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 Key to Vascepa's CV Benefits

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

Spotlight on CAR T-Cell Therapy

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

New Members for AJAC Board

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

In order to minimize patients’ and providers’ risks of contracting COVID-19, ophthalmologic practices implemented a series of precautions at the onset of the pandemic. These included deferral or delay in routine visits, elective surgical procedures, and screening consultations.

As a part of these guidelines, the American Academy of Ophthalmology (AAO) also released a compilation of urgent and emergent procedures deemed to be appropriate to carry out during the pandemic’s initial phases while also deferring elective and routine care. However, the effects these changes on patients’ 

To analyze the extent of changes in the frequency of urgent or emergent vitreoretinal surgical procedures across multiple centers during an expanded time frame, researchers compiled billing data from January 2019 through May 2020 from 17 US institutions representing 15 states.

, show that early in the COVID-19 pandemic, there was a nationwide decrease in critical vitreoretinal surgical procedures deemed as urgent or emergent.

As part of the cross-sectional study, the researchers categorized institutions into regional groups (Northeast, South, Midwest, and West Coast) while publicly available records were used to determine when stay-at-home orders were initiated. Using 

 codes, the investigators identified incidents of urgent or emergent vitreoretinal surgical procedures via the deidentified data. Codes were then classified as intravitreal injections, lasers and cryotherapy, retinal detachment (RD) repairs, and other vitrectomies.

A total of 17 (12 academic [tax-exempt] and 5 private [non–tax-exempt]) institutions accounting for 526,536 billed operations and procedures were included in the final analysis. Of the codes included, 483,313 accounted for injections; 19,257 for lasers or cryotherapy; 14,949 for RD repairs; and 9017 for other vitrectomies.

According to authors, “relative to 2019, a weekly institutional decrease in injections was observed from March 30 to May 2, 2020, with a maximal 38.6% decrease (from a mean [SD] of 437.8 [436.3] to 273.8 [269.0] injections) from April 6 to 12, 2020 (95% CI, −259 to −69 injections; 

In addition, weekly decreases were identified that spanned a longer interval, at least until May 31, 2020:

For lasers and cryotherapy, with a maximal 79.6% decrease (from a mean [SD] of 6.6 [7.7] to 1.5 [2.0] procedures) from April 6 to 12, 2020 (95% CI, −6.8 to −3.3 procedures; 

For RD repairs, with a maximal 59.4% decrease (from a mean [SD] of 3.5 [4.0] to 1.6 [2.2] repairs) from April 13 to 19, 2020 (95% CI, −2.7 to −1.4 repairs; 

For other vitrectomies, with a maximal 84.3% decrease (from a mean [SD] of 3.0 [3.1] to 0.4 [0.8] other vitrectomies) from April 6 to 12, 2020 (95% CI, −3.3 to −1.8 other vitrectomies; 

The researchers found no differences after adjusting for region, setting, or state-level stay-at-home orders. Results show that during the initial exponential growth phase of the COVID-19 pandemic in the United States, there was a widespread reduction in urgent ophthalmic procedures.

“Although it is unknown to what extent vitreoretinal intervention would have decreased without AAO recommendations, this change suggests that ophthalmologists were engrossed in a transformation that may continue to affect a large subset of US retina practices and their patients,” the authors wrote. As the pandemic persists, this number may remain low due to office-level precautions.

Notably, the significant decrease in the frequency of intravitreal injections observed in April 2020 did not persist into the later weeks of May 2020, as declines were continuously observed in other groups during this time frame. This may be due to the fact that patients receiving intravitreal injections were more diligent about maintaining their treatment schedule to preserve their vision. However, health system factors, socioeconomic factors, and other variables may account for this observation.

The limited time frame included in this study marks a limitation, in addition to the exclusion of some 

“It remains unclear what the ultimate long-term effects will be from the decrease in urgent or emergent surgical procedures across the US, and whether the decrease will be sustained during the COVID-19 resurgences,” the researchers concluded. “Future investigation will be required to assess the full duration of this decrease and the long-term visual impact. Research is currently ongoing to assess this end point.”

Breazzano MP, Nair AA, Arevalo JF, et al. Frequency of urgent or emergent vitreoretinal surgical procedures in the United States during the COVID-19 pandemic

. Published online March 4, 2021. doi:10.1001/jamaophthalmol.2021.0036

Articles

Early in the COVID-19 pandemic, there was a nationwide decrease in critical vitreoretinal surgical procedures deemed as urgent or emergent, according to findings published in JAMA Ophthalmology. 



Early Months of Pandemic Saw Decreased Rates of Vitreoretinal Surgical Procedures

's parent company, MJH Life Sciences, since 2011. She has an MA in business and economic reporting from New York University.

Individuals who are fully vaccinated against COVID-19 will be able to meet in small, private gatherings with other vaccinated individuals or low-risk individuals who are unvaccinated without masking or social distancing, according to the CDC.

 long-awaited guidelines for fully vaccinated people with the caveat that the guidance is not final and will be updated based on the level of community spread and the proportion of the population that is fully vaccinated. In addition, the CDC is still recommending that fully vaccinated individuals continue to wear masks in public, maintain distance, and follow other public health measures.

The CDC considers an individual fully vaccinated after they have received the second dose of the 2-dose vaccines from Pfizer/BioNTech or Moderna or at least 2 weeks after receiving Johnson & Johnson’s single-dose vaccine.

The guidance comes shortly after some states have announced they are lifting mask mandates and ready to fully reopen. On March 2, Governor Greg Abbott 

 that he was lifting Texas’ mask mandate and opening businesses and facilities to 100% capacity. 

 that Massachusetts is allowing restaurants to operate without limits, Mississippi ended its mask mandate, and South Carolina removed limits on large gatherings.

In a news conference with the White House COVID-19 Team, CDC Director Rochelle P. Walensky, MD, MPH, noted that 59 million individuals in the United States have received at least 1 dose of a vaccine and 31 million individuals are fully vaccinated.

“We’ve been through a lot this past year, and with more and more people getting vaccinated each day, we are starting to turn a corner,” she said. “And as more Americans are vaccinated, a growing body of evidence now tells us that there are some activities that fully vaccinated people can resume at low risk to themselves.”

Clinical trial data has shown that COVID-19 vaccines are highly effective at protecting vaccinated individuals against severe illness, hospitalization, and death, but there remains a small risk that they can become infected with a mild disease or be asymptomatic and potentially transmit the disease to unvaccinated individuals, Walensky said. As the science of COVID-19 evolves, the recommendations will be updated.

“Importantly, our guidance must balance the risk to people who have been fully vaccinated, the risk to those who have not yet received a vaccine, and the impact on the larger community transmission of COVID-19,” she said.

The guidance focuses on activities that fully vaccinated individuals can resume in a private setting. Fully vaccinated individuals can visit in small gatherings indoors, in a private setting without masks or distancing. The scenario becomes a little more complicated if vaccinated people are meeting with unvaccinated people.

In a scenario where fully vaccinated people are visiting one household of unvaccinated people, people do not need to wear masks or distance as long as they, and members of their household, are not considered high risk for COVID-19. If the fully vaccinated people are visiting a household with anyone who is considered high risk, everyone, “regardless of vaccination status,” should wear a mask and distance, as well as meet either outdoors or in a well-ventilated place. Walensky reminded that anyone over the age of 65 and people with underlying conditions such as cancer, heart disease, or diabetes are at higher risk of severe disease.

In situations where fully vaccinated people are meeting with unvaccinated people from multiple households, everyone should wear a mask, distance, and meet outdoors.

The CDC also provided guidance on quarantining. People who are fully vaccinated will no longer need to quarantine or get tested if they are asymptomatic after they are exposed to someone with COVID-19.

In addition, the CDC is continuing to recommend that everyone, whether or not they are vaccinated, avoid medium and large gatherings and wear a mask, distance, and follow other public health measures when in public spaces.

Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, also spoke and provided an update on the future of investigational direct-acting antivirals against SARS-CoV-2, highlighting how the process is akin to the successful development of antiviral drugs for HIV.

The replication cycles of SARS-CoV-2 and HIV are similar, he said. As with the HIV replication cycle, creating targeting therapeutics to fight the virus that causes COVID-19 will involve identifying vulnerable targets in the SARS-CoV-2 replication cycle and then designing the drugs to block those targets and prevent the individual virions from releasing.

In HIV, he noted, this research, targeting fusion and entry inhibitors, reverse transcriptase inhibitors, integrase inhibitors, and protease inhibitors, paved the way for drug classes that led to “an extraordinary number of drugs which when used in combinations has transformed the life of HIV-infected individuals giving them an almost normal lifespan, although the drug needs to be given, essentially, for the rest of their lives.”

The replication cycle of SARS-CoV-2 is similar, with viral entry and viral release; Fauci said that areas of current development in investigational direct-acting antivirals include entry inhibitors, polymerase inhibitors, and protease inhibitors, ranging from the preclinical stage to phase 2a.

There is 1 polymerase inhibitor approved, remdesivir from Gilead Sciences. Another candidate, molnupiravir from Ridgeback Biotherapeutics and Merck, showed a faster decrease in time to negativity of infectious virus in symptomatic patients, 

Despite the positive news, officials continued to urge caution, given that there are still about 60,000 new cases a day in the United States and most of the country remains unvaccinated.  The CDC did not update its travel guidance and continues to recommend that everyone avoid nonessential travel.

This is “a first step, not our final destination,” Walensky noted, adding that CDC will update these guidelines as more people are vaccinated and as understanding of vaccination immunity evolves.

“COVID-19 continues to exact a tremendous toll on our nation,” she said. “Like you, I want to be able to return to everyday activities and engage with our friends, families, and communities.”

In a briefing, the White House COVID-19 Team discussed the first guidance from the CDC on activities that individuals fully vaccinated against COVID-19 can safely resume, and Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, gave an update on antiretroviral drug development.

CDC Provides First Guidance on Safe Activities for Fully Vaccinated Individuals

This past Saturday, the Senate passed the $1.9 trillion coronavirus relief package, sending it back to the House of Representatives for final approval, which is expected by Tuesday. Reported by 

, the bill is expected to be signed into law by President Joe Biden prior to the March 14 deadline, when enhanced federal unemployment benefits are set to expire. In addition to 

direct payments of $1400 to most Americans

, the bill would provide a $300 weekly increase to jobless benefits into September and an expansion of the child tax credit for 1 year.

FDA to Address Toxic Heavy Metals in Baby Food

, the FDA plans to investigate reports of toxic heavy metals commonly found in baby food. Spotlighted by a 

 released last month by the House Oversight subcommittee, findings indicated that major baby food companies were selling products that their own internal testing showed contained arsenic, lead, and cadmium at levels that health experts would consider unsafe for infants. As the FDA begins their investigation, the agency told baby food makers they are expected to actively reduce heavy metal levels in their products flagged by internal food safety controls.

FDA Issues EUA for Novel Test to Detect Past COVID-19 Infection

 an emergency authorization for a first-of-its-kind-test developed by Seattle-based Adaptive Biotechnologies that leverages machine learning to detect past COVID-19 infections. Unlike prior tests that assessed levels of coronavirus antibodies, the T-Detect COVID test looks for evidence of past infection in the body’s adaptive immune system, particularly T cells, that function by helping the body remember past viruses.

The House of Representatives is expected to grant final approval to the COVID-19 relief bill by Tuesday; FDA probes major baby food companies selling products containing unsafe levels of toxic heavy metals; FDA issues emergency authorization for novel test to detect past COVID-19 infection. 

What We're Reading: COVID-19 Relief Bill Updates; FDA Probes Toxic Metals in Baby Food; Novel Test Approved to Detect Past Infection

Robin Gelburd, JD, is the President of FAIR Health, a national, independent nonprofit organization with the mission of bringing transparency to healthcare costs and health insurance information. FAIR Health possesses the nation’s largest collection of private healthcare claims data, which includes over 31 billion claim records contributed by payers and administrators who insure or process claims for private insurance plans covering more than 150 million individuals. Certified by CMS as a national Qualified Entity, FAIR Health also receives data representing the experience of all individuals enrolled in traditional Medicare Parts A, B and D; FAIR Health houses data on Medicare Advantage enrollees in its private claims data repository. Gelburd is a nationally recognized expert on healthcare policy, data and transparency.

Telehealth claim lines increased 2,817 percent nationally from December 2019 to December 2020, rising from 0.22 percent of medical claim lines in December 2019 to 6.51 percent in December 2020, according to new data from FAIR Health’s 

 (Exhibit 1). From month to month, the telehealth share of medical claim lines rose 8.3 percent nationally, from 6.01 percent in November 2020 to 6.51 percent in December 2020. The data represent the privately insured population, excluding Medicare and Medicaid. With the addition of December, the Telehealth Tracker now has a complete 12 months of data for 2020 as compared to 2019.

Exhibit 1. Monthly Telehealth Regional Tracker, December 2020, United States

Trends in the four US census regions (Midwest, Northeast, South and West) were similar to those in the nation as a whole. In each region, there were large percent increases in volume of telehealth claim lines from December 2019 to December 2020; smaller increases occurred from November to December 2020 in every region but the Midwest, where the volume of claim lines dropped 0.3 percent.

Higher telehealth utilization from March to December 2020 in comparison with the same months in 2019 was likely a result of the COVID-19 pandemic, as patients and providers turned to telehealth as a way of reducing the risk of disease transmission associated with in-person visits.

Other notable findings of the December Monthly Telehealth Regional Tracker concern the top five telehealth diagnoses by volume. In December 2020, COVID-19, for the first time, became one of the top five telehealth diagnoses nationally and in every region. Its prominence may reflect the surging number of COVID-19 cases and relatively fewer telehealth visits for other conditions, such as the flu, cases of which have been 

From November to December 2020, mental health conditions continued to be the number one telehealth diagnosis nationally and in every region. Exposure to communicable diseases continued to be number two on the national list of telehealth diagnoses and to appear in the top five in all regions. Exposure to communicable diseases was likely related to the pandemic, as patients contacted providers via telehealth out of concern they had been exposed to COVID-19.

Also notable was the lack of change in the top five procedure codes by utilization. There were no changes nationally or by region from November to December 2020 in the top five procedure codes, even though there had been changes in at least some regions in previous months. This suggests that the telehealth procedures being performed might have stabilized by December.

About the Monthly Telehealth Regional Tracker

Launched in May as a free service, the Monthly Telehealth Regional Tracker uses FAIR Health data to track how telehealth is evolving from month to month. An interactive map of the four US census regions allows the user to view an infographic on telehealth in a specific month in the nation as a whole or in individual regions. In addition to data on the volume of claim lines, diagnoses and procedure codes, each infographic includes findings on urban versus rural usage.

FAIR Health’s Monthly Telehealth Regional Tracker now provides a complete picture of the year 2020 in comparison to 2019. As the COVID-19 pandemic persists, we will continue to monitor how the pandemic affects the evolution of telehealth.

For the Monthly Telehealth Regional Tracker, click 

, a national, independent nonprofit organization with the mission of bringing transparency to healthcare costs and health insurance information. FAIR Health possesses the nation’s largest collection of private healthcare claims data, which includes over 32 billion claim records and is growing at a rate of over 2 billion claim records a year. Certified by the Centers for Medicare & Medicaid Services (CMS) as a national Qualified Entity, FAIR Health also receives data representing the experience of all individuals enrolled in traditional Medicare Parts A, B and D; FAIR Health includes among the private claims data in its database, data on Medicare Advantage enrollees. Ms. Gelburd is a nationally recognized expert on healthcare policy, data and transparency.

Robin Gelburd, JD, president of FAIR Health, discusses the dramatic increase in telehealth claims throughout 2020.

Telehealth Claim Lines Increase 2817 Percent From December 2019 to December 2020

Clinical pathways in cancer care are beyond the “new” phase, but oncology practices and health systems are still learning all the ways they can bring greater standardization to care, eliminate unnecessary care, improve data collection, and drive value.

 the administrative director for Oncology Research and Innovation at 

eisinger Cancer Institute, shared during a session of the virtual meeting of the Association of Community Cancer Centers, held March 1-5, 2021.

Geisinger implemented Elsevier’s ClinicalPath in medical and radiation oncology in April 2019, starting with a “soft demo” and a weeklong training process. The pathways product was rolled out at all sites a month later. The health system decided to integrate ClinicalPath into its Epic electronic health record (EHR) management system, because incorporation into the workflow was seen as critical to getting physicians to adopt pathways.

Pharmacists oversaw a process in which the pathway regimen library was “harmonized” with Epic, to systematically update new workflows in hematology and oncology. This was a key process, because Geisinger actively takes part in clinical trials.

“Accruing to clinical trials is an important part of what we do, and we know that it means a great deal that our clinicians have clinical trial information at that decision-making point,”

Wojtowicz said. To have all options available when clinicians were talking to patients, “we wanted to implement across all these specialties, and we wanted to do it as rapidly as possible.”

“A lot of the credit goes to the team that really made that happen,” he said.

body was at the starting line, the tool was actually launched; it just wasn't promoted to the broad practice that it was live and accessible.”

During this period, the physician champions worked with the pathways to achieve buy in among the others—and allow time for tweaks and integrating with other workflows. And then a month later, it was time to flip the switch. Over a week, the pathways team met with clinicians and let them try the pathways system to give them opportunities for training and practice.

Wojtowicz shared a decision tree slide that showed each step, starting with whether a diagnosis was or was not on a pathway. The mapping system was critical, he said.

We know that clinical pathways oftentimes will not cover every single scenario that's out there, or every decision that an oncologist needs to make. So, you have to be able to map that out—what’s that pathway look like? Or, what do those workflows look like when it's a non-pathway related decision versus pathway related.”

This “visualization” process allowed the team, and by extension, physicians, the chance to think through what the workflow would look like and helped with implementation.

Integrating workflows in medical oncology with the EHR definitely presented some challenges, but physicians were determined to have one way to interact with the system. In the beginning, extra information had to be tailored and removed. “And that did require that [for] some regimens they had to differentiate, and we had to build new ones. But I think that was a worthwhile exercise, because everyone required consensus, discussion, and agreement around that direction.”

The final step was to ensure that the pathways were multidisciplinary—that physicians could work with a system that would allow transparency between medical and radiation oncology so that treatment options could be presented together to patients. “What worked for us was that the system allowed for this transfer of data,” so if a decision was made in medical oncology, it was shared with radiation oncology.

“That was a huge thing as far as workflow goes, because we really had to be prepared to have not only the individual clinician be able to handle the workflow, but then you kind of get to that next level where its, “How about the multidisciplinary workflow?’” he said. “You’ve got to make it simpler for those things to happen.”

Going forward, the next step is to make use of new data on the pathway system that allows artificial intelligence to use predictive analytics to inform decision makers in the practice.

“It doesn’t really stop there,” he said. More value will come from investments health systems are making in predictive analytics.

“We started bringing our clinical pathways decision data to the discrete elements that come out of that decision, we started bringing that into data tables, and linking it back with our clinical information to gain better insights about when decisions were made, and what's happening after that.” This allows clinicians to decide what care plans should look like and how much monitoring should occur.

Geisinger also opted to include prognostic questions. Tough as it is, physicians are asked if they would be surprised if the patient were to die in the next year. The answer helps drive more palliative care referrals.

The health system is cognizant that it is asking doctors to take time to gather data, to add clicks to their day, Wojtowicz said. Adoption rates have been good, and the process continues to improve.

From the health system’s perspective, “they’re extracting data in discrete fashion, and merging it back with some of our clinical data to make the most out of it.”

An administrator in the Geisinger Cancer Institute discusses the rollout of ClinicalPath. 

Geisinger’s “Soft Demo” Proves Key for a Successful Clinical Pathways Rollout

Although federal guidelines recommend patients with 

 have regular physical activity, actual exercise rates lag. Survey results presented recently at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2021 Annual Meeting found that most specialists were not aware of these physical recommendations, however, suggesting a possible role for them to play.

The researchers sent a 15-item survey to 979 randomly selected AAAAI members to ask about their self-reported awareness of physical activity recommendations and their current clinical practices. Respondents were asked to rate their knowledge about a variety of topics related to asthma and physical activity on a scale of 1 to 5 (1 = no knowledge, 5 = very knowledgeable).

The overall survey response rate was small (9.3%); of those who did answer, the majority were allergists or immunologists with an average of 18.1 years in independent practice.

Of those who responded, 80% of participants were not aware of specific physical activity guidelines for patients with asthma, while 66% said they were aware that moderate exercise has shown improved outcomes for these patients.

The survey also revealed the 3 main barriers to more direct involvement for providers to counsel their patients with asthma about exercise: limited time to discuss, lack of knowledge about how and when to refer patients, and the need to prioritize other health behaviors.

The survey asked about existing knowledge gaps that needed to be filled in order to provide assistance to their patients. Most were unsure about how much they knew about how to refer patients to a supervised exercise program, which patients to refer, or how to counsel patients. Some respondents reported having no knowledge about any of those considerations.

97% agreed that patients with asthma should exercise, while 84% agreed when asked if patients with severe asthma should exercise

90% support the idea of incorporating exercise counseling into practice, while only 69% actually did so

62% indicated they were knowledgeable about when to counsel patients on exercise

53% said they knew how to encourage patients to participate in exercise

Most agreed that there are 5 ways to facilitate this kind of knowledge to their patients, including patient handouts, posters in the waiting room, exercise referral forms, practitioner education, or emailed information to providers.

Nyenhuis SM, Gregory KL, Kahwash BM, Sharp LK. Asthma care provider perspectives on exercise promotion in people with asthma: An examination of knowledge, practices, barriers, and facilitators. Presented at the American Academy of Allergy, Asthma & Immunology 2021 Annual Meeting, February 26-March 1, 2021; Poster 127.

Asthma and immunology specialists responding to a survey about physical activity for patients with asthma were mostly unaware of any guidelines but seemed willing to learn more about how to incorporate them into practice.

Encouraging Patients With Asthma to Exercise Easier Said Than Done, Survey Finds 

Karen Kobelski is the Vice President and General Manager of Clinical Surveillance, Compliance & Data Solutions at Wolters Kluwer. She brings more than 25 years of experience to her position, which expands her previous leadership role over the Safety & Surveillance group to also include the Health Language portfolio of data normalization solutions.

CMS has made clear its intent to provide patients access to their health information in a user-friendly format, when and where they need it. The 

Interoperability and Patient Access final rule

 applies to CMS-regulated health plans, and the agency fully expects health plans to be ready for enforcement starting on July 1, 2021. That means there are just a few months left to prepare.

CMS further communicated their intent to advance the cause of interoperability when they released the 

Reducing Provider and Patient Burden Proposed Rule

 in December of last year. This rule would require automation of pre-certification activities using fast health care interoperability resources 

The federal push to liberate patient data requires a lot of work on the part of payers and their technology partners. In addition to modernizing legacy IT infrastructures, payers will need to be ready to shoulder the increasing burden of member transparency, and some payers are further along than others.

Plans should make no mistake that enforcement is coming and be prepared to do much more than check a box. Disparate and siloed data across health plan organizations will need to be completely transformed to achieve compliance but also to ensure sensitive patient information is protected and patients can understand the information being shared with them. Balancing compliance with patient comprehension and privacy is no small feat, but best practices are emerging.

CMS has identified FHIR as the key to unlocking valuable data for consumer and developer use and made clear its commitment to FHIR-based APIs in supporting the needs of patients and fueling innovation.

By July 1, payers must have in place a FHIR-based API that “allows patients to easily access their claims and encounter information, including cost, as well as a defined sub-set of their clinical information through third-party applications of their choice.” Further, as part of the 

, the ONC adopted the US Core Data for Interoperability standard for electronic health information to be accessed and shared using certified API technology. This standardized set comprises 16 data classes and 52 data elements.

Health plans will need to have robust data management and governance strategies in place. First, a single source of reverential data is required for the accurate exchange of information through FHIR APIs. Second, the ability to map non-standard data to the common health care terminologies that are identified in the FHIR implementation guides will become an essential component of their interoperability strategy. In short, a FHIR terminology service with advanced data mapping capabilities will prove to be a strategic advantage as health plans strive to capture maximum value from their data.

Certainly, the increased exchange of information will present new challenges to health data security and privacy. As health care organizations deploy the frameworks to support meaningful data sharing and greater care coordination across the continuum, one area that must not be overlooked is the compliant protection of sensitive health information. The mechanism for sharing data may be changing but the need to protect that data as it is exchanged remains the same.

Health plans may consider the use of sensitivity codes to help identify and filter sensitive diagnoses, procedures, labs and drugs across 6 key categories:

Sensitivity codes will require ongoing management and many payers are looking to experienced partners to fill that role.

Consumer-friendly descriptors for comprehension

Perhaps most important is acknowledging that for patients to act on their health data, they need to be able to understand it. The gap that exists between the language that clinicians and payers use and what patients understand is well known, but the Patient Access rule is forcing the issue to the fore.

The right strategy for effectively communicating with members and increasing transparency begins with terminology management that can generate consumer-friendly descriptions alongside industry codes within patient-facing documents. For instance, while a typical claim might designate a foodborne bacillus cereus intoxication, an accompanying consumer-friendly description would simply read food poisoning. These consumer-friendly descriptions may also be used in member portals, 

, and paper-based communications to truly engage patients.

By taking proactive steps to communicate with stakeholders—especially patients—payers can design and execute an implementation plan that not only satisfies the requirements of the Interoperability and Patient Access final rule but also moves the industry closer to the goal of putting patients truly at the center of health care.

In preparing for the upcoming implementation of the Interoperability and Patient Access final rule by CMS, best practices for health plans include prioritizing data mapping, sensitivity codes for privacy, and consumer-friendly language in accessible data for patients.

Contributor: How Balancing Compliance, Comprehension, and Privacy Can Optimize Access to Patient Data

The American system of insurance doesn’t work, because we give the best care at the lowest cost to the people who don't need it and the worst care at the highest cost to the people who do, noted Robert K. Massie, Jr, PhD, MA, of the Society for Progress. He was born with severe factor VIII hemophilia in August 1956 and contracted 

 in 1978, as well as hepatitis C, from contaminated blood products—and received care outside of the United States growing up, which he credits with saving his life.

Is insurance in the United States broken?

I mean, let me be really blunt about this. Most Americans do not realize how ridiculous we look to the rest of the world, which has solved the medical distribution problem going back to 1948.

I've traveled all over the world, and I just want to tell you: the absurdities, the bankruptcies, the failures, the poor medical outcomes that happen in the United States do not take place in most other countries. I've been treated in France, I've been treated in England, which people make fun of, and yet it's wonderful, wonderful care.

I, at one point in my career, toured and looked at the medical systems in Sweden and Denmark and Switzerland and Germany. Recently, I was in Italy. The Italian system is not perfect, but let me tell you something: no one in any of those countries ever, ever worries, are they going to get medical care. Just think about that. Whereas in the United States, medical costs are among the highest—in some cases, the highest—cause of medical bankruptcy and an untold number of horrible medical outcomes, and a huge amount of completely unnecessary stress in people's lives, as parents worry about their children or they’re seniors.

And the truth is, we've have more or less solved this if you happen to be 65. We have Medicare. I'm about to turn 65. But because of a really broken and perverse ideology in the United States, we are denying ourselves a system and a right that pretty much everybody else in the developed world has. And it's absolutely shocking.

I started working on this in the 70s. So here I am, I'm going on 45 years of looking at the question of national health insurance. And yet, as you might imagine, the system we have now, if you really think about it, the concept of insurance doesn't work here. Because insurance is based on the idea that we all get paid a little money but none of us knows who's gonna get their house burned down, for example. So we all pay a little fire insurance.

Modern medicine is about predicting accurately who's going to get which diseases. And as we become more and more genetically adept at figuring out who has a predisposition for a disease, then we can identify preexisting conditions before they exist. I mean, really preexisting, long before we actually even experienced them.

And so what do insurance companies do? They try and get rid of the people who need medical care, except for the fact that we now have Obamacare, which is still there, that prevents people from being kicked off.

To put as simply as possible: we give the best care at the lowest cost to the people who don't need it. And we give the worst care at the highest cost to the people who actually need medical care. And that's about as dumb as you can get, and yet that is an accurate description of the American system.

So yes, the outcomes would be dramatically better. We would be using preventive care rather than acute care, we would dramatically lower costs, and we would have much healthier people. But unfortunately, the American people do not realize what's happening in the rest of the country or have lost enough of their own sense of self-worth that they aren't willing to demand what virtually everybody else says because somehow we think it's impossible. That's sad. It's long overdue and needs to be changed.

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The American system of insurance doesn’t work, noted Robert K. Massie, Jr, PhD, MA, of the Society for Progress.

Dr Robert Massie: The Insurance System Needs Fixing in the United States

The FDA Friday approved axicabtagene ciloleucel (Yescarta) for the treatment of adult patients with relapsed or refractory follicular 

 following 2 or more lines of systemic therapy.

The decision was based on data from the phase 2 ZUMA-5 trial (NCT03105336), in which the chimeric antigen receptor (CAR) T-cell treatment elicited a response in 91% of patients with relapsed or refractory follicular lymphoma (n = 81); 74% of patients had a continued remission at 18 months.

Among all patients with follicular lymphoma, the median duration of response was not reached at a median follow-up of 14.5 months.

In the safety analysis conducted in 146 patients, grade 3 or higher cytokine release syndrome and neurologic adverse effects were reported in 8% and 21% of patients, respectively.

, Kite, a Gilead company, said the approval marks the first CAR T-cell therapy approved for patients with indolent follicular lymphoma, follows FDA Breakthrough Therapy Designation and a priority review, as well as the third approved indication for a Kite cell therapy.

For these patients in the third line of therapy, the 5-year survival rate is only 20%, said Caron A. Jacobson, MD, MMSc, Medical Director, Immune Effector Cell Therapy Program, Dana-Farber Cancer Institute and Assistant Professor of Medicine, Harvard Medical School.

The FDA approved axicabtagene ciloleucel (Yescarta) for the treatment of adult patients with relapsed or refractory follicular lymphoma following 2 or more lines of systemic therapy.

FDA Clears Axi-Cel for Relapsed/Refractory Indolent Follicular Lymphoma

Despite many patients receiving medical evaluations, specialty referrals, and prescription therapeutics, almost 40% of 

 cases remained unexplained, according to a poster presented at the 

American Academy of Allergy, Asthma & Immunology 2021 Annual Meeting

Chronic cough is defined as a cough lasting more than 8 weeks. Unexplained chronic cough (UCC) is a chronic cough subset where an apparent cause for symptoms cannot be found after thorough analysis. It is estimated that UCC affects between 5% and 10% of American adults.

Despite an identified etiology, health care professionals pursue medication trials and imaging tests until a diagnosis is determined, which can put a large burden on the health care system and patients.

Primary care providers are usually the first health care specialists to evaluate UCC. However, it’s not clear how common UCC occurs in the primary care population.

Investigators set out to characterize the prevalence of new onset chronic cough presented to primary care clinics and identify those patients who were classified as having UCC.

The observational, retrospective study incorporated real-world data from the Northwestern Medicine Enterprise Data Warehouse electronic health record repository on adult patients visiting an outpatient primary care clinic within a tertiary center between 2015 and 2018. Patient charts were examined for 3.5 years from initial primary care physician visit.

During the study period, 122 patients visited a primary care physician. Of those patients, 98 were identified to be the final chronic cough cohort. Patients in this cohort had a mean age of 61.1 (15.3) years, were mostly White (74.5%), and were mostly comprised of women (67%).

Sixty-four patients received a referral to a specialist, 28.1% (n= 18) of which were for patients with UCC. Forty-five (45.9%) patients within the chronic cough cohort were referred to 1 or more specialists. The most common specialties referred to were pulmonology (31.6%), allergy and immunology (13.2%), otolaryngology (12.2%), and gastroenterology (8.2%).

The most common medications prescribed to patients with UCC were intranasal steroid or azelastine nasal spray (89.2%), antibiotics (70.3%), oral steroid (62.2%), acid reflux medication (59.5%), and inhaled corticosteroid either alone or in combination with a long-acting beta agonist (59.5%).

After 3.5 years after the first primary care visit, 61 (62.2%) patients were determined to have a chronic cough and 37 (37.8%) had UCC with no clear etiology.

Twenty-seven percent (n = 10) of patients with UCC who saw a specialist still did not have an apparent reason for their cough, whereas 62.2% (n = 61) eventually received a diagnosis. Of the patients who received an official diagnosis, 39.3% (n = 24) had a multifactorial cough that had more than 1 etiology.

The most common diagnoses found were gastroesophageal reflux disease (41.0%), rhinitis (39.3%), asthma (23.0%), and 

“Further clinical characterization will inform future research and treatment directions for chronic cough,” wrote the investigators.

Patel AK, Vu T-HT, Guo A, Sinard RN, Peters AT. Characterizing new onset chronic cough in primary care clinics. Presented at the American Academy of Allergy, Asthma & Immunology 2021 Annual Meeting, February 26-March 1, 2021; Poster 190.

Despite receiving specialty referrals and multiple prescriptions medications, nearly 40% of patients with an unexplained chronic cough are not given a proper diagnosis.

Nearly 40% of Chronic Cough Cases Remain Unexplained After Extensive Testing, Therapy

examines the current state of the tools used to evaluate health-related quality of life (HRQOL) in oncological trials, highlighting the efficacy and drawbacks of those tools when applied to patients with solid-tumor cancers undergoing immunotherapy. Given the high cost and potential toxicities of immunotherapy in these patients, developing and validating targeted and effective tools to evaluate HRQOL over the course of therapy in those patients should remain a priority, the authors wrote.

While immuno-oncology (IO) therapies have become a cornerstone in some cancer types and have undoubtedly improved traditional study end points in terms of survival, immune-related adverse events (irAEs) are a common effect of IO agents that can significantly affect HRQOL during and after therapy. Therefore, the authors stress the importance of adequate risk-benefit assessments to ensure that “meaningful and valuable” IO therapies are approved for the treatment of cancer and noted that unlike AEs that typically occur during treatment with other agents like chemotherapy, irAEs do not necessarily have a dose-response or dose-toxicity relationship.

“An evaluation of the benefit of these IO agents must include a determination of their effects on HRQOL to ascertain the real value of the treatments beyond traditional statistically significant efficacy,” they wrote. “HRQOL is a complex, abstract, and multidimensional idea that describes an individual’s satisfaction with life in the domains considered most vital.” This encompasses measures like general health (defined in the review as physical, social, and psychosocial health), as well as cancer- and therapy-related effects like symptoms and side effects.

 (PROs), which have become increasingly common in cancer clinical trials, as a key element of successful HRQOL assessment in patients on IO with solid tumors. Examples of oncology-specific PRO tools are the Functional Assessment of Cancer Therapy-General (FACT-G) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Both have been extensively validated, are familiar to most researchers, and are available in multiple languages.

The PRO adaptation of the National Cancer Institute’s Common Terminology Criteria for Adverse Events (PRO-CTCAE) has helped with collecting data on symptomatic AEs, although it was initially developed for either surgery, radiation, and/or chemotherapy—not IO therapy, which has additional relevant AEs— according to the study authors.

Despite the existence of these tools for cancer in general, authors raise the question of whether they are sufficiently sensitive to effectively monitor the HRQOL of patients undergoing IO treatment for cancer. The inclusion of symptomatic irAEs in such tools is paramount if they are used to monitor this patient population. And despite the differences between IO therapy and more traditional treatments, many trials utilize conventional HRQOL tools and consider HRQOL a secondary or exploratory end point, according to the review. Those are both limitations in gauging quality of life over the course of treatment and for risk-benefit assessment of IO therapies.

“Currently, there is no widely adopted, validated instrument that has been tailored for this patient population, although a tool to measure HRQOL has been developed in patients receiving immune checkpoint modulators,” the authors wrote. There are 2 major issues in PROs for IO therapy clinical trials, they said:

All the possible symptomatic irAEs from IO therapy need to be identified and translated into PRO items

Patient input is required to confirm that specific symptomatic irAEs impact HRQOL and then develop and validate tools or modules specific to the various classes of immunotherapies

The PRO-CTCAE, for example, does include items that that cover some of the more common irAEs—fatigue, rash, and pruritus. But some other common irAE symptoms—like tremors, neck swelling, muscle weakness, weight gain, shivering, or bleeding in stool—are not in the PRO-CTCAE item library. Although some efforts are underway to mitigate this knowledge gap, there is more work to be done, the authors concluded. That includes developing PRO tools for the new

 that are now being studied and added to the treatment armamentarium. Integrating PRO tools into early-phase trials to inform the development of tools for later studies will be key, they said.

“With the rising number of IO agents available, it has become clear that a more thorough understanding of irAEs is needed to generate a more complete picture of the risks and benefits associated with these treatments,” they wrote. “For this to occur, more comprehensive capturing of irAEs is required, and the effects of irAEs have on HRQOL must be evaluated. Efforts to develop these tools are underway and will be an important step forward in the understanding and accurate reporting of irAEs.”

Importantly, the HRQOL data collected from these trails will inform regulatory applications and ensure that new IO therapy approvals have undergone thorough risk-benefit and value analyses, ultimately affecting health care policy overall.

Voon PJ, Cella D, Hansen AR. Health-related quality-of- life assessment of patients with solid tumors on immuno-oncology therapies. 

Published online March 4, 2021. doi:10.1002/cncr.33457

A review published in Cancer examines the efficacy and drawbacks of tools used to evaluate health-related quality of life in immuno-oncology clinical trials.