The American Cough Conference was held June 11-12. Coverage from the meeting, which brought together health care professionals involved in the research and management of patients with cough, is now available.

Coverage of the American Cough Conference

The SLEEP Meeting was held June 10-13. Coverage includes session summaries and interviews with key opinion leaders in sleep and circadian science.

Coverage of the SLEEP Meeting

Coverage from the EHA2021 Virtual Congress, including session summaries, poster write-ups, and interviews with key opinion leaders is now available

Coverage of EHA 2021

If 2020 was dominated by the news of how COVID-19 spread across the globe, then 2021 has so far been focused on ending the pandemic through vaccine distribution.

A Timeline of COVID-19 Vaccine Developments in 2021

We interview experts on investigational treatments such as liso-cel, and ask how to bring them to community practice.

Spotlight on CAR T-Cell Therapy

The American Journal of Accountable Care® features research and commentary on new payment models.

New Members for AJAC Board

Early intensive treatment (EIT) for relapsing-remitting 

 (RRMS) proved to be more efficacious at slowing disease accumulation compared with initiating therapy with a moderate-efficacy disease-modifying treatment (DMT) before escalating to a higher-efficacy DMT, according to 

Therapeutic Advances in Neurological Disorders.

“The most important goal of MS therapy is prevention of long-term disability accumulation,” the authors wrote. “But no consensus exists on how aggressively to treat RRMS nor on the timing of the treatment.”

The Italian MS Register provided the multicenter, observational, retrospective cohort study data on 726 patients with RRMS who were included in the final analysis because they had at least 5 years of follow-up, a first visit within the 3 years after disease onset, and at least 3 Expanded Disability Status Scale (EDSS) score evaluations—all after DMT initiation. These cohorts consisted of the EIT group (n = 363), whose first DMT was fingolimod, natalizumab, mitoxantrone, alemtuzumab, ocrelizumab, or cladribine, and the escalation to higher-efficacy DMT group (ESC; n = 363), whose first DMT was glatiramer acetate (GA), interferon (IFN) beta, azathioprine, teriflunomide, or dimethylfumarate treatment before switching to the higher-efficacy agent after at least 1 year and because of lack of efficacy.

With their cohort followed for a median (interquartile range [IQR]) of 8.5 (6.5-11.7) years, the overall results show that the mean delta-EDSS differences increased at 3 important time points:

In fact, the authors pointed out, “the mean annual delta-EDSS values were all significantly (

< .02) higher in the ESC group compared with the EIT group.”

EIT patients were older at first DMT (mean [SD] age, 31.13 [10.06] years) compared with the ESC patients (mean [SD] age, 29.37 [9.22] years).

EIT patients had a shorter disease duration at first DMT (12.69 [9.61] months) vs the ESC patients (14.04 [9.64] months).

EIT patients were more disabled at first DMT (EDSS score, 2.63 [1.60]) vs the ESC patients (EDSS score, 1.85 [1.26]).

EIT patients had fewer EDSS evaluations at their first follow-up (21.99 [15.71]) vs the ESC patients (24.43 [16.75]).

Patients in the ESC group most often started their DMT therapy with IFB beta 1a subcutaneous (44.63%), followed by IFN beta 1a intramuscular (19.83%), IFN beta 1b subcutaneous (19.56%), GA (9.09%), and azathioprine (6.89%). After a median (IQR) of 6.3 (3.1-8.4) years, they usually escalated to natalizumab (42.98%), fingolimod (38.84%), mitoxantrone (14.05%), ocrelizumab (2.20%), alemtuzumab (n = 6, 1.65%), or cladribine (0.28%).

In contrast, patients in the EIT group most often had as their first DMT, natalizumab (40.77%), followed by mitoxantrone (38.84%), fingolimod (17.63%), and cladribine (2.75%). None received alemtuzumab or ocrelizumab. Their median (IQR) exposure was 7.2 (5.3-10.3) years.

At baseline, EDSS scores were close to equal (ESC cohort, 2.63 [1.54]; EIT cohort, 2.61 [1.57]), but EIT patients were slightly older (31.04 [10.02] vs 30.28 [9.26] years) and more of them had a disease relapse in the 2 years before DMT initiation (313 [86.23%] vs 308 [84.85%]).

Overall, from baseline to year 10 (the final year of follow-up), despite estimated EDSS scores increasing in both groups—from a mean 2.45 (95% CI, 2.26-2.64) at baseline to 3.07 (95% CI 2.81-3.33) in the EIT group and 2.52 (95% CI, 2.33-2.71) to 3.81 (95% CI, 3.58-4.04) in the ESC group—the authors highlighted how “in our study, the EIT algorithm was strongly associated with lower disability progression, expressed by the increase of the 12-month EDSS score, and this effect not only persisted, but continued to increase over time.”

“These findings may drive the treatment decisions of physicians, in particular in the cases of naïve patients with poor prognosis factors at the onset of disease,” the concluded.

Still, further studies are necessary, they emphasized, in light of long-term safety concerns regarding severe adverse events connected to the higher-efficacy DMTs.

Iaffaldano P, Lucisano G, Caputo F, et al; Italian MS Register. Long-term disability trajectories in relapsing multiple sclerosis patients treated with early intensive or escalation treatment strategies. 

 Published online May 31, 2021. doi:10.1177/1756286421101957

Articles

Early intensive treatment was more efficacious at slowing disease accumulation in patients with relapsing-remitting multiple sclerosis (RRMS) vs initiating therapy with a moderate-efficacy disease-modifying treatment (DMT) prior to switching to a higher-efficacy DMT.

Early Intensive DMT Use May Prevent Greater Long-term Disability in RRMS

® since 2019 after receiving his Bachelor's degree at Rutgers University–New Brunswick in journalism and economics.

 examining paraquat (PQ) exposure with risk of Parkinson disease (PD), a recent study published in the 

Journal of Occupational Medicine and Toxicology

 indicates that the herbicide has no association with increased risk of PD or death from any cause.


With research over the past 35 years having evaluated 

, including rural living, well-water consumption, farming, and pesticide exposure with risk of PD, researchers highlight that notable interest has focused on the quaternary ammonium herbicide PQ due to its structural similarity with a toxin, called 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (or 

), that has been shown to cause permanent parkinsonism in humans.

“Many experimental animal and in vitro studies of PQ have been performed looking for effects, such as deficits in dopaminergic neurons, but there remain many challenges in interpreting the relevance of these studies to humans,” said the study authors.

Leveraging one of the few cohort studies examining PD and exposure to PQ, the researchers performed a longer follow-up for a mortality study of workers involved in the manufacture of PQ in 4 plants at Widnes, England, from 1961 to 1995. In a 

 that followed these workers until 2009, no exposure-related health effects were observed, including PD.

Conducting an extended follow-up of 7.5 years, health data of 926 male and 42 female workers derived from the UK National Health Service digital database were included in the retrospective cohort analysis. Mortality rates for males were compared with national and local rates, including rates for PD as a mentioned cause of death.

“The primary objective of the study was to assess whether there is any evidence of increased PD mortality as the underlying cause of death or as a mentioned cause of death,” noted the study authors. “A secondary objective was to provide updated information on mortality from major causes of death to confirm the absence of other exposure-related effects.”


Of the study participants, 117 workers were indicated to have had high PQ exposure, with 202 workers linked with medium exposure. The average age of male workers at first exposure was 32.8 years, accounting for 33,805 person-years of follow-up.

By the end of the follow-up, 394 male and 21 female workers had died. There were 4 death certificates for male workers that mentioned PD, in which 2 deaths indicated PD as the underlying cause. Notably, at least 6 certificates of male workers would have been expected to have mentioned PD (standardized mortality ratio [SMR], 0.67; 95% CI, 0.18-1.72). No relationship was identified with duration or level of exposure, and none of the death certificates of the 21 deceased female workers mentioned PD.

Furthermore, in comparison with local rates, workers exhibited reduced mortality rates for major causes of death, including lung cancer (SMR, 0.74; 95% CI, 0.52-1.02).


“The study provided no evidence of an increased risk of PD, or increased mortalities from other causes among PQ production workers whose exposure to PQ on a daily basis was at least comparable to that of a PQ sprayer or mixer/loader,” concluded the study authors.

Tomenson JA, Campbell C. Mortality from Parkinson’s disease and other causes among a workforce manufacturing paraquat: an updated retrospective cohort study. 

. Published online May 27, 2021. doi:10.1186/s12995-021-00309-z

Occupational exposure to the herbicide paraquat was not found to be associated with a greater risk of Parkinson disease or increased risk of mortality related to other causes.

Work Exposure to Paraquat Not Associated With Increased Risk of Parkinson Disease, Mortality

A study evaluating the opinions of older adults with chronic obstructive pulmonary disease (

) found motivators and barriers to using wearable physical activity trackers and active video games (AVGs).

, are from the first qualitative study to investigate the perceptions of older adults with COPD on their use of technology to aid their physical rehabilitation.

“This information will be useful to guide the future optimization or development of health technology, such as AVGs to encourage physical activity in older adults with chronic disease,” wrote the investigators.

Wearable activity trackers and activity monitoring apps provide patients with COPD constructive feedback, encouragement, and the ability to automatically update their physicians on their condition. Additionally, AVGs, which involve physical activity to play a game, have proven to be an alternative and enjoyable form of exercise for older patients with chronic neurological and cardiac diseases.

However, few studies have examined the factors that may influence the usefulness of these technology-based interventions for physical activity in older adults. Data on long-term adherence to AVG interventions in elderly patients with chronic diseases have also been limited and contradictory.

The investigators adopted an exploratory approach by conducting interviews with patients with COPD who were recruited from several pulmonary support groups in the Brisbane, Australia, area. All participants had to have a COPD diagnosis and previous experience with a formal exercise program, such as pulmonary rehabilitation, to help manage their COPD.

Nineteen adults with a mean (SD) age of 70 (6) years were enrolled in the analysis, 11 of whom were female (58%). The participants reported having experience with several technological devices: computers (n = 13), smart televisions (n = 3), tablets (n = 9), smartphones (n = 14), and smart watches or wearable activity trackers (n = 3).

The participants reported a lack of education or instruction on various technologies as a barrier to using them, and some felt that their knowledge was outdated or forgotten. However, the patients stressed that technology was essential to their lives and that they generally saw the value in wearing activity trackers, with some reporting they served as a helpful reminder to move and reach activity goals.

Competition was cited as both a motivator and a barrier to using wearable activity trackers and AVGs. Some participants expressed that having their performance compared with other people who didn’t have a chronic disease or had a less severe disease seemed unfair while others said that a competitive aspect increased their motivation.

In addition, some participants said that AVGs gave them an opportunity to play alongside family members and were useful to pass the time. However, some patients reported that having no one to play with discouraged them, and some said that they felt unable to play some games because they required physical activity that was too difficult for their age or disease state.

Some patients said that they didn’t have the equipment to participate in AVGs, with some reporting that only their grandchildren had access to certain gaming consoles.

In general, the participants were positive about the idea of sharing data with clinicians, but some expressed concerns over the accuracy of the information or whether providers would be interested in or have the time to review that information. Data privacy was not identified as a big concern.

“There is some evidence that suggests that older adults are not particularly concerned about the privacy implications of sharing physical activity data, although this could be because they are not as aware of the risks,” wrote the investigators.

They suggested that clinician perspectives should be incorporated when designing an intervention involving the sharing of patient health data to ensure that clinicians can interpret and use the data sent from activity trackers.

“Clinicians may benefit from education or professional development training specific to the use of technologies to ensure clinicians are aware of the strengths and limitations of these devices and can competently integrate data from these technologies into clinical decision making,” the investigators said.

The researchers identified the primarily Caucasian sample and a potential self-selection bias of patients more likely to use technology as study limitations.

“AVG interventions designed for people with COPD should place an emphasis on the health benefits and enjoyment, should be able to be played with other people, and should use equipment that people with COPD already have, or are familiar with (eg, smartphones, tablets),” noted the investigators.

Simmich J, MAndrusiak A, Russel T, Smith S, Hartley N. Perspectives of older adults with chronic disease on the use of wearable technology and video games for physical activity. 

. Published online May 30, 2021. Accessed June 21, 2021. doi: 10.1177/20552076211019900

Older adults with chronic obstructive pulmonary disease (COPD) identified factors likely to encourage or discourage patients from utilizing different technologies to track and improve physical activity.

Older Adults With COPD Report Barriers, Motivators to Using Wearable Activity Trackers

A lot of data at this year’s Scientific Sessions will reflect changes in pharmacological therapy in type 2 diabetes, said Robert A. Gabbay, MD, PhD, the chief science and medical officer at the American Diabetes Association (ADA). The virtual conference will take place June 25-29, 2021.

How is ADA’s collaboration with other disciplines bringing sodium glucose co-transporter 2 (SGLT-2s) and glucagon-like peptide-1 receptor agonists (GLP-1 RAs) to more patients and earlier in their disease trajectory? 

Really, one of the big changes in diabetes and pharmacological therapy of type 2 diabetes (T2D) has been the discovery of the cardiovascular benefits of SGLT-2 and GLP-1 receptor agonists. That is an evolving story. You'll see a lot of data at our Scientific Sessions that will be covering that. Part of this is really, how do we coordinate care more effectively? How do we ensure that the people that could benefit from these drugs, in fact do? Today, it's the minority of people that would be eligible, that are receiving these treatments. If you look at our standards of care, one of the big changes over the last year has been to elevate these treatments to consider use very early in the course of diabetes management for individuals that are at high risk for atherosclerotic cardiovascular disease or chronic kidney disease.

At this year’s Scientific Sessions, there are sessions that address the questions of genetic vs social influences in the development of diabetes, as well as the role of social stress on health. What have we learned in this area in recent years?

This broader area of social determinants of health have really taken on greater urgency. We've seen this play out in health disparities during the recent COVID-19 pandemic, and the disproportionate effect of the pandemic on people of color. You can see a lot of presentations focusing on this area. There was also a wonderful scientific review that was published by the American Diabetes Association that looks at this field in its entirety and identifies where the challenges are and some thoughts about what to do. I think you’ll see a number of presentations at the Scientific Sessions that will cover various aspects of health disparities. That dovetails with an effort by the American Diabetes Association around health equity. We have taken a strong stand on this area for all of the obvious reasons. In many ways, we feel that if we can address the inequities in health care for people with diabetes, it's going to be the same type of thing and same type of approaches beyond that. That includes anything from having access to healthy foods to having access to the technologies that can help people live healthier with their diabetes. On our website, at 

, you can see a patient bill of rights that speaks to many of these issues of what we’re advocating for.

Videos

Robert A. Gabbay, MD, PhD, the chief science and medical officer at the American Diabetes Association (ADA), previews sessions to be presented at the ADA's 81st Scientific Sessions. 

Dr Robert Gabbay Previews the ADA’s 81st Scientific Sessions

Gun violence is one of the most prominent public health issues facing America today, and accounted for 

 in 2020 alone—the highest number in decades. But a major driver of gun-related deaths in this country that often goes unmentioned is suicide.

Research shows that having access to a firearm significantly increases the risk of suicide via firearm, and during the pandemic, amid an unprecedented surge in firearm purchases, these purchasers appeared far more likely to have experienced suicidal ideation.

To learn more about the intersection between COVID-19, firearm ownership, and suicide, and to mark National Gun Violence Awareness Month, we spoke with Michael D. Anestis, PhD, an associate professor at the 

On this episode of Managed Care Cast, Anestis discusses his most recent research on the paramount importance of safe firearm storage, this epidemic’s disproportionate impact on people of color, and future steps needed to help decrease rates of gun-inflicted suicide. Anestis also serves as the executive director of the 

This episode of Managed Care Cast will discuss subjects related to suicide, suicide ideology, and gun violence. If you or a loved one is in crisis, please contact the 

Listen above or through one of these podcast services:

Podcasts

Michael D. Anestis, PhD, executive director of the New Jersey Gun Violence Research Center and associate professor at the Rutgers School of Public Health, discusses his research on firearm ownership and suicide, in addition to steps needed to help decrease rates of gun-inflicted suicide and gun violence in general. 

Understanding the Intersection Between COVID-19, Firearm Ownership, and Suicide

Vibhas Ratanjee is a senior practice expert with Gallup, based in Gallup's Irvine, California office. Vibhas is a well-known speaker and author and has contributed several articles on leadership and organizational development as well as how new technology will alter the future of work and the customer experience. His writing has featured in several global publications, including the Gallup Business Journal and the Harvard Business Review. Vibhas specializes in organizational development, culture change, and executive-level engagement strategies, including strengths-based leadership and succession management. Vibhas is also an executive coach and a leadership consultant to senior executives and CEOs. Vibhas works extensively in the healthcare and financial services sector.

Agility has long been a big buzzword, but its salience and importance has been growing.

 found that 9 out of 10 executives said organizational agility was critical to business success and growing in importance over time. But according to Gallup's 

 before the pandemic, only 18% of employees felt that their companies were genuinely agile.

Customers may not see the disconnect between leadership priorities and ground-level realities, but they can feel the effects–especially health care customers. Gallup 

 in 2020 shows that 6 in 10 Americans believe the US health care system is in a state of crisis (16%) or has significant problems (45%), the worst results Gallup has found since 1994 (except once in 2001).

The pandemic laid the problem bare. Health care providers worldwide struggled to acquire personal protective equipment, critical ventilators and beds, and according to Gallup 

 in the height of the pandemic, a little less than 1 in 2 health care workers felt that they had enough communication and a clear plan of action for COVID-19. The record on agility in health care has been dismal at a time when agility was needed the most.

But in the end, patient satisfaction is the final arbiter of a medical institution. And most patients (8 in 10) are not very satisfied with the quality of medical care in the United States in 

. After a year like that, this might be expected. But that number hasn’t changed since 2000.

The ability to respond quickly to the customer and the environment is why leaders believe agility is essential. But in a hospital, agility isn’t just about being faster and more patient-centric; it’s also about finding new ways of working more purposefully. Gallup believes that in health care, purposeful agility includes 3 key elements:

, so hospitals can do more with less, navigate disruption, and collaborate cross-functionally and with external partners to keep health care staff engaged, inspired and productive.

, which generates prompt responses and promotes flexibility. That’s increasingly important as alternatives emerge to the traditional health care hospital setup.

, because focusing on getting things done removes friction and improves outcomes. That has weighty implications for value-based care in the post-COVID world.

are an excellent example of agility in health care. Typically, it takes 10-15 years before a vaccine meets all FDA protocols, but the Pfizer and BioNTech vaccines were authorized just 8 months after trials. Many others vaccines followed agile development, trials and approval without cutting corners on safety and efficacy. In the US, development and trials were expedited through the efforts of the government and distributed at a rapid rate under the aegis of Operation Warp Speed. Vaccine development and deployment also required extensive global cooperation, strategic planning and the collective talents of clinical and non-clinical employees, partners, vendors, and distributors across the world.

Evidence of the presence of the agility mindset should reassure health care leaders that their people have the mindset that enables fast decision-making, experimentation, and learning. But evidence of the agility mindset doesn’t make a hospital culture agile. To that end, health care providers ought to ask themselves these 2 questions to understand their organizations’ capacity for agility:

Do we have the right tools and processes to respond quickly to business needs?

Do we have the right mindset to respond quickly to business needs?

If the answers are yes, the organization is in an advantageous position: Gallup 

 shows that those who feel that they have the agility mindset and the right processes for agility are 3 times more like to be confident in the financial future of their organizations and a whopping 5 times more likely to feel their organization is ahead of their competition.

If the answers are no, shifting into an agile-ready culture may be required.

Gallup’s research on agility finds that there are 7 fundamental shifts common to highly agile leaders. Driving these changes through a hospital can help significantly advance a culture of agility.

From Disciplinary Silos to Agile Collaboration

Hospitals moved to team-based patient care some time ago as a logical response to the many clinical, nonclinical and technical staff touch points patients require. That level of collaboration is necessary for critical clinical outcomes and to avoid medical errors–which cause 250,000 deaths a year, according to some 

–yet hospitals themselves may not reflect that collaborative behavior.

Leaders must intentionally focus their teams on the agile behaviors that can topple barriers and encourage broad-based collaboration through cross-functional project and sprints aimed at specific quality or clinical outcomes. Agile collaboration must be at a broader level of the ecosystem—critically between clinicians and administrators and amongst providers, payers, manufacturers, and regulators.

From Unstructured to Agile Decision-Making

Health care is unpredictable, which makes objective decisions hard to reach. Nonetheless, timely, quality decisions are crucial to success for health care providers, and unfocused, unstructured decision making is a barrier to agile working. As health policies and practices change, decisions based on old data and legacy systems will prove increasingly ineffective.

Applying agility to decision making will require gaining inputs across the spectrum of health care workers­—clinicians, engineers, managers, data scientists, and, importantly, frontline staff—to reach informed, objective decisions. Patients, too, must be included through a shared decision making (SDM) model, in which patients exercise the right to choose their treatment.

By its nature, health care is risk-averse. The practice requires precision and clarity, and its sole purpose is to reduce patients’ risk of ill health. But disruptions like the pandemic emphasize the need for greater risk tolerance.

Hospital leaders must educate their teams on prudent risk-taking through education, risk simulation training, and coaching. Importantly they must engage their team's assessment and dialogue around risk, market trends, and potential disruptions in the health care model at the local and global levels.

Many health care organizations are structured on a traditional command-and-control model. This creates order, structure, and consistency, but it is ill-suited for the kind of rapid development and strategy pivots required in the modern, post-pandemic health care reality.

 shows that managers are crucial to engagement and empowerment—70% of the variance in team engagement is due to the managers—but health care managers are not always trained to engage, inspire, and support health care staff. Development is necessary for any manager, but more so in teams that need to drive greater empowerment, speed, agility, and performance.

Health care leaders must get adept at involving and engaging their teams through purposeful rounding, eliminating barriers to clinical care, and gaining a deeper understanding of individual engagement needs.

Managers who develop the power of engagement and the purpose of agility are enormous assets in a changing environment. In the health care environment, in which laborious command-and-control systems are increasingly ineffective, such managers are crucial.

From Incidental to Purposeful Technology Adoption

Technology is transforming health care. According to Gallup analytics, the use of telehealth alone will explode, and hospitals are becoming more and more interested in tech that drives value for patients.

But not all health care technology is as effective as it should be. Perhaps the poster child of disappointing technology is the electronic health record (EHR). It’s 

 that 30%-50% of EHR implementation efforts fail. So, solving a health care process problem is not as easy as throwing technology at it. Post-pandemic, there is a greater need for health care providers to use technology purposefully to shift from traditional ways of working to a more user-centered design of new tech.

This will require a high degree of technology readiness from health care administrators, executives, and technologists and an orientation toward the purposeful utilization of technology to directly impact the patient, clinician, and hospital staff experience.

Testing, validation, and technology adoption should also include user feedback through prototyping or the use of micro-test sites that simulate the patient experience and perfect user interface and user experience delivery before going to market.

Much of the talk about business agility centers on the speed with which employees can take action to solve problems. Speed requires employee empowerment, decentralized decision-making, and a focus on procedural simplicity. But recent Gallup research has shown that only 13% of US employees feel that they always look for the simplest way to get the job done in their company.

That’s worrisome. Agility is not about setting up new structures, task forces, and processes. Agility is about simplicity. Simplifying may mean replacing unproductive and highly complex, and bureaucratic systems that impede performance and productivity. It may also mean undercutting organizational rigidity and bureaucracy.

Centering simplification efforts around the patients and involving team members across clinical and non-clinical functions is vital. Cross-functional team huddles help, as do problem-solving or clinical quality projects that map the patient journey across the broad spectrum of patient experiences.

From Knowledge Hoarding to Knowledge Sharing

Health care organizations today are data-rich. Data can save lives, making effective and efficient use and sharing of data, knowledge, and information even more critical

A Healthcare Information and Management Systems Society (HIMSS)

 reported that one of their top digital innovation goals centered on modern collaboration, in addition to enhanced security, interoperable data, and patient satisfaction. Meanwhile, agile health care organizations must center their data and knowledge sharing on what driving value for end-customers and patients.

Therefore, an agile hospital needs a knowledge management system with a heavy external customer orientation rather than an internal process orientation–and all that information and knowledge must be widely shared.

Here, a key element is integrating data sets and knowledge across all patient interactions and episodes into one 

. That single view will enhance effectiveness, reduce risks, and significantly enhance data privacy, PHI, and HIPAA compliance.

These 7 fundamental shifts to an agile culture are vital and require broad-based adoption to be successful. Agility, after all, is the ability to adapt to market dynamics nimbly and respond to health care needs rapidly. This means that organizational agility is not the same thing as "agile methods." The core elements of truly agile culture are adaptability, speed, and execution–and those aren’t methods. They’re means.

To be truly agile, health care leaders must try harder to invest in developing capable managers who are focused on engagement. To be better, they must fuel their organizations by investing in talent—the talent with the right mindset is empowered with tools, systems, and processes to drive change. And they need an organizational culture that values flexibility, innovation, and agile risk-taking.

Agility has long been a big buzzword, but its salience and importance has been growing. Gallup’s research on agility finds that there are 7 fundamental shifts common to highly agile leaders—driving these changes through a hospital can help significantly advance a culture of agility.

Contributor: Seven Shifts to an Agile Culture in Health Care

Biden Delays June Donation Target, Will Send 55 Million Vaccines

With logistical hurdles and millions of vaccine doses produced by AstraZeneca still undergoing safety review, the Biden administration announced yesterday that it is delaying the total target donation shipment of 

 and will instead ship 55 million doses worldwide. As reported by 

, President Joe Biden had previously committed to sending the 80 million doses by the end of June, but will now allocate the doses by this time frame, with shipments potentially being extended until July or beyond. Of the 55 million vaccine doses shipped, approximately 41 million will be sent through 

.                                                                                            

Nearly 10 Million Enrolled in Medicaid, CHIP Amid Pandemic

 by CMS released yesterday, a record high of individuals, over 80 million, are now insured through Medicaid and the Children’s Health Insurance Program (CHIP). Notably, a 13.9% increase in enrollment occurred between February 2020, the month before the public health emergency was declared, and January 2021, amounting to 9.9 million new enrollees in the 2 programs. The boost in enrollment was found most prominently in Medicaid, as Medicaid enrollment increased from 64 million to 73 million and CHIP enrollment increased by approximately 123,000.


Stark Rates of Death by Suicide in US Military

 indicates that since 9/11, 4 times as many US service members and veterans have died by suicide compared with those killed in combat. As reported by 

, a significant majority of the deaths by suicide were among veterans, who accounted for 22,261 of the 30,177 reported cases; meanwhile, 7057 had been killed in combat during that time. The report’s author, Thomas Suitt III, said the number of deaths by suicide is likely an underestimate for active duty members and veterans, and that research finds that some service members may not receive the medical treatment they need.

The Biden administration shifts its planned vaccine donation from 80 million to 55 million vaccines amid ongoing safety review of AstraZeneca doses; a CMS report indicates that nearly 10 million individuals enrolled in Medicaid and CHIP amid the pandemic; significantly more deaths by suicide are reported than combat deaths in the US military.

What We’re Reading: Latest on Vaccine Donations; Surge in Medicaid Enrollment; Suicide Rates in the Military

When you’re evaluating a patient, how do you start to make those determinations? There have been things that have come up about undertreatment vs overtreatment, hitting aggressively, dealing with insurance issues. Some of these factors are important to you as a clinician and some are less important. When you see a patient, how do you determine what you think should be their first- or second-line therapies?

The first thing that is very important is that I don’t think about individual products or brands. I think of modes of action. I keep a mode of action, or a class of a treatment. That becomes very important because formularies change from year to year, and if a patient has already stepped through a third mode of action, particularly if they chose to move on because of ineffectiveness, that should not have to be recycled. When I’m looking at a patient, the gestalt of the patient is relevant. What factors does the patient bring to the table? Is there incomplete recovery from an attack? How does the MRI look? Where are the lesions? Is there a family history of autoimmunity? Is there a family history of MS [multiple sclerosis] in this particular individual? In a way, it’s a 360-degree view of the patient.

I mentioned that about 75% of patients are women. At initial diagnosis, family issues are on the table. We may choose a medication at that point that allows itself insertion while the family planning issues are ongoing. I have taken a bit of issue with the term aggressive. When natalizumab first came out, it was a well-tolerated medication. Problems arose afterward that it had the PML [progressive multifocal leukoencephalopathy] risk associated with it. From then on in the field, we were thinking of it as high efficacy with a lot of potential safety baggage. We have since learned there is a group of patients on natalizumab who are not at the same level of risk for PML as others. Our newer entrants in the higher efficacy group are quite safe medications overall, which haven’t had this baggage of additional safety risks that manifested shortly after introduction into the market.

If I were to propose to somebody, “Listen, we’re going to effectively treat your heart attack the next time you have an MI [myocardial infarction],” most people would probably look at me and think I’m of a quackish persuasion. That’s not necessarily a good thing. In a certain way, as a neurologist, I can try to prevent injury, but I can’t really fix [the disease]. I would like to transition to where we look at MS as a manageable disease with the tools we have. Many times, if a patient come to me with more than 10 lesions or with lesions in the spinal cord, this patient is already stigmatized to having a higher risk of disability progression over time. The best time to intervene in that disease is now, when I see this particular patient. I understand what Dr Ross said regarding persisting with insurance companies. Naturally, formularies have become stiffer, so we sometimes need to transition. We are also working outside of the formularies with our legislators in the states to perhaps educate that if the plans are too rigid, they might find some legislative inducements that will help them to understand that conditions like MS need to be treated from the beginning in an effective way. As an MS physician, I operate on the biases with the plans, I operate with the patient, the nongovernmental groups, and I also engage with my friends from the legislative side within the jurisdictions that we cover.

 Your heart attack analogy might be appropriate now. Maybe 20 or 30 years ago, we actually did say things like, “We’re going to treat your second heart attack much more aggressively.” Maybe we’re just playing a little catch-up. Dr Okuda, do you agree, more specifically about some of the things, the lesions, spinal cord lesions, and the degree of disease present that make you want to—I’ll use a car analogy because of our background—turbocharge your response?

It would be great if payers were to stratify groups when it comes to making decisions about authorizing a given treatment. What I mean by that is identifying key clinical, paraclinical, and even baseline demographic factors. Race and ethnicity are massive. We know that those who are non-White, Asian, African American, Black, or Hispanic have different trajectories. There are a wealth of pediatric MS experiences in which these young kids and teens are Hispanic. The incidence and prevalence of multiple sclerosis in people who are Black or African American may be higher than those who are White. We know they recover less well from relapses, their relapses are more severe, and they accrue more neurologic disability over time compared to their White counterparts. It would be nice to start with that.

Other key factors, young age is a big because we know our condition of interest is one that’s dependent upon the age of the individual. The decade of greatest risk is likely age 20 to 30. Of course, it’s not age 50 to 60, and 60 and beyond. By then, we start to get into this realm of immunosenescence. And race and ethnicity are massive.

Moving beyond that, historically in our field, we’ve used a super old term, burden of disease, which really means the volume or lesion number in your brain or spinal cord. That still has meaning because we know that disease occurs well before people present to us for the first time. We don’t know whether we can change their outcome at age 45 when we’re seeing them at age 26 because of the amount of damage that may have already occurred prior to them seeing us. The amount of lesions is important. Where the lesions are is super important as well. Does it involve the optic nerve? Does it involve the brain stem, the cerebellum, the connections there, or the spinal cord? Involvement there will automatically place people in a higher category of neurological impairment. They’re also at risk for subsequent disability accumulation over time.

As you’re caring for someone, in terms of surveillance, you can also look at their relapse history. We know that’s a high correlate to markers of aggressive or highly active MS, along with collecting new lesions on repeat MRI scans. We’re not at the point where we can use neurofilament light. All of us may be of the belief that it’s a super valuable tool, but we don’t have another biomarker that’s exceptionally valuable in our field beyond the MRI scan and what we see clinically in front of us.

Thomas Leist, MD and Darin Okuda, MD provide insight into first-line treatment selection for MS and the patient factors involved. 

Selecting First-Line Therapy in MS

As someone who’s been involved in medication management, I feel as if the structure around MS [multiple sclerosis] management, or at least the paradigm around MS management, has changed pretty dramatically over the last, say, 15 years. There was the use of self-injected medications. Like we did with a lot of things, like hypertension—you start with a β-blocker, then you add an ACE [angiotensin-converting enzyme] inhibitor—it’s like progressive therapy. It feels like that paradigm has changed in MS. Dr Okuda, you could talk a little about that. You’ve been an advocate for early aggressive therapy for quite some time. Maybe you could talk about how you’ve helped change that paradigm away from incremental therapy to more aggressive early stage therapy.

 What may be important is to go back in history and understand why we had an escalation approach back in the day. It was because of the limited treatments we had. In 1993, we had Betaseron. Around that time, a patient had to win a lottery to receive treatment. I believe Avonex and Copaxone followed in 1996. In early 2000, you had Rebif, then the introduction of Tysabri, or natalizumab, and the entry of a variety of oral treatments. What has happened over the past 10 or 15 years is we’ve had a number of different treatments that have differing mechanisms of action. Science has advanced as well, highlighting how other cell types may be more important in the pathophysiology of multiple sclerosis. The availability of higher efficacy agents has had an effect. That list may vary. Some would put alemtuzumab, Tysabri, ocrelizumab, Mavenclad, and ofatumumab within that list, and may include or leave out Zeposia, fingolimod, and Mayzent. Then you have everything else.

Looking back on history, that’s all we had. All we knew was if things seemed worse, we would escalate you to an interferon-based therapy if you were on copolymer. Now, we have a wealth of treatments to choose from. The rationale for using a high efficacy treatment first is to allow for preservation of neuronal tissue. When an exacerbation occurs, if history is correct, an MRI relapse will outnumber a clinical relapse 10:1, and that’s a key marker in the no evidence of disease activity metric that has been created, whether or not we agree upon that as being a valuable tool. We see a lot more disease on MRI than clinical symptoms that represent exacerbations.

We embark on this high efficacy approach in an effort to prevent disease from happening, because we can’t take that away. If someone has optic neuritis or a bad spinal cord relapse, steroids do not improve their long-term outcome. It is what it is, and you hope that recovery is full. It’ll be dependent on race and ethnicity, as Dr Leist mentioned, and a whole variety of other factors. The philosophy of giving the best first appears to be a smart philosophy. It may not be the right philosophy in all cases, though, because there is risk of overtreating people. The risk to the system and the payer is missing a group of individuals who then have disease activity and progression in which they’re now pulling on resources that need to be covered by the payer because of inadequate disease management.

I want to pull Dr Ross in here, if I may, and talk about balancing patient concerns, coverage, determinations, the desire, and the paradigm changing to be more aggressive earlier based on what’s now available. You’re probably caught in the middle of that conversation quite a bit. How do you help balance those determinations between aggressive therapy and coverage determination? One of the things I took away from what Dr Okuda said was that the definition of high efficacy is not necessarily standardized. 

 Is that fair to say? How do you help people navigate through that?

 The troubling part is that not all of the payers have adjusted their preferred agents. They may still have the more traditional, older agents listed as preferred on their formulary. When you have a physician who wants to be aggressive early—maybe the patient has lesions in suspicious places, maybe they’re young, their ethnicity is higher risk, or it looks like they’re going to have advancing, progressing disease—and you want to start them on something that’s more high efficacy than your traditional Copaxone, or glatiramer acetate, trying to convince the payer that they need to go along with that and justifying your reasoning, when there are no national guidelines or anything that we have to argue one way or the other, can be challenging.

It can almost scare off a new patient when you’re telling them that you’re going to put them on an excellent medication that just came out that we have a lot of high hopes for and could keep them from getting worse in the long run, but they start getting scary letters from their insurance companies saying it’s not preferred and they want to switch to something else that’s cheaper. I have patients who will say to me, “But I want to save my insurance company money.” I’m like, “That’s very nice, but we need to do what’s good for you and make it work.” It can be quite challenging.

Experts in MS discuss the evolution in treatment options over time and the shift towards use of early high-efficacy therapy. 

Paradigm Shift in MS Management

Susan Weidner is senior vice president, IntrinsiQ Specialty Solutions.

In the United States, CMS is the single largest payer for health care. In 2019, Medicare enrolled more than 60 million beneficiaries, and enrollment is expected to exceed 80 million by 2030.

 Medicare Part B provides coverage for beneficiaries for drugs and biologics that are administered in physician offices or hospital-based clinics by infusion or injection. It also covers certain other drugs, including some oral anticancer therapies, oral antiemetics, immunosuppressive drugs, and home infusions.

 In 2017, 7 of the top 10 drugs reimbursed by Medicare Part B were mainly, or exclusively, for oncology or related supportive care indications and accounted for over $8.7 billion in spending.

 This amount is expected to increase as the majority of new cancers in the United States are diagnosed in the Medicare-aged population, which is expanding as baby boomers age.

Medicare Part B Reimbursement Methodology


Medicare Part B provides reimbursement at a rate of the average sales price (ASP) plus a 6% add-on fee (ASP 6), a methodology that relies on market-based prices to set reimbursement rates.

 The 6% is provided as an add-on payment to cover expenses related to the needs of physician-administered drugs. Among these are purchasing variability, shipping fees, complex administration, ongoing patient monitoring and education, and overhead for storage and handling requirements.

ASP was enacted in 2005 as part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and generally reflects the average price of a drug’s sales to all purchasers in the United States, including commercial payers. The ASP is calculated for each Healthcare Common Procedure Coding System (HCPCS) code included in Part B coverage with a 2-quarter lag, as shown in 

. HCPCS codes may include drugs from a single source or, more commonly, from more than 1 manufacturer. Drug manufacturers provide data for the calculation to CMS quarterly.

As HCPCS codes frequently include drugs from multiple manufacturers, ASP 6 provides reimbursement at 106% of the blended ASP for all products within an HCPCS code on a volume-weighted basis. Payment for a single-source drug with a unique HCPCS is, in general, based upon either 106% of the ASP or 103% of the wholesale acquisition cost (WAC), whichever is lower.


When reporting price, manufacturers must account for concessions, including volume discounts, prompt-pay discounts, cash discounts, free goods contingent on any purchase requirement, chargebacks, and rebates.

Due to additional legislation via the Budget Control Act of 2011 and the Balanced Budget and Emergency Deficit Control Act beginning in 2013, the actual Medicare Part B reimbursement to providers effectively became ASP plus a 4.3% add-on fee (ASP 4.3). This legislation required payment reductions in federal expenses through a sequestration order. The effects of sequestration on Part B drug reimbursement resulted in a drop in ASP from 6% to 4.3% and in WAC from 3% to 1.35%. This, in turn, resulted in the reimbursement methodology currently in use for Medicare Part B. Additionally, due to a known error surrounding prompt-pay discounts provided to distributors but not passed on to providers, actual realized reimbursement is likely closer to ASP plus 2.3%.

Issues Facing Medicare Part B Reimbursement


Despite a paucity of published data, the Medicare Payment Advisory Commission (MedPAC) provided a report to Congress in 2017 detailing their concerns with ASP, which included a lack of competition creation and the potential for incentivizing providers to choose higher-priced drugs.

Additionally, Ridley et al recently published a conceptual model showing that launch prices have increased under this reimbursement model due to its reliance on lagged pricing.

 These publications maintain the perception that physicians are incentivized and driven by increased prices of drugs and that higher prices indicate higher profit and margin. In this review, we will explore recent literature that provides evidence directly contradicting these concerns.