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This week, President Joe Biden plans to take executive action on health insurance as he moves to reopen federal marketplaces selling Affordable Care Act (ACA) health plans and lower barriers to joining Medicaid, according to a report Tuesday in 

Citing individuals inside and outside the administration, the effort is aimed at assisting Americans who lost their health insurance as a result of job losses or other factors stemming from the coronavirus disease 2019 (COVID-19) pandemic. Typically, open enrollment would not occur until a restricted 6-week period at the end of the year.

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 to manufacture a COVID-19 booster shot designed to be more effective against emerging variants of the coronavirus 

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President Joe Biden reportedly will take executive action to reopen federal marketplaces selling ACA health plans; Moderna announces plans to manufacture a booster shot designed to be more effective against emerging variants of the coronavirus; the first US reported case of the Brazil coronavirus variant is found in Minnesota.

What We're Reading: Biden Reportedly Reopening ACA Enrollment; Moderna Developing COVID-19 Booster; Brazil Variant Now in US

 To determine whether enough primary care providers are in close proximity to where dual-eligible beneficiaries live to provide the capacity needed for integrated care models.

Secondary data analysis using dual-eligible enrollment data and health care workforce data.

 We determined the density of dual-eligible beneficiaries per 1000 population in 2017 for each of 3142 US counties. County-level supply of primary care physicians (PCPs), primary care nurse practitioners, and physician assistants was determined.

 One-third of the 791 counties with the highest density of dual-eligible beneficiaries had PCP shortages. Counties with the highest density of dual-eligible beneficiaries and the fewest primary care clinicians of any type were concentrated in Southeastern states. These areas also had some of the highest coronavirus disease 2019 outbreaks within their states.

 States in the Southeastern region of the United States with some of the most restrictive scope-of-practice laws have an inadequate supply of primary care providers to serve a high concentration of dual-eligible beneficiaries. The fragmented care of the dually eligible population leads to extremely high costs, prompting policy makers to consider integrated delivery models that emphasize primary care. However, primary care workforce shortages will be an enduring challenge without scope-of-practice reforms.

Primary care workforce shortages will likely hamper the effectiveness of integrated delivery models for dual-eligible beneficiaries and limit the ability to expand policy scale.

The workforce shortages will be an enduring challenge in states without scope-of-practice law reforms.

Dual-eligible beneficiaries’ inadequate access to primary care cannot be addressed without systematic state-level approaches. States with large dually eligible populations should assess the resources available for expanding access to primary care.

The effects of the coronavirus disease 2019 pandemic reinforce the need to grow the primary care workforce in the Southeast to address pent-up service demand that awaits the resumption of normal care patterns.

Twelve million people are enrolled in both Medicare and Medicaid. Known as “dual-eligible beneficiaries,” they account for 20% of Medicare beneficiaries and 15% of those receiving Medicaid, but account for one-third of total expenditures for each program.

 Most qualify for Medicare on the basis of age or a disability, and all dual-eligible beneficiaries have incomes below or near the federal poverty level. This population suffers disproportionately from chronic conditions and fragmented care.

To help overcome historically fragmented and uncoordinated care, CMS has developed integrated care delivery models, including the Program of All-Inclusive Care for the Elderly, the Medicare Advantage Dual-Eligible Special Needs Plans, and the recent Financial Alignment Initiative. Although these models largely rely on adequate access to primary care, there are well-documented shortages of primary care physicians (PCPs).

 We investigate whether dual-eligible enrollees are concentrated in different areas of the country and whether primary care clinicians, including PCPs, nurse practitioners (NPs), and physician assistants (PAs), are geographically colocated in these areas. Without an adequate primary care workforce available, implementing integrated care delivery models for dual-eligible beneficiaries may be in vain.

We conducted a cross-sectional analysis using data on the geographic locations of dual-eligible beneficiaries and primary care providers. Enrollment data from the Office of Medicare-Medicaid Coordination were used to calculate the population density of dual-eligible beneficiaries,

 defined as the number of dual-eligible beneficiaries receiving full or partial Medicaid benefits per 1000 population in each of the 3142 US counties. We categorized counties according to dually eligible beneficiary density quartiles.

To determine the county supply of PCPs, we used the Health Resources and Services Administration 2017 designation for whole-county Health Professional Shortage Areas (HPSAs). HPSA data came from the Area Health Resources Files (AHRF), which are commonly used to identify county-level socioeconomic, demographic, and health workforce characteristics. AHRF data were also used to identify PAs in each county. Because the HPSA designation only considers PCPs, to identify primary care NPs (PCNPs) we used methods previously developed, based on National Provider Identifier numbers from CMS.

 We calculated the county-level number of PCNPs and PAs per 1000 population and categorized them into the highest (ie, ≥ 75th percentile) and lowest (ie, < 25th percentile) supply density quartiles.

There were substantive regional variations in dual-eligible beneficiary density and in primary care workforce supply, as shown in the 

. Panel A shows that one-third (n = 271) of the 791 counties with the highest density of dual-eligible beneficiaries were designated as HPSAs and were more likely to be rural and located in the Southeast region of the country. Many of these counties were also encumbered by high poverty rates and a heavy burden of chronic conditions.

Panel B reveals that in nearly half (n = 128) of the 271 counties with both a high-density dual-eligible population and a PCP shortage, the density of PCNPs was the highest. That is, the distribution of PCNPs was within the highest quartile of the overall supply of PCNPs in the country. Conversely, in 52 of these counties, the number of PCNPs per 1000 population ranked in the lowest quartile. The majority of counties with high-density dual-eligible beneficiaries and PCP shortages also ranked in the bottom quartile of the PA supply (panel C).

Although we found that the highest supply of PCNPs was located in many counties with a high concentration of dual-eligible beneficiaries along with PCP shortages, we also found counties in the same regions with the lowest supply of PCNPs and the lowest supply of PAs. Panel D shows that 23 (8%) of high-density dual-eligible counties with HPSA designations ranked in the lowest quartile for both PCNPs and PAs. These counties had very high poverty rates, 14 were rural, and most were in Southeastern states, including Texas, Louisiana, Alabama, Georgia, and South Carolina. These counties are essentially “primary care deserts”—they had the highest density of dual-eligible beneficiaries and the fewest primary care clinicians of any type.

Finally, in the face of the competing challenge of the coronavirus disease 2019 (COVID-19) pandemic, we observed the prevalence of infection rates in counties with a high density of dual-eligible beneficiaries to understand the challenge of coordinating care for these beneficiaries. Using cumulative, total confirmed COVID-19 cases reported in each county,

 we found that 11 of these primary care desert counties also ranked in the top quartile of COVID-19 cases per capita within their states. Although there have been issues regarding test accuracy for confirming COVID-19 infections, results of serologic surveys have shown that confirmed cases represent a significant undercount of actual infection rates.

We also found that areas with shortages of primary care clinicians were those where there were high concentrations of poverty at the county level (data not shown). These findings align with those of other investigators who have reported that low-income populations in the Southern and South Central areas of the United States experience access barriers and worse health outcomes compared with similar low-income individuals in other regions.

Improving the care for dual-eligible beneficiaries through integrated care delivery models is a vital policy initiative. Although CMS urges states to adopt these new models, primary care workforce shortages in the United States will likely hamper the effectiveness of these initiatives and limit their ability to expand their scale. Federal, state, and local stakeholders need to develop systematic approaches that address barriers that restrict provider roles in caring for patients in need.

For decades, the federal government has relied on programs to try to increase the number of PCPs in underserved areas, such as loan payment programs, recruiting rural students to become physicians,

 or giving bonus payments to PCPs for services delivered in HPSAs. The Affordable Care Act also implemented primary care incentive programs for both PCPs and nonphysician primary care providers. However, dual-eligible beneficiaries and others in underserved areas continue to have inadequate access to care.

The disproportionate impact of the pandemic further reinforces the need for integrated care delivery and financing between Medicare and Medicaid, particularly in areas where the dual-eligible population is concentrated. Notably, in response to the COVID-19 pandemic, CMS has temporarily eased supervision restrictions on NPs and promoted telemedicine to reduce care access barriers faced by vulnerable populations.

The quality of care provided to vulnerable populations, such as dual-eligible beneficiaries, by PCNPs and PAs has been proved to be comparable with that delivered by PCPs.

 However, at the state level, scope-of-practice regulations often restrain the flexibility of having care furnished by nonphysician providers. All PAs are required to practice in collaboration with a physician,

 and as shown by our results, the density of PA supply highly overlaps with the density of PCP supply. This limits their capability to fill gaps in areas with a shortage of PCPs.

Our study reveals that some regions of the United States need to improve the distribution of the primary care workforce to serve dual-eligible beneficiaries and to provide adequate care. We found that most of these areas were in Southeastern states, which impose the most restrictive scope-of-practice regulations that limit the capacity of NPs. Such restrictions may also increase NPs’ reluctance to locate in these states. Thus, a first step to expand access to care is to lessen the state-imposed restrictions on scope of practice for NPs.

Amid the COVID-19 pandemic, Florida, Tennessee, Kentucky, Louisiana, New Jersey, New York, Wisconsin, and West Virginia all lifted the restrictions on NPs’ scope of practice. However, because most of these regulatory changes are temporary, in response to the pandemic, a more permanent broadening of licensure scope is required. NPs are unlikely to relocate to these regions unless the easing of restrictions is more enduring.

At the local level, we observed that some counties were able to recruit NPs to practice locations where PCP shortages existed with a high concentration of dual-eligible beneficiaries. Although other counties were not able to successfully recruit NPs, they were frequently in the same states as counties that did, even in states with restrictive scope-of-practice laws. This finding suggests that there may be local leaders in some health systems who have surmounted constraining barriers, such as scope-of-practice restrictions, to successfully recruit PCNPs to fulfill a primary care need. It would therefore be helpful to reach out to these health care system leaders to understand how they addressed this issue.

Local stakeholders in states with large dually eligible populations should take advantage of the resources available for expanding access to primary care. Successful approaches at local levels in other parts of the state may be available. In 2017, the National Academy of Medicine published “Vital Directions for Health and Health Care,” which is a framework for better health and well-being, high-value health care, and strong science and technology to help guide policy makers to improve health care in the United States.

 Using this framework, North Carolina health care leaders recently convened a symposium to examine actions needed to achieve more affordable quality care and to assess the state’s capacity to improve care.

 Other states or local leaders can use this framework to guide reforms to augment the primary care workforce and deal with workforce challenges with vulnerable populations, such as dual-eligible beneficiaries.

The current pause in nonurgent health services due to the pandemic is having more devastating economic effects on rural clinics and hospitals,particularly in the Southeast. These are places that have already experienced a serious loss of physicians and hospitals, even before the COVID-19 crisis.

 Further, many primary care practices are having financial difficulties because the pandemic has created a barrier to non–COVID-19 office visits. Many have furloughed health care workers because the loss in practice volumes has created unanticipated financial strain. Disrupted and delayed routine care for dual-eligible beneficiaries, most of whom have chronic conditions, will likely result in relapses of conditions and/or exacerbations after relapse. The pandemic reinforces the need to grow the primary care workforce in the Southeastern region to address the pent-up service demand that awaits the resumption of normal care patterns. Because of the inelastic supply of PCPs, an expanded scope of practice may be an essential strategy to attract advanced nonphysician primary care providers, such as PCNPs, who can help coordinate the care for dual-eligible beneficiaries with costly chronic conditions.

This will likely disrupt the current ways of organizing, sustaining, and growing the workforce. Without policy changes to strengthen the primary care workforce, vulnerable populations like dual-eligible beneficiaries will continue to endure fragmented care in areas with preponderant primary care shortages.

Primary care workforce shortages will likely hamper the effectiveness of integrated delivery models for dual-eligible beneficiaries and limit the ability to expand policy scale. These shortages will be an enduring challenge in states without scope-of-practice law reforms. Dual-eligible beneficiaries’ inadequate access to primary care cannot be addressed without systematic state-level approaches. 


 Division of Health Services Management and Policy, College of Public Health (WYX, SMR), and Division of General Internal Medicine, College of Medicine (WYX, SMR), The Ohio State University, Columbus, OH; Center for Interdisciplinary Health Workforce Studies, College of Nursing, Montana State University (PB), Bozeman, MT.

 Dr Retchin discloses that he receives fees and equity for his service as a member of the Board of Directors for Aveanna Healthcare, a large pediatric and adult home health care company. He also notes his service as a Commissioner on the Medicaid and CHIP Payment and Access Commission, for which he receives per diem payments and expenses for attendance at commission meetings. The remaining authors report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

 Concept and design (WYX, SMR, PB); acquisition of data (WYX); analysis and interpretation of data (WYX, SMR, PB); drafting of the manuscript (WYX, SMR, PB); critical revision of the manuscript for important intellectual content (WYX, SMR, PB); and statistical analysis (WYX, SMR).

 Wendy Y. Xu, PhD, The Ohio State University, 208 Cunz Hall, 1841 Neil Ave, Columbus, OH 43210. Email: xu.1636@osu.edu.

1. Feng Z, Vadnais A, Vreeland E, Haber S, Wiener J, Baker B. Analysis of pathways to dual eligible status: final report. Office of the Assistant Secretary for Planning and Evaluation. May 9, 2019. Accessed November 20, 2020. https://aspe.hhs.gov/basic-report/analysis-pathways-dual-eligible-status-final-report

2. Auerbach DI, Buerhaus PI, Staiger DO. Implications of the rapid growth of the nurse practitioner workforce in the US. 

. 2020;39(2):273-279. doi:10.1377/hlthaff.2019.00686

3. MMCO statistical & analytic reports. CMS. Accessed November 20, 2020. https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/Analytics.html

4. Xue Y, Smith JA, Spetz J. Primary care nurse practitioners and physicians in low-income and rural areas, 2010-2016. 

. 2019;321(1):102-105. doi:10.1001/jama.2018.17944

5. Iglehart JK. The challenging quest to improve rural health care. 

. 2018;378(5):473-479. doi:10.1056/NEJMhpr1707176

6. County poverty rate for the United States: 2013-2017. United States Census Bureau. December 6, 2018. Accessed November 20, 2020. https://www.census.gov/library/visualizations/2018/comm/acs-5yr-poverty-all-counties.html

7. US coronavirus cases and deaths. USAFacts. Accessed May 15, 2020. https://usafacts.org/visualizations/coronavirus-covid-19-spread-map/

8. Commercial laboratory seroprevalence surveys. CDC. Accessed September 23, 2020. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/commercial-lab-surveys.html

9. Schoen C, Radley DC, Riley P, et al. Health care in the two Americas: findings from the scorecard on state health system performance for low-income populations. The Commonwealth Fund. September 18, 2013. Accessed August 22, 2019. https://www.commonwealthfund.org/publications/fund-reports/2013/sep/health-care-two-americas-findings-scorecard-state-health-system

10. Shipman SA, Wendling A, Jones KC, Kovar-Gough I, Orlowski JM, Phillips J. The decline in rural medical students: a growing gap in geographic diversity threatens the rural physician workforce. 

. 2019;38(2):2011-2018. doi:10.1377/hlthaff.2019.00924

11. DesRoches CM, Clarke S, Perloff J, O’Reilly-Jacob M, Buerhaus P. The quality of primary care provided by nurse practitioners to vulnerable Medicare beneficiaries. 

. 2017;65(6):679-688. doi:10.1016/j.outlook.2017.06.007

12. Morgan PA, Smith VA, Berkowitz TSZ, et al. Impact of physicians, nurse practitioners, and physician assistants on utilization and costs for complex patients. 

. 2019;38(6):1028-1036. doi:10.1377/hlthaff.2019.00014

13. Jackson GL, Smith VA, Edelman D, et al. Intermediate diabetes outcomes in patients managed by physicians, nurse practitioners, or physician assistants: a cohort study. 

. 2018;169(12):825-835. doi:10.7326/M17-1987

14. PA scope of practice laws. Barton Associates. Accessed September 20, 2020.
https://www.bartonassociates.com/locum-tenens-resources/pa-scope-of-practice-laws

15. Physician assistant scope of practice laws. Kaiser Family Foundation. July 24, 2015. Accessed September 15, 2020. https://www.kff.org/other/state-indicator/physician-assistant-scope-of-practice-laws/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D

16. Dzau VJ, McClellan MB, McGinnis JM, et al. Vital directions for health and health care: priorities from a National Academy of Medicine initiative. 

. 2017;317(14):1461-1470. doi:10.1001/jama.2017.1964

17. Fraher E, Balu R, Buerhaus P, George J, Murillo CL, Washington AE. Developing a workforce for health in North Carolina: planning for the future. 

. 2020;81(3):184-188. doi:10.18043/ncm.81.3.185

18. Cutler DM, Nikpay S, Huckman RS. The business of medicine in the era of COVID-19. 

. 2020;323(20):2003-2004. doi:10.1001/jama.2020.7242

19. Skinner L, Staiger DO, Auerbach DI, Buerhaus PI. Implications of an aging rural physician workforce. 

. 2019;381(4):299-301. doi:10.1056/NEJMp1900808

20. Fraher EP, Pittman P, Frogner B, et al. Ensuring and sustaining a pandemic workforce. 

. 2020;382(23):2181-2183. doi:10.1056/NEJMp2006376

States with the most restrictive scope-of-practice laws have an inadequate supply of primary care clinicians to serve a high concentration of dual-eligible beneficiaries.

Dual-Eligible Beneficiaries and Inadequate Access to Primary Care Providers

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Several factors will have a significant impact in the health care industry in 2021, such as management of disparities in vaccine administration, greater investment in telehealth, and potential mergers and acquisitions between hospitals, said Gurpreet Singh, MBA, US Health Services Leader at PwC.

: Hello, I'm Matthew Gavidia. Today on the MJH Life Sciences’ Medical World News, 

 is pleased to welcome Gurpreet Singh, US Health Services Leader at PricewaterhouseCoopers, or PwC. Great to have you on. Can you just introduce yourself and tell us a little bit about your work?

: Hi, Matthew, thanks for having me today. My name is Gurpreet Singh, a partner at PwC. I run our health services practice in the United States. I cover a lot of the issues that are occurring today and some of the investments that some of our health services, payers, providers, and pharma will be making in 2021. Happy to share some ideas today!


: Can you speak a little bit about PwC Health Research Institute’s (HRI) annual 

: Every year, PwC conducts a top issues for 

 report. The purpose of doing that is really just to stay ahead of the trends and the investments that are going to be made in the marketplace. This year is different, as you said, than most years. In past years, we've covered a lot of the strategic issues, some of which are actually relevant for today, like virtual care, telemedicine, digital therapeutics, even deals and activity with mergers and acquisitions. And actually, many of those issues we'll talk about today are relevant for today's market.

One difference I would say is that a lot of the issues are much more acute, meaning to actually stay ahead of the demand flow, to stay ahead of the forecasting necessary for serving patients as we know we need to, some of the investments will need to be made a little more aggressively and more quickly. So, we'll talk a little bit about what some of those issues are.

: A takeaway from this year’s report was the reception to telehealth, which has emerged significantly to provide necessary care without the threat of infection. While more health care providers are using telehealth for primary care services, appointment issues have been reported by over 60% of minority groups during a telehealth visit, including Black and Latinx consumers.

Based on the report, how can telehealth be better optimized to address communities who may not be technologically proficient or have the necessary resources available?

: Telehealth and virtual care really expanded rapidly and very quickly over a short period of time. For many years, we had been hoping that there was a catalyst for virtual care, in many ways to actually create efficiency. And last year, we talked about convenience, access, and choice for consumers.


Now, with the pandemic, obviously, we've been forced into using new channels, and if I put a silver lining on 2020, and hopefully in 2021, there's now an opportunity to create a platform for virtual and telemedicine. Just some specific examples, in talking to one of the large national health care providers, they said in the month of February, they did 3000 virtual visits that month, prepandemic. In May, they did 270,000 virtual visits. So, that's an incredible growth from a demand standpoint, but as you would imagine, some of the growing pains of moving that quickly create some of the experience issues that you and I see as consumers.


Some of the things that we are starting to see are what I would consider to be consumer experience–oriented issues. As an example, when you go physically into a doctor's office, usually you're doing the appointment, and then when you check out, there's a formal process for checking out, there's a formal process for getting your labs or your next appointment. In the virtual setting, that workflow, that process, that experience that we had in the physical is not there in the virtual. And so what most health care providers and payers should be thinking about are, what are the tactics that you can put in place to actually create a unified experience that goes not just from start appointment to end appointment, but actually everything from when I start feeling sick and I need to make an appointment to the point at which I need to consider a follow-up.

Those are some of the things that we're starting to see. It's exacerbated, as we're also seeing with different demographics. What we see in 

, for example, is that some people don't have access to all the computing and smartphones, or what have you, that many of these platforms run on. And what we're finding is, it's important to really make the investment in those technologies and maybe even communicating and educating where the health care literacy isn't as good.

We found a little over 50% of technical issues occurring during the virtual visits, and we expect in 2021 a significant investment from third parties, from technology companies, and from payers and providers.


: What aspects of this year’s report should also be spotlighted as major issues to monitor in 2021?

: So, one of the things that we also conducted as part of the study is, we did a consumer survey as well on who is willing to take the vaccine. As we know, in 2021, we’ll spend much of the year vaccinating individuals and working through the population in the severity that we need to.

We did a study to look at who would be willing to take the vaccine in the first year, and found some pretty fascinating results, I would say. What we found is that most people are willing and prefer to actually get the vaccine in a physician's office. However, for Black and Latinx consumers, they had slightly less trust with physicians and the physician offices. In fact, 27% and 28%, respectively, Black and Latinx consumers, said they would go to a physician or physician office.

On the flip side, we're seeing a demographic and an age group shift in the 18-to-24 category, many of them want to go to urgent care clinics to actually get their vaccination, which may not be completely new or surprising. But when you look at now male vs female, we found that more men (73%) were willing to take the vaccine in the first year versus women (53%).


So, what does all that mean? Understanding your customer, understanding what their wants and needs are, and maybe even educating them through customer relationship management, through being more proactive, through targeting them with the channels that they would prefer is going to be really important in this upcoming year.

: Lastly, do you have any other concluding thoughts?

: Yeah, maybe one other thing that I would suggest, that is going to happen in 2021, is because of the profitability issues and because of the rapid change in 2020, we would expect to see portfolios adjusting as well. What I mean by that is, we've even started to see in 2020 some mergers and acquisitions between hospitals, maybe an academic medical center with a faith-based institution, to cover the community in a more equitable way, if you will.

We'll see some deal activity pretty significantly in the health care provider space, but we'll also see it in the payer space. I mentioned a little bit earlier that in order to understand that demand within the communities, it's really important to understand the workforce that you have.

One of the things that we found early in the pandemic is that there were hotspots. New York, for example, was a hotspot early in the pandemic, and there were some really great stories about other regions like Cleveland, Minneapolis, Minnesota, and Pittsburgh sending health care workers to New York to help solve for some of those capacity gaps, but now we're all in a hot spot, right? And so it's difficult to actually move resources from one region to another. So, what that means is you have to stay proactive with some of those activities, and being proactive means understanding the demand and understanding what's going to happen in 2021.


: To learn more, visit our website at AJMC.com. I’m Matthew Gavidia, thanks for joining us!

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Several factors will have a significant impact in the health care industry in 2021, such as management of disparities in vaccine administration and greater investment in telehealth, said Gurpreet Singh, MBA, US Health Services Leader at PwC.

Spotlighting Top Health Care Issues to Monitor in 2021

 since 2019 and has a BA in philosophy and journalism & professional writing from The College of New Jersey. 

Metabolic surgery is more effective than conventional medical therapy in the long-term control of type 2 

 of a 10-year follow-up study of a randomized controlled trial published in 

Bariatric surgery, or metabolic surgery, has long been considered a treatment option for improving short-term to mid-term symptoms of those with T2D. Several randomized controlled trials showed the surgery can lead to improved hyperglycemia, prolonged disease remission, reduced cardiometabolic risk, reduced hypertension, and lower incidence of 

However, “although observational studies of traditional bariatric surgery suggest that diabetes remission can persist long term, it is difficult to extrapolate these findings to the broader population of patients with T2D,” researchers wrote. 

As there are currently no data published beyond 5 years from randomized controlled trails on the efficacy of metabolic surgery for T2D, investigators aimed to report 10-year outcomes of patients with advanced T2D who underwent Roux-en-Y gastric bypass (RYGB) or biliopancreatic diversion (BPD) and compare them with patients who received medical therapy plus lifestyle interventions.

The open-label, single-center trial was conducted at a tertiary hospital in Rome, Italy. All participants were between ages 30 and 60, had a body mass index (BMI) of 35 kg/m

 or greater, a history of T2D lasting at least 5 years, and glycated hemoglobin (A1c) concentrations of 7% or higher. Individuals were randomly assigned (1:1:1) to either medical therapy, RYGB, or BPD by a computerized system.

Over the course of 10 years, medical therapy options were updated and included administration of various oral hyperglycemic agents, insulin, glucagon-like peptide 1 (GLP-1) analogues and sodium-glucose cotransporter-2 (SGLT-2) inhibitors. Patients in this arm also were managed by a team of diabetologists, dieticians, and nurses, advised to reduce overall energy and fat intake, and to increase physical activity.

All participants completed visits at baseline, at 1, 3, 6, 9, and 12 months, every 6 months until 60 months had passed, and every year thereafter. After 2 years, patients with poorly controlled diabetes who requested surgical treatment were permitted to cross over to the surgery group.

The study’s primary outcome was durability of diabetes remission at 10 years, defined as the combination of fasting plasma glucose less than 100 mg/dL and A1c less than 6.5% without continuous pharmacological therapy for at least 1 year.

A total of 60 patients were randomized to the 3 groups between April 30, 2009 and October 31, 2011; 57 completed the 10-year follow-up. Of the 40 patients who underwent surgery, 15 (37.5%) maintained remission after 10 years.

10-year remission rates in the intention to treat (ITT) population were 5.5% for medical therapy (95% CI, 1–25.7; 1 participant went into remission after crossover to surgery); 50% for BPD (95% CI, 29.9–70.1); and 25% for RYGB (95% CI, 11.2–46.9; 

20 (58.8%) of 34 participants who were observed to be in remission at 2 years had a relapse of hyperglycemia during the follow-up period (BPD 52.6% [95% CI, 31.7–72.7]; RYGB 66.7% [95% CI, 41.7–84.8])

All individuals with relapse maintained adequate glycemic control at 10 years, with mean A1c of 6.7% (0.2)

Median diabetes-free survival time was 5 years (95% CI, 4 to infinite value) in RYGB and 9 years (95% CI, 5 to infinite value) in BPD; a log-rank test (

= .25) indicated no difference between the 2 surgical groups

Participants in the RYGB and BPD groups had fewer diabetes-related complications than those in the medical therapy group (relative risk, 0.07; 95% CI, 0.01–0.48, for both comparisons)

Serious adverse events occurred more frequently among participants in the BPD group (odds ratio [OR] for BPD vs medical therapy 2.7; 95% CI, 1.3–5.6; OR for RYGB vs medical therapy, 0.7; 95% CI, 0.3–1.9

After 10 years, patients who underwent surgery exhibited significantly greater A1c percentage reduction from baseline than those in the medical arm, while target A1c of less than 7% was met in 87.5% of patients who underwent surgery and in none in the medical therapy group.

Patients who underwent surgery also had significantly lower body weight, BMI and waist circumference, and reduced diabetes-related complications and cardiovascular risk at 10 years. In addition, these patients exhibited better kidney function, quality of life, and reduced medication use compared with those who did not have surgery.

“The deterioration of glycemic control observed in the medical therapy group after 5 years, despite no substantial weight regain and increased use of effective modern drugs, is a reminder of the progressive nature of T2D and, by contrast, attests to the remarkable anti-diabetes potency of metabolic surgery,” researchers noted.

The American Diabetes Association defines a diabetes cure as persistent remission of hyperglycemia without need for any pharmacological therapy for more than 5 years. Therefore, “The findings from this study provide the most robust scientific evidence yet that full-blown T2D is a curable disease, not inevitably progressive and irreversible,” 

, MD, the chair of bariatric and metabolic surgery at King’s College London and senior study author. “In addition to representing a major advance in the treatment of diabetes, metabolic surgery is our best lead to the elusive cause of the disease.”

The study’s small sample size marks a limitation, in addition to the fact it was conducted at a single center. Data also show the risk of relapse appeared to be highest within the first 5 years after surgery but declined significantly thereafter. More data is needed to corroborate this finding and larger prospective observations are warranted to help define when or if surveillance frequency can be reduced post-surgery. 

As BPD and RYGB resulted in a reduction in long-term medication use, cardiovascular risk factors and diabetes-related complications, authors noted results support the notion metabolic surgery can be a cost-effective approach to treating T2D.

“Metabolic surgery is arguably the most effective available therapy for T2D and can be a life-saving option for many patients,” Rubino said. “It should be appropriately prioritized in times of pandemic and beyond."

Mingrone G, Panunzi S, De Gaetano A, et al. Metabolic surgery versus conventional medical therapy in patients with type 2 diabetes: 10-year follow-up of an open-label, single-centre, ransomised controlled trial. 

2021;397(10271):293-304. doi:10.1016/S0140-6736(20)32649-0

Metabolic surgery is more effective than conventional medical therapy in the long-term control of type 2 diabetes (T2D), according to results of a 10-year follow-up study of a randomized controlled trial published in The Lancet. 

Metabolic Surgery Superior to Drug Therapy at Controlling Type 2 Diabetes, Study Says

A recent comparative effectiveness study looked at secukinumab compared with ustekinumab for 

 by emulating a real-world clinical setting.

, found that secukinumab resulted in more patients achieving a Psoriasis Area and Severity Index (PASI) score of 2 or lower after 12 months of therapy compared with ustekinumab.

However, both drugs had lower treatment effectiveness in the simulated real-world clinical setting than in a trial setting, hinting that psoriasis therapies may be less effective than clinical trial data have shown.

The researchers conducted the comparative effectiveness study to overcome some of the limitations of randomized clinical trials (RCTs); they noted, for instance, that head-to-head studies comparing one drug to another are rare in the pharmaceutical industry. In addition, RCTs do not fully reflect real-world outcomes, and evidence of the comparative efficacy of nonbiologic systemic therapies is lacking.

In addition to comparing the 2 therapies, the researchers sought to test whether they could repeat the relative effectiveness estimate of the 

, a randomized clinical trial that compared secukinumab with ustekinumab for psoriasis. That trial found that secukinumab was superior to ustekinumab at week 16 at achieving PASI 90, along with attaining greater improvement in health-related quality of life.

The researchers emulated a trial using data from the 

British Association of Dermatologists Biologics and Immunomodulators Register

 (BADBIR) in an effort to provide treatment effect estimates. BADBIR is an observational, multicenter, longitudinal pharmacovigilance study in the United Kingdom and Ireland that is assessing the safety of biologic treatments for patients with moderate to severe psoriasis. The National Institute for Health and Clinical Excellence has recommended that all UK patients taking biologics for psoriasis join the registry.

The authors wrote that “a target trial emulation approach can provide robust estimates of relative effectiveness that can be used for clinical and regulatory decision-making.” Effectiveness, they wrote, is the performance of a therapy in a clinical setting, while efficacy is how a therapy performs in an ideal setting. Data such as the kind from this observational, emulated trial can help to quantify the gap between efficacy and effectiveness.

Participants had chronic plaque psoriasis, were 18 years or older, and had at least 1 record of a PASI score of 12 or higher before beginning secukinumab or ustekinumab.

The study was performed between November 2007 and August 2019. The primary outcomes were the risk ratio (RR) and the risk difference (RD) for achieving PASI of 2 or lower after 12 months of therapy for secukinumab compared with ustekinumab. The researchers used propensity score (PS) 1:1 matched analysis and inverse probability treatment weighted analysis to account for potential confounding between the 2 groups.

Only eligible participants with no missing baseline data for the potential confounders were included in the final analysis; if outcome data were missing, the outcome was imputed as a nonresponder after 12 months of treatment if the treatment ended before that time point (whether for ineffectiveness or for an adverse event). The outcome was credited as a responder if the treatment was discontinued after 12 months because of disease remission.

A total of 1231 patients were analyzed, with 917 receiving ustekinumab and 314 receiving secukinumab. In all analyses except under the nonresponder imputation method, secukinumab was superior to ustekinumab in the proportion of participants achieving a PASI of 2 or lower (PS-weighted complete case analysis: RR, 1.28; 95% CI, 1.06-1.55; RD, 11.9%; 95% CI, 1.6-22.1).

All analyses reached regulatory agreement in both PS-matching and PS-weighted analyses (except for nonresponder imputation) with the CLEAR RCT. The estimate of the superior effectiveness of secukinumab also met the estimate agreement with the CLEAR trial.

Taking the point estimate from the complete case analysis under PS weighting, the researchers found a 17.5% reduction for secukinumab and a 15.1% reduction for ustekinumab between efficacy and effectiveness using the 12-month end point, with secukinumab having statistically superior effectiveness compared with ustekinumab.

This study was the first to use a target trial approach in comparative effectiveness research of systemic therapies for psoriasis, the authors asserted.

You ZZN, Mason KJ, Hampton PJ, et al. Randomized trial replication using observational data for comparative effectiveness of secukinumab and ustekinumab in psoriasis: A study from the British Association of Dermatologists Biologics and Immunomodulators Register. 

2021;157(1):66-73. doi:10.1001/jamadermatol.2020.4202

The study sought to understand how psoriasis treatments perform in real-world settings.

Researchers Try to Replicate Secukinumab, Ustekinumab Study With Registry Data

Daratumumab, alone and in combination with a proteasome inhibitor and immunomodulation, represents an important addition to the armamentarium of care for improving patient outcomes, especially response rate and progression-free survival, noted Mark Wildgust, PhD, vice president of Global Medical Affairs/Oncology at Janssen.

Why have immunomodulatory drugs been so successful in relapsed/refractory multiple myeloma?

I think we've learned that immunomodulatory agents like lenalidomide [Revlimid] and pomalidomide have been quite effective. I think if you go back a couple of steps in terms of how we've got to where we are today, we saw thalidomide become a really important component of care. We're kind of moving then from that older chemotherapy-based regimen approach. You saw agents like thalidomide coming forward—brand new mechanism of action, modulating the microenvironment and seeing improvements. We then saw proteasome inhibitors [PIs] come forward, like Velcade. And then we saw them being used by themselves, then we saw them being used with IMiDs [immunomodulatory drugs].

And I think today what we see is that IMiDs are an important component of care. But 

 for a second, I think that if you look at the magnitude of benefit that we're adding when we're adding daratumumab to these regimens, it's really clear today that daratumumab is in itself a critical, essential agent in terms of improving outcomes for patients.

And so I think we're at a point now where we can build regimens, like daratumumab plus a PI plus an IMiD, and we can get these very, very high response rates, depth of response, and improvement in PFS [progression-free survival]. And I think building those regimens today is really important. But I think daratumumab is a key part of that, and an IMiD is a piece of that, whether it be thalidomide, Revlimid, or pomalidomide.

Daratumumab represents an important addition to the armamentarium of care for improving patient outcomes, said Mark Wildgust, PhD, vice president of Global Medical Affairs/Oncology at Janssen.

Dr Mark Wildgust: Daratumumab Critical to Improving Patient Response

Patients with narcolepsy type 1 (NT1) who worked or studied from home amid the coronavirus disease 2019 (COVID-19) pandemic exhibited an increase in nocturnal sleep time and reduced daytime sleepiness, according to study findings published in 

 examining the influence of the pandemic on patients from Brazil with NT1, it was reported that these populations presented with changes in bedtime and waking schedules. While no association was found between changes in place of work and narcolepsy symptoms, this change in sleeping schedules may have an extensive impact on the circadian rhythm of patients with NT1, which could then exacerbate adverse symptoms such as 

For the current study, researchers sought to further examine the role of changes brought by lockdown measures caused by COVID-19 in the working schedules of patients with NT1 from Italy, which presented with the most cases and deaths related to COVID-19 from February to March 2020 and was the first country to adopt lockdown measures in Europe.

Examining a patient cohort under stable long-term treatment (N = 50 patients; aged >18 years; 40% men), researchers performed routine follow-up visits via telephone from April 10 to May 15, 2020. Patients were divided into 3 groups:

those with unchanged working schedule (n = 20)

those forced to work/study at home (n = 22), and

“Current sleep–wake habit and symptom severity were compared with prelockdown assessment (6 months before) in the 3 patient groups,” added the study authors.


When comparing groups, patients with NT1 who had lost their occupation showed no significant differences compared with a prepandemic assessment. Conversely, those with unchanged schedules reported a significant increase in disturbed nocturnal sleep complaints ranging from 15% to 40%.


Patients with NT1 in the working/studying at home group showed a significant increase in reported nocturnal sleep time, from 7.9 to 8.3 hours, and frequency of daytime napping, from 27.3% prepandemic to 54.4% in the follow-up. These variables contributed to a significant decrease in daytime sleepiness intensity, as measured by the 

However, patients in the working/studying at home group showed a small but statistically significant increase in their body mass index, from 23.4 to 23.8. Patients in this group were also noted to be younger both at time of evaluation and at time of diagnosis, as well as more likely to be students.

Patients with narcolepsy type 1 who are working or studying from home amid the coronavirus disease 2019 pandemic exhibited an increase in nocturnal sleep time and reduced daytime sleepiness. These patients also presented with significant weight gain.