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Lorlatinib: Another first-line option for ALK-positive NSCLC?
Lorlatinib also produced a higher overall and intracranial response rate, prolonging progression to CNS disease.
These findings “support the use of lorlatinib as a highly effective first-line therapy for patients with advanced ALK-positive NSCLC,” said Benjamin Solomon, MBBS, PhD, of the Peter MacCallum Cancer Centre in Melbourne.
“The CROWN study clearly establishes lorlatinib as another option” among other first-line ALK inhibitors, Dr. Solomon said when presenting the findings at the European Society for Medical Oncology Virtual Congress 2020.
“We now have multiple options for first-line treatment of patients with ALK-positive lung cancer,” noted study discussant Christine Lovly, MD, PhD, a medical oncologist and associate professor at Vanderbilt University Medical Center in Nashville, Tenn.
The question now, she said, is how to choose among these options. The drugs have all bested crizotinib in trials but haven’t gone head to head against one another.
Lorlatinib and CROWN
Lorlatinib is currently approved in the United States to treat ALK-positive metastatic NSCLC that has progressed on crizotinib and at least one other ALK inhibitor. Lorlatinib was granted accelerated approval for this indication based on response rate and duration.
The CROWN study was intended to support the conversion to full approval, according to Pfizer, which is developing both lorlatinib and crizotinib. Pfizer also plans to use the results of CROWN to seek a first-line indication for lorlatinib in NSCLC.
CROWN enrolled 296 patients with stage IIIB/IV ALK-positive NSCLC who had received no prior systemic treatment. Patients with asymptomatic treated or untreated CNS metastases were eligible.
There were 149 patients randomized to lorlatinib at 100 mg daily and 147 randomized to crizotinib at 250 mg twice daily. Five patients in the crizotinib arm were included in the analysis but were not treated, Dr. Solomon said.
The median age was 61 years in the lorlatinib arm and 56 years in the crizotinib arm. Nearly all patients were White (48% in the lorlatinib arm and 49% in the crizotinib arm) or Asian (44% in both arms). A majority of patients were women (56% in the lorlatinib arm and 62% in the crizotinib arm), and more than half said they never smoked (54% in the lorlatinib arm and 64% in the crizotinib arm).
Response and PFS
According to blinded independent central review, the objective response rate was 76% with lorlatinib (113/149) and 58% with crizotinib (85/147). There were four complete responses with lorlatinib and none with crizotinib.
Among patients who had measurable or nonmeasurable brain metastases at baseline, the intracranial ORR was 66% with lorlatinib (25/38) and 20% (8/40) with crizotinib. In patients with only measurable brain metastases at baseline, the intracranial ORR was 82% with lorlatinib (14/17) and 23% with crizotinib (3/13).
The 12-month PFS rate was 78% in the lorlatinib arm and 39% in the crizotinib arm. The median PFS was 9.3 months in the crizotinib arm but was not reached in the lorlatinib arm, which “corresponded to a 72% reduction in the risk of death or progression [hazard ratio, 0.21; P < .001],” Dr. Solomon said.
“[T]he PFS for alectinib in the first line is approximately 3 years,” Dr. Lovly noted. “We anxiously await additional data for lorlatinib to see how long the PFS will be.”
The median time to intracranial progression was 16.6 months in the crizotinib arm but was not reached in the lorlatinib arm (HR, 0.07; P < .001).
“These data indicate the ability of lorlatinib not only to delay the progression of existing brain metastases, but also to prevent the development of new brain metastases,” Dr. Solomon said.
Dr. Lovly noted that the efficacy of lorlatinib in the brain is “quite compelling,” but other ALK inhibitors have demonstrated similar results.
As for overall survival, the data are still immature. The median overall survival was not reached with lorlatinib or crizotinib (HR, 0.72).
Toxicity
Dr. Solomon noted that lorlatinib “does have a different toxicity profile, compared to other ALK inhibitors.” Specifically, lorlatinib is associated with hypercholesterolemia and hypertriglyceridemia, which have not been seen with other ALK inhibitors.
Lorlatinib is also associated with neurocognitive problems, including inattention, memory impairment, and mild confusion. Mood effects include emotional lability – “someone watching a movie might burst into tears when they wouldn’t have otherwise,” Dr. Solomon said – as well as anxiety and depression.
“So it’s important to tell not just the patient but their family about these things so that they identify when [the events] happen,” Dr. Solomon said. “That’s key because [the events are] completely reversible when you stop the drug. With dose interruption, those effects will resolve.”
Other adverse events that were more common with lorlatinib (a 10% or greater difference in frequency from crizotinib) included edema, weight gain, and peripheral neuropathy. Diarrhea, nausea, fatigue, vision disorders, constipation, and increased liver enzymes were more common with crizotinib. Grade 3-4 adverse events led to discontinuation in fewer than 10% of patients in each arm.
The study was funded by Pfizer, and the investigators included employees. Dr. Solomon is an adviser for Pfizer and other companies, and Dr. Lovly’s industry ties included being both an advisor and speaker for Pfizer.
SOURCE: Solomon B et al. ESMO 2020, Abstract LBA2.
Lorlatinib also produced a higher overall and intracranial response rate, prolonging progression to CNS disease.
These findings “support the use of lorlatinib as a highly effective first-line therapy for patients with advanced ALK-positive NSCLC,” said Benjamin Solomon, MBBS, PhD, of the Peter MacCallum Cancer Centre in Melbourne.
“The CROWN study clearly establishes lorlatinib as another option” among other first-line ALK inhibitors, Dr. Solomon said when presenting the findings at the European Society for Medical Oncology Virtual Congress 2020.
“We now have multiple options for first-line treatment of patients with ALK-positive lung cancer,” noted study discussant Christine Lovly, MD, PhD, a medical oncologist and associate professor at Vanderbilt University Medical Center in Nashville, Tenn.
The question now, she said, is how to choose among these options. The drugs have all bested crizotinib in trials but haven’t gone head to head against one another.
Lorlatinib and CROWN
Lorlatinib is currently approved in the United States to treat ALK-positive metastatic NSCLC that has progressed on crizotinib and at least one other ALK inhibitor. Lorlatinib was granted accelerated approval for this indication based on response rate and duration.
The CROWN study was intended to support the conversion to full approval, according to Pfizer, which is developing both lorlatinib and crizotinib. Pfizer also plans to use the results of CROWN to seek a first-line indication for lorlatinib in NSCLC.
CROWN enrolled 296 patients with stage IIIB/IV ALK-positive NSCLC who had received no prior systemic treatment. Patients with asymptomatic treated or untreated CNS metastases were eligible.
There were 149 patients randomized to lorlatinib at 100 mg daily and 147 randomized to crizotinib at 250 mg twice daily. Five patients in the crizotinib arm were included in the analysis but were not treated, Dr. Solomon said.
The median age was 61 years in the lorlatinib arm and 56 years in the crizotinib arm. Nearly all patients were White (48% in the lorlatinib arm and 49% in the crizotinib arm) or Asian (44% in both arms). A majority of patients were women (56% in the lorlatinib arm and 62% in the crizotinib arm), and more than half said they never smoked (54% in the lorlatinib arm and 64% in the crizotinib arm).
Response and PFS
According to blinded independent central review, the objective response rate was 76% with lorlatinib (113/149) and 58% with crizotinib (85/147). There were four complete responses with lorlatinib and none with crizotinib.
Among patients who had measurable or nonmeasurable brain metastases at baseline, the intracranial ORR was 66% with lorlatinib (25/38) and 20% (8/40) with crizotinib. In patients with only measurable brain metastases at baseline, the intracranial ORR was 82% with lorlatinib (14/17) and 23% with crizotinib (3/13).
The 12-month PFS rate was 78% in the lorlatinib arm and 39% in the crizotinib arm. The median PFS was 9.3 months in the crizotinib arm but was not reached in the lorlatinib arm, which “corresponded to a 72% reduction in the risk of death or progression [hazard ratio, 0.21; P < .001],” Dr. Solomon said.
“[T]he PFS for alectinib in the first line is approximately 3 years,” Dr. Lovly noted. “We anxiously await additional data for lorlatinib to see how long the PFS will be.”
The median time to intracranial progression was 16.6 months in the crizotinib arm but was not reached in the lorlatinib arm (HR, 0.07; P < .001).
“These data indicate the ability of lorlatinib not only to delay the progression of existing brain metastases, but also to prevent the development of new brain metastases,” Dr. Solomon said.
Dr. Lovly noted that the efficacy of lorlatinib in the brain is “quite compelling,” but other ALK inhibitors have demonstrated similar results.
As for overall survival, the data are still immature. The median overall survival was not reached with lorlatinib or crizotinib (HR, 0.72).
Toxicity
Dr. Solomon noted that lorlatinib “does have a different toxicity profile, compared to other ALK inhibitors.” Specifically, lorlatinib is associated with hypercholesterolemia and hypertriglyceridemia, which have not been seen with other ALK inhibitors.
Lorlatinib is also associated with neurocognitive problems, including inattention, memory impairment, and mild confusion. Mood effects include emotional lability – “someone watching a movie might burst into tears when they wouldn’t have otherwise,” Dr. Solomon said – as well as anxiety and depression.
“So it’s important to tell not just the patient but their family about these things so that they identify when [the events] happen,” Dr. Solomon said. “That’s key because [the events are] completely reversible when you stop the drug. With dose interruption, those effects will resolve.”
Other adverse events that were more common with lorlatinib (a 10% or greater difference in frequency from crizotinib) included edema, weight gain, and peripheral neuropathy. Diarrhea, nausea, fatigue, vision disorders, constipation, and increased liver enzymes were more common with crizotinib. Grade 3-4 adverse events led to discontinuation in fewer than 10% of patients in each arm.
The study was funded by Pfizer, and the investigators included employees. Dr. Solomon is an adviser for Pfizer and other companies, and Dr. Lovly’s industry ties included being both an advisor and speaker for Pfizer.
SOURCE: Solomon B et al. ESMO 2020, Abstract LBA2.
Lorlatinib also produced a higher overall and intracranial response rate, prolonging progression to CNS disease.
These findings “support the use of lorlatinib as a highly effective first-line therapy for patients with advanced ALK-positive NSCLC,” said Benjamin Solomon, MBBS, PhD, of the Peter MacCallum Cancer Centre in Melbourne.
“The CROWN study clearly establishes lorlatinib as another option” among other first-line ALK inhibitors, Dr. Solomon said when presenting the findings at the European Society for Medical Oncology Virtual Congress 2020.
“We now have multiple options for first-line treatment of patients with ALK-positive lung cancer,” noted study discussant Christine Lovly, MD, PhD, a medical oncologist and associate professor at Vanderbilt University Medical Center in Nashville, Tenn.
The question now, she said, is how to choose among these options. The drugs have all bested crizotinib in trials but haven’t gone head to head against one another.
Lorlatinib and CROWN
Lorlatinib is currently approved in the United States to treat ALK-positive metastatic NSCLC that has progressed on crizotinib and at least one other ALK inhibitor. Lorlatinib was granted accelerated approval for this indication based on response rate and duration.
The CROWN study was intended to support the conversion to full approval, according to Pfizer, which is developing both lorlatinib and crizotinib. Pfizer also plans to use the results of CROWN to seek a first-line indication for lorlatinib in NSCLC.
CROWN enrolled 296 patients with stage IIIB/IV ALK-positive NSCLC who had received no prior systemic treatment. Patients with asymptomatic treated or untreated CNS metastases were eligible.
There were 149 patients randomized to lorlatinib at 100 mg daily and 147 randomized to crizotinib at 250 mg twice daily. Five patients in the crizotinib arm were included in the analysis but were not treated, Dr. Solomon said.
The median age was 61 years in the lorlatinib arm and 56 years in the crizotinib arm. Nearly all patients were White (48% in the lorlatinib arm and 49% in the crizotinib arm) or Asian (44% in both arms). A majority of patients were women (56% in the lorlatinib arm and 62% in the crizotinib arm), and more than half said they never smoked (54% in the lorlatinib arm and 64% in the crizotinib arm).
Response and PFS
According to blinded independent central review, the objective response rate was 76% with lorlatinib (113/149) and 58% with crizotinib (85/147). There were four complete responses with lorlatinib and none with crizotinib.
Among patients who had measurable or nonmeasurable brain metastases at baseline, the intracranial ORR was 66% with lorlatinib (25/38) and 20% (8/40) with crizotinib. In patients with only measurable brain metastases at baseline, the intracranial ORR was 82% with lorlatinib (14/17) and 23% with crizotinib (3/13).
The 12-month PFS rate was 78% in the lorlatinib arm and 39% in the crizotinib arm. The median PFS was 9.3 months in the crizotinib arm but was not reached in the lorlatinib arm, which “corresponded to a 72% reduction in the risk of death or progression [hazard ratio, 0.21; P < .001],” Dr. Solomon said.
“[T]he PFS for alectinib in the first line is approximately 3 years,” Dr. Lovly noted. “We anxiously await additional data for lorlatinib to see how long the PFS will be.”
The median time to intracranial progression was 16.6 months in the crizotinib arm but was not reached in the lorlatinib arm (HR, 0.07; P < .001).
“These data indicate the ability of lorlatinib not only to delay the progression of existing brain metastases, but also to prevent the development of new brain metastases,” Dr. Solomon said.
Dr. Lovly noted that the efficacy of lorlatinib in the brain is “quite compelling,” but other ALK inhibitors have demonstrated similar results.
As for overall survival, the data are still immature. The median overall survival was not reached with lorlatinib or crizotinib (HR, 0.72).
Toxicity
Dr. Solomon noted that lorlatinib “does have a different toxicity profile, compared to other ALK inhibitors.” Specifically, lorlatinib is associated with hypercholesterolemia and hypertriglyceridemia, which have not been seen with other ALK inhibitors.
Lorlatinib is also associated with neurocognitive problems, including inattention, memory impairment, and mild confusion. Mood effects include emotional lability – “someone watching a movie might burst into tears when they wouldn’t have otherwise,” Dr. Solomon said – as well as anxiety and depression.
“So it’s important to tell not just the patient but their family about these things so that they identify when [the events] happen,” Dr. Solomon said. “That’s key because [the events are] completely reversible when you stop the drug. With dose interruption, those effects will resolve.”
Other adverse events that were more common with lorlatinib (a 10% or greater difference in frequency from crizotinib) included edema, weight gain, and peripheral neuropathy. Diarrhea, nausea, fatigue, vision disorders, constipation, and increased liver enzymes were more common with crizotinib. Grade 3-4 adverse events led to discontinuation in fewer than 10% of patients in each arm.
The study was funded by Pfizer, and the investigators included employees. Dr. Solomon is an adviser for Pfizer and other companies, and Dr. Lovly’s industry ties included being both an advisor and speaker for Pfizer.
SOURCE: Solomon B et al. ESMO 2020, Abstract LBA2.
FROM ESMO 2020
CDC adds then retracts aerosols as main COVID-19 mode of transmission
The CDC had updated information on coronavirus spread and had acknowledged the prominence of aerosol transmission.
CDC’s new information still says that Sars-CoV-2 is commonly spread between people who are within about 6 feet of each other, which has been the agency’s stance for months now.
However, the deleted update had added it is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection. This is thought to be the main way the virus spreads.”
Responding to Medscape Medical News questions about the update, Jasmine Reed, spokesperson for the CDC, told Medscape Medical News, “A draft version of proposed changes to these recommendations was posted in error to the agency’s official website. CDC is currently updating its recommendations regarding airborne transmission of SARS-CoV-2 (the virus that causes COVID-19). Once this process has been completed, the updated language will be posted.”
Previous information
Previously, the CDC said the virus is spread mainly among people who are within about 6 feet of each another through respiratory droplets propelled when an infected person coughs, sneezes, or talks.
Previous guidance also said, “These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.”
The now deleted update said, “There is growing evidence that droplets and airborne particles can remain suspended in the air and be breathed in by others, and travel distances beyond 6 feet (for example, during choir practice, in restaurants, or in fitness classes).”
On July 6, Clinical Infectious Diseases published the paper “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.
The authors write, “There is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).
The World Health Organization (WHO) acknowledged after this research was published that airborne transmission of the virus may play a role in infection, especially in poorly ventilated rooms and buildings, but have yet to declare aerosols as a definitive contributor.
WHO has long stated that coronavirus is spread mainly by droplets that, once expelled by coughs and sneezes of infected people, fall quickly to the floor.
The CDC update was made Friday without announcement.
“This has been one of the problems all along,” said Leana Wen, MD, an emergency physician and public health professor at George Washington University, Washington, DC. “The guidance from CDC changes on their website, but there’s no press conference, there’s no explanation of why they’re changing this now.”
Again Monday, there was no announcement that information had changed.
Update added air purifiers for prevention
The CDC continues to recommend staying 6 feet from others, washing hands, wearing a mask and routinely disinfecting frequently touched surfaces.
The update had added, “Use air purifiers to help reduce airborne germs in indoor spaces.”
Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick
This article first appeared on Medscape.com.
The CDC had updated information on coronavirus spread and had acknowledged the prominence of aerosol transmission.
CDC’s new information still says that Sars-CoV-2 is commonly spread between people who are within about 6 feet of each other, which has been the agency’s stance for months now.
However, the deleted update had added it is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection. This is thought to be the main way the virus spreads.”
Responding to Medscape Medical News questions about the update, Jasmine Reed, spokesperson for the CDC, told Medscape Medical News, “A draft version of proposed changes to these recommendations was posted in error to the agency’s official website. CDC is currently updating its recommendations regarding airborne transmission of SARS-CoV-2 (the virus that causes COVID-19). Once this process has been completed, the updated language will be posted.”
Previous information
Previously, the CDC said the virus is spread mainly among people who are within about 6 feet of each another through respiratory droplets propelled when an infected person coughs, sneezes, or talks.
Previous guidance also said, “These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.”
The now deleted update said, “There is growing evidence that droplets and airborne particles can remain suspended in the air and be breathed in by others, and travel distances beyond 6 feet (for example, during choir practice, in restaurants, or in fitness classes).”
On July 6, Clinical Infectious Diseases published the paper “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.
The authors write, “There is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).
The World Health Organization (WHO) acknowledged after this research was published that airborne transmission of the virus may play a role in infection, especially in poorly ventilated rooms and buildings, but have yet to declare aerosols as a definitive contributor.
WHO has long stated that coronavirus is spread mainly by droplets that, once expelled by coughs and sneezes of infected people, fall quickly to the floor.
The CDC update was made Friday without announcement.
“This has been one of the problems all along,” said Leana Wen, MD, an emergency physician and public health professor at George Washington University, Washington, DC. “The guidance from CDC changes on their website, but there’s no press conference, there’s no explanation of why they’re changing this now.”
Again Monday, there was no announcement that information had changed.
Update added air purifiers for prevention
The CDC continues to recommend staying 6 feet from others, washing hands, wearing a mask and routinely disinfecting frequently touched surfaces.
The update had added, “Use air purifiers to help reduce airborne germs in indoor spaces.”
Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick
This article first appeared on Medscape.com.
The CDC had updated information on coronavirus spread and had acknowledged the prominence of aerosol transmission.
CDC’s new information still says that Sars-CoV-2 is commonly spread between people who are within about 6 feet of each other, which has been the agency’s stance for months now.
However, the deleted update had added it is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection. This is thought to be the main way the virus spreads.”
Responding to Medscape Medical News questions about the update, Jasmine Reed, spokesperson for the CDC, told Medscape Medical News, “A draft version of proposed changes to these recommendations was posted in error to the agency’s official website. CDC is currently updating its recommendations regarding airborne transmission of SARS-CoV-2 (the virus that causes COVID-19). Once this process has been completed, the updated language will be posted.”
Previous information
Previously, the CDC said the virus is spread mainly among people who are within about 6 feet of each another through respiratory droplets propelled when an infected person coughs, sneezes, or talks.
Previous guidance also said, “These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.”
The now deleted update said, “There is growing evidence that droplets and airborne particles can remain suspended in the air and be breathed in by others, and travel distances beyond 6 feet (for example, during choir practice, in restaurants, or in fitness classes).”
On July 6, Clinical Infectious Diseases published the paper “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.
The authors write, “There is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).
The World Health Organization (WHO) acknowledged after this research was published that airborne transmission of the virus may play a role in infection, especially in poorly ventilated rooms and buildings, but have yet to declare aerosols as a definitive contributor.
WHO has long stated that coronavirus is spread mainly by droplets that, once expelled by coughs and sneezes of infected people, fall quickly to the floor.
The CDC update was made Friday without announcement.
“This has been one of the problems all along,” said Leana Wen, MD, an emergency physician and public health professor at George Washington University, Washington, DC. “The guidance from CDC changes on their website, but there’s no press conference, there’s no explanation of why they’re changing this now.”
Again Monday, there was no announcement that information had changed.
Update added air purifiers for prevention
The CDC continues to recommend staying 6 feet from others, washing hands, wearing a mask and routinely disinfecting frequently touched surfaces.
The update had added, “Use air purifiers to help reduce airborne germs in indoor spaces.”
Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick
This article first appeared on Medscape.com.
What will be the future of American medicine?
For at least the last 6 months, and what seems like much longer, the United States has been in a period of great upheaval unseen for decades. Thanks in part to a novel coronavirus that quickly spread globally, along with social and racial tensions reaching a boiling point after nationwide economic uncertainty and the deaths of George Floyd and Breonna Taylor at the hands of law enforcement. In the year of a presidential election, leaders both elected and running are looking for solutions. Medicine has also been scrambling for answers as hospitals deal with ever growing censuses and dwindling resources, which have placed a strain on budgets, employees, and communities. Through these difficult times, there appears to be a resolve to investigate how we arrived here, where do we want to go, and what will take us there. As industries look to foster more inclusive and diverse environments, health care also looks to lead this philosophical shift toward a more equitable system. In the meantime, minorities, particularly African Americans, are dying at alarming rates.
With state government shutdowns, school closures, and a transition to work from home, Americans have been increasingly cognizant of issues that are more likely to be drowned out by the routine of previously “normal” life. As the staggering coronavirus infection numbers and deaths began to be published, undeniable trends were laid bare for the country to see. While the pandemic has been a deadly scare for the entire nation, the risk of serious complications or death for others was undeniable or even likely. For many Americans of underrepresented groups, but for Black people in general, 2020 has been another checkpoint in a long straight path, as centuries of systemic injustices and racist policies enacted through legislation, health policy have left these communities far behind and incredibly unprepared for this latest challenge.
For millions of Black Americans, although there is never acceptance of it, living with inequality has become a way of life. Much is known about the eventually desegregated lunch counters and public transportation but health care also facilitated disparities that have manifested themselves in the disparate outcomes we see today. Although Brown v Board of Education eliminated the legal precedent of segregated public spaces, enforcement was not immediately unanimous. In the paper The Politics of Racial Disparities, author David Smith describes the segregation in the state hospital in the state capital of Mississippi. Accounts detailed the dismay of white patients who traveled in the same elevators as Black patients, separate floors new and expectant Black mothers were admitted to, and even policies that discouraged Black and White children from utilizing play areas at the same time. All of these policies and the resistance to change were occurring in the 1960s as the larger national appetite toward overt discrimination began to sour. Although the deep south has historically held the reputation of outdated values, this was not solely a regional problem.
Nationwide, African Americans, as well as other minorities, are very aware of the health pitfalls that await them once leaving the hospital as newborns. According to CDC data, they are more likely than White non-Hispanic White adults to be diagnosed with diabetes and hypertension. Eighty percent of African American women are overweight or obese compared with 65% of non-Hispanic White women. These comorbidities have been especially telling this year as they account for a large proportion of comorbid conditions listed on deceased COVID-19 patients’ death certificates.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, and member of the White House coronavirus task force, is particularly concerned about these trends. He stated in a recent interview that the virus is, “shedding another bright light on a systemic problem that has been with us for a very long period of time.” While he does not explicitly state what the systemic problem is, you could assume it relates to racial injustice. He also goes on to say, “…social determinants of health put people of color in a position-because of employment, socioeconomic status, availability of jobs-that makes it more likely for them to be in contact with an infected person and not be able to separate themselves.”
When these statistics are quoted, discussions of personal responsibility are often discussed; however, these arguments do not stand up against the long documented, intentional exclusion of minorities, in particular Black people, from the health systems and economic opportunities the country has to offer. Lacking any significant economic power, these communities have no buffer against a pandemic, no option but to show up for work. Additionally, these jobs cannot be done in the comfort of one’s living room. Large cities, such as New York City, served as a harbinger to what could happen when masks and social distancing was ignored, as well as a tendency to blame overcrowding. More investigation unearths that the true culprit in major metropolitan areas is not the size but its effects on resident social habits. Dr. Mary Bassett explains in The New York Times, “The answer is simple: the high cost of housing.” Multigenerational households are more prevalent among minority communities, explaining the rapid spread through these epicenters.
The historical legacy of redlining and other laws that were exclusionary and hostile to racial equality have made systems much more difficult to change, even when the parties involved are willing to take a more active role in change. The question is will it be enough to have merely stopped these practices or will a more active role in reversal of policies and their intended effects be needed?
Medicine is grappling with its role in the larger context of how to provide better access and better care. The Affordable Care Act, signed into law by President Barack Obama in 2010, aimed to begin that journey. When the mandate for individual states to opt in was struck down in 2012, state legislators were able to decide whether to opt into a Medicaid agreement with the government, providing basic care to all citizens of their state. Twelve states currently have not opted into the Medicaid expansion, leaving a significant portion of their residents uninsured. Of those states, a majority have minority populations represented at levels greater than the national average.
Medicine should use this opportunity to position itself as an ally in the fight for equality. The American dream story has always been structured around innovation and discovery. The medical field shares in this delight when coincidence, discovery, and problem solving intersect. This country prides itself on its abilities to problem solve and has sold this branding to the rest of the world. America loves winning, our current President repeatedly says so. What greater win would equal care and elimination of racial disparities in chronic diseases. As our health leaders assemble solutions for a multifactorial problem, the public must become more engaged to assist in creating solutions, maintain dedication and focus on the goals, and continue to hold leaders and elected officials accountable.
Increased diversity in health-care spaces both on the ground and in leadership will help ensure less represented voices are heard. We must invest in our education system to broaden the representation of minority physicians who often do not represent their population’s share. Changes must also go beyond direct patient care and population health measures but must also address the social determinants of health, such as a livable wage, fair and affordable housing, and wealth inequality.
With federal support for biomedical research becoming more difficult, the path for the next big innovation becomes increasingly expensive and never guaranteed. We hope to create a safe and effective COVID-19 vaccine. The elimination of race as an indirect determinant of health is a worthwhile goal that, if achieved, would be near the top of the list of this country’s achievements. With 1.2 trillion spent on health care in 2019 (Brookings institute), we cannot afford not to.
Dr. Williams is Affiliate Professor, Division of Pulmonary, Critical Care, and Sleep Medicine, University of Mississippi; and the G.V. (Sonny) Montgomery VA Medical Center, Jackson, Mississippi.
For at least the last 6 months, and what seems like much longer, the United States has been in a period of great upheaval unseen for decades. Thanks in part to a novel coronavirus that quickly spread globally, along with social and racial tensions reaching a boiling point after nationwide economic uncertainty and the deaths of George Floyd and Breonna Taylor at the hands of law enforcement. In the year of a presidential election, leaders both elected and running are looking for solutions. Medicine has also been scrambling for answers as hospitals deal with ever growing censuses and dwindling resources, which have placed a strain on budgets, employees, and communities. Through these difficult times, there appears to be a resolve to investigate how we arrived here, where do we want to go, and what will take us there. As industries look to foster more inclusive and diverse environments, health care also looks to lead this philosophical shift toward a more equitable system. In the meantime, minorities, particularly African Americans, are dying at alarming rates.
With state government shutdowns, school closures, and a transition to work from home, Americans have been increasingly cognizant of issues that are more likely to be drowned out by the routine of previously “normal” life. As the staggering coronavirus infection numbers and deaths began to be published, undeniable trends were laid bare for the country to see. While the pandemic has been a deadly scare for the entire nation, the risk of serious complications or death for others was undeniable or even likely. For many Americans of underrepresented groups, but for Black people in general, 2020 has been another checkpoint in a long straight path, as centuries of systemic injustices and racist policies enacted through legislation, health policy have left these communities far behind and incredibly unprepared for this latest challenge.
For millions of Black Americans, although there is never acceptance of it, living with inequality has become a way of life. Much is known about the eventually desegregated lunch counters and public transportation but health care also facilitated disparities that have manifested themselves in the disparate outcomes we see today. Although Brown v Board of Education eliminated the legal precedent of segregated public spaces, enforcement was not immediately unanimous. In the paper The Politics of Racial Disparities, author David Smith describes the segregation in the state hospital in the state capital of Mississippi. Accounts detailed the dismay of white patients who traveled in the same elevators as Black patients, separate floors new and expectant Black mothers were admitted to, and even policies that discouraged Black and White children from utilizing play areas at the same time. All of these policies and the resistance to change were occurring in the 1960s as the larger national appetite toward overt discrimination began to sour. Although the deep south has historically held the reputation of outdated values, this was not solely a regional problem.
Nationwide, African Americans, as well as other minorities, are very aware of the health pitfalls that await them once leaving the hospital as newborns. According to CDC data, they are more likely than White non-Hispanic White adults to be diagnosed with diabetes and hypertension. Eighty percent of African American women are overweight or obese compared with 65% of non-Hispanic White women. These comorbidities have been especially telling this year as they account for a large proportion of comorbid conditions listed on deceased COVID-19 patients’ death certificates.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, and member of the White House coronavirus task force, is particularly concerned about these trends. He stated in a recent interview that the virus is, “shedding another bright light on a systemic problem that has been with us for a very long period of time.” While he does not explicitly state what the systemic problem is, you could assume it relates to racial injustice. He also goes on to say, “…social determinants of health put people of color in a position-because of employment, socioeconomic status, availability of jobs-that makes it more likely for them to be in contact with an infected person and not be able to separate themselves.”
When these statistics are quoted, discussions of personal responsibility are often discussed; however, these arguments do not stand up against the long documented, intentional exclusion of minorities, in particular Black people, from the health systems and economic opportunities the country has to offer. Lacking any significant economic power, these communities have no buffer against a pandemic, no option but to show up for work. Additionally, these jobs cannot be done in the comfort of one’s living room. Large cities, such as New York City, served as a harbinger to what could happen when masks and social distancing was ignored, as well as a tendency to blame overcrowding. More investigation unearths that the true culprit in major metropolitan areas is not the size but its effects on resident social habits. Dr. Mary Bassett explains in The New York Times, “The answer is simple: the high cost of housing.” Multigenerational households are more prevalent among minority communities, explaining the rapid spread through these epicenters.
The historical legacy of redlining and other laws that were exclusionary and hostile to racial equality have made systems much more difficult to change, even when the parties involved are willing to take a more active role in change. The question is will it be enough to have merely stopped these practices or will a more active role in reversal of policies and their intended effects be needed?
Medicine is grappling with its role in the larger context of how to provide better access and better care. The Affordable Care Act, signed into law by President Barack Obama in 2010, aimed to begin that journey. When the mandate for individual states to opt in was struck down in 2012, state legislators were able to decide whether to opt into a Medicaid agreement with the government, providing basic care to all citizens of their state. Twelve states currently have not opted into the Medicaid expansion, leaving a significant portion of their residents uninsured. Of those states, a majority have minority populations represented at levels greater than the national average.
Medicine should use this opportunity to position itself as an ally in the fight for equality. The American dream story has always been structured around innovation and discovery. The medical field shares in this delight when coincidence, discovery, and problem solving intersect. This country prides itself on its abilities to problem solve and has sold this branding to the rest of the world. America loves winning, our current President repeatedly says so. What greater win would equal care and elimination of racial disparities in chronic diseases. As our health leaders assemble solutions for a multifactorial problem, the public must become more engaged to assist in creating solutions, maintain dedication and focus on the goals, and continue to hold leaders and elected officials accountable.
Increased diversity in health-care spaces both on the ground and in leadership will help ensure less represented voices are heard. We must invest in our education system to broaden the representation of minority physicians who often do not represent their population’s share. Changes must also go beyond direct patient care and population health measures but must also address the social determinants of health, such as a livable wage, fair and affordable housing, and wealth inequality.
With federal support for biomedical research becoming more difficult, the path for the next big innovation becomes increasingly expensive and never guaranteed. We hope to create a safe and effective COVID-19 vaccine. The elimination of race as an indirect determinant of health is a worthwhile goal that, if achieved, would be near the top of the list of this country’s achievements. With 1.2 trillion spent on health care in 2019 (Brookings institute), we cannot afford not to.
Dr. Williams is Affiliate Professor, Division of Pulmonary, Critical Care, and Sleep Medicine, University of Mississippi; and the G.V. (Sonny) Montgomery VA Medical Center, Jackson, Mississippi.
For at least the last 6 months, and what seems like much longer, the United States has been in a period of great upheaval unseen for decades. Thanks in part to a novel coronavirus that quickly spread globally, along with social and racial tensions reaching a boiling point after nationwide economic uncertainty and the deaths of George Floyd and Breonna Taylor at the hands of law enforcement. In the year of a presidential election, leaders both elected and running are looking for solutions. Medicine has also been scrambling for answers as hospitals deal with ever growing censuses and dwindling resources, which have placed a strain on budgets, employees, and communities. Through these difficult times, there appears to be a resolve to investigate how we arrived here, where do we want to go, and what will take us there. As industries look to foster more inclusive and diverse environments, health care also looks to lead this philosophical shift toward a more equitable system. In the meantime, minorities, particularly African Americans, are dying at alarming rates.
With state government shutdowns, school closures, and a transition to work from home, Americans have been increasingly cognizant of issues that are more likely to be drowned out by the routine of previously “normal” life. As the staggering coronavirus infection numbers and deaths began to be published, undeniable trends were laid bare for the country to see. While the pandemic has been a deadly scare for the entire nation, the risk of serious complications or death for others was undeniable or even likely. For many Americans of underrepresented groups, but for Black people in general, 2020 has been another checkpoint in a long straight path, as centuries of systemic injustices and racist policies enacted through legislation, health policy have left these communities far behind and incredibly unprepared for this latest challenge.
For millions of Black Americans, although there is never acceptance of it, living with inequality has become a way of life. Much is known about the eventually desegregated lunch counters and public transportation but health care also facilitated disparities that have manifested themselves in the disparate outcomes we see today. Although Brown v Board of Education eliminated the legal precedent of segregated public spaces, enforcement was not immediately unanimous. In the paper The Politics of Racial Disparities, author David Smith describes the segregation in the state hospital in the state capital of Mississippi. Accounts detailed the dismay of white patients who traveled in the same elevators as Black patients, separate floors new and expectant Black mothers were admitted to, and even policies that discouraged Black and White children from utilizing play areas at the same time. All of these policies and the resistance to change were occurring in the 1960s as the larger national appetite toward overt discrimination began to sour. Although the deep south has historically held the reputation of outdated values, this was not solely a regional problem.
Nationwide, African Americans, as well as other minorities, are very aware of the health pitfalls that await them once leaving the hospital as newborns. According to CDC data, they are more likely than White non-Hispanic White adults to be diagnosed with diabetes and hypertension. Eighty percent of African American women are overweight or obese compared with 65% of non-Hispanic White women. These comorbidities have been especially telling this year as they account for a large proportion of comorbid conditions listed on deceased COVID-19 patients’ death certificates.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, and member of the White House coronavirus task force, is particularly concerned about these trends. He stated in a recent interview that the virus is, “shedding another bright light on a systemic problem that has been with us for a very long period of time.” While he does not explicitly state what the systemic problem is, you could assume it relates to racial injustice. He also goes on to say, “…social determinants of health put people of color in a position-because of employment, socioeconomic status, availability of jobs-that makes it more likely for them to be in contact with an infected person and not be able to separate themselves.”
When these statistics are quoted, discussions of personal responsibility are often discussed; however, these arguments do not stand up against the long documented, intentional exclusion of minorities, in particular Black people, from the health systems and economic opportunities the country has to offer. Lacking any significant economic power, these communities have no buffer against a pandemic, no option but to show up for work. Additionally, these jobs cannot be done in the comfort of one’s living room. Large cities, such as New York City, served as a harbinger to what could happen when masks and social distancing was ignored, as well as a tendency to blame overcrowding. More investigation unearths that the true culprit in major metropolitan areas is not the size but its effects on resident social habits. Dr. Mary Bassett explains in The New York Times, “The answer is simple: the high cost of housing.” Multigenerational households are more prevalent among minority communities, explaining the rapid spread through these epicenters.
The historical legacy of redlining and other laws that were exclusionary and hostile to racial equality have made systems much more difficult to change, even when the parties involved are willing to take a more active role in change. The question is will it be enough to have merely stopped these practices or will a more active role in reversal of policies and their intended effects be needed?
Medicine is grappling with its role in the larger context of how to provide better access and better care. The Affordable Care Act, signed into law by President Barack Obama in 2010, aimed to begin that journey. When the mandate for individual states to opt in was struck down in 2012, state legislators were able to decide whether to opt into a Medicaid agreement with the government, providing basic care to all citizens of their state. Twelve states currently have not opted into the Medicaid expansion, leaving a significant portion of their residents uninsured. Of those states, a majority have minority populations represented at levels greater than the national average.
Medicine should use this opportunity to position itself as an ally in the fight for equality. The American dream story has always been structured around innovation and discovery. The medical field shares in this delight when coincidence, discovery, and problem solving intersect. This country prides itself on its abilities to problem solve and has sold this branding to the rest of the world. America loves winning, our current President repeatedly says so. What greater win would equal care and elimination of racial disparities in chronic diseases. As our health leaders assemble solutions for a multifactorial problem, the public must become more engaged to assist in creating solutions, maintain dedication and focus on the goals, and continue to hold leaders and elected officials accountable.
Increased diversity in health-care spaces both on the ground and in leadership will help ensure less represented voices are heard. We must invest in our education system to broaden the representation of minority physicians who often do not represent their population’s share. Changes must also go beyond direct patient care and population health measures but must also address the social determinants of health, such as a livable wage, fair and affordable housing, and wealth inequality.
With federal support for biomedical research becoming more difficult, the path for the next big innovation becomes increasingly expensive and never guaranteed. We hope to create a safe and effective COVID-19 vaccine. The elimination of race as an indirect determinant of health is a worthwhile goal that, if achieved, would be near the top of the list of this country’s achievements. With 1.2 trillion spent on health care in 2019 (Brookings institute), we cannot afford not to.
Dr. Williams is Affiliate Professor, Division of Pulmonary, Critical Care, and Sleep Medicine, University of Mississippi; and the G.V. (Sonny) Montgomery VA Medical Center, Jackson, Mississippi.
Without Ginsburg, judicial threats to the ACA, reproductive rights heighten
On Feb. 27, 2018, I got an email from the Heritage Foundation that alerted me to a news conference that afternoon held by Republican attorneys general of Texas and other states. It was referred to only as a “discussion about the Affordable Care Act lawsuit.”
I sent the following note to my editor: “I’m off to the Hill anyway. I could stop by this. You never know what it might morph into.”
Few people took that case very seriously – barely a handful of reporters attended the news conference. But it has now “morphed into” the latest existential threat to the Affordable Care Act, scheduled for oral arguments at the Supreme Court a week after the general election in November. And with the death of Justice Ruth Bader Ginsburg on Friday, that case could well morph into the threat that brings down the law in its entirety.
Democrats are raising alarms about the future of the law without Ms. Ginsburg. House Speaker Nancy Pelosi, speaking on ABC’s “This Week” Sunday morning, said that part of the strategy by President Trump and Senate Republicans to quickly fill her seat was to help undermine the ACA.
“The president is rushing to make some kind of a decision because … Nov. 10 is when the arguments begin on the Affordable Care Act,” she said. “He doesn’t want to crush the virus. He wants to crush the Affordable Care Act.”
Ms. Ginsburg’s death could throw an already chaotic general election campaign during a pandemic into even more turmoil.
Let’s take them one at a time.
The ACA under fire – again
The GOP attorneys general argued in February 2018 that the Republican-sponsored tax cut bill Congress passed two months earlier had rendered the ACA unconstitutional by reducing to zero the ACA’s penalty for not having insurance. They based their argument on Chief Justice John Roberts’ 2012 conclusion that the ACA was valid, interpreting that penalty as a constitutionally appropriate tax.
Most legal scholars, including several who challenged the law before the Supreme Court in 2012 and again in 2015, find the argument that the entire law should fall to be unconvincing. “If courts invalidate an entire law merely because Congress eliminates or revises one part, as happened here, that may well inhibit necessary reform of federal legislation in the future by turning it into an ‘all or nothing’ proposition,” wrote a group of conservative and liberal law professors in a brief filed in the case.
Still, in December 2018, U.S. District Judge Reed O’Connor in Texas accepted the GOP argument and declared the law unconstitutional. In December 2019, a three-judge 5th Circuit appeals court panel in New Orleans agreed that without the penalty the requirement to buy insurance is unconstitutional. But it sent the case back to Mr. O’Connor to suggest that perhaps the entire law need not fall.
Not wanting to wait the months or years that reconsideration would take, Democratic attorneys general defending the ACA asked the Supreme Court to hear the case this year. (Democrats are defending the law in court because the Trump administration decided to support the GOP attorneys general’s case.) The court agreed to take the case but scheduled arguments for the week after the November election.
While the fate of the ACA was and is a live political issue, few legal observers were terribly worried about the legal outcome of the case, now known as Texas v. California, if only because the case seemed much weaker than the 2012 and 2015 cases in which Mr. Roberts joined the court’s four liberals. In the 2015 case, which challenged the validity of federal tax subsidies helping millions of Americans buy health insurance on the ACA’s marketplaces, both Mr. Roberts and now-retired Justice Anthony Kennedy voted to uphold the law.
But without Ms. Ginsburg, the case could wind up in a 4-4 tie, even if Mr. Roberts supports the law’s constitutionality. That could let the lower-court ruling stand, although it would not be binding on other courts outside of the 5th Circuit. The court could also put off the arguments or, if the Republican Senate replaces Ms. Ginsburg with another conservative justice before arguments are heard, Republicans could secure a 5-4 ruling against the law. Some court observers argue that Justice Brett Kavanaugh has not favored invalidating an entire statute if only part of it is flawed and might not approve overturning the ACA. Still, what started out as an effort to energize Republican voters for the 2018 midterms after Congress failed to “repeal and replace” the health law in 2017 could end up throwing the nation’s entire health system into chaos.
At least 20 million Americans – and likely many more who sought coverage since the start of the coronavirus pandemic — who buy insurance through the ACA marketplaces or have Medicaid through the law’s expansion could lose coverage right away. Many millions more would lose the law’s popular protections guaranteeing coverage for people with preexisting health conditions, including those who have had COVID-19.
Adult children under age 26 years would no longer be guaranteed the right to remain on their parents’ health plans, and Medicare patients would lose enhanced prescription drug coverage. Women would lose guaranteed access to birth control at no out-of-pocket cost.
But a sudden elimination would affect more than just health care consumers. Insurance companies, drug companies, hospitals, and doctors have all changed the way they do business because of incentives and penalties in the health law. If it’s struck down, many of the “rules of the road” would literally be wiped away, including billing and payment mechanisms.
A new Democratic president could not drop the lawsuit because the Trump administration is not the plaintiff (the GOP attorneys general are). But a Democratic Congress and president could in theory make the entire issue go away by reinstating the penalty for failure to have insurance, even at a minimal amount. However, as far as the health law goes, for now, nothing is a sure thing.
As Nicholas Bagley, a law professor at the University of Michigan, Ann Arbor, who specializes in health issues, tweeted: “Among other things, the Affordable Care Act now dangles from a thread.”
Reproductive rights
A woman’s right to abortion – and even to birth control – also has been hanging by a thread at the high court for more than a decade. This past term, Mr. Roberts joined the liberals to invalidate a Louisiana law that would have closed most of the state’s abortion clinics, but he made it clear it was not a vote for abortion rights. The Louisiana law was too similar to a Texas law the court (without his vote) struck down in 2016, Mr. Roberts argued.
Ms. Ginsburg had been a stalwart supporter of reproductive freedom for women. In her nearly 3 decades on the court, she always voted with backers of abortion rights and birth control and led the dissenters in 2007 when the court upheld a federal ban on a specific abortion procedure.
Adding a justice opposed to abortion to the bench – which is what Trump has promised his supporters – would almost certainly tilt the court in favor of far more dramatic restrictions on the procedure and possibly an overturn of the landmark 1973 ruling Roe v. Wade.
But not only is abortion on the line: The court in recent years has repeatedly ruled that employers with religious objections can refuse to provide contraception.
And waiting in the lower-court pipeline are cases involving federal funding of Planned Parenthood in both the Medicaid and federal family planning programs, and the ability of individual health workers to decline to participate in abortion and other procedures.
For Ms. Ginsburg, those issues came down to a clear question of a woman’s guarantee of equal status under the law.
“Women, it is now acknowledged, have the talent, capacity, and right ‘to participate equally in the economic and social life of the Nation,’ ” she wrote in her dissent in that 2007 abortion case. “Their ability to realize their full potential, the Court recognized, is intimately connected to ‘their ability to control their reproductive lives.’ ”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
On Feb. 27, 2018, I got an email from the Heritage Foundation that alerted me to a news conference that afternoon held by Republican attorneys general of Texas and other states. It was referred to only as a “discussion about the Affordable Care Act lawsuit.”
I sent the following note to my editor: “I’m off to the Hill anyway. I could stop by this. You never know what it might morph into.”
Few people took that case very seriously – barely a handful of reporters attended the news conference. But it has now “morphed into” the latest existential threat to the Affordable Care Act, scheduled for oral arguments at the Supreme Court a week after the general election in November. And with the death of Justice Ruth Bader Ginsburg on Friday, that case could well morph into the threat that brings down the law in its entirety.
Democrats are raising alarms about the future of the law without Ms. Ginsburg. House Speaker Nancy Pelosi, speaking on ABC’s “This Week” Sunday morning, said that part of the strategy by President Trump and Senate Republicans to quickly fill her seat was to help undermine the ACA.
“The president is rushing to make some kind of a decision because … Nov. 10 is when the arguments begin on the Affordable Care Act,” she said. “He doesn’t want to crush the virus. He wants to crush the Affordable Care Act.”
Ms. Ginsburg’s death could throw an already chaotic general election campaign during a pandemic into even more turmoil.
Let’s take them one at a time.
The ACA under fire – again
The GOP attorneys general argued in February 2018 that the Republican-sponsored tax cut bill Congress passed two months earlier had rendered the ACA unconstitutional by reducing to zero the ACA’s penalty for not having insurance. They based their argument on Chief Justice John Roberts’ 2012 conclusion that the ACA was valid, interpreting that penalty as a constitutionally appropriate tax.
Most legal scholars, including several who challenged the law before the Supreme Court in 2012 and again in 2015, find the argument that the entire law should fall to be unconvincing. “If courts invalidate an entire law merely because Congress eliminates or revises one part, as happened here, that may well inhibit necessary reform of federal legislation in the future by turning it into an ‘all or nothing’ proposition,” wrote a group of conservative and liberal law professors in a brief filed in the case.
Still, in December 2018, U.S. District Judge Reed O’Connor in Texas accepted the GOP argument and declared the law unconstitutional. In December 2019, a three-judge 5th Circuit appeals court panel in New Orleans agreed that without the penalty the requirement to buy insurance is unconstitutional. But it sent the case back to Mr. O’Connor to suggest that perhaps the entire law need not fall.
Not wanting to wait the months or years that reconsideration would take, Democratic attorneys general defending the ACA asked the Supreme Court to hear the case this year. (Democrats are defending the law in court because the Trump administration decided to support the GOP attorneys general’s case.) The court agreed to take the case but scheduled arguments for the week after the November election.
While the fate of the ACA was and is a live political issue, few legal observers were terribly worried about the legal outcome of the case, now known as Texas v. California, if only because the case seemed much weaker than the 2012 and 2015 cases in which Mr. Roberts joined the court’s four liberals. In the 2015 case, which challenged the validity of federal tax subsidies helping millions of Americans buy health insurance on the ACA’s marketplaces, both Mr. Roberts and now-retired Justice Anthony Kennedy voted to uphold the law.
But without Ms. Ginsburg, the case could wind up in a 4-4 tie, even if Mr. Roberts supports the law’s constitutionality. That could let the lower-court ruling stand, although it would not be binding on other courts outside of the 5th Circuit. The court could also put off the arguments or, if the Republican Senate replaces Ms. Ginsburg with another conservative justice before arguments are heard, Republicans could secure a 5-4 ruling against the law. Some court observers argue that Justice Brett Kavanaugh has not favored invalidating an entire statute if only part of it is flawed and might not approve overturning the ACA. Still, what started out as an effort to energize Republican voters for the 2018 midterms after Congress failed to “repeal and replace” the health law in 2017 could end up throwing the nation’s entire health system into chaos.
At least 20 million Americans – and likely many more who sought coverage since the start of the coronavirus pandemic — who buy insurance through the ACA marketplaces or have Medicaid through the law’s expansion could lose coverage right away. Many millions more would lose the law’s popular protections guaranteeing coverage for people with preexisting health conditions, including those who have had COVID-19.
Adult children under age 26 years would no longer be guaranteed the right to remain on their parents’ health plans, and Medicare patients would lose enhanced prescription drug coverage. Women would lose guaranteed access to birth control at no out-of-pocket cost.
But a sudden elimination would affect more than just health care consumers. Insurance companies, drug companies, hospitals, and doctors have all changed the way they do business because of incentives and penalties in the health law. If it’s struck down, many of the “rules of the road” would literally be wiped away, including billing and payment mechanisms.
A new Democratic president could not drop the lawsuit because the Trump administration is not the plaintiff (the GOP attorneys general are). But a Democratic Congress and president could in theory make the entire issue go away by reinstating the penalty for failure to have insurance, even at a minimal amount. However, as far as the health law goes, for now, nothing is a sure thing.
As Nicholas Bagley, a law professor at the University of Michigan, Ann Arbor, who specializes in health issues, tweeted: “Among other things, the Affordable Care Act now dangles from a thread.”
Reproductive rights
A woman’s right to abortion – and even to birth control – also has been hanging by a thread at the high court for more than a decade. This past term, Mr. Roberts joined the liberals to invalidate a Louisiana law that would have closed most of the state’s abortion clinics, but he made it clear it was not a vote for abortion rights. The Louisiana law was too similar to a Texas law the court (without his vote) struck down in 2016, Mr. Roberts argued.
Ms. Ginsburg had been a stalwart supporter of reproductive freedom for women. In her nearly 3 decades on the court, she always voted with backers of abortion rights and birth control and led the dissenters in 2007 when the court upheld a federal ban on a specific abortion procedure.
Adding a justice opposed to abortion to the bench – which is what Trump has promised his supporters – would almost certainly tilt the court in favor of far more dramatic restrictions on the procedure and possibly an overturn of the landmark 1973 ruling Roe v. Wade.
But not only is abortion on the line: The court in recent years has repeatedly ruled that employers with religious objections can refuse to provide contraception.
And waiting in the lower-court pipeline are cases involving federal funding of Planned Parenthood in both the Medicaid and federal family planning programs, and the ability of individual health workers to decline to participate in abortion and other procedures.
For Ms. Ginsburg, those issues came down to a clear question of a woman’s guarantee of equal status under the law.
“Women, it is now acknowledged, have the talent, capacity, and right ‘to participate equally in the economic and social life of the Nation,’ ” she wrote in her dissent in that 2007 abortion case. “Their ability to realize their full potential, the Court recognized, is intimately connected to ‘their ability to control their reproductive lives.’ ”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
On Feb. 27, 2018, I got an email from the Heritage Foundation that alerted me to a news conference that afternoon held by Republican attorneys general of Texas and other states. It was referred to only as a “discussion about the Affordable Care Act lawsuit.”
I sent the following note to my editor: “I’m off to the Hill anyway. I could stop by this. You never know what it might morph into.”
Few people took that case very seriously – barely a handful of reporters attended the news conference. But it has now “morphed into” the latest existential threat to the Affordable Care Act, scheduled for oral arguments at the Supreme Court a week after the general election in November. And with the death of Justice Ruth Bader Ginsburg on Friday, that case could well morph into the threat that brings down the law in its entirety.
Democrats are raising alarms about the future of the law without Ms. Ginsburg. House Speaker Nancy Pelosi, speaking on ABC’s “This Week” Sunday morning, said that part of the strategy by President Trump and Senate Republicans to quickly fill her seat was to help undermine the ACA.
“The president is rushing to make some kind of a decision because … Nov. 10 is when the arguments begin on the Affordable Care Act,” she said. “He doesn’t want to crush the virus. He wants to crush the Affordable Care Act.”
Ms. Ginsburg’s death could throw an already chaotic general election campaign during a pandemic into even more turmoil.
Let’s take them one at a time.
The ACA under fire – again
The GOP attorneys general argued in February 2018 that the Republican-sponsored tax cut bill Congress passed two months earlier had rendered the ACA unconstitutional by reducing to zero the ACA’s penalty for not having insurance. They based their argument on Chief Justice John Roberts’ 2012 conclusion that the ACA was valid, interpreting that penalty as a constitutionally appropriate tax.
Most legal scholars, including several who challenged the law before the Supreme Court in 2012 and again in 2015, find the argument that the entire law should fall to be unconvincing. “If courts invalidate an entire law merely because Congress eliminates or revises one part, as happened here, that may well inhibit necessary reform of federal legislation in the future by turning it into an ‘all or nothing’ proposition,” wrote a group of conservative and liberal law professors in a brief filed in the case.
Still, in December 2018, U.S. District Judge Reed O’Connor in Texas accepted the GOP argument and declared the law unconstitutional. In December 2019, a three-judge 5th Circuit appeals court panel in New Orleans agreed that without the penalty the requirement to buy insurance is unconstitutional. But it sent the case back to Mr. O’Connor to suggest that perhaps the entire law need not fall.
Not wanting to wait the months or years that reconsideration would take, Democratic attorneys general defending the ACA asked the Supreme Court to hear the case this year. (Democrats are defending the law in court because the Trump administration decided to support the GOP attorneys general’s case.) The court agreed to take the case but scheduled arguments for the week after the November election.
While the fate of the ACA was and is a live political issue, few legal observers were terribly worried about the legal outcome of the case, now known as Texas v. California, if only because the case seemed much weaker than the 2012 and 2015 cases in which Mr. Roberts joined the court’s four liberals. In the 2015 case, which challenged the validity of federal tax subsidies helping millions of Americans buy health insurance on the ACA’s marketplaces, both Mr. Roberts and now-retired Justice Anthony Kennedy voted to uphold the law.
But without Ms. Ginsburg, the case could wind up in a 4-4 tie, even if Mr. Roberts supports the law’s constitutionality. That could let the lower-court ruling stand, although it would not be binding on other courts outside of the 5th Circuit. The court could also put off the arguments or, if the Republican Senate replaces Ms. Ginsburg with another conservative justice before arguments are heard, Republicans could secure a 5-4 ruling against the law. Some court observers argue that Justice Brett Kavanaugh has not favored invalidating an entire statute if only part of it is flawed and might not approve overturning the ACA. Still, what started out as an effort to energize Republican voters for the 2018 midterms after Congress failed to “repeal and replace” the health law in 2017 could end up throwing the nation’s entire health system into chaos.
At least 20 million Americans – and likely many more who sought coverage since the start of the coronavirus pandemic — who buy insurance through the ACA marketplaces or have Medicaid through the law’s expansion could lose coverage right away. Many millions more would lose the law’s popular protections guaranteeing coverage for people with preexisting health conditions, including those who have had COVID-19.
Adult children under age 26 years would no longer be guaranteed the right to remain on their parents’ health plans, and Medicare patients would lose enhanced prescription drug coverage. Women would lose guaranteed access to birth control at no out-of-pocket cost.
But a sudden elimination would affect more than just health care consumers. Insurance companies, drug companies, hospitals, and doctors have all changed the way they do business because of incentives and penalties in the health law. If it’s struck down, many of the “rules of the road” would literally be wiped away, including billing and payment mechanisms.
A new Democratic president could not drop the lawsuit because the Trump administration is not the plaintiff (the GOP attorneys general are). But a Democratic Congress and president could in theory make the entire issue go away by reinstating the penalty for failure to have insurance, even at a minimal amount. However, as far as the health law goes, for now, nothing is a sure thing.
As Nicholas Bagley, a law professor at the University of Michigan, Ann Arbor, who specializes in health issues, tweeted: “Among other things, the Affordable Care Act now dangles from a thread.”
Reproductive rights
A woman’s right to abortion – and even to birth control – also has been hanging by a thread at the high court for more than a decade. This past term, Mr. Roberts joined the liberals to invalidate a Louisiana law that would have closed most of the state’s abortion clinics, but he made it clear it was not a vote for abortion rights. The Louisiana law was too similar to a Texas law the court (without his vote) struck down in 2016, Mr. Roberts argued.
Ms. Ginsburg had been a stalwart supporter of reproductive freedom for women. In her nearly 3 decades on the court, she always voted with backers of abortion rights and birth control and led the dissenters in 2007 when the court upheld a federal ban on a specific abortion procedure.
Adding a justice opposed to abortion to the bench – which is what Trump has promised his supporters – would almost certainly tilt the court in favor of far more dramatic restrictions on the procedure and possibly an overturn of the landmark 1973 ruling Roe v. Wade.
But not only is abortion on the line: The court in recent years has repeatedly ruled that employers with religious objections can refuse to provide contraception.
And waiting in the lower-court pipeline are cases involving federal funding of Planned Parenthood in both the Medicaid and federal family planning programs, and the ability of individual health workers to decline to participate in abortion and other procedures.
For Ms. Ginsburg, those issues came down to a clear question of a woman’s guarantee of equal status under the law.
“Women, it is now acknowledged, have the talent, capacity, and right ‘to participate equally in the economic and social life of the Nation,’ ” she wrote in her dissent in that 2007 abortion case. “Their ability to realize their full potential, the Court recognized, is intimately connected to ‘their ability to control their reproductive lives.’ ”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
Sustaining high performance during the COVID-19 pandemic: Time for a paradigm shift?
Last week, I was working in our COVID ICU. Today, I had a day to catch up, and sat down at my desk to start answering patient phone calls and work on my overflowing e-mail inbox. On the top was a message reminding me that my mandatory online training requirements are overdue.
Many of my overdue tasks date back to somewhere between early March and mid-May, at a time when the United States was feeling the first real effects of the global COVID-19 pandemic. The radical disruption to our personal and professional lives was palpable. As physicians practicing chest medicine, we and our interprofessional teams faced the unknown every day as we cared for patients suffering from an illness we had never seen. Change was everywhere, and keeping up with new policy, practice protocols, and the reports and speculation that emanated from every corner of our society became an impossible proposition. We tried, though, because our patients and hospitals needed us – because people were dying. As physicians, we felt our moral responsibility to care for our patients to the best of our ability, and to keep ourselves and our team members – not to mention our family – safe and healthy.
Since that time, life has remained far from normal, but oddly a new routine has started to emerge. I’m getting used to wearing a mask outside of my house, and my skills with virtual meeting software have increased exponentially. As the months passed, my social media feed started to display images of families taking summer vacations – often in areas of the United States known for its wide open spaces – while riots over racial inequality raged in our major cities, and a second wave of COVID-19 cases hit many states across our country.
As highly trained professionals engaged on the front line of this pandemic, we have faced the challenges of COVID-19 with hard work and innovation. The countless extra hours have paid off, and what appeared to be a bizarre dichotomy, my social media feed I think reflected a real and appropriate need for us to take time to recover from the stresses of the spring and summer. Now fall is upon us, and with it the threat of another wave of new COVID cases. There is much more work that needs to be done.
Highly trained athletes understand the importance of a deliberate approach to their daily activities. A balance between stress and recovery is necessary to both sustain high performance and avoid injuries from overuse. Similarly, chronic excessive demands without adequate time to recover can create a state psychologists call “nonfunctional overreaching” – a short term reduction in performance that only returns to normal after a period of sustained rest. Although most of this work has been done in the sports psychology literature, it does not take a vivid imagination to extend these concepts into the health-care environment. As time goes on, we won’t be able to deliver the best care we can to our patients or family unless we take time to take care of ourselves.
In July, CHEST launched a new initiative to offer our members a series of monthly webinars to discuss the science of sustaining high performance and practical approaches to support individual, team, and organizational wellness during these challenging times. We have recruited nationally recognized experts from both within and outside of our subspecialty for this initiative and have partnered with the American Association of Critical-Care Nurses, the American Association for Respiratory Care, and The National Board for Respiratory Care to support all members of our interprofessional team.
Our efforts over the first 6 months of this initiative are focused on the science of high performance, including the latest tips for sleep, nutrition, and exercise, and are available in the new CHEST Wellness Resource Center to help you recover at the end of an exhausting day at work and help keep you at your best for tomorrow. Recognizing the tremendous toll that the first wave of the pandemic took on many members of our community, we have also identified resources to help recognize and provide timely assistance to those who need it the most. Our initiative also includes opportunities to express gratitude to our nursing and respiratory therapy colleagues for the sacrifices they make every day and to celebrate the things that put a smile on our faces and make the work day a little easier.
Physicians are resilient people, instilled through their training and the nature of their practice every day – but they are still people. The epidemic of burnout among health-care providers was well documented prior to the current pandemic, and without intervention, the ongoing pandemic will only increase the risk of deteriorating performance, errors, and injury to ourselves and members of our health-care team. It is important to emphasize that this wellness initiative is only the first step in our journey. Our health-care system was far from perfect before this pandemic, and with this challenge comes an opportunity for a paradigm shift – a chance for us to shape our practice environment in new and innovative ways to better serve our patients and support the teams who care for them. Our talented community of CHEST members are the individuals best suited to drive these practice improvements, both now and in the future. To do this effectively in this unprecedented time, however, is going to require members of our discipline to be more deliberate than ever in their approach to caring for themselves, their families, and their health-care teams as part of their everyday practice ... because those e-mails are not going to take care of themselves, and neither are the patients who will continue to turn to us for help in the months and years to come.
I would like to acknowledge and thank Dr. Steve Simpson and Dr. Tim Murgu for their thoughtful feedback and contributions to this article.
Last week, I was working in our COVID ICU. Today, I had a day to catch up, and sat down at my desk to start answering patient phone calls and work on my overflowing e-mail inbox. On the top was a message reminding me that my mandatory online training requirements are overdue.
Many of my overdue tasks date back to somewhere between early March and mid-May, at a time when the United States was feeling the first real effects of the global COVID-19 pandemic. The radical disruption to our personal and professional lives was palpable. As physicians practicing chest medicine, we and our interprofessional teams faced the unknown every day as we cared for patients suffering from an illness we had never seen. Change was everywhere, and keeping up with new policy, practice protocols, and the reports and speculation that emanated from every corner of our society became an impossible proposition. We tried, though, because our patients and hospitals needed us – because people were dying. As physicians, we felt our moral responsibility to care for our patients to the best of our ability, and to keep ourselves and our team members – not to mention our family – safe and healthy.
Since that time, life has remained far from normal, but oddly a new routine has started to emerge. I’m getting used to wearing a mask outside of my house, and my skills with virtual meeting software have increased exponentially. As the months passed, my social media feed started to display images of families taking summer vacations – often in areas of the United States known for its wide open spaces – while riots over racial inequality raged in our major cities, and a second wave of COVID-19 cases hit many states across our country.
As highly trained professionals engaged on the front line of this pandemic, we have faced the challenges of COVID-19 with hard work and innovation. The countless extra hours have paid off, and what appeared to be a bizarre dichotomy, my social media feed I think reflected a real and appropriate need for us to take time to recover from the stresses of the spring and summer. Now fall is upon us, and with it the threat of another wave of new COVID cases. There is much more work that needs to be done.
Highly trained athletes understand the importance of a deliberate approach to their daily activities. A balance between stress and recovery is necessary to both sustain high performance and avoid injuries from overuse. Similarly, chronic excessive demands without adequate time to recover can create a state psychologists call “nonfunctional overreaching” – a short term reduction in performance that only returns to normal after a period of sustained rest. Although most of this work has been done in the sports psychology literature, it does not take a vivid imagination to extend these concepts into the health-care environment. As time goes on, we won’t be able to deliver the best care we can to our patients or family unless we take time to take care of ourselves.
In July, CHEST launched a new initiative to offer our members a series of monthly webinars to discuss the science of sustaining high performance and practical approaches to support individual, team, and organizational wellness during these challenging times. We have recruited nationally recognized experts from both within and outside of our subspecialty for this initiative and have partnered with the American Association of Critical-Care Nurses, the American Association for Respiratory Care, and The National Board for Respiratory Care to support all members of our interprofessional team.
Our efforts over the first 6 months of this initiative are focused on the science of high performance, including the latest tips for sleep, nutrition, and exercise, and are available in the new CHEST Wellness Resource Center to help you recover at the end of an exhausting day at work and help keep you at your best for tomorrow. Recognizing the tremendous toll that the first wave of the pandemic took on many members of our community, we have also identified resources to help recognize and provide timely assistance to those who need it the most. Our initiative also includes opportunities to express gratitude to our nursing and respiratory therapy colleagues for the sacrifices they make every day and to celebrate the things that put a smile on our faces and make the work day a little easier.
Physicians are resilient people, instilled through their training and the nature of their practice every day – but they are still people. The epidemic of burnout among health-care providers was well documented prior to the current pandemic, and without intervention, the ongoing pandemic will only increase the risk of deteriorating performance, errors, and injury to ourselves and members of our health-care team. It is important to emphasize that this wellness initiative is only the first step in our journey. Our health-care system was far from perfect before this pandemic, and with this challenge comes an opportunity for a paradigm shift – a chance for us to shape our practice environment in new and innovative ways to better serve our patients and support the teams who care for them. Our talented community of CHEST members are the individuals best suited to drive these practice improvements, both now and in the future. To do this effectively in this unprecedented time, however, is going to require members of our discipline to be more deliberate than ever in their approach to caring for themselves, their families, and their health-care teams as part of their everyday practice ... because those e-mails are not going to take care of themselves, and neither are the patients who will continue to turn to us for help in the months and years to come.
I would like to acknowledge and thank Dr. Steve Simpson and Dr. Tim Murgu for their thoughtful feedback and contributions to this article.
Last week, I was working in our COVID ICU. Today, I had a day to catch up, and sat down at my desk to start answering patient phone calls and work on my overflowing e-mail inbox. On the top was a message reminding me that my mandatory online training requirements are overdue.
Many of my overdue tasks date back to somewhere between early March and mid-May, at a time when the United States was feeling the first real effects of the global COVID-19 pandemic. The radical disruption to our personal and professional lives was palpable. As physicians practicing chest medicine, we and our interprofessional teams faced the unknown every day as we cared for patients suffering from an illness we had never seen. Change was everywhere, and keeping up with new policy, practice protocols, and the reports and speculation that emanated from every corner of our society became an impossible proposition. We tried, though, because our patients and hospitals needed us – because people were dying. As physicians, we felt our moral responsibility to care for our patients to the best of our ability, and to keep ourselves and our team members – not to mention our family – safe and healthy.
Since that time, life has remained far from normal, but oddly a new routine has started to emerge. I’m getting used to wearing a mask outside of my house, and my skills with virtual meeting software have increased exponentially. As the months passed, my social media feed started to display images of families taking summer vacations – often in areas of the United States known for its wide open spaces – while riots over racial inequality raged in our major cities, and a second wave of COVID-19 cases hit many states across our country.
As highly trained professionals engaged on the front line of this pandemic, we have faced the challenges of COVID-19 with hard work and innovation. The countless extra hours have paid off, and what appeared to be a bizarre dichotomy, my social media feed I think reflected a real and appropriate need for us to take time to recover from the stresses of the spring and summer. Now fall is upon us, and with it the threat of another wave of new COVID cases. There is much more work that needs to be done.
Highly trained athletes understand the importance of a deliberate approach to their daily activities. A balance between stress and recovery is necessary to both sustain high performance and avoid injuries from overuse. Similarly, chronic excessive demands without adequate time to recover can create a state psychologists call “nonfunctional overreaching” – a short term reduction in performance that only returns to normal after a period of sustained rest. Although most of this work has been done in the sports psychology literature, it does not take a vivid imagination to extend these concepts into the health-care environment. As time goes on, we won’t be able to deliver the best care we can to our patients or family unless we take time to take care of ourselves.
In July, CHEST launched a new initiative to offer our members a series of monthly webinars to discuss the science of sustaining high performance and practical approaches to support individual, team, and organizational wellness during these challenging times. We have recruited nationally recognized experts from both within and outside of our subspecialty for this initiative and have partnered with the American Association of Critical-Care Nurses, the American Association for Respiratory Care, and The National Board for Respiratory Care to support all members of our interprofessional team.
Our efforts over the first 6 months of this initiative are focused on the science of high performance, including the latest tips for sleep, nutrition, and exercise, and are available in the new CHEST Wellness Resource Center to help you recover at the end of an exhausting day at work and help keep you at your best for tomorrow. Recognizing the tremendous toll that the first wave of the pandemic took on many members of our community, we have also identified resources to help recognize and provide timely assistance to those who need it the most. Our initiative also includes opportunities to express gratitude to our nursing and respiratory therapy colleagues for the sacrifices they make every day and to celebrate the things that put a smile on our faces and make the work day a little easier.
Physicians are resilient people, instilled through their training and the nature of their practice every day – but they are still people. The epidemic of burnout among health-care providers was well documented prior to the current pandemic, and without intervention, the ongoing pandemic will only increase the risk of deteriorating performance, errors, and injury to ourselves and members of our health-care team. It is important to emphasize that this wellness initiative is only the first step in our journey. Our health-care system was far from perfect before this pandemic, and with this challenge comes an opportunity for a paradigm shift – a chance for us to shape our practice environment in new and innovative ways to better serve our patients and support the teams who care for them. Our talented community of CHEST members are the individuals best suited to drive these practice improvements, both now and in the future. To do this effectively in this unprecedented time, however, is going to require members of our discipline to be more deliberate than ever in their approach to caring for themselves, their families, and their health-care teams as part of their everyday practice ... because those e-mails are not going to take care of themselves, and neither are the patients who will continue to turn to us for help in the months and years to come.
I would like to acknowledge and thank Dr. Steve Simpson and Dr. Tim Murgu for their thoughtful feedback and contributions to this article.
Pesco-Mediterranean diet, fasting ‘ideal’ to reduce CVD risk
A Pesco-Mediterranean diet consisting of plants, legumes, nuts, whole grains, extra-virgin olive oil (EVOO), moderate amounts of dairy products, and fish and/or seafood, together with intermittent fasting (also called time-restricted eating), can reduce risk for cardiovascular disease (CVD), according to a new review.
The authors presented the research and conceptual underpinnings of this approach, which “proposes that following a Pesco-Mediterranean diet with time-restricted eating is evidence-based and ideal for reducing cardiovascular risk,” study coauthor Sarah Smith, PhD, RN, of Saint Luke’s Mid America Heart Institute, Kansas City, Mo., said in an interview.
The review was published online September 14 in the Journal of the American College of Cardiology.
‘Omnivore’s dilemma’
A host of epidemiologic studies and randomized clinical trials support an association between the traditional Mediterranean diet and lower risk for all-cause and CVD mortality, coronary heart disease, metabolic syndrome, neurodegenerative diseases, and other adverse outcome. The diet has been subsequently endorsed by several sets of guidelines, including those from the Department of Health & Human Services and the Department of Agriculture, and the 2019 American Heart Association/American College of Cardiology primary prevention guidelines.
“Although humans are omnivores and can subsist on a myriad of foods, the ideal diet for health remains a dilemma for many people,” lead author James H. O’Keefe, MD, director of preventive cardiology at Saint Luke’s, said in a news release.
“Plant-rich diets reduce CVD risk; however, veganism is difficult to follow and can result in important nutrient deficiencies,” he stated.
On the other hand, “the standard American diet is high in red meat, especially processed meat from animals raised in inhumane conditions, fed unnatural foods, and often treated with hormones and antibiotics,” the authors pointed out.
Together with overconsumption of red meat, sugar and processed food contribute to poor health outcomes, Dr. Smith noted.
The review was designed to present the Pesco-Mediterranean diet as “a solution to the ‘omnivore’s dilemma’ about what to eat,” said Dr. O’Keefe.
Study coauthor Ibrahim M. Saeed, MD, a cardiologist at Saint Luke’s, added that the research “attempts to emphasize the results of landmark prospective trials that highlight good, healthy eating options rather than just [foods that people would] want to avoid.”
Key components
The traditional Mediterranean diet includes “unrestricted use of EVOO,” but the quality of the olive oil is “crucial” and it must be unrefined and cold pressed, the authors emphasized.
The “highly bioactive” polyphenols likely “underlie EVOO’s numerous cardiometabolic benefits,” the researchers wrote, noting that the 2014 PREDIMED trial provided “first-level scientific evidence of [EVOO’s] cardioprotective effects [if used] within the context of the Mediterranean diet.”
The authors recommend “generous use” of EVOO in salad dressings and vegetable dishes, pasta, rice, fish, sauces, or legumes.
They also review the role of tree nuts, noting that they are “nutrient-dense foods rich in unsaturated fats, fiber, protein, polyphenols, phytosterols, tocopherols, and nonsodium minerals” and have been shown beneficial in CVD prevention.
Legumes play a “central role” in the Mediterranean diet and are an “excellent source” of vegetable protein, folate, magnesium, and fiber. Legume consumption is associated with lowered risk for CVD, as well as improved blood glucose, cholesterol, blood pressure, and body weight, the authors stated.
Whole grains like barley, whole oats, brown rice, and quinoa are likewise central components of the traditional Mediterranean diet. The authors warned that refined grain products and commercial precooked pasta or pizza should be “consumed only in small amounts.”
Window of time
In time-restricted eating (which is one type of intermittent fasting), the daily intake of food is limited to a window of time, usually 6-12 hours each day, the authors explained.
When done regularly, this type of eating has been shown to both decrease intra-abdominal adipose tissue and reduce free-radical production. Additionally, it “elicits powerful cellular responses” that may reduce risks for systemic inflammation, diabetes, CVD, cancer, and neurodegenerative diseases.
However, the authors warned, the evidence supporting time-restricted eating is still preliminary.
‘Let food be thy medicine’
Andrew Freeman, MD, cochair of the ACC’s nutrition & lifestyle work group, cautioned that many American plant-based Mediterranean diets often include large amount of feta cheese and lamb and foods are often “heavily doused” in olive oil, while the traditional Mediterranean diet consists primarily of greens and lentils and is plant based.
“The goal would be to have a whole grain and leafy vegetables as the center of the meal, and – if an animal product such as fish is included – it should be limited to as little as possible and used as the garnish rather than the main dish,” he stated.
Moreover, fish are often exposed to large amount of toxins, heavy metals, and microplastics, so “don’t overdo eating fish,” he advised.
Dr. Freeman said that intermittent fasting “has a lot of promise and no harm” and concentrating food consumption during a shorter period in the day instead of “grazing throughout the day” will reduce constant snacking. “But don’t gorge yourself during those hours,” he warned.
Dr. Freeman concluded by citing the guidance of Hippocrates: “Let food be thy medicine.
“There’s some real truth to that,” he added.
No source of funding was listed. Dr. Smith and Dr. Freeman disclosed no relevant financial relationships. Dr. O’Keefe has a major ownership interest in CardioTabs, a supplement company that sells some products containing omega-3 fatty acids.
A version of this article originally appeared on Medscape.com.
A Pesco-Mediterranean diet consisting of plants, legumes, nuts, whole grains, extra-virgin olive oil (EVOO), moderate amounts of dairy products, and fish and/or seafood, together with intermittent fasting (also called time-restricted eating), can reduce risk for cardiovascular disease (CVD), according to a new review.
The authors presented the research and conceptual underpinnings of this approach, which “proposes that following a Pesco-Mediterranean diet with time-restricted eating is evidence-based and ideal for reducing cardiovascular risk,” study coauthor Sarah Smith, PhD, RN, of Saint Luke’s Mid America Heart Institute, Kansas City, Mo., said in an interview.
The review was published online September 14 in the Journal of the American College of Cardiology.
‘Omnivore’s dilemma’
A host of epidemiologic studies and randomized clinical trials support an association between the traditional Mediterranean diet and lower risk for all-cause and CVD mortality, coronary heart disease, metabolic syndrome, neurodegenerative diseases, and other adverse outcome. The diet has been subsequently endorsed by several sets of guidelines, including those from the Department of Health & Human Services and the Department of Agriculture, and the 2019 American Heart Association/American College of Cardiology primary prevention guidelines.
“Although humans are omnivores and can subsist on a myriad of foods, the ideal diet for health remains a dilemma for many people,” lead author James H. O’Keefe, MD, director of preventive cardiology at Saint Luke’s, said in a news release.
“Plant-rich diets reduce CVD risk; however, veganism is difficult to follow and can result in important nutrient deficiencies,” he stated.
On the other hand, “the standard American diet is high in red meat, especially processed meat from animals raised in inhumane conditions, fed unnatural foods, and often treated with hormones and antibiotics,” the authors pointed out.
Together with overconsumption of red meat, sugar and processed food contribute to poor health outcomes, Dr. Smith noted.
The review was designed to present the Pesco-Mediterranean diet as “a solution to the ‘omnivore’s dilemma’ about what to eat,” said Dr. O’Keefe.
Study coauthor Ibrahim M. Saeed, MD, a cardiologist at Saint Luke’s, added that the research “attempts to emphasize the results of landmark prospective trials that highlight good, healthy eating options rather than just [foods that people would] want to avoid.”
Key components
The traditional Mediterranean diet includes “unrestricted use of EVOO,” but the quality of the olive oil is “crucial” and it must be unrefined and cold pressed, the authors emphasized.
The “highly bioactive” polyphenols likely “underlie EVOO’s numerous cardiometabolic benefits,” the researchers wrote, noting that the 2014 PREDIMED trial provided “first-level scientific evidence of [EVOO’s] cardioprotective effects [if used] within the context of the Mediterranean diet.”
The authors recommend “generous use” of EVOO in salad dressings and vegetable dishes, pasta, rice, fish, sauces, or legumes.
They also review the role of tree nuts, noting that they are “nutrient-dense foods rich in unsaturated fats, fiber, protein, polyphenols, phytosterols, tocopherols, and nonsodium minerals” and have been shown beneficial in CVD prevention.
Legumes play a “central role” in the Mediterranean diet and are an “excellent source” of vegetable protein, folate, magnesium, and fiber. Legume consumption is associated with lowered risk for CVD, as well as improved blood glucose, cholesterol, blood pressure, and body weight, the authors stated.
Whole grains like barley, whole oats, brown rice, and quinoa are likewise central components of the traditional Mediterranean diet. The authors warned that refined grain products and commercial precooked pasta or pizza should be “consumed only in small amounts.”
Window of time
In time-restricted eating (which is one type of intermittent fasting), the daily intake of food is limited to a window of time, usually 6-12 hours each day, the authors explained.
When done regularly, this type of eating has been shown to both decrease intra-abdominal adipose tissue and reduce free-radical production. Additionally, it “elicits powerful cellular responses” that may reduce risks for systemic inflammation, diabetes, CVD, cancer, and neurodegenerative diseases.
However, the authors warned, the evidence supporting time-restricted eating is still preliminary.
‘Let food be thy medicine’
Andrew Freeman, MD, cochair of the ACC’s nutrition & lifestyle work group, cautioned that many American plant-based Mediterranean diets often include large amount of feta cheese and lamb and foods are often “heavily doused” in olive oil, while the traditional Mediterranean diet consists primarily of greens and lentils and is plant based.
“The goal would be to have a whole grain and leafy vegetables as the center of the meal, and – if an animal product such as fish is included – it should be limited to as little as possible and used as the garnish rather than the main dish,” he stated.
Moreover, fish are often exposed to large amount of toxins, heavy metals, and microplastics, so “don’t overdo eating fish,” he advised.
Dr. Freeman said that intermittent fasting “has a lot of promise and no harm” and concentrating food consumption during a shorter period in the day instead of “grazing throughout the day” will reduce constant snacking. “But don’t gorge yourself during those hours,” he warned.
Dr. Freeman concluded by citing the guidance of Hippocrates: “Let food be thy medicine.
“There’s some real truth to that,” he added.
No source of funding was listed. Dr. Smith and Dr. Freeman disclosed no relevant financial relationships. Dr. O’Keefe has a major ownership interest in CardioTabs, a supplement company that sells some products containing omega-3 fatty acids.
A version of this article originally appeared on Medscape.com.
A Pesco-Mediterranean diet consisting of plants, legumes, nuts, whole grains, extra-virgin olive oil (EVOO), moderate amounts of dairy products, and fish and/or seafood, together with intermittent fasting (also called time-restricted eating), can reduce risk for cardiovascular disease (CVD), according to a new review.
The authors presented the research and conceptual underpinnings of this approach, which “proposes that following a Pesco-Mediterranean diet with time-restricted eating is evidence-based and ideal for reducing cardiovascular risk,” study coauthor Sarah Smith, PhD, RN, of Saint Luke’s Mid America Heart Institute, Kansas City, Mo., said in an interview.
The review was published online September 14 in the Journal of the American College of Cardiology.
‘Omnivore’s dilemma’
A host of epidemiologic studies and randomized clinical trials support an association between the traditional Mediterranean diet and lower risk for all-cause and CVD mortality, coronary heart disease, metabolic syndrome, neurodegenerative diseases, and other adverse outcome. The diet has been subsequently endorsed by several sets of guidelines, including those from the Department of Health & Human Services and the Department of Agriculture, and the 2019 American Heart Association/American College of Cardiology primary prevention guidelines.
“Although humans are omnivores and can subsist on a myriad of foods, the ideal diet for health remains a dilemma for many people,” lead author James H. O’Keefe, MD, director of preventive cardiology at Saint Luke’s, said in a news release.
“Plant-rich diets reduce CVD risk; however, veganism is difficult to follow and can result in important nutrient deficiencies,” he stated.
On the other hand, “the standard American diet is high in red meat, especially processed meat from animals raised in inhumane conditions, fed unnatural foods, and often treated with hormones and antibiotics,” the authors pointed out.
Together with overconsumption of red meat, sugar and processed food contribute to poor health outcomes, Dr. Smith noted.
The review was designed to present the Pesco-Mediterranean diet as “a solution to the ‘omnivore’s dilemma’ about what to eat,” said Dr. O’Keefe.
Study coauthor Ibrahim M. Saeed, MD, a cardiologist at Saint Luke’s, added that the research “attempts to emphasize the results of landmark prospective trials that highlight good, healthy eating options rather than just [foods that people would] want to avoid.”
Key components
The traditional Mediterranean diet includes “unrestricted use of EVOO,” but the quality of the olive oil is “crucial” and it must be unrefined and cold pressed, the authors emphasized.
The “highly bioactive” polyphenols likely “underlie EVOO’s numerous cardiometabolic benefits,” the researchers wrote, noting that the 2014 PREDIMED trial provided “first-level scientific evidence of [EVOO’s] cardioprotective effects [if used] within the context of the Mediterranean diet.”
The authors recommend “generous use” of EVOO in salad dressings and vegetable dishes, pasta, rice, fish, sauces, or legumes.
They also review the role of tree nuts, noting that they are “nutrient-dense foods rich in unsaturated fats, fiber, protein, polyphenols, phytosterols, tocopherols, and nonsodium minerals” and have been shown beneficial in CVD prevention.
Legumes play a “central role” in the Mediterranean diet and are an “excellent source” of vegetable protein, folate, magnesium, and fiber. Legume consumption is associated with lowered risk for CVD, as well as improved blood glucose, cholesterol, blood pressure, and body weight, the authors stated.
Whole grains like barley, whole oats, brown rice, and quinoa are likewise central components of the traditional Mediterranean diet. The authors warned that refined grain products and commercial precooked pasta or pizza should be “consumed only in small amounts.”
Window of time
In time-restricted eating (which is one type of intermittent fasting), the daily intake of food is limited to a window of time, usually 6-12 hours each day, the authors explained.
When done regularly, this type of eating has been shown to both decrease intra-abdominal adipose tissue and reduce free-radical production. Additionally, it “elicits powerful cellular responses” that may reduce risks for systemic inflammation, diabetes, CVD, cancer, and neurodegenerative diseases.
However, the authors warned, the evidence supporting time-restricted eating is still preliminary.
‘Let food be thy medicine’
Andrew Freeman, MD, cochair of the ACC’s nutrition & lifestyle work group, cautioned that many American plant-based Mediterranean diets often include large amount of feta cheese and lamb and foods are often “heavily doused” in olive oil, while the traditional Mediterranean diet consists primarily of greens and lentils and is plant based.
“The goal would be to have a whole grain and leafy vegetables as the center of the meal, and – if an animal product such as fish is included – it should be limited to as little as possible and used as the garnish rather than the main dish,” he stated.
Moreover, fish are often exposed to large amount of toxins, heavy metals, and microplastics, so “don’t overdo eating fish,” he advised.
Dr. Freeman said that intermittent fasting “has a lot of promise and no harm” and concentrating food consumption during a shorter period in the day instead of “grazing throughout the day” will reduce constant snacking. “But don’t gorge yourself during those hours,” he warned.
Dr. Freeman concluded by citing the guidance of Hippocrates: “Let food be thy medicine.
“There’s some real truth to that,” he added.
No source of funding was listed. Dr. Smith and Dr. Freeman disclosed no relevant financial relationships. Dr. O’Keefe has a major ownership interest in CardioTabs, a supplement company that sells some products containing omega-3 fatty acids.
A version of this article originally appeared on Medscape.com.
Observational study again suggests lasting impact of COVID-19 on heart
A new study using cardiac magnetic resonance (CMR) imaging to examine the effects of novel coronavirus infection on the heart showed signs suggestive of myocarditis in 4 out of 26 competitive athletes who recovered from asymptomatic or mild cases of COVID-19.
While these and other similar findings are concerning, commentators are saying the results are preliminary and do not indicate widespread CMR screening is appropriate.
Two of the 4 patients showing signs of myocarditis in this series had no symptoms of COVID-19 but tested positive on routine testing. An additional 12 student athletes (46%) showed late gadolinium enhancement (LGE), of whom 8 (30.8%) had LGE without T2 elevation suggestive of prior myocardial injury.
An additional 12 student athletes (46%) showed late gadolinium enhancement (LGE), of whom 8 (31%) had LGE without T2 elevation suggestive of prior myocardial injury.
This finding, said Saurabh Rajpal, MBBS, MD, the study’s lead author, “could suggest prior myocardial injury or it could suggest athletic myocardial adaptation.”
In a research letter published in JAMA Cardiology, Rajpal and colleagues at Ohio State University in Columbus, described the findings of comprehensive CMR examinations in competitive athletes referred to the sport medicine clinic after testing positive for COVID-19 on reverse transcriptase-polymerase chain reaction between June and August 2020.
The university had made the decision in the spring to use CMR imaging as a screening tool for return to play, said Dr. Rajpal. While CMR is being used for research purposes, the American College of Cardiology’s recent “consensus expert opinion” statement on resumption of sport and exercise after COVID-19 infection does not require CMR imaging for resumption of competitive activity (JAMA Cardiol. 2020 May 13. doi:10.1001/jamacardio.2020.2136).
None of the athletes required hospitalization for their illness, and only 27% reported mild symptoms during the short-term infection, including sore throat, shortness of breath, myalgia, and fever.
On the day of CMR imaging, ECG and transthoracic echocardiography were performed, and serum troponin I was measured. There were no diagnostic ST/T wave changes, ventricular function and volumes were normal, and no athletes showed elevated serum troponin levels.
The updated Lake Louise Criteria were used to assess CMR findings consistent with myocarditis.
“I don’t think this is a COVID-specific issue. We have seen myocarditis after other viral infections; it’s just that COVID-19 is the most studied thus far, and with strenuous activity, inflammation in the heart can be risky,” Dr. Rajpal said in an interview. He added that more long-term and larger studies with control populations are needed.
His group is continuing to follow these athletes and has suggested that CMR “may provide an excellent risk-stratification assessment for myocarditis in athletes who have recovered from COVID-19 to guide safe competitive sports participation.”
Significance still unknown
Matthew Martinez, MD, the director of sports cardiology at Atlantic Health – Morristown (N.J.) Medical Center and the Gagnon Cardiovascular Institute, urged caution in making too much of the findings of this small study.
“We know that viruses cause myocardial damage and myocarditis. What we don’t know is how important these findings are. And in terms of risk, would we find the same phenomenon if we did this, say, in flu patients or in other age groups?” Dr. Martinez said in an interview.
“I haven’t seen all the images, but what I’d want to know is are these very subtle findings? Are these overt findings? Is this part of an active individual with symptoms? I need to know a little more data before I can tell if this influences the increased risk of sudden cardiac death that we often associate with myocarditis. I’m not sure how this should influence making decisions with regards to return to play.”
Dr. Martinez, who is the ACC’s chair of Sports and Exercise but was not an author of their recent guidance on return to sport, said that he is not routinely using CMR to assess athletes post-infection, as per the ACC’s recommendations.
“My approach is to evaluate anybody with a history of COVID infection and, first, determine whether it was an important infection with significant symptoms or not. And then, if they’re participating at a high level or are professional athletes, I would suggest an ECG, echo, and troponin. That’s our recommendation for the last several months and is still an appropriate way to evaluate that group.”
“In the presence of an abnormality or ongoing symptoms, I would ask for an MRI at that point,” said Dr. Martinez.
“We just don’t have much data on athletes with no symptoms to use to interpret these CMR findings and the study didn’t offer any controls. We don’t even know if these findings are new findings or old findings that have just been identified now,” he added.
New, updated recommendations from the ACC are coming soon, said Dr. Martinez. “I do not expect them to include CMR as first line.”
Cardiologists concerned about misinformation
This is at least the fourth study showing myocardial damage post-COVID-19 infection and there is concern in the medical community that the media has overstated the risks of heart damage, especially in athletes, and at the same time overstated the benefits of CMR.
In particular, Puntmann et al reported in July a 100-patient study that showed evidence of myocardial inflammation by CMR in 78% of patients recently recovered from a bout of COVID-19 (JAMA Cardiol. 2020 Jul 27; doi:10.1001/jamacardio.2020.3557).
“That paper is completely problematic,” John Mandrola, MD, of Baptists Medical Associates, Louisville, Ky., said in an interview. “It has the same overarching weaknesses [of other studies] that it’s observational and retrospective, but there were also numerical issues. So to me that paper is an interesting observation, but utterly unconvincing and preliminary,” said Dr. Mandrola.
Those limitations didn’t stop the study from garnering media attention, however. The Altmetric score (an attention score that tracks all mentions of an article in the media and on social media) for the Puntmann et al paper is approaching 13,000, including coverage from 276 news outlets and more than 19,000 tweets, putting it in the 99th percentile of all research outputs tracked by Altmetric to date.
To counter this, an “open letter” posted online just days before the Rajpal study published urging professional societies to “offer clear guidance discouraging CMR screening for COVID-19 related heart abnormalities in asymptomatic members of the general public.” The letter was signed by 51 clinicians, researchers, and imaging specialists from around the world.
Dr. Mandrola, one of the signatories, said: “This topic really scares people, and when it gets in the media like this, I think the leaders of these societies need to come out and say something really clear on major news networks letting people know that it’s just way too premature to start doing CMRs on every athlete that’s gotten this virus.”
“I understand that the current guidelines may be clear that CMR is not a first-line test for this indication, but when the media coverage is so extensive and so overblown, I wonder how much impact the guidelines will have in countering this fear that’s in the community,” he added.
Asked to comment on the letter, Dr. Rajpal said he agrees with the signatories that asymptomatic people from general population do not need routine cardiac MRI. “However, competitive athletes are a different story. Testing depends on risk assessment in specific population and competitive athletes as per our protocol will get enhanced cardiac workup including CMR for responsible and safe start of competitive sports. ... In the present scenario, while we get more data including control data, we will continue with our current protocol.”
Dr. Mandrola is Medscape Cardiology’s Chief Cardiology Consultant. MDedge is part of the Medscape Professional Network.
This article first appeared on Medscape.com.
A new study using cardiac magnetic resonance (CMR) imaging to examine the effects of novel coronavirus infection on the heart showed signs suggestive of myocarditis in 4 out of 26 competitive athletes who recovered from asymptomatic or mild cases of COVID-19.
While these and other similar findings are concerning, commentators are saying the results are preliminary and do not indicate widespread CMR screening is appropriate.
Two of the 4 patients showing signs of myocarditis in this series had no symptoms of COVID-19 but tested positive on routine testing. An additional 12 student athletes (46%) showed late gadolinium enhancement (LGE), of whom 8 (30.8%) had LGE without T2 elevation suggestive of prior myocardial injury.
An additional 12 student athletes (46%) showed late gadolinium enhancement (LGE), of whom 8 (31%) had LGE without T2 elevation suggestive of prior myocardial injury.
This finding, said Saurabh Rajpal, MBBS, MD, the study’s lead author, “could suggest prior myocardial injury or it could suggest athletic myocardial adaptation.”
In a research letter published in JAMA Cardiology, Rajpal and colleagues at Ohio State University in Columbus, described the findings of comprehensive CMR examinations in competitive athletes referred to the sport medicine clinic after testing positive for COVID-19 on reverse transcriptase-polymerase chain reaction between June and August 2020.
The university had made the decision in the spring to use CMR imaging as a screening tool for return to play, said Dr. Rajpal. While CMR is being used for research purposes, the American College of Cardiology’s recent “consensus expert opinion” statement on resumption of sport and exercise after COVID-19 infection does not require CMR imaging for resumption of competitive activity (JAMA Cardiol. 2020 May 13. doi:10.1001/jamacardio.2020.2136).
None of the athletes required hospitalization for their illness, and only 27% reported mild symptoms during the short-term infection, including sore throat, shortness of breath, myalgia, and fever.
On the day of CMR imaging, ECG and transthoracic echocardiography were performed, and serum troponin I was measured. There were no diagnostic ST/T wave changes, ventricular function and volumes were normal, and no athletes showed elevated serum troponin levels.
The updated Lake Louise Criteria were used to assess CMR findings consistent with myocarditis.
“I don’t think this is a COVID-specific issue. We have seen myocarditis after other viral infections; it’s just that COVID-19 is the most studied thus far, and with strenuous activity, inflammation in the heart can be risky,” Dr. Rajpal said in an interview. He added that more long-term and larger studies with control populations are needed.
His group is continuing to follow these athletes and has suggested that CMR “may provide an excellent risk-stratification assessment for myocarditis in athletes who have recovered from COVID-19 to guide safe competitive sports participation.”
Significance still unknown
Matthew Martinez, MD, the director of sports cardiology at Atlantic Health – Morristown (N.J.) Medical Center and the Gagnon Cardiovascular Institute, urged caution in making too much of the findings of this small study.
“We know that viruses cause myocardial damage and myocarditis. What we don’t know is how important these findings are. And in terms of risk, would we find the same phenomenon if we did this, say, in flu patients or in other age groups?” Dr. Martinez said in an interview.
“I haven’t seen all the images, but what I’d want to know is are these very subtle findings? Are these overt findings? Is this part of an active individual with symptoms? I need to know a little more data before I can tell if this influences the increased risk of sudden cardiac death that we often associate with myocarditis. I’m not sure how this should influence making decisions with regards to return to play.”
Dr. Martinez, who is the ACC’s chair of Sports and Exercise but was not an author of their recent guidance on return to sport, said that he is not routinely using CMR to assess athletes post-infection, as per the ACC’s recommendations.
“My approach is to evaluate anybody with a history of COVID infection and, first, determine whether it was an important infection with significant symptoms or not. And then, if they’re participating at a high level or are professional athletes, I would suggest an ECG, echo, and troponin. That’s our recommendation for the last several months and is still an appropriate way to evaluate that group.”
“In the presence of an abnormality or ongoing symptoms, I would ask for an MRI at that point,” said Dr. Martinez.
“We just don’t have much data on athletes with no symptoms to use to interpret these CMR findings and the study didn’t offer any controls. We don’t even know if these findings are new findings or old findings that have just been identified now,” he added.
New, updated recommendations from the ACC are coming soon, said Dr. Martinez. “I do not expect them to include CMR as first line.”
Cardiologists concerned about misinformation
This is at least the fourth study showing myocardial damage post-COVID-19 infection and there is concern in the medical community that the media has overstated the risks of heart damage, especially in athletes, and at the same time overstated the benefits of CMR.
In particular, Puntmann et al reported in July a 100-patient study that showed evidence of myocardial inflammation by CMR in 78% of patients recently recovered from a bout of COVID-19 (JAMA Cardiol. 2020 Jul 27; doi:10.1001/jamacardio.2020.3557).
“That paper is completely problematic,” John Mandrola, MD, of Baptists Medical Associates, Louisville, Ky., said in an interview. “It has the same overarching weaknesses [of other studies] that it’s observational and retrospective, but there were also numerical issues. So to me that paper is an interesting observation, but utterly unconvincing and preliminary,” said Dr. Mandrola.
Those limitations didn’t stop the study from garnering media attention, however. The Altmetric score (an attention score that tracks all mentions of an article in the media and on social media) for the Puntmann et al paper is approaching 13,000, including coverage from 276 news outlets and more than 19,000 tweets, putting it in the 99th percentile of all research outputs tracked by Altmetric to date.
To counter this, an “open letter” posted online just days before the Rajpal study published urging professional societies to “offer clear guidance discouraging CMR screening for COVID-19 related heart abnormalities in asymptomatic members of the general public.” The letter was signed by 51 clinicians, researchers, and imaging specialists from around the world.
Dr. Mandrola, one of the signatories, said: “This topic really scares people, and when it gets in the media like this, I think the leaders of these societies need to come out and say something really clear on major news networks letting people know that it’s just way too premature to start doing CMRs on every athlete that’s gotten this virus.”
“I understand that the current guidelines may be clear that CMR is not a first-line test for this indication, but when the media coverage is so extensive and so overblown, I wonder how much impact the guidelines will have in countering this fear that’s in the community,” he added.
Asked to comment on the letter, Dr. Rajpal said he agrees with the signatories that asymptomatic people from general population do not need routine cardiac MRI. “However, competitive athletes are a different story. Testing depends on risk assessment in specific population and competitive athletes as per our protocol will get enhanced cardiac workup including CMR for responsible and safe start of competitive sports. ... In the present scenario, while we get more data including control data, we will continue with our current protocol.”
Dr. Mandrola is Medscape Cardiology’s Chief Cardiology Consultant. MDedge is part of the Medscape Professional Network.
This article first appeared on Medscape.com.
A new study using cardiac magnetic resonance (CMR) imaging to examine the effects of novel coronavirus infection on the heart showed signs suggestive of myocarditis in 4 out of 26 competitive athletes who recovered from asymptomatic or mild cases of COVID-19.
While these and other similar findings are concerning, commentators are saying the results are preliminary and do not indicate widespread CMR screening is appropriate.
Two of the 4 patients showing signs of myocarditis in this series had no symptoms of COVID-19 but tested positive on routine testing. An additional 12 student athletes (46%) showed late gadolinium enhancement (LGE), of whom 8 (30.8%) had LGE without T2 elevation suggestive of prior myocardial injury.
An additional 12 student athletes (46%) showed late gadolinium enhancement (LGE), of whom 8 (31%) had LGE without T2 elevation suggestive of prior myocardial injury.
This finding, said Saurabh Rajpal, MBBS, MD, the study’s lead author, “could suggest prior myocardial injury or it could suggest athletic myocardial adaptation.”
In a research letter published in JAMA Cardiology, Rajpal and colleagues at Ohio State University in Columbus, described the findings of comprehensive CMR examinations in competitive athletes referred to the sport medicine clinic after testing positive for COVID-19 on reverse transcriptase-polymerase chain reaction between June and August 2020.
The university had made the decision in the spring to use CMR imaging as a screening tool for return to play, said Dr. Rajpal. While CMR is being used for research purposes, the American College of Cardiology’s recent “consensus expert opinion” statement on resumption of sport and exercise after COVID-19 infection does not require CMR imaging for resumption of competitive activity (JAMA Cardiol. 2020 May 13. doi:10.1001/jamacardio.2020.2136).
None of the athletes required hospitalization for their illness, and only 27% reported mild symptoms during the short-term infection, including sore throat, shortness of breath, myalgia, and fever.
On the day of CMR imaging, ECG and transthoracic echocardiography were performed, and serum troponin I was measured. There were no diagnostic ST/T wave changes, ventricular function and volumes were normal, and no athletes showed elevated serum troponin levels.
The updated Lake Louise Criteria were used to assess CMR findings consistent with myocarditis.
“I don’t think this is a COVID-specific issue. We have seen myocarditis after other viral infections; it’s just that COVID-19 is the most studied thus far, and with strenuous activity, inflammation in the heart can be risky,” Dr. Rajpal said in an interview. He added that more long-term and larger studies with control populations are needed.
His group is continuing to follow these athletes and has suggested that CMR “may provide an excellent risk-stratification assessment for myocarditis in athletes who have recovered from COVID-19 to guide safe competitive sports participation.”
Significance still unknown
Matthew Martinez, MD, the director of sports cardiology at Atlantic Health – Morristown (N.J.) Medical Center and the Gagnon Cardiovascular Institute, urged caution in making too much of the findings of this small study.
“We know that viruses cause myocardial damage and myocarditis. What we don’t know is how important these findings are. And in terms of risk, would we find the same phenomenon if we did this, say, in flu patients or in other age groups?” Dr. Martinez said in an interview.
“I haven’t seen all the images, but what I’d want to know is are these very subtle findings? Are these overt findings? Is this part of an active individual with symptoms? I need to know a little more data before I can tell if this influences the increased risk of sudden cardiac death that we often associate with myocarditis. I’m not sure how this should influence making decisions with regards to return to play.”
Dr. Martinez, who is the ACC’s chair of Sports and Exercise but was not an author of their recent guidance on return to sport, said that he is not routinely using CMR to assess athletes post-infection, as per the ACC’s recommendations.
“My approach is to evaluate anybody with a history of COVID infection and, first, determine whether it was an important infection with significant symptoms or not. And then, if they’re participating at a high level or are professional athletes, I would suggest an ECG, echo, and troponin. That’s our recommendation for the last several months and is still an appropriate way to evaluate that group.”
“In the presence of an abnormality or ongoing symptoms, I would ask for an MRI at that point,” said Dr. Martinez.
“We just don’t have much data on athletes with no symptoms to use to interpret these CMR findings and the study didn’t offer any controls. We don’t even know if these findings are new findings or old findings that have just been identified now,” he added.
New, updated recommendations from the ACC are coming soon, said Dr. Martinez. “I do not expect them to include CMR as first line.”
Cardiologists concerned about misinformation
This is at least the fourth study showing myocardial damage post-COVID-19 infection and there is concern in the medical community that the media has overstated the risks of heart damage, especially in athletes, and at the same time overstated the benefits of CMR.
In particular, Puntmann et al reported in July a 100-patient study that showed evidence of myocardial inflammation by CMR in 78% of patients recently recovered from a bout of COVID-19 (JAMA Cardiol. 2020 Jul 27; doi:10.1001/jamacardio.2020.3557).
“That paper is completely problematic,” John Mandrola, MD, of Baptists Medical Associates, Louisville, Ky., said in an interview. “It has the same overarching weaknesses [of other studies] that it’s observational and retrospective, but there were also numerical issues. So to me that paper is an interesting observation, but utterly unconvincing and preliminary,” said Dr. Mandrola.
Those limitations didn’t stop the study from garnering media attention, however. The Altmetric score (an attention score that tracks all mentions of an article in the media and on social media) for the Puntmann et al paper is approaching 13,000, including coverage from 276 news outlets and more than 19,000 tweets, putting it in the 99th percentile of all research outputs tracked by Altmetric to date.
To counter this, an “open letter” posted online just days before the Rajpal study published urging professional societies to “offer clear guidance discouraging CMR screening for COVID-19 related heart abnormalities in asymptomatic members of the general public.” The letter was signed by 51 clinicians, researchers, and imaging specialists from around the world.
Dr. Mandrola, one of the signatories, said: “This topic really scares people, and when it gets in the media like this, I think the leaders of these societies need to come out and say something really clear on major news networks letting people know that it’s just way too premature to start doing CMRs on every athlete that’s gotten this virus.”
“I understand that the current guidelines may be clear that CMR is not a first-line test for this indication, but when the media coverage is so extensive and so overblown, I wonder how much impact the guidelines will have in countering this fear that’s in the community,” he added.
Asked to comment on the letter, Dr. Rajpal said he agrees with the signatories that asymptomatic people from general population do not need routine cardiac MRI. “However, competitive athletes are a different story. Testing depends on risk assessment in specific population and competitive athletes as per our protocol will get enhanced cardiac workup including CMR for responsible and safe start of competitive sports. ... In the present scenario, while we get more data including control data, we will continue with our current protocol.”
Dr. Mandrola is Medscape Cardiology’s Chief Cardiology Consultant. MDedge is part of the Medscape Professional Network.
This article first appeared on Medscape.com.
Physician reimbursement 2021: Who are the big winners?
Amid all the chaos and problems caused by COVID-19, one might hope that physicians would get a break on their complicated payment-reporting programs.
But that’s not the case: The government recently released the 2021 proposed rule for the Quality Payment Program (QPP), often referred to by its most popular participation track, the Merit-Based Incentive Payment System (MIPS). The program, which launched in 2017, gets annual updates, and this year is no different.
Some good news has made primary care and some other physicians happy.
The government’s proposal includes significant changes to reimbursement for all physicians.
Specialties that rely heavily on office-based E/M services are delighted at this change. Those include internists, family physicians, neurologists, pulmonologists, dermatologists, and all other specialties that rely heavily on office encounters.
According to the estimates from the Centers for Medicare & Medicaid Services (CMS), endocrinologists and rheumatologists are the big winners, at 17% and 16% projected increases, respectively. The government has been pushing to make this shift in reimbursement from surgeries and procedures to office visits for years. Although some physicians may celebrate the change, others will not.
The reimbursement plan for professional services depends on budget neutrality, meaning that the budget increases need to be counterbalanced by budget declines. Specialties that rely heavily on procedures and surgeries will suffer losses. These corresponding reductions felt by proceduralists and surgeons will counterbalance the good fortune of physicians who rely on office visits for the bulk of their revenue. Radiologists, for example, are projected by CMS to experience a 11% downturn, and cardiac surgeons face a 9% decline.
These consequences are significant. The 2021 shift may be the single biggest transfer of reimbursement in the history of the scale, which was adopted in the early 1990s.
If the change affected only Medicare reimbursement, perhaps it would be less significant. Because the majority of private payers use the government’s scale – the resource-based relative value scale – the impact will reverberate across physicians’ bottom lines. Given the state of many physicians’ finances, driven by the pandemic, this may send some affected physicians into a downward spiral.
The boost to E/M reimbursement – which represents approximately 20% of the overall Medicare payout to physicians each year – puts downward pressure on the professional services conversion factor as well.
For 2021, it is proposed to be $32.2605, representing a decrease of $3.83 from the 2020 conversion factor of $36.0896. The resultant conversion factor – which serves as a multiplier applied to the relative value unit to come up with the payment – effectively reduces payments to physicians across the board by 10.6%. Thus, even those who enjoy the benefits of the new E/M increases will see the potential reimbursement high point cut down.
Before launching into the changes in store for 2021, it’s good to determine whether you are an eligible clinician: You need to have more than $90,000 in Medicare Part B charges per year, see more than 200 Medicare Part B patients per year, and provide 200 or more covered professional services to Part B patients.
The program is voluntary, but there are steep penalties for eligible clinicians who don’t participate. For the 2021 reporting year, a 9% penalty will be imposed on Medicare reimbursement in 2023 in the event of participation failure. You can verify your participation status here; you’ll need your National Provider Identifier to run the search, but it takes only seconds to determine your eligibility.
A 9% penalty is a pretty big hit to your income. With 9% at stake, eligible clinicians need to actively engage in the program. Although there have been changes, the basic four-category system remains the same for the MIPS track, as follows: quality, cost, improvement activities, and promoting interoperability.
The four category weights, used to evaluate performance, are changing in 2021. Cost category weight goes up by 5 percentage points, to be 20% of the clinician’s score, and the quality category goes down by 5 percentage points to contribute 40% to the weight. Promoting interoperability remains 25% of the score, with improvement activities constituting the final 15%.
Other key changes include the following:
- The CMS’s Web interface for submission for quality measures will be shuttered in 2021. Users of this submission method will have to find and use another way to report their quality measures.
- Quality measures will be scored against pre-COVID benchmarks in lieu of comparisons with the 2020 reporting year; 206 quality measures are proposed for 2021, compared with the current list of 219.
- Telehealth will be incorporated in the cost category by updates to the measure specifications for the episode-based and total per capita cost measures.
- A new health information exchange measure is added to the promoting interoperability category, and “incorporating” replaces “reconciling” in the reporting requirement “Support Electronic Referral Loops by Receiving and Incorporating Health Information.”
To avoid the 9% penalty, eligible clinicians must earn 50 points in 2021, up from 45 in the current year. Achieving “exceptional performance” remains at 85 points. This elevated level of engagement allows access to a pot of money Congress set aside for high performers.
Many physicians feel that too much work is required to earn the “paltry” bonuses; even a perfect score of 100 has only resulted in bonuses of 1.88% and 1.68%, respectively, in the past 2 years. That includes the $500 million allocation that Congress set aside; this extra funding to reward exceptional performance is only available for the first 6 years of the law. Although the 2019 scores have been released to participants, CMS has not yet announced the overall national average, but it’s expected to be minimal.
The combination of meager payouts and a diminishing funding mechanism has physicians questioning participation altogether. My recent conversations with physicians who qualify for the program revealed their intention to participate, but only at a level to achieve the minimum threshold of 45 points this year and 50 in 2021. With so little upside, it’s impossible to make a business case to aim for the stars.
Perhaps the biggest change in 2021, however, is that the program is not making the previously planned switch to MIPS Value Pathways (MVPs). MVPs were designed to align the four performance categories around a specialty, medical condition, or patient population.
CMS introduced MVPs by giving an example of diabetes: “Endocrinologist reports same ‘foundation’ of PI [promoting interoperability] and population health measures as all other clinicians but now has a MIPS Value Pathway with measures and activities that focus on diabetes prevention and treatment.” CMS had expected MVPs to launch in 2021 for all program participants; because of the pandemic, CMS announced an extension for at least 1 year. This comes as a relief to physicians who are just trying to keep the lights on given the financial pressures brought on by the pandemic.
MVPs, however, will be incorporated into the MIPS Alternative Payment Model (APM) participation segment. This will affect many physicians because this is the path that accountable care organizations (ACOs) have taken. If you are part of an ACO and you report through it, you’ll see some more changes than your colleagues in 2021.
The good news is that ACOs that participate in MIPS and the Medicare Shared Savings Program will have to report only once to satisfy the requirements for both programs. The construct for this new APM-based program is called the “APM Performance Pathway.” This pathway incorporates six population health–based measures that cross-cut specialties.
CMS is also proposing that telemedicine reimbursement will become permanent. As of now, telemedicine services will only be paid when a public health emergency has been declared. This ability to reimburse physicians for telemedicine would end when the current public health emergency is over. CMS is proposing to extend reimbursement beyond the pandemic, which will benefit all physicians who perform these remote encounters.
The CMS proposal would also make some other requirements easier to achieve. The use of codes 99495 and 99496 – the transitional care management codes – is expanding by reducing several key accompanying-services restrictions. Before the public health emergency, there were constraints related to scope of practice; the proposal would extend the ability of advanced practice providers to order diagnostic tests, even after the public health emergency ends.
Furthermore, the proposal reduces restrictions related to billing for remote physiologic monitoring services and outlines the possibility of a new, higher-paying virtual visit code.
Although the Quality Payment Program will undergo some changes, they are minor. Be aware of the requirement to hit the 50-point mark to avoid the steep penalties, however. Perhaps greater benefit will be achieved through the government’s continued push to refine the reimbursement system. As a result of budget neutrality, however, these changes will boost some physicians while resulting in losses for others.
The government’s proposed changes are not final, and there is a period during which they are accepting comments on the proposal; the final rule will be announced in November.
If you want to wash your hands of this now, apply for the 2020 performance year hardship for the Quality Payment Program. The application is now open and available through December 31, 2020; completing it will release you of any program requirements in 2020 (and avoid that hefty 9% penalty on your 2022 reimbursement).
This way, you won’t have to concern yourself with any of these rules until next year; the government’s extension of this “get out of jail free” card is a welcome relief for physicians who are frustrated by the regulatory burdens despite the pressure exerted by COVID. Spending 15 minutes to complete this form is well worth your time and may eliminate much of your worry.
A version of this article originally appeared on Medscape.com.
Amid all the chaos and problems caused by COVID-19, one might hope that physicians would get a break on their complicated payment-reporting programs.
But that’s not the case: The government recently released the 2021 proposed rule for the Quality Payment Program (QPP), often referred to by its most popular participation track, the Merit-Based Incentive Payment System (MIPS). The program, which launched in 2017, gets annual updates, and this year is no different.
Some good news has made primary care and some other physicians happy.
The government’s proposal includes significant changes to reimbursement for all physicians.
Specialties that rely heavily on office-based E/M services are delighted at this change. Those include internists, family physicians, neurologists, pulmonologists, dermatologists, and all other specialties that rely heavily on office encounters.
According to the estimates from the Centers for Medicare & Medicaid Services (CMS), endocrinologists and rheumatologists are the big winners, at 17% and 16% projected increases, respectively. The government has been pushing to make this shift in reimbursement from surgeries and procedures to office visits for years. Although some physicians may celebrate the change, others will not.
The reimbursement plan for professional services depends on budget neutrality, meaning that the budget increases need to be counterbalanced by budget declines. Specialties that rely heavily on procedures and surgeries will suffer losses. These corresponding reductions felt by proceduralists and surgeons will counterbalance the good fortune of physicians who rely on office visits for the bulk of their revenue. Radiologists, for example, are projected by CMS to experience a 11% downturn, and cardiac surgeons face a 9% decline.
These consequences are significant. The 2021 shift may be the single biggest transfer of reimbursement in the history of the scale, which was adopted in the early 1990s.
If the change affected only Medicare reimbursement, perhaps it would be less significant. Because the majority of private payers use the government’s scale – the resource-based relative value scale – the impact will reverberate across physicians’ bottom lines. Given the state of many physicians’ finances, driven by the pandemic, this may send some affected physicians into a downward spiral.
The boost to E/M reimbursement – which represents approximately 20% of the overall Medicare payout to physicians each year – puts downward pressure on the professional services conversion factor as well.
For 2021, it is proposed to be $32.2605, representing a decrease of $3.83 from the 2020 conversion factor of $36.0896. The resultant conversion factor – which serves as a multiplier applied to the relative value unit to come up with the payment – effectively reduces payments to physicians across the board by 10.6%. Thus, even those who enjoy the benefits of the new E/M increases will see the potential reimbursement high point cut down.
Before launching into the changes in store for 2021, it’s good to determine whether you are an eligible clinician: You need to have more than $90,000 in Medicare Part B charges per year, see more than 200 Medicare Part B patients per year, and provide 200 or more covered professional services to Part B patients.
The program is voluntary, but there are steep penalties for eligible clinicians who don’t participate. For the 2021 reporting year, a 9% penalty will be imposed on Medicare reimbursement in 2023 in the event of participation failure. You can verify your participation status here; you’ll need your National Provider Identifier to run the search, but it takes only seconds to determine your eligibility.
A 9% penalty is a pretty big hit to your income. With 9% at stake, eligible clinicians need to actively engage in the program. Although there have been changes, the basic four-category system remains the same for the MIPS track, as follows: quality, cost, improvement activities, and promoting interoperability.
The four category weights, used to evaluate performance, are changing in 2021. Cost category weight goes up by 5 percentage points, to be 20% of the clinician’s score, and the quality category goes down by 5 percentage points to contribute 40% to the weight. Promoting interoperability remains 25% of the score, with improvement activities constituting the final 15%.
Other key changes include the following:
- The CMS’s Web interface for submission for quality measures will be shuttered in 2021. Users of this submission method will have to find and use another way to report their quality measures.
- Quality measures will be scored against pre-COVID benchmarks in lieu of comparisons with the 2020 reporting year; 206 quality measures are proposed for 2021, compared with the current list of 219.
- Telehealth will be incorporated in the cost category by updates to the measure specifications for the episode-based and total per capita cost measures.
- A new health information exchange measure is added to the promoting interoperability category, and “incorporating” replaces “reconciling” in the reporting requirement “Support Electronic Referral Loops by Receiving and Incorporating Health Information.”
To avoid the 9% penalty, eligible clinicians must earn 50 points in 2021, up from 45 in the current year. Achieving “exceptional performance” remains at 85 points. This elevated level of engagement allows access to a pot of money Congress set aside for high performers.
Many physicians feel that too much work is required to earn the “paltry” bonuses; even a perfect score of 100 has only resulted in bonuses of 1.88% and 1.68%, respectively, in the past 2 years. That includes the $500 million allocation that Congress set aside; this extra funding to reward exceptional performance is only available for the first 6 years of the law. Although the 2019 scores have been released to participants, CMS has not yet announced the overall national average, but it’s expected to be minimal.
The combination of meager payouts and a diminishing funding mechanism has physicians questioning participation altogether. My recent conversations with physicians who qualify for the program revealed their intention to participate, but only at a level to achieve the minimum threshold of 45 points this year and 50 in 2021. With so little upside, it’s impossible to make a business case to aim for the stars.
Perhaps the biggest change in 2021, however, is that the program is not making the previously planned switch to MIPS Value Pathways (MVPs). MVPs were designed to align the four performance categories around a specialty, medical condition, or patient population.
CMS introduced MVPs by giving an example of diabetes: “Endocrinologist reports same ‘foundation’ of PI [promoting interoperability] and population health measures as all other clinicians but now has a MIPS Value Pathway with measures and activities that focus on diabetes prevention and treatment.” CMS had expected MVPs to launch in 2021 for all program participants; because of the pandemic, CMS announced an extension for at least 1 year. This comes as a relief to physicians who are just trying to keep the lights on given the financial pressures brought on by the pandemic.
MVPs, however, will be incorporated into the MIPS Alternative Payment Model (APM) participation segment. This will affect many physicians because this is the path that accountable care organizations (ACOs) have taken. If you are part of an ACO and you report through it, you’ll see some more changes than your colleagues in 2021.
The good news is that ACOs that participate in MIPS and the Medicare Shared Savings Program will have to report only once to satisfy the requirements for both programs. The construct for this new APM-based program is called the “APM Performance Pathway.” This pathway incorporates six population health–based measures that cross-cut specialties.
CMS is also proposing that telemedicine reimbursement will become permanent. As of now, telemedicine services will only be paid when a public health emergency has been declared. This ability to reimburse physicians for telemedicine would end when the current public health emergency is over. CMS is proposing to extend reimbursement beyond the pandemic, which will benefit all physicians who perform these remote encounters.
The CMS proposal would also make some other requirements easier to achieve. The use of codes 99495 and 99496 – the transitional care management codes – is expanding by reducing several key accompanying-services restrictions. Before the public health emergency, there were constraints related to scope of practice; the proposal would extend the ability of advanced practice providers to order diagnostic tests, even after the public health emergency ends.
Furthermore, the proposal reduces restrictions related to billing for remote physiologic monitoring services and outlines the possibility of a new, higher-paying virtual visit code.
Although the Quality Payment Program will undergo some changes, they are minor. Be aware of the requirement to hit the 50-point mark to avoid the steep penalties, however. Perhaps greater benefit will be achieved through the government’s continued push to refine the reimbursement system. As a result of budget neutrality, however, these changes will boost some physicians while resulting in losses for others.
The government’s proposed changes are not final, and there is a period during which they are accepting comments on the proposal; the final rule will be announced in November.
If you want to wash your hands of this now, apply for the 2020 performance year hardship for the Quality Payment Program. The application is now open and available through December 31, 2020; completing it will release you of any program requirements in 2020 (and avoid that hefty 9% penalty on your 2022 reimbursement).
This way, you won’t have to concern yourself with any of these rules until next year; the government’s extension of this “get out of jail free” card is a welcome relief for physicians who are frustrated by the regulatory burdens despite the pressure exerted by COVID. Spending 15 minutes to complete this form is well worth your time and may eliminate much of your worry.
A version of this article originally appeared on Medscape.com.
Amid all the chaos and problems caused by COVID-19, one might hope that physicians would get a break on their complicated payment-reporting programs.
But that’s not the case: The government recently released the 2021 proposed rule for the Quality Payment Program (QPP), often referred to by its most popular participation track, the Merit-Based Incentive Payment System (MIPS). The program, which launched in 2017, gets annual updates, and this year is no different.
Some good news has made primary care and some other physicians happy.
The government’s proposal includes significant changes to reimbursement for all physicians.
Specialties that rely heavily on office-based E/M services are delighted at this change. Those include internists, family physicians, neurologists, pulmonologists, dermatologists, and all other specialties that rely heavily on office encounters.
According to the estimates from the Centers for Medicare & Medicaid Services (CMS), endocrinologists and rheumatologists are the big winners, at 17% and 16% projected increases, respectively. The government has been pushing to make this shift in reimbursement from surgeries and procedures to office visits for years. Although some physicians may celebrate the change, others will not.
The reimbursement plan for professional services depends on budget neutrality, meaning that the budget increases need to be counterbalanced by budget declines. Specialties that rely heavily on procedures and surgeries will suffer losses. These corresponding reductions felt by proceduralists and surgeons will counterbalance the good fortune of physicians who rely on office visits for the bulk of their revenue. Radiologists, for example, are projected by CMS to experience a 11% downturn, and cardiac surgeons face a 9% decline.
These consequences are significant. The 2021 shift may be the single biggest transfer of reimbursement in the history of the scale, which was adopted in the early 1990s.
If the change affected only Medicare reimbursement, perhaps it would be less significant. Because the majority of private payers use the government’s scale – the resource-based relative value scale – the impact will reverberate across physicians’ bottom lines. Given the state of many physicians’ finances, driven by the pandemic, this may send some affected physicians into a downward spiral.
The boost to E/M reimbursement – which represents approximately 20% of the overall Medicare payout to physicians each year – puts downward pressure on the professional services conversion factor as well.
For 2021, it is proposed to be $32.2605, representing a decrease of $3.83 from the 2020 conversion factor of $36.0896. The resultant conversion factor – which serves as a multiplier applied to the relative value unit to come up with the payment – effectively reduces payments to physicians across the board by 10.6%. Thus, even those who enjoy the benefits of the new E/M increases will see the potential reimbursement high point cut down.
Before launching into the changes in store for 2021, it’s good to determine whether you are an eligible clinician: You need to have more than $90,000 in Medicare Part B charges per year, see more than 200 Medicare Part B patients per year, and provide 200 or more covered professional services to Part B patients.
The program is voluntary, but there are steep penalties for eligible clinicians who don’t participate. For the 2021 reporting year, a 9% penalty will be imposed on Medicare reimbursement in 2023 in the event of participation failure. You can verify your participation status here; you’ll need your National Provider Identifier to run the search, but it takes only seconds to determine your eligibility.
A 9% penalty is a pretty big hit to your income. With 9% at stake, eligible clinicians need to actively engage in the program. Although there have been changes, the basic four-category system remains the same for the MIPS track, as follows: quality, cost, improvement activities, and promoting interoperability.
The four category weights, used to evaluate performance, are changing in 2021. Cost category weight goes up by 5 percentage points, to be 20% of the clinician’s score, and the quality category goes down by 5 percentage points to contribute 40% to the weight. Promoting interoperability remains 25% of the score, with improvement activities constituting the final 15%.
Other key changes include the following:
- The CMS’s Web interface for submission for quality measures will be shuttered in 2021. Users of this submission method will have to find and use another way to report their quality measures.
- Quality measures will be scored against pre-COVID benchmarks in lieu of comparisons with the 2020 reporting year; 206 quality measures are proposed for 2021, compared with the current list of 219.
- Telehealth will be incorporated in the cost category by updates to the measure specifications for the episode-based and total per capita cost measures.
- A new health information exchange measure is added to the promoting interoperability category, and “incorporating” replaces “reconciling” in the reporting requirement “Support Electronic Referral Loops by Receiving and Incorporating Health Information.”
To avoid the 9% penalty, eligible clinicians must earn 50 points in 2021, up from 45 in the current year. Achieving “exceptional performance” remains at 85 points. This elevated level of engagement allows access to a pot of money Congress set aside for high performers.
Many physicians feel that too much work is required to earn the “paltry” bonuses; even a perfect score of 100 has only resulted in bonuses of 1.88% and 1.68%, respectively, in the past 2 years. That includes the $500 million allocation that Congress set aside; this extra funding to reward exceptional performance is only available for the first 6 years of the law. Although the 2019 scores have been released to participants, CMS has not yet announced the overall national average, but it’s expected to be minimal.
The combination of meager payouts and a diminishing funding mechanism has physicians questioning participation altogether. My recent conversations with physicians who qualify for the program revealed their intention to participate, but only at a level to achieve the minimum threshold of 45 points this year and 50 in 2021. With so little upside, it’s impossible to make a business case to aim for the stars.
Perhaps the biggest change in 2021, however, is that the program is not making the previously planned switch to MIPS Value Pathways (MVPs). MVPs were designed to align the four performance categories around a specialty, medical condition, or patient population.
CMS introduced MVPs by giving an example of diabetes: “Endocrinologist reports same ‘foundation’ of PI [promoting interoperability] and population health measures as all other clinicians but now has a MIPS Value Pathway with measures and activities that focus on diabetes prevention and treatment.” CMS had expected MVPs to launch in 2021 for all program participants; because of the pandemic, CMS announced an extension for at least 1 year. This comes as a relief to physicians who are just trying to keep the lights on given the financial pressures brought on by the pandemic.
MVPs, however, will be incorporated into the MIPS Alternative Payment Model (APM) participation segment. This will affect many physicians because this is the path that accountable care organizations (ACOs) have taken. If you are part of an ACO and you report through it, you’ll see some more changes than your colleagues in 2021.
The good news is that ACOs that participate in MIPS and the Medicare Shared Savings Program will have to report only once to satisfy the requirements for both programs. The construct for this new APM-based program is called the “APM Performance Pathway.” This pathway incorporates six population health–based measures that cross-cut specialties.
CMS is also proposing that telemedicine reimbursement will become permanent. As of now, telemedicine services will only be paid when a public health emergency has been declared. This ability to reimburse physicians for telemedicine would end when the current public health emergency is over. CMS is proposing to extend reimbursement beyond the pandemic, which will benefit all physicians who perform these remote encounters.
The CMS proposal would also make some other requirements easier to achieve. The use of codes 99495 and 99496 – the transitional care management codes – is expanding by reducing several key accompanying-services restrictions. Before the public health emergency, there were constraints related to scope of practice; the proposal would extend the ability of advanced practice providers to order diagnostic tests, even after the public health emergency ends.
Furthermore, the proposal reduces restrictions related to billing for remote physiologic monitoring services and outlines the possibility of a new, higher-paying virtual visit code.
Although the Quality Payment Program will undergo some changes, they are minor. Be aware of the requirement to hit the 50-point mark to avoid the steep penalties, however. Perhaps greater benefit will be achieved through the government’s continued push to refine the reimbursement system. As a result of budget neutrality, however, these changes will boost some physicians while resulting in losses for others.
The government’s proposed changes are not final, and there is a period during which they are accepting comments on the proposal; the final rule will be announced in November.
If you want to wash your hands of this now, apply for the 2020 performance year hardship for the Quality Payment Program. The application is now open and available through December 31, 2020; completing it will release you of any program requirements in 2020 (and avoid that hefty 9% penalty on your 2022 reimbursement).
This way, you won’t have to concern yourself with any of these rules until next year; the government’s extension of this “get out of jail free” card is a welcome relief for physicians who are frustrated by the regulatory burdens despite the pressure exerted by COVID. Spending 15 minutes to complete this form is well worth your time and may eliminate much of your worry.
A version of this article originally appeared on Medscape.com.
Wildfires’ toxic air leaves damage long after the smoke clears
When researchers arrived in Seeley Lake, Mont., a town tucked in the northern Rockies, 3 years ago, they could still smell the smoke a day after it cleared from devastating wildfires. Their plan was to chart how long it took for people to recover from living for 7 weeks surrounded by relentless smoke.
They still don’t know, because most residents haven’t recovered. In fact, they’ve gotten worse.
Forest fires had funneled hazardous air into Seeley Lake, a town of fewer than 2,000 people, for 49 days. The air quality was so bad that on some days the monitoring stations couldn’t measure the extent of the pollution. The intensity of the smoke and the length of time residents had been trapped in it were unprecedented, prompting county officials to issue their first evacuation orders because of smoke, not fire risk.
Many people stayed. That made Seeley Lake an ideal place to track the long-term health of people inundated by wildfire pollution.
So far, researchers have found that people’s lung capacity declined in the first 2 years after the smoke cleared. Chris Migliaccio, PhD, an immunologist with the University of Montana, Missoula, and associates found the percentage of residents whose lung function sank below normal thresholds more than doubled in the first year after the fire and remained low a year after that.
“There’s something wrong there,” Dr. Migliaccio said.
While it’s long been known that smoke can be dangerous when in the thick of it – triggering asthma attacks, cardiac arrests, hospitalizations and more – the Seeley Lake research confirmed what public health experts feared: Wildfire haze can have consequences long after it’s gone.
That doesn’t bode well for the 78 million people in the western United States now confronting historic wildfires.
Toxic air from fires has blanketed California and the Pacific Northwest for weeks now, causing some of the world’s worst air quality. California fires have burned roughly 2.3 million acres so far this year, and the wildfire season isn’t over yet. Oregon estimates 500,000 people in the state have been under a notice to either prepare to evacuate or leave. Smoke from the West Coast blazes has drifted as far away as Europe.
Extreme wildfires are predicted to become a regular occurrence because of climate change. And, as more people increasingly settle in fire-prone places, the risks increase. That’s shifted wildfires from being a perennial reality for rural mountain towns to becoming an annual threat for areas across the West.
Perry Hystad, PhD, an associate professor at Oregon State University, Corvallis, said the Seeley Lake research offers unique insights into wildfire smoke’s impact, which until recently had largely been unexplored. He said similar studies are likely to follow because of this fire season.
“This is the question that everybody is asking,” Dr. Hystad said. “‘I’ve been sitting in smoke for 2 weeks, how concerned should I be?’”
Dr. Migliaccio wants to know whether the lung damage he saw in Seeley Lake is reversible – or even treatable. (Think of an inhaler for asthma or other medication that prevents swollen airways.)
But those discoveries will have to wait. The team hasn’t been able to return to Seeley Lake this year because of the coronavirus pandemic.
Dr. Migliaccio said more research is needed on whether wildfire smoke damages organs besides the lungs, and whether routine exposure makes people more susceptible to diseases.
The combination of the fire season and the pandemic has spurred other questions as well, like whether heavy smoke exposure could lead to more COVID-19 deaths. A recent study showed a spike in influenza cases following major fire seasons.
“Now you have the combination of flu season and COVID and the wildfires,” Dr. Migliaccio said. “How are all these things going to interact come late fall or winter?”
A case study
Seeley Lake has long known smoke. It sits in a narrow valley between vast stretches of thick forests.
On a recent September day, Boyd Gossard stood on his back porch and pointed toward the mountains that were ablaze in 2017.
Mr. Gossard, 80, expects to have some summer days veiled in haze. But that year, he said, he could hardly see his neighbor’s house a few hundred feet away.
“I’ve seen a lot of smoke in my career,” said Mr. Gossard, who worked in timber management and served as a wildland firefighter. “But having to just live in it like this was very different. It got to you after a while.”
When Missoula County health officials urged people to leave town and flee the hazardous smoke, many residents stayed close to home. Some said their jobs wouldn’t let them leave. Others didn’t have a place to go – or the money to get there.
Health officials warned those who stayed to avoid exercising and breathing too hard, to remain inside, and to follow steps to make their homes as smoke free as possible. The health department also worked to get air filters to those who needed them most.
But when flames got too close, some people had to sleep outside in campsites on the other side of town.
Understanding the science of smoke
One of the known dangers of smoke is particulate matter. Smaller than the width of a human hair, it can bypass a body’s defenses, lodging deep into lungs. Lu Hu, PhD, an atmospheric chemist with the University of Montana, said air quality reports are based on how much of that pollution is in the air.
“It’s like lead; there’s no safe level, but still we have a safety measure for what’s allowable,” Dr. Hu said. “Some things kill you fast and some things kill you slowly.”
While air quality measurements can gauge the overall amount of pollution, they can’t assess which specific toxins people are inhaling. Dr. Hu is collaborating with other scientists to better predict how smoke travels and what pollutants people actually breathe.
He said smoke’s chemistry changes based on how far it travels and what’s burning, among other factors.
Over the past few years, teams of researchers drove trucks along fire lines to collect smoke samples. Other scientists boarded cargo planes and flew into smoke plumes to take samples right from a fire’s source. Still others stationed at a mountain lookout captured smoke drifting in from nearby fires. And ground-level machines at a Missoula site logged data over 2 summers.
Bob Yokelson, PhD, a longtime smoke researcher with the University of Montana, said scientists are getting closer to understanding its contents. And, he said, “it’s not all bad news.”
Temperature and sunlight can change some pollutants over time. Some dangerous particles seem to disappear. But others, such as ozone, can increase as smoke ages.
Dr. Yokelson said scientists are still a long way from determining a safe level of exposure to the hundred-odd pollutants in smoke.
“We can complete the circle by measuring not only what’s in smoke, but measuring what’s happening to the people who breathe it,” Dr. Yokelson said. “That’s where the future of health research on smoke is going to go.”
Coping with nowhere to flee
In the meantime, those studying wildland smoke hope what they’ve learned so far can better prepare people to live in the haze when evacuation isn’t an option.
Joan Wollan, 82, was one of the Seeley Lake study participants. She stayed put during the 2017 fire because her house at the time sat on a border of the evacuation zone. The air made her eyes burn and her husband cough. She ordered air filters to create cleaner air inside her home, which helped.
On a recent day, the air in Mrs. Wollan’s new neighborhood in Missoula turned that familiar gray-orange as traces of fires from elsewhere appeared. Local health officials warned that western Montana could get hit by some of the worst air quality the state had seen since those 2017 fires.
If it got bad enough, Mrs. Wollan said, she’d get the filters out of storage or look for a way to get to cleaner air – “if there is someplace in Montana that isn’t smoky.”
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
When researchers arrived in Seeley Lake, Mont., a town tucked in the northern Rockies, 3 years ago, they could still smell the smoke a day after it cleared from devastating wildfires. Their plan was to chart how long it took for people to recover from living for 7 weeks surrounded by relentless smoke.
They still don’t know, because most residents haven’t recovered. In fact, they’ve gotten worse.
Forest fires had funneled hazardous air into Seeley Lake, a town of fewer than 2,000 people, for 49 days. The air quality was so bad that on some days the monitoring stations couldn’t measure the extent of the pollution. The intensity of the smoke and the length of time residents had been trapped in it were unprecedented, prompting county officials to issue their first evacuation orders because of smoke, not fire risk.
Many people stayed. That made Seeley Lake an ideal place to track the long-term health of people inundated by wildfire pollution.
So far, researchers have found that people’s lung capacity declined in the first 2 years after the smoke cleared. Chris Migliaccio, PhD, an immunologist with the University of Montana, Missoula, and associates found the percentage of residents whose lung function sank below normal thresholds more than doubled in the first year after the fire and remained low a year after that.
“There’s something wrong there,” Dr. Migliaccio said.
While it’s long been known that smoke can be dangerous when in the thick of it – triggering asthma attacks, cardiac arrests, hospitalizations and more – the Seeley Lake research confirmed what public health experts feared: Wildfire haze can have consequences long after it’s gone.
That doesn’t bode well for the 78 million people in the western United States now confronting historic wildfires.
Toxic air from fires has blanketed California and the Pacific Northwest for weeks now, causing some of the world’s worst air quality. California fires have burned roughly 2.3 million acres so far this year, and the wildfire season isn’t over yet. Oregon estimates 500,000 people in the state have been under a notice to either prepare to evacuate or leave. Smoke from the West Coast blazes has drifted as far away as Europe.
Extreme wildfires are predicted to become a regular occurrence because of climate change. And, as more people increasingly settle in fire-prone places, the risks increase. That’s shifted wildfires from being a perennial reality for rural mountain towns to becoming an annual threat for areas across the West.
Perry Hystad, PhD, an associate professor at Oregon State University, Corvallis, said the Seeley Lake research offers unique insights into wildfire smoke’s impact, which until recently had largely been unexplored. He said similar studies are likely to follow because of this fire season.
“This is the question that everybody is asking,” Dr. Hystad said. “‘I’ve been sitting in smoke for 2 weeks, how concerned should I be?’”
Dr. Migliaccio wants to know whether the lung damage he saw in Seeley Lake is reversible – or even treatable. (Think of an inhaler for asthma or other medication that prevents swollen airways.)
But those discoveries will have to wait. The team hasn’t been able to return to Seeley Lake this year because of the coronavirus pandemic.
Dr. Migliaccio said more research is needed on whether wildfire smoke damages organs besides the lungs, and whether routine exposure makes people more susceptible to diseases.
The combination of the fire season and the pandemic has spurred other questions as well, like whether heavy smoke exposure could lead to more COVID-19 deaths. A recent study showed a spike in influenza cases following major fire seasons.
“Now you have the combination of flu season and COVID and the wildfires,” Dr. Migliaccio said. “How are all these things going to interact come late fall or winter?”
A case study
Seeley Lake has long known smoke. It sits in a narrow valley between vast stretches of thick forests.
On a recent September day, Boyd Gossard stood on his back porch and pointed toward the mountains that were ablaze in 2017.
Mr. Gossard, 80, expects to have some summer days veiled in haze. But that year, he said, he could hardly see his neighbor’s house a few hundred feet away.
“I’ve seen a lot of smoke in my career,” said Mr. Gossard, who worked in timber management and served as a wildland firefighter. “But having to just live in it like this was very different. It got to you after a while.”
When Missoula County health officials urged people to leave town and flee the hazardous smoke, many residents stayed close to home. Some said their jobs wouldn’t let them leave. Others didn’t have a place to go – or the money to get there.
Health officials warned those who stayed to avoid exercising and breathing too hard, to remain inside, and to follow steps to make their homes as smoke free as possible. The health department also worked to get air filters to those who needed them most.
But when flames got too close, some people had to sleep outside in campsites on the other side of town.
Understanding the science of smoke
One of the known dangers of smoke is particulate matter. Smaller than the width of a human hair, it can bypass a body’s defenses, lodging deep into lungs. Lu Hu, PhD, an atmospheric chemist with the University of Montana, said air quality reports are based on how much of that pollution is in the air.
“It’s like lead; there’s no safe level, but still we have a safety measure for what’s allowable,” Dr. Hu said. “Some things kill you fast and some things kill you slowly.”
While air quality measurements can gauge the overall amount of pollution, they can’t assess which specific toxins people are inhaling. Dr. Hu is collaborating with other scientists to better predict how smoke travels and what pollutants people actually breathe.
He said smoke’s chemistry changes based on how far it travels and what’s burning, among other factors.
Over the past few years, teams of researchers drove trucks along fire lines to collect smoke samples. Other scientists boarded cargo planes and flew into smoke plumes to take samples right from a fire’s source. Still others stationed at a mountain lookout captured smoke drifting in from nearby fires. And ground-level machines at a Missoula site logged data over 2 summers.
Bob Yokelson, PhD, a longtime smoke researcher with the University of Montana, said scientists are getting closer to understanding its contents. And, he said, “it’s not all bad news.”
Temperature and sunlight can change some pollutants over time. Some dangerous particles seem to disappear. But others, such as ozone, can increase as smoke ages.
Dr. Yokelson said scientists are still a long way from determining a safe level of exposure to the hundred-odd pollutants in smoke.
“We can complete the circle by measuring not only what’s in smoke, but measuring what’s happening to the people who breathe it,” Dr. Yokelson said. “That’s where the future of health research on smoke is going to go.”
Coping with nowhere to flee
In the meantime, those studying wildland smoke hope what they’ve learned so far can better prepare people to live in the haze when evacuation isn’t an option.
Joan Wollan, 82, was one of the Seeley Lake study participants. She stayed put during the 2017 fire because her house at the time sat on a border of the evacuation zone. The air made her eyes burn and her husband cough. She ordered air filters to create cleaner air inside her home, which helped.
On a recent day, the air in Mrs. Wollan’s new neighborhood in Missoula turned that familiar gray-orange as traces of fires from elsewhere appeared. Local health officials warned that western Montana could get hit by some of the worst air quality the state had seen since those 2017 fires.
If it got bad enough, Mrs. Wollan said, she’d get the filters out of storage or look for a way to get to cleaner air – “if there is someplace in Montana that isn’t smoky.”
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
When researchers arrived in Seeley Lake, Mont., a town tucked in the northern Rockies, 3 years ago, they could still smell the smoke a day after it cleared from devastating wildfires. Their plan was to chart how long it took for people to recover from living for 7 weeks surrounded by relentless smoke.
They still don’t know, because most residents haven’t recovered. In fact, they’ve gotten worse.
Forest fires had funneled hazardous air into Seeley Lake, a town of fewer than 2,000 people, for 49 days. The air quality was so bad that on some days the monitoring stations couldn’t measure the extent of the pollution. The intensity of the smoke and the length of time residents had been trapped in it were unprecedented, prompting county officials to issue their first evacuation orders because of smoke, not fire risk.
Many people stayed. That made Seeley Lake an ideal place to track the long-term health of people inundated by wildfire pollution.
So far, researchers have found that people’s lung capacity declined in the first 2 years after the smoke cleared. Chris Migliaccio, PhD, an immunologist with the University of Montana, Missoula, and associates found the percentage of residents whose lung function sank below normal thresholds more than doubled in the first year after the fire and remained low a year after that.
“There’s something wrong there,” Dr. Migliaccio said.
While it’s long been known that smoke can be dangerous when in the thick of it – triggering asthma attacks, cardiac arrests, hospitalizations and more – the Seeley Lake research confirmed what public health experts feared: Wildfire haze can have consequences long after it’s gone.
That doesn’t bode well for the 78 million people in the western United States now confronting historic wildfires.
Toxic air from fires has blanketed California and the Pacific Northwest for weeks now, causing some of the world’s worst air quality. California fires have burned roughly 2.3 million acres so far this year, and the wildfire season isn’t over yet. Oregon estimates 500,000 people in the state have been under a notice to either prepare to evacuate or leave. Smoke from the West Coast blazes has drifted as far away as Europe.
Extreme wildfires are predicted to become a regular occurrence because of climate change. And, as more people increasingly settle in fire-prone places, the risks increase. That’s shifted wildfires from being a perennial reality for rural mountain towns to becoming an annual threat for areas across the West.
Perry Hystad, PhD, an associate professor at Oregon State University, Corvallis, said the Seeley Lake research offers unique insights into wildfire smoke’s impact, which until recently had largely been unexplored. He said similar studies are likely to follow because of this fire season.
“This is the question that everybody is asking,” Dr. Hystad said. “‘I’ve been sitting in smoke for 2 weeks, how concerned should I be?’”
Dr. Migliaccio wants to know whether the lung damage he saw in Seeley Lake is reversible – or even treatable. (Think of an inhaler for asthma or other medication that prevents swollen airways.)
But those discoveries will have to wait. The team hasn’t been able to return to Seeley Lake this year because of the coronavirus pandemic.
Dr. Migliaccio said more research is needed on whether wildfire smoke damages organs besides the lungs, and whether routine exposure makes people more susceptible to diseases.
The combination of the fire season and the pandemic has spurred other questions as well, like whether heavy smoke exposure could lead to more COVID-19 deaths. A recent study showed a spike in influenza cases following major fire seasons.
“Now you have the combination of flu season and COVID and the wildfires,” Dr. Migliaccio said. “How are all these things going to interact come late fall or winter?”
A case study
Seeley Lake has long known smoke. It sits in a narrow valley between vast stretches of thick forests.
On a recent September day, Boyd Gossard stood on his back porch and pointed toward the mountains that were ablaze in 2017.
Mr. Gossard, 80, expects to have some summer days veiled in haze. But that year, he said, he could hardly see his neighbor’s house a few hundred feet away.
“I’ve seen a lot of smoke in my career,” said Mr. Gossard, who worked in timber management and served as a wildland firefighter. “But having to just live in it like this was very different. It got to you after a while.”
When Missoula County health officials urged people to leave town and flee the hazardous smoke, many residents stayed close to home. Some said their jobs wouldn’t let them leave. Others didn’t have a place to go – or the money to get there.
Health officials warned those who stayed to avoid exercising and breathing too hard, to remain inside, and to follow steps to make their homes as smoke free as possible. The health department also worked to get air filters to those who needed them most.
But when flames got too close, some people had to sleep outside in campsites on the other side of town.
Understanding the science of smoke
One of the known dangers of smoke is particulate matter. Smaller than the width of a human hair, it can bypass a body’s defenses, lodging deep into lungs. Lu Hu, PhD, an atmospheric chemist with the University of Montana, said air quality reports are based on how much of that pollution is in the air.
“It’s like lead; there’s no safe level, but still we have a safety measure for what’s allowable,” Dr. Hu said. “Some things kill you fast and some things kill you slowly.”
While air quality measurements can gauge the overall amount of pollution, they can’t assess which specific toxins people are inhaling. Dr. Hu is collaborating with other scientists to better predict how smoke travels and what pollutants people actually breathe.
He said smoke’s chemistry changes based on how far it travels and what’s burning, among other factors.
Over the past few years, teams of researchers drove trucks along fire lines to collect smoke samples. Other scientists boarded cargo planes and flew into smoke plumes to take samples right from a fire’s source. Still others stationed at a mountain lookout captured smoke drifting in from nearby fires. And ground-level machines at a Missoula site logged data over 2 summers.
Bob Yokelson, PhD, a longtime smoke researcher with the University of Montana, said scientists are getting closer to understanding its contents. And, he said, “it’s not all bad news.”
Temperature and sunlight can change some pollutants over time. Some dangerous particles seem to disappear. But others, such as ozone, can increase as smoke ages.
Dr. Yokelson said scientists are still a long way from determining a safe level of exposure to the hundred-odd pollutants in smoke.
“We can complete the circle by measuring not only what’s in smoke, but measuring what’s happening to the people who breathe it,” Dr. Yokelson said. “That’s where the future of health research on smoke is going to go.”
Coping with nowhere to flee
In the meantime, those studying wildland smoke hope what they’ve learned so far can better prepare people to live in the haze when evacuation isn’t an option.
Joan Wollan, 82, was one of the Seeley Lake study participants. She stayed put during the 2017 fire because her house at the time sat on a border of the evacuation zone. The air made her eyes burn and her husband cough. She ordered air filters to create cleaner air inside her home, which helped.
On a recent day, the air in Mrs. Wollan’s new neighborhood in Missoula turned that familiar gray-orange as traces of fires from elsewhere appeared. Local health officials warned that western Montana could get hit by some of the worst air quality the state had seen since those 2017 fires.
If it got bad enough, Mrs. Wollan said, she’d get the filters out of storage or look for a way to get to cleaner air – “if there is someplace in Montana that isn’t smoky.”
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
Low vitamin D in COVID-19 predicts ICU admission, poor survival
Having low serum vitamin D levels was an independent risk factor for having symptomatic COVID-19 with respiratory distress requiring admission to intensive care – as opposed to having mild COVID-19 – and for not surviving, in a new study from Italy.
“Our data give strong observational support to previous suggestions that reduced vitamin D levels may favor the appearance of severe respiratory dysfunction and increase the mortality risk in patients affected with COVID-19,” the researchers report.
Luigi Gennari, MD, PhD, Department of Medicine, Surgery, and Neurosciences, University of Siena, Italy, presented these findings during the virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting.
Gennari told Medscape Medical News that this analysis suggests determining vitamin D levels (25 hydroxyvitamin D) in people testing positive for SARS-Cov-2 infection might help predict their risk of severe disease.
However, further research is needed to explore whether vitamin D supplements could prevent the risk of respiratory failure in patients with SARS-Cov-2 infection, he stressed.
In the meantime, Gennari said: “I believe that, particularly in the winter season (when the solar ultraviolet-B (UVB) radiation exposure does not allow the skin to synthesize vitamin D in most countries), the use of vitamin D supplementation and correction of vitamin D deficiency might be of major relevance for the reduction of the clinical burden of the ongoing and future outbreaks of SARS-CoV-2 infection.
Invited to comment, David Meltzer, MD, PhD, chief of hospital medicine at University of Chicago Medicine, Illinois, who was not involved with the study, agrees.
“I think this body of work suggests that people should be taking supplements if they cannot increase sun exposure on a sustained basis,” Meltzer said. “The abstract supports multiple prior findings that suggest that higher vitamin D levels are associated with improved outcomes.”
And JoAnn E. Manson, MD, DrPH, of Harvard Medical School and Brigham and Women’s Hospital, who was not involved with the research but has spoken about the topic in a video report for Medscape, said: “We know from several studies that a low vitamin D level is associated with a higher risk of having COVID-19 and severe illness, but correlation does not prove causation.”
“I think that improving vitamin D status is a promising way to reduce the risk of severe illness, but we need randomized controlled trials to prove cause and effect,” she told Medscape Medical News.
103 patients with severe COVID-19, 52 with mild COVID-19, 206 controls
Gennari said several lines of evidence suggest that vitamin D deficiency might be a risk factor for COVID-19 severity.
Countries with lower average levels of vitamin D or lower UVB radiation exposure have higher COVID-19 mortality, and “demographic groups known to be at higher risk of vitamin D deficiency (such as black individuals, the elderly, nursing home residents, and those with obesity and diabetes) are at high risk of COVID-19 hospitalization/mortality, he noted.
There is a high prevalence of vitamin D deficiency in Italy, where mortality rates from COVID-19 have been particularly high.
To examine the relationship between vitamin D levels and COVID-19 severity/mortality, the researchers studied three groups:
- 103 symptomatic patients with COVID-19 with respiratory insufficiency who were admitted to a Milan hospital from March 9 to April 30.
- 52 patients with mild COVID-19, recruited from patients and staff from a nearby nursing home who had a positive test for COVID-19.
- 206 healthy controls, matched 2:1 with symptomatic patients of the same age, weight, and gender, from 3174 patients who had vitamin D measured during a routine check-up from January to March 2020.
Patients in the hospitalized group had lower mean vitamin D levels (18.2 ng/mL) than those with mild COVID-19 (30.3 ng/mL) or those in the control group (25.4 ng/mL).
Patients with symptomatic versus mild COVID-19 were slightly older and more likely to have at least one comorbidity and less likely to be taking a vitamin D supplement at baseline (30% vs 79%).
Among symptomatic patients, mean vitamin D levels were inversely associated with interleukin (IL)-6 and C-reactive protein, “both of which are a direct expression of the inflammatory status,” Gennari noted.
About half of the hospitalized patients (49) were admitted to a ward and discharged after a mean stay of 16 days (none died).
The other 54 hospitalized patients were admitted to the intensive care unit with severe acute respiratory distress; 38 patients received continuous positive airway pressure (CPAP) and 16 patients received endotracheal intubation.
Of the 54 patients admitted to ICU, 19 patients died from respiratory distress after a mean of 19 days, “consistent with the literature,” and the other 35 patients were discharged after a mean of 21 days.
Patients with severe COVID-19 who were admitted to the ICU, as opposed to a ward, were more likely to be male, have at least one comorbidity, have higher baseline IL-6 levels and neutrophil counts, and lower lymphocyte and platelet counts.
They also had lower mean vitamin D levels (14.4 vs 22.4 ng/mL) and were more likely to have vitamin D deficiency (vitamin D <20 ng/mL; 80% vs. 45%).
Patients admitted to ICU who died had lower baseline vitamin D levels than those who survived (13.2 vs. 19.3 ng/mL).
Vitamin D levels were inversely associated with respiratory distress requiring ICU admission (odds ratio, 1.06; P = .038) and with mortality (OR, 1.18, P = 029), independent of IL-6 levels and other comorbidities.
“That vitamin D levels are associated with improved outcomes independent of IL-6 could reflect that IL-6 is an imperfect measure of the inflammatory process or that vitamin D is related to outcomes for other reasons, such as enhancement of innate or adaptive immunity,” said Meltzer.
He added that “this is not to exclude the possibility that vitamin D has important immunomodulatory effects.”
Gennari, Meltzer, and Manson have reported no relevant financial relationships.
This article first appeared on Medscape.com.
Having low serum vitamin D levels was an independent risk factor for having symptomatic COVID-19 with respiratory distress requiring admission to intensive care – as opposed to having mild COVID-19 – and for not surviving, in a new study from Italy.
“Our data give strong observational support to previous suggestions that reduced vitamin D levels may favor the appearance of severe respiratory dysfunction and increase the mortality risk in patients affected with COVID-19,” the researchers report.
Luigi Gennari, MD, PhD, Department of Medicine, Surgery, and Neurosciences, University of Siena, Italy, presented these findings during the virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting.
Gennari told Medscape Medical News that this analysis suggests determining vitamin D levels (25 hydroxyvitamin D) in people testing positive for SARS-Cov-2 infection might help predict their risk of severe disease.
However, further research is needed to explore whether vitamin D supplements could prevent the risk of respiratory failure in patients with SARS-Cov-2 infection, he stressed.
In the meantime, Gennari said: “I believe that, particularly in the winter season (when the solar ultraviolet-B (UVB) radiation exposure does not allow the skin to synthesize vitamin D in most countries), the use of vitamin D supplementation and correction of vitamin D deficiency might be of major relevance for the reduction of the clinical burden of the ongoing and future outbreaks of SARS-CoV-2 infection.
Invited to comment, David Meltzer, MD, PhD, chief of hospital medicine at University of Chicago Medicine, Illinois, who was not involved with the study, agrees.
“I think this body of work suggests that people should be taking supplements if they cannot increase sun exposure on a sustained basis,” Meltzer said. “The abstract supports multiple prior findings that suggest that higher vitamin D levels are associated with improved outcomes.”
And JoAnn E. Manson, MD, DrPH, of Harvard Medical School and Brigham and Women’s Hospital, who was not involved with the research but has spoken about the topic in a video report for Medscape, said: “We know from several studies that a low vitamin D level is associated with a higher risk of having COVID-19 and severe illness, but correlation does not prove causation.”
“I think that improving vitamin D status is a promising way to reduce the risk of severe illness, but we need randomized controlled trials to prove cause and effect,” she told Medscape Medical News.
103 patients with severe COVID-19, 52 with mild COVID-19, 206 controls
Gennari said several lines of evidence suggest that vitamin D deficiency might be a risk factor for COVID-19 severity.
Countries with lower average levels of vitamin D or lower UVB radiation exposure have higher COVID-19 mortality, and “demographic groups known to be at higher risk of vitamin D deficiency (such as black individuals, the elderly, nursing home residents, and those with obesity and diabetes) are at high risk of COVID-19 hospitalization/mortality, he noted.
There is a high prevalence of vitamin D deficiency in Italy, where mortality rates from COVID-19 have been particularly high.
To examine the relationship between vitamin D levels and COVID-19 severity/mortality, the researchers studied three groups:
- 103 symptomatic patients with COVID-19 with respiratory insufficiency who were admitted to a Milan hospital from March 9 to April 30.
- 52 patients with mild COVID-19, recruited from patients and staff from a nearby nursing home who had a positive test for COVID-19.
- 206 healthy controls, matched 2:1 with symptomatic patients of the same age, weight, and gender, from 3174 patients who had vitamin D measured during a routine check-up from January to March 2020.
Patients in the hospitalized group had lower mean vitamin D levels (18.2 ng/mL) than those with mild COVID-19 (30.3 ng/mL) or those in the control group (25.4 ng/mL).
Patients with symptomatic versus mild COVID-19 were slightly older and more likely to have at least one comorbidity and less likely to be taking a vitamin D supplement at baseline (30% vs 79%).
Among symptomatic patients, mean vitamin D levels were inversely associated with interleukin (IL)-6 and C-reactive protein, “both of which are a direct expression of the inflammatory status,” Gennari noted.
About half of the hospitalized patients (49) were admitted to a ward and discharged after a mean stay of 16 days (none died).
The other 54 hospitalized patients were admitted to the intensive care unit with severe acute respiratory distress; 38 patients received continuous positive airway pressure (CPAP) and 16 patients received endotracheal intubation.
Of the 54 patients admitted to ICU, 19 patients died from respiratory distress after a mean of 19 days, “consistent with the literature,” and the other 35 patients were discharged after a mean of 21 days.
Patients with severe COVID-19 who were admitted to the ICU, as opposed to a ward, were more likely to be male, have at least one comorbidity, have higher baseline IL-6 levels and neutrophil counts, and lower lymphocyte and platelet counts.
They also had lower mean vitamin D levels (14.4 vs 22.4 ng/mL) and were more likely to have vitamin D deficiency (vitamin D <20 ng/mL; 80% vs. 45%).
Patients admitted to ICU who died had lower baseline vitamin D levels than those who survived (13.2 vs. 19.3 ng/mL).
Vitamin D levels were inversely associated with respiratory distress requiring ICU admission (odds ratio, 1.06; P = .038) and with mortality (OR, 1.18, P = 029), independent of IL-6 levels and other comorbidities.
“That vitamin D levels are associated with improved outcomes independent of IL-6 could reflect that IL-6 is an imperfect measure of the inflammatory process or that vitamin D is related to outcomes for other reasons, such as enhancement of innate or adaptive immunity,” said Meltzer.
He added that “this is not to exclude the possibility that vitamin D has important immunomodulatory effects.”
Gennari, Meltzer, and Manson have reported no relevant financial relationships.
This article first appeared on Medscape.com.
Having low serum vitamin D levels was an independent risk factor for having symptomatic COVID-19 with respiratory distress requiring admission to intensive care – as opposed to having mild COVID-19 – and for not surviving, in a new study from Italy.
“Our data give strong observational support to previous suggestions that reduced vitamin D levels may favor the appearance of severe respiratory dysfunction and increase the mortality risk in patients affected with COVID-19,” the researchers report.
Luigi Gennari, MD, PhD, Department of Medicine, Surgery, and Neurosciences, University of Siena, Italy, presented these findings during the virtual American Society of Bone and Mineral Research (ASBMR) 2020 annual meeting.
Gennari told Medscape Medical News that this analysis suggests determining vitamin D levels (25 hydroxyvitamin D) in people testing positive for SARS-Cov-2 infection might help predict their risk of severe disease.
However, further research is needed to explore whether vitamin D supplements could prevent the risk of respiratory failure in patients with SARS-Cov-2 infection, he stressed.
In the meantime, Gennari said: “I believe that, particularly in the winter season (when the solar ultraviolet-B (UVB) radiation exposure does not allow the skin to synthesize vitamin D in most countries), the use of vitamin D supplementation and correction of vitamin D deficiency might be of major relevance for the reduction of the clinical burden of the ongoing and future outbreaks of SARS-CoV-2 infection.
Invited to comment, David Meltzer, MD, PhD, chief of hospital medicine at University of Chicago Medicine, Illinois, who was not involved with the study, agrees.
“I think this body of work suggests that people should be taking supplements if they cannot increase sun exposure on a sustained basis,” Meltzer said. “The abstract supports multiple prior findings that suggest that higher vitamin D levels are associated with improved outcomes.”
And JoAnn E. Manson, MD, DrPH, of Harvard Medical School and Brigham and Women’s Hospital, who was not involved with the research but has spoken about the topic in a video report for Medscape, said: “We know from several studies that a low vitamin D level is associated with a higher risk of having COVID-19 and severe illness, but correlation does not prove causation.”
“I think that improving vitamin D status is a promising way to reduce the risk of severe illness, but we need randomized controlled trials to prove cause and effect,” she told Medscape Medical News.
103 patients with severe COVID-19, 52 with mild COVID-19, 206 controls
Gennari said several lines of evidence suggest that vitamin D deficiency might be a risk factor for COVID-19 severity.
Countries with lower average levels of vitamin D or lower UVB radiation exposure have higher COVID-19 mortality, and “demographic groups known to be at higher risk of vitamin D deficiency (such as black individuals, the elderly, nursing home residents, and those with obesity and diabetes) are at high risk of COVID-19 hospitalization/mortality, he noted.
There is a high prevalence of vitamin D deficiency in Italy, where mortality rates from COVID-19 have been particularly high.
To examine the relationship between vitamin D levels and COVID-19 severity/mortality, the researchers studied three groups:
- 103 symptomatic patients with COVID-19 with respiratory insufficiency who were admitted to a Milan hospital from March 9 to April 30.
- 52 patients with mild COVID-19, recruited from patients and staff from a nearby nursing home who had a positive test for COVID-19.
- 206 healthy controls, matched 2:1 with symptomatic patients of the same age, weight, and gender, from 3174 patients who had vitamin D measured during a routine check-up from January to March 2020.
Patients in the hospitalized group had lower mean vitamin D levels (18.2 ng/mL) than those with mild COVID-19 (30.3 ng/mL) or those in the control group (25.4 ng/mL).
Patients with symptomatic versus mild COVID-19 were slightly older and more likely to have at least one comorbidity and less likely to be taking a vitamin D supplement at baseline (30% vs 79%).
Among symptomatic patients, mean vitamin D levels were inversely associated with interleukin (IL)-6 and C-reactive protein, “both of which are a direct expression of the inflammatory status,” Gennari noted.
About half of the hospitalized patients (49) were admitted to a ward and discharged after a mean stay of 16 days (none died).
The other 54 hospitalized patients were admitted to the intensive care unit with severe acute respiratory distress; 38 patients received continuous positive airway pressure (CPAP) and 16 patients received endotracheal intubation.
Of the 54 patients admitted to ICU, 19 patients died from respiratory distress after a mean of 19 days, “consistent with the literature,” and the other 35 patients were discharged after a mean of 21 days.
Patients with severe COVID-19 who were admitted to the ICU, as opposed to a ward, were more likely to be male, have at least one comorbidity, have higher baseline IL-6 levels and neutrophil counts, and lower lymphocyte and platelet counts.
They also had lower mean vitamin D levels (14.4 vs 22.4 ng/mL) and were more likely to have vitamin D deficiency (vitamin D <20 ng/mL; 80% vs. 45%).
Patients admitted to ICU who died had lower baseline vitamin D levels than those who survived (13.2 vs. 19.3 ng/mL).
Vitamin D levels were inversely associated with respiratory distress requiring ICU admission (odds ratio, 1.06; P = .038) and with mortality (OR, 1.18, P = 029), independent of IL-6 levels and other comorbidities.
“That vitamin D levels are associated with improved outcomes independent of IL-6 could reflect that IL-6 is an imperfect measure of the inflammatory process or that vitamin D is related to outcomes for other reasons, such as enhancement of innate or adaptive immunity,” said Meltzer.
He added that “this is not to exclude the possibility that vitamin D has important immunomodulatory effects.”
Gennari, Meltzer, and Manson have reported no relevant financial relationships.
This article first appeared on Medscape.com.
FROM ASBMR 2020