to previously announced plans, the company’s goal was to have 1,500 of the hubs up and running by the end of 2021, but Lynch said the company would have about 1,000 in operation by that time.

CVS is offering COVID-19 vaccinations at 9,600 sites and providing testing for the virus at thousands of locations, many of which serve vulnerable communities, Rumbarger said.

CVS’ most recent move is adding licensed therapists at certain HealthHUB locations as demand for behavioral health services has soared in light of the pandemic.

Walgreens is focusing on partnering with providers In late 2020, it announced it was closing 150 clinics that it operated on its own. It still partners with local health systems to operate clinics. But the company’s major play in retail healthcare is its partnership with VillageMD, a primary care company headquartered in Chicago. The plan is to develop at least 600 VillageMD clinics, which operate under the name Village Medical, in more than 30 markets over the next four years, with hundreds more to follow, Rick Gates, Walgreens’ senior vice president of pharmacy, said in an email to 

. Currently there are more than 50 Village Medical clinics in Walgreens stores, most of them in the Sunbelt.

During the pandemic, the drugstore giant has conducted more than 8 million COVID-19 tests and provided more than 25 million vaccinations, Gates said. With millions losing their jobs, the company has lowered prices on hundreds of medications, he said,

Physicians and others have raised concerns about retail healthcare further fragmenting American healthcare. But Gates said data from the current Village Medical clinics indicate improvements in medication adherence and fewer emergency room visits, unnecessary hospitalizations and readmissions for patients with chronic conditions.

Walmart is calling its in-store clinics Walmart Health. The retail giant opened its first clinic in Dallas, Georgia, about 30 miles outside Atlanta, in 2019. Now it has clinics in stores elsewhere in Georgia, Texas and Arkansas. A price list on the company website for Dallas, Georgia, showed that a Walmart Health office visit costs $40; a dental exam with X-rays, $25; and a new patient therapy session, $60. The retailer’s wide range of services and low prices make it “convenient and cost-effective,” says Trzcinski, the Forrester analyst. Walmart has also priced many generic medicines at $4, which may help with getting people to take their medication as prescribed. “Cost is a huge barrier for folks being able to adhere to their medications,” Trzcinski says.

In late June 2021, Walmart acquired telehealth provider MeMD. “Today people expect omnichannel access to care, and adding telehealth to our Walmart Health care strategies allows us to provide in-person and digital care across our multiple assets and solutions,” says Cheryl Pegus, executive vice president of Walmart Health & Wellness, said in a news release announcing the planned acquisition.

Although Walmart doesn’t have as large a footprint as CVS and Walgreens do, it has a strong presence in rural areas, where access to healthcare may be hard to come by, notes Clarin.

is an independent journalist in Tampa, Florida, who writes about business and healthcare.

But CVS, Walgreens and Walmart differ in how they are setting up in-store health clinics.

Retailers Want to Provide You Healthcare, Not Just Sell you Stuff 

In lung cancer especially, the ability to identify genomic alterations in patients’ tissue or blood samples has opened the door for more widespread adoption of targeted and immunotherapies, says Luca Quagliata, Ph.D., BCMAS, vice president and global head of medical affairs at Thermo Fisher Scientific, a healthcare tech and testing company headquartered in suburban Boston. Therapies tailored to lung cancers with certain genomic signatures have replaced chemotherapy as a first-line treatment for patients with lung cancer, he says, and advances in biomarker testing have decreased the turnaround time for results.

“We are no longer trying to convince people that genomic testing is valuable in lung cancer,” Quagliata says. “There is enough evidence to show its clinical utility.”

Quagliata also says testing has shifted from being done almost exclusively for patients with late-stage cancer to those with cancers diagnosed at an early stage as more targeted treatments prove to be effective in patients who are treated with surgery. This move “upstream” means fewer patients need to be treated with chemotherapy and radiation. Quagliata is also upbeat about the future of liquid biopsies, which detect early signs of cancer in blood samples rather than on samples of tissue from site of the tumor. “The value of liquid biopsy is that it is much less invasive to patients and has a simpler laboratory workflow when compared to acquiring and testing tissue samples,” Quagliata says. “ Thermo Fisher has a liquid biopsy product.

Raymond U. Osarogiagbon, M.D., FACP, the director of the multidisciplinary thoracic oncology program at the Baptist Cancer Center in Memphis, Tennessee, notes that as recently as 2012, almost half of advanced nonsquamous non-small cell lung cancers (NSCLCs) had no known biomarker that could be targeted for treatment. Now only about 1 in 10 of such cancers lacks biomarkers, he says, and the list of biomarkers — typically, a mutated gene — for which there are FDA-approved has grown from just two treatments to 10.

Targeted therapy for certain subsets of biomarker-specified lung cancer significantly improve survival. But Osarogiagbon says use of targeted therapy in patients lacking the specific target can cause harm. If the cancer doesn’t have the target, a targeted therapy is tantamount to no treatment. The longer that continues, the greater the harm. Therefore, biomarker testing is a key, fundamental part of successful targeted therapy. Several of the biomarker-delineated subsets of lung cancer are infrequent, occurring in fewer than 5% of all patients, notes Osargiagbon. “There is no clinical means of identifying patients with the relevant biomarker-delineated subsets. Therefore, there is the need for comprehensive genomic testing, so no patient gets left behind.” 

Additionally, there’s evidence that immune checkpoint inhibitor therapy, with drugs such as Keytruda (pembrolizumab) and Yervoy (ipilimumab), is ineffective in patients whose cancer is driven by certain genomic abnormalities, such as EGFR and ALK gene mutations. “Prior therapy with immune checkpoint inhibitors seems to significantly increase the danger of pneumonitis (inflammation of the lungs) — which can be debilitating, even life-threatening — when the correct targeted oral therapy agent is subsequently used,” Osarogiagbon says.

When it approves a targeted therapy, the FDA also often approves a companion test that can identify the biomarker for that targeted therapy. There are also tests developed by researchers and laboratories that haven’t been approved by the agency. “For companion diagnostic tests, the FDA has set the bar very high for accuracy and validation,” Quagliata says. “For assays that are not FDA approved, including LDTs (laboratory developed tests), Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (there are) standards for high-complexity laboratories to safeguard the quality of tests.”

When it comes to the expense of testing, Quagliata says it is essential to pull back and the see the situation from a broader perspective. “Rather than put patients on inefficient therapies as a first-line treatment, genetic testing allows clinicians to make more informed decisions, becoming more efficient in their prescribing, thus helping save on downstream treatment costs,” Quagliata says.

Osarogiagbon says American healthcare is moving rapidly from tests for a single biomarker to comprehensive genomic testing because the broader approach is faster, safer and more cost-effective for patients. “Unfortunately, even though the cost of so-called next generation sequencing (NGS) is dropping as more testing options and vendors enter the market, there remains the perception that these tests are expensive and might not be paid for by third-party payers,” he says. Another major concern is the turnaround time. Getting an NGS result can take several weeks.

Insurance coverage of biomarker testing is a wild card into biomarker testing. “Reimbursement has become a complex matter as even within the non-small cell lung cancer space, differences exist in several areas that impact payer coverage, including sample type, test size, test content, use case, and the stage of disease,” Quagliata says. In general, among patients with late-stage NSCLC, Medicare provides coverage, Medicaid does not, and commercial plans vary, according to Quagliata.

But as more studies are done, Quagliata believes the evidence for NGS being more efficient and cost-effective will get stronger. Matching patients with targeted therapies at an earlier stage will reduce unnecessary spending for payers and patients.

Andrew Hertler, M.D., chief medical officer at New Century Health, a subsidiary of Evolent Health, says the cost of the biomarker testing ranges from $2,000 to $4,000, though there can be additional costs if there’s a need to re-biopsy the tumor. Hertler sees a challenge in making sure the tests are accurate. “There have been some very disturbing studies done where people have sent the same specimen out to multiple different laboratories and not had consistent results — I think somewhere on the order of 50% of the time — so we clearly still badly need to come up with standardized validated reliable procedures,” he says. But Hertler notes that variability may also be in the cancer itself. “We know cancers are genetically unstable.”

The challenge in getting biomarker testing and targeted therapy is not so much with the patients as with their doctors and the healthcare systems in which they practice, as well as third-party coverage policies for these rapidly emerging options. Osarogiagbon is an adviser on the No One Missed campaign by LUNGevity Foundation, which brings essential education to the public around comprehensive biomarker testing in lung cancer.

“Patients quickly understand the benefit of this approach, given the striking improvements in results and greater convenience,” he says. “The main barriers are not patient-level; they are provider-, institutional- and social policy-level.”

Most clinicians are recommending comprehensive biomarker testing, which includes NGS and PDL1 Tumor Proportion Score testing.

“Single-gene tests waste time and expose patients to the danger of inordinate delay in identifying potentially lifesaving biomarkers that guide treatment,” Osarogiagbon says. “Ideally, these tests should be done reflexively when the patient diagnosed and the testing is automatically ordered, thereby saving precious time.”

Hertler says that when talking with patients, providers should explain biomarker testing methods clearly and note that targeted therapies don’t work for everybody, and even when they do work, the enthusiasm can have people carried away about the prospects. “People are doing better and have less side effects from their therapy and can live a more normal life, but we don’t have
a cure.”

Keith Loria is a freelance medical writer in the Washington, D.C., area.

Treatments aimed at certain mutations have proliferated and moved upstream to earlier-stage lung cancers. But there are many questions about insurance coverage and which tests to use to identify the biomarkers that help guide treatment. 

The Mainstreaming  of Targeted Lung Cancer Treatment

When Terri Kirkpatrick, a community health worker, meets a new client, the first question she asks is, “how are you feeling today?”

The question isn’t just an icebreaker. It’s laying the foundation for the relationship Kirkpatrick hopes to build with her clients. She knows how vulnerable and anxious women coming into Strong Beginnings feel. She was once a client of the program for pregnant Black mothers with behavioral health needs.

“I can truly say that I was born to be community health worker,” Kirkpatrick says, adding that she has an experiential understanding of the disparities the program’s clients live with.

Kirkpatrick has been a Strong Beginnings community health worker for 23 years. The program, a partnership between Spectrum Health, a Michigan-based managed care organization, and nine community organizations, facilitates home visits by nurses, nutritionists and community health workers.

Like most community health workers, Kirkpatrick has a job that takes her outside the traditional boundaries of healthcare. She helps the women in the program with whatever needs they might have, including food and housing, job and career support. “Whatever their priority is, that’s what I focus on,” she says. “I’m here for them.”

The community health worker model has been around, in one form or another, for 100 years, says Scott Tornek, chief strategy officer for the Penn Center for Community Health Workers at the Penn Medicine. “It’s not a new concept,” says Tornek. “It has gone through boom-and-bust cycles for decades.”

Now it is booming. It started after passage of the ACA in 2010 and the subsequent move toward risk-based contracts that create incentives to reduce the cost of care and prevent illness. According to the CDC, more than 23 states have or are considering community health worker programs.

Yet community health workers have not been fully embraced by the U.S. healthcare system. Even if they result in overall savings, the programs can be expensive to operate. Pilot projects may get off to a good start but then shut down when the funding runs out.

But many experts, physicians and healthcare executives see the community health workers as a way to deal with much-talked-about social determinants of health. The question, then, concerns how hospitals, health systems, payers and government health officials can make community health workers part of the everyday reality of American healthcare. “It’s a complicated question,” Tornek says. “But I think it starts with sustainable funding, especially for Medicaid and for people who are underserved — marginalized people who are in those insurance groups.”

About a decade ago, Shreya Kangovi, M.D., M.S., a pediatrician caring for patients in West Philadelphia, asked herself that same question. In the ensuing years, Kangovi, along with a team of researchers from the Perelman School of Medicine at the University of Pennsylvania, created the Individualized Management for Patient-Centered Targets, or IMPaCT, program. Some key aspects of IMPaCT were developed based on interviews with more than 1,500 patients. Each was asked what was stopping them from staying healthy. The answers: food, housing, transportation and other problems. Next, an operational program was designed. Kangovi and her colleagues tested IMPaCT in randomized controlled trials and published the results.

Tornek says the key to the program’s success is hiring the right people. “We look for people who reflect the patients we serve, who are from the same communities, who have shared life experiences, who are naturally empathetic, who are good listeners, and who will bring food to a neighbor in need who is sick,” Tornek says. “You can’t train for that.”

The IMPaCT program involves training community health worker managers, most of whom have a background in social work. The program integrates community health workers with the patient’s care team. Patient satisfaction with IMPaCT is high, Tornek says, and employee turnover is a low 2%.

Community health worker salaries can vary. In large cities, starting salaries range from the high-$20,000s to the mid-$30,000s. An experienced community health worker can make up to $52,000 a year, according to the website Explorehealthcarecareers.org.

“The community health worker quarterbacks the nonclinical and nonmedical relationship with the patient,” Tornek says. “The community health worker in our model helps patients set and achieve their goals to get back on track quickly. How does that translate into health? It could be controlling their diabetes by shopping for healthier foods so they stay out of the hospital.” 

Three controlled, randomized studies showed positive results. But a study showing that community health workers could save money had not been done. That changed in February 2020, when Kangovi, now the executive director of the Penn Center, reported results in 

. The study followed 302 patients considered at high risk for health problems between July 2013 and October 2014.

The patients were randomly divided: 150 in an intervention group that received services from the community health workers and 152 in a control group. All patients came from “high-poverty neighborhoods” and each had at least two chronic diseases. At the study’s one-year follow-up, 98 patients in the control group had been hospitalized, compared with 68 patients in the intervention group. The total inpatient and outpatient bill for intervention patients was about $ 2.5 million compared with $3.9 million for the control group. Kangovi and her co-investigators reported that the team of community health workers saved Medicaid $1.4 million. They calculated that the savings divided by program expenses ($567,950.82) yielded a return on investment within a single fiscal year of $2.47 for every dollar invested.

Over the past seven years, IMPaCT and Penn Center’s 30 community health workers have seen 13,000 patients. Depending on the goals they are trying to achieve, most patients work with program’s community health workers for three to six months. Some return, but most don’t.

Penn has exported its IMPaCT program to 20 states and 50 healthcare organizations, large health systems, payers, nonprofit organizations and departments of health. The adopters include ChristianaCare in Delaware, BJC HealthCare in St. Louis and Blue Cross Blue Shield of North Carolina.

But even successful programs like Penn Center and Strong Beginnings are constantly concerned about funding. Strong Beginnings runs on an annual budget of $2 million and includes funding from federal and state sources plus a $500,000 contribution from Spectrum Health. Penn Center does not publish its annual budget, but Tornek says the organization’s external work is self-funded and that Penn Medicine pays for the patients it refers. “We are doing a lot with pretty limited resources, quite frankly,” Tornek says.

Community health worker programs need to be on a firm financial footing to help vulnerable patients and reduce admissions, Tornek says. He would like to see Congress and the federal government’s various health agencies increase funding and help build a sustainable, long-term infrastructure to support community health programs.

“It’s a compressed question,” Tornek says. “There is institutional racism and health equity issues. How do we level the playing field? It’s a complicated question, but I think it starts with sustainable funding.”

is an independent journalist in the Philadelphia area who writes about healthcare and other issues. Aine Cryts contributed reporting.

Community health workers can address social determinants of health, and some programs have been shown to reduce healthcare costs.

Healthcare and More, by and for the Community

n the coming years, the federal Medicare program will either need more funding or be forced to make serious spending cuts. The Medicare program is popular with voters and has support among politicians in both parties. But partly because of the expense of the response to the COVID-19 pandemic, policy makers may look to curtail Medicare spending and, more particularly, the Medicare Advantage (MA) program.

Medicare cuts may be needed because one of the two trust funds the government uses to pay for parts of the Medicare program is facing a severe shortfall, according to the Congressional Budget Office (CBO). In February, CBO predicted that the Hospital Insurance Trust Fund would be insolvent within five years.

In response, the Medicare Payment Advisory Commission (MedPAC), a nonpartisan organization established by statute to advise Congress on Medicare policies and programs, suggested eliminating the bonus payments the MA plans get as part of the Star Rating system, which rates the quality of the plans on a scale from 1 to 5.

This is not the first time the Medicare program has been on shaky financial footing; shoulders may shrug as more pressing matters dominate political and policy debates.

But it is only the second time that a projection predicted insolvency within five years, according to the Alliance for Health Policy, a nonpartisan organization that helps policy makers understand health policy. Adding to the sense of urgency is the demographic bulge of baby boomers aging into Medicare coverage at the rate of 10,000 seniors per day for the next 18 years. The past 15 years have been boom times for MA plans, and most indications are that the upswing will continue. But now there are some clouds on the horizon.

The Medicare program is the country’s largest purchaser of healthcare by far, spending nearly $900 billion this year to provide coverage for some 62 million Medicare beneficiaries, about 38 million of whom are in traditional Medicare, and
24 million of whom are in Medicare Advantage plans.

A growing proportion of the $900 billion is flowing to MA plans. CBO projections show that by 2030, more than half of Medicare beneficiaries will be in MA plans. Twenty years ago, only 13% of Medicare beneficiaries were in MA plans. Enrollment has grown because beneficiaries often get drug, dental and vision coverage with an MA plan. The trade-off is a narrower network of providers than traditional Medicare, but surveys show that most MA enrollees are satisfied with their choices. The MA plans say they are increasingly shouldering the burden of Medicare beneficiaries with complex, chronic conditions and health problems rooted in the social determinants of health.

MA has become a major line of business for many of the country’s largest health insurers. The largest commercial health insurers in the MA market are, in order of market size, UnitedHealthcare, Humana, the Blue Cross Blue Shield plans, CVS Health, Kaiser Permanente, Centene, and Cigna, KFF reports. According to the foundation’s researchers, the gross margins — the difference between the premiums insurers collect and the claims they pay out — are larger for insurers in the MA market than in other insurance markets. In 2020, the per-member, per-month gross margin in MA was $188, compared with $143 in the individual market and $80 in the group market, according to KFF calculations.

In its annual report to Congress in June, MedPAC made recommendations for adjusting MA payments. Among them was lowering the benchmarks that the federal government uses to set the per-
beneficiary capitated payments to MA plans by about 2%, according to Gretchen Jacobson, a Commonwealth Fund vice president who focuses on Medicare issues.

The benchmarks are tied to calculations of what it costs to cover a beneficiary in traditional fee-for-service Medicare in the county or region where the MA plan has beneficiaries. Reducing the benchmark would save $10 billion over five years, MedPAC estimated.

That change would, however, have a relatively minor effect on spending compared with eliminating the Star Rating system and other bonus payments Medicare sends to health insurers when plans hit quality metrics, observes Jacobson. The targets include familiar measures such as the proportion of beneficiaries who have been screened for certain cancers, the number with controlled diabetes and hypertension, and the timeliness of insurance approvals and reviews, such as prior authorizations.

The vast majority (80%) of beneficiaries in MA plans are enrolled in plans with ratings of 4 or more stars. That’s good news from a healthcare quality perspective. If it is working as intended, the Star Rating system is supposed to be an incentive to improve care, make preventive services accessible, and encourage insurers to operate fairly and efficiently. But there are questions about how accurately the star ratings reflect quality because of how ratings are calculated. Although Medicare officials consider these questions, the amount that the federal government pays out in bonuses has grown. Over the past six years, what the Medicare program pays in Star Rating bonuses to MA insurers has nearly quadrupled, from $3 billion in 2015 to $11.6 billion this year.

In the past, MedPAC has recommended changes to the Star-Rating system, but doing so could be problematic because ending payments for quality would go against the grain of promoting value-based care, she observes.

“If implemented, that recommendation (to eliminate the StarRating system) would be a very big change,” Jacobson notes. The suggestion to drop the star ratings would follow a recommendation that MedPac made in January 2020 to drop the quality-based bonus system entirely because CMS’ use of a variety of quality-based bonus systems has become extremely complicated, she adds.

Of course, any hint that payments to health plans might decline is bound to stir up fierce opposition from health insurers who rely on the growth of MA enrollment and annual increases in payments for each enrollee to increase revenues, margin and profits. But any consideration of reining in Medicare spending is a step in the right direction, in David Muhlestein’s opinion.

“It’s important that people are willing to reassess how we think about and pay for Medicare and Medicare Advantage, and to make different proposals,” says Muhlestein, the chief strategy and research officer for the consulting firm Leavitt Partners. But CMS doesn’t need to wait to reduce what Medicare spends each year because it could do so when it issues its annual fee schedules that set payment levels for physicians, hospitals and other providers.

“Medicare has the ability to lower their rates and ratchet them down over time,” he notes. “However, there is not a lot of political capital that gives them the sufficient protection they would need to lower rates.” Physicians, hospitals and health plans all say they need a raise every year.

“If you talk to members of Congress about reducing what Medicare pays, there are so many political barriers to do that with fee-for-service Medicare, and it’s likely to be difficult to do it in Medicare Advantage, too,” Muhlestein says. UnitedHealthcare, Humana and the Blues plans have about 60% of the MA market, he notes.

“You can be assured that if there’s going to be any effort to reduce what Medicare pays, those companies will fight that idea tooth and nail — and probably be successful.”

Joseph Burns is an independent journalist in Cape Cod who writes about healthcare and managed care.

Medicare funding shortfalls may trickle down to the Medicare Advantage plans and the Star Rating program bonuses, which have quadrupled in recent years. 

Medicare Advantage Plans, on a Roll, Could See Some Cuts 

Prices in American healthcare are difficult to nail down because they are obscured by secret negotiations between payers and providers and, in the case of drugs, pharmaceutical manufacturers. But that is beginning to change. Despite court challenges and uneven compliance, hospitals were forced to start disclosing prices at the beginning of this year.

Now, because of rules issued by the Trump administration, it is the PBMs’ turn. The price transparency rule, different parts of which go into effect next year and in 2023, would require disclosure of cost-sharing estimates to plan members, which isn’t controversial, but also the net prices that PBMs pay to drugmakers after discounts and rebates, which is. The U.S. Chamber of Commerce and the Pharmaceutical Care Management Association (PCMA), the PBM industry’s trade group, filed lawsuits challenging the net price disclosures in August.

Consumer advocates and others say disclosure of net drug prices would shed long-overdue light on the true price of drugs and how much money different players in the drug supply chain, particularly PBMs, are making.

Ironically, the anti-ACA Trump administration leaned on some disclosure provisions in the healthcare reform law to justify the price transparency rules. PCMA argues in its 85-page brief that this legal maneuver went way beyond the intent of the ACA provisions and that the ACA also didn’t contemplate sharing “machine readable” files that net pricing disclosures would require.

The trade group also argues that that disclosure of pricing information will be bad for health plans and their members because it will undercut the ability of PBMs to negotiate price concessions. Disclosure of net prices will establish a “pricing floor,” argues the brief, and will allow for tacit collusion among manufacturers, who will not be willing to offer prices below those of their competitors.

Prices in American healthcare are difficult to nail down because they are obscured by secret negotiations between payers and providers and, in the case of drugs, pharmaceutical manufacturers. But that is beginning to change.

PCMA Challenges Disclosure Rules

For an assortment of reasons, the federal government hasn’t taken any action on regulating drug prices, so a handful of states have taken matters into their own hands. New York, Massachusetts, Maine, Maryland and New Hampshire have established entities with drug pricing powers. Harvard Medical School researchers published an informative overview of the state government efforts in the 

As happens when healthcare policy devolves to the states, there’s a lot of variety in how the state-level drug pricing regulation is playing out. The Maine and New Hampshire drug pricing boards advise non-Medicaid, state-financed health plans, but they can’t impose requirements. The Maryland board is also focused on non-Medicaid, state-financed health plans, but it can set upper payment limits on drugs. The Massachusetts board is not a separate board but the Massachusetts Health Policy Commission was set up to find ways to control overall healthcare spending in the state, not just expenditures on drugs. New York has two drug boards, one for the state’s Medicaid program and the other for state-regulated commercial health insurers.

Only the board in New York with authority over the Medicaid program has completed drug-pricing reviews. The Harvard researchers say those reviews have resulted in savings for New York. After the board decided Vertex’s Orkambi (lumacaftor/ivacaftor), a cystic fibrosis drug, was priced too high, the state reached a confidential supplemental rebate agreement with Vertex.

A decision by the board that the state should peg the price for Remicade (infliximab) to the price of an infliximab biosimilar led to another supplemental rebate agreement that benefited the state, according to the Harvard researchers.

For an assortment of reasons, the federal government hasn’t taken any action on regulating drug prices, so a handful of states have taken matters into their own hands. 

MHE September 2021