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Amanda Bogle, a healthcare attorney at Sheppard Mullin, discusses the evolving regulatory landscape for pharmacies, stressing the importance of external legal advice to navigate the complexities of 340B, PBM and Medicaid regulations.

A Conversation with Amanda Bogle, Healthcare Attorney at Sheppard Mullin

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COVID-19 forced providers and health plans to hit the brakes on traditional approaches to managing care—and then continue the journey in another vehicle, at a pace that seemed to approach 100 miles per hour.

Downshifting Risk Through Payer-Provider Partnerships on the Road to Value-Based Care

America's primary care physicians (PCPs) and endocrinologists are struggling to meet the growing demand for diabetes care, with 85% of endocrinologists and 58% of PCPs feeling overwhelmed by the increasing number of patients, according to a new 

In collaboration with independent market research firm PureSpectrum, the survey of more than 100 PCPs and 100 endocrinologists highlights the critical gaps in patient education and coaching, which are essential for proper diabetes management.

According to the report, diabetes is one of the biggest challenges to the nation's healthcare system.

More than 11% of American adults are living with a diabetes diagnosis and 38% are categorized as being pre-diabetic. The estimated cost of diagnosed diabetes comes out to $400 billion per year. Government data also projects a shortfall of over 87,000 PCPs by 2037.

Although the importance of ongoing education is known for patients, less than half of those with diabetes receive formal instruction on managing their condition.

In the study, findings displayed that health plans and pharmacy benefit managers (PBMs) are pressuring clinicians to steer patients away from durable medical equipment (DME) companies, which traditionally offer more comprehensive chronic care education and coaching.

While 91% of PCPs report providing diabetes-specific coaching and education, only 65% believe their patients have adequate access. In addition, 86% of endocrinologists and PCPs agree that a lack of ongoing education is a major factor in low patient adherence to therapy.

Proper education and coaching are essential components of diabetes management, according to Arti Masturzo, M.D., chief medical officer at CCS.

“The data is clear: Proper education and coaching are not optional extras — they’re fundamental to successful diabetes management,” Masturzo said. “As we face a projected surge to 39.7 million Americans diagnosed with diabetes by 2030, we must urgently address these systemic gaps in patient support and education.”

One way to close these gaps is through policy changes and incentives that encourage health plans and PBMs to prioritize education-focused care over cost-driven decision-making, Masturzo suggests.

Some potential solutions include outcomes-based contracts between health plans and PBMs that include patient education metrics, CMS-driven incentives that reward improvements such as medication adherence and policy changes requiring PBMs to allocate a percentage of rebates toward patient education initiatives.

In addition, mandates for comprehensive patient education programs specific to technologies such as continuous glucose monitors (CGMs) and financial incentives for health plans implementing comprehensive medication education programs could enhance patient support.

To measure the effectiveness of education programs, Masturzo explained CCS evaluates key performance indicators such as CGM adherence, time in range, projected A1C, reduction of care gaps including preventive screenings, engagement of patients on assessment for social determinants of health, behavioral health, DSMES measures (ADCES7) and patient and healthcare provider satisfaction data.

CCS also focuses on the impact its programs have on overburdened referring physicians, acting as an extension of the care team to defragment chronic care management for patients, providers and health plans.

The benefits of prescribing CGM therapy through DME providers rather than pharmacies are also highlighted in the report.

For instance, 73% of endocrinologists and 69% of PCPs prefer prescribing CGMs through a DME provider because they offer superior health coaching and education.

However, 45% of PCPs and 76% of endocrinologists report feeling pressured by health plans to prescribe through pharmacies instead.

While this is true, 92% of PCPs and 91% of endocrinologists would be more likely to prescribe CGMs through a DME provider if it ensured better patient education and coaching.

To reduce the administrative burden on providers and allow them to focus more on patient education, CCS has built clinical solutions that assist with educating patients on CGM utilization and training care teams to provide the same support directly.

The organization’s predictive analytics platform, PropheSee, also helps keep people on prescribed therapy, while a holistic approach involving coaching on lifestyle changes such as nutrition and exercise ensures that diabetes patients have all the necessary resources to thrive.

Research supports the idea that patients using CGMs have higher therapy adherence and lower overall healthcare costs when they receive their supplies through a DME provider.

Healthcare providers play a crucial role in patient care, fostering trust and long-term relationships with their patients.

Steven Edelman, M.D., professor of medicine at the University of California San Diego, claimed that clinicians should have the authority to make decisions that prioritize patient outcomes rather than being subject to external pressures from health plans.

Ensuring patients have access to the education, resources and support necessary for managing their health is crucial for improving diabetes care in the U.S.

Clinical

Gaps in Diabetes Patient Education and Rising Healthcare Costs

The toll of combat exposure and post-traumatic stress disorder (PTSD) is still disrupting the lives of soldiers who returned from Vietnam more than a half-century ago, according to two studies that followed and checked in with the same men — fewer than 0.4% of U.S. military there were women — over 35 years.

Among the most striking findings: Soldiers who saw combat in the 1960s and ’70s were nearly twice as likely to have a diagnosed heart condition in 2020 compared to vets in noncombat roles. And veterans with heart disease reported significantly more comorbid chronic illnesses like arthritis and respiratory conditions, including sleep apnea, emphysema and asthma.

Both trends were influenced by the extent of combat experience, with rates of heart disease and chronic illness highest among those who faced the most intense combat fighting. Chronic illnesses also were reported more often by men with PTSD.

Another eye-catching finding: Veterans with subthreshold PTSD – those whose symptoms indicate clear evidence of distress but don’t meet the threshold for a diagnosis – were found to have worse physical and mental health outcomes compared with those who never experienced PTSD symptoms.

A quarter of participants reported having subthreshold PTSD in at least one of the three survey waves. The condition often is not sufficient to qualify for the VA’s PTSD services.

“Veterans with subthreshold PTSD suffer significant health burdens that are often overlooked,” Steven D. Stellman, Ph.D., one of the authors and professor emeritus of epidemiology at Columbia Mailman School of Public Health in New York, said in a university 

, emphasizing that VA policies need to be updated to include them in care and treatment programs.

Steven Stellman and Jeanne Mager Stellman, Ph.D., a professor emerita of health policy and management at the school, were co-senior authors of both studies. The papers were produced by the same team of researchers, and other researchers were based at the Boston VA. The studies were published five weeks apart in the 

Journal of Occupational and Environmental Medicine

Both studies used data from surveys mailed to a random sample of 12,400 war veterans in 1984 and 1998 and, in 2020, to a subset of 729 living veterans who had responded to both previous surveys, making this one of the longest studies of Vietnam veterans. The surveys asked about combat exposure, probable PTSD and history of diagnosed chronic illness.

The participants were, on average, 72.5 years old during the most recent wave of data collection five years ago.

The first study, posted online on Dec. 18, 2024, focused on the impact of persistent combat-related PTSD on heart disease and chronic disease comorbidity in aging Vietnam War veterans.

, posted online Jan. 21, 2025, analyzed the persistence and patterns of combat-related PTSD, medical, and social dysfunction in male military veterans 50 years after deployment to Vietnam. 

The social dysfunction study identified four distinct PTSD patterns over 35 years among male veterans who were 69- to 75-years-old in 2020. The majority (56%) were found to have never had PTSD. The second-largest group (25%) had subthreshold PTSD. Just under 10% had PTSD in the past but not currently. And 9% were found to currently have PTSD, rising to nearly 16% among those who were exposed to heavy combat. This was consistent with the strong combat-PTSD dose-response relationship that was found to persist over time.

Veterans with PTSD or subthreshold PTSD reported significantly worse life satisfaction, higher levels of depression and anxiety, and poorer overall health compared with those who’d never had the condition or had it in the past but not currently.

The findings underscore the importance of early and ongoing social and mental health support for veterans reintegrating into civilian life, Jeanne Stellman said: “Veterans who had fewer community social supports upon their return from Vietnam were more likely to develop PTSD.”

Overall, she said, “This research reinforces how the trauma of war continues to affect veterans long after the war ends.”

Two groundbreaking studies shed light on combat’s lasting physical and psychological damage more than 50 years on. 

Many Aging Vietnam War Vets Are Still Battling PTSD, Along With Chronic Illnesses, That Combat Exposure May Make More Likely, New Research Finds

Although doctors prescribe pharmaceuticals for various ailments, they also understand that drugs are only one way to improve a patient’s health. Another is food. The “food is medicine” movement is not new, but it is gaining prominence. The idea is to bolster treatment by providing nutritious foods and medically tailored meals to address diet-related illnesses (diabetes, heart disease and some cancers) and supporting those with conditions such as cancer and kidney disease.

The food is medicine concept is wide-ranging, from specifically made, medically tailored meals to produce prescriptions to nutrition security programs such as the Supplemental Nutrition Assistance Program. One problem for payers — whether government programs, private insurers or philanthropies — is ensuring that the program provides nutritious and appropriate foods. What’s missing from this equation is standards.

Studies have shown that medically tailored meals can improve health metrics. A recent study by the

 investigated health outcomes of medically tailored meals. It found that 62% of clients with hypertension significantly improved their blood pressure and those with diabetes improved their hemoglobin A1c levels when receiving these meals for at least two months, indicating that their diseases may be better managed through proper nutrition. Also, 88% of those with obesity decreased their body mass index or ensured it remained stable. In 

, researchers estimated that in Pennsylvania, increasing access for at-risk patients could save $4,370 per patient annually in health costs.

Another study showed that providing medically tailored meals for those with diet-sensitive conditions and activity limitations could save $13.6 billion in national healthcare costs, averting 1.67 million hospitalizations annually.

Drugs approved by the FDA undergo rigorous testing. “People go to the pharmacy and don’t question [quality] because it’s approved,” Sue Daugherty, R.D.N., L.D.N., CEO of MANNA, an organization providing these meals to people with serious illnesses, says. “With medically tailored meals, anyone can say they’re doing it and there’s no regulation on what that means.” There has been some controversy, however. Some medically tailored meals have been marketed as “dietitian approved,” including meals marked as “heart healthy” or “renal friendly,” that contain high levels of saturated fat, sodium and additives.

Gaining accreditation can assure payers and patients that the food includes nutritious components in the right quantities. “There has to be some type of regulation showing you’re getting what you were prescribed,” says Daugherty. MANNA was 

 by the Food Is Medicine Coalition last month. The coalition is a nonprofit national collective of agencies providing medically tailored meals. The accreditation is rigorous, Daugherty says. During the accreditation process, meals are tested; for a renal diet, the testing measures how much phosphorous, potassium and sodium are in a meal, for example. Also, patients and the program must have access to dietitians.

MANNA has been providing patients with medically tailored meals since 2005. In 2023, they served meals to patients with 85 different illnesses. Diabetes is the disease required for most people entering the program. “Our research shows that we have [the] most impact on superutilizers — the 5% who cost the healthcare system 50% of the [healthcare] cost,” she says. These patients have complex needs. She is seeing an increase in patients with high-risk pregnancies or heart diseases receiving meals for whom low-sodium diets are recommended.

Standardizing how to identify a person’s social risk factors and using validated screening tools are important to appropriately refer patients to community-based providers, Denise Diaz Payán, Ph.D., M.P.P., an associate professor at the University of California Irvine Joe C. Wen School of Population & Public Health, says. “People are using all kinds of screening tools at their convenience,” she says. “You’ll hear feedback from facilities that they don’t have time, they don’t have a person to do the screening.”

Medically tailored meals are an appealing idea, but there is little regulation or standardization.

A Key Ingredient to ‘Food is Medicine’: Standardization

The Cigna Group released their revenue report for 2024 which showcased their 27% revenue jump to $247.1 billion — with Evernorth much to credit.

Evernorth, which includes pharmacy benefit services such as Express Scripts, contributed to the increase that clocked in at $195.3 billion in 2023.

David M. Cordani, chairman and CEO of The Cigna Group, highlighted Evernorth’s contributions during a conference call discussing the results.

“Evernorth continues to drive strong results in line with our expectations, primarily driven by our specialty and care services segment,” Cordani said.

The numbers highlight this statement, with pharmacy benefit services reaching $111.8 billion in adjusted revenue, a 46% jump from $76.8 billion in 2023.

Cigna's 27% Revenue Increase in 2024 and the Outlook on 2025

In addition, specialty and care services recorded $90.3 billion in adjusted revenue, marking an 18% increase from the previous year.

Evernorth's growth pattern has remained consistent, establishing itself as the backbone of Cigna’s financial performance.

As Cordani noted, Evernorth's leadership in biosimilars plays a crucial role in addressing major healthcare challenges.

For instance, the company introduced the Humira interchangeable biosimilar last summer, offering eligible patients access at $0 cost. 

By the end of 2024, nearly 50% of eligible Humira prescriptions were filled with biosimilars, and Evernorth is now extending this benefit to the interchangeable Stelera biosimilar.

Over the next five years, Cordani said approximately $100 billion in specialty drug spend in the U.S. will be subject to biosimilar and generic competition, positioning Evernorth to lead the way in delivering significant savings.

He also emphasized the growing need for affordable prescription drugs, especially with the rising use of GLP-1 medications, which have become a major driver of drug spending trends.

While these medications are relatively inexpensive to produce, U.S. patients are paying several times more than those in other countries, even with full pass-through rebates.

Brian Setzer

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