This week on Tuning Into The C-Suite Briana Contreras spoke with CEO Kate Ryder about the role of telemedicine in pregnancy care, how it impacts the prenatal model and how it will influence the patient journey post-coronavirus pandemic.

Kate Ryder of Maven Talks Role of Telemedicine in Pregnancy Care, its Effect on Patients Post-COVID

According to a new survey conducted by the Harris Poll on behalf of the American 

of U.S. adults say the 2020 U.S. presidential election is a significant source of stress in their life. This is a large increase from the 2016 presidential election when 52% felt the same.

The survey also found regardless of political affiliation, majorities say the election overall is a significant source of stress. This could be caused by a number of reasons such as the uncertainty of COVID-19, how healthcare has responded to the pandemic, issues of racial disparity and the continuous uncertainty among each unique candidate.

As healthcare issues continue to dominate the news, the survey found adults with a chronic condition are consistently more likely than those who do not have a chronic condition to report the election as a source of stress in their life (55% vs. 45% in 2016 and 71% vs. 64% in 2020). Although, in 2020, people with chronic conditions are significantly more likely to say the election is a very significant source of stress for them (39% vs. 28%). In 2016 this response yielded no significant difference (20% vs. 17%).

This year, 77% of Americans say the future of our nation is a significant source of stress, up from 66% in 2019. Likewise, the current political climate is reported as a significant source of stress by more than two-thirds of Americans (68%), compared with 62% who said the same in 2019.

“This has been a year unlike any other in living memory,” says Arthur C. Evans Jr., PhD, APA’s chief executive officer, in a release on their website. “Not only are we in the midst of a global pandemic that has killed more than 200,000 Americans, but we are also facing increasing division and hostility in the presidential election. Add to that racial turmoil in our cities, the unsteady economy and climate change that has fueled widespread wildfires and other natural disasters. The result is an accumulation of stressors that are taking a physical and emotional toll on Americans.”

According to the APA, evidence-based tips to help people manage their stress related to the election are:

Uncertainty is stressful and some people are better at dealing with uncertainty than others, the site says. The election, the global pandemic and social unrest are all adding to a sense of uncertainty in our lives. 

Avoid dwelling on things you can’t control.

 When uncertainty strikes, many people immediately imagine worst-case scenarios. Break the habit of ruminating on bad outcomes.

 If following the news, watching the debates or scrolling through social media is causing you stress, limit your consumption of these platforms. Give yourself permission to take a break from the news.

. Rather than fixating on news coverage, find an activity that you really enjoy and spend time doing it. Get involved in issues that are meaningful to you. 

. Spend time with friends and family. People who have at least one or two friends or family members to turn to for emotional support during stressful times tend to cope better than people who don’t have such support.

. Moving helps us release the energy we experience when we feel stressed.

Realize that we might not know who won the election on Election Day.

 If you think this will raise your anxiety, keep busy with things that you enjoy and stay connected to social support so that you aren’t continually checking for what could be viewed as “bad” news.

Articles

According to a new survey provided by the American Psychological Association (APA), more than 68% of U.S. adults say the 2020 U.S. presidential election is a significant source of stress in their life. The APA offers advice on how to handle election stress.



This Year's Election a Source of More Stress for Americans than 2016

Pfizer has yet to conduct an interim analysis

 that Pfizer has not conducted an analysis of the COVID-19 vaccine that it is developing with BioNTech. 

’s star reporter puts a good-news, bad-news spin on that development.

It could be good news because it means the vaccine hasn’t fallen short of the trial protocol’s proof of efficacy. The bad-news, glass-half-full take: The lack of analysis may mean that the trial will take longer than to yield answers about the vaccine’s efficacy than the company had hoped. In the COVID-19 vaccine race, Pfizer has been consistently touted as the frontrunner so the slower pace takes on added salience. As Herper explains, results from the trial may be emerging more slowly than predicted because there are not enough events — COVID-19 cases — occurring to establish a statistically valid difference between the vaccinated group and the control group. Pfizer had indicated in August that an interim analysis would be conducted in October, Herper reported.

Medicare, Medicaid to cover out-of-pocket costs of COVID-19 vaccine

CMS will make an announcement soon (later today or tomorrow) that Medicare and Medicaid beneficiaries won’t have any out-of-pocket costs related to getting a COVID-19 vaccine that has received an emergency use authorization, 

The political news website said the announcement would come today or tomorrow.

AstraZeneca says its vaccine boosts immunity in the elderly

One of the questions hanging over the COVID-19 candidates is how much protection might the vaccines provide to the groups of people who are most likely to suffer serious cases of the disease, such as the elderly. The immune system becomes less robust with age, so whether a vaccine will rev up a strong immune response is not a sure thing. 

But on Monday, AstraZeneca said some early results from the trial of its vaccine, which is code named AZD 1222, show that it’s produced a strong immune response in older adults, according to several news outlets.

 an unnamed company official as saying that “it is encouraging to see immunogenicity responses were similar between older and younger adults and that reactogenicity was lower in older adults, where the COVID-19 disease severity is higher.” Reactogenicity is the term for the fever, aches, and soreness at the injection site vaccines commonly produce. 


Jonathan Ball, professor of virology at the University of Nottingham, told 

, which broke the story about the AstraZeneca trial, that the immunogenicity in older adults is a “promising sign,” but he cautioned that “ultimately, it’s whether the vaccine protects against serious disease that’s crucial and we will only know that from phase 3 trials.”

 reported the positive results included people age 70 and older.

The AstraZeneca vaccine was co-invented by researchers at the University of Oxford and a spin-off company of the university, 

AstraZeneca, Johnson & Johnson resume trials in the U.S.

Speaking of AstraZeneca, the British drugmaker restarted enrollment in its phase 3 trial in the U.S. on Friday, as did Johnson & Johnson. HHS Secretary Alex Azar hailed the resumption on Twitter on Friday.  “It's worth repeating. These pauses show that the science- and data-driven process is working as it should," Azar added in a 

AstraZeneca paused its trial in September after a women in the United Kingdom developed neurological symptoms that some news reports identified as transverse myelitis, although that has never been fully confirmed.

 that said it was “preparing to resume recruitment” into the phase 3 trial of its vaccine. The company had paused the trial, dubbed ENSEMBLE, on Oct. 12 because a study volunteer developed what was described as an “unexplained illness.” In an interview with 

last week, the company’s chief scientific officer, 

, M.D., said no one at the company knew whether the person had received the vaccine or the placebo.

Moderna rephase 3 trial is fully enrolled

The Cambridge, Massachusetts, biotech company announced on Thursday that the phase 3 trial of its COVID-19 trial had 

 and that more than 25,000 of the volunteers had received the second of the two-shot vaccinations. The company press releasee thanked 

, a contract research organization headquartered in Wilmington, North Carolina, for the success. Moderna, which is calling its trail the COVE study, has some graphics on its website that show the diversity of the people have volunteered for the study. As of Oct. 21, 63% were White, 20% Hispanic/Latinx, and 10% Black. One of the slides show the enrollment of white volunteers far outnumbering the nonwhite white volunteers during the summer months and then, starting in late September, a switch to the nonwhite volunteers exceeding the number of white volunteers.

Egypt emerging as COVID-19 hub for the developing world

 reported yesterday that Egypt’s location, vaccine-making capacity and large population (100 million people) may make it proving ground and manufacturing center for COVID-19 vaccines in the developing world.

The newspaper reported that Chinese officials have talked about COVID-19 manufacturing in the North African nation. Importation of vaccines may also be in the works.

Pharmacies eyed for distribution of vaccine

During last Thursday’s daylong meeting of FDA’s Vaccine and Related Biological Products Advisory Committee, Janell Routh, M.D., of the CDC talked up pharmacies as a distribution channel for COVID-19 vaccine(s).

Routh showed the advisory panel a map of the locations of the large chain pharmacies and independent drugstores, according to an account of the meeting by Forbes Senior Contributor Bruce Japsen.

“Pharmacies can help increase access to vaccines,” Routh said (according to Japsen). “Almost 90% of Americans live within a 10-mile radius of a pharmacy.”

A little over a week ago, on Oct. 16, HHS announced a 

 to administer COVID-19 to residents of long-term care facilities with no out-of-pocket costs to the residents.

Pfizer, the reputed leader in the COVID-19 vaccine race, may not have efficacy results for awhile. Meanwhile, AstraZeneca and Johnson & Johnson have resuming  enrolling volunteers in the U.S. in their late-stage trials.

Weekly COVID-19 Vaccine Update: Pfizer Trial Slower Than Hoped; AstraZeneca, Johnson & Johnson U.S. Enrollment Resumes, Pharmacies Eyed for Distribution  

Sriraman Srinivasan, M.D., MBA, chief medical officer, Advanced ICU Care, Bethesda, Maryland

I started my life in India and moved to Toronto at the age of 6. I grew up idolizing Wayne Gretzky and played a lot of ice hockey. In fact, as young as age 12, I organized a yearly hockey pool in which my friends and I drafted NHL players, and I served as league commissioner. In those days without the internet, I updated everyone’s standings weekly after going through the box scores in the Sunday newspaper. That taught me to be consistent and reliable and to double-check my work, because people counted on me.

After undergraduate studies at the University of Toronto, it was on to St. George’s University in Grenada for my medical studies; Georgetown University for my medical residency; and, finally, a fellowship in critical care at George Washington University.

Most of my leadership highlights come from volunteering to take on roles that others did not want. That led me to opportunities that propelled my career by serving first where help was needed.

I was always fascinated by the ability that a doctor had to save someone’s life through direct and purposeful action. This feeling was affirmed when I witnessed a student die of cardiac arrest in the gym I worked at in my 20s. Naturally, I chose critical care as my area of interest because it gave me exposure to caring for the sickest of the sick.

What has been your biggest learning experience in the industry? What did it teach you?

Listen, listen, listen. The client will tell you what they want or need. Be flexible, and tailor solutions to their individual needs. We all want a system-based approach, but one size does not fit all. In telemedicine, we have to work hard to build rapport with local bedside staff to earn their trust so that we can co-manage patients. We all have good intentions, but it takes time to build those relationships, which starts with listening.

How has COVID-19 affected your responsibilities and how your organization operates? How might your job and your organization change because of the pandemic?

We cared for critically ill patients via telemedicine long before COVID-19, but we still made several adjustments. We did disaster planning for staffing needs and the possibility of reduced bedside staff. We rapidly deployed surge capacity at client hospitals to care for additional patients. We also stayed abreast of best practices in medical management that we shared with our partners. Our company already operated in a virtual environment, so there wasn’t an interruption in services.

How has the current discussion of racism and healthcare inequity affected you, your outlook and your organization? What has been the short-term response, and what do you envision happening over the longer term to your organization and American healthcare?

This is a very important discussion at a very important time in our history. Our organization revolves around the remote provision of healthcare services to a diverse set of communities via technology. Because we don’t engage with health insurance, we don’t ever turn away a patient, and we provide 24/7 year-round access to an ICU doctor. We care for everyone equitably, regardless of creed or color. Our staff comes from a diverse background across the country in seven domestic operations centers and two international ones. We focus squarely on one’s abilities and interest in telemedicine in our hiring practices.

What other kinds of changes do you expect to see in healthcare in the next five to 10 years?

The door for telemedicine has been opened, and it is something that patients have longed for. Remote provision of care is here to stay, but it has a steep learning curve. Many doctors come to us as 20-year veterans of in-person care and need to learn a lot about technology, situational awareness and management principles before caring for patients remotely. Physicians will need to become better coaches and empower not only patients but also the allied health professionals that they share the healthcare space with.

What have you enjoyed about social distancing and extra stay-at-home time during the past few months?

Quite honestly, I finally learned what my kids were doing in school since I had to start doing some home schooling. It’s been great to be more involved and, hopefully, I made a positive impression on them for the future.

Managed Healthcare Executive's October issue headlines 10 healthcare leaders in its fourth annual "10 Emerging Industry Leaders" feature. MHE spotlights each leader individually with a video interview to accompany the Q&A between MHE and the emerging leader.



10 Emerging Industry Leaders: Sriraman Srinivasan

As a chief human resources officer, I and the rest of the world experienced 2020 as a year of unpredicted challenges and changes that overwhelmed—and still have the potential to overwhelm—entire industries.

Now that I’ve worked amidst COVID-19 as a chief HR officer for the nation’s leading provider of end-of-life care, it’s clear that healthcare HR professionals—if they haven’t already—must reshape the workplace each and every day by focusing intently and with new eyes on what matters most during this ongoing pandemic: employees.

The time is now to invest in people, make talent retention and acquisition a primary HR focus, and acknowledge things will not return to where they were any time soon, if at all. We can create a new future by doing the right thing now for employees, having a clear framework for change, and finding new solutions by asking key questions:

What do employees need to work successfully during a pandemic?

What do they need as individuals facing equally challenging personal issues at home?

What are they telling us as their managers and how can we respond in ways that are employee-focused, heartfelt, action-oriented, and reassuring? 

What information do we need as managers and HR executives to innovate and support change? 

How can we respond in real time and communicate new solutions effectively to all stakeholders?

The 2021-Forward Approach to Healthcare HR: 3 Guiding Principles

One of the biggest HR challenges during COVID-19 has been the ability to assess and change rapidly as a healthcare provider so we can:

support our healthcare partners and the patients they refer to us

continue to provide safe, compassionate, end-of-life care to our patients and their families

Consider these guiding principles as you shape employee policies and the workplace for 2021:

1. Refocus HR and Talent Acquisition in the Healthcare Industry

Throw out traditional HR thinking as you adapt to the new healthcare climate. HR professionals must act quickly with a refreshed view of all policies that affect clinical and non-clinical employees in the healthcare ecosystem, starting with recruiting and interviewing.

If they haven’t already, video platforms can effectively replace in-person job fairs and in-office screening interviews, followed by as much virtual or cloud-based pre-training and on-boarding as possible. Supporting these activities outside of the traditional face-to-face interview process and new-employee ramp-up process reassures candidates of the employer’s commitment to safety, while still providing the necessary tools and training to support new-hire success.

Likewise, additional training gives existing employees the information and confidence they need to face new challenges, learn new technologies, work safely, and carry out new care protocols. Once COVID-19 entered the healthcare lexicon, for example, VITAS quickly launched 35 new training modules on a range of topics: personal protective equipment use, hand-washing practices, safe patient care, and return-to-office safety standards. Employees learned new processes for using telehealth platforms for patient-family consultations, patient evaluations, seamless hospice admissions, caregiver education and other routine hospice services, including virtual chaplain-led prayer sessions and social worker visits.

Re-think how work is done from the employees’ perspective. Does everyone have to remain in the office? Is work-at-home a possibility for some employees? Is job-sharing an option for employees who want to continue working but on a limited schedule because of family responsibilities? How can traditional offices be re-configured or altered to accommodate physical barriers, social distancing, and employee safety?

A bit of creativity and flexibility can relieve employees’ new and ongoing worries—while simultaneously proving to them that their employer is aware of their challenges and willing to meet them head-on with new solutions.



2. Focus on Employees: What do They Need and When do They Need It?

Human resources professionals must focus energy where it matters most: on the employees. What new types of benefits and policies will support them as satisfied healthcare employees, individuals, and family members?

Benefits that make a real difference for employees include additional paid time off (PTO), more generous PTO rollover policies, and extended leaves of absence, especially for those who become ill/quarantined or who have childcare or eldercare responsibilities at home. Many employees worry most about their ability to keep working and providing for their families. Easing that worry by giving them time they need to recover or care for their loved ones, while assuring them their job will be waiting for them, demonstrates to employees that they are valued.

What about perks for employees who worry about their health and safety, regardless of whether they sign on for company-provided health coverage? Consider free access to a telehealth service (even if only for a limited time) for employees and their families. While the pandemic has brought telemedicine into the spotlight, 

 expect to use virtual care after the pandemic resolves, making this benefit a surefire way to support employees for the long-term. 

Furthermore, this type of benefit can reassure employees that they can continue to receive routine medical care—especially if their own physicians’ offices are operating at limited capacity or if they feel an emergency department visit during a pandemic is too risky. Other perks can include company-provided flu vaccine programs or vouchers, emotional/mental health counseling services to address employee stress and anxiety, even road-assistance services for employees who use their own vehicles for work and worry about being stranded during a pandemic.

Newly visible initiatives can also serve as evidence of employer awareness, understanding, and response to new realities. Designation of an infection control manager, for example, has the potential to make employees feel more confident if they know someone is regularly monitoring employee health, quarantine status, and return-to-work protocols according to recent guidelines.



Expect and Reward Change, and Don’t Look Away for a Second Because More Is Coming

This pandemic was a wake-up call, a giant global shiver that quickly ushered in change for the entire healthcare profession and numerous once-routine aspects of daily life. Change related to COVID-19 will continue to emerge in predictable and unexpected ways.

As HR professionals, we must be aware and ready to react, respond, and implement change at any given moment. Some employees may leave, while others will re-dedicate themselves to an even stronger work ethic and purpose. Interested candidates will need assurances that their decision to enter healthcare will be supported, valued, and rewarded. Our job as HR professionals is to work with every single employee and recruit to help them continue to succeed so that we, as healthcare providers, can continue to provide care.

What Key Activities Can Support a 2021-Forward Approach?

Regular, daily communication among all executives and managers creates a critical pipeline of information, data, ideas, needs, and brainstorming. Sustain regular communication from top-down and bottom-up people-first perspectives. Constant sharing of information and data keeps the company nimble, agile, and poised to pivot at a moment’s notice.

What’s ahead for HR? The year 2020 has taught us to remain prepared for anything. It has also reinforced the wisdom of focusing our attention where it matters most: on our employees, so they can do their jobs effectively, continue to pursue their passions, and support the company’s growth and success.

Diane Psaras is chief human resources officer and executive vice president at VITAS® Healthcare, the nation’s leading provider of end-of-life care.

Healthcare HR professionals—if they haven’t already—must reshape the workplace each and every day by focusing intently and with new eyes on what matters most during this ongoing pandemic: employees.

Re-Focusing HR in Wake of COVID-19: Tips for Healthcare Professionals

As a byproduct of the COVID-19 pandemic, the healthcare industry is faced with a formidable challenge—how to safeguard long-term health when in-person preventive care is reduced, and has been for most of the year. 

 have sought preventive care and testing over the past six months due to precautionary social distancing measures against the COVID-19 virus. This includes a nearly 60% drop in vaccinations, as well as declines in more invasive procedures such as mammograms and colonoscopies. Coming out of the first wave of the pandemic, robust 

 are needed, not only to mitigate against risk of contracting COVID-19, but to maintain general public health.

As payer and provider organizations look to improve health outcomes around the far-reaching impacts of the pandemic, they must consider the unique needs of some of our most vulnerable populations, such as new and expecting mothers and their infants. Due to COVID-19, many hospitals began discharging mothers quickly, sometimes within 24 hours, to reduce risk of contracting the virus and free up hospital resources. But these early discharges have had unintended consequences. Hospital lactation consultants no longer have the time they desperately need to properly support a breastfeeding mother before she goes home. If a new mom is discharged within 24 or 48 hours, they’re leaving without the benefit of that counseling, which may mean the difference between being able to successfully breastfeed, or not.

Breastfeeding rates are a critical measure of population health

Breastfeeding is a vital population health issue because it has many health benefits for mother and infant. 

, 84% of children in the U.S. are breastfed for some amount of time, but only 46.9% are exclusively breastfeeding at three months and only 25.6% at six months. This isn’t good enough. Breastfeeding rates impact cost of care as well as maternal and infant mortality, and should be part of health plans’ comprehensive population health strategies. An analysis of data from 

The United States Breastfeeding Committee

 shows just a 5% drop in breastfeeding and infant vaccination rates could result in devastating costs to the U.S. healthcare system due to preventable illnesses and deaths, including increased cases of hypertension and diabetes in mothers, and higher rates of obesity, lower respiratory tract infections, and potentially fatal necrotizing enterocolitis in infants.

Ensuring that all new moms who wish to breastfeed are able to do so will help improve outcomes and lower overall costs for health plans. According to 

, expecting moms covered by Medicaid intend to breastfeed exclusively at around the same level as commercially insured expecting moms (17% and 21%). However, they struggle with putting these plans into practice. New moms covered by Medicaid are less than half as likely (8%) to breastfeed exclusively, compared to new moms covered by private insurance (17%). This indicates that moms covered by Medicaid would exclusively breastfeed at similar rates as moms with commercial insurance, if they only had the support to do so. In fact, due to the pandemic and a need to bolster babies’ immunity, moms covered by Medicaid who are not currently breastfeeding are changing their minds at a slightly higher rate than those with commercial insurance – 16% of non-breastfeeding moms covered by Medicaid are now considering it due to its health benefits, compared to 12% of non-breastfeeding moms with commercial insurance.

Moms covered by Medicaid face unique challenges

Almost three-quarters of new and expecting moms reported concern about in-person medical visits post-delivery, and almost one in five said they would try to postpone scheduled appointments. However, moms covered by Medicaid were 27% more likely to report that they may try to delay some scheduled appointments due to concerns about COVID-19, compared to mothers with commercial insurance. This gap is significant, because postpartum support that’s normally in-person, like lactation support, will continue to be available for higher socio-economic households who can afford private sessions and house visits – luxuries moms covered by Medicaid may not have access to.

In addition, 70% of moms covered by Medicaid reported that they feel COVID-19 will affect their ability to breastfeed, compared to only 43% of moms covered by private insurance – a statistic that could be related to being disproportionately employed in sectors that are less adaptable to telework and the flexibility that comes with it. Moms covered by Medicaid are some of the most vulnerable, and they are at risk of being left behind.

Telehealth can help bridge the resource gap

The good news is that telehealth can be an equalizer. Eighty-one percent of Americans owned a smartphone in 2019, according to 

, a device key to taking advantage of telehealth access. But owning a smart device is only the first step. Unfortunately, 

just 36% of people making less than $25,000

 say they have access to telehealth – a percentage that increases steeply as income rises. This inequity is likely due to several factors, the main one being that before the pandemic, commercial health plans provided and promoted telehealth at higher rates than Medicaid plans.

Maternal and infant telehealth, including virtual lactation support, should be key to any health plan’s population health strategy – it’s critical to give new moms access to the support they need, when they need it. This is especially important for Medicaid plans, as these tools will help bridge the healthcare gap between socioeconomic levels. Safeguarding maternal and infant health is a significant part of bolstering population health during the pandemic – and beyond.

Melanie Silverman, MS, RD, IBCLC, is a registered dietitian and board certified lactation consultant and is currently the Chief Clinical Officer for 

, a telehealth mobile application for new parents

As payer and provider organizations look to improve health outcomes around the far-reaching impacts of the pandemic, they must consider the unique needs of some of our most vulnerable populations, such as new and expecting mothers and their infants.

Medicaid Plans Need to Prioritize Maternal, Infant Telehealth

The pharmacy benefit management (PBM) industry used to occupy a rather small, obscure corner in the back offices of the American healthcare system. PBMs were just prescription claims processors. But over the past 20 years or so, the industry consolidated and the remaining companies became powerful middlemen in the complex pharmaceutical supply chain. Now the industry has an increasingly high profile (not always for favorable reasons) and has consolidated even further, with its large players owned by or partnering with even larger companies.

Yet plenty of smaller players have survived and even thrived by finding a niche, such as workers’ compensation, specialty drugs or certain types of diseases. They offer an alternative to dominant companies and the traditional marketplace, which can be layered and complicated, notes Daniel Jordon, managing director at the Graham Company, an insurance broker and consultant business in Philadelphia. They can be more aggressive and have more programs with cost containment as the goal, he says: “Many of them are not rebate driven. Many just want to be completely clinically driven.”

The niche players “keep the big folks on their toes,” says Joseph Paduda, president of CompPharma, a consultant to workers’ compensation PBMs.

Still, there is no question that the PBM industry is now a land where giants roam. Caremark, which is part of CVS Health; Express Scripts, which was acquired by Cigna in 2018; and OptumRx, part of UnitedHealth Group, accounted for about three-quarters of the market in 2018 as measured by prescription claims managed, according to Adam Fein’s Drug Channels website. Add in the next three biggest players — Humana Pharmacy Solutions, MedImpact Healthcare Systems and Prime Therapeutics — and those six companies control 95% of the PBM market, according to Fein.

Size gives the larger PBMs an obvious advantage when it comes to buying power. “If you don’t have really significant buying power, it’s really tough to compete,” Paduda says. The large PBMs have the means to negotiate rebates and discounts from drug manufacturers. The arguments about the role of large PBMs, rebates and discounts follow some well-trodden paths. The large PBMs contend that they use their buying power to negotiate lower drug prices and that employers and other payers receive a large chunk of those rebates. A report on PBMs by the Pew Charitable Trusts said that a survey of health plan and PBM executives found that the proportion of rebates from manufacturers to PBMs that gets passed on to health plans increased from 78% in 2012 to 91% in 2016. Critics of the industry say that the PBMs still pocket huge sums of rebate money and keep the amounts a secret. The Pew report says manufacturer rebates more than doubled between 2012, when they were just under $40 billion, and 2016, when they were reached $90 billion.

Because the smaller PBMs have less leverage with prices, “they have to compete on the basis of something else,” such as focusing on certain diseases or niche business, such as workers’ compensation, Paduda says.

“It’s a David and Goliath scenario,” with the small players competing against the large PBMs, says David Fields, president and CEO of Navitus Health Solutions, a midmarket PBM in Madison, Wisconsin. Navitus, which is a division of SSM Health, the Catholic integrated health system headquartered in St. Louis, and Costco, says it passes on all the rebates and discounts it receives and that its revenues come from a set administrative fee. In 2019, Navitus passed on $650 million in rebates back to its clients and expects to return $750 million to $800 million this year, according to Fields. “Rebate-chasing formularies tend to drive up the overall cost” of drugs, he says. “We believe they (rebates) are not the do all and end all.” Instead, Field says, Navitus looks to design the best formularies for its patients’ health.

Mesfin Tegenu, M.S., president of PerformRx, a midmarket PBM in Philadelphia and a division of AmeriHealth Caritas, a Medicaid managed care plan, acknowledged in an email interview the difficulties of being a smaller player in an industry dominated by companies with annual revenues in the billions. “Today’s midsize PBMs are navigating a business environment in a consolidated market. This inhibits competition by midsize PBMs, which may make innovation both in program development and technology more challenging,” he said.

Tegenu also mentioned the nimbleness that others say is an asset of the bantamweights. “Smaller PBMs bring significant flexibility and customization tailored to local market needs. They also adopt innovation faster to improve patient pharmaceutical expense at point of sale, while not causing inflation in brand drugs,” he adds.

Although smaller PBMs tend to do a good job for the employers and members they serve, they may be viewed as a little risky by clients because they typically don’t have a long history, according to Jordon at The Graham Company. He says that COVID-19 has made businesses even more cautious. They don’t want to rock the boat right now by switching to a smaller PBM, according to Jordon: “Everything feels a little unstable.”

SSM Health announced in March that Costco was purchasing a minority stake in the PBM for an undisclosed amount. Fields says the cultures of the two companies are in sync because both support keeping costs low for their customers: “It’s incumbent to provide value to the customers we serve.”

Navitus isn’t the only PBM experiencing changes. In 2019, Anthem launched its own PBM, IngenioRx, to serve its health plan members and those of other plans.

Ironically, the success of the smaller PBMs may make them attractive acquisition targets, consolidating the industry even further. Paduda says larger PBMs may buy up their smaller competitors that focus on specialty medications because the cost of those drugs is so high.

In a report on PBMs earlier this year, S&P Global said that “large vertically integrated PBMs should continue to leverage their scale and vast services to maintain market share. … We continue to expect subscale PBMs are at greater risk of losing clients to larger competitors.” The financial analytics firm also said that it expects more consolidation among midmarket PBMs.

High drug prices are one of the main reasons the PBM industry has found itself in the spotlight and the subject of criticism, particularly withrespect to rebates. Early last year, the Trump administration proposed changing anti-kickback rules so rebates would go directly to consumers rather than PBMs; later in theplan was abandoned. But “it’s much more complicated than they think,” says Jordon. “How would we possibly unwind all this?” Instead, he says, “I think the market will solve itself.”

Paduda believes there will be significant pressure on Joe Biden to lower drug prices if he wins the presidency. Drug manufacturers are more likely to be affected by Biden policies, but PBMrebates and transparency may also come into play, in Paduda’s opinion.

““Irrespective of which party is in power, there will be a continued focus on transparency,” says Fields. “There’s not enough transparency going on, especially in the pharmaceutical world.”

Susan Ladika is a health and business writer in Tampa, Florida.

In the consolidated PBM industry, smaller companies say they can be nimble and not driven by rebates. But are they acquisition targets? 

In Land of Giants, Smaller PBMs Find a Niche

M.P.A., M.P.M., director, social determinants of health integration and partnerships, CareSource, Dayton, Ohio

I grew up in the small town of Mansfield, Ohio. I earned a bachelor’s in sociology from Spelman College, a master’s in public administration from University of Delaware and a master’s in project management from Keller Graduate School. My most recent achievement was becoming a certified life coach during the pandemic.

I am grateful for the opportunities and guidance afforded to me at CareSource, where I humbly began as an administrative clerk. I am proud that I have had the opportunity to advocate for Medicaid expansion and speak to political leaders at the White House and on Capitol Hill about the social determinants of health work at CareSource.

I love to serve and learn from people. As a sociology major, I studied the development, functions and structuring of people. As the director of social determinants of health integration and partnerships at CareSource, I continue to follow my passion as I focus on social barriers that affect health outcomes.

Healthcare will always relentlessly evolve. This taught me to be flexible and forward thinking. It has also taught me the importance of intentional strategy with grace. We must be willing to be nimble but firm to be effective.

The CareSource life services department started in 2015, with a focus on the social determinants of health of employment and training through the launch of the JobConnect program. Since then, the team has expanded efforts in housing, food, nutrition, transportation, special populations and advocacy. The knowledge and lessons learned from the program positioned us to be better prepared for the exacerbation of social barriers by COVID-19. As a result of the pandemic, CareSource has provided access to telemedicine, enhanced our focus on community partnerships and provided financial support in our communities.

As an African American mother of two African American children, I have been affected personally and professionally by the current discussion on racism. Personally, I have worked to speak my truth in love as a way to raise awareness of inequities and discrimination. Professionally, our organization has been very intentional, driving fundamental shifts in diversity and inclusion by revamping our diversity, equity, and inclusion program; providing additional support for minority employee resource groups; engaging industry experts through conversation and corporatewide education; and regularly assembling diverse staff members to listen, to seek to understand and to enact change.

I see this as a pivotal point in our country’s history to change the future. My hope is that this season will not be a fleeting performance but the start of real change through effective, ongoing and sustainable action.

I expect to see continued, wide-ranging advancements in technology. COVID-19 created an immediate necessity to quickly transform business operations; for example, more telemedicine. Many changes had been advocated for but were denied until COVID-19 demanded immediate action. I believe technology will continue to be the catalyst for re-imagining how we improve. I also believe that many COVID-19-related policy changes will be permanently adopted into law.

I have enjoyed spending all the extra time with my husband and two children, ages 7 and 4. The rigors of working from home and virtual learning have been a challenge, but we have all grown. I have an increased passion for exercise, which was discovered by dancing with my kids on the Wii. I have also found a greater appreciation for nature and being intentional about having quiet times to fuel myself. This season is difficult in uniquely personal ways for everyone, but I have found many gems that a slower-paced life affords.

Managed Healthcare Executive's October issue headlines 10 healthcare leaders in its fourth annual "10 Emerging Industry Leaders" feature. MHE spotlights each leader individually with a Q&A interview between MHE and the emerging leader.



10 Emerging Industry Leaders: Toni Jones

Multiple sclerosis (MS) typically affects people in their prime working years, most often striking between the ages of 20 and 50. Rates of unemployment are high. As many as four out of every five people with the neurological condition that affects movement, gait and vision may be unemployed. 

 compares two groups of patients with MS to identify the factors that may influence their likelihood of holding a job.

“While much is known about the demographic and disease variables associated with 

unemployment in MS, less is known about the role of person-specific factors and one's engagement in health-related behaviors,” wrote author 

, Ph.D., senior research scientist at the Center for Neuropsychology and Neuroscience Research of the Kessler Foundation in East Hanover, New Jersey. The 

 funds research into people with disabilities and the employment issues they face.

Previous studies have examined MS and employment but were retrospective. The press release accompanying the publication of Strober’s findings says hers is the first to study the issue prospectively.

Strober’s study included 252 people with MS and divided them into two groups: “at risk” for leaving the workforce (n = 67) and “not at risk” (n = 185). The participants in the “at risk” group reported that they were considering reducing their hours or leaving the workforce altogether because of difficulties related to their MS.

Participants in the study were between the ages of 20 and 64 and were currently employed. They completed an online survey about a number of topics, including work status and history, disease symptoms, personality, coping, self-efficacy and disease management. Participants also completed the Symbol Digit Modalities Test (SDMT), which measures processing speed.

The “at risk” and “not at risk” groups were similar as far as age, gender, education, and disease duration were concerned. There was, though, a difference in disease course: A greater proportion of patients in the “at risk” group had a progressive course (13% vs 3%).

The “at risk” group also reported greater levels of fatigue, sleep disturbance, pain, depression and anxiety. Based on their survey responses, they also had greater levels of neuroticism; lower levels of extraversion, conscientiousness and agreeableness; lower MS self-efficacy; and a greater use of maladaptive coping.

In addition, they reported lower “locus of control” — how strongly people believe that they have power over situations and experiences that affect their lives. The “at risk” group was also less likely to engage in positive health-related behaviors, such as healthy eating, exercise and social/intellectual activities.

“What is perhaps is more novel and exciting about the present findings is the fact that engagement in health-related behaviors, specifically diet and exercise proved to be a significant predictor even when disease and person-specific factors were taken into account,” Strober wrote.

Among the limitations that she noted was almost all (94%) of the patients in the study had a relapsing-remitting course, which was likely because the individuals recruited were still working and at the early stage of being considered “at risk” for unemployment. The study also did not include a measure of disease severity, because it relied on medical information from the patients’ neurologists, many of which did not report something like the Expanded Disability Status Scale.

"Risk of unemployment is highest during the first three to five years after diagnosis, so we need to be able to intervene early to prevent job losses, and their subsequent impact on physical and mental health, as well as on personal and family finances. This study points to factors related to risk of unemployment that may be amenable to early intervention," Strober said in the 

. "While further research is needed, professionals who provide MS care should be aware of the potential impact of this diagnosis on future employment and be prepared to intervene before individuals leave the workforce."

People with MS who are at risk for joblessness have poorer health-related habits and lower “locus of control” scores, according to findings by Kessler Foundation researcher Lauren Strober.

Prospective Study Identifies Factors Associated With Unemployment Among People With MS

 the antiviral drug Veklury (remdesivir) to treat patients with coronavirus disease 2019 (COVID-19) when they need hospitalization. It is the first therapeutic to receive full FDA approval, which covers adults and children at least 12 years of age who weigh at least 88 pounds. The approval for Gilead Sciences does not cover some pediatric patients who had received the drug under the May 1, 2020, emergency use authorization (EUA); instead, the EUA was revised for younger patients as clinical trials in this population continue. FDA said the approval was based on data from three trials involving patients hospitalized with mild to severe COVID-19, including a 1,062-patient trial by the National Institute of Allergy and Infectious Diseases, which found patients taking the drug recovered five days earlier than those taking a placebo.

Priority review for new Tagrisso indication. 

AstraZeneca’s Tagrisso (osimertinib) has been granted 

 for its supplemental new drug application for the adjuvant treatment of patients with early-stage epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC) following surgery for tumor removal. Although 30% of these patients are diagnosed in time for current treatment regimens to cure their disease, up to 50% see disease recurrence. FDA’s action follows results from the ADAURA trial presented in May at the American Society of Clinical Oncology, which found that Tagrisso improved disease-free survival 79% compared with placebo, and that the two-year, disease-free survival rate was 89%, compared with 53% for placebo. Priority review will shorten the review timeline to six months from the standard 10 months.

Second breakthrough therapy designation for olorofim. 

F2G has received its second breakthrough therapy designation for 

, which is in phase 2b development for the treatment of life-threatening fungal infections. This new breakthrough designation is for coccidioidomycosis, or valley fever. FDA has previously granted olorofim orphan drug designation coccidioidomycosis, an endemic fungal infection that occurs primarily in the desert Southwest of the United States but also in Mexico, Central America, and South America. Infection begins by inhalation and can spread to any part of the body, even in otherwise healthy individuals. When the infection reaches the brain, it produces a devastating illness that cannot always be controlled with any currently available agent.

Gilead's Veklury gets full approval; AstraZeneca's Tagrisso heads toward second indication in NSCLC; another use for experimental antifungal therapy.

FDA Updates: COVID-19 Drug Approval, Priority Review for Tagrisso in New Indication

COVID-19 has transformed telehealth. Within weeks of the pandemic, most practices across America had adopted some type of virtual service. Recent 

 of patients and providers suggest this trend will continue. Meanwhile, telemedicine types are shifting to meet changing demand. Prior to COVID-19, “tele-urgent care” was predominant; however, the pandemic has spurred adoption of telehealth for 

 too. As telemedicine expands, our notion of quality must evolve too.

Quality impacts health outcomes. But do in-person quality measures meaningfully translate to telemedicine? Do the same measures that predict a doctor’s ability to deliver excellent in-person care also predict if s/he is a good “virtualist?”

As telemedicine expands, quality measures related to accessibility and equity, must be adopted. Limited broadband/smartphone access and low digital literacy among certain populations may impact use. For example, during the height of the pandemic, University of California San Francisco (UCSF) primary care clinics saw an over 4000% increase in virtual service utilization; yet when comparing patient visits before the pandemic to afterward, they observed significant decreases among elderly, non-English speaking, and Medicaid patients. 

Beyond access, a variety of other telehealth quality measures should be compared to in-person care, including diagnostic accuracy, unplanned Emergency Department (ED) visits/hospitalizations, no-show rates, medication adherence, and patient satisfaction. Unfortunately, multiple literature reviews suggest that telemedicine quality has yet to be evaluated in rigorous, standardized approaches. Some work has begun through the National Quality Forum Telehealth Framework and American Telemedicine Association, and some medical specialty societies have created telehealth guidelines. However, these efforts must be fast-tracked to meet the speed of telemedicine expansion.

Patients often lack access to quality metrics. Consequently, they typically rely on web-based reviews to choose physicians, which studies suggest are poor predictors of quality. To solve this, the private sector has developed data-based, quality-predictive algorithms. For example, an algorithm developed by Grand Rounds Inc., assesses provider quality based on specialty-specific measures. Primary care physicians, for instance, are recommended based on their patterns of pain medication prescribing, preventive screening, and specialty referrals, and their ability to develop longitudinal patient relationships. These measures have been independently validated by Harvard-based researchers as effective predictors of provider quality, and recommendations derived from these measures are available to patients whose employers offer algorithm access as a benefit. However, other consumers can’t simply obtain information on a physician’s practicing patterns when searching the internet. Telehealth offers an opportunity to change this; as telehealth quality measures are developed, transparency will be essential in improving equitable access to quality care.

The industry needs standardized quality measures, as the pandemic-associated expansion of telehealth will likely continue. This must be addressed urgently, because as the next wave of the pandemic approaches, in-person care may be further impacted.

We must start by identifying the right quality metrics, and then ensuring the information is readily available to patients, health systems and providers themselves. The goal should be to help consumers gauge telehealth providers, and provide healthcare workers/systems with feedback (e.g. through push notifications) for continuous improvement.