Renuka Tipirneni, MD, of the University of Michigan, was named the recipient of the 2020 Seema S. Sonnad Emerging Leader in Managed Care Research Award.

Congratulations to the 2020 Recipient of the Emerging Leader in Managed Care Research Award!

The Mediterranean diet, which is known to have health benefits, may help prevent rheumatoid arthritis in current or previous smoker.

Mediterranean Diet May Prevent RA in Current or Previous Smokers

Higher levels of the omega-3 fatty acid eicosapentaenoic acid (EPA) found in the blood appear to explain why icosapent ethyl drives down the risk of a cardiovascular (CV) event.

REDUCE-IT: Serum EPA Levels Hold Key to Vascepa's Dramatic CV Benefits

In addressing sleep-related challenges prior to and influenced by the coronavirus disease 2019 (COVID-19) pandemic, a study published today in 

 outlines factors that contribute to optimal 

The authors, from the University of Florida College of Medicine in Gainesville, sought to provide the latest research and guidelines to help parents in adjusting sleep schedules for their children, especially amid COVID-19 pandemic. As they note, the pandemic has significantly altered normal sleep patterns for children and teenagers.

Speaking on the importance of sleep, the researchers highlighted that if children and teenagers do not receive their recommended duration, they can be irritable and undergo behavioral changes, attention difficulties, and memory problems. According to a 

, these behavioral issues may impact their school performance, as well as their physical and mental health.

Based on recommendations from the American Academy of Sleep Medicine, sleep duration need varies among children and adolescents, by age:

For those aged 3 to 5 years, guidelines recommend 10 to 13 hours

To assess whether sleep may be impaired, the researchers say to look for signs, such as difficulty getting up in the morning, falling asleep during the day (outside the appropriate napping age), longer weekend sleep, yawning, or poor behavior.

If impaired, how can parents improve sleep hygiene for their children?

As a first step, the researchers say to establish a daily routine for all family members, with set times for waking up, meals, school or work, recreation, and bed. “School-aged children and adolescents can help create their schedules, but parents must provide healthy boundaries,” said the study authors.

Next, a consistent evening routine characterized by a regular bedtime was touted, as was avoiding caffeinated drinks and technology usage. In fact, the researchers say that electronic devices should be removed from the child’s room at night because of the blue light that stimulates wakefulness.

After-bedtime snacks and drinks were also noted to stimulate wakefulness. “Finally, keep sleep spaces dark and cool, but a night-light is OK," the authors said.

Depending on the severity of a child’s sleep hygiene, the researchers said that it may take a few weeks to gradually transition to earlier bed and rise times as it's easier to stay up later than to go to sleep earlier.

“Set [an] awake-time goal, and gradually move bedtime earlier by 10 minutes every 3 to 4 days. Once a child can fall asleep within 30 minutes of bedtime, move bedtime 10 minutes earlier the next night.”

As a child continues to adhere to new bedtime routines, the researchers say to move up wake time and to avoid napping if possible, with a limit of 20 minutes if needed.

Additional recommendations include using light-blocking shades to make the bedroom dark, using a fan or air conditioner to keep the bedroom cool, reading a calming story before bedtime, and if thirsty, drinking a small glass of water.

If these recommendations do not help to improve a child’s sleep-wake schedule or if behaviors such as snoring, gasping, kicking, or sleeping too much are observed, the researchers say that these could be signs of a different health issue.

“Adjusting sleep schedules can be challenging at first and will take time to implement,” they note. “Sleep is a critical part of health for children and adolescents, so make sleep a consistent priority and your child will benefit from this for years to come.”

Stern M, Wagner MH, Thompson LA. Current and COVID-19 challenges with childhood and adolescent sleep. 

. Published online September 28, 2020. doi:10.1001/jamapediatrics.2020.2784

Articles

In addressing sleep-related challenges prior to and influenced by the coronavirus disease 2019 pandemic, researchers outline factors that contribute to optimal sleep hygiene among children and adolescents.

What Can Improve Sleep Hygiene in Children, Adolescents? 

 based on sexual orientation in the United States.

Disparities in migraine prevalence based on race/ethnicity, sex, and socioeconomic status have previously been established. However, there is a lack of research on disparities based on sexual orientation, researchers said.

“Sexual minority groups (eg, lesbian, gay, bisexual, and other nonheterosexual people) may experience unique discrimination, stigma, and barriers to health care access, thus leading to disparities in physical and mental health,” authors wrote.

To better understand the relationship between sexual orientation and migraine, researchers analyzed data from Wave V of the National Longitudinal Study of Adolescent to Adult Health. The cross-sectional, nationally representative sample consisted of adults aged 31 to 42 and data analysis took place between May 2020 and June 2020.

The sample consisted of 9894 adults with a mean age of 37.33. Migraine was determined based on self-reported responses to an interview question consistent with the International Classification of Headache Disorders diagnostic criteria for migraine without aura: “Have you ever had five or more headaches that were at least four hours long; one-sided, pulsating, intense, or worsened by activity; and associated with nausea, vomiting, or sensitivity to light or sound?”

Participants were classified into 3 groups: exclusively heterosexual; mostly heterosexual but somewhat attracted to people of one’s own sex; or lesbian, gay, or bisexual.

Fifty-one percent (n = 5705) of the sample were women and the majority (n = 8426 [85.8%]) identified as exclusively heterosexual. Ten percent (n = 1062) identified as mostly heterosexual while 4.2% (n = 406) identified as lesbian, gay, or bisexual.

The prevalence of migraine was higher among individuals who reported being mostly heterosexual (n = 327 [30.3%]) and lesbian, gay, or bisexual (n  =  112 [30.7%]) compared with those who reported being exclusively heterosexual (n = 1631 [19.4%])

Compared with individuals who were exclusively heterosexual, those who were mostly heterosexual had higher odds of migraine in an unadjusted model (odds ratio [OR], 1.80 [95% CI, 1.49-2.18]; 

 < .001) and an adjusted model (adjusted OR, 1.35 [95% CI, 1.10-1.65]; 

Compared with individuals who were exclusively heterosexual, those who were lesbian, gay, or bisexual had higher odds of migraine in an unadjusted model (OR, 1.83 [95% CI, 1.36-2.46]; 

 < .001) and an adjusted model (adjusted OR, 1.58 [95% CI, 1.17-2.14]; 

Previous research has also shown a high prevalence of migraine and other physical health outcomes among adults in sexual minority groups in California, but the current study is the first to the authors’ knowledge to reveal theses disparities among a nationally representative sample.

Authors hypothesize the combination of prejudice, stigma, and discrimination, defined as sexual minority stress, may contribute to increased odds of experiencing migraine in this cohort. Members of sexual minority groups can also encounter barriers to health care and may experience greater mental and physical health problems compared with the general population.

Due to limited power, researchers were unable to analyze the association of migraine prevalence with specific sexual orientations (lesbian, gay, bisexual), marking a limitation to the study. Additional limitations include self-reported measures and inability to differentiate sexual identity from behavior.

“Clinicians and researchers should be aware of health disparities in migraine, including sexual orientation, in addition to biological and behavioral risk factors,” authors concluded.

Nagata JM, Ganson KT, Tabler J, Blashill AJ, Murray SB. Disparities across sexual orientation in migraine among US adults. 

. Published online September 28, 2020. doi:10.1001/jamaneurol.2020.3406

New research published in JAMA Neurology highlights disparities in migraine based on sexual orientation in the United States. 

Study Examines Relationship Between Sexual Orientation, Migraine Prevalence 

There is a clear need for better therapies to treat triple-negative breast cancer, says Aditya Bardia, 

 breast medical oncologist at Massachusetts General Hospital, Harvard Medical School, when discussing the results of the phase 3 

 that he presented at this year’s virtual European Society for Medical Oncology (ESMO) conference.

What study and data did you present at ESMO?

On behalf of the coauthors, I presented the results of the ASCENT trial, a randomized phase 3 study of sacituzumab govitecan vs treatment of physician’s choice for patients with previously treated metastatic triple-negative breast cancer.

As a background, triple-negative breast cancer represents the aggressive form of breast cancer. It tends to affect young women, African Americans, and clinically is an unmet need. The response rate to standard chemotherapy is in the range of 5% to 10% and median progression-free survival around 2 months. So there’s a need for better therapies.

We’ve been involved with the development of an agent called sacituzumab govitecan, which is a novel antibody-drug conjugate. It targets TROP2, which is overexpressed in a majority of triple-negative breast cancers. The antibody against TROP2, it has a hydrolyzable linker, and the payload linked to the antibody is SN-38, the active metabolite of irinotecan.

So this antibody-drug conjugate has 3 unique properties. The first is that it’s highly specific for TROP2; it’s a first-in-class TROP2 antibody-drug conjugate. Second, it has a high drug to antibody ratio; on average, 7.6 SN-38 molecules per antibody. And third, hydrolysis of the linker allows SN-38 release extracellularly, resulting in bystander effect. Thus, it can affect cells that have low expression of TROP2 or even no expression of TROP2 because of this bystander [effect].

[In] the phase 1/phase 2 trial, a response rate of 33% was seen with this agent, which resulted in accelerated approval earlier this year by the FDA. So, the ASCENT trial was the confirmatory phase 3 trial with this agent comparing sacituzumab govitecan vs treatment of physician’s choice, and the primary end point of the study was progression-free survival.

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There is a clear need for better therapies to treat triple-negative breast cancer, especially when progression-free survival is around 2%, says Aditya Bardia, MBBS, MPH, breast medical oncologist at Massachusetts General Hospital, Harvard Medical School.

Dr Aditya Bardia Discusses the Advantages of Sacituzumab Govitecan for Triple-Negative Breast Cancer

Despite progress on cancer treatments, patients with cancer are 

 in care, incidence of disease, and outcomes. During a panel discussion at Patient-Centered Oncology Care®, moderated by meeting Co-Chair Joseph Alvarnas, MD, vice president of government affairs, senior medical director for employer strategy, and clinical professor, City of Hope, and editor-in-chief, 

, speakers highlighted injustices in the US health care system, the risk of financial toxicity, and how providers can do a better job to ensure their patients achieve health equity.

Karen Winkfield, MD, PhD, incoming executive director, Meharry-Vanderbilt Alliance, and Emeline Aviki, MD, MBA, assistant attending, Department of Surgery, Memorial Sloan Kettering Cancer Center (MSK), both explained they were first exposed to disparities as medical students at Duke University and then again when they both started working in Boston.

Medical students often went into rural communities or Black communities to try and improve access to care, but Boston had universal health care coverage before the Affordable Care Act, and it was there that the stark differences of access to care despite insurance coverage became apparent, Winkfield explained.

“It started me on this pathway to understand what some of the other barriers were,” she said. “What are some of the issues that patients are experiencing with respect to their access to care, their inability, perhaps, to access care?”

Winkfield ended up changing career paths from biochemistry to focus on community engagement research, which she viewed as the place to find pertinent information that would “revolutionize” how health care engaged with communities.

Aviki had a slightly different path. During medical school, she also got her MBA, and through her research on alternative payment models and value-based care, she came to realize that the payment models focused on the finances for payers and providers but “left the patients out of the whole equation.” She began to do work on financial toxicity, which describes the financial burden from direct and indirect health care costs on patients that can increase psychosocial distress and adversely affect patient outcomes and quality of life.

At MSK, Aviki is on an affordability task force that attempts to not only improve awareness of patients who might be at risk of financial toxicity but also to “educate providers and patients with respect to early signs of toxicity and how we can empower providers to attack that toxicity before it ever occurs.”

But how exactly do providers help enact change in the system? According to Jeanne Regnante, chief health equity and diversity officer, LUNGevity Foundation, health systems, providers, and other organizations need to start learning from one another and doing a better job of asking questions.

“I think the work in this area requires humbleness, in general, and it requires somebody to always be aware that they might not know something and ask the question,” Regnante explained.

Engaging with vulnerable communities means understanding that you haven’t lived their life and you don’t understand the challenges they are faced with. LUNGevity recently went through its first phase of implicit bias training, during which the staff brought awareness to one’s own assumptions.

Winkfield agreed that humility is necessary in this area of work and when it comes to addressing and understanding how someone’s culture fits into their health and health care.

“I do not believe in cultural competency,” she said. It implies that someone can watch a video and understand someone’s culture. “No, it’s really about humility.”

This humility applies to culture, finances, and even sexual identity. Instead of asking a woman about her husband, clinicians should ask more generally who lives at home with her.

“It's the questions that you ask that can show people that you're open to someone having a lifestyle that's different from, you know, the ‘mainstream,’” Winkfield explained.’’

Medical schools have to do a better job of training people to ask the questions. Ask a person what their diet is instead of assuming the Black patient eats fried chicken and collard greens, she said.

One conversation that is difficult for providers to have is the cost of care. MSK surveyed its clinicians, and of the 350 who responded, 95% said they want to help patients with their financial issues during treatment. But the same proportion said they felt ill equipped to ask the question because they didn’t know what to do with the answer they got, said Aviki.

The taboo of asking financial questions needs to be eliminated entirely, she said. Patients need to feel like they can report financial issues, and physicians should feel like they can ask patients about financial issues. However, Aviki thinks simply making it routine to ask every patient at every visit can help normalize the conversation around finances to make patients feel more comfortable about bringing up issues on their own.

“We are willing to pay tens of thousands of dollars a month for a 3-month progression-free survival difference,” she pointed out. “Well, we can gain that and more by addressing patients’ financial issues and social determinants, as well.”

Ultimately, it will cost more money to put in place the processes and hire new people and analyze the data to be able to address disparities, Regnante admitted. But spending that money will mean making more resources available and ensuring that innovations get to all patients. Winkfield added that the cost is up front, but in reality, the US health care system loses billions of dollars every year because of health disparities. Investing the money now will mean setting up patient navigation, doing financial toxicity screens, and putting patients in touch with needed resources.

“Please take the time to get to know the person in front of you, and figure out what their needs are,” Winkfield implored the audience. “We may not always be able to meet every single one of their needs, but just by asking, we will help to engender the trust that is vital to make sure our patients feel well cared for.”

Speakers at Patient-Centered Oncology Care® highlighted injustices in the US health care system, the risk of financial toxicity, and how providers can do a better job to ensure their patients achieve health equity, during a panel discussion.

Addressing Cancer Disparities Requires Asking Questions and Putting Aside Assumptions

Recently, 2 separate district courts secured a pair of victories for Medicare beneficiaries who use continuous glucose monitor (CGM) technologies to manage their 

, while bipartisan legislation aimed at increasing access to the Medicare Diabetes Prevention program (MDPP) was introduced by Senators Tim Scott, R-South Carolina, and Mark Warner, D-Virginia.

In recent years, CGM systems have become popular among patients with diabetes as a way to quickly and accurately monitor their blood glucose levels, and in early September, Abbott’s FreeStlye Libre 2 

 system became available to Medicare patients who meet certain eligibility coverage criteria. However, the coronavirus disease 2019 (COVID-19) pandemic has further emphasized the importance and potential of remote diabetes management.

On September 23, the second Circuit Court of Appeals ruled that Medicare beneficiaries can combine claims denied by Medicare to meet the dollar amount necessary for judicial review, according to a press release from Parrish Law Offices.

, was brought by a Medicare beneficiary (Jonathan Bloom) who used a CGM device to manage type 1 diabetes (T1D) and sought coverage to offset the CGM costs. However, Bloom was denied coverage by the Medicare Appeals Council and subsequently challenged the decision.

The Third District Court ruled that Medicare must cover CGMs, but ruled 2 of the 3 challenged decisions did not meet the $1500 amount-in-controversy threshold for federal court jurisdiction. The court also held the Medicare Act did not permit Bloom to cure the jurisdictional deficiency by aggregating the 3 amounts.

However, “the Second Circuit held, based on the text of the statute and reinforced by its regulatory and legislative history, that the Medicare Act does not prohibit plaintiff from aggregating his claims for the first time in district court,” according to 

. The findings ultimately allowed for recovery on all 3 claims.

, the district court for the Northern District of California found Medicare’s claim that CGMs are not “primarily and customarily used to serve a medical purpose” unreasonable and not entitled to deference. The District Court ordered coverage of CGM claims and reflects the Fourth District Court’s ruling that Medicare’s position is contrary to law.

Although these rulings mark a step in the right direction for patients, Medicare beneficiaries still face significant hurdles securing access to CGM technology, Parrish Law Offices states, as Medicare and Medicare Advantage plans continue to deny coverage of some CGMs. A class action lawsuit is currently filed in the District of Columbia seeking coverage as far back as 2012 for beneficiaries whose CGM claims were denied.

In addition to CGM technologies, virtual diabetes management programs have gained traction in recent years. In 2017, the digital health provider 

 won full CDC recognition for mobile and online applications of the Diabetes Prevention Program (DPP). The program was the first virtual provider to achieve this status and was first offered to Medicare beneficiaries in 2018 as part of the Medicare DPP (MDPP).

“Noom’s virtual DPP program delivers the same positive outcomes as in-person MDPP programs and has the added benefit of being accessible anywhere and at any time, as part of our mission to help more people lead healthier lives,” said Noom cofounder and CEO Saeju Jeong.

 (S 4709) aims to increase access to the 

 by allowing CDC virtual suppliers, like Noom, to participate in the program.

“To ensure that all individuals have the tools needed to combat this preventable disease, the PREVENT DIABETES Act would help expand access to virtual classes under the existing Medicare Diabetes Prevention Program,” Warner said.

Specifically, the MDPP Extended Model leverages evidence-based interventions to prevent onset of type 2 diabetes (T2D) in at-risk Medicare beneficiaries, but it is currently only available through in-person sessions. By expanding virtual access to the model, individuals in rural or medically underserved areas will be able to participate in the program.

“This commonsense and cost-saving expansion will ensure that more Americans at-risk of developing diabetes who are living in either rural or medically underserved communities, can participate in this critical program that has been proven to delay the full onset of this preventable disease,” Warner continued.

In the wake of COVID-19, HHS has temporarily allowed beneficiaries to access the program via a virtual platform, but bill authors argue that the change still excludes a number of providers and does not ensure long-term access to a virtual benefit.

“The introduction of the PREVENT Diabetes Act is a positive first step toward ensuring all seniors are able to access this critical preventive service through the Medicare DPP Expanded Model. We urge Congress to expeditiously advance this bill as part of its digital health care agenda,” Jeong said.

The bill received support from the American Diabetes Association, the American Medical Association, and the National Kidney Foundation, among others.

Recently, 2 district courts secured a pair of victories for Medicare beneficiaries who use continuous glucose monitor technologies to manage their diabetes, while senators introduced bipartisan legislation aimed at increasing access to the Medicare Diabetes Prevention Program. 

Progress Made in Diabetes Technology Coverage, Access Among Medicare Beneficiaries  

Experts Skeptical of Executive Order on Preexisting Conditions

This past Thursday, President Donald Trump signed an executive order that he says would provide health coverage to Americans with preexisting conditions regardless of one’s health history, sparking skepticism among health law and health policy experts on how the order would be enforced. According to 

, experts point to the lack of technical content appearing in the text of the executive order, which does not in itself guarantee protections provided to those with preexisting conditions in the Affordable Care Act.

Study Finds No COVID-19 Complications in Infants of Laboring Mothers

Pregnant patients with coronavirus disease 2019 (COVID-19) giving birth from March 25 to July 24 found no significant differences in outcomes in newborns compared with those negative for the virus, but a higher likelihood of labor complications was noted, according to a Swedish study p

 reported that laboring women positive for COVID-19 were indicated as more likely to experience 

, a serious labor complication linked with high blood pressure and protein in the urine.

 found that 4 states, Wisconsin, Oregon, Minnesota, and Utah, have all hit records for single-day increases in the number of COVID-19 infections, r

. According to findings, Wisconsin was shown to have the largest number of new infections out of the 4 states this past Friday, totaling to 2629. This comes as Wisconsin Governor Tony Evers declared a new public health emergency last Tuesday and extended the state’s mandatory mask mandate.

Experts are skeptical of an executive order on preexisting conditions; study finds no differences in outcomes for newborns of women with coronavirus disease 2019 (COVID-19); COVID-19 cases on the rise in 4 states.

What We're Reading: Preexisting Condition Mandate; Giving Birth Amid Pandemic; Rising COVID-19 Cases

Coronavirus disease 2019 (COVID-19) is a pandemic disease that has had a major impact on the world health care system and has brought catastrophic damage to the world and seriously affected normal life. Although the incidence of COVID-19 has slowed in China, new COVID-19 cases have been reported in hospitals there. China gradually realized that hospitals with concentrated personnel may become a potential danger area for new outbreaks because outpatient hemodialysis patients can go back and forth between the hospital and their own residences every day. They may become the group who will be most easily infected with severe acute respiratory syndrome coronavirus 2, the virus that causes COVID-19. We introduce a mobile phone app that may effectively prevent and manage COVID-19 in outpatient hemodialysis patients in Sichuan Province.

Coronavirus disease 2019 (COVID-19) is a pandemic disease that has had a major impact on the world health care system.

 As of June 1, 2020, 6,096,628 confirmed cases and 369,456 deaths have been reported worldwide. The pandemic has wreaked catastrophic damage internationally and has seriously affected the normal lives of people everywhere.

The incidence of COVID-19, which has had a great impact on China, especially its tourism and catering industries, has slowed in China, where most new cases are in foreign patients and there are no more than 100 cases. However, COVID-19 cases have recently been reported in hospitals in many cities of Heilongjiang Province. Authorities gradually realized that hospitals may become a potential danger area for new outbreaks. Health administration departments all over China have imposed stricter control requirements on hospitals, including nucleic acid testing for newly admitted patients and those who accompany them, temperature testing, and epidemiological history registration for all outpatients.

However, outpatient hemodialysis patients may become the group who will be most easily infected with severe acute respiratory syndrome coronavirus 2, the virus that causes COVID-19.

 Unlike inpatients, who can be controlled in closed management, outpatient hemodialysis patients can go back and forth between the hospital and their own residences every day. Additionally, they differ from sporadic outpatients in that outpatients on hemodialysis will go to the hospital very frequently and gather together for a long time (4 hours or longer). It is very easy for a COVID-19 outbreak to occur among outpatient hemodialysis patients.

 Then, once patients are infected, it is hard to find an alternate place where so many hemodialysis patients can be properly arranged for dialysis treatment. Therefore, methods to carry out effective prevention and control of COVID-19 for outpatients on hemodialysis are worth exploring. Here, we introduce a mobile phone app, Sichuan Health Pass, which is widely used in Sichuan Province, China.

This app can be embedded in WeChat, the most widely used social platform software in China (

]). After clicking this app in WeChat to register with one’s real name, it is automatically filled in with all information on the registrant’s identification card and their mobile phone contact information. After logging into the app, a health QR code is displayed, which refreshes dynamically every day (

). When the registrant enters the hospital or high-risk gathering area, the security personnel require the registrant to show their health QR code before being allowed inside.

Normally, the QR code is green, indicating that the registrant has minimal risk of COVID-19 epidemiology. Once the registrant has contact with suspected or infected patients with the virus or has recently visited the COVID-19 epidemic area, the health administration department will automatically report the registrant’s identification number to the software, and the registrant’s health QR code will turn orange. Once the registrant receives a diagnosis of suspected or confirmed COVID-19, the health QR code will turn red. An orange or red QR code will cause the registrant to be unable to enter the controlled area or be forced to isolate.

A nurse is on duty at the door of the hemodialysis center. Each patient who comes to the hemodialysis center is required to have their temperature checked and show their health QR code. If it is green, they can be treated normally. Patients with an orange code will be moved to the corner of the last shift of dialysis treatment; at the same time, the patient is required to take protective measures, such as wearing a mask, and nurses will take 3-tier prevention measures to treat all patients. If the code is red, they will be refused entry and asked to go to the designated hospital for isolation dialysis treatment.

Nearly 40,000 outpatients are receiving hemodialysis in Sichuan Province, China. After the application of this mobile phone software for COVID-19 prevention and control, the vast majority of hospitals reported that the screening work intensity and the pressure of prevention and control were greatly reduced. It is no longer necessary to fill in the form of epidemiological inquiry for dialysis patients every day, and it is no longer a concern that patients may hide possible epidemiological contacts. The operation of the whole hemodialysis center has gradually recovered to a calmer state. Most importantly, since the mobile phone software has been put into use, no new event of aggregated infection among outpatients with hemodialysis in Sichuan Province has occurred.

We will continue to discuss and analyze the role of the Health Pass program for early warning of COVID-19 in the future.

Yaqin Du and Jin Feng contributed equally to this work and are listed as co–first authors.

 Department of Nephrology (YD, YL, DH, QH, GL, LW, FD) and Department of Traditional Chinese Medicine (JF), Sichuan Provincial People’s Hospital, University of Electronic Science and Technology of China,Chengdu, China; Sichuan Center for Disease Control and Prevention (JD), Chengdu, China; Hemodialysis Center, Sichuan Center for Disease Control and Prevention (YX), Chengdu, China; Department of Nephrology, Chengdu Jinniu District People’s Hospital, Sichuan Provincial People’s Hospital, Jinniu Hospital (YD, FD), Chengdu, China.

 This work was supported by Sichuan Science and Technology Program (2019YFH0069), Sichuan Provincial People’s Hospital Clinical Research and Transformation Fund (2018LY12), and Primary Health Development Research Center of Sichuan Province Program (swfz18-Z-6).

 The 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 (YD, JF, FD); drafting of the manuscript (YD); critical revision of the manuscript for important intellectual content (JF, FD); provision of patients or study materials (JD, YL, YX, DH, QH, GL, LW); obtaining funding (FD); administrative, technical, or logistic support (JF, JD, YL, YX, DH, QH, GL, LW, FD); and supervision (YD, JF, JD, YL, YX, DH, QH, GL, LW, FD).

 Fei Deng, MS, Department of Nephrology, Sichuan Provincial People’s Hospital, University of Electronic Science and Technology of China, Chengdu, 610072, China. Email: dengfei@med.uestc.edu.cn.

1. Alberici F, Delbarba E, Manenti C, et al; Brescia Renal COVID Task Force. Management of patients on dialysis and with kidney transplantation during SARS-CoV-2 (COVID-19) pandemic in Brescia, Italy. 

. 2020;5(5):580-585. doi:10.1016/j.ekir.2020.04.001

2. Tu H, Tu S, Gao S, Shao A, Sheng J. Current epidemiological and clinical features of COVID-19; a global perspective from China.

. 2020;81(1):1-9. doi:10.1016/j.jinf.2020.04.011

3. Rombolà G, Brunini F. COVID-19 and dialysis: why we should be worried.

. 2020;33(3) 401-403. doi:10.1007/s40620-020-00737-w

4. Brioni E, Leopaldi D, Magnaghi C, et al. Covid-19 in patients on dialysis: infection prevention and control strategies. Article in Italian. 

The authors introduce a mobile phone app that may effectively prevent and manage coronavirus disease 2019 (COVID-19) in outpatient hemodialysis patients in Sichuan Province, China.

Effective Prevention and Management of COVID-19 in Outpatient Hemodialysis Patients

Nothing about taking care of patients with cancer during the coronavirus disease 2019 (COVID-19) pandemic has been easy, but those practices that had already embraced transformation under the Oncology Care Model (OCM) are finding that its monthly payments and other features offer stability during an unprecedented health emergency.

That’s what Alexandra Chong, PhD, lead for the OCM within the Center for Medicare and Medicaid Innovation (CMMI), told the hundreds of online attendees Friday as she kicked off the 9th annual meeting of Patient-Centered Oncology Care®, the marquee annual event presented by 

“We are living in a totally different world,” said event co-chair Kashyap Patel, MD, who is CEO of Carolina Blood and Cancer Care Associates of Rock Hill, South Carolina, as he introduced Chong. “What we are learning is how COVID-19 impacts not just us as what we do in the office, but how it impacts the rapid adaptation and changes from the payer perspective.”

Chong spent much of her talk walking attendees through the fine points of the OCM, which had been poised to transition toward Oncology Care First (OCF), a next-generation model built on a bundled-payment framework instead of fee-for-service (FFS). As Chong explained, due to COVID-19, the OCM was extended another year through 2022, and CMMI has not yet fleshed out the details of OCF.

OCM is “an episode-based model,” Chong said, one that attaches 2 reimbursement elements to each practice’s commitment to reach certain financial and quality benchmarks while meeting practice standards that include having 24/7 access to medical records and developing care and survivorship plans with patient input. Although the number of practices in the OCM is 138, the number of physicians involved exceeds 7000, and the model now reaches 150,000 Medicare patients each year, or about a quarter of all FFS beneficiaries.

Practices in the OCM receive $168 per patient per month in Monthly Enhanced Oncology Services (MEOS) for delivering this higher-level care, as well as Performance-based Payments (PP) which come after each 6-month evaluation period ends. As Chong explained, the work practices undertook to redesign their practices for the “high touch” requirements of the OCM was not easy—and a learning process for both sides. But it’s paying dividends now. Practices that rely on administering expensive therapies—and having new patients walk through the door—have seen revenue plummet as people skip cancer screenings. But those in the OCM have had some lifelines.

“We decided to retain the billing and keeping up those MEOS payments, because we have heard across all of our practices, or majority of our practices, that a lot of the infrastructure that was put into place for the implementation of OCM, has really helped our practices in terms of still achieving or still have focusing their care on their beneficiaries,” Chong said.

To be sure, the OCM is not perfect, and Chong said CMMI has heard the message from participating physicians that it must rethink reporting requirements and turn around performance data in a time frame that lets practices fix problems quickly. Because of COVID-19, CMMI has made some data reporting requirements optional during the Public Health Emergency, including aggregate quality measure reporting and beneficiary-level clinical and staging data reporting.

“A majority of our practices still reported on this data, even though it was optional,” Chong said.

Before COVID-19 hit, she said, the OCM was gaining momentum as it headed into its final year. A third of the practices in the model had agreed to take on 2-sided risk or “some type of downside risk,” she said.

By embracing the tools that make the OCM work, Chong said, “Participants have been able to not lose that momentum in providing the high quality care that they committed to their beneficiaries.”

Later Friday, Patel led a panel discussion on shifting from the OCM to the OCF, which featured Aaron Lyss, MBA, director of Strategic Payor Relations, OneOncology; Terrill Jordan, president and CEO, Regional Cancer Care Associates; Mariam Alboustani, manager, Pharmacy Services, Blue Cross Blue Shield of Michigan; and Randall Oyer, MD, of Lancaster Cancer Center/Penn Medicine.

Early in the day, Patel likened the OCM to “an architect’s blueprint” of how cancer care should work, one that participants have put time and resources to build. He launched the panel discussion by asking what the OCF should look like when it’s fully presented. Jordan said that the ground has shifted with COVID-19 and CMMI must acknowledge that population that comes through the door post-pandemic will be different. “We will have to think about that, and challenge CMS/CMMI to take that into account appropriately,” he said.

CMMI had a brief stakeholders’ meeting November 4, 2019 to discuss its OCF outline, Patel said, but there’s been little information since that time. Oyer said the concerns among practices remain: physicians worry about improving outcomes, decreasing administrative burden, and maintaining revenue. “We are also concerned about what our patients are facing, making access available to people across our entire community, providing quality outcomes and patient experience. And then we're all concerned about our organizations—we work in these organizations.”

With financial stability at the practice level, he said, it’s hard to deliver good care and be a community resource. Doing things the right way depends on having resources to build a good team, Oyer said. “One of the really good things that came out of OCM for us was that everybody on the team understood their value.

Like Jordan, Oyer values transparency. “”People see a line of sight between what they do in their daily practice and what results they want to accomplish.”

Lyss said achieving buy-in throughout an organization was important for success in the OCM and will be even more so in the OCF. The challenges ahead only become achievable, he said, “through a culture throughout the organization that is committed to value. And that is committed to evolve, adapting to change.

Practice transformation, he said, “is going to take time. It's going to be really hard, there are no shortcuts.”

Alboustani said her payer is working with practices on the data sharing challenges of the OCM, but that success in shifting to value-based care isn’t just about an individual model—it’s about recognizing that value-based care isn’t going away. “It’s not a phase. It’s probably going to become the norm down the line—and we all have to collaborate. We all have.to work better into making this efficient for everyone for the patient, for the plan and for the provider.”

As practice transformation evolves, Jordan said so must the concept of shared savings. Practices cannot keep squeezing savings out the practice of oncology—and it’s a reason why some have left the OCM even as they embrace its transformation principles. “The idea that you're essentially judged against or measured against your own historic performance. I think it's a real problem,” he said. “You should get measured against the market that you're in. The variability in those markets is significant.”

For a practice that started out in the COME HOME Project, a precursor to OCM, “You've already taken a lot of the actions that were necessary to reduce costs. And so your baseline is lower. It completely undercuts your efforts. … In terms of where we're going, I think, I think we're probably headed toward capitation. That's what it looks like, in some form.”

CMMI's Alexandra Chong, PhD, discusses COVID-19 related flexibilities under the Oncology Care Model, and a panel discusses its successor.

Infrastructure of OCM Helps Practices Through COVID-19, Chong Says

Precision medicine has brought about new treatment paradigms for patients with 

 (MM), but a subset of patients are high-risk and will not achieve the maximum benefit while suffering high levels of toxicity.

, is that scientists do not yet have a reliable method of identifying which patients are suitable for the most effective treatments and which are not.

As more and more people live longer, cancer among the elderly is expected to be a significant public health burden. Higher rates of MM is one likely outcome, as two-thirds of patients with the cancer are aged 70 or older at diagnosis.

While novel biologic agents have led to better overall survival in patients with MM, older and unfit patients deemed ineligible for stem cell transplantation have not benefited from these novel agents to the same extent.

“These patients do not have a greater incidence of molecularly high-risk disease and so these differences are likely to be accounted for by differences in patient physiology, increased treatment-related toxicity limiting delivery of effective therapy and less effective, rigorous anti-myeloma treatment being given (undertreatment),” wrote corresponding author Gordon Cook, PhD, of Leeds University, and colleagues.

With such a disparity of outcomes, it has become critically important to correctly categorize patients so that those who can tolerate the optimal therapy are given it, and those too frail can be given less-toxic personalized treatments. The problem is that it can be difficult to accurately identify which patient belongs in which category.

Life expectancy can vary significantly among older patients with MM, suggesting that chronological age alone is not a sufficient indicator to categorize a patient as highly vulnerable.

a significant number of patients are being classified as as transplant non-eligible (TNE) based largely on their age, even though they could in fact tolerate therapy.

Cook and colleagues wrote that the solution is to develop better ways to assess physiological age in patients with MM, as well as their ability to deal with the burden of MM and therapy for MM.

The authors said the International Myeloma Working Group’s (IMWG) frailty scoring system remains the standard approach. However, they said the system needs to be refined, including with prospective testing of potential biomarkers of frailty. The idea of using biomarkers to assess frailty and vulnerability in a cancer setting is still new, but Cook and colleagues believe it has strong potential. In their report, they argued systematic testing of such biomarkers is needed, so that eventually biomarkers can be recommended not only as prognostic tools, but also as predictive tools.

Cook and colleagues said the United Kingdom’s Myeloma Research Alliance (UKMRA) has developed a 

 in which patients will be randomized to a treatment-adaptive arm, in which dose reductions will be based on IMWG frailty scores, and compared to a treatment-reactive arm, where therapeutic modifications will be based on toxicity and tolerance. They hope the study will help develop a biological scoring tool to predict tolerance. The study began enrolling patients in March.

“Hopefully we are approaching a time where such measurements, once validated prospectively, will be used to direct safe, effective and personalized treatment,” they concluded.

Cook G, Larocca A, Facon T, Zweegman S, Engelhardt M. Defining the vulnerable patient with myeloma-a frailty position paper of the European Myeloma Network. 

. 2020;34(9):2285-2294. doi:10.1038/s41375-020-0918-6

A subset of patients with multiple myeloma (MM) are not eligible for the most effective therapies, but a new study suggests clinicians may be inaccurately defining that subset.

Frailty Definitions Too Imprecise in Patients With MM, New Paper Suggests

 recaps the top managed care news of the week.



This week, the top managed care news included a Supreme Court vacancy that could shape the fate of the Affordable Care Act; the pandemic’s effects on access to care; a look at the opportunities presented by the virtual format of Patient-Centered Oncology Care® 2020.

Listen above or through one of these podcast services:

Read more about the stories in this podcast:

How a Supreme Court Vacancy Can Shape the Fate of the ACA, Reproductive Rights

Access to Parkinson Disease Medication Affected in Low-Income Countries

ACR Survey Reveals Patients Struggle to Maintain Access to Care During COVID-19 Pandemic

FDA Accepts Anti-BCMA Ide-cel for MM for Priority Review

Incorporating Value Into Physician Payment and Patient Cost Sharing

Podcasts

Every week, The American Journal of Managed Care® recaps the top managed care news of the week, and you can now listen to it on our podcast, Managed Care Cast.